Quality Control in a BioMedical Laboratory

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Record Keeping

An efficient laboratory will be able to monitor the records of specimens from the time the samples arrive until the time that results are released. Logbooks are an essential step in the recording of laboratory specimens and should be kept confidential. Any specimen that is determined to be inadequate for testing or that does not contain the essential information e.g. for HIV testing, should not be tested and a note should be entered in the logbook. A worksheet must accompany each test run in the laboratory. The worksheet serves as a guide when placing samples on the run. QC records are important in validating laboratory results. A standard operating procedure manual should be kept in the laboratory at all times and should be reviewed and updated frequently.

B. Monitoring Laboratory Staff

Laboratory managers may wish to periodically monitor the performance of their laboratory staff. Samples with known results may be resubmitted discreetly along with the routine workload.

C. Vigilance in the Laboratory

Vigilance refers to the watchfulness and consists of always

  1. watching that the identification on the specimen matches that of the requisition slip.
  2. noting the condition of specimens as they are received
  3. reviewing QC charts everyday
  4. observing co-workers
  5. taking care that the laboratory remains a safe place to work
  6. rechecking paperwork and worksheets before reporting a result  

D. Verification of True Positive and Negatives

A positive HIV result is a serious concern and each laboratory must be absolutely certain that each positive specimen result is correct. Once a sample is found to be positive by a screening test, an aliquot from the initial specimen tube should be retested, Wherever possible, a second specimen should be collected from the individual and rested to eliminate any possible handling, labeling, or clerical errors.

E. Parallel Testing of Resubmitted specimens

Parallel testing of resubmitted specimens is important in those patients whose specimens have yielded indeterminate results.

 
Overview
Definitions
Quality Assurance
- Record Keeping
- Reviewing Transcriptional measures
Quality Control
- Warning Rules
Quality Assessment
Quality Control in Clinical Virology
Written Procedures
Pathology Department Accreditation
Audit in the Clinical Laboratory
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