Home

Biovigilance Component - Department of Health & Hospitals

1. Completing the Incident Reporting Summary data form In the examples provided during this training session cases 1 and 3 do not have high priority Incident process codes and would not require a full incident report unless your facility chose to complete one Case 2 would require a full report because the incident code on the form SC 01 is a high priority code To enter summary data in NHSN select Summary Data Add from the left navigation bar NHSN National Healthcare Safety Network ISD CLFT NHSN1 NHSN Home My Info Contact us Help Log O Logged into Pleasant Valley Hospital ID 10312 as RUBY Facility Pleasant Valley Hospital ID 10312 is following the BV component Hemovigilance Module Blood Product Incidents Reporting Summary Data Mandatory fields marked with Print PDF Form Facility ID 10312 Pleasant Valley Hospital Month January me Year 2009 v Total of of adverse Process code Incident code aie incidents reactions Total Monthly Reports PC Product check in PC 01 Data entry incomplete not performed incorrect SC Sample collection SC 01 Sample labeled with incorrect patient name i i if UM Product manipulation UM 05 Labeling incorrect n Ul Product issue a UI 09 Not checkingj incorrect checking of unit and or patient information 1 Add Row Clear All Rows Any adverse reaction that results from an incident requires a f
2. Line Listing All Adverse Reaction Data Frequency Table All Adverse Reaction Data fillgar Chart All Adverse Reaction Data Pie Chart All Adverse Reaction Data custom Output E February Adverse Reactions Elai Monthly Adverse Reactions Males Once you have modified your report you may want to save the new format as an additional output option Change the output name click on Save As and now it will appear under your Custom Output option Additional Tips about Modified Output Check this box Select a time period or Leave Blank for Cumulative Time Period if you will be running oe Date Variable Beginning Ending the same report v format for any time pE period for example monthly O Enter Date variable Time period at the time you click the Run button Other Options Modify Variables To Display By Clicking Modify List Specify Sort Variables By Clicking Modify List Click Publish if Select Page by variable you want to share this custom output with other users in your facility Run Save Save As Reset l Back lf you want to be queried for the time period at the moment when you run a particular report for example if you run the same report once a month every month check the box to Enter Date variable Time period at the time you click the Run button Click on the Publish button if you want to make your custom output available to all NHSN users with analysis rights in yo
3. Mm Severity DY W Appendix C Severity Grade and Imputability for Adverse Reactions Severity Grade 1 Non Severe e Medical intervention e g symptomatic treatment required but lack of such would not result in permanent damage or impairment of a body function Grade 2 Severe e Inpatient hospitalization or prolongation of hospitalization directly attributable to the event and or o Persistent or significant disability or incapacity o A medical or surgical intervention that is necessary to preclude permanent damage or impairment of a body function Grade 3 Life threatening e Major intervention required following the transfusion vasopressors intubation transfer to intensive care to prevent death Grade 4 Death e The recipient died following an adverse transfusion reaction Note Grade 4 should be used only if death is possibly probably or definitely related to transfusion Ifthe patient died of another cause the severity of the reaction should be graded as 1 2 or 3 as appropriate Severity grade is described in the first part of Appendix C However some reactions are graded within their definition Use the definition grading if available Imputability nce the investigation af the adverse transfusion reaction is completed this is the assessment of the strength of the relationship between the transfusion and the adverse reaction Definite certain Conclusive evidence beyond reasonable doubt that the advers
4. Facility Pleasant Valley Hospital ID 10312 is following the BV component Reporting Plan eian s NHSN Hemovigilance Module Home Page Use the Navigation bar on the left to access the features of the Assurance of Confidentiality The information obtained in this surveillance sy Summary Data of any individual or institution is collected vith a guarantee that it vill be held for the purposes stated and vill not othervise be disclosed or released witho Analysis the institution in accordance with Sections 304 306 and 308 d of the Public 242k and 242m d At the beginning of each month enter a Monthly Reporting Plan to inform CDC of what you will be reporting for the month You can enter several plans at one time If you are not sure whether you have entered a reporting plan click on Find to locate any plans that have been previously entered NHSN National Healthcare Safety Network ISD CLFT NHSN 1 NHSN Home My Info Contact us Help Log Out Logged into Pleasant Valley Hospital ID 10312 as RUBY Facility Pleasant Valley Hospital ID 10312 is following the BV component Add Monthly Reporting Plan Mandatory fields marked with Print PDF Form Facility ID Pleasant Valley Hospital ID 10312 Month January Year 2009 4 C No Biovigilance Modules Followed this Month Hemovigilance Module All reporting is facility wide Copy from Previous Month Adverse transfusion reactions amp all
5. Inadequate rise of post transfusion hemoglobin level or rapid fall in hemoglobin back to pre transfusion levels OR Otherwise unexplained appearance of spherocytes NOTE If performed post transfusion increases in LDH and bilirubin which subsequently falls back to baseline in the following days Probable Newly identified red blood cell alloantibody Possible N A 15 Relationship to Transfusion Imputability Use grades as provided Definite in Appendix C Newly identified red blood cell alloantibody AND Occurs between 24 hours and 28 days after a transfusion AND Positive direct antiglobulin test with identification of a new antibody either in the serum or eluate AND No other explanation for drop in hemoglobin Probable Occurs between 24 hours and 28 days after a transfusion AND No other explanation for drop in hemoglobin AND No confirmation on serologic testing Possible N A NHSN Biovigilance Component protocol C Delayed serologic transfusion reaction DSTR Demonstration of new clinically significant alloantibodies against red blood cells between 24 hours to 28 days after a transfusion despite an adequate hemoglobin response to transfusion that is maintained See Appendix D for common antibodies associated with DSTR Case Definition Criteria Grade Severity Relationship to Transfusion Imputability Signs amp Symptoms Laboratory Radiology Defi
6. LRAPHRBC IRLRAPHRBC Further blood product mapping for only the primary blood product types is shown on this list While compCDCdesc provides detailed mapping of products an additional variable prodT ype has been created that lists a broader category of blood product for example platelets RBCs plasma etc Advanced Options Pathogen data for any reported infections a Unit level Component details from Adverse Reaction forms Advanced Create New custom Option patient level Data coc Defined Output ElLine Listing All Patients Ppathogen level Data ene Defined Output ElLine Listing All AdxRxn Pathogen Data ElFrequency Table All AdvRxn Pathogen Data Gillgar Chart All AdvRxn Pathogen Data pic Chart All AdvRxn Pathogen Data unit level Data rcpc Defined Outpu CPP APF FL A gt gt CAAA AA A There are also some additional output options included in the Advanced section Because pathogen information for infections and blood component details contain more information than can be comfortably viewed in your standard adverse reaction line list the information is available separately Unit level Data Blood Component List m o0 much information to include on the Adverse Reaction line list thcare Safety Network or All Adverse Reaction Unit Data at 9 12 AM VRXNCOMP advRxn hemoCode implicated compCode compCDCDesc productType numUnits unitNumber bloodGroupUnit adminDateTime adminTo
7. shortly after transfusion For the purpose of classification this type of allergic reaction would be graded as 2 severe 3 life threatening or 4 death depending on the course and outcome of the reaction Relationship to Transfusion Imputability Definite No other evidence of environmental drug or dietary risks AND Occurs within 1 2 hours of transfusion Probable Other potential causes in an individual with known susceptibility atopic previous allergic reactions to transfusions AND Occurs within 1 2 hours of transfusion Possible Other likely causes such as medication or exposures but transfusion cannot be ruled out usually a first reaction of this sort AND Occur 2 4 hours after transfusion NHSN Biovigilance Component protocol a A 2 Hemolytic transfusion reaction A reaction where there are clinical and laboratory signs of increased destruction of transfused red blood cells Hemolysis can occur intravascularly or extravascularly and can be immediate acute or delayed A Acute hemolytic transfusion reaction AHTR Rapid destruction of red blood cells immediately after or within 24 hours of a transfusion Clinical and laboratory signs of hemolysis are present No single criterion exists to definitively diagnose this rare disorder See Appendix D for common antibodies associated with AHTR Case Definition Criteria Grade Severity Signs amp Symptoms Laboratory
8. ss Microsoft Access table mdb a Use Export Data Sets if you want to manipulate your NHSN data using other software outside of NHSN This is the first option you see on the Modify screen There are two types of datasets that can be exported These are analysis data sets There are also output data sets i e just contain data of the output option as seen on the previous slides Getting Started Generate data sets m ry modifying reports and charts using different variables as shown in this session m You can t hurt anything by playing with the options available We ve covered a lot of material in this training but getting started in analysis is easy The first thing you should do is generate your data sets Try modifying reports and charts using different variables as we have shown in this session While you may change the appearance of reports in the Analysis section of NHSN previously entered data in patient adverse reaction and incident records remain unchanged In other words you can t hurt anything by playing with the report options O SN What s Next en a Additional analysis features including the ability to calculate rates will be coming soon User feedback on additional reports and analysis features that would be useful is always welcome As more data are input into the Hemovigilance Module additional features such as the ability to calculate rates wil
9. the safety efficacy or quality of blood blood components or plasma derivatives or b the safety of recipients High priority incident An accident or error that has high potential for wrongful transfusion in a recipient This would include sample labeling errors wrong patient collected processing needs not indicated not done misunderstood misinterpreted etc Near miss An incident that is discovered before the start of the transfusion and that could have led to a wrongful transfusion or reaction in a recipient An incident is an accident or error that could lead to an adverse outcome affecting the safety efficacy or quality of blood blood components or plasma derivatives or the safety of recipients A high priority incident in NHSN is an accident or error that has high potential for wrongful transfusion in a recipient This would include sample labeling errors wrong patient collected processing needs not indicated not done misunderstood misinterpreted etc A near miss is an incident that is discovered before the start of the transfusion and that could have led to a transfusion reaction in a recipient Data Collection and Reporting Requirements for Hemovigilance Module v Submit a monthly reporting plan to inform CDC that adverse reactions will be reported for the month and select the reporting method for incidents Adhere to the protocol exactly as described in the NHSN Manual Biovigilance Component Pro
10. your facility used at the time of this event was ISBT 128 or Codabar Required Enter the ISBT 128 or Codabar code for the type of blood product administered Use only the first part of the code that identifies the type of product Enter all components administered during the 24 hour period prior to any acute transfusion reaction If the adverse reaction is a delayed reaction enter the component s determined to be the most likely cause of the reaction based on temporal relationship and clinical judgment In the example label the ISBT 128 code is directly below the bar line and is E0472 Dd T2V00 WASHED RED BLOOD CELLS IRRADIATED From 450 mL Whole Blood Store ai 1 t06 C Note The code you enter into NHSN will be compared to ISBT 128 or Codabar master lists and the associated description will appear on the screen If the code is not found either due to entry error or further processing which changed the code you will receive a warning but will be allowed to save the record of Units Required Enter the total number of units of the component that was administered to the patient as indicated by the component code However if the patient reaction was TRALI GVHD or infection any implicated unit must be entered on a single line so that the unit number can be entered Additional units can be entered on another line Use the worksheet on page 4 to enter additional units or components Unit number Conditionally required If the
11. 27 2009 and Time of discovery will be the time the nurse called the blood bank to tell them of her possible mistake The facility location where the incident was discovered is the Emergency Department The incident discovery was a Human lucky catch based on the nurse s suspicion that she had made an error The point in the process where the incident was first discovered was during sample testing The incident occurred at 1 45 a m when the nurse drew the sample from the patient in the Emergency Department Job function of the worker involved in the incident RNU Registered Nurse Where in the process did the incident first occur SC Sample collection v Incident code SC 01 Sample labeled with incorrect patient name v Incident summary Nurse collecting samples from two patients placed label for one patient on the other patient s sample She called blood bank once L J Select incident result 3 Near miss unplanned recovery Product action Check all that apply Not applicable Product retrieved Product destroyed Product issued but not transfused Product transfused Record other action check all that apply CI Record corrected Floor clinic notified J Attending physician notified Cl Additional testing Patient sample re collected Other Investigation Results Did this incident receive root cause analysis N No Although there are two workers involved in this inci
12. Clicking Modify List Specify Sort Variables By Clicking Modify List Variable Name Label abx_mean NHSN ABX Pooled Mean ABX_pctl10 NHSN ABX 10th Percentile ABX_pctl25 NHSN ABX 25th Percentile ABX_pctl50 NHSN ABX 50th Percentile ABX_pctl75 NHSN ABX 75th Percentile ABX_pctl90 NHSN ABX 90th Percentile ABXCount ABX Incident Count ABXFistulaCount ABX Count Fistula ABXGraftCount ABX Count Graft ABXPCLCount ABX Count Perm Central Line ABXPorCount ABX Count Port ABXRate ABX Rate abxStandards Use ABX Susc Stds abxStart In unit IV Antimicrobial Start ABXTCLCount ABX Count Temp Central Line If you are customizing your reports it s possible that information from the form or screen is not shown on the standard or canned reports we have provided In order to select or change the variables to be shown on a report you need to know the name of the variable In the Modify screen you will see a link titled Print Variable Reference List on the right side under Other Options This contains an alphabetical list of all variables and variable names The use of some variables is limited by output type Changing Title of Reports Output Name can be changed Output Title can be changed H NHSN Home Logged into Pleasant Valley Hospital ID 10312 as RUBY Facility Pleasant Valley Hospital ID 10312 is folloving the BV component Reporting Plan Line Listing Analysis Data Set HVAdvRxn Export Analysis Data Set D G
13. Contact I nformation 1 Access and print required enrollment forms forms already Enroll a facility Enroll Facility Please Select Desired Option Ag Get Adobe Acrobat Reader for PDE files If you have not completed these forms obtain the forms now and complete them before proceeding g BR carta aBsian 4 amp E O Bof Ole E a En Sr Een ES som MA At this time you will see a screen to Enroll a Facility Notice that you are also provided the option at this point to print the survey and contact information forms You should already have those forms completed as we discussed in Slide 7 You ll need the information from those forms to complete the enrollment process so have them handy before you click on Enroll a Facility Enroll your facility B NHSN 1 0 40 Enroll Facility Microsoft Internet Explorer File Edit View Favorites Tools Help Back gt A A Qsearch GaFavorites meda J Aw Sy DH Address https sdn2 cdc gov enapp welcome do activity_key 1145 al A E CD Department of Health and Human Services Centers for Disease Control and Prevention NHSN National Healthcare Safety Network Home Once you have completed your Hemovigilance Access and print required enrollment forms Module Survey and 2 Enroll facility Contact I nformation forms Enroll Facility Please Select Desired Option Nox fobs Get Adobe Acrobat Reader for PDF files Ie wear 4 aise 1 amp F O E o
14. Criteria Centers for Disease Control and Prevention Digital ID Enrollment Step 4 Choose a Challenge Phrase The challenge phrase is a password or phrase that you will need to provide every time you access the CDC Secure Data Network and is also required to revoke your Digital ID For security reasons a challenge phrase must e Be at least 8 characters long e Contain only English letters numbers or any of these characters lt Contain at least one non alphabetic character Not contain your name or any part of your email address Not be a word unless the word is either Broken up by one or more non alphabetic characters Prefixed or suffixed by three or more non alphabetic characters Not contain more than two consecutive repeating characters Contain at least 4 unique characters Challenge phrases are case sensitive so be sure to remember if any letters are capitalized While not required a challenge phrase containing mixed case letters is more secure and we invite you to consider using one N T Challenge Phrase secccees Confirm eeeceeee You are provided with the rules for creating your challenge phrase and given some examples Remember to write it down using the correct case and put it in a secure place After entering and confirming your phrase click on next Need SDN Help WY rr aa CDCHome Search Health Topics A Z f S Centers for Disease Control and Preve
15. E mail Address RFP9 CDC GOV Fax Number User Group Facility Mount Sinai Medical Center 10127 User Rolex ADMIN ASW ADMIN PS ALLRIGHTS HCW ALLRIGHTS PS Sits Rights The Facility Administrator should give the Biovigilance Primary Contact administrative user rights We ll refer to this person as the BV Primary Contact Save and this message will appear se NHSN Home Logged into Mount Sinai Medical Center ID 10127 as MSHEPARD Facility Mount Sinai Medical Center ID 10127 is following the PS component Reporting PI en aa EditUser Rights Event M Users rights saved successfully Procedure Summary Data Analysis Surveys Users Mount Sinai Medi D Add D Find Facility Group Log Out User ID RUBY ID 1102 Facility List s Healthcare Rights iara Personnel Biovigilance i Safety Administrator All Rights User rights are discussed Analyze Data in more detail later Enter Data View Data Once the rights are saved you should see the message that the rights have been saved successfully System notifies BV contact by email From NHSN CDC Sent Fri 212012009 12 42 PM To Phelps Ruby COCICCIDINCRDCIDY CTR Cc Subject Change of status for your Facility The facility administrator for Mount Sinai Medical Center has chosen to start following the Biovigilance component You have been designated as the Primary Contact for that component Since BV contact has also been added as a user an ema
16. F Enter any Not Done Negative Cognate or cross No cognate or cross Not tested for cpa ebayn dr results of reacting antigen present reacting antigen present cognate antigen Investigation Results Donor or unit HLA specificity O O O O O antibody studies if Donor or unit HNA specificity O O Recipient HLA specificity O O O e rfo rm ed O O O Recipient HNA specificity 24 If the adverse reaction meets the definition for transfusion associated graft vs host disease you will be asked whether the patient received any non irradiated blood products in the 2 months preceding the diagnosis For transfusion related acute lung injury or TRALI a table is provided to capture results of donor and recipient antibody studies if performed Although this field is not required if the information is available please provide it Outcome Must be entered in order to save the record a Indicate if the patient died regardless of whether the death was related to the transfusion reaction Follow FDA reporting rules for fatalities Outcome Outcome DEATH Death EIN i v Note deaths attributable to transfusion must be reported to FDA Date of death If recipient died relationship of transfusion to death Patient outcome must be entered in order for you to save the record Indicate if the patient died regardless of whether the death was related to the transfusion Please continue to follow FDA reporting
17. MM DD O Codabar M DD VYYY B IE Facility RB Year Reaction Details is the first section of the Adverse Reaction screen You see also a Link Unlink to Incidents button We will discuss this later in the training Reaction Details m Date and time reaction occurred For acute reactions use date and time indicated on blood transfusion reaction report nursing notes flow sheets etc For delayed reactions use date reaction A documented at the next patient visit or date of test identifying new antibodies For a reaction observed only by the patient use reported date Time may be unknown For example a patient receiving an outpatient transfusion calls and reports symptoms after returning home Date and time reaction occurred are required fields This should be the first time the patient was observed to have a reaction as indicated on the blood transfusion reaction report nursing notes flow sheets etc For delayed reactions use date reaction documented at the next patient visit or date of test identifying new antibodies Time of reaction in those cases may be unknown Reaction Details __ Facility location where reaction occurred Location where the patient was at the time the reaction was first observed and or documented May or may not be where the patient was transfused If a reaction is reported from home or is delayed use the fac
18. Microsoft Internet Explorer gt x Fie Edit View Favorites Tools Help Back gt A A Asearch GFavorites Meda S B7 3 mM 7 BH Address https id1 cde gov certphrase login asp T YPE 33554433 amp REALMOID 06 da66a7 3e efe3 402f bd4a 184523445d66 amp GUID jf gt A SAFER HEALTHIER PEOPLE SDN Support 800 532 9929 770 216 1276 cdcsdn cdc gov Done HAstart Hem i connec I inbox l Pe Mmicroso E Forms Emeroso S0N Ln CDC Home Search Health Topics A Z Secure Data Network WARNING This is a U S Government computer system which may be accessed and used only for official government business by authorized personnel Unauthorized access or use may subject violators to criminal civil and or administrative action There is no right to privacy on this system All information on this computer system may be monitored intercepted recorded read copied and shared by authorized personnel for official purposes including criminal investigations Access or use of this system whether authorized or unauthorized constitutes consent to these terms Title 18 U S C Please enter your challenge phrase PERRO Forgot your shot ll encase Click here 8 ti internet ISB 1 10 PM 48 Here s how you log into NHSN Each time you log into the SDN you will be asked for your challenge phrase Remember that it is case sensitive Click on NHSN Reporting 24 CDC Pu
19. NHSN National Healthcare Safety Network ISD CLFT NHSN1 i NHSN Home Logged into Pleasant Valley Hospital ID 10312 as RUBY Facility Pleasant Valley Hospital ID 10312 is following the BV component Reporting Plan Patient Memberships Incident acetate Groups that have access to this facility s data Summary Data Al Test Group 10318 Sata Analysis Another Test Group 10436 Rights uewp MMS Test Group3 10300 Test Group for Blaine 10288 Grae ueve Users Facility NHSN Home Surveys Enter ID and Password for this facility to join a new group Group ID F Joi Group Joining Password e G HELP D Nominate roup Q Log Out The Facility Administrator manages the Group memberships A facility can be a member of more than one Group as shown on this slide If the facility needs to leave the Group the Facility Administrator would perform this action 1 2 3 4 5 6 Ts 8 Example Facility A has joined a patient safety organization reporting Group As part of the Group s intent to collect data from Group facilities rights must be conferred for the following beginning January 2009 Patient information with identifiers Monthly Reporting Plan Analysis Annual Facility Survey In plan adverse reaction events In plan incident events In plan incident reporting summary data Monthly denominators Now let s look at an example Facility A has joined a patient safety organiz
20. NHSN surveillance methodology used authority and confidentiality for NHSN data entry field requirements data collection and reporting requirements and key terms used in hemovigilance Objectives 2 v The hemovigilance protocol AND accompanying materials v Tables of Instructions v Adverse reaction case definition criteria severity grade and imputability v Blood product codes use in NHSN v Facility Survey v Monthly denominators v Incident codes v Incident form v Blood Product Incidents Reporting Summary data v Adverse Reaction form We will also discuss the materials that are used in the Hemovigilance Module including the protocol tables of instructions case definitions blood product codes annual facility survey monthly denominators incident codes and data reporting forms including the Incident form Blood Product Incidents Reporting Summary Data and Adverse Reaction form National Healthcare Safety Network NHSN is an internet based surveillance system that monitors patient and healthcare personnel safety It integrates surveillance systems previously managed separately in the Division of Healthcare Quality Promotion DHQP National Nosocomial Infections Surveillance system NIN Dialysis Surveillance Network DSN National Surveillance System for Healthcare Workers OENE The National Healthcare Safety Network or NHSN is an internet based surveillance system that monitors patient
21. No Required Use definitions as they appear in Appendix B of 13 the protocol Only one reaction can be reported per form Report the final diagnosis of the reaction after the investigation is complete or if no further information can be obtained Additional information can be added later if necessary Check one of the following Allergic reaction Hemolytic transfusion reaction Acute hemolytic transfusion Check if the recipient experienced an AHTR and indicate reaction AHTR the cause If the recipient experienced a DHTR check and indicate the cause Check if the recipient experienced a DSTR and list the reaction DSTR Cause documented cause of the reaction Febrile non hemolytic transfusion Using the definitions in Appendix B of the protocol check if reaction the recipient experienced a febrile non hemolytic transfusion reaction Hypotensive transfusion reaction Check if the recipient experienced a hypotensive transfusion reaction Do not check if hypotension is a symptom of another more specific and or severe reaction Infection A Indicate the type of Infection Bacterial Viral Other If the recipient was determined to have an infection check the infection type and indicate the organism Follow protocol definitions in Appendix B paying specific attention Blood culture performed on Conditionally required Check whether or not a culture unit was performed on the unit that was administered to the If Y
22. Radiology Clinical or laboratory signs of hemolysis Definitive Occurs during immediately after or within 24 hours of transfusion WITH ANY of the following e Chills rigors Fever Back flank pain Hypotension Hemoglobinuria occurring during or shortly after transfusion e Epistaxis e Oliguria anuria e Renal failure e Disseminated intravascular coagulation DIC e Pain and or oozing at IV site AND EITHER ABO incompatibility or other allotypic RBC antigen incompatibility Clerical check indicates that the patient s name and blood group on the blood unit are different than the recipients name and blood group Probable Any combination of clinical features as above Possible N A 03 17 2009 V1 Final Use severity grades as Definitive Positive direct antiglobulin test for anti lgG or anti C3 AND Positive elution test with alloantibody present on the transfused red blood cells AND gt 2 of the following e Elevated LDH Elevated bilirubin Low haptoglobin Hemoglobinuria Low fibrinogen Elevated plasma hemoglobin Probable Incomplete definitive criteria laboratory confirmation Possible N A provided in Appendix C Relationship to Transfusion Imputability Definite Occurs during immediately after or within 24 hours of transfusion AND EITHER There is known ABO or other allotypic RBC antigen incompatibility OR Serologic work up c w AHTR AND No other cause of acute hemolysis
23. Reporting Summary Data CDC 57 302 Required if Incidents Reporting summary data with detailed reporting of high priority incidents is selected as the method of choice on the monthly reporting plan High priority incidents are indicated by a next to the code Detailed incident reports for those resulting in an adverse reaction should be completed regardless of code In addition detailed incident reports can be filed for any incident where additional information is desired regardless of the method of reporting used Be sure to include the detailed reports in your totals on the summary data form Hemovigilance Monthly Reporting Denominators CDC 57 303 Use this form to report monthly denominators that will be used in the calculation of rates See tables of instructions for form completion details Hemovigilance Incident CDC 57 305 Use one form per reported incident See tables of instructions for form completion details Methods Denominators monthly e Number of products transfused e Number of samples collected for type and screen or crossmatch Numerators e Each reported incident e Adverse reactions associated with incidents e High priority incidents e Other form variables as needed Proposed Data Analysis and Output Facilities will be able to generate standard and custom reports In addition certain reports will be generated using information from all participating facilities after the first year of data collection
24. Reporting Plan completing and entering a Hemovigilance Incident form in NHSN Incident result and root cause analysis definitions real case examples completing the Incident Summary data form linking Incidents with Adverse Reactions and finally creating custom fields and labels Key Terms in Hemovigilance Incident Reporting Consistent with International Society of Blood Transfusion ISBT definitions Incident An accident or error that could lead to an adverse outcome affecting a the safety efficacy or quality of blood blood components or plasma derivatives or b the safety of recipients Accident An unexpected or unplanned event not attributable to deviation from standard operating procedures Error An unexpected unplanned deviation from standard operating procedure that is likely attributable to a human or system problem High priority incident An accident or error that has high potential for wrongful transfusion in a recipient This would include sample labeling errors collecting a sample from the wrong patient processing needs not indicated not done misunderstood or misinterpreted Near miss An incident that is discovered before the start of the transfusion and could have led to a wrongful transfusion or reaction in a recipient Our terms are consistent with International Society of Blood Transfusion ISBT definitions An incident is an accident or error that could lead to an adverse outcome affecting a
25. SC 04 Collected in wrong tube type SC 05 Sample QNS SC 06 Sample hemolyzed SC 07 Label incomplete illegible incorrect SC 08 Sample collected in error SC 09 Requisition arrives without samples SC 10 Wristband incorrect or not available SC 11 Sample contaminated You will see that a number of errors are listed that could potentially occur during the process when blood is drawn from the patient for type and crossmatch Each error has a code next to it For example if the sample was drawn from the wrong patient the process or error code would be SCO3 EUGEN adie Categories PC Product check in Products received from outside source Return to inventory from patient care area SR Sample receipt Receipt of sample in transfusion services ST Sample testing Testing of sample type amp crossmatch US Product storage Storage of blood and blood products in Transfusion Services AV Available for issue Quality management of product inventory SE Product selection When products are selected for transfusion UM Product manipulation When pooling irradiating dividing thawing and labeling products UI Product issue Issue of blood products from Transfusion Services MS Other As was mentioned in an earlier slide errors can occur in both Transfusion Services and clinical service areas Transfusion Service process points include PC or product check in where products are either received from an outsi
26. Secure Data Network to we apply for a Digital Certificate a nee inser for NHSN Enrollment activity and accessing NHSN enrollment Step 4 Print and complete NHSN enrollment Receive email confirming online and submit enrollment and website consent form Step 5 Print sign and return signed NHSN will activate your facility consent form to NHSN when consent is received Enrollment IS complete Receive NHSN Enrollment NHSN application ready for use Email Access the NHSN application through the SDN by selecting the NHSN Reporting activity This slide depicts the 5 step enrollment process graphically Now let s review each of the steps in detail About NHSN Communication Updates Enrollment Requirements FAQs About Enrollment FAQs About Mandatory Reporting NHSN Security Begin Enrollment Enrollment Training Enrollment Forms Patient Safety Component Healthcare Personnel Resource Library Contact NHSN FAQs About e Enrollment National Healthcare Safety Network step 1 Review and Accept the Rules of Behavior Begin Enrollment Process Enrolling in NHSN is a multiple step process outlined below that is completed by the person designated to serve as the Facility Administrator The steps must be followed in the order listed to ensure a successful enrollment The person designated as the NHSN Facility Administrator is the only person who can enroll a facilit
27. See Possible Clinical criteria for Laboratory criteria Use grades as provided in Appendix C 19 Definite Protocol criterion Definitive OR Probable Probable N A Possible Protocol criterion Possible NHSN Biovigilance Component protocol 6 Transfusion associated circulatory overload TACO Volume infusion that cannot be effectively processed by the recipient either due to high rates and volumes of infusion or underlying cardiac or pulmonary pathology Case Definition Criteria Signs amp Symptoms Definitive Definitive N A Characterized by new onset or exacerbation of gt 3 of the following within 6 hours of transfusion e Acute respiratory distress dyspnea orthopnea cough e Evidence of positive fluid balance e Elevated BNP Brain Natriuretic Peptide e Radiographic evidence of pulmonary edema e Evidence of left heart failure e Elevated CVP central venous pressure Probable N A Probable N A Possible N A Possible N A 03 17 2009 V1 Final Laboratory Radiology Grade Severity Use grades as provided in Appendix C 20 Relationship to Transfusion Imputability Definite Meets definitive protocol criterion and no other cause of volume overload Probable Judgment call by the attending physician Patient received other fluids and transfusion is likely contributory to volume overload Possible For patients with pre existing cardiac insuf
28. Service Housekeeper Infection Control Professional Laundry Staff Maintenance Engineering Morgue Technician Other Ancillary Staff Other First Responder Occupational Health Professional Other Medical Staff Other Technician Therapist 28 PHA PHW PLT PSY RCH RDT RTT STU VOL OTH Pharmacist Public Health Worker Physical Therapist Psychiatric Technician Researcher Radiologic Technologist Respiratory Therapist Tech Other Student Volunteer Other Specify NHSN Biovigilance Component protocol 7 UDC WY T I Appendix F Incident Codes based on MERS TM amp TESS L Product Check In Products Received from Outside Source PC 01 Data entry incomplete not performed incorrect PC 02 Shipment incomplete incorrect PC 03 Product amp paperwork do not match PC 04 Shipped under inappropriate conditions PC 05 Inappropriate return to inventory PC 06 Product confirmation PC 07 Administrative check 2 check LCI Product Test Request Clinical Service PR 01 Order for wrong patient PR 02 Order incorrectly entered on line PR 03 Special needs not indicated on order e g CMV negative auto PR 04 Order not done incomplete incorrect PR 05 Inappropriate incorrect test ordered PR 06 Inappropriate incorrect blood product ordered L Sample Collection Service Collecting Samples SC 01 Sample labeled with incorrect patient name SC 02 Not labeled SC 03 Wrong patient collected SC 04 Collected
29. UM 03 Wrong component selected UM 04 Administrative check at time of manipulation UM 05 Labeling incorrect UM 09 Special processing not done incorrectly Gone SE 11 Special processing noi done Sample Testing for Type Crossmatch ST 01 Data entry incorrecynol performed ST 02 Appropriate sample checks not done ST 03 Computer warning overridden ST 05 Sample tube w incorrect acoassion label ST 07 Sample tubes mixed up ST 09 Sampie tubes mislabeled wrong patient name nurnber ST 12 Patiem testing not performed ST 13 Incorrect testing method chosen ST 14 Testing performed incorectty ST 15 Test result misinterpreted ST 17 ABOURh error caught on final check ST 15 Current amp historical ABOURN don t match ST 19 Additional testing nat performed ST 20 Administrative check at time work Pertormed ST 22 Sample storage incorrecvYinappropriate Product Selection SE 01 Incorrect product component selected SE 02 Oma entry incomplete incorrect SE 03 Not checking incorrect checking of product andor patent information SE 05 Historical fie misinterpreted not checked SE 07 Special processing needs not checked SE 09 Special processing needs not understood or misinterpreted Order Received amp Entered by TX Services __ UM 01 Data entry incomplete OF Incorrect UM 07 Special processing needs not checked UM 08 Special processing needs misunderstoad or misimerpresed Laboratory Equipment ST 10 Eq
30. a digital certificate for the two most common browsers Internet Explorer IE and Netscape Communicator Netscape Digital ID Subscriber Agreement The issuance of Digital IDs through this system is governed by the Verisign Certification Practice Statement CPS By applying for accepting or using a Digital ID through this system you are agreeing to the terms of the Verisign Subscriber Agreement Agreement By clicking the Enrol button below you indicate your acceptance of thi agreement If you do not agree to the terms of this agreement you should not coplete this application process or use the Digital ID After you read Complete terms for the VeriSign CPS and Digital ID Subscriber Agreement can bq fou here Click Enroll To enroll for a CDC Secure Data Network Digital ID click here Enroll qm Questions Go to the Online Help or Contact SDN Support This page last reviewed Mar 14 2003 Done internet B start 4 OEK E connecte inbox m E microsoft b4 whatis t MARE what E secure o i HG 11 18 am After you have read the entire page including the Digital ID Subscriber Agreement click on enroll Complete application for digital certificate Pant D A eras a CDC Home Search Health Topics A Z Centers for Disease Control and Prevention Digital ID Enrollment SAFER HEALTHIER PEOPLE To begin enrollment for a CDC Digital ID complete this enrollment form and click Ne
31. and healthcare personnel safety It integrates surveillance systems that were previously managed separately in CDC s Division of Healthcare Quality Promotion NNIS or the National Nosocomial Infections Surveillance system DSN or the Dialysis Surveillance Network and NaSH or the National Surveillance System for Healthcare Workers Purposes of NHSN Collect data from a sample of U S healthcare facilities to permit valid estimation of the Magnitude of adverse events among patients and healthcare personnel including e Healthcare associated infections e Adverse reactions associated with blood transfusion e Incidents associated with blood transfusion e Blood and body fluid exposures for healthcare personnel m Analyze and report collected data to permit recognition of trends The purposes of NHSN are to collect data from a sample of U S healthcare facilities to permit valid estimation of the magnitude of adverse events among patients and healthcare personnel including healthcare associated infections adverse reactions associated with blood transfusions incidents associated with blood transfusion and blood and body fluid exposures in healthcare personnel Analyzing and reporting these data permits recognition of trends Purposes of NHSN Provide facilities with data that can be used for inter facility comparisons and local quality improvement activities Assist facilities in developing surveillance and analysis methods th
32. cannot save the record if these fields are left blank Items with a karat are conditionally required Conditionally required means that the item is required only if certain other conditions are met For example if you enter an infection as the adverse reaction you will be required to also enter the type of infection and pathogen s Patient ID should be a number that is unique to the patient and can be used across all visits Most facilities use medical record number Patient ID gender and date of birth are required demographics Your facility may also want to collect patient name and race ethnicity In Hemovigilance blood group is also a required field that appears on the Patient screen Adverse Reactions Participating facilities will report monthly Each transfusion associated adverse reaction Date and time of reaction Facility location Signs amp symptoms laboratory results Component and unit details Adverse reaction e Use case definition criteria found in the protocol e Grade of severity e Relationship to transfusion e Outcome REPORT THE REACTION AFTER THE INVESTIGATION IS COMPLETE One reaction per form gt 1 reaction during a single transfusion episode use additional form s Adverse reactions in the transfusion recipient are to be reported every month Date and time of reaction facility location where the reaction was observed signs amp symptoms laboratory component and unit details and type of reac
33. in wrong tube type SC 05 Sample QNS SC 06 Sample hemolyzed SC 07 Label incomplete illegible incorrect other than patient name SC 08 Sample collected in error SC 09 Requisition arrives without samples SC 10 Wristband incorrect not available SC 11 Sample contaminated LJ Sample Handling Service Collecting Samples SH 01 Sample arrives without requisition SH 02 Requisition amp sample label don t match SH 03 Patient ID incorrect illegible on requisition SH 05 No phlebotomist witness identification SH 06 Sample arrives with incorrect requisition SH 07 Patient information other than ID 03 17 2009 V1 Final L Sample Receipt Transfusion Service SR 01 Sample processed in error SR 02 Historical review incorrect not done SR 03 Demographic review data entry incorrect not done SR 04 Sample incorrectly accessioned test product SR 05 Duplicate sample sent L Sample Testing Transfusion Service ST 01 Data entry incorrect not performed ST 02 Appropriate sample checks not done ST 03 Computer warning overridden ST 05 Sample tube w incorrect accession label ST 07 Sample tubes mixed up ST 09 Test tubes mislabeled wrong patient name number ST 10 Equipment problem ST 12 Patient testing not performed ST 13 Incorrect testing method chosen ST 14 Testing performed incorrectly ST 15 Test result misinterpreted ST 16 Inappropriate expired reagents used ST 17 ABO Rh error caught on final check ST 18 Current amp h
34. incidents associated with reactions Required Monthly reporting denominators C Incidents reporting summary data with detailed reporting of high priority incidents OR LJIncidents reporting detailed reports of all incidents This is the NHSN screen of the Monthly Reporting Plan Since adverse reaction reporting and monthly denominators are required for participation in the Hemovigilance Module these fields are auto filled by the system All you have to do is select your reporting method for incidents After entering your information click on Save gre Incident Reporting Complete full report for any incident That results in an adverse reaction of a patient That has a sign next to the codes on the Blood Products Incident Reporting Summary Data form e These are high priority codes i e there is potential for patient harm e Codes are PR 03 SC 01 SC 02 SC 03 SC 07 SC 10 SH 03 ST 03 ST 07 ST 09 UM 07 UM 08 UM 09 UI 06 UT 01 UT 02 Where product reaches the patient even if there is no harm Provide summary data on other errors Clerical or technical function errors that have little likelihood mul of impacting the patient Wa m Required fields are indicated by an asterisk Complete a full report for any incident that results in an adverse reaction in a patient that is a high priority incident or where product reaches the patient even if there is no harm to the patient Provi
35. injury Acute pancreatitis Cardiopulmonary bypass Drug overdose 03 17 2009 V1 Final Grade Severity Laboratory Radiology Definitive Bilateral infiltrates on chest radiograph in Appendix C Probable N A Possible N A 23 Use grades as provided Relationship to Transfusion Imputability If protocol criterion Definitive then relationship is Definite If protocol criterion Possible then relationship is Possible NHSN Biovigilance Component protocol 10 Infection Any infectious organism is available from the pathogen list in NHSN The pathogens in this table appear at the top of the drop down list because 1 they have public health significance for hemovigilance 2 are common blood stream infection pathogens and or 3 are routinely screened in blood donors Bacterial Escherichia coli Cytomegalovirus CMV Babesiosis Creutzfeldt Jakob Klebsiella oxytoca Enterovirus Babesia microti Disease Variant Klebsiella pneumoniae Epstein Barr EBV Chagas vCJD Pseudomonas aeruginosa Hepatitis A Trypanosoma cruzi Serratia marcescens Hepatitis B Malaria Staphylococcus aureus Hepatitis C Plasmodium spp Staphylococcus Human Immunodeficiency Virus 1 epidermidis HIV 1 Staphylococcus Human Immunodeficiency Virus 2 lugdunensis HIV 2 Syphilis Human Parvovirus B 19 Treponema pallidum Human T Cell Lymphotropic or Yersinia enterocolitica leukemia Virus 1 HTLV 1 Human T Cell Lymphotropic
36. involve both active and passive surveillance methods NHSN Surveillance Methodology PATIENT BASED Monitoring patients for adverse reactions of transfusion Educate staff to recognize and report all blood transfusion related events Review patient charts Investigate all reports of blood transfusion related events Discuss with caregivers Patient based surveillance in hemovigilance involves monitoring individual patients for adverse reactions of transfusion Transfusion staff will be expected to provide guidance to patient care staff in identifying and reporting blood transfusion adverse reactions All reports of blood transfusion related events should be investigated to ensure reporting is as complete as possible This may include reviewing patient charts and discussing the event with caregivers NHSN Surveillance Methodology PROSPECTIVE vs RETROSPECTIVE __ Monitoring patients while still in the institution gt RETROSPECTIVE Case finding based solely on chart review after patient discharged Prospective surveillance involves on going monitoring of patients for events while they are still in the institution Retrospective surveillance is case finding that is based on chart review after patient discharge Prospective surveillance is the recommended method of surveillance for hemovigilance NHSN Surveillance Methodology PRIORITY DIRECTED vs COMPREHENSIVE gt PRIORITY DIRECTED Objec
37. is 03 17 2009 V1 Final 10 NHSN Biovigilance Component protocol Z completed Mechanisms for facilities to use the NHSN Hemovigilance Module to help generate FDA required reports are being developed Aggregate analysis and reports could include 1 Incident rates based on numbers of reported incidents per number of samples collected for type and screen or crossmatch 2 High priority incident rates derived from numbers of reported incidents with high priority incident codes per number of samples collected for type and screen or crossmatch 3 Adverse reaction rates derived from number of incidents resulting in adverse reactions per number of samples collected for type and screen or crossmatch Facility level reports 1 Line listing of detailed incidents reported in a time period Includes discovery date time location occurrence date time location event code for where in process the incident first occurred incident result product action other action 2 Custom report of incidents of a particular type for example sample labeling errors 3 Incidents resulting in adverse reactions REFERENCES 1 AABB Survey The 2005 nationwide blood collection and utilization survey report Available at http www aabb org apps docs O5nbcusrpt pdf 2 Eder AF Chambers L Noninfectious complications of blood transfusion Arch Pathol Lab Med 2007 131 708 718 3 Linden JV Wagner K Voytovich AE Sheehan J Transfusion errors in
38. it CDC must receive the signed form within 60 days Step 4 of Enrollment is now complete You will receive an email to confirm enrollment which will include a link to access the Agreement to Participate and Consent form You have 30 days to access this form It will open in pdf format After you have accessed the agreement CDC must receive the signed copy within 60 days i National Healthcare 7 Safety Network Step 5 Print sign and return Agreement to Participate and Consent form to NHSN Step 5 Print sign and return the Agreement to Participate and Consent form to NHSN NS Agreement to Participate and Agreement to Participate and Page 103 7 required for awing We agies co patk lose Inen Nacional Heakncare Sofecy Necwork NHY for Deceme Concrol and Preven COC win cne underscanding crac we candkcominut our atk losin a any cime We understand ecne tg wok none dace are peling collecoed oy cne NHS N for COC In ks rok a t Orevercion agency Purposesat NHSN Pack losdon inche NHSN vefieces cene Individual faciikys needfor nign q adverse evens aasoc laeda kn neaka are delivery and cenel desire co Ourposes of tne NHSN are co Collece daca from a sam ok of neakncare facilities Incne Unked estiman of che magnkude of advere evers among orken Collece daca from asamo of neakncare facilities Incne Unked escinacion of coe sdnerence co oracckes Kno Oo DF assoc kod aesocksced Infeccions H0J1 Colle
39. name Email address JDoe organization org Facility Identifier Please select a facility identifier CMS ID AHAID O VAStation Code O CDC Registration ID O None Selected identifier ID 123456789 NHSN Training Date certify that have completed all of the appropriate required NHSN trainings on 11 01 2007 Now that you have accepted the Rules of Behavior it s time to register You will be asked to complete name and email address of the Facility Administrator and provide a facility identifier number Use either the American Hospital Association AHA ID or CMS provider ID also called HCFA or Medicare number Veterans Affairs hospitals should enter their VA station number The training completion date is the date you completed all of the CDC required trainings for NHSN If you attended a face to face training course you can use that date Otherwise review training sessions such as this one that are on line and enter the date that you completed the last one Once you have completed information on this screen click on save Receive email with instructions for obtaining digital certificate Welcome You are now registered in the National Healthcare Safety Network NHSN In order to begin the NHSN enrollment process you will need to obtain and install a digital certificate onto your computer Enrollment Guide beginning at Step 3 to obtain and install the digital certificate so that you will be able to acces
40. need assistance Thank you A W A a ji National Healthcare ty Network Biovigilance Component Enrolling an Existing NHSN Facility into Biovigilance and Facility Set up SAFER HEALTHIER PEOPLE Welcome to the National Healthcare Safety Network Biovigilance Component training In this session we will cover Enrolling an Existing NHSN Facility into Biovigilance and Facility Set up Describe the role of the Facility Administrator Outline the steps for a facility previously enrolled in NHSN Patient Safety Component to enroll in the Biovigilance Component Once enrolled we will show you how to Add Users Map Facility Locations Provide rules for managing information across components The objectives of this training are to describe the role of the Facility Administrator and outline the steps for a facility previously enrolled in the NHSN Patient Safety Component to enroll in the Biovigilance Component Once your facility is enrolled we will show you how to add users and map facility locations We will also provide you with the rules for managing information across components Facility Administrator Roles Each facility has one Facility Administrator for NHSN User rights are m Each component of NHSN should discussed in more detail later in this have at least one person with suse aaa administrative rights for that component Each active component of NHSN must have a Primary Cont
41. ng isk mom Ser in eodeaal atac lity may sooty for e envolimenc Imo cme NHSN There amp no fee for pack loshon Incne NHSN Assurance af Cantienth lity We furcnes understand cnx as a pack ioar inene NHSN our faciiiky nas osenghvencne Oss urarce of Confkierciaiky 7The Informacion oocsined In cok survelilance sarcen cnc would perm k Memlkacbon of 4 of Ineckucbon amp colecc edwiken a quaranes cnc k lll oe neki In serkete conmkiene Ill o2 cne Ourdoses scaced and wlll noc ccm be oe dEcksed or rebased w Cnour cme comer Individual or cne Insckcucion In accordance wkn Section 334 305 and 308 d of cne Puol Servke dec 62 USC 2420 242m and 242m d Consent The olay comace pesong Ikeed on coe nex page egress chat daca collecoed and sud alll of com okee and acc usme Co cme oest of NE or ner KN bage Teac king Primary Cantact lt As tne Peinacy CORATE Jine comem 00 folly exactly tne sekcoed ovonocok and repo com okre andaccurane dace Ina cimety manner In order co malncsin acche scacus Incne NHSN NHSN Patient Sakty Primary Gontct Person Name Tke Signcure Dene NHSEN Healthcare Personne Safety Primary Contact Person OF differant frare Pablert Safety Privary Contact Name Tre Signxure Dene NHSN Herovigiance Primary Contact Person Name Tr Siqnacuce Official Authorized To Bind This Facility To The Terms Of This Agreement ka coofcrascra As anok bal aucnor Red c
42. order to improve safety and quality Event Discovery Ways of Reporting Errors Complete an incident report or other form unique to your facility Complete a Hemovigilance Incident form C Paper form entered into NHSN N es Report directly into NHSN ENR m Enter information on existing supporting documentation Requisition Pick up slip Laboratory Information System LIS correction record MEET There are several ways of reporting errors Complete an incident report or other form unique to your facility complete a Hemovigilance Incident form using either the paper data collection form or reporting directly into NHSN and entering information on existing documentation such as a requisition pick up slip or Laboratory Information System LIS correction record What Errors to Report Any error that occurs from product receipt to transfusion Near misses and actual events where product is administered to the patient Locations where errors happen Transfusion service Clinical service Errors will be categorized using process codes Report any error that occurs from product receipt to transfusion Report both near misses and actual events where product is administered to the patient Errors can occur in transfusion service departments as well as in clinical service areas Errors will be categorized using process codes Product Delivered from Supplier PC 01 Data entry incoenpiete nat p
43. rules for fatalities associated with blood transfusion Remember that entering information into NHSN does not result in FDA reporting which must be done separately Save the Record Any record or form in NHSN must be saved before exiting You cant exit a record and go back later to finish without saving You can t save a record unless all required fields have been entered a The system will give a warning if you attempt to exit the record without saving Outcome Outcome DEATH Death v Note deaths attributable to transfusion must be reported to FDA Date of death 01 25 2009 If recipient died relationship of transfusion to death DOU Doubtful Custom Fields Comments Saving the record Any record or form in NHSN must be saved before exiting the system You cannot exit a record in the middle of data entry and go back later to finish it without losing the data you entered You cannot save the record unless all required fields have been entered first Since most fields in this form are required this means that essentially you have to complete the entire record before saving Remember that we recommend adverse reaction forms be entered after you have all of your information The system will warn you if you attempt to exit the record without saving Linking Adverse Reactions and Incidents e Use when adverse reaction is the result of an incident Enter incident before the adverse re
44. selecting records for females only As you gain experience modifying reports you may want to refine your report further by using additional selection criteria You can select records meeting certain criteria through the use of operators that are listed here In this example we select only the records where gender female Using Selection Criteria Adverse reaction line list for 2 1 2009 2 28 2009 Selected for gender female National Healthcare Safety Network Adverse Reactions in Females February 2009 Custom title As of April 9 2009 at 10 16 AM Date Range HVADVRXN advRxnDate 02 01 2009 to 02 28 2009 CDC Hours Adverse Component Date Time Adverse Admin Linked Reaction Patient Age At Code Expiration Unit Reaction to Incident Adverse ID ID Reactign Gender Location Description Date Administereg Date Time Reaction 1 Reaction 111 DS1514 O F INMEDCC RBC Red 02 05 2009 02FEB09 10 00 02FEB09 12 12 2 _ FNHTR blood cells 112 DA1234 7T2 F I PLSWARD IRRBC 02 15 2009 O2FEB09 19 13 02FEB09 13 40 Irradiated red blood cells 115 A100 JNORCATH LRRBC 02 10 2009 O2FEB09 11 45 02FEB09 12 12 Leukocyte reduced red blood cells This is an example of the output we generated for February 2009 that shows all adverse reactions for females Notice that it includes our custom title and variable labels Selection Criteria Further details of how to use are contained in the Online HELP Manual
45. that situational or domain specific knowledge or information is transferred to all new or inexperienced staff e Failure relating to the quality and availability of the protocols procedures within the department e g too complicated inaccurate unrealistic absent or poorly presented e Internal management decisions when faced with conflicting demands or objectives Failures resulting from collective approach and its attendant modes of behavior to risks in the investigating organization These are organizational cultural attitudes and behaviors For example if the organizational culture is one where compliance with safety related procedures is low or procedures are not enforced Human e Human failures originating beyond the control and responsibility of the investigating organization This could include individuals in other departments e Inability of an individual to apply their existing knowledge to a novel situation Example a blood bank technologist who is unable to solve a complex antibody identification problem e The incorrect fit between an individual s training or education and a particular task Example expecting a technician to solve the same type of difficult problem as a technologist e A lack of task coordination within a health care team Example an essential task not being performed because everyone thought that someone else had completed the task 03 17 2009 V1 Final 31 NHSN Biovigilance Component protocol e Incorrect or i
46. the safety efficacy or quality of blood blood components or plasma derivatives or b the safety of recipients An accident is defined as an unexpected or unplanned event not attributable to deviation from standard operating procedures while an error is an unexpected unplanned deviation from standard operating procedure that is likely attributable to a human or system problem In NHSN Incident reporting we also have high priority incident reporting A high priority incident is an accident or error that has high potential for wrongful transfusion in a recipient This would include sample labeling errors collecting a sample from the wrong patient special processing needs not indicated not done misunderstood or misinterpreted We define a near miss as an incident that is discovered before the start of the transfusion and could have led to a wrongful transfusion or reaction in a recipient Why Report Errors Needs defined by reported events Customer complaints Reported incidents Audit findings A process improvement identification tool Provides a means to capture track and trend data Measure success of a process improvement initiative Data can be used to promote and support change Compare to peers Use aggregate data to compare yourself with other facilities of similar size and transfusion volume Why report errors Often a facility s needs can be determined by reported events such as custom
47. the specimen was not drawn from J Jones but from B Smith She was looking after both patients and believed she put J Jones label on B Smith s specimen Let s look at a second example On 1 27 2009 a specimen was received in the blood bank at 2 a m with a request for a type and screen for patient J Jones who was in the Emergency Department At the time of receipt the sample and request met all established acceptance criteria and the sample was processed The patient s blood group was A with a negative antibody screen Approximately one hour later the nurse that had drawn J Jones specimen phoned the blood bank tech and asked that the specimen be discarded The nurse was almost positive that the specimen was not drawn from J Jones but from another patient B Smith She was looking after both patients and believed that she had accidentally put J Jones label on B Smith s specimen A FA Case 2 cont At that time the technologist asked that new samples be drawn for both Jones and Smith since no sample had been received at all for Smith Upon receipt and completion of testing the first type A did not match the second type O for patient Jones A third confirmatory specimen was requested for Jones and tested O This confirmed the nurse s suspicion that the first soecimen had been mislabeled At that time the technologist asked that new samples be drawn for both Jones and Smith since no samp
48. the patient SH or sample handling errors involve paperwork accompanying the sample or testing RP is request for pick up or the time the product is requested Finally UT or product administration errors occur at the time the patient is transfused Provide rules for each data field ata Table 3 Instructions for Completion of the Blood Product Incidents Reporting lt Table 4 Instructions for Completion of Monthly Reporting Denominators CDC 57 303 i O FomFiid Instructions for Form Completion Facility ID The NHSN assigned facility ID number will be autoentered i by the computer Table 6 Instructions for Completion of the Hemovigilance Incident Form CDC 57 305 Instructions for Form Completion The NHSWN assigned facility ID number will be autoentered by the computer ncident Autoentered NHS N assigned number Local Incident or Log Optional Your facility Incident report log or other number used locally to track the incident Date of discovery Required Enter the date the incident was discovered This is the earliest date at which the incident was known and should be either the same or later than the date of occurrence It must be a date that falls within the monitoring month Time of discovery Tables of Instructions are located on the NHSN website and include detailed rules for entering each data field Please be sure to refer to these to make sure you correctly understand the context of each quest
49. the total number in each box Indicate the number of adverse reactions associated with an incident if any It is expected that for each adverse reaction listed on this form there will be an associated Adverse Reaction form entered into NHSN High priority codes are indicated by a cross and require a full incident report Case 1 At 8 a m on 1 15 2009 a unit of red cells was being electronically crossmatched for a patient When entering the unit into the laboratory information system LIS the tech noticed that the expiry date in the LIS did not match the date on the unit Upon further investigation it was discovered that the bar code reader had not been used when the product had been checked into inventory 3 days before sometime in the morning resulting in the manual entry of an incorrect expiry date The supervisor was notified and the expiry date of the unit was corrected in the LIS There was no delay in providing blood for the patient as the tech selected another unit rather than waiting for a correction to be made for the first unit Now that we ve gone through the Incident reporting process let s try some real case examples At 8 a m on 1 15 2009 a unit of red cells was being electronically crossmatched for a patient When entering the unit into the laboratory information system or LIS the technician noticed that the expiry date in the LIS did not match the date on the unit Upon further investigation it was discovered
50. within NHSN click on top right of page ation NHSN Home My Info Contact us Help Log Out _ j 4 rot et i a ents g Index Search i Print Page Search FF ca P Welcome to the NHSN Online Manual Safety Component i Bioviglance Component Hemovigilance M 1 Hemoviglance Key Terms eA ae ae i ernier Modde Arrua Faiy aetan relevant to the NHSN application In an effort to ensure st tandardization of data collection and The NHSN Online Manual that guides the NHSN user through the definitions reporting instructions and Fiala a 7 How to Use Selection Criteria Rate Table Medica tons Updated 04 23 7009 Further details and instructions for using selection criteria are contained in the NHSN Online Manual which you can access by clicking on Help in the upper right hand corner of the page Displaying Different Variables 1 Other Options Modify Variables To Display By Clicking Modify List SS Select Variables to include in Line Listing Available Variables Selected Variables advRxnDesc a advRxnOutcome F advRxnToDeathDay bedsize birthWt birthWtCode birthWtCodeDesc bloodGroupUnit compCDC compCode deathDate deathDateYH deathDateY deathDae7Q deathDateYr dob hemoAdvRxnlD patlD ageAtHVAdvRxn gender location compCDCDesc expfreDate adminDate Time aivRxnDate Time AdminT oAdvRxnHrs flinkedIncid1 advRxn protoGradeDesc protoCritDesc protoRela
51. 1 Appropriate monitoring of patient not done UT 12 Floor clinic did not check for existing products in their area UT 13 Labeling problem on unit UT 19 Transfusion protocol not followed CI Other MS 99 NHSN Biovigilance Component protocol Appendix G Incident Reporting Definitions Incident Result 1 No Recovery harm Product was transfused and the patient experienced an adverse reaction 2 No Recovery no harm Product was transfused but the patient did not experience an adverse reaction 3 Near miss unplanned recovery Product was not transfused The incident was discovered ad hoc by accident a human lucky catch etc It was not discovered through formalized facility standard operating procedures or other previously instituted checks and balances 4 Near miss planned recovery Product was not transfused The incident was discovered through standardized processes or barriers built into the system to prevent errors Root Cause Analysis Result s Technical e Technical failures beyond the control and responsibility of the facility e Failure due to poor design of equipment software labels or forms e Correct design but not constructed properly or set up in in accessible areas e Other material defects Organizational e Failure at an organizational level beyond the control and responsibility of the facility or department where the incident occurred e Failure resulting from inadequate measures taken to ensure
52. 6 and 308 d of the Public Health Service Act 42 USC 242b 242k and 242m d AABB provided technical assistance in the development of this hemovigilance module as part of a collaboration with CDC however AABB has no direct access to the data or other information contained in this or any other NHSN module All data collected through this P module are protected by the same information security safeguards that apply to all NHSN modules Advancing Transfusion and Cellular Therapies Worldwide Once you are logged into NHSN and are on the Hemovigilance Module Home Page select Analysis from the left navigation bar If you do not see Analysis in your navigation bar it means that you do not have the rights to perform analysis as described in Slide 2 Contact your NHSN facility administrator or Biovigilance Primary Contact to have the proper rights set up Step 1 Generate Data Sets By generating data sets SAS data sets are created containing individual patient adverse reaction and incident records that have been entered into NHSN up to that moment Must be done prior to selecting Output Options Department of Health and Human Services Centers for Disease Control and Prevention NHSN National Healthcare Safety Network ISD CLFT NHSN1 NHSN Home My Info Conf a NHSN Home Logged into Pleasant Valley Hospital ID 10312 as RUBY Facility Pleasant Valley Hospital ID 10312 is folloving the BV component Reporting Pla
53. AABB provided technical assistance in the development of this hemovigilance module as part of a collaboration with CDC however AABB has no direct access to the data or other information contained in this or any other NHSN module All data collected through this module are protected by the same information security safeguards that E apply to all NHSN modules Advancing Transfusion and Cellular Therapies Worldwide Once you have logged into NHSN through the SDN you will see the Hemovigilance Module home page The menu bar on your left side is referred to as the navigation bar Monthly Reporting Plan Add Monthly Reporting Plan prior to entering any data for the month you plan to report If you are not sure if the plan has been entered use Find to locate any plans previously added You can add plans for more than one month at a time Department of Health and Human Services Centers for Disease Control and Prevention NHSN National Healthcare Safety Network ISD CLFT NHSN1 T NHSN Home pasati nto Pleasant Valley Hospital ID 1 12 as RUBY Fa cility Pleasant Valley Hospita i ID 1 031 ae ollowing the BV component Reporting Plan q mags NHSN Hemovigilance Module Home Page Patient Intiternt Reaction 7 pnb tere The information obtain int Summary Data of ndividu co i 5 tor the pu eleased witho Analysis the institution in acco or di ections 304 3 306 and 308 4 of the Public 242k and 242m d Use th
54. ALLERG CODABARIN 04900 WBDRBC A 02JAN09 21 02 Whole blood derived red blood cells AHTR CODABARIY LRAPHRBC RBCs 1 123456778 10JAN09 09 30 Leukocyte reduced apheresis red blood cells DSTR ISBT128 N E0155 IRWBDRBC 02JAN09 03 33 Irradiated whole blood derived red blood cells FNHTR ISBT128 E0155 IRWBDRBC 02FEB09 10 00 Irradiated whole blood derived red blood cells WBDRBC 02FEB09 13 13 Whole blood derived red blood cells This slide provides an example of unit level data for blood components transfused per patient record Pathogen Data for Infections Under Advanced Options National Healthcare Safety Network Line Listing for All Adverse Reaction Pathogen Data As of April 21 2009 at 8 55 AM Date Range All HVADVRXNCOMP 130 RP2134 INBURNCC IN 137 RP32123 INCARDCC JIN 176 RP3245 INCARDCC IN aa CODABAR 03323 ACBA BABMI SA sc z ACBA BABMI SA CODABAR 04900 ACBA ACB ACBA CODABAR 03311 ACB ACBA 140 DS1314_ INOR 140 081314 CODABAR 03311 CODABAR 03311 N CODABAR 04900 N HEPC emv wnv_ wv wnv CODABAR 04900 HEPC emv fwnv WNV WNV CODABAR 03323 HEPC cas HEPC HEPC CODABAR 03323 N HEPC eas HEPC HEPC CODABAR 04900 ko _ STALU facs CODABAR 03311 N Iko statu acs 121 RP579232 INMEDCC 121 RP579232 INMEDCC 123 RP379923 INBURNUNIT IN WOR N 123 RP379923 INBURNUNIT IN 120 R
55. Adverse Reaction Data Collection and Entry Target Audience a seei Blood transfusion services personnel responsible for collecting and or entering information on blood transfusion recipient adverse reactions lf you will be classifying or identifying adverse reactions you should be familiar with applying the Adverse Reaction Case Definitions as described in the protocol Separate training is provided for these sA You should have completed Training 1 slides Me Biovigilance Component Hemovigilance Overview This training is intended for blood transfusion services personnel who will be collecting and or entering information on blood transfusion recipient adverse reactions If you will be classifying or identifying adverse reactions you must view Adverse Reaction Case Definition Exercises first You should have already completed Training 1 Biovigilance Component Hemovigilance Overview Goals of this Session Provide step by step instructions for entry of Monthly Reporting Plan Adverse Reaction and Denominator forms in NHSN Show how to find an Adverse Reaction previously entered in NHSN Describe how to link incidents and adverse reactions Create custom fields and labels Please be sure to read the protocol Use Tables of Instructions until you are familiar with form field requirements Protocol and instructions are available on the NHSN website http www cdc gov ncidod dhqp nhsn_biovig html The goals
56. Atlanta Developmental Disabilities Surveillance Program 1996 and 2000 Search pe me bet nf ban lth aan ater naita Fae a a El 8 Blocaintranet aaa aw E inbo J Mer F2 ado E nes Amer a Trai cv eeu 7 49 Once you are in the SDN click on NHSN Reporting Hemovigilance Home Page Department of Health and Human Services Centers for Disease Control and Prevention NHSN National Healthcare Safety Network ISD CLFT NHSN1 NHSN Home My Info Contactus Help Log Out Y NHSN Home Logged into Pleasant Valley Hospital ID 10312 as RUBY Facility Pleasant Valley Hospital ID 10312 is folloving the BV component Reporting Plan Patient Incident Reaction Use the Navigation bar on the left to access the features of the application Summary Data Analysis Assurance of Confidentiality The information obtained in this surveillance system that would permit identification of any individual or institution is collected with a guarantee that it vill be held in strict confidence Surveys vill be used only for the purposes stated and will not otherwise be disclosed or released without the consent of Users the individual or the institution in accordance with Sections 304 306 and 308 d of the Public Health Service Act 42 USC 242b 242k and 242m d Facility Group AABB provided technical assistance in the development of this hemovigilance module as part of a collaboration with CDC
57. ES were any culture Conditionally required Check Yes if any culture results i results positive on the unit were positive and indicate up to three Blood culture performed on Required Check whether or not any blood culture was recipient post transfusion performed on the recipient who received the transfusion 1 8 2009 14 Form Field Instructions for Form Completion administered If YES were any culture Conditionally required Check Yes if any culture results results positive for the recipient were positive and indicate up to three Organism organisms identified ARE ad if the recipient experienced post transfusion purpura PTP as defined in Appendix B of the protocol overload TACO using the criterion in Appendix B of the protocol Transfusion associated dyspnea Check if the recipient experienced dyspnea that was not TAD part of a more specific and or severe reaction Transfusion associated graft vs Check if the recipient developed graft vs host disease host disease TA GVHD Has the patient received Conditionally required Indicate if the recipient received any non irradiated blood lany irradiated blood products in the past 2 months product s in the past two months Transfusion related acute lung Using the diagnostic criterion in Appendix B of the injury TRALI protocol indicate whether the recipient experienced a TRALI Antibody studies Optional If antibody studies were performed on the donor performed and
58. HSN1 NHSN Home My Dh NHSN Home Logged into Mount Sinai Medical Center ID 10127 as RUBY k Facility Mount Sinai Medical Center ID 10127 is folloving the BV com Reporting Plan Add Annual Facility Survey Patient Incident Reaction Mandatory fields marked with Tracking Facility ID Mount Sinai Medical Center ID 10127 v Summary Data Analysis Survey year a Surveys Facility Characteristics For all questions use past full calendar year annual statistics Users 1 Ownership si Facility Group B Is your hospital affiliated with a medical school saj Log Out If Yes check type of affiliation MAJOR GRADUATE LIMITED 3 Community setting of facility bi 4 Total beds set up and staffed The first time the BV contact or other BV user with administrative rights logs into the Biovigilance Component the Hemovigilance facility survey will be displayed The survey must be completed before any data can be entered into the Hemovigilance Module Facility Survey Facility Characteristics Bed size Specialty Volume of surgeries Transfusion Services Characteristics Facility areas served Number and specialty of employees Accreditation Samples collected Volume transfused Transfusion Services Computerization Systems used Specimen Handling Which staff handle specimens Patient identification and collection procedures Procedures for type and screen crossmatch Let s
59. Healthcare Personnel Safety Y Biovigilance General D Confer Rights Patient With Identifiers Without Identifiers D Join Monthly Reporting Plan Leave Nominate Log Out Data Analysis J Annual Hemovigilance Facility Survey d m Confer rights to patient data with or without identifiers Identifiers include all patient information including patient name date of birth gender race ethnicity Conferring rights to the Annual Hemovigilance Facility Survey will include facility contact information name address phone and facility type Now let s look at how rights can be conferred to a Group in Biovigilance Confer rights to patient data with or without identifiers Identifiers include all patient information including patient name date of birth gender and race ethnicity so if the Group is going to perform analysis using any of these fields rights will have to be conferred with identifiers Conferring rights to information on the Annual Hemovigilance Facility Survey will include access to facility contact information name address phone and facility type Confer Rights to a Group Biovigilance Component NHSN National Healthcare Safety Network ISD CLFT NHSN1 NHSN Home My Info Contact us Help Loc B NHSN Home Logged into Pleasant Valley Hospital ID 10312 as RUBY Facility Pleasant Valley Hospital ID 10312 is following the BV component Reporting Plan SESE Confer Rights Biovigilance Inci
60. IRLRRBC j AS 1 RED BLOOD CELLS LEUKOCYTES REDUCED DIVIDED ACDA anticoagulant by pheresis Part A or 1 LRRBC 43 1 RED BLOOD CELLS LEUKOCYTES REDUCED DIVIDED ACDA anticoagulant by pheresis Part B or 2 LRRBC 45 1 RED BLOOD CELLS LEUKOCYTES REDUCED DIVIDED ACDA anticoagulant by pheresis Part C or 3 LRRBC 43 1 RED BLOOD CELLS LEUKOCYTES REDUCED DIVIDED ACDA anticoagulant by pheresis Part D or 4 LRRBC 43 1 RED BLOOD CELLS LEUKOCYTES REDUCED DIVIDED ACDA anticoagulant by pheresis Part E or 5 LRRBC 43 1 RED BLOOD CELLS LEUKOCYTES REDUCED DIVIDED ACDA anticoagulant by pheresis Part F or 6 LRRBC 43 1 RED BLOOD CELLS LEUKOCYTES REDUCED DIVIDED ACDA anticoagulant by pheresis Part G or 7 LRRBC 43 1 RED BLOOD CELLS LEUKOCYTES REDUCED DIVIDED ACDA anticoagulant by pheresis Part H or 3 LRRB d i a ho sl ee REDUCED IRRADIA ihe Delememnmmauientyiby poeesia second bag of agiouble Lgpelood TE y ISBT 128 new standard RED BLOOD CELLS CPD 450mL refy RBC RED BLOOD CELLS CPD 450mLrefg Open RBC NHSN mapping RED BLOOD CELLS CPD 450mL refg Open lrradiated IRRBC RED BLOOD CELLS CPD 450mL refg Open irradiated ResLeu lt 5log6 IRLRRBC codes used for RED BLOOD CELLS CPD 450mL refg Open lrradiated Plasma added IRRBC analysis RED BLOOD CELLS CPD 450mL refg Open ResLeu lt 5lag6 LRREC RED BLOOD CELLS CPD 450mL refg Open Albumin added RBC RED BLOOD CELLS CPD 450mL tefg Open Plasma added RBC RED BLOOD CELLS CPD 450mLrefg lr
61. LERG DHTR DSTR FNHTR HTR INF PTP TA GVHD TACO TAD TRALI 0 0 0 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 Oo Plasma 0 0 0 0 0 0 0 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 ooo ooo oo gt Z 1 5 41 gt 70 8 11 8 2 70 24 32 5 41 6 06 03 9 09 i 3 03 27 27 6 06 50 00 100 00 100 00 00 00 50 00 100 00 100 00 WholeBlood 2 0 0 1 0 0 5 41 0 00 0 00 0 00 2 70 0 00 0 00 0 00 0 00 0 00 0 00 0 00 33 33 0 00 0 00 0 00 0 00 0 00 0 00 50 0 0 00 3 1 9 2 Ss J lt 1 2 1 2 70 5 41 2 70 3 03 6 06 3 03 100 00 100 00 100 00 1 0 0 0 Own oo o owo o oO oo oo oo 2 gt gt 1 gt 4 237 3 11 8 4 41 2 70 4 2 70 8 11 100 00 On this slide is an example of a frequency table We ve provided default variables of adverse reaction by blood product type but you can modify using other variables Frequency Table for Incidents National Healthcare Safety Network Frequency Table for All Incident Data As of May 28 2009 at 8 17 AM Date Range All HVINCID Frequency Table of whenOccurDesc by incidResultDesc incidResultDesc Incident Result Description Process Code Description recovery harm no harm unplanned recovery planned recovery Tota We wetiieforine tt a ee O o ee i e S S e S S sermon E S E S S E e S S A e a S S E a a E E e S UT Product administration Ol
62. Log Logged into Pleasant Valley Hospital ID 10312 as RUBY Facility Pleasant Valley Hospital ID 10312 is following the BV component NHSN Hemovigilance Module Home Page Use the Navigation bar on the left to access the features of the application Assurance of Confidentiality The information obtained in this surveillance system that would permit identification of any individual or institution is collected with a quarantee that it will be held in strict confidence will be used only for the purposes stated and will not otherwise be disclosed or released without the consent of Once you have begun reporting adverse reactions you may need to access a record previously entered Use the Find selection on the left navigation bar under Reaction NHSN National Healthcare Safety Network ISD CLFT NHSN1 NHSN Home My Info Contact us Help Log Out Logged into Pleasant Valley Hospital ID 10312 as RUBY Facility Pleasant Valley Hospital ID 10312 is following the BV component Find Reaction e Enter search criteria and click Find Reaction Information Facility ID Pleasant Valley Hospital ID 10312 v Adverse Reaction Patient ID E Last Name First Name Social Security Secondary ID Location Date reaction occurred A screen will come up that will allow you to enter criteria that can narrow your search If no criteria are entered and you click on F
63. Manual Biovigilance Component Protocol Hemovigilance Module Division of Healthcare Quality Promotion National Center for Preparedness Detection and Control of Infectious Diseases Centers for Disease Control and Prevention Atlanta GA USA 03 17 2009 V1 Final 4 NHSN Biovigilance Component protocol BAS Ha ON sacs ape cases Seen cise sete eget re masc ebb mee eee meeeieea E E 3 I Hemovigilance Module cccccccecccsccceecceeceueceuecauecaeeceeseeeceeecueecuecsuecauesauecaeesaeecseecueesueeseueseesseessaeees 4 BUTT eile p ss terete getters am E AEE cies serene andi E E E EE EE E 4 A PY SS CF SAC HOI Ss cece arse sede a EOE aaa aaa aE aee Neni 5 SER eE S S 5 FCI SIS FAS iesire aranean EA OER Ea EEEE A EAA EEEE EE ERAEN RNEER 6 DEON S eoe e r E E EEA E A E EE E E A E E E E EE 6 FO E A E E nandestaesetoepeake baeads T Nig le Cnt E E E ee ee T Proposed Data Analysis and OU QUE sivccscatccsciccancensecnnanedanavanensuaeswnantcevdabesamnauveusinsWulgiaa tac savensndnectwecion T BANCO N a E N E E 8 SETI a E E E E E T 9 FS SIF S10 SENS sorericrrren irere EE A EE E E EE E i 9 DEUDOR ranae E E E E E S E EE 9 FON E A A E E E R an eeernieaees 10 MENOT e A E E E A AA 10 Proposed Data Analysis and Output cccccccc cece seceeeeceeeeeeeeeeeeeeeseeeeeeeeeteeeteeeseeeeeaseeeseeseeeeeeeas 10 Appendix A Signs amp Symptoms Laboratory Definitions cc ccccccccceecceeeeeeeeeeeeeseeeeeeeeseeeeaeeeseeeeaeess 12 A
64. Medical Critical Care Status Active First assign your facility code and label for a location For example your code or how a location is referred to in your facility might be 61East 61East is a Pediatric ICU in your institution That will be your label The code and label are what you use in reporting an event for that location The code and label can be the same but you might want one to be more descriptive than the other Locations Your Code 61EAST Your Label PEDIATRIC ICU CDC Location Description Status Act Next you will map your location code to a CDC Location Description Choose the location type that most closely resembles your facility location This is an important step because it enables CDC to do aggregate analyses across facilities for the same location type in this example pediatric medical critical care units Next you will map your facility location with the corresponding CDC description In our example 61East your Pediatric ICU is mapped to CDC location Pediatric Medical Critical Care When mapping choose the CDC location type that most closely represents the facility you are mapping Mapping locations is important because it allows aggregate analyses across facilities to be performed for the same location type Locations a When you have entered the required Information click Add Ihe following message will appear at the top of the scre
65. Microsoft Internet Explorer l x File Edit View Favorites Tools Help Back 7 gt A A Qsearch GFavorites Pmeda S Ey 3 w 7 ES Address la https iia cde ESAS MISE CAE NE AS htm Go Links R gt CDC Home Search Health Topics A Z al Ope j Cani n f r Disease Control and Prevention Digital ID Enrollment SAFER HEALTHIER PEOPLE SDN Support At this site you may register to become a client of the CDC Secure Data Network SDN Registering to become a client involves two separate but related activities 800 532 9929 770 216 1276 e Obtaining permission to use one or more sensitive CDC information systems cdesdn cdc gov gP y Obtaining and installing a CDC digital certificate You can be granted permission to access a sensitive CDC system only by an authorized representative of that system The registration information you enter in your application pages will be forwarded to the appropriate system representative for approval Obtaining the CDC digital certificate is contingent upon this approval It is expected that if you have proceeded this far you already have some understanding with the CDC program s representative and your request for access is likely to be approved If this is not the case you should stop now and contact the CDC program s representative first to discuss obtaining access System Requirements To obtain a CDC digital certificate and access the CDC Secure Data Network your syst
66. N is comprised of several components Patient Safety Healthcare Personnel Safety Biovigilance and Research and Development Each component can have one or more modules For example the Patient Safety Component has Device Associated Procedure Associated Medication Associated High Risk Inpatient Influenza and Multidrug Resistant and C difficile Associated Disease modules Currently in Biovigilance there is a single module Hemovigilance Therefore the terms biovigilance and hemovigilance are used interchangeably in NHSN Authority and Confidentiality for NHSN Public Health Service Act 42 USC 242b 242k and 242m d Confidentiality Protection Sections 304 306 and 308 d of the PHS Act The information contained in this surveillance system that would permit identification of any individual or institution is collected with a guarantee that it will be held in strict confidence will be used only for the purposes stated and will not be disclosed or released without the consent of the individual or the institution in accordance with Sections 304 306 and 308 d of the Public Health Service Act 42 USC 242b 242k and 242m d Authority and Confidentiality for NHSN is provided through the Public Health Service Act 42 USC 242b 242k and 242m Confidentiality protection states The information contained in this surveillance system that would permit identification of any individual or institution is collected with a gu
67. New York State an analysis of 10 years experience Transfusion 2000 40 1207 1213 03 17 2009 V1 Final 11 NHSN Biovigilance Component protocol Appendix A Signs amp Symptoms Related to Transfusion Reactions Laboratory Definitions Chills rigors A feeling of cold with shivering or shaking and pallor occurring during or within 4 hours of transfusion Dark urine Urine becomes dark or reddish brown Decrease in blood pressure A drop in systolic blood pressure by 2 30 mm Hg during or within 4 hours of the completion of transfusion Diffuse hemorrhage Characterized by diffuse uncontrollable bleeding at puncture sites catheter wounds including hematuria surgical wounds or diffuse mucocutaneous bleeding during or within 4 hours of the completion of transfusion Fever An increase of 2 1 C in temperature over the pre transfusion temperature during or within 4 hours of the completion of the transfusion Hematuria Presence of blood or red blood cells in the urine Hemoglobinemia The presence of free hemoglobin in the blood plasma Hypoxemia Abnormal deficiency in the concentration of oxygen in arterial blood PaOz FiO2 gt 300 mm Hg OR Oxygen saturation is lt 90 on room air Increase in blood pressure A rise in systolic blood pressure by 2 30 mm HG during or within 4 hours of the completion of transfusion Jaundice New onset or worsening of yellow discoloration icterus of the skin or scl
68. O Medium CO Low If YES indicate result of analysis Check all that apply O Technical O Organizational LJ Human O Patient related O Other specify See Appendix G of protocol for definitions Root Cause Analysis Result s Technical e Technical failures beyond the control and responsibility of the facility e Failure due to poor design of equipment software labels or forms e Correct design but not constructed properly or set up in in accessible areas Other material defects Organizational e Failure at an organizational level beyond the control and responsibility of the facility or department where the incident accurred e Failure resulting from inadequate measures taken to ensure that situational or domain specific knowledge or information is transferred to all new or inexperienced staff e Failure relating ta the quality and availability of the protacols procedures within the department fe q too complicated inaccurate unrealistic absent or poorly presented Internal management decisions when faced with conflicting demands or objectives Failures resulting fram collective approach and its attendant modes of behavior to risks in the investigating organization These are organizational cultural attitudes and behaviors For example ifthe organizational culture is one where compliance with safety related procedures is low or procedures are not enforced Human failures originating beyond the control and responsibility of the investiga
69. OCYTES REDUCED DIVIDED ACDA anticoagulant by pheresis Part C or 3 LRRBC AS 1 RED BLOOD CELLS LEUKOCYTES REDUCED DIVIDED ACDA anticoagulant by pheresis Part D or 4 LRRBC AS 1 RED BLOOD CELLS LEUKOCYTES REDUCED DIVIDED ACDA anticoagulant by pheresis Part E or 5 LRRBC AS 1 RED BLOOD CELLS LEUKOCYTES REDUCED DIVIDED ACDA anticoagulant by pheresis Part F or 6 LRRBC AS 1 RED BLOOD CELLS LEUKOCYTES REDUCED DIVIDED ACDA anticoagulant by pheresis Part G or 7 LRRBC AS 1 RED BLOOD CELLS LEUKOCYTES REDUCED DIVIDED ACDA anticoagulant by pheresis Part H or 8 LRRB RED BLOOD CELLS CPD 450mL refg RED BLOOD CELLS CPD 450mL tefg Open RED BLOOD CELLS CPD 450mL refg Open lrradiated RED BLOOD CELLS CPD 450mL refg Open lrradiated ResLeu lt 5log6 RED BLOOD CELLS CPD 450mL refg Open lrradiated Plasma added RED BLOOD CELLS CPD 450mL refg Open ResLeu lt 5log6 RED BLOOD CELLS CPD 450mL refg Open Albumin added RED BLOOD CELLS CPD 450mL tefg Open Plasma added RED BLOOD CELLS CPD 450mL tefg lrradiated RED BLOOD CELLS CPD 450mL refg lrradiated ResLeu lt 5log6 Lae Ap BB PLAAS LEU GATES REDUCED IRRADIA EDCA eerie ere pheresis ites second bag of aggouble tgpmlood a ee RBC icb NHSN mapping IRRBC IRLRRBC codes used for IRRBC reVars NASI LRREC RBC RBC IRRBC IRLRRBC As we discussed in the Hemovigilance Overview training NHSN is set up to allow entry of ISBT 128 or Codabar codes for blood products You must select
70. Oe E a On AA EEEN Ge eOGM sem Select Enroll a Facility Online Facility Enrollment T MHSN 1 0 40 Enroll Facility Microsoft Internet Explorer Fe Edt vew Favorites Toot Hp Back ooa Quen gree Pen F AraM BEE seach we 2 1 Cha Oty Yahoo answers ghGames Shopeng Facility mang Poo Address line 1 Ts Address line 2 PO Address ling 3 Poo City Doo S lt r facility zip code O does not l Main telephone number any of the 3 For each identifier lighadeet W enter the number code or check Not AppTtaphesiiyour facility does identifiers you will not have tha Select Cif AMA ID Not Applicable be instructed to Select T if cms ID Not Applicable contact NHSN for Select T if VA Station Code Not Applicable a number eed CES Eli ge Su ee Sr ete ein fein Enter facility identification information as directed You will be asked to provide AHA ID or CMS ID or VA Station Code Enter one of the ID numbers and select not applicable for the other choices If your facility does not have any of these numbers please contact NHSN for a number at NHSN cdc gov Step 4 Enrollment Now Complete m You will receive an email to confirm enrollment and Be provided a link with which to access the Agreement to Participate and Consent form You have 30 days to access the consent form e Consent form will open in a pdf document Once you have accessed
71. P2379 INBMTSCA IN B B 120 RP2379 INBMTSCA IN 120 RP2379 _ INBMTSCA os ey We Pes le ibs bec Mee A TN The Pathogen Data for Infections list shows results of pathogen testing in donor unit and recipient as entered on the Adverse Reaction form for transfusion associated infections Pathogen Code List a ACBA Acinetobacter baumannii ACBA ADWY Adenovirus ADY BF Bacteroides fragilis BF BURCE Burkholderia cepacia BURCE CA Candida albicans CD Clostridium difficile CF Citrobacter freundii CID Citrobacter diversus CID CMY Cytomegalovirus CMY CNS Staphylococcus coagulase CNS CP Candida parapsilosis CP CT Candida tropicalis CT EA Enterobacter aerogenes EA EC Escherichia coli EC ENC Enterobacter cloacae ENC ENTFM Enterococcus faecium ENTFM ENTFS Enterococcus faecalis ENTFS ENTRO Enterovirus ENTRO FLUA Influenzae A FLUA FLUE Influenzae B FLUB Short pathogen list occurs at top of drop down list in Adverse Reaction screen if reaction infection Long list includes every known pathogen You will become familiar with the codes most often used The pathogen code list in NHSN is extensive To reduce the burden of scrolling through a long list we have what we call the short list This list appears at the top of the pathogen drop down box and in Hemovigilance contains pathogens that are tested for in blood donors or are more commonly seen in transfusion as
72. Plus any two of the following 2 Laboratory evidence that the same recipient was negative for this organism prior to transfusion OR 3 Laboratory evidence of the same organism in other recipients if any from the same donor as the initial case recipient OR 4 Laboratory evidence of the same organism infecting the donor OR 5 Laboratory evidence of the same organism in the recipient unit upon residual testing Possible indeterminate 1 An investigation trigger 2 Information essential for confirming or ruling out a case is missing not available or cannot be obtained 3 Case fails to meet definition for definite probable or ruled out Doubtful or Ruled Out Do not file a report with NHSN 1 Laboratory evidence that the donor is negative for infection OR 2 Laboratory evidence that the recipient had infection with this organism prior to transfusion 03 17 2009 V1 Final 25 NHSN Biovigilance Component protocol Appendix C Severity Grade and Imputability for Adverse Reactions Severity Grade 1 Non Severe e Medical intervention e g symptomatic treatment required but lack of such would not result in permanent damage or impairment of a body function Grade 2 Severe e Inpatient hospitalization or prolongation of hospitalization directly attributable to the event and or o Persistent or significant disability or incapacity OR o A medical or surgical intervention that is necessary to preclude permanent damage or impairment of a bo
73. Probable No serologic evidence AND Blood bank testing usually shows abnormal results but AHTR may also be due to erythrocyte auto antibodies in the recipient Possible Evidence of non immune contributing factors e g mechanical factors inducing hemolysis malfunction of a pump a blood warmer use of hypotonic solutions etc 14 NHSN Biovigilance Component protocol B Delayed hemolytic transfusion reaction DHTR The recipient develops antibody to RBC antigens Usually manifests between 24 hours and 28 days after a transfusion and clinical or biological signs of hemolysis are present See Appendix D for common antibodies associated with DHTR Grade Severity Case Definition Criteria Signs amp Symptoms Clinical or laboratory symptoms Definitive Patient may be asymptomatic or have similar but milder symptoms to AHTR Examples of milder symptoms include NOTE These are NOT required to meet case criteria Chills rigors Fever Jaundice Back flank pain Hypotension Hemoglobinuria hematuria Oliguria anuria Probable Same as above except there is no serologic confirmation of HTR Possible N A 03 17 2009 V1 Final Definitive Positive direct antiglobulin Coombs test AND EITHER Positive elution test with Laboratory Radiology alloantibody present on the transfused red blood cells OR Newly identified red blood cell alloantibody in recipient serum AND EITHER
74. SBT 128 or Codabar master lists and the associated description will appear on the screen If the code is not found either due to entry error or further processing which changed the ISBT code you will receive a warning but will be allowed to save the record Multiple unit If multiple units enter the component code and the total number of units for each kind of product destroyed Note The code you enter into NHSN will be compared to ISBT 128 or Codabar master lists and the associated description will appear on the screen If the code is not found either due to entry error or further processing which changed the ISBT code you will receive a warning but will be allowed to save the record Product issued but not Check if the unit was issued to the patient care area for transfusion but NOT transfused Product transfused If the unit was transfused indicate whether the patient s experienced an adverse reaction as a result of the transfusion If Yes indicate the facility ID number of the patient s Note to link an adverse event with an incident the incident must be entered into NHSN first Required If any other action was performed due to this incident check all that apply If Other is selected briefly describe the action Required Check Yes if a formal documented root cause analysis cause analysis of the incident was performed _ _ _ _ If YES indicate result of analysis Conditionally required If a root c
75. Senices paloi he bdllys cor lahorskey O ves O Wo S How many dedicaed Trretslon Senices seria hew Number of echeical FTEs Oncudirg supenisces Number ofdedicaed prysidan FTEs Humber of MLT Humber ot WT D OS NS III RA R SER ICES IIIS BES SORES PREE ORCI E RE PAREREA PE CERNE ERER ORS SERRER BRS IRS CK 20S GODINI OOK I gt GOD GOH D OOK DIDIA ODA E HOD E IDE D D E KE E K DE E 20D OE DE OO OA gt O D BAERE B85 B88 988 E888 R PRE SEES BEES BOER BE BR ER IR PARSE BIS EEE POOR ROOD WHO HK OD G D E O D D L HOOD GOK WOOHOO KE IK OO OO A A KE HO HOOD baleen artey ariel BR KERRIER BR BORGIR BE BOOGIE S BICC Be SEER Se ee Sumas ae SEES ee Bee Sa RID PIO DOO HON HOD OHIO TOOK MOHD DA 2 GOTH GA OC 2 OOD HOE See A a EAR 8 TA WIRD PAANS DARA SARIN AAR ONE UAT Wk SUSE DOAA SE HE PRE PSEA C000 B byu sy em BBT izecomplian O ves O Wo 10 amp your Trerewusion Seruces Labombkey Acoedied O ves O Wo tyes selectal Pelapply O College ofAmencon Pabologise CAP O AABB Howls your hospl isl sogedi ed Check ore O Tre Jddinicommission O Centers tor Medicare ard Medicaid Senices Do you hae a commillee hal reuews blood ullimton O ves O Wo Tots number ofsamples collected Produc and bid number otud reareteed Check all Pol apply Whole blood denued red blecd cells Unie AlQUOk Aphesis red blood cells Urnie Allquok Whole blood denued plaklelcomceniaes Unik Mihalis your suerage pod sie Apberesis paklek Uni
76. Step 3 Go to SDN to apply for a digital certificate for NHSN Enrollment activity SAFER HEALTHIER PEOPLE Let s look at the process of applying for a digital certificate What is SDN SDN is Secure Data Network Provides security control services to most CDC systems including NHSN e Physical and environmental controls The computer room that houses NHSN is physically secure and environmental controls are used to protect NHSN computing resources from system damage or failure e Network controls SDN is located behind a firewall and is protected by a centralized security gateway proxy server e User Authentication All users must authenticate their identities with digital certificates First what is SDN SDN stands for Secure Data Network It provides the security control services to most CDC systems including NHSN Security controls include physical and environmental that is the computer room that houses NHSN is physically secure and environmental controls are used to protect NHSN computing resources from system damage or failure Network controls include the firewall SDN sits behind that is protected by a centralized security gateway called a proxy server Users must authenticate their identities with digital certificates What is a Digital Certificate f ee P A digital certificate provides an electronic means of proving your identity in order to securely conduct business with NHSN Digital certi
77. TA GVHD the unit number can be left blank Enter the unit expiration date the blood group of the unit and check that it was implicated in the reaction Investigation Results Was a particular unit implicated in the adverse reaction Y Yes Adverse reaction ALLERG Allergic reaction i Case Definition Criteria DEF Definitive v ji Grade NS Non severe v iii Relationship DEF Definite Outcome Outcome NOSEQ Minor or no sequelae v Custom Fields Investigation results Based on the case definition criteria this patient suffered an allergic reaction Select this from the drop down box Since the patient had two symptoms urticaria and pruritis it met the definitive criterion for an allergic reaction Severity grade is 1 non severe since she experienced relief once Diphenhydramine was administered and had no further symptoms The imputability is definite because there were no other known risks and there was a strong temporal relationship between the transfusion and the occurrence of the reaction within 1 2 hours of transfusion For outcome the patient had minor or no sequelae NHSN Home Reporting Plan Patient Incident Reaction B Add 0 Find summary Dat See ler eee Find an Adverse Reaction Department of Health and Human Services Centers for Disease Control and Prevention NHSN National Healthcare Safety Network ISD CLFT NHSN1 NHSN Home My Info Contact us Help
78. This is an example of an incidents frequency table that has been modified to show frequency numbers without row and column percents Bar Chart As of April 9 2009 at 8 52 AM Date Range All HVADVRXN advRxn ALLERG Count 3 Default variables for bar chart are adverse reaction by product type This is a bar chart for adverse reactions The default variables are adverse reaction by product type In this example we are showing the number of allergic reactions by blood product received Pie Chart April 14 2009 at 9 41 AM Date Range All HVADVRXN FREQUENCY of productType Default variables for pie chart are aciFon AHTR aon adverse reaction by a product type 2 50 RBCs 4 100 WholeBiood 2 50 Finally here we have an example of the pie chart The default variables are adverse reaction type and product type transfused with each pie showing a single reaction by percent of product type transfused For example for adverse reaction AHTR or Acute Hemolytic Transfusion Reaction all blood products associated with the reaction were red blood cells or RBCs For allergic reaction 50 of reactions were in patients who received RBCs and 50 in patients who received whole blood Modifying Customizing Output Variable names vs variable labels Changing title of reports Modifying date variables Selecting a time period Using selection criteria Displaying different variables Changing sort order Modifying a pie
79. Yes if adverse events adverse events entered into a including adverse reactions and medical incidents reported to or occurring within your department are entered into a system that is used across your facility as opposed to a system that is maintained entirely within your department 26 Do you use positive patient ID Conditionally required Skip to question 27 if you do not use identification technology for any positive patient ID identification technology Transfusion Services R i hed prin hel ga wom ae required Check Yes if a physician can enter order entry for test requesting orders for laboratory testing directly into the computer system 28 Do you have physician on line Conditionally required Check Yes if a physician can directly order entry for product requesting order blood and blood products through a computer system Transfusion Services Specimens Handling Testing 29 Are the Transfusion Service Required Indicate the frequency with which samples for specimens drawn by a dedicated transfusion services are drawn by dedicated phlebotomy staff phlebotomy team vs patient care area staff or other toe Indicate the type s of labels used for patient used at your facility identification on the sample tube 31 Are phlebotomy staff allowed Required If phlebotomy staff are allowed to manually correct to correct errors in patient name spelling medical record number etc on the specimen identificatio
80. Ziff j National Healthcare Safety Network Biovigilance Component Hemovigilance Overview SAFER HEALTHIER PEOPLE Welcome to the National Healthcare Safety Network Biovigilance Component Hemovigilance Overview Target Audience m his session is designed for hose who will collect and analyze Biovigilance BV Component data or enroll a facility into NHSN to participate in the BV component e NHSN Facility Administrator Biovigilance Hemovigilance Primary Contact e Blood Transfusion Services Staff A facility considering joining NHSN for Biovigilance This session is designed for persons who will collect and analyze Biovigilance Component data or enroll a facility into NHSN to participate in the Biovigilance Component This could include your designated NHSN Facility Administrator Biovigilance or Hemovigilance Primary Contact or other Blood Transfusion Services Staff who will be collecting and reporting data into NHSN If your facility is considering joining NHSN for Biovigilance this session provides a summary of what is required Objectives 1 By the end of this session be familiar with Purposes of NHSN Components of NHSN Surveillance methodology used in NHSN Authority and confidentiality for NHSN Data entry fields in NHSN Data collection and reporting requirements Key terms used in hemovigilance The objectives of this session are to describe the purposes of NHSN the components of
81. a Ooo cells derived Irradiated 3 Leukocyte reduced Irradiated amp leukocyte reduced Apheresis TOTAL Irradiated Leukocyte reduced Irradiated amp leukocyte reduced Platelets Whole blood TOTAL derived Irradiated Leukocyte reduced Irradiated amp leukocyte Monthly Reporting Denominators Form At the end of the reporting month enter your denominators for numbers of units and aliquots transfused in the month for the blood products listed Note that number of units transfused and aliquots transfused should be mutually exclusive Refer to the Tables of Instructions for additional details on completing this information Monthly Reporting Denominators Provide denominators for incident and adverse reaction rates Information from facility survey provides additional denominators and information that can be used in aggregate analysis Department of Health and Human Services Centers for Disease Control and Prevention NHSN National Healthcare Safety Network ISD CLFT NHSN1 NHSN Home My Info Contact u P NHSN Home to nt Valley Hospital ID 10312 as RUBY sant Valley Hospital ID 10312 is following th V Reporting Plan Patient Ad d H Incident Reaction Summary Data D Add D Find Analysis Your monthly reporting denominators provide totals that can be used to calculate incident and adverse reaction rates Information on your Hemovigilance Facility Survey provides additional denom
82. act Let s talk about the role of the Facility Administrator in NHSN Each facility has one Facility Administrator The Facility Administrator should be an individual who has authority in both Patient Safety and Biovigilance if possible Each component of NHSN should have at least one person with administrative user rights for that component Finally each active component of NHSN must have a Primary Contact T Adding a New A Component The NHSN Facility Administrator should add the Primary Contact for the Biovigilance Component The Primary Contact or other primary user should be given administrative user rights for the Biovigilance Component A person cannot obtain a digital certificate until the Biovigilance Primary Contact or other user with administrative rights has added him or her as a user Each user must have his or her own digital certificate Instructions for obtaining a digital certificate are contained in the User Start up Guide Adding a New Component The NHSN Facility Administrator should add the Primary Contact for the Biovigilance Component The Primary Contact or other primary user should be given administrative user rights for the Biovigilance Component Additional users cannot obtain a digital certificate until the Biovigilance Primary Contact or other user with administrative rights has added him or her as a user As you may recall from Training 2 each user MUST have his or her own digital certificate Us
83. action Fields associated with linking Link unlink on Adverse Reaction form Product action on Incident form e If the unit was transfused was a patient reaction associated with this incident If Yes enter patient ID facility assigned ID for that patient e g medical record number Linking adverse reactions and incidents Adverse reactions and incident records are linked when an adverse reaction is the result of an incident Information about how many adverse reactions resulted from an incident or error may be useful to your facility and in aggregate analysis Enter the incident record into NHSN first Fields associated with linking are shown on the next slide Reaction Details Date reaction occurred 01 10 2009 Facility location where reaction occurred Li INHONCSCA IN ACUTE SCA HONC v Time reaction occurred 10 O HH MM i OR Time unknown Link Unlink To Incidents Reaction is Linked Occurrence Date incident occurred 01 10 2009 Where in the facility did the incident occur Time incident occurred 08 00 HH MM NPTCBLOOD NONPTC NA LAB BLOOD X Time approximate Time unknown Job function of the worker involved in the incident CLT Clinical Lab Technician Where in the process did the incident first occur SE Product selection Incident code SE 01 Incorrect product component selected Incident summary Technician took incorrect component off shelf Select
84. action observed in the patient Optional If the recipient died enter the date of death Regardless of whether or not the death was transfusion related Conditionally required If the patient who experienced the reaction died indicate the relationship of the transfusion to death using the relationship descriptions defined in the protocol Optional Up to two date fields and 10 alphanumeric fields that may be customized for local use NOTE Each Custom Field must be set up in the Facility Custom Options section of the application before the field can be selected for use Optional Enter any information about the adverse reaction This information may or may not be analyzed 16 Table 6 Instructions for Completion of the Hemovigilance Incident Form CDC 57 305 eee Instructions for Form Completion Facility ID The NHSN assigned facility ID number will be autoentered by the computer Incident Autoentered NHSN Autoentered NHSN assigned number number s Incident or Log e it Your facility Incident report log or other number used locally to track the incident Discovery Date of discovery Required Enter the date the incident was discovered This is the earliest date at which the incident was known and should be either the same or later than the date of occurrence It must be a date that falls within the monitoring month Required Enter the exact time of discovery using the 24 hour clock Military
85. additional information that may be used in analysis Custom Fields and Labels Facilities have the option of creating custom fields 2 date fields 2numeric fields 10 alphanumeric Comments can be entered but information cannot be used in analysis Hemovigilance Incident M8 No 092 0556 Custom Fields Comments Custom Fields and Labels Facilities have the option of creating custom fields if they are interested in collecting additional information not contained on our forms Two date fields 2 numeric fields and 10 alphanumeric fields can be set up Information in these fields is not used in aggregate analysis but is for individual facility use Custom Field Labels To label custom fields for any existing form select the Form Type and Form from the drop down lists If one of the Summary Data forms is selected it may be customized by location by selecting a value from the Your Location Code drop down list Enter labels for any custom fields you wish to have displayed on the screen Form Type 4 Form v Description D Customize Form Date eee I beo D Facility Info D Add Edit Component Numeric Label 1 l Label 2 Alphanumeric Label 1 Label 2 Label 1 Label 2 To set up custom fields in NHSN select Facility Customize forms on the left navigation bar Follow the instructions on the screen You can create custom fields for the Incident form Adverse Reac
86. adminToAdvRxnHrs linkedincid1 advRxn a ites 1 105 AHTR m Linked Reaction _ ALLERG 105 AHTR Output headers can be shown in one of two ways either by variable name or variable label Variable name is the name of the field as it is stored in the NHSN database Variable label is more familiar and user friendly It is what the user sees on the screen or on the form The default for reports is the variable name To Show Variable Labels Use Modify and check box Use Variable Labels then run the report Line Listing Analysis Data Set HVAdvRxn Export Analysis Data Set Modify Attributes of the Output Last Modified On 04 03 2009 Output Type Line Listing Output Name Line Listing All Adverse Reaction Data Output Title Line Listing for All Adverse Reaction Data Output formats include HTML PDF CSV comma separated value RTF rich text format Select output format Output Format HTN Use Variable Labels si renal To show variable labels go to the Modify screen and under Select output format you will see a check box next to Use Variable Labels Note that you can also select the file format for your output Options include HTML PDF CSV or comma separated value and RTF or rich text format Where to Find Variable Names m Click on Modify m Variables are listed alphabetically Other Options Print Variable Reference List gt Modify Variables To Display By
87. ailable for issue O Product selection O Product manipulation O Request for pick up O Product issue O Product administration O Post transfusion review audit O other specify Let s look at how we would complete an Incident form for the example just given Facility ID and Incident will be auto filled by NHSN on data entry The local incident or Log is the number the institution assigned to the error for example what appeared on the formal incident report or log in the facility The date and time of discovery were the moment the technician noticed the error when entering the unit into the LIS Since none of the descriptions of How the incident was first discovered describe our scenario we will check Other and write a brief description Since the incident was discovered during an electronic crossmatch our point in the process for discovery will be at Sample testing Case 1 Occurrence Date the incident occurred Time the incident occurred Where in the facility did the _01 12_ _ _09_ _00_ HH MM incident occur Time approximate O Time unknown Job function of the worker involved in the incident Use CDC Occupation Type codes on page 5 O If Other specify Where in the process did the incident first occur Check one Product check in O Product test request O Sample collection CO Sample handling O Sample receipt Sample testing O Product storage O Available for issue O Product selection O Product m
88. al Healthcare Safety Network ISD CLFT NHSN1 Y NHSN Home Logged into Pleasant Valley Hospital ID 10312 as RUBY Facility Pleasant Valley Hospital ID 10312 is folloving the BV component Reporting Plan Patient Memberships Incident Microsoft Internet Explorer x Pd The decision to join a group is a decision made by a facility administrator Existence of a group organization in NHSN should not be construed as a recommendation From CDC to join the group CDC cannot be held accountable for how group users use data access granted to the group by a Facility Facuny Group Enter ID and Password for this facility to join a new group Confer Rights Group ID 12345 Leave i Group Joining Password eeeee Nominate bainiziis j i Log Out Once the Facility Administrator clicks on Join Group this message will appear The decision to join a group is a decision made by a facility administrator Existence of a group organization in NHSN should not be construed as a recommendation from CDC to join the group CDC cannot be held accountable for how group users use data access granted to the group by a facility Administrator Confers Rights to a Group NHSN National Healthcare Safety Network ISD CLFT NHSN1 y NHSN Home Logged into Pleasant Valley Hospital ID 10312 as RUBY eee Confer Rights Biovigilance Incident M Please select the rights that group AABB Group should have to facility Pleasant Valley i Hosp
89. ame email address and phone number and then hit the Submit button The new group administrator will be notified when the group has been added and will supply potential member facilities with the information yecessary to join the group including the joining password Create new NHSWN user Administrator f User ID Up to 32 letters and or numbers no spaces or special characters First Name Middle Name Last Name Title Address line ne Address line a Address line m 3 City State l j Zip Code J Phone 404 555 1234 Ext Fax Pager Number E mail jdoe organization com Submit Back Enter information about the Group Administrator Only certain fields are required The name and email address of the Group Administrator are very important and must be entered Once nominated Group Administrator m Receives an email notification from NHSN containing the Group ID and instructions about obtaining a digital certificate f Group Administrator already has a digital certificate will not need a new one Just request a new program activity e Program National Healthcare Safety Network NHSN Activity NHSN Reporting oe NOTE Groups do not enroll Once the Group Administrator has been nominated an email notification will be sent from NHSN that contains the Group ID number and instructions for obtaining a digital certificate If t
90. an and hematologist were notified immediately At 8 45 a m the patient began to experience dyspnea chest pain nausea and developed acute kidney failure with a urine output of 40 mi hr and a rise in creatinine LDH potassium and bilirubin The hemoglobin dropped from 10 7 to 8 3 The patient did not require dialysis and urine output was normal by the next day In the days that followed hydration was maintained at 80 ml hr Ap e renal function continued to improve She was discharged on i Now let s look at one last example This is an incident that resulted in an adverse reaction in a patient At 8 30 a m on 1 8 2009 the blood bank discovered that a wrong unit may have been issued to patient B Thomas The technologist called the ICU and asked the nurse to check the identification of two units that had been issued for patient B Thomas One of the bags issued had the name and hospital number of another patient with the same last name The patient had already received the incorrect unit starting at 4 55 a m that day The attending physician and hematologist were notified immediately At 8 45 a m the patient began to experience dyspnea chest pain nausea and developed acute kidney failure with a urine output of 40 ml hour and a rise in creatinine LDH potassium and bilirubin Her hemoglobin dropped from 10 7 to 8 3 She did not require dialysis and urine output was normal by the next day In the days that followed hydration was maintain
91. and arbitrating the editing of this information across components Locations f a facility is already enrolled in NHSN locations will have been set up but some non patient care areas may need to be added for Biovigilance A location used in only one component can be edited or deactivated by any user with rights to edit location records location used in both Patient Safety and Biovigilance can only be edited by the Facility Administrator However a location can be activated or deactivated by any user with rights to do so T ia YA 1NF NAH Sall If a facility is already enrolled in NHSN for Patient Safety locations will have been set up but some non patient care areas may need to be added for Biovigilance A location that is used in only one component can be edited or deactivated by any user with rights to edit location records A location that is used in both Patient Safety and Biovigilance can only be edited by the Facility Administrator However a location can be activated or deactivated by any user with rights to do SO Locations Facility locations are used to stratify data in NHSN Before any data can be entered facility specific locations must be identified and set up Locations are defined as physical areas of the facility In the Biovigilance Component this refers to any area of the facility where patients are transfused could experience an adverse reaction and or where blood products may
92. anipulation O Request for pick up O Product issue O Product administration O Other specify Enter Incident Code See Incident Codes on Page 4of Form _ OR O Incident detail not specified Incident summary Incident result Check one O 1 No recovery harm O 2 No recovery no harm O 3 Near miss unplanned recovery 4 Near miss planned recovery In the Case 1 example the technician knew that the error had occurred 3 days earlier in the morning when the product had been checked in so we ll enter the date and time but indicate that the time was approximate The incident occurred in the blood bank or Transfusion Services The worker who checked the product in and had manually entered the wrong expiry date was a medical lab technician therefore MLT is the occupation code The process code is PC or Product check in and the exact code is PC 01 which includes Data entry incorrect A brief summary of the error is provided in the text field Our Incident result code is 4 or Near miss planned recovery because the technician followed facility procedures by comparing information on the unit to what was already entered into the LIS Product action Check all that apply X Not applicable O Product retrieved LJ Product destroyed Code system used Check one LJ ISBT 128 O Codabar Indicate whether single or multiple units were destroyed Single unit a Unit Z OR b Component Code Multip
93. arantee that it will be held in strict confidence will be used only for the purposes stated and will not be disclosed or released without the consent of the individual or the institution in accordance with Sections 304 306 and 308d of the Public Health Service Act NHSN Surveillance Methodology in Hemovigilance p IPN Active amp passive a Patient based Prospective Comprehensive ncidence rates Next we will discuss the surveillance methodologies used in NHSN for Hemovigilance These include active and passive surveillance patient based prospective comprehensive and incidence rates Let s look at each method in more detail NHSN Surveillance Methodology ACTIVE vs PASSIVE gt ACTIVE Trained personnel use standard definitions and a variety of data sources to identify events gt PASSIVE Personnel not trained to do surveillance report events but required to report any reactions thought to be associated with a blood transfusion to transfusion services When performing active surveillance trained personnel such as staff in Hospital Blood Transfusion Services use standard definitions and a variety of data sources to identify events Passive surveillance in hemovigilance involves situations where personnel not trained to perform surveillance are required to report blood transfusion adverse reactions to blood transfusion services as a part of their job responsibilities Hemovigilance will
94. as robustly as errors and negative outcomes All reports should be entered within 30 days of the month of the date of discovery for the event when possible Definitions See Appendix F for descriptions of Incident Result and Root Cause Analysis Result Adverse event An undesirable and unintended occurrence before during or after transfusion of blood or a blood component and may be related to the administration of the blood or component It may be the result of an incident and it may or may not result in a reaction in a recipient High priority incident Any incident that has high potential for wrongful transfusion in a recipient i e wrong blood in tube These include sample labeling errors wrong patient collected and special processing needs not indicated not done misunderstood misinterpreted etc Incident Any error or accident that could lead to an adverse outcome affecting a the safety efficacy or quality of blood blood components or plasma derivatives or b the safety of recipients 03 17 2009 V1 Final O NHSN Biovigilance Component protocol i miss a incident that is discovered before the start of the transfusion and that could have led to a wrongful transfusion or to a reaction in a recipient Forms Hemovigilance Monthly Reporting Plan CDC 57 301 Complete one plan at the beginning of each month See tables of instructions for form completion details Hemovigilance Module Blood Product Incidents
95. asma transfused If none enter 0 Do not include the units eae eee from which the aliquots were made in your unitcount _ Apheresis plasma Conditionally required Enter the number of units and number of aliquots of apheresis plasma transfused Do not include the Cryoprecipitate Conditionally required Enter the number of units of eS EENES EEEE NEEESE E EEA cryoprecipitate transfused 22 _ Granulocytes Conditionally required Enter the number of units and number of aliquots of granulocytes transfused Do not include the Lymphocytes Conditionally required Enter the number of units and number of aliquots of lymphocytes transfused Do not include the units from which the aliquots were made in your unit count 15 Are any of the following Required Check any products that are maintained and administered through Transfusion jordered through your department Services 16 Does your facility attempt to Required Check Yes if it is facility policy to transfuse only transfuse only leukocyte reduced leukocyte reduced cellular components regardless of whether cellular components some products are transfused that are not leukocyte reduced 17 Units transfused by Optional If data are available please provide samples department service collected and units transfused by department or service 18 Are all units stored in the Required If some units are routinely stored in other parts of Transfusion Services area your facility check No and
96. at least one urban cluster of at least 10 000 but less than 50 000 in the population Rural Areas classified as Balance of County by the U S Census Bureau there are no urban areas of at least 10 000 inhabitants department eee Inpatient and outpatient surgeries performed at per year your facility in the past full year re Indicate the trauma level 1 2 3 or 4 of your facility certified facility or N A Transfusion Services Characteristics 7 Primary classification of facility Required Check all that apply areas served by Transfusion Services 8 Is your Transfusion Services Required Check Yes if your transfusion service functions as part of the facility s core a part of the core laboratory rather than independently laboratory 9 How many dedicated Required Include supervisors Consider 2 part time workers Transfusion Services staff are as a single full time equivalent FTE For Medical Laboratory there Technician MLT and Medical Technologist MT put total FTEs or equivalent if some staff are part time 10 Is your Transfusion Services Required Check Yes if your Transfusion Services laboratory accredited department is laboratory accredited and indicate the accrediting organization accredited reviews blood utilization established that meets regularly to review blood utilization 13 What is the total number of Required The total number of samples collected for type and samples collected
97. at permit timely recognition of patient and healthcare personnel safety problems and prompt intervention with appropriate measures Conduct collaborative research studies with members NHSN can provide facilities with data that can be used for inter facility comparison and local quality improvement activities It can assist facilities in developing surveillance and analysis methods that permit timely recognition of patient and healthcare personnel safety problems and prompt intervention with appropriate measures In addition collaborative research can be conducted with NHSN members Staff Expected to Participate in the Hemovigilance Module Transfusion services staff responsible for quality assurance and technical oversight Other personnel can be trained to Screen for events Collect denominator data W L Enter data ni Analyze data Facility staff who are expected to participate in the Hemovigilance Module include transfusion services staff responsible for quality assurance and technical oversight Other personnel can be trained to screen for events collect denominator data enter data and analyze data NHSN Structure National Healthcare Safety Network Research Patient Safety b o on Component i omponent amp ALA Since Hemovigilance is currently the only module in Biovigilance these terms are used interchangeably in NHSN This slide depicts the current structure of NHSN NHS
98. ata User ID RUBY ID 664 Tace aantshilelamelamen Analysis the new user saki Facility List click Save Add a ind The Edit User Facility Healthcare Bi aes screen oe Personnel Biovigilance will appear Administrator All Rights Analyze Data Enter Data View Data Customize advan Rights ae e ea After entering information on the new user click Save Next you want to edit the user s rights User Rights About User Rights When a new user is added to NHSN he or she must be assigned rights to the facility s data If rights are not assigned the user will not have access to any system features other than his or her own contact information User rights can be assigned by activity view enter analyze or be customized as desired The assigned rights will not only determine the training required for that user but will also determine the options available to him or her on the navigation bar Suggestions for blood transfusion services At least one person in your department should have administrative user rights Persons who review or analyze data may not need rights to enter or edit the data Let s talk about User rights When a new user is added to NHSN he she must be assigned rights to his her facility s data If no rights are assigned he she can log in but will not be able to see anything other than his her own contact information User rights are assigned by activit
99. ate analysis is performed Enter Monthly Reporting Plan at the beginning of the month This informs CDC of what you intend to report Data must be reported for every month of the year if your facility chooses to participate in the Hemovigilance Module Let s review some key points from the Hemovigilance Overview training The Hemovigilance Facility Survey is completed the first time the Biovigilance Component is invoked The survey contains information that can be used to Stratify facilities in aggregate analysis for example bed size annual transfusion volume etc Enter your monthly reporting plan at the beginning of the month This informs CDC of what you intend to report For the Hemovigilance Module data must be reported for every month of the year in which you participate NHSN Data Fields Asterisked items are required fields This means that you cannot save the record if these fields are left blank Items witha are conditionally required i e required only if certain other conditions are met Patient ID should be a number that is unique to that patient and can be used across all visits Most facilities use medical record number Patient ID gender and date of birth are required demographics Your facility may also want to collect patient name and race ethnicity Blood group is a required field NHSN data fields have standard characteristics Items marked with a red asterisk are required fields This means that you
100. ated acute lung injury TRALI 0 0 0 ccc ecccececeeecceeeeeeeeseeeseeeaeeeseeeeseeseeeeaeeesaeees 23 LORE a cee acide E case even pete tac aes Worle ctl acct ET EE E E E E 24 Appendix C Severity Grade and Imputability ccc ceccceeeeeeceeeceeeeeeeeeeeeeeeseeeeaeeeseceeeeeeseeeeeeeaeeeees 26 Appendix D Common Antibodies Associated with Hemolytic Transfusion Reactions c cccceeee ee 2 Appendix E NHSN Occupation Type COdes ccccccccceccseeceeeceeeeeeeceeeeeeeeeeeeeeeteeesseeeseeseeenseesueeseeeseeeaes 28 Appendix F Incident COdeS cccccccecceeeceeeteeeteeeseecteeeeseceneceeceueceueceeetseeteeeteetaeeteenseeegeeeneesseeteeeteenes 29 Appendix G Incident Reporting Definitions 0 0 0 0 ecccccceccceeece eee eeceeee cess eeeeeeseeeseeeneeseetseeeaeesaeenaeeteeenes 31 03 17 2009 V1 Final 2 NHSN Biovigilance Component protocol Background Patient safety related to medical intervention has become an increasing public health concern in recent years The Patient Safety and Quality Improvement Act of 2005 Public Law 109 41 intends to improve patient safety by encouraging voluntary and confidential reporting of events that adversely affect patients In 2006 the Department of Health and Human Services HHS Advisory Committee on Blood Safety and Availability ACBSA convened to make recommendations to improve patient safety related to transfusion and transplantation ACBSA membership includes liaisons fr
101. ation reporting Group As part of the Group s intent to collect data from group facilities rights must be conferred beginning January 2009 and ending December 2009 In this example rights to patient information including identifiers Monthly Reporting Plan Analysis Annual Facility Survey in plan adverse reaction events in plan incident events in plan incident reporting Summary data and monthly denominators will need to be conferred Example Facility Administrator Joins Group One facility has nominated the patient safety organization as a Group Once nominated the Group Administrator obtains digital certificate logs into NHSN and sets up the Group Joining Password Group Administrator provides Facility Administrator with Group ID and Group Joining Password Facility Administrator joins Group Grou Confer Rights Join Group ID 10516 Enter ID and Password for this facility to join a new group i Group Joining Password eeecece Nominate Log Out One facility nominated the patient safety organization as a Group Once nominated the Group Administrator obtains a digital certificate logs into NHSN and sets the Group Joining Password The Group Administrator then provides all Facility Administrators like the one from Facility A with the Group ID and Group Joining Password The Facility Administrator then joins the Group by selecting Group Join from the navigation bar in NHSN as shown at the botto
102. attempt to exit a record d without saving you will receive a warning 4re you sure you want to navigate away from this page Changes found Do you want to save changes Press OK to continue or Cancel to stay on the current page Once you have entered your incident report into NHSN don t forget to save the record Click on the Save button at the bottom of the screen You will be told that the record has been saved successfully If you attempt to exit the record before saving you will receive a warning message The NHSN incident number is provided at the time the record is saved as shown in the statement Incident 130 created successfully Linking Adverse Reactions and Incidents so Use when adverse reaction is the result of an incident Information from linked events is used in analysis Enter incident before the adverse reaction Fields associated with linking Link unlink on Adverse Reaction form Product action on Incident form e Ifthe unit was transfused was a patient reaction associated with this incident If Yes enter patient ID facility assigned ID for that patient e g medical record number Linking Adverse Reactions and Incidents In NHSN we link adverse reactions that are the result of an incident Information from linked events is used in analysis In order to successfully link a record enter the Incident form before the Adverse Reaction form There are certain fields associated with linking
103. ause analysis was performed check the results using the definitions provided in the protocol Custom Fields Optional Up to two date fields and 10 alphanumeric fields that may be customized for local use NOTE Each Custom Field must be set up in the Facility Custom Options section of the application before the field can be selected for use ee Enter any information on the incident This information may or may not be analyzed 1 8 2009 19 ational Healthcare afety Network Biovigilance Component Enrollment for Facility New to NHSN SAFER HEALTHIER s PEOPLE Welcome to the National Healthcare Safety Network Biovigilance Component Enrollment for Facility New to NHSN training session Target Audience m his training is designed for anyone who may be assigned as NHSN Facility Administrator for a facility enrolling in NHSN Biovigilance Component This training is designed for anyone who may be assigned as NHSN Facility Administrator for a facility enrolling in the NHSN Biovigilance Component If your facility already participates in the NHSN Patient Safety Component please view Training 3 which covers enrolling an existing NHSN facility into Biovigilance Objectives Define the role of the NHSN Facility Administrator in the enrollment process Discuss how email is used in NHSN Print and Complete enrollment forms Describe the 5 steps of NHSN enrollment Define SDN and digital certificate Once you are enr
104. be handled Here s more information about locations Locations are used to stratify data in NHSN Before any data can be entered facility specific locations must be set up Locations are defined as physical areas of the facility In the BV component this refers to any area where patients are transfused could experience an adverse reaction and or where blood products may be handled Locations You will map each location in the facility to a standard CDC Location The CDC Location descriptions must be reviewed before mapping facility specific locations Locations are mapped to a standard CDC location to allow for aggregate comparison of data Be sure to review the location descriptions before mapping your facility locations Locations A list of all standard CDC locations and descriptions can be found in the CDC Locations amp Descriptions document CDC Location Label Location Description INPATIENT LOCATIONS Inpatient Adult Critical Care Burn Critical Care Critical care area specializing in the car of patents with significantimajor burns Medical Cardiac Critical Care Critical care area specializing in the care of patients with serious heart problems that do not require heart surgery surgical Cardiothoracic Critical Care Critical care area specializing in the care of patients following cardiac and thorace surgery Medical Critical Care Critical care area for patients who are being
105. blic Health Partners Microsoft Internet Explorer File Edit View Favorites Tools Help Back gt A A Qsearch GaFavorites Bmeda Bv 3 a 7 BH Z v Search Web 2 Gmail mMy yahoo EJ Answers Games Shopping Music CDC Public Health Partners National Healthcare Safety Network NHSN This Week in MMWR August 11 2006 Vol 55 No 31 gt NHSN Administration The Global HIV AIDS Pandemic 2006 gt HI Prevalence Among Populations of Men Who Have Sex with Men Thailand 2003 and 2005 gt HIY Counseling Testing and Care of Tuberculosis Patients at Chest Clinics Guyana 2005 gt NHSN Reporting 2006 Recommendations and Reports August 11 2006 Vol 55 No RR 12 April 21 2006 Vol 55 No RR 6 To locate HHS personnel enter the search Prevention of Rotavirus Gastroenteritis Among Infants and Children Recommendations of the criteria below Note partial names are Advisory Committee on Immunization Practices ACIP fabley Mold Prevention Strategies and Possible Health Effects in the Aftermath of Hurricanes and Major acceptable IET Last OE MORE 3 name First name Surveillance Summaries July 14 2006 Vol 55 No SS 7 A 2 o Surveillance for Certain Health Behaviors Among States and Selected Local Areas Behavioral gency Risk Factor Surveillance System United States 2004 gt Prevalence of Four Developmental Disabilities Among Children Aged 8 Years Metropolitan
106. by using any of the following criteria NHSN incident Incident process code for example all incidents with a code of SC 01 all incidents that occurred in a specific facility location and all incidents reported in a particular time period The more criteria you use the narrower the search If you don t enter any criteria and click on Find you will be given a list of all incidents that have been reported by your facility into NHSN Incident Reporting Summary m n the examples provided during this training cases 1 and 3 are not high priority and do not require a full Incident report unless your facility chooses to complete a full report on each incident Case 2 would require a complete report because the incident code on the form SC01 is a high priority code Cases 1 and 3 could be entered under the appropriate process code on the summary form at the completion of the monitoring month To enter summary data Department of Health and Human Services Centers for Disease Control and Prevention NHSN National Healthcare Safety Network ISD CLFT NHSN 1 NHSN Home My Info Co U NHSN Home Logged into Pleasant Valley Hospital ID 10312 as RUBY Facility Pleasant Valley Hospital ID 10312 is following the BV component Reporting Plan F pm a kites Aad Hemovigilance Summary Data Incident Reaction Summary Data Type Blood Product Incidents Reporting Summary Data Summary Data D Add continue Back D Find
107. cal Education GME are selected by officials of a medical school department or by a joint committee of the institution teaching staff and medical school faculty Medical school faculty other than the institution s attending staff are regularly scheduled to participate in the teaching programs of the institution No graduate affiliation is indicated if medical school faculty participation is limited to an occasional lecture or consultation visit or if the institution s residents attend medical school teaching conferences only as visitors A contractual arrangement specifies the medical school participation in the organization and supervision of the GME program in the institution e There is some degree of exchange of residents between this institution and the principal teaching institution of the medical school Limited affiliation signifies that the institution is affiliated with the medical school s teaching program only for brief and or unique rotations of students or residents 3 Community setting of facility Optional Check the setting that most closely fits the location of your facility 1 8 2009 1 Instructions for Form Completion Urban Areas classified as a Metropolitan Statistical Area by the U S Census Bureau each area must have at least one urbanized area of 50 000 or more inhabitants Suburban Areas classified as Micropolitan Statistical Area by the U S Census Bureau each Micropolitan statistical area must have
108. cate the four digit year Adverse transfusion reactions amp Required The minimum reporting requirement is all all incidents associated with transfusion reactions reported and any incidents thought to reactions be associated with the occurrence of a transfusion reaction Monthly reporting denominators Required Report actual numbers of products transfused in the month using the Monthly Reporting Denominators form These numbers will be used to calculate rates Choose one of two incident reporting options Incidents Reporting summary Check if you want to provide total numbers of incidents by data with detailed reporting of high each incident code Note that any code with a requires priority events detailed incident reports for those events In addition any incident resulting in a recipient adverse reaction requires an Incident form be completed regardless of incident code Incidents Reporting detailed Check if you plan to enter individual detailed reports for all reports of all incidents incidents where a report has been filed in blood transfusion services 1 8 2009 6 Table 3 Instructions for Completion of the Blood Product Incidents Reporting Summary Data CDC 57 302 gears Instructions for Form Completion Facility ID The NHSN assigned facility ID number will be autoentered by the computer a Enter this form at the end of the month for which you are reporting Year Process Point Total number of inc
109. ce daca trom asamok of neakncare facilities Incne Unked escimacion of cne mMagnkude of adverse sext and Inc eng ohed and okod orod ucts Anahyze and sepo collecoed daca co perme recognition of cien Provide fac lkk w kn few edjusced dace cnac can oe used for esl qualicy Im orowenenc acchiciss Assetti ikkes In deveboingsucvelilance and anshs amp mecnocd of paclere and neakncare worker safecy oronlems and oom o mess ures Conducc collaporactve sesearcn scudies win NHSN men per fac enkem bhgy of emerging HO and oscnogens asses one In od furcner craraccerke HO omogen andcnele mecnank ms of se ahernachve s uevellance and orevertion scranegies Elig iblitty Criteria Fac likes oaece Inscing Inne NHSN must meer coe tolka Ing chert Bes pons fide neakncare ta lley Inen Unked Scenes of amery taken a fac iliky cnac k lod In one of ene tolka ing nacional daca Assan Aa Cemers for Hedk ae and Hedk ak Serwvk esl Iva Have emall addeesses for NHSN users and nign posed I mernet wlll use OO access NHS N and cne anilicy co dow nbad a digkal ca for eacn sucnorbed user Be willing oo folka Cnt semed NHS N com poner oromocok amp accurane daca Inacimety manner ducing morna nen report Be willing co s nave suen dace Win COC for cne ourposes scaned Be sok co orovide writen comem for oarck losion Incne NHS cnet ewer uclve leaders nin e g Cake Boer uhe Off eer Consent aN Agreement to Participate and Consent P zo Data Colection and R
110. chart Saving modified output Creating new reports Exporting data sets Now let s discuss ways to modify or customize your reports in order to change the way your data are displayed or change the data elements in your report We ll discuss the difference between variable names and variable labels how to change the title of your report modifying date variables selecting records from a particular time period using selection criteria displaying different variables changing sort order modifying a pie chart saving modified output creating new reports and exporting data sets Variable Names vs Labels Output headers shown in two ways Variable name patl ageAtHVAdvRxn iB 48 69 Patient I O Reaction Gender Location 144 RP57923 48 F EM22 691M nder location r uaa compCDCDesc WB Whole blood blood cells F INHONCSCA RBC Red M iia INSOPTSCA INHONCSCA INLDWARD RBC Red blood cells CDC Component Code Description WB Whole blood RBC Red blood cells RBC Red blood cells 42 12 2009 cua 06JAN09 12 06 01 15 2009 ee 10JAN09 10 00 02 02 2010 e 20JAN09 13 15 Hours Date Time Adverse Admin Expiration Unit Reaction to Date Administered Date Time Reaction 12 12 2009 si O6JANO9 12 06 87 01 15 2009 10JAN09 09 30 10JAN09 10 00 1 02 02 2010 02JAN09 03 33 20JAN09 13 15 442 expireDate adminDateTime advRxnDateTime
111. click on the Print button NHSN a surveillance system of the Centers for Disease Control and Prevention CDC allows a participating healthcare facilities to enter data associated with healthcare safety such as surgical site infections antimicrobial use and resistance bloodstream infections dialysis incidents and healthcare worker vaccinations NHSN provides analysis tools that generate reports using the aggregated data reports about infection rates national and local comparisons etc NHSN also provides links to best practices guidelines and lessons learned NHSN processes and stores a variety of sensitive data that are provided by healthcare facilities This information requires protection from unauthorized access disclosure or modification based on confidentiality integrity and availability requirements These Rules of Behavior apply to all users of the NHSN web based computer system Purpose Print Version aca Read the Rules of Behavior on the NHSN website and click on agree Print a copy for your records If you do not agree enrollment will be discontinued The website is shown on a previous slide and is http www cdc gov nhsn a N i Wy if 3 ZZ 77 National Healthcare I Safety Networ Step 2 Register Step 2 Register Important Be sure you use the exact same email address each time in NHSN NHSN Registration Personal Informati Lastname Doe Firstname Jane Middle
112. ct information that will be required is the user s valid email address This email address must be the same one identified by the user during his or her application for a digital certificate Phone Number Extension Fax Number E mail Address JDOE YOURFACILITY ORG Address line 1 Address line 2 Address line 3 City State l 7 County Zip Code Zip Code Ext Home Phone Number Home Extension Beeper User Contact Information The user s valid email address is also required It must be the same one identified by the user when applying for their digital certificate Users l NOTE Please make sure N the email address is correct Entering an incorrect email address will prevent the new user from obtaining a digital certificate and from gaining access to NHSN 20 Remember that a valid email address is very important for NHSN users Entering an incorrect email address will prevent a new user from obtaining the digital certificate necessary to access NHSN Users CCIIULCIS LOT JISCASE COTLTOL ANU FICVCHLLOTL NHSN National Healthcare Safety Network ISD CLFT NHSN1 NHSN Home T NHSN Home Logged into Pleasant Valley Hospital ID 10312 as RUBY Facility Pleasant Valley Hospital ID 10312 is folloving the BV component Reporting Plan Edit User Rights Patient Edit User Rights piisi Reaction After entering Summary D
113. ction Patient ID RP54379_ Social Security Secondary ID Last Name Johnson First Name Mary Middle Name Ann Gender F Female Date of Birth 10 21 1960 Ethnicity NOHISP Not Hispanic or Not Latino Race American Indian Alaska Native Asian Black or African American Native Hawaiian Other Pacific Islander White Blood Group B Reaction Details Date reaction occurred 01 08 2009 Facility location where reaction occurred INMEDCC IN ACUTE CC M Time reaction occurred o8 45 HH MM OR Time unknown First we enter the patient demographics This facility collects some optional information such as patient name and race ethnicity Patient Mary Johnson s blood group is B When the patient ID is entered the system will check to see if that patient was previously entered in NHSN If so information on the patient will be auto filled Reaction Details Date reaction occurred 01 08 2009 BA Facility location where reaction occurred l INMEDCC IN ACUTE CC M Time reaction occurred 08 45 HH MM OR Time unknown Link Unlink To Incidents Reaction is not Linked Signs and symptoms laboratory check all that apply CI Shock C Headache C Pain at infusion site Dark urine C Fever Cl Abdominal pain CI Nausea vomiting C Chills rigors C Jaundice L Back pain Cl Other skin rash CL Hypoxemia Urticaria Cl Chest pa
114. d locations click on Facility on the navigation bar then select Locations Ihe following screen will appear B a 4 NHSN Home Locations Reporting Plan Patient fattrochans Incident To Add a record fil in the form with the required fields Reactio clack on the Acid button z3 To Fiad a recond dick on the Find button One of more fields can be fled in Summary Data search to those values A io a a record perform a Find on the desired record Glick on alysis wWalues into the form amd ed the values 1o save the chan es Surveys To fe one or more records perform Find on the desired record s conmesnonding boies then dick on the Gelete button Users Press the hear button to start ower with a new form pr Facility Customize Forms Export Data D Facility Info Add Edit Component Locations Group Log Out Mandatory hes te Add or Ede a record marked with Now that we ve covered the rules we ll demonstrate how to set up a location Click on Facility in the left navigation bar Then select Location A Location screen will come up Locations he first step is to assign your facility code and label for a location he code and label will be what you use when reporting an event for that location he code and the label can be the same In this example the label is more descriptive than the code Your Code Your Label PEDIATR C ICU CDC Location Description Pediatic
115. dard operating procedures or other previously instituted checks and balances Result 4 Near miss planned recovery means that product did not reach the patient and the incident was discovered through standardized procedures or barriers built into the system to prevent such errors Occurrence Product action q Use Not applicable when incident occurs in transfusion XO services and no product has been issued Record other action Product action Check all thaapply LJ Not applicable O Product retrieved O Product destroyed Code system used Check one LJ ISBT 128 LJ Codabar Indicate whether single or multiple units were destroyed Single unit a Unit ess eee OR b Component Code Multiple units Component Code s __ of Units of Units Code of Units _ Add add LJ Product issued but not transfused LJ Product transfused If the unit was transfused was a patient reaction associated with this incident O ves O no If YES Patient ID _ Patient ID Record other action Check all that apply O Record corrected O Floorfclinic notified O Attending physician notified O Additional testing O Patient sample re collected O Other specify Product action must coordinate with Incident Result If your Incident Result code is 1 or 2 then product action must be that the product was transfused Product retrieved Product destroyed and Product issued but not transfused can be used with code 3 o
116. dations of the criteria below Nofe partial names are Advisory Committee on Immunization Practices ACIP fable gt Mold Prevention Strategies and Possible Health Effects in the Aftermath of Hurricanes and Maio acceptable TA ee A wore name Firstname Surveillance Summaries July 14 2006 Vol 55 No SS 7 A H gt Surveillance for Certain Health Behaviors Among States and Selected Local Areas Behavioral gency z Risk Factor Surveillance System United States 2004 gt Prevalence of Four Developmental Disabilities Among Children Aged 8 Years Metropolitan Atlanta Developmental Disabilities Surveillance Program 1996 and 2000 MORE 3 eal RO E 3g a amp Local intranet start BR O E disc Slinbo ai micr Fado E nes mer Sirra Eco tie BB OSes 7 46 pm You will be taken to a screen for CDC Public Health Partners Notice in the top left corner there is a box labeled My Applications Click on NHSN Enrollment Access and print forms E NHSN 1 0 40 Enroll Facility Microsoft Internet Explorer File Edit View Favorites Tools Help Back gt A A Qsearch Favorites Stee ESEA RAEES cdc Go Links My Yahoo EJ Answers Games Shopping fMusic Department of Health and Human Ser Centers for Disease Control and Prevention You should hava p NHSN National Healthcare Safety Network completed your Hemovigilance Module Survey and
117. ddle Name Date of xe Gender ba Birth ad Ethnicity v Race American Indian Alaska Native Asian Black or African American C Native Hawaiian Other Pacific Islander C white Blood Group Notice that when you add the patient in the Adverse Reaction screen two additional fields appear on the screen Adverse Reaction and Blood Group The Adverse Reaction is generated by NHSN Remember to refer to your Tables of Instructions for details on entering data on this form As we mentioned in an earlier slide your facility may also want to require that Patient Name and Race ethnicity be entered Reaction Details Date reactionetEurred EB Facility location where reaction occurred Time reaction occurred HH MM OR Time unknown n Link Unlink To Incidents Reaction is not Linked Signs and symptoms laboratory check all that apply C Shock Cl Headache Pain at infusion site C Dark urine C Fever C Abdominal pain CI Nausea vomiting C chills rigors C Jaundice Cl Back pain C Other skin rash Cl Hypoxemia CJ urticaria C Chest pain C Shortness of breath Cl Hemoglobinemia Cl Oliguria C Flank pain Cl Diffuse hemorrhage C Hematuria Cl Increase in blood pressure C Decrease in blood pressure Cl other pain C other Component Details Component code check Date Time system used Se ES Unit expiration MM DD YYYY OIsBT 128 i date 5 Required for TRALI GVHD Infection HH MM
118. de a text description of the incident beyond what is described in the code It is recommended that you not put the names of the workers or any patients involved Use generic descriptions such as nurse patient physician etc Incident result Required Check the outcome of the incident using the definitions provided in the protocol Product action Required Check all that apply Not applicable Conditionally required If the incident occurred before a product was selected check this box If this box is checked no other answer can be selected for this a ene ee ee question Product retrieved Conditionally required Check if the blood product or component involved in the incident was intercepted or held FONERENISEE EEEN EN PESTES EIEEE EE EEE OESEEEEE rior to transfusion of the patient 2 222 Product destroyed Conditionally required Check if the incident resulted in roduct being destroyed for any reason 2 Code system used Conditionally required If product was destroyed indicate the code system used to label the product ISBT 128 or eee eee eee eee Codabar aaa Indicate whether single or If product was destroyed indicate whether single or multiple units were destroyed ____ multiple units were destroyed aaa Single unit If a single unit enter the individual unit number or the component code 1 8 2009 18 Form Field Instructions for Form Completion Note The component code you enter into NHSN will be compared to I
119. de source or where products are returned to inventory from a patient care area SR or sample receipt is the point at which a patient sample is received in transfusion services ST or sample testing includes type and crossmatch and other testing of the patient sample US or product storage covers errors that occur during storage of blood and blood products AV or available for issue includes quality management of product inventory SE or product selection is the point at which products are selected for transfusion UM or product manipulation errors occur during pooling irradiating dividing thawing and labeling products UI or product issue is the point when products are issued to departments outside of Transfusion Services If errors do no fall into one of the points above you can use code MS for miscellaneous or other errors Clinical Service Categories PR Product test request Request of a test or product by clinical service online or requisition SC Sample collection Service collecting the samples SH Sample Handling Paperwork accompanying the sample for testing RP Request for pick up Product request UT Product administration Product transfused MS Other Clinical service process areas include PR or product test request when the test or product is requested by a clinical service This can include online and paper or requisition requests SC or sample collection errors occur at the time the sample is drawn from
120. de summary data for other errors such as clerical or technical function errors that have little likelihood of impacting the patient Remember that required fields are indicated by an asterisk Incident Form Report any incident that is reported to and documented by your department m Incident system number generated by NHSN m Local incident or log Your institution number for this incident e g the number on the incident report that was filed Hemovigilance Incident Incident system generated Local Incident or Log Date of discovery __ FACES Ai Where in the facility was the incident discovere d Time of discovery _ _o _ HH MM O Time approximate O Time unknown How was the incident first discovered Check one O Computer system alarm or warning C Comparison of product label to patient information i DD aaa be ici Report any incident that is reported to and documented by your department Incident is the system generated number in NHSN The Local incident or log is the number your facility used to track the incident such as the number on the incident report or other untoward occurrence form that was filed within your own facility Discovery Date of discovery the earliest date at which the incident was known to have occurred Should be same date or later than the date of 01001011210105 Should fall within the month you are monitoring ime of discov
121. dent the nurse and the technologist in the blood bank it is the nurse who made the error so we will enter her job function code The process point at which the error first occurred was during Sample collection Our incident code will be SC 01 sample labeled with incorrect patient name Notice that we have entered a brief summary of the incident in the text field Our incident result will be 3 or Near miss unplanned recovery since the error was detected only because of the nurse s feeling that she had done something wrong Product action is not applicable because a unit had not yet been issued for the patient Our Record other action was that the patient sample was re collected In this example no root cause analysis was performed At the bottom of this page you would click on the Save button in order to save the record Case 3 A request for transfusion for 2 RBC units was received in the blood bank at 8 30 a m on 1 5 2009 The patient had a current type and screen on file and qualified for an electronic crossmatch Two units were selected and the electronic crossmatch was performed The units were labeled and placed in the appropriate storage unit awaiting pick up The nursing unit was subsequently notified that the blood was ready for pick up The porter arrived at 10 00 a m with appropriate documentation to pick up the first unit When issuing the unit the tech noticed that the unit number on
122. dent Mf Please select the rights that group AABB Group should have to facility Pleasant Valley Reaction Hospital Summary Data Analysis Surveys Users Facility eee Rights Patient With Identifiers Without Identifiers DO Join Monthly Reporting Plan D Leave ae a D Nominate Annual Hemovigilance Facility Survey a Log Out Data Analysis F Patient Safety Healthcare Personnel Safety Biovigilance General View Options Incidents and Adverse Reactions Plan Month Year Month Year Event i Al y to All Add Row Clear All Rows Summary Data for Events Plan Month Year Month Year T Al to Plan options include All In Out and Both Event is Adverse Reaction or Incident Summary Data include Blood Product Incidents Reporting Summary Data amp Hemovigilance Monthly Reporting Denominators E Plan options include All or access to data In or Out of plan and for any time period Currently Biovigilance only allows entry of In plan data By selecting In rather than All you will also be required to select your time periods month year for which the group has access to your data Event will either be Adverse Reaction or Incident Summary data include Blood Product Incidents Reporting Summary Data and Hemovigilance Monthly Reporting Denominators Facility Administrator Manages Group Memberships Department of Health and Human Services Centers for Disease Control and Prevention
123. dically check your email for a response from SDN Requests are usually processed in 48 74 hours When you receive your email from SDN it will include a link and instructions for downloading the certificate Contact your facility IT department for assistance in installing your certificate Your computer must have administrative rights in order for the certificate to be installed These rights can be assigned temporarily Detailed instructions for installing the certificate are included in the Facility Administrator Enrollment Guide Remember to make a back up copy of the certificate Ti ii sat AAN ii 7 National Healthcare I Safety Network Step 4 Complete NHSN Enrollment Online Now that you have installed your digital certificate you are ready to enroll in NHSN National Healthcare Sa fety Network To log onto the N HSN Client authenti S via the SDN go to ae httos sdn cdc gov e You will be presented with a Client Authentication screen click OK To log into NHSN via the SDN go to sdn cdc gov You will be presented with a client authentication screen Click OK Enter your SDN challenge phrase click Submit CDC Public Health Partners Search COC oov WARNING This is a U S Government computer system which may be accessed and used only for official government business by authorized personnel Unauthorized access or use may subject violators to criminal civil and or administrative action There i
124. dy function Grade 3 Life threatening e Major intervention required following the transfusion vasopressors intubation transfer to intensive care to prevent death Grade 4 Death e The recipient died following an adverse transfusion reaction Note Grade 4 should be used only if death is possibly probably or definitely related to transfusion If the patient died of another cause the severity of the reaction should be graded as 1 2 or 3 as appropriate Imputability Once the investigation of the adverse transfusion reaction is completed this is the assessment of the strength of the relationship between the transfusion and the adverse reaction Definite certain Conclusive evidence beyond reasonable doubt that the adverse event can be attributed to the transfusion Probable likely Evidence is clearly in favor of attributing the adverse event to the transfusion Possible Evidence is indeterminate for attributing the adverse event to the transfusion or an alternate cause Doubtful Evidence is clearly in favor of attributing the adverse event to causes other than the transfusion Ruled Out Conclusive evidence beyond reasonable doubt that the adverse event can be attributed to causes other than the transfusion Not Determined The relationship between the adverse reaction and the transfusion is unknown or not stated Adverse reactions for which Imputability is doubtful or ruled out should not be routinely reported The only tim
125. e AllQuok Whole blood derued plasma ind FFP hewed ek Unik Aphesis pasma Unie Aliquok Cryopredpise Mumberotuve rercteed Grariocyes Mumberotudk rareteed AllQuok lymphocyes Wumberotud rarcteed AlIQUOk Are ary ov he slowing adminis ered rough Trare tslon Seruces Check all Pel apply O Albumin O fackes Qil Wil lt ATILek O immuregicbuin hy O mmuwgioddin iMorsubcubrecs O AnD O Wore Does your bdlli y alempi b reige only leukocye teduced cellular comporenk O ves O wo The Hemovigilance Module Annual Facility Survey is completed the first time the administrator enrolls in the Biovigilance Component Facility Survey Facility Characteristics Bed size Specialty Volume of surgeries Transfusion Services Characteristics Facility areas served Number and specialty of employees Accreditation Samples collected Volume transfused Transfusion Services Computerization Systems used Specimen Handling Which staff handle specimens Patient identification and collection procedures Procedures for type and screen crossmatch The facility survey collects information that can be used in aggregate analysis Facility characteristics such as bed size specialty and volume of surgeries and characteristics of Transfusion Services such as facility areas served number and specialty of employees accreditation total samples collected and volume of products transfused a
126. e these categories can be used is where a reaction was initially thought to be transfusion related but later information revealed a non transfusion related cause 03 17 2009 V1 Final 26 NHSN Biovigilance Component protocol 7 UDC m T I Appendix D Common Antibodies Associated with Hemolytic Transfusion Reactions AHTR DHTR DSTR Anti A Anti B Anti A B Anti C Anti D Anti E Anti c Anti e Anti K Anti k Anti Jk Anti Jk Anti S Anti Fy Anti Fy Anti M Other 03 17 2009 V1 Final 27 NHSN Biovigilance Component protocol Lab MLT IVT PHL MTE Nursing Staff CNA LPN NMW NUA NUP RNU Physician FEL MST PHY RES Technicians EMT HEM ORS PCT Other Personnel CLA TRA Appendix E NHSN Occupation Type Job Function Codes Medical Lab Technician IVT Team Staff Phlebotomist IV Team Medical Technologist Nurse Anesthetist Licensed Practical Nurse Nurse Midwife Nursing Assistant Nurse Practitioner Registered Nurse Fellow Medical Student Physician Intern Resident EMT Paramedic Hemodialysis Technician OR Surgery Technician Patient Care Technician Clerical administrative Transport Messenger Porter Additional Occupation Types ATT CSS CSW DIT DNA DNH DNO FOS HSK ICP LAU MNT MOR OAS OFR OH OMS OTT 03 17 2009 V1 Final Attendant orderly Central Supply Counselor Social Worker Dietician Dental Assistant Tech Dental Hygienist Other Dental Worker Food
127. e Navigation bar on the left to access the features of the rante rposes ay nd val not other se be bded a Select Reporting Plan Then Add Add the Monthly Reporting Plan prior to entering any data for the month you plan to report If you are not sure if the plan has been entered use Find to locate any plans previously added You can add plans for more than one month at a time NHSN National Healthcare Safety Network ISD CLFT NHSN1 NHSN Home My Info Contact us Help Log Out Logged into Pleasant Valley Hospital ID 10312 as RUBY Facility Pleasant Valley Hospital ID 10312 is following the BV component Add Monthly Reporting Plan Mandatory fields marked with Print PDF Form Facility ID Pleasant Valley Hospital ID 10312 _ Month v Year v Hemovigilance Module All reporting is facility wide Copy from Previous Month Adverse transfusion reactions amp all incidents associated with reactions Required Monthly reporting denominators Cl Incidents reporting summary data with detailed reporting of high priority incidents OR JIncidents reporting detailed reports of all incidents a _ a In the Hemovigilance Module there are not too many choices of what to report Adverse Reactions reporting is required so NHSN auio fills that selection for you You do however have to select the type of Incidents reporting you plan to do Add Patient Can be entered two ways Departmen
128. e each year as a result of medical errors In terms of blood safety mistransfusion of blood failure to give the right product to the right patient is the error of greatest concern The purpose of the Hemovigilance Module is to collect analyze and report information on blood transfusion related adverse events This will include two sections adverse reactions and incident reporting A Adverse Reactions Over the past three decades emphasis on the detection and prevention of infectious disease transmission through transfused blood and blood products led to FDA requirements for routine testing of each blood unit for a variety of bloodborne pathogens With enactment of these testing requirements and the subsequent decrease in the incidence of transfusion transmitted infections the remaining problem of reactions from non infectious causes became more apparent A recent review article classified these reactions as early onset during or within hours of the transfusion or late onset days to months following transfusion and provided estimates of reaction occurrence Although the estimates varied considerably depending on the study severe reactions have fatal event rates of 1 per million to 1 per 8 million transfused components Severe early reactions such as Transfusion Related Acute Lung Injury TRALI showed fatal events to be 1 for every 3 6 6 million blood products administered Febrile non hemolytic reactions while uncomfortable for the patie
129. e event can be attributed to the transfusion Probable likely Evidence is clearly in favor of attributing the adverse event to the transfusion Possible Evidence is indeterminate for attributing the adverse event to the transfusion or an alternate cause Dowhtiul Evidence is clearly in favor of attibuting the adverse event to causes other than the transfusion Ruled Out Conclusive evidence beyond reasonable doubt that the adverse event can be attributed to causes other than the transfusion Not Determined The relationship between the adverse reaction and the transfusion is unknown or not stated Adverse reactions for which Imputability is doubtful or ned out should not be routinely reported The only time these categories can be used is where a reaction was initially thought ta be transtusion related but later information revealed a non transfusion related cause Imputability or the strength of the relationship between the transfusion and the adverse reaction is described in the second part of Appendix C Note that if imputability is doubtful or ruled out the reaction should not be reported The only time those categories are used is to classify a reaction that was initially reported as related but was later found to be due to another non transfusion related cause Investigation Results Infection Specify up to 3 organisms Follow case definition criteria in protocol Appendix B a Severity and Imputability are in protocol A
130. e navigation bar and select Add User ID User ID Each user must be assigned a unique User ID Although the User ID is displayed in NHSN it is not used to log in to NHSN The User ID can be any combination of up to 32 letters and or numbers Spaces and special characters are not allowed Mandatory fields marked with SEE User o JANEDBTS Analysis Each user must be assigned his her own User ID Although this ID is displayed in NHSN you do not use it to log in The User ID can be any combination of up to 32 letters and or numbers Spaces and special characters are not allowed Users User Name The user s first and last name are required Optional information such as title and user type can also be added e Logged into Pleasant Valley Hospital ID 10312 as RUBY Facility Pleasant Valley Hospital ID 10312 is folloving the BV component i Add User uee Mandatory fields marked with ta User ID JANEDBTS Up to 32 letters and or numbers no spaces or special d Prefix First Name Middle Name Last Name Doe Title User Active Y Yes User Type HE Hospital Epidemiologist Phone Number Fax Number E mail Address The user s ID first and last names are required fields Optional information can be entered such as title and user type if desired Users User Contact Information The only piece of conta
131. e result of an incident error or accident and may or may not result in a reaction in the recipient Adverse reaction An undesirable response or effect in a patient temporally associated with the administration of blood or blood component s It may or may not be the result of an incident or an interaction between a recipient and blood which is a biologically active product 03 17 2009 V1 Final 6 NHSN Biovigilance Component protocol Forms Hemovigilance Module Monthly Reporting Plan CDC 57 301 Complete one plan at the beginning of each month See tables of instructions for form completion details Hemovigilance Monthly Reporting Denominators CDC 57 303 Use this form to report monthly denominators that will be used in the calculation of rates See tables of instructions for form completion details Hemovigilance Adverse Reaction CDC 57 304 Report each transfusion associated adverse reaction using this form Report one reaction per form If a patient experiences more than one adverse reaction during or following the same transfusion episode complete a separate form for each reaction making sure that the definition of one reaction is not included in the definition of the other e g hypotensive transfusion reaction should only be reported if hypotension is not a part of the symptom description of another more specific reaction experienced by the patient during the same episode Methods Denominators minimum time p
132. e the Group ID number and joining password have been received from the Group Administrator the Facility Administrator or facility user with administrative rights joins the Group for his her own facility From the Group section of the navigation bar he she selects Join and then enters the Group ID and Group Joining Password Join a Group Department of Health and Human Services Centers for Disease Control and Prevention NHSN National Healthcare Safety Network ISD CLFT NHSN1 F NHSN Home Logged into Pleasant Valley Hospital ID 10312 as RUBY Facility Pleasant Valley Hospital ID 10312 is folloving the BV component Reporting Plan ane Memberships Incident ae ees Groups that have access to this facility s data ae Another Test Group 10436 Pee MMS Test Group3 10300 z Surveys Test Group for Blaine 10288 aroni Users Facility Group Confer Rights ion Group ID DO Leave Nominate Log Out NHSN Home Enter ID and Password for this facility to join a new group ni Join Group Joining Password Group OneLP This is the Group Membership page in NHSN where Group ID and Joining Password are entered as described in the previous slide Notice that a facility can participate in multiple groups as shown in the box that states Groups that have access to this facility s data Join a Group 0 H D Department of Health and Human Services lig WI Centers for Disease Control and Prevention Tid NHSN Nation
133. ed at 80 ml hr and the patient s renal function continued to improve She was discharged on 1 15 2009 Department of Health and Human Services Centers for Disease Control and Prevention NHSN National Healthcare Safety Network ISD CLFT NHSN1 Y NHSN Home Logged into Pleasant Valley Hospital ID 10312 as RUBY Facility Pleasant Valley Hospital ID 10312 is folloving the BV component Reporting Plan Add Incident NHSN Home My Info Contact us Help Log Out Mandatory fields marked with Print PDF Form Facility ID Pleasant Valley Hospital ID 10312 v Incident Local Incident or Log 456 Discovery Date of discovery 01 08 2009 Time of discovery o8 30 HH MM ClTime approximate Time unknown Where in the facility was the incident discovered i NPTCBLOOD NONPTC NALAB BLOOD How was the incident first discovered AUDIT Routine audit or supervisory review At what point in the process was the incident first discovered RA Post Transfusion Review Audit This incident was discovered at 8 30 a m on 1 8 2009 when the blood bank through routine review discovered that a wrong unit had been issued The point in the process at which the incident was first discovered was RA or Post Transfusion Review Audit Occurrence Weds oa ae dices 01 08 2009 Where in the facility did the incident occur aaea aE NPTCBLOOD NONPTC NA LAB BLOOD Ti
134. ed in only one component any user with edit rights in that component can edit the information or delete the record If a patient record has been entered or used in both Patient Safety and BV only the Facility Administrator can edit the information or delete the record However if the Facility Administrator attempts to delete a patient record any events pertaining to that patient must be deleted first Summary Ye In this training you learned The role of the Facility Administrator How to add the Biovigilance Component to an existing NHSN facility How to set up Users Locations Rules for managing information across components To summarize in this session we discussed the role of the Facility Administrator adding the Biovigilance Component to an existing NHSN facility setting up users and locations and rules for managing information across components National ee eles afety Network eae or Need Help Contact User Suppor For further information please read the resources on the NHSN website that were referred to in this training If you have questions or need help send an email to NHSN at Thank you T3 K Wf A SS s T National Healthcare Safety Network Groups in Biovigilance SAFER HEALTHIER PEOPLE Welcome to the National Healthcare Safety Network training on Groups in Biovigilance Target Audience Facilities interested in joining or creating a group in NHSN Organ
135. educed and whole blood derived red blood cells not modified by any of those methods that were transfused during the month If none enter 0 Do not include the units Required Indicate the number of units and aliquots of irradiated only RBCs that were transfused If none enter 0 Do not include the units from which the aliquots were made in your unit count Leukocyte reduced Required Indicate the number of units and aliquots of leukocyte reduced only RBCs that were transfused If none enter 0 Do not include the units from which the aliquots were made in your unit count Required Indicate the total number of units and aliquots of leukocyte reduced RBCs transfused that were both irradiated and leukocyte reduced If none enter 0 Do not include the units from which the aliquots were made in your unit count Total apheresis Required Enter the total number of units and aliquots of irradiated leukocyte reduced irradiated amp leukocyte reduced and apheresis RBCs not modified by those methods that were transfused during the month If none enter 0 Do not include the units from which the aliquots were made in your unit count Irradiated Required Indicate the number of units and aliquots of irradiated only apheresis RBCs that were transfused If none enter 0 Do not include the units from which the aliquots were made in your unit count Leukocyte reduced Required Indicate the number of units and aliquots of leukocyte reduced o
136. em must conform to the following minimum requirements Intel based system with a 486 CPU or greater e Windows 98 Windows NT 4 0 or greater Internet connectivity M 24 2 Done Internet Astart G1 O FK El connecte linbox mi El Microsoft BA whatis t MARE what Ile Isecure D You will be taken to the SDN registration page Read the entire page SDN Registration Page Z Secure Data Network Enrollment Microsoft Internet Explorer l x File Edit View Favorites Tools Help Back gt A A Gsearch Favorites Meda J Ary 3 w 3H Address a https ca cde gov sdncode sdnapp doc RegistrationDoc htm gt Go Links 7 multiple certificates Only one digital ID is required to verify your identity for any and a SDN systems you access from the same computer and the same browser Digital IDs can be copied exported from one machine to another and SDN allows for this The process is not routine however and in some cases Digital IDs cannot be exported from one operating system to another from one type of browser to another or even from one version of a browser to another version of the same browser Obtaining and installing a Digital ID is not difficult but in the process your browser may present you with many technical messages We have no control over the messages your browser displays Documentation is available for the enrollment process and is intended to assist you in obtaining
137. en Once you have entered the location mapping information click on Add You will receive a message telling you that the location has been successfully added Patient Record fa patient record has been entered in a component that is now inactive date of birth gender and birthweight cannot be edited nor can the record be deleted lf a patient record has been entered and used in only one component any user with appropriate rights in that component can edit the information or delete the record lf a patient record has been entered or used in both Patient Safety and Biovigilance e g a patient entered as part of a patient safety event also was entered for a blood transfusion adverse reaction only the Facility Administrator can edit the information or delete the record lf the Facility Administrator attempts to delete the record any event records pertaining to that patient must be deleted first Other information used by both Patient Safety and BV is the Patient Record Healthcare associated infection influenza vaccination and process of care events for a patient are captured in the Patient Safety Component In Biovigilance the same patient may have been entered for an adverse reaction event related to blood transfusion If a patient record has been entered in a component that is now inactive date of birth gender and birthweight if entered cannot be edited or deleted If a patient record has been entered and us
138. en Technische Universiteit Eindhoven 03 17 2009 V1 Final 32 NHSN Biovigilance Component protocol Table 1 Instructions for Completion of the Hemovigilance Module Annual Facility Survey CDC 57 300 For all questions referring to past year use calendar year not fiscal year Instructions for Form Completion Facility ID The NHSN assigned facility ID number will be autoentered by the computer Survey Year Required This should be the most recent previous year for which annual facility statistics are available For example if you are completing this in February 2008 your survey year should be 2007 Facility Characteristics 1 Ownership Required Check the ownership type that most closely represents your facility 2 Is your hospital affiliated with a Required If your hospital is associated with a medical school indicate the type of affiliation Major affiliation is defined as Training programs 1 year in length each resident would spend 2 months at the affiliate institution Training programs 2 years in length each resident would spend 4 months at the affiliate over the 2 year period Training programs 3 or more years in length each resident would spend at least 6 months at the affiliate over the entire training period Graduate affiliation is defined as The institution is affiliated with the medical school only for its graduate programs and one or more is in effect e House staff of the Graduate Medi
139. en ResLeu lt 5lag6 FREE RED BLOOD CELLS CPD 450mLirefg Open Albumin added RBC RED BLOOD CELLS CPD 450mLrefg Open Plasma added RBC RED BLOOD CELLS CPD 450mLirefgllrradiated IRRBC RED BLOOD CELLSICPD 450mL refgllrradiated ResLeu lt Slog6 IRLRRBC To illustrate how the mapping works this slide shows a snapshot of a section from each of the two code lists The NHSN mapping codes are shown in the right hand column Blood Product Mapping for PVE MES Product Description Apheresis platelets Irradiated apheresis platelets Leukocyte reduced apheresis platelets Irradiated leukocyte reduced apheresis platelets Whole blood derived platelets Irradiated whole blood derived platelets Leukocyte reduced whole blood derived platelets Irradiated leukocyte reduced whole blood derived platelets VVhole blood derived red blood cells Irradiated whole blood derived red blood cells Leukocyte reduced whole blood derived red blood cells Irradiated leukocyte reduced whole blood derived red blood cells Apheresis red blood cells 17 Irradiated apheresis red blood cells Leukocyte reduced apheresis red blood cells 19 Irradiated leukocyte reduced apheresis red blood cells 20 VVhole blood derived plasma Apheresis plasma Cryoprecipitate Granulocytes Lymphocytes 25 Whole blood Serum Mononuclear cells Leukocytes compCDCdesc prodTYPE IRVVBDPLAT LRVYVBDPLAT IRLRVY BDPLAT VWBDRBC IRVVBDRBC LRVVBDRBC IRLRVVBDRBC APHRBC IRAPHRBC
140. enerate Data Sets Modify Attributes of the Output Output Options Last Modified On 04 08 2009 Users Output Type Line Listing v S tput Name Line Listing All Adverse Reaction Data Output Title February Adverse Reactions in Females TSS To change the title of your reports go to the section on the Modify screen to Modify Attributes of the Output You can change the Output Name or the Output Title by simply typing in a new name Modifying Date Variables For any date variable you can select month quarter half year or year instead of specific dates For example Month February 1 February 28 e Beginning 02 2009 a i a0 010 R072722 0101S e Can also span multiple months for example 02 2009 03 2009 Quarter January 1 March 31 e Beginning 2009Q1 or Q2 Q3 Q4 e Ending 2009Q1 Half year January 1 June 30 e Beginning 2009H1 or H2 e Ending 2009H1 Year January 1 December 31 e Beginning 2009 e Ending 2009 Select a time period or Leave Blank for Cumulative Time Period Select the variable Date Variable Beginning Ending with the same time advRxnDateYM 2 2009 02 2009 period for example YM Year Month NL Enter Date yefiable Time period at the time you click the Run button You can modify date variables in a number of ways using specific dates or time periods For example you can run a report for an entire month by selecting only the mon
141. ent Incident is the NHSN assigned number System will bring up incidents that have the same Patient ID as reported on the Adverse Reaction form NHSN National Healthcare Safety Network ISD CLFT NHSN1 Logged into Pleasant Valley Hospital ID 10312 as RUBY Facility Pleasant Valley Hospital ID 10312 is following the BV component Incident Link List NHSN Home My Info Contact us Help Log Out First Previous Next Last Displaying 1 1 of 1 Check all that apply SE 01 Displaying 1 1 of 1 105 rp57923 01 10 2009 First Previous Next Last The actual linking process is initiated from the Adverse Reaction event screen When you click on this button the system will bring up a list of all incidents entered that have the same Patient ID as reported on the Adverse Reaction form The Incident is the NHSN assigned number as shown on slide 47 Find an Incident Locate any incidents that have already been entered using NHSN incident Incident code e g all incidents with code SC 01 All incidents that occurred in a specific facility location All incidents within a certain time period HHBH Halemal Healilsare Salety Helv 150 ELFT HHEN wad m t Walley Hopital IG 2022 as AUE apt POD12 ia alis Find Incident Clicking on Find without entering criteria will bring up a list of all incidents 5 You can locate any incidents that have already been entered
142. ent Guide is available on the NHSN website and contains important additional information to guide you through the enrollment process NHSN Website http www cdc gov nhsn CDC Home DC Centers for Disease Control and Prevention Your Online Source for Credible Health Information OE The National Healthcare Safety Network NHSN is a voluntary ae secure internet based surveillance system that integrates and Tose te mj L xL expands legacy patient and healthcare personnel safety i Lgl Email page surveillance systems managed by the Division of Healthcare 8 Print page Quality Promotion DHQP at CDC NHSN also includes a new A component for hospitals to monitor adverse reactions and a ts n Bookmark and share incidents associated with receipt of blood and blood products Bia visibepets Component i Enrollment is open to all types of healthcare facilities in the NHSN Biovigilance Component GOX United States including acute care hospitals long term acute E I Get email updates care hospitals psychiatric hospitals rehabilitation hospitals Biovigilance To receive email outpatient dialysis centers ambulatory surgery centers and long updates about NHSN term care facilities For more information click on the topics below enter your email address Topics Data amp Statistics About NHSN Patient Safety Component States with Facilities Using NHSN Overview External Peer Review Procedure Device Dialysis E
143. entered in NHSN are available to CDC and the facility as soon as they are saved There is no transmission lag Data can be edited after saving Some exceptions with linked information fully explained in other training m Most records can be deleted Now let s talk about some basics of data entry in NHSN Data entered into NHSN are immediately available to CDC and to your facility as soon as they are saved There is no transmission time lag Data can be edited after you have saved or submitted a record There are some exceptions with linked data that are covered in detail in other trainings Most but not all record types can be deleted For example once an annual Facility Survey is entered it can be edited but it cannot be deleted Types of Data Fields Required fields Indicated by red asterisk next to field label Must be completed Conditionally required Answering a field is conditional based on the answer to a previous field e g Name of accrediting organization if laboratory is accredited Optional NHSN does not require the data and the information will not be used in analyses by CDC 23 Data fields in NHSN can be one of three types required conditionally required or optional Required fields are indicated by a red asterisk and must be completed in order to save the record Patient date of birth and gender are examples of required fields in NHSN A conditionally required fie
144. eporting Require ments for Partkipaton Once sxered Ino cnet NHSN esc nta iiky m ust enn WHS NJ nernec pased dace encry Inectace and or daca Im port cook for es Successfully com okee an annual survey for eac n com poner selecoed Successfully com olece one or more modules of ene com poner selecoed Suey requires cnt tolka ing forte kad mno ahned eming alee cach rost ug efor wey ol ibe rods kawil be sxa fot tbat woot Ouais fo at kaat ore rod aebeucd fota niman ol rosrba ol ibe cob sda yom u ma Phd ie de tbe croc a fibe Bonilem mno wmn denon koe model twe Oats foe bE ESLI yom LD P LS ELE Mailed Agbee w tbe ackecd nod b gt powm lja creak sa deao ikd i tbe yA Ostin tbe mo stba wies gee g roie YASU nods kad e s d Tho elad aetrcilaece wcutodolgy damor uw for rbe nod sk wed da Drac iked I L Pesol Area cree AER Oa Ta a0 O MLE ae wy Oo Oc eo ea eostad fot tbe rod sh a 10 mcd of tbe oemi sle u COC watis F Tsd ofide mosh Mm boxe mo srba wigs the ded kinne Pitie teenaerc odst ofo hove Troaeta de e m ed coef Lda sgae omend Paaa o salty sro acest sot checka tbat waacaa t be deus fo comekic d ds acy NHS Nitec ikkes m ut agree co report oo Zae neak sucnorkies coose adege crac ace kerrik Incoele fac lley oy ene s uevelllanke syscem and amou wnk acm comacced oy COC Falluee co com oly Wen crease requirements will sesuk Ina keadeasal trom cne H tac licks Ill pe offered coe ooporcunicy 00 dow nbad enel dace pore pel
145. er complaints incident reports and internal and external audit findings Error reporting is a process improvement identification tool that provides a means for capturing tracking and trending data It can be used to measure the success of process improvement initiatives and promote and support change Eventually information can be used in aggregate to compare your facility with others of similar size and transfusion volume Reasons Why Employees Do Not Report Mistakes Too busy Complicated and time consuming documentation process Not able to report anonymously Hesitancy to tell on someone Fear of disciplinary action Belief that it is unnecessary to report when no negative outcome Easier to just fix error than tell about it Lack of knowledge of what to report Lack of knowledge of how to report Lack of awareness of the value of reporting in order to improve safety and quality There are a number of reasons why employees do not report mistakes They feel they are too busy the documentation process is complicated and time consuming they are not able to report anonymously there s a hesitancy to tell on someone fear of disciplinary action a belief that it is unnecessary to report when there is no negative outcome sometimes it s easier to just fix the error than to tell about it there s a lack of knowledge of what to report a lack of knowledge of how to report and a lack of awareness of the value of reporting in
146. era scleral icterus secondary to an increased level of bilirubin Nausea vomiting Nausea and or vomiting experienced during or within 4 hours of the completion of transfusion Oliguria New onset of decreased urinary output within 72 hours of the identification of the blood transfusion reaction lt 500 cc output per 24 hours Other skin rash Other non urticarial skin rash experienced during or within 4 hours of the completion of transfusion Pain abdominal back chest flank headache pain at infusion site or other pain Pain experienced at any site during or within 4 hours of completion of transfusion Pruritis itching Shock A drop in blood pressure accompanied by a drop in cardiac output including rapid heart rate increase to 2 100 beats per minute rapid breathing cutaneous vasoconstriction pallor sweating decreased or scanty urine production agitation and or loss of consciousness that required fluid resuscitation with or without inotropic support Shortness of breath dyspnea New onset or significant worsening of shortness of breath or a significant increase in respiratory rate with or without hypoxemia during or within 24 hours of the completion of transfusion Urticaria Raised red spots with or without itching or generalized itching without redness during or within 4 hours of the completion of the transfusion 03 17 2009 V1 Final 12 NHSN Biovigilance Component protocol Append
147. erformed incorrect PC 02 Shipman incomplete incorrect PC 03 Product and paperwork don t maich PC 04 Shipped under inappropriate condmons PC 05 Inapprapriate retum ta Inwemory PC 06 Product confirmation PC 07 Administrative check Product Storage US 01 Incarrect storage of product in transfusion service US 02 Expired product in stock US 03 Inappropriate monitoring of storage device US 04 Unit stared on incorrect ABO shelf Sample Handling and Receipt SH 01 Sampie arrives without requisition SH 02 Requistion amp sample label don t maich SH 03 Patien ID incorecyilegibie on requisition SH 05 No phiebotomist witness idenstication SH 06 Sample arrives wiih incorrect requisition SH 07 Patient information missing or incorrect on requisition SH 10 Sample transpor issues SR 01 Sample processed in error SR 04 Sample incorrectly accessioned SR 05 Duplicate sample sent ot Physician Orders Blood Praduct PR 01 Order for wrong patient PR 02 Order incorrectly amered onina PR 03 Special needs not indicated an order CMY etc PR 04 Order nat done incomplete incorrect PR 05 Inappropnatetincorrect test ordered PR 06 Inappropriaieincorrect Bhod product ordered Product Manipulation Order Entered into System by Nursing Unit Staff PR 01 Order for wrong parent PR 02 Order incorrectly emered ordine SKIP IF MD ORDERS DIRECTLY ST 16 Inappropeiate expired magerts used
148. eriod for a report is monthly e Number of units of any particular product transfused Numerators e Each reported adverse reaction Adverse reactions that meet case definition criteria as a definitive or probable case will be included as the numerator in all reports unless stated otherwise e Deaths related to transfusion e Others as needed depending on the analysis Proposed Data Analysis and Output Facilities will have the ability to generate a number of custom reports In addition certain reports will be generated using information from all participating facilities after the first year of data collection is completed Mechanisms for facilities to use the NHSN hemovigilance module to help generate FDA required reports are being developed Aggregate analysis 1 Rates of each adverse reaction by product transfused 2 Comparison of reaction rates as compared to other facilities of similar structure and size 3 Fatality rates 03 17 2009 V1 Final 7 NHSN Biovigilance Component protocol 4 Other analyses and reports may be generated as need dictates Facility level reports 1 Detailed line listing of all reactions by selected time period This includes patient demographics reaction occurrence details time location etc component information protocol criterion met grade and relationship patient outcome 2 Frequency report Month numbers of each reaction per product transfused total of each product transfused for the time pe
149. erred by a facility to a Group CDC cannot be held accountable for how the Group uses the facility s data and there is no assurance of confidentiality Before conferring rights to any Group a facility may want to work with the Group to ensure that any necessary documentation or mechanisms are in place to protect the confidentiality of its data to the extent possible The Assurance of Confidentiality that is provided to NHSN facilities by CDC applies to information reported to CDC through NHSN that is maintained and used by CDC in aggregate reports Once rights have been conferred by a facility to a Group CDC cannot be held accountable for how the Group uses the facility s data and there is no assurance of confidentiality Before conferring rights to any Group a facility may want to work with the Group to ensure that any necessary documentation or mechanisms are in place to protect the confidentiality of its data to the extent possible Confer Rights to a Group Biovigilance Component NHSN National Healthcare Safety Network ISD CLFT NHSN1 NHSN Home My Info Contact us Help Log Out NHSN Home Logged into Pleasant Valley Hospital ID 10312 as RUBY Facility Pleasant Valley Hospital ID 10312 is following the BV component Reporting Plan sane Confer Rights Biovigilance Incident WM Please select the rights that group AABB Group should have to facility Pleasant Valley Reaction Hospital Patient Safety Y
150. ers who need to apply for a digital certificate should read and follow the instructions provided in the User Start up Guide that is available on the NHSN website Facility Administrator logs in to httos sdn cdc gov Clicks on NHSN Reporting CDC Public Health Partners You are logged in as Maggie Dudeck My Applications Morbidity and Mortality Weekly Re National Healthcare Safety Network NHSWN This Week in MMWR November 9 2007 Great American Smokeout Nove WHSN Enrollment Cigarette Smoking Among Adults WHSN Reporting shimurium Infection A Request Additional Activities Recommendations and Reports Novem Electronic Reference gt Interpreting and Managing Blood Li Lead Recommendations of CDC Select a database and search term to locate gt Appendix Guide to Resources fc journals Database PubMed ka Search for Let s outline the steps for the Facility Administrator of a facility previously enrolled in NHSN Patient Safety Component to add the Biovigilance Component The Facility Administrator logs into the Secure Data Network or SDN and clicks on NHSN Reporting Select Facility gt Add Edit Component Department of Health and Human Services Centers for Disease Control and Prevention NHSN National Healthcare Safety Network ISD CLFT NHSN1 NHSN Hi Logged into Mount Sinai Medical Center ID 10127 as RUBY Facility Mount Sinai Medical Center ID 10127 is follow
151. ery enter exact time using military time 24 hour clock If you know approximate time provide estimate otherwise check Time Unknown m Where in the facility was the incident discovered Select a facility defined location from the drop down list This may or may not be the same location where the incident occurred Discovery Date of discovery _ f f 2 _ _ Where in the facility was the incident discovered Time of discovery _ _ _ HH MM O Time approximate LJ Time unknown The date of discovery is the earliest date at which the incident was known to have occurred It should be the same date or later than the date of occurrence It should also be a date that falls within the month you are monitoring Enter the exact time of discovery using the 24 hour clock or military time If for example you Know the error occurred around the time of shift change at 7 a m but don t know the exact time you would enter 07 00 and check time approximate Select a location for Where in the facility was the incident discovered from your facility location drop down list This may or may not be the same location where the incident occurred Discovery How was the incident first discovered Check the box of the description that most closely describes how the error was discovered If Other is selected include a brief description in the space provided m At what point
152. es could not be tested in the donor Possible Apparent TA GVHD when alternative explanations of cause are likely but TA GVHD cannot be confirmed such as with negative chimerism studies or in the setting of allogeneic solid organ transplantation NHSN Biovigilance Component protocol T 9 Transfusion related acute lung injury TRALI Acute hypoxemia with PaO fraction of inspired oxygen F10 ratio of 300 mm Hg or less combined with chest x ray showing bilateral infiltrates in the absence of left atrial hypertension i e circulatory overload There is abrupt onset in association with transfusion Case Definition Criteria Signs amp Symptoms Definitive NO evidence of acute lung injury ALI prior to transfusion AND Acute onset of ALI during or within 6 hours of transfusion AND Hypoxemia defined by e PaQz2 FiO2 lt 300 mm Hg OR e Oxygen saturation is lt 90 on room air OR e Other clinical evidence AND NO evidence of left atrial hypertension i e circulatory overload AND NO temporal relationship to an alternative risk factor for ALI during or within 6 hours of completion of transfusion Probable N A Possible Same as definitive EXCEPT there is a temporal relationship to one of the following alternate risk factors e Direct Lung Injury Aspiration Pneumonia Toxic inhalation Lung contusion Near drowning e Indirect Lung Injury o Severe sepsis Shock Multiple trauma Burn
153. f a The index donation testing was negative and b The donor was subsequently found to be infected but c The recipient had no pre transfusion history of the same infection For a decision on imputability the following evidence is considered 1 Evidence of contamination of the recipient unit upon residual testing 2 Pre and post transfusion infection status e g seroconversion in the recipient 03 17 2009 V1 Final 24 NHSN Biovigilance Component protocol 3 Evidence of other recipients with infection from the same organism who received blood from the same donor 4 Evidence of donor infection with the same organism Imputability only report definite probable or possible Definite 1 An investigation trigger with laboratory evidence of the suspected organism in the recipient AND 2 Laboratory evidence that the same recipient was negative for this organism prior to transfusion AND 3 Laboratory evidence of the same organism in the donor NOTE For bacterial cases identification of the organism in the unit upon residual testing is equivalent to laboratory evidence of the same organism in the donor AND EITHER 4 Laboratory evidence of the same organism in any other recipients from the same donor as the initial case recipient OR 5 Laboratory evidence of the same organism in the recipient unit upon residual testing Probable 1 An investigation trigger with laboratory evidence of the suspected organism in the recipient
154. f each reporting month be sure to enter your monthly denominators Select Summary Data on the left navigation bar and Hemovigilance Monthly Reporting Denominators as your Summary Data Type Department of Health and Human Services Centers for Disease Control and Prevention NHSN National Healthcare Safety Network ISD CLFT NHSN1 NHSN Home My Info Contactus Help Log Out Logged into Pleasant Valley Hospital ID 10312 as RUBY Facility Pleasant Valley Hospital ID 10312 is following the BV component Hemovigilance Module Monthly Reporting Denominators Mandatory fields marked with Print PDF Form Facility ID 10312 Pleasant Valley Hospital Month January v Year 2009 v Units Aliquots Product Transfused Transfused Red blood cells Whole blood TOTAL derived Irradiated Leukocyte reduced Irradiated amp leukocyte i i These are total products in specific categories that have been transfused for the month Please refer to the Tables of Instructions for details of how to complete each field Except for the Total fields other categories are mutually exclusive We are not collecting denominators for every type of product for example there is no category for Whole Blood These denominators will be used to calculate rates of adverse reactions or incidents so you will want to be sure they are accurate The Hemovigilance Annual Facility Survey provides
155. ficates provide the following benefits Data being sent to NHSN is encrypted so that only CDC can read it Provides assurance to NHSN that the data have not been changed in transit Certifies that the certificate owner actually transmitted the data What is a digital certificate A digital certificate provides an electronic means of proving your identity in order to securely conduct business with NHSN By securely conducting business your digital certificate ensures that data being sent to NHSN is encrypted so that only NHSN can read it provides assurance to NHSN that data have not been changed in transit and certifies that the owner of the certificate actually transmitted the data Additional Information about Digital Certificates User specific do not share your digital certificate with another user Each user must have his own digital certificate Installed on your computer Make a copy as soon as it is installed Can be installed on additional computers CDC pays for the digital certificate Digital certificates expire 12 months from the date of installation You must apply for a new certificate each year Here is some additional information about digital certificates A digital certificate is user specific It cannot be shared with another user Each user must have his or her own digital certificate The digital certificate is installed on your computer Make a copy of your certificate as soon as it is i
156. ficiency imputability should not be classified higher than possible NHSN Biovigilance Component protocol 7 Transfusion associated dyspnea TAD Characterized by respiratory distress within 24 hours of transfusion that does not meet the criteria of TRALI TACO or allergic reaction Respiratory distress should not be explained by the patient s underlying condition Case Definition Criteria Grade Severity Relationship to Transfusion Imputability Signs amp Symptoms Laboratory Radiology Definitive Definitive N A Use grades as provided in Use the general criteria of Acute respiratory distress Appendix C Imputability in Appendix C AND Occurs within 24 hours of transfusion AND TRALI TACO allergic reaction and patient s underlying condition ruled out Probable N A Probable N A Possible N A Possible N A 03 17 2009 V1 Final 21 NHSN Biovigilance Component protocol 8 Transfusion associated graft vs host disease TA GVHD The introduction of immunocompetent lymphocytes into susceptible hosts The allogeneic lymphocytes engraft proliferate and destroy host cells Case Definition Criteria Signs amp Symptoms Definitive A clinical syndrome occurring from 2 days to 6 weeks following transfusion characterized by symptoms of e Fever e Characteristic rash erythematous maculopapular eruption centrally that spreads to extremities and may progress to generalized erythroder
157. fields marked with Print PDF Form Facility ID Pleasant Valley Hospital ID 10312 a Incident Local Incident or Log 5678 Discovery Date of discovery 01 05 2009 Where in the facility was the incident discovered hele te en NPTCBLOOD NONPTC NA LAB BLOOD Time of discovery 10 00 HH MM Time approximate Time unknown How was the incident first discovered OTHER Other Specify Comparison of unit label with transfusion slip At what point in the process was the incident first discovered Ul Product issue v Our date and time of discovery are 1 5 2009 at 10 00 a m because that was the moment the tech noticed that the unit number on the bag did not match the one on the transfusion slip The incident was discovered in the blood bank Since the incident was discovered by comparison of the unit label with the transfusion slip it does not quite fit any of the pre defined selections under How was the incident first discovered so we will select Other and provide brief text in the specify field The point in the process at which the incident was first discovered was Ul or Product issue Occurrence Date incident occurred 01 05 2009 ze Where in the facility did the incident occur NPTCBLOOD NONPTC NA LAB BLOOD Time incident occurred 08 30 HH MM Aino MlTime approximate Time unknown Job function of the worker involved in the incide
158. gged into Pleasant Valley Hospital ID 10312 as RUBY Facility Pleasant Valley Hospital ID 10312 is following the BV component Nominate Group Q ueve Note This form should be used for nominating organizations that serve as groups If the proposed administrator for the group is already a user in the NHSN system check the Use Existing NHSN User option below For that case you will be prompted to enter the unique e mail address of that person If the proposed administrator does not already exist check the Create New NHSN User option For that case you will be prompted to provide a User ID and initial password for that user along with the person s name email address and phone number Enter group data Mandatory fields marked with Group Name HV Test Type of Group QI Quality Improvement Patient Safety Organization If group type is Other enter type here Group Administrator Information Use existing NHSN user Create new NHSN user Let s take a look at how this appears on the NHSN screen In this example the Facility Administrator from Pleasant Valley Hospital has nominated HV Test Group a patient safety organization Since the Group Administrator is not a current NHSN user click on the circle to Create new NHSN user Group Administrator Information ose existing NHSN user Create new NHSN user ote To specify a new user as the administrator of this group enter that person s n
159. hallenge phrase must e Be at least 8 characters long e Contain only English letters numbers or any of these characters 6 5 4 e Contain at least one non alphabetic character e Not contain your name or any part of your email address e Not be a word unless the word is either Broken up by one or more non alphabetic characters Prefixed or suffixed by three or more non alphabetic characters e Not contain more than two consecutive repeating characters e Contain at least 4 unique characters Challenge phrases are case sensitive so be sure to remember if any letters are capitalized While not required a challenge phrase containing mixed case letters is more secure and we invite you to consider using one More Information and Examples Challenge Phrase 30 Next you will be asked to enter a challenge phrase or password About Your Challenge hrase Password that you use to log into SDN and access NHSN Case sensitive Write it down and store in a secure place Do not share your phrase with anyone including co workers and IT staff Must meet certain criteria Your challenge phrase is the password you use to log into SDN and access NHSN It is case sensitive Write it down and put it in a secure place Do not share your phrase with anyone The phrase must meet certain criteria SAFER HEALTHIER PEOPLE SDN Support 800 532 9929 770 454 4863 phintech cdc gov Challenge Phrase
160. hat is available to you in Biovigilance Some of the reports you see listed are canned reports with pre defined variables but any report can be modified Output Options Line Listing Frequency Table Bar Chart Pie Chart Four canned output options or report styles are available line listing frequency table bar chart and pie chart Line Listing Sample adverse reaction line list using test records Canned report of data reported for all adverse reactions but can be modified National Healthcare Safety Network Adverse Reactions in February 2009 As of April 9 2009 at 10 19 AM Date Range HVADVRXN advRxnDate 02 01 2009 to 02 28 2009 CDC Hours Case Component Date Time Adverse Admin Definition Code Expiration Unit Reaction to Grade Criteria Location Description Date Administered Date Time Reaction Reaction Description Description INMEDCC RBC Red 02 05 2009 02FEB09 10 00 02FEB09 12 12 2 FNHTR LT Life POS blood cells threatening Possible 112 DA1234 F INPLSWARD IRRBC 02 15 2009 02FEB09 13 13 02FEB09 13 40 D Death DEF Irradiated Definitive red blood cells 113 DA2345 V PEDSOTSCA RBC Red 02 11 2010 01FEB08 16 16 12FEB09 12 12 9044 _ ALLERG LT Life DEF blood cells threatening Definitive INORCATH LRRBC 02 10 2009 O2FEB09 11 45 02FEB09 12 12 NS Non POS Leukocyte severe Possible reduced red blood cells This slide shows a line listing u
161. he Group Administrator already has a digital certificate another one will not be necessary He she would just request a new program activity For this it would be Program NHSN Activity NHSN Reporting Although the Group Administrator must have a digital certificate the Group does not enroll in NHSN Email from NHSN to Group Administrator You have been designated as the Group Administrator for the following NHSN group Group Name HV Test Group ID 10001 Group Type Quality Improvement Patient Safety Organization This group nomination was performed by Name Jane Doe Phone 404 555 1234 In order to access NHSN you will need to obtain and install a digital certificate onto the computer you plan to use for connecting to the NHSN Please print a copy of the document entitled SDN Enrollment Guide A Guide for using the Secure Data Network to Obtain a Digital Certificate and to Enroll in a CDC Program from the following URL etc Here is an example of the email the Group Administrator receives once the Group has been nominated by a facility The email contains the Group ID number the Group Administrator will share with joining facilities After acquiring digital certificate Group Administrator m Logs in to NHSN Reporting and sets Group joining password Shares the Group ID and joining password with those NHSN facilities that should join the Group oe NOTE The Group ID is a 5 digit number assigned b
162. her a patient reaction was associated with the incident and enter the Patient ID for B Thomas This is the same Patient ID that will be used when we complete and enter our Adverse Reaction form into NHSN Case 4 Investigation Result Investigation Results Did this incident receive root cause analysis Y Yes Results of analysis Check all that apply Cl Technical C Organizational M Human J Patient related Other Custom Fields m A full Incident report in NHSN must be completed for any incident where product has reached the patient regardless of whether the patient is harmed This incident also received root cause analysis and it was deemed to be due to human failure A full incident report in NHSN must be completed for any incident where product has reached the patient regardless of whether the patient is harmed Save the Record m Any record form in NHSN must be saved before exiting You can t partially complete a record and return later to finish You can t save a record until all required fields have been completed Comments NHSN National Healthcare Safety Network ISD CLFT NHSN1 NHSN Home My I F NHSN Home Logged into Pleasant Valley Hospital ID 10312 as RUBY Facility Pleasant Valley Hospital ID 10312 is following the BV component Reporting Plan ie Add Incident Patient Incident M Incident 130 created successfully D Add D Find Windows Internet Explorer If you
163. heresis LRRBC AS 1 RED BLOOD CELLS LEUKOCYTES REDUCED IRRADIATED ACDA anticoagulant by pheresis IRLRRB Cg AS 1 RED BLOOD CELLS LEUKOCYTES REDUCED DIVIDED ACDA anticoagulant by pheresis Part A or 1 LRRBC AS 1 RED BLOOD CELLS LEUKOCYTES REDUCED DIVIDED ACDA anticoaguilant by pheresis Part B or 2 LRRBC AS 1 RED BLOOD CELLS LEUKOCYTES REDUCED DIVIDED ACDA anticoagulant by pheresis Part C or 3 LRRBC AS 1 RED BLOOD CELLS LEUKOCYTES REDUCED DI IDED ACDA anticoagulant by pheresis Part D or 4 LRRBC AS 1 RED BLOOD CELLS LEUKOCYTES REDUCED DIVIDED ACDA anticoagulant by pheresis Part E or 5 LRRBC 4S 1 RED BLOOD CELLS LEUKOCYTES REDUCED DIVIDED A CDA anticoagulant by pheresis Part F or 6 LRRBC AS 1 RED BLOOD CELLS LEUKOCYTES REDUCED DIVIDED ACDA anticoaguiant by pheresis Part G or 7 LRRBC AS 1 RED BLOOD CELLS LEUKOCYTES REDUCED DIVIDED ACDA anticoaquiant by pheresis Part H or 8 LRRB ig 3 S 4BED BL GEhbd 5 LEUI TES REDUCED IRRADIA T DiparemMaquiantiby pheresis econd b uble ramlood lajo ESAF BLOG Salts LEUKGIBTES REDUCI pure pas guianes phoresis second bag giaa ble rg lood ISBT 128 new standard RED BLOOD CELLSICPD 450mLitefg RBC RED BLOOD CELLSICPD 450mLrefg Open RBC NHSN mapping RED BLOOD CELLS CPD 450mLirefg Openlirradiated IRRBC RED BLOOD CELLS CPD 450mL refq Openllrradiated ResLeu lt 5lag IRLRRBC codes RED BLOOD CELLS CPD 450mL refg Open lrradiated Plasma added IRRBC RED BLOOD CELLS CPD 450mLirefg Op
164. however AABB has no direct access to Log Out the data or other information contained in this or any other NHSN module All data collected through this module are protected by the same information security safeguards that apply to all NHSN modules Advancing Transfusion and Cellular Therapies Worldwide NHSN Hemovigilance Module Home Page NHSN maintenance may occur nightly between 12am and 6am Eastern time You will be taken to the Hemovigilance Module Home Page You are now ready to set up your facility Review 5 Step NHSN Enrollment Process Facility Administrator Reviews and accepts Rules of Behavior Registers Applies for and installs an SDN digital certificate for NHSN Enrollment activity Prints completes and submits enrollment forms online Prints signs and returns Consent Form to NHSN Let s review the five step NHSN enrollment process First the Facility Administrator reviews and accepts the Rules of Behavior Next register After registering apply for and install the SDN digital certificate for NHSN Enrollment Activity Then print complete and submit your enrollment forms on line Last print and sign your Agreement to Participate and Consent and send by surface mail to NHSN National Healthcare MIS Safety Network Questions or Need Help Contact User Suppor That concludes our Enrollment Training Please contact NHSN at NHSN cdc gov if you have questions or
165. iddle Name gt Gender Date ofBirth Ea Birth Weight grams Race American Indian Alaska Native Asian C Black or African American C Native Hawaiian Other Pacific Islander 12 CI white For Hemovigilance we suggest that you add Patient when you add the adverse reaction because the Patient screen from the navigation bar does not include Blood Group If you enter a patient using Add Patient you will still be required to add the patient s blood group when you enter the adverse reaction Note that birthweight is a field on this screen that you don t see on the Adverse Reaction screen If you are entering information on a neonate you may want to enter this information Patient Identifiers Some are optional but your facility may prefer to use them wo additional fields appear on this screen for Hemovigilance Adverse Reaction generated by NHSN Blood Group NHSN National Healthcare Safety Network ISD CLFT NHSN1 NHSN Home My Info Contactus Help Log Out Logged into DHQP MEMORIAL HOSPITAL ID 10018 as RUBY Facility DHQP MEMORIAL HOSPITAL ID 10018 is following HV component Add Adverse Reaction Mandatory fields marked with Print PDF Form mode add headerMode view appcontext null Patient Information Q HELP Facility ID DHQP MEMORIAL HOSPITAL ID 10018 Adverse Reaction N Patient ID Social Security N Siia Last Name First Name Mi
166. idents of adverse reactions associated with incident TOTAL Monthly Reports 1 8 2009 Required Indicate the four digit year 0 Indicate the four digit Required Indicate the four digit year 0 Required Enter the total number of incidents for each process point incident code Incident codes marked by a are high priority events and must have a detailed neen form also completed Be sure to include any incidents that were reported using the Incident form in the totals on this form If no incidents were observed for a particular process code leave it blank Required Enter the total number of adverse reactions that were observed for any incident code Any incident that resulted in an adverse reaction must have an Incident form completed Required Enter the total number of incidents and adverse reactions associated with incidents for the month If no incidents or adverse reactions associated with incidents ere observed enter 0 in the appropriate field Table 4 Instructions for Completion of Monthly Reporting Denominators CDC 57 303 kere Instructions for Form Completion Facility ID The NHSN assigned facility ID number will be autoentered by the computer Month Required Enter the month for which you are reporting This form is completed and entered after the completion of the month for which you are reporting Units and Aliquots Transfused irradiated leukocyte reduced irradiated amp leukocyte r
167. idents reporting summary data with detailed reporting of high riority incidents OR O Incidents reporting detailed reports of all incidents Hemovigilance requires monthly reporting of all adverse reactions Facilities have the option of filing a detailed long report of all incidents or can file long reports for high priority incidents and summary only data for minor incidents Provide numbers that will be used to calculate rates of adverse events by product transfused SS ERER Hemovigilance Module Monthly Reporting Denominators Facility ID Month Year Transfused Transfused O Apheresis TOTAL Pe Irradiated O Oooo n Indicates required fields Red blood Whole blood TOTAL cells derived Irradiated Leukocyte reduced Irradiated amp leukocyte reduced Irradiated amp leukocyte reduced Platelets Whole blood TOTAL derived Irradiated Leukocyte reduced Irradiated amp leukocyte reduced gt t D Monthly reporting denominators will provide numbers to determine rates of adverse reactions by product transfused Use the Tables of Instructions for guidelines on completing to make sure you are filling it out correctly ey OSS Ya way To Start m Contact the infection prevention control department and or hospital epidemiologist in your facility to determine if your facility is currently a member of NHSN If your facility already participates in NHSN for patient safe
168. ied to be sorted by CDC component code description Modifying a Pie Chart National Healthcare Safety Network Pie Chart for All Aclverse Reactions As of Aprl 14 2009 at 9 43 AM Date Range All HVADYVRXN FREQUENCY of compCDCDesc advRxn ALLERG IRVWWBDRBC 1 25 BORBOC 4 25 Other Options Select Variables to include Chart Variable Stratification Variable Page by _compCDCDesc v advRxn wv Number of pies across a page 2 Number of pies down a page 15 Placement of the Percent Outside Placement of the Slice Label Outside Placement of the Value Outside sa You have a few options to choose from when creating a pie chart In the example shown here we modified our pie chart to show percent frequency of each adverse reaction type by component code description Notice that you can also change the number of pies across the page down a page and specify where values are placed saving Modified Output Last Modified On 04 21 2009 Output Type Line Listing wi Output Name February Adverse Reactions ae TE Line Listing for All Adverse Reaction Data Other Options 2 Click on Save As Modify Variables To Display By Clicking Modify List Specify Sort Variables By Clicking Modify List Select Page by variable v amp Hemovigilance Module J 3 Report will appear under Custom Output Hv Adverse Reaction Data Save As Reset coc Defined Output
169. il with instructions for ap ying Tok a digital certificate a _ be sent by NHSN HSN User Start up uide NHSN will notify the BV contact by email that he or she has been successfully added as the primary contact Once the BV contact has been added as a user he she will also receive an email with instructions for applying for his her digital certificate This will be discussed in more detail later in this session Once the BV user with administrative rights has received and installed his her digital certificate he she logs into NHSN CDC Department of Health and Human Services Se Centers for Disease Control and Prevention NHSN National Healthcare Safety Network ISD CLFT NHSN1 Welcome to the NHSN Landing Page Select a facility and component then click Submit to go to the Home Page User RUBY Select facility group from dropdown list Fac Mount Sinai Medical Center ID 10127 Select facility within the above group Select component Biovigilance Submit Let s look at what happens once the BV contact has received and installed his her digital certificate Biovigilance Primary Contact or BV user with administrative rights will see this form the first time he she logs in The survey must be completed before any data can be entered in the Hemovigilance Module Department of Health and Human Services Centers for Disease Control and Prevention NHSN National Healthcare Safety Network ISD CLFT N
170. ility location where the patient was transfused Signs amp Symptoms laboratory results Enter any symptoms and laboratory results used to determine the type of adverse reaction Enter the facility location where the reaction was observed If a reaction is reported or experienced after the patient has left the facility enter the location where the patient was transfused Enter any signs and symptoms or laboratory results used to support the adverse reaction definition Va nT RIAAN Rr BS fran Component Details Nea Enter date time of transfusion Record time using the 24 hour clock military time Component code Use first part of number that describes the product ISBT 128 Codabar Enter the components tranfused that have a temporal relationship to the adverse reaction reported Use one line for multiple units of same product unless one is clearly associated with the adverse reaction put that product on a separate line Multiple rows of products can be added Add Row Unit number must be entered for TRALI TA GVHD or Infection otherwise it is optional Implicated in the adverse reaction If a particular unit is thought to be the cause of the reaction check the box Component Details Component Date Time code check of Unit number Unit expiration Blood Implicated in MM DD YYYY system used ar Required for TRALI date group of the adverse HH MM OISBT 128 GVHD Infection MM DD YYYY unit
171. in C Shortness of breath C Hemoglobinemia C Oliguria Cl Flank pain Cl Diffuse hemorrhage C Hematuria Cl Increase in blood pressure Cl Decrease in blood pressure C Other pain M Other specify pruritis Component Details m i Component code check Date Time system used MM DD YYYY rsBT 128 HH MM Codabar Implicated in the adverse reaction Unit expiration Blood date group MM DD YYYY of unit Unit number Required for TRALI GVHD Infection 01 08 2009 EB E4713 1h rey mnz Ele wl o3 45 Thawed Apheresis FRESH FROZEN PI ASMAI ACD Year Reaction details Enter the date and time the reaction occurred In our example it was 1 8 2009 and the time was 08 45 At the time of the reaction this patient was located in medical critical care Check off any symptoms that the patient experienced that support the case definition This patient had urticaria and pruritis Under component details enter the date of the transfusion and the time the unit was started Select the code system used by your facility either ISBT 128 or Codabar and enter the blood product code Blood product codes are contained in the system and a description of the product should come up If for some reason the code you need is not there enter a code that most closely matches the product type for example RBCs irradiated leukocyte reduced Since this patient did not have a TRALI infection or
172. in the past screen or crossmatch in the previous calendar year year 14 Products and units transfused Required Check each product transfused and indicate the total number of units transfused in the past year For each product checked the number of units must be gt 0 Do not include the units from which the aliquots were made in your unit count aaa i Whole blood derived WBD Conditionally required Indicate the number of WBD RBC units red blood cells RBCs transfused and the number of aliquots transfused If no units Units amp Aliquots or aliquots were made or transfused enter 0 Do not include 1 8 2009 2 Instructions for Form Completion units transfused and the number of aliquots transfused If no units or aliquots were made or transfused enter 0 Do not include the units from which the aliquots were made in your Se unit count aa platelet concentrates should be the total of units transfused regardless of the pool size that created the unit For i example a 6 pool unit would equal 1 unit transfused What is your average pool size Conditionally required Indicate your average pool size platelets transfused and the number of aliquots transfused If no apheresis platelet units or aliquots were transfused enter 0 Do not include the units from which the aliquots were made Whole blood derived plasma Conditionally required Check if WBD plasma was transfused Enter the number of units and number of aliquots of WBD pl
173. in the process was the incident first discovered Check the box for the process point at the time the incident was discovered Use the code descriptions on page 4 of the Incident form or Appendix F in the protocol How was the incident first discovered Check one CO Computer system alarm or warning O Comparison of product label to patient information O Comparison of sample and paperwork J Comparison of product label to physician order O Historical record previous type check J Human lucky catch O Observation by staff of unit plate reagent sample equipment LJ Patient transfusion reaction O Repeat or sample re testing LJ Routine audit or supervisory review LJ Visual inventory review O Other specify At what point in the process was the incident first discovered Check one O Product check in O Product test request O Sample collection O Sample handling O Sample receipt O Sample testing O Product storage O Available for issue O Product selection O Product manipulation O Request for pick up O Product issue O Product administration O Post transfusion review audit O other specify How was the incident first discovered Select the option that most closely describes how the incident was discovered If you select Other please include a brief description At what point in the process was the incident first discovered Check the box for the process point at the time the incident was discovered We are only interes
174. in the symptoms NHSN Biovigilance Component protocol 5 Post transfusion purpura PTP Characterized by thrombocytopenia usually arising 5 12 days following transfusion of cellular blood components with findings of antibodies in the patient directed against the Human Platelet Antigen HPA system Case Definition Criteria Grade Severity Relationship to Transfusion Imputability Laboratory Radiology Signs amp Symptoms Definitive Thrombocytopenia decrease to lt 20 of pre transfusion count AND Occurs 5 12 days post transfusion Probable Thrombocytopenia decrease to lt 20 of pre transfusion count BUT 5 12 days post transfusion timeframe not met OR Thrombocytopenia decrease to lt 20 of pre transfusion count with competing explanations OR Drop in platelets between 20 and 80 of pre transfusion count Possible Clinical and Laboratory presentation meet definitive or probable criteria BUT alternate explanations more likely OR Clinical presentation meets definitive or probable criteria HOWEVER HPA antibodies not tested or negative 03 17 2009 V1 Final Definitive Alloantibodies in the patient directed against HPA 1a or other platelet specific antigen detected at or after development of reaction Probable Alloantibodies in the patient directed against HPA 1a or other platelet specific antigen detected at or after development of reaction Possible
175. inators and stratification variables for use in aggregate analysis Department of Health and Human Services Centers for Disease Control and Prevention NHSN National Healthcare Safety Network ISD CLFT NHSN1 NHSN Home My Info Contact us Help Log Out Logged into Pleasant Valley Hospital ID 10312 as RUBY Facility Pleasant Valley Hospital ID 10312 is following the BV component Hemovigilance Module Monthly Reporting Denominators Mandatory fields marked with Print PDF Form Facility ID 10312 Pleasant Valley Hospital Month January v Year 2009 Units Aliquots Product Transfused Transfused Red blood cells Whole blood TOTAL derived Irradiated Leukocyte reduced Irradiated amp leukocyte S Ef To enter your denominators in NHSN select Summary Data from the left navigation bar and Add As with other forms in NHSN you can select Find to locate any previously entered forms Custom Fields and Labels m Facilities have the option of creating custom fields 2 date fields 2 numeric fields 10 alphanumeric m Comments can be entered but information cannot be used in analysis Hemovigilance Adverse Reaction Custom Fields Facilities have the option of creating custom fields in their forms There are 2 date fields 2 numeric fields and 10 alphanumeric fields This information can be used by the facility bu
176. incident result 1 No recovery harm Product action Check all that apply Product retrieved Product destroyed Product issued but no ansfused X Product transfused Was a patient reaction associated with this incide Patients Patient ID rp57923 On the Adverse Reaction screen you will see a link unlink button On the Incident screen if the Incident Result is 1 No recovery harm this means that the product reached the patient and caused a reaction Under Product Action you will select Product transfused and will be asked for the Patient ID for any patient or patients affected by the error The Patient ID is your unique facility ID for that patient Linking Incident is the NHSN assigned number m System will bring up incidents that have the same patient ID as reported for the adverse reaction NHSN National Healthcare Safety Network ISD CLFT NHSN1 NHSN Home My Info Contact us Help Log Out UBY g th asu n BV component Incident Link List ged into Pleas ty Pleasant Log ant Valley Hospital ID 10312 as Facilit Valley Hospital ID 10312 is fol First Previous Next Last Displaying 1 1 of 1 Check all that Incidenf Patient Date incident Where in the process the incident Incident apply ID occurred first occurred code 105 rp57923 01 10 2009 ZE SE 01 First Previous Next Last Displaying 1 1 of 1 Link Unlink Once the Incident form has been entered and y
177. ind all adverse reactions that have been entered will be shown W NHSN Home Reporting Plan Patient Incident Reaction D Add D Find Summary Data Analysis Surveys Users Facility Group a Cli ori Adverse Reactions cking on the Reaction will ng up that record Department of Health and Human Services Centers for Disease Control and Prevention NHSN National Healthcare Safety Network ISD CLFT NHSN 1 Logged into Pleas Facility Pleasant V First Previous Next Last Delete d L First Previous Next Last NHSN Home My Info Contact us Help Log Out ant Valley Hospital ID 10312 as RUBY alley Hospital ID is following the BV component Reaction List Displaying 1 2 of 2 Reaction date 01 06 2009 01 10 2009 Displaying 1 2 of 2 Facility ID 10312 10312 Reaction Patient ID DA6789 RPS7923 If the system finds any adverse reaction records that meet your search criteria they will appear on the screen like this Click on the reaction to bring up the record you want to view or edit Monthly Reporting Denominators Form Enter at the end of the reporting month Number of units transfused and number of aliquots transfused should be mutually exclusive See Tables of Instructions for more details Hemovigilance Module Monthly Reporting Denominators Facility ID Month Year Indicates required fields Transfused Transfused Red blood Whole blood mor
178. indicate areas where other storage facilities are located If Other is checked specify the location 19 To what extent does Required Check only the processes that are performed within Transfusion Services modify your department and facility products 1 8 2009 3 Instructions for Form Completion 20 Do you collect blood for Required Indicate Yes if your facility performs blood transfusion at your facility collection in house If Yes check all types of collections that apply 21 Does your facility perform viral Required If viral testing is performed but not in house check testing on blood for transfusion _ No Transfusion Services Computerization 22 Is Transfusion Services Required Skip the following section if the answer to this computerized question is No If your department uses an electronic system for any part of the blood product issuing process answer Yes Indicate all systems used in your department 23 Is your system ISBT 128 Conditionally required Check Yes if your department uses compliant the ISBT 128 code system for unit labeling 24 Does the Transfusion Conditionally required If your department system directly Services system interface with the accesses the patient registration system i e electronic patient registration system interface and exchange of information check Yes 25 Are Transfusion Services Conditionally required Check
179. ined in this surveillance system that would permit identification of any individual or institution is collected with a guarantee that it will be held in strict confidence vill be used only for the purposes stated and will not otherwise be disclosed or released without the consent of the individual or the institution in accordance with Sections 304 306 and 308 d of the Public Health Service Act 42 USC 242b 242k and 242m d AABB provided technical assistance in the development of this hemovigilance the data or other information contained in this or any other NHSN module All data collected through this module are protected by the same information security E safeguards that apply to all NHSN modules Advancing Transfusion and Cellular Therapies Worldwide NHSN maintenance may occur nightly between 12am and 6am Eastern time E O Once the survey is completed you are taken to the Hemovigilance Module home page Add Users o add a user to your facility click Users on the side W NHSN Home Reporting Plan navigation bar then click patient bc T Incident Ad d Reaction Summary Data Ihe Add User screen is n Survevs Users displayed ET Find Facility Group Log Out Now you are ready to add users to the BV Component Users can be added by anyone with administrative rights in the BV Component Users are the people who will be entering viewing and or analyzing data Click on User on the left sid
180. ing the PS component Y NHSN Home Reporting Plan Patient Event Procedure Summary Data Analysis Surveys LIG OE5 Facility LcustomizePorms D Export Data D Facility Info Add Edit Component Locations Surgeons Group Log Out NHSN Patient Safety Component Home Page Use the Navigation bar on the left to access the features of the app Assurance of Confidentiality The information obtained in this surveillance syste identification of any individual or institution is collected with a guarantee that it wi confidence will be used only for the purposes stated and will not otherwise be dis the consent of the individual or the institution in accordance with Sections 304 31 Health Service Act 42 USC 242b 242k and 242m d NHSN maintenance may occur nightly between 12am and 6am Eastern time Get Adobe Acrobat Reader for PDF files Once on the Patient Safety Component home page select Facility Add edit Component from the navigation bar on the left You will see a list of components Check the box for Biovigilance Status A Active You can print Hemovigilance Mod raci Component Activated Deactivated y Biovigilancd 02 20 2009 Healthcare Perst e 11 30 2005 Patient Safety 11 30 2005 Contact Information Check the box for Biovigilance Note that the Hemovigilance Module Annual Facility Survey form can be printed from that screen Enter a Biovigilance Primary Contact Con
181. ion being asked on the forms steps for Reporting Incidents in NHSN Beginning of the month Enter Monthly Reporting Plan Throughout the month or at the end enter individual Incident forms Forms should be entered within 30 days of the close of the month whenever possible End of the month Enter Blood Product Incidents Reporting Summary Data form End of the month Enter Hemovigilance Monthly Denominator form Now let s go over the steps for entering incident reports into NHSN At the beginning of each month enter your Monthly Reporting Plan Throughout the month or at the end of the month enter your individual incident forms Forms should be entered within 30 days of the close of the month whenever possible At the end of the month enter the Blood Product Incidents Reporting Summary Data and Hemovigilance Monthly Denominators Monthly Reporting Plan Data Collection Form ey Wetan Hemovigilance Module Monthly Reporting Plan Facility ID Month __ Year_ _ All reporting is facility wide C Adverse transfusion reactions amp all incidents associated with reactions C Monthly reporting denominators Incidents reporting summary data with detailed reporting of high o rity incidents OR L Incidents reporting detailed reports of all incidents Use detailed reports of all incidents if your facility does not have an alternative method of collecting incident information and or yo
182. istorical ABO Rh don t match ST 19 Additional testing not performed ST 20 Administrative check at time work performed ST 22 Sample storage incorrect inappropriate L Product Storage Transfusion Service US 01 Incorrect storage of unit in transfusion service US 02 Expired product in stock US 03 Inappropriate monitoring of storage device US 04 Unit stored on incorrect ABO shelf L Available for Issue Transfusion Service AV 01 Inventory audits AV 02 Product status not incorrectly updated in computer AV 03 Supplier recall AV 04 Product ordered incorrectly not submitted L Product Selection Transfusion Service SE 01 Incorrect product component selected 29 L Product Manipulation Transfusion Service UM 01 Data entry incomplete incorrect UM 02 Record review incomplete incorrect UM 03 Wrong component selected UM 04 Administrative check at time of manipulation UM 05 Labeling incorrect UM 07 Special processing needs not checked UM 08 Special processing misunderstood or misinterpreted UM 09 Special processing not done incorrectly done LI Request for Pick up Clinical Service RP 01 Request for pick up on wrong patient RP 02 Incorrect product requested for pick up RP 03 Product requested prior to obtaining consent RP 04 Product requested for pick up pt not available RP 05 Product requested for pick up IV not ready RP 06 Request for pick up incomplete RP 10 Product transport issues L Product Issue Transfusio
183. ital NHSN Home My Info Contact us Help Loc Facility Pleasant Valley Hospital ID 10312 is following the BV component General View Options Patient With Identifiers Without Identifiers Monthly Reporting Plan Annual Hemovigilance Facility Survey O Data Analysis O Incidents and Adverse Reactions Plan Month Year Month Year All to Summary Data for Events Plan Month Year Month Year T Aly ve to The Facility Administrator confers rights to a Group This means that the Facility Administrator selects the information from his her facility that the Group will be allowed to access About Conferring Rights Group is given rights to access certain data from a facility Group can analyze the data of its member facilities NHSN facilities in the Group cannot see one another s data m Facilities can confer rights By Component Let s talk about conferring rights A Group is given rights to access certain data from a facility A Group can analyze the data of its member facilities NHSN facilities that participate in a Group cannot see one another s data Facilities can confer rights to the Group by Component Plan Status Date Range and Event Confidentiality of Data m he Assurance of Confidentiality that is provided to NHSN facilities boy CDC applies to information reported to CDC through NHSN that is maintained and used by CDC in aggregate reports Once rights have been conf
184. ities directly to FDA as required by Title 21 CFR 606 170 b Remember reporting to NHSN DOES NOT take the place of FDA reporting Annual Facility Survey Completed on enrollment for new NHSN facilities or when joining the Biovigilance Component for existing facilities First survey data for the full calendar year before submission date Completed once a year after enrollment for the previous year Collects information that can be used as denominators for determining rates and facility characteristics that can be used for aggregate comparisons See Tables of Instructions for information on completing a NIN Eee mee Hemovigilance Module Annual Facility Survey Required fields Tracking Facility ID Survey Year Facility Characteristics For all questions use past full calendar year annual statistics 1 Ownership Check one O Forproft J Government Military OO Not for profit including church EO Veteran s Affairs OO Physician owned 0 Managed Care Organization _ ls your hospital affiliated with a medical school 0 Yes OO No If yes type of affiliation OO Major 0 Graduate J Limited Community setting of facility OQ Urban OJ Suburban Rural Total beds set up and staffed The Annual Facility Survey is completed on enrollment to the Biovigilance Component and must be completed before a facility can enter any data The survey should include data for the previous full calendar year for example a facility e
185. ix B Adverse Reaction Definitions and Case Definition Criteria 1 Allergic reaction The result of an interaction of an allergen with preformed antibodies In some instances infusion of antibodies from an atopic donor may also be involved It may present with only mucocutaneous signs and symptoms Case Definition Criteria Signs amp Symptoms Laboratory Radiology Definitive N A Definitive 2 2 of the following occurring during the transfusion e Morbilliform rash with or without pruritus Urticaria hives Pruritis Generalized flushing Localized angioedema Edema of lips tongue and uvula Erythema and edema of the periorbital area Conjunctival edema Respiratory distress bronchospasm Hypotension Probable N A Possible N A 03 17 2009 V1 Final Probable N A Possible N A 13 Grade Severity Grade 1 No immediate risk to the life of the patient AND Responds quickly to symptomatic treatment Grade 2 4 Involves respiratory and or cardiovascular systems and presents like an anaphylactic reaction There is anaphylaxis when in addition to mucocutaneous symptoms there are airway symptoms or hypotension or associated symptoms like hypotonia syncope The respiratory signs and symptoms may be laryngeal tightness in the throat dysphagia dysphonia hoarseness stridor or pulmonary dyspnea cough wheezing bronchospasm hypoxemia Such a reaction usually occurs during or very
186. izations that become a Group in NHSN his training assumes you have viewed Training 1 Biovigilance Component Overview training slides This training is intended for facilities interested in joining or nominating a Group in NHSN and organizations that become a Group in NHSN This training assumes you have viewed Training 1 Biovigilance Component Overview Training Slides Objectives Review the definition of a Group in NHSN Demonstrate how to nominate a Group Discuss the steps taken by a new Group Administrator Discuss the steps taken by a Facility Administrator or user with administrative rights Describe how a facility can join and confer rights to a Group Review example of Conferred Rights The objectives of this training are to review the definition of a Group in NHSN demonstrate how to nominate a Group discuss the steps taken by a new Group Administrator discuss the steps taken by the Facility Administrator or user with administrative rights describe how a facility can join and confer rights to a Group and review an example of Conferred Rights What is a Group m A Group is a collection of facilities that have joined together within the NHSN framework to share some or all of their data at a single Group level for a mutual purpose e g performance improvement state and or public reporting Facility A Facility B Facility C Facility D Facility E Member HV Group Member HV Group Member HV Group What i
187. know that the incident occurred during the night use your best guess for the time Otherwise enter Time Unknown Where in the facility did the Required Enter the facility location where the incident incident occur happened This may or may not be where the incident 1 8 2009 17 a Instructions for Form Completion was was discovered Job function of the worker involved re Enter the job function of the worker involved in in the Incident the incident using the codes on page 5 of the form or in Appendix E of the protocol This is the worker who was involved in the incident at the time it occurred and may have been responsible for the error This is not necessarily the person who discovered the error or incident Where in the process did the Required Check the box for the point in the process incident first occur where the error or incident is thought to have first occurred Enter Incident Code Required Using the codes on page 3 code the specifics of the incident If no detail is provided beyond the point in the process check Incident detail not specified The code for any incident where detail is not specified is the point in the process plus 00 For example if an unspecified error occurred during product check in the code would be PC 00 If the codes provided do not explain the incident check Other and briefly describe the point in the process at which the incident occurred Incident summary Optional Provi
188. l be provided Feedback on additional report and analysis features that would be of benefit to you and your facility is strongly encouraged to give comments jji N I National Healthcare AEREN Safety Network Questions or Need Help Contact User Suppor If you have any questions or problems NHSN User Support is here to help Just send an e mail to NHSN cdc gov Thank you
189. lable Variables S OA Available Variables Selected Variables advRxnDateYQ a oor J adminDate compCDCDesc advRxnDateYr adminDateTime advRxnDesc advRxnOutcome advRxnOutcomeDes advRxnT oDeathDay ageAtHVAdvRxn bedsize birthWt birthWtCode bithWtCodeDesc bloodGroupUnit advRxnDateTime ET advRxnDateYH compcocDes0 advRxnDateYM deathDate deathDateYH deathDateYM deathDateYQ deathDateYr dob ethnicity ethnicityDesc You can specify the sort order of your report by clicking on Modify List next to Specify Sort Variables under Other Options The default sort variable is listed in the right hand column Use the right arrow to add a sort variable and the left arrow to remove the sort variable as shown on this slide Once you ve made the change don t forget to save Change Sort Order Output Date Range All HVADVRXN i coc y 0 p Component Code i j i e e e Location Description nid This list is sorted INNSWARD IRLRAPHRBC 08 06 2010 o8FEBO by CDC component code description IRLRAPHRBC 01 IRLRWBDRBC 04 15 2010 u 24 110 HEM22 INLDWARD IRWBDRBC 02 92 2010 O2JAN09 03 33 20JAN09 13 15 442 111 DS1514 INMEDCC IRWBDRBC P5 2009 0O2FEB09 10 00 02FEB09 12 12 aa IRWBDRBC 2 11 2010 a ance 9044 peri IRWBDRBC 02 10 2009 ee gue 1 122 RP37923 INBMTSCA 01 20 2009 17JAN09 03 00 25JAN09 03 00 This slide shows an example of your output that has been modif
190. later determined not to be transfusion related based on new or additional information Adverse reaction reports should be entered into NHSN after the investigation of the reaction has been completed and imputability has been determined to the extent possible Ideally most reports should be entered within 30 days of the month of the event However new information can be entered at any time Please Note Reporting of adverse reactions into the NHSN hemovigilance surveillance system does NOT take the place of current reporting requirements for blood transfusion associated adverse events to Food and Drug Administration FDA Hospitals and transfusion services should immediately report complications that may be related to the blood donor or to the manufacture of the blood components to the collection facility Code of Federal Regulations Title 21 CFR 606 170 a 2006 and are required to report suspected transfusion related fatalities directly to FDA Code of Federal Regulations Title 21 CFR 606 170 b 2006 Definitions Signs and symptoms definitions are in Appendix A Specific adverse reaction definitions and case definition criteria are in Appendix B Common antibodies associated with hemolytic transfusion reactions are listed in Appendix D Adverse event An undesirable and unintended event occurring before during or after transfusion of blood or blood components that may be related to the administration of the blood or component It may be th
191. ld is a field that is required based on the answer to a previous question For example if a question about laboratory accreditation is answered in the affirmative the system would then require that the name of the accrediting organization be completed Optional fields provide additional information but the data are not required by CDC are not used in CDC analysis and the record can be saved whether the fields are completed or not An example would be Patient First and Last Name NHSN Lhe leet LE HH odule Hemovigilance Patient Demographics e Patient ID number gender date of birth required Includes blood group in Hemovigilance Module Events Adverse Reaction Incident Survey Annual Facility Survey Summary Form Blood Product Incidents Reporting Summary Data Denominator Monthly Reporting Denominators Custom Fields and Labels NHSN utilizes standard terminology across and or within a component The patient record includes a unique facility identification number Such as medical record number gender and date of birth Other fields are optional Within the Biovigilance Component Patient Blood Group is a required field Events in Biovigilance include Adverse Reaction and Incident Facilities are required to submit an Annual Facility Survey Blood Products Incident Reporting Summary Data form is an example of a summary form Monthly Reporting Denominators provide breakdowns and totals of blood products
192. le had been received at all for Smith Upon receipt and completion of testing the first type A did not match the second type O for patient Jones A third confirmatory specimen was requested for Jones and was also O This confirmed the nurse s suspicion that the first specimen had been mislabeled NHSN National Healthcare Safety Network ISD CLFT NHSN1 NHSN Home My Info Contact us Help Log Out Logged into Pleasant Valley Hospital ID 10312 as RUBY Facility Pleasant Valley Hospital ID 10312 is following the BV component Add Incident Mandatory fields marked with Print PDF Form Facility ID Pleasant Valley Hospital ID 10312 Incident Local Incident or Log 123 Discovery Date of discovery 01 27 2009 Where in the facility was the incident discovered f OUTED OUT ACUTE ED Time of discovery 03 00 HH MM ClTime approximate Time unknown How was the incident first discovered CATCH Human lucky catch At what point in the process was the incident first discovered ST Sample testing Occurrence Date incident occurred 101 27 2009 Where in the facility did the incident occur o bia OUTED OUT ACUTE ED Time incident occurred 01 45 HH MM ClTime approximate Time unknown Let s enter this case using NHSN Facility ID and Incident are NHSN generated Enter your local Incident or Log Date of discovery will be 1
193. le units Component Code s _ _ ss _ CH OF Units _ of Units _ Code _ se C OOF Units Add addii LJ Product issued but not transfused O Product transfused If the unit was transfused was a patient reaction associated with this incident Ol ves O no If ES Patient ID Patient ID Record other action Check all that apply X Record corrected O Floor clinic notified O Attending physician notified O Additional testing O Patient sample re collected O Other specify Did this incident receive root cause analysis Future O YES X NO Severity Code check one 34 O High O Medium O Low Product action will be not applicable because no unit had been issued at the time the incident was discovered However Record other action will be record corrected since the supervisor was notified and the LIS was changed In this example the institution did not perform a root cause analysis r Case 2 On 1 27 2009 a specimen was received in the blood bank at 2 a m with a request to do a type and screen for patient J Jones who was in the Emergency Department At the time of receipt the sample and request met all established acceptance criteria and the sample was processed The patient s blood group was A positive with a negative antibody screen Approximately 1 hour later the nurse that had drawn J Jones specimen phoned the blood bank tech and asked that the specimen be discarded as she was almost positive that
194. led to mistransfusions which may or may not have led to an adverse reaction Included in incident reporting is the reporting of a near miss which is an incident that is discovered before the incorrect product reaches the patient I Hemovigilance Module Introduction Based on the last published Nationwide Blood Collection and Utilization Survey Report the total supply of whole blood and red blood cells collected in the United States in 2004 was approximately 15 million units which were processed into 29 million blood products Recipients received on average 2 units each resulting in a national estimate of 5 3 million patients transfused While the risk of infectious disease as a result of transfusion can often be estimated for example the risk of HIV is approximately 1 in 2 million estimates of transfusion related non infectious adverse reactions and incidents associated with transfusion are not collected in the United States using a routine reporting system with standard definitions Therefore actual numbers or percentages of events are unknown In the survey of data from 2004 1 322 medical facilities reported 32 128 transfusion related reactions that required diagnostic or therapeutic intervention While any transfusion associated adverse reaction is considered rare the general consensus in the United States is that there could be considerable underreporting based on surveillance reports of similar events from national surveillance
195. m of this slide Example Facility Administrator Confers rights to Group aves _Patient Safety V_ Healthcare Personnel Safety _Biovigilance Facility General oa View Options u 5 0 as Rights Patient With Identifiers Without Identifiers So Monthly Reporting Plan D Leave e Wicca Annual Hemovigilance Facility Survey Log Out Data Analysis Incidents and Adverse Reactions Plan Month Year Event i In be 1 amp 2009 Adverse Reaction jin w f1 2009 Incident v Summary Data for Events Plan Month Year Month won i 2009 to 12 Denominator Data for Events Plan Month Year Month Year Min 1 20097 to 12 2009 After joining the Group the Facility Administrator confers rights This screen shows an example of the rights the administrator selected Rights are conferred to data reported beginning January 2009 and ending December 2009 and include patient information with identifiers Monthly Reporting Plan Analysis Annual Facility Survey in plan adverse reaction events in plan incident events in plan incident reporting summary data and monthly denominators Let s Review In this session we Reviewed the definition of a Group in NHSN Demonstrated how to Nominate a Group Discussed the steps taken by a new Group Administrator Discussed the steps taken by the Facility Administrator or the facility user with administrative rights Joining a G
196. m your facility agrees to follow protocols and use definitions exactly as written and submit acceptable Biovigilance Component data for all 12 months of the year including submitting an annual survey Email in NHSN m Most communication to users from NHSN occurs through email Here are some tips to ensure you don t miss anything you need Set your email soam blocker settings to allow emails from nhsn cdc gov and PHINTech cdc gov Dorf ql Print and save all emails from nhsn cdc gov and TUB PHINTech cdc gov during the enrollment process m You use the same email address throughout the NHSN enrollment process and application for your digital certificate g 12 Email plays a very important role in NHSN Most communication to users from NHSN occurs through email Here are some tips to ensure you don t miss any information need Set your ama pam blocker settings to allow emails from NHSN cdc gov and PHINTech cdc gov Be sure to print and save all emails from NHSN and PHINTech ine the aed process Remember you MUST use the same email address throughout the NHSN enrollment process and application for your digital certificate How do get started in NHSN Step 1 Steps the Facility Review and accept Administrator must take Rules of Behavior Step 2 Receive email with instructions Register for obtaining a digital certificate Step 3 Go to
197. ma and hemorrhagic bullous formation in severe cases Hepatomegaly Diarrhea Probable Clinical presentation c w TA GVHD described above Possible Clinical presentation c w TA GVHD described above 03 17 2009 V1 Final Laboratory Radiology Definitive Liver dysfunction elevated ALT AST Alkaline phosphatase and elevated bilirubin AND Pancytopenia NOTE If performed marrow study shows hypoplasia aplastic anemia or marked hypocellularity with a lymphohistiocytic infiltrate AND WBC chimerism in the absence of alternative diagnoses i e not attributable to a source other than transfusion AND Characteristic histological appearances on skin biopsy or liver biopsy Probable Meets definitive criteria EXCEPT not confirmed by chimerism i e not done or negative Possible Meets definitive criteria EXCEPT neither confirmed by chimerism i e not done or negative nor biopsy results 22 Grade Severity Grade 1 N A Grade 2 Patient had marked symptoms responded to treatment Grade 3 Patient alive due to treatment e g immunosuppression Grade 4 Patient died from TA GVHD Relationship to Transfusion Imputability Definite Meets definitive protocol criterion and related to blood donor Matching chimeric alleles in donor and recipient Probable Presentation consistent with TA GVHD however chimerism demonstrated in recipient but matching allel
198. me incident occurred 03 00 HH MM Ml Time approximate Time unknown Job function of the worker involved in the incident MLT Medical Laboratory Technician a Where in the process did the incident first occur Ul Product issue vij Incident code Ul 09 Not checking incorrect checking of unit and or patient information Incident summary 7 Unit labeled with one patient name and medical record number issued to another patient with the same last name iwi Select incident result 1 No recovery harm Product action Check all that apply Not applicable Product retrieved Product destroyed Product issued but not transfused Product transfused Was a patient reaction associated with this incident Y Yes Patients Patient ID If rp1502 The incident occurred on 1 8 2009 at approximately 3 00 a m when the wrong unit was issued by the Medical Lab Technician Therefore the incident occurred during product issue The process code is UI 09 or Not checking incorrect checking of unit or patient information A brief summary of the incident is provided in the text field The incident result is 1 No recovery harm because the error was not caught until after the patient had been transfused The patient experienced an adverse reaction and was therefore harmed as a result of the incident Product action is that product was transfused We select Yes to the question of whet
199. mmary of exactly what happened Then check the final result of the incident Occurrence Incident Result Definitions See Appendix G of protocol for definitions Incident Result 1 No Recovery harm Product was transfused and the patient experienced an adverse reaction 2 No Recovery no harm Product was transfused but the patient did not experience an adverse reaction 3 Near miss unplanned recovery Product was not transfused The incident was discovered ad hoc by accident a human lucky catch etc It was not discovered through formalized facility standard operating procedures or other previously instituted checks and balances Near miss planned recovery Product was not transfused The incident was discovered through standardized processes or barriers built into the system to prevent errors Please use the protocol definitions for Incident Result Result 1 No recovery harm means that product reached the patient was transfused and the patient experienced an adverse reaction as a result of the incident Result 2 No recovery no harm means that product was transfused but the patient did not experience an adverse reaction as a result of the incident Result 3 Near miss unplanned recovery means that product was not transfused and the incident was discovered ad hoc by accident through a human lucky catch etc In other words the incident was not discovered through formalized facility stan
200. n Generate Data Sets Patient Incident Reaction Summary Data i han Data Sets Date Last Generated Action aJl Do not navigate away from D Output Options CA the screen while data sets Surveys n ERE Apr 6 2009 2 34PM Generate New are being generated Facility Group The data set generation process will take several minutes Do not logoff or close Log Out this window while the process is running You may minimize the browser window and work in other applications while you wait E EPITO aa a a eS eee ae aan uevp Generate Biovigilance Analysis Data Sets The first task you must perform is to generate data sets By generating data sets SAS data sets are created containing individual patient adverse reaction incident records and denominator data that have been entered into NHSN up to that moment This step must be performed before selecting Output Options Please take note of the instruction that you must stay on this screen while the data sets are being generated Y NHSN Home Reporting Plan Patient Incident Reaction Summary Data Analysis Step 2 Output Options Once data sets have been generated select Output Options Department of Health and Human Services Centers for Disease Control and Prevention NHSN National Healthcare Safety Network ISD CLFT NHSN1 NHSN Home My Info Conta Logged into Pleasant Valley Hospital ID 10312 as RUBY Facility Pleasant Valley Hospital ID 10312 is foll
201. n Service UI 01 Data entry incomplete incorrect UI 02 Record review incomplete incorrect UI 03 Pick up slip did not match patient information UI 04 Incorrect unit selected wrong person or right person wrong order UI 05 Issue delayed UI 06 LIS warning overridden Ul 07 Computer issue not completed UI 09 Not checking incorrect checking of unit and or patient information UI 11 Unit delivered to incorrect location UI 19 Wrong product issued UI 20 Administrative review self 2 check at issue UI 22 Issue approval not obtained documented LJ Product Administration Clinical Service UT 01 Administered product to wrong patient UT 02 Administered wrong product to patient UT 03 Product not administered UT 04 Incorrect storage of product on floor UT 05 Administrative review unit patient at bedside UT 06 Administered product w incompatible IV fluid UT 07 Administration delayed UT 08 Wrong unit chosen from satellite refrigerator UT 10 Administered components in inappropriate NHSN Biovigilance Component protocol missing incorrect on asi SH 10 Sample transport issues 03 17 2009 V1 Final SE 02 Data entry incomplete incorrect SE 03 Not checking incorrect checking of product and or patient information SE 05 Historical file misinterpreted not checked SE 07 Special processing needs not checked SE 09 Special processing needs not understood or misinterpreted SE 11 Special processing not done 30 order UT 1
202. n on pre transfusion label at the time of blood draw for sample testing check Yes specimen labels hospital wide reporting computer system 32 What items canbe used to Required Check all pieces of information that can be used to verify patient identification during verify patient identification as specified in your hospital policy specimen collection and prior to product administration 33 How are routine type and Required Check all that apply manual automatic or both screen done The total of the three percentage fields should 100 34 Is the ABO group of a pre Required If Yes indicate the circumstances for when this is 1 8 2009 4 Is the confirmation required on Conditionally required a separately collected specimen before a RBC unit of Group A B or AB is issued for transfusion 35 How many RBC type and crossmatch procedures were performed at your facility by any RBC Crossmatch Estimated done by each method electronically serologically don t know 1 8 2009 Required Enter the number of RBC crossmatch procedures performed in the last year Indicate the done by each method Some specimens may be crossmatched by both methods therefore totals can be gt 100 Table 2 Instructions for Completion of the Monthly Reporting Plan CDC 57 301 Forel Instructions tor Form Completion by the computer to indicate the plan for that month Year Required Indi
203. nal Healthcare Safety Network NHSN as the surveillance system that could most closely meet the data requirements for a national surveillance system for blood transfusion adverse event tracking In evaluating patient safety the system was envisioned to capture both adverse events and errors and accidents Using the International Society of Blood Transfusion ISBT definition an adverse event is defined as an undesirable and unintended occurrence before during or after transfusion of blood or blood components that may be related to the administration of the blood or blood component It may be the result of an incident and it may or may not result in a reaction in a recipient An incident is defined as an accident or error that could lead to an adverse event affecting a the safety efficacy or quality of blood blood components or plasma derivatives or b the safety of recipients An accident is an unexpected or unplanned event not attributable to deviation from standard 03 17 2009 V1 Final 3 NHSN Biovigilance Component protocol operating procedures while an error is an unexpected unplanned deviation from standard operating procedure that is likely attributable to a human or system problem derived from Canadian Transfusion Adverse Event Reporting Form User Manual April 2004 The system includes the tracking trending and analysis of transfusion errors and deviations from standard operating procedures or hospital policies that have
204. nce Module MEMES m Protocol Provides rules for surveillance and reference materials Read it before collecting and reporting data in NHSN Case definition criteria for adverse reactions of blood transfusion based on International Society of Blood Transfusion ISBT definitions e Definitive probable possible e Severity grade e Relationship to transfusion imputability Incident reporting definitions The Hemovigilance protocol provides rules for surveillance and reference materials It should be read before collecting and reporting any data in NHSN Case definition criteria and definitions used for reporting incidents are also included Hemovigilance Module WEEL Incident codes Incident codes derived from MERS TM Columbia University and TESS Canadian system Blood product code lists Codabar ISBT 128 u Data collection forms WE aao at Additional references or materials you will be using include Incident error process codes blood product code lists for Codabar and ISBT 128 coding data collection forms and Tables of Instructions We ll discuss the materials in more detail in the following slides Hemovigilance Protocol Provides rules for hemovigilance surveillance so that all participating facilities collect information the same way Appendices include case definitions other definitions and code lists used in the hemovigilance module Content based on input from AABB CDC worki
205. ncidents and near misses where the error is discovered before the incorrect product reaches the patient 03 17 2009 V1 Final 8 NHSN Biovigilance Component protocol Settings Surveillance should be performed by hospital transfusion services and can be performed in any adult or pediatric acute or chronic care facility where transfusion occurs including patient care areas for general medical and surgical patients obstetrics and gynecology orthopedic cancer other chronic disease and any other patient care setting with transfusion services Requirements Participating facilities are required to report all incidents but have two reporting options 1 Individual detailed reports for every incident reported OR 2 Total numbers of all incidents reported by incident code with detailed incident reports required of high priority events includes any incident associated with an adverse reaction regardless of incident code Option 1 is recommended for facilities that do not have an electronic reporting method for incidents and may want to use NHSN for this purpose For facilities that maintain their own in house system option 2 may be preferable Report any incident for which an incident report has been filed in blood transfusion services Detailed incident reports must be filed for any incident associated with an adverse reaction regardless of whether it resulted in harm to the patient or not Near miss reports should be documented
206. ncomplete assessment of a situation including related conditions of the patient and materials to be used before starting the transfusion Example failure to correctly identify the patient by checking the wristband e Faulty task planning and execution Example washing red blood cells using the same protocol as that used for platelets e Failure in monitoring a process or patient status Examples a trained technologist operating an automated instrument and not realizing that a pipette that dispenses a reagent is clogged Failure of the patient care staff to observe an allergic reaction in a patient after a transfusion is started e Failure in performance of highly developed skills Example a technologist adding drops of reagents to a row of test tubes misses a tube or a computer entry error e Failure in whole body movements Slips trips and falls Examples a blood bag slipping out of one s hands and breaking or a person tripping over a loose tile on the floor Patient related e Failures related to patient characteristics or conditions which are beyond the control of staff and influence treatment Other Cannot be classified under any of the other categories References MERS TM 2001 Medical Event Reporting System for Transfusion Medicine reference manual version 3 0 New York Available at http www mers tm net Vuuren WV Shea CE Schaaf TW van der 1997 The development of an incident analysis tool for the medical field Eindhov
207. ng group members Approved by working group CDC and other agencies of HHS A facility agrees to follow the protocol when they sign on to NHSN READ the Aeee before collecting and reporting data for NHSN ka Sem alban The National Healthcare Safety Network CNHSN Manual Biovigilance Component rotocol Hemovigilance Module NA eh a ee rn ee aaa ae a i ae ae _ When a facility signs the Agreement to Participate and Consent in NHSN they agree to follow the protocol The Hemovigilance protocol provides the rules for surveillance and definitions that are important in ensuring that all facilities perform surveillance in the same way Case definition criteria for adverse reactions have been developed by the Hemovigilance Working Group a group of transfusion medicine specialists that was convened in collaboration with AABB These case definitions were based on International Society of Blood Transfusion ISBT definitions and should be adhered to precisely when reporting adverse reactions Severity grade and imputability or relationship of the transfusion to the reaction are also to be reported Again please read the protocol before collecting and reporting any data in NHSN Tables of Instructions L 2 WALA ABIL Table 1 Instructions for Completion of the Hemovigilance Module Annual Facility Survey CDC 57 300 For all questions referring to past year use calendar year not fiscal year Instructions for Form C
208. nitive Definitive Use grades as provided in Definite No clinical or laboratory signs of After a transfusion there Appendix C Recent RBC transfusion hemolysis is demonstration of new with subsequent formation clinically significant of newly identified RBC antibodies against red alloantibody blood cells which were OR not present in the pre Positive direct antiglobulin transfusion specimen test EITHER THROUGH Positive direct antiglobulin test OR Probable N A Positive antibody screen with newly identified Possible N A RBC alloantibody Probable N A Probable N A Possible N A Possible N A 03 17 2009 V1 Final 16 NHSN Biovigilance Component protocol 3 Hypotensive transfusion reaction Drop in systolic and or diastolic blood pressure of gt 30 mm Hg occurring during or within one hour of completing transfusion Case Definition Criteria Grade Severity Laboratory Radiology Definitive N A Signs amp Symptoms Definitive ALL OF THE FOLLOWING e Hypotension Drop in systolic and or diastolic blood pressure of gt 30 mm Hg NOTE Other symptoms like facial flushing dyspnea or abdominal cramps may occur but usually hypotension is the sole manifestation Occurs within 15 minutes after the start of the transfusion Responds rapidly within 10 minutes to cessation of transfusion and supportive treatment All other categories of adverse reactions presenting with hypotension must have been excl
209. nly apheresis RBCs that were transfused If none enter 0 Do not include the units from which the aliquots were made in your unit count Irradiated amp Required Indicate the total number of units and aliquots of leukocyte reduced apheresis RBCs transfused that were both irradiated and 1 8 2009 8 Instructions for Form Completion leukocyte reduced If none enter 0 Do not include the units from which the aliquots were made in your unit count Total whole blood Required Enter the total number of units of irradiated leukocyte reduced irradiated amp leukocyte reduced and WBD platelets not modified by any of those methods that were transfused during the month If none enter O Indicate the number of units of irradiated only WBD platelets that were transfused If none enter 0 Leukocyte reduced ae oy nor the number of units aliquots of eae ee en ony HBO pots Pat were rants ree enter 0 Irradiated amp Required Indicate the total number of units of WBD reduced If none enter 0 Total apheresis Required Enter the total number of units and aliquots of platelets irradiated leukocyte reduced irradiated amp leukocyte reduced and apheresis platelets not modified by those methods that were transfused during the month If none enter 0 Do not include the units from which the aliquots were made in your unit count Irradiated Required Indicate the number of units and aliquots of irradiated only apheresis pla
210. nrolling in April 2009 would complete a survey using 2008 data The survey contains information that can be used as denominators for determining rates and facility characteristics that can be used for aggregate comparisons Monthly Reporting Plan m he Monthly Reporting Plan informs CDC which modules a facility is following during a given month m Facilities choosing to participate in the Hemovigilance Module must file a plan every month and report all adverse reactions and incidents A facility may enter data only for months in which plans are on file As we mentioned earlier the Monthly Reporting Plan informs CDC which modules a facility is following during a given month A plan must be filed before your facility enters data for a given month Facilities choosing to participate in the Hemovigilance Module must file a plan every month but their selections of what to report are limited by the protocol and must include adverse reactions and incidents Monthly Reporting Plan Hemovigilance requires monthly reporting of all adverse reactions m Facilities can choose whether to file detailed incident reports for all incidents or provide summary only data for minor incidents Hemovigilance Module Monthly Reporting Plan Facility ID Month ____ ef Year All reporting is facility wide Adverse transfusion reactions amp all incidents associated with reactions Monthly reporting denominators Inc
211. nstalled The digital certificate can be installed on additional computers but is still specific to the individual user Certificates expire 12 months from the date of installation and you must apply for a new one each year You will need the assistance of your IT department in installing your digital certificate Access SDN to apply for a digital certificate lt Cortes for Disease Control and Prevention PrE ID Enrollment SDN Support WARNING 800 532 9929 is 5S G m cessed a 770 454 4863 rized personnel Unauthorized ac pap bec viola phintech cdc gov ne T ere is no ri o privacy on aiar pues ari Ali he rmatio i i e Ajai read copied and shared a utho tigatio se of this ai stem whethe aaa ized or unauth reas de i 18 U S c Enter Enrollment Password Please enter the password for CDC s Digital ID Services and click Accept Password sscceesse Questions Go to the Online Help or Contact SDN Support The website and password needed to apply for a digital certificate are provided to you in the email described in Step 2 Now that you know what a digital certificate is lets discuss how to access SDN to apply for a digital certificate The website and password needed for you to access SDN are provided to you in the email that was sent to you during enrollment This was described on slide 18 Enter your enrollment password and click on Accept SDN Registration Page F Secure Data Network Enrollment
212. nstrate how to generate data sets in Hemovigilance describe output options in Hemovigilance show how to generate output customize or modify output discuss documentation needed to generate reports in Hemovigilance describe advanced options in analysis demonstrate how to export your output for manipulation outside of NHSN and how to create custom output sets Analysis in NHSN Once you are logged into NHSN and are on the Hemovigilance Module Home Page select Analysis from the left navigation bar Department of Health and Human Services Centers for Disease Control and Prevention NHSN National Healthcare Safety Network ISD CLFT NHSN1 NHSN Home My Info Contact us Help Ei NHSN H ogged into Pleasant Valley Hospital ID 10312 as RUBY f ome Logge C easant valley spital sUSte as n Facility Pleasant Valley Hospital ID 10312 is following the BV component Reporting Plan Patient Incident Reaction SummaryYata NHSN Hemovigilance Module Home Page Use the Navigation bar on the left to access the features of the application Assurance of Confidentiality The information obtained in this surveillance system that would permit identification of any individual or institution is collected with a guarantee that it will be held in strict confidence will be used only for the purposes stated and will not otherwise be disclosed or released without the consent of the individual or the institution in accordance with Sections 304 30
213. nt MLT Medical Laboratory Technician Where in the process did the incident first occur UM Product manipulation Incident code UM 05 Labeling incorrect v Incident summary Labels were switched when two units were issued at the same time Select incident result 4 Near miss planned recovery Y Product action Check all that apply C Not applicable Product retrieved Cl Product destroyed ClProduct issued but not transfused Product transfused Record other action check all that apply ClRecord corrected Floor clinic notified Cl Attending physician notified Cl Additional testing Patient sample re collected M Other specify Labels corrected and product issued The date and time the incident occurred were the moment when the units were labeled So we entered 1 5 2009 at 8 30 a m The incident occurred in the blood bank The job function of the worker involved in the incident was MLT This was the person who mislabeled the units Our incident code is UM 05 The incident occurred during product manipulation and labeling was incorrect A brief description of the incident is written in the Incident summary field The incident result was 4 Near miss planned recovery We would call this planned recovery because the facility had a standard operating procedure in place that unit label should always be compared with the transfusion slip before the unit is issued P
214. nt usually are not associated with severe morbidity or mortality and are reported to occur in 1 in 100 per products transfused depending upon the type of product The lack of consistent reporting of transfusion related adverse reactions demonstrates the need for routine national surveillance to provide data that are more representative of actual events Settings Surveillance should be performed by hospital transfusion services and can be performed in any adult or pediatric acute or chronic care facility where transfusion occurs including patient care areas for 03 17 2009 V1 Final 5 NHSN Biovigilance Component protocol emergency and general medical and surgical patients obstetrics and gynecology orthopedic cancer other chronic disease and any other patient care setting with transfusion services Requirements All blood or blood component transfusion associated adverse reactions in a 12 month period are to be reported A reporting plan should be filed at the beginning of each month Adverse reactions considered to be transfusion associated are those for which imputability relationship to transfusion is determined to be definite probable or possible see definitions in Appendix C Adverse reactions for which imputability is doubtful or ruled out should not be routinely reported The only time doubtful or ruled out categories should be used is when a reaction that was initially reported in the system to be transfusion related was
215. ntion Digital ID Enrollment SAFER HEALTHIER PEOPLE SDN Support Digital Certificate Request Received 800 532 9929 770 454 4863 Your request for a digital certificate has been received phintech cdc gov You will receive an e mail when your request is approved which includes instructions for installing your digital certificate Please note that processing time may vary depending upon the nature of the enrollment request If you do not receive an e mail notification within 72 hours you may inquire about the status of your request by contacting the program administrator Questions Go to the Online Help or Contact SDN Support You will then see a message that your digital certificate request has been received In the left navigation bar phone numbers and email address for SDN user support are provided After Applying for Your Certificate Check your email Requests are processed by SDN usually within 48 72 hours Email will include a link and instructions to download the certificate Contact your facility IT department for assistance in installing your digital certificate Your computer must have administrative rights in order that the certificate be installed These rights can be assigned temporarily Detailed instructions for installing the certificate are contained in the NHSN Facility Administrator Enrollment Guide Make a back up copy of the certificate After applying for your certificate perio
216. nts amp My Custom Output output Sets Create New Output Set EEE monthly Reports Here s an example of an output set that has been created Once a month a line listing of Incident Unit data and a line listing of Adverse Reaction data can be run at one time by selecting the Run button Export Data Sets m Option under Modify button is at top of page Use to display and manipulate your data outside of NHSN Exports the entire dataset without modifications NHSN National Healthcare Safety Network ISD CLFT NHSN1 NHSN Ho i NHSN Home ogen nto Pleasant Valley Hospital oa 10312 as RUBY acility Pleasant Valley Hospi tal ID 10 12 is folloving the BV component Line Listing Analysis Data Set HVAdvRxn Export Analysis Data Set O Generate Data Sets Modify Attributes of the Output Output Options Last Modified On 04 21 2009 Output Type Line Listing v Output Name Line Listing All Adverse Reaction Data to Pleasant Valley Hos pital ID 10312 as lity pisss ant Valley Hospital ID 10312 is follow Export Output Optiort Other export formats available MicrosoftAccess 97 table mdb Delimited file comma separated values csv Delimited file tab delimited values txt Excel spreadsheet xls Excel 5 0 or 7 0 95 spreadsheet xls Dbase 5 0 IV Ill Ill and II files dbf F SAS for windows V7 8 9 sas7bdat Exporting data set HVAdvRxn Select data export format
217. nual survey for your facility v Pass quality control acceptance checks that assess the data for completeness and accuracy v Agree to report to state health authorities those events identified in the surveillance system for which reporting is required and any for which you are contacted by CDC A facility survey will be required each year you choose to participate You will be asked to pass quality control acceptance checks that assess data for completeness and accuracy You agree to report to state health authorities those events identified in the surveillance system for which reporting is required and any for which you are contacted by CDC Data Collection and Reporting Requirements for Hemovigilance Module AND v Immediately report complications that may be related to the blood donor or to the manufacture of the blood components to the collection facility Code of Federal Regulations Title 21 CFR 606 170 a 2006 v Report suspected transfusion related fatalities directly to the FDA Code of Federal __ Regulations Title 21 CFR 606 170 b 2006 And Please remember to follow FDA requirements for reporting which is through a system that is separate from NHSN Report immediately any complications that may be related to the blood donor or to the manufacture of the blood components to the collection facility as required by the Code of Federal Regulations Title 21 CFR 606 170 a Report suspected transfusion related fatal
218. o olnd cne fac lley s pec Fled otka J warrarccnacd nave esd and cenae J underscand cne cerms of Cnk aqreemenc and nereny comem 00 allie cne fac likey co otklone Incne NHSN Name Tr Signscure Faclity Name Hain Facility Tekonone Num per Sree Address Cry Scat en Picam amad comne cogy fie yeaa Atul ongral m MAGN aneus WG alr Ceran Aee Con ard Peeran 1600 Cb fon Aad Ma aden Ge 10111 ee me ae This form describes the purposes of NHSN eligibility criteria reporting requirements and assurance of confidentiality Enter primary contact for enrolled component s oe aN Agreement to Participate and Consent cranes i To kit Pri Ta ntact s 1 ee an aE IE se EN ee one seco o ok and emt com oe Signatures must aTi fcc ura dacs Ins fy maner oder oo malmal ec cee CRIE INEN cme WHOA e be original If HHEN Patent Satety Primary ontact Persan S not there NHSN swe ooo Ee will return the PR eaha an ae TE oe ntact Pe rean wd Fat lart KAPAH n ae form to you TEE TIEU ce HHSEN Bkr W lane Primary Gontact Pe rean Hane Tree Sgur Ds Make a copy for Okkal Authareed Ta Blin eee clip Ta The Ter Haa fei ay ment kq SOO fcr fcr undeaeandem oni G En e a a e A your own files Hame Tek amme ee TE Must have a sain rei Tarare narea u O C level high level A corporate official w O Se such as CEO or aae a a aa COO signature The Primary Contac
219. of this session are to provide step by step instructions for entry of the Monthly Reporting Plan Adverse Reaction and Monthly Denominator forms in NHSN We ll show how to find an Adverse Reaction previously entered describe how to link incidents and adverse reactions and create custom fields and labels Please be sure to read the protocol Use Tables of Instructions until you are familiar with the form fields The protocol and instruction tables are available on the NHSN website Table 4 Instructions for Completion of Monthly Reporting Denominators CDC 57 303 Table 5 Instructions for Completion of the Hemovigilance Adverse Reaction Form CDC 57 304 Formic Instructions for Form Completion Facility ID The NHSN assigned facility ID number will be autoentered by the computer Adverse Reaction ____JNHSNeassigned number atient Information Required Enter the medical record number or other facility alphanumeric identification for the patient Required Check M Male or F Female Required Enter the date of birth using this format MM DDIVYYY The Tables of Instructions are organized by form and provide the rules for entering data in each of the fields Review 4 Gi pS ON Hemovigilance facility survey is completed the first time Biovigilance Component Hemovigilance Module is invoked Provides variables that can be used to stratify facilities e g bed size transfusion volume etc when aggreg
220. ollection and Entry 36 Here are additional trainings provided depending on the type of user If you are the Facility Administrator and your facility is new to NHSN view Training 2 Biovigilance Component Enrollment for Facility New to NHSN If your facility already participates in NHSN you and or your Facility Administrator may want to view Training 3 Biovigilance Component Enrolling an Existing NHSN Facility into Biovigilance and Facility Set up Training 5 discusses Groups in Biovigilance The other trainings available are for transfusion services personnel who will be collecting and reporting data for NHSN Training 4 Biovigilance Component Hemovigilance Incident Reporting is designed for persons collecting information on incidents This might be the individual responsible for quality control in your department Adverse Reactions Case Definition Exercises discusses case definition criteria severity and imputability in detail and includes case examples Training 6 Biovigilance Component Adverse Reaction Data Collection and Entry provides details of completing the Adverse Reaction data collection form T National Healthcare INNIN Safety Network Questions or Need Help Contact User Suppor Congratulations You have completed the Hemovigilance Overview If you have any questions about NHSN please send an e mail to user support nhsn cdc gov The National Healthcare Safety Network NHSN
221. olled describe how NHSN is accessed The objectives of this training are to define the role of the NHSN Facility Administrator in the enrollment process discuss how email is used in NHSN print and complete enrollment forms describe the 5 steps in NHSN enrollment define SDN and digital certificate and once you are enrolled describe how NHSN is accessed NHSN Facility Administrator Only person who can enroll a facility Has add edit delete rights to facility s data Can add edit delete users and their data access rights Can nominate join confer rights leave a group A A group is an entity with which your facility may want to y1 share its data e g state health department AABB other patient safety organization etc m Only person who can reassign the role of Facility Administrator to another user The NHSN Facility Administrator is the only person who can enroll a facility The administrator has add edit delete rights to its facility s data can add edit and delete users and their data access rights can nominate join confer rights or leave a group and is the only person who can reassign the role of Facility Administrator to another user A group is an entity with which your facility may want to share its data This could include a state health department patient safety organization corporate headquarters and so forth NHSN Facility Administrator Enrollment Guide The NHSN Facility Administrator Enrollm
222. om federal public health agencies as well as representatives from industry patient advocates and the blood collection and transfusion communities A recommendation was given to the Secretary of HHS by ACSBA that a national system was needed for surveillance of recipient outcomes of blood and blood products Such systems often referred to as hemovigilance exist in most other developed countries but not in the United States Subsequently the American Association of Blood Banks AABB formed an Inter organizational Task Force on Biovigilance with representation from both governmental and non governmental organizations in the United States The committee defined as their main task to develop a comprehensive and integrated national patient safety program to collect analyze and report on the outcomes of collection and transfusion and or transplantation of blood components and derivatives cells tissues and organs The program should be outcome driven with the objectives of providing early warning systems of safety issues exchanging of safety information and promoting education and the application of evidence for practice improvement While biovigilance also includes organ and tissue transplant safety blood safety or hemovigilance was the first topic of focus After a review of the different systems that can be used to collect transfusion safety data the AABB Biovigilance Task Force recommended a public private partnership using CDC s Natio
223. ompletion The NHSN assigned facility ID number will be autoentered by the computer Required This should be the most recent previous year for which annual facility statistics are available For example if you are completing this in February 2008 your ear should be 2007 Facility Characteristics Cee ieee Check the ownership type that most closely represents your facility 2 ls your hospital affiliated with a Required If your hospital is associated with a medical medical school school indicate the type of affiliation affiliation is defined as Details and business rules for all form fields to ensure correct interpretation Use these each time you complete a form until you are familiar with the rules The tables of instructions are organized by form and include details and business rules for all form fields to assist you in completing the forms We recommend that you use these instructions each time until you become familiar with the rules Forms Used in Hemovigilance Forms Annual Facility Survey se Monthly Reporting Plan Blood Product Incidents Reporting summary Data Monthly Reporting Denominators Adverse Reaction Incident The data collection forms used in hemovigilance include the Annual Facility Survey Monthly Reporting Plan Blood Product Incidents Reporting Summary Data Monthly Reporting Denominators Adverse Reaction and Incident Data Entry in NHSN Data
224. on each of the two forms We ll look at them on the next slide Reaction Details Facility location where reaction occurred _INHONCSCA INACUTE SCA HONC Time reaction occurred 10 0 HH MM OR CJ Time unknown Adverse ee R Reaction Occurrence Date incident occurred 01 10 2009 Where in the facility did the incident occur Time incident occurred 08 00 HH MM NPTCBLOOD NONPTC NA LAB BLOOD X Time approximate Time unknown Job function of the worker involved in the incident CLT Clinical Lab Technician Where in the process did the incident first occur SE Product selection Incident code SE 01 Incorrect product component selected Incident detail not specified Incident summary Technician took incorrect component off shelf Select incident result 1 No recovery harm Product action Check all that apply Product retrieved Product destroyed Product issued but no ansfused Incident SC reen X Product transfused Was a patient reaction associated with this incide Patients Patient ID rp57923 On the Adverse Reaction event screen you have a button to select that will Link Unlink the event to an incident On the Incident form and remember the Incident form is the first one you enter Product Action will be Product transfused Answer Yes to the question of whether a patient reaction was associated with the incident and then enter the Patient ID s associated with the incid
225. one or the other before entering the code When you enter a 5 digit code in NHSN the product description should appear If it does not please make sure you have entered the correct code If you have and the description still does not appear please contact NHSN user support and provide the code and product description Blood Product Codes In NHSN Product Action Used to indicate the type of product if product is destroyed as a result of an incident Enter of units destroyed for each type of product If a single unit is destroyed you have the option of entering the unit Unit can be entered for ISBT 128 or Codabar You can add multiple component codes by clicking on the Add Row button Select incident result 3 Near miss unplanned recovery Product action Check all that apply C Not applicable Cl Product retrieved M Product destroyed CodeSystem used ISBT128 ISBT 128 Single or multiple units destroyed M Multiple Units Component codes Component code E0154 RBC RED BLOOD CELLS CPD 450mL refg Open Number of units 3 This is a screen shot from NHSN to show you how the product description should look You can add multiple component codes by clicking on the Add row button You can delete rows by clicking on the trashcan that appears to the left of the code Investigation Results Did this incident receive root cause analysis Future O ves O no Severity Code check one O High
226. or leukemia Virus 2 HTLV 2 West Nile Virus Flaviviridae Investigation triggers for infections thought to be transfusion transmitted Any of these 1 Identification by testing e g gram stain other smear staining culture or other method of an unexpected bacterial mycobacterial or fungal organism in a recipient within the time period from exposure i e transfusion to onset of infection appropriate for the suspected pathogen 2 Identification of an unexpected virus in the recipient by testing e g culture direct fluorescent antibody or polymerase chain reaction within the time period from exposure i e transfusion to onset of infection appropriate for the suspected virus 3 Identification of an unexpected parasite in the recipient by blood smear histopathology or stool testing for ova parasites within the time period from exposure i e transfusion to onset of infection appropriate for the suspected parasite 4 Any of the above laboratory findings in the recipient unit upon residual testing 5 Unexplained clinical events occurring after transfusion that are consistent with transfusion transmitted disease such as a Encephalitis meningitis or other unexplained central nervous system abnormalities b Sepsis with or without multi system organ failure c Recipient death 6 In addition for infections routinely screened in the blood donor any infection in the recipient occurring within 6 months after transfusion i
227. or the recipient check the results Check one box per line underlying cause was never determined diagnosed but is not described above list it here For adverse reaction selected Required indicate Case Definition Criteria Use the definitions as described i Case Definition Criteria in the protocol Only those reactions meeting the criteria ll Grade as definitive probable or possible should be reported lil Relationship to Transfusion Grade is the severity of the reaction Use the severity grade descriptions as defined in the table for the specific adverse reaction in Appendix B of the protocol If not defined under the specific reaction use the severity grade descriptions in Appendix C Relationship to Transfusion is Imputability or the likelihood that it was the transfusion that caused the reaction Use the relationship definitions as listed for each adverse reaction or specified in Appendix C of the protocol Doubtful or ruled out should only be used if after initial investigation and entry into NHSN it is later determined that a reaction thought to be related to the transfusion 1 8 2009 15 ae Instructions for Form Completion ae Death Major or long term sequelae Minor or no sequelae Not determined Date of Death If recipient died relationship of transfusion to death Custom Fields Comments 1 8 2009 Required Enter the outcome of the patient Sequelae refer to any late effects of the adverse re
228. ors at the end of the reporting month Let s review what we learned in this session One form is completed for each adverse reaction Report adverse reactions for every month of the year Use case definition criteria to define a reaction Report the severity and imputability for each reaction Report the reaction after the investigation is complete Patient outcome must be entered in order to save the record When linking an adverse reaction to an incident enter the incident record first Continue to follow your standard FDA reporting rules Participation in NHSN does not take the place of that reporting Finally be sure to enter your monthly denominators at the close of the reporting month IN National Healthcare Hill LAM safety Network Questions or Need Help Contact User Suppor This concludes our Adverse Reaction Data Collection and Entry training For questions or user assistance send an email to NHSN cdc gov 7 National Healthcare Safety Network Biovigilance Component Hemovigilance Module Introduction to Analysis SAFER HEALTHIER PEOPLE Welcome to the National Healthcare Safety Network training session Hemovigilance Module Introduction to Analysis Target Audience This training is intended for persons who will be generating and analyzing data in the Hemovigilance Module and have user rights set up so that they may do so his could include supervisors or managers in Transfusion Ser
229. ou are entering the corresponding Adverse Reaction form you will select the Link button When you click on that button a listing of incident records for that Patient ID will be displayed Review the date incident occurred and the NHSN assigned Incident Check the box of the record you want to link and click on the Link Unlink button at the bottom of the screen Case Example Adverse Reaction At approximately 08 45 a m on 1 8 2009 patient M Johnson was halfway through a transfusion of plasma when she complained of itchiness on her arms bilaterally The nurse slowed the transfusion rate but within 5 minutes bright red macula appeared on both forearms Diphenhydramine was administered with relief of symptoms Transfusion reaction investigation was negative for hemolysis The patient had not been previously transfused Now that we ve reviewed the entire Adverse Reaction form let s work through a case example At 8 45 a m on January 8 2009 patient Mary Johnson was halfway through receiving a transfusion of fresh frozen plasma when she complained of itchiness on her arms bilaterally The nurse slowed the transfusion rate but within 5 minutes bright red macula appeared on both forearms Diphenhydramine was administered with relief of symptoms Transfusion reaction investigation was negative for hemolysis The patient had not been previously transfused Patient Information Pleasant Valley Hospital ID 10312 v Adverse Rea
230. owing the BV component Biovigilance Component Analysis Output Options _Expandall_ _ Collapse All_ Lists major options available O Generate DataSets Hemovigilance Module Output Options Surveys Users Facility Advanced CiMy Custom Output Published Output Once data sets have been generated select Output Options from the left navigation bar The first screen will show the major analysis output options available Expand All Lists every output option that is available Some reports are canned with pre defined variables but can be modified by the user Department of Health and Human Services Centers for Disease Control and Prevention HSN National Healthcare Safety Network ISD CLFT NHSN1 NHSN Home My y NHSN Home Logged into Pleasant Valley Hospital ID 10312 as RUBY Necility Pleasa 0312 follor nt Valley Hospital ID 10312 is folloving the BV component Reporting Plan Biovigilance Component Analysis Output Options Summary Data Analysis D Generate Data Sets Hemovigilance Module Output Options Surveys Users Facility 2 Line Listing All Adverse Reaction Data Modify Group 2 Frequency Table All Adverse Reaction Data Modify Log Out 3 fillgar Chart All Adverse Reaction Data Modify _ rie chart pe Lun Mody A s C HV Adverse ReactiereDSta Ege Defined Output If you click on the left button Expand All you will see a list of every option t
231. patient reaction is TRALI GVHD or any type of infection this information is required Enter the individual unit number as it appears on the product label 1 8 2009 12 Unit expiration date Blood group of unit Implicated in the adverse reaction WoOO000 07 123456 SE NOTE If your institution is using the Codabar system the unit number can be entered in the spaces provided Start at the top left space and fill in the blanks The number will be concatenated and stored as a single number Required Enter the unit expiration date as indicated on the product label using format MM DD YYYY In the ISBT 128 example label the expiration date is 02 11 2007 Experalion Dieta Time ii FEB 2007 15 20 Required Enter the blood group of the unit administered or N A for products where it is not applicable Example O RhD POSITIVE Conditionally required If a single unit was considered to be the probable cause of the reaction check the box on the line listing the implicated unit Multiple units cannot be checked If the patient received multiple units and you are not sure which one caused the reaction do not check any Investigation Results Was a particular unit implicated in Required If a box was checked next to a component the adverse reaction thought to be the cause of the reaction this will be equal If no boxes for an implicated unit are checked Adverse reaction 1 8 2009 this is equal to
232. potension are unlikely but not fully excluded Possible Other conditions that could readily explain hypotension are present NHSN Biovigilance Component protocol 4 Febrile non hemolytic transfusion reaction FNHTR Fever and or chills without hemolysis occurring in the patient up to 4 hours during and after transfusion If transfusion related the most common cause is a reaction to passively transfused cytokines or a reaction of recipient antibodies and leukocytes in the donor s blood Case Definition Criteria Signs amp Symptoms Laboratory Radiology If Performed but not required to meet definitive criteria Definitive Fever 38 C oral or equivalent and a change of 1 C from pre transfusion value AND Occurs during or within 4 hours of transfusion Probable N A Possible N A 03 17 2009 V1 Final Negative culture of residual component Negative post transfusion patient blood culture Lab findings not consistent with acute hemolysis as cause of fever Grade Severity Use grades as provided in Appendix C 18 Relationship to Transfusion Imputability Definite Meets definitive protocol criterion and the patient has no other conditions that could explain symptoms Probable Other conditions that could explain fever chills are unlikely but not fully excluded Possible Other conditions are present or were present before the transfusion that could expla
233. ppendix B Adverse Reaction Definitions and Case Definition Criterion ccccceccceeeeeeeeeeeeeeeeeeeees 13 Mls PANG TO AC UO crc ete rseaceceeen 5 E E E E 13 2 Hemolytic transfusion FEACTION ccccceccceeeceececeeeeeeeeceeeceueecaceseuceseeseaeeseeessueesaeeseueesaeeseeeesaeeeseeees 14 A Acute hemolytic transfusion reaction AHTR ccccccececeecceeeceeeeceeeeseeeceeceseeeseueeseeeseueeaeeesaues 14 B Delayed hemolytic transfusion reaction DHTR cccccccceeccececeeeceeeeceeeseeeeeeeeeeeeseeeseeeeeeess 15 C Delayed serologic transfusion reaction DSTR c ccc ccccc cece eececececeeeeseeeeeeeeeeeeseueesaeeseeeeeeeeaes 16 3 Hypotensive transfusion reaction cccccccccseccceeecseeceeeceeeeceeeeeucesaeeseueesaeessueeseeesaeeseeesaeeseneesaaes 17 4 Febrile non hemolytic transfusion reaction FNHTR cccceccsececeeeeeeeeceeeeeeeeeeeeeseeeseeeeeeeesaeeeaes 18 3 IOS tral srl SlO MOUND a P TEI cece ezsenateatencaiencenncesercsuetane teesesalonaneeaselupecetaiseteurose meee baneemacrseneemette 19 6 Transfusion associated circulatory Overload TACO cccccccceccceecceeeeeeeeeeeeeseeeeeeeeseeesseeeseeeeaeees 20 7 Transfusion associated dyspnea TAD ccccccccceececceceeeeseeeeececeeeeeueeseeessuceseesseeeseeessneeseesaees 21 8 Transfusion associated graft vs host disease GVHD ccc ceccceccceeeeceeeeeeeseeeseeeeseeesaeeeseens 22 9 Transfusion rel
234. ppendix C Investigation Results Was a particular unit implicated in the adverse reaction N No Adverse reaction INF Infection a Infection type 4 Specify infection organism Blood culture performed on unit a Blood culture performed on recipient post transfusion i Case Definition Criteria POS Possible v ii Grade NS Non severe v iii Relationship POS Possible s_ Some adverse reactions have additional information requirements Infections should be reported only after carefully reviewing the guidelines in Appendix B to ensure the case definition requirements are satisfied Select the infection type from the drop down box Up to 3 organisms pathogens can be reported Please indicate whether blood cultures were done on the unit transfused the recipient post transfusion or both Investigation Results TA GVHD amp TRALI m TA GVHD Was a particular unit implicated in the adverse reaction N No v Indicate whether Adverse reaction TA GVHD Transfusion associated graft vs host disease Y p atient BER Has tha patient received any non irradiated blood products in the past 2 months y received non irradiated 0 01070 Investigation Results products in Was a particular unit implicated in the adverse reaction N No past 2 Adverse reaction TRALI Transfusion related acute lung injury months Antibody studies performed E TRALI Test results positive
235. process is use process code with 00 e g an incident during product administration would be UT 00 m Incident summary brief but descriptive text of exactly what happened m Incident result Where in the process did the incident first occur Check one O Product check in O Product test request O Sample collection O Sample handling O Sample receipt O Sample testing O Product storage O Available for issue Ol Product selection O Product manipulation O Request for pick up O Product issue O Product administration O Other specify Enter Incident Code See Incident Codes on Page 4 of Form OR O Incident detail not specified Incident summary Tncident result Check one LJ i No recovery harm O 2 No recovery no harm L 3 Near miss unplanned recovery Ol 4 Near miss planned recovery Enter the incident code of where in the process the incident first occurred This is the first time point at which the error or accident occurred Some errors occur at multiple points for example if a wrong unit is issued to a patient and the nurse administering the transfusion also fails to detect that the unit is for someone else the first place the error occurred was at product issue If you don t know the details of the incident but know the step in the process enter the process code with a 00 For example an incident during product administration would be UT 00 Please enter a brief but descriptive narrative in the incident su
236. programs in the United Kingdom and Canada Collection of data regarding near misses helps to increase the comprehensiveness of incident surveillance Five layers of safeguards established by the Food and Drug Administration FDA have become standard operating procedure for blood establishments and others involved in the collection and distribution of blood and blood products These safeguards include screening of blood donors testing of blood for bloodborne pathogens including HIV hepatitis B amp C viruses syphilis West Nile virus and others maintaining lists of deferred donors persons either temporarily or permanently excluded from blood donation routine quarantine of all blood products until infectious disease testing and final donor eligibility determination has been completed and investigation of any problems associated with blood 03 17 2009 V1 Final 4 NHSN Biovigilance Component protocol products including breaching of safeguards errors accidents or any other event that could jeopardize blood product safety Despite the rigorous safeguards in place non infectious complications of transfusion can still occur due to the complex physiological mechanisms involved in transfusions In addition the risk of error associated with administration of a particular blood product to a particular patient is a persistent concern In 1999 the Institute of Medicine report To Err is Human estimated that between 44 000 and 98 000 Americans di
237. quisites a View Training 1 Biovigilance Component Overview Have copies of Hemovigilance protocol Tables of Instructions and the following forms available for reference Hemovigilance Module Monthly Reporting Plan Incident form Blood Products Incident Reporting Summary Data Monthly Denominator form We strongly recommend that you take the Biovigilance Component Overview training before viewing this session You may want to print out copies of the Hemovigilance protocol Tables of Instructions and the following forms for reference Hemovigilance Module Monthly Reporting Plan Incident form Blood Products Incident Reporting Summary Data and Monthly Denominator form Objectives m n this session we ll discuss Key terms used in incident reporting Why error reporting is important Why employees don t always report mistakes Using process codes to categorize errors Using the Tables of Instructions Completing a Monthly Reporting Plan aaan and entering a Hemovigilance Incident form in Incident result and root cause analysis definitions Real case examples Completing the Incident Summary data form Linking Incidents with Adverse Reactions Custom fields and labels In this session we will discuss key terms used in incident reporting why error reporting is important why employees don t always report mistakes using process codes to categorize errors using the Tables of Instructions completing your Monthly
238. r 4 If product was destroyed due to the incident for example a freezer breaks down select the code system used that is ISBT 128 or Codabar and enter the unit number or component code if only a single unit is involved If multiple units are destroyed put the component code and number of units for each component type destroyed We ll discuss component codes in more detail in the next slide Use Not applicable when the error occurred in transfusion services and no product had yet been issued If product was transfused indicate if a reaction was associated with the incident Remember that your Result code must be a 1 if this is answered Yes Indicate record keeping and other actions that are taken as a result of the incident ig Blood Product Codes Codabar being phased out CPDA 1 WHOLE BLOOD LEUKOCYTES REDUCED IRRADIATED LOW VOLUME QPDA 1 WHOLE BLOOD LEUKOCYTES REDUCED IRRADIATED 250 mI GP2D WHOLE BLOOD LEUKOCYTES REDUCED IRRADIATED WB F WB WB ES 1 RED BLOOD CELLS LEUKOCYTES REDUCED ACDA anticoagulant by pheresis for second bag of a double red blood cell pheresis AS 1 RED BLOOD CELLS LEUKOCYTES REDUCED IRRADIATED ACDA anticoagulant by pheresis LRRBC IRLRRB Cl AS 1 RED BLOOD CELLS LEUKOCYTES REDUCED DIVIDED ACDA anticoaqulant by pheresis Part 4 or 1 LRRBC AS 1 RED BLOOD CELLS LEUKOCYTES REDUCED DIVIDED ACDA anticoagulant by pheresis Part B or 2 LRRBC AS 1 RED BLOOD CELLS LEUK
239. radiated IRRBC RED BLOOD CELLS CPD 450mL tefg lrradiated ResLeu lt 5log6 IRLRRBC For surveillance purposes we are interested in the part of the component code that tells us the product the patient received Here are examples of Codabar and ISBT 128 product code lists In either system we are interested in the first five characters Investigation Results One event per Adverse Reaction form Enter reactions after investigation is complete however changes can be made later if necessary Some reactions have sub questions that will show on screen once the reaction is selected Use case definition criteria severity and imputability from alem 01101101010 F Investigation Results Was a particular unit implicated in the adverse reaction N No Adverse reaction AHTR Acute hemolytic transfusion reaction Immune Antibody b C Non immune i Case Definition Criteria POS Possible v ii Grade NS Non severe w iii Relationship POS Possible Reporting investigation results Remember to report only one reaction per form Enter the form after the investigation is complete Some reactions have sub questions that will appear on the screen after you have selected the reaction Use the case definition criteria severity and imputability that are in protocol Appendices B and C Case Definition Criteria B Delayed hemolytic transfusion reaction DHTR The recipient develops antibody to RBC an
240. re some of the items requested The level of computerization of Transfusion Services and methods of specimen handling including patient identification and collection and procedures for type and screen and crossmatch are also included in the survey Once a survey has been completed the first year subsequent surveys are auto filled with information from the previous year and only require editing or updating 5 Step Enrollment Process a Facility Administrator must Review and accept Rules of Behavior Complete registration form online Apply for and install an SDN digital certificate for NHSN Enrollment activity Print complete and submit online e Facility Contact Information Form e Hemovigilance Module Annual Facility Survey Print sign and return Consent Form to NHSN e Agree to follow protocols and use definitions exactly e Send acceptable Biovigilance Component data for all 12 months in the year including annual survey Your state or other group may require additional data reporting There are five steps to the enrollment process The Facility Administrator must review and accept the Rules of Behavior complete the on line registration form apply for and install an SDN digital certificate for NHSN enrollment activity print complete and then submit on line the Facility Contact Information form and the Hemovigilance Module Annual Facility Survey and print sign and return the consent form to NHSN By signing the consent for
241. reaches the patient requires a complete Incident form regardless of whether the patient experienced a reaction or not Acknowledgements Incident process codes are based on MERS TM Medical Event Reporting System for Transfusion Medicine Columbia University and TESS Transfusion Error Surveillance System Public Health Agency of Canada Thank you to Helen Downie MLT Sunnybrook Health Sciences Centre Toronto Ontario Canada for providing the background material on error reporting and case examples for this training Our Incident process codes are based on those used in the Medical Event Reporting System for Transfusion Medicine or MERS TM and the Transfusion Error Surveillance System or TESS A special thank you to Helen Downie of Sunnybrook Health Sciences Centre Ontario Canada for providing the background material and case examples used in this training While the case examples are real the names of the individuals involved have been changed E National Healthcare AAA Safety Network Questions or Need Help Contact User Suppor That concludes our training on Incident Se If you have questions or need help please contact NHSN User Support at NHSN An ki T National Healthcare Safety Network Biovigilance Component Adverse Reaction Data Collection and Entry SAFER HEALTHIER PEOPLE Welcome to the National Healthcare Safety Network Biovigilance Component Training This session covers
242. reaction Codabar Click on trash panto eee 01 02 2009 EB 00120 12 12 2009 EJ A x oO a rW 21 02 ACD A WHOLE BLOOD Add Row Component details Enter the start date and time the first transfusion associated with the reaction was administered Use the 24 hour clock or military time Select the system your facility uses for component code Enter the first part of the number that describes the product If the patient received multiple units of the same product you can use a single line Multiple rows of products can be added by clicking on Add Row Unit number is only required if the patient experienced TRALI TA graft vs host disease or infection In those cases only a single product can be entered on a row If a particular unit is considered responsible for the reaction check the Implicated in the adverse reaction box If the patient received multiple units in the time period associated with the transfusion the unit causing the reaction may be unknown Blood Product Codes Codabar being phased out CPDA 1 WHOLE BLOOD LEUKOCYTES REDUCED IRRADIATED LOVY VOLUME QPDA 1 WHOLE BLOOD LEUKOCYTES REDUCED IRRADIATED 250 ml GP2D WHOLE BLOOD LEUKOCYTES REDUCED IRRADIATED BS 1 RED BLOOD CELLS LEUKOCYTES REDUCED ACDA anticoagulant by pheresis for second bag of a double red blood cell A pheresis LRRBC 43 1 RED BLOOD CELLS LEUKOCYTES REDUCED IRRADIATED ACDA anticoagulant by pheresis
243. riod 3 Fatality report Patient ID date of reaction type of reaction product s received date of death relationship to transfusion 4 Adverse reaction rates by type of product case definition criteria definitive or probable line data 5 Adverse reaction symptom report Patient ID number date adverse reaction case definition criteria definitive probable or possible product s received signs amp symptoms severity 6 ABO Incompatibility report events where blood group of recipient is different than blood group transfused Patient ID number date blood group of recipient blood group of unit product transfused adverse reaction B Incidents In transfusion medicine most incidents do not result in harm to the patient Studies have shown the risk of erroneous or mistransfusion of red cell RBC units to be approximately 1 in 14 000 to 1 in 38 000 A mistransfusion is failure to give the correct blood to the intended recipient and is a preventable human error in the worst consequence this can result in major ABO incompatibility and patient illness or death Transfusion incidents can involve errors in more than one step of the process of getting the right blood to the right patient Identification of where in the process these incidents occur can provide information that will help facilities improve their procedures Data collection for incident reporting is intended to provide numbers of occurrences and types of i
244. rmation sheet asks for facility identification and contact information The Facility Administrator and contacts for each of the components you are participating in should be completed The Facility Administrator and component contact can be the same person However the component contact should be an individual who has knowledge of the subject matter contained in that component Hemovigilance Module Annual Facility Surve 17 Unie Treredced by Deparimenteeruce x NSN Hemo vigilance Module Annual Fact lity Survey Regured ted Tracing 8 Fadly id Suruey Year Ealt charan bri giog For all ques lors use pasl tdl cenda yea anria sls ics 1 Owrership Check ore O feorpratt O Geuemment O Miry O Wolt prodl Incuding church O veers Ats O Prysidarrowred O mereged Cae Omerimion 2 b yos hosplid ailiaed wih amedio sctod O ves O Wo Nyes ype oratillalon O mao O cae O Umed 3 communi y selirg obdily O uban O Sbu O Rura 4 Tota beds selup ard ztd 5 Wumberotsurgenes penomed per year realeni Oubalent 6 Alwhel Feumaleuel is you tdllycerlied CO tk Iantu don servos s Charaoiricios 7 Pimay daesitcalon of bdil y eas sened by Trereteion Senices Check all Pelapply O Cerera medica ard supica OF Obzercs ard gyrecdcgy O Orbopedic O carcerener O choncdsexe O Children s gerer medica ad supica O chiders obepedic O chiders crecercener DO chiders cteoricdiseme O Ofer ped tha 5 b your Tarcislion
245. roduct and Record other action was that product was retrieved before issue and re labeled Case 3 Investigation Result See protocol Appendix G for description of root cause analysis results Investigation Results Did this incident receive root cause analysis Y Yes Results of analysis Check all that apply Cl Technical J Organizational MlHuman _J Patient related Other e Incorrect or incomplete assessment of a situation including related conditions of the patient and materials to be used before starting the transfusion Example failure to correctly identity the patient by checking the wristband A root cause analysis of this incident was performed and the result was that this was a human failure This is defined as failure due to incorrect or incomplete assessment of a situation including related conditions of the patient and materials to be used before starting the transfusion In our case it was incorrect labeling Case 4 Incident Resulting in Adverse Reaction At 08 30 a m on 1 8 2009 the blood bank discovered that a wrong unit may have been issued to patient B Thomas The technologist called the ICU and asked the nurse to check the identification of two units that had been issued for patient B Thomas One of the bags issued had the name and hospital number of another patient with the same last name The patient had already received the incorrect unit starting at 04 55 a m that day The attending physici
246. roup Conferring rights to a Group Reviewed an example of Conferred Rights Let s review what was discussed in this session We reviewed the definition of a Group in NHSN and demonstrated how a Facility Administrator nominates a Group Then we discussed the steps taken by the Group Administrator and the Facility Administrator or the facility user with administrative rights The Facility Administrator joins the Group and Confers rights to the Group Finally we viewed an example of Conferred Rights WS National Healthcare Safety Network Questions or Need Help Contact User Suppor That concludes our a on oe in Biovigilance If you have questions or need help please contact NHSN Thank you 77 National Healthcare afety Network Biovigilance Component Hemovigilance Incident Reporting SAFER HEALTHIER PEOPLE Welcome to the National Healthcare Safety Network Biovigilance Component Hemovigilance Incident reporting training session Target Audience Staff in Blood Transfusion Services departments who will be collecting and or entering incident report data into the Hemovigilance module of NHSN Staff who will be analyzing incident report data This training session is intended for staff in Blood Transfusion Services departments who will be collecting and or entering incident report data into the Hemovigilance Module of NHSN and for staff who will be analyzing Incident report data Prere
247. rt Step 2 Select A Program 800 532 9929 770 454 4863 phintech cdc gov Select the program whose activities you want to join National Healthcare Safety Network NHSN National Select Agent Registry NEPHTN NETSS Nutrition Next you will be asked to Select a Program Select National Healthcare Safety Network NHSN Select activities Click on NHSN Enrollment SUR p O Centers for Disease Control and Prevention Digital ID Enrollment SAFER HEALTHIER PEOPLE SDN Support Step 2 Select A Program 800 532 9929 770 454 4863 phintech cdc gov Select the program whose activities you want to join National Healthcare Safety Network National Select Agent Registry NEPHTN NETSS Nutrition NVSN Step 3 Select Activities Select one or more National Healthcare Safety Network NHSN activities from the list NHSN Reporting NHSN Upload Select an activity Your activity will be NHSN Enrollment Create a challenge phrase password pe pe CDC Home Search Health Topics A Z Dt a Centers for Disease Control and Prevention Digital ID Enrollment SAFER HEALTHIER PEOPLE Step 4 Choose a Challenge Phrase SDN Support The challenge phrase is a password or phrase that you will need to provide every time you 800 532 9929 access the CDC Secure Data Network and is also required to revoke your Digital ID 770 454 4863 phintech cdc gov For security reasons a c
248. s a Group in NHSN A Group is a collection of facilities that have joined together within the NHSN framework to share some or all of their data at a single Group level for a mutual purpose for example for performance improvement or state and or public reporting In the example on this slide facilities B D and E have joined the HV Group They enter data into NHSN and by conferring rights to HV Group give HV Group the ability to see the data that they have entered into NHSN Nominate a Group Facility Administrator selects Nominate from the Group section of NHSN navigation bar Enters the name and type of Group Enters the information about the Group Administrator Submits NOTE Nominating a group does not automatically join the facility to the Group The first step is to nominate a Group This is done by a Facility Administrator from one of the facilities that will participate in the Group The Facility Administrator selects Group Nominate on the left navigation bar then enters the name and types of group information about the Group Administrator and clicks on the Submit button Please note that by nominating a Group the Facility Administrator has not yet joined his her own facility to the group PAZA Only one NHSN facilit completes this step j Centers ior Disease Control and Prevention NHSN National Healthcare Safety Network ISD CLFT NHSN 1 NHSN Home My Info Contact us Help Log Out Lo
249. s no right to privacy on this system All information on this computer system may be monitored intercepted recorded read copied and shared by authorized personnel for official purposes including criminal investigations Access or use of this system whether authorized or unauthorized constitutes consent to these terms Title 18 U S C m SISA Please enter your challenge phrase T Forgot your challenge phrase Click here your SDN challenge phrase or password and click Submit Click on NHSN Enrollment Z CDC Public Health Partners Microsoft Internet Explorer File Edit View Favorites Tools Help cals ae dba A QsSearch GaFavorites Sire Siar auyaKa Search Web TAE IEF oC Public Health Partners my Yahoo EJ Answers Games iShopping Music Search CDC gov Ooo l Go National Healthcare Safety Network NHSN This Week in MMWR August 11 2006 Vol 55 No 31 The Global HIVIAIDS Pandemic 2006 NHSN E I it gt HI Prevalence Among Populations of Men Who Have Sex with Men Thailand 2003 and 2005 7 aS een gt HIY Counseling Testing and Care of Tuberculosis Patients at Chest Clinics Guyana 2005 2006 gt Request Additional Activities Recommendations and Reports August 11 2006 Vol 55 No RR 12 April 21 2006 Vol 55 No RR 6 To locate HHS personnel enter the search Prevention of Rotavirus Gastroenteritis Among Infants and Children Recommen
250. s the NHSN application through CDC s Secure Data Network SDN This document can be accessed at http www cdc gov ncidod dhqp nhsn documents html From the Centers for Disease Control and Prevention Digital ID Enrollment page https ca cdc gov you will be prompted for the enrollment password which is cde sdn apply Be sure to include the exclamation points and use lower case and underscores Follow the onscreen instructions to apply for a digital certificate During the process you will be prompted to select a Program and a Program specific Activity For Program select National Healthcare Safety Network NHSH For Activity select NHSN Enrollment VERY IMPORTANT After you obtain and install your digital certificate Step 3d in the NHSN Facility Administrator Enrollment Guide access the SDN https sdn cdc gov enter your challenge phrase and select Applications This will launch the NHSN Enroll Facility page Be sure to indicate yourself as the NHSN Facility Administrator If you have difficulties obtaining a digital certificate please contact SDN at 800 532 9929 or 770 936 3636 or PHINTech cdc gov or nhsnfcdec gov website at http uww cdc gov ncidod dhqp nhsn members html You will receive an email from NHSN telling you that you are now registered in NHSN This email provides instructions for obtaining your digital certificate an AWI i ids H 2 77 National Healthcare I Safety Network
251. sing adverse reaction test records We provide a canned report with a pre defined set of variables but you can also modify this report as we will show later in this training session Line Listing Sample incident report line list Canned report of data reported for incidents but can be modified When Occurred Product Process Incident Product Occurance Code Incident Code Result Action Occurance Location Description Description 100 05JAN09 10 05 INLTACSCA PC Product PC 00 Not specified 4 Near check in miss planned recovery 105 10JAN09 08 00 NPTCBLOOD SE Product SE 01 Incorrect 1 No selection product component recovery selected harm 110 01FEB09 00 00 NPTCBLOOD US Product US 00 Not specified 4 Near storage miss planned recovery 118 02MAR09 16 05 NPTCBLOOD AV Available AV 00 Not specified 4 Near for issue Here is an example of a line listing using sample incident reports Again this report has a pre defined set of variables but can be modified Frequency Table Default variables are adverse reaction by product type Can be modified Variable names amp labels will be discussed later in this training National Healthcare Safety Network Frequency Table for All Adverse Reactions As of May 5 2009 at 8 39 AM Date Range All HVADVRXN Frequency Table of productType by advRxn Percent ahia Row Pct Col Pct productType AHTR AL
252. sociated infections What you see on the drop down list is the pathogen code followed by the more detailed description Create Output Sets Use when you have multiple reports to run at standard intervals for example monthly My Custom Output output Sets Create New Output Set Published Output Use the Create Output Set option when you have multiple reports to run at standard intervals Create Output Sets Select the reports you need Logged into Pleasant Valley Hospital ID 10312 as RUBY Facility Pleasant Valley Hospital ID 10312 is following the BV component Available Output Options a Output Name Analysis Data Set Rta Sets NOOUOWSOOOUOO HVAdvRxnComp HVAdvRxnComp HVAdvRxnComp HVAdvRxnComp BvVPatients HVAdvRxnComp HVIncidComp HVAdvRxn HVAdvRxn HVAdvRxn HVAdvRxn Date Created 04 13 2009 04 13 2009 04 13 2009 04 13 2009 04 06 2009 04 13 2009 04 13 2009 04 06 2009 04 06 2009 04 06 2009 04 06 2009 When you select Create New Output Set you will be shown a list of all the reports standard and custom that are available to you Select the ones you want by checking the left hand box Create Output Sets 5v component Output Set Mandatory fields marked with Output Set L na Monthly Reports K Output Set Title Output Name Line Listing All Incident Unit Data Modify Line Listing All Adverse Reaction Data Modify Adverse Reactions amp Incide
253. t for each enrolled component should be pre printed on the form if not enter it The form must be signed by someone at your facility authorized to give permission to submit facility and patient data to CDC This is usually someone like the Chief Executive Officer or Chief Operating Officer After the form is signed make a copy for your records and send the original by surface mail not overnight or FEDEX to NHSN at the address listed in the Facility Administrator Enrollment Guide WA a T A N Tr BEE 1 So WZ Pah 77 National Healthcare I Safety Network NHSN will activate your facility when Consent Is received and send you an enrollment approval email Once NHSN has received your Agreement to Participate and Consent you will receive an enrollment approval email Enrollment is complete NHSN Facility Administrator can now access NHSN Reporting through the SDN to add users and set up facility for reporting in NHSN a See Training 3 Biovigilance Component Enrolling an Existing NHSN Facility into Biovigilance and Facility Set up Enrollment is complete Your NHSN Facility Administrator can now access NHSN reporting through the SDN to add users and set up your facility Information on setting up your facility is provided in Training 3 Biovigilance Component Enrolling an Existing NHSN Facility into Biovigilance and Facility Set up Enter your SDN challenge phrase click Submit g SDN Login Page
254. t is not used in aggregate analysis The comments field is available but information contained therein is not used in analysis Custom Field Labels To label custom fields for any existing form select the Form Type and Form from the drop down lists NHSN Home If one of the Summary Data forms is selected it may be customized by location by selecting a value from the Your Location Code drop down list wri al Enter labels for any custom fields you wish to have displayed on the screen Incident Reaction Form Type v Summary Data f Form D Analysis e T Status Active vj Description Date Label 1 Label 2 P aTala di Bpi D Facility Info Add Edit Component Numeric B Locations Label 1 Label 2 Log Out Alphanumeric Label 1 q Label 2 To enter custom fields and labels in NHSN select Facility Customize Forms at the left navigation bar Instructions are provided on the screen Let s Review _ One reaction per form Report for every month of the year Use case definition criteria to define a reaction Report severity and imputability for each reaction Report the reaction after the investigation is complete Patient outcome must be entered to save the record When linking an adverse reaction to an incident enter the incident first Continue to follow standard FDA reporting rules NHSN surveillance does not replace FDA reporting Enter monthly denominat
255. t of Health and Human Services Centers for Disease Control and Prevention NHSN National Healthcare Safety Network ISD CLFT NHSN1 NHSN Home My Info Co Logged into DHQP MEMORIAL HOSPITAL Facility DHQP MEMORIAL HOSPITAL ID 10018 is following HV component Reporting Plan are Welcome to the NHSN Home Page incident Use the Navigation bar on the left to access the features of the application NHSN Home My Info Y NHSN Home a Add Adverse Reaction atient is following HV component Reaction D Add Mandatory fields marked with D Find mode add headerMode view appcontext null You have two options for adding a patient You can select Patient from the navigation bar or you can add your patient at the same time you add the adverse reaction for that patient CD Department of Health and Human Services Centers for Disease Control and Prevention NHSN National Healthcare Safety Network ISD CLFT NHSN1 NHSN Home My Info Contact us Hel gt NHSN Home Logged into Pleasant Valley Hospital ID 10312 as RUBY Facility Pleasant Valley Hospital ID 10312 is folloyjeerfhe BV component Reporting Plan Bana Add Patient Add D Find D Import Mandatory fields marked with ee Patient Information P Facility ID Pleasant Valley Hospital ID 10312 gt Patient ID Social Security Secondary ID Last Name First Name M
256. t type and note Group A recipient of group O bone marrow transplant currently typing as mixed field Reaction Details es Enter the date the reaction was first observed in the patient oe Enter the time the reaction was first observed in the patient If the time is unknown check Time Unknown Facility location where reaction Required Enter the facility location where the patient was Occurred at the time the reaction was first observed Is this reaction associated with an Required If this adverse reaction is associated with a incident documented incident reported on the Hemovigilance Incident Form select Yes If YES Incident Conditionally required The incident number is the system generated number assigned by NHSN at the time the incident is entered Note to link an adverse reaction with an incident the incident must be entered into NHSN first Signs and symptoms laboratory Required Check all signs and symptoms observed in the patient at the time the reaction occurred and any associated laboratory findings These may or may not be directly associated with the observed reaction since patients receiving transfusions have underlying medical 1 8 2009 11 Instructions for Form Completion conditions See Appendix A in the Hemovigilance protocol for definitions Component Details each component was started Component code Check system Required Check whether the product labeling system used
257. tact BV Biovigilance Contact User ID First Name Ruby Middle Name You will be reminded that Last Name Phelps a survey must be entered Title Click to MAAL Ee LDO 4 survey for the current calendar year must be entered before you can begin using the new component Address li You will be prompted to complete the survey the first time you try to logon to the new component Address line Address li St Zip Code 30329 Zip Code Ext Phone 404 639 0252 Ext Fax E mail RFP9 CDC GOV Pager Number Enter a Biovigilance Primary Contact This will most likely be someone in Blood Transfusion Services Make sure you enter a valid email address for this person Notice the reminder that the Hemovigilance Annual Facility Survey must be completed prior to starting to enter any data into Biovigilance Click OK to continue Facility Administrator gives BV Primary Contact administrative user rights E NHSN Home Logged into Mount Sinai Medical Center ID 10127 as RUBY Facility Mount Sinai Medical Center ID 10127 is following the PS component Reporting Plan aiai View User Event Procedure User ID Summary Data Contact Type Analysis Prefix Surveys First Name Ruby D Add Middle Name D Find Facility Group Log Out User Type HE Hospital Epidemiologist User Active Y Last Name Phelps Title Phone Number Extension
258. talk about the facility survey The survey questions are answered based on prior year data So if you are entering a survey in February 2009 you would be answering questions using 2008 data Once a survey has been entered for your facility in the first year subsequent year survey fields are auto populated and will just need review and editing The survey includes information about your facility that can be used in comparative and aggregate analyses Information includes bed size specialty volume of surgeries performed Transfusion Services characteristics including facility areas served number and specialty of employees accreditation samples collected and volumes transfused In addition questions about computerization in your department and specimen handling procedures are addressed Y NHSN Home Reporting Plan Patient Incident Reaction Summary Data Analysis Surveys Users Facility Group Log Out NHSN Hemovigilance Module Home Page Department of Health and Human Services Centers for Disease Control and Prevention NHSN National Healthcare Safety Network ISD CLFT NHSN1 NHSN Home My Info Contact us Help Log Out Logged into Pleasant Valley Hospital ID 10312 as RUBY Facility Pleasant Valley Hospital ID 10312 is following the BV component NHSN Hemovigilance Module Home Page Use the Navigation bar on the left to access the features of the application Assurance of Confidentiality The information obta
259. ted in the high level process category at the time the incident was discovered Use the code descriptions on page 4 of the Incident form or in Appendix F of the protocol Occurrence 2a 4 am m Date and time the incident occurred m Where in the facility did the incident occur m Job function of the worker involved Use CDC occupation codes The worker who most likely made the error Where in the facility did the Date the incident occurred Timne the incident occurred incident occur ee a een L __ t__ _ CHAM O Time approximate pE O Time unknown Job function of the worker involved in the incident Use CDC Occupation Type codes on page 5 O If Other specify Next we will complete the section on incident occurrence First enter the date and time the incident occurred If you don t know the exact time check time approximate as described in slide 21 Enter the facility location where the actual incident or error happened For example if a sample is mislabeled at the time it is drawn from the patient enter the location where the sample was drawn Enter the CDC occupation code contained at the end of the Incident form and also listed in Appendix E of the protocol of the person most closely involved in the incident Often this will be the worker who made the error Occurrence m Where in the process did the incident first occur Incident code If detail of incident is unknown but step in
260. telets that were transfused If none enter 0 Do not include the units from which the aliquots were made in your unit count Leukocyte reduced Required Indicate the number of units and aliquots of leukocyte reduced only apheresis platelets that were transfused If none enter 0 Do not include the units from which the aliquots were made in your unit count Irradiated amp Required Indicate the total number of units and aliquots of leukocyte reduced apheresis platelets transfused that were both irradiated and leukocyte reduced If none enter 0 Do not include the units from which the aliquots were made in your unit count Plasma all types Required Enter the total number of units and aliquots of all Total whole blood derived types of whole blood derived plasma that were transfused during the month This includes fresh frozen plasma thawed etc If none enter 0 Do not include the units from which the aliquots were made in your unit count Plasma all types Required Enter the total number of units and aliquots of all Total apheresis types of apheresis plasma that were transfused during the month This includes fresh frozen plasma thawed etc If none enter 0 Do not include the units from which the aliquots were made in your unit count Cryoprecipitate Required Enter the total number of units of all types of cryoprecipitate transfused during the month This includes modified cryoprecipitate Platelets 1 8 2009 9 Ins
261. tes Reporting e Be a bona fide healthcare facili ay in the ited States of e Facility Administrator To receive email America for example be listed in or associated with a d 5 NHSN Security e updates about NHSN faci Ti ty that is s listed in one of tia follow tate nati ona e a A eae DA enter your email Begin Enrollment data ba es ADMINISTRATOR address About NHSN Enrollment Training o American Hospital Association AHA e Group Administrator Enrollment Forms o Centers for Medicare and Medicaid Services CMS e System Requirements SPL 2 _ Submit 7 Patient Safet o Veteran s Affairs VA What s this Submit Before starting the enrollment process we recommend that you print the forms you will need and have them completely filled out and handy at the time you actually enroll your facility For the Biovigilance Component this includes the Facility Contact Information form and the Hemovigilance Annual Facility Survey Please note that once you start the online enrollment process you can t save a partial form and return later to finish Facility Contact Information NN Facility Contact Information Page 1012 Facilicy Name Malin Tekonone Num per Halling address Chey Coury Scae Chee Qonlkaok COhee Qonlkaoke O ke Qonlkaok Jf nome of cne a pove kertin b soolksok emer COC orovided Envolimem x O Pacer Safecy Com poner O Hakmar Personel Safecy Com poner The Facility Contact Info
262. th and the year run a quarterly report by selecting a year and specifying Q1 Q2 Q3 or Q4 Run a semi annual report using H for the first or 2nd half of year or just specify the year for a yearly report If you choose to run a report by time period be sure to select the variable name that fits the time period selecting a Time Period Select output format Output Format HTML In this example we would get a line list of all adverse reactions reported in February 2009 Use Variable Labels Select a time period or Leave Blank for Cumulative Time Period Date Variable Beginning Ending advRxnDate v 2 01 2009 02 28 2009 Clear Time Period O Enter Date variable Time period at the time you click the Run button This slide shows an example of creating a report using date variables Here you would get a report of all adverse reactions that occurred in the month of February 2009 Note that entering month day year is another way of selecting records by month Using Selection Criteria a Speciff an operator and yalue s for selection criteria Greater than i aea s Greater than or equal to Variable Operator Value s ae el gender v F Female vi Less than or equal to Not equal to Save lew In a set of defined values Not in a set of defined values Between Within a range of values Specify Other Selection Criteria Show Criteria Column Row Clear Criteria gender il WL F Here we are
263. that the bar code reader had not been used when the product had been checked into inventory 3 days before sometime in the morning resulting in the manual entry of an incorrect expiry date The supervisor was notified and the expiry date of the unit was corrected in the LIS There was no delay in providing blood for the patient as the technician selected another unit rather than waiting for a correction to be made to the first unit Facility ID _12345____ Incident system generated Local Incident or Log _ Date of discovery _01_ _15_ 2009 __ Where in the facility was the incident discovered Time of discovery _08 _O00_ HH MM _Blood bank__ O Time approximate O Time unknown How was the incident first discovered Check one O Computer system alarm or warning O Comparison of product label to patient information O Comparison of sample and paperwork J Comparison of product label to physician order O Historical record previous type check O Human lucky catch O Observation by staff of unit plate reagent sample equipment CL Patient transfusion reaction O Repeat or sample re testing CL Routine audit or supervisory review O Visual inventory review X Other specify _comparison of product label to LIS At what point in the process was the incident first discovered Check one O Product check in O Product test request O Sample collection O Sample handling O Sample receipt X Sample testing O Product storage O Av
264. the bag did not match the one on the transfusion slip Further investigation showed that the labels had been switched when the units were labeled for transfusion The technologist immediately re labeled the units and issued the first one to the porter who had been waiting Here s another example A request for transfusion for 2 units of packed red blood cells was received in the blood bank at 8 30 a m on 1 5 2009 The patient had a current type and screen on file and qualified for an electronic crossmatch Two units were selected and the electronic crossmatch was performed The units were labeled and placed in the appropriate storage unit awaiting pick up The nursing unit was subsequently notified that the blood was ready for pick up The porter arrived at 10 00 a m with appropriate documentation to pick up the first unit When issuing the unit the tech noticed that the unit number on the bag did not match the one on the transfusion slip Further investigation showed that the labels had been switched when the units were labeled for transfusion The tech immediately re labeled the units and issued the first one to the porter who had been waiting NHSN National Healthcare Safety Network ISD CLFT NHSN1 NHSN Home My Info Contact us Help Log Out y NHSN Home Logged into Pleasant Valley Hospital ID 10312 as RUBY Facility Pleasant Valley Hospital ID 10312 is folloving the BV component eee Add Incident Incident Mandatory
265. tigens Usually manifests between 24 hours and 26 days after a transfusion and clinical or biological signs of hemolysis lare present Case Definition Criteria Grade Severity Relationship to Transfusion Imp utability Signs amp Symptoms Laboratory Radiology Clinical or eboratory symptoms Use grades as provided Definite Definitive Definitive in Appendix C Newly identified red blood Patient may be asymptomatic or Positive direct antiglobulin cell alloantibody have similar but milder Coombs test AND symptoms to AHTR AND EITHER Occurs between 24 hours Positive elution test with and 28 days after a Examples of milder symptoms alloantibody present on the transfusion include NOTE These are NOT transfused red blood cells AND required to meet case criteria OR Positive direct antiglobulin Chillsfrigors Newly identified red blood cell test with identification of a Fever alloantibody in recipient new antibody either in the Jaundice serum serum or eluate Backilank pain AND EITHER AND Hypotension Inadequate rise of post No other explanation for Hemoglobinuria hematuria transfusion hemoglobin level drop in hemoglobin Oliguria anuria or rapid fall in hemoglobin l back to pre transfusion levels OR Otherwise unexplained appearance of spherocytes Probable This is an example of the case definition criteria If you will be reporting adverse reactions remember to view the Adverse Reaction Case Definition Exercises training slides
266. time If the exact time is not known indicate the approximate time and check the Time Approximate box For example if you know that the incident occurred during the night use your best guess for the time Otherwise enter Time Unknown Where in the facility was the Required Enter your facility defined location code for the incident discovered place where the incident was discovered This may or may not be where the incident occurred How was the incident first Required Check the box that most closely represents discovered how the incident or error was FIRST discovered to have occurred If Other is selected briefly describe how the incident was discovered At what point in the process was Required Check the box for the point in processing where the incident first discovered the incident was first noted This may or may not be the point in the process where the error occurred If you are unsure about which box to check the descriptive sub categories in the Incident Codes on page 4 of the form may help Date the incident occurred Required Enter the date the incident occurred This will be on or before the date the incident was discovered Time the incident occurred Required Enter the exact time the incident occurred using the 24 hour clock Military time If the exact time is not known indicate the approximate time and check the Time Time of discovery Approximate box For example if you
267. ting organization This could include individuals in other departments Inability of an individual to apply their existing knowledge ta a navel situation Example a blood bank A root cause analysis is a formal administrative investigation aimed at identifying the problems or causes of an incident Please see Appendix G of the protocol for detailed definitions of root cause analysis results Check Yes if a root cause analysis of this incident was performed and check all results of the analysis If you are not sure if one was done answer No to this question a NSN staly Newark Hemovigilance Module Blood Product Incidents Reporting Summary data Facility ID Month ___ _ Z Year All reporting is faciity wide Include numbers of indiy individual reports in the totais Process Point Total of Adverse Number of Transfusion Reactions ST cidents Associated w Incident PC Product PCUUDetainctspeciied Gia Eaa a received from T Product amp paperwork do not mate outside ST SR RE OE reper eee any C Earn ete e es PR D0 Detail not specified iesea al Liihakssai dalana Request PET Order incorrectly entered on line Clinical jal needs not Indicated on order eg Service CMV V negati e auto not qonencomplete incorre At the completion of a reporting month complete an Incident Reporting Summary Data form Count up the total number of incidents in each process code category and put
268. tion severity grade and imputability should be collected Report the reaction after the investigation is complete However if information needs to be changed later the record can be edited Report one reaction per form or event If a patient has multiple reactions during a single transfusion episode report each on a separate form NHSN Home Reporting Plan Patient Incident Reaction Summary Data Analysis Surveys Users Facility Group Log Out Navigating in NHSN Use menu bar on left side of screen Department of Health and Human Services Centers for Disease Control and Prevention NHSN National Healthcare Safety Network ISD CLFT NHSN1 NHSN Home My Info Contact us Help Log Out Logged into Pleasant Valley Hospital ID 10312 as RUBY Facility Pleasant Valley Hospital ID 10312 is following the BV component NHSN Hemovigilance Module Home Page Use the Navigation bar on the left to access the features of the application Assurance of Confidentiality The information obtained in this surveillance system that would permit identification of any individual or institution is collected with a guarantee that it will be held in strict confidence will be used only for the purposes stated and will not otherwise be disclosed or released without the consent of the individual or the institution in accordance with Sections 304 306 and 308 d of the Public Health Service Act 42 USC 242b 242k and 242m d
269. tion form and Monthly Denominator forms in Hemovigilance Let s Review Incident reporting in NHSN provides a means to capture track and trend errors to gt Measure success of process improvement initiatives gt Compare your facility performance with other facilities PMi a Monthly Reporting Plan prior to any month you intend to enter ata High priority incidents are indicated by a sign and require a complete Incident form Other incidents can be reported using the Blood Product Incidents Reporting Summary Data form Any incident resulting in an adverse reaction of a patient requires a complete Incident form Any incident where product reaches the patient requires a complete AR form regardless of whether the patient experienced an adverse reaction Let s briefly review what we ve learned in this session Incident reporting in NHSN provides a means to capture track and trend errors in order to measure the success of process improvement initiatives and compare your facility performance with other facilities Be sure to enter a Monthly Reporting Plan prior to reporting any data for the month High priority incidents are indicated by a plus sign on the Blood Product Incidents Reporting Summary Data form and require a complete Incident form Other incidents can be reported as summary information except that any incident resulting in an adverse reaction of a patient requires a complete Incident form And any incident where product
270. tionDesc advRxnOutcomeDesc ty Date Time Adverse Unit Reaction Administered Date Time Reaction ee eee 87 Expiration Date 12 12 2009 01 15 2009 10JAN09 09 30 10JAN09 10 00 1 Reaction Description Description In this example we will add date of birth dob to our line list and remove age at time of adverse reaction Grade _ ALLERG NS Non 105 AHTR severe S Severe Case Definition Criteria POS Possible DEF Definitive Relationship Description POS Possible DEF Definite Outcome Description ND Not determined SEQ Major or long term sequelae Date of Birth 08 05 1997 10 22 1960 Here we have an example of how you would change the variables displayed on a report First under Other Options you click on Modify List On the right hand side of the screen you will see variables displayed that appear on the default report On the left hand side are all the variables available for displaying on your report Use the right arrow in the center to add variables to the report and the left arrow to remove variables from the report In this example we added date of birth or dob to the report and removed age at the time of the adverse reaction Once you ve made the change be sure to click on save at the bottom of the window Changing Sort Order l Select Sort Order in Line Listing Select Sort Order in Line Listing Avai
271. tives for surveillance are defined and focused on specific events processes organisms and or patients populations gt COMPREHENSIVE Continuous monitoring of all patients for transfusion related events Priority directed surveillance objectives are defined and focused on specific events processes organisms and or patient populations Comprehensive surveillance provides continuous monitoring of all patients receiving transfusion for transfusion related events Hemovigilance will use comprehensive methodology NHSN Surveillance Methodology RISK ADJUSTED vs CRUDE RATES gt RISK ADJUSTED Rates are controlled for variations in the distribution of major risk factors associated with an event s occurrence Comparison of rates is useful gt Rates assume equal distribution of risk factors for all events Comparison of rates not recommended Rates in hemovigilance will be crude until we have collected enough data for risk adjustment 16 The last method we will discuss is the use of risk adjusted or crude rates in analysis Risk adjusted rates are controlled for variations in the distribution of major risk factors associated with an event s occurrence Comparison of risk adjusted rates between facilities is useful Crude rates assume equal distribution of risk factors for all events and are not useful for comparison Rates in hemovigilance will be crude until enough data have been collected for risk adjustment Hemovigila
272. tocol Hemovigilance Module Follow instructions for data collection as outlined in Tables of Instructions 27 Now that you have been introduced to the protocol forms and terminology let s discuss the data collection and reporting requirements for participation in NHSN Biovigilance Component First you submit a Monthly Reporting Plan to inform CDC that adverse reactions will be reported and select the reporting method you will use for incidents As discussed earlier we ask that you adhere to the protocol exactly as written and follow the instructions for data collection as outlined in the tables of instructions Data Collection and Reporting Requirements for __ Hemovigilance Module continued v Use surveillance methodology as described in the protocol and in this presentation v Report events and appropriate summary or denominator data indicated on the plan to CDC within 30 days of the end of the previous month v Submit data for every month of the calendar year Use the surveillance methodology as described in the protocol and this presentation Be sure to report events and appropriate summary or denominator data indicated on your plan to CDC within 30 days of the end of the previous month or as directed in the protocol In the Biovigilance Component you are expected to submit data for every month of the calendar year Data Collection and Reporting Requirements for Hemovigilance Module continued v Complete an an
273. transfused that can be used later on in calculating rates Some forms allow facilities to add their own custom fields and labels Key Terms in Hemovigilance Adverse event An undesirable and unintended event occurring before during or after transfusion of blood or blood components that may be related to the administration of the blood or component It may be the result of an incident and may or may not result in a reaction in the recipient Adverse reaction An undesirable response or effect in a patient temporally associated with the administration of blood or blood components It may be the result of an incident or an interaction between a recipient and blood a biologically active product Key terms in hemovigilance were developed to be consistent with ISBT terminology An adverse event is an undesirable or unintended event occurring before during or after transfusion of blood or blood components that may be related to the administration of the blood or component It may be the result of an incident and may or may not result in a reaction in the recipient An adverse reaction is an undesirable response or effect in a patient temporally associated with the administration of blood or blood components It may be the result of an incident or an interaction between a recipient and blood a biologically active product Key Terms in Hemovigilance Incident An accident or error that could lead to an adverse outcome affecting a
274. treated for nonsurgical conditions Medical Surgical Critical Care An area where crbcally ill patients with medical and or surgical conditions are managed Neurologic Crtcal Care Critical car area specializing in treating life threatening neurological diseases A list of all standard CDC locations and descriptions are found in the CDC Locations amp Descriptions document available on the NHSN website Locations Patient Care Areas 80 Rule The specific CDC Location for a patient care area is determined by the type of patients receiving care 80 of the patients must be of a consistent type to classify the location as that specific type In assigning a location use the 80 rule The specific CDC location is determined by the type of patients receiving care in that location Eighty percent of the patients must be of a specific type for example surgical or cardiac care to classify the location as that type Locations Patient Care Areas f your facility participates in the Patient Safety Component discuss these locations with your NHSN Patient Safety Primary Contact and or Facility Administrator Each location in your facility should only be set up once If your facility already participates in the Patient Safety Component discuss adding any locations with your Facility Administrator or Patient Safety Primary Contact Each facility location should only be set up once Locations o ad
275. tructions for Form Completion from patients for type and screen or crossmatch in that month Custom Fields Optional Up to 5 numeric fields may be customized for local use NOTE Each Custom Field must be set up in the Facility Custom Options section of the application before the field can be selected for use Total samples collected Required Enter the total number of blood samples collected 1 8 2009 10 Table 5 Instructions for Completion of the Hemovigilance Adverse Reaction Form CDC 57 304 eee Instructions for Form Completion Facility ID The NHSN assigned facility ID number will be autoentered by the computer Adverse Reaction NHSN assigned number Patient Information Patient ID Required Enter the medical record number or other facility alohanumeric identification for the patient Gender Required Check M Male or F Female Date of birth Required Enter the date of birth using this format MM DD YYYY Patient s blood group Required Select the blood group for the patient recipient of the blood product s who experienced the reaction If for any reason a type and crossmatch was not done check that box Note Some patient blood types do not fall into the traditional categories If that is the case select the most relevant type and note the issue in the comments section of the form e g if a patient is typing with mixed field reactions following bone marrow transplant select the predominan
276. ty there will be an existing facility administrator If your facility is joining NHSN for the first time and only for biovigilance designate a Facility Administrator anyone in your department who will be primarily responsible for NHSN participation Now that you have been introduced to the Biovigilance Component Hemovigilance Module in NHSN here are steps to take to start the enrollment process First contact the infection prevention control department and or the hospital epidemiologist to determine if your facility is currently a member of NHSN in the Patient Safety Component If your facility already participates in NHSN there will be an existing Facility Administrator If your facility is joining NHSN for the first time and only for Biovigilance designate a Facility Administrator The Facility Administrator is the person who will be primarily responsible for NHSN participation Next Steps Facility Administrator should view Training 2 Biovigilance Component Enrollment for Facility New to NHSN Training 3 Biovigilance Component Enrolling an Existing NHSN Facility into Biovigilance and Facility Set up Training 5 Groups in Biovigilance Subject matter training for blood transfusion services personnel Training 4 Biovigilance Component Hemovigilance Incident Reporting Biovigilance Component Adverse Reactions Case Definition Exercises Training 6 Biovigilance Component Adverse Reaction Data C
277. uded Note If the patient meets the criteria for another more specific adverse transfusion reaction Grade 1 The recipient required no more than discontinuation of transfusion and symptomatic management AND No long term morbidity Grade 2 The recipient required in patient hospitalization or prolongation of hospitalization due to hypotension or hypotension led directly to long term morbidity e g brain damage AND Vasopressors not required Grade 3 The recipient required vasopressors Grade 4 with hypotension as a symptom Patient died as a result of of that reaction the specific adverse reaction should be reported rather than the hypotension hypotensive transfusion reaction or as a result of treatment directed at resolving symptoms of hypotensive transfusion reaction Probable Same as definitive criteria EXCEPT Onset is greater than 15 minutes after start of transfusion OR Does not respond within 10 minutes to cessation of transfusion and supportive treatment Probable N A Possible N A Possible Same as definitive criteria EXCEPT Other conditions are present or were present before the transfusion that could explain hypotension 03 17 2009 V1 Final 17 Relationship to Transfusion Imputability Definite Meets definitive protocol criterion The patient has no other conditions that could explain hypotension Probable Other conditions that could explain hy
278. uipment problem Request for Pick up mos RP 01 Request for pick up on wrong patient RP 02 Incorrect product requested for pick up RP 03 Product requested prior to obtaining consent RP 04 Product requested for pick up patie not available RP 05 Product requested for pick up IV not ready RP 06 Request for pick up incornplete RP 10 Product transport sses _ Blood Drawn from Patient for Type amp Crossmatch SC 01 Sampie labeled wincorect patient name SC 02 Nat labeled SC 03 Wrong patient collected SC 04 Collected in wrong tube type SC 05 Sampie QNS SC 06 Sample hemolyzed SC 07 Label incompiese liegiie noarrect SC 06 Sampie collected in error SC 09 Requishion arrives without samples SC 10 Wristband incorrect or not available SC 11 Sample contaminated Product Available for Issue AV 01 Inwamory Audits AV 02 Product status not incorrectly updated in computer AV 03 Supplier recall AV 04 Product ordered ncorrectiyinot submited i Ul 01 Data entry incomplete incorrect Ul 02 Record review incomplete incarrect UI 03 Pick up slip did not match patient information Ul 04 Incorrect unit selected UI 05 Issue delayed UI 06 LIS warning overridden UI O7 Compimer issue not completed UI 09 Nat checking incarrect checking of unit andor patient formation Ul 17 Unit delivered to incorrect location Ul 19 Wrong product issued UI 20 Administrative review Ul 22 Issue approval not obtained doc
279. ull incident form and adverse reaction form m Here s how we would enter our 4 case examples Use the complete Process Code as entered in the Occurrence section Incident Code field First select your point in the process for example PC Product Check in In the field to your right you will see a drop down list with all the codes under category PC For Case 1 the incident code was PC 01 Select it and then put in the total number of incidents for the month that had that code If any adverse reactions are associated with that code put in the total number for the month Notice that on the NSHN screen summary data form you only need to enter totals for incident process codes that were used Monthly Reporting Denominators m Provide denominators for analysis of incidents and adverse reactions m Information from facility survey provides additional denominators and information that can be used in analysis Department of Health and Human Services Centers for Disease Control and Prevention NHSN National Healthcare Safety Network ISD CLFT NHSN1 NHSN Home My Info Contact u F NHSN Home Logged into Pleasant Valley Hospital ID 10312 as RI Facility Pleasant Valley Hospital ID 10312 is following the BV component Reporting Plan pa A Add Hemovigilance Summary Data Patient Incident Reaction Summary Data o Add Continue Back D Find Analysis v Monthly Reporting Denominators At the end o
280. umented Review of Patient History p by TX Services UM 02 Record review ncompictetinceerect SR 02 Historical review correct or not done SR 03 Demographic reviews data emry incorrectinct done Temporary Storage on Nursing Unit UT 04 Incorrect storage of Product on floor UT 08 Wrong unr chosen from satellite refrigerator UT 12 Flooricinc did not check for existing products in their arca Product Administration UT 01 Administered product to wrong patent UT 02 Administered wrong product ta patent UT 03 Product not administered UT 05 Administrative review UT 08 Administered product wi incompatible ITV fluid UT 07 Admmistraton delayed UT 10 Administered components in wrong order UT 11 Appropriate monitoring of patient net done UT 13 Labeling problem on unit UT 19 Transfusion protocol nat followed This slide provides one illustration of blood processing starting from the top left corner when product is delivered to the healthcare facility going across the top then to the bottom left all the way to the bottom right when the blood product reaches the patient and is transfused Errors can occur anywhere in the process Let s take a closer look at one point in the process where blood is drawn from the patient for type and crossmatch Blood Drawn from Patient for Type amp Crossmatch T ev e ips ox SC 01 Sample labeled w incorrect patient name SC 02 Not labeled SC 03 Wrong patient collected
281. ur facility Documentation Needed to Create Custom Output in Hemovigilance Variable names shown previously Blood product mapping list m Pathogen code list Documentation needed if you want to create custom output in Hemovigilance includes the variable name list that was shown previously the blood product mapping list and the pathogen code list Blood Product Mapping for Reports and Analysis m wo product code systems Codabar and ISBT 128 Combines multiple codes based on blood product m Variable compCDCdesc e Categories of interest created by Hemovigilance Working Group e Monthly denominator form has same categories As has been discussed in other Hemovigilance training sets there are two blood product code lists supported in NHSN ISBT 128 and Codabar To facilitate analysis of adverse events by blood product the codes have been mapped to several primary categories of blood product based on feedback from Hemovigilance Working Group members and are called by variable name compCDCdesc The same categories are used for the Hemovigilance Monthly Denominator form Blood Product Codes Codabar being phased out CPDA 1 WHOLE BLOOD LEUKOCYTES REDUCED IRRADIATED LOWY VOLUME QPDA 1 WHOLE BLOOD LEUKOCYTES REDUCED IRRADIATED 250 ml QP2D WHOLE BLOOD LEUKOCYTES REDUCED IRRADIATED BS 1 RED BLOOD CELLS LEUKOCYTES REDUCED ACDA anticoagulant by pheresis for second bag of a double red blood cell a p
282. ur volume of tranfusions is low There are two methods to choose from for reporting incidents Incidents reporting summary data with detailed reporting of high priority incidents is the method we recommend Using this method you complete a detailed incident report for all incidents that are termed high priority and any other errors where there was a high likelihood that the error could have resulted in harm to the patient If you look at your summary data form high priority codes have a plus sign next to the code Also any error whether high priority or not should have a full incident report entered if product reaches the patient regardless of whether an adverse reaction occurs For non high priority or minor incidents you will collect total numbers of errors for each category and enter those on a summary form at the end of the month If your facility does not have an alternative method for collecting incidents or your transfusion volume is low you may want to enter full information for every incident Monthly Reporting Plan m Add Monthly Reporting Plan prior to entering any data for the month you plan to report If you are not sure if the plan has been entered use Find to locate any plans previously added Department of Health and Human Services Centers for Disease Control and Prevention NHSN National Healthcare Safety Network ISD CLFT NHSN1 i NHSN Hore Logged into Pleasant Valley Hospital ID 10312 as RUBY
283. vent Confidentiality How data are used Medication associated MDRO amp t HRIIV Modules Contact NHSN b Centers for Disease Enrollment Requirements Healthcare Personnel Safety Control and Eligibility Required Training Component 5 i di Prevention 6 Reporting amp System Requirements Benefits of Participation Facility i National Healthcare Security Begin Enrollment Level Options BBF Exposure SR niaka To enroll your facility go to the NHSN Website Step by step instructions are provided Print and Complete the Required Enrollment Forms m Print these forms prior to starting the online enrollment process Facility Contact Information Hemovigilance Annual Facility Survey m Make sure you have all information on the forms completed prior to entering the data online Once you start the online enrollment process you can t save and return later to finish COCE Lanos Lil bests Controt one Prevention dible Health Informatic A Z Index A National Healthcare Safety Network NHSN NHSN Text size EJ m L xu gl Email page Communication Updates j WER o Enrollment Requirements Oh This pag Print page nrolilment ey EET e Eligibility Criteria Bookmark and share Requirements Eligibility Criteria pees oer FAQs About Enrollment Facilities participating in the NHSN must meet the following yaa eal der irements riteri he i FAQs About Mandatory CERA e Required Training L Get email upda
284. vices and or other persons within your facility who require information about the events reported in NHSN Users should have administrative rights all rights or analysis rights in order to perform these tasks This training is intended for persons who will be generating and analyzing data in the Hemovigilance Module and have user rights set up so that they may do so This could include supervisors or managers in Transfusion Services and or other persons within your facility who require information about the events reported in NHSN Users should have administrative rights all rights or analysis rights in order to perform the tasks described in this session Objectives AS Once your facility has entered Incident and Adverse Reaction data for at least one month you may want to see reports of what has been entered This session will Show how to access data for analysis in NHSN Demonstrate how to generate data sets in Hemovigilance Describe output options in Hemovigilance Show how to generate output Show how to customize modify output Discuss documentation needed to generate reports Describe advanced options in Analysis Show how to export your output for manipulation outside of NHSN Create custom output sets Once your facility has entered Incident and Adverse Reaction data for at least one month you may want to see reports of what has been entered This session will show you how to access data for analysis in NHSN demo
285. xt SDN Support Please Note 800 532 9929 770 454 4863 8 phintech cdc gov e Internet Explorer 5 x or greater or Netscape Communicator 6 x or greater is required to use the CDC Secure Data Network If your browser doesn t meet this requirement please upgrade your browser before applying e Be sure your email address is correctly entered Without a valid email address you will be unable to install your digital certificate Step 1 Enter Personal Information Items with are required Prefix a Preferred Name i First Name Janie Middle Name Last Name Doe Degree Email Address janiedoe genhosp o I ager seer Program or Employer General Hospital Division Employer Type Academic Research Organization Job Type Biomedical Research Complete your on line application for the digital certificate Be sure to complete all required fields that are asterisked Remember to use the email address you used during registration Step 2 Microsoft Internet Explorer Q Your email address must be correct to receive vour Digital IC Is this your correct email address janiedoedgenhoasp org cared You will be asked to verify that the email address you are providing is the correct one select a program Click on National Healthcare Safety Network NHSN CDC Home Search Health Topics A Z e Centers for Disease Control and Prevention Digital ID Enrollment SDN Suppo
286. y view enter analyze or rights can be customized as desired The assigned rights help to determine the training the person needs and also determine the options available to the user on the left navigation bar Suggestions for assigning rights in BV are that at least one BV user have administrative rights Persons who only analyze or review data may not need data entry or edit rights Users Once user rights have been assigned and saved the user will receive an email from NHSN with instructions for accessing the Rules of Behavior and obtaining a digital certificate See the NHSN User Start up Guide available on the NHSN website Once a user has been entered and assigned rights that user will receive an email from NHSN with instructions for accessing the Rules of Behavior and applying for a digital certificate The NHSN User Startup Guide contains details of this process and is available on the NHSN website Rules for Managing Information Across Components Iwo areas that overlap Patient Safety and Biovigilance Locations Patient Record a Facility Administrator manages and arbitrates editing information across components Patient Bioviail S Safety lovigilance Component Component There will be some information in NHSN that is used across components Two areas overlap in Patient Safety and Biovigilance Locations and Patient Record The Facility Administrator will be responsible for managing
287. y NHSN not the Group Name After acquiring his her digital certificate the Group Administrator logs into NHSN Reporting and sets a Group joining password The Group ID and password are then shared with all the NHSN facilities that should join the group Remember that the Group ID is the 5 digit number assigned by NHSN It is NOT the Group Name Group Administrator Sets Joining Password Department of Health and Human Services Centers for Disease Control and Prevention NHSN National Healthcare Safety Network Logged into Maggie s Test Group ID 11933 as MAGGIE Reporting Plan All Facilities Selected Patient en E Event Paea Facilities whose data can be accessed by this group Summary Data Analysis Enter and verify the joining Surveys password Users he n Organization Click Set Password ala Info Set joining password for this group in E Joining Password New Password eeee Evict Members Fr eli tank P Toa Log Out To set the joining password the Group Administrator goes into NHSN and selects Organization Joining Password from the left navigation bar enters and verifies the password and clicks on Set Password Facility Administrator Joins a Group From the Group section of NHSN navigation bar the Facility Administrator selects Join Enters the Group ID Enters the Group Joining Password fo Group ID and Joining Password are B Srovided by the Group Administrator Onc
288. y in NHSN or reassign the role of Facility Administrator This person will also have the ability to nominate groups that is entities with which your hospital wants to share some all of its data e g state or county health department corporate headquarters For complete detailed enrollment instructions please download the B NHSN Facility Administrator Enrollment Guide June 2008 PDF 970 KB 29 pages Before attempting to enroll as the Facility Administrator you must When you have completed the required trainings and read the above documents you are ready to enroll Follow the steps below to complete the enrollment process NOTE Please make sure that your email system will not block emails from nhsn cdc gov and PHINTech cdc gov before beginning enrollment 1 Read the NHSN Rules of Behavior n order to participate in the NHSN read and agree to abide by the following rules of Detayi equarding the system s security Step 1 Review and accept the Rules of Behavior After reading click on Agree CDC Department of Health and Human Services Centers for Disease Control and Prevention National Healthcare Safety Network NHSN Facility Group Administrator Rules of Behavior In order to participate in the NHSN you must read and agree to abide by the following rules of behavior for safeguarding the system s security Scroll through the document below and click on Agree or Do Not Agree button To print a copy of the rules

Biovigilance Component - Department of Health & Hospitals

Contents

Download Pdf Manuals

Related Search

Related Contents

Biovigilance Component - Department of Health &amp; Hospitals

Contents

Download Pdf Manuals

Related Search

Related Contents

Biovigilance Component - Department of Health & Hospitals