ISO 15189 Accreditation Program Offered by CAP

ISO 15189 Accreditation remains voluntary for laboratories here in the United States

CEO SUMMARY: Two strong trends in laboratory management can be seen in the College of American Pathologists’ (CAP) move to offer accreditation to ISO 15189:2007. The first trend is the movement toward quality management systems such as Lean and Six Sigma. The second trend is the global convergence of laboratory operations. Also, a growing number of countries are basing laboratory accreditation on ISO 15189, which is another reason why CAP is adding this new service.

BY ANNOUNCING A SUPPLEMENTARY NEW LABORATORY ACCREDITATION PROGRAM that incorporates the ISO 15189 quality management system for medical laboratories, the College of American Pathologists (CAP) is helping to move ISO 15189 closer to becoming a global standard in accreditation.

Scheduled to be available to U.S. medical labs in the fourth quarter of this year, CAP’s program accredits laboratories that conform to ISO 15189:2007 from the International Organization of Standardization (ISO). ISO 15189:2007 uses medical lab-specific accreditation criteria, procedures, and processes to evaluate a lab’s technical competence and its management system.

The accreditation to ISO 15189:2007 will be separate and distinct from the CAP Laboratory Accreditation Program (LAP) and will be done in addition to CLIA accreditation. It does not replace LAP. A laboratory that chooses to become accredited to ISO 15189:2007 will have an ISO assessment by professional assessors separate from LAP inspection.

ISO will account for quality management systems throughout the laboratory and other parts of an organization that interact with the laboratory. Any clinical lab can apply for this new accreditation.

“Laboratories accredited to the ISO 15189:2007 standard will be well positioned to rapidly respond to the changing health care environment and to demonstrate measurable quality to their customers,” said pathologist Cordelia Sever, M.D., FCAP, Chair of the CAP ISO Program and Accreditation Committee. “Currently ISO 15189:2007 is a complement to what CAP offers. It is not in lieu of any CAP program and it is voluntary. The CAP LAP is a prescriptive, CLIA- based standard, whereas ISO is an international standard that is not based on CLIA (the Clinical Laboratory Improvement Act).

“ISO 15189:2007 is an internationally recognized standard, and in some countries, it is the standard by which laboratories are reimbursed,” Sever added. “Although it is not currently a standard in the United States, we believe that a laboratory working to achieve best practices in quality management systems will want to be ISO 15189:2007 accredited.

“Since CAP already accredits labs in more than 40 countries, this ISO-based program supports developments internationally,” Sever continued. “We recognized the importance of having an ISO-based laboratory accreditation option as we expand into Canada and into other nations. Medical laboratory accreditation is a core competency at CAP.

“CAP has extensive experience with ISO 15189,” Sever noted. “Back in 2003, when the ISO 15189 standards were developed, CAP was a significant contributor. This new ISO 15189 accreditation program was developed to help reinforce ISO’s goals and standards while supporting CAP’s mission of advocating excellence in the practice of pathology and laboratory medicine.

Key Differences

“Here are the key differences between ISO 15189:2007 accreditation and LAP accreditation,” Sever added. “Accreditation to ISO 15189:2007 is strictly voluntary in the United States. In contrast to LAP’s annual cycle, the ISO accreditation follows a three-year timeline. The time it will take to attain initial accreditation to ISO depends largely on a lab’s readiness, internal resources, and the laboratory’s level of commitment. In the first and second years of this program, two surveillance assessments are scheduled. During the third year, a reaccreditation assessment takes place onsite.”

THE DARK REPORT observes that CAP is getting involved with ISO 15189:2007 accreditation at the right time. As the lab industry becomes more global in nature, a steady convergence in the organizational structure of laboratories can be seen. ISO 15189:2007 is one factor that supports this ongoing international convergence in clinical laboratory operations.

ISO 15189 Incorporates Quality Systems for Labs

ISO 15189:2007 IS AN ACCREDITATION PROGRAM AND QUALITY MANAGEMENT SYSTEM for medical laboratories that focuses on the continuum of care directly connected with improved patient safety and risk reduction.

The ISO system outlines standards for quality and competence specific to medical laboratories. It is a road map to help clinical labs develop their quality management systems and assess their own competence. It provides guidance regarding the structure of a lab’s quality management system. It integrates both preventive measures and improvement opportunities with a focus on patients. There is no tie to the federal Centers for Medicare & Medicaid Services (CMS) for reimbursement.

Any laboratory conducting medical testing such as private medical centers, hospitals, and commercial reference labs should consider applying for the accreditation program to help achieve accreditation to ISO 15189:2007.

ISO 15189:2007 uses criteria and procedures specifically developed to determine technical competence. Assessors will conduct a thorough evaluation of all factors in a laboratory that affect the production of test or calibration data. ISO 15189:2007 uses standards (best practices or benchmarks) to assess factors, including:

  • Customer satisfaction and quality of care
  • Quality management system
  • Validity and appropriateness of test methods
  • Traceability of measurements and calibration to national standards
  • External services and suppliers
  • Technical competence of staff
  • Testing environment
  • Suitability, calibration, and maintenance of test equipment
  • Sampling, handling, and transportation of test items



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