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Certification, accreditation, and federal approvals are a vital part of the business of running a clinical diagnostic lab. Many laboratory managers assume it means miles of red tape and numerous roadblocks. But that’s not necessarily true. In fact, it can be a fantastic opportunity. If you approach it with the right mindset, you could make improvements that have a lasting impact on your lab’s productivity and profitability.
Certification and accreditation are programs that ensure your lab meets or exceeds industry standards for clinical laboratory testing. Accreditation may focus on specific tests or methodologies where the regulations have additional complexities, but both are based on federal and regulatory requirements. Approval at the federal level is often seen as the largest hurdle from a regulatory perspective.
The Clinical Laboratory Improvement Amendments (CLIA) program, managed by the Centers for Medicare and Medicaid Services (CMS), originated from a set of federal regulatory standards from 1988. Laboratory systems, assays, and examinations are graded based on seven criteria:
Any clinical lab testing performed on people in the United States, with exceptions for clinical trials and basic research, has to be CLIA-certified.
Similarly, many labs seek to be formally accredited by a body such as the College of American Pathologists (CAP). This accreditation program offers more guidance, interaction, and instruction, as well as fosters continuous improvement. And, while CAP rules are based on the CLIA regulations, they’re even stricter.
Both CLIA certification and CAP accreditation focus on traceability, from the requirements gathering phase through to testing. They also emphasize the “how” of processing rather than the “design”. Historically, they have lacked requirements for software processes, but that’s starting to change. For labs, that means a modern, scalable, easy-to-use software solution that takes advantage of automation is becoming an increasingly important component of the certification or accreditation process.
Certification and accreditation aren’t the only roadblocks that labs must navigate around. They also need to obtain U.S. Food and Drug Administration (FDA) approvals, such as FDA 21 CFR 11.
To realize these FDA approvals, labs must document software systems thoroughly—all components, services, and integrations have to be defendable in case of an audit. Labs must be able to show that requirements are linked to software design and architecture, as well as linked to defined tests, which clearly exercise requirement functionality. Additionally, both production path and edge-case testing have to be performed. For every executed test, you must provide evidence that the test was conducted, the result was as expected, and processing matches the design of the system.
FDA submissions should be assessed internally at multiple levels. Generally, the lab director/manager, regulatory personnel, and key lab staff are all involved in the review of prepared materials. Submission documents go through a rigorous process of approvals and tracking to ensure changes are limited to those required and are documented clearly. Any discrepancies in test execution (including typos) have to be recorded independently from the test execution, with the differences explained and approved by key stakeholders.
The level of traceability and documentation of software systems required to ensure submissions to the FDA are correct is much higher than what we see in place at many labs. Often labs depend on their own processes for traceability in addition to (or in lieu of) depending on a laboratory information management system (LIMS) or laboratory information system (LIS). However, even when a LIMS or LIS system is in place and used for traceability purposes, labs may be hesitant to rely solely on this system. In fact, we frequently see that standard operating procedures and software processes are not aligned.
In order to be successful in preparing an FDA submission, or achieving certification or accreditation, your lab’s software and laboratory systems must be in harmony. Any divergence between processing and functionality presents possible audit challenges by accreditation bodies, which can lead to extended time frames, greater cost, and missed opportunities in the market.
In my next post, we’ll look at how you can make your laboratory certification, accreditation, or federal approvals process easier.
