LAB-QM-PRE-003 — Specimen Handling, Packaging and Transportation Policy

1.0 Purpose

To describe the requirements for handling, processing, packaging, and transporting diagnostic specimens (blood, urine, and other body-fluid specimens) in the pre-centrifugation, centrifugation, and post-centrifugation phases — whether within the Laboratory, from patient care areas to the Laboratory, or externally to a reference laboratory — so that: collected specimens are labeled accurately and all pertinent information is received; specimens are handled and transported appropriately; specimens are distributed to the appropriate section for analysis within a time frame matching their urgency; and specimens for referral are identified and processed accordingly. Blood specimens (serum, plasma, or whole blood) are handled and processed with attention to the variables of the pre-centrifugation, centrifugation, and post-centrifugation phases, so that pre-examination errors from improper blood specimen handling are recognized and reduced or eliminated across the disciplines performing blood-specimen examinations within TCH's confirmed scope of service.

2.0 Scope

This policy applies to all specimens processed and prepared for transport in the collection, receiving, and accessioning areas of the Laboratory, and to Nursing/patient care area personnel who transport specimens to the Laboratory. It covers the handling and processing of blood specimens (serum, plasma, or whole blood) for examination procedures, including the pre-centrifugation, centrifugation, and post-centrifugation phases. This policy applies to all Medical Technologists and Laboratory Aides involved in blood specimen handling.

3.0 Definitions

• Diagnostic specimen — any human material (excreta, secreta, blood and its components, tissue and tissue fluids) being transported for purposes of diagnosis.
• Centrifugation phase — the time period when the specimen is inside the centrifuge.
• Pre-centrifugation phase — the time period after specimen collection and before specimen centrifugation.
• Post-centrifugation phase — the time period after centrifuging the specimen and before removal of an aliquot of serum or plasma for testing.
• Pre-examination procedures — steps starting, in chronological order, from the clinician's request and including the examination requisition, patient preparation, primary sample collection, and transportation to and within the laboratory, ending when the analytical examination procedure begins.
• Secondary tube — a tube used to contain the resultant plasma/ serum yielded by centrifugation of a primary additive/serum tube.
• Separated serum/plasma — serum or plasma completely separated from contact with cells or a clot (by pipette removal, or by a chemical/physical barrier such as a separator device); should be visually free of erythrocytes (0.1%–1% intact cells do not contribute to a hemolysis effect).
• Uncentrifuged specimen — a blood specimen that was not centrifuged.

4.0 Responsibility

4.1 Hospital Director

• Exercises executive oversight and supports transport resources (standing governance and policy approval per Organization and Governance).

4.2 Pathologist

• Provides clinical direction regarding specimen integrity and handling criteria (standing clinical oversight per Organization and Governance).

4.3 Chief Medical Technologist / Laboratory Quality Manager

• Reviews and approves this policy; ensures compliance with applicable regulatory, accreditation, national, and international standards.
• Coordinates and facilitates implementation of this policy among Medical Technologists and Laboratory Aides; creates/delivers educational materials supporting it.
• Conducts periodic internal audits to ensure compliance (see Internal Audit).

4.4 Medical Technologists

• Follow and adhere to this procedure at all times.

4.5 Laboratory Aides

• Follow and adhere to this procedure at all times.
• Laboratory Aides do not perform, verify, interpret or release laboratory examinations or results.
• Laboratory Aides do not perform blood specimen centrifugation, separation, or other technical handling steps described in this policy.

4.6 Nursing, Courier, and Referral Laboratory

• Follow and adhere to this procedure at all times.

5.0 Policy / Procedure

5.1 Policy Statement

It is the policy of the Laboratory that all specimens are transported, handled, and tracked according to established safety and infection control policies, so that pre-examination errors due to improper handling are reduced or eliminated. This covers packaging instructions, personnel training, and a specimen tracking system.

Specimens are packaged and transported so that contents will not leak and will arrive in good condition, protecting both the integrity of the specimen and the interests of the Laboratory and the patient. The Laboratory maintains a system to preserve specimen identity during receipt, processing, examination, and archiving.

These guidelines apply across chemistry, hematology, immunology, and serology — the disciplines performing blood-specimen examinations within TCH's confirmed scope of service.

This policy covers the pre-examination phase specifically — transportation to the Laboratory, initial receiving/sorting, pre-centrifugation/centrifugation handling, and packaging/transportation for send-out specimens. Specimen receipt, transport, rejection, and recollection are documented on F-QM-PRE-003-A-V0.

5.2 Transportation and Handling of Specimens (Within TCH)

• Check the specimen for any special transport requirements before dispatch.
• Secure specimen container lids/closure caps for a complete, leak-proof seal.
• Transport specimens in trays or racks to the Laboratory with the accompanying requisition in a zip-lock biohazard bag: fold the requisition into thirds (sticker-label portion face up) and insert it into the bag's rear pocket, with the specimen in the main pouch.
• Bring specimens to the Laboratory promptly — improper transport or storage may invalidate test results.
• Specimens submitted in a syringe are unacceptable unless specifically indicated for that test's collection method; the submitting unit is asked to submit a new specimen or to transfer it into an acceptable container at the Laboratory.
• Cracked, damaged, or overturned containers that are leaking on receipt constitute a biologic hazard and are discarded; the submitting unit is notified to submit a new specimen.
• Specimens collected by Laboratory phlebotomists are subject to the same packaging and transport controls above.

5.3 Specimens Collected for Point-of-Care Testing (POCT)

• Before collecting a POCT specimen, the clinician/nurse identifies the patient using at least two identifiers.
• If the specimen will be tested immediately, in the patient's presence, labeling is not required.
• If the specimen will leave the patient's presence but be tested immediately, it is labeled (in the patient's presence) with the patient's name and MRN.
• If there will be a delay in testing, it is labeled (in the patient's presence) with the patient's name, MRN, date/time of collection, and the name of the collecting nurse/clinician.

5.4 Specimens Submitted to Outside/Referral Laboratories

Send-out specimen labeling, requisitioning, invoice-vs-log verification, and dispatch follow Referral Laboratory Policy Section 5.5 — not duplicated here.

5.5 Receiving of Specimens

Initial acceptance (before the porter/nurse leaves the receiving area): the requisition and specimen tube are checked for complete patient identification data (name, MRN/file number, order number, at least two independent identifiers), a clearly written (non-abbreviated) diagnosis where applicable, tube adequacy (not overfilled/underfilled), absence of contamination, and secure biohazard-bag packaging with the requisition folded and placed correctly.

If any of these is not met, the specimen is not received; if met, the porter/nurse may leave and the specimen is logged in the receiving log sheet.

Handling accepted specimens: specimens are logged with date/time of receipt and assigned a unique accession number; patient details are re-checked against both requisition and specimen label; the correct tube type is confirmed; time from collection is checked (samples exceeding 120 minutes in transit are evaluated against the specific test's stability requirements — see Specimen Collection Policy Section 5.6); and the submitting clinician or nurse is promptly notified of any rejection with the reason, documented on the Specimen Receipt, Transport, Rejection & Recollection Log (F-QM-PRE-003-A-V0).

Preparing for centrifugation on receipt: specimens are sorted and prepared for centrifugation on receipt, allowing sufficient clotting time (clot-activator tubes: 5–30 minutes; anticoagulated specimens may be centrifuged immediately).

Specimens requiring unseparated whole blood (e.g., blood lead, cyclosporin, HbA1c) are not centrifuged; if such a specimen is accidentally centrifuged, the tube is sent to the testing location for evaluation rather than discarded. Chilled specimens (2–8°C) are kept at that temperature until ready for centrifuging.

Rejection documentation: specimens rejected at receipt or during processing (preparation/centrifugation/separation) are documented on the Specimen Receipt, Transport, Rejection & Recollection Log (F-QM-PRE-003-A-V0).

Universal rejection criteria are owned by Specimen Collection Policy Section 5.6; the following additional criteria from the absorbed blood specimen handling content also apply here: grossly icteric samples; samples requiring chilling but delivered at room temperature; and exceeding a 2-hour stability window from collection. Rejected/unacceptable specimens are not returned to the requesting unit; recollection guidance follows Specimen Collection Policy.

5.6 Sorting

All specimens are delivered to and sorted in a designated Laboratory area. STAT specimens are identified, marked, and their urgency brought to the attention of the responsible Technologist (see Turnaround Time and Stat Testing Policy). Specimens requiring referral, freezing, refrigeration, or room-temperature storage are separated and stored accordingly pending referral or analysis.

Out of TCH's current scope: microbiology-culture time-stamping and Histopathology/Cytology send-out sorting instructions are retained for completeness only - these functions are not currently within TCH's scope per Scope of Service and Laboratory User Information Policy.

5.7 Specimen Tracking System

Log sheets serve as the specimen tracking material at each stage: an outpatient/phlebotomy-area log sheet (specimen info, who/when collected, requesting physician); an inpatient laboratory-receiving log sheet (Specimen Receipt, Transport, Rejection & Recollection Log, F-QM-PRE-003-A-V0, completed by the nurse who brought the sample, same content); sectional daily bench records or logbooks tracking where, who, and when each test was performed; and a send-out log sheet for referred specimens (Referral Laboratory Register, Annual Evaluation & Send-Out Log, F-QM-PRE-002-A-V0, see Referral Laboratory Policy Section 5.5).

5.8 Pre-Centrifugation and Centrifugation Requirements

• Blood tubes are kept capped, vertical, closure-up, and kept closed at all times, to promote complete clot formation and reduce hemolysis risk and spill hazard, and to prevent CO2 loss (which can affect pH, ionized calcium, and acid phosphatase results), exogenous contamination, evaporation, spills, and aerosols.
• Serum samples must be clotted before centrifugation; anticoagulated samples may be centrifuged immediately after collection. Rimming the tube (using an applicator stick to release an attached clot) is not recommended, as it is a potential source of laboratory-induced hemolysis. Residual fibrin may interfere with some assays (e.g., troponin) and is minimized by following recommended clotting/centrifugation times.
• Serum (red-top/clot-activator) tubes are mixed by gentle inversion as specified by the manufacturer — proper mixing is critical to achieving appropriate clotting.
• Specimens for photosensitive analytes (e.g., bilirubin, vitamin B12, vitamin A/B6, beta carotene, porphyrins) are protected from light exposure (aluminum foil wrap, amber container, or equivalent).
• Specimens for referral are centrifuged prior to transport/send-out where applicable.
• Serum is removed from the clot as soon as possible after centrifugation (maximum 2 hours) for red-top tubes without a serum separator barrier.
• Whole-blood samples are not chilled unless specifically required by the test's sample requirements; samples for whole-blood analysis are not centrifuged/separated.
• Tubes remain closed and are centrifuged with caps in place, in a balanced load, using a centrifuge with adequate closure protection. Centrifugation settings are specified in relative centrifugal force (RCF, ×g) rather than RPM alone. Manufacturer literature is consulted for centrifuge time and RCF; RCF (not RPM) is the preferred unit, calculated as RCF = 1.118 × 10⁻⁵ × r × n² (r = rotating radius in cm; n = speed in RPM).
• Clinical Chemistry specimen preparation: serum specimens are allowed to clot completely before centrifugation. Serum/plasma separation centrifugation is performed at approximately 1000–1300 ×g for approximately 10 minutes (gel separator tubes in a fixed-angle rotor may require the longer centrifugation time), or at the parameters specified by the collection-tube/reagent manufacturer's instructions for use where these differ. Separated-serum handling then follows items 6 and 12–14 below.
• Microscopy / urine sediment preparation: urine specimens for sediment examination are centrifuged at approximately 400 ×g for 5 minutes (standardized 10–12 mL aliquot, per CLSI GP16-A3), unless the method or manufacturer's instructions specify otherwise.
• TCH's equipment-specific centrifugation settings shall be verified against the Laboratory's actual centrifuge (rotor radius and manufacturer instructions) and documented in the applicable section SOP/work instruction before use.
• SST tubes and red-top non-additive tubes are not centrifuged more than once; if re-centrifugation is needed for improved serum quality, serum is instead aspirated into a properly labeled clean tube. Specimen tubes for potassium measurement are not centrifuged more than once (results are falsely increased); if further separation is needed, serum/plasma is transferred to another tube before centrifuging again. Additional serum/plasma harvesting after initial removal is not attempted, as it alters the plasma-to-erythrocyte ratio and can introduce cellular-leakage error.
• Serum/plasma is physically separated from cells/clot as soon as possible, per manufacturer guidelines, unless documented evidence shows longer contact does not affect results. Separated serum/plasma is stored at room temperature no longer than 8 hours; if testing will not be completed within 8 hours, it is refrigerated (serum/plasma is refrigerated if testing is not complete within 5 hours); if not completed within 48 hours (or storage will exceed 48 hours), it is frozen at or below −20°C. Frozen serum/plasma is thawed only once (not repeatedly frozen/thawed), at room temperature, and inverted 10–20 times to disrupt concentration gradients (no foam formation). Contact time with a gel separator barrier is limited per the device-specific manufacturer's references.
• Serum, plasma, and whole-blood samples are kept covered and air-tight at all times to prevent contamination, evaporation, concentration changes, or spills.

5.9 Processing of Specimens

Specimens are processed one at a time to prevent confusion. The requisition number is recorded for traceability. If a single tube must be shared by multiple sections, the serum/plasma is aliquoted and each processing section is informed.

At the close of shift, remaining specimens are placed in a designated "specimens of the day" storage area/refrigerator; specimens requiring ice or freezing are bagged separately with a note indicating the required storage condition.

5.10 Sample Identification and Aliquoting

Each sample is assigned a unique identification/accession number. Where aliquots are prepared, they are made into properly labeled, screw-cap (or equivalent impregnable) tubes, retaining the unique identifier on every aliquot, portion, or slide.

5.11 Storage

Aliquots of serum/plasma that have been in contact with cells for more than two hours are not stored without documenting the pre-centrifugation delay in the record. Specimens are stored under the storage conditions and time limits in Section 5.8 above and per Laboratory Retention Schedule Policy.

Access to in-laboratory specimen storage areas (refrigerators, freezers, and any designated specimen-storage location) is restricted per Facilities and Environmental Conditions Section 10.2 (Access Control) — storage areas are restricted areas, accessible only to authorized Laboratory personnel or authorized visitors under appropriate supervision.

5.12 Packaging and Transportation of Diagnostic Specimens (Send-Out)

All specimens for external transport are packed to withstand leakage, shock, and pressure changes:

• Volume ≤ 50 mL: the specimen is placed in a securely closed, watertight primary container (tube/vial/ampoule); the primary container is placed inside a durable, watertight secondary container (multiple primary containers may share one secondary container, provided total contents do not exceed 50 mL); absorbent material sufficient to absorb the entire primary-container contents is placed between the primary and secondary containers; the secondary container is placed inside an outer transportation container of cardboard, wood, or equivalent strength (bags/envelopes are not acceptable outer containers).
• Volume > 50 mL: all of the above, plus shock-absorbent material (at least equal in volume to the absorbent material used) between the secondary container and the outer shipping container; single primary containers do not exceed 1000 mL; the total diagnostic specimen volume within a single outer transportation container does not exceed 4,000 mL.
• Dry ice (if used as refrigerant) is placed outside the secondary container; if used between the secondary container and outer shipping container, shock-absorbent material keeps the secondary container from loosening as the dry ice sublimates; the outer package is vented.
• Refrigerants: the cooling agent is placed outside the secondary container; ice is not used unless specifically required — cold bricks/gel packs are preferred.
• Notifiable-disease specimen referral: specimens referred for notifiable/reportable-disease testing (e.g., to DOH-designated reference laboratories) follow Referral Laboratory Policy, coordinated with TCH's Infection Prevention and Control practice.

5.13 Referring Client/Sender and Courier Responsibilities

The sender (TCH Laboratory) is responsible for correctly marking and labeling each package of diagnostic specimens for any courier not operated by TCH itself, following the courier's own instructions. A courier that discovers evidence of leakage or damage to a package promptly isolates it and notifies the Laboratory and the receiving referral laboratory.

Where a courier service (rather than a TCH-operated transport) is used, the system requires notification of receipt to TCH immediately upon delivery.

5.14 Safety Precautions

Because it is often impossible to know which specimens might be infectious, all patient and Laboratory specimens are treated as infectious and handled according to standard precautions (combining universal precautions and body substance isolation practices), which are broader than universal precautions alone (which address only blood-borne pathogen transmission), per Hand Hygiene Policy Section 5.1 and hand hygiene per Hand Hygiene Policy.

Specimens are collected/ transferred into a leak-proof primary container with a secure closure; snap-top closures that may produce a spray on opening are avoided; the outside of the primary container is not contaminated during collection.

5.15 Internal Transport Within the Laboratory (TCH Workflow)

Specimens are collected only by authorized personnel and are brought to the laboratory receiving area; the collection area and the receiving area are physically close.

After specimens have been received and accessioned, Laboratory Aides may carry or transport already-collected and already-received urine and stool specimens from the receiving area to the microscopy area for processing — a short internal distance of approximately 3–4 metres — under the direction of the Medical Technologists.

This is a carrying/transport function only. Laboratory Aides do not collect or extract specimens from patients and do not perform any technical examination or result function (see Internal Laboratory Rules and Regulations Policy). During such internal transport, specimen identification, integrity, containment (secure, leak-proof closure and biohazard bagging as applicable), and applicable handling controls shall be maintained.

6.0 Records

Send-out tracking uses the Referral Laboratory Register, Annual Evaluation & Send-Out Log, F-QM-PRE-002-A-V0 (owned by Referral Laboratory Policy).

7.0 References

• DOH QMS Tool for Clinical Laboratories (2024), Section 3 — Service Delivery
• DOH Administrative Order No. 2021-0037, Annex B1 — Technical Standards for Clinical Laboratories
• ISO 15189:2022, Clause 7.2 — Pre-examination processes
• WHO Laboratory Quality Management System Handbook, Chapter 5 — Sample management
• JCI Accreditation Standards for Hospitals, AOP.5.7 — Specimen collection, identification, handling, and transport
• CLSI GP44-A4, Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests
• CLSI M29-A3, Protection of Laboratory Workers from Occupationally Acquired Infections
• CLSI GP16-A3, Urinalysis; Approved Guideline

Companion policies:

• Specimen Collection Policy — specimen collection, positive identification, and universal rejection criteria
• Referral Laboratory Policy — send-out specimen requisitioning, packaging, and referral tracking
• Laboratory Retention Schedule Policy — retention periods for accessioning, rejection, and tracking records

Controlled visual annex:

• IG-06 — Specimen Handling and Transport — one-page visual annex to this policy, controlled under Document Control Policy Section 5.2.6 and registered in F-QM-002-B-V0. Master files: infographics/IG-06-Specimen-Handling-and-Transport-LAB-QM-PRE-003.png (PNG, print PDF, and editable HTML).