Quality Control: Introduction

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

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.

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--immediately 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

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

The Quality Assurance Cycle

Patient/Client Prep Sample Collection Reporting Data and Lab Management Safety Customer Service Personnel Competency Test Evaluations

Sample Receipt and Accessioning

Record Keeping Quality Control Testing Sample Transport

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

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, MartinLewis
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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 Materials: Calibrators

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 Materials: Important 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 biohazardous
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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,

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