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Home / Documents / F-QM-ANA-004-A-V0

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-V0Parent DocumentLAB-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

ItemSurvey 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 LabYYYY-MM-DD at HH:MM
Receiving Medical Technologist____________________________________, RMT
Package Physical Condition[ ] Intact, cold chain maintained, sealed [ ] Compromised / Thawed (Record details in remarks)
Arrival TemperatureObserved: ______ °C (Acceptable Storage: [ ] 2–8°C [ ] -20°C [ ] Ambient)
Results Submission DeadlineYYYY-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 IDAnalyte(s) AssignedAssigned Medical TechnologistPrimary Duty ShiftDate ReconstitutedDate TestedTesting MT Signature
[ ] AM [ ] PM [ ] NightYYYY-MM-DDYYYY-MM-DD
[ ] AM [ ] PM [ ] NightYYYY-MM-DDYYYY-MM-DD
[ ] AM [ ] PM [ ] NightYYYY-MM-DDYYYY-MM-DD
[ ] AM [ ] PM [ ] NightYYYY-MM-DDYYYY-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 IDAnalyteInstrument / Method UsedReagent Lot & ExpiryDaily IQC Prior to RunRaw Instrument ResultFinal Reported Value & UnitsTesting 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.

ParameterFinding / ScoreAcceptable CriterionPerformance Status
Date Evaluation Report ReceivedYYYY-MM-DDWithin 30 days of submission—
Overall Survey Score / Passing Rate________ %Target: >= 80% (or Acceptable)[ ] ACCEPTABLE [ ] UNACCEPTABLE
Individual Analyte SDI / Z-ScoresMin: _____ Max: _____Absolute Z-score <= 2.0[ ] Within Limits [ ] Outlier Detected
Root-Cause Investigation Triggered?[ ] No (Score >= 80% and allZ<= 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 InitiatedTarget / Peer MeanReported TCH ResultSDI / Z-Score
PT-INV-YYYY-____YYYY-MM-DD

5.2 Systematic Error Source Checklist

CategoryVerification ItemFinding / Details
Clerical / ReportingTranscription error, decimal placement, unit error, wrong method code submitted[ ] Verified Normal [ ] Discrepancy Found
Sample QualityReconstitution volume accurate, mixing technique, hemolysis or turbidity noted[ ] Verified Normal [ ] Defect Identified
Reagent / CalibratorReagent lot in-date, proper storage observed, calibration curve verified[ ] Verified Normal [ ] Reagent Issue Found
Instrument / EquipmentPreventive maintenance current, optical/flow-cell clean, zero flags on run[ ] Verified Normal [ ] Hardware Error Flagged
Internal Quality ControlDaily IQC within ±2 SD on test day, Levey-Jennings shift/trend absent[ ] In Control [ ] Shift/Trend Identified
Testing PersonnelStandard operating procedure followed verbatim, pipetting calibrated[ ] Verified Normal [ ] Technique Error Noted

5.3 Retest Analysis & Patient Impact Evaluation

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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 NameTesting SectionAlternative Assessment MechanismTesting CadenceReference Partner Facility
1Peripheral Blood Smear MorphologyHematologySplit-sample slide exchange / Pathologist peer-reviewSemi-AnnualSamar Provincial Hospital (SPH)
2Urine Sediment Microscopic ReviewClinical MicroscopyPhotomicrograph exchange / Blind replicate reviewSemi-AnnualSPH / Chief Medical Technologist
3Dengue Duo Rapid Diagnostic TestSerologyConfirmed positive/negative retain panel retestSemi-AnnualValidated panel / SPH
4HBsAg / Syphilis Rapid TestSerologyBlind split-sample testing with reference laboratorySemi-AnnualSamar Provincial Hospital (SPH)

6.2 Semi-Annual Split-Sample Assessment Record

Sample IDPrimary TCH ResultComparison / SPH ResultDifference / DeviationAllowable CriterionConformance (Pass / Fail)
Sample 01Quantitative: ±10% / Qualitative: 100%[ ] Pass [ ] Fail
Sample 02Quantitative: ±10% / Qualitative: 100%[ ] Pass [ ] Fail
Sample 03Quantitative: ±10% / Qualitative: 100%[ ] Pass [ ] Fail
Sample 04Quantitative: ±10% / Qualitative: 100%[ ] Pass [ ] Fail
Sample 05Quantitative: ±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 NamePRC License NumberDateSignature

7.2 Chief Medical Technologist / Laboratory Quality Manager

7.3 Pathologist / Head of Laboratory