Accreditation Of Medical Laboratories

Medical laboratories seek recognition as being compliant with particular standards for a number of reasons. In some countries, accreditation is mandatory and in others it may be voluntary, but in any case it recognizes competence, facilitates exchanges of services, provides a valuable management tool, and ensures that the needs and requirements of all users are met. Moreover, it may be a precondition for a contract and an essential tool for reassuring laboratory professionals who aim to practice in accordance with accepted norms.[1] Table 1 shows the main benefits of accreditation for the medical laboratory, for the health-care system, and for patients.

The term ''accreditation,'' as applied to organizations rather than to specialty clinical training, reflects the origins of systematic assessment of hospitals against explicit standards and began in the United States in 1917.[2] According to the ISO/IEC Guide 2 definition, accreditation is ''a procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks.''[3] The distinction between certification and accreditation represented, in the past, a source of debate and concern. Certification activity is based upon standards such as ISO 9001:2000 which delineate the ''requirements for quality-management systems'' and are applicable to any activity. Accreditation systems are based on standards that, in addition to ''requirements for quality systems,'' take care of ''technical requirements'' that relate to achieving competence in all aspects of the specific activity, laboratory medicine in our case. Until the recent publication of the ISO 15189:2003 International Standard ''Medical laboratories—Particular requirements for quality and competence,'' there were no sector-specific ISO standards for quality management and technical competence in medical laboratories.1-4-1 This is the reason why medical laboratories, in the past, had a choice between two separate and distinct lines for achieving recognition. The first line focuses on ''requirements for quality-management systems'' that are, by definition, applicable to any organization, and, generally, it is represented by the ISO 9000:2000 series.[5] The second line, with its origin in assessing the technical competence of a laboratory, is represented by ISO 17025:1999, a generic standard used in the accreditation of testing or calibration laboratory1-6-1 (Fig. 1). Alternatively, other programs for laboratory accreditation are delivered by organization such as Clinical Pathology Accreditation (CPA-UK)[7] or College of Clinical Pathology (CAP) in the United States based on professional standards that basically aim to evaluate and improve technical competence. The availability of an International Standard specifically developed for medical laboratories should overpass any possible dispute and it should harmonize the laboratory approach to quality assessment and improvement. In fact, ISO 15189:2003 recognizes the importance of quality-management systems, as described in ISO 9000:2000, as well as technical requirements contained in ISO/IEC 17025:1999, but, in addition, it contains specific requirements for an organization, such as medical laboratories that, in addition to analytical competence, have to assure consultative and interpretative activities. The relationship between ISO 15189:2003, ISO/IEC 17025:1999, and ISO 9001:2000 is similar to that of a set of three ''Russian dolls'' (Fig. 2):

Table 1 Benefits of accreditation a) Benefits for the laboratory

- Improving quality of the work

- Perfect documentation of the workflow

- Total quality management

- Education and increasing professional competence

- Focus on patients' outcomes

- Encouragement to develop interdepartmental cooperation b) Benefits for the health-care system

- Improved quality of the system

- Perfect documentation

- Results comparability

- Personnel and equipment specifications

- Improved efficacy of laboratory services

- Competition based on quality among different laboratories c) Benefits for the patient

- Improving quality of the system

- Results comparability

- Transparency in information on laboratory quality

- Improved safety and trust

- Value for money the inner doll being ISO 9001, the middle doll being ISO/ IEC 17025, and the outer, ''all embracing doll,'' being ISO 15189.[8]

Getting Started With Dumbbells

Getting Started With Dumbbells

The use of dumbbells gives you a much more comprehensive strengthening effect because the workout engages your stabilizer muscles, in addition to the muscle you may be pin-pointing. Without all of the belts and artificial stabilizers of a machine, you also engage your core muscles, which are your body's natural stabilizers.

Get My Free Ebook

Post a comment