What to Expect When you’re Expecting (or not Expecting) a Lab Inspection

Written by on March 2, 2012 in Practice tips - No comments
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By Libby Knollmeyer

Prior to the Clinical Laboratory Improvement Amendments (CLIA) of 1988, only laboratories participating in interstate commerce underwent inspections. The enactment subjected all laboratories to inspection, required all non-waived laboratories to be inspected and gave CLIA the right to appear at any time to inspect a lab.

There are two types of inspections for non-waived labs: routine and non-routine

Routine inspections take place every two years as mandated by CLIA, regardless of which agency is responsible for the examination. If a lab has a Certificate of Compliance, CLIA will be their inspecting agency. If the laboratory has opted for a Certificate of Accreditation from one of the approved accrediting organizations, their inspections will be performed by that agency.

Inspections are set on a two year cycle and the renewal of the laboratory’s certificate is dependent upon successful results. If no deficiencies are cited, the certificate will be renewed after the inspection is completed. If deficiencies are cited during the inspection, the laboratory will receive a deficiency report and a timeline to submit a plan of correction. Once the plan of correction is accepted by the inspecting agency, the certificate will be renewed. Failure to achieve a successful conclusion to the inspection process will result in the cancellation of the lab’s certificate, and therefore loss of privileges to do lab testing and to bill for such services.

The inspection cycle differs slightly for a new laboratory. CLIA or the accrediting agency will do an inspection after the lab has been in operation for three to six months to ensure all regulations are being followed. CLIA and the accrediting agencies do not inspect prior to the lab starting test operations because the lab has not generated data for them to review. It should be noted that states which require state lab licensing in addition to CLIA certification frequently require inspection of the lab before the license number can be assigned and before the lab begins to operate. The CLIA application will not be released to Centers for Medicare and Medicaid Services (CMS) until the state is satisfied that the lab has everything in order. Both state lab licensing and CLIA certification depend on this inspection. Check your state’s requirements to determine if it has regulations for laboratories in addition to those enforced by CLIA.

Non-routine inspections include validation inspections, off-cycle inspections and inspections generated by a complaint against the laboratory. Validation inspections occur when the primary inspection is performed by an accrediting agency, and CLIA opts to inspect the lab again behind the accrediting agency. CLIA has an assigned number of validation inspections to perform each year, but the selection process is random. Being selected for a validation inspection doesn’t necessarily mean CLIA thinks there are any problems; the lab could have been selected for a validation inspection merely because it was convenient in location and scheduling for the CLIA inspector.

Off-cycle inspections occur when there have been problems identified in the lab and the routine inspection led to serious deficiencies. CLIA and the Commission on Office Laboratory Accreditation (COLA) will frequently follow-up a routine inspection that prompted deficiencies with a second inspection to prove that the plan of correction (plan of required improvement if COLA) was actually put into place and effective. Sometimes labs do so poorly on an inspection that they request an off-cycle inspection to get back in good standing and get the Certificate of Accreditation renewed. Regardless of when an off-cycle inspection takes place, the routine inspection will remain on the established every-two-year cycle tied to the expiration date of their certificate.

Any complaint against a laboratory can generate an inspection, and usually does. The agency to which the complaint was sent will normally do the inspection. The extent of the inspection will depend on the severity of the complaint, but the inspector has the right to look into any part of the laboratory on a complaint-generated inspection.

Waived labs do not generally undergo inspections by CLIA, but are subject to be inspected at any time if there is a complaint generated, or if they are selected as one of the small percentage of waived labs that CLIA inspects routinely. There has been discussion of including waived labs in the routine inspection cycle, but to date that has not occurred. CLIA and COLA follow the same policies regarding waived labs; the College of American Pathologists (CAP) does not recognize the waived test category and treats all tests with the same regulations as for moderate or highly complex laboratories. The Joint Commission (TJC) operates almost exclusively in the hospital arena where waived labs are nonexistent; it is unlikely that any physician office laboratory (POL) would opt for TJC accreditation so inspection of waived labs is a non-issue for TJC.

Should I bring in a consultant to prepare for an inspection?

The answer to that question depends on the training and experience of the staff running the laboratory, but in general, getting a consultant’s opinion and input on the lab’s preparedness for an inspection is a good idea. The time to benefit most from a consultant’s input, however, is early on in the setup of the laboratory. If the lab is set up in compliance with all lab regulations, the staff is educated adequately about those requirements and if good processes for maintaining regulatory compliance are established from the beginning, then passing an inspection becomes just another day’s work.

Want more information about inspections? Libby Knollmeyer has a wonderful checklist called “I’m Your CLIA Inspector – What am I Going to Look for?” that she will be glad to share with Med Monthly readers who email her with a request (eknollmeyer@triad.rr.com)

Elizabeth “Libby” Knollmeyer, B.S., MT (ASCP)
has over 40 years experience in the laboratory industry. She specializes in financial, operational management and compliance issues for hospital and physician office laboratories. Libby has a wide variety of experience with her areas of special expertise including financial review and management, compliance and regulatory assistance and lab design. She can be reached at eknollmeyer@triad.rr.com.

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