A medical laboratory is a laboratory where tests are done on clinical specimens in order to get information about the health of a patient, with diagnosis and treatment as its primary objective. In 1980, an automated instrument was introduced to run clinical tests in medical laboratory. Quality was one of the main concerns in producing reliable result. During that period of time, only non-standardized quality control was available as many countries had their own accreditation processes. Thereafter, most of the medical laboratories were selected under ISO/IEC 17025 as a guideline for accreditation, as this is the only standard for competence and calibration laboratories. However, this standard did not prove to be effective as different medical laboratories have different settings as compared to the normal calibrating or testing laboratories.
ISO 15189 was introduced in 2003 and became the new quality standard specifically for medical laboratories. This new standard was developed by International Organization for Standardization (ISO) based on ISO/IEC 17025 (general requirements for the competence of testing and calibration laboratories) and ISO 9001(quality management systems requirements). This is a unique document that takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to patient care. ISO 15189 is maintained by the Technical Committee ISO/TC 212 who responsible for clinical laboratory testing and in vitro diagnostic test systems (Cohen and Ramphal, 2014). They had revised and produced revised editions in 2007 and 2012. The content of the ISO 15189 standard itself comprises five elements, namely scope, normative references, terms and definitions, management requirements and technical requirements. Like many other ISO standards, the implementation requires demonstrated management commitment, elaborate and controlled documentation, regular audits and reviews in order to ensure that the management system is effective and efficient in performing its basic function.
What is meant by accredited laboratory?
‘Accreditation’’ is defined as officially recognized or authorized of the performance quality by Accreditation Organization. An accredited laboratory is a laboratory which meets both the technical competence and the management system requirements essential in delivering technically valid results consistently. In other words, an accredited laboratory is competent and has quality in the work performed by qualified and trained personnel in accordance with the approved and documented protocols or procedures.
Who is the Accreditation Organisation in Malaysia?
In Malaysia, the Department of Standard Malaysia under the Ministry of Science, Technology and Innovation (MOSTI) is one of the main accreditation bodies. It is established on 28 August 1996 and plays an important role in standardisation and accreditation in Malaysia. All duties and functions are governed by the Standards of Malaysia Act 1996 (Act 549) under the National Laboratory Accreditation Scheme of Malaysia (SAMM).
The Accreditation Process
The accreditation process can be divided into 6 major steps as elaborated below.
- Preparation and self-examination:
The medical laboratory seeking accreditation status prepares materials that effectively display the accomplishments according to the standards set by the accreditation organization. They must also create a written report of its accomplishments.
- Processing of Application (Administrative)
Application will be checked for basic requirements and for completeness. Application will be acknowledged and an invoice will be sent requesting the applicant for payment of appropriate application fee. The applicant will be asked to respond on the acceptability of members of the assessment team.
A SAMM accreditation staff or an appointed lead assessor will be assigned to perform on-site documentation review of the applicant’s quality manual and associated documents assessing the adequacy of applicant’s documented management system against accreditation criteria MS ISO 15189 and SAMM requirements. If the review report indicates that the applicant has adequately addressed all system elements of SAMM criteria and requirements, the Lead Assessor will arrange for the conduct of an on-site pre-assessment.
This assessment is divided into preliminary assessment and the compliance assessment. The aim of the assessment is to establish whether a medical laboratory can competently perform those calibrations / tests according to accreditation standard. An assessment takes the form of detailed discussion between the laboratory staff and the assessors, together with an inspection of the premises, record system, internal quality control programmes, the equipment (including an examination of any calibration information) and internal audit records. . The assessors normally witness the performance of some routine calibration / testing. Laboratory will also be checked and assessed on their performance in any related proficiency testing programme available in the country or overseas by qualified SAMM assessors and other technical assessors who have been selected on the basis of their technical expertise and experience.
- Visit and Examination:
This is a formal compliance assessment of the applicant laboratory which carried out by appointed assessors from Standards Malaysia assessment team. The applicant and Standards Malaysia must confirm the scope of testing and must resolve all outstanding issues and problems before compliance assessment could be proceeded. The purpose of the formal on-site compliance assessment is to verify the laboratory’s technical competence and the effectiveness and maturity of the management system implemented. For these reasons, the management, technical and administrative staffs shall be interviewed and test / calibration records and overall record system, files, training records, validation or test performance data, proficiency testing records, investigation and resolution record and other related documentation will be examined by the assessment team.
- Judgment action made by accreditation organization:
The accreditation organization will call upon a meeting to review the steps and affirm or deny accreditation status for the medical laboratory.
- Continuous review
By accepting accreditation status, a medical laboratory agrees to undergo a review on a rotating basis every few years. A medical laboratory is usually required to go through all the steps of the accreditation process each time it is reviewed. The purpose of the continuous review is to ensure that the accredited medical laboratory continues to maintain the required management and technical accreditation standards.
The Benefits to the society
Accreditation is a very comprehensive process which covers management, staffs, customers, physical labs, technical quality and improvements actvities.
To the public, accreditation reduces the risk for businesses and their customers by assuring them that the accredited laboratories are competent to carry out the work they undertake. Customers need not worry about the laboratory results or reports as accredited medical laboratories is recognized worldwide and are competent to provide reliable and accurate test results. False positives and negatives, which can directly affect compliance with regulations, are minimized.
To the government or regulators, accredited medical laboratory can assure eligibility in data used to establish baselines for key analyses and decisions. This will reduce uncertainties associated with decisions which affect the protection of human health and the environment. At the same time, it increases public confidence and eliminates redundant reviews while improving the efficiency of the assessment process which in turn may reduce costs.
To the laboratory staffs, they will be more aware and confident in their work as competency and proficiency assessment is mandatory. All staffs who work under the accredited laboratory must be a qualified and trained worker. A comprehensive orientation and induction program is necessary to serve as an introduction for new laboratory staff. Besides, staffs will enjoy working in a conducive work environment which ensures personal safety, comfort and hygiene as required in accreditation.
To the management, there will be a clearly defined organizational structure including clear assignment of responsibilities and authorities. With a good management practice, a systematic work flow and a good monitoring system, costs associated with laboratory problems, including re-testing, re-sampling, and lost time can be minimized. Besides, the government offers tax incentives in the form of tax deductions for the costs such as Assessment Fee, Annual Fee and other Fee imposed by Standards Malaysia. The tax deduction is applicable for all programs operated by Standards Malaysia under its various accreditation schemes.
To achieve accreditation status, a revision of existing or development of a new system is required. Various documents and systems including the laboratory quality manual, quality policies, standard operating procedure manual, staff competency assessment, complaint/incidence reporting systems, quality indicator internal audits documents and records of quality control systems need to be revised and documented. Regular internal audits and reviews must be carried out to ensure that the management system is effective and efficient in performing its basic function. The establishment may take some time and commitment from staff and management is definitely required to accomplish its accreditation status. Staff limitation may be a challenge as laboratory support to customers must continue at the same time. Therefore, support and commitment from laboratory management plays an important role in this issue, especially in workforce distribution.
Establishing the various standard quality requirements may be expensive and labor-intensive. For example, signing up the External Quality Assurance Program is one of the important criteria in Quality Management System to ensure the quality of tests. This program must be enrolled annually and involves cost. Besides, training is also needed, especially in developing new quality system or process. This would require an experience or trained personnel to provide the training or assist in establishing the new system. In addition, by adoption of new standard or system, it may require some major alterations in the daily laboratory operations, which were not initially welcomed by staffs. However, regular training with emphasis on post-accreditation benefits and persistence will lead to better and further understanding and cooperation. Management’s commitment plays important role in overcoming this challenge.
Besides, the laboratory work environment has to meet the safety requirements in the standard. This will be a big challenge to old medical laboratories which have obsolesced designs. Thus, major renovations will be necessary and financial budgets will be a limitation for expansion or renovation.
After a medical laboratory is being awarded with accreditation, the process of quality improvement does not end there. Accredited medical laboratory will be subjected to surveillance reassessments to ensure continuing compliance with SAMM accreditation criteria and requirements. Any quality system which does not fulfil the criteria and requirements will result in the suspension of accreditation status. A key component of sustaining a good laboratory management is through continuous promotion of quality improvement.
Cohen, S. and Ramphal, R.R. (2014). The need for a quality standard for assurance in medical research laboratories. African Journal of Hospitality, Tourism and Leisure, 3(1), 1-10 from http//:www.ajhtl.com
Laboratory accreditation scheme of Malaysia (2013). An introduction of SAMM to calibration and testing laboratories. Issue 3. Retrievedfrom http://www.jsm.gov.my/documents/
Department of Standards Malaysia. http://www.jsm.gov.my/