William Castellani, MD, FCAP, is professor, Division of Clinical Pathology, at Penn State Hershey, Milton S. Hershey Medical Center
What has been the CAP’s role in developing ISO 15189?
The CAP has been involved since 1995, when work on the standard began. The CAP sponsored a liaison to both the
ISO technical committee that produced it, TC-212 (Clinical laboratory testing and in vitro diagnostic test systems), and Working Group 1 (Quality management in the clinical laboratory).
Thomas L. Gavan was in Working Group 1 from the beginning.
I replaced him in 2002.
We currently have two members of the CAP 15189 committee serving on Working Group 1 of TC-212 – myself and Chris Lehman. John Eckfeldt, a former member of the CAP 15189 committee, also serves on TC-212.
You’re a busy person. Why did you choose to participate in TC 212?
I have been involved with the CAP’s Commission on Laboratory Accreditation since 1992, and I felt that there was considerable value in an international standard that provided a common framework for laboratory quality and competence. Also, I knew that the document had the potential to establish standards in the US, and I wanted to monitor that.
What do you see ISO 15189 providing for laboratories that goes beyond earlier standards such as CLIA/CAP Laboratory Accreditation Program, and the CLSI guidance documents on quality?
ISO 15189 provides an organized standard for a quality system that insures ongoing activities directed at patient care.
CLIA was focused on details and technical procedures. CLSI took a significant role, both in the development of guidelines and by serving as the secretarial support for TC-212, in helping to give practical foundation to the ISO 15189 standard. The standard itself provides the framework for a process approach to laboratory quality and competence, serving as the accreditation standard that allows a laboratory to identify what it does well and what it can improve upon in its service to the patient.
Why is the CAP a good administrator for this program?
Because we helped develop the ISO 15189 standard, the CAP understands the intent of the requirements and how the pieces of the standard fit together. We understand the efforts that are involved in implementing a quality system that meets the standard.
The CAP has 50 years of experience in knowing what lab accreditation means for patient care.
What is the role of the CAP15189 Committee?
The committee provides guidance to the accreditation process. It ensures that the assessments that CAP 15189 staff perform are valid, complete, and consistent with requirements of the CAP and good patient care.
CAP15189 Committee Roster
What do you see as the role for the CAP 15189 quality management education modules?
The quality management modules play three roles.
First, to provide basic information to potential laboratories who are interested in the program. The modules help laboratories understand the work involved, but also help laboratories see how much they’ve already done in the area of quality management that is relevant to the standard.
Second, to provide a common understanding among laboratories that participate in the program. The modules show examples of what a working program looks like in terms of its process mapping, internal audits, management reviews, document control system, quality manual, and root cause analysis work.
Third, to provide a resource for participants of other accreditation programs in the US to help foster improvements in their quality systems. Even if a laboratory is working within a CLIA framework, or a CAP Laboratory Accreditation Program framework, the modules will give them ideas for specific things they can do to improve their quality system.
Request contact or more information