D.8 - POC 50 CBOC Specimen Processing and Shipping.pdf

VISN 22 Consolidated Pathology & Laboratory Medicine Service

Raymond G. Murphy Medical Center New Mexico VA Health Care System

Albuquerque, NM 87108 Title: CBOC Specimen Processing & Shipping Document Number: POC 50 (Procedure)

Effective Date: 2/02/2022 Version: 1.0

Approved by: Brittany Coffman Approved Date: 11/14/2022

Last Reviewed by: Maria Montano Last Reviewed: 11/14/2024

POC 50 CBOC Specimen Processing & Shipping

Copy of version 1.0 (approved and current)

Last Approval or Periodic Review Completed

11/14/2024

Next Periodic Review Needed On or Before

11/14/2026

Effective Date 2/02/2022

Controlled Copy ID 46033

Location CBOC Services Performance Work Statement (PWS) attachment emailed to Ramonalisa Aviles

Organization New Mexico VA- Main Lab

Approval and Periodic Review Signatures

Type Description Date Version Performed By Notes

Periodic review POC Supervisor 11/14/2024 1.0 Maria Montano

Approval Lab Director 11/14/2022 1.0 Brittany Coffman

Approval Lab Director 2/02/2022 1.0

Julie Harrington

Approval POC Supervisor 2/02/2022 1.0 Maria Montano

Prior History

POC.0075 CBOC Specimen Processing & Shipping 5 8/28/2017

Version History

Version Status Type Date Added Date Effective Date Retired

1.0 Approved and Current Initial version 12/15/2021 2/02/2022 Indefinite

Purpose To establish guidelines for the appropriate processing and shipping of patient specimens from the Community Based Clinics to the NMVAHCS Laboratory.

Proper collection, handling, and transporting of specimens are fundamental to the quality of specimens for analytical testing in the laboratory. Transportation of samples requires compliance with federal transportation regulations.

Safety Practice Universal Precautions. Follow all facility Infection Control procedures to prevent exposure to bloodborne pathogens.

Discard all blood collection sharps in biohazard waste containers approved for sharps disposal.

Transferring a sample collected using a syringe to a tube is not recommended.

Additional manipulation of sharps increases the potential for needlestick injury.

Take precautions to protect against exposure to aerosols and splashes from open sample containers.

Review and Print Lab Orders from CPRS Prior to Collection

Refer to the Lab Test Information in CPRS for sample requirements, completion times, and process accordingly.

Print the lab orders to be collected from CPRS. The printed orders specify the sample and tube type for collection.

Not all tests can be shipped due to sample stability limitations.

Contact Pathology & Laboratory Medicine service 7 days/week, 24 hours/day at ext. 2383 for clarification on collection instructions.

Patient Identification

Identify the patient using two identifiers prior to collection. Full name, birth date, and SSN are acceptable identifiers.

Whenever possible, have the patient state his identifiers: “Please tell me your date of birth.” Do not ask a ‘yes’ or ‘no’ question like, “Is your birthday May 7th?”

Fill Tubes Adequately

Collect sample according to NMVAHCSthe procedure described in POC.0053 “CBOC Venipuncture Procedur.e”.

Allow tubes to fill until the vacuum is exhausted to ensure the proper blood-to-additive ratio.

Overfilling or under-filling of tubes will result in an incorrect blood-to-additive ratio and may lead to incorrect analytical results.

Specimen Labeling

Label all collection tubes in the presence of the patient Correctly labeled specimens contain the following information:

a. Patient’s full name

b. Full SSN

c. Collection date and time (use military time)

d. Collector’s initials

Place the label lengthwise on the tube just below the cap. The label must not overlap itself, protrude from the sides, extend onto the tube cap/stopper or obscure the view of the specimen inside the tube.

It is acceptable to trim the end of the label. However, do not remove any

Approved and current. Effective starting 2/02/2022. POC 50 (version 1.0) CBOC Specimen Processing & Shipping

Controlled copy ID 46033. Printed on 12/11/2024 9:08 (MST). Page 1 of 7 patient ID or collection date/time information.

Centrifugatio n

For tests that require serum or plasma, blood tubes must be spun in a centrifuge to separate the fluid from the red blood cells. The serum or plasma must be transferred to a properly labeled transport tube.

Allow Tubes for Serum to Clot

a. Tubes for serum like the Gold or Red top contain no anticoagulant and are intended to clot completely before being centrifuged.

b. Separation of serum from cells should take place within 1 hour of collection.

c. Allow blood Vacutainer tubes for Serum to clot thoroughly before centrifugation. BD recommends the following clotting times:

60 minutes for Red Top tube (no gel separator) 30 minutes for Gold Top (BD SST) tube

d. Patients with abnormal clotting times due to disease or anticoagulant therapy require more time for complete clot formation.

Tubes for Plasma like the light green top Lithium Heparin gel-separator tube do not need to sit for any period of time before centrifugation. These tubes are not intended to clot.

Centrifuge to Separate Plasma/Serum from Red Blood Cells

a. Balance tubes in the centrifuge. Match tubes of the same fill level and make sure that tubes are properly seated.

b. Spin gel tubes at 1100 – 1300 RCF (g) for 15 minutes if using a fixed angle centrifuge or 10 minutes if using a swing rotor centrifuge.

c. Spin all non-gel tubes at less than or equal to 1300 RCF (g) for 10 minutes.

d. Allow centrifuge to come to a complete stop before attempting to remove tubes.

Important Note: Do not re-centrifuge gel separator tubes. Aspirate serum or plasma from the tube and place in a clean test tube to re-centrifuge.

Transfer Sample to Transport Tube

After centrifuging, carefully remove tube stoppers to prevent aerosolization.

Gauze or a stopper removal device may be used.

Transfer serum or plasma to a plastic transport tube using a polyethylene transfer pipette. Do not aspirate any of the red cells into the pipette.

Securely fix lid on transport tube to prevent leakage.

Label all tubes with the patient’s full name, full social security number, date and time of collection and initials of collector.

Mark transport tubes to indicate sample type.

a. Mark Plasma tubes with a green marker on the lid and label.

b. If the sample is from a tube other than a Green or Gold top, write the tube type on the label. For example, “Plain Red”, “Dark Green” Refrigerate separated samples until just prior to packing the shipping box.

EDTA

Lavender Top Tubes

Do not centrifuge tubes for CBC (Hemogram & Five-Part Diff)

Approved and current. Effective starting 2/02/2022. POC 50 (version 1.0) CBOC Specimen Processing & Shipping

Controlled copy ID 46033. Printed on 12/11/2024 9:08 (MST). Page 2 of 7

HGB & HCT only Reticulocyte count Hemoglobin A1C RBC Folate

These tests are performed on whole blood only

Samples for Prothrombin Time

(PT) & INR

Prothrombin Time (PT) & INR specimens can be shipped to the Raymond G.

Murphy Medical Center Laboratory for testing with the following restrictions:

a. Specimens must be maintained at room temperature (15-30C)

b. Testing must occur within 24 hours of collection

Collection Instructions

a. Collect in a light blue top tube (3.2% sodium citrate additive)

b. Gently mix immediately after collection to help prevent clotting

c. Tube must be filled within 10% of the marked draw volume of the tube to ensure the right blood to anticoagulant ratio

d. If using a butterfly collection kit, use a waste tube to clear the excess air from the device tubing Handling & Storage Instructions

a. Tube must remain unopened

b. Do not centrifuge tube

c. Do not store in the refrigerator. Do not ship with frozen gel ice pack.

d. Specimen is stable for 24 hours at room temperature

Rejection Conditions

a. PT & INR testing cannot be performed on specimens that are improperly labeled, hemolyzed, clotted, underfilled, overfilled, or collected in the wrong tube.

b. Specimens will be rejected if the correct shipping temperature was not maintained or if the specimen was shipped with ice.

c. Tests other than PT/INR (e.g. PTT) cannot be performed Shipping Instructions: See the Packing Samples for Shipment section of this document for detailed instructions on shipping room temperature specimens.

Approved and current. Effective starting 2/02/2022. POC 50 (version 1.0) CBOC Specimen Processing & Shipping

Controlled copy ID 46033. Printed on 12/11/2024 9:08 (MST). Page 3 of 7

Urine Samples Random Urine Collections:

a. Instruct the patient to collect the urine into a sample cup labeled with their ID information.

b. Transfer the urine to the appropriate transport tube using a polyethylene transfer pipette or BD urine transfer device (straw).

Preserving Urines for Shipping

a. Ship urine samples in the appropriate preservative transport tube.

b. Label tubes with the patient’s full name, full social security number, and date and time of collection.

c. Refrigerate all urines until just prior to packing the shipping box

Test Preservative/Transport Tube Urinalysis UA Transport tube Urine Culture & Sensitivity (C&S)

Urine C&S Tube

Microalbumin No preservative is required, but it is advised to ship in the BD No Additive (Z) tube

Urine Tox Screen No preservative required, store refrigerated Ship in 50-mL screw top tube

24-Hour Urine Collections

a. No preservative is required for most 24-hour collections

24-Hour Urine – Processing for Transport

1. Write on the printed test order:

Total Volume collected (in milliliters) Start and End dates/times

2. Gently mix the sample.

Pour off a portion (30-50 mL) into a transport tube.

3. Label the transport tube with:

Patient’s full name and full SSN Total Volume of urine collected (for example, 1550 mL)

4. Discard the remainder of the sample in the toilet.

Do not send the 24-hour collection container to the NMVAHCS Lab.

Samples in Preservative Cups

ThinPrep Pap, Cytology and Histology samples

a. Carefully seal each labeled sample cup in a re-closeable biohazard bag along with an absorbent pad, such as a paper towel.

b. Include a completed request form.

Stool Samples Stool Culture and Sensitivity (C&S)

a. Vial with orange lid - “Para-Pak C&S”

b. Using the collection spoon in the pack, add sufficient stool to bring the liquid level up to the "fill to here" line (approximately 5 ml of sample).

c. Mix well to ensure adequate mixing with the preservative. When mixing is completed the sample should appear homogeneous.

d. Label container with full name, full SSN and collection date/time

Approved and current. Effective starting 2/02/2022. POC 50 (version 1.0) CBOC Specimen Processing & Shipping

Controlled copy ID 46033. Printed on 12/11/2024 9:08 (MST). Page 4 of 7

Ova and Parasite Exam (O&P)

a. Each kit contains one vial with 15 mL LV-PVA-fixative (grey lid) and one vial with 15mL 10% formalin preservative (pink lid). Each vial has a built-in collection spoon.

b. Using the collection spoon in the pack, add sufficient stool to bring the liquid level up to the "fill to here" line (approximately 5 ml of sample).

c. Mix well to ensure adequate mixing with the preservative. When mixing is completed the sample should appear homogeneous.

d. Label both vials with full name, full SSN and collection date/time

e. Preserved stool is stable for 7 days

Clostridium Difficile (C. Diff)

a. Test name in CPRS/VistA: “C. DIFF TOXIN EIA

b. Unpreserved sample stable for 72 hours at 2-8C

c. Collect in clean container. Ship in sterile urine cup.

d. Formed stools are not accepted.

Giardia

a. Test name in CPRS/VistA: GIARDIA (ELISA)

b. Performed on stool preserved in the 10% Formalin (pink lid) vial for O&P exam or in the Para-Pak C&S vial (orange lid).

Fecal Occult Blood Test (FOBT)

a. Use FIT collection kit (distributed by Lab to clinics)

b. Samples are stable for 14 days at ambient temperature and up to 30 days if stored between 2-8C

Specimen Storage

Refrigerated Specimens

a. Prior to shipment store specimens between 2-8C in a temperature monitored refrigerator.

b. Ship in an insulated container using frozen gel ice packs to maintain temperature.

c. Specimens should never come in with the frozen gel ice pack.

Room Temperature Specimens

a. Prior to shipment store specimens between 15-30C

b. Keep away from extremes of heat or cold.

c. Ship in a separate insulated container without frozen gel ice packs.

d. Shipping containers may require the addition of a room temperature or refrigerated gel pack due to seasonal temperature variations.

e. Do not ship room temperature and refrigerated specimens in the same insulated container.

Documents to Include:

Test Orders and Packing List

Each shipping container must include a specimen manifest and printed test requisitions for the enclosed specimens.

A manifest is a packing list of all the specimens in the container to be shipped.

It is an inventory of the actual contents of the box that is used to ensure all specimens that were shipped have been accounted for when the container arrives in lab.

Approved and current. Effective starting 2/02/2022. POC 50 (version 1.0) CBOC Specimen Processing & Shipping

Controlled copy ID 46033. Printed on 12/11/2024 9:08 (MST). Page 5 of 7

General Packing Instructions

The patient label should be affixed to the tubes. Do not place labels on the biohazard bag.

Place specimens in plastic biohazard bag.

Specimens from different patients must be placed in separate bags.

One patient per bag

Place the printed requisition in the outer pocket of the biohazard bag, separate from the specimens. Alternatively, requisitions can be placed in an envelope between the inner Styrofoam liner and outer cardboard of the shipping box.

Packing Specimens for Shipment:

Refrigerated

Refrigerated Specimens (temperature range 2-8C) Ship with frozen gel packs to ensure temperature refrigerated temperature is maintained. Freeze gel pack overnight before use.

Additional frozen gel ice packs may be required in warmer months to maintain specimen integrity during transport.

Do not allow specimens to come into direct contact with frozen gel ice packs.

Use a plastic canister, paper toweling or other material to separate.

Packing & Labeling the Shipping Container – Refrigerated Specimens

1. Place the tubes in a biohazard-labeled plastic bag along with an absorbent pad or paper towel. Carefully seal the bag.

2. Line the bottom of a Styrofoam-lined shipping container with frozen gel ice packs. Place the canisters in the container.

3. Complete a Shipping Manifest for the container

The manifest should match the contents of the box exactly.

Do not indicate samples on the manifest that will not be shipped.

4. Place the accompanying printed orders and sample manifest in the box, separate from the samples.

5. Seal the box and apply appropriate labels (e.g. tamper-evident label) A label reading “UN3373 Biological Substance Category B” should be clearly visible indicating that the box contains samples for diagnostic testing.

6. Complete the courier’s waybill according to the courier’s instructions and affix to the box

7. Email the tracking numbers for each container to the NMVAHCS Laboratory

Packing Specimens for Shipment:

Room Temperature

Room Temperature Specimens (temperature range 15-30C) Temperature can be affected by prolonged exposure to heat or cold during shipping. The addition of a cold or room temperature gel pack to the shipping container will help maintain room temperature during transport.

a. Warm Weather Conditions Pack container with a refrigerated gel pack Refrigerate the gel pack for a least 3 hours before use Do not let specimens come in direct contact with the cooled pack

b. Cold Weather Conditions Pack container with a room temperature gel pack Store the gel pack at room temperature for a least 3 hours before adding to the shipping container

Approved and current. Effective starting 2/02/2022. POC 50 (version 1.0) CBOC Specimen Processing & Shipping

Controlled copy ID 46033. Printed on 12/11/2024 9:08 (MST). Page 6 of 7

Packing & Labeling the Shipping Container – Room Temp. Specimens

1. Place the tubes in a biohazard-labeled plastic bag along with an absorbent pad or paper towel. Carefully seal the bag.

2. Line the bottom of a Styrofoam-lined shipping container with one large gel pack.

3. Complete a Shipping Manifest for the container

The manifest should match the contents of the box exactly.

Do not indicate samples on the manifest that will not be shipped.

4. Place the accompanying printed orders and sample manifest in the box, separate from the samples.

5. Seal the box and apply appropriate labels. (e.g. tamper-evident label) A label reading “UN3373 Biological Substance Category B” should be clearly visible indicating that the box contains samples for diagnostic testing.

6. Complete the courier’s waybill according to the courier’s instructions and affix to the box

7. Email the tracking numbers for each container to the NMVAHCS Laboratory

Laboratory Contacts

Contact Pathology & Laboratory Medicine Service 7 days/week, 24 hours/day at ext. 2383 for clarification on collection instructions.

Be sure to mention that you are calling from a CBOC and need instructions for processing/preserving and shipping.

Additionally, the Ancillary Testing Department is available to answer any questions on collection, processing or shipping of samples Monday through Friday 7:00 am to 3:30 pm at ext. 5087.

References “BD Vacutainer Evacuated Blood Collection System”, Becton Dickinson Co, Franklin Lakes, NJ, 07417, 2010.

IATA Dangerous Goods Regulations, Packing Instruction 650, January 2015.

NMVAHCS P&LMS Policies & Procedures:

POC.0053 CBOC Venipuncture Procedure POC.0077 CBOC Urinalysis Transport POC.0044 CBOC Urine Culture Transport POC.0048 CBOC/CCBOC Lab Specimen Acceptability Reference Guide POC.0013 CBOC Urine Transport Guide POC.0074 CBOC Specimen Manifest

Approved and current. Effective starting 2/02/2022. POC 50 (version 1.0) CBOC Specimen Processing & Shipping

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