Quality assurance documentation
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Quality Assurance Documentation. Procedures and Records. Stacy M. Howard, MT(ASCP). Quality System Documentation. Policies. Processes. Procedures. Purpose. Ensure consistency of laboratory operations in the pursuit of quality Train new laboratory personnel Troubleshoot problem areas.

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Quality Assurance Documentation

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Quality assurance documentation

Quality Assurance Documentation

Procedures and Records

Stacy M. Howard, MT(ASCP)


Quality system documentation

Quality System Documentation

Policies

Processes

Procedures


Purpose

Purpose

  • Ensure consistency of laboratory operations in the pursuit of quality

  • Train new laboratory personnel

  • Troubleshoot problem areas


Procedure manual

Procedure Manual

A collection of written policies that

establishes acceptable procedures for

the laboratory


A technical procedure must include

A Technical Procedure must include:

  • Title

    • Descriptive of test performed

  • Principle

    • Clinical Reasons for performing the test

  • Specimen requirements

    • Criteria for specimen collection, labeling, rejection, storage, transport

    • Procedures for submission to central labs

    • Procedures for microscopic examinations


A technical procedure must include1

A Technical Procedure must include:

  • Reagents or Media, Supplies, Equipment

    • Preparation of reagents, stains, or other materials used in testing

    • Storage Requirements

  • Calibration (If applicable)

    • Frequency, step-wise instructions


A technical procedure must include2

A Technical Procedure must include:

  • Quality Control

    • Identify control materials to use

    • Preparation, handling, and storage

    • Frequency of testing

    • Expected results

    • Corrective actions

    • Recording and storage of QC data

    • Alternatives (If no QC materials are available)


A technical procedure must include3

A Technical Procedure must include:

  • Step-by-step instructions

    • Quantitative Testing

    • Qualitative Testing

    • Interpretation

  • Calculations (if applicable)


A technical procedure must include4

A Technical Procedure must include:

  • Reporting Results

    • Reference intervals

    • Procedures for reporting abnormal results

    • Reporting format

  • Procedure Notes

    • Special precautions

    • Possible sources of error

    • TAT

    • Answers to common problems


A technical procedure must include5

A Technical Procedure must include:

  • Limitations of Methods

  • A troubleshooting or back-up plan

  • References

  • Effective Date

  • Signature of Laboratory Director


Procedure manual layout

Procedure Manual: Layout

  • No set format

    • Should be determined by the lab’s needs and organization

    • Job Aids

      • Loose-leaf binder, Card Index System

      • Flow Diagrams, Poster

  • Clearly presented in a language familiar to all

  • Should be easily accessible

  • Expected to be used


Resources

Resources

  • Manufacturer’s product inserts

  • NCCLS PG2-A2

  • Journals

  • Publications

  • Textbooks

  • Research and validation


Why record

Why Record?

  • Minimized chances of error through clarity of instructions – Technical Procedures

  • Sharing of information

  • Revisit information; reference

  • Quality Assurance monitoring

    • continuous action/service

  • Management tool

    • Policy and planning


Qa records

QA Records

  • Technical procedures

  • Specimen log book

  • Laboratory workbooks/sheets

  • Instrument printouts – Maintenance records

  • QC / EQA records

  • Personnel

  • Patient test reports

  • Quality improvement records


Summary effective recording

Summary: Effective Recording

  • Focus on accuracy and detail

  • Focus on clarity and legibility

  • Check ! Recheck!

  • Never assume. Verify and validate

  • No short cuts. Follow standardized procedures

  • Always focus on testing objective

    • Patient Management

    • Public Health Management


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