Sunday, 29 April 2007

LMQA - External Quality Control Systems

Hey guys,

So far, i have found some information regarding external QC systems. Apparently, it's more of getting external companies to review your systems from what i understand. I might be wrong, do let me know your input.

I've complied it as below:

External Quality Control Systems (EQAS)


[ISO/REMCO N. 231, 1991]
External quality assessment (EQA) refers to a system of objectively checking laboratory results by means of an external agency, including comparison of a laboratory’s results at intervals with those of other laboratories, the main objective being the establishment of trueness.


To ensure the reliability of test results between different laboratories- Required by CLIA for laboratory accreditation- Provide a check on internal quality control- Detect errors in a lab's methods- Provides comparison of different testing methods to determine best suitable one.


To improve and standardize the quality of accuracy and precision via:
- Improvement of analytical capabilities
- Standardization [inter-laboratory comparability]
- Introduction of a world-wide efficiency proficiency testing system.

Key issues

• Samples:
– Sample state [Stable for the period of the exercise]
– Real or commutable
– characterize sample, maintain database
– Different endogenous/ spiked content covering the range of concentrations of interest

• Regular frequency; Panel preparation
–Select sample for retest

• Sample distribution
– Coordinate shipping, review sample state, documentation

• Resources
– Lab facilities, staff, equipments, lab layout, materials

• Data analysis including:
– methods to identify deviations from normal distribution
– methods to identify outliers or robust statistics

• Performance evaluation


- Standards set by WHO, or Relevant health organizations/associations (CSAP, CLIA etc).

- Used to evaluate the accuracy of participating laboratory routine testing methods in adhering to standardized test methods.

- Several (8-10) bacterial/viral strains/clinical samples are sent out to participating laboratories annually.

- For stereotyping or antimicrobial susceptibility testing to be done

- Laboratories will report their findings to WHO

- WHO will determine how accurate the findings are in correlation to their own true results

- The evaluations of the laboratory testing systems will be sent to them in individual reports
o Mean results of sample analysis
o Number of labs using same method
o Standard deviation index
o Lower and upper limits of acceptability of results
o standard deviation of results by the comparative method

- Used to determine if their routine methods are up to standard or need to be rectified.

- must be tested with the laboratory's regular patient load (in Clinical Laboratories context)
- number of times that patients' samples are tested routinely should not differ from when participating in external quality control programme/system
- Laboratories in external quality control programme must not compare results with each other.
- Laboratories may not send samples to another company for analysis
- All steps carried out must be documented accordingly

EVALUATION (external quality control review):

Report or evaluation sent:

- contain transmittal letter
- standardized language
- opinion paragraph
- required/supporting exhibits

May be from:
- 1 organisation (WHO)
- Peer evaluation (in some unions such as EU), in participating countries.

Generally 3 types of opinions:

1) Unmodified Opinion
- Issued when the review team finds company’s quality control system to be adequate and designed properly

2) Modified Opinion
- Issued when quality control system did not function satisfactorily as prescribed, causing significant deficiencies

3) Adverse Opinion
- Issued when quality control system was inadequate as prescribed, not functioning adequately

Disclaimer opinion
- may be present when review team could not successfully assess some procedures due to limiting conditions present.



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