36C25819R0003-015.pdf

Phoenix VA Health Care System Phoenix, Arizona

Policy Memorandum No. ll3-10 March 8,2018

COLLECTION AND TRANSPORTATION OF PATIENT SPECIMENS

TO THE LABOR^ATORY

1. PURPOSE: Establish policy and procedures at the Phoenix VA Health Care System (PVAHCS) and its Community Based Outpatient Clinics (CBOCs) for the proper collection and submission of specimens that preserves the quality of the specimen for proper diagnosis. This policy and procedures comply with the College of American Pathologists' (CAP) regu lations, Clin ica I Laboratory I m provement Amend ments (CLIA) Standards and Compliance Directives initiated by the Department of Health and Human Services.

2. POLICY: Patient specimens shall be collected and transported to ensure the specimen is viable for testing upon arrival at the Laboratory. Maintaíning specimens in a state as close as possible to that at the time of collection facilitates correct test results and accurate diagnoses.

a. Scope: This policy applies to specimens (both anatomic and body fluids) collected at any service within the Phoenix VA Health Care System for submission to the Laboratory as well as to providers of a contracted medical institution. Pathology staff will perform all valid orders and may not alter or cancel orders. Pathology reports may be billed to third party insurance by Medical Care Cost Recovery (MCCR) as allowed by law.

b. Specimen identification: All patient specimens shall be labeled via computer-generated standardized labels with the following information:

1) Complete patient name

2) Full social security number.

3) Date and time of collection (procedure date and time).

4) Specimen type, source and laterality(e.9. proximal, distal, left, right...).

5) Provider Name (Attending, not resident, fellow or other); last name, first initial.

c. Specimen receipt: Anatomic specimens shall be received at the Receiving Window of the Laboratory with either a requisition form, printed order or a manifest of specimens. These document(s) shall be initialed for receipt by staff at the Receiving Window and a copy shall be returned to the collecting location by the Courier. Blood and other body fluids do not require return of orders/requisitions to the collecting location unless specifically requested.

Phoenix VA Health Gare System

Policy Memorandum No. 113-10 March 8,2018

d. Specimen requirements: The Anatomic Pathology Section (Histology) shall be contacted to address questions and inquire on special requirements for any specimen requiring special examination. Refer to Attachment A for requirements of various sample types.

3. DEFINITIONS:

a. Properlv Labeled Specimen - Specimen with computer-generated labels containing complete patient name, social security number, specimen type, source and laterality, procedure date and time, and the provider name.

b. Specimen Source - the anatomic origin of the specimen, including topography, laterality.

1) Fluids must be identified by type (urine, blood, CSF, BAL etc.). For urines, specify method of collection (void, clean-catch, catheter etc.).

a) For blood, specify whether arterial, venous, capillary/fingerstick; identify anatomic location and laterality of the phlebotomy.

b) Other body fluids, identify the type of fluid and method of collection (exempli gratia (e.g).thoracentesis, via drain, BAL, etc.).

c. Anatomic Specimen - Tissue samples (e.9. surgical specimens), cytology (e.9.

fine needle aspirates (FNA), gynecologic PAP samples etc.), implants, biopsies, organs, bone marrow etc. These specimens are considered irreplaceable. This generally excludes blood and urine, except for urine samples submitted for cytology. The source of the specimen written on the label may be an abbreviated format of the location on the req u isitio n/o rd e r/ma n ifest.

1) For example, Colon #1 Transverse on the container label will refer to Colon #1 Transverse colon polyp proximal 6 centimeters, listed on the requisition.

2) Subsequent samples would be labeled as Colon #2 Colon, Rectum #1 Proximal, Rectum #2 Distal etc., with corresponding expanded information on the requisition for each sample.

d. Fresh Specimens - Transport Media and Fixatives - Fresh specimens are placed in a container without any fixatives that preserve a specimen and prevent autolysis of the sample. Formalin is a common fixative for tissue specimens. Transport media is a liquid used to slow down tissue degradation, but is not a fixative.

1) Some tissues must be delivered fresh to the laboratory. Refer to Appendix A for guidelines on collection and handling for different specimen types.

Policy Memorandum No. 113-10 March 8,2018

e. Specimen Trackinq Svstem - A system designed to track the status of the specimen at any time to maintain accurate chain of custody from originating provider to the Laboratory.

f. Courier - Contracted Service, staff or volunteer who picks up the specimen at the site where the patient specimens are collected and delivers the specimen to the Laboratory.

g. Transport Container - A sealable leak-proof container with biohazard identification used to contain specimen cups, vials, tubes, syringes or other container and minimize leakage or loss of sample during transport. These are placed into a temperature controlled container for transport and delivery to the Laboratory by a Courier. Refer to the Laboratory Test Description in VistA for collection and transport requirements of each desired test.

h. Transport Time: The time measured from placement of specimens at a pick-up location, to the time that specimen is delivered to the laboratory by a courier.

i. Specimen Requisition Form - A specimen submission form used for irreplaceable specimens, such as tissue, cytology specimens, etc. Brief clinical information including the patient's history, clinical diagnosis, and the question for pathologist, etc., should be provided to facilitate establishing a diagnosis.

j. Specimen Manifest - A printed list of specimens that were ordered in CPRS by providers and collected by the off-site phlebotomist, nurses, and healthcare aids.

4. PROCEDURES:

a. Create Order/ConsulURequisition and Collect Specimen. Requisition forms shall be computer generated and authorized by the requesting provider.

b. ln case of computer downtime, a manual Fluid/Tissue Examination Form or PAP Examination Form must be filled out and be transported with the specimen. These forms are accessible for download via the intranet Pathologv & Laboratorv Medicine Service web page.

c. Tissue specimens shall be collected either fresh or in fixative or transport media and sealed in a biohazard plastic bag (see below) with a completed requisition form placed in the side pocket of the bag to avoid damage from spills or leakage.

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Policy Memorandum No. ll3-10 March 8,2018

d. Confirm Positive Patient ldentification:

1) Collected specimen containers shall be labeled with a computer-generated label by an ordering provider or a designee. The container must be labeled and matched with the req u isitio n/o rde r/man ifest.

2) Affix the label to the container, and not to the lid

3) Prior to leaving the immediate area of collection, ensure that the requisition/order/manifest information matches the label(s) on the container

e. Prepare Specimens for Transport to the Laboratory:

1) Specimens delivered to the Laboratory without the providers' electronic orders or requisition shall be rejected by the Laboratory, without exception.

2) Fresh anatomic specimens must be delivered within one hour of collection to the Laboratory for processing and testing. Batching fresh specimens for later transport and delivery will compromise specimen integrity and is not allowed.

3) When a specimen is too large for the container (e.9. amputated limbs), place it in two layers of red plastic bags, each layer of plastic bag is taped securely with appropriate label attached.

4) Blood specimens shall be properly labeled (see below), stored on a rack and recorded on a printed manifest.

5) Urine collected in a specimen cup (BD or equivalent) shall be transferred as soon as possible into sealed tubes (BD or equivalent) containing preservatives.

a) Each tube shall be labeled for only one single test.

b) For example, if three tests are ordered for a urine specimen (e.9.

urinalysis, culture, and microalbumin), the urine shall be transferred into three separate tubes appropriate for each test type and labeled with the requested test.

f . All collected specimens with requisition forms, printed orders and/or manifests shall be ready for the Courier at the pickup station as close as possible to the time of collection.

Policy Memorandum No. 113-10 March 8,2018

1) The Courier shall transfer the specimens into the transport container with the accompanying requisition form(s), order(s), or manifest(s) to ensure all the specimens and their components are accounted for on the specimen requisition form(s), orde(s) or manifest(s).

2) From now on the specimen is in the Courie/s custody, until it arrives at the Laboratory Receiving Window.

3) When the Courier arrives at the Receiving Window of the Laboratory, the Receptionist shall check in all specimens listed on the requisition form(s), orde(s) and/or manifest(s) with the Courier and affix their initials with date/time received to the accompanying requisition form(s), order(s), or manifest(s).

4) The Courier shall retum a copy of the anatomic specimen requisition form(s), order(s) or manifest(s) back to each originating Service location. This closes the loop and provides documentation to the originating Service that its specimens were transported and delivered to the Laboratory. Requisitions for blood and body fluids do not require return of documentation unless specifically requested.

5. RESPONSIBILITIES:

a Chief. Patholoov & Laboratorv Medicine Service (P&LMS), is responsible for the implementation of this policy

b. Service and Section Chiefs are responsible for ensuring the Providers, Couriers and Receptionists follow this policy and procedure.

c. Lab Qualitv Assurance Manaoer is responsible for data collection and evaluating compliance with this policy.

6. RESPONSIBLE BOARD: Quality Executive Board

7. REFERENGES:

a. VHA Handbook 1106.02 Pathology and Laboratory Medicine Service Procedures, January 29, 2016.

b. Clinical Laboratory lmprovement Amendments of 1988, October 31 , 1988

8. RESCISSION: Policy Memorandum No. 113-10, Collection and Submission of Surgical and Cytology Specimens, dated October 18,2016.

Policy Memorandum No. 113-10 March 8,2018

9. ATTACHMENTS:

a. Appendix A: Specimen Specific Requirements for ldentification, Handling and Transport

b. Appendix B: Sample Labeling for Anatomic Specimens

10. FOLLOW-UP RESPONSIBILIW: Chief, P&LMS

1 1 . EXPIRATION DATE: March 2021.

RIMAANN O.

lt Medical Center Director

Policy Memorandum No. 113-10 March 8,2018

Appendix A c

Specimen Specific Requirements for ldentification.

Handling and Transport

a. Soecimens for F Sectionino

1) The surgeon determines when a specimen requires afrozen section diagnosis and notifies the grossing Pathologist via the Histology lab at extension 7898 or 7088.

2) The specimen is transported and delivered to the Histology lab by operating room (OR) staff.

3) The Pathologist has 20 minutes to render a diagnosis on the frozen section and communicate those results to the provider. Time of receipt and time of result communication is documented in the pathology report. Additionaltime is allotted for multiple specimens or margins submitted.

4) The specimen(s) will then be submitted for formalin fixation and final evaluation of permanent sections.

b. Urinarv Stones:

1) Place in the specimen container dry and send to the Pathology Laboratory

Non-Tissue Specimens: i.e., prosthetics, hardware, etc.,

1) Place in the specimen container dry and send to the Pathology Laboratory.

d. Bullets: lf it is an active police case, the police will be notified and the bullet will be given directly to the police by OR personnel. lf it is not an active police case, then the following should be done:

1) Protect the bullet from being marred. Do not use metal forceps or place in metal pan, etc. Handle with gauze.

2) Place in specimen container.

3) Label in standard manner, plus signature.

4) Initial the requisition.

5) Fill out the logbook and submit bullet like a normal specimen.

6) The grossing Pathologist will gross the bullet in, and then they will send the bullet out for special testing to the Joint Pathology Center if appropriate.

e Suroical n Exceotions: All surgical specimens will be submitted to the Pathology Laboratory; however, the following list contains possible exceptions. There should be an alternative procedure for documenting the removal and disposition of any specimen or devices not submitted to Pathology Laboratory. Submission of the following specimens can be determined by the attending surgeon:

1) Any specimen that must be returned to the manufacturing company (i.e.

grafts).

2) Arthroscopy meniscectomy specimens.

3) Bone segments removed as part of corrective or reconstructive orthopedic procedures (e.9. rotator cuff repair, synostosis repair, spinal fusion).

Policy Memorandum No. 113-10 March 8,2018

Appendix A

4) Cataracts.

5) Debridements (i.e. with a brush, etc.).

6) Fat removed by liposuction.

7) Intrauterine contraceptive devices without attached soft tissue.

8) Mastoidectomy specimens (specimens too small to obtain)

9) Medical devices such as catheters, gastrostomy tubes, myringotomy tubes.

1 0)Middle ear ossicles.

11)Normal toenails and fingernails that are incidentally removed.

12)Orthopedic hardware and other radio-opaque mechanical devices.

13)Rib segments or other tissues removed only for purposes of gaining surgical access, provided the patient does not have a history of malignancy.

14)Saphenous vein segments harvested for coronary artery bypass.

1S)Skin or other normal tissue removed during a cosmetic or reconstructive.

1 6)Procedure (e.9., blepharoplasty, cleft palate repair, abdominoplasty.

17)Rhytidectomy, syndactyly repair), provided it is not contiguous with a lesion and the patient does not have a history of malignancy.

18)Stents, and sutures that have not contributed to patient illness, injury or death.

19)Teeth when there is no attached soft tissue.

20)Therapeutic rad ioactive sou rces.

f. Specimens Exempt from Microscopic Examination: The following are specimens that often require only a gross examination, but exceptions are made at the pathologist's discretion;

1) Accessory digits, bunions, hammertoes.

2) Extraocular muscle from corrective surgical procedures.

3) lnguinal hernia sacs.

4) Nasal bone and cartilage from rhinoplasty or septoplasty.

5) Prosthetic cardiac valves without attached tissue.

6) Torn meniscus.

7) Varicose veins.

8) Bone of knee (osteoarthritis), head of femur (osteoarthritis).

9) Atheromatous plaque.

g. Muscle or Nerve Biopsv: When a muscle or nerve biopsy must be obtained, the surgeon must notify the Pathology and Laboratory Medicine Service (P&LMS) at least seven (7) days prior to the procedure. Specimen handling will be coordinated by the surgeon and the pathologist.

h. Lvmph Node Biopsv/Excision: A pathologist is called as soon as possible regarding lymph node specimens, if a provider has special handling requests. The Pathologist decides how the lymph node tissue is to be handled to address the provideds clinical impression. Specimen(s) is(are) sent to the Laboratorv fresh.

within one hour of collection: Pathologists will decide how to triage each specimen based upon findings from touch prep analysis of the fresh tissue.

Policy Memorandum No. 113-10 March 8,2018

Appendix A

i. Specimens for Gvtologv: All specimens must be accompanied by a computer-generated requisition (e.9. Consultation Sheet) that includes the patient's information and medical history and states that the specimen is for cytology. Specimens are sent within t hour of collection to the laboratory to preserve specimen diagnostic quality.

Cytology specimens delivered to Histology shall be processed the next business day.

1) Deliverv locations within the laboratorv:

a) Before 3:30pm -- specimens are delivered directly to the Histology

Receiving Window.

b) After 3:30pm - specimens are delivered to the main Laboratory

Receiving Window and stored in the Chemistry Section walk-in refrigerator in the area specified for cytology.

2) Bodv fluids. i.e. pleural, peritoneal, ascites, cerebrospinal fluid (CSF), BALs, Bronchial or Esophagealwashing, and Wang needle biopsies should be submitted fresh/unfixed with no additional additives and labeled in accordance with Attachment B.

3) Wano needle samples shall be placed in a small quantity of normal saline during transport to the laboratory to preserve the tissue architecture. Saline soaked gauze is too disruptive to the tissue.

4) Fine Needle Aspiration (FNA):

a) Label slides with the patient's name and full Social Security number.

b) Spread and smear the liquid material between two slides and pull apart.

c) lmmediately place half of the slide smears in a Coplin jar of 95% alcohol, and allow the remainder to air dry.

d) Discharge the remaining contents of the syringe into a formalin container and label it in accordance with Attachment B. Histology will make a cellblock from this residual material if sufficient cellular material is available.

e) FNA is not optimal for diagnosis of hematolymphoid malignancy. Please call pathologist for guidance if indicated.

5) Papanicolaou (PAP) smears:

a) PAP is collected in a PreservCyt solution with broom/cytobrush.

b) Follow the manufacture/s instructions for the sample type. DO NOT leave the broom or brush in the vial for ThinPrep specimens.

c) Labelthe sample in accordance with Attachment B.

d) The computer-generated Consultation Sheet must include the patient's information and medical history.

e) Contact Histology at ext. 7898 or ext. 7088 for instructions and supplies.

Kidnev Biopsv:

1) Submit samples fresh; a Pathologist will evaluate the biopsies, and place one in3o/o glutaraldehyde, one in immunofluorescence media, and one in formalin.

These samples are sent out for testing.

Policy Memorandum No. ll3-10 March 8,2018

Appendix A

k. Skin Biopsies for Direct lmmunofluorescence:

1) Place one sample in Michels media or equivalent, and one sample into formalin.

2l Do not submit these specimens on Friday's. Michels has limited stability, and should be processed within 48 hours to maximize specimen viability.

3) Skin samples for Direct lmmunofluorescence are sent to Tucson and then to a reference laboratory for testing.

l. Stents:

1) Place stent in plastic conical tube filled with Cytolyt solution or saline

2) Container must be labeled in accordance with Attachment B

3) Contact Histology at ext. 7898 or ext. 7088 for instructions and supplies.

m. Urine:

1) Received unfixed in a plastic urine container. Specimen must be refrigerated within t hour of collection, if unable to deliver to Laboratory after voiding.

2) Label the specimen in accordance with Attachment B.

3) Early morning voiding is the best sample.

4) When requesting three samples, have patient void early morning for three consecutive days. Have the patient refrigerate the samples if s/he is unable to deliver to Laboratory after voiding.

l0

Policy Memorandum No. 113-10 March 8,2018

Appendix B esophagus 20 centirÍeters Êsophagus 30 centimeters Gestric antrum

Sample Labeling for Anatomic Specimens

Label Requirements:

1) Patient's full name

2) Patient's full Social Security Number

3) Date and time of specimen collection

4) Specimen type, source and laterality (e.9. proximal, distal, left, right etc.)

5) Provider Name (Attending, not resident, fellow, etc.); last name, first initial

6) Affixed to the side of container

Requisition must match the container label:

Example:

zzresr. cHocoLATE BOB oo.ã' r*oceor* ¿ (Ð E so p h c-5't 5

>>SURGICAL PATHOLOGY REQUEST

specimen collected Date/Tiñe rF KNovIN Date aug 25, 2010@1020 llüul[lilrfilll

DOB; C; ' '

or E/.zs' ':::î /lr o_

PECIMEN(s) 1.ro.2Þ

Providen Last name F¡rst s c'li ni Eval cal for

PROVTDER

rmpressì on :

H pyìori

DAVTS, MTCHAEL

Pr{(€r cxoÕó¡-nrg goe

¡s srief clínìcal Hìstory:

screenì ng

Prior History of:

Radiation Therapy No Chemotherapy. NoInstrumentatìon No

DOB:

e_ zr)

ZiEsr.CHócöLRrE eos Pro(€r PRocEDUR e (Ð {ç.s{ r i c ilUUfHl i,"ipiWf,e MI to:ztt

. L,¡lnatienfsñ¡lfsoc¡alsect¡rityNumber

Reasons for Rejection:

1) No requisition sheet

2) lmproperly labeled specimen

3) Unlabeled specimen

4) Evidence of leak or spill

5) lllegible label

6) lnadequate preservation

Questions? Call Histology extens¡on 7898 ll