CLIENT GUIDE Version 1.1: August 8 th 2017

CLIENT GUIDE Version 1.1: August 8 th 2017 Address: 3 Eastern Main Road, San Juan, Trinidad Phone: 1-868-674-PATH (7284) OR 1-868-221-5508 Fax: 1-868-674-7284 Website: www.nexgenpathology.com E-mail: mypath@nexgenpathology.com CAP #: 9400219 Lab Director: Wesley Greaves M.D.

Table of Contents 1. General Information...3 1.1 About Nexgen Pathology... 3 1.2 Contact Information & Opening Hours... 3 1.3 Scope of Laboratory Services... 4 2. Specimen Collection Materials and Supplies...4 3. Specimen Collection Procedures...5 3.1 Anatomic Pathology/Histology... 5 General Guidelines... 5 Special Notes... 5 3.2 Cytology... 7 Non-gynecological Cytology... 7 Gynecological Cytology... 7 3.3 Molecular Microbiology... 9 ThinPrep Vials... 9 Urine/Aptima Urine Collection Kit... 9 Aptima Unisex Swab Device... 10 Aptima Vaginal Swab Device... 11 3.4 Biochemistry and Hematology... 12 Blood Collection and Handling... 12 Microbiology Specimens... 15 Urine specimens... 15 Home Draw Program... 17 4. Specimen Identification requirements... 18 4.1 General... 18 4.2 Special Requirements by Specimen Type... 18 Blood specimens... 18 Bone Marrow specimens/aspirate slides... 18 Intraoperative consultations... 18 5. Test Requests & Specimen Pick Up... 19 5.1 General... 19 5.2 Phone Requests for Testing... 19 1

5.3 Cancellation of a requested test... 19 5.4 Stat test requests... 19 5.5 Time Sensitive Specimens... 19 5.6 Requesting Molecular Microbiology Testing... 19 5.7 Specimen Pick Up... 20 6. Test Reports... 21 6.1 Report Delivery... 21 6.2 Turnaround Time... 21 6.3 Critical Test Result Reporting... 21 Definition of Critical Test Results... 21 Notification Process... 21 Critical Test Result Chart... 23 7. Billing and Payments... 24 8. Reference Laboratories... 25 9. Appendix... 26 Appendix 1- Complete Test Listing... 26 Appendix 2.1- ThinPrep Collection Guide- Broom... 28 Appendix 2.2- ThinPrep Collection Guide- Brush & Spatula... 29 Appendix 3- Specimen Requisition Form (Anatomic Pathology)... 30 Appendix 4- Aptima Urine Collection Procedure Guide... 31 Appendix 5.1- Aptima Unisex Swab Collection Procedure (Female)... 32 Appendix 5.2- Aptima Unisex Swab Collection Procedure (Male)... 33 Appendix 6- Aptima Vaginal Swab Collection Procedure... 34 Appendix 7- Specimen Requisition Form (Biochemistry Testing)... 35 2

General Information 1.1 About Nexgen Pathology Nexgen Pathology was founded in 2013 with the aim of providing affordable, world-class medical laboratory services to Trinidad & Tobago and the region. Since its inception, Nexgen Pathology has grown to become a full-service medical laboratory, offering cutting-edge diagnostic services in line with international standards and best practices. We offer a comprehensive range of medical laboratory testing in biochemistry, hematology, immunohematology, serology, microbiology, surgical pathology, cytology, molecular diagnostics and genetics through in-house testing as well as in collaboration with our partner laboratories worldwide. Nexgen Pathology is enrolled in External Quality Assessment (EQA), also known as Proficiency Testing (PT), with the College of American Pathologists (CAP) and is currently in the process of obtaining full CAP accreditation by August 2017. 1.2 Contact Information & Opening Hours Address: 3 Eastern Main Road, San Juan, Trinidad & Tobago Phone: 1-868-674-7284/ 1-868-221-5508 Fax: 1-868-674-7284 E-mail: mypath@nexgenpathology.com Website: www.nexgenpathology.com Hours of Operation: Monday to Friday, 7am to 5pm; Saturday, 8 am to 1pm 3

1.3 Scope of Laboratory Services Anatomic and Clinical Pathology For a full test list by department please refer to Appendix 1. Specimen Collection Materials and Supplies As part of our service, we provide a range of complimentary collection materials including but not limited to: Formalin-filled containers ThinPrep Vials Aptima Collection Devices (Molecular Microbiology Swabs (High vaginal & Wound) Blood collection tubes Kindly contact our office to request. 4

Specimen Collection Procedures 3.1 Anatomic Pathology/Histology General Guidelines i. Tissue specimens should be placed in an appropriately sized container to prevent distortion of tissues, facilitate proper fixation and prevent spillage or evaporation of fixative. ii. Containers which can easily break or rupture (eg. Glass or Styrofoam) or those which may react with fixatives (eg. Metal or biodegradable plastics) are not recommended. Medical grade Polyethylene containers with snap or screw cap lids are highly recommended for surgical specimens. iii. Specimens should be submerged in 10 % neutral buffered formalin at ratio of 15:1 (15 units of formalin to 1 unit of specimen). iv. Fasten the lid of the container securely to prevent leakage in transit and ensure that the outside of the container is devoid of any contaminant (blood, tissue or fixative). v. Place a clear label with two patient identifiers (Name and Date of birth) as well as the specimen type on the specimen container. vi. Fill out the requisition form with all appropriate information and contact the laboratory for pick up. Special Notes Specimens for IHC testing Specimens that may require IHC testing should be sent to the lab as soon as possible. These specimens should be fixed for at least 6 hours but no longer than 72 hours, as over-fixation can adversely affect the IHC staining quality. Large Specimens: Large specimens must be received by the laboratory as soon as possible. Diffusion of formalin into tissue is a relatively slow process (approximately 1mm penetration per hour). As a result, larger specimens take longer to fix, especially if they are complex masses of tissue. Moreover as the mode of penetration occurs from the surface to the interior, larger masses may not receive appropriate internal fixation before cell autolysis occurs (i.e. tissue degradation). To avoid this, tissue sectioning must be performed by a qualified pathologist or pathologist assistant to expose the internal sections to fixative whilst avoiding damage surgical margins or diagnostically relevant tissues. Muscle Biopsies Muscle biopsy specimens should be transported on ice in a solution of 5 % saline. Ideally the muscle should be attached to a piece of cork board or laid flat in gauze to reduce shrinkage of the muscle fibres. Intraoperative Consultations (IOC) or Fresh specimens These specimens should be wrapped in gauze with a 5 % saline solution to keep them moist. They should be refrigerated during transport and taken immediately to the laboratory. In the 5

event of receiving and IOC, priority of transport to the laboratory is given over any other specimen/task. Bone Marrow aspirate and Biopsies If a biopsy specimen is obtained, place in 10% formalin. For the aspirated specimen, place ½ of the aspirate material in a small EDTA tube (Lavender top). Invert the tube several times and pour the remaining half into a sterile container. Prepare 8-12 smear slides and label them with the patient name, Date and specimen type (bone marrow aspirate). The remaining aspirate can be placed in 10% formalin after clotting. Air-dry all slides and send to the laboratory for processing. (NOTE: the most recent CBC results on the patient should also be sent). Blood and bone marrow specimens for time-sensitive tests (primarily flow cytometry and chromosome analysis) need to arrive at the lab ideally by 12:00 noon Monday-Thursday. If this is not possible, Friday by 12:00noon is also an option. Specimens arriving after 12 noon Monday-Thursday should be avoided where possible as these specimens need to be shipped for processing. These specimens CANNOT reach the lab after 12 noon on a Friday or the day before a public holiday as they will not be processed in time. 6

3.2 Cytology Non-gynecological Cytology Fresh fluids All fluids for cytology evaluation must be submitted fresh. These specimens should be submitted to the lab on the same day that they are taken. If that is not possible they should be stored at 4ºC and transported to the lab within 24 hours. The containers must be labelled with the patient s name and date of birth as well as the specimen type (fluid type and body site). FNA specimens submitted in Cytolyt Cytolyt is a buffered preservative solution that functions as a storage medium and it is also lyses blood cells and other obscuring materials in the specimen, thus resulting in a better slide quality for diagnosis by the pathologist and the ability to make cell blocks for ancillary testing (e.g. IHC). i. Cytolyt can be provided to you upon request from the lab for use with fine needle aspiration specimens only. ii. 1ml of specimen should be added to the 2 mls of Cytolyt (already provided in vial). At least three (3) vials per specimen are recommended, especially when preparation of a cell block for possible additional testing is likely. iii. Specimens in Cytolyt can be stored at room temperature but must be transported to the lab within 24 hours. Cytology smears All glass slides submitted for non-gynecological cytology should be labelled with the patient s name, date of birth and the specimen type. There should also be an indication of the slide preparation technique used (i.e. fixed or air dried). The slides should be transported in a sturdy container to avoid breakage. Gynecological Cytology Conventional smears All glass slides submitted for gynecological cytology should be labelled with the patient s name, date of birth and date of procedure. The slides should be transported in a sturdy container to avoid breakage. ThinPrep specimens All ThinPrep vials submitted for gynecological cytology should be labelled with the patient s name, date of birth and date of procedure. These vials can be stored at room temperature and once a specimen is introduced into the vial it is viable for 30 days. 7

*DO NOT SUBMIT THIN PREP VIALS WITH THE COLLECTION DEVICE (I.E. BRUSH OR BROOM) STILL IN IT. They should be rinsed in the ThinPrep vial by pushing it into the bottom of the vial and swirling vigorously to release the cells and it should then be discarded (refer to Appendix 2). Do not remove or cover the Nexgen Pathology label on the vial. This is used to monitor vial usage so that the physician s stock can be replenished upon depletion. 8

3.3 Molecular Microbiology Specimen types for molecular microbiology evaluation include ThinPrep vials, urine, Aptima unisex swabs, Aptima vaginal swabs or Aptima urine collection kits. ThinPrep Vials i. ThinPrep vials can be used for HPV, HPV reflex genotyping, Chlamydia & Gonorrhea and Trichomonas testing. ii. The specimens are collected in the same manner as a Pap smear and the submission requirements are the same as those outlined in the Cytology section. iii. For tests requested on the ThinPrep vials the requisition form must CLEARLY indicate which tests are required by selecting the appropriate boxes under the Women s Health Test section of the Nexgen Pathology requisition form (see Appendix 3). iv. If a Nexgen Pathology requisition is not being used the test requests must be clearly indicated on the form. Urine/Aptima Urine Collection Kit i. Urine can be submitted for Chlamydia/Gonorrhoea and Trichomonas vaginalis testing in either a standard urine collection cup (fresh) or in an Aptima urine collection vial. ii. For both modes of collection, the container/vial should be labelled the vial with the patient s name, date of birth and date of collection. iii. The patient should not have urinated for at least one hour prior to specimen collection. iv. For collection in a standard urine cup: The patient should be directed to provide approximately 20 to 30 ml of firstcatch urine. Collection of larger volumes of urine may result in specimen dilution that may reduce test sensitivity. The must be submitted within 24 hours of collection to the lab or can be transferred into an Aptima urine collection kit. v. For collection in the Aptima urine collection kit: Remove cap from the urine specimen transport tube (do not touch the foil cap) and transfer 2 ml of urine into the tube using the disposable pipette provided. The correct volume of urine has been added when the fluid level is between the black fill lines on the tube label. If the volume is below or above the two black lines the specimen will be rejected (refer to Appendix 4). Recap the urine specimen transport tube (do not touch the foil cap). After collection in the urine specimen transport tube the specimen can be stored at room temperature and is viable in this medium for 30 days. The urine specimen must be transferred into the Aptima urine specimen transport tube within 24 hours of collection. 9

Aptima Unisex Swab Device Unisex swabs can be used for Chlamydia/Gonorrhoea and Trichomonas vaginalis testing ONLY. They can NOT be used for HPV testing (refer to Appendix 5). Specimen collection for Females i. Label the swab container with the patient s name, date of birth and procedure date. ii. Use the cleaning swab (white swab) to remove excess mucous from cervix and surrounding mucosa. DISCARD THIS SWAB. iii. Insert collection swab (blue swab) into endocervical canal. Gently rotate the swab clockwise for 10 to 30 seconds to ensure adequate sampling. iv. Withdraw swab carefully, avoiding any contact with the vaginal mucosa. v. While holding the swab in hand, unscrew the tube cap. DO NOT SPILL THE TUBE CONTENTS! If the contents are spilled, discard and get a new Aptima unisex swab transport tube. vi. Immediately place the swab into the transport tube so that the tip of the swab is visible below the tube label. vii. Carefully break the swab s shaft at the score line against the side of the tube. viii. Discard the top portion of the swab shaft. The remaining portion remains in the tube and must be submitted. ix. Recap the transport tube (DO NOT TOUCH THE FOIL CAP). Specimen collection for males Patient should not have urinated for at least 1 hour prior to specimen collection. i. Label the swab container with the patient s name, date of birth and procedure date. ii. Discard the cleaning swab (white swab) as this is not required for male specimen collection. iii. Insert specimen collection swab (blue swab) 2 to 4 cm into urethra. iv. Gently rotate swab clockwise for 2 to 3 seconds in urethra to ensure adequate sampling. v. Withdraw swab carefully. vi. While holding the swab in hand, unscrew the tube cap. DO NOT SPILL THE TUBE CONTENTS! If the contents are spilled, discard and get a new Aptima unisex swab transport tube. vii. Immediately place the swab into the transport tube so that the tip of the swab is visible below the tube label. viii. Carefully break the swab s shaft at the score line against the side of the tube. ix. Discard the top portion of the swab shaft. The remaining portion remains in the tube and must be submitted. x. Recap the transport tube (DO NOT TOUCH THE FOIL CAP). 10

After collection these specimens are viable in this medium for 60 days at room temperature. Aptima Vaginal Swab Device Vaginal swabs can be used for Chlamydia/Gonorrhoea and Trichomonas vaginalis testing ONLY. The can NOT be used for HPV testing (refer to Appendix 6). i. Partially open swab package and remove the swab. DO NOT touch the soft tip or lay the swab down. If the tip is touched, laid down or dropped discard and get a new Aptima vaginal swab specimen collection kit. ii. Hold swab by placing the thumb and forefinger in the middle of the swab shaft covering the black score line. DO NOT hold the swab shaft below the score line. iii. Carefully insert the swab into the vagina about 2 inches (5 cm) past the introitus and gently rotate the swab for 10 to 30 seconds. Make sure that the swab touches the vagina walls so that moisture is absorbed by the swab. iv. Withdraw swab without touching the skin. v. While holding the swab in hand, unscrew the tube cap. DO NOT SPILL THE TUBE CONTENTS! If the contents are spilled, discard and get a new Aptima unisex swab transport tube. vi. Immediately place the swab into the transport tube so that the black score line is at the top of the tube. vii. Align the score line with the top edge of the tube and carefully break the swab shaft. viii. The swab with drop to the bottom of the vial. ix. Discard the top portion of the swab shaft. The remaining portion remains in the tube and must be submitted. x. Recap the transport tube (DO NOT TOUCH THE FOIL CAP). xi. Label the swab container with the patient s name, date of birth and procedure date. After collection these specimens are viable in this medium for 60 days at room temperature. 11

3.4 Biochemistry and Hematology Blood Collection and Handling Clients (Doctors offices or clinics) can collect blood specimens after following the correct order of collection (Table 1). Identify the specimen correctly (with full name and date of birth) with a properly completed filled laboratory request form. If delivering specimens, they should be transported under the appropriate conditions. For correct sampling/transport conditions, see section: Specimen Transport, otherwise collected by our scheduled couriers. For your convenience, our requisition form indicates the colour blood tube for blood collection for each test (refer to Appendix 7). Venepuncture Procedure Positively identify the patient by two forms of identification; ask the patient to state and spell his/her name and give you his/her birth date. Check these against the requisition form. i. Check the requisition form for requested tests, other patient information and any special draw requirements. Gather the tubes and supplies that you will need for the draw. ii. Position the patient in a chair. iii. iv. Wash your hands or use alcohol hand sanitizer. Select a suitable site for venepuncture, by placing the tourniquet 3 to 4 inches above the selected puncture site on the patient. v. Do not put the tourniquet on too tightly or leave it on the patient longer than 1 minute. vi. vii. viii. Next, put on non-latex gloves, and palpate for a vein. When a vein is selected, cleanse the area in a circular motion, beginning at the site and working outward. Allow the area to air dry. After the area is cleansed, it should not be touched or palpated again. If you find it necessary to re-evaluate the site by palpation, the area needs to be re-cleansed before the venepuncture is performed. Ask the patient to make a fist; avoid pumping the fist. Grasp the patient s arm firmly using your thumb to draw the skin taut and anchor the vein. Swiftly insert the needle through the skin into the lumen of the vein. The needle should form a 15-30 degree angle with the arm surface. Avoid excess probing. ix. When the last tube is filling, remove the tourniquet. x. Remove the needle from the patient's arm using a swift backward motion. xi. Place gauze immediately on the puncture site. Apply and hold adequate pressure to avoid formation of a hematoma. After holding pressure for 1-2 minutes, tape a fresh piece of gauze or Band-Aid to the puncture site. xii. xiii. xiv. xv. Dispose of contaminated materials/supplies in designated containers. Rotate and invert the collection device to mix the blood collected. Label all appropriate tubes. Remove your gloves and wash your hands. 12

Note: The larger median cubital and cephalic veins are the usual choice, but the basilic vein on the dorsum of the arm or dorsal hand veins are also acceptable. Foot veins are a last resort because of the higher probability of complications. Order of Draw (Phlebotomy) In order to limit interference/carry-over of anticoagulant from one tube to the other tube type (when doing multiple draws), it is advised to maintain the sequence of drawing specimens as indicated in Table 1. The different tube types for tests are indicated on the clinical request Appendix 1. It is very important to collect the correct volume of blood into the tube as the ratio of the anticoagulant to blood volume can influence the test results. After blood collection, make sure that all tubes are gently, properly inverted, NOT MIXED, to avoid unnecessary clotting. TERMS: SPS Sodium polyanethole sulfonate SST Serum Separator Tube EDTA ethylenediaminetetraacetic acid FDP Fibrin degradation products 13

Aside from these, there is a tube with royal blue top that contains FDP. The draw is used when there is an order to test deep vein thrombosis or blood clot in a deep vein, pulmonary embolism, stroke and other blood clotting disorders. Also used for heavy metal testing. Blood Specimen Handling and Processing (Clients that separate and prepare their specimens) i. Pre-centrifugation Handling - The first critical step in the lab testing process, after obtaining the specimen, is the preparation of the blood specimens. Specimen integrity can be maintained by following some basic handling processes: Fill tubes to the stated draw volume to ensure the proper blood-to-additive ratio. Allow the tubes to fill until the vacuum is exhausted and blood flow ceases. Vacutainer tubes should be stored at 4-25 C (39-77 F). Tubes should not be used beyond the designated expiration date. Mix all gel barrier and additive tubes by gentle inversion 5 to10 times immediately after the draw. This assists in the clotting process. This also assures homogenous mixing of the additives with the blood in all types of additive tubes. Serum separator tubes should clot for a full 30 minutes in a vertical position prior to centrifugation. Short clotting times can result in fibrin formation, which may interfere with complete gel barrier formation. ii. Blood Specimen Centrifugation It is recommended that serum be physically separated from contact with cells as soon as possible, with a maximum time limit of 2 hours from the time of collection. Complete gel barrier formation (gel barrier tubes) is time, temperature and G-force dependent. The uniformity of the barrier is time dependent; an incomplete barrier could result from shortened centrifugation times. In general, for a horizontal, swing-bucket centrifuge, the recommended spin time is 10 minutes. For a fixed-angle centrifuge, the recommended spin time is 15 minutes. NOTE: Gel flow may be impeded if chilled before or after centrifugation. Tubes should remain closed at all times during the centrifugation process. Place the closed tubes in the centrifuge as a balanced load noting the following: o Opposing tube holders must be identical and contain the same cushion or none at all. o Opposing tube holders must be empty or loaded with equally weighted specimens (tubes of the same size and equal in fill). o If an odd number of specimens is to be spun, fill a tube with water to match the weight of the unpaired specimen and place it across from this specimen. 14

iii. Centrifuge Safety Interference with an activated centrifuge by an impatient employee can result in bodily injury in the form of direct trauma or aerosolization of hazardous droplets. Centrifuges must never be operated without a cover in place. Uncovered specimen tubes must not be centrifuged. Centrifuges must never be slowed down or stopped by grasping part(s) of the device with your hand or by applying another object against the rotating equipment. Be sure the centrifuge is appropriately balanced before activating. If an abnormal noise, vibration, or sound is noted while the centrifuge is in operation, immediately stop the unit (turn off the switch) and check for a possible load imbalance. Clean the centrifuge daily with a disinfectant and paper towel. Broken tubes or liquid spills must be cleaned immediately. Microbiology Specimens Tests are performed on blood, urine, feces, sputum, wound swabs and other bodily fluids while applying conventional techniques for bacterial identification and susceptibility testing. Test Specimen Type Volume Blood Culture Aerobic or anaerobic bottle Pediatric 2 ml Adult 5 ml Urine Micro/Culture Urine (in sterile container) 1 ml minimum Wound Culture Specimen site swab 1 swab Vaginal Culture Specimen site swab 1 swab Sputum Culture Sputum 1-5 ml Feces: Culture Feces (in sterile container) 1-2 g Occult Blood Feces (in sterile container) 1-2 g Urine specimens i. Testing on urine ranges from a routine urinalysis to a microbiology culture to chemistry tests on random or 24-hour collections to cytology studies. ii. Routine urinalysis requires at least 3 ml of specimen (IN STERILE CUP). A first morning specimen is preferred. iii. Specimens for culture must be collected by clean catch. iv. Routine urinalysis specimens submitted in non-sterile containers will be rejected. v. Collection kits for both urinalysis and culture are available from NGP upon request. vi. Many chemistry studies require a 24-hour collection. Some analytes call for a preservative to be added to the collection container at the start of the collection. Contact the reference desk for information about 24-hour urine requirements. Containers with the appropriate preservative are available upon request. vii. viii. As a rule, all urine specimens should be refrigerated until transported to the laboratory. Collection instructions for clean catch and 24-hour specimens follow and should be explained to patients. 15

Instructions for clean catch urine collection Female Step 1. Wash hands thoroughly with soap and water. Rinse well and dry with a paper towel. Step 2. With one hand, spread the labia (skin folds around the urinary opening) apart. Cleanse the area with (3) cleansing (antiseptic) towelettes. Keep this hand in place during the washing and urinating process. Step 3. Make a single front to back motion with each of the (3) towelettes in sequence. - 1 ST wipe the left - 2 nd wipe the right - 3 rd wipe the middle Discard the used towelettes into the toilet bowl. Step 4. Begin urinating into the toilet making sure to keep skin folds apart with the fingers. Step 5. Without stopping the stream position urine container to catch the specimen. Do not allow the container to touch the legs or clothing. Keep fingers away from the rim and inner surfaces of the container. Step 6. Once container is ¾ filled with urine discard (urinate) excess urine into the toilet bowl. Step 7. Label the specimen container (not the lid) with your name, (date and time of collection). Male Step 1. Wash hands thoroughly with soap and water. Rinse well and dry with a paper towel. Step 2. Use two towelettes to clean the head of the penis. If uncircumcised retract foreskin then wipe the head of the penis. Step 3. Begin urinating into the toilet making sure to keep foreskin retracted while urinating if uncircumcised. Step 4. Without stopping the stream position urine container to catch the specimen. Do not allow the container to touch your legs, clothing or penis. Keep fingers away from the rim and inner surfaces of the container. Step 5. Once container is ¾ filled with urine discard excess urine into the toilet bowl. Step 6. Label the specimen container (not the lid) with your name, (date and time of collection). 24 Hour Urine Collection Instructions i. Check with your physician first, then, if possible, discontinue medications 48 to 72 hours before collection. ii. Maintain your normal intake of fluids during the collection unless your physician tells you otherwise. iii. Start the collection between 6am and 8am. Write the start time on the bottle label. iv. Empty the bladder and discard this specimen. 16

v. Begin the 24-hour collection. Save ALL urine for the next 24 hours. vi. Urinate at the end of the 24 hours and add this specimen to the collection. vii. Refrigerate the specimen during the entire 24-hour period. viii. If the container has a preservative, be careful not to get it on your skin. ix. Do not add anything except urine to the container. x. Return the entire specimen to the laboratory or collection point. Home Draw Program Nexgen Pathology offers a home draw program to provide phlebotomy services to patients who are living at home, and are unable to present to the laboratory. Requests for home draw service must be accompanied by a written physician s order that will include the test(s) requested. Appointments are scheduled Monday through Friday ONLY, excluding public holidays, and can be made by calling or office at (868)674-7284 or 221-5508. 17

Specimen Identification requirements 4.1 General Proper labelling of all specimens and accompanying requisition forms is essential in order to eliminate patient identification errors. All specimens must have a minimum of two patient identifiers AND the specimen type. The corresponding specimen requisition should bear the same identifiers as the specimen. For specimen requisition forms, the following information must be included for specimen acceptance: 1. Full Patient Name 2. Patient Date of Birth 3. Patient Sex 4. Requesting Physician s Name 5. Requesting Institution 6. Date of Procedure 7. Request Type 8. Specimen identification 9. Last Menstrual Period (If applicable) 10. Date of Previous Pap and result (If applicable) 4.2 Special Requirements by Specimen Type Blood specimens All blood specimens should also have the draw time on the specimen container. For Sodium citrate vials the draw time is necessary to ensure proper testing. If it is not available on the form, a verbal confirmation of draw time from the phlebotomist is sufficient. EDTA or whole blood specimens should also have an indicator of draw time. Bone Marrow specimens/aspirate slides Each slide should have a patient identifier. The specimen container should indicate the contents (bone marrow biopsy/clot or both). Intraoperative consultations IOC specimens are highly time sensitive materials. The time of pick up should be recorded as well as the time of arrival to the laboratory. NOTE: Nexgen Pathology currently uses touch-prep as the standard IOC preparation. 18

Test Requests & Specimen Pick Up 5.1 General All specimen requests must be approved by an authorized medical practitioner or representative of a medical body. This is should be indicated on the requisition form by an official signature or a company stamp. 5.2 Phone Requests for Testing All phone requests for testing must be done by a qualified physician or designated personnel. Phone requests may include a request for additional testing or an addendum to an existing case. In order to ensure accuracy, the Nexgen Pathology employee receiving the order is required to fully read back the test request to the physician or designee. The information will then be transcribed onto a requisition form and sent for processing. 5.3 Cancellation of a requested test Test requests can only be cancelled with the possibility of a refund if the cancellation request is received within 12 hours of specimen pick-up AND if processing has not begun. Cancellation requests that do not meet these criteria will only be processed at the discretion of the clinical director or laboratory manager. 5.4 Stat test requests If any report is needed urgently, this request can be placed directly on the requisition form. Write URGENT on the top of the form. Indicating the reason for the urgency is also recommended as it will allow staff to better coordinate processing to facilitate the request. 5.5 Time Sensitive Specimens Blood and bone marrow specimens for time-sensitive tests (primarily flow cytometry and chromosome analysis) must arrive by 12 noon Monday-Thursday. Specimens will be accepted for processing after 12 noon Monday-Thursday; however this practice is highly discouraged as cell viability is critical to ensure the accuracy of these tests. Specimens received for flow cytometry and chromosome analysis before 12 noon on Fridays will still be processed, but will attract an additional fee. These specimens will not be accepted if they arrive after 12 noon on a Friday or the day before a public holiday. 5.6 Requesting Molecular Microbiology Testing Once a Pap smear is required the Pap test box should be checked under the TEST(S) section of the requisition form. Pap + HPV Co-test - a Pap and an HPV high risk test will be performed HPV only - only an HPV test will be performed HPV + Reflex genotyping (types 16 + 18/45) - an HPV high risk test is performed and only if it is positive a genotyping test for types 16 + 18/45 is performed. 19

Pap + Reflex HPV - if the Pap test is abnormal (ASCUS and above) an HPV high risk test is then performed Trichomonas vaginalis - a Trichomonas vaginalis test is performed. Chlamydia trachomatis/neisseria gonorrhoea - a Chlamydia trachomatis/neisseria gonorrhoea test is performed. Notes: HPV genotyping cannot be requested alone; an HPV high risk test must always be performed first. Once a ThinPrep vial has been processed for Pap testing, Chlamydia/Gonorrhoea and Trichomonas testing cannot be performed. As such these tests MUST be requested at the time of specimen submission. If the Pap has already been prepared and these tests are required an alternative specimen type must be submitted (see below). HPV high risk testing can be requested on a ThinPrep vial up to one month after original specimen collection. Once a month has passed a new specimen would have to be taken. HPV testing can only be requested on ThinPrep specimens. 5.7 Specimen Pick Up For your convenience, our professional and friendly couriers are available for specimen collection Monday to Friday 7am to 5pm and Saturday 8am to 12noon. Let us know of a pick-up schedule that suits your needs. We understand that patient care is a 24/7 endeavour. If you require a specimen pick up outside of our routine courier schedule, give us a call and we will make every effort to accommodate your needs. 20

Test Reports 6.1 Report Delivery Reports can be delivered electronically via e-mail and/or in hard copy via our courier service. Kindly indicate your preference via phone or on the requisition form. 6.2 Turnaround Time The turnaround time is defined as the time between specimen pick-up and delivery of the report to the physician via e-mail or in person. Turnaround time varies by department and/or by the complexity of the specimen. Nexgen Pathology turnaround times are as follows: Hematopathology 5-7 working days Immunohistochemistry 2-3 working days Large complex specimens/cancer cases 5-7 working days Microbiology Culture 3-4 working days Molecular & Genetics 5-24 working days Molecular Microbiology 7-10 working days Non-gynecological cytology 3-5 working days Non-routine Biochemistry and Hematology 2 working days Pap smear 5-7 working days Routine Biochemistry and Hematology 1 working day Routine Histology (small biopsies and simple specimens) 3-5 working days 6.3 Critical Test Result Reporting Definition of Critical Test Results Laboratory results that are outside the normal range to a degree that may have significant medical implications for the patient, and/or require immediate action and prompt clinical intervention Notification Process All critical test results are immediately communicated directly to the receiver Requesting Physician or other appropriate representative or an otherwise appropriately deemed representative as indicated by the requesting physician (e.g. nursing assistant). This communication will be delivered by the sender via telephone call or via an email with the header Subject: [IMPORTANT] REPORT WITH A CRITICAL RESULT The following information will be documented by the sender: Name and credentials of sender Name and credentials of receiver Test name Test value/interpretation Date and time 21

NOTE: The sender must receive confirmation of receipt and acceptance of responsibility for follow up by the receiver, e.g. via read-back of results, follow up e-mail or phone call. 22

Critical Test Result Chart The following table gives a listing of the type of results which are deemed critical: Test Critical Values Surgical Pathology 1. New diagnosis of primary or metastatic malignancy or suspected malignancy 2. Significant unexpected finding that requires urgent action Cytology Specimens 3. New diagnosis of primary or metastatic malignancy or suspected malignancy 4. Significant unexpected finding that requires urgent action Biochemistry Specimens COMPLETE BLOOD COUNT (CBC) RANGE UNIT LOWER LIMIT UPPER LIMIT WBC 4.0 11.0 10^3/ul 2.0 20.0 Hb Male: 13 18 g/dl 6.0 20.0 Female: 11.6 16.5 HCT 36.0 54.0 % 18 60 RBC Male: 4.5 6.5 10^6/ul 2.0 7.0 Female: 3.9 5.6 PLTs 150-400 10^3/ul 40 900 SERUM/PLASMA Bun 7.0 23.0 mg/dl >= 60 Cr 0.6 1.3 mg/dl >= 4.0 K+ 3.5 5.1 mmol/l 2.8 6.0 Glucose < 140 mg/dl 50 450 Cal 8.5 10.5 mg/dl 6 13 UA Child: 2.0 5.5 mg/dl >= 13 Male: 3.5 7.2 Female: 2.6 6.0 Total bilirubin 0.2 1.3 mg/dl >= 15 All other Liver >= 300 Enzymes DENGUE NEG-POS POSITIVE HIV NEG-POS POSITIVE 23

Billing and Payments We offer a number of billing options for your convenience. Whether you prefer to pay on specimen submission or monthly invoices, have a chat with our Client Satisfaction Unit to work out a plan that suits your needs. 24

Reference Laboratories Requests for tests that are not performed on site at Nexgen Pathology are referred to one of various reference laboratories. Reference laboratories used by Nexgen Pathology are: Accredited by a recognised accreditation body Acceptable to the laboratory medical director Acceptable to the medical staff Any issues with reference laboratory tests can be routed through Nexgen Pathology. 25

Appendix Appendix 1- Complete Test Listing 26

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Appendix 2.1- ThinPrep Collection Guide- Broom 28

Appendix 2.2- ThinPrep Collection Guide- Brush & Spatula 29

Appendix 3- Specimen Requisition Form (Anatomic Pathology) 30

Appendix 4- Aptima Urine Collection Procedure Guide 31

Appendix 5.1- Aptima Unisex Swab Collection Procedure (Female) 32

Appendix 5.2- Aptima Unisex Swab Collection Procedure (Male) 33

Appendix 6- Aptima Vaginal Swab Collection Procedure 34

Appendix 7- Specimen Requisition Form (Biochemistry Testing) 35