SOP-P-001 — Phlebotomy Section Reception, Unacceptable Specimen Management, and Adverse Reaction First Aid SOP

1.0 Purpose

This SOP gives the bench procedure for phlebotomy reception and for screening primary specimens before testing and rejecting those that are unsuitable. It also covers failed collections, patient refusals, and the immediate first aid and emergency escalation for a patient who has an adverse reaction or collapses.

2.0 Scope

This SOP applies to all blood collection, specimen receiving, and pre-analytical work in the inpatient wards, the outpatient department (OPD), and Clinical Laboratory reception at Tarangnan Community Hospital (TCH). For the detailed venipuncture and capillary collection steps, see Adult and Pediatric Venipuncture Procedure Sop and Capillary Blood Collection By Skin Puncture Sop.

3.0 Definitions

• Unacceptable Specimen: Primary specimen that fails established quality, volume, container, or identification criteria, making it unsuitable for clinical analysis.
• Quantity Not Sufficient (QNS): Specimen volume below the analytical minimum required for testing or below the mandatory fill line for proper blood-to-additive ratio.
• Vasovagal Reaction / Syncope: Neurocardiogenic reflex triggered by pain, fear, or anxiety, causing sudden hypotension, bradycardia, dizziness, pallor, sweating, or transient loss of consciousness.
• Hematoma: Localized swelling filled with blood beneath the skin caused by vessel leakage during or following puncture.
• Two-Attempt Limit: Mandatory restriction capping collection attempts to a maximum of two venipunctures or skin punctures per patient encounter for any individual collector.

4.0 Responsibility

4.1 Hospital Director

• Approves this SOP.
• Keeps hospital-wide emergency support and basic life support infrastructure operational.

4.2 Pathologist

• Provides clinical and technical oversight of collection guidelines and specimen acceptance criteria.
• Authorizes testing exceptions on irreplaceable, compromised specimens when clinically warranted.

4.3 Chief Medical Technologist / Laboratory Quality Manager

• Maintains this SOP, verifies staff competency, and oversees pre-analytical quality indicators.
• Is the escalation point for difficult collections, recurring rejections, and adverse occurrences.

4.4 Medical Technologists

• Screen every specimen received against the rejection criteria before testing.
• Follow the two-attempt puncture limit and the escalation rules.
• Give first aid as soon as an adverse patient reaction is seen, activate emergency codes when indicated, and log the occurrence.

4.5 Laboratory Aides

• Help with patient reception, seating, positioning, and specimen transport, and keep clean collection supplies stocked.
• Tell a Medical Technologist at once if a patient is in distress or a specimen container is visibly damaged.
• Shall not perform venipuncture, evaluate specimen acceptability, or provide clinical care independently.

4.6 Patient Care Area Personnel (Nursing)

• Coordinate inpatient preparation, help during ward collections, and arrange recollection when a specimen is rejected.

5.0 Policy / Procedure

Phlebotomy specimen reception, two-attempt venipuncture escalation, specimen acceptability screening, and adverse reaction management follow the operational sequence outlined below (see Figure 1).

Figure 1 — Two-attempt venipuncture limit, specimen rejection, and adverse reaction flow

5.1 General Pre-Analytical Rules

• Verify patient identity and collection encounter request details using at least two independent identifiers (full patient name and hospital medical record number). Bed or room numbers shall never serve as identifiers.
• Observe standard precautions, thorough hand hygiene, and single-use safety devices during every collection encounter.
• Label every specimen container at the bedside or phlebotomy chair immediately following collection in the presence of the patient. Pre-labeling containers before collection is prohibited.

5.2 Specimen Screening Criteria

Screen specimen container, fill volume, and tube condition for every specimen delivered to the laboratory:

5.3 Specimen Acceptability and Rejection Actions

• Accession specimen into laboratory logbook or LIS and route to testing section. Specimen accepted for testing proceeds to analytical processing.
• When a specimen meets rejection criteria, record defect, contact ordering nurse by telephone, and request recollection. Provide patient name, MRN, specific reason for rejection, and recollection instructions.
• Record the defect on the Rejected Specimens Tracking Sheet with date, time, collector name, test requested, rejection reason, and nurse notified.
• Flag test order in LIS as rejected or cancelled with a standardized disposition comment (such as "Specimen rejected: clotted EDTA, recollection requested" or "Specimen rejected: gross hemolysis"). Dispose of specimen per laboratory biohazard waste protocols; never return contaminated blood tubes to clinical wards.
• In rare emergency circumstances where a specimen is completely irreplaceable (such as precious pediatric blood or CSF), testing may proceed only with direct authorization from the Pathologist or attending physician. The final report shall carry an unambiguous cautionary comment documenting specimen condition and potential analytical interference.
• Dispose of rejected biohazardous blood tubes per hospital waste management protocols; never return contaminated blood tubes to clinical wards.

5.4 Management of Unsuccessful Collection and Patient Refusal

• Attempt venipuncture on patient adhering strictly to collection protocols. No collector shall attempt venipuncture or skin puncture more than twice on the same patient. If the initial attempt fails, a second attempt by collector is permitted on an alternative site; probing is prohibited.
• If initial attempt fails, evaluate alternative sites. If two attempts fail, stop procedure, bandage puncture sites, and consult the Chief Medical Technologist / Laboratory Quality Manager or another Medical Technologist on duty.
• Chief Medical Technologist evaluates vasculature and determines attempt by different collector, uses a specialized device (such as a winged infusion set), or declares specimen unattainable. If a specimen obtained by different collector is secured, proceed to specimen screening.
• If specimen unattainable after escalation, immediately inform attending nurse and physician so clinical alternatives or delayed recollection can be scheduled. Document specimen not collected difficult access in the requisition record and LIS.
• For patient refusals: - Maintain a courteous, calm demeanor and explain the diagnostic importance of the test without arguing or coercing. - If the patient persists in refusing, respect their autonomy, cease the encounter, and notify the charge nurse. - For STAT orders, enter "Patient Refused: Nurse Notified" into the LIS immediately. For routine orders, confirm final status with the ward before shift end.

5.5 Prevention and Management of Adverse Reactions

• Prevent adverse events by applying standard precautions and proper patient positioning: - Inpatients shall be drawn while supine in bed. Outpatients shall be seated securely in a dedicated phlebotomy chair with supportive armrests. - Never draw blood while a patient is standing or seated on an unbacked stool. - Observe the patient throughout collection for early signs of distress: anxiety, pallor, cold perspiration, sighing, rapid shallow breathing, or vacant staring.
• Monitor every patient encounter for adverse reaction or patient syncope. If syncope or adverse symptoms occur, abort draw immediately, secure sharps, lower patient head, elevate legs. Assess whether patient unresponsiveness or collapse occurs: if the patient recovers promptly, monitor vital signs until fully alert; provide cool damp towel, and abort draw immediately; document adverse reaction. If severe patient unresponsiveness or collapse persists, initiate emergency response per Section 5.6. Manage specific complications per the protocol below:

5.6 Emergency Response for Collapsed Patient in Collection Area

• Check patient responsiveness, airway patency, breathing, and carotid pulse immediately.
• Call out loudly for assistance from laboratory colleagues. Never leave an unconscious patient unattended to seek help.
• Instruct an available colleague or aide to announce hospital emergency response (Code Blue) following the hospital telephone protocol, stating caller name, location ("Clinical Laboratory Phlebotomy Room"), and patient status.
• If the patient is pulseless and breathless, begin chest compressions and cardiopulmonary resuscitation (CPR) immediately per hospital Basic Life Support (BLS) protocols until the hospital resuscitation team arrives to provide clinical emergency care.
• Deliver clear verbal handover to the responding clinical team detailing time of collapse, interventions performed, and collection details. Complete Occurrence Report Form (F-QM-010-A-V0) and notify the Chief Medical Technologist / Laboratory Quality Manager.

5.7 Documentation, Occurrence Reporting, and Quality Improvement

• Document every adverse reaction, failed collection, and rejected specimen in the relevant logbook, LIS comment field, and occurrence report system.
• Significant clinical incidents, collapse events, and arterial punctures require formal investigation under Occurrence Management Policy.
• Monitor pre-analytical indicators monthly: specimen rejection rate, hemolyzed specimen rate, QNS rate, recollection frequency, and vasovagal event rate under Continual Improvement and Performance Improvement Program Policy.

6.0 Records

7.0 References

• DOH Clinical Laboratory QMS Tool, Section 3 — Service Delivery
• DOH Administrative Order No. 2021-0037, Annex B1 — Technical Standards for Clinical Laboratories
• ISO 15189:2022, Section 7.2 — Pre-examination Processes
• WHO Guidelines on Drawing Blood: Best Practices in Phlebotomy (2010)
• CLSI GP41, Collection of Diagnostic Venous Blood Specimens
• CLSI GP44, Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests

Companion policies:

• Specimen Collection Policy — Primary specimen collection requirements, acceptance, and rejection rules
• Occurrence Management Policy — Nonconformance, adverse reaction reporting, and incident investigation
• Laboratory Retention Schedule Policy — Mandatory retention periods for requisitions, rejection logs, and incident records