Home

ISO Training Program (CBSPD)

1. gt WAITING LIST Yes PROVIDE ITEM WHEN AVAILABLE TO MEDICAL Yes SUPPLY FOR DISTRIBUTION Y WRITE PT NAME AND RM ON BOTH HALVES OF PROVIDE ITEM TO RECORD EQUIPMENT ISSUE EQUIP CONTROL MEDICAL SUPPLY ON WAITING LIST TAG FORDISTRIBUTION DoS sss Y REMOVE BOTTOM HALF OF CONTROL TAG TOP HALF OF TAG REMAINS W EQUIPMENT PLACE TAG IN FILE SLOT FOR ITEM RECORD PT NAME RM ROUNDS ARE COMPLETE NO AND OR UNIT AND ISSUE DATE EQUIPMENT IS NO LONGER NEEDED AND IS RETURNED TO SPD FOR REPROCESSING 48 SPD STAFF REMOVE UPPER HALF OF gt TAG AND PROVIDE TO MEDICALSUPPLY MEDICAL SUPPLY STAFF MATCH TAG TO ITEM IN EQUIPMENT FILE RECORD DATE OF RETURN AND REMOVE BOTTOM HALF OF TAG FROM THE FILE SPD STAFF PROCESSEQUIPMENT ACCORDING TO DEPARTMENTALPOLICY ANDPROCEDURES OBTAIN NEW EQUIPMENT CONTROL TAG WRITE THE FOLLOWING INFORMATION ON BOTH HALVES OF THE CONTROL TAG ITEM DESCRIPTION Y Gee 46830 ATTACH TAG TO THE CLEANED DISINFECTED EQUIPMENT AND RETURN TO STORAGE FOR USE 49 Loaner Instruments Equipment Lending Borrowing Develop policies and procedures for consignment or borrowing surgical instrumentation from other healthcare facilities or vendors to include the following e Acquisition
2. Quality Control Program for Central Service ISO Sub Committee Authors Pat Bain RN CIC Infection Control Coordinator Englewood Hospital 350 Engle Street Englewood NJ 07631 Bob Brockson CSR OR Technician Hunterdon Medical Center 2100 Wescott Drive Flemington NJ 08822 Anne Cofiell CRCST FCS 703 Country Club Parkway Mount Laurel NJ 08054 Nancy Chobin RN CSPDM Saint Barnabas Health Care System Livingston NJ 07039 Donald L Hatfield Director Central Sterile Supply South Jersey Hospital 65 South State Street Vineland NJ 08360 Maureen L Lelko RN CSPDT Manager Central Service Warren Hospital 185 Roseberry St Phillipsburg NJ 08865 Teckla A Maresca LPN CSPDM Manager Central Service Saint Clare s Health Services Pocono Rd Denville NJ 07801 Anthony Monaco MA HO New Jersey Department of Health and Senior Services PO Box 369 Trenton NJ 08625 Rosemary Perry RN CIC Infection Control Coordinator Holy Name Hospital 718 Teaneck Road Teaneck NJ 07666 Nora Wikander RN CSPDM Director SPD Saint Joseph s Wayne Hospital 224 Hamburg Turnpike Wayne NJ 07470 Carol Wicki RN CSPDT Central Service Hackettstown Community Hospital 651 Willow Grove Street Hacketstown NJ 07840 Fred Wycoff Director Central Sterile Supply South Jersey Hospital 65 South State Street Vineland NJ 08360 ISO Sub Committee Contributors Thomas Bishop SPD Director Atlantic Cit
3. Manufacturer must provide in writing their recommended cycles parameters for Pre vacuum gravity displacement EtO cycles BI testing performed cycles and parameters EtO aeration Load configurations including location of trays sets inside sterilizer maximum number of containers in load etc Dry times Sterility maintenance 17 User Responsibilities e Pre purchase evaluation BI testing and drying times 1 2 Test representative sterilizer with large load and small load tests Containers should contain largest of instruments in sets For all other sterilizers only need small load tests pre vacuum sterilizers e Maximum load test pre vacuum 1 2 3 4 5 e Small 1 2 Drying should Two containers over drain line Two containers on each of other shelves Chamber fully loaded with other items Measures steam penetration in full load cycle Same test for gravity displacement cycles oad test One container with BIs placed on bottom shelf over the drain in otherwise EMPTY sterilizer Measures the effect of small loads where air can get entrapped inside the containers EtO testing refer to AAMI document for testing of EO cycles be evaluated by controlled random sample in which a set is opened at completion of drying cooling time and observe for residual condensate Hospital policy will dictate frequency of sampling Documentation is maintained within the department
4. Safe Handling and Biological Decontamination of Medical Devices in Health Care Facilities and Non Clinical Settings b ASHCSP Training Manual for Central Service Technicians IAHCSMM Central Service Technical Training Manual 5 Edition 66 APPENDIX Automated Documentation Tracking Systems 1 Materiel Management Microsystems Inc 1031 East Circle Drive Milwaukee WI 53217 Phone 262 240 9900 www mmmicros stems com Sterile Processing Microsystem SPM is a comprehensive asset management computer system Using bar code technology SPM tracks instrument sets and equipment throughout the processing cycle Among its many functions SPM allows the user to monitor employee productivity levels track instrument replacements and repairs identify sterilizer set incompatibility view instrument set usage rates view total value of instrument and equipment inventory print updated count sheets and numerous reports which provide solutions to staffing levels productivity inventory allocation and financial status 2 3M Health Care 15 Henderson Drive West Caldwell NJ 07006 6689 Phone 973 575 2042 FAX 973 575 2678 RKS system Catalog 1213 Software database product for maintaining sterilization assurance and related records Replaces traditional paper forms log books and envelopes 3 Rosebud Solutions 411 East Washington Street Ann Arbor MI 48104 Phone 888 980 8255 FAX 734 996 2069 Tray Mast
5. The items are properly wrapped The items are appropriately labeled The items are appropriately contained in plastic External and internal indicators are intact External indicator autoclave tape is intact Packages have no tears or abrasions Rigid transport container is locked or sealed All items received back from an out sourced venue must be properly logged with verification of the log See Appendix Receipt of Finished Product Sending Facility must have Policies for receiving finished product from an off site processor The facility must inspect all packages and pouches for abrasions tears or damage of any kind prior to beginning the sterilization process The receiving facility will then notify the sender that the load s is are ready for pick up by authorized personnel Only official facility personnel may transport items 60 All sterile items being returned to sender must be wrapped and placed sterilization maintenance dust cover large enough to accommodate the item e This might include large clear and clean plastic trash bags which may be utilized only if sterilization maintenance dust covers are not available It shall be the responsibility of the receiving department to inspect all packages returned for any kind of damage prior to use Although items or packages might show outdates or an event related sterilization label this inspection is most important due to any incident that migh
6. o Soiled instruments which cannot be cleaned or disinfected due to the lack of functional CS SPD facilities may be transported only if they are properly contained in a sealed rigid container 1 Develop criteria for transport container 2 Develop preconditioning standards 1 moisture foam or gel for instruments prior to and during transport o Training of transport personnel which shall include but not limited to 1 Handling 2 Emergency situations e Sending clean instruments for sterilization only o The sending facility must notify the receiving facility that the transport is underway and the estimated return date time items slated for transport must be properly cleaned decontaminated when possible and placed in a sealed rigid container prior to transport o Ifthe facility decides to pre package cleaned instruments prior to shipment for sterilization then all appropriate internal external indicators must be in place 1 Packaging must be compatible with the sterilization process Policies and procedures for cleaning disinfection and processing all items to be transported shall be based on manufacturer s recommendation o The major exception to pre cleaning instruments prior to shipment for reprocessing and or repair is regarding shipment of scopes that have failed a leak test 1 Key Players a CS SPD Manager Director Processing Facility b CS SPD Manager Director Sending Facility c Transportation Dep
7. e Prioritize process improvement initiatives based upon their impact on patient care and customer satisfaction In the beginning try to select an issue that is not complex and will result in noticeable change and or improvement so that team members are not frustrated For example development of a back up instrument cart to provide supply of back up instruments thereby preventing case delays and opening entire sets for needed instruments o Communication issues being resolved by walkie talkies or separate hot line for OR 63 Focus on the process not the people o Personality issues and turf wars This can be the demise of effective communications between the departments o Much is dependent on the educational levels of management and staff of each department The length of service of both department managers may be an asset or liability address these turf issues up front Prior experiences with each department play a large role to resolve perceived bad experiences Utilize CQI approach to resolving issues don t assign blame look for realistic solutions which may include compromise on both sides CS SPD Manager reviews and oversees high level disinfection and sterilization practices for the facility Hospital Purchasing Policy CS SPD Manager Director must be included in the pre purchase decision making for e Processing equipment Instruments devices requiring reprocess
8. 62 Continuing education programs and courses provided by professional associations should be encouraged by management to insure that staff keeps current with the changes in regulations technology and materiel management e Continuing Education Credits are required for maintaining manager and technician certifications It is important to encourage staff to get involved with their local or national professional associations e The experience will build pride self esteem and leadership Competency Competencies should be developed for all key processes in the department e Each employee should be required to meet the competency level each year Confirm competency with oral written test and or observation as identified Competencies should be focused on activities falling into one of the following categories e High Risk e High Volume e Prone to Error e Identified Problem Areas Process Improvement The CS SPD Manager Director should be an active member of the facility s Process Improvement amp Infection Control committees Develop an OR CS SPD CQI Process Improvement Committee Committee membership should include staff representation from both departments and all shifts e Co chairs should be representative from both departments e Identify an administrative liaison for support e Identify tools to measure issues with current processes 1 Instrument survey case cart accountability forms flash documents
9. CS SPD Director Manager b OR Manager c CS SPD and OR personnel 2 References a AAMI Recommended Practices i 5746 Good Hospital Practice Steam Sterilization amp Sterility Assurance H 5733 Guidelines for the Selection and Use of Reusable Rigid Sterilization Container Systems for Ethylene Oxide and Steam Sterilization in Health Care Facilities 11607 RCO Packaging for terminally sterilized medical devices May 1997 b ASHCSP Training Manual for Central Service Technicians Chapter 8 IAHCSMM Central Service Technical Manual Chapter 10 d New Jersey State Regulations i NJAC 8 43G 8 1 b NJAC 8 43G 8 3 c 19 Chemical Indicator Integrator in 2 opposite corners Bottom Basket of Tray BI vials in 4 corners of tray not touching sides metal and 1 vial suspended from the lid Rigid Container Test Pack Should contain instrumentation inside container Make sure filters in place E Chemical Indicators To insure that chemical indicators integrators CIs are properly used the following should be performed e In service for CS SPD or OR personnel in use of e In service CS SPD personnel in proper location of CI inside packs versus rigid containers e Develop a means of reporting sets with missing filters e List and filters on count sheets as added reminder to staff 1 Key Players a CS SPD Director Manager b CS SPD Staff c OR
10. Problems should be reported to a point person within Central Service Safety issues and repetitive problems are issues that need follow up Follow the manufacturer s instructions for cleaning Develop procedures which include e Sorting instruments for cleaning amp decontamination e Rinse amp removal of gross soil e Use of ultrasonic cleaner e Mechanical washer for all hinged and metal instruments e Manual cleaning for items with a lumen delicate items and or items that are moisture sensitive eye instruments Establish competencies for e Processing equipment e Insuring the temperatures and detergent concentrations are appropriate monitored and verified e Each device processed per manufacturers instructions Preventive maintenance policies for mechanical cleaning equipment should be established regardless of who is to perform the task manufacturer vendor in house maintenance e Develop maintenance log Policies and procedures for patient care equipment may differ from medical instruments A specific workflow will have to be developed to include e Soiled storage on floors and scheduling and transport must be clearly defined e Cleaning disinfectant solutions as defined by the manufacturer and approved by the facility s Infection Control Committee e Functional inspection and repairs reported to Bio Med e Storage 1 Key Players a Manufacturers b CS SPD Manager Director c CS SPD Techn
11. e Perform evaluation of services e Determine pricing e Contact clients for references satisfaction e Obtain contract e Verify loaners available for cameras scopes e Consider pay for use program for scopes cameras e Develop schedule for routine maintenance i e sharpening of curettes gouges etc e Establish budget line for repairs Surgical instruments need to be kept in good repair Develop policy procedure to ensure instruments are repaired in a timely manner and that there is an ongoing preventive maintenance program for sharps 51 e Identify which department budget will be responsible for the repairs e Develop a process for identifying instruments needing repair 1 e tag instrument safety pin repair tags use colored plastic tags Make sure all OR and CS SPD Staff aware of the mechanism being used e Decontaminate or follow repair company or manufacturer instructions for return of damaged soiled devices e Once identified the instrument should be removed from the tray and set aside usually in a predetermined area 1 Repair box bin e Identify who is responsible to coordinate the repairs be specific in responsibilities e Before sending instrumentation to other than the original manufacturer check the manufacturer s warranty some instruments are warranted for five years and will be repaired replaced for free during that time 4 Select a repair company jointly between OR CS SPD and Materi
12. repairs of sterilizers implantable devices verification of rigid containers test packages and positive test results Written documentation or a decision tree should be established as to the actions taken in response to a positive biological monitor 25 1 Key Players a CS SPD Manager Director b Manufacturer c CS SPD Technician 2 References a New Jersey State Regulations i NJAC 8 43G 8 8 c 1 5 H NJAC 8 43G 8 8 a 4 b AAMI Recommended Practices i 5746 Good Hospital Practice Steam Sterilization and Sterility Assurance H TIR 25 Chemical Indicators Guidance for the Selection Use and Interpretation of Results in Health Care Facilities June 2000 ST 60 Sterilization of Health Care Products Chemical Indicators Part I 1996 iv ST 59 Sterilization of Health Care Products Biological Indicators Part I 1999 v ST19 Sterilization of Health Care Products Biological Indicators Biological Indicators for Moist Heat Sterilization Part III 1999 vi Sterilization Part 3 Industrial Process Control 2003 edition Unloading Sterilizer A system shall be established and maintained for release of product after sterilization Each release decision shall be documented including identification of the person making the decision Release documentation shall e Specify the load or include a reference to the specification for the load e Include records from routine testing e Inc
13. AND HAVE TOIDENTIFY THEMINITIALPACKAGE OR gt CONTENTS REDO PACKAGE PREPARE LOT LABEL GUN WITH LOT NUMBER AND EXPIRATION 4 DATE FOR THE LOAD PRINT LABEL AND CHECK FOR LEGIBILITY OF INFORMATION LABEL LEGIBLE CHANGE INK ROLLER Yes INFORMATION CORRECT Yes Y LABEL EACH ITEMAND RECORD DOES LOAD CONTAIN IMPLANTS Yes Y No gt RECORD ON STERILIZATION amp 4 CORRECT INFORMATION PREPARE Yes BIOLOGICAL TEST PACK PLACE ITEMS ON STERILIZER CARRAIGE IN A MANNER THAT ALLOWS FOR CONTACT BY THE STERILANT PLACE TEST PACK ON 4 BOTTOM OF CARRAIGE DIRECTLY OVER THE DRAIN OPEN STERILIZER DOOR LINE CAR AND CARRAIGE UP WITH TRACKS IN CHAMBER PUSH CAR FORWARD UNTIL IT LOCKS IN PLACE Y RELEASE CARRAIGE FROM CAR AND PUSHIT INTO THE STERILIZERCHAMBER Y RELEASE CAR FROM STERILIZER PULL BACK TO ALLOW FOR DOOR CLOSURE Y CLOSE DOOR AND TIGHTEN UNTIL YOU CANNO LONGER TURN THE WHEEL 30 CHECK CYCLE PARAMETER TIMES TEMPERATURE PRESSURE DATE EXPOSURE TIME DRYING TIME RESET CYCLE PARAMETERS PARAME
14. Staff 2 References a AAMI Recommended Practices i ST 33 Guidelines for the Selection and Use of Rigid Container Systems for Steam and Ethylene Oxide Gas in Health Care Facilities ii ST 46 Good Hospital Practice Steam Sterilization amp Sterility Assurance ST 60 Sterilization of Healthcare products Chemical Indicators Part 1996 iv TIR 25 RCO Guidance for selection use and interpretation of results in Health Care Facilities June 2000 b ASHCSP Central Service Technician Training Manual Chapter 6 c ISHCSMM Central Service Technician Manual Chapter13 d New Jersey State Regulations i 8 43G 8 8 c F Product Identification Labeling Identification of sets and trays can be enhanced by e Marking all flat Mayo trays with permanent non toxic marker e Utilization of clip on ID tags for inner baskets e Assuring that wrapped trays instruments are identified with contents e Identifying items that are missing from the set package e Verify all tags on baskets replacing as needed 1 Key Players a CS SPD Director Manager b CS SPD Staff 21 G Sterility Maintenance Dust Covering lt Dust covers should meet AAMII recommendations of 2 to 3 mils in thickness Dust covers be correctly applied by e In servicing personnel in selection of correct size for item correct application and sealing of dust cover e Ensure proper labeling of dust cover e In servic
15. c Employee Health 2 References a Occupational Safety and Health Administration OSHA 1984 29 CFR 1910 20 b Occupational Exposure to Ethylene Oxide 1988 29 CFR Part 1910 1047 c Ethylene Oxide Gas Sterilization Emergency Response Plan Virtua West Jersey Health System d New Jersey State Regulations i NJAC 8 43G 8 11 g NJAC 8 43G 8 2 d H Low Temperature Gas Plasma Physical Settings It is essential to follow all of the sterilizer manufacturer s instructions as the source for policies and procedures relating to its use This will include Materials must be compatible with the process e g plastic compatible instrument trays polypropylene silicone wrap and pads It is not recommended to use linen paper or foam The manufacturer provides a complete list of recommended materials in their user manual o Since this technology is relatively new it is essential that new devices or devices in question have been validated in the process See user manual or ask manufacturer to send the validation information e Chemical Indicator Biological Testing There are specific biological and chemical indicators with instructions for their use The manager should obtain data from the manufacturer on the reliability safety performance characteristics sterility assurance level SAL storage requirements and location of the BI in the load frequency and shelf life This data will support the manager in developing spec
16. differentiate storeroom items vs special order items Quality Assurance Develop a QA system for tracking receiving errors e As stock is received it should be checked against the packing list e Report discrepancies to designated supervisory personnel e Advise Materiel Management Develop a QA system for tracking distribution errors e Monitor compliance with par levels e Monitor compliance with restocking case or specialty carts 44 Develop a QA system for identification documentation and reporting damage e Package integrity upon receiving e Package integrity due to in house handling D Delivery Develop Policies and Procedures defining the distribution process route and frequency A schedule for cleaning and disinfecting transport devices must be established e Transportation carts and or containers should be cleaned between uses e Carts should be dedicated for transport of clean sterile items Clean or sterile medical surgical supplies should be protected from contamination damage or loss during transport Distribution carts must have solid bottoms Distribution carts should not be left unattended Develop system to insure that manufacturers recommendations for processing must remains with the device to end user and CS SPD 1 Key Players a Materiel Manager b CS SPD Manager Director c Finance d Customers e Supply Distribution Manager 2 References a New Jersey State Regulatio
17. e Accountability e Disposition Acquisition A system should be established to identify each employee s role for handling loaner instrumentation equipment e Designate people within the healthcare facility that can accept request e Designate people within the healthcare facility that can process and make arrangements with vendors or other healthcare facilities to fill the request Designate people responsible for transport of instrumentation equipment to central service Develop a communication chain for loaner instruments equipment When loaner instruments are requested from a company CS SPD must be advised of the following see sample forms in appendix e What is ordered e What is needed e How 15 it arriving e g Fed X sales representative e When is it arriving e Written manufacturer s recommendations for processing requirements including decontamination preparation and sterilization exposure times and temperatures e Where will it be received e When is it needed time date of case and surgeon How when will it be returned Accountability for Non Hospital Owned Instrumentation Equipment Includes e Physician owned e Manufacturer loaners e Borrowed from other institutions e Consignment Identify accountability for lost or damaged instruments equipment Develop documentation form for the acceptance of instruments from vendors or other healthcare facilities See appendix 50 Non Hospital
18. e Drying times may have to be extended Pre conditioning the load may help e Evaluate weight and density of sets e Evaluate use of absorbent materials inside containers contaminated In the best interest of patient any set containing moisture or has visible water should be conside Other QA Issues e SPD shall develop a policy for all end users to report wet packs e Filter material not interchangeable e Stacking inside the sterilizer steam low temperature gas plasma must follow the container manufacturer s recommendations Do not stack containers from different manufacturers e Develop practice of container inspection before use 1 integrity of gaskets 18 Transport of soiled instruments in containers verify with container manufacturer if container can be used for soiled transport of instruments Need quality repairs original equipment manufacturer OEM preferred Check quality of repairs on return Get documentation from container manufacturer regarding what items the manufacturer has validated to be processed inside the container e g drills lumens etc Routine BI testing maximum load type and small load type should be performed on loads containing mainly containers Frequency to be determined by the facility but at a minimum annually Where multiple manufacturer containers are used BI Testing must be performed for each manufacturers container 1 Key Players a
19. e Number of FTE s needed to support the system e Evaluation of system IX User friendly X Data retrieval available XI Ease of making changes O O OO 53 Linen Processing A Develop Standards Expectations for linen supplies used by CS SPD 4 Set par levels for each type of linen product required on a daily basis gowns wrappers drapes towels etc e Establishing inventory levels and maintaining them requires the cooperation of suppliers and users Develop a system to notify linen services of discrepancies Delivery specifications to include but not limited to Delinting Holes Tears e Repair e Stains e Reject policy e Thread wear e Emergency back up inventory e Protection during delivery New linen needs to be laundered before use Determine if a back up of paper products will be necessary for emergencies 1 Key Players a CS SPD Manager Director b Linen Services Manager Director c CS SPD Staff 2 References a AAMI Recommended Practice i 5765 Processing of Reusable Surgical Textiles for use in Healthcare Facilities 2000 b OSHA 29CFR 1910 1030 c New Jersey State Regulations i NJAC 8 43G 8 7 c B Inspection Develop policies procedures that define acceptable level of quality the facility wishes to maintain e Include how unacceptable items will be handled e Include proper rotation of stock 54 Using the quality standards established inspect each linen
20. for GI endoscopes before automated or manual disinfection The following issues shall be included The use of enzymatic detergent Disassembly so that all surfaces may be reached for thorough cleaning o Size and use of brushes Asystem to identify cleaning adapters for suction biopsy air and water channels for all scopes Define the use of cleaning adapters or pistols for special endoscope channels e g elevator channel forward water jet double channel scopes o Flushing all channels with the detergent solution to remove debris o Define rinsing drying and purging the endoscope and all channels Automated Reprocessing The above cleaning and leak testing procedures must be followed before using automatic reprocessor Prepare the endoscope reprocessor according to the manufacturer s instructions Place the endoscope in the reprocessor and attach all channel adapters according to manufacturer s instructions Identify the scope manufacturer type of scope 1 colonscope for every adapter used Acolor coded tape applied to adapters can be used to identify specific scopes Because elevator channels have small lumens pumps or pistols can be added to automated equipment to facilitate cleaning However you should verify with the scope manufacturer on the compatibility of the water pressure If the machine has a cycle that uses detergent it should be a product that is compatible with the reprocessor and
21. information you ve never accessed before e Available on line connection facilitates off site monitoring archiving system upgrades and service diagnostics 69 OFF SITE PROCESSING LOG The department of CS SPD hereby attests that all out sourced items logged below have been received in proper condition wrapped sealed in plastic with all appropriate labels and tape intact Also the sterilizer tape and biological testing results have accompanied all items returned from the out sourced venue This form shall be maintained according to State and or Federal regulations Date Item Description Sent to Date Initials Sent No Received 70
22. owned instrumentation poses issues of financial and liability ramifications All instruments brought into the institution for a particular case should comply with ASHCSP IAHCSMM Position Paper on Loaner Instrumentation See samples in Appendix The facility should develop a count sheet or packing list to be used from receipt of the instrumentation to pick up for return back e Assure complete processing directions are on file for staff reference including flash sterilization instructions e Assure that in servicing has been completed for all staff that will be using or handling instruments or equipment e Develop policies and procedures to assure that all loaner instrumentation is cleaned before sterilization and after use before leaving the facility If instrumentation is lent to borrowed by another facility document the process usually on the Lender s facility s Lend Borrow form See Appendix e It is essential that trays instruments not released without the consent of the Peri Operative Director or designate and that all information is communicated documented and posted H Disposition Develop policy to insure return of items to vendor or other healthcare facility Repair of Instruments Inadequate inconsistent repair maintenance of surgical instruments devices be best addressed by the following actions e Obtain information from several repair maintenance companies with on site repair capability
23. product before use looking for e Stains e Residue e Holes Tears Chemical Thermal Damage e Lint Debris 4 If using a tracking system scan or mark item as received y 1 Key Players a Linen Services Manager Director b CS SPD Manager Director Peri Operative Manager Director d CS SPD Technicians 2 References a AAMI Recommended Practices i 5765 Processing of Reusable Surgical Textiles for use in Health Care Facilities 2000 b OSHA 29CFR 1910 1030 c AORN Recommended Practices Surgical Attire Gowns and Drapes C Repair Holes Tears Cuts e Use heat sealed patches Use vulcanized material Durable Allow for effective sterilization Applied according to manufacturer s instructions or a validated process e No sewing patches cross stitching O O OO items that have been repaired need to be carefully inspected to assure area has been correctly repaired 1 Key Players a CS SPD Manager Director b Linen Services Manager Director c CS SPD Technicians 55 D Rewash Elect to request because of e Stains e Debris e Residue Detergent and or bleach 4 Counts as additional life cycle for the item Assure items replaced when sent for rewash to avoid shortages 1 Key Players a CS SPD Manager Director b CS SPD Technician 2 References a AAMI Recommended Practice i 5765 Processing of Reusable Surgical Textil
24. reference for specialty items e Changes to trays shall be authorized by department head designee This should be documented on a change form e In service staff and test competencies e Precept new employees until competencies are verified for each set e Develop and implement a QA tool to track customer satisfaction e Ideally all sets within the hospital should be inventoried Primary instrument vendors offer this service usually free along with computer software sometimes free depending on yearly instrument expenditure for instrument count sheets identification and cost tracking e The process should provide assurance that when changes are made they occur in all like trays in a timely manner e When developing count sheets use standard descriptions with detail including proper name of instrument length curved or straight as well as the manufacturer and a catalog number even if the manufacturer is not the same on all trays the catalog number is a good cross reference etc 1 Key Players a OR Service Leaders b Instrument Manufacturers c CS SPD Manager Director d CS SPD Staff 2 References a AORN Standards Recommended Practices amp Guidelines Instruments and Powered Equipment Care amp Cleaning 2000 15 b New Jersey State Regulations i NJAC 8 43G 8 3 b c Missing instruments broken damaged instruments can best be addressed by Implement mandatory instrument counts at completion of
25. to verify function Maintain a log of the temperature and humidity in the area to determine actual values and their relationship to staff complaints Have air exchanges and negative pressure verified Investigate possibility of utilizing a free standing area specific air conditioner if warranted In cases where the problem can only be solved with major changes to the department you will need support from Infection Control Risk Management Employee Health and Administration 1 Key Players a Infection Control Committee b Infection Control Professional c CS SPD Manager Director d Human Resources e Risk Management 2 References a New Jersey State Regulations i NJAC 8 43G 8 4 a 1 NJAC 8 43G 14 1 d 2 NJAC 8 43G 8 6 e b AAMI Recommended Practices i ST35 Safe Handling and Biological Decontamination of Medical Devices in Health Care Facilities and Non Clinical Settings H ST46 Good Hospital Practice Steam Sterilization and Sterility Assurance c 29 CFR 190030 OSHA s Blood Borne Pathogens Regulation d ASHCSP Training Manual for Central Service Technicians Chapter 4 IAHCSMM Central Service Technical Manual Chapter 4 f AORN Standards Recommended Practices and Guidelines Soiled Transport confine contain Policies and procedures must be established for containment systems for used instruments There may be different containment systems based upon the individual needs of t
26. which includes e The contents must be specific and identify each item in the load e The Sterilizer used e Operator e Presence of an implant if applicable e Presence of a biological if applicable A policy should be established to affix lot control label information immediately before the sterilization process e An exception shall be made for low temperature gas plasma 23 lt The sterilizer recording chart or print out tape should be dated and maintained with the load information Each cycle printout should be reviewed and signed by the operator Bowie Dick Dynamic Air Removal tests should be run daily on all pre vacuum sterilizers and be part of this record The process should include an audit of these records on a regular basis to insure their completeness and accuracy e Sterilizer test results are monitored and documented before sterilizer is put to use e Sterilization records shall be monitored on a daily basis e Sterilization records should be retained according to legal or risk management policies 1 Key Players a CS SPD Manager Director b CS SPD Technician 2 References a AAMI Recommended Practice i 5 46 Good Hospital Practice Steam Sterilization and Sterility Assurance b New Jersey State Regulations i NJAC 8 43G 8 8 c H NJAC 8 43G 8 11 f C Loading Sterilizer Similar items requiring the same cycle parameters should be grouped together Procedures describing load contents and
27. 000 c Association for Practitioners in Infection Control Inc APIC guideline for selection and use of disinfectants AJIC Vol 18 Number 2 1999 d Centers for Disease Control and Prevention Draft Guideline for Environmental Infection Control in Healthcare Facilities 2001 e New Jersey State Regulations i NJAC 8 43G 8 7 a b Chemical Indicator Biological Testing There are many variables that can affect the efficacy of the chemicals used to process medical devices A system shall be established to monitor the efficacy of the chemicals being used Chemical test strips are used to determine the use life of the product Policies should be established for frequency and documentation of results There are specific biological monitors for chemical sterilants The manager should obtain data from the manufacturer on the reliability safety performance characteristics sterility assurance level SAL storage requirements and shelf life This data will support the manager in developing specific polices for use placement and storage Key Players a Manufacturer b CS SPD Manager Director c CS SPD Technician 37 2 References a New Jersey State Regulations i NJAC 8 43G 8 8 a 2 H NJAC 8 43G 8 7 e Quality Control e Chemical sterilants high level disinfectant systems may be employed in several departments within the healthcare facility It is important that all departments coordinate policies and procedu
28. AAMI Recommended Practice i 5746 Good Hospital Practice Steam Sterilization and Sterility Assurance c New Jersey State Regulations i NJAC 8 43G 8 10 Results e The quality of the entire sterilization process depends on the accuracy and reliability of cycle parameters This data is necessary to determine if a product can be released The records should be retained so that it is possible to demonstrate retrospectively that the load had been properly sterilized Identification of the operator should be unique and restricted to the individual for traceability o Cycle failure must be reported to a designated person and documentation of actions taken in response to the failure should be maintained on file Recalls Most positive Bls the result of operator error Therefore it is important to immediately speak with the technician who performed the task and ask exactly how each step of the process was performed There are multiple reasons for a positive BI to occur which include o Overloading the sterilizer o Selecting incorrect cycle o Wrong packaging materials 27 o Improper handling of BI o Incubator malfunction If the initial BI is positive use of the sterilizer should be discontinued Repeat the BI in a challenge test pack Refer to your decision tree Documentation of all actions taken in response to this event shall be recorded and maintained 1 Key Players a CS SPD Manager Director b Serv
29. Control Coordinator d CS SPD Technicians 2 References a New Jersey State Regulations i NJAC 8 43G 8 7 c b AAMI Recommended Practice i 5746 Good Hospital Practice Steam Sterilization and Sterility Assurance F Training Training is based on procedural responsibilities and may include e Principles and methods of linen processing e Principles and methods of Infection Control Procedures for sorting inspecting folding and preparing surgical packs Sterilization methods 1 Key Players a CS SPD Manager Director b In service Education Department c Human Resource Department d CS SPD Staff 2 References a AAMI Recommended Practice i ST65 Processing of Reusable Surgical Textiles for use in Healthcare Facilities 2000 b OSHA 29 CFR 1910 0130 c IAHCSMM Central Service Technical Training Manual Chapter 13 57 Work Flow ot Linen Sorting Tusp ction Ee Pack Ste Rint zation Steere Storace DisteiBut 104 CARs 58 Off Site Processing A Soiled Instrument Transportation Coordination between the institution and reprocessing facility is paramount in developing policies and procedures for instrument shipment Develop polices and procedures for the transportation of soiled instruments to an off site processing facility e Transporting soiled instruments
30. E INNER VIAL STERILIZER AND PULL BACK FROM CHAMBER DON PROTECTIVE EYE WEAR amp GLOVES REMOVE TEST PACK BIOLOGICAL Yes OPEN TEST PACK REMOVE TEST VIAL ALLOW VIAL COOL FOR 5 MINUTES No Y REMOVE GLOVES REMOVE ALLOW GOODS TO COOL ON STERILIZER EXE CAR FOR 15 MINUTES 4 RECORD TEST BEFORE OFF LOADING ONTO WIRE CART AND CONTROL INFORMATIONIN LOG BOOK DATE AND MARK CONTROL VIAL PLACE VIAL INTO INCUBATOR PUSH VIAL INTO SLOT CRUSHING THE INNER VIAL CLOSE INCUBATOR CHECK PACKAGES AS THEY ARE LABELS LEGIBLE OFF LOADED CHEMICAL INDICATORS CHANGED PACKAGES INTACT FREE FROM DAMAGE LOT LABEL ON PACKAGE ITEMS ACCEPTABLE FOR USE Yes REMOVEIMPANTABLE ITEMS AND PLACE ON QUARANTINE RACK COMPLETEIMPLANT RECORD TAKE GOODS TO THE CA CART AREA OR THE O R FOR STORAGE AND OR DISTRIBUTION SE UNWRAP ITEM AND REPROCESS 32 G Ethylene Oxide Sterilization Physical Settings There are three systems for ethylene oxide sterilization on the market today a mixture of ethylene oxide and hydrochlorofluorocarbon HCFC ethylene oxide and carbon dioxide and 100 ethylene oxide Each has its own characteristics see MSDS sheet and the cycles are pre set by the sterilizer manufacturer Operating policies should be established based upon manufacturer s instruction whic
31. ORD PROPER ITEM HAND CLEAN FUNCTIONINGOF TESTICHECK GROSSLY Yes BEFORE DOORS AND ACCORDING TO SOILED CONTINUING WHEELS PERFORM PROCEDURE LEAK e TEST SHARPS TO i SHARPS CONTAINER NEEDS IDENTIFY ITEM W REPAIR TAG BEFORE ee Y CONTINUING LIQUIDS TO HOPPER Yes Yes REQUIRES ATTENTION Y PREPARE REPORT RECYCLABLETO WORK TODEPT CORRECT ORDER OF CONTAINERS SEND TO RECORD Yes MAINT v ITEM REQUIRES 5 TAG FOR REPAIR SPECIAL COMPLETE REPAIR HANDLING ORDER Y PROCESS APPROPRIATE ACEORONG TO PUT ITEM TO ONE CONTAINERS ITEM v SIDE TO PROCESS REPAIRED PROCEDURE SEND TO BIOMEDICAL LATERPER ly Yes ORENGINEERING PROCEDURE FOR THE ITEMIN REMAINDER TO QUESTION REGULAR CONTAINER lt v Y Y PREPARE SCOPE FOR ETO STERILIZER AFTER SCOPE HAS BEEN STERILIZED SEND IT OUT FORREPAIR ITEM RETURNED FROM REPAIR REPROCESS FILE REPAIR TAG FOR Y TRACKING LOAD BASINS INTO LOAD INSTRUMENTS BASIN RACK FOR OPEN INTO TRAY WASHER STERILIZER Y ITEMRETURNED REPAIRED Y LOAD TRAY ON TO LOAD BASIN RACK WASHER ON TO FEEDER FOR DECONTAMINATOR WASHER RACK STERILIZER CLEAN DISINFECT ACCORDING TO PROCEDURE LOAD WASHER FEEDER DECONTAMINATOR AUTOMATICALLY RACK INTO UNIT PULLS RACK IN Y STARTC
32. Regulation c New Jersey State Regulations i NJAC 8 43G 8 1 b d ASHCSP Training Manual for Central Service Technicians Chapter 4 e IAHCSMM Central Service Technical Manual Chapter 5 C Selection amp Use of Chemicals The selection of chemicals is based on the following factors e Identify types of soils you will be dealing with e Identify methods of cleaning available their mechanics and limitations 1 Manual 2 Mechanical e Identify items being processed and any special needs such as pre soaking manual cleaning susceptibility to heat and moisture and potential damage from alkaline or acid detergents chemicals e Select cleaning agents detergents that are designated for use by the methods you will be using to clean and the products you will be cleaning e Make sure selected detergents are compatible with items and their components being cleaned Read and follow manufacturer s instructions on all selected agents 1 dilution water temperature amp soak time e If working with enzymatic agents designed to work on protein soils make sure they contain detergents and are not designed as a pre soak only e Know the water chemistry and effect it may have on your detergents 1 Coordinate activities with your plant engineer 2 Water hardness and pH of your water supply should be provided to the detergent manufacturer D Cleaning 3 Consideration may be necessary to use softened filtered demineralize
33. Sterility Assurance B Physical Environment 4 Organization of space within sterile storage is important the following issues need to be addressed All storage locations need to be clearly labeled e Use label guns remove old adhesive tape residues e Communicate new items added to stock and location items removed from stock e Provide a tool for replacement of stock before last item is issued e Assign responsibility for checking stock and ordering items on continual basis e Ensure all items dispensed and received are accurately documented e Perform cycle counts to verify accuracy of inventory information e Reconcile stock discrepancies e Use signs to identify equipment out for repair or stock outs and anticipated date of availability e Develop and maintain a locator file e Maintain a tracking system so items can be located in a timely manner e Maintain storage space as per the local fire code 1 VI Distribution A Systems Key Players a CS SPD Supervisory Staff b Materiel Manager c CS SPD Staff Usually a combination of systems is used in order to provide optimum efficiency and cost effectiveness Meet with Materiel Management and user departments to assess their needs and the needs of the facility e Type of system s selected needs to O O OO Provide supply history and usage Provide control and documentation of all medical surgical supplies Be timely and accurate Mee
34. TERS AS CORRECT INDICATED CHECK PRINTER TAPE TO BE SURE THERE IS ADEQUATE 4 IF RED LINE APPEARS ON EDGE OF TAPE REPLACE Y PUSH CYCLE START BUTTON Y COMPLETESTERILIZATIONRECORD DATERECORD RECORD CYCLE START TIME APPLY LOT LABEL IN SPACE PROVIDED FOR CYCLE RECORDPRESSURE AND TEMPERATURE e INITIAL SPACE CYCLE STARTED BY WHEN CYCLE COMPLETE BUZZER SOUNDS UNLOCKDOOR CRACK DOOR OPEN APPROXIMATELY 2 DO NOT OPEN DOOR FULLY FOR 10 MINUTES CHECK PRINTOUT TO ASSURE CYCLE PARAMETERS HAVE BEEN MET EXPOSURETIME TEMEPRATURE PRESSURE DRYINGTIME UNWRAP AND IF CYCLE PARAMETERS PARAMETERS REPROCESSALL SET INCORRECTLY MET GOODS RESET Yes COMPLETE STERILIZATIONRECORD CHECK CYCLE START TIME RECORD CYCLE END TIME IF THE CAUSE OF THE PROBLEM CAN NOT BE DETERMINEDTAKETHE CHECK PRESSURE AND TEMPERATURE lt STERILIZER OUT OF SERVICE RECORD INITIAL IN SPACE CYCLE COMPLETED BY y AND NOTIFY THE BIOMEDICAL DEPT AND THE SPD MANAGER 31 OPEN DOOR FULLY LINE STERILIZER CARRAIGE UP WITH CHAMBER TRACKS LOCK IN PLACE USING PROTECTIVE GLOVES REMOVE FROM CHAMBER ONTO CARRAIGE MAKE SURE CAR LOCKS ONTO CARRAIGE RELEASE CAR AND CARRAIGE FROM CHECK INDICATOR ON TEST VIAL CAREFULLY PLACE TEST VIAL IN INCUBATOR SLOT PUSH VIAL INTO SLOT CRUSHING TH
35. YCLE CYCLESTARTS REASSEMBLE AND ADD ACCESSORIES Y TAG ITEM WITHTWO PART TAG PER PROCEDURE a OLD STAFF RESPONSIBLE TRACKING J 7 SEND ITEMS 5 FURTHERPROCESSING OR REUSE F 13 PREPARATION PACKAGING A Dress Code It is important to establish a dress code that is practical and identifies the risks present in the work environment Non compliance can be a result of many factors Policies should address at least the following e Clearly define with signage restricted areas requiring hospital laundered attire e Determine why people are entering restricted areas and if a process could be changed to make it unnecessary for them to do so e Consistently enforce access to restricted areas by properly attired personnel e Provide hats and cover gowns or jumpsuits at entrance s to restricted areas 1 Key Players a CS SPD Director Manager b Infection Control c Staff Development 2 References a New Jersey State Regulations i NJAC 8 43G 8 4 a b AAMI Recommended Practice i 5 46 Good Hospital Practice Steam Sterilization and Sterility Assurance B Assembly Surgical instruments supplies and most other medical devices must be prepared and packaged so that their sterility can be maintained until used Preparation involves inspecting items for e Cleanliness e Ensuring that all parts are pres
36. al Department Service for evaluation and or repair e Retention of service repair records o Use as documentation for replacement of non repairable equipment 47 EQUIPMENT ORDERED FOR PATIENT USE IS ITEM Equipment Tracking Process NURSING CALLS MEDICALSUPPLY Yes MEDICAL AVAILABLE ON UNIT SUPPLY OPEN No Yes NURSING CHECKS ANOTHER UNIT Y NURSING WRITE PT NAME amp RM ON BOTH ITEM HALVES OF Yes AVAILABL CONTROL TAG a No Y ADVISE SPD STAFF WHATISNEEDED THEY WILLCONDUCT ASEARCHFORITEM No gt REMOVE BOTTOM HALF OF CONTROL TAG AND LEAVE AT DESK FOR MEDICAL SUPPLY PICK UP TOP HALF OF TAG REMAINS WITH EQUIPMENT NURSING CALLS ADN OR DESIGNATE Y MEDICAL SUPPLY PICK UP TAGS amp CHECK ITEM PARLEVELS TOASSURE TAGS ARE AVAILABLE FOR ALL EQUIPMENT USED ADN OR DESIGNATE GOES TO MEDICAL SUPPLY TO OBTAIN ITEM Y RECORD REPLACEMENTS NEEDED If tags not available advise nursing staff equipment will not be replaced until tag available RETURN MEDICAL SUPPLY WITH TAGS WHEN WRITE PT amp RM ON BOTH HALVES OF CONTROL TAG Pe oe REMOVE BOTTOM HALF CONTROL TAG HALF TAG REMAINS Wi EQUIPMENT EVE BOTTON HALF OF TAG IN MEDICAL
37. all surgical procedures Implement placement of instruments in respective containers or trays at completion of case In service all users of surgical instruments in the proper care and handling Implement a damaged instrument tagging system to indicate repair needs Document all instances of missing abused instruments Document staff competencies in proper care and handling of surgical instrumentation 1 Key Players a OR Manager b CS SPD Manager Director c OR surgical technicians d OR Nurses e CS SPD Staff f Surgeons 2 References a AORN Standards Recommended Practices amp Guidelines Instruments and Powered Equipment Care amp Cleaning 2000 Patient care equipment not set up correctly can be resolved by Obtaining user manuals for all patient care equipment Developing policies and procedures for assembly testing and cleaning Develop a storage procedure and a means to identify equipment ready for use In servicing CS SPD staff Determining staff competencies Assuring supply of needed components readily available 1 Key Players a CS SPD Manager Director b CS SPD Technician 2 References a ASHCSP Recommended Practice for Patient Care Equipment b IAHCSMM Central Service Technical Manual Chapter 8 c New Jersey State Regulations i NJAC 8 43G 8 4 c 16 C Packaging Materials 2 To protect wrappers or packaging material from damage and or tearing evaluate the
38. artment d CS SPD Staff Both Facilities e Infection Control 2 References a AAMI Recommended Practices i ST35 Safe Handling and Biological Decontamination of Medical Devices in Health Care Facilities and Non Clinical Settings b New Jersey State Regulations i NJAC 8 43G 8 5 c 1 2 3 59 B Processing Receiving facility must have the following For pre packaged instruments the receiving facility must inspect all packages and pouches for abrasions tears or damage of any kind prior to beginning the sterilization process The receiving facility shall appropriately label for outdates or event related sterilization All load and processing records should be maintained at the processing facility for a period agreed to by risk management of both facilities A recall system shall be established to notify the off site facility of a positive biological result Policies for processing instruments by ethylene oxide EtO shall be established and include the following Items received from any department which must by manufacturer s recommendation be processed by sterilization shall be transported off site to the nearest facility having the license and capabilities accordingly provided that the sending facility has no capabilities for EtO The sending facility shall have a written agreement for such services CS SPD personnel must inspect all items being returned from an out sourced venue for the following
39. ature of the aeration process the characteristics of the airflow and intended use of the item The medical device manufacturer must determine proper aeration times and provide written recommendations which are used to formulate department procedures e Some medical devices may require additional aeration than that provided by the pre set cycle A system should be developed to identify items requiring additional aeration e Temperature and duration of aeration shall be monitored and documented Employee Safety e The New Jersey Department of Environmental Protection requires licensing for those individuals working directly with ethylene oxide Applicators licenses and operating permits should be posted and expiration dates logged to insure that renewal licenses are obtained e OSHA established strict regulatory standards for the use of ethylene oxide which also includes the development of an EtO Emergency Plan A sample is provided in Appendix Polices and procedures should be based upon federal standards Monitoring and alarm systems records should be maintained and checked by management 34 e There are specific requirements for retention of EtO records when employees are potentially exposed to EtO at or above the action level or above the short term excursion limit Records may be kept in employee s health file and a master file for easy reference and auditing 1 Key Players a CS SPD Manager Director b CS SPD Technician
40. d or even distilled water in at least the final rinse stages The time lapse between use and cleaning process can adversely affect the cleaning process Foams and gels are recommended for prolonged time lapse Develop the process for use based upon the above mentioned factors Key Players Manufacturers b CS SPD Manager Director Infection Control Professional d Infection Control Committee Materiel Management 2 References a AAMI Recommended Practices i ST35 Safe Handling and Biological Decontamination of Medical Devices in Health Care Facilities and Non Clinical Settings ASHCSP Training Manual for Central Service Technicians Chapter 4 IAHCSMM Central Service Technical Training Manual Chapter 5 New Jersey State Regulations i NJAC 8 43G 8 7 a H NJAC 8 43G 8 7 d Hi NJAC 8 43G 8 7 e American Journal of Infection Control Guidelines for Selection amp Use of Disinfectants 1996 24 313 42 Develop policies and procedures that address the information required from the manufacturer before the device s can be processed Cleaning agents Cleaning implements Rinse requirements distilled water deionized water Temperature restrictions Reuse limitations Moisture sensitivity Lubrication via mechanical washers Testing requirements The first step is to develop the workflow process starting with inspection of instruments received from patient care areas
41. develop specific work practices or procedures Staff involvement is critical to developing procedures for each step of the manufacturing process as you will be asking them to document how they perform their duties on a daily basis There are many different approaches to accomplish this task However the following method may prove to be the easiest First choose a procedure and have your employees develop a handwritten flow chart of each step in the process It is best to begin with a basic process and avoid unusual or special situations such as an OR emergency loaner instrumentation or portable patient care equipment These situations require deviation from the normal process and should be avoided until the basic process is developed Specific flow charts will need to be established for each situation Once a flow chart has been established for each step of the manufacturing process employees should provide a written description of exactly what they do at each step of the flow chart In essence you are looking for what to do when to do it and who and what are needed to do it Once the current work practices have been developed and flow charts developed a review process should be performed by management and staff The department s work practices should be compared to the ISO outline in this document to ensure that all issues are covered At the same time work practices can be compared to hospital policy state and federal regulations a
42. e completely dry before re assembly e Inspection of scopes should include the following factors o Should have unobstructed view with no black spots cloudiness or other imperfections If noted send the scope for repair o If smudges are noted clean eyepiece and distal tip with 70 alcohol o Check for bends dents in shaft o Check eye piece sealing cup for damage e Sterilize per the scope manufacturer s instructions EtO low temperature gas plasma are commonly employed for reprocessing Some rigid scopes are labeled steam autoclaveable only 1 Key Players CS SPD Manager Director Endoscopy Manager Director OR Manager Director Endoscopy Technician e CS SPD Technician 2 References a Society of Gastroenterology Nurses and Associates Standards for Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes 2000 b Association for Practitioners in Infection Control APIC Guidelines for Infection Prevention and Control in Flexible Endoscopy 2000 Central Service Technical Manual Chapter 7 e Ff Sterile Storage A Handling of Sterile Product Develop clear and concise procedures for rotation of stock e First in first out FIFO Fill from right pull from left Fill from back pull from front Check packaging integrity and outdates 41 e Monitor compliance 1 Key Players a CS SPD Manager Director b Materiel Personnel 2 References a IAHCSMM C
43. el Management and establish a process for sending instruments for repair or repair on site which reduces downtime of instruments e Identify acceptable turn around times for instruments being sent out for repair Replace with back up instrument supply when possible e CS SPD needs to have a back up supply of instruments on hand e Determine what quantity and whose budget will be billed for replacements When repaired instruments are returned they should be inspected for functionality and then decontaminated before sterilization Ifthe instrument needing repair is a one of a kind is in limited quantity determine if a loaner needs to be obtained Make sure to determine with the OR if the tray can be used without the instrument used on a limited basis or take the tray out of circulation until the instrument is repaired replaced e Develop a repair log to identify what is out if a loaner is brought in identify loaner with serial and possibly a specific color instrument tape to make retrieval easier and update when repair complete Develop policy procedure for use of loaner instruments provided by the original equipment manufacturer OEM while the facility s instrument is being repaired Track the loaner device to ensure prompt retrieval for return to the manufacturer e One suggestion is to use surgical instrument marking tape in a color specific to loaner instruments When the loaner device is received the serial numbe
44. ent and functional e Assembling multiple component sets or packs Obtain technical data from packaging manufacturer to assure Air removal e Permitting the sterilant to contact all surfaces of the device e Protecting the device from contamination during storage handling and before it is used shelf life e Packaged to allow item to be removed aseptically Provide equipment supplies needed for inspection testing functionality preventive maintenance 1 lighted magnifying lamps special lubricants theraband to test sharpness etc e In service CS SPD employees Determine competencies for each device 14 1 Key Players a CS SPD Director Manager b CS SPD Staff c Device manufacturers 2 References a AORN Standards Recommended Practices amp Guidelines Instruments and Powered Equipment Care amp Cleaning 2000 b New Jersey State Regulations i NJAC 8 43G 8 1 b c d NJAC 8 43G 8 4 b Policies for assembly of surgical instrument sets should be established e Develop accurate count sheets for all trays processed e The weight of an instrument set should be based on whether personnel can use proper body mechanics in carrying the set Also the design and density of individual instruments and the distribution of mass the density in the set will impact the ability to dry the set The department should work with the end users to control set weight e Use copies of catalog diagrams for
45. entral Service Technical Manual Chapter 12 b AAMI Recommended Practice i 5746 Good Hospital Practice Steam Sterilization and Sterility Assurance c ASHCSP Training Manual for Central Service Technicians Chapter 8 d New Jersey State Regulations i NJAC 8 43G 8 1 b Evaluate stock on hand e Inventory control methodologies e Delete obsolete stock trays e Review par levels for stock and floor trays e Work with Materiel Management in developing and adjusting inventory e Purchase plastic bins for storage of supplies e Look at shelving configurations maximize space utilization 1 Key Players a Department Manager b Materiel Manager 2 References a AAMI Recommended Practice i 5 46 Good Hospital Practice Steam Sterilization and Sterility Assurance Environmental storage conditions can have a significant impact on sterile storage The following issues should be addressed e Involve Infection Control and Engineering to maintain temperature and humidity range for area e Purchase and install thermometer hygrometer and monitor document temperature and humidity daily e Post signs and enforce restriction to area to indicate authorized personnel only 1 Key Players a CS SPD Supervisory Staff b Infection Control c Engineering d Administration e CS SPD Staff 42 2 References a AAMI Recommended Practice i 5746 Good Hospital Practice Steam Sterilization and
46. er is a complete management system for sterile processing of instruments and trays The technician uses a wireless palm top scanner to document all tray activity such as decontamination packing sterilizing stocking issuing and returning Users have the option to define sterilization settings You can specify minimum maximum and current quantities for each tray type in each storage location Use pictures of completed trays and individual instruments to help technicians pack trays accurately 4 Census Technologies Inc 113 Seaboard Lane Suite B200 Franklin TN 37067 Phone 615 963 3872 FAX 615 963 3847 CENSIS Technologies Inc harnesses patented laser inscripting methods coupled with state of the art scanners and proprietary Internet based software concerned with managing expensive surgical inventories CENSIS provides the only system that can accurately and efficiently measure the utility of individual surgical instruments and also the containers they reside in It provides management and staff with the tools to optimize inventories monitor productivity and enhance training evaluation and quality assurance 5 Healthcare Systems Management Inc 95 Old Short Hills Road West Orange NJ 07052 Phone 973 322 0296 FAX 973 322 4217 Email contactus htmtrilogy com Trilogytm is an integrated state of the art computer assisted Training Testing Tracking system Its interactive multimedia productivity software uniquely combines se
47. es for use in Health Care Facilities 2000 E Preparation Packaging Storage Physical Environment e Space allocation should be based on the processes and responsibilities of linen handling Based on your specific responsibilities the following equipment may be needed o Light and work tables Transport carts o Patch Machine Bins for rewash repair and discard e Ifresponsible for repairs and or delinting except for towels a separate room is required e Recommended temperature controlled and monitored to a range between 20 C 23 C 68 F 73 F Relative humidity to be maintained and monitored at 30 60 e 10 air exchanges per hour will minimize lint particles in the air Traffic should be restricted to authorized personnel only Controlled best with walls or partitions to separate functions Develop policies procedures that bring consistency to how products are wrapped each and every time e Manufacturer s instructions for use should be the basis of the packaging policies and procedures in order to achieve successful sterilization maintain sterility until opened and provide for the removal of the contents without contamination 56 4 CS SPSD staff assigned to linen processing should follow policies procedures for cleaning table surfaces at the end of each shift and shelving and carts on a scheduled basis 1 Key Players a CS SPD Manager Director b Plant Engineering Manager Director c Infection
48. f proper chemicals and cleaning methodologies e Principles of instrument identification testing and assembly into sets e Use of appropriate chemical and biological indicators specific to the sterilization process selected e Use of preceptors throughout the duration of the orientation process e Return demonstrations to validate competency Continuing Training When new procedures and or changes occur an in service should be done and documented to assure all staff have the necessary information Staff meetings used for education should be documented and provided to all staff The use of infection control practitioners sales representatives OR service leaders surgical instrument manufacturer s catalogs and professional journals can be used to assist in the educational process A good way to educate OR CS SPD staff is through use of a task force for instrument and process issues Weekly monthly in services are essential In the beginning the meetings will probably be weekly then move on to monthly e Alternate the location OR CS SPD Neutral e Hold meetings to time frames established e Set topics agenda and keep to it Cross training of OR CS SPD Staff is recommended to improve the communications between the departments e Should be started as part of orientation for personnel both OR and CS SPD e Should include a tour of the respective departments e Assign personnel to respective departments for minimally a full day
49. following Evaluate packaging materials used Evaluate package contents for suitability with packaging materials 1 peel pack Investigate handling of sterile packs post sterilization Investigate condition of autoclave and storage racks wires loose burrs on edges Identify storage locations conditions In service CS SPD and OR personnel on proper handling of sterile packs Determine staff competencies for handling of sterile packs Line storage wire shelves with foam vinyl or plastic in sterile storage Investigate purchase of additional rigid containers D Rigid amp Flash Container Sterilization Systems Evaluation need to evaluate as with any other major change in packaging systems They are reusable and come in a variety of materials and sizes various metals aluminum and polymers Cleaning Disassembly Recommendations Reduction of bioburden essential All non disposal components must be cleaned after each use including filters valves internal baskets etc Reusable identification system tags inside and outside of container Remove all disposable process indicators locks filters etc prior to cleaning Dividers sorting pins may have to be removed if they interfere with proper cleaning Cleaning Agents Methods Follow container manufacturer s instructions for detergent selection and usage manual or mechanical Configuration of sets inside container can affect drying and sterilization cycles
50. g e g suitable work area and equipment proper attire etc 22 o The OR should maintain a file of manufacturers instructions for flash sterilizing their devices Many manufacturers of complex instrumentation do not recommend flash sterilization for their device While there are specific cycles for porous and non porous items complex instrumentation may require special exposure times It is the responsibility of the OR to maintain documentation of items being flashed This record should be audited on a regular basis and used for budget preparation to increase inventory of those items being frequently flash sterilized o The CS SPD Director is ultimately responsible for all sterilization within the facility and must audit the flash sterilization log as well as the sterilizer monitoring records on a regular basis 1 Key Players a OR Director Instrument Technician b Infection Control Professional c Instrument Manufacturer d CS SPD Manager Director e CS SPD Technician 2 References a Labeling Reusable Medical Devices for Reprocessing in Healthcare Facilities FDA Document www fda gov cdrh ode 198 pdf b New Jersey State Regulations i NJAC 8 43G 8 1 d c Selecting a Sterilization Process by Natalie Lind Infection Control amp Sterilization Technology December 1996 B Documentation For each sterilization cycle load contents and lot control information are recorded on a sterilization log
51. g storage Storage e Storage of endoscopes with the removable parts detached lowers the risk of trapping liquid inside the instrument and facilitates continued drying of the channels and channel openings e Define storage conditions to protect the scope from damage dust free and provide ventilation Processing of Endoscopic Accessories e Items that penetrate mucosal barriers e g biopsy forceps are considered critical and therefore must be sterilized before use e Only sterile water should be used to fill the bottle for endoscopic irrigation o The water bottle and its connecting tubing should be sterilized or receive high level disinfection at least daily Documentation of Devices Processed e endoscopes reprocessed should be maintained in a log which includes Date Patient Name Medical Record number Processor Endoscopist Serial number of the scope used O OOO Rigid Endoscopes e Follow scope manufacturer s instructions for cleaning disassembly inspection testing and re assembly 40 e Cleaning of scopes should include the following factors Ifrecommended disassemble scope s light guide adapter and eyepiece cup Do not lose pieces keep together for re assembly after cleaning Do not clean more than one scope at a time to avoid damage Do not place in mechanical washers manual clean only o Use neutral pH detergents o Rinse well After cleaning make sure threads ar
52. h shall include the following o Instructions for installation storage and use o Safety precautions to be taken during routine use as well as recommended sterilizer settings safety precautions for terminating a cycle in progress and explanation of how pressure recordings should be interpreted to detect chamber leaks Technical information about the chamber temperature and pressure ranges acceptable during operation Validation procedures used to establish that the recommended cycle parameters provide a 10 sterility assurance level Types of items for which EtO sterilization is appropriate Selection of appropriate packaging materials o Environmental humidity control Designate a specific area for Prep and Packaging Chemical Indicator Integrator Biological Testing Various types of external and internal chemical indicators integrators are available each with different response characteristics The manager should obtain data from the manufacturer on the reliability sterility assurance level safety performance characteristics storage requirements and shelf life This data will support the manager in developing specific polices for use placement and storage Policies for the type of chemical indicator integrator should establish placement frequency of use interpretation and actions taken in response to a non responsive or inconclusive chemical indicator integrator An auditing system should be established to insu
53. he tasks as well as end users Develop staff competencies for processing of complex devices 1 Key Players a Department Manager b Employees c Manufacturer d Materiel Management e Risk Management 2 References a AAMI Recommended Practices i 2 Designing Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities A Guide for Device Manufacturers H 5733 Guidelines for the Selection and Use of Reusable Rigid Sterilization Container Systems for Ethylene Oxide and Steam Sterilization in Health Care Facilities b FDA Guidelines for the Reuse of Single Use Devices c New Jersey State Regulations i NJAC 8 43G 8 1 d NJAC 8 43G 8 4 b d IAHCSMM Central Service Technical Manual Chapter 8 e ASHCSP Training Manual for Central Service Technicians f Management of Loaner Instrumentation and Implants Position Paper 2 ASHCSP amp IAHCSMM 10 95 II DECONTAMINATION A PPE Dress Code Develop policies and procedures for the uses of personnel protective equipment PPE that are clear concise and include the potential for disciplinary action PPE is dependent upon the task to be performed Educate employees with regards to what attire is to be worn during specific activities how it is to be worn and why it is worn Impervious gown Cuffed gloves Face mask Face Eye protection Shoe covers Head cover Develop annual competenc
54. he user 1 OR Med Surg ICU Same Day Off Site Facility Responsibilities for pre cleaning and soaking should be clearly defined and include Suitable detergent Removal of gross soils at point of use Proper storage location and use of biohazard labels Transport procedures Scheduling pick up or delivery of soiled instruments may vary from hospital to hospital based upon the number of shifts that CS SPD operates It is important to establish the flow of soiled instruments and equipment from the various users with time frames A flow chart will help to identify sources volume of goods and times Identify the unexpected situations that arise such as unscheduled surgeries emergencies back to back cases or special requests e Communicate with the units to insure impact on labor product patient care or quality is not compromised 1 Key Players a Department Managers in various units should help to identify the role of their staff and needs of their units b CS SPD employees will help to define current practice c Infection Control for review and comment d Safety Officer to identify any unsafe practices 2 References a AAMI Recommended Practices i ST35 Safe Handling and Biological Decontamination of Medical Devices in Health Care Facilities and Non Clinical Settings H 5746 Good Hospital Practice Steam Sterilization and Sterility Assurance b 29 CFR 190030 OSHA s Blood Borne Pathogens
55. ical Settings H 5 46 Good Hospital Practice Steam Sterilization and Sterility Assurance IAHCSMM Central Service Technical Manual Chapter 5 ASHCSP Training Manual for Central Service Technicians Chapter 4 U S Veterans Administration Department of Medicine and Surgery Manual H 08 9 and MP 2 1983A and 1983B 11 Decontamination Process Flowchart SOILED ITEMS ARE RETURNED TO SPD DECONTAMINATION Y STAFF DONS PROTECTIVEATTIRE Y Y Y PATIENT CARE INSTRUMENTATION SURGICAL CASE EQUIPMENT ALLDEPARTMENTS CARTS ENDOSCOPES REMOVE TAPE x Y OR TAPE EMPTY CART AND RESIDUE SEND TAKE TO EQUIPMENT SORTITEMS gt EMPTY CART AREA THROUGH CART WASHER r INSPECTSCOPE Y FOR DAMAGE DISASSEMBLE No No DISPOSABLES DISCARDDISPOSABLE ITEMS DRY CART AT DAMAGED Yes T ves END OF CYCLE Y Y y v OPEN AND CHECK FOR DISCARD Yes CLEAN DISINFECT INSPECT FOR DAMAGE OR ACCORDING TO Y ACCORDING TO DAMAGE OR GROSS SOIL TYPE OF WASTE REPORT PROCEDURE GROSS SOIL No OF CHECK CART FOR REC
56. ice Provider c CS SPD Technician 2 References a Here s what to do when a load goes bad by Karen Sandrick Materiels Management September 1998 b New Jersey State Regulations i 8 43G 8 8 d 1 2 4 Administrative Concerns The CS SPD Manager Director is responsible for the safety and effectiveness of the sterilizers wherever they are located Regular cleaning and routine maintenance repair that is documented and kept on file in the CS SPD department should maintain the sterilizers The manufacturer s service representative or specifically trained personnel should perform maintenance A complete service manual and instructions for safe and effective operation of the sterilizer should be available where the sterilizer is located Sterilizer maintenance records should be retained according to hospital policy 28 Steam Sterilization Process PACKAGES READY TO BE STERILIZED VISUALLY INSPECT PACKAGE FOR ACCEPTABILTY FOR STERILIZATION PROCESS APPROPRIATE PACKAGING MATERIAL Vise Yes PACKAGE SEALED Vas EXTERNAL ACCEPTABLE FOR OTHER DAMAGE APPROPRIATELY CHEMICAL INDICATORS PROCESS ON PKG No RE WRAP PACKAGE No gt TOCOMPLY WITH 4 PROCESS NEEDS CHECK PACKAGE Yes LABEL PREPARER S INITIALS PRESENT CONTENTS IDENTIFIED Yes No No Y Y RELABEL PACKAGE FIND PREPARER
57. ician d Bio Med Personnel 2 References a AAMI Recommended Practices 1 ST35 Safe Handling and Biological Decontamination of Medical Devices in Health Care Facilities and Non Clinical Settings 5 46 Good Hospital Practice Steam Sterilization and Sterility Assurance b ASHCSP Training Manual for Central Service Technicians IAHCSMM Central Service Technical Manual Chapter 5 d Enforcement Priorities for Single Use Devices Reprocessed by Third Parties and Hospitals CDRH FDA 8 00 10 e New Jersey State Regulations i NJAC 8 43G 8 1 b c H NJAC 8 43G 8 7 f NJAC 8 43G 8 4 c Physical Environment Specifications for temperature humidity air exchanges are clearly defined but monitoring equipment and systems shall be established to insure that environmental conditions are maintained The space within CS SPD shall follow the recommended flow of product at each stage of the process Employee policies and procedures must clearly define traffic patterns to prevent cross contamination and should include hand washing and appropriate use of PPE 1 Key Players a CS SPD Director b Engineering Infection Control 2 References a New Jersey State Regulations i NJAC 8 43G 8 4 a NJAC 8 43G 8 6 a b AAMI Recommended Practices 1 ST35 Safe Handling and Biological Decontamination of Medical Devices in Health Care Facilities and Non Clin
58. ies for the use of PPE As part of JCAHO survey practices they may ask to see documentation as to what action is taken if an employee fails to follow procedure OSHA makes mention in the Blood Borne Pathogen Ruling that not only the employer who fails to provide PPE but the employee who fails to follow procedures for the use of PPE both face disciplinary action As a useful tool to meeting these standards and as a means to stress the importance of PPE you may want to develop a written agreement between employer and employee Such an agreement should be reviewed and signed by the employee annually When developing such a policy it is imperative that the agreement has the approval of Human Resources and or Risk Management Employees do not wear protective attire because it is uncomfortable When employees feel the PPE is uncomfortable it may help to investigate other materials and products It is important to involve the staff in the selection process If an impervious gown or jump suit is being used as part of the protective attire consider changing to a long sleeved impervious apron The environment may be the cause of the uncomfortable working conditions and may warrant the following action Discuss available environmental controls with engineering to determine what limitations exist such as the ability to control environmental conditions within decontamination without affecting other areas Request that available systems be checked
59. iewed and updated every three years It is important to follow government regulations as well as national guidelines when developing hospital policy as it provides the means to defend proposed policies and enhances the professionalism and credibility of the manager and department Policies are broad based documents that provide direction to personnel in all aspects of Central Service such as but not limited to receiving decontamination preparation sterilization storage and distribution Government regulations are minimum standards that must be met and may differ from national standards or guidelines In cases where they differ the more stringent of the two should be selected Each chapter of this document references the state and federal regulations as well as the national guidelines that should be utilized when creating or revising hospital policy In order to develop meaningful policies it is necessary to obtain the most current versions of these regulations and standards Once you have the current regulations and standards you need to compare existing hospital policy to these guidelines to determine discrepancies and correct them Once policies have been reviewed and or revised they must be submitted through your organizational chain of command for final adoption In most cases revisions will be submitted to the infection control committee and or safety committees for review and approval The next step in establishing a quality system is to
60. ific polices for use placement and storage e Designate a specific area for prep and package 1 Key Players a Manufacturer b CS SPD Manager Director c CS SPD Technician 35 2 References a New Jersey State Regulations i NJAC 8 43G 8 8 a 3 H NJAC 8 43G 8 8 c 3 b IAHCSMM Central Service Technical Manual Chapter 10 I Dry Heat Sterilization Dry Heat Sterilization is the method of choice for sterilizing talc Policies and procedures shall be established to insure appropriate time and temperature An alternative to processing talc is to buy it sterile The FDA has approved for marketing sterile talc produced by the Bryan Corporation Woburn MA telephone 800 343 7711 e Chemical Indicator Biological Testing There are specific biological and chemical indicators with instructions for their use The manager should obtain data from the manufacturer on the reliability safety performance characteristics sterility assurance level SAL storage requirements and shelf life This data will support the manager in developing specific polices for use placement and storage 1 Key Players a CS SPD Manager Director b CS SPD Technician 2 References a Purdue IAHCSMM Self Study Lesson on Dry Heat Sterilization J Chemical Sterilants and High Level Disinfection Physical Settings e The conditions given on the product label for high level disinfection or sterilization are determined by the manufacturer u
61. ing Develop a policy and procedure that is to be followed by all departments with regards to notification of CS SPD of new devices being considered that require cleaning disinfection and or sterilization Develop a policy regarding reuse of single use medical devices e In House reprocessing e Third Party reprocessors 1 Key Players q o Pp B rR rm rma Processing Manager Administration Operating Room Management CS SPD amp OR Staff Materiel Management Vendor Surgeon Infection Control Risk Management Staff Development Radiology Respiratory Therapy Cardiac Cath Lab Endoscopy All other user departments Patient Advocate Finance 2 References 64 a AAMI Recommended Practice i TIR12 Designing Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities A Guide for Device Manufacturers b FDA Enforcement Priorities for Single Use Devices Reprocessed by Third Parties or Hospitals Aug 14 2000 IAHCSMM Central Service Technical Manual Chapter 14 d ASHCSP Training Manual for Central Service Technicians Environmental Sanitation Policies for housekeeping should specify areas to be cleaned frequency of cleaning chemicals to be used employee health concerns and designate who is responsible These policies should include Care of environmental surfaces such as floors walls counter tops sinks Cleaning of processing equip
62. ing personnel in proper use of heat seal machine e Verification competent return demonstrations e Ensuring supply of necessary size dust covers 2 Key Players a CS SPD Manager Director b CS SPD Staff 3 References a AAMI Recommended Practice i ST 46 Good Hospital Practice Steam Sterilization amp Sterility Assurance b ASHCSP Central Service Technician Training Manual Chapter 6 IAHCSMM Central Service Technician Manual Chapter 12 IV STERILIZATION A Selection of Sterilization Process CS SPD managers should in service surgical staff and user departments regarding the total time required to complete sterilization cycles including EtO aeration and steaming cool down time and communicating with user departments as needed to prioritize their needs Standardize EtO cycle start times to insure devices are available for first case e CS SPD Operating Room and Infection Control should adopt policies and procedures that include but are not limited to the following o Coming from the OR to CS SPD to be cleaned and sterilized e g Stat stickers flagging phone communication etc In CS SPD and must be sent to the OR to be flash sterilized for immediate use e g complete cleaning inventory etc OR and will be cleaned and sterilized for immediate use e Certain principles should apply The item should be cleaned in CS SPD if the OR cannot meet the same standards for proper cleanin
63. l problems Regardless of the role that you play you must follow the documented procedure for corrective action It s important to have good closure which means that the problem has been completely analyzed permanently remedied recorded implemented and reviewed Now you may begin your journey down the quality systems path Please use this guidance document as a guiding light As time goes on and we receive feedback from those brave souls that embark on this most difficult journey we will revise and update this document This is truly an endless journey which will lead to a more efficient system safe medical surgical devices for patients increased productivity reduced costs and employee satisfaction This is a guidance document that should be used as a tool in developing a quality control system in Central Services References will change over time as well as Central Supply issues ISO COURSE OUTLINE KEY ISSUES Manufacturer s Written Recommendations Prior to purchase of a medical device the Materiel Purchasing Management department should confirm that the facility has the capability to follow the manufacturer s recommendations for reprocessing the item The responsibilities for purchasing medical devices may vary from institution to institution It may also vary by department within any given institution A representative from CS SPD shall be a member of any committee involved in product eva
64. lf paced self testing programs of mission critical training which encompasses hundreds of interactive exercises with unlimited competency test questions that lead to certification The tracking system provides Real Time instructional tools customized according to client needs Count sheets and Tray Sets are created for individual surgical procedures that also highlight surgeon preferences sterilization practices reprocessing guidelines decontamination procedures and surgical services procedures as identified by user requesters The instrument and tray update library allows the creation of thousands of additional instruments and images to be integrated into yet the most user friendly and efficient tracking software available This system meets the educational needs of the OR and sterile processors by its unique software that permits downloading of digital photos of all instrumentation In addition procedures can be downloaded for in services competency testing and reminders 68 6 Getinge Castle Inc 1777 East Henrietta Road Rochester NY 14623 3133 Phone 800 475 9040 ext 5701 T DOC stands for TOTAL DOCUMENTATION It is the fast and easy way to collect organize analyze and archive sterile processing and mobile equipment data Bar code technology lets you know exactly where all of your goods are all the time e Hand held scanner records information and stores it electronically Easy to read screen display lets you view and manage
65. luation or purchasing Manufacturers are required to provide validated instructions for reprocessing reusable medical devices Compare the device manufacturer s recommendations to the facility s own processing capabilities The facility is responsible for insuring that they have the facilities and equipment to execute the instructions The CS SPD department should have a policy and procedure for reporting to the FDA any manufacturer who does not provide validated instructions for cleaning and sterilization of their device 1 References www fda gov medwatch report hcp htm for voluntary reporting procedures Develop a check sheet to assure that all possible needs are addressed during interaction with manufacturer or review of their literature Method s for cleaning Can the item be immersed in solution Chemical restrictions Temperature restrictions Exposure time Drying requirements Aeration requirements if EtO sterilized Packaging requirements If the device has its own sterilization container consideration must be given to its care and handling as well as testing for process efficacy in your sterilizer How was the product tested Pre vacuum Gravity Displacement EtO LTGP What was the load configuration Where was the item placed inside the sterilizer Middle shelf Bottom shelf Develop procedures for complex devices Maintain instructions in a file readily accessible to employees performing t
66. lude records from the sterilization cycle Documentation shall be maintained whenever a breach of hospital policy or procedures occurs i e cleaning release of items etc 1 Key Players a CS SPD Manager Director b CS SPD Technician 2 References a ISO 13683 Sterilization of health care products Requirements for validation and routine control of moist heat sterilization in health care facilities January 1996 b ASHCSP Central Service Technician Training Manual Chapter 5 c New Jersey State Regulations i 8 43G 8 1 e 6 26 F Quality Assurance Quality Control system shall be established and maintained for release of product after sterilization For each load the release documentation shall Specify the load or include a reference to the specification for the load o Include records from routine testing o Include records from the sterilization cycle e The quality of steam is an important aspect of successful steam sterilization CS SPD Directors should work closely with their Plant Engineering Directors to ensure that the recommended steam quality and purity are consistently maintained e Wet packs most frequently occur in the steam sterilization process and policies should be established to respond to this issue 1 Key Players a CS SPD Manager Director b Plant Engineer c CS SPD Technician 2 References a Technique Manual Wet Pack Problem Solving Guide Steris Corporation 2003 b
67. ment Use of protective attire Gown Hair Cover Shoe Cover Mask Gloves Eye Protection Use of specific utensils such as hand brushes Develop procedures for care of reusable brushes Environmental Services has the responsibility of reducing the bio burden in CS SPD Meet with Infection Control and Environmental Services to develop cleaning protocols for department develop rationale for 7 day cleaning schedule Determine which departments are responsible for specialty cleaning 1 vents develop schedule Develop schedule where cleaning is done in hourly segments i e on weekends rather than entire area at once Maintenance of environmental surfaces and plumbing is a function of Plant Operations and work orders should go through a designated employee and records maintained The pest control program should include e A logbook with all pesticides used within the department e A logbook for staff to identify the location of activity within the department e Maintenance work orders to seal openings repair water leaks or eliminate potential harborage areas Policies and procedures must be established for the collection storage and disposal of Regulated Medical Waste Solid Waste and Recyclable Waste 65 1 Key Players a CS SPD Manager Director b Infection Control c Engineering d CS SPD Staff e Pest Control Operator References a AAMI Recommended Practices 1 5735
68. nd national guidelines By including staff in the process of comparing their work practices to outside sources you are empowering them to identify problems and improve practices Management and staff should review existing work practices looking for the following 1 Poor work practices 2 Short cuts 3 Duplication of effort 4 Staffing shortfalls 5 Special requirements for specific products 6 Additional training in servicing needs for staff 7 Compliance with State and Federal regulations as well as national standards As part of this process each should prepare recommendations for change Consideration of customer needs is also a major component of the quality system process The department s ability to satisfy its customers needs on a consistent basis 15 the first step towards being considered reliable and professional by your organization In each section of this ISO guidance document key players are identified Although it is the manager s responsibility to work with the department s customers to identify their needs at least one staff member should be included in the process Time should be taken to work with departments to 1 Review and revise forms 2 Determine documentation issues 3 Determine appropriate scheduling 4 Develop communication systems Once management and staff have had an opportunity to review the work practices and prepare their recommendations it s time to meet and collabora
69. ns i NJAC 8 43G 8 1 c NJAC 8 43G 8 5 c 5 b AAMI Recommended Practice i 5746 Good Hospital Practice Steam Sterilization and Sterility Assurance IAHCSMM Central Service Technical Manual Chapter 17 d ASHCSP Training Manual for Central Service Technicians Chapter 9 VII Inventory Control A Methodology systems must meet the facility s needs and minimize the overall cost of acquiring handling and maintaining supplies in storage 45 B Instrument Inventory Surgical instruments represent an asset that needs to be managed It is recommended that a physical inventory of surgical instruments and devices be performed Often this will be performed at no cost as a value added service when a prime vendor agreement for surgical instruments is negotiated e The inventory should be provided on a disk e For facilities without prime vendor agreements knowing tray values and the number of trays can provide a rough instrument inventory value for reference It is essential that the inventory be maintained by amending additions deletions as they occur e The inventory list becomes an important management tool to identify tray contents costs for replacement and accountability of sets to prevent loss Administrative Considerations Staffing CS SPD needs to have sufficient staffing to permit processing of equipment and trays for the OR in a timely manner to avoid case delay
70. nvolve booking personnel in process See sample Priority Processing form in Appendix of this document 46 Some instrument manufacturers will provide instruments and devices 1 endoscopic cameras light cords and instruments on a fee per use basis There are advantages to this system because the facility can request any amount of instrumentation and is billed only when the system is used The instrument manufacturer assumes all responsibility for repairs and additional equipment needs The facility has the further advantage of up to date technology that can be replaced as needed since the equipment is not owned by the facility This process also encourages standardization of systems which facilitates in service and processing issues for both the OR and CS SPD staffs Patient Care Equipment All patient care equipment must be inspected by the biomedical department service prior to being placed into service The biomedical department is responsible for the Preventative Maintenance PM on Patient Care Equipment Develop Policies Procedures for tracking patient care equipment from distribution to return e Track equipment to each patient and return after each patient use e Use serial number or inventory control number Develop Policies and Procedures for handling damaged broken or malfunctioning equipment e Mechanism to identify malfunction problem specifying problem and unit e Decontamination e Send to Bio Medic
71. o apply the widely accepted International Standards Organization ISO quality system model to Central Services We believe that this system which was developed in 1987 is applicable to Central Services as manufacturers of sterile reusable instruments and devices The production of a sterile product encompasses many complex manual and mechanical processes In today s health care system the customer base has expanded to include ambulatory care facilities physicians and even neighboring hospitals The suppliers of medical devices are manufacturing complex instruments that require specialized cleaning methodologies including specific detergents and equipment All these factors make the task of documenting a quality system based upon ISO an important mandate In order to establish a starting point for Central Service in their quest for a quality system it was necessary to identify the primary functions within the department Thirteen functions common to Central Service were identified With these functions in mind you are ready to move on to the first step in creating a quality system which is to document your process Since each hospital provides different services based upon its customer base and its mechanical and physical layout it is important to develop policies and procedures that are specific to your process State Regulations and the Joint Commission on Accreditation of Healthcare Organizations JCAHO require hospital policies to be rev
72. placement configurations should be developed Procedures for configuring mixed or heterogeneous loads should be developed Process audits should be performed and documented to ensure compliance Staff competencies for proper package placement and sterilizer rack loading need to be documented 1 Key Players a CS SPD Manager Director b CS SPD Technician 2 References a AAMI Recommended Practice i 5746 Good Hospital Practice Steam Sterilization and Sterility Assurance b Sterilizer manufacturer s user manual D Steam Sterilization Processes Physical settings 24 The sterilizer manufacturer s recommendation for cycles should be followed at all times If a device manufacturer recommends a different cycle for a particular device the sterilizer manufacturer should be consulted and the issue resolved by verification of results A rigid sterilization container system frequently requires changes in the normal cycle and it is important to verify that the cycle selected accomplishes sterilization All rigid container systems must be verified in the facility s sterilizer upon purchase or if significant changes in the process occur Documentation should be maintained on file Chemical Indicator Integrator Biological Testing The selection of biological and chemical monitors is based upon the intended use of the monitor The manager should obtain data from the manufacturer on the reliability sterility a
73. r should be noted on a Log Form for Loaner Instruments indicating the date received name of the instrument serial number of the device if known and tray set service e When the facility s device returns from repair the loaner can be easily retrieved by the serial number and tape identification 52 X e Document on the Log form the date the loaner device was retrieved and returned 1 Key Players a OR Manager b CS SPD Manager Director c Materiel Management d CS SPD Staff 2 References a AORN Recommended Practices Preparation of Surgical Instruments amp Power Equipment IAHCSMM Central Service Technician Manual Chapter 17 c New Jersey State Regulations i NJAC 8 43G 8 11 b NJAC 8 43G 8 10 Automated Documentation Systems There are a number of automated systems to manage the instrument processing process such as instrument tracking systems sterilizer documentation systems computerized count sheet programs and OR scheduling systems to name a few Any system must be evaluated for an institution s requirements and must include Compatibility with IT amp S e Costs relating to the following Basic system Upgrades Additional stations Wiring Education time 1 What is included a On site b Off site 2 Time frames allotted o Licensing agreement Technical support Implementation time frame 1 Number of hours from company a Additional time charges 2 Facility man hours required
74. re system compliance with chemical monitor procedures This system may consist of a reporting system from the end user or breaking down completed packs or customer complaints When selecting a biological monitor the manufacturer s recommendations for storage handling use and microbiological testing should be used to develop procedures Policies for use of biological monitors should address testing upon frequency of use for installation of new equipment after major repairs of sterilizers implantable devices and positive test results 33 e Written documentation or a decision tree should be established as to the actions taken in response to a positive biological monitor 1 Key Players EtO Supplier CS SPD Manager Director Department Heads CS SPD Technician Safety Risk Manager 2 References a New Jersey State Regulations i NJAC 8 43G 8 8 c 2 H NJAC 8 43G 8 8 a 1 b AAMI Recommended Practices i ST 41 Ethylene oxide sterilization in health care facilities Safety and effectiveness H ST 21 RCO Sterilization of Health Care Products Biological Indicators Biological Indicators for Ethylene Oxide Sterilization Part II 1999 c ASHCSP Ethylene Oxide Use in Hospitals e Ff Aeration e Sterilization by ethylene oxide leaves toxic residuals that must be removed by mechanical aeration A departmental policy should take into consideration properties of the item being sterilized the type and temper
75. res to insure a consistent standard of care throughout the facility 1 Key Players a Department Heads b CS SPD Manager Director 2 References a New Jersey State Regulations i NJAC 8 43G 8 1 c Processing Rigid and Flexible Fiberoptic Scopes Transport of Used Scopes e The initial steps in the reprocessing begin in the patient s room immediately after removal of the insertion tube from the patient and before removing the endoscope from the power source e Follow the scope manufacturer s written instructions for processing e Suction the solution through the biopsy suction channel until the solution is visibly clean e Transport the endoscope very loosely coiled to the Decontamination Room in an enclosed container e Reprocessing should not take place in the procedure room Decontamination e Have the following equipment available PPE based upon risk o Leakage tester equipment o Channel cleaning adapters per manufacturer s instructions o Sink filled with enzymatic detergent prepared according to manufacturer s instructions o Channel cleaning brushes and lint free swabs Lint free cloth Leak Testing e Perform a leak test of the endoscope following manufacturer s instructions e Follow the manufacturer s instructions or third party repair service instructions if a leak is detected or the endoscope appears damaged for shipping instructions 38 Cleaning Develop cleaning procedures
76. s and impacting on successful patient outcomes Monitoring staff productivity will assist in documenting staffing levels A career ladder should be established to help encourage professional growth and retention of personnel There is no national standard that is available to assist in developing staffing levels Budget There needs to be adequate dollars for CS SPD staffing and overtime as needed to support the OR schedule and emergency cases Monies need to be budgeted for instrument replacement for lost instruments repairs and additional instruments as determined by flash sterilization records and other indicators 1 new surgical services Productivity and volume need to be tracked because increases in either will impact on operational expenses and staffing Regulatory impact Compliance with all regulatory issues regarding employee safety Blood Borne Pathogens and Sharps injuries must be ensured Develop a joint Peri Operative CS SPD Policy and Procedure that addresses scheduling conflicts The OR Booking Department needs to be provided with a current equipment instrument list to prevent scheduling conflicts 1 schedules 3 Arthroscopies at 7 30 AM in different rooms but only 2 Arthroscopy sets are available for use CS SPD needs to determine realistic turn around times for limited instrument sets and make sure the OR is aware of the turn around time Develop a procedure to communicate the need for quick turn around and i
77. sing FDA recommended testing protocols The user should read and follow the label instructions to determine time temperature concentration and use conditions It is important that the manager check with each device manufacturer of the devices to be processed for materials compatibility and device functionality data regarding the chemical sterilant or high level disinfectant intended for use Chemical sterilants high level disinfectants vary in their toxicity It is important to obtain the material safety data sheet MSDS from the manufacturer of the chemical in order to develop employee safety procedures o If automated systems are used that circulate the sterilant around and through the medical device it is important to follow the manufacturer s recommendations for control of exposure conditions and calibration 36 Polices and procedures for final rinse drying and storage must be established for each type of device being processed 1 Key Players a Manufacturer b CS SPD Manager Director c CS SPD Technician 2 References a AAMI Recommended Practices i TIR 7 Chemical Sterilants and High Level Disinfectants A Guide to Selection and Use January 1999 ii ST 58 Safe Use and Handling of Gultaraldehyde based Products in Health Care Facilities b Society of Gastroenterology Nurses and Associates Standards for Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes 2
78. ssurance level safety performance characteristics storage requirements and shelf life This data will support the manager in developing specific polices for use placement and storage The Bowie Dick Dynamic Air Removal test is used to evaluate the effectiveness of air removal during the pre vacuum phase of a pre vacuum sterilizer cycle and to detect air leakage into the sterilizer during the vacuum phase This test is not a routine sterilization cycle indicator and the manufacturer s instructions for use must be followed when establishing a monitoring program for this test An auditing system should be established to insure system compliance with chemical monitor procedures This system may consist of a reporting system from the end user or breaking down completed packs or customer complaints The selection of biological indicators varies based upon response characteristics desired for the type of steam system employed The manufacturer of the biological indicator BI should provide the user written instructions on storage handling use sterility assurance level SAL and microbiological testing of their products This data will support the manager in developing specific policies for use placement handling incubation reading results record keeping storage and disposal of processed and unprocessed indicators Policies for use of biological monitors should address frequency of use installation of new equipment relocation of equipment
79. t occur in transit 1 Key Players a CS SPD Manager Director Reprocessing Facility b CS SPD Manager Director Sending Facility c Staff Both Facilities d Transportation Staff e Infection Control 2 References a AAMI Recommended Practices i 5746 Good Hospital Practice Steam Sterilization and Sterility Assurance H 5 41 Good Hospital Practice Ethylene Oxide Sterilization and Sterility Assurance b New Jersey State Regulations i NJAC 8 43G 8 5 c 4 5 Administrative Considerations A Training It is essential that each employee receive standardized departmental orientation which is documented and contains the following components e Dress Code e Attendance Expectations time requests call in e Departmental Policies e PPE e Work Flow e Institutional Tour e Staff Introductions e Departmental Hazards o High level Disinfectants EtO Steam under Pressure Noise Hazards Chemical Sterilants O O OO 61 B On the Job Training This training should include at a minimum the following components each step should be expanded to include the key components of the process e Review of policies and procedures e Compliance with the device manufacturer s written instructions for cleaning packaging and sterilization e Identification of all regulatory issues and compliance e Basic infection control and microbiology e Intensive Decontamination methodologies including selection and use o
80. t the needs of the customers Provide for off hour acquisition and accountability of supplies and patient care equipment e Factors influencing the type s of system s selected are Needs of the customers Elevator constraints Types of services the facility provides 43 o Size of the facility o Physical design and age of the facility o Financial resources e Types of Distribution Systems o Demand Requisition amp Delivery System Par Level Stocking including automated par level stocking e g Pyxis Omnicell Exchange Cart Case Carts Specialty Carts Stockless or Just in Time JIT O O OO Work Practices All systems require accurate selection careful handling and timely delivery of needed items Arrange stock efficiently either alphabetically numerically by stock number or functionally by related groups so it can be easily found when needed Label all storage locations Place heavier items on lower shelves and lighter items on higher shelves Develop departmental par levels Inventory either manually or with a hand held computer Par levels need to be reviewed at least annually and revised as needed or appropriate For unique specialty supplies develop a requisition form that contains a list of all the items along with par levels For specialty carts bins procedure carts etc develop a list of the supplies with their location on the cart for restocking Develop a system to
81. te to improve these practices You should have before you the actual practices changes based on government regulations and or national guidelines input from customers revised documents and forms and management assessment of work practices Before the process begins a recorder should be appointed to keep the minutes and prepare drafts of the final document for review prior to the next meeting Each step of the process should be reviewed and input solicited from each person present There should be rules set for the process to assure that everyone 15 heard in an orderly and fair manner It is important that the group set attainable goals for each session and not attempt to do more than is reasonable at one session Once the work practices have been revised and all parties are in agreement a draft will be prepared This draft will be distributed to all members of the group for final review before the next session At the next meeting the changes should be minimal and once everyone has had the opportunity to comment the practice should be unanimously approved Once done the practice will be initiated It is imperative that the practice not be changed or adapted to individual circumstances Any recommendations for change or improvement must be made to and approved by the group This will assure standardized practice and improve the performance of all employees and on all shifts The last step is to determine how you are going to monitor and measure
82. the efficacy of the process Determine the critical steps in the process and develop a method to continuously monitor and measure the efficiency of the process Prepare documentation that will allow you to collect the data necessary to monitor the process Internal audits should be conducted You may use peer review management audits or outside audits as a means of detecting problems It s important to determine how the audit function will be performed the frequency of the audit process verification of corrective action and report on the effectiveness of corrective action It s important to focus on the process and not the outcome Important tools to use are the responses from customers such as customer surveys informal customer comments and complaints The group must decide how you collect this data and how to analyze the data The final issue is process improvement Think of process improvement as a race without a finish line At each stage of the system identify goals or objectives that the staff can use to improve the system Start small and work off your successes You may include both corrective action and preventive action as process improvement In the case of corrective action you are fixing problems in an effort to make the system meet your known needs In this instance the process isn t working as planned or wasn t right from the beginning and is in need of repair Preventive action on the other hand is intended to avoid potentia
83. the endoscope Verify cycle exposure time and temperature for the liquid chemical disinfectant in use The final step for all automated reprocessors is an alcohol rinse preceding purging all channels with compressed air A preventive maintenance program is recommended for automated reprocessing equipment and all flexible scopes Manual High Level Disinfection The above cleaning and leak testing procedures must be followed prior to high level disinfection Verify that the solution has been tested for Minimum Recommended Concentration MRC Define the process to insure disinfectant reaches into all channels of the endoscope 39 e Develop a method to insure soak time and temperature prescribed by the manufacturer of the disinfectant e Flush all channels completely with air before removing the endoscope from the disinfectant Rinsing Identify the type of rinse water to be used 1 tap filtered sterile and how it is performed Drying same for Automated or Manually Reprocessed Scopes e Define the limits for use of high air pressure High pressure air can damage the internal channels of flexible GI scopes e Flush all channels including accessory channels with alcohol e Purge all channels with air e Remove all channel adapters e Dry the exterior of the endoscope with a soft lint free cloth e Thoroughly rinse and dry all removable parts Do not attach removable parts valves etc to the endoscope durin
84. y Medical Center 1925 Pacific Avenue Atlantic City NJ 08401 Susan Campano Deborah Heart amp Lung Hospital 200 Trenton Road Browns Mills NJ 08015 Jacqueline Donnelley Warren Hospital 185 Roseberry Street Phillipsburg NJ 08865 Diane Eby Kessler Memorial Hospital 600 South White Horse Pike Hammonton NJ 08037 Sue Ellen Erickson Perioperative Educator Newark Beth Israel Medical Center 201 Lyons Ave Newark NJ 07112 Carlene Evans Monmouth Medical Center 300 Second Avenue Long Branch NJ 07740 Mary Lesica Central Services Supervisor Chilton Memorial Hospital 97 West Parkway Pompton Plains NJ 07444 Terri Matthews RN CNOR Director of PT Care CSP Community Medical Center 99 Route 37 West Toms River NJ 08755 Patricia Musialowski Director of Sterile Processing Somerset Medical Center 110 Rehill Avenue Somerville NJ 08876 Elizabeth Myers Chilton Memorial Hospital 97 West Parkway Pompton Plains NJ 07444 Sue Nitshe President Mid Atlantic Central Service Assn 77 Hackett Road Woostown NJ 08098 Barbara Olive RN SPD Department Atlantic City Medical Center Mainland Division Jimmie Leeds Road Pomona NJ 08240 Glenda Santiago Warren Hospital 185 Roseberry Street Phillipsburg NJ 08865 INTRODUCTION Quality assurance systems have been applied to many services within health care facilities often leading to great confusion and misunderstanding The intent of this document is t

ISO Training Program (CBSPD)

Contents

Download Pdf Manuals

Related Search

Related Contents