|Year : 2014 | Volume
| Issue : 1 | Page : 1-3
Accreditation of medical laboratories: A perspective
Rebachandra Singh Heigrujam, Ng Brajachand Singh
Department of Microbiology, Regional Institute of Medical Sciences, Imphal, Manipur, India
|Date of Web Publication||24-Jun-2014|
Rebachandra Singh Heigrujam
Department of Microbiology, Regional Institute of Medical Sciences, Imphal, Manipur
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Heigrujam RS, Singh NB. Accreditation of medical laboratories: A perspective. J Med Soc 2014;28:1-3
∗The authors are NABL assessors
The number of laboratory tests in relation to disease has increased manifold in the recent times. To meet the demand, there is an increase in the number of laboratories in the public sector as well as private sector. However, the results generated by the tests often intrigue the patient, patient party and the treating physician as well. This necessitates laboratory accreditation and is the need of the hour for the medical laboratories.
Accreditation is the procedure by which an accreditation body gives formal recognition that a body (laboratory) or person (signatory authority) is competent to carry out specific tasks (scope).  This procedure imparts official credit, authorization and registration of a laboratory that it has demonstrated its capability, competence and capability to carry out its specified scope.  It involves assessment, re-assessment and surveillance at regular intervals so as to ensure that commitment to quality is a continuous process.  Further, accreditation reinforces and reassures quality by creating an opportunity to look back upon the pitfalls which eventually creeps into the system as soon as we take our eyes off it. 
At the global level, International Organization for Standardization (ISO), a worldwide federation with more than 162 member countries publishes its guidelines as international standards.  The International Laboratory Accreditation Cooperation (ILAC) and International Accreditation Forum (IAF) deal specifically with laboratories.  The ILAC delegates the tasks to regional bodies like Asia Pacific Laboratory Accreditation Cooperation (APLAC) through ISO standards. A memorandum of understanding (MOU) is signed between the accreditation bodies to make these guidelines globally acceptable and is in mutual recognition agreement (MRA) with International Accreditation Bodies (ILAC and IAF) and ISO. In India, National Accreditation Board for Testing and Calibration Laboratories (NABL) is the MRA partner and a full member of APLAC (hence ILAC) [Figure 1]. It is a registered autonomous body under the aegis of Department of Sciences and Technology, Government of India and is the sole authorized laboratory accreditation body in India. It provides third party assessment of quality and technical competence.
|Figure 1: International, regional and national accreditation bodies and their interlinking via MRA MOU. SADCA: South African development co-operation for accreditation; IAAC: Inter American accreditation co-operation; EA: European co-operation for accreditation; MOU: Memorandum of understanding; MRA: Mutual recognition agreement|
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Though in many countries accreditation is mandatory for laboratories, it is in the infancy stage in India though many private laboratories are volunteering for accreditation mainly to meet commercial requirements. A big step towards the concept of accreditation was taken by Department of AIDS Control (DAC) (Formerly National AIDS Control Organisation) (NACO) during its attempt to accreditate HIV testing National Reference Laboratories (NRLs) and State Reference Laboratories (SRLs) thereby familiarizing the requirements and procedures of accreditation. For HIV testing network up-gradation and management, DAC provides fund for quality assurance and quality control through the State AIDS Control Societies (SACS) and positioned staff at various levels. There is one Apex Laboratory at National AIDS Research Institute (NARI), 12 NRLs and 118 SRLs. The SRLs are linked to ICTCS.  About 491 medical laboratories are accredited by NABL as on date (1/5/2014). 
To get accredited, a laboratory has to fulfill all the parameters mentioned in the ISO 15189, which is an international standard. Initially, a person should be trained on Laboratory Quality Management System (Lab. QMS) and Internal Audit program as per ISO 15189 standard (latest version) at an authorized training center.  All laboratory personnel should be trained as per ISO 15189 (NABL 112)  and the documents should be written in accordance to their guidelines. Several guidelines are available in the NABL website < www.nabl-india.org > free viz. NABL 153  (application form for medical laboratories), NABL 100  (general information brochure) 160  (guide for preparing quality manual), NABL 161  (guide for internal audits and management review), and NABL 131  (terms and conditions for maintaining NABL accreditation). All the above documents will give an insight to the whole process of NABL accreditation. ISO 15189:2012  depicts management and technical requirement through 4.1-4.15 and 5.1-5.10 clauses and sub clauses respectively in great detail. The management requirement includes 4.1 organization and management responsibility, 4.2 quality management system, 4.3 document control, 4.4 service agreements, 4.5 examination by referral laboratories, 4.6 external services and supplies, 4.7 advisory service, 4.8 resolution of complaints, 4.9 identification and control of nonconformities, 4.10 corrective action, 4.11 preventive action, 4.12 continual improvement, 4.13 control of records, 4.14 evaluation and audits and 4.15 management review as the main headings. Technical requirement incorporate 5.1 personnel, 5.2 accommodation and environmental conditions, 5.3 laboratory equipments, reagents and consumables, 5.4 pre-examination processes, 5.5 examination processes, 5.6 ensuring quality of examination results, 5.7 post-examination processes, 5.8 reporting of the results, 5.9 release of results, and 5.10 laboratory information management.
The concept of management requirement focus on the commitment to the policy and procedures to ensure quality services as defined in the standard. All the activities should be documented so that non conformities cannot be raised during the accreditation process.  The process involves a lot of documentation. In fact, any and every activity performed should be recorded and properly filed as not recorded will amount to activity not done.
In the pyramid of laboratory documentation [Figure 2], the hierarchy of documents should include test forms/formats, consent form, worksheet, registers, test reports/records, feedback/complaints, etc., at the base followed by standard operating procedures prepared as per guidelines of standard. Quality system procedures to deal with the special situation like indeterminate results, corrective action and preventive action, etc., scope and organization chart should be available. However, the most important step toward the process of accreditation is to prepare a quality manual. It is the most vital document and has to be sent to the NABL when applying for accreditation.
|Figure 2: Hierarchy of documentations in Laboratory Quality Management System required for accreditation|
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Laboratory personnel should be trained, qualified and competent to carry out the specified task. Continuing medical education program is a requirement for the personnel to update their knowledge and changing technology and be familiar with the standards for understanding activities related to the quality system.
Laboratory space allocated and design should ensure that laboratory work is not hampered and that laboratory personnel, patients and visitors are not harmed during the laboratory procedure including bio-safety recommendations and waste disposal.
Laboratory equipments should be calibrated at regular intervals and under preventive maintenance. Quality reagents and consumable should be procured and used.The laboratory should have a good inventory management system to do the same.
The performance and reliability of a laboratory is judged by the test report. To ensure quality in testing would require pre-examination procedures such as collection, transport, history of taking antibiotics, time of collection, presence of device, etc. which determine the uncertainty of result affecting the test results and their interpretation. Therefore, the management should emphasize the importance of proper collection of specimen to doctors. Before a laboratory applies for NABL accreditation, it is mandatory for the laboratory to participate in external quality assurance scheme (EQAS) as per standard guidelines. For Microbiology, NABL recognizes EQAS program run by various institutes like L and T Microbiology Research Centre, Sankara Nethralaya, Chennai and Indian Association of Medical Microbiologist. Where EQAS is not available interlaboratory comparison (ILC) should be done with accredited laboratories. However, special situations may arise when ILC is not feasible, for example cerebrospinal fluid sample in which further transport is not possible, split test within the laboratory using two different technicians may be the best alternative though not ideal. ,
Though under ideal condition, one must first set up a laboratory, establish a Lab. QMS, start processing, perform an internal audit, improve the system as per ISO 15189 or NABL 112 guidelines, apply for EQAS and once having satisfactory results apply for NABL accreditation, it may be a difficult task. Therefore, applying for accreditation and developing the laboratory alongside provide another option as improvement become mandatory as the date of inspection nears. 
Besides getting international recognition and acceptance, the accreditation process will be able to give confidence to both the testing laboratory and referring physician regarding the reliability of the test report to diagnose an individual patient and also manage patient empirically by generating reliable epidemiological data. 
However, the teaching and training of laboratory medical specialists in India does not introduce them to these concepts, and it is high time that one gets acquainted with the process. Therefore, all laboratory medical specialists should undergo orientation training to understand ISO standard and bring about quality in the system.
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[Figure 1], [Figure 2]
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