Saint Luke s Pathology Associates, P.A. COLLECTION MANUAL Renner Blvd Ste A Lenexa, Kansas 66219

Transcription

1 Saint Luke s Pathology Associates, P.A. COLLECTION MANUAL Renner Blvd Ste A Lenexa, Kansas 66219

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3 Added Dr. Ravis and Cushing Memorial CLIA 10/12/2011 number, Added Drs. Rosales and Singh. Added LoVong Kiatoukaysi, QA approval page. Change courier contract, updated staff 04/15/13 Updated staff, deleted Low-Risk Panel from HPV testing panel, removed testing site information from send-out tests, added statement about add-on testing Deborah F. Zaroor for HPV out of the SurePath vial, deleted Cystic Fibrosis testing 7/22/2013 Added signatures for all site medical director LoVong Kiatoukaysi, QA 2/18/2015 Biennial Review Ameripath Staff 3/14/2016 Updated address, phone numbers and minor revisons LoVong Kiatoukaysi, QA TABLE OF CONTENTS Page # General Information 1 Phone Numbers 2 Laboratory Accreditations 3 Test Methodologies 3 Results and Reporting 4 Web Portal Reporting Details (see pages 39-42) Special Tests 5 Consultation with a Pathologist 5 Compliance with Federal and Regulatory Agencies 6 Test Ordering and Specimen Submission 6 Medical Necessity and Advanced Beneficiary Notice (ABN s) 6 Professional Courtesy 7 Indigent Care / Hardship Cases 7/8 Overview of Histology / Cytology Specimens 9 Specimen Labeling 9 Requisitions 10 Specimen Packaging 10 Specimen Rejection Policy 11 Verbal Orders 11 Courier Services 11 Ordering of Supplies 11/12 Requests for Slides 13 Non-Gynecological Cytology Specimens Specimen Submission 14 Body Cavity Fluids and Washings 15 Urine 16 Sputum 17

4 Cerebrospinal Fluid (CSF) 18 Body Fluid (Gout) 18 Breast Fluids / Nipple Secretions 19 Breast Cyst Aspirations 20 Respiratory Specimens Bronchial Washing 21 Bronchial Brushing 22 Fine Needle Aspiration (FNA) Biopsy 23 Gynecological (Cervical/Vaginal) Cytology Specimens Specimen Collection 25 Cervical and Vaginal (ThinPrep Paps) 25 Imaged ThinPrep Pap 26 SurePath Pap 27 Conventional Pap Smear 28 Specimen for Clinical Testing Anatomic Pathology - Histology (Tissue) Specimens Specimen Containers 31 Routine Specimen Requisitions 31 Routine Fixative and Transport 32 Intraoperative Tissue Consultations 33 Specimen Collection Bone Marrows 33 Gout Specimen 33 Stone Analysis Calculus 33 Specific Specimen Requirements Lymph Nodes 33 Frozen Section or Intraoperative Consultation 33 Cytogenetics Testing on Products of Conception 33 Flow Cytometry 33 Direct Immunofluorescence (DIF or IF) 33 Electron Microscopy 34 HER2 Testing in Breast Cancer Specimens 34 Muscle Biopsies Muscle Enzyme Histochemistry 34 Renal Biopsies Transplant and Native 34 Specimens for Clinical Testing Chlamydia and Gonorrhea by PCR 36 Group B Strep by PCR 37/38 Herpes Simplex Virus I/II by PCR 38 Human Papilloma Virus (HPV) 39 Urine for UroVysion Testing 39 AmeriPath Physician Web Portal A Direct Route to your patient s reports Examples of the following: AmeriPath Requisitions

5 General Surgical Cytology/Pathology (GYN/Tissue) Informed Consent ABN (Advanced Beneficiary Notice) Dermatology GI Integrated with stickers for labeling Non-Gyn Cytology UroPath Supply Order Form 45 Add on Test Verification Form for Cytology Add on Test Verification Form for Tissue Specimens

6 GENERAL INFORMATION PREFACE The purpose of the manual is to: 1. Provide instruction on the collection and submission of cytology and histology specimens; 2. Help ensure that the optimal specimen and information are obtained for accurate and timely diagnosis; 3. Save patients the unnecessary costs of repeated tests. Detailed information is provided regarding specimen requirements, specimen collection and labeling, and data management. If you cannot find the answer to your question in the manual, please call the laboratory. AmeriPath Kansas City operates as the technical processing laboratory with Saint Luke s Pathology Associates, P.A., providing professional medical services. AmeriPath strives to maintain a reputation for quality, innovation and dependability, and we welcome comments and suggestions to further that effort. Tests desired by clients that are not performed at AmeriPath are referred to qualified, licensed reference laboratories chosen for the quality of service provided, including but not limited to: accuracy, reliability, turn around time, and range of services offered. 1

7 PATHOLOGY AND ADMINISTRATIVE STAFF Elizabeth Manion, M.D. Managing Medical Director Bradley J. Carmichael, M.D.- Staff Pathologist Paul P. Pettavel, M.D.- Staff Pathologist Scott M. Ravis, M.D.- Dermatopathologist Cecilia M. Rosales, M.D.- Technical Director Histology, Dermatopathologist, R. Scott Strobach, M.D.- Staff Pathologist Patrima K. Singh, M.D.- Quality Assurance Director, Staff Pathologist Phillip A. Munoz, M.D.- Staff Pathologist Monisha Dandekar, M.D.- Staff Pathologist Ashley Schneider, M.D.- Staff Pathologist Administrative Staff David Hollaway Beth DeLapp Lucia Laude LoVong Kiatoukaysi Anthony Carpenter Matthew Kentner Paul Campbell - Director Regional AP Laboratory Operations - Laboratory Operations Administrator, Client Service Transcription Supervisor - Histology Supervisor - Quality Assurance - Cytology - IT Services - Courier Services (Quest Diagnostics) PHONE NUMBERS Main Fax Billing Inquiries Courier - Specimen Pick-Up

8 Client Services ( Monday Friday, 8 am 5 pm) Cytology Collection Information Histology Collection Information Pathologists Daytime, Monday Friday, (8 am 5 pm) After Hours, weekends, and holidays (paging service) LABORATORY ACCREDITATIONS College of American Pathologists, CAP Lenexa Laboratory St. Luke s East St. Luke s North St. Luke s Plaza St. Luke s South Golden Valley Hospital Center for Medicare/Medicaid Services, CLIA Lenexa Laboratory St. Luke s East St. Luke s North St. Luke s Plaza St. Luke s South St. Luke s Cushing St. Luke s Dermatology (Dr. Ravis) Golden Valley Hospital - 26D D D D D D D D TEST METHODOLOGIES Upon request, the laboratory will provide clients a list of current test methods, including performance specifications. When the laboratory changes an analytic methodology, reagents, reference ranges, or anything else that may significantly impact patient test results or their interpretation, the change will be communicated and explained through the use of direct mailings, or as part of the test report itself. 3

9 RESULTS and REPORTING Results of cytology and histology evaluations are entered into the laboratory computer system as the tests are completed. The reports are generated at sign-out to the submitting client from the computer system and are distributed through the mail, delivered by our courier, faxed, direct print, or delivered via the internet using HIPAA compliant procedures. Our sales support representative will assist you in your reporting options. Saint Luke s Hospitals - Inpatient or registered outpatient final reports to include addendum reports may be viewed in the Saint Luke s Epic Electronic Health Records system. Web Portal Clients that would like to view their reports via the AmeriPath Web Portal via the internet, may contact Sales Support at Referring physician copies: If a copy of the report needs to be sent to a referring physician the following must be noted on the requisition: Referring physician first and last name Referring physician phone and fax numbers The Client Services Department has been designed to give physicians, nurses, and office personnel, as well as hospital-based pathologists and laboratory personnel a central location to call for report results and/or status and any other inquires. Please note: Patient test results will be faxed upon request to authorized providers following the return receipt of the HIPAA required fax number verification form. All fax numbers used for transmitting patient information must be verified prior to initial use and a minimum of annually thereafter. SPECIAL TESTS The following special tests are available in addition to routine cytology and histology: 1. Cytogenetic Studies 2. Electron Microscopy 4

10 3. Flow Cytometry 4. Fine Needle Aspiration Biopsy and Interpretation 5. HPV, HSV, Chlamydia, Gonorrhea, Group B Strep, and Cystic Fibrosis Testing 6. Immunohistochemistry, including Estrogen/Progesterone Receptor Her2Neu Her2Neu by FISH, EGFR MSI by PCR 7. Immunofluorescence 8. Muscle Enzyme Histochemistry 9. Oncotech 10. Oncotype 11. Renal Biopsies Transplant and Native 12. Urinary Stone Analysis 13. UroVysion Analysis DISTRIBUTION OF MANUAL This manual is distributed to all hospitals, physician offices, and surgical centers utilizing AmeriPath Saint Luke s Pathology Associates, P.A., services. CONSULTATION WITH A PATHOLOGIST Clinicians are welcome to consult with a pathologist regarding patient test results. The Client Services department will facilitate communication with the appropriate pathologist. COMPLIANCE WITH FEDERAL AND REGULATORY AGENCIES Saint Luke s Pathology Associates, P.A. (SLPA) is committed to maintaining a culture which promotes prevention, detection, and resolution of instances of conduct that do not conform to: Federal and state laws Regulatory agency requirements Federal, state and private payer health care program requirements The laboratory s ethics and business policies 5

11 As part of this commitment, physicians are notified of the following requirements. SLPA will update physicians as to changes in the medical necessity and billing compliance requirements relating to cytology and histology in order to protect both the physician and the laboratory. TEST ORDERING AND SPECIMEN SUBMISSION Physicians or other authorized personnel such as nurse practitioners may order laboratory tests. All orders must be accompanied by a written requisition, including add-on tests. A written requisition will be requested at the time a verbal order is placed, and should be submitted within 24 hours. Requisitions are retained an appropriate time period so as to meet all regulatory requirements. All specimens must be appropriately labeled with two patient identifiers. Acceptable identifiers are: 1. The patient s full name (full last name, then full first name or initial) or a unique ID code is always required. 2. The second patient identifier may be one of the following: Date of birth (month/date/year) Other unique patient identifier that is also on the test requisition (eg., hospital or office ID number.) A barcode label if the barcode matches a unique identifier on the test requisition. MEDICAL NECESSITY AND ADVANCED BENEFICIARY NOTICE (ABN s) Laboratories can submit claims to federally funded health programs only for services considered medically necessary. An ICD-9 code should be submitted with all orders substantiating the medical necessity of the testing. A notable exception to the medical necessity rule is that screening Pap smears are allowed once every two years. For Pap smears performed more often than every two years, or other tests, which do not meet the federally defined criteria for medical necessity, an Advanced Beneficiary Notice (ABN), supplied separately, must be completed. The ABN gives the patient advance notice that Medicare will not pay for the procedure. PROFESSIONAL COURTESY Due to stringent compliance regulations, AmeriPath Kansas City does not offer Professional Courtesy discounts to clients, physicians, or their families, and employees. 6

12 Indigent Care/Hardship Cases AmeriPath will not waive a charge, deductible or co-payment based on the indigence of the patient without proper documentation of the patient's indigence. There should be documentation in our files for all adjustments of this nature. Proper documentation includes at a minimum one of the following: a) A completed "Request for Discount/Financial Hardship" form from the patient requesting that charges be waived or discounted based on indigence together with financial information demonstrating indigence. Guidelines for determining financial hardship are as follows: Financial Hardship/Indigence Levels Annual Salary Discount Amount < 24, % > 24,000 but < 26, % > 26,000 but < 28, % > 28,000 but < 30, % > 30,000 but < 32, % > 32,000 but < 34, % > 34,000 but < 36, % > 36,000 but < 38, % > 38,000 but < 40, % AmeriPath may increase the amount of the discount on a case-by-case basis for special circumstances and/or unusual financial hardships. b) A written request, on the requisition, indicating financial hardship as determined by the referring physician. The referring physician can make this determination based on his knowledge and assessment of the patient's financial situation. The referring physician must sign and date the request. In addition, the referring physician must have waived his/her office charges based on this indigence, and his/her signature on the requisition witnesses to this statement. 7

13 c) The hospital identifies the patient as a charity case or indigent patient and waives their charges accordingly. In addition, written documentation must accompany such request from the hospital. Indigence is defined as the inability to pay the fees owed without incurring substantial hardship. Fees that are waived as a result of the indigence (i.e., charity care) of a patient shall not be recognized as revenues, and accordingly, should not be treated as an expense or contractual adjustment when waived. OVERVIEW OF HISTOLOGY/CYTOLOGY SPECIMENS Once removed from the patient, specimens must be immediately preserved to avoid deterioration. See the following list for guidance in determining which section of this manual to refer to for the appropriate instructions. CYTOLOGY Body Fluids Urine Sputum CSF (Spinal Fluid) Breast fluids Cervical/Vaginal (Paps) Fine Needle Aspirations (FNA) Bronchial Specimens HISTOLOGY All tissue specimens including: Breast Biopsies Cervical/ECC/EMB Endometrial Biopsies Gastrointestinal Biopsies Muscle Biopsies Prostate Biopsies Renal Biopsies Transplant and Native Specimens Skin Biopsies Skin Immunofluorescence Vas Deferens SPECIMEN LABELING Always verify the identification of the patient by asking their name. If there are multiple specimens, place each specimen in a separate container and clearly note the specimen type/source in addition to the patient s name. All specimens should be labeled at the time of collection with at least two patient identifiers. 1) The patient's name (full last name, then full first name or initial) or a unique ID code is always required. 2) The second patient identifier may be one of the following: Date of birth (month/date/year) Other unique patient identifier that is also on the test requisition, e.g. hospital or 8

14 office ID code or file number A requisition number or specimen barcode label Other barcode labels can be used if barcode matches the unique identifiers on the printed requisition (the barcode does not need to be human readable) NOTE: Location-based identifiers are NOT acceptable, e.g. hospital room number or street address REQUISITIONS Each specimen submitted must be accompanied by an AmeriPath requisition form. We know that proper and timely billing of your patients is one of your concerns. In order for us to accomplish this task, we must have accurate patient information from you, which must be legibly written on the requisition form accompanying the specimen. (A separate patient information sheet may be attached to the requisition.) Please include the following: Complete patient name as it appears on the primary insurance card. Complete address of the patient. Patient s date of birth and social security number. (SSN is not required but is very useful for patient identification.) Guarantor s name and date of birth if other than patient. Complete insurance information. It is best to attach a copy of patient s insurance card(s), front and back, to the requisition. Appropriate ICD-10 code. Patient s clinical history. This is a regulatory requirement because of its importance in rendering an accurate diagnosis. Requesting physician s first and last name. Circle the appropriate choice if multiple physician names appear on the requisition. Specimen type and source. Specimen collection date. The procedures or special tests desired. If the above information is not complete and legible, processing of the specimen may be delayed while we contact your office by phone or fax to obtain the required information. The second copy of the requisition is for your office use and may be disposed of if not needed by your office. 9

15 SPECIMEN PACKAGING Use only approved well-constructed containers and packaging materials. Secure container lids so that there is no leaking, and seal the container into a biohazard bag. Place the requisition in the outer pocket of the bag. Please place only one patient s sample(s) in per biohazard bag. SPECIMEN REJECTION POLICY It is our policy at AmeriPath to meet all regulatory agency guidelines and to provide the best patient care possible. To do so, we must enforce the following procedures: All requisitions must have the patient s name, a second identifier such as a date of birth or patient ID number, tissue type and all pertinent available clinical history. All specimen containers must be labeled with the patient s name, a second patient identifier and tissue type. All slides, smears, and frozen section specimens must be received labeled with the patient s name and date of birth or second unique identifier. The above procedures must be followed, otherwise the requisition and specimen will be returned to the referring physician office for appropriate identification via courier the following day. A letter explaining the reason for the rejection of the specimen will be included. Additionally, specimens will be rejected when slides are broken beyond repair, a specimen is received in a syringe with an intact needle, or the names on the specimen and requisition do not match. VERBAL ORDERS Any additional testing which is verbally requested must be followed up with a written ADD ON TEST form (preferably within 24 hours) in order to comply with regulatory requirements. The ADD ON TEST form may be faxed to (you may copy the add on tissue or cytology form included at the back of this manual). COURIER SERVICES When specimens are ready to be picked up, place in the designated area for courier pickup. If your office is not on a regular pick-up schedule, call us at or

16 to request a courier pick-up. Also, call if you have a specimen that requires immediate pick-up in order to maintain specimen integrity (such as fresh tissue). If you have prior knowledge of any special procedure, it is preferable to give 24 hours notice of special needs. ORDERING SUPPLIES All clients will be supplied with specimen containers, routine fixative (10% formalin), bags for submitting specimen containers, and requisition forms. We have a wide selection of supplies to fit each specimen requirement. Fill out the AmeriPath Supply Requisition form with the order date and contact person. Indicate the amount of each supply that you will need. Place the supply requisition form in the courier pick-up box or fax it to Our policy is to fill all supply requests within 48 hours. If you need the supplies sooner, please call and speak to a Client Services Representative. We will make every effort to meet your needs. 11

17 REQUESTS FOR SLIDES Requests to have slides sent out for a second opinion should be called to , allowing a hour notice for this service when possible. Please provide the following information to the Client Services Representative: Patient name Date of birth Date of service Name, address and phone number of the facility where slides are being referred. Name of physician who will be reviewing the slides Requests from Physicians, Laboratories or Hospitals for copies of reports, slides or blocks will be sent upon request; no patient authorization is required if the information is used for continuance of care treatment. Requests from Patients or Family Members: Patient requests are accommodated whenever possible. Reports, slides and blocks may be released directly to the patient, or sent to another institution. A signed authorization from the patient is required, with verification of identity of the requestor (driver's license or identification card with photo) when the slides or blocks are picked-up. A dated, faxed authorization from the patient is acceptable as documentation for phone requests. It must state exactly where the materials are being sent. Family members may not access a patient's report or other material without written authorization from the patient. 12

18 NON-GYNECOLOGICAL CYTOLOGY SPECIMENS SPECIMEN SUBMISSION All cytology specimens should be submitted to the laboratory as soon as possible after collection. Delay will result in deterioration of unfixed specimens. If a delay is unavoidable (more than 1 hour), please refrigerate specimens until they are picked up. All requests for cytologic examination must be submitted on AmeriPath requisition forms, (see appendix for copy of Non-Gynecologic requisitions). Fluid and mucoid cytology specimens are processed with the ThinPrep Technique. All cytology specimens should be submitted fresh or on CytoLyt (site-o-lite) preservative. Do not add Carbowax Fixative (Saccomonno Fluid) to a cytology specimen. The laboratory does not accept syringe needles. Flush the barrel of the needle into the specimen container, using the proper preservative and dispose of the needle into a sharps container. If questions arise as to how a cytology specimen should be handled that are not answered in this manual, call

19 SPECIMEN COLLECTION Body Cavity Fluids and Washings Pleural, pericardial, peritoneal, and pelvic: Equipment: clean container (such as a sterile urine container) AmeriPath Non-Gynecological Cytology requisition NOTE: Specimens and requisition must be labeled with the patient s name, a second unique identifier (see page 8 for specimen labeling requirements) and the source of the specimen. Procedure: 1. Perform tap. 2. Place sample in clean specimen container or heparinized glass bottle. 3. Have specimen delivered immediately to the laboratory. If there is a delay, add 30 ml CytoLyt or refrigerate. Please note on the container if CytoLyt has been added. Test Performed At: Reference Values: Run STAT: CPT Code: AmeriPath Laboratories Renner Blvd Ste A Lenexa, Kansas Descriptive Report No ThinPrep Non-gyn 14

20 Urine: Equipment: Clean container AmeriPath Non-gynecological Cytology requisition NOTE: Specimens and requisition must be labeled with the patient s name, a second unique identifier (see page 8 for specimen labeling requirements) and the source of the specimen. Procedure Notes: 1. A voided urine specimen should be obtained after the patient has been well hydrated and approximately three hours after the last void. 2. Do NOT submit the first morning void for cytology. 3. Clean catch samples are necessary. Female patients should be instructed to spread the labia during collection, then pass and discard a small amount of urine. Collect the remainder. Males should be instructed to pass and discard a small amount of urine and collect the remainder. 4. If then patient is unable to cooperate satisfactorily, a catheterized specimen should be obtained. Note the method of collection on the requisition form. 5. Do not submit 24-hour collection specimens for cytology. These are unsatisfactory due to cellular degeneration. Procedure: 1. Provide patient with clean container and instructions. 2. Submit approximately 50 ml of urine to ensure a sufficient sample. 3. Have specimen delivered to the laboratory immediately. If there is a delay, add 30 ml CytoLyt or refrigerate. Please note on the container if CytoLyt has been added. Test Performed At: Reference Values: Run STAT: CPT Code: AmeriPath Laboratories Renner Blvd Ste A Lenexa, Kansas Descriptive Report No ThinPrep Non-gyn 15

21 Sputum Equipment: Wide mouth plastic container AmeriPath Non-gynecological Cytology requisition NOTE: Specimens and requisition must be labeled with the patient s name, a second unique identifier (see page 8 for specimen labeling requirements) and the source of the specimen. Procedure: 1. Instruct patient to collect specimen as soon as they wake up. 2. Instruct patient to rinse mouth with water, then cough deeply into container. 3. Inform patient that several coughs over a period of 2 to 3 hours may be necessary to produce a sufficient sample. 4. Have specimen delivered to the laboratory immediately. If there is a delay, add 30 ml CytoLyt solution and mix well. Please note on the container if CytoLyt has been added. 5. If three consecutive specimens are to be collected, all three specimens can be delivered on the third day of collection, provided the earlier specimens are fixed with CytoLyt. Test Performed At: Reference Values: Run STAT: CPT Code: AmeriPath Laboratories Renner Blvd Ste A Lenexa, Kansas Descriptive Report No ThinPrep Non-gyn 16

22 Cerebrospinal Fluid (CSF) Equipment: Clean container AmeriPath Non-gynecological Cytology requisition NOTE: Specimens and requisition must be labeled with the patient s name, a second unique identifier (see page 8 for specimen labeling requirements) and the source of the specimen. Procedure Notes: Procedure: 1. Submit the largest volume of fluid possible. 2. Do NOT add CytoLyt to this specimen. 1. Perform spinal tap. 2. Place sample in clean container. 3. Have the specimen delivered to the laboratory immediately. Test Performed At: Reference Values: Run STAT: CPT Code: AmeriPath Laboratories Renner Blvd Ste A Lenexa, Kansas Descriptive Report No ThinPrep Non-gyn 17

23 Breast Fluids Material may be obtained either from secretions expressed from the nipple or by aspiration of cystic lesions. Body Fluids (Gout) Evaluation of tissue and/or fluid for gout (urate) crystal identification: - Tissue or fluids should be submitted in absolute alcohol or fresh to avoid dissolution of the crystals in aqueous solution (crystals are water soluble). - DO NOT use saline solution or formalin. NIPPLE SECRETIONS Equipment: Glass slides 95% alcohol or spray fixative AmeriPath Non-gynecological Cytology requisition NOTE: Specimens and requisition must be labeled with the patient s name, a second unique identifier (see page 9 for specimen labeling requirements) and the source of the specimen. Procedure Notes: Procedure: 1. If secretion appears when pressure is applied to a particular area, it is advisable to note this on the requisition form and prepare a specifically identified slide from this material. This may be helpful in guiding future biopsy. 2. Cellularity tends to increase with each expression and 4-6 slides should be made if possible. 1. Label glass slides with patient s first and last name and specimen source and date of birth or a second unique identifier. 2. Express material from nipple by gentle compression of the areolar area between thumb and forefinger directly onto glass slide. 3. Gently spread material over surface of slide. 18

24 4. Immediately fix specimen by dropping slide into 95% alcohol or spray with fixative. Do NOT allow specimen to air dry. Test Performed At: Reference Values: Run STAT: CPT Code: AmeriPath Laboratories Renner Blvd Ste A Lenexa, Kansas Descriptive Report No smear and interpretation. BREAST CYST ASPIRATIONS Equipment: Clean container AmeriPath Non-gynecological Cytology requisition NOTE: Specimens and requisition must be labeled with the patient s name, a second unique identifier (see page 8 for specimen labeling requirements) and the source of the specimen. Procedure Notes: Procedure: 1. Most breast cyst fluids do not need cytologic examination and can be discarded. 2. Submit the cyst fluid if: a. the cyst is recurrent b. the fluid appears bloody (brownish fluid suggestive of old bleeding, not fresh blood due to the procedure) c. the patient is postmenopausal and not on hormone replacement therapy 1. Perform aspiration. 2. Place specimen in clean container. 3. Have specimen delivered to the laboratory immediately. If there is a delay, add an equal volume of CytoLyt or refrigerate. Please note on the container if CytoLyt has been added. Test Performed At: Reference Values: AmeriPath Laboratories Renner Blvd Ste A Lenexa, Kansas Descriptive Report 19

25 Run STAT: CPT Code: No ThinPrep Non-gyn 20

26 Respiratory Specimens: Bronchial Washing Equipment: Clean container or bronchial trap. AmeriPath Non-gynecological Cytology requisition NOTE: Specimens and requisition must be labeled with the patient s name, a second unique identifier (see page 8 for specimen labeling requirements) and the source of the specimen. Procedure: 1. Perform bronchoscopy. 2. Place sample in bronchial trap or clean specimen container. Note: If clinical testing is required submit a separate specimen to Saint Luke s Regional Laboratory. 3. Have specimen delivered to the laboratory immediately. If there is a delay, add an equal volume of CytoLyt or refrigerate. Please note on the container if CytoLyt has been added. 4. Order additional testing on the requisition such as GMS, PCP, Oil Red-O, and/or Iron stain if desired. Additional CPT codes will apply for special stains. Test Performed At: Reference Values: Run STAT: CPT Code: AmeriPath Laboratories Renner Blvd Ste A Lenexa, Kansas Descriptive Report No ThinPrep Non-gyn 21

27 Bronchial Brushing Equipment: Clean container or bronchial trap. AmeriPath Non-gynecological Cytology requisition NOTE: Specimens and requisition must be labeled with the patient s name, a second unique identifier (see page 8 for specimen labeling requirements) and the source of the specimen. Procedure: 1. Perform bronchoscopy. 2. Cut brush, leaving 1 inch stem and place in bronchial trap or clean specimen container. Cover with enough saline to cover the brush. Note: If clinical testing is required submit a separate specimen to Saint Luke s Regional Laboratory. 3. Have specimen delivered to the laboratory immediately. If there is a delay, add an equal volume of CytoLyt or refrigerate. Please note on the container if CytoLyt has been added. 4. Order additional testing on the requisition such as GMS, PCP, Oil Red-O, Iron stain if desired. Additional CPT codes will apply for special stains. Test Performed At: Reference Values: Run STAT: CPT Code: AmeriPath Laboratories Renner Blvd Ste A Lenexa, Kansas Descriptive Report No ThinPrep Non-gyn 22

28 Fine Needle Aspiration (FNA) Biopsy Clinicians should have experience to perform FNA s in their offices. Lack of experience often results in inadequate or insufficient specimens. Cytotechnologists are available for FNA adequacy assessments at the Saint Luke s Hospital campus (Plaza Only). To schedule an FNA with adequacy assessment, please call (816) at least 48 hours before the scheduled procedure. Cytotechnologist s are available from 8 A.M. to 4 P.M. Monday thru Friday on a first scheduled basis. Equipment: glass slides 22, 23 or 25 gauge needles Aspiration gun syringe to fit into gun alcohol swabs 4 x 4 cotton gauze pads 95% alcohol or spray fixative AmeriPath requisition Procedure: 1. Localize the lesion by palpation. The lesion must be easily palpable to obtain an adequate specimen. 2. Attach the needle to the syringe, then attach the syringe to the gun. Inspire air into the syringe to ensure adequate suction. Leave a small amount of air in the syringe before aspiration. 3. Localize and stabilize the lesion with one hand. Clean the surrounding skin with an alcohol swab. 4. Insert the needle into the lesion. Apply suction with the aspiration gun. 5. Move the needle rapidly back and forth in the lesion while changing the direction of the needle. Continue until material is evident in the needle hub. 6. Release suction before withdrawing the needle. Withdraw the needle and have the patient or an assistant apply pressure to the puncture site with cotton gauze. 7. Pre -label 6 to 8 slides with the patient s first and last name, date of birth, and the site of the specimen (i.e. left breast). 8. Prepare smears by placing a small drop of material near the labeled end of the slide. Smear material across the surface of the slide using another slide. Place one slide immediately in 95% alcohol fixative, or spray fix immediately. Allow the other slide to air dry. Prepare more smears if identifiable specimen is still present in the needle hub. 9. Rinse the remainder of the material left in the needle into CytoLyt solution. 10. Repeat aspiration 3 times to ensure an adequate specimen is obtained. All of the needle rinses from the same site can be placed in the same CytoLyt solution. 23

29 11. Complete the AmeriPath requisition form including clinical impression and all pertinent clinical history. Indicate that the specimen is an FNA and specify the site of the aspiration. 12. Have the specimen delivered to the laboratory for further processing and interpretation. Test Performed At: Reference Values: Run STAT: CPT Code: AmeriPath Laboratories Renner Blvd Ste A Lenexa, Kansas Descriptive Report No specimen adequacy evaluation when requested Interpretation and report 24

30 GYNECOLOGICAL (CERVICAL/VAGINAL) CYTOLOGY SPECIMENS SPECIMEN COLLECTION GYNECOLOGICAL CYTOLOGY SPECIMENS CERVICAL/ENDOCERVICAL AND VAGINAL PAP TESTS The adequacy of Pap test collection is determined by: 1. Accurate patient and specimen identification 2. The presence of an adequate squamous component 3. The presence of an adequate endocervical component (in premenopausal females with a cervix) 4. Adequate cellular preservation 5. Pertinent clinical history (see below) Because of the importance of the patient s clinical history in interpreting the Pap test, be sure to note any relevant information such as: Cigarette Smoker Total hysterectomy Supracervical hysterectomy Pregnant (weeks) Postpartum (weeks) Postmenopausal (year) Family Hx Cervical Cancer Early onset of sexual activity IUD Post-coital bleeding Postmenopausal bleeding Routine examination Repeat Pap Previous GYN Malignancy History of HPV or dysplasia Immuno-compromised Abnormal GYN Exam (e.g. HPV, Cervical lesion) Abnormal Pap within last 3 yrs DES exposure Estrogen Replacement therapy 5 or more full-term pregnancies Multiple sexual partners Birth control pills History of STD s Pelvic radiation Vaccinated for HPV Pap test results are typically reported within 5 business days following receipt into the laboratory. Procedure Notes for Pap test collection: 1. To ensure an adequate specimen: Samples from both the ectocervix and endocervix including the transformation zone are essential. The patient should be instructed not to use vaginal medications, spermicide or douches 24 hours prior to collection of the Pap test. Patient should refrain from intercourse for 24 hours prior to collection. Vaginal discharge or secretion (when present in large amounts) should be removed before obtaining the cervical sample. It is preferred that lubricant NOT be used when obtaining a pap specimen. 2. If testing for sexually transmitted diseases is indicated, the cervical cytology sample should be taken first. 3. If a suspicious area is visualized, a separate sample from the area may be obtained and appropriately designated separate collection. 4. Complete the requisition form as previously instructed and include ALL of the following information: a. specimen source (i.e. cervical/endocervical or vaginal) 25

31 b. relevant clinical history (as noted above) c. last menstrual period (LMP) d. collection date 5. No refrigeration is necessary. Unacceptable Specimens No or illegible patient identification on the specimen container or the test requisition Mismatch between name of patient on specimen and name on test requisition Slides broken beyond repair Leakage of sample during transport Expired liquid-based preservative/vial SurePath Pap Test (blue vial) without a collection device Imaged THINPREP PAP ThinPrep Pap test is a liquid-based cell preparation system, collected in PreservCyt solution and processed using the Hologic instrumentation. Monolayer preparations are screened by cytotechnologists using computer assisted imaging technology, with pathologist review of all abnormal cases Supplies Cervical/ Endocervical Brush/Spatula Procedure Unlubricated speculum (warm water or saline may be used) PreservCyt solution vial Endocervical brush/spatula or Broom-like device Requisition Obtain cellular material as per Hologic s instructions from the cervix using a spatula or endocervical brush: ThinPrep Brush/Spatula 1. Insert vaginal speculum WITHOUT any lubricant. The use of lubricant has been known to interfere with the ThinPrep process, resulting in unsatisfactory for evaluation Paps due to low cellularity. 2. Obtain an adequate sampling from the ectocervix using a plastic spatula. 3. Rinse the spatula into the PreservCyt Solution vial by swirling the spatula vigorously in the vial 10 times. Discard the spatula. 4. Obtain an adequate sampling from the endocervix using an endocervical brush device. Insert the brush into the cervix until only the bottommost fibers are exposed. Slowly rotate a quarter or half turn in one direction. Do NOT over-rotate. 5. IMMEDIATELY rinse the brush in the PreservCyt solution by rotating the device in the solution 10 times while pushing against the PreservCyt vial wall. Swirl the brush vigorously to further release material. Discard the brush. 6. Tighten the cap so that the torque line on the cap passes the torque line on the vial. 7. Label the vial with the patient s first and last name and 2 nd identifier Broom-like Device Procedure Obtain cellular material as per Hologic s instructions from the cervix using a broom device: ThinPrep/Broom-like Device 1. Insert vaginal speculum WITHOUT any lubricant. The use of lubricant has been known to interfere with the ThinPrep process, resulting in unsatisfactory for evaluation Paps due to low cellularity. 2. Obtain an adequate sample from the cervix using a broom-like device. Insert the central bristles of the broom into the endocervical canal deep enough to allow the shorter bristles to fully contact the ectocervix. Push 26

32 Additional Testing Available From ThinPrep Specimens gently, and rotate the broom in a clockwise direction 5 times. 3. IMMEDIATELY rinse the broom into the PreservCyt Solution vial by pushing the broom into the bottom of the vial 10 times, forcing the bristles apart. As a final step, swirl the broom vigorously to further release material. Discard the collection device. 4. Tighten the cap so that the torque line on the cap passes the torque line on the vial. Label the vial with the patient s first and last name and 2 nd identifier. Collect the following specimens alone or with a Pap test as you would for a ThinPrep Pap. 1. HPV E6/E7 mrna 2. Human Papilloma Virus (HPV) DNA 3. Chlamydia rrna by TMA 4. Gonorrhea rrna by TMA 5. Herpes Simplex Virus I/II (HSV) DNA 6. Group B Streptococcus (GBS) DNA 7. HPV Genotyping (16,18 & 16,18/45 mrna by TMA) 8. HPV Genotyping DNA by PCR 9. Vaginitis Panel Gardnerella DNA Candida DNA Trichomonas DNA Trichomonas rrna by TMA SurePath Pap without Imaging The SurePath Pap test is a liquid based thin layer cell preparation system, collected in SurePath Preservative Fluid and processed using the PrepStain System. Slides are manually screened by cytotechnologists, with pathologist review of all abnormal cases. Supplies Procedure Rejection Criteria Unlubricated speculum (warm water or saline may be used) Brush (Rovers Cervex-Brush) SurePath Preservative Vial Requisition Obtain cellular material as per instructions from the cervix using a Cervex device: Surepath 1. Label the SurePath vial with the patient first and last name and 2 nd identifier. 2. After visualization of the cervix is completed, use the Rovers Cervex-Brush to collect an adequate sample. 3. Insert the central long tines into the cervical/endocervical canal applying gentle pressure. 4. As these are being inserted, the device should be twisted slowly. Maintaining gentle pressure, hold the stem between the thumb and forefinger then rotate the brush five times in a clockwise direction. Do not alter the direction of the brush during sampling. 5. Transfer the entire sample by placing your thumb against the back of the brush pad, simply disconnect the entire brush from the stem into the SurePath preservative vial. Chapter 2 Recap the vial and tighten. SurePath Pap specimens submitted without the collection devices in the vial are not compliant with the FDA approved Pap testing methodology and will be rejected for testing. 27

33 Additional Testing Available from SurePath Pap Specimens Collect the following specimens alone or with a Pap test as you would for a SurePath Pap. 1. HPV E6/E7 mrna (cervical/endocervical sources only) 2. Human Papilloma Virus (HPV) DNA 3. Chlamydia rrna by TMA 4. Gonorrhea rrna by TMA 5. Herpes Simplex Virus I/II (HSV) DNA 6. Group B Streptococcus (GBS) DNA 7. HPV Genotyping (16,18 & 16,18/45 mrna by TMA) 8. HPV Genotyping DNA by PCR 9. Vaginitis Panel Gardnerella DNA Candida DNA Trichomonas DNA Trichomonas rrna by TMA Conventional Pap Smear Supplies Procedure Clean glass slide with frosted end Ayre spatula and cotton tipped swab Endocervical brush or cervical brush (Cervex brush) Spray fixative Requisition 1. Label frosted end of slide with patient s first and last name and 2 nd identifier. 2. Ensure that fixative is readily available. 3. Insert vaginal speculum WITHOUT any lubricant. 4. Two areas of cervix are to be sampled - the portico and the endocervical canal. 5. Visually inspect the cervix. Using the Ayre spatula, insert long end into the external os and rotate in one direction at least one complete 360-degree turn. Gently smear contents adherent to the spatula onto the surface of the labeled slide. Spray with fixative immediately, covering smeared area with a thin film of the spray. 6. If the endocervical canal is to be sampled separately, use moistened cotton tipped applicator or an endocervical brush. Insert into endocervical canal, rotate 360 degrees and withdraw. Smear specimen onto an unused portion of the slide with the spatula. Immediately spray with fixative. 7. The cervical brush (Cervex or broom ) samples the ectocervix and endocervix at the same time. Insert the longer central portion of the device into the endocervical canal, rotate at last 360 degrees and withdraw. Smear the material onto a slide in a sweeping movement and spray fix immediately. Note: Immediate fixation is imperative. No delay should occur after the cytologic material is placed on the slide. SPECIMENS FOR CLINICAL TESTING ALL specimens should be labeled at the time of collection with at least 2 patient identifiers and source. Chlamydia and Gonorrhea rrna by TMA Please note the specimen sources that are acceptable for this testing: vaginal; cervical; endocervical; urethral; urine. 28

34 While vaginal samples are acceptable for Chlamydia testing, endocervical specimens are recommended for Gonorrhea. Oral or anal specimens, or swabs from external lesions are not accepted. Labs performing cytology: Aliquot PreservCyt or SurePath solution before performance of liquid based cytology testing. A. ThinPrep Pap 1. Collect per ThinPrep protocol (see page 11): ThinPrep Brush/Spatula Specimen stability Room temperature: 14 days Refrigerated: 30 days B. Aptima Vaginal (orange tube) or Unisex (white tube) Swab Kits NOTE: Results from the Aptima Combo 2 Assay should be interpreted in conjunction with other laboratory and clinical data available to the clinician. 1. Collect per instructions: Aptima Vaginal Swab instructions Aptima Unisex Swab Collection instructions C. Preservative Fluid /Multi-swab 1. Use Swab Collection and Transport Kit. 2. Rotate the swab 5-10 times while sampling to allow enough cells to adhere to the swab tip. 3. Place swab(s) in tube after collection. 4. No refrigeration is necessary. 5. Write preservative fluid on the requisition as specimen being submitted. D. Urine (must be received within 24 hours of collection) 1. Patient must NOT have urinated for at least two hours prior to collection. 2. Collect 10 to 50 ml of FIRST catch urine into clean, polypropylene container without preservatives. 3. Refrigerate specimens (2-8 degrees) until pick-up by courier. 4. Write urine on the requisition as specimen being submitted. 5. Aptima urine kits may be used. Specimen stability Room temperature: 30 days if in Aptima transport medium Refrigerated: 30 days E. SurePath 1. Collect as per SurePath protocol (see page 12): Surepath Specimen stability Room temperature: 4 days from collection Refrigerated: 30 days F. M4-Viral Transport Media 1. Collect per M-4 kit instructions Aptima Trichomonas by TMA *Urine, Aptima Swab, urine kit Collect per Atima Urine Kit guidelines 29

35 Group B Streptococcus DNA Note: Drug sensitivities cannot be performed using a DNA detection methodology. A. Preservative Fluid/ Multi-swab 1. Use Swab Collection and Transport Kit. 2. Kit may be used for anal and vaginal samples. Combination anal/vaginal samples can be used by placing both swabs into a single transport tube. 3. Rotate the swab 5-10 times while sampling to allow enough cells to adhere to the swab tip. 4. Place swab(s) in tube after collection. 5. No refrigeration is necessary. 6. Note Preservative Fluid on requisition. 7. Label the specimen with patient name, 2 nd identifier, and source. B. ThinPrep 1. Collect per ThinPrep protocol. C. SurePath 1. Collect per SurePath protocol. Supplies Specimen Stability Preferred Sample Procedure Notes Procedure Rapid GBS DNA **Source Specific Vaginal/Rectal Copan Swab 24 hours at room temperature 1-6 days if refrigerated Combination vaginal/rectal samples placed into a single transport tube **Drug susceptibility testing MAY be performed on this medium for penicillinallergic patients** (REQUEST: reflex for drug susceptibility testing on requisition Excessive mucous, lubricant and/or blood may cause inhibition of DNA amplification/detection resulting in a possible false negative. Rotate both swabs 5-10 times while sampling vaginal then rectal areas to ensure enough cells adhere to the swab tip. Place swabs in collection device. Herpes Simplex Virus I/II by PCR A. Preservative Fluid/Multi-swab (acceptable collection for male and female external genital lesions; cervical or vaginal sampling) 1. Use Swab Collection and Transport Kit 2. Rotate the swab 5-10 times while sampling to allow enough cells to adhere to the swab tip. 3. Place swab(s) in tube after collection. 4. No refrigeration is necessary. 5. Note Preservative Fluid on requisition. 6. Label the specimen with patient name, 2 nd identifier, and source. B. ThinPrep 1. Collect per ThinPrep protocol. C. M4-Viral Transport Media (Note: Only media acceptable for mouth, anal, and eye sources; acceptable for swab of vesicle fluid or scrapings) 30

36 1. Female a. Clean area by removing any excess mucus, blood, or examination lubricants. Discard this swab. b. Insert second swab into the endocervical canal. Rotate clockwise for 3-5 seconds and withdraw. c. Insert swab into transport tube. Break shaft of swab and close securely. Do not force swab into the bottom of the tube, swab should be suspended in the media. Leave swab in the media. d. Note M4 on requisition. 2. Malea. Patient should not urinate 2 hours prior to sampling. b. Insert the small sterile swab 2-4 cm into the urethra. Rotate 3-5 seconds and withdraw. c. Insert the swab into the transport media. Break shaft of swab and close securely. Do not force swab into the bottom of the tube, swab should be suspended in the media. Leave swab in the media. d. Note M4 on requisition. D. SurePath 1. Collect per SurePath protocol. Aptima Human Papilloma Virus (HPV) E6/E7 mrna by TMA Note: Must include specimen source. A. ThinPrep 1. Collect per ThinPrep protocol (see page 11). 2. May be used for Anal/rectal collection. B. SurePath (cervical/endocervical sources only) 1. Collect per SurePath protocol. 2. Specimen stability: 7 days from collection Note: Must include specimen source. Digene Human Papilloma Virus (HPV) DNA A. ThinPrep 1. Collect per ThinPrep protocol B. SurePath 1. Collect per SurePath protocol C. Digene Cervical Swab 1. Collect per Digene protocol. Refer to Digene cervical swab specimen collection kit. 2. Note Digene cervical swab on requisition. Note: Must include specimen source. A. ThinPrep 1. Collect per ThinPrep protocol. 2. May be used for Anal/rectal collection. Aptima HPV Genotyping 16/18/45 by TMA C. SurePath (**Endocervical/Cervical sources only) 1. Collect per SurePath protocol 31

37 Surepath Urine for UroVysion Testing 1. Use AmeriPath Urine Cytology Kit. 2. Collect ml of urine in labeled collection container. Do NOT collect first morning urine. 3. Immediately pour an equal amount of fixative into the specimen collection container with the urine. 4. Place fixative bottle back into the kit box and return with the specimen. 5. Place cap on urine collection container and secure tightly. 6. Place urine collection container into plastic zip-lock specimen bag and seal. 7. Place sealed plastic bag containing the specimen collection container into the Urine Cytology Kit Box. 8. Complete test requisition. 9. Label specimen with patient name, 2 nd identifier, and source Vaginitis Panel (DNA) (Includes Trichomonas CPT 87661*, Gardnerella CPT 87511*, and Candida Albicans CPT 87481*, which can also be ordered individually) A. ThinPrep Collect per ThinPrep protocol. B. SurePath Collect per SurePath protocol. C. Preservative Fluid/Multi-Swab 1. Use Swab Collection and Transport Kit. 2. Rotate the swab 5-10 times while sampling to allow enough cells to adhere to the swab tip. 3. Place swab(s) in tube after collection. 4. No refrigeration is necessary. 5. Note Preservative Fluid and source on requisition. * The CPT codes provided are based on AMA guidelines and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed. Vaginitis Panel by BD Affirm (Includes Trichomonas CPT 87660*, Gardnerella CPT 87510*, and Candida, CPT 87480*) (Note: Sample stability is 72 hours from time of collection) 1. Use BD Affirm VPIII Swab kit (Refer to kit instructions for transport instructions) 2. Collect vaginal sample using Pap collection method. 3. Using the sterile swab, obtain a sample from the posterior vaginal fornix. Twist or roll the swab against the vaginal wall 2 or 3 times, ensuring the entire circumference of the 32

38 swab has touched the vaginal wall. Swab the lateral vaginal wall while removing the swab. 4. Immediately place the swab in the Sample Collection Tube. 5. With the swab touching the BOTTOM if the collection tube, grasp the pre-scored handle of the swab just above the top of the tube and bend until the swab breaks. Discard the broken handle into an infectious waste container. 6. Place the cap on the tube and firmly press until properly sealed. 7. Label with tube with patient first and last name and date & time collected. 8. Place into specimen transport bag with properly completed requisition form. * The CPT codes provided are based on AMA guidelines and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed. HISTOLOGY (TISSUE) SPECIMENS Tissue specimens submitted to Pathology must meet certain requirements before they will be accepted for examination. If you have questions about the collection of histologic specimens that are not answered in this manual, please call SPECIMEN CONTAINERS All specimens shall be placed in well-constructed containers with lids tightly secured to prevent leaking. The container (not the lid) shall be labeled with the patient s first and last name, a second unique identifier, and specimen source (see page 8 for specimen labeling requirements). Multiple specimens should be placed in separate containers with each source clearly identified in addition to the patient s name. Most tissue specimens are submitted in formalin, which contains formaldehyde. Warning: Use caution when handling formaldehyde as it may be carcinogenic. It is toxic if inhaled or swallowed and can be irritating to the eyes, respiratory system and skin. Repeated or prolonged exposure increases health risks. A formalin warning label must be attached to the container. Most containers are prelabeled by the factory before use. If a pre-labeled container is not used, please identify the solution in the container by labeling the container appropriately (i.e. formalin, glutaraldehyde, saline, etc.). 33

39 ROUTINE SPECIMEN REQUISITIONS Routine specimens must be accompanied by an AmeriPath requisition form. Complete the requisition as previously instructed and include the following information: Any preoperative and postoperative diagnoses to the degree known Pertinent clinical information Specimen source listed numerically if multiple specimens ROUTINE SPECIMEN FIXATION AND TRANSPORT 1. Place routine tissue specimens in a properly labeled container that contains 10% formalin solution. The size of the container should be proportionate to the size of the specimen so that the formalin:tissue ratio is approximately 20:1. 2. Make sure the lid is straight and tight on the specimen container before bagging it. This is to prevent leaking and possible damage to the specimen. Seal the specimen into a biohazard bag, and place the requisition in the side pouch of the bag. 3. Notify the laboratory of the need for a pick-up if your clinic is not on a regular pickup schedule. If it is After Hours call MYQUEST ( ). INTRAOPERATIVE TISSUE CONSULTATIONS FROZEN SECTIONS 1. To notify the laboratory of an intraoperative tissue consult or frozen section, please call to schedule. When possible, a 24-hour advance notice is appreciated. 2. Specimens for frozen section or intraoperative consult will be submitted fresh (NOT in formalin or other tissue fixative). Please call for instructions. 3. Label the specimen containers as described above. 4. Complete an AmeriPath requisition form as previously instructed, including the following information: Clinical history/preoperative diagnosis Specimen source, listed in numerical order if multiple specimens Any special instructions or information SPECIMEN COLLECTION 34

40 Bone Marrow Routine Histology If you are a Saint Luke s entity, please contact Saint Luke s Regional Laboratory Hematology Department for supplies and instructions If you are not a Saint Luke s entity please call for instructions. Gout Specimen Evaluation of tissue and/or fluid for gout (urate) crystal identification: - Tissue or fluids should be submitted in absolute alcohol or fresh to avoid dissolution of the crystals in aqueous solution (crystals are water soluble). - DO NOT use saline solution or formalin. Urinary Stone (Calculus) Analysis Procedure: 1. Air dry stone after removal. 2. Place in a clean, dry container (such as a sterile urine container). Do not transport in liquid or tape as analysis will be hindered and/or delayed, compromising results. 3. Label container with patient s first and last name and specimen source. Submit with completed AmeriPath requisition. NOTE: If you are a Saint Luke s entity, please contact Saint Luke s Regional Laboratory at or Saint Luke s Laboratory Client Services at for instruction. SPECIFIC SPECIMEN REQUIREMENTS The following specimens should be received fresh and require IMMEDIATE processing. Monday through Friday, 7:00 AM 5:00 PM, contact the laboratory at for instructions. For after hours, weekends, or holidays, please call the Saint Luke s Hospital Operator at to page the pathologist on-call. Golden Valley Memorial Hospital call Diagnostic Lymph Node Biopsies (including flow cytometry and/or cytogenetics) must be received fresh. 35

41 2. Frozen Section or Intraoperative Consultation Tissue must be received fresh ASAP. Call for specific instructions. 3. Products of Conception for Cytogenetics submit a portion of the sample fresh in sterile container. Maintain at room temperature. Call for immediate pick-up. Place in formalin if cytogenetics is not required. 4. Tissue biopsies for Flow Cytometry should be placed immediately in RPMI media. If RPMI is not available, call for instructions. 5. Tissue biopsies for Direct Immunofluorescence Place in Michael s Transport Media. A second specimen at the same site or ½ of the original biopsy should be placed in 10% formalin for correlative light microscopy. Michael s Transport Media is available by request. Please see page 11 for AmeriPath Supply Order instructions. 6. Tissue for Electron Microscopy (other than renal biopsies) must be received fresh in saline or immediately placed in 2.5% glutaraldehyde. Tissue fragments must be 1 mm or smaller. If glutaraldehyde is not available, please call for instructions. 7. HER2 Testing in Breast Cancer Specimens - ASCO/CAP Guidelines 1. Required fixative is 10% Neutral Buffered Formalin 2. Record time on the requisition that biopsy is placed into fixative. 8. Tissue for Muscle Enzyme Histochemistry Please call in advance to notify AmeriPath that a muscle biopsy is scheduled or Specific instructions are included in the Gross Room manual at each hospital entity. Submit on saline moistened gauze to the gross room. Once received, transport on ice will be arranged (not frozen) to the Saint Luke s Plaza Gross Room. Instructions will be sent upon request via fax. A STAT courier will need to be scheduled to pick up the specimen(s). 9. Renal Biopsy Specimens Transplant and Native Specific instructions and kits with Zeus and Carson s fixatives are available in each hospital gross room. A complete patient history and billing information must be submitted with the completed requisition. Please notify client services at when a biopsy is collected. A STAT courier will need to be scheduled to pick up the specimen(s). If you are a client office, please call for instructions. 36

42 SPECIMENS FOR CLINICAL TESTING Chlamydia and Gonorrhea by PCR A. ThinPrep Pap (preferred collection) 1. Collect per ThinPrep protocol (see pages 24-25). B. M4-Viral Transport Media 1. Female a. Clean area by removing any excess mucus, blood, or examination lubricants. Discard this swab. b. Insert second swab into the endocervical canal. Rotate clockwise for 3-5 seconds and withdraw. c. Insert swab into transport tube. Break shaft of swab and close securely. Leave swab in the media. 2. Malea. Patient should not urinate 2 hours prior to sampling. b. Insert the small sterile swab 2-4 cm into the urethra. Rotate 3-5 seconds and withdraw. c. Insert the swab into the transport media. Break shaft of swab and close securely. Leave swab in the media. NOTE: Do not force swab into the bottom of the tube, swab should be suspended in the media C. Gen-Probe Media 1. Collect per Gen-Probe protocol. Refer to Gen-Probe specimen collection kit. D. Urine 1. Male - Chlamydia and Gonorrhea a. Patient must NOT have urinated for at least two hours prior to collection. b. Collect 10 to 50 ml of FIRST catch urine into clean, polypropylene container without preservatives. c. Refrigerate specimens (2-8 degrees) until pick-up by courier. d. Check Chlamydia and/or Gonorrhea box on requisition and write urine as specimen being submitted 37

43 2. Female Chlamydia only a. Patient must NOT have urinated for at last two hours prior to collection. b. Collect 10 to 50 ml of FIRST catch urine into clean, polypropylene container without preservatives. c. Refrigerate specimens (2-8 degrees) until pick-up by courier. d. Check Chlamydia box on requisition and write urine as specimen being submitted. E. SurePath Pap 1. Collect as for Pap smear (see page 29). F. Swab Collection and Transport Kit 1. May be used for vaginal samples 2. Rotate the swab 5-10 times while sampling to allow enough cells to adhere to the swab tip. 3. Place swab(s) in tube after collection. 4. No refrigeration is necessary. G. BD Probetec 1. Collect per BD Probetec protocol. Refer to BD Probetec specimen collection kit. Vaginosis Panel A. Submit BD Affirm VP III swab per specimen collection guidelines on packaging. The BD Affirm is only viable for 72 hours once collected. A reduction in sensitivity may occur is transport time exceeds 72 hours. AmeriPath will reject specimens older than 72 hours. AmeriPath will only accept those specimens where the entire vaginosis panel is ordered. Group B Strep by PCR A. Transport Media (preferred collection) 7. Use Swab Collection and Transport Kit. 8. Kit may be used for anal and vaginal samples. Combination anal/vaginal samples can be used by placing both swabs into a single transport tube. 9. Rotate the swab 5-10 times while sampling to allow enough cells to adhere to the swab tip. 10. Place swab(s) in tube after collection. 11. No refrigeration is necessary. 38

44 Note: Drug sensitivities cannot be performed using PCR methodology. B. ThinPrep Pap 1. Collect per ThinPrep protocol (see pages 24-25). Herpes Simplex Virus I/II by PCR A. Transport Media (preferred collection) 7. Use Swab Collection and Transport Kit. 8. Kit may be used for penile or vaginal samples. 9. Rotate the swab 5-10 times while sampling to allow enough cells to adhere to the swab tip. 10. Place swab(s) in tube after collection. 11. No refrigeration is necessary. B. ThinPrep Pap 1. Collect per ThinPrep protocol (see pages 24-25). C. M4-Viral Transport Media 3. Female a. Clean area by removing any excess mucus, blood, or examination lubricants. Discard this swab. b. Insert second swab into the endocervical canal. Rotate clockwise for 3-5 seconds and withdraw. c. Insert swab into transport tube. Break shaft of swab and close securely. Leave swab in the media. 4. Malea. Patient should not urinate 2 hours prior to sampling. b. Insert the small sterile swab 2-4 cm into the urethra. Rotate 3-5 seconds and withdraw c. Insert the swab into the transport media. Break shaft of swab and close securely. Leave swab in the media. (continued) NOTE: Do not force swab into the bottom of the tube, swab should be suspended in the media D. Urine 1. Collect in a sterile cup. Urine sample is good for 48 hours and must be kept refrigerated. Human Papilloma Virus (HPV) A. ThinPrep Pap (preferred collection) 39

45 1. Collect per ThinPrep protocol (see pages 24-25). D. Digene Cervical Swab 1. Collect per Digene protocol. Refer to Digene cervical swab specimen collection kit. E. SurePath Pap 1. Collect per SurePath protocol (see page 29) Urine for UroVysion Testing 1. Use AmeriPath Urine Cytology Kit. 2. Collect ml of urine in labeled collection container. Do NOT collect first morning urine. 3. Immediately pour an equal amount of fixative into the specimen collection container with the urine. 4. Place fixative bottle back into the kit box and return with the specimen. 5. Place cap on urine collection container and secure tightly. 6. Label specimen with patient s name and a second unique identifier. 7. Place urine collection container into plastic zip-lock specimen bag and seal. 8. Place sealed plastic bag containing the specimen collection container into the Urine Cytology Kit Box. 9. Complete test requisition. CPT codes: 88271X4, 88274X1 40

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50 *NOTICE NEW CONTACT INFORMATION* Supply Request Form Orders processed within two business days. Order Date: *Contact Name: Fax Orders To: *Contact Phone: *Required Information Or Contact Allyx: *Client Name And Address: Updated 2/3/2016 Client Name 1234 Client Address St. Kansas City, MO Cytology Supplies Qty. UOM Pathology Supplies Qty. UOM SurePath Vials 25/Flat 20 ml Formalin Cont. 192/Case SurePath Brushes/Spatulas SurePath Brooms ThinPrep Vials 25/Bag 25/Bag 25/Flat 40 ml Formalin Cont. 96/Case 60 ml Formalin Cont. 96/Case 120 ml Formalin Cont. 96/Case ThinPrep Brushes/Spatulas 25/Bag 16oz (500ml) Empty Cont. 100/Case ThinPrep Brooms 25/Bag 32oz (1L) Empty Cont. 100/Case Sterile Collection Cups 100/Case 64oz (2L) Empty Cont. 20/Case Cytolyt Collection Cups 50/Case 165oz (5L) Empty Cont. 10/Case Cytology Spray Fixative Each Michel s Fixative Each AmeriPath Swabs Kits Each 2.5 Gal. Formalin Cube Each Collection Kits Qty. UOM Requisitions Qty. UOM Prostate Kits Each OB/GYN Each Stone-A-Lyzer Kits Each Dermatopathology Each PCA3 Kits Each Surgical Pathology Each Urovision Kits Each Non-Gyn Cytology Each Specimen Transport SM MED 100/Bag 100/Bag GI Prostate Pathology Each Each Bags LG 50/Bag ABN Forms Each FOR AMERIPATH USE ONLY: Other Supplies Qty. UOM Date Sent: Time Sent: Sent By: 45

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