Continuous Quality improvement
High Quality laboratory results are generated when all phases of the measurement process are
conducted properly.
Factors which promote high quality results include:
1) Competent, well-trained and motivated laboratory staff.
2) Quality laboratory facilities.
3) Well-maintained, high-quality laboratory equipment.
4) High quality laboratory methods.
5) Clear commitment of management to quality laboratory results.
Quality Assurance:
The goal of quality assurance is to monitor and evaluate the overall quality of the testing process
including pre-analytic, analytic and post analytic phases.
The basic mechanism for QA is the quality audit , quality audits should be conducted by the
Lab , the results should be documented including remedial actions taken to address
conditions that merit correction.
Quality Audit: Patient test management
The quality audit for patient test management shall be conducted at least yearly and consist of:
1) A survey of the technical supervisors of the procedures used in the lab, the survey should
include requests for information on:
– Any changes which need to be made in patient preparation, specimen collection, labeling ,
preservation and transportation.
– Any changes which need to be made in completeness and relevance of patient information
obtained at the time , the specimen is required, and the use and appropriateness of specimen
rejection criteria based on their experience and interactions with persons requesting the tests.
-Laboratory reporting errors encountered since last survey.
-Non-Trivial problems in communication with persons requesting patient tests.
-Non -Trivial complaints from outside the laboratory about performance of the lab.
2) A random sampling of test reports issued since the last audit to evaluate:
whether data was released in a timely manner, whether the report was legible, whether the
report was in proper format ( including reference ranges, units of measure, matrix of
measurement, notation for inadequate specimen , sent only to the authorized individual
requesting the results )
Quality Audit: Quality Control.
Quality control address the analytical phase of measurement.
QC materials are used to assure quality of the analytical phase.
the purpose of the quality audit of the QC is to assure the QC analyses were performed and
appropriate actions taken when out of control conditions occurred.
the quality audit of quality control shall be conducted at least yearly and should consist of:
1- A review of QC for a random sampling of procedures covering a period of not less than one
year, the review evaluates whether appropriate corrective action was performed and
documented out-of-control conditions.
2-A review of the procedures used to establish the reference range for a sampling of procedures,
assuring that problems were satisfactorily resolved.
3) A review of the proficiency testing results of procedures for not less than one year.
The review will assess whether unacceptable performance on PT has been adequately corrected.
4) If applicable , a review of procedure which are performed by two different methods or two
different instruments or at two different sites, the review shall document that at least once every
six months a set of at least five sample spanning the re portable range are run on both
instruments, if The re portable range differs on two instruments, they should be compared in
concentration range that is included in the re portable range of each instrument.
Quality Audit: Personnel
Well trained and competent personnel are essential for good laboratory performance, the quality
audit personnel shall be conducted at least yearly and should consist of an audit the
documentation of personnel training and evaluation to check whether testing personnel have
been evaluated in the last year , the laboratory must document the results of the audit.
Quality assurance review with staff:
The director reviews pertinent quality audit information with appropriate staff to assure
effective remedial actions are taken, staff who have been involved in the audit are also notified
by branch chief if performance was acceptable and no remedial is needed.