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F-QM-POST-001-A-V0 — Official Laboratory Result Validation, Format Review & Amended/Corrected Report Form

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

Parent document: LAB-QM-POST-001 — Laboratory Reporting Policy (parent is encoded in the form number)

Rendered in-browser from the project's Word file F-QM-POST-001-A-V0-result-validation-checklist.docx (policies-docx / forms-docx — the file Junry reviews). Formatting is faithful, not pixel-perfect; the DOCX is the official copy.

Document #	F-QM-POST-001-A-V0	Parent Document	LAB-QM-POST-001 — Laboratory Reporting Policy

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Part 1 — Multi-Stage Result Validation Checklist

The testing Medical Technologist completes this checklist before printing, authorizing, or transmitting patient findings.

1.1 Pre-Analytical Verification

Verification Item	Status (Pass / Fail)	Remarks
1. Requisition matches specimen primary container (Full Name, HRN/MRN, Age, Sex)	[ ] Pass [ ] Fail
2. Specimen collection date, time, and source recorded accurately	[ ] Pass [ ] Fail
3. Specimen integrity acceptable (no gross hemolysis, lipemia, micro-clots, or insufficient volume)	[ ] Pass [ ] Fail

1.2 Analytical Verification

Verification Item	Status (Pass / Fail)	Remarks
1. Daily internal QC (IQC) within acceptable limits (±2 SD) on testing run	[ ] Pass [ ] Fail
2. Instrument calibration curve verified; zero hardware error flags on printout	[ ] Pass [ ] Fail
3. Biological plausibility verified; result plausible against clinical diagnosis	[ ] Pass [ ] Fail
4. Critical (panic) values identified and telephoned per Reporting Critical Values Policy	[ ] Pass [ ] NA

1.3 Post-Analytical Verification

Verification Item	Status (Pass / Fail)	Remarks
1. Standard reference intervals and measurement units correctly stated	[ ] Pass [ ] Fail
2. Verified by performing Medical Technologist; countersigned by Pathologist	[ ] Pass [ ] Fail
3. Transcription into Excel-integrated LIS verified with zero typographical errors	[ ] Pass [ ] Fail

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Part 2 — Clinical Laboratory Report Format Compliance Audit

Conducted semi-annually on a random sample of issued reports across all clinical sections.

Element #	Mandatory Report Element	Standard Basis	Compliant (Yes / No)
1	Full patient demographic identifiers (Name, MRN, Age, Sex)	ISO 7.4.1.6; AO 2021-0037	[ ] Yes [ ] No
2	Attending physician name and clinical location (Ward/ER/OPD)	ISO 7.4.1.6; DOH QMS Tool	[ ] Yes [ ] No
3	Specimen primary type and anatomical collection site	ISO 7.4.1.6	[ ] Yes [ ] No
4	Date and time of specimen collection and receipt in laboratory	ISO 7.4.1.6; AO 2021-0037	[ ] Yes [ ] No
5	Test name and standardized analytical methodology	ISO 7.4.1.6	[ ] Yes [ ] No
6	Numerical result with standard conventional reporting units	ISO 7.4.1.6	[ ] Yes [ ] No
7	Age- and sex-specific biological reference intervals displayed	ISO 7.4.1.6; AO 2021-0037	[ ] Yes [ ] No
8	High, low, and critical result flags visually distinct	ISO 7.4.1.6	[ ] Yes [ ] No
9	Date and time of result verification and official release	ISO 7.4.1.6; AO 2021-0037	[ ] Yes [ ] No
10	Performing Medical Technologist printed name, PRC #, and wet signature	AO 2021-0037 Annex A V.B.5	[ ] Yes [ ] No
11	Pathologist printed name, PRC license #, and wet signature	AO 2021-0037 Annex B1 Item 26	[ ] Yes [ ] No
12	Hospital official header, laboratory address, and DOH license number	AO 2021-0037; ISO 7.4.1.6	[ ] Yes [ ] No
13	Patient confidentiality notice printed per RA 10173	LAB-QM-005; RA 10173	[ ] Yes [ ] No
14	SPH referral results retained on referral lab's official form	AO 2021-0037 Annex C Item A.7	[ ] Yes [ ] No
15	Interpretive comments provided for abnormal microscopic morphology	ISO 7.4.1.6	[ ] Yes [ ] No

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Part 3 — Amended / Corrected Report Documentation & Notification Record

Mandatory whenever an already-released laboratory report is modified or amended due to an identified error.

3.1 Patient and Case Identification

Patient Full Name: ____________________________________ Hospital No. (MRN): __________________
Ward / ER / Clinic: ____________________________________ Attending Physician: Dr. ________________
Original Accession No.: ________________ Original Release Date & Time: YYYY-MM-DD at HH:MM
Date & Time Error Discovered: YYYY-MM-DD at HH:MM | Discovered By: ________________________, RMT

3.2 Result Correction Data

Examination / Analyte	Original (Erroneous) Value	Corrected (New) Value	Reference Interval	Units

3.3 Root-Cause Categorization

[ ] Clerical / Transcription Error: Typographical error, transposed digits, or wrong Excel cell entry.
[ ] Technical / Analytical Error: Instrument baseline drift, pipette volume error, or reagent defect.
[ ] Pre-Analytical Specimen Error: Misidentified primary tube or unnoted partial clot.

3.4 Clinician Notification & Mandatory Verbatim Comment

Attending Physician Contacted: Dr. ________________________ Contact Time: YYYY-MM-DD at HH:MM
Read-Back Verification Completed: [ ] Yes (Mandatory target within 30 minutes of error detection)
Mandatory Verbatim Report Comment Affixed to Corrected Report: "This result was previously reported as [original value] and corrected to be [corrected value]; Dr. [physician name] was verbally informed and read-back verification was confirmed on [date] at [time]."
Nonconformance Logged: [ ] Occurrence logged in Incident Log (Form F-QM-010-A-V0)

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Part 4 — Review and Pathologist Endorsement

4.1 Reporting Medical Technologist

Name & PRC License No.: ____________________________________ Date: ____________________
Signature: ________________________________________

4.2 Chief Medical Technologist / Laboratory Quality Manager

Corrective Review: [ ] Clinical notification verified [ ] Electronic LIS audit trail corrected
Signature: ________________________________________ Date: ____________________

4.3 Pathologist / Head of Laboratory

Pathologist Sign-Off: [ ] Approved [ ] Clinical review completed with attending physician
Signature: ________________________________________ Date: ____________________