quality assurance documentation
Download
Skip this Video
Download Presentation
Quality Assurance Documentation

Loading in 2 Seconds...

play fullscreen
1 / 16

Quality Assurance Documentation - PowerPoint PPT Presentation


  • 77 Views
  • Uploaded on

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.

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about ' Quality Assurance Documentation ' - lyn


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
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
ad