105-A Cooper Court, Los Gatos, CA 95032

Transcription

1 105-A Cooper Court, Los Gatos, CA Directory of Services 2018

2 T A B L E O F C O N T E N T S Preface 4 MISSION STATEMENT... 4 PATHOLOGY STAFF... 5 PHONE NUMBERS... 6 LABORATORY ACCREDITATIONS... 6 RESULTS AND REPORTS... 6 DIRECTORY OF SERVICES... 7 WEBSITE 7 Compliance with Federal and Regulatory Agencies 8 TEST ORDERING AND SPECIMEN SUBMISSION... 8 MEDICAL NECESSITY AND ADVANCED BENEFICIARY NOTICE (ABN)... 8 PROFESSIONAL COURTESY... 8 Cytology Specimens 9 LABELING... 9 REQUISITIONS... 9 SPECIMEN PACKAGING SPECIMEN REJECTION POLICY VERBAL ORDERS COURIER SERVICES ORDERING SUPPLIES SUBMITTING SPECIMENS TO THE LABORATORY Collection of GYN Specimens 12 PATIENT PREPARATION COLLECTING CONVENTIONAL SMEARS THINPREP COLLECTION SUREPATH COLLECTION DNA Testing Available from the Thinprep/SurePath Vials 16 Vaginosis Testing (BDAffirm VP III) 17 Introduction Specimen Collection Specimen Collection Diagram Collection of Non-GYN Specimens 19 BODY FLUID CAVITIES (PLEURAL, PERITONEAL AND PERICARDIAL). 19 URINE UROVYSION/IMMUNOCYT BLADDER CANCER DETECTION SPUTUM CEREBROSPINAL FLUID (CSF) NIPPLE SECRETIONS CYST ASPIRATIONS

3 FINE NEEDLE ASPIRATION (FNA) BIOPSY TEST FOR SPERM PRESENCE (POST-VASECTOMY) SPECIMEN COLLECTION AND HANDLING Collection of Histology Specimens (Tissue Biopsies) 23 FIXATION SPECIMEN PACKAGING REQUISITIONS SPECIMEN REJECTION POLICY VERBAL ORDERS SPECIMENS FOR ROUTINE HISTOLOGY Courier Services (800) ext PROSTATE BIOPSIES SPECIFIC SPECIMEN REQUIREMENTS

4 MISSION STATEMENT P R E F A C E This document was written for the following reasons: 1. To provide instruction on the collection and submission of cytology and histology specimens 2. To ensure that the optimal specimen and information is obtained for accurate and timely diagnosis 3. To save patients the inconvenience and 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 questions in the manual, please call the laboratory. Tests desired by clients that are not performed at APMG 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. APMG strives to maintain a reputation for quality, innovation and dependability and we welcome comments and suggestions to further that effort. All laboratories are not the same. At Associated Pathology Medical Group, Inc (APMG), we believe that part of your reputation as a physician depends on the laboratory you choose. Your patients come to you for quality medical service and accurate, timely laboratory testing. It is not just our reputation on the line. It is also your reputation. We are proud of our tradition of personal service and exceptional testing quality. Our laboratory encourages an atmosphere of personal consultation among medical professionals. You will always find a pathologist or technologist available to assist you with your special needs and questions. This handbook serves as a reference for the services offered by APMG. It should also facilitate the appropriate utilization of these services by providing easily accessible answers to those questions most frequently asked regarding the tests we perform. This handbook reflects a considerable effort on the part of many individuals on the technical, supervisory and senior professional staff within our laboratory. We have attempted to provide a complete and useful guide, but we appreciate that there are undoubtedly some oversights. Our plan is to continue to update this handbook at frequent intervals; and we welcome any suggestions that you may have for improvement of future editions. 4

5 PATHOLOGY STAFF Julia S. Chan, MD Board Certified in Anatomic and Clinical Pathology and Cytopathology, with special interests in Dermatopathology, women s health and gastrointestinal pathology. Carlene A. Hawksley, MD Board Certified in Anatomic and Clinical Pathology. Special interests include microbiology, fine needle aspiration cytology and women s health. Paula S. Quinn, MD Board Certified in Anatomic and Clinical Pathology. Special interests include hematopathology and gastrointestinal pathology. Werner J. Stamm, MD Board Certified in Anatomic and Clinical Pathology. Advanced training in fine needle aspiration biopsy and special interest in gynecological cytopathology. Ken W. Westphal, MD Board Certified in Anatomic and Clinical Pathology. Special interests include immunohistochemistry and gastrointestinal pathology. Jeffrey F. Young, MD (Laboratory Director) Board Certified in Anatomic and Clinical Pathology. Fellowship training in oncological pathology and special interest in gynecological cytopathology and quality assurance. Leonard A. Valentino, MD Board Certified in Anatomic and Clinical Pathology, Dermatopathology and Nuclear Medicine. Katharine Brady, MD Board Certified in Anatomic and Clinical Pathology and Hematopathology. M. Quinn Wickham, MD Board Certified in Anatomic and Clinical Pathology. Joe Song Annie Patel CEO Medical and Client Services Manager 408/ / Rick Glass Cindy Stratton Territory Manager Business Development Manager 408/ / Roberta Tarbox Priscilla Suarez Billing Supervisor Histology Laboratory Coordinator 408/ /

6 Gayle Guthrie Rodel Del Rosario Cytology Manager Logistics/Courier Services Manager 408/ / Peter Nguyen Lina Wang IT Manager Executive Assistant 408/ / Mary Chu Molecular Microbiology 408/ PHONE NUMBERS Main Number...408/ Billing Department / Medical/Client Services (8:00 a.m.-5:00 p.m.) / x 1 (report copies, slide requests) Logistics (8:00 a.m.-5:00 p.m.) / x 2 (specimen pick-up, supplies) After Hours Specimen Pick-Up / x 2715 Cytology / (collection information on liquid specimens or slides) Histology / (collection information on tissue biopsies) Pathologists (during the day) / x 1 Fax number / LABORATORY ACCREDITATIONS College of American Pathologists: Laboratory # U.S. Department of Health and Human Services: CLIA #05D State of California: CLF RESULTS AND REPORTS Results of cytology and histology evaluations are entered into the APMG computer system as the tests are completed. The reports are generated from the computer 6

7 system and are sent to the clinician via in-house couriers. Reports are faxed for significant results or upon request. APMG has the capacity to deliver electronic reports via a secure web interface. Please contact your APMG Territory Manager if this would be of interest to your practice. The Medical Services Department has been designed in order 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, to access specific reports and to facilitate communication between physician clients and our pathologists. Slide requests are also handled in this department. Our Logistics Department is available to order pathology and cytology supplies and arrange for specimen pick-up. DIRECTORY OF SERVICES This manual is available to all APMG clients. Manuals are automatically distributed to all new accounts. When significant changes are made, updated manuals will be distributed to all physician offices and surgical centers utilizing APMG services. WEBSITE APMG clients may order supplies and requisitions by visiting our web sit at 7

8 C O M P L I A N C E W I T H F E D E R A L A N D R E G U L A T O R Y A G E N C I E S APMG 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 ethical and business policies As part of this commitment, physicians are notified of the following requirements. APMG 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 Laboratory tests may be ordered by physicians or other authorized personnel, such as nurse practitioners. All orders must be accompanied by a written requisition, including add-on tests. All specimens (bottles and vials) must be appropriately labeled. MEDICAL NECESSITY AND ADVANCED BENEFICIARY NOTICE (ABN) Laboratories can submit claims to federally funded health programs only for services considered medically necessary. An ICD-10CM 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 of pap smears is 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 ABN (located on the requisition form), must be completed. The ABN gives the patient advance notice that Medicare will not pay for the procedure. PROFESSIONAL COURTESY APMG, in accordance with the Anti-Kickback Statute and California State Law, does not provide free laboratory testing for health care providers, their families, and their employees. 8

9 C Y T O L O G Y S P E C I M E N S To ensure optimal specimens and test results, APMG provides instructions on the collection, preparation, handling and transport of cytology specimens. LABELING The patient s name must be placed on the collection vial (not the lid) or on the frosted end of the slide. If there are multiple specimens, place each in a separate container and clearly note the specimen source in addition to the patient name. Specimens not labeled will be returned for proper identification. REQUISITIONS An APMG requisition must accompany each specimen. To ensure accurate reporting of test results and proper and timely billing, we must have accurate patient information from our clients. Please include the following legibly written information: Patient s date of birth and social security number Complete address of the patient Guarantor s name if other than the patient Complete insurance information. A copy of the patient s insurance card(s), front and back, attached to the requisition, is best Complete patient name as it appears on the primary insurance card Appropriate ICD-10 Code Patient s clinical history (abnormal bleeding, grossly visible lesion, etc.) Requesting physician s first and last name (Circle appropriate choice if multiple physician names appear on the requisition) Physician or designee s authorization. Specimen type and source Specimen collection date Type of test/methodology requested Menstrual status (LMP, hysterectomy, pregnant, hormone therapy) Previous abnormal cytology results, previous treatment, biopsy or surgical procedure Patients risk status for developing cervical cancer, e.g. high risk 9

10 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 data. The requested information must be submitted in writing before tests can be performed. SPECIMEN PACKAGING A secure container ensures safe transport of the specimen. Please make sure to tighten 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. SPECIMEN REJECTION POLICY It is our policy at APMG 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, specimen source, and all available clinical history. All specimen containers and slides must be labeled with the patient s name. The above procedures must be followed; otherwise the requisition and specimen will be returned via courier to the referring physician for appropriate identification the following day, with a letter explaining the reason for rejection of the specimen. 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 specimens and requisitions do not match. VERBAL ORDERS Any additional testing which is verbally requested MUST be followed up with a written requisition in order to comply with regulatory requirements. COURIER SERVICES When specimens are ready to be picked up, place them in the designated courier area for courier pick-up. If your office is not on a regular pick-up schedule, call APMG at 800/ x 2715 to request a courier pick-up. If you are calling after hours, please call 800/ x 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 such needs, it is preferable to give APMG 24- hour notice. 10

11 ORDERING SUPPLIES All clients will be supplied with ThinPrep vials and collection devices for liquid-based specimens, pap kits for conventional smears, frosted end slides, bags for submitting specimen containers and requisition forms. To order supplies: Fill out the APMG Supply Requisition Form completely, including the office or practice name, address, phone number, date of order and contact person. Indicate the amount of each supply you will need. Place the supply requisition form in the courier pick-up box, or fax it to 408/ Remember, you can order online if you like. NOTE: Our policy is to fill all supply requests within 48 hours. If you need the supplies sooner, please call 800/ x 2715 and speak to the Logistics/Courier manager. We will make every effort to meet your needs. Standing orders are available with certain restrictions. SUBMITTING SPECIMENS TO THE LABORATORY All cytology specimens should be submitted to the laboratory as soon as possible after collection. Additional delay results in deterioration of unfixed specimens. If delay is unavoidable (more than 1 hour), please refrigerate specimens until they are picked up. Should you require specimen pick-up after normal business hours or at other times when your office is closed, a secure stainless steel lockbox can be provided to you at no cost. APMG lockboxes may be hung over any door or may be placed on the ground outside your office. Specimens placed in the lockbox will be picked up by an APMG courier later that same day and delivered to the laboratory. To receive a lockbox for your office, simply call 800/ x

12 PATIENT PREPARATION C O L L E C T I O N O F G Y N S P E C I M E N S Sampling during menses is discouraged. Optimally, patients should schedule appointments approximately 10 to 18 days after the first day of their menstrual period. Patients should avoid use of tampons, birth control foams, jellys or other vaginal creams, vaginal medication or vaginal contraceptives 48 hours prior to the test. Patients should refrain from intercourse 48 hours prior to the test. Patients should not douche 48 hours before the test Use only water-based lubricants, as sparingly as possible. COLLECTING CONVENTIONAL SMEARS Collection of cervical/vaginal specimens for conventional smear preparation using the spatula and endocervical brush: The vaginal fornix and ectocervix should be sampled before sampling the endocervix/transformation zone. A sample of the ectocervix is taken using a plastic spatula. The notched end of the spatula that corresponds to the contour of the cervix is rotated 360 around the circumference of the cervical os, retaining the sample on the upper surface of the spatula. Grossly visible lesions, including irregular, discolored or friable areas should be directly sampled and can be placed on a separate slide, especially if the lesion is distant from other collection areas. The spatula is held with the specimen face up while the endocervical sample is collected. Sampling of the endocervix requires insertion of the endocervical brush into the endocervical canal until only the bristles closest to the hand are visible. The brush is rotated and removed. At this time, the sample on the spatula is spread evenly and thinly lengthwise down one half of the labeled slide surface, using a single uniform motion. The endocervical brush is then rolled along the remaining half of the labeled slide surface by turning the brush handle and slightly bending the bristles with gentle pressure. The brush should not be smeared with force or in multiple directions. The entire slide is then rapidly fixed by spray fixative that has been provided by the laboratory. The collection devices are discarded. 12

13 Please note that the use of the endocervical brush may be contraindicated in pregnant patients. Refer to the package insert. If the above-described sampling order is reversed, bleeding secondary to abrasion from the brush may obscure the cellular material. THINPREP COLLECTION Collection of cervical/vaginal specimens for liquid-based preparations using the spatula and endocervical brush: Obtain an adequate sample from the ectocervix using a plastic spatula. Rinse the spatula into the vial by swirling the spatula vigorously in the vial 10 times. Discard the spatula. Obtain an adequate sampling from the endocervix using an endocervical brush device. Insert the brush into the cervix until the bottommost fibers are exposed. Slowly rotate 1/4 to1/2 turn in one direction. Do not over-rotate. Rinse the brush in the solution immediately by rotating the device in the solution 10 times while pushing against the vial wall. Swirl the brush vigorously to further release material. Discard the brush. Tighten the cap so the torque line on the cap passes the torque line on the vial. Collection of cervical/vaginal specimens for liquid-based preparations using the broom-like device: Obtain an adequate sampling from the endocervix 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 gently, and rotate the broom in a clockwise direction 5 times. Rinse the broom in the vial solution immediately 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. Tighten the cap so that the torque line on the cap passes the torque line on the vial. Failure to rinse the brush or broom vigorously and immediately after sampling may result in too few cells being collected for evaluation. This may result in an unsatisfactory Pap smear or QNS (quality not sufficient) molecular testing result. 13

14 SUREPATH COLLECTION MEDICAL GROUP

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16 D N A T E S T I N G A V A I L A B L E F R O M T H E T H I N P R E P / S U R E P A T H V I A L S The infectious organisms and genetic diseases listed below can be detected by using DNA PCR testing methods. Specimens may be collected concurrent with the Pap smear (except GBS, which requires rectal and vaginal sampling) or separately using small collection vials provided by the laboratory. Human papilloma virus (high and low risk types of HPV) Chlamydia trachomatis Neisseira gonorrhoeae 16

17 V A G I N O S I S T E S T I N G ( B D A F F I R M V P I I I ) Introduction The BD Affirm VP III microbial identification test uses DNA probe technology to identify the three main pathogens that cause vaginitis: Candida, Gardnerella and Trichomonas. This assay has superior sensitivity and specificity when compared to wet mount and gram stain and correlates well with the culture results. Specimen Collection Specimen collection is a critical step an personnel collecting vaginal fluid specimens should be well trained, to minimize the possibility of inadequate specimens. The BD Affirm VP III Ambient Temperature Support System is used for collection and extended transport. After collection, the specimen is stable for up to 72 hours at either ambient temperature or refrigerated. Open the seal and remove components of the collection/transport system. Tear/remove dropper and break ampule. Dispense fluid into the sample collection tube. Remove swab and collect the specimen. Use an unlubricated speculum (without jelly or water) to visualize the posterior vaginal fornix. The sample should be collected from the posterior vaginal fornix. Twist or roll the swab against the vaginal wall two or three times, ensuring that the entire circumference of the swab has touched the vaginal wall. Swab the lateral wall while removing the swab. Immediately place the swab into the sample collection tube. With the swab touching the bottom of the collection tube, grasp the pre-scored handle of the swab just above the top of the tube and bend until the swab breaks. The score mark on the swab is approximately 1 cm above the top of the collection tube. Discard the broken handle. Place the cap over the exposed end of the swab and firmly press the cap onto the tube. The cap will snap onto the tube when it is properly seated. Place patient label on tube. The label should include patient identification information and the time of the sample was collected. 17

18 Specimen Collection Diagram 18

19 C O L L E C T I O N O F N O N - G Y N S P E C I M E N S BODY FLUID CAVITIES (PLEURAL, PERITONEAL AND PERICARDIAL) Perform tap. Place sample in a clean container (such as a sterile urine container or glass aspiration bottle). Have specimen delivered immediately to the laboratory. If there is an anticipated delay, the specimen should be refrigerated. 1 ml of EDTA per 500 ml of specimen should be added. 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. URINE A voided urine specimen should be obtained after the patient has been well hydrated, approximately three hours after the last void. Do not submit the first morning void for cytology. Clean catch samples are necessary. Female patients should be instructed to spread the labia during collection. The first portion of the urine stream is not collected. The remainder of the sample is collected into the container. Males should be instructed to pass and discard a small amount of urine and then collect the mid-portion of the specimen. Do not collect the last portion. If the patient is unable to cooperate satisfactorily, a catheterized specimen should be obtained. Method of collection should be stated on the requisition form. 50 ml is a sufficient sample. Do not submit a 24- hour collection for cytology. These are unsatisfactory because of cellular degeneration. Collect 50 to 100 ml of urine into a labeled, sterile container. Immediately pour an equal amount of fixative into the urine. The laboratory provides containers and fixative. 19

20 UROVYSION/IMMUNOCYT BLADDER CANCER DETECTION Specimen Types Voided urine (not limited to time of day, although first morning voids should be avoided when possible) or bladder washings are acceptable. Specimen Volume A minimum of ml of specimen are required, preserve immediately with an equal volume of alcohol (70% or greater). Aliquotted samples are not suggested if possible. Preserved pooled specimens are acceptable and preferred when specimen cellularity is known to be low. Specimen Collection APMG Urine Cytology Kit. Shipping Requirements Once preserved, the specimen can be maintained and shipped at room temperature for up to 7 days. Please note that if the preserved specimen cannot be delivered to the laboratory within 24 hours, refrigeration is preferred. SPUTUM The sample is collected in a wide mouth plastic container. The preferred specimen is that produced by a deep cough as soon as the patient awakens in the morning. The patient should be asked to rinse his mouth with water before coughing. If sputum production is scanty, several coughs over a period of two to three hours may be necessary to produce a sufficient sample. Have specimen delivered to the laboratory as soon as collection is completed. If more than 2-3 hours delay is anticipated before processing, submit specimen in a ThinPrep vial. The specimen should be labeled with the patient s first and last name and the source of the specimen. If three consecutive specimens are to be collected, all three can be delivered on the third day of collection. CEREBROSPINAL FLUID (CSF) The specimen for cytologic examination should be collected in a separate container. As large a volume as possible should be submitted. Have the specimen delivered to the laboratory without delay. Do not add CYTOLYT to this specimen. 20

21 NIPPLE SECRETIONS Equipment: Glass slides (available from the laboratory) 95% alcohol or spray fixative. Procedure: Express material from nipple by gentle compression of the areolar area between thumb and finger. Material is expressed directly onto the glass slide, and gently spread over its surface. The slide is immediately dropped in 95% alcohol or spray fixed. Do not allow drying to occur. CYST ASPIRATIONS Expel aspirate from syringe into a sterile capped container. If preferred, immediately fixed smears can also be submitted together with the fluid. If delay before processing will exceed 1 hour, refrigerate or add an equal volume of CYTOLYT solution. 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. Equipment: Glass slides 22, 23 or 25 gauge needles Aspiration gun Syringe to fit in gun Alcohol swabs Cotton 4 x 4 gauze pads Spray fixative or 95% alcohol Procedure 4. The lesion is localized by palpation. The lesion must be easily palpable to obtain an adequate specimen. 5. The needle is attached to the syringe, which is attached to the aspiration gun. Inspire air into syringe to ensure adequate suction. Leave a small amount of air in syringe before aspiration. 6. Localize and stabilize the lesion with one hand. Clean skin with alcohol swab. Insert needle into lesion with opposite hand. Apply suction with aspiration gun. 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. Release suction before withdrawing the needle. Withdraw needle and have patient or assistant apply pressure to puncture site with cotton gauze. 21

22 7. Prepare smears by placing a small drop of material near the labeled end and smearing with another slide. Prepare both fixed and unfixed smears. Fixed smears must be immediately spray fixed. 8. Label slides with the patient s first and last name, whether fixed or airdried, and the site of specimen (e.g. left breast ). 9. Complete cytology requisition form. Indicate that the specimen is an FNA and specify the site aspirated, the clinical impression and all pertinent clinical history. Note: The pathologists at APMG are available to provide advice on aspiration technique, specimen collection, smear preparation, etc. Dr. Stamm, in particular, has extensive experience in performing fine needle aspiration biopsies. TEST FOR SPERM PRESENCE (POST-VASECTOMY) Principle: 1. Bilateral vasectomy has been a popular means of rendering the male infertile by interrupting the sperm passage provided that the surgery is carried out properly and sufficient time has elapsed to allow viable spermatozoa to be cleared from the reproductive tract. Generally ejaculates may be necessary in order to accomplish this. 2. In this procedure, seminal fluid is evaluated microscopically to determine the presence/absence of spermatozoa, for the purpose of determining the completeness of vasectomy. SPECIMEN COLLECTION AND HANDLING 1. The specimen may be obtained either at home or in the physician s office by masturbation. In either case, the specimen should be collected in a sterile plastic urine container supplied by the laboratory. Specimens obtained in condoms and sheaths are acceptable, but not preferred. 2. It is recommended that specimens for sperm presence should be received in the laboratory within 2 to 3 hours after collection, although time received is not critical. 3. Complete the Urology Requisition form including the time of collection. 4. If time of delivery is delayed, keep specimen refrigerated. 22

23 C O L L E C T I O N O F H I S T O L O G Y S P E C I M E N S ( T I S S U E B I O P S I E S ) FIXATION Upon collection, specimens must be immediately preserved to avoid deterioration. Most tissue specimens are submitted in 10% buffered formalin. Pre-filled formalin containers, in a variety of sizes, can be ordered through our client services department. Use caution when handling formalin. It is toxic if inhaled or swallowed and can be irritating to the eyes, respiratory system, and skin. There is a risk of serious damage to eyes. Formalin may cause cancer, and repeated or prolonged exposure increases the risk. A formalin warning label must be attached to the container. NOTE: Most containers are pre-labeled by the factory before use. If a pre-labeled container is not used, please identify the solution containing the specimen on the specimen container (e.g. formalin, glutaraldehyde, saline, etc.). SPECIMEN PACKAGING 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. All specimens shall be placed in containers with lids tightly secured to prevent leaking. The container (not the lid) shall be labeled with the patient s first and last name, date of collection and specimen source. Multiple specimens should be placed in separate containers with each source clearly identified (in addition to the patient s name). Seal the container into a biohazard bag. Place the requisition in the outer pocket of the bag. 23

24 REQUISITIONS An APMG requisition form must accompany each specimen submitted. We know that proper and timely reporting of results is one of your concerns. In order for us to accomplish this, we must have accurate patient and specimen information from you, which must be legibly written on the requisition accompanying the specimen. Please include the following: Complete patient first and last name Complete address of the patient Patient s date of birth and social security number (SS# not required but very useful for patient identification) Patient s pertinent clinical history Specimen type and source(s) listed numerically if multiple specimen sources To the degree known, any preoperative and postoperative diagnosis Specimen collection date The procedures or special tests desired Complete insurance information. A copy of the patient s insurance card(s), front and back, attached to the requisition, is best Appropriate ICD-10 Code (optional) Requesting physician s first and last name Physician or designee s authorization 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 requested information will need to be provided before tests can be performed. The second copy of the requisition is for your office use, and may be disposed of if not needed by your office. 24

25 SPECIMEN REJECTION POLICY It is our policy at APMG to meet all regulatory agency guidelines and to provide the best patient care possible. To do so we must enforce the following procedures: 1. All requisitions must have the patient s name, tissue type and all available clinical history. 2. All specimen containers must be labeled with the patient s name and tissue type. The above procedures must be followed, otherwise the requisition and specimen will be returned to you for appropriate identification via courier the following day, with a letter explaining the reason for rejection of the specimen. 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 specimens and requisitions do not match. VERBAL ORDERS Any additional testing or procedures that are verbally requested MUST be followed by a written requisition within 30 working days in order to comply with regulatory requirements. Tissue specimens submitted for histopathology must meet the requirements listed above before they can be accepted for examination. If you have questions about the collection of histology specimens, call 408/ SPECIMENS FOR ROUTINE HISTOLOGY Collect specimen and place in a properly labeled container with 10% formalin. Make sure the lid is tightly secured and the container is identified with the patient s name and the specimen site. Submit with an APMG requisition. If your practice or office is not on a regular pick-up schedule, notify the laboratory by calling: Courier Services (800) ext

26 PROSTATE BIOPSIES Obtain biopsy specimen and place directly into a vial containing formalin. Multiple core specimens from the same sextant area should be placed in the same specimen collection vial. If you are submitting biopsies from separate prostate sites (e.g. left and right, base and apex, medial and lateral, etc.), we suggest you use our prostate histology collection kit for your convenience. Make sure specimen labels corresponding with the biopsy site location are placed on the corresponding collection vials. Place tightly sealed specimen container into a biohazard bag and place a completed APMG test requisition form into the outer pouch of the plastic bag. If you are using the prostate collection kit, place the entire specimen container tray into the biohazard bag provided and seal. Insert the test requisition and place the bagged tray into the collection kit box and close the lid. SPECIFIC SPECIMEN REQUIREMENTS Tissue Biopsies for Immunofluorescence: Place in Michel s transport solution. This can be obtained through a supply order through APMG courier services. 26