Starting a new laboratory can be confusing. It’s more complicated than just filling out a few forms and mailing them in. CLIA requires every laboratory to have a “Laboratory Director”, or person-in-charge of all aspects of the lab. The “Laboratory Director” is more than just someone who signs forms. The Laboratory Director is responsible for hiring competent and qualified people to perform the testing, approving the tests to be performed, approving policies and procedures, and ensuring tests are performed correctly and results are accurate and reliable. In short, the Laboratory Director is responsible for everything that happens in the lab. In addition, CLIA has specific requirements for who can be a Laboratory Director. Laboratory Director Qualification requirements differ depending on what type of CLIA certificate for which a lab applies, and not all physicians qualify to be a Laboratory Director.
Once a qualified Laboratory Director is chosen, the lab must determine what tests are to be performed (which will determine what type of CLIA certificate the laboratory needs); choose appropriate instruments for the tests selected and the layout of the lab space; create policies and procedures; hire qualified personnel to perform the testing; submit all the forms required by the State to open a laboratory; and if the lab seeks a “Certificate of Compliance” or a “Certificate of Accreditation,” pass an initial inspection.
Once a laboratory has submitted all the required paperwork to obtain a CLIA certificate, several different things may happen, depending on the type of certificate the Laboratory Director seeks. A lab requesting a “Certificate of Waiver” or “Certificate of Provider Performed Microscopy Procedures” (PPMP) will receive their certificate the mail. If a lab wishes to be accredited, they will receive a temporary CLIA certificate or “Certificate of Registration” in the mail. The “Certificate of Registration” will be effective until the accrediting body inspects the laboratory, after which, the lab receives a “Certificate of Accreditation.”
A laboratory requesting a “Certificate of Compliance” will also first receive a “Certificate of Registration”, in the mail. An initial CLIA inspection, performed by a representative from the State in which the laboratory is located, will typically take place between three and six months of the “effective date” listed on the CLIA Certificate of Registration. If the laboratory has not met all of the CLIA regulations, the inspector will issue one or more “citations” (sometimes called “deficiencies”) on an official report, called a CMS-2567, or “Statement of Deficiencies.” Each citation on the report must be addressed and corrected by the laboratory within a certain timeframe. CLIA will not issue a Certificate of Compliance unless the laboratory has corrected all deficiencies cited. Once the lab has met all CLIA regulations, a new CLIA “Certificate of Compliance” will be received in the mail. It’s important to note the “effective date” on the new CLIA certificate is the same “effective date” that was on the Certificate of Registration.
Sound confusing? It definitely can be! That’s why ProLab Consulting, LLC offers services for the start-up laboratory. With our Initial Laboratory Set-Up Assistance, we will prepare and submit all the forms needed to obtain a CLIA certificate; evaluate the Laboratory Director, and other personnel qualifications; create policies and procedures required by CLIA; assist with instrument validation; and provide support and education for the laboratory seeking a Certificate of Accreditation. Additionally, we provide assistance with your initial CLIA inspection and prepare the “Plan of Correction,” if needed.
If you are seeking a Certificate of Waiver or Certificate of PPMP, ProLab Consulting, offers Certificate of Waiver Set-Up Assistance (PPMP certificates are treated by CLIA in the same manner as waiver certificates). Visit our Services page for information on Certificate of Waiver services offered by ProLab Consulting, LLC or CLICK HERE to contact us.