3. 3
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.
4. 4
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
5. 5
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
6. 6
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
7. 7
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
8. 8
The Quality Assurance Cycle
•Data and Lab
Management
•Safety
•Customer
Service
Patient/Client Prep
Sample Collection
Sample Receipt
and Accessioning
Sample Transport
Quality Control
Record Keeping
Reporting
Personnel Competency
Test Evaluations
Testing
9. 9
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
10. 10
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
11. 11
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
12. 12
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
13. 13
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
14. 14
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
15. 15
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
16. 16
Microbiology QC:
Media Preparation
• Record amount prepared
• Source
• Lot number
• Sterilization method
• Preparation date and Expiration date
• Prepared by
17. 17
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
18. 18
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
19. 19
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
20. 20
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
21. 21
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
22. 22
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
24. 24
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
25. 25
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
26. 26
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
27. 27
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 bio-
hazardous
28. 28
Managing Control Materials
• Sufficient material from same lot number or
serum pool for one year’s testing- preserved
and stabilized
• May be frozen, freeze-dried
-Requires very accurate reconstitution if
this step is necessary
• Always store as recommended by
manufacturer
30. 30
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
31. 31
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,
Editor's Notes
#12:Qualitative tests
Tests that do not have measurable endpoints, for example:
Growth-no growth
Positive-negative
Color change
#17:Check for sterility – incubate uninoculated plate – continue only if no growth
#19:Discussion of where to get control organisms
Discuss media used in their labs and what organisms should be used to test it.
ATCC – best, but other sources may be available.
May use known organisms from their lab and make stock cultures??
#21:I think you could include a pretty long list here, that are worldwide in application.
#22:Establish patterns in your patient population and advise health care providers.
So providers can initiate treatment if necessary before susceptibility testing is complete
#24:Monitor control values on a run-by-run basis using the Levey-Jennings chart and/or Westgard rules
Develop Levey-Jennings chart using the calculated values for mean, SD, and range
#27:Values cover medical decision points – often use high and low, or normal and abnormal
#29:1. QC Sample
The Sources of QC Samples
QC samples can be obtained from a number of different sources:
Producing your own external control - requires resources because there are many validation and testing steps. Can produce very large volumes with exact specifications.
Selecting a diagnostic sample - must meet QC sample requirements. Cheaper option but difficult to get very large volumes so may have to change QC samples often. This will inhibit the collection of longitudinal and batch to batch data.
Obtaining a QC sample form another laboratory - saves time, but does not guarantee a well standardised and validated product. Collaboration between laboratories assists in providing the large volume required and may decrease costs.
Samples provided as participation in an External QC Programme -this is the preferable option as it provides follow up and feedback on your performance in comparison to other laboratories.
Commercially available controls - e.g. BBI Accurun (Boston Biomedica Inc) are purchased by the millilitre and are expensive. Samples are ‘stand alone’ because no results are collected and no feedback is provided. BBI Accurun is a very stable sample due to its production process which involves heat treatment. Because of this the sample is not as sensitive to small fluctuations and may only identify large shifts in variation shifts, similar to the positive control.
