LAB-QM-POST-004 — Laboratory Retention Schedule Policy (Specimens, Documents and Records)

1.0 Purpose

To describe how long Laboratory documents and records are stored and retained, in accordance with applicable regulatory and accreditation requirements. To describe how long specimens are stored and retained in the Laboratory after testing.

2.0 Scope

Applies to Laboratory technical staff and all Laboratory records in all sections. Applies to Laboratory technical staff and all specimens in all sections.

3.0 Definitions

• Document — information and its supporting medium.
• Record — evidence of results achieved or activities performed (noun); the act of documenting such results/activities (verb).
• Raw data — original documentation/laboratory records (or verified copies) in which original observations and results are reported.
• Specimen retention time — the minimum time a tested specimen is held and stored in the Laboratory (allowing repeat testing, add-on testing, or investigation if needed).
• Indefinitely — longer than 30 years.

4.0 Responsibility

4.1 Hospital Director

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

4.2 Pathologist

• Provides clinical direction regarding post-examination requirements and result significance (standing clinical oversight per Organization and Governance).

4.3 Chief Medical Technologist / Laboratory Quality Manager

• Reviews/approves this policy at least annually; ensures compliance with applicable standards.
• Conducts periodic internal audits of document/record storage and retention to ensure compliance (see Internal Audit).

4.4 Medical Technologists

• Store and retain specimens in proper condition per the retention times in Section 5.2 below.
• Store and retain documents/records per the approved retention schedule (Section 5.6 below).

4.5 Laboratory Aides

• Store and retain specimens in proper condition per the retention times in Section 5.2 below.
• Store and retain documents/records per the approved retention schedule (Section 5.6 below).

5.0 Policy / Procedure

5.1 Policy Statement

This policy establishes one retention schedule for the Laboratory, in two parts: Part A Specimens (Sections 5.2 to 5.5) and Part B Documents and Records (Sections 5.6 and 5.7).

Laboratory documents and records are protected at all times from loss, destruction, tampering, and unauthorized access, and are kept for the required minimum retention/storage period per applicable regulatory and accreditation requirements. Laboratory specimens are kept for the required minimum retention and storage period, ensuring their stability and enabling repeat or add-on testing when needed.

Storage temperatures are monitored daily per Equipment Temperature Monitoring Policy.

5.2 Part A — Specimens: Retention Periods (General Laboratory Specimens)

General laboratory specimens:

• Whole blood and urine specimens: retained no less than 24 hours.
• Serum, plasma, cerebrospinal fluid, and other body fluid specimens: retained no less than 48 hours.
• Permanently fixed and stained blood films: retained no less than 7 days.

Outpatient/inpatient distinction:

• Outpatient specimens (not for compatibility testing): retained no less than 24 hours.
• Inpatient specimens: retained no less than 72 hours.

Out of TCH's current scope: retention periods specific to Anatomic Pathology specimens are retained for completeness only — Histopathology/Cytology are not currently within TCH's scope per Scope of Service and Laboratory User Information Policy. Retention periods specific to Microbiology cultures are likewise not applicable given Microbiology culture is outside TCH's current scope.

5.3 Part A — Specimens: Storage Process

All blood tubes received in a shift are collected in a biohazard zip-lock bag and stored upright in a designated refrigerator, labeled with the date, day, and shift received. The refrigerator's temperature is monitored per Equipment Temperature Monitoring Policy.

When a stored specimen is needed (e.g. for add-on or repeat testing per Turnaround Time and Stat Testing Policy), the pouch is located by date/shift, and the tube carefully retrieved and confirmed against patient/specimen identification.

5.4 Part A — Specimens: Disposal After Retention

Retained specimens shall be discarded after the retention period in Section 5.2 has elapsed. Discarded specimens are pathological (biohazard) waste and shall be segregated, identified, and disposed of per Hand Hygiene Policy Section 5.4 (Waste Segregation and Disposal), in accordance with the DOH QMS Tool requirement on disposal of pathologic specimens after retention (Items 7.5.1-7.5.2).

5.5 Part A — Specimens: Discontinuation of Operations

If the Laboratory discontinues operations, remaining specimens and related records are handled per this policy and applicable DOH-Philippines requirements. Category-specific discontinuation provisions tied to out-of-scope specimen types (e.g., Histopathology/Cytology slides, blocks, and tissues) apply only if TCH's scope expands to include those functions.

5.6 Part B — Documents and Records: Retention Schedule (General Laboratory Records)

Retention periods in this section follow DOH Department Circular No. 2021-0226 (Records Disposition Schedule of the Department of Health, approved by the National Archives of the Philippines, May 2021), which superseded DOH Department Circular No. 70 s. 1996. Where the Circular sets no period for a record type, the period is laboratory-defined under ISO 15189:2022 Clause 8.4.3 and is marked as such.

General laboratory records:

• General laboratory test results (instrument printouts, worksheets, and result records kept by the laboratory): 5 years.
• Laboratory test reports (issued patient test reports, original and corrected or amended): 2 years. Results filed in the patient chart are retained with the chart by Medical Records: in-patient records 10 years after discharge; out-patient records 7 years after last consultation.
• Test request forms / specimen requisitions (including a patient chart or medical record used as the requisition itself): 2 years after last entry.
• Accession registries and logbooks:10 years.
• Quality control records (internal quality control and calibration verification records): 2 years.
• Proficiency testing (NEQAS) records and quality system assessment records:5 years. Alternative proficiency assessment records follow the same period.
• Specimen rejection records:1 year.
• Equipment maintenance and preventive maintenance records:2 years after the equipment is declared unserviceable.
• Personnel competency and training records (including employee identification records: signatures, initials, and identification codes): 3 years after the employee's last day of employment.
• Healthcare waste disposal records:2 years.
• Inspection, audit, and assessment records:5 years. Management review records:2 years.
• Obsolete controlled documents (superseded policies, SOPs, work instructions, and forms): 2 years after supersession.
• Method and instrument validation and verification records (laboratory-defined): retained for the entire period the method or instrument is in use, plus 2 years after discontinuation.

5.7 Part B — Documents and Records: Storage

Records are stored in the Laboratory's records storage area (protected from heat, water, fire, or other damage), with access limited to authorized staff. Storage of specimens and documents, the subject of DOH QMS Tool Item 2.2.3, is specified in Section 5.3 (specimens) and in this section (documents and records).

5.8 Out-of-Scope Retention Categories

Anatomic Pathology records (surgical pathology reports, outside consultations, images — retained 10 years) are retained for completeness only — Histopathology/Cytology are not currently within TCH's scope per Scope of Service and Laboratory User Information Policy. These schedules should be activated without further rework if TCH's scope of service ever expands to include these functions.

6.0 Records

Retention schedules for specimens, documents, and records are established directly in Sections 5.2 and 5.6 of this policy; no separate standalone reference log is required.

7.0 References

• DOH QMS Tool for Clinical Laboratories (2024), Section 3 — Service Delivery (Documents & Records and Technical Procedures Manual sub-areas; Items 2.2.3, 7.5.1–7.5.2)
• DOH Administrative Order No. 2021-0037, Annex B1, Item 29 — Retention of documents, records, slides, and specimens
• DOH Department Circular No. 2021-0226, Records Disposition Schedule of the Department of Health (National Archives of the Philippines-approved, May 2021) — the governing retention schedule applied in Section 5.6; supersedes DOH Department Circular No. 70 s. 1996
• Republic Act No. 9470, National Archives of the Philippines Act of 2007
• ISO 15189:2022, Clause 8.4.3 "Retention of records" — Control of records and retention requirements
• JCI Accreditation Standards for Hospitals, MOI.3 and AOP.5.7 — Retention and safe management of records and specimens

Companion policies:

• Document Control Policy — general document and records control framework
• Equipment Temperature Monitoring Policy — storage-refrigerator temperature monitoring for retained specimens
• Hand Hygiene Policy — waste segregation and disposal of retained specimens after retention period

Controlled visual annex:

• IG-13 — Keep It How Long — Retention at a Glance — 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-13-Keep-It-How-Long-LAB-QM-POST-004.png (PNG, print PDF, and editable HTML).