D.9 MCM 113-03 - INFORMATION CONCERNING THE LABORATORY TESTS - ATTACHED.docx

D. 9 MCM 113-03 INFORMATION CONCERNING THE LABORATORY TESTS

SPECIMEN COLLECTION AND PROCESSING

1. PURPOSE: To establish the policies and procedures for collecting and processing laboratory specimens as set forth in the Laboratory Accreditation Standards.

2. POLICY: Proper collection and processing of laboratory specimens are critical to ensure accurate and timely test results. Safety of the patient, of the person collecting the specimen, and of all those who handle and process the specimen will be ensured. VA San Diego Healthcare System (VASDHS) staff shall maintain compliance with the standards for specimen collection and processing established by the Department of Veterans Affairs, Clinical and Laboratory Standards Institute, College of American Pathologists (CAP), Food and Drug Administration (FDA), American Association of Blood Banks (AABB), and the Joint Commission (JC).

a. All the orderable tests within CPRS, except for specialized tests (stated below), can be ordered and results are available for STAT testing 24 hours a day/7 days a week. The laboratory will not accept verbal orders, including add-ons. Test orders shall NOT be accepted without the healthcare providers electronically signing the orders, or an appropriate order being signed and released by “policy” (see MCM 11-62 “Electronic Patient Care Orders”).

b. Universal precautions, established by the Occupational Safety and Health Administration (OSHA), will be used when collecting and processing a specimen to preclude the possible infection of patients, staff, laboratory personnel, or contamination of the work area.

c. All the collected specimens shall be labeled with the patient’s full name, full social security number, CPRS order number, date and time of collection, and the collectors’ initials or signature. Specimens obtained from other than blood or urine sources also require identification of the source and type of specimen. The identification of each patient from whom a specimen was collected will be verified by actively identifying the patient, according to the VASDHS Medical Center Memorandum 11-64, patient Identification, by comparing the full name and SSN provided by the patient to the label being placed on the specimen. To maintain privacy in outpatient blood draw in the main hospital and CBOCs, DOB would be used verbally as the second identification rather than SSN.

3. DEFINITIONS:

a. Electronic Orders: Lab test orders and verbal orders electronically entered by providers and nursing staff in the ordering system in the electronic health record.

b. Blood Drawing Schedule: The scheduled collection by the phlebotomists on the wards and ICU/DOU for routine blood draws.

c. Written Requisition: Written requisitions are paper documents and used ONLY for ordering specialized tests. They include Research Specimens, and Environmental Culture Requisitions (Contact Microbiology at extension 3367 for forms). These tests cannot be ordered through the Electronic Health Record at this time.

d. Specimen: Anything from the patient’s body (blood, body fluid, or tissue) submitted for analysis, including foreign bodies.

(1) Replaceable Specimens: Any specimens that can be redrawn or collected, such as peripheral blood and urine.

(2) Irreplaceable Specimens: Specimens that are difficult to obtain, obtained by invasive procedures and/or cannot be recollected, such as tissues, spinal fluid specimens, and critical timed collections or STAT specimens. The tissue and body fluid specimens MUST be received with an attached print of electronic order, including contact number for notification.

(3) Properly Labeled Specimens: Specimens labeled with AT LEAST TWO (2) legible patient identifiers (full name, and complete SSN), ordering provider’s name, date and time, CPRS order number, and initials or signatures of the collector.

(4) Improperly Labeled Specimens: Incomplete name or social security number, name on specimen does not match name on order, wrong patient sample in tube, two patient labels on sample, one label secured to multiple specimens, no label, illegible label, both identifiers correct but other required information incorrect or missing (i.e., source, CPRS order, etc.). Additional definitions see Appendix C.

(5) Unacceptable Specimens: A specimen that will be rejected for testing at Specimen Processing due to lack of order, improper identification, improper or damaged label by spill or contamination, inadequate in volume or amount, hemolyzed, collected in wrong container, or other barrier to safely or accurately perform the test.

(6) Research Specimens: Any specimen collected for the purpose of internal or external research approved through the appropriate committees and IRB. All research specimens must be approved through the laboratory management with an active contract in place.

e. “No Draws”: For all routine collections, specimen not obtained by laboratory staff due to patient refusal, patient not present in wards, IV/ heplock/ cast shunt on both arms, patient in respiratory isolation, and unsuccessful draws. A phlebotomist will make no more than two attempts to collect a specimen. After two failed attempts, on a difficult stick patient, another phlebotomist will be assigned to perform the specimen collection. All “no draws” must be endorsed to the RN in charge of the patient by the collection personnel. Specimen collection staff shall document who was contacted and at what time the communication was made on the collection list for tracking purposes. If the patient is still an inpatient, phlebotomist will reorder for next collection list per RN’s request. If patient has discharged, lab orders will be deleted with comment “Patient discharged, notified RN”. Phlebotomist will not reorder lab.

f. Lab Test Information: In CPRS, under Tools/Lab Test Information, is a list of the laboratory test(s) that can be ordered. It includes test names and synonyms, accessioning section, highest urgency level available, tube/container required and special instructions for preparation of the patient and/or handling the specimen.

g. “Lab Collect (LC)”: Refers to inpatient blood collection on the wards by phlebotomists at routinely scheduled time points: 4:00am (DOU&ICU ONLY), 6:00am, 10:00am, 2:00pm, 6:00pm, and 10:00pm. In order to be collected at these time points, the test orders must be signed at least 30 minutes prior to the above collection time points. The phlebotomists shall generate a collection list 30 minutes prior to the time points and go to the wards to draw according to the collection list.

h. “Ward Collect (W C)”: Refers to inpatient specimen collection outside of the above routine scheduled lab collection. These include:

(1) TIMED draws/protocols (i.e. drug levels, peak, trough, heparin protocol)

(2) STAT draws

(3) LINE draws (when the patient has a line in their vessel) done by RNs

(4) Phlebotomists must be called, as soon as orders are placed, for the TIMED and STAT draws. They are not responsible for LINE draws.

i. “Send Patient (SP)”: Refers to outpatient specimen collection in the hospital Outpatient Blood Drawing area in La Jolla, or specimen collection at an external satellite clinic (CBOC). The SEND PATIENT (SP) orders expire 90 days after the collection date specified in the order. The Lab only collects the patient samples when the CPRS orders are in the period of 30 days ahead and 90 days back/past from the desired collection date.

4. RESPONSIBILITIES:

a. Chief, Pathology and Laboratory Medicine Service (PALMS):

(1) Schedule sufficient staff to collect, receive and process lab specimens.

(2) Maintain a current test description information list in the computer.

(3) Seek approval of the Medical Executive Council (MEC) for policies and procedures.

(4) Comply with mandated standards when collecting and processing laboratory specimens.

(5) Monitor and ensure patient and physician satisfaction with customer service.

(6) Conduct Quality Assurance reviews of specimen collection and processing procedure.

b. Ordering Licensed Independent Provider:

(1) Place accurate electronic lab orders.

(2) Be responsible for electronically signing orders they have placed in CPRS on time.

(3) Ensure blood specimens not drawn by laboratory personnel are properly collected, labeled and delivered to the laboratory.

(4) Ensure sterile fluids or tissue specimens are properly collected, labeled and delivered to the laboratory, along with printed hard copies of the electronic orders and/or consults, specifying appropriate specimen types requested in the computer, e.g., knee aspirate or synovial fluid, not “knee” or “fluid”.

(5) Ensure the correct specimen(s) are properly labeled and timely delivered in correct container(s) to the PALMS Specimen Processing window.

c. Escort Personnel: Deliver properly labeled specimens and accompanied requisition forms (for tissue and cytology specimens) to Specimen Processing as soon as possible. Clock in the time the specimen arrives at the Specimen Processing on the requisition form. Processing staff who receives tissue & cytology specimens will check the tally of the escort for the patient’s name and the number of samples in the biohazard bags, each patient listed is signed with date & time, a copy is made of the tally sheets to keep with the Anatomic specimen bag.

d. Specimen Processing Personnel:

(6) Check that received specimens are properly ordered, labeled, transported in correct container, delivered timely, associated with an order number, and, for body fluids or tissues, accompanied with a hard copy of the CPRS surgical pathology/cytology consult and/or CPRS orders.

(7) Identify unacceptable specimen(s) and notify the ordering provider. Reject the replaceable specimen(s). Put the irreplaceable specimen(s) on hold for accession until all errors are corrected by ordering provider.

(8) Cannot correct any discrepancies or errors associated with the incoming specimens. Only the ordering provider can make the correction.

5. PROCEDURES: ( see Appendix A for additional ordering specifics)

a. Providers shall utilize electronic orders for all laboratory tests unless specified below.

b. Written requests shall only be limited to the specimens stated above under 3c. Written Requisition or if the computer system is not operational.

c. Special or rare tests not available in CPRS shall be ordered utilizing the “consult restricted lab test” menu in CPRS.

d. Anatomic Pathology Orders:

(1) All Surgical and Cytopathology specimen requests must be ordered via Consults Pathology in CPRS.

(2) The only allowable exception for not placing a consult request is for a specimen generated from OR requests that instead use the electronic requisitions, which are transmitted within VistA from the Surgery package to the Lab package. All specimens must be accompanied by printed electronic consult or printed electronic requisitions when arriving to the laboratory.

(3) For any FRESH specimen notify Processing desk for personal hand-off so the Specimen Processing can bring them to Histology for immediate processing.

(4) Fresh specimens submitted after hours (M-F after 4:30pm, and weekends): Notify Specimen Processing staff in person so the specimen can be placed in the refrigerator. Specimen Processing staff will immediately notify the Surgical Pathology resident on-call for further instructions.

(5) Since most of the specimens generated for tissue examination are irreplaceable, If there is any discrepancy between specimen labels and the CPRS Pathology Consult Form, the specimen will be placed on hold until the discrepancy is reconciled by the provider by filling out the “Irreplaceable Misidentified Specimen Waiver Form” (Appendix B) with signature prior to processing.

(6) For any pathology specimen that is shared with microbiology or another section of the laboratory, a copy of the Pathology consult request MUST be sent with the specimen to avoid delay in processing. Examples of specimens commonly shared by multiple sections in the laboratory include effusions, bronchial cytology specimens, CSF and fresh tissue. If there are multiple labels generated for the same container (i.e., several tests performed from a single specimen), only one label is affixed to the specimen; the remaining labels will be sent to the Laboratory along with the labeled specimen.

e. For blood tubes, the label is placed lengthwise from top to bottom on the tube beginning directly under the cap. There should be a section of tube that is not covered by the label (a “window”) so that the serum or plasma in the tube can be visualized.

f. After the specimen(s) has been collected, it shall be properly labeled with the patient’s full name, full social security number, CPRS order number (s), date and time of collection, and the collectors’ initials or signature, type of specimen, and site of collection.

g. Escort personnel shall deliver the specimen(s) to the PALMS Specimen Processing as soon as possible, stamp in the time of the specimen delivery on the requisition form by the clock at the Specimen Processing window.

h. The Specimen Processing personnel shall check each specimen for the properly labeled information with the electronically entered orders in CPRS, make sure all the information is correct, and accession the specimen’s CPRS order number into the VISTA lab package for testing.

i. If the specimen processor identifies any inconsistency between the specimen labels and the electronic orders, incompletely identified labels, or improper or illegible labels, or any other errors that make the specimen unacceptable for testing, the ordering provider shall be notified and if the specimen is replaceable, it will be rejected and discarded. The processor shall document who was contacted and at what time the communication was made.

j. In the event that an irreplaceable specimen has been found to be unacceptable for testing, the ordering provider shall be notified, and the specimen shall be placed on hold until the provider has signed a “Specimen Mishandling Report Form” (Appendix B) to document that they take full responsibility for laboratory testing to proceed. Ordering, labeling or any other errors shall not be corrected by phone or by processing personnel.

k. The ordering provider(s) is ultimately responsible for the correct order, correct collection, correct specimen, correct label, correct transportation and timely delivery of the specimen to the lab.

l. The specimen will be held within the lab for a limited time, depending on the stability of the analyte for testing.

6. REFERENCES:

a. College of American Pathologists Standards for Accreditation of Laboratories

b. Joint Commission for Accreditation of Healthcare Organization, Accreditation manual for Pathology and Clinical Laboratory Services, Current edition.

c. Department of Veterans Affairs Manual, MP-2, “Clinical Program,” part VI, “Pathology and Laboratory Medicine Services.

d. VA San Diego Healthcare System, Infection Control Manuals and specimen Collection Manual

e. CLSO-GP16A, H1-A4, H3-A4, H4-A3, H14-A2, H-18-A, H21-A3

f. Blood Bank Policy “SD-BB-TRM-S0106: Blood Bank Specimens

g. MCM 11-63 Electronic Patient Care Orders

h. VHA Handbook 1106.01 “Pathology and Laboratory Medicine Service Procedures” January 29, 2016.

i. Anatomic Pathology Policy “SD-ANP-S0100 (Anatomic Pathology Specimen Receiving)” and “SD-ANP-S0101 (Specimen Rejection for Anatomic Pathology).”

7. RECERTIFICATION DATE: October 2028.

8. FOLLOW-UP RESPONSIBILITY: Chief, Pathology and Laboratory Medicine Service (113).

9. RECOMMENDED REVIEW DATE: October 2026.

10. RESCISSION: Memorandum 113-03, dated February 5, 2020.

11. DATE APPROVED BY MEC: November 15, 2023.

Attachments: A, B, C Distribution: SharePoint

D.9 MCM 113-03 INFORMATION CONCERNING THE LABORATORY TESTS - 36C26225R0004

VA SAN DIEGO HEALTHCARE SYSTEM MEMORANDUM 113-03

San Diego, CA October 13, 2023

DETAILED SPECIMEN COLLECTION AND ORDERING PROCEDURES

1. Blood Bank Specimen

a. Blood bank specimen tubes should have the signature or initials of the person who drew the specimen, plus the date and time the specimen was drawn.

b. A second person must also sign the Blood Bank Specimen Collection Form and verify that the sample label has accurate patient identifiers and that the VASD Blood Bank Specimen Collection Form matches the identifiers on the patient’s armband.

c. The person who draws the blood sample(s) must identify the patient in a positive manner by requesting the patient to state their name and social security number and comparing the information with that on the VASD Blood Bank Specimen Collection Form and label, and with the information on the patient’s wristband.

d. Information on the patient’s wristband must match the information on the VASD Blood Bank Specimen Collection Form and on the specimen label.

(1) If there is a discrepancy or lack of documentation, the specimen will be rejected and a redraw will be requested.

(2) The phlebotomist must not rely on a bed tag, charts or records placed nearby.

(3) In the absence of an identification band, the phlebotomist should await application of a suitable band before collecting the specimen.

(4) In the Medical Center, inpatients must have a patient identification wristband placed on their arm prior to collecting any specimen.

(5) Samples for preoperative cross matches and outpatient transfusions may be collected at the CBOCs and in La Jolla outpatient blood draw. ID ARMBAND EXCEPTION: the requirement for the patient to be wearing an ID band will be waived. Instead, copies will be made of 2 patient identifiers: driver’s license, VA card, and military ID or similar ID with patient’s photo.

2. Inpatient Specimen Collection

a. STAT and TIMED collections (Ward Collect) must be ordered electronically with a follow-up by phone call to the Specimen Collection desk at ext. 4159 or Customer Service at ext. 3668. After hours (5:30 pm

– 6:30 am), call Specimen Processing at ext. 7707. STAT service is available 24 hours/day and 7 days/week.

b. The Routine Collection (Lab Collect) is scheduled as follows: 4:00am (only for ICU & DOU), 6:00am, 10:00am, 2:00pm, 6:00pm and 10:00pm.

Note: To expedite patient discharge, the 6:00am draws are collected and tested as soon as possible to release the test result before 8:00am. A sweep (attempt for collection of specimens) is continued from 6:30am- 8:00am to collect the 6:00am draws missed by the phlebotomist. Any specimens not collected due to varying reasons (“No Draws”), such as patient not available, hard sticks, etc., will be reported to the RN in charge of the patient and documented by the phlebotomist. The current order will be deleted, and a re-order of the tests is required for the next collection time, if the tests are still needed. If still unable to collect on next collection list, the orders will be deleted and re-ordered as WARD COLLECT. This is applicable for all Lab collection draws except if the patient is discharged. See Specimen Collection and Processing 3e.

c. Computer collection lists are built 30 minutes prior to the next scheduled collection time by Specimen Collection personnel. All lab requests and add-ons must be entered in CPRS, by the provider, no later than 30 minutes prior to the next scheduled collection time as listed in 5.a above.

(1) If the phlebotomist is unsuccessful in obtaining the specimens at any of the collection draws because a patient is difficult to draw (hard stick), an attempt by another phlebotomist will be made. If the second phlebotomist is not successful, the RN in charge will be informed and documented.

(2) Inpatients can be sent down to Specimen Collection for blood draw or collections of other specimens if assessed to be clinically stable.

3. Outpatient Specimen Collection (“Send Patient”)

a. Outpatient specimen collection service is available from 6:30am-5:30pm Monday through Friday and 9:00am-12:00pm Saturday, at the Specimen Collection at the La Jolla Main Hospital.

b. Outpatient specimen collection service at the CBOCs (see individual websites).

c. The Lab will check all the pending orders and only collect samples when the CPRS orders are in the period of 30 days ahead and 90 days back/past.

d. The La Jolla Main Hospital Specimen Collection room is not configured to handle a patient on a gurney. DO NOT send either inpatients or outpatients on gurneys to the Phlebotomy room. Patients should remain in the clinic area from which the order was placed and staff should contact Specimen Collection at ext. 4159. PALMS staff will come to the patient location for specimen collection. Special tests from ref lab for bone marrow might has short stability & will not receive specimen on weekend. Prefer to collect and deliver bone marrow sample to Send outs office Mon-Thur before noon. Contact Send out office ext. 6970 for Pathologist’s approval and confirmation.

e. Specimens collected at the CBOCs shall be delivered to the La Jolla Main Hospital Specimen Processing (Room 1242).

4. Specialty Test Ordering

a. Fine Needle Aspiration (FNA) biopsy procedures are scheduled as follows:

(1) Endobronchial ultrasound guided FNA (EBUS) or Navigational bronchoscopy with biopsy are scheduled every Thursday by the pulmonary nurse coordinator. The schedule must be communicated via VISTA email at least 2 days prior to the procedure to ensure adequate pathology coverage.

(2) Endoscopic ultrasound guided FNA (EUS) procedures are scheduled every Tuesday and Friday by the GI nurse coordinator. The schedule must be communicated via outlook email a week before the procedures to ensure adequate pathology coverage.

(3) Any add on FNA procedures must be promptly communicated to the cytology laboratory by calling ext. 7729/7728 to provide adequate time of preparation. The caller must provide detailed information regarding location, Patient ID and site of FNA.

b. Lymphocyte Subsets and T-Cell Subsets (Flow Cytometry) should be ordered electronically using CPRS.

c. Leukemia/Lymphoma Panels for Flow Cytometry should be ordered electronically using CPRS. Please ensure correct specimen type is selected. Note: The Flow Cytometry lab is closed on weekends and Holidays. For critical samples after hours page the CP resident on call (619) 290-5303 for assistance.

d. Bone marrow technical support must be scheduled, at least 24 hours in advanced, with Hematology section at ext. 3420. and are performed Monday through Friday from 8:00am—2:30pm. Bone Marrow request outside the routine hours must be approved by the Director of the Clinical Core Laboratory.

e. Cortisol – drawn 6:00am – 8:00am daily for patients. . Random sample maybe ordered when patient is on Cortisol or during Addisons and Cushing disease workup.

f. Testosterone – secretion is episodic with peak between 6 and 8am. Testosterone will decrease by 40% – 50% by 8pm. Specimen will be drawn between 6am – 9am.

g. OR (blue stickers) – deliver specimens and requisition directly to each checked-off departments (on blue stickers).

h. Intraoperative PTH intact – delivered directly to Processing. Monday through Friday during scheduled OR times. Please call in advanced to 7707 to expedite requests.

i. Blood cultures should be ordered by either “Ward Collect” or “Send Patient” to ensure proper collection time is documented. For urgent cases, once the blood culture is ordered, please immediately call lab ext. 4159 or 3668 for collection.

5. Microbiology

a. Specimens other than blood are not collected by laboratory personnel on the floors or in clinics. Patients may self-collect certain specimens (urine, stool, or sputum) and bring the specimen to the Specimen Collection area of the Laboratory or Blood Draw stations in the CBOCs.

b. Specimens delivered for microbiology examination, other than blood must be labeled with the specimen source. All specimens should be labeled with date and time of collection. Specimens arriving in fixative such as formalin, dry swabs, improper or non-sterile containers are not acceptable for culture.

c. All specimens other than urine or stool are saved for 1 week after submission if there is sufficient material. More than one specimen of urine, stool, sputum (AFB culture excluded), wound or throat culture, submitted on the same day from the same source are not acceptable for culture unless they are replacing inadequate specimens or are collected in a different manner, e.g., voided and catheterized urine specimens.

d. More than one swab must be sent if a provider orders multiple cultures (bacterial, AFB, fungal and viral culture). If additional swabs cannot be sent, the provider will be asked to prioritize the orders. Amount of CSF or other body fluids must exceed 1mL for the laboratory to complete all tests requested. If you are requesting additional tests such as multiple serologies or viral PCR then 3 or more ml of fluid should be submitted.

e. Anaerobic cultures should not be requested from swabbed material. Anaerobic cultures are not done on autopsy material, respiratory specimens including bronchial wash, decubitus ulcer material (not punch biopsy of tissue under eschar), feces, gastric contents or washings, midstream or catheterized urine (unless prior authorization from the laboratory), mouth, nose, or prostatic secretions, ileostomy or colostomy material, enteric fistula or intestinal contents, or vaginal secretions.

f. Wound and respiratory specimens sent for culture require a Gram stain to evaluate specimen quality. Gram stains are not performed on the following specimens: throat, and vaginal swabs for Neisseria gonorrhoeae, any catheter or implanted device, and direct blood collection.

g. Blood cultures

(1) Acceptable cultures include an aerobic and anaerobic set of culture bottles drawn according to instruction listed elsewhere. These are very useful for identifying line infections if the site of the blood draw is written on the bottles in the set. It is also useful for diagnosing bacterial endocarditis and for distinguishing true bacteremia from skin flora from contamination.

(2) The number of blood cultures is limited to 3 sets of bottles per patient per day unless special permission is given through the Infectious Disease section.

(3) Only one fungal blood culture (isolator tube) per day per patient. The automated blood culture instrument is capable of isolating most organisms including yeast in 2-3 days

h. Stool/Feces

(1) Cultures will be performed on unformed or liquid stool specimens received by the laboratory within 2 hours of collection - unformed stool is defined as taking the shape of the container. Culture for enteric pathogens (other than for C. difficile) and ova and parasite exam will not be performed on hospitalized patients after the third hospital day without prior consultation from the Infectious Disease team. Stool cultures will include exam for routine enteric pathogens (Salmonella, Shigella, Campylobacter, E. coli H7:0157 and Aeromonas) – if Yersinia or Vibrio infections are suspected, please notify laboratory of the pathogen suspected. A screen for Shiga toxins 1 & 2 will be performed as part of a routine stool culture. Stool for culture or ova and parasite exam from outpatients must be received in a PARAPAK collection kit labeled with date and time of collection. Stool culture will be performed only on one sample (most recently collected) if more than a single PARAK is submitted.

(2) C. difficile Toxin PCR assay will be performed on fresh unformed or liquid stool only. Additional requests for toxin PCR assay on stool specimens that are positive for toxin will not be accepted for 7 days, as continued presence or absence of toxin is not useful for guiding therapy. The assay is not to be used for test of cure.

(3) The test COLORECTAL CANCER screen, FIT test (Fecal Immunochemical test) is orderable on the outpatient menu and consists of one collection sample vial. The test OCCULT blood is to be used for single samples. Tests ordered incorrectly by providers will be corrected to meet VA guidelines

i. Wound

(1) Tissue and aspirates are the samples of choice from abscesses, ulcers, lesions, and wounds. Anaerobe cultures will be performed on deep wounds and aspirates and not from superficial sites such as skin.

(2) All wounds must have a Gram stain; if not ordered, the test will be added

(3) For swabs from wounds, anaerobic cultures will be performed ONLY if specifically ordered.

(4) OR specimens – please send biopsy tissue or aspirated fluids not the swabs. Quantitative culture of OR-collected tissue will be performed only after routine wound culture displays little or no growth.

j. Urine

(1) Culture: A clean catch – midstream urine is acceptable for culture. Urine must arrive in the lab within 2 hours of collection. From outpatient clinics, urine must be transported in a gray-top urine collection device. Urine for culture should not be collected from a drainage bag. If patients have indwelling urinary catheter; collect urine from the tubing port using aseptic technique. If a patient has an external urinary catheter, catheterize the patient to obtain an adequate urine sample for culture. Indwelling urinary catheter tips are not acceptable for culture.

(2) A colony count will be performed and reported on all urines received for culture. Specimens that yield one to three probable pathogens with ≥50,000 cfu/mL will be reported. If a urine culture growth shows more than 3 potential pathogens it is generally considered to be a poorly collected specimen and the lab will request another sample. Urine with ≥3 organisms will be reported as “Mixed Bacteria: Review collection technique and submit new urine”. Urines collected from Spinal Cord Injury (SCI) patients will continue to be worked-up and reported when the number potential pathogens are ≥3 organisms.

(3) Urine for urinalysis and culture will NOT be acceptable for Chlamydia/ Gonorrhea testing as the first part of the void containing infected cells is needed, not a mid-stream sample.

(4) AFB urine culture. Only the first morning specimen is acceptable for AFB culture. Specimen collection containers are available from the lab. Random urine samples or 24-hour collections are not acceptable.

k. Sputum/Respiratory samples

(1) Throat cultures are screened for beta hemolytic streptococci only and they will be serologically identified. Throat cultures for other potential pathogens need to be requested specifically.

(2) All sputum samples must have a Gram stain – one will be added per policy if not ordered by the provider. Sputum heavily contaminated with saliva (≥10 epithelial cells and/or ≤25 white blood cells per low power field) is unacceptable for culture. A provider will be notified to resubmit a new sample.

(3) Criteria for sputum specimen collection for active TB work up:

(a) Sputum specimens should be obtained at least 8 hours apart (at least one of these obtained in the early morning) for AFB smear and culture to help clinically rule out active pulmonary TB.

(b) Cepheid Xpert® MTB/RIF PCR test can be performed on sputum. However, at least one test should be performed on a high-quality early morning sputum specimen.

(c) Submitted sputum specimens can be split for sputum AFB smear/culture and Cepheid Xpert® MTB/RIF PCR testing when possible. However, additional sputum specimens may be required for sputum AFB smear/culture if the sample provided is of a limited quantity.

(d) Please see MCM 11-36: Tuberculosis Prevention for complete details including quantity of specimens and tests required to rule out active TB.

(4) All respiratory specimens for AFB smear/culture must reach the La Jolla lab by 9AM Monday through Friday to be processed on the same day as collected. Specimens collected after 9AM on Friday through the weekend will be processed on Monday.

(5) Pneumocystis DFAs will be sent to reference facility on induced sputum or bronchial specimens only.

l. Genital Cultures

(1) Transport all genital specimens for culture to the lab immediately. Due to the fastidious nature of genital pathogens such as Neisseria gonorrhoeae, genital specimens for culture must NOT be refrigerated or exposed to cold temperatures even for short periods of time.

(2) PCR technology requires stringent collection criteria – urine for GC/Chlamydia is not the same specimen as urine collected for culture and sensitivity and urinalysis. PCR is generally more sensitive than culture for detection of Neisseria gonorrhoeae and Chlamydia trachomatis.

m. Virology Specimen Collection: Samples must be sent to the lab using the red-top Viral Transport Medium with pink fluid. Virology specimens other than the Influenza/RSV PCR assay and Respiratory PCR Panel (BioFire) are sent to a reference laboratory for examination. Slides for vial DFA are available from the Sent Outs Department. The swab and viral transport medium are available from Microbiology.

6. Anatomic Pathology

a. Surgical Pathology

(1) All surgical pathology specimens are immediately fixed in 10% formalin after removal from the body except for certain specimens that are submitted “fresh” or without any additive/fixative. Examples of specimens submitted without fixative are resections, calculi (stones) or hardware. 10% formalin containers are supplied by Logistics Department.

(2) Frozen section tests are ordered using a typewritten requisition slip generated from the VISTA Surgery Package. The Surgery staff must call ext. 7729, alerting Surgical Pathology staff that a frozen section is being sent down either through the pneumatic tube or by escort service. If using escort service, instruct escort to deliver specimen directly to Room 1715 pathology laboratory to avoid delay. When the specimen is sent down, it must be accompanied by a Tissue Examination requisition slip (SF515).

(3) Muscle and nerve biopsies-Providers must communicate with Anatomic Pathology Department at ext. 7728 at least 24 hours before the procedure to receive further instructions for collection and send out to a reference laboratory.

(a) The muscle biopsy specimen should be a longitudinal piece of muscle approximately 1.0 cm I diameter and at least 3 cm in length. Nerve biopsy specimens should be a minimum of 1 inch (2.5 cm) in length. Samples should be covered in gauze moistened with saline. The specimens must NOT be immersed in saline or water.

(b) If the specimen can be received in the Neuropathology lab within 4 hours from the time of biopsy, it can be sent FRESH. Place the biopsy in a dry petri dish and cover with a gauze moistened with saline. The specimen MUST NOT be immersed in saline and should not be moistened with water. Seal the dish in a polyethylene bag and place on wet ice in a Styrofoam box for transport. Have courier standing by as the muscle is prepared, to ensure prompt delivery.

(c) For nerve biopsy, if EM is desired, obtain a sample (1cmx2mm) fixed under moderate tension in a bubble of glutaraldehyde on dental wax. Submit in 2-3% buffered glutaraldehyde.

(4) Lymph nodes: Lymphoma protocol: Lymph node should be sent fresh and then a portion of the lymph node will be placed in RPMI and sent to Flow Cytometry. The remaining portions of lymph node will be grossed for permanent sections unless otherwise noted (i.e., molecular studies etc.)

(5) Breast specimens:

(a) Breast core specimens must be placed immediately in 10% formalin

(b) Breast lumpectomy or mastectomy specimens must be placed in 10% formalin immediately or within 1 hour after removal from the body (ischemic time). Time of removal and time of fixation is documented in the pathology request form. Fresh specimens must be delivered immediately to the pathology laboratory for proper handling.

i. Cold Ischemic time- time of removal from the body to the time of fixation should be less than 1 hour

ii. Fixation time- time of specimen fixed in 10% formalin.

(6) Kidney biopsies:

(a) Biopsy kits containing 3 vials: 10% formalin, glutaraldehyde and Michel’s solution are provided by the pathology laboratory at room 1715 or call extension 7728 for assistance.

(b) Stat kidney biopsy specimens (transplant) must be communicated promptly to pathology staff at extension 7728 room 1715 for immediate processing and send out to a reference laboratory.

(7) Research specimens- these specimens are delivered fresh by the researcher. An IRB must be approved prior to procurement of tissue.

b. Cytology:

(1) Gynecologic samples are collected at the Provider’s Clinic using the instructions (see below) included in the Hologic Physician’s kit. Supplies are provided by the logistics department. Specimen is sent to the cytology laboratory with accompanying Pathology-consult request.

(2) Collection of Anal-rectal Cytology:

(a) Prepare anal-rectal cytology kit for use. Open Thin Prep Preservcyt vial before obtaining specimen. Prepare specimen labels

(b) Moisten Dacron swab with tap water. The Dacron swab is inserted about 5-6 cm into the anal canal past the anal verge, into the rectal vault.

(c) Firm lateral pressure is applied to the swab handle as it is rotated and slowly withdrawn from the anal canal, inscribing a cone-shaped arc.

(d) Ensure that the transition zone is sampled, as this is the area most likely to develop a squamous intraepithelial lesion (SIL).

(e) Transfer specimen to the ThinPrep vial by placing the swab in the preservative in the vial and agitate vigorously several times to release the cellular material from the swab

(f) Remove swab from vial and discard.

(g) Specimen with accompanying Pathology consult request sent to the cytology laboratory for processing.

(3) Directions for Outpatient Urine Cytology Collection- Patients are directed to the first floor Blood Drawing area to collect containers needed for collection.

(a) Obtain three (3) clear urine preservative containers and three (3) empty sterile containers. Please use the empty containers to collect and transfer your specimen into urine containers that contain the preservatives.DO NOT urinate directly into the cups with the preservatives, due to the fixative being toxic.

(b) Collect a urine specimen container (One per day), for three (3) consecutive days MID DAY specimen is the best sample for collection. DO NOT collect the first morning sample upon waking.

(c) Prior to collection of each specimen container, ensure that an indicated date of collection is written on the labeled cup.

(d) Urinate into the empty transfer urine container. Pour urine into the (1) of three (3) preservative containers up to the second black line. DO NOT fill sample past the second black line.

(e) Please refrigerate or keep all three (3) urine collection containers away from heat and deliver to the laboratory

(f) Bring the three (3) urine collection containers to the VASDHC (La Jolla) or other branch Clinics which may be more convenient for travel.

(4) Other Urinary specimens including bladder barbotage, ureteral washings, renal pelvis wash, and urethral washings are collected in a container with an equal amount (1:1 ratio) of Cytolyt Solution for cellular preservation. If cytolyt solution is not available, sample can be delivered immediately without fixative to cytology laboratory for processing. Cytolyt Solution is provided by the cytology laboratory.

(5) Non-gynecological specimens that are submitted FRESH (without any fixative) include:

(a) Effusions- pleural (thoracentesis fluid), peritoneal (ascites, paracentesis fluid), and pericardial fluid.

(b) Respiratory specimens including BAL, bronchial washings, or Transbronchial needle aspirates (TBNA).

(c) Pelvic washings

(d) Cerebrospinal fluid (CSF)

(6) Brushings on slides from esophagus, gastric or common bile duct are immediately fixed in a container filled with 95% alcohol. Slides must be labeled with 2 patient identifiers (last name, and last 4 SSN). Brush can be submitted in a properly labeled container with saline solution.

(7) Fine Needle Aspiration biopsies from Head and Neck, and Endocrinology are submitted using FNA kit provided by the cytology laboratory. Smears on slides are air dried and some are fixed in 95% alcohol solution. Needle rinses are washed in a vial containing preservcyt solution for preservation. Submit specimens with a copy of Pathology-Cytology Consult request.

(8) Tzanck Smear Collection procedure:

(a) Have a jar of 95% alcohol open and close by so that the slides can be dropped into the alcohol for immediate fixation

(b) Pre-label slides with patient name and last 4 digits of SSN

(c) Materials for procedure are provided by cytology lab at room 1714, ext. 7729.

(d) Open a fresh vesicle and scrape the base of the vesicle with scalpel blade. The edges of the lesion will have the best yield of cells showing viral changes.

(e) Cellular material is carefully spread onto pre-labeled slides and immediately dropped into 95% alcohol. Air-dried smears are unacceptable.

(f) Submit specimen with a copy of the Pathology-Cytology consult request

(9) Thyroid Nodule Biopsy + ThyroSeq collection workflow for Endocrine Clinic, Head and Neck Service, and Interventional Radiology Service (IR)

(a) Materials: One ThyroSeq vial for each nodule biopsied.

(b) Procedure: Thyroid Nodule Biopsy is performed in usual manner. At least one FNA pass should be dedicated for rinse in the ThyroSeq vial. Rinse the needle 3 times in the ThyroSeq vial, aspirating the ThyroSeqPreserve solution into the needle/syringe and expressing all the solution back into the ThyroSeq vial.

(c) Additional passes from the same nodule can be rinsed into the ThyroSeq vial, either using dedicated passes or rinsing the needle after cytology slides are made.

(d) Workflow for collection and processing:

i. ThyroSeq vials require label with a VA patient sticker, with collection date noted and nodule sampled (if more than one).

ii. Send ThyroSeq vial on ice to Lab Processing window in its own specimen bag labeled “ThyroSeq for Send-out freezer”.

iii. Send-out will bank ThyroSeq vials while awaiting cytology results.

(e) If the cytology is:

i. Insufficient (Bethesda I) or benign (Bethesda II), the ThyroSeq vial will be disposed.

ii. Indeterminate (Bethesda III or IV), pathology will reflexively send out for ThyroSeq testing.

(f) Suspicious for malignancy/ malignant (Bethesda V or VI), ThyroSeq will not automatically be sent. If the caring provider wants ThyroSeq to be sent, that provider must enter a “Restricted Pathology” order with rationale for wanting the ThyroSeq testing. The ThyroSeq vial will be held for 4 weeks and be automatically disposed of 4 weeks after collection.

(10) Other specimens not listed above is best submitted fresh or in saline solution to cytology laboratory for processing.

Irreplaceable Misidentified Specimen Waiver Form

Irreplaceable Specimens: Specimens that are obtained by invasive procedures and/or cannot be recollected, such as tissues, spinal fluid specimens, timed drug level collections

Copy to QA Coordinator: Yes

CERTIFICATION

THIS SECTION OF FORM IS MANDATORY

By signing below I take full responsibility for labeling/re-labeling of the above listed patient samples/specimens

Missed or incomplete Labeling Definitions

1 - Mislabeled specimen OR Specimen/requisition (order sheet) mismatch

A mislabeled specimen is one on which 1 or both patient identifiers are incorrect. A specimen with a label from a different patient, 2 contradictory labels on 1 specimen, or labels that did not correspond to the requisition were considered mislabeled. OR A specimen received with a requisition (order sheet) that does not match the request and/or patient identified on the specimen tube.

(a) Patient name on label is different than the patient’s name indicated by the unique identifying number on the specimen.

(b) Specimen arrives with 2 labels of which 1 label specifies "Barbara Jones" and the second label identifies "Susie StJohn".

(c) Identification information on label does not match requisition (order sheet).

(d) A stool specimen arrives in the lab with a label and order indicating that the specimen should have been a urine.

(e) A specimen arrives in hematology in a red top clot tube with an order and label for CBC purple top tube on it.

(f) Patient record indicates type A blood, lab result shows specimen to be Type O.

2 - Unlabeled specimen

A specimen received by laboratory without a label OR without any patient identifiers on the label.

Test tube contains blood, but a label is not provided.

3 - Partially labeled specimen OR partially completed requisition (order sheet)

Specimen or requisition (order sheet) does not include 2 patient identifiers.

Specimen arrives with patient name of "Robert Smith", but no other unique identifier is provided.

4 - Incomplete specimen label

(b) Paperwork is missing required clinical information (ex. Brief clinical history)

5 - Illegible specimen label

Submit one (1) Blood Bank Specimen Collection Form with each type and screen sample.

TRM-F0106 Blood Bank Specimen Collection Form v.6

PATIENT LABEL: Must include full first and last name and full SSN

PATIENT IDENTIFICATION

LAB Order # (To be Completed by Lab Staff)

PHLEBOTOMIST ATTESTATION

· I collected this blood sample.

· I have performed positive identification of this patient.

· I compared the full name and social security number on the sample label and verified that they exactly match the identifiers on the patient’s armband and on this collection form.

· My signature/initials and the date and time of collection are written on the blood specimen label.

· I labeled the sample and obtained a second person’s verification before leaving the patient’s bedside.

PHLEBOTOMIST SIGNATURE

PHLEBOTOMIST FULL NAME [PRINT CLEARLY]

Collection Date: Collection Time:

History Check (To be Completed by Blood Bank Staff Only)

□ No Local History □ No Remote History

· Previous ABO/Rh:

Previous antibody? (circle one) Yes No If Yes, list: Anti- Special Transfusion Requirements:

· None

· Irradiated

· Leukoreduced

· Other (list):

BB Tech/date:

VERIFIER ATTESTATION

· I witnessed the person identified above collect this blood sample.

· I have read the full name and social security number on the sample and verified that they exactly match the identifiers on the patient’s arm band and on this collection form.

· I verified the collection before leaving the patient’s bedside (N/A if verifier is the patient).

VERIFIER SIGNATURE

VERIFIER FULL NAME [PRINT CLEARLY]

COMPLETE THIS SECTION DURING COMPUTER DOWNTIME ONLY

· DAT

· ABO/Rh image1.emf image2.emf image3.png