LAB-QM-007 — Control of Records Policy

1.0 Purpose

This policy establishes the requirements for creating, completing, correcting, reviewing, storing, retrieving, retaining, archiving, and disposing of Quality Management System (QMS) records in the Clinical Laboratory, including paper-record correction rules and the personnel audit trail that attributes every critical testing step to the individual who performed it.

2.0 Scope

This policy applies to all Medical Technologists and Laboratory Aides and covers all paper, electronic, instrument-generated, and Laboratory Information System (LIS) records created or maintained by the Clinical Laboratory across pre-examination, examination, and post-examination activities. Section 5.4 governs corrections to internal laboratory paper records only; corrections to released patient reports are governed by Laboratory Reporting Policy.

Section 5.5 governs task attribution (personnel audit trail); employee 201 dossiers, training records, and competency assessments are governed by the Human Resource series (Orientation Policy, Competency Assessment Policy, and Personnel Records Policy).

3.0 Definitions

• Record — documented objective evidence of an activity performed, observation made, measurement taken, decision reached, or result achieved.
• Blank Form vs. Completed Form — a blank form is a controlled template registered in the Forms Index under its parent policy/SOP; once filled in during laboratory operations, it becomes a quality record governed by this policy.
• Personnel Audit Trail — documented traceability identifying who performed a critical testing task or step, and when, where, and why it was performed.
• Critical Task / Step — any action in the total testing process whose performance affects result accuracy, reliability, or traceability (including specimen collection, receipt/accessioning, analysis, result entry, verification, and release).
• Retention, Archiving, and Disposal — Retention is the required period a record must remain complete, legible, protected, and retrievable; Archiving is controlled storage of inactive records still within their retention period; Disposal is authorized, secure destruction or deletion of records after their retention period expires.

4.0 Responsibility

4.1 Hospital Director

• Ensures institutional resources are available for record storage, protection, and archival (standing governance and policy approval duties are defined in Organization and Governance).

4.2 Pathologist

• Reviews this policy for clinical and technical adequacy prior to approval (standing governance and clinical oversight duties are defined in Organization and Governance).

4.3 Chief Medical Technologist / Laboratory Quality Manager

• Oversees the Record Management System, maintains this policy and F-QM-007-A-V0, and orients staff on record control and correction rules.
• Periodically verifies that personnel audit trails (specimen labels, bench logbooks, and LIS entries) and paper-record corrections are completed accurately and consistently.
• Ensures secure record storage and archiving, and authorizes record disposal once retention periods in Laboratory Retention Schedule Policy are met.

4.4 Medical Technologists

• Create and complete records legibly and accurately at the time of the activity using approved forms, and record their initials/ID and date/time at every required step.
• Correct paper-record errors strictly in accordance with the single-line strike procedure in Section 5.4, protect records from damage or unauthorized disclosure, and report any record deficiencies.

4.5 Laboratory Aides

• Perform assigned non-technical record-handling support (such as carrying and filing records or logging authorized specimen transport) and legibly record their initials/ID and date/time where required.
• Do not perform technical record review, authorize technical corrections, interpret record content, dispose of records, or collect patient specimens.

5.0 Policy / Procedure

5.1 Record Management Principles

The Clinical Laboratory shall establish and maintain a controlled Record Management System ensuring that records are accurate, complete, legible, readily identifiable, traceable, protected from unauthorized alteration or loss, easily retrievable, properly retained, securely archived, and disposed of in accordance with approved requirements. Records shall provide objective evidence that laboratory activities have been performed in accordance with approved controlled documents.

The following principles govern all record management:

• Authenticity — records shall accurately represent the activity, observation, measurement, decision, or event being documented. Records shall not be falsified, fabricated, or intentionally altered in a manner that compromises their integrity.
• Accuracy — information recorded shall be complete and accurate, and shall be recorded at the time the activity is performed whenever practicable.
• Legibility — records shall remain readable throughout the required retention period; entries shall be made in permanent, legible form appropriate to the recording medium.
• Traceability — each record shall be traceable to the corresponding activity, process, equipment (where applicable), specimen (where applicable), personnel, date, and time where required.
• Integrity — records shall be protected against unauthorized alteration, deletion, deterioration, loss, or damage; where corrections are necessary, the original information shall remain identifiable.
• Confidentiality — records containing patient, personnel, operational, or other confidential information shall be protected against unauthorized access or disclosure; access shall be limited to authorized personnel based on assigned responsibilities.
• Availability — records shall remain readily retrievable throughout their required retention period to support patient care, quality activities, internal audits, external assessments, regulatory inspections, Management Review, and legal requirements.

5.2 Classification of Records

Quality Management System records include, but are not limited to:

• Quality records — Internal Audit reports, Management Review minutes, Corrective and Preventive Action (CAPA) records, risk assessment records, and Quality Indicator reports.
• Technical records — quality control records, calibration records, maintenance records, method verification and validation records, and equipment performance records.
• Operational records — inventory records, temperature monitoring logs, specimen rejection logs, occurrence reports, and corrective action records.
• Personnel records — competency assessments, orientation records, continuing education and training records, and authorization records.
• Administrative records — document review records, distribution logs, approval records, revision records, and communication records.

Classification determines the category of a record; all categories are managed under the requirements of this policy.

5.3 Record Creation and Completion

Records shall be created at the time the activity is performed or as soon as practicable thereafter. Records shall accurately represent the activity being documented and shall not be completed in advance or reconstructed unless specifically authorized and appropriately documented.

Entries shall be complete, accurate, legible, permanent where applicable, and readily understandable. All required information shall be recorded; blank fields shall not be left where information is required.

Each record shall contain sufficient information to permit identification and traceability, which may include record title, date, time, process, equipment identification, specimen identification, personnel identification, location, and a unique record number or identifier.

5.4 Correcting Records

It is the Laboratory's policy to instantaneously correct, upon discovery, any error made on a laboratory paper record.

Corrections shall preserve the original recorded information. Where corrections are necessary:

• The original entry shall remain legible.
• The corrected information shall be entered adjacent to the original entry.
• The correction shall be identifiable.
• The correction shall include the date and the signature or initials of the person making the correction.
• The reason for the correction shall be documented when appropriate.

Methods that obscure, erase, overwrite, or otherwise render the original information unreadable shall not be permitted.

Important:

• Never obliterate, write over, tape over, or otherwise obscure an incorrect entry (e.g., with correction fluid/tape).
• Never discard the original record.

Correction steps for a laboratory paper record:

Worked example — a completed correction on a worksheet. A Medical Technologist writes "Negative" on a worksheet and immediately discovers the correct entry is "Positive". The Technologist draws a single dark-ink line through "Negative" (the original entry stays fully legible), writes "Positive" beside it, adds their initials RC, and adds the date 15-06-2026.

The corrected line on the record therefore reads:

• Negative (struck through with a single line) Positive RC 15-06-2026
• Nothing is erased, written over, taped over, covered with correction fluid/tape, or otherwise obliterated, and the original record is never discarded.

Section 5.4 does not apply to correcting patient reports. Corrections to already-released patient reports are governed by Laboratory Reporting Policy.

5.5 Record Traceability and Personnel Audit Trail

The Clinical Laboratory shall implement a system that allows for the identification of who performed a critical task/step, and of when, where, and why that task/step was performed.

Access to, entry of, and changes to patient data shall remain traceable to the personnel who performed them.

5.5.1 Specimen Labeling (Sampling)

The individual responsible for specimen collection includes their initials and staff/badge ID on the sample label, for both inpatient and outpatient specimens.

5.5.2 Laboratory Log Sheets

• Receiving/specimen log sheet — specimens reach the laboratory through authorized channels: collected from patients by Medical Technologists (phlebotomy-trained personnel), or brought/transported to the laboratory by authorized personnel (which may include Laboratory Aides strictly carrying/transporting already-collected specimens, never performing collection). For such specimens, the log sheet records: date of collection, patient name, identifier (e.g. hospital/record number), location, requesting physician, test(s) requested, and the name/ID of the person responsible for collecting the specimen.
• Section work sheets — each section of the laboratory maintains its own log sheet(s) recording the patient's name, test(s) requested, time the specimen was received, the name of the technologist performing the procedure, and the time the procedure was completed.
• Traceability of who performed a given task can also be established through TCH's Laboratory Information System (LIS) — the Excel-integrated system maintained by the Chief Medical Technologist / Laboratory Quality Manager — where entries are attributable to the staff member who made them.

5.5.3 Result Entry

After a test procedure is completed, the result is entered into the applicable worksheet/log and, where applicable, TCH's LIS. The name or ID of the technologist who entered/typed the result must be identifiable in the record.

5.6 Electronic Records

Electronic records shall be created and maintained using approved laboratory information systems or authorized electronic platforms, and shall provide integrity equivalent to paper records. They shall be protected through appropriate controls including, where applicable, user authentication, access control, audit trails, data backup, system security, and protection against unauthorized modification.

5.7 Record Review

Records requiring review shall be reviewed by authorized personnel to verify completeness, accuracy, technical acceptability, required signatures or approvals, and compliance with applicable procedures. Deficiencies identified during review shall be addressed through established laboratory processes.

5.8 Storage and Protection

Records shall be stored under conditions that preserve their integrity, legibility, confidentiality, accessibility, and protection from deterioration.

Paper records shall be protected from fire, water damage, excessive humidity, dust, insects or pests, unauthorized removal, and physical deterioration; storage areas shall be organized to facilitate efficient retrieval.

Electronic records shall be protected against unauthorized access, accidental deletion, system failure, data corruption, cybersecurity threats, and hardware failure; appropriate backup and recovery measures shall be maintained.

Access to records shall be limited to authorized personnel according to assigned responsibilities. Confidential information shall not be disclosed except as authorized by law, regulation, institutional policy, or patient consent where applicable.

5.9 Retrieval of Records

The Clinical Laboratory shall establish methods for prompt retrieval of records when required for patient care, internal audits, external assessments, regulatory inspections, investigations, Management Review, and legal requirements. Retrieval methods shall preserve record integrity and confidentiality.

5.10 Record Retention

Records shall be retained for periods established by applicable legal, regulatory, accreditation, and institutional requirements so they remain available for patient care, quality management activities, regulatory inspections, audits, and investigations.

Numeric retention periods for all laboratory records are owned by Laboratory Retention Schedule Policy (Laboratory Retention Schedule Policy) and summarized in the Master Document and Records Control Register (F-QM-002-B-V0, parent: Document Control Policy); this policy does not restate numeric periods. Throughout the retention period, records shall remain legible, complete, protected from deterioration or unauthorized alteration, and readily retrievable by authorized personnel.

5.11 Archiving

Records no longer required for routine operational use but still within their required retention period shall be archived in a controlled manner that preserves integrity, traceability, confidentiality, and accessibility. Archived records shall remain protected from environmental damage, unauthorized access, and accidental loss.

The archive system shall allow authorized personnel to identify archived records, retrieve them within a reasonable timeframe, and return them after use.

5.12 Disposal of Records

Records that have exceeded their required retention period in Laboratory Retention Schedule Policy may be disposed of only after written authorization by the Chief Medical Technologist / Laboratory Quality Manager using F-QM-002-A-V0 (Document Change, Review & Disposal Request Form). Disposal shall be conducted using secure shredding, incineration, or permanent electronic deletion so confidential information cannot be recovered.

Disposal records shall be retained in accordance with Laboratory Retention Schedule Policy.

5.13 Monitoring of the Record Management System

The effectiveness of the Record Management System shall be monitored through internal audits (Internal Audit), Management Review (Management Review), record retrieval checks, user feedback, CAPA (Corrective and Preventive Action Policy), and quality indicators (Continual Improvement and Performance Improvement Program Policy).

6.0 Records

Paper-record corrections require no separate form and are made directly on the affected record per Section 5.4. Record retention tracking and disposal authorizations are recorded using F-QM-002-B-V0 and F-QM-002-A-V0 under Document Control Policy, and retained per Laboratory Retention Schedule Policy.

7.0 References

• DOH-Philippines QMS Tool, Section 2 — Resource Management; Section 3 — Service Delivery; Section 6 — Information Management System
• DOH Administrative Order No. 2021-0037, Annex A — General Guidelines; Annex B1 — Technical Standards for Clinical Laboratories
• ISO 15189:2022, Section 8 — Management System Requirements
• WHO LQMS Handbook, Chapter 16 — Documents and Records
• DOH Department Circular No. 70 s. 1996, Revised Guidelines on the Disposal of Valueless Records in Government Hospitals and Other Health Facilities
• Republic Act No. 9470, National Archives of the Philippines Act of 2007

Companion policies:

• Document Control Policy — document control architecture and master register (F-QM-002-A-V0, F-QM-002-B-V0)
• Laboratory Reporting Policy — governs amendments and corrections to already-released patient reports
• Laboratory Retention Schedule Policy — single authoritative owner of numeric retention periods for all laboratory records and specimens

Controlled visual annex:

• IG-15 — Records Done Right — 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-15-Records-Done-Right-LAB-QM-007.png (PNG, print PDF, and editable HTML).