Regulatory bodies exist to ensure both the safety of the personnel working in the laboratory, as well as the quality of the work being done on behalf of the patient. There are a number of different regulatory bodies that can have jurisdiction over your lab including JCO, CAP, CLIA, OSHA, and the FDA.
JCO: JCO is an acronym for the Joint Commission. The Joint Commission offers accreditation and certification to healthcare entities. Accreditation is earned by the organization as a whole, which would include hospitals, doctor’s offices, nursing homes, etc. Certification on the other hand, is earned by a specific service within the organization, like just the laboratory service, as opposed to the entire hospital system.
Whether being accredited or certified, the group in question is subject to an evaluation to make sure the group meets their standards and also demonstrates improvement activities. They look for patient care, safety, and quality and will evaluate processes and technology. If they meet the standards, they get a gold seal of approval that they can use to demonstrate they are an accredited healthcare organization. Once an accreditation or certification is earned, the group is subject to continued on-site surveys to maintain accreditation, which occur 18-24 months apart.
CAP: CAP is one that pretty much everyone is familiar with; the College of American Pathologists. CAP accredits various types of laboratories, not just anatomic pathology, so the checklists you receive are customized to the testing that your laboratory performs. The evaluation for CAP accreditation is done by peers, so the evaluators are other laboratorians from similar type laboratories. CAP ensures you are meeting regulatory standards, but also encourages sharing of best practices and improved education, which is accomplished by the peer to peer evaluation model. There is an online training for peer evaluators offered by CAP, which you can also take as someone who is going to be evaluated by CAP as a way to prepare for CAP inspection.
CAP has a 7 step cycle for accreditation:
1. Applies and completes application
2. Receives custom checklists and prepares for inspection
3. CAP assigns inspector
4. Inspection conducted
5. Corrects cited deficiencies and demonstrates compliance
6. Meets requirements and is accredited for two years
7. Performs a self-inspection at year two
CLIA: CLIA is another one that most everyone is familiar with; CLIA refers to the Clinical Laboratory Improvement Amendments, so CLIA is not an organization, it is standards set by CMS (The Centers for Medicare & Medicaid Services) that govern laboratory testing. CLIA certification is important because if you want to get reimbursed by Medicare and Medicaid, you need to be properly certified. When you apply for CLIA certification, your forms actually go to the state agency from your state, not the federal government, so there are varying fee schedules, etc from state to state.
OSHA: OSHA stands for the Occupational Safety and Health Administration. They are a division of the Department of Labor and they are responsible for making sure that your workplace is safe. They are concerned with things like chemical, biological, physical and safety hazards. OSHA is responsible for the safety of all workplaces, so obviously it can’t come in and inspect everyone so priority is given to cases where an inspection is deemed necessary, for example if there is a complaint, imminent danger, a severe injury or illness, or a referral. There is generally no notice given for OSHA inspections, they will just show up, or even conduct a phone investigation.
FDA: The FDA is the Food and Drug Administration, which is not necessarily an organization that you think of as having jurisdiction over a histology lab, however the FDA is involved with testing classification. There are three testing classifications for the histology lab specified by the FDA, IVD (in vitro diagnostic), ASR (analyte specific reagents), and RUO (research use only).
So how do all of these regulatory agencies interact and overlap with each other? Do you need to be accredited by all of them? The answer to that is no. CMS granted CAP deeming authority which means that CAP inspection can stand in lieu of a CMS inspection. It is also recognized by JCO and some state requirements. You can find more in depth information about the interaction or “crosswalks” between agencies in the NSH on demand webinar, Navigating the Regulatory Environment, presented by Traci DeGeer.