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Quality Assurance Documentation

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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  1. Quality Assurance Documentation Procedures and Records Stacy M. Howard, MT(ASCP)

  2. Quality System Documentation Policies Processes Procedures

  3. Purpose • Ensure consistency of laboratory operations in the pursuit of quality • Train new laboratory personnel • Troubleshoot problem areas

  4. Procedure Manual A collection of written policies that establishes acceptable procedures for the laboratory

  5. 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

  6. 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

  7. 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)

  8. A Technical Procedure must include: • Step-by-step instructions • Quantitative Testing • Qualitative Testing • Interpretation • Calculations (if applicable)

  9. 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

  10. A Technical Procedure must include: • Limitations of Methods • A troubleshooting or back-up plan • References • Effective Date • Signature of Laboratory Director

  11. 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

  12. Resources • Manufacturer’s product inserts • NCCLS PG2-A2 • Journals • Publications • Textbooks • Research and validation

  13. 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

  14. QA Records • Technical procedures • Specimen log book • Laboratory workbooks/sheets • Instrument printouts – Maintenance records • QC / EQA records • Personnel • Patient test reports • Quality improvement records

  15. 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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