F-QM-ANA-004-A-V0 — EQAS / NEQAS Enrollment, Result Evaluation, Discordance Investigation & Alternative Assessment Log
Type: Form · Version: V0 · Status: DRAFT — UNAPPROVED · Served read-only from the bundled QMS copies. The Drive master is untouched.
Parent document: LAB-QM-ANA-004 — External Quality Assessment (Proficiency Testing and Alternative Assessment) Policy (parent is encoded in the form number)
Rendered in-browser from the project's Word file F-QM-ANA-004-A-V0-pt-survey-master-packet.docx (policies-docx / forms-docx — the file Junry reviews). Formatting is faithful, not pixel-perfect; the DOCX is the official copy.
| Document # | F-QM-ANA-004-A-V0 | Parent Document | LAB-QM-ANA-004 — External Quality Assessment Policy |
|---|
Keep one master packet for each external proficiency testing survey cycle (NEQAS-SLH, NEQAS-NKTI, or DOH-accredited EQAS provider) and for semi-annual alternative assessment rounds.
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Part 1 — Survey Receipt, Package Inspection & Administrative Data
| Item | Survey Details |
|---|---|
| EQAP / PT Provider | [ ] NEQAS-SLH (Infectious / Serology) [ ] NEQAS-NKTI (Hematology / Clinical Microscopy) [ ] Other DOH-Accredited Provider: ________________ |
| Program / Survey Title | |
| Cycle / Event Tracking No. | |
| Date & Time Received in Lab | YYYY-MM-DD at HH:MM |
| Receiving Medical Technologist | ____________________________________, RMT |
| Package Physical Condition | [ ] Intact, cold chain maintained, sealed [ ] Compromised / Thawed (Record details in remarks) |
| Arrival Temperature | Observed: ______ °C (Acceptable Storage: [ ] 2–8°C [ ] -20°C [ ] Ambient) |
| Results Submission Deadline | YYYY-MM-DD |
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Part 2 — Staff Testing Assignment & Routine Rotation Record
Policy Mandate: Treat PT samples as part of the routine workload. Rotate them among all Medical Technologists who perform patient testing. Do not use special replicate runs or contact other laboratories about them.
| Sample ID | Analyte(s) Assigned | Assigned Medical Technologist | Primary Duty Shift | Date Reconstituted | Date Tested | Testing MT Signature |
|---|---|---|---|---|---|---|
| [ ] AM [ ] PM [ ] Night | YYYY-MM-DD | YYYY-MM-DD | ||||
| [ ] AM [ ] PM [ ] Night | YYYY-MM-DD | YYYY-MM-DD | ||||
| [ ] AM [ ] PM [ ] Night | YYYY-MM-DD | YYYY-MM-DD | ||||
| [ ] AM [ ] PM [ ] Night | YYYY-MM-DD | YYYY-MM-DD |
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Part 3 — Analytical Worksheet & Raw Results Recording
Record instrument name, reagent lot, calibration status, daily IQC, and raw instrument readout.
| Sample ID | Analyte | Instrument / Method Used | Reagent Lot & Expiry | Daily IQC Prior to Run | Raw Instrument Result | Final Reported Value & Units | Testing MT Signature |
|---|---|---|---|---|---|---|---|
| [ ] In Control | |||||||
| [ ] In Control | |||||||
| [ ] In Control | |||||||
| [ ] In Control |
Online Portal Submission Verification: Date Submitted to Provider Portal: YYYY-MM-DD | Submitted by: _______________________, RMT Confirmation / Submission Receipt Filed: [ ] Yes [ ] Electronic screenshot / printout attached to packet
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Part 4 — Provider Performance Evaluation, Review & Scoring
Completed upon receipt of the official summary evaluation report from the PT provider.
| Parameter | Finding / Score | Acceptable Criterion | Performance Status |
|---|---|---|---|
| Date Evaluation Report Received | YYYY-MM-DD | Within 30 days of submission | — |
| Overall Survey Score / Passing Rate | ________ % | Target: >= 80% (or Acceptable) | [ ] ACCEPTABLE [ ] UNACCEPTABLE |
| Individual Analyte SDI / Z-Scores | Min: _____ Max: _____ | Absolute Z-score <= 2.0 | [ ] Within Limits [ ] Outlier Detected |
| Root-Cause Investigation Triggered? | [ ] No (Score >= 80% and all | Z | <= 2.0) [ ] Yes (Proceed to Part 5 below) |
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Part 5 — Investigation of Discordant PT Finding & Root-Cause Analysis
Required for any analyte score < 80% or absolute Z-score > 2.0. Complete the investigation within thirty (30) calendar days after the evaluation report is received.
5.1 Investigation Tracking & Event Identification
| Investigation Ref No. | Date Initiated | Target / Peer Mean | Reported TCH Result | SDI / Z-Score |
|---|---|---|---|---|
| PT-INV-YYYY-____ | YYYY-MM-DD |
5.2 Systematic Error Source Checklist
| Category | Verification Item | Finding / Details |
|---|---|---|
| Clerical / Reporting | Transcription error, decimal placement, unit error, wrong method code submitted | [ ] Verified Normal [ ] Discrepancy Found |
| Sample Quality | Reconstitution volume accurate, mixing technique, hemolysis or turbidity noted | [ ] Verified Normal [ ] Defect Identified |
| Reagent / Calibrator | Reagent lot in-date, proper storage observed, calibration curve verified | [ ] Verified Normal [ ] Reagent Issue Found |
| Instrument / Equipment | Preventive maintenance current, optical/flow-cell clean, zero flags on run | [ ] Verified Normal [ ] Hardware Error Flagged |
| Internal Quality Control | Daily IQC within ±2 SD on test day, Levey-Jennings shift/trend absent | [ ] In Control [ ] Shift/Trend Identified |
| Testing Personnel | Standard operating procedure followed verbatim, pipetting calibrated | [ ] Verified Normal [ ] Technique Error Noted |
5.3 Retest Analysis & Patient Impact Evaluation
- Retest of retained PT sample performed: Date: YYYY-MM-DD | Retest Result: ________________
- Finding: [ ] Retest confirms original reported value (methodological/calibration issue) [ ] Retest matches peer target (transcription/pre-analytical sample error)
- Patient Result Impact: Were clinical patient samples tested in the affected run? [ ] No [ ] Yes
- If Yes, were amended reports required? [ ] No [ ] Yes (Amended reports issued per Laboratory Reporting Policy)
- Corrective & Preventive Action (CAPA) Logged: [ ] CAPA Plan Initiated (Form F-QM-011-A-V0, Ref No.: ________________)
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Part 6 — Alternative Proficiency Assessment Register & Protocol
Maintained for tests performed at TCH where formal commercial EQAP/PT is unavailable or impractical (e.g., peripheral smear morphology, urine sediment microscopy, rapid serology test kits).
6.1 Master Register of Analytes Under Alternative Assessment
| Item No. | Test / Analyte Name | Testing Section | Alternative Assessment Mechanism | Testing Cadence | Reference Partner Facility |
|---|---|---|---|---|---|
| 1 | Peripheral Blood Smear Morphology | Hematology | Split-sample slide exchange / Pathologist peer-review | Semi-Annual | Samar Provincial Hospital (SPH) |
| 2 | Urine Sediment Microscopic Review | Clinical Microscopy | Photomicrograph exchange / Blind replicate review | Semi-Annual | SPH / Chief Medical Technologist |
| 3 | Dengue Duo Rapid Diagnostic Test | Serology | Confirmed positive/negative retain panel retest | Semi-Annual | Validated panel / SPH |
| 4 | HBsAg / Syphilis Rapid Test | Serology | Blind split-sample testing with reference laboratory | Semi-Annual | Samar Provincial Hospital (SPH) |
6.2 Semi-Annual Split-Sample Assessment Record
- Event Tracking No.: AAR-YYYY-____ | Round: [ ] Round 1 (Jan–Jun) [ ] Round 2 (Jul–Dec) | Date: YYYY-MM-DD
- Analyte Evaluated: ________________________ | Testing Medical Technologist: ________________________, RMT
| Sample ID | Primary TCH Result | Comparison / SPH Result | Difference / Deviation | Allowable Criterion | Conformance (Pass / Fail) |
|---|---|---|---|---|---|
| Sample 01 | Quantitative: ±10% / Qualitative: 100% | [ ] Pass [ ] Fail | |||
| Sample 02 | Quantitative: ±10% / Qualitative: 100% | [ ] Pass [ ] Fail | |||
| Sample 03 | Quantitative: ±10% / Qualitative: 100% | [ ] Pass [ ] Fail | |||
| Sample 04 | Quantitative: ±10% / Qualitative: 100% | [ ] Pass [ ] Fail | |||
| Sample 05 | Quantitative: ±10% / Qualitative: 100% | [ ] Pass [ ] Fail |
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Part 7 — Review and Pathologist Sign-Off
7.1 Medical Technologists
We confirm that external quality assessment samples and alternative assessments were handled in the same way as routine patient specimens.
| Technologist Name | PRC License Number | Date | Signature |
|---|---|---|---|
7.2 Chief Medical Technologist / Laboratory Quality Manager
- Summary Evaluation: [ ] Satisfactory overall performance [ ] Corrective action closed and verified
- Signature: ________________________________________ Date: ____________________
7.3 Pathologist / Head of Laboratory
- Final Clinical Authorization: [ ] Approved [ ] Additional reassessment required
- Signature: ________________________________________ Date: ____________________
