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F-QM-007-A-V0 — Laboratory Department Personnel Audit Trail and Signature Register

Type: Form · Version: V0 · Status: DRAFT — UNAPPROVED · Served read-only from the bundled QMS copies. The Drive master is untouched.

Parent document: LAB-QM-007 — Control of Records Policy (parent is encoded in the form number)

Rendered in-browser from the project's Word file F-QM-007-A-V0-laboratory-department-personnel-audit-trail-form.docx (policies-docx / forms-docx — the file Junry reviews). Formatting is faithful, not pixel-perfect; the DOCX is the official copy.

Document #	F-QM-007-A-V0	Parent Document	LAB-QM-007 — Control of Records Policy

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Instructions for Use

Purpose: This form is the controlled master register of authorized handwritten initials and specimen signatures. It supports real-time attribution of critical clinical activities under ISO 15189:2022 Clause 8.4.2, DOH A.O. 2021-0037 Annex B1 Item 26, and DOH QMS Tool Section 1.5.2.
Mandatory Completion: Every newly hired or appointed Medical Technologist and Laboratory Aide shall complete an entry in the applicable roster on or before the first day of active clinical duty.
Traceability: Initials, abbreviations, and signatures on laboratory worksheets, maintenance logs, temperature sheets, receiving logs, and patient result forms must match the specimen recorded in this registry.
Maintenance: When a staff member resigns or leaves, the Chief Medical Technologist / Laboratory Quality Manager records the deactivation date and archives the record per Laboratory Retention Schedule Policy.

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Part 1 — Medical Technologists Signature and Initials Roster

Licensed technical personnel authorized to perform examinations, verify quality control, validate results, and release laboratory reports:

No.	Full Printed Name	PRC License Number	PRC Validity Date	Official Initials	Specimen Wet Signature	Date Activated	Date Deactivated
1
2
3
4
5
6

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Part 2 — Laboratory Aides Signature and Initials Roster

Non-technical support personnel authorized to help with receiving, internal transport, cleaning, and environmental logs:

No.	Full Printed Name	Official Job Designation	Official Initials	Specimen Wet Signature	Date Activated	Date Deactivated
1		Laboratory Aide
2		Laboratory Aide
3		Laboratory Aide

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Part 3 — Task Attribution & Critical Process Audit Trail

Log for real-time attribution of critical processes, manual result overrides, and paper record corrections:

Date	Time	Critical Task / Step Performed	Specimen / Record ID	Location / Analyzer	Performed By (Name / Staff ID)	Initials	Reason / Clinical Notes	Verified By (Initials & Date)

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Part 4 — Annual Audit and Master Certification

The Chief Medical Technologist and Pathologist verify this register annually to confirm that clinical records are completed only by authorized personnel:

Role	Name	PRC License Number	Signature	Date
Chief Medical Technologist / LQM	Junry, RMT
Pathologist / Head of Laboratory
Hospital Director