Client Service Manual - Pathology Laboratory
Contents
1. SC DM E P S sere Ares poem CENTERS FOR MEDICARU amp MEDICAID SERVICES CLINICAL LABORATORY IMPROVEMENT AMENDMENTS CERTIFICATE OF ACCREDITATION f LABURALURY AMT ANT ADDILESS CUA LO NUMBER PATHOLOGY LABORATORY PC ES 2620 IORIZON DR Se SUITE 100 LIFEC HIV DATE 3 GRANO RAPIDS MI 49536 1227 09 28 2015 J LABORATORY TMRFCTOR EXPIRATION DATIL P TIMOTHY J PELKLY 02 27 2015 e yi 24 of s Buble Tel Servico Ac 42 VAC 2630 as endet bre thr t Fico at eke ld na shen Le can Quid ter appre Imatie wd may aoepi lumen specimens ree rkr purpar uf e a g Leboer tory examin separas LL aii dell beali undil the aspiraci n alate alv lut s subjece tm remeatian sar il Far yinlsaii n af the Ac or die cogio piegmulizited iis inde fr PEAR gu I AU Buh Dlectot B Diylslea of Laboracosy Servii es Xm vep end Cealdention Gree Center for Medlcold and Srale Qpyrat i Manlcadaa ac other sin ice ANA Se ACA RNA mant E e UE UA EA Corsi Oz07 a ent donde ui M EE Tipon currently huf a Ccrtili ac ef Conipliance pr Certificate ol Acer etica belor iz a Hat of the Tlivensery speelalrics snbspocialtics you ite cett fled ia perf ma and their efleccive dete LAB CERTIFICATION 20ODER ERPECTI VE DALE LAL CERTIFICATION GALE EEEISZUVT ATT BALA OLOGY i130 OR222002 YOL COS 1120 2AKASITOLOGY 1132. Client Manual INSURANCE PARTICIPATION LIST 81 73 EMAU RORA DIAGNOSTICS Pathology Laboratory Laboratory AARP Beech Street US Health amp Life card copy front amp back Blue Preferred Chandler Group AETNA US Healthcare Blue Choice Blue Preferred Plus ChoiceCare Network ASR Physician s Care Blue Cross Blue Shield all but BCN primary Champus CIGNA Cofinity Community Blue DirectCare America Ethix Great Lakes Federal Mogul First Health Great West HAP Healthscope card copy front amp back Health Plus Humana IBA Integrated Health Plan IHP McLaren Health Plan all but Medicaid or healthcare employee plan Mail Handlers Medicaid Medicare MESSA all but CareSource Midwest For Paps patient must sign ABN Health Plan McLaren Medicaid MultiPlan OneHealth PHCS PHP PPOM Cofinity Preferred Choices all but healthcare employee plan card copy front amp back Primary Health Services Principal Priority Health Promerica all but healthcare employee plan RealHealth Multiplan SmartHealth Plans HPO Network TRICARE Cash Paying Patients discount that you have applied United Healthcare UMR United Medical Resource We understand that your practice may offer patient discounts on a case by case basis We can match your patient bill discounts up to 50 of our standard fee To comply with Anti kickback Regulations your requ
3. 095 IIIIIIIIIIII com 005 IIIIIIIIIIII RA 2620 Horten Drive somm 90955 IIIIIIIIIIII Attach fhe patenti OOND demographic and inauranos Inormstion 005 IIIIIIIIIIII L hos Sis Prog b Ft 7 Bias Pro Oniy L Sic Corea Oriy 7 Cota Manja 119002099 Pupo i1 Olla O U O O O 0 QD O O Q cO O0 O 0 O DO O SAFETY DATA SHEET HOLOGIC 4 Product and company identification Product name ThinPrep CytoLyt Solution Product code Address 4 Fisher Crescent Mount Wellington Auckland New Zealand Telephone number 04 9 377 3338 Emergency Telephone 3E Hotline 64 800 451719 Number E mail sds hologic com Manufacturer Hologic Inc Address 250 Campus Drive Supplier Pharmaco NZ Ltd Marlborough Massachusetts 01752 USA Telephone number 1 800 442 9892 Emergency Telephone 3E Hotline 1 866 519 4752 Number Access code E mail sds hologic com Recommended use and Limitations on use Recommended use A methanol based buffered preservative solution used to support cells during transport and slide preparation SDS number RD 01529 Rev 001 2 Hazards identification GHS classification Physical hazards Flammable liquids Category 3 Health hazards Acute toxicity oral Category 3 Acute toxicity dermal Category 3 Acute toxicity inhalation Category 3 Specific target organ toxicity single Category 1 exposure Environmental hazards Not class ed Hazards not stated here are Not classified Not applicable or C
4. Tissue strips ink the border nearest the cervical os and document it on the requisition Place in a labeled lavender cassette into a 40 ml formalin jar Large specimen ie appendix breast reduction colon amputation mastectomy placenta uterus Place specimen in the smallest container 1 qt 2 qt 1 gal that allows full immersion Carefully add bulk formalin completely immersing the specimen 4 Package for transport e Log the case on the Specimen Manifest e Tighten the lid and then seal the jar s in a bio transport bag Keep large containers upright Fold the requisition form and place in the outer sleeve of the bio transport bag name visible Stable at room temperature Lockbox specimens Place an activated hand warmer in the lockbox at lt 15 F See Lockbox Instructions Limitations Formalin fixation precludes chromosome studies flow cytometry and frozen section See Biopsy Fresh Tissue Supplies Formalin pre fill jar 40ml 60ml cassette large container 1qt 2 at 1 gal bulk formalin ink requisition form bio transport bag Formalin Caution Eye splash rinse for 15 minutes then seek immediate medical attention Ingestion Poison do not induce vomiting seek immediate medical attention Carcinogen avoid prolonged contact and inhalation See Formalin MSDS Guideline Links ASCCP Guidelines for Women s Health collections Turn around time 93 at 24 hours ancillary stains may add 24 hours Collection Man
5. BD Male Urethra Collection Kit Alternate collections BD Collection Kit for Endocervical Specimens or BD Male Urethra Specimen Collection Kit or BD Urine Preservative Transport UPT Caution PreservCyt Eye splash rinse for 15 minutes then seek immediate medical attention Poison ingestion of as little as 4 oz can cause blindness do not induce vomiting drink 2 glasses of water and seek immediate medical attention See PreservCyt MSDS Standing Orders You will be prompted to renew your standing order annually You may change a standing order at any time You may override a Standing Order on any given test by changing the requisition order Guideline CDC recommends annual chlamydia screening for all sexually active females 25 and under and for women older than 25 with risk factors such as a new Sex partner or multiple partners Turn around time 93 at 24 hours Collection Manual HERPES SIMPLEX I amp II Em AURORA Pathology Laboratory Laboratory 1 Complete a requisition form incomplete data may cause delay or rejection e Clinician name practice location e Patient name address phone date of birth MRN or Visit Number e Date of service time of collection e History signs and symptoms e Include a billing face sheet and or copy of the insurance card 2 Label the vial 2 ID s on each vial Include two patient identifiers Patient Name ie bar code MRN Visit Date of Birth e Label the vial as HSV or Lesion
6. 3 Collection utilizing the BD Collection Kit for Endocervical Specimens pink handle e Discard the white swab immediately e Sample the visible ano genital lesion with the pink handled swab e Insert the swab into the collection vial e Break of the swab handle by bending the pink handle until it snaps Seal the vial with only the pink swab inside 4 Package for transport Log the case on the Specimen Manifest e Tighten the lid and then seal the vial in a bio transport bag Keep large containers upright Fold the requisition form and place in the outer sleeve of the bio transport bag name visible Stable at room temperature for 14 days Method BD Viper HSV sensitivity 96 7 specificity 95 1 HSV II sensitivity 98 4 specificity 80 6 Supplies BD Collection Kit for Endocervical Specimens pink handle requisition form bio transport bag Guideline Sample visible ano genital lesions Turn around time run once per week Collection Manual ORAL OR CUTANEOUS HERPES simPLEx 18 11 MWAURORA Pathology Laboratory Laboratory 1 Complete a requisition form incomplete data may cause delay or rejection e Clinician name practice location e Patient name address phone date of birth MRN or Visit Number e Date of service time of collection e History signs and symptoms e Include a billing face sheet and or copy of the insurance card Indicate site oral skin and anogenital 2 Label the vial 2 ID s on each vial I
7. 5 days run weekly HPV expanded genotype specifies 16 18 31 35 39 45 51 52 56 58 59 66 68 Sensitivity Specificity methodology TAT lt 5 days run weekly Standing Orders You will be prompted to renew your standing order annually You may change a standing order at any time You may override a Standing Order on any given test by changing the requisition order Supplies PreservCyt Solution Cytobrush Spatula requisition form bio transport bag Viability 6 weeks without refrigeration tests may be ordered up to 6 weeks after collection PreservCyt Caution Eye splash rinse for 15 minutes then seek immediate medical attention Poison ingestion of as little as 4 oz can cause blindness do not induce vomiting drink 2 glasses of water and seek immediate medical attention See PreservCyt MSDS Guideline Links ASCCP Guidelines for Women s Health collections Collection Manual CHLAMYDIA 8 GONORRHEA EM AURORA Pathology Laboratory Laboratory 1 Complete a requisition form incomplete data may cause delay or rejection Clinician name practice location Patient name address phone date of birth MRN or Visit Number Date of service time of collection History signs and symptoms Include a billing face sheet and or copy of the insurance card 2 Label the vial 2 ID s on each vial Include two patient identifiers Patient Name ie bar code MRN Visit Date of Birth 3 Collection Collect a
8. exfoliated cells will be diminished or obscured by personal lubricants or spermicides In addition the patient should avoid scheduling her appointment during heavy menstrual bleeding If you would like Hologic patient education materials for your office please visit www hologiccustomersolutions com 1 Lukewarm Water For a patient without physical or physiologic reasons for needing lubricant lukewarm water may be used to warm and lubricate the speculum This protocol has the least risk to the quality of the Pap sample collected Professional organizations including ACOG and CLSI recognize that excessive use of lubricant may contaminate or obscure the Pap sample 2 Lubricant Gels If lubricant must be used due to patient discomfort or other circumstances lubricant should be used sparingly and applied only to the exterior sides of the speculum blades avoiding contact with the tip of the speculum 4 see pictures below When a lubricant is used sparingly and appropriately it poses little risk to the quality of the Pap sample However when a lubricant is used in excess it can adversely affect the Pap sample Hologic evaluated a variety of popular lubricants and found those containing carbomer or carbopol polymers thickening agents interfere with the ThinPrep Pap test when found in the sample vial Hologic recognizes the varying availability of different types of lubricants and recommends that if used any lubricant should be applied spari
9. 4 times Immediately rinse the broom in the vial rotating 10 times while pressing against the vial wall e Swish the broom vigorously to further release sample Discard the broom 8 A vaginal sample is not routinely collected e Collect a vaginal sample using a plastic spatula for Hysterectomy patients sample the lateral vaginal wall a Visualized vaginal lesions scrape the lesion and follow with a biopsy Suspected endometrial carcinoma sample the vaginal pool Immediately swish the spatula 10 times in the vial to release the sample Discard the spatula 9 Package for transport e Log the case on the Specimen Manifest e Tighten the vial lid and then seal the vial in a bio transport bag Fold the requisition form and place in the outer sleeve of the bio transport bag name visible e Stable at room temperature Limitations The Pap Test is a screening test with irreducible false negative and false positive rates Correlate with clinical findings Management guidelines are recommendations and not a substitute for clinical judgment High yield collection is imperative Lubricant can interfere with processing Supplies PreservCyt Solution Cytobrush Spatula requisition form bio transport bag PreservCyt Caution Eye splash rinse for 15 minutes then seek immediate medical attention Poison ingestion of as little as 4 oz can cause blindness do not induce vomiting drink 2 glasses of water and seek immediate medical attention
10. ECCO device into formalin in a secure manner 5 Package for transport Log the case on the Specimen Manifest e Tighten the lid and then seal the jar s in a bio transport bag Keep large containers upright Fold the requisition form and place in the outer sleeve of the bio transport bag name visible Stable at room temperature Lockbox specimens Place an activated hand warmer in the lockbox at lt 15 F See Lockbox Instructions Limitations Formalin fixation precludes chromosome studies flow cytometry and frozen section See Biopsy Fresh Tissue Supplies Formalin pre fill jar 40ml 60ml cassette large container 1qt 2 at 1 gal bulk formalin ink requisition form bio transport bag Formalin Caution Eye splash rinse for 15 minutes then seek immediate medical attention Ingestion Poison do not induce vomiting seek immediate medical attention Carcinogen avoid prolonged contact and inhalation See Formalin MSDS Guideline Links ASCCP Guidelines for Women s Health collections Turn around time 93 at 24 hours ancillary stains may add 24 hours Collection Manual SOFTBIOPSY GYNECOLOGICAL BIOPSY DEVICE F Y AURORA Pathology Laboratory 1 Complete a requisition form incomplete data may cause delay or rejection e Clinician name practice location Patient name address phone date of birth MRN or Visit Number Date of service time of collection Tissue site position and laterality Label multi part
11. cause reproductive and fetel effects Target Organs Lunos respiralory system eyes skin Vie P hare CAEN AHAN TO Cien Man Servicys 620M Page 1 7 BD Material Safety Data Sheet acc to ISO DIS 11014 Date Prepared 03 01 2011 Reviewed On 02 11 2011 1 Identification of the substance mixture and of the company undertaking Catalog Number 446255 Details of the supplier of the safety data sheet BD Diagnostic Systems 7 Loveton Circle Sparks MD 21152 Telephone 410 771 0100 or 800 638 8663 ion Department Technical Service telephone number In case af a chemical emergency spill fire exposure or accident contact BD Diagnostic Systems 410 771 0100 or 800 638 8663 or ChemTrec at 800 424 9300 2 CompositionAnformation on ingredients Chemical characterization Mixture Dangerous pea E 67483 500 3 Hazards identification Classification of the substance or mixture Classification according to Directive 67 5448 EEC or Directive 199945 EC E Toxic Toxic by inhalation in contact with skin and jf swallowed freely penetrates the skin and may carry dissolved chemicals into the Classification system and expanded upon Labelling according guidelines The product has been classified and marked in accordance with regulations on hazardous materials Code letter and hazard designation of product T Toxic F Highly flammable methanol dimethyl sulfoxide
12. in the outer sleeve of the bio transport bag name visible Stable at room temperature Method Autogenomics Spot On sensitivity 97 1 specificity 84 2 Supplies PreservCyt Solution Cytobrush Spatula requisition form bio transport bag Caution PreservCyt Eye splash rinse for 15 minutes then seek immediate medical attention Poison ingestion of as little as 4 oz can cause blindness do not induce vomiting drink 2 glasses of water and seek immediate medical attention See PreservCyt MSDS Guideline Symptomatic patient or REFLEX if vaginitis screen BD Affirm is Positive for Candida or REFLEX if Pap indicates Candida sp Turn around time 4 days from order or after Reflexed test is complete Collection Manual UROGEN PANEL Ureaplasma and Mycoplasma EM AURORA U urealyticum M genitalium M hominis Pathology Laboratory 1 Complete a requisition form incomplete data may cause delay or rejection e Clinician name practice location Patient name address phone date of birth MRN or Visit Number Date of service time of collection History signs and symptoms Include a billing face sheet and or copy of the insurance card 2 Label the vial 2 ID s on each vial Include two patient identifiers Patient Name ie bar code MRN Visit Date of Birth 3 Collection e Collect a ThinPrep cervical endocervical sample See Collection Manual PAP TEST 4 Package for transport Log the case on the Speci
13. specimens A B C etc with corresponding descriptions History signs and symptoms Additional tests ie special stains immunohistochemistry Include a billing face sheet and or copy of the insurance card 2 Label each biopsy jar 2 ID s and a specimen site on each jar Include two patient identifiers Patient Name ie bar code MRN Visit Date of Birth e Include the specimen collection site labeled A B C etc corresponding to the requisition Apply the label to the jar 3 Obtain an adequate tissue sample For the best yield and placement dry the lesion area with a cotton applicator or gauze prior to obtaining biopsy Gently press the round tip on to the center of the lesion or cervical quadrant involved Use pressure similar to tooth brushing A one or two handed technique may be utilized Once the fabric pad is pressed firmly against the cervix target area rotate the device 360 clockwise for three to five rotations Alternatively 6 10 half 180 rotations like key turning in each direction may be used Remove and inspect the Kylon fabric pad The Kylon fabric device head will be filled with tissue and mucous 4 Transfer sample to biopsy jar Snap the tip of the SoftBiopsy device and place the tip into formalin in a secure manner e Discard the acrylic handle 5 Package for transport e Log the case on the Specimen Manifest e Tighten the lid and then seal the jar s in a bio transport bag K
14. vacuum for very bloody lesions to avoid diluting the sample with copious amounts of blood More vacuum or a larger gauge needle for fatty or fibrous lesions Move the needle within the mass in a back and forth cutting motion Keep the needle tip within the mass e Change the angle of the needle to aspirate different areas of the mass Release the vacuum Withdraw the needle at a 90 angle 5 Prepare one fixed slide and one air dried slide per pass Prepare 2 slides per pass by labeling one slide AD air dried and one slide FX fixed Carefully remove the needle from the syringe apply vacuum to the syringe and reattach the needle Angle the needle bevel flat against the FX slide and expel the entire needle contents Invert the AD slide over the FX slide allow the sample to spread and gently pull the slides apart top to bottom Immediately immerse the FX slide in the lavender top alcohol slide vial Allow the AD slide to air dry fanning the slide to hasten drying will enhance the smear e Rinse the needle contents into the saline vial Open the saline vial and draw saline up through the needle into the syringe hub Express the rinse back into the saline vial Collect the needle rinses from all passes into the one saline vial For multiple passes repeat step 5 using a new needle and syringe for each pass 6 Package for transport Log the case on the Specimen Manifest e Tighten the lid s and then seal the
15. vial on hand if the Vagiriti Screen tom 80 Affem indicates that test is negative for al Candida Gar nereila aed Trichomonas Collection Manual COMPLETING THE REQUISITION EM AURORA Pathology Laboratory Laboratory DHHS and other requirements for test requisitions The Department of Health and Human Services Federal Register Vol 55 No 50 has mandated standards regarding receipt of patient information to ensure patient safety Note that on each test container DHHS has specified TWO test IDs first last name ie MRN date of birth requisition bar code number SSN last 4 digits Additionally we require complete insurance and patient information to properly bill for our services Each test submitted must include the following e Clinician name practice location e Patient name address phone e Patient gender e Patient date of birth or age e Patient MRN or Visit Number when for locations with an emr e Date of service Relevant clinical history signs and symptoms Requests for special stains immunohistochemistry etc List of submitted specimens and the intent of the review Include a billing face sheet or copy of the insurance card s To ensure that all necessary information is being provided to the laboratory we have designed a Laboratory Requisition Form prompting capture of the necessary information Our Requisition Forms are bar coded with corresponding bar coded labels to satisfy one of the two test
16. vial s in a bio transport bag Close the AD slides in the blue slide mailers and seal in the bio transport bag Place the requisition form and FNA Cytology Worksheet in the outer sleeve of the bio transport bag Stable at room temperature Collection Manual URINE CYTOLOGY Em AURORA Pathology Laboratory Laboratory 1 Complete a requisition form incomplete data may cause delay or rejection e Clinician name practice location Patient name address phone date of birth MRN or Visit Number Method of specimen collection for example voided urine catheter or wash renal barbotage Relevant history i e hematuria fever history of UTI history of bladder cancer history of renal disease CT scan findings and suspected diagnosis e Related treatments including chemotherapy radiation and surgery Include a billing face sheet and or copy of the insurance card 2 Label the CytoL yt jar 2 ID s and a specimen site on each jar Include two patient identifiers Patient Name ie bar code MRN Visit Date of Birth Include the specimen collection site labeled A B C etc corresponding to the requisition Apply the label to the jar 3 Collect 20ml to 80ml of voided urine Donot collect the first urine of the day The second urine is preferred e Provide the patient a moist towelette with instructions to wipe the area around the urethral opening e Instruct the patient to collect a mid stream specimen directly into t
17. 0 WRGLOGY 140 D12201 Li CP ATsIOLCGCY 612 2020366 CYYCLOGY 313 tii AG FOI MORE INFORMATEON ATOWL CLEA VISO LTR WERSIT AT WWO CMS EUIS CON AGELA OR CONTACT VOU LOCAL STATE AGENCY PLEASE SEE F1 RI VT RST TON YOUR SPACE AGEISCY S ADIDRIAS AND PHONE NUMPER PTEASE CON YAGI YOUR SIATE ACENCY COM ANY CHANG TOYOTA COMMENT CEKTIPICATE Sigo ui peg UEDUD Y 2 Dope JUPE Wonguperow AXOIEXOqt I Wo mowes wey Dec gt CN P N Z Grp 2 2 GOT LSE saw 22 SIUSTUAIMbOT COMO JIE JET sasumsse PUE GOmmo JO dhysastiee 2012931p ur STOUT ev CALMS A JEOTIRUIOMLE 100 20p uoneaupzuaav WOHDIp2402D ulit OF PIOZ OY 4oquiaoacg o1 4OLI 41320 PINOYS uorsadsuisy UDA OL Y uoiyrpagoay AIO OAOGLT SISIDO OYIO 4 uD2142t4F fO 9823100 241 Aq panpoaaop Agasay Si PUD uomojrmpa422r 40f SPAPPUDIS 2jgo2iddb jp POLL SOY Te008c K TE TOQUE VT 5 W8b 6STI GT OV Http LE 2i0qumpy dy I CH Soja f Aysouny unonpin spidny pubs 4409n40qv T ojota MOJAG pain 440ID40q0 241 104 satio SIST OJOLIE d UBILIDUNY JO 3330 3Y I Sigo ui peg UEDUD Y 2 Dope JUPE Wonguperow AXOIEXOqt I Wo mowes wey Dec gt CN P N Z Grp 2 2 GOT LSE saw 22 SIUSTUAIMbOT COMO JIE JET sasumsse PUE GOmmo JO dhysastiee 2012931p ur STOUT ev CALMS A JEOTIRUIOMLE 100 20p uoneaupzuaav WOHDIp2402D ulit OF PIOZ OY 4oquiaoacg o1 4OLI 41320 PINOYS uorsadsuisy UDA OL Y uoiyrpagoay AIO OAOGLT SISIDO OYIO 4 uD2142t4F fO 9823100 241 Aq panpoaaop Aga
18. 2302 2 4 23022866 23032058 23032050 23032067 230 32055 23035155 2303 7238 23037239 23038528 23045111 23045112 23745684 73245685 23253998 23266200 23305510 23314028 23324079 23314033 22314034 23314035 23314026 23314037 23314935 23214039 23314040 23316154 23216155 23316156 23126796 23126797 23427198 243 68A 245 685 253 998 286 201 305 510 214 25 314 02 314 028 314 074 314 030 314 033 314 0134 314 035 314 038 116 152 316 155 356 156 316154 316155 316156 426 796 426 797 427 094 57211 57011 16 57011 GA 570114 59001 20 Synonyms None Company Identlficatlon Fisher Sclentifle 1 Reagent Lane Felr Lawn NJ 07410 For information call 201 796 2100 Emergency Number 201 796 7100 For CHEMTREC assistance call 500 424 9300 For International CHEMTREC assistance call 703 527 2087 Section 2 Composition Information on Ingredients r enam Eee s NC eras 200 001 8 200 659 6 Hu Eun anapa e Clbasic rasphaze renozasic Section 3 Hazards Identification EMERGENCY OVERVIEW Appearance colerless liqui Flash Point gt 20 deg F Warning Hannfu if in aleG Harmful if absorbec through the skin Contalns formaldehyde which can cause cancer May cause severe skin Hritatlon May cause adergic resplratory and skin reaclion May cause respiratory tract irzirat on Way cause eye irritation and transient injury May carse lung damage May cause pulmonary ecema May
19. 82 3 specificity 98 4 Gardnerella sensitivity 95 2 specificity 100 Trichomonas sensitivity 92 8 specificity 99 9 Supplies BD Affirm VPIII Ambient Temperature Transport System requisition form bio transport bag Guideline Links ASCCP Guidelines for Women s Health collections Transport Media Caution Poison avoid ingestion inhalation and skin contact Flammable See BD Affirm Transport System MSDS Turn around time 93 at 24 hours Collection Manual BACTERIAL VAGINOSIS PANEL Em AURORA B fragilis G vaginalis M mulieris M curtisii A vaginae P bivia Pathology Laboratory 1 Complete a requisition form incomplete data may cause delay or rejection e Clinician name practice location Patient name address phone date of birth MRN or Visit Number Date of service time of collection History signs and symptoms Include a billing face sheet and or copy of the insurance card 2 Label the vial 2 ID s on each vial Include two patient identifiers Patient Name ie bar code MRN Visit Date of Birth 3 Collection e Collect a ThinPrep cervical endocervical sample See Collection Manual PAP TEST 4 Package for transport Log the case on the Specimen Manifest e Tighten the lid and then seal the jar s in a bio transport bag Fold the requisition form and place in the outer sleeve of the bio transport bag name visible e Stable at room temperature Method Autogenomics Spot
20. Client Services Manual TABLE OF CONTENTS AURORA Pathology Laboratory GENERAL INFORMATION Contact Information amp Hours of Operation Billing Policies Insurance Participation list COLLECTION MANUAL Biopsy in Formalin Biopsy Fresh Tissue Bone Marrow Aspiration and Biopsy Fine Needle Aspiration and FNA Worksheet Urine Cytology Pap Test Human Papilloma Virus HPV HR HPV 16 18 HPV expanded genotyping Chlamydia amp Gonorrhea CT NG Herpes Simplex II HSV 1 amp II Oral or Cutaneous Herpes Simplex Virus amp Il HSV 1 amp II Vaginitis Screen BD Affirm Candida Gardnerella Trichomonas Bacterial Vaginosis Panel B fragilis G vaginalis M mulieris M curtisii A vaginae P bivia Candida Panel C albicans parapsilosis tropicalis glabrata krusei Urogen Panel Ureaplasma urealyticum Mobiluncus genitalium Mobiluncus hominis Cystic Fibrosis Consultations REFERENCE MATERIALS Completing the Requisition Form Pap Test Results Explained The 2001 Bethesda System Appropriate Use of Lubricant for Pap Collection Hologic LINK to ASCCP Consensus Guidelines at www asccp org Consensus2012 FORMS AND DOCUMENTS Supply Order Form General Requisition Form Surgical Requisition Form Advanced Beneficiary Notice Medicare MSDS CytoLyt MSDS Formalin MSDS BD Affirm Ambient Transport System CLIA License CAP License Collection Manual AURORA CONTACT INFORMATION MAURORA Patholog
21. IDs required by the DHHS An example Requistion Form follows Please note that lack of all the data items will result in delay of testing Pap Test Results Explained The 2001 Bethesda System What is the 2001 Bethesda System Prior to 1988 there were several reporting formats in use for cervical cytology Pap tests A 1988 meeting in Bethesda Maryland brought together representatives from over three dozen national and international health agencies including the American Cancer Society American College of Obstetricians and Gynecologists American Society of Clinical Pathologists American Society for Colposcopy and Cervical Pathology and the American Society of Cytopathology The result was the standardization of cervical cytology reporting known as Bethesda 88 The Bethesda Workshops reconvened in 1991 and again in 2001 The 2001 workshop was a yearlong iterative review resulting in the current system of reporting The 2001 Bethesda System reflects important advances in biological understanding of cervical neoplasia and cervical screening technologies The 2001 Bethesda System Nomenclature GENERAL CATEGORY amp DESCRIPTIVE DIAGNOSIS NEGATIVE for Intraepithelial Lesion or Malignancy EPITHELIAL CELL ABNORMALITY SQUAMOUS e ASC US atypical squamous cells uncertain significance ASC H atypical squamous cells exclude a high grade lesion LSIL low grade squamous intraepithelial lesion encompasses HPV CIN1 and VAIN1 HS
22. IL high grade squamous intraepithelial lesion encompasses CIN2 CIN3 CIS and VAIN 2 3 e SQUAMOUS CELL CARCINOMA EPITHELIAL CELL ABNORMALITY GLANDULAR e ATYPICAL GLANDULAR CELLS will specify endocervical endometrial or NOS A comment may be included to indicate a high degree of suspicion if applicable ADENCARCINOMA IN SITU ENDOCERVICAL consistent with e ADENOCARCINOMA will specify endocervical endometrial or other MALIGNANT CELLS PRESENT for undifferentiated or non epithelial lesions a description will be provided DESCRIPTIVE FINDINGS e Endometrial cells present Benign appearing endometrial cells in a woman gt or 40 years of age No evidence of squamous intraepithelial lesion Comment Endometrial cells after age 40 particularly out of phase or after menopause may be associated with benign endometrium hormonal alterations and less commonly endometrial uterine abnormalities Clinical correlation is recommended OTHER FINDINGS ORGANISMS Fungal organisms morphologically consistent with Candida spp Trichomonas vaginalis Bacteria morphologically consistent with Actinomyces spp e Shift in flora suggestive of bacterial vaginosis Cellular changes consistent with Herpes simplex virus OTHER NON NEOPLASTIC FINDINGS Acute inflammatory response Reactive epithelial changes consistent with repair and or benign epithelial reaction Reactive cellular changes consistent with radiation e
23. On sensitivity 100 specificity 82 4 Supplies PreservCyt Solution Cytobrush Spatula requisition form bio transport bag Caution PreservCyt Eye splash rinse for 15 minutes then seek immediate medical attention Poison ingestion of as little as 4 oz can cause blindness do not induce vomiting drink 2 glasses of water and seek immediate medical attention See PreservCyt MSDS Guideline Symptomatic patients or REFLEX if vaginitis screen BD Affirm is Negative or REFLEX if Pap indicates a shift in vaginal flora Turn around time 4 days from order or after Reflexed test is complete Collection Manual CANDIDA PANEL Em AURORA Candida albicans parapsilosis tropicalis glabrata and krusei Pathology Laboratory 1 Complete a requisition form incomplete data may cause delay or rejection e Clinician name practice location e Patient name address phone date of birth MRN or Visit Number Date of service time of collection History signs and symptoms Include a billing face sheet and or copy of the insurance card 2 Label the vial 2 ID s on each vial Include two patient identifiers Patient Name ie bar code MRN Visit Date of Birth 3 Collection e Collect a ThinPrep cervical endocervical sample See Collection Manual PAP TEST 4 Package for transport e Log the case on the Specimen Manifest e Tighten the lid and then seal the jar s in a bio transport bag Fold the requisition form and place
24. See PreservCyt MSDS Guideline Links ASCCP Guidelines for Women s Health collections Collection Manual HPV DNA Human Papilloma Virus EMAURORA Pathology Laboratory Laboratory 1 Complete a requisition form incomplete data may cause delay or rejection e Clinician name practice location e Patient name address phone date of birth MRN or Visit Number Date of service time of collection History signs and symptoms Include a billing face sheet and or copy of the insurance card 2 Label a ThinPrep vial 2 ID s on each vial Include two patient identifiers Patient Name ie bar code MRN Visit Date of Birth 3 Collect a ThinPrep cervical endocervical sample See Collection Manual PAP TEST 4 Ordering HPV HR high risk probe options Ona current order check HPV high risk probe and check any result Ona current order REFLEX check HPV high risk probe and check the applicable Pap diagnoses Standing Order REFLEX is available 5 Ordering HPV 16 18 genotype reflex if HPV HR is Positive On a current order check HPV16 18 and check the Pap diagnoses to REFLEX Standing Order REFLEX is available 6 Ordering HPV expanded genotype reflex if HPV HR is Positive Ona current order check HPV expanded genotype and check the Pap diagnoses to REFLEX 7 Package for transport Log the case on the Specimen Manifest e Tighten the lid and then seal the vial in a bio transport bag Fold th
25. TION FNA EMAURORA Pathology Laboratory 1 Complete a requisition form incomplete data may cause delay or rejection e Clinician name practice location Patient name address phone date of birth MRN or Visit Number Date of service Include a billing face sheet and or copy of the insurance card Provide site and clinical history on requisition or FNA Cytology Worksheet included with FNA kit Organ site laterality or other position Lesion features i e hard soft size duration painful attached growth a History including prior diagnosis clinical diagnosis symptoms treatment 2 Label each biopsy jar and slide 2 ID s and a specimen site on each jar and slide e Include two patient identifiers Patient Name i e bar code MRN Visit Date of Birth Label the slides not the mailers in pencil Ink will dissolve during processing 3 Evacuate prominent cysts if present prior to aspirating the solid mass If lt 1 ml of cystic fluid prepare slides per instructions in section 5 below If gt 1 ml of cystic fluid express the evacuated cyst fluid into a labeled CytoLyt vial 4 Aspirate solid mass lesions Collect multiple passes Three passes are usually sufficient for the diagnosis of a solid lesion Use a new syringe and needle for each pass e Insert the needle into the mass at a 90 angle Apply appropriate vacuum to the syringe Moderate vacuum for non bloody lesions Minimal
26. ThinPrep cervical endocervical sample See Collection Manual PAP TEST Alternate female collection BD Collection Kit for Endocervical Specimens pink handle Sample the endocervix with the pink swab Insert the pink swab into the collection vial Break of the swab handle by bending the pink handle until it snaps Seal the vial with only the pink swab inside Male collection Use the BD Male Urethra Specimen Collection Kit blue handle Insert the swab into the urethra and turn 1 2 turn Insert the swab into the collection vial Break of the swab handle by bending the blue handle until it snaps Seal the vial with the swab inside Urine collection for female and male Use the BD Urine Preservative Transport UPT Instruct the patient to collect 20ml to 60ml voided urine into a sterile urine cup Pipette 2ml 3ml urine into the UPT to the range of the Fill Window do not overfill a Securely cap the UPT tube and mix well Discard the pipette 4 Package for transport Log the case on the Specimen Manifest Tighten the lid and then seal the container in a bio transport bag Fold the requisition form and place in the outer sleeve of the bio transport bag name visible Stable at room temperature for 30 days Method BD Viper CT Qx and GC Qx CT sensitivity 94 1 specificity 99 8 NG sensitivity 95 3 specificity 99 9 Supplies PreservCyt Solution Cytobrush Spatula requisition form bio transport bag Male
27. e requisition form and place in the outer sleeve of the bio transport bag name visible Stable at room temperature HPV HR Cervista HPV HR is a screen for 16 18 31 35 39 45 51 52 56 58 59 66 68 Sensitivity 92 896 Run daily HPV 16 18 Cervista 16 18 is intended for use in conjunction with HPV HR TAT lt 5 days run weekly HPV expanded genotype specifies 16 18 31 35 39 45 51 52 56 58 59 66 68 Sensitivity Specificity methodology TAT lt 5 days run weekly Standing Orders You will be prompted to renew your standing order annually You may change a standing order at any time You may override a Standing Order on any given test by changing the requisition order Supplies PreservCyt Solution Cytobrush Spatula requisition form bio transport bag Viability 6 weeks without refrigeration tests may be ordered up to 6 weeks after collection PreservCyt Caution Eye splash rinse for 15 minutes then seek immediate medical attention Poison ingestion of as little as 4 oz can cause blindness do not induce vomiting drink 2 glasses of water and seek immediate medical attention See PreservCyt MSDS Guideline Links ASCCP Guidelines for Women s Health collections Collection Manual HPV DNA Human Papilloma Virus EMAURORA Pathology Laboratory Laboratory 1 Complete a requisition form incomplete data may cause delay or rejection e Clinician name practice location e Patient name address pho
28. eep large containers upright Fold the requisition form and place in the outer sleeve of the bio transport bag name visible e Refrigeration is required until transported Limitations Specimens submitted fresh no formalin Pre schedule transport to coincide with surgery Refrigerate until transported Supplies Sterile urine container requisition form bio transport bag Caution Fresh tissue should be handled observing Universal Precautions Turn around time Chromosome study preliminary report 48 hours Flow cytometry 72 hours Frozen section provisional diagnosis STAT Collection Manual BONE MARROW ASPIRATION amp BIOPSY EM AURORA Pathology Laboratory Laboratory 1 Complete a requisition form incomplete data may cause delay or rejection e Clinician name practice location e Patient name address phone date of birth MRN or Visit Number Date of service time of collection Tissue site position and laterality Label multi part specimens A B C etc with corresponding descriptions History signs symptoms and specify known cell type ie B cell small cleaved cell e Attach most recent CBC and differential reports Include a billing face sheet and or copy of the insurance card 2 Label each biopsy jar 2 ID s and a specimen site on each jar Include two patient identifiers Patient Name ie bar code MRN Visit Date of Birth e Include the specimen collection site labeled A B C etc corresponding to the re
29. eep large containers upright Fold the requisition form and place in the outer sleeve of the bio transport bag name visible e Stable at room temperature Lockbox specimens Place an activated hand warmer in the lockbox at lt 15 F See Lockbox Instructions Limitations Formalin fixation precludes chromosome studies flow cytometry and frozen section See Biopsy Fresh Tissue Supplies Formalin pre fill jar 40ml 60ml cassette large container 1qt 2 at 1 gal bulk formalin ink requisition form bio transport bag Formalin Caution Eye splash rinse for 15 minutes then seek immediate medical attention Ingestion Poison do not induce vomiting seek immediate medical attention Carcinogen avoid prolonged contact and inhalation See Formalin MSDS Guideline Links ASCCP Guidelines for Women s Health collections Turn around time 93 at 24 hours ancillary stains may add 24 hours Aurora D 7 All labels for collection vials MUST include at least 2 patient identifiers Patient Name and DO8 or Patient Name amp Reg Form Sticker Mark ong type of Pap test either screening or diagnostic select only one option We do have standing orders upon request We do have standing orders for pts 25 and younger upon request Voided Urine pt must not have urinated 1 hr prior 20 60 ml Fill UPT tube no more ar no less than indicated within window on the contalner 2 Or mary reflex this test f we have Thin Prep
30. est must be in writing and must specify the percentage Collection Manual BIOPSY EXCISION IN FORMALIN EM AURORA Pathology Laboratory Laboratory 1 Complete a requisition form incomplete data may cause delay or rejection e Clinician name practice location e Patient name address phone date of birth MRN or Visit Number Date of service time of collection Tissue site position and laterality Label multi part specimens A B C etc with corresponding descriptions History signs and symptoms Additional tests ie special stains immunohistochemistry Include a billing face sheet and or copy of the insurance card 2 Label each biopsy jar 2 ID s and a specimen site on each jar Include two patient identifiers Patient Name ie bar code MRN Visit Date of Birth Include the specimen collection site labeled A B C etc corresponding to the requisition Apply the label to the jar 3 Submit the specimen in formalin Small Specimen ie breast core skin cervical biopsy ECC Gl polyp prostate core Immerse each discreet specimen in a separate 40ml formalin jar Mark relevant margins with suture Indicate significance of suture on the requisition Diathermy Loop Excision Cone ink the squamo columnar junction at the 12 o clock position Do not cut the specimen open o lt 1 5cm place in a labeled white cassette into a 60 ml formalin jar o gt 1 5cm immerse directly into a 40 ml formalin jar
31. ffect SPECIMEN ADEQUACY SATISFACTORY FOR EVALUATION e The presence or lack of an endocervical component will be noted if there is a cervical sample Incomplete clinical history ie missing menstrual status birth date or specimen source Technical limitations ie partially obscuring blood or inflammation incomplete fixation UNSATISFACTORY processed amp examined but not suitable for diagnosis specify reason UNSATISFACTORY rejected amp not processed specify reason COMMENTS As applicable includes recommendations verification of reflex testing explanations or further descriptions of the findings November 1 2012 Dear Colleague On occasion Hologic personnel are asked to provide information concerning the use of lubricants when collecting a Pap sample using the ThinPrep Pap Test As part of Hologic s continuing education for clinicians and laboratorians this bulletin addresses the proper preparation of the cervix for an adequate Pap sample collection pertaining to the ThinPrep Pap Test and the use of lubricants on the speculum Steps taken by the dinician from patient education to improved sampling technique may ensure that the sample collected maximizes the potential of the Pap test Patient Education Women should be counseled to refrain from intercourse douching using tampons or using intravaginal medication for at least 48 hours before the examination to decrease the possibility that the number of
32. he pre filled CytoL yt jar 4 Package for transport Log the case on the Specimen Manifest Tighten the lid and then seal the jar in a bio transport bag Fold the requisition form and place in the outer sleeve of the bio transport bag name visible Stable at room temperature Limitations Microbiology or culture amp sensitivity are separate collections and must not be submitted in CytoLyt Refer to your clinical laboratory collection procedures Supplies CytoLyt pre filled jar requisition form bio transport bag CytoLyt Caution Eye splash rinse for 15 minutes then seek immediate medical attention Poison ingestion of as little as 4 oz can cause blindness do not induce vomiting drink 2 glasses of water and seek immediate medical attention See CytoLyt MSDS Guideline Links Turn around time 93 at 24 hours ancillary stains may add 24 hours Collection Manual PAP TEST ThinPrep EV AURORA Pathology Laboratory Laboratory 1 Instruct the patient e Avoid douching intercourse and lubricants 24 hours prior to exam e Schedule the exam for the non menstrual portion of her cycle if possible 2 Complete a requisition form incomplete data may cause delay or rejection e Clinician name practice location e Patient name address phone date of birth MRN or Visit Number Date of service e Reason for Pap specify PAP screen low risk PAP screen high risk or PAP diagnostic e History signs and symptoms ICD9 Menst
33. lassification not possible 999 Signal word Hazard statement wa RR Bquid and vapor Toxic if swallowed Toxic in contact with skin Toxic if inhaled Causes damage to organs Central nervous system liver and kidneys Precautionary statement Prevention Avoid breathing dust fume gas mist vapors spray Use only outdoors or in a well ventilated area Wash thoroughly after handling Do not eat drink or smoke when using this product Wear dothing eye protection face protection Response In case of fire IF SWALLOWED Immediately call a POISON CENTER or doctor physician Rinse mouth Wash contaminated before reuse IF INHALED Remove to fresh air and keep at rest in a position comfortable for breathing Call a POISON CENTER or doctoriphysician IF exposed Call a POISON CENTER or doctor physician Disposal Dispose of waste and residues in accordance with local authority requirements Other hazards None known ThinPrep CytoLyt Solution SDS New Zealand 910019 Version 01 Revision date Issue date 01 22 2013 1 6 Page af 8 Material Safety Data Sheet 1096 Neutral buffered formalin ACC 88082 Section 1 Chemical Product and Company Identification MSDS Name 105 Neutral buffered formalin Catalog Numbers NC9633612 NC9638613 023 798 027 274 U28 866 032 054 032 060 032 067 032 069 035 159 037 238 037 235 039 528 045 112 23 005 255 25 005 53 23 005 500 23 011 120 23 111 114 23 11 123 23011212 23023 9B
34. men Manifest e Tighten the lid and then seal the jar s in a bio transport bag Fold the requisition form and place in the outer sleeve of the bio transport bag name visible Stable at room temperature Method Autogenomics Spot On sensitivity 100 specificity 100 to reference samples Supplies PreservCyt Solution Cytobrush Spatula requisition form bio transport bag Caution PreservCyt Eye splash rinse for 15 minutes then seek immediate medical attention Poison ingestion of as little as 4 oz can cause blindness do not induce vomiting drink 2 glasses of water and seek immediate medical attention See PreservCyt MSDS Guideline Symptomatic patient Turn around time 72 hours Collection Manual CONSULTATIONS Em AURORA Pathology Laboratory Laboratory Consultation specimens may be submitted to Aurora Diagnostics Pathology Laboratory for formal pathologist review and reporting Specimens may be submitted as completed cases with prepared slides and reports or as cases requiring further testing including immunohistochemical stains Consults are accepted from attending physicians and from pathologists Consult reports are sent to the requesting physician and the original laboratory 1 Complete a requisition form incomplete data may cause delay or rejection Clinician name practice location Patient name address phone date of birth MRN or Visit Number Date of service time of collection Relevant clinical his
35. nclude two patient identifiers Patient Name i e bar code MRN Visit Date of Birth e Label the vial as HSV or Lesion 3 Collection utilizing the BD Collection Kit for Endocervical Specimens pink handle e Discard the white swab immediately e Sample the visible oral or cutaneous lesion with the pink handled swab e Insert the swab into the collection vial e Break of the swab handle by bending the pink handle until it snaps Seal the vial with only the pink swab inside 4 Package for transport Log the case on the Specimen Manifest e Tighten the lid and then seal the vial in a bio transport bag Keep large containers upright Fold the requisition form and place in the outer sleeve of the bio transport bag name visible e Stable at room temperature for 14 days Note This test is not FDA approved It has been validated at Pathology Laboratory CLIA ID 23D0380021 Method BD Viper Supplies BD Collection Kit for Endocervical Specimens pink handle requisition form bio transport bag Guideline Sample visible oral or cutaneous lesions Turn around time run once per week Collection Manual VAGINITIS SCREEN Candida Gardnerella Trichomonas EM AURORA Pathology Laboratory Laboratory 1 Complete a requisition form incomplete data may cause delay or rejection e Clinician name practice location e Patient name address phone date of birth MRN or Visit Number Date of service time of collection History sig
36. ne date of birth MRN or Visit Number Date of service time of collection History signs and symptoms Include a billing face sheet and or copy of the insurance card 2 Label a ThinPrep vial 2 ID s on each vial Include two patient identifiers Patient Name ie bar code MRN Visit Date of Birth 3 Collect a ThinPrep cervical endocervical sample See Collection Manual PAP TEST 4 Ordering HPV HR high risk probe options Ona current order check HPV high risk probe and check any result Ona current order REFLEX check HPV high risk probe and check the applicable Pap diagnoses Standing Order REFLEX is available 5 Ordering HPV 16 18 genotype reflex if HPV HR is Positive On a current order check HPV16 18 and check the Pap diagnoses to REFLEX Standing Order REFLEX is available 6 Ordering HPV expanded genotype reflex if HPV HR is Positive Ona current order check HPV expanded genotype and check the Pap diagnoses to REFLEX 7 Package for transport Log the case on the Specimen Manifest e Tighten the lid and then seal the vial in a bio transport bag Fold the requisition form and place in the outer sleeve of the bio transport bag name visible Stable at room temperature HPV HR Cervista HPV HR is a screen for 16 18 31 35 39 45 51 52 56 58 59 66 68 Sensitivity 92 896 Run daily HPV 16 18 Cervista 16 18 is intended for use in conjunction with HPV HR TAT lt
37. ngly as described below HOLOGIC EEan FMAURORA DIAGNOSTICS Pathology Laboralary LABORATORY SUPPLY ORDER FORM Please fax to 616 530 0575 Today s Date Office Practice Name Address Caty State Zip Code Contact Name Phone number ext Notes Comments Special Requests Date filled Filled by Defvered on Via route circie cholce s A B LOCAL HOLL LATE ML FEDEX UPS SALES Pathology Laboratory 2520 Horizon Drive SE Sute 100 Grand Rapids Michigan 49546 866 530 1860 www pathiab ws o D OG O G l3 O i 3 i H O O o db ooooooooo III l 516776 IIIIIIIIIII onze Wa De III l 516776 2620 Hortzon Drive SE Sutte 100 Grand MI 49546 Rapids 616 530 1860 fax 616 530 0575 tollfree 866 530 1860 1 Ra ax to Candida pand of Tita p positivo for Candida Relax to Yagrems pana of Tham p if mogative lor Garharo ka RERLEXE Pap suggests Candids spocas IIIIIIIIIII ene teehee IIIIIIIIII l z e A E er 3 18 31 37 5 99 48 51 52 Sa SE 52 55 68 Cardia Cadera Vichomor as k Lircay tin 7 eas Cabres parapstan vas gban inso A igk G ngak M m a M arisi A vagas P bira gt L Da Y Q D D 19 C D D D G amp G OG 19 O D amp jo OLG x O OQ OQ 09 Q x 013 Q 70 00 XO QC U o uu oorsie IIIIIIIIIII oom s 907615 WANN LIT i I i i gi m 4 ose LI sawm d fa Lid
38. ns and symptoms Include a billing face sheet and or copy of the insurance card 2 Label the vial 2 ID s per vial Include two patient identifiers Patient Name ie bar code MRN Visit Date of Birth Include date and time of collection on the vial time sensitive specimen 3 Collect the specimen using BD Affirm Collection Device e Break the ampule and dispense the Transport Media into the Sample Collection Tube Use the swab to obtain a sample form the posterior vaginal fornix Twist the swab against the vaginal wall 3 times Swab the lateral vaginal wall while removing the swab Immediately place the swab in the Sample Collection Tube SCT Break the swab at the pre scored mark by bending the handle until it breaks Leave the swab in the Tube and discard the handle into the bio waste Press the cap onto the Tube with the Swab inside The cap will snap when properly sealed 4 Package for transport Log the case on the Specimen Manifest e Assure the cap is firmly sealed and then seal the vial in a bio transport bag Fold the requisition form and place in the outer sleeve of the bio transport bag name visible e Stable for 3 days at room temperature Must be received by the lab within 72 hours Limitations Source is limited to vaginal samples using the only materials from the BD kit Swab must be submitted in the Tube with Transport Media Test must be received at the lab within 72 hours Candida sensitivity
39. ollection It must be signed by the patient prior to the testing then submitted to us with the specimen Commercial Insurance Billing We bill most commercial carriers directly when provided insurance card information See the Insurance Participation List Patient Payment Responsibility We bill first to the insurances provided with the test requisition We balance bill patients for cash amounts owed Please include patient address and phone number with all test requisitions j We are obligated by our contracts with third party payors to balance bill each CO PAYS patient for any co payment DEDUCTIBLES We are obligated by our contracts with third party payors to balance bill each patient for any deductible Some plans deny payment for certain tests even though the physician deemed the NON COVERED TEST test advisable We will bill the patient where their insurance excludes payment Denials are sometimes successfully argued by the patient but insurers do not hear arguments from the laboratory CASH PAY no insurance We will bill uninsured patients directly Please include all patient demographic information requested on the test requisition As a clinician you may occasionally offer a patient discounts We can match your patient bill discounts up to 50 of our standard fee To comply with Anti kickback Regulations your request must be in writing and must attest to the percentage discount that you have applied DISCOUNTS
40. opy of the insurance card 2 Label each biopsy jar 2 ID s and a specimen site on each jar Include two patient identifiers Patient Name ie bar code MRN Visit Date of Birth Include the specimen collection site labeled A B C etc corresponding to the requisition Apply the label to the jar 3 Obtain an adequate tissue sample Carefully and slowly insert the tapered device head into the endocervical canal until the Kylon fabric is not visible or as deeply as can comfortably fit While pressing the Kylon pad against the inner canal rotate the Soft ECCO device at least 3 rotations clockwise and 3 rotations counter clockwise while pressing the fabric against the endocervical canal firmly The marker notches on the shaft and near the head of the device can be used to count the number rotations DO NOT FORCE THE DEVICE INTO A STENOTIC OS OR INSERT THE DEVICE PAST THE INTERNAL ENDOCERVICAL OS The Kylon fabric device head will be abundantly covered with a blood tinged mucoid sample Inspect the fabric and if it does not appear sample is sufficient repeat the biopsy with a second device and send two samples in one vial 4 Transfer sample to biopsy jar Place your index and thumb on the handle shaft of the device with the scored mark between the fingers of the right and left hand The Soft ECCO head will separate from the handle by bending firmly Discard the acrylic handle Place the head of the Soft
41. quisition Apply the label to the jar 3 Submit the specimen as bone marrow biopsy Aspirate clot submit in a 40 ml formalin jar labeled A Aspirate clot Core biopsy submit in a 40 ml formalin jar labeled B Core biopsy Prepared slides label each slide with patient name and site and secure in a plastic slide mailer Peripheral smear unstained 1 2 slides Touch prep slide unstained 2 slides Bone marrow aspirate slides unstained 3 5 slides 4 Package for transport Log the case on the Specimen Manifest Tighten the lid and then seal the jar s in a bio transport bag Submit slides in a separate bio transport bag from the formalin containers Fold the requisition form and place in the outer sleeve of the bio transport bag name visible Stable at room temperature Lockbox specimens Place an activated hand warmer in the lockbox at lt 15 F See Lockbox Instructions Limitations Formalin fixation precludes chromosome studies flow cytometry and frozen section See Biopsy Fresh Tissue Supplies Formalin pre fill jar 40ml microscope slides slide mailers requisition form bio transport bag Formalin Caution Eye splash rinse for 15 minutes then seek immediate medical attention Ingestion Poison do not induce vomiting seek immediate medical attention Carcinogen avoid prolonged contact and inhalation See Formalin MSDS Turn around time 48 hours Collection Manual FINE NEEDLE ASPIRA
42. rual status LMP pregnant postpartum postmenopausal hysterectomy hormones e Medicare ABN submitted for all Medicare patients e Include a billing face sheet and or copy of the insurance card 3 Label the vial 2 ID s on the vial e Include two patient identifiers Patient Name i e bar code MRN Visit date of birth 4 Pre collection procedures e Lubricate the sides of the speculum with minimal lubricant avoid the speculum head or use water See reference 3 4 Appropriate Use of Lubricant for Pap Collection Hologic Nov 2012 Collect the Pap Test prior to all other gyn collections Visualize the cervix and describe visible lesions Remove excess mucous exudate and blood by gently dabbing with gauze 5 Collect a cervical sample e Rotate the spatula 360 around the ectocervix Include erosion borders Immediately swish the spatula 10 times in the vial to release the sample Discard the spatula 6 Collect an endocervical sample e Insert the cytobrush into the endocervical canal until only a few bristles remain exposed Rotate slowly 1 2 turn Added rotation may cause bleeding Immediately rinse the brush in the vial rotating 10 times while pressing against the vial wall e Swish the brush vigorously to further release sample Discard the brush 7 Collect cervical endocervical sample utilizing the broom e nsert the broom into the endocervical canal leaving a few of the broom bristles out of the canal Rotate the broom 360 four
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44. tory signs and symptoms Requests for special stains immunohistochemistry etc List of submitted specimens and the intent of the review Include a billing face sheet and or copy of the insurance card 2 Submit materials for review Include two patient identifiers Patient Name ie bar code MRN Visit Date of Birth Provide the original slides representing all aspects of all cases to be reviewed Provide the tissue block if additional testing is to be performed Provide copies of all test requisition forms and final report results 3 Package for transport Submit slides in slide mailers Use padded envelopes or a box with cushioning filler 4 Delivery options Fedex to Aurora Diagnostics Pathology Laboratory 2620 Horizon Drive SE Suite 100 Grand Rapids MI 49546 Delivery via pre established courier For assistance in selecting the most appropriate option call 866 530 1860 Collection Manual SOFT ECCO ENDOCERVICAL CURETTE EM AURORA Pathology Laboratory Laboratory 1 Complete a requisition form incomplete data may cause delay or rejection e Clinician name practice location Patient name address phone date of birth MRN or Visit Number Date of service time of collection Tissue site position and laterality Label multi part specimens A B C etc with corresponding descriptions e History signs and symptoms e Additional tests ie special stains immunohistochemistry Include a billing face sheet and or c
45. ual BIOPSY FRESH TISSUE EM AURORA DIAGNOSTICS Pathology Laboratory Laboratory 1 Call the laboratory to pre arrange transport These are RUSH specimens and must be scheduled 2 Complete a requisition form incomplete data may cause delay or rejection e Clinician name practice location Patient name address phone date of birth MRN or Visit Number Date of service time of collection Tissue site position and laterality Label multi part specimens A B C etc with corresponding descriptions History signs and symptoms Test s specify chromosome study flow cytometry or frozen section on the requisition Include a billing face sheet and or copy of the insurance card 3 Label each container 2 ID s and a specimen site on each jar Include two patient identifiers Patient Name ie bar code MRN Visit Date of Birth e Include the specimen collection site labeled A B C etc corresponding to the requisition Apply the label to the jar 4 Submit the specimen as fresh tissue Chromosome study submit in saline soaked gauze in a sterile container Flow cytometry submit in saline soaked gauze in a sterile container or flow transport media Frozen section submit in saline soaked gauze in a sterile container Provide phone number for STAT result reporting 5 Package for transport e Log the case on the Specimen Manifest e Tighten the lid and then seal the container s in a bio transport bag K
46. y Laboratory Laboratory Main Laboratory 866 530 1860 Monday Friday 7 30am 5 00pm 616 530 0575 fax Billing Department 888 208 6228 Monday Friday 8 00am 5 00pm 616 532 8040 fax Email info auroradx com Pathologists 866 530 1860 Houssam Attal MD David M Graham MD Kim A Mills MD Timothy J Pelkey MD Sales Client Services Donna DeWolf ddewolf auroradx com 616 450 2081 Operations Mark Tanis mtanis auroradx com 866 530 1860 Aurora Diagnostics Pathology Laboratory 2620 Horizon Drive SE Suite 100 Grand Rapids MI 49546 www auroradxpathlab com Client Manual BILLING POLICIES s EM AURORA Pathology Laboratory Laboratory Correct billing minimizes the number of patient complaints and phone calls and makes us all more efficient We require the complete patient demographic billing insurance data and ICD coding or reason for test in order to properly submit a claim Assignment We participate with most carriers and accept assignment As required by contract co pays deductibles and non covered tests as applicable are routinely billed to the patient after Explanation of Benefits is received ICD Code The ICD code billing code must be provided with the test requisition or signs symptoms reason for visit Medicaid Due to the increase in Medicaid HMO plans it is imperative that you submit a copy of the patient Medicaid card Medicare An ABN Advanced Beneficiary Notice is required by Medicare for Pap Test c
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