Process Improvement

The Laboratory must develop and institute a Quality Management System (QMS) to ensure
that it is delivering quality services to its clients. The system identifies key quality elements
or indicators essential to the proper functioning of the laboratory, and establishes a method
for the systematic monitoring of these indicators in order to detect, correct and prevent
errors. Thus the QMS provides opportunities for ongoing improvement.

The responsibility of ensuring quality in the laboratory lies with the Management i.e. the
Laboratory Director, the Microbiology Supervisor and the Laboratory’s Quality Manager.
However, every person working in the laboratory must ensure maintenance and
improvement of the quality systems. This is facilitated by the use of Quality indicators.
Examples of quality indicators:
Quality indicators may be derived from any of the following operational areas:

1. PRE-ANALYTICAL
 Test requests-appropriate for the diagnosis
 Specimen collection-timing, appropriate sample and number
 Specimen transport-appropriate container, delay in transport
2. ANALYTICAL
 Specimen receiving –time to accession and process
 Specimen processing -appropriate choice of media and incubation conditions
 Testing and review
 Results reporting
 Specimen retention and appropriate discard
 Personnel-training, competency
 Equipment
 Purchasing and inventory
 Documents and Records
 Occurrence Management
 Service and Satisfaction-client survey
 Laboratory Information systems-security violations, unscheduled downtimes
 Safety-needle stick injuries, laboratory accidents that expose staff to infectious
aerosols.
3. POST-ANALYTICAL
 Application of results in patient management, e.g. choice of appropriate
antimicrobial therapy, appropriate action to the report of a critical value.

4.9.1 Handout: Process Improvement

 Once the indicators have been selected:
i. Decide what to measure for the selected indicator.
ii. Set the standard for the selected indicator.
iii. Set the threshold for the selected indicator.
iv. Determine the frequency of each activity
v. Identify the responsible person for data collection. Staff cannot audit their own
work.
vi. Determine the means by which this information will be analyzed.
External Assessments evaluate the quality management system and are conducted by
sources outside the laboratory. They include:
 Participation in External Quality Assurance
 Accreditation Assessment.

Internal Audit Programme: The laboratory may periodically decide to review the
laboratories quality management system including work operations. The audit assesses
compliance with internal policies, processes, procedures and applicable
regulations/requirements.

Evaluation of Results
For each parameter chosen, the rate of deviation from the established standard along with
the reason and the source of the error need to be determined by data collection and
statistics.
The results will be evaluated on an on-going basis such that necessary corrective action can
be taken in a timely manner. Appropriate corrective action will be taken, and a repeat
analysis done to evaluate the efficacy of the corrective action taken.
A summary of the results will be prepared for the Laboratory’s Quarterly QA report and
discussed with the Director and staff.

Quality Improvement Plan for the Microbiology Laboratory

Quality Improvement Plans (QIPs) are integral to Quality Systems, and are designed to
provide a means for continuous quality improvement which will help to ensure that laboratory
testing is of the highest quality.

The implementation of the quality management system model enhances the ability of the
laboratory to reduce or eliminate error and to achieve and maintain quality. The quality
system ensures that the laboratory has processes that are efficient and effective, and that
meet regulatory requirements. The responsibility of developing, implementing and
overseeing the QIP lies with the Laboratory Administration.

4.9.1 Handout: Process Improvement