Because of changes in the regulatory environment, increased globalization, and heightened emphasis on education and communication, laboratory accreditation that is recognized worldwide is one of the keys to providing the highest level of quality patient care. Accreditation affirms the competency of the laboratory to perform certain processes and tasks consistently.

How does a laboratory qualify for accreditation? In the United States, an accredited laboratory is one that is inspected by a private nonprofit accrediting organization that has been approved by the Centers for Medicare and Medicaid Services (CMS), and the laboratory’s performance and procedures are considered as equivalent to or more stringent than CMS's regulatory requirements. Accreditation organizations approved by CMS include AABB, American Osteopathic Association (AOA), American Society for Histocompatibility and Immunogenetics (ASHI), College of American Pathologists (CAP), COLA, and the Joint Commission.

The ultimate goal of accreditation is to continuously improve the quality of laboratory performance and to maximize patient safety. Accreditation includes peer review and inspection, education, and compliance with standards.

CAP Accreditation Program Improves Patient Safety

CAP is one of several agencies named above that performs inspections and accredits laboratories. Founded in 1947, CAP began the Laboratory Accreditation Program in 1962. Now, the CAP Laboratory Accreditation Program inspects and accredits more than 6,000 hospital, reference, and clinical laboratories throughout the world.

When asked about the importance of CAP accreditation, Stephen Sarewitz, MD, Department of Pathology, Valley Medical Center, and Chair of the Checklists Committee of the CAP Commission on Laboratory Accreditation, says, “At the most basic level, the reason why the program was developed was to ensure the highest possible quality for patient care and patient safety in accredited laboratories, to help laboratories apply state-of-the-art best practices, and to allow for comparable testing among laboratories.” He adds, “Accreditation also ensures that the laboratories meet or exceed regulatory requirements.” 

The CAP program involves on-site inspection every two years. In the non-on-site inspection year, the laboratories conduct self-inspections. In the United States, CAP on-site inspections are unannounced. R. Neill Carey, PhD, FACB, Clinical Chemist, in a CAP-accredited laboratory at Peninsula Regional Medical Center, comments, “You need to perform quality testing all the time. The days of announced inspections are over.”

Dr. Sarewitz notes, “Another integral part of the CAP program is proficiency testing. Blind samples are sent from the CAP Accreditation Program and the laboratories must return their results, which are compared with other participating laboratories.”

Laboratories choosing to voluntarily comply with the CAP Accreditation Program are reviewed by volunteer inspectors acting as peer reviewers. “Inspection teams are mostly comprised of practicing laboratorians—pathologists, clinical scientists, medical technologists—who are assigned to inspect other laboratories. The reason both parties participate is for mutual benefit—to exchange ideas and to learn best practices,” explains Dr. Sarewitz.

The laboratories are inspected against a series of requirements—termed checklists—to determine if they meet accreditation requirements. Dr. Sarewitz says, “The checklists come primarily from the CAP resource committees that are groups of experts in each field who develop the list of what laboratories should be doing for quality testing. There are other inputs from other groups as well, including participating laboratory staff, members and staff of the Commission on Laboratory Accreditation, as well as state regulatory agencies and the inspectors themselves.” The inspectors and the laboratories to be inspected receive the checklist of questions in advance of the inspection and can access updated checklists on the CAP website.

CLSI Documents Support the Accreditation Process

CLSI’s standards and guidelines support clinical laboratory professionals seeking to meet accreditation requirements. At Peninsula Regional Medical Center, “CLSI documents are used in the background as a method of ensuring quality. When we get ready for inspections, we go through the checklists and mark down areas where different documents can be found that support what is being asked for in the question,” says Dr. Carey.

Numerous CLSI consensus documents are referenced in the CAP Laboratory Accreditation Program Inspection Checklists. Dr. Carey explains, “In each checklist, there are notes for inspectors and laboratories. These notes challenge both the laboratory and the inspector to go beyond the question to figure out what to do to meet the requirements. CLSI documents are often referenced in the notes.”

“When you bring a new method into the laboratory, you validate it by using the methods in the CLSI documents. Then, you know you have followed step-by-step procedures based on consensus expert opinion,” comments Dr. Carey.
 
For example, says Dr. Carey, “We use CLSI document User Verification of Performance for Precision and Trueness (EP15), which has an experiment for verifying the precision and trueness of an assay, and has a protocol for seeing how well the assay recovers the value of a reference material.”

CLSI documents are used in various areas of the laboratory. A. Beth Prouse, MS, MT(ASCP), Clinical Microbiologist, Peninsula Regional Medical Center, says, “Two CLSI documents, Performance Standards for Antimicrobial Susceptibility Testing (M100) and Quality Control for Commercially Prepared Microbiological Culture Media (M22), stand out as particularly useful in helping to fulfill accreditation requirements in the Microbiology area.”

She explains, “M100 gives us the suggested grouping of antibiotics that we report out for bacteria classes. It has guidelines on how to do weekly and daily testing for antibiotics quality control (QC), QC organisms for AST, ranges for QC, and interpretations for patient results. In addition, M100 provides recommendations for screening and confirming new resistance mechanisms that may present themselves.”

She adds, “M22 is also a very important document when preparing for inspection. It provides guidelines on what media are exempt and nonexempt.” Prouse notes, “CLSI has risen above other organizations in providing best practices for susceptibility testing.”

Pursuit of Continuous Quality in the Laboratory

Programs have been established and implemented by regulatory agencies and certifying bodies so that laboratories can create a culture of patient safety and continuously improve the quality of laboratory practice. CLSI’s mission is to support these same goals through the development of voluntary consensus standards and guidelines that focus on the significant issues faced by laboratorians. By using an independent, consensus-driven process that balances the viewpoints of industry, government, and the healthcare professions, the resulting documents are invaluable tools to help organizations meet requirements with efficiency and effectiveness. Dr. Sarewitz concludes, “The idea behind accreditation is that laboratories will follow state-of-the-art best practices. We view CLSI documents as codifications of those best practices. CLSI documents are considered references—gold standards for laboratories in many areas.”

The CLSI website provides an index of the CLSI documents referenced in CAP checklists that can be explored at a glance. These documents can be used as educational and reference tools for the laboratories as well as the inspectors.
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