|Year : 2013 | Volume
| Issue : 3 | Page : 217-218
Accreditation of Microbiology Laboratories: A Perspective
Department of Microbiology, All India Institute of Medical Sciences, New Delhi - 110 029, India
|Date of Submission||20-Jul-2013|
|Date of Acceptance||19-Jul-2013|
|Date of Web Publication||25-Jul-2013|
Department of Microbiology, All India Institute of Medical Sciences, New Delhi - 110 029
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Kapil A. Accreditation of Microbiology Laboratories: A Perspective. Indian J Med Microbiol 2013;31:217-8
In the present times the requirement and dependence on Microbiology tests has increased in the clinical practice especially for the specific diagnosis of infectious diseases. On one hand, managing the emerging and re-emerging infections continue to pose a challenge in the community; the hospital-acquired infections are also on the rise due to the ever increasing numbers of compromised host, a price paid by the advances in diagnostics and therapeutics in medical practice. Expectation by the global community is to provide quality diagnostic services so as to generate a globally comparable data for surveillance purposes. The other dimension added is the public awareness, which has increased, and evidence-based treatment is considered as patient's right.
In this perspective, the responsibilities of the Microbiology laboratories have increased and Medical Microbiologists are expected to provide quality services for patient management as well as surveillance of infections and monitoring of antimicrobial resistance. A step in the direction is the accreditation of the laboratories, which will ensure the reliability and acceptability of the results and help in increasing the confidence of the users and employees, as this involves a third party audit.
'Accreditation is an approved procedure by which regulatory authorities or authorised body accord formal recognition to a laboratory to undertake specific task, provided that the pre-defined standards are met by'.  It involves re-assessment and surveillance at regular intervals so as to ensure that commitment to quality is a continuous process.
In many countries it is mandatory. As of now in India, more private laboratories are volunteering for accreditation, mainly to meet commercial requirements. The move by National AIDS Control Organization HIV testing National Reference Laboratories and State Reference Laboratories to be accredited has brought in the concept to government organisations and also has familiarised them with the requirements of the accreditation process. Some other government bodies have made accreditation mandatory for laboratory services. There is no doubt that extra expenditure to strengthen infrastructure is required to begin with, but in long term the quality pays. The organisation providing accreditation to the laboratories in India is the National Board Accreditation for Testing and Calibration Laboratories (NABL), Department of Science and Technology. The process of accreditation takes into account all the parameters as per ISO 15189,  which is an International Standard. The teaching and training of a Medical Microbiologist in India does not introduce them to these concepts and it is time that one get familiar with the process. Therefore all medical microbiologists should undergo an orientation training to understand the ISO standard.
As a concept, the standard has management and technical requirements. The management requirements include commitment to the policy and procedures to ensure quality services as defined in the standard. As the saying goes 'what is not documented is not done', so the process involves a lot of documentation of almost all activities, which get scrutinised during the process of audit in order to look for any non-conformity to the policy and procedures laid down in the quality systems.
The Technical parameters of the standard include requirements of manpower and their competence, equipment, environment, material and use of standard laboratory methods.
The manpower has to be qualified and competent. Regular in-house training of technical staff and participation in continuing medical education (CME) programmes for the medical microbiologists and laboratory is a requirement. The staff should be familiar with the standard and participate in undertaking activities related to the quality system.
Accommodation must be sufficient to avoid any unsafe procedures or incompatible activities being done together. The placement of equipment and working benches should be such that clearing possible areas of hand washing and surfaces of floors and walls should be possible to clean. The combustible items should be placed safely. Microbiologist should be aware of Biosafety recommendations and waste handling rules in India.
The equipment has to be under preventive maintenance, the measuring equipment should be calibrated at regular intervals by an accredited laboratory. All the materials and reagents have to be procured through a system, which ensures purchase of quality reagents.
All these processes revolve around a key component of quality results in the laboratory. The continuous monitoring involves use of standard operating procedures (SOPs) and periodic evaluation of these procedures so as to update them with changing technology and knowledge. Daily internal quality control should be in place besides also addressing the pre-examination and the post-examination procedures, turnaround time of reports and release of reports by authorised personals. The SOPs and work instructions should be available to all staff but in a manner that they cannot be changed or modified by any unauthorised person (document control). Wherever national guidelines are available, for example HIV testing strategies, waste management and handing rules, RNTCP guidelines, etc., they have to be followed.
The important requirement of the accredited laboratories is the regular conduct of internal audit in which all components of the laboratory are audited by a trained internal auditor and the non-conformities or NCs (i.e. not following the standard or deviation from protocols or errors in reports) are presented to the management so as to have their commitment for a corrective action on time. Internal audit should be done honestly and religiously avoiding any conflict of interest. The aim is to identify any non-conformity at an early stage. Immediate step is to correct what is wrong and undertake the root cause analysis, take preventive action so as to ensure that there will be no recurrence. That is actually the crux of the accreditation process ensuring commitment to ongoing adherence to quality systems and continual improvement.
At the end of the day the performance of a laboratory is judged by reliability of its test reports. We know that in Microbiology, the pre-examination procedures like collection, transport and time of collection of samples, history of antibiotics, presence of a device, etc., are important variables, which determine the uncertainty of results affecting the test results and their interpretation. Unlike biochemistry or haematological parameters, these are not quantifiable. This is a challenge to monitor these and correct them by regular interaction and education of the clinicians and nurses. Here management has a role to play in bringing the doctors to follow proper collection and transport methods.
Participating in external quality assurance schemes (EQAS) is mandatory as per the standard. In India IAMM conducts this program with a scope for culture, gram stain antimicrobial susceptibility and selected serological tests. We need to move forward in this direction with increase in the scope of tests. It is required that even the proficiency testing provides should be accredited and effort is being made in the direction by IAMM. In some tests where EQAS is not formally available, Inter Laboratory Comparison (ILC) should be done with other accredited laboratories. The number of laboratories that should participate in ILC is still unresolved as in every city in India we may not yet have a large number of accredited laboratories to get a statistically significant comparison. Though feasible in serum/blood samples, stored micro-organisms or slides, there are specimen where culture is required immediately on receiving, for example quantitative bacterial culture or ethically two cultures cannot be taken such as blood or CSF culture and therefore where further transport for ILC is not possible, split test within the laboratory using two different technicians can be done. Though these alternatives are not ideal and have limitations, but at present it is the best alternative.
Accreditation of Microbiology laboratories will be a great step to gain international recognition. Not only it gives confidence to the treating physician regarding the reliability of the report to diagnose an individual patient, but it will also build evidence to manage patients empirically by generating reliable epidemiological data. For the surveillance of infections and monitoring antimicrobial resistance for national and international networking let us hope that the Indian Medical Microbiologists take the laboratory services to internationally recognised standards in the coming times, despite all constraints.
*The author is a member of the technical committee of NABL, DST, Government of India and the opinion expressed in the editorial are her personal views on the subject.
| ~ References|| |
|1.||Kumara S, Bhatia R. Guideline for Peripheral and Intermediate in Quality Assurance in Bacteriology and Immunology. WHO Regional Publication, South-East Asia Series No. 28, WHO SEARO; 2003. p. 74- 80. |
|2.||International Organization Standards. ISO 15189:2007 (E). |