TOTAL QUALITY MANAGEMENT (TQM) OF THE CLINICAL LABORATORY

TOTAL QUALITY MANAGEMENT (TQM) OF THE CLINICAL LABORATORY

(Taken from Tietz Textbook of Clinical Chemistry, 4th Edition)

A QLP includes analytical process, general policies, practices, and procedures that are carried out in laboratory and which are required for proper functioning of laboratory. How is laboratory functioning?

QC emphasizes statistical control procedures and non statistical check like linearity checks, reagent and standard checks, temperature monitors, etc. Quality controls represents those techniques and procedures that monitor performance parameters, it helps to monitor sources or error, estimates, the magnitude of errors, and alert laboratory personnel when there are indications that quality has deteriorated, under varying operating conditions. QC consists of tools required to maintain quality. How is the reliability and accuracy of the work and report maintained?

QA (also called proficiency testing) is concerned with broader measure and monitors of laboratory performance, such as turnaround time, specimen identification, patient identification, and test utility. QA encompasses the whole system. QA is done by identification of problem through QI and elimination of problem through QP. How to assure the lab procedure are reliable and accurate?

QI provides a problem solving process for identifying the root cause of a problem and identifying a remedy for the problem. What are the problems faced and how it is dealt?

QP is necessary to standardize the remedy, establish measures for monitoring performance, ensure that the performance is within quality requirement and document new QLP. How problems are dealt?

The new process is then implemented through QLP, measured and monitored through QC and QA, improved through QI, and replanned through QP.

The five-Q framework defines how quality can be managed using PDCA cycle (plan, do, check and act). QP provides the planning step, QLP establishes standard processes for doing things, QC and QA provide measures for checking how well things are done, and QI provides a mechanism for acting on those measures. It provides mechanism or process to be followed to attain the quality requirement.

ELEMENTS OF QUALITY ASSURANCE PROGRAM

Quality assurance program consists of broad spectrum of practices, plans and procedures that will assure (to be sure and confident) that the quality will be maintained. There are several essential elements of quality assurance program.

Commitment:

Dedication to quality service must be the first priority. A true commitment is required by laboratory directors, managers, and supervisors as well as laboratory personnel if the efforts are to be successful.

Facilities and resources:

Laboratory should have administrative support, adequate space, equipment, materials, supplies, staffing, budgeting resources, etc. These facilities and resources should be encouraging to all the persons involved in the service.

Technical competence:

Highly skilled personnel are essential for high quality service. The educational background and experience of all personnel are important. In service training programs helps to develop required skills and competence in running quality laboratory service.

Technical procedures

High quality technical procedures are necessary to provide quality laboratory services. There are 4 groups of technical procedures to be maintained in high quality for quality service.

a.      Control of Preanalytical conditions or variables like test request, patient preparation, patient identification, specimen collection and transportation, specimen processing, preparation of work lists and logs, maintenance of records, labeling of specimen, etc.

b.      The control of analytical variables, like analytical methodology, standardization and calibration procedures, documentation of analytical procedures, monitoring of equipment etc.

c.       Monitoring of analytical quality by using statistical methods and control charts

d.      Control post analytical variables like report delivery, transcription, proper dispatch procedure, etc.

Problem solving mechanism:

There must be a mechanism to identify the problem and implement the solution by making necessary adjustment. These includes in service training programs from QC specialist, frequent use of quality control programs, involvement in External quality assessment program and proficiency testing programs. Administration must heighten the interest of laboratory workers, there must be smooth supply of resources, incentives for good working, providing techniqual skills to handle instrumental problems, etc.