In the United States, the Centers for Medicare and Medicaid Services (CMS) regulates all human laboratory testing (except research and Department of Defense laboratories) to determine compliance and improve patient care. The agency’s Clinical Laboratory Improvement Amendments (CLIA) covers about 251,000 laboratory entities. In addition, the Department of Defense laboratories (in military facilities and Veterans Affairs hospitals) accept and adhere to the CLIA requirements.
Passed by Congress passed in 1988, CLIA established quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results.
Through the survey process, the CLIA program is designed to ensure quality laboratory testing. All laboratories issued a CLIA certificate and all CLIA-exempt laboratories must comply with the applicable inspection requirements.
CMS developed its outcome-oriented survey process to determine a laboratory’s regulatory compliance, but also to assist the lab in improving patient care. The universal inspection policy includes an initial inspection and a biennial recertification inspection.
Laboratories issued a registration certificate are required to allow an initial inspection to assess the laboratory’s regulation compliance before issuance of a certificate of compliance. These inspections may occur any time during the laboratory’s hours of operation and may include review of PPM testing. Subsequent inspections may be conducted by CMS or its representatives on a biennial basis or as deemed necessary to ensure compliance.
Compliance history often dictates the occurrence of subsequent inspections. Laboratories demonstrating CLIA compliance (based on type and number of deficiencies cited previously, proficiency testing performance, and number and types of complaints lodged) may be invited to submit a self-survey document. The option to fill out an Alternative Quality Assessment Survey (AQAS) is available every other survey cycle (a two-year period).
The basis for good quality patient care serves as a foundation for performing well on inspections. In other words, laboratories that pay particular attention to doing what needs to be done and documenting accordingly will be handily prepared for an inspection.
“I stress attention to day-to-day requirements, both in performing bench activities and documenting actions taken, to ensure that these activities meet quality expectations,” said William Castellani, MD, FCAP, is a retired clinical pathologist and professor of pathology, Penn State Milton S Hershey Medical Center in Hershey, Penn. He serves on the College of American Pathologists (CAP) Commission on Laboratory Accreditation as Inter-Region Commissioner and is a member of the Council on Accreditation.
Laboratories ought to take care in ensuring standard operating processes (SOPs) match the actual activities/processes in the laboratory, advised Castellani. It’s also important to follow the accepted/required processes with attention to detail, such as implementing new methods in an appropriate order, delegating responsibility effectively and assessing competency as required.
When laboratories take these steps, they are essentially prepared for an on-site inspection at any time. “If you ensure that all processes are in order, then constant preparedness follows naturally,” Castellani shared.
According to Castellani, being prepared also includes having a succession or coverage plan in place so that if one person is not available to do his assigned activities (especially in the quality system), then someone else is available to step in.
“Ideally, a person will step in seamlessly, but at the very least, he should have an awareness of what tasks needs to be covered,” Castellani explained.
Castellani recommends a few basic tenets to make sure all lab employees understand what the inspection entails and are prepared at all times. He believes it’s crucial to engrain the following in employees:
1. Know what your job entails and execute it,
2. Don’t be afraid to ask questions/double-check by looking things up, and
3. Become comfortable with people looking over your shoulder.
According to Castellani, the most important aspects of inspection preparedness are the CLIA mandated bench competency, director sign-off on new procedures and ensuring that SOPs are correct and followed.
Rebecca Mayer Knutsen is on staff with ADVANCE.