Jan 10, 2022Darryl Elzie, PsyD, MHA, MT(ASCP), CQA(ASQ)
Quite often, medical laboratories dread inspections. They are considered anxiety- and stress-inducing events that many laboratories would rather not go through. However, for well-prepared laboratories, inspections can be an opportunity to showcase the quality of their results and a time to exchange ideas.
Accredited laboratories performing high or moderate complexity patient testing are required by federal regulations to undergo inspection at least every two years. There are currently seven approved accreditation organizations (AO) under the Clinical Laboratory Improvement Amendments (CLIA):
Each AO has its own inspection method to ensure laboratories meet regulatory and accrediting standards to provide good patient care. Most of them use trained surveyors with experience in the medical laboratory.
Of the seven organizations, the College of American Pathologists (CAP) uses a peer review method to perform inspections of accredited laboratories. The CAP team of inspectors is typically comprised of laboratorians from similarly sized medical laboratories. When inspecting large laboratories, the team also has a representative from CAP to assist with the assessment. Large CAP inspection teams often have laboratorians from different hospital systems to ensure that experienced inspectors review all disciplines.
All CAP inspectors are required to successfully complete team leader or team member training on the CAP website. The training provides in-depth instruction on how inspections should be conducted and emphasizes a collegial collaboration style. Inspectors are asked to focus on the checklist requirements and trained to be nonconfrontational in their inspection approach. Each inspector is encouraged to engage in open and transparent communication.
Inspectors are directed to read, observe, ask, and discover during the inspection process. Inspectors observe and use their work experience when reviewing checklist items to ensure the laboratory meets the requirements.
After a successful inspection, CAP-accredited laboratories must perform a reciprocal inspection sometime during the off-year of their inspection cycle. Laboratories are asked to inspect another laboratory of similar size. Large independent laboratories or laboratories that are part of a health system will also inspect other large laboratories or perform multiple inspections of similar system laboratories. These types of inspections often require multiple days to a week to complete.
CAP also offers coordinated inspection for laboratories also accredited by the Association for the Advancement of Blood and Biotherapies (AABB) (formerly the American Association of Blood Banks). Often, the inspector will perform the AABB and CAP inspections simultaneously. Combining the inspections for both organizations saves the laboratory and both accrediting bodies time and resources, and reduces stress.
CAP’s peer review inspection process offers many benefits to inspected laboratories and the inspection team members, such as collaboration and exposure to different methods. As the Centers for Medicare & Medicaid Services reports, more than 260,000 medical laboratories perform patient testing, so it is reasonable to expect that many laboratories do things differently.
The exchange of ideas and observation of different practices allows inspectors to use what they have learned to improve their laboratories. Similarly, inspectors may share some of their real-world experience and processes (especially if they involve the same type of work or testing platform), providing the laboratory they are inspecting with valuable insights.
Another benefit of performing CAP inspections that is not often talked about is that being a member of the CAP team allows laboratorians to get out of the lab and interact with their coworkers and industry colleagues in a different environment. Hanging out and socializing with other laboratory professionals can be quite an enjoyable and eye-opening experience.
CAP reimburses inspectors for all costs associated with performing inspections, including transportation, and provides a generous meal allowance. Moreover, laboratory staff morale often increases when employees have the opportunity to travel and perform CAP inspections at other facilities.
Peers understand the challenges of the medical laboratory
While some other laboratory AOs use their own surveyors, CAP has chosen the peer review inspection process. All AOs’ checklists strictly follow CLIA regulations and guidelines to validate the laboratories under their purview, ensuring they deliver high-quality care to their patients in a safe environment. Inspections by CAP also have the benefit of actively facilitating the exchange of ideas and assisting laboratories in keeping pace with the ever-evolving clinical laboratory environment.
Inspections are often a necessary but stress-inducing biennial activity all medical laboratories must undergo. However, laboratories that partake in the CAP peer review process can be assured that they are being inspected by peers who work in the medical laboratory and understand the daily challenges of meeting the needs of health care providers and patients.