Indian Journal of Medical Microbiology Medknow Publications on behalf of Indian Association of Medical Microbiology ISSN: 0255-0857 EISSN: 1998-3646 Vol. 30, Num. 1, 2012, pp. 1-2

Indian Journal of Medical Microbiology, Vol. 30, No. 1, January-March, 2012, pp. 1-2

Editorial

Are clinical microbiology laboratories missing out quality control and quality assurance in laboratory management?

R Kanungo

Dean-Research and Prof. of Microbiology, Pondicherry Institute of Medical Sciences, Puducherry - 605 014, India

Correspondence Address:
R Kanungo
Dean-Research and Prof. of Microbiology, Pondicherry Institute of Medical Sciences, Puducherry - 605 014
India
rkanungo1@gmail.com

Date of Submission: 08-Feb-2012
Date of Acceptance: 11-Feb-2012

Code Number: mb12001

PMID: 22361752

DOI: 10.4103/0255-0857.93012

Impact of laboratory services in patient care is increasing as evidence-based medicine replaces clinical acumen in diagnosis of diseases. Clinical Microbiology is poised to move from laboratories to the bedside and beyond, into the community. Traditional isolation and identification methods are slowly giving way to automated and instrument-based techniques. Conventional serology is being replaced by rapid antigen/antibody detection systems. Specific and sensitive techniques based on various molecular methods are being increasingly used by diagnostic laboratories. Innovative methods are being introduced to the market at regular intervals with intense competition and marketing strategies. In the absence of monitoring mechanisms for post-marketing checks on the quality of diagnostic kits, it is left to the individual laboratories to set standards by implementing quality systems in the work place.

As the patient′s right to quality service becomes a reality, diagnostic laboratories must respond by improving their quality and accountability. There is a need for a monitoring mechanism. Accreditation of laboratories by national and international agencies is one way of ensuring improved laboratory services. While accreditation by these agencies is obligatory for laboratories in the private sector, public sector laboratories are being encouraged to get accredited. International studies and clinical trials mandate participating laboratories to get accredited by international agencies like College of American Pathologists (CAP), American Society of Clinical pathologists (ASCP) and the National Accrediting Board of calibrating Laboratories (NABL).

A systematic approach to check the quality of the laboratory is to follow the workflow through pre-analytic, analytic and post-analytic phase. This will help detect errors in the process. In the pre-analytic phase, quality of sample, time of collection and mode of transport are the factors that affect the quality of test and its outcome. Awareness and understanding of these critical parameters by the technical persons working on the bench is an important step in ensuring quality in the laboratory.

Basic tenets of any test in the analytic phase must follow standard prescribed guidelines. Efficacy of kits must be checked prior to use with standard samples. Testing procedure must follow standard procedures. Results must be interpreted using predefined criteria based on national/international recommendations. An example would be the case of antibiotic susceptibility testing. Interpretative criteria of Clinical Laboratory Standards Institute (CLSI) must be followed. Testing procedures for many organisms have not been standardised or are in the evolutionary stage. It is not advisable to carry out inappropriate methods in these instances. Maintenance of quality control charts and logs and taking immediate corrective actions in case of errors are an integral part of quality control activity in the laboratory. Levy Jennings for ELISA and Shewhart′s plot of zone diameters in the case of antibiotic susceptibility are some of the charts which help detect errors in the laboratory.

Post-analytic phase must emphasise standard documentation and archiving procedures for timely retrieval and dissemination of results. These are some of the key components of the quality of a diagnostic laboratory. Results must reach the treating clinician in the shortest possible time to avoid irrational management.

Automated techniques for identification and determination of resistance phenotype are the latest addition to the diagnostic arsenal. Innovations in media such as chromogenic screening media to detect methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE) and extended-spectrum beta-lactamase (ESBL) have come into the market. It is imperative to maintain strict quality control using standard strains and reagents when using commercially available media and test kits. Expiry date, shelf life and temperature for transport and storage have to be specifically monitored.

In recent years, molecular methods are increasingly being developed not only to detect infectious diseases but also for detection of genes carrying antimicrobial resistance. Innovative molecular methods require quality validation and quality checks in interpretation. Laboratories performing these tests need to validate the accuracy of kits and home-brewed polymerase chain reaction (PCR) before they can be applied to patient samples.

Regular training of personnel to develop new skills and re-emphasise standard testing procedures, quality control and basic concepts of quality assurance are essential parts of quality management of the laboratory. Proficiency testing, inter-laboratory comparisons and participation in external quality assurance (EQA) programmes will ensure good clinical laboratory practice.

A mechanism to monitor a laboratory′s capacity to cope with the changing trends is essential. One way of achieving this would be to establish EQA programmes to cover all types of diagnostic tests including molecular methods, which will be within the reach of every laboratory in the country. A single agency may not have the capacity to offer all the tests. Strengths of individual organisations with their capacity in a particular area may be tapped to establish reference laboratories. At present, there are some laboratories which undertake EQA for specific tests. Laboratory Division of National AIDS Control Organization (NACO) through National AIDS Research Institute (NARI) carries out one such quality assurance program for HIV serology. It runs a very efficient program with mechanism of follow-up and monitoring in a cascading manner involving national and state reference laboratories.

As laboratories move forward to play a major role in patient care and management, there is a need to take a relook at the existing practices and implement quality control and quality assurance as essential components of laboratory management.