An Introduction to Laboratory Regulations – Part III (Accreditation)

So far we have reviewed the different federal regulatory agencies responsible for establishing laboratory testing guidelines, a brief overview of the different roles each department plays, as well as a discussion on testing complexity. In today’s post we’ll cover the optional accreditations available to labs, and how accreditation differs from certification.

In the simplest of terms, certification is a mandatory requirement, whereas accreditation is optional. Certification is required in order for laboratories to receive payments from Medicare or Medicaid. Laboratories must meet the minimum requirements set forth by CLIA to earn and maintain their certification status.

Accreditation is an extra additional step that laboratories can take to set themselves apart from neighboring labs by holding themselves to a higher standard. Accredited laboratories must still adhere to the minimum CLIA requirements, but there are additional rules and requirements to be satisfied depending upon the different accreditation agencies.

More rules and paperwork, why would anyone volunteer to take that on? Depending on the size, complexity, and client population that your lab serves, the benefits to obtaining accreditation can greatly outweigh the challenges of maintaining that accreditation status.

One of the requirements to maintaining your CLIA certification is routine inspections to confirm compliance with the rules. Accreditation agencies require inspections as well, but thankfully in most cases your CLIA inspection can be satisfied by your accrediting agency; meaning your lab will receive a single inspection to satisfy both groups. Results will vary for each lab, but generally speaking the accreditation inspections are perceived to be easier to get through than those conducted by the federal inspectors. For example, agencies like The CAP and COLA tend to be more focused on sharing of ideas and good laboratory practices, rather than coming in as the “lab police” and looking only for problems. The explanation of their regulatory requirements tends to be more user friendly and easier to interpret as well, rather than the formal CLIA laws which are legal documents and read as such.

Recognition by an accrediting agency confirms that the laboratory is qualified and competent to perform testing for which it has received the accreditation for. This stamp of approval can help patients and clients feel comfortable in choosing your laboratory for their testing needs. For laboratories that perform testing as part of clinical trial evaluations, this can help reduce the number of requested on-site audits by the client themselves, as the client may choose to rely on the third-party accreditation assessment due to their high standards. It may also help encourage new clients to choose you for their testing needs, as the accreditation confirms your commitment to higher quality standards.

Another possible benefit of having accreditation status is the impact on your laboratory staff. Continually striving to raise the bar on your standards and going above the bare minimum instills a sense of professionalism in your employees. By continually reviewing the regulations and preparing for or responding to inspections, staff are more likely to be committed to complying with your organization’s quality management system and standards of performance. Staff who are familiar with the requirements and the reasoning behind why a certain task is performed or documented, are more likely to comply with those policies and procedures.

There are currently 7 CLIA approved accreditation agencies: https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/AOList.pdf. Some agencies are focused on a specific discipline, such as AABB for transfusion medicine, and others are more encompassing for all of the laboratory departments.  Organizations looking to become accredited should research each option in order to determine which ones would be best to meet their specific needs. It is also common for labs to maintain more than one accreditation at a time, for example AABB and CAP. As always, the regulatory agency with the most stringent rules would be the ones the lab is expected to adhere to. In cases of joint accreditation, multiple inspectors may be needed to complete the biennial inspection; however the agencies will try to coordinate efforts and work together so that the inspections occur simultaneously. Sticking with our AABB & CAP example, CAP will work with AABB to locate an AABB approved inspector for the transfusion medicine checklist, while the remainder of the CAP inspection will be carried out by CAP inspectors. The AABB inspector would then inspect the transfusion medicine department for compliance with both CAP and AABB requirements at the same time.

The accreditation process may be challenging, but once you have obtained that esteemed status, the opportunities for continual education and improvement of your laboratory will be endless.


-Kyle Nevins, MS, MLS(ASCP)CM is one of ASCP’s 2018 Top 5 in the 40 Under Forty recognition program. She has worked in the medical laboratory profession for over 18 years. In her current position, she transitions between performing laboratory audits across the entire Northwell Health System on Long Island, NY, consulting for at-risk laboratories outside of Northwell Health, bringing laboratories up to regulatory standards, and acting as supervisor and mentor in labs with management gaps.

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