Quality Control: Introduction

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Quality ControlIntroduction
Pawan Angra MS Division of Laboratory
Systems Public Health Practice Program
Office Centers for Disease Control and Prevention

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Who is Responsible???

• Lab Tech-The person who performs testing
• Supervisor-The person who is responsible for
  day-to-day activities, training, delegation of
  work
• Director-The person who is responsible for
  entire seamless operation, planning, and control
  of all activities
• Ministry of Health-Place responsible for
  infrastructure, man power, and resources.

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Lab Tech

• Must be trained to perform the tests
• Follow SOPs
• Must run QC samples
• Maintain all the record up to date
• Inform the Supervisor of any problems---immediatel
  y
• Corrective actions taken by them must be noted
  down and any implications on other samples

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Supervisor

• Train the Lab tech for the assigned job
• Provide periodic training to the lab techs
• Prepare the controls and check the values
• Prepare and update the SOPs -easy to understand
• Keep record of Equipment Maintenance, problems,
  and repairs
• Keep records of training, SOPs, equipment, etc.
• Ensure all Lab tasks on time

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Lab Director

• Arrange resources
• Planning ahead for the laboratory operation
• Introduce new more efficient technologies as and
  when required
• Hire persons capable of performing the task
• Provide help and guidance to staff
• Provide insight to MoH

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MoH

• Responsible for the health of entire population
  and health related issues
• Must provide resources, infrastructure, and
  guidelines to the laboratories
• Encourage to join the Para-medical health
  professions by providing opportunities of growth
  and education

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The Quality Assurance Cycle
Pre-Analytic
Patient/Client Prep Sample Collection
Personnel Competency Test Evaluations
Reporting

• Data and Lab Management
• Safety
• Customer Service

Post-Analytic
Sample Receipt and Accessioning
Record Keeping
Sample Transport
Quality Control
Testing
Analytic
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Quality Control

• Definitions
• Qualitative Quality Control
• Quantitative QC How to implement
• Selection and managing control materials
• Statistical Analysis of QC data
• Monitoring quality control data

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What is Quality Control?

• Process or system for monitoring the quality of
  laboratory testing, and the accuracy and
  precision of results
• Routinely collect and analyze data from every
  test run or procedure
• Allows for immediate corrective action

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Designing a QC Program

• Establish written Lab policies, Requisition
  forms, SOPs, Report forms, and Revisions and
  Corrective action plan
• Assure complete documentation and review
• Assure proper controls, standards, chemicals and
  storage
• Equipment control and maintenance
• Train all staff and periodic retraining
• Periodic Internal audits

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Qualitative vs.Quantitative

• Qualitative test
• determines whether the substance being tested for
  is present or absent
• Quantitative test
• measures the amount of a substance present

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Qualitative QC

• Quality control is performed for both, system is
  somewhat different
• Controls available
• Agglutination / precipitation controls Blood
  Bank / Serology / Micro / Biochemistry / RPR/TPHA
• Colour change Dipstick technology, Pregnancy
  test
• Sterlization ampules, Occult blood, Biochemical
  reactions
• Opacity tube standards McFarland std tubes

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Lab Chemicals and Supplies

• Check upon receipt
• -Correct order
• -Clear and legible label
• -Content
• -Expiry date
• -Storage conditions
• Label date received
• Enter in your inventory book

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Stains, Reagents, Antisera, Media

• Bulk containers- Date of opening
• Prepared contents Label containers
• Contents
• Concentration
• Date prepared and expiration date/shelf life
• Storage condition
• Placed in service
• Prepared by

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Microbiology QC Media Preparation

• Record amount prepared
• Source
• Lot number
• Sterilization method
• Preparation date and Expiration date
• Prepared by

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Microbiology QC

• Check
• Sterility
• Ability to support growth
• Indicative, selective, or inhibitory
  characteristics of the medium
• Biochemical response
• Test QC organisms with each new batch or lot
  number
• Check for growth of fastidious organisms on media
  of choice incubate at time and temp recommended
• RECORD Results on Media QC form

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Quality Control Stains and Reagents

• Gram stain QC
• Use gram positive and gram negative organisms to
  check stains daily
• Other
• Check as used positive and negative reactions

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Stock QC organisms

• Check for purity
• Organisms- maintained must be adequate to check
  all media and test systems.
• E. coli MacConkey, EMB, susceptibility tests
• Staphylococcus aureus Blood agar, Mannitol ,
  susceptibility tests
• Neisseria gonorrhoeae Chocolate agar,
  Martin-Lewis

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Detecting Errors

• Medium contaminated Check Autoclave
• No Growth of control organism
• -Check culture medium, preparation method,
  Sterility method, viability of organisms
• Gram are Gram - Check stain solutions

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Detecting Errors

• Many organisms have predictable antimicrobial
  test results
• Staphylococcus spp. are usually susceptible to
  vancomycin
• Streptococcus pyogenes are always susceptible to
  penicillin
• Klebsiella pneumoniae are resistant to ampicillin

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Sources of Error

• Unusual pattern
• Purity check
• rule out error by checking identification of
  organism
• repeat antimicrobial susceptibility test
• Report if repeat testing yields same result, or
  refer the isolate to a reference laboratory for
  confirmation

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Quality Control Quantitative Tests

• How to implement a laboratory quality control
  program?

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Implementing a QC Program Quantitative Tests

• Select high quality controls
• Collect at least 20 control values over a period
  of 20-30 days for each level of control
• Perform statistical analysis
• Develop Levey-Jennings chart
• Monitor control values using the Levey-Jennings
  chart and/or Westgard rules
• Take immediate corrective action, if needed
• Record actions taken

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Selecting Control MaterialsCalibrators

• Have a known concentration of the substance
  (analyte) being measured
• Used to adjust instrument, kit, test system in
  order to standardize the assay
• Sometimes called a standard, although usually not
  a true standard
• This is not a control

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Selecting Control Materials Controls

• A control also has a known amount of an analyte
  but is used to monitor the precision and
  accuracy of an assay method once it has been
  calibrated.
• Use 2 or three levels of controls
• Include with patient samples when performing a
  test
• Used to validate reliability of the test system

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Control MaterialsImportant Characteristics

• Values cover medical decision points
• Similar to the test specimen (matrix)
• Available in large quantity
• Stored in small aliquots
• Ideally, should last for at least 1 year
• Often use biological material, consider
  bio-hazardous

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Managing Control Materials

• Sufficient material from same lot number or serum
  pool for one years testing- preserved and
  stabilized
• May be frozen, freeze-dried
• -Requires very accurate reconstitution if
  this step is necessary
• Always store as recommended by manufacturer

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Sources of QC Samples

• Appropriate diagnostic samples
• Obtained from
• Another laboratory
• EQA provider
• Commercial product

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Types of Control Materials

• Assayed
• mean calculated by the manufacturer
• must verify in the laboratory
• Un-assayed
• less expensive
• must perform data analysis
• Home made or In-house
• pooled sera collected in the laboratory
• characterized
• preserved in small quantities for daily use

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Summary

• Every one is responsible for Quality of
  laboratory results
• Qualitative QC - In all areas of Medical
  laboratory
• Quantitative QC - Qualitative QC plus determine
  the control values
• Control materials - Reliable source, stable, and
  enough to last for a year,