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The International Organization for Standardization (ISO) and Laboratory Accreditation Program (LAP): A Review

Article-The International Organization for Standardization (ISO) and Laboratory Accreditation Program (LAP): A Review

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Accreditation is the official process of recognising an establishment as having the status and the qualifications to perform a particular activity. It gives you an independent assurance that your business is capable of delivering outstanding patient care. It also ensures that your standards for quality are maintained and will continue to improve regardless of changes in personnel. 

Some laboratories consider accreditation as an expensive burden that requires time and resources, whereas others see the lack of accreditation as an example of poor quality of standards and an inability to produce accurate results. With accreditation, laboratories are more likely to work through a quality management system and produce better quality of work. They have a higher chance of performing better on proficiency tests and appealing to highly qualified employees. Moreover, their patients become well-informed customers of medicine and public reporting of quality indicators. After taking into consideration cost and determining the right accreditation for your laboratory, accreditation can become tremendously valuable because of its long-term benefits. 

There are currently several laboratory accrediting agencies, the most notable of which include:

1) ISO: 15189: Medical laboratories - Requirements for Quality and Competence
2) CAP: Laboratory Accreditation Program (LAP)
3) AABB: AABB Accreditation Program: Blood Banks and Transfusion Services
4) JCI: Joint Commission International Accreditation Standards for Laboratories

ISO: International Organization for Standardization
The International Organization for Standardization (ISO) is an independent, non-governmental organisation headquartered in Geneva, Switzerland. In 1926, it began as the International Federation of the National Standardizing Associations (ISA) and continued onwards until October 1946, when ISA and UNSCC (United Nations Standards Coordinating Committee) delegates from 25 countries met in London and agreed to join forces to create the new International Organization for Standardization (ISO). It officially began its operations in February, 1947. Since then, the ISO has produced over 21,000 International Standards, ranging from industrial and commercial standards to standards of Information Technologies (IT), graphical symbols, conformity assessment, metrology, manufactures, and consumers. It has become one of the largest developers of voluntary international standards in the world and by far, its most popular standards are the ISO 9000 Quality Management, ISO 14001 Environmental Management Systems Standard and ISO/IEC 27001 Information Security Management.
At one point in time, every country in Europe had its own accreditation system. Medical laboratories were becoming more sophisticated and this brought about the need to create a new quality standard for medical laboratories. In 1994, the ISO TC212 met in Philadelphia with 33 countries to start this process. It took seven years to develop the ISO 15189: Medical laboratories - Requirements for Quality and Competence.
Standard is based on two well known ISO Standards:  ISO/IEC 17025 (General Requirements for the Competence of Testing and Calibration Laboratories) and ISO 9001(Quality Management System Requirements). Once a laboratory is accredited, it follows a three-year re-accreditation cycle; in the first and second years of the programme, two surveillance assessments are scheduled and during the third year, a re-accreditation onsite assessment takes place.

LAP: Laboratory Accreditation Program
In the majority of countries, especially the U.S., laboratories are accredited by the College of American Pathologists (CAP). The CAP offers the Laboratory Accreditation Program (LAP), which has been around for over 50 years.  The LAP is a voluntary peer review process in which an on-site inspection is performed by practicing laboratory technicians. These volunteers use checklists appropriate for various laboratory disciplines and each laboratory has a minimum of three checklists:  a general checklist (for the whole lab), an ALL common checklist (one per section), and a section-specific checklist (can be one or more depending on the section’s scope of tests). A CAP Accreditation cycle spans two years and accredited laboratories are required to perform self-inspection 12 months after their initial accreditation.
Before choosing an accreditation, the laboratory needs to decide which one appeals to their particular blend of tests and technologists by taking into consideration their scope of service, workload, staffing, facility and most importantly, financial ability. u
Gap analysis is an important tool to use when aiming to obtain a different accreditation. It works by determining the differences and similarities between all types of laboratory accreditations. For example, CAP and ISO-15189 are two different accreditations. If you are CAP accredited and want to go for ISO accreditation, or vice versa, you would find it useful to know that these accreditations both have quality management,  personnel requirements, and identical analytical processing schemes; pre examination, examination, and post-examination. In addition, these accreditations also share laboratory information management, resolution of complaints, non-conformities, reporting of results, laboratory equipment, reagents, and consumables. On the other hand, we can also discover differences and deficits between both of these accreditations when analysing them. However, we will not be going into these details as they are beyond the scope of this article.   

The College of American Pathologist: ISO-15189 Accreditation Program
In 2008, CAP launched its CAP-ISO 15189 Accreditation Program. This programme is based on the ISO 15189:2007. To be eligible for this accreditation, the laboratory must be CAP accredited first. The laboratory fills out the application form and sends it to the CAP, alongside the requested documentation. 

Criteria and Requirements
Our laboratory has been CAP-accredited for the last several years. When management sought to attain ISO-15189, we observed the following differences: 

Management Review: As per ISO-15189, each laboratory is required to review its quality management system at least once a year. The review should have input data of your QMS (internal and external assessments, audits, risk management, KPIs, complaints monitoring and the resolution of, suppliers and vendors’ evaluation, and changes in scope of service).  The purpose behind the review of data is to identify causes of nonconformities, observe trends and patterns that indicate process problems, and to establish the actions required for the upcoming year following the outcome of the review. 

Uncertainty of Measurements: Medical pathology laboratories are required to determine or estimate the measurement of uncertainty for all quantitative results; as per ISO-15189. Studies have shown that all laboratory activities may be subject to variation and that these variations can occur during all the phases of diagnostic procedures (pre-analytical; analytical and post analytical processes). All these variations can be sources of uncertainty of measurement. Effect of these sources are combined and used to calculate an estimate of the uncertainty of a result. There are several ways to calculate uncertainty. One method includes the total imprecision of a quantitative method as reflected by routine QC (IQC data). When using this method, it is important to collect data over a long period of time to encompass as many routine changes as possible (maintenance, calibration, lot change, etc.).

Quality Manager (QM): QM is a member of staff who is responsible for quality management and reports directly to the laboratory leader on a regular basis (at least twice a month and more often if necessary). According to WHO, a quality manager monitors the laboratory QMS and ensures that policies are implemented on a continuous basis, and monitors all IQC procedures, ensuring that the laboratory participates in appropriate EQA schemes and that corrective action is taken on the results, as appropriate.

Service Agreements: SLA occurs on managerial level; staff and supervisors are usually not involved. However, supervisors can request modifications for SLA if they see that it is negatively impacting their section. Laboratories are required to have records of regular reviews of agreements and all changes to an agreement shall be documented and communicated to all affected parties.

Traceability: Traceability refers to tracing your results to a stated reference, usually national or international, through an unbroken chain. SI units of measurements are the most common recommended measuring scales.

Auditors Training: Audits shall be conducted by personnel trained to assess the performance of managerial and technical processes of the quality management system. This may entail additional costs for certain laboratories.

POCT (Point of Care Testing): POCT is not part of ISO-15189 but it is similar in structure to ISO-15189 standards. Its accreditation is ISO 22870. It has both Management Requirements (which is less detailed in comparison to 15189) and Technical Requirements (which lacks 5.9 and 5.10: Release of Results and Laboratory Information Management).

Safety: Safety is very limited in ISO-15189. It is mentioned in only one section: 5.2: Accommodation and Environmental Conditions. It has a separate accreditation-ISO 15190: Requirements for Safety in a Medical Laboratory-which was published in 2003. 
Whether you go for CAP, ISO, AABB, JCI, or any other accreditation, remember that inspection is an open-book exam, which requires beforehand preparation. Get staff involved, make sure the leaders are committed to the process, inspect yourself and, if possible, have another laboratory do your mock inspection.  

References available on request.

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