LAB-QM-PRE-001 — Specimen Collection Policy

1.0 Purpose

To describe the collection procedures and specimen requirements for the Laboratory, providing instruction on specimen collection and transportation, and information on requisitioning, special collection, and handling requirements needed by Laboratory, Nursing, and Medical staff.

2.0 Scope

This policy applies to Laboratory Phlebotomists, Technologists, Technicians, Medical, Nursing, and Collection Area personnel involved in laboratory specimen collection.

3.0 Definitions

• Specimen/Sample — one or more parts taken from a primary sample (the two terms are used interchangeably in this policy).
• Turnaround time (TAT) — the time interval encompassing the entire examination process, from when a result is needed to when it is available to act upon.
• Accession — the steps ensuring a specific patient specimen and its accompanying documentation are unmistakably identified as referring to the same patient.
• Venipuncture — puncture of a vein for collecting blood specimens for analysis.
• Automated skin puncture device — a single-use lancet/blade device used for collecting a capillary blood specimen.
• Capillary blood — blood obtained by skin puncture, containing a mixture of blood from arterioles, venules, and interstitial/ intracellular fluids.

4.0 Responsibility

4.1 Hospital Director

• Exercises executive oversight and supports hospital-wide specimen procurement resources (standing governance and policy approval per Organization and Governance).

4.2 Pathologist

• Provides clinical and technical direction regarding specimen collection suitability (standing clinical oversight per Organization and Governance).

4.3 Chief Medical Technologist / Laboratory Quality Manager

• Maintains, updates, and revises this policy as necessary, and communicates changes to end users.
• Ensures the compliance of this policy with applicable regulatory, accreditation, national, and international standards.
• Conducts periodic internal audits to ensure compliance (see Internal Audit).

4.4 Medical Technologists

• Analyze submitted samples (STAT tests are given priority).

4.5 Laboratory Aides

• Read, understand, and comply with this policy.

4.6 Medical, Nursing, and Patient Care Area Collection Personnel

• Collect and deliver samples to the Laboratory as quickly as possible, with strict adherence to standard precautions.

4.7 Heads of Patient-Care Areas Involved in Phlebotomy Activities

• Make these guidelines available to staff as a reference and ensure they are followed.

5.0 Policy / Procedure

5.1 Policy Statement

Proper sample procurement and handling is integral to a valid, timely laboratory result. Specimens are obtained with strict adherence to standard precautions, using proper phlebotomy technique and acceptable collection methods, collected in the proper container, correctly labeled, and promptly transported to the Laboratory. It is the policy of the Laboratory to reject samples where these guidelines are not followed.

Specimen collection is the first step in result accuracy and precision — the collector ensures appropriate collection conditions are met so that an accurate, precise result can be issued.

5.2 Reviewing the Request

Before collection, the collector confirms: whose test(s) are being requested; what specimen(s) are to be collected; when the specimen will be collected; and what container(s) are required.

5.3 Patient Identification

• Identify the patient with at least two identifiers (Medical Record Number and full patient name). The phlebotomist/nurse collector does not rely on a bed tag, chart, or records placed nearby — a hospital location (bed/room number) is not an acceptable identifier.
• Acceptable identifiers include (not limited to): full name; assigned identification number (MRN); requisition number; accession number; a government-issued photo ID; or another person-specific identifier.
• Outpatient: ask the patient's name and compare against another form of identification (e.g., a valid photo ID); there must be a three-way match between the requisition, the patient's own statement of name, and the label.
• Inpatient: ask the patient for the same information and compare with the request form, pre-printed labels, and the patient's wristband/identification bracelet.
• Unconscious, cognitively impaired, or non-communicating patient: ask a nurse, relative, or friend to identify the patient by name and identification number; document the name of the verifier; compare against the request form and (for inpatients) the wristband.
• Unidentified emergency patient: assign a temporary master identification number per hospital policy; complete labels/forms with that number; when a permanent number is later assigned, cross- reference it to the temporary one. The name/designation is attached to the patient's body (wristband or similar), never only to the bed.
• Any identification discrepancy, however minor, is reported to the responsible nurse/physician and resolved before specimen collection.
• Basic ABO/Rh typing is within TCH's scope per Scope of Service and Laboratory User Information Policy.

5.4 Test Request

A test request/order is required to initiate collection, and must contain (as applicable): the requesting physician's identification and contact information; the patient's name and unique identifier; the patient's location, age, and sex; the test(s) to be performed; the specimen source; date/time of collection; and the identity of the person collecting the specimen.

Test requests are documented on the Laboratory Test Request, Informed Consent & Pre-Collection Checklist (F-QM-PRE-001-A-V0). The Laboratory has no way of knowing if the wrong test was ordered on the wrong patient — this is identified only through a complaint or chart audit.

5.5 Sample Acceptance (Receipt)

On receipt, both the test request and the sample are checked for adequacy, accuracy, and completeness: full patient name; MRN; date/time of collection; collector's initials/ID; date/time of reception; proper packaging; specimen quantity/quality; request completion; and any label/request discrepancy. Discrepancies are corrected before proceeding; the use of a suboptimal specimen is clearly noted in the reported result.

A final accept/reject decision is made (see Figure 1).

Figure 1 — Specimen acceptance, rejection, and irreplaceable specimen exception flow

5.6 Universal Criteria for Sample Rejection

Rejection criteria include (not limited to): incomplete/lacking positive identification, or discrepancy with the request; unlabeled specimen; mislabeled or fewer than two identifiers; illegible identifiers; label/requisition mismatch not resolved by the collector's confirmation procedure; over- or under-filled collection tubes (including anticoagulated tube significantly underfilled or overfilled including below/above the fill line); insufficient volume (QNS) for the test(s); wrong specimen type; inappropriate container or storage condition for the required test stability; contaminated specimen (bathroom tissue, lubricant, water, or other foreign material in the specimen; blood transferred incorrectly); grossly hemolyzed, frankly lipemic, or icteric where the examination procedure requires rejection or cautionary comment; clotted anticoagulated specimens or partially clotted anticoagulated blood (including microclots) where clotting interferes with the examination; improperly collected capillary specimen (e.g., milking/scooping artifact with hemolysis or tissue-fluid dilution); delayed urinalysis specimen beyond acceptable hold (see urinary examination SOP and Specimen Handling Packaging Transportation Policy); transport time/temperature outside validated limits causing compromised stability; samples submitted in a syringe with a needle attached (unless specifically indicated); and cracked, damaged, or leaking containers (discarded as a biologic hazard).

Rejected/unacceptable specimens are not returned to the requesting unit. All rejections are documented on the Specimen Receipt, Transport, Rejection & Recollection Log (F-QM-PRE-003-A-V0, see Specimen Handling Packaging Transportation Policy Section 6.0).

5.7 Handling Misidentified or Discrepant Samples

• Non-recollectable samples initially found misidentified or unidentified are investigated for criteria establishing uniqueness (e.g., the only specimen of its kind obtained at that time/location). The person who collected the sample and the person confirming its identity are documented on the Laboratory Test Request, Informed Consent & Pre-Collection Checklist (F-QM-PRE-001-A-V0, see Section 6.0).
• Discrepant results (a result inconsistent with a recent prior result on the same patient — a "delta check") are investigated: all samples with the same collection date/time as the suspect sample are identified, the ordering clinician is consulted, and if misidentification is confirmed, all affected samples are cancelled and the requesting physician notified, with the notification documented.
• All mislabeled, unlabeled, or incompletely/illegibly labeled samples are recorded on the Specimen Receipt, Transport, Rejection & Recollection Log (F-QM-PRE-003-A-V0). Recurring labeling-error patterns may warrant a corrective action (see Corrective and Preventive Action Policy).

5.8 Specimen Labeling

• Primary specimen containers are labeled with at least two patient identifiers (MRN or full name — not bed/room number), using a computer-generated sticker where available.
• Required label information: patient's full name; MRN; specimen number (for computer-ordered tests); date/time of collection; collector's initials/ID; and specimen source (if other than blood).
• Specimens are labeled immediately after collection, at the patient's side, before leaving the patient. Tubes are never pre-labeled before drawing, and specimens are never handed to someone else to label.
• Handwritten labels (e.g., during computer downtime) require at minimum the two patient identifiers and the collector's ID.
• Label correction: best practice is to recollect the specimen. If recollection is not possible or practical (e.g., an irreplaceable specimen, a test that cannot tolerate delay), correction of label information is permitted only when the person who collected the sample confirms the identity of the sample and patient by signing the specimen identification confirmation section of F-QM-PRE-001-A-V0 (see Section 6.0); a record of all such corrections is maintained. The Laboratory investigates labeling errors and develops corrective action as appropriate (see Corrective and Preventive Action Policy).

5.9 Specimen Collection

• Inpatients: Nursing staff is responsible for blood and non-blood specimen collection and transport; patients difficult to draw may be referred to the Laboratory. For medical emergencies or special handling, Nursing contacts the Chief Medical Technologist.
• Outpatients: Laboratory phlebotomists collect specimens during defined operating hours; Medical Technologists cover outside those hours.
• Neonate patients: specimens from neonates are collected only by personnel specially competent in neonatal/pediatric phlebotomy.
• Specimen collection for send-out (referral): the Laboratory follows all requisition, collection, and handling specifications required by the reference laboratory (see Referral Laboratory Policy). The Technologist preparing an aliquot for send-out labels the send-out container and requisition with at least two identifiers plus collection date/time, and any additional information the reference laboratory requires; before dispatch, the send-out test(s) on the invoice are visually verified against the send-out/shipping log, with any discrepancy resolved before the courier's pickup.

5.10 General Specimen Collection Requirements

• Blood tubes are kept vertical, closure-up, to promote clotting and reduce hemolysis risk.
• Anticoagulated specimens for hematology are mixed thoroughly before analysis; CBC and blood-film specimens are collected in potassium EDTA.
• Urine specimens are examined within 1–2 hours of collection; 24-hour urine specimens may require special preservatives.
• Out of TCH's current scope: coagulation-specific tube handling (sodium citrate) and blood culture/viral culture collection are retained for completeness only — coagulation testing and blood culture (Microbiology) are not currently within TCH's scope per Scope of Service and Laboratory User Information Policy.

5.11 Order of Draw

Specimens shall be collected in the TCH order of draw defined in SOP-P-002 Section 5.7.

5.12 Blood Specimen That Cannot Be Obtained

If a specimen cannot be obtained: reposition the needle slightly (do not probe or attempt lateral relocation); try another tube in case of a defective vacuum; a venipuncture is not attempted more than twice — if unsuccessful, another person attempts the draw or the physician is notified.

Capillary/skin-puncture collection is used where appropriate, following manufacturer instructions; punctures are not performed on swollen sites, previous puncture sites, earlobes, or (for infants) the posterior heel curvature or the arch of the foot.

5.13 Special Situations

• Timed specimens (e.g., glucose tolerance testing, therapeutic drug monitoring) are collected at the precisely specified interval; for drug monitoring, the dose/time of last dose and collection time are recorded.
• Indwelling lines/vascular access devices: Laboratory phlebotomists do not draw from these sites without complete, documented training, consistent with hospital policy.
• Out of TCH's current scope: blood alcohol/legal chain-of-custody specimens, trace-element (e.g., zinc) collection, and immunohematology gel-tube limitations are retained for completeness only.

5.14 Recognizing and Handling Adverse Reactions to Phlebotomy

Collection personnel shall observe patients before, during, and after collection for early signs of adverse reactions, and manage complications and patient collapse in accordance with SOP-P-001.

5.15 Standard Precautions

All patient and laboratory specimens are treated as infectious and handled according to standard precautions (combining universal precautions and body substance isolation practices), per Hand Hygiene Policy Section 5.1 and hand hygiene per Hand Hygiene Policy. Collection precautions (tray/collection-area handling, isolation-patient procedures) are in Hand Hygiene Policy Section 5.6.

6.0 Records

Rejected specimens are documented on the Specimen Receipt, Transport, Rejection & Recollection Log, F-QM-PRE-003-A-V0 (owned by Specimen Handling Packaging Transportation Policy — shared across the pre-examination and analytical phases).

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 GP41-A6, Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture

Companion policies:

• Referral Laboratory Policy — send-out specimen handling and reference laboratory coordination
• Specimen Handling Packaging Transportation Policy — post-collection handling, transport, and receipt/rejection logging
• Laboratory Retention Schedule Policy — retention periods for request forms and accessioning records

Controlled visual annex:

• IG-03 — Do Not Accept — Specimen Rejection — 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-03-Do-Not-Accept-Specimen-Rejection-LAB-QM-PRE-001.png (PNG, print PDF, and editable HTML).