Quality Management in Medical Laboratories for Accreditation


Austin J Pathol Lab Med. 2017; 4(1): 1019.

Quality Management in Medical Laboratories for Accreditation

Rayat CS*

Department of Histopathology, Postgraduate Institute of Medical Education & Research, India

*Corresponding author: Charan Singh Rayat, Department of Histopathology, Postgraduate Institute of Medical Education & Research, Chandigarh-160012, India

Received: March 20, 2017; Accepted: March 27, 2017; Published: April 03, 2017


Quality assurance in medical laboratories requires a great deal of compliance of an International Standard or a National Standard for quality and competence. A medical laboratory or clinical laboratory is a laboratory for the examination of materials derived from the human body for a purpose of providing necessary information for diagnosis, prevention and treatment of disease as well as for follow up evaluation of health of a patient during the treatment of an ailment. The investigations could be biological, hematological, immunohematological, biochemical, microbiological, immunological, biophysical, cytological, histological, immunopathological, molecular or genetic. Modern medicine warrants the thorough investigations of biological material derived from the body of a patient to ascertain the cause and effect of disease before the commencement of medical or surgical treatment. Various laboratory investigations and interpretations of results provide advisory service to the consultant physician and/or surgeon. The ‘International Organization for Standardization’ (ISO) is an ‘International Authority’ for setting up standard guidelines for various organizations and laboratories. The International Organization for Standardization is based in Geneva, Switzerland and 163 countries are its members. The ISO collaborates closely with the ‘International Electrotechnical Commission (IEC) on all matters of ‘Electrotechnical Standardization’. The ISO 15189 was compiled by Technical Committee ISO/TC-212, for ‘Clinical laboratory testing and in vitro diagnostic test systems’. The International Standard for Medical Laboratories was first published in the year 2005 based on ISO 15189:2003 (1st Edition) and later revised as ISO 15189:2007 (2nd Edition). Further revision was done in the year 2010 and the current version ISO 15189:2012 (3rd Edition) [1] provides standard guidelines for ‘Requirements for Quality and Competence in Medical Laboratories’. The ISO 15189:2012 is based upon ISO/IEC 17025:2005 [2] and ISO 9001.

The main goal of ISO 15189:2012 is the ‘Global Harmonization of Medical Laboratories’ in terms of quality of their services. A medical laboratory’s fulfilment of the requirements of standard (both the technical competence requirements as well as quality management system requirements) means that the laboratory could be accredited for consistency in technically valid results. Bodies of National Standards of various countries have been adapting ISO 15189:2012 for regulating requirements of quality and competence in medical laboratories. The quality policy in medical laboratories has been adapted from ISO 9000:2005 [3]. The ISO 9000 family of standards describes the fundamentals of quality management systems and specifies the terminology for quality management systems. The ISO 9001 specifies requirements for a quality management system where an organization needs to exhibit its ability to provide products or services that fulfill customer as well as applicable regulatory requirements [4]. The organization would also aim to enhance customer satisfaction. The term quality has its inherent characteristics like poor, good or excellent quality. The fulfillment of requirements of ISO Standard would assure the excellent quality.

The ‘College of American Pathologists’ (CAP) is an ‘Accreditation Authority’ approved by the ‘Centres for Medicare and Medicaid Services’ (CMS) in the United States of America (USA) [5]. CAP- 15189SM is a voluntary non-regulatory accreditation to the ‘ISO 15189:2012 Standard’ as published by ISO. The CAP 15189SM does not replace CAP’s ‘Clinical Laboratory Improvement Amendments’ (CLIA) based ‘Laboratory Accreditation Program’, but complements CAP accreditation as well as other quality systems. The accreditation program optimizes the processes to improve patient care, strengthens quality standards while reducing institutional errors and risks as well as controls cost of investigations. The CAP-15189SM is also an educational program that offers a highly disciplined approach to implementing and sustaining quality assurance parameters. The laboratories certified under the standard module also work towards continual improvement, recognize their problems and seek intelligent solutions, thereby enhancing patient care as well as customer and staff satisfaction.

Let us have a look at the scope and fundamentals of ISO 15189:2012. Scope: This International Standard can be used by the medical/clinical laboratories in developing their quality assurance systems as well as assessing their own competence. It can also be used for conformity assessment or recognizing the competence of medical laboratories by regulating authorities, laboratory customers and accreditation bodies. Terms and definitions: The procedure by which an authority gives formal recognition that an organization or medical/ clinical laboratory is competent to carry out specific tasks is termed as ‘accreditation’. The scheduled time frame/interval about examination results for an alert test indicating risk to the patient of injury or death is termed as ‘alert interval/critical interval’. The process by which patient’s examination results are sent to ‘Laboratory Information System’ (LIS) and compared with laboratory defined reference values automatically and included in the patient report formats is termed as ‘automated selection and reporting of results’. The specified interval of the distribution of values taken from a biological reference population is termed as ‘biological reference interval’ [6]. The demonstrated ability to apply knowledge and expertise/skill for assuring quality is called ‘competence’. The documented, implemented and maintained way to carry out a specific activity or process has been termed as ‘documented procedure’. The measure/extent of degree to which a set of inherent characteristics fulfils the desired requirements is termed as ‘quality indicator’.

The management system poised to direct and control an organization in terms of quality has been termed as ‘Quality management system’. The roots of quality management system are ‘quality policy’ and ‘quality objectives’. Overall intensions and direction of a laboratory management in relation to quality is termed as ‘quality policy’ and something aimed or sought to be delivered with quality has been termed as ‘quality objective’.

Sections 4 and 5 of the ISO 15189:2012 deliberate on the ‘Management Requirements’ and ‘Technical Requirements’ respectively. Management Requirements are: i) Organization and management responsibility, ii) Quality management system, iii) Document control, iv) Service agreement, v) Examination of referral laboratories, vi) External services and supplies, vii) Advisory services, viii) Resolution of Complaints, ix) Identification and control of nonconformities, x) Corrective action, xi) Preventive action, xii) Continual improvement, xiii) Control of records, xiv) Evaluation and audit, and xv) Management reviews. Technical Requirements are: i) Personnel, ii) Accommodation and environmental conditions, iii) Laboratory equipment, reagents and consumables, iv) Preexamination process, v) Examination process, vi) Ensuring quality of examination results, vii) Post examination process, viii) Reporting results, ix) Release of reports, and x) Laboratory information system. The scope of implementation of ISO 15189:2012 has been illustrated in (Figure 1).