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Guest Lab Consultant Libby Knollmeyer: What to Expect When You’re Expecting (or Not Expecting) a Lab Inspection

Prior to CLIA ’88 (Clinical Laboratory Improvement Amendments of 1988) only laboratories participating in interstate commerce underwent inspections. Since the enactment of CLIA ’88, all laboratories are subject to inspection, and all non-waived laboratories are inspected. CLIA has the right to appear at any point in 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 inspection. If a lab has a Certificate of Compliance, CLIA will be the inspecting agency. If the laboratory has opted for a Certificate of Accreditation from one of the approved accrediting agencies, that agency will perform the inspection. Either way, the inspections are set on a two year cycle and the renewal of the laboratory’s certificate is dependent upon successful completion of the inspection. If no deficiencies are cited, the certificate will be renewed very soon after the inspection is completed. If deficiencies are cited during the inspection, the laboratory will receive a deficiency report and will be given 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 lab testing.

The inspection cycle differs slightly for a newly set-up laboratory. CLIA or the accrediting agency will come in to do an inspection after the lab has been in operation for 3 – 6 months to ensure everything required is in place and all regulations are being followed. CLIA and the accrediting agencies do not inspect prior to the lab starting testing operations because they want the lab to generate data for them to review upon their inspection.

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 has begun operating. The CLIA application will not be released to CMS until the state is satisfied that the lab has everything in order, so both state lab licensing and CLIA certification will be dependent on this inspection. Check with your state to determine if it has regulations for laboratories in addition to CLIA regulations.

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 for the most part. So being selected for a validation inspection doesn’t necessarily mean CLIA thinks there are any problems. A 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 COLA (Commission on Office Laboratory Accreditation) will frequently follow-up a routine inspection that generated deficiencies with a second inspection to satisfy the inspector 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 usually 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; CAP (College of American Pathologists) 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, if 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 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 MMP readers who email her with a request (eknollmeyer@triad.rr.com).


Guest Author Libby Knollmeyer

Consultant Elizabeth “Libby” Knollmeyer, B.S., MT (ASCP) has over 40 years experience in the laboratory industry and has set up many laboratories! She specializes in financial, operational management and compliance issues for both hospital and physician office laboratories. Libby has a wide variety of experience with her areas of special expertise including financial review and management, Quality Management protocols, outreach development, compliance and regulatory assistance, lab design and up fitting, lab remodeling, and market research for IVD manufacturers. She works independently and with large consulting groups to provide interim management for hospitals, and serves as adviser to lab equipment and supply distributors. She consults (and enjoys traveling) throughout the US and internationally. She can be reached at (336) 288-5823 or at eknollmeyer@triad.rr.com.

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Laboratory Consultant Libby Knollmeyer: What is the Difference Between CLIA and COLA?

CLIA (Clinical Laboratory Improvement Amendments of ’88) is the basic set of regulations governing all laboratories that test human specimens (with rare exceptions). It is the minimum standard for labs.
CLIA has given “deemed status” to several other agencies allowing them to accredit labs and inspect the labs in CLIA’s stead. COLA is one of these agencies (as are CAP and The Joint Commission). All accrediting agencies must be at least as strict as CLIA, or to phrase it a different way, all accrediting agencies must have the same regulations as CLIA does, and then may add additional regulations on top of the CLIA regulations if they wish.

There is little difference between CLIA and COLA from a regulatory viewpoint. COLA enforces a few more requirements than CLIA does, but the differences are relatively minor. One example is that COLA requires correlation studies be done when a new instrument is installed to compare the new instrument to an old instrument or a reference lab method and CLIA does not. Another is that CLIA requires an overlap of old control lot numbers to new control lot numbers but doesn’t specify a number of times they must be run together; COLA requires overlapping old and new 5 times. So there are differences, but it is pretty easy to see that the differences in regulations are not extreme. CLIA publishes their Interpretive Guidelines on the Internet for all to read so you have ready access to the information as to how a regulation is going to be applied; COLA does not and will not share their Interpretive Guidelines (they consider it proprietary information), so understanding how a questionable regulation will be applied is left to a guess or a phone call to COLA headquarters in Maryland.

From a personnel standpoint, there is no difference between CLIA and COLA. COLA follows the CLIA requirements for personnel qualifications and responsibilities, both for moderately complex labs and for highly complex labs.

From an inspection standpoint, there can be notable differences, depending on the state in which the lab is located. CLIA is a federal program but is administered at the state level in each state. While the regulations they enforce are the same, the quality of the CLIA departments from one state to another varies widely. COLA is a nationwide program and the inspectors move freely between states as needed to inspect labs. Both agencies train their inspectors, so in a perfect world all inspections would be the same within an agency. Unfortunately, however, that is not the real life situation. The quality of the inspectors and the inspections they perform can vary widely ”“ in each agency. In many states, CLIA is short-staffed so delays are common. On the whole, COLA is probably a little more uniform throughout the country than CLIA is, but CLIA is usually more dependable with post-inspection routine and follow-up than COLA.

The costs associated with CLIA and COLA are pretty much the same. Both base their costs on the number of non-waived tests performed in a year’s time. All labs pay CLIA a Certificate Fee””the cost of renewing the CLIA identification number. And all non-waived labs pay a Compliance Fee to cover the cost of their inspection, but the Compliance Fee is billed by the inspecting agency, so if you’re inspected by CLIA the Compliance Fee will be billed by CLIA and if you are accredited by COLA, the COLA fee covers the cost of the inspection.

Several states have state lab regulations on top of CLIA regulations that are enforced. Pennsylvania, New York, Massachusetts, Maryland, Illinois, and California are several examples. Whenever there is state licensure of labs in addition to CLIA licensure, the fees will usually be higher because there will be both a CLIA and a state fee. If your lab is located in a state with additional state regulations, be sure and find out how the state regulations differ from CLIA and/or COLA (depending on which you choose for compliance). And be aware that when CLIA amends a regulation to make it less strict, COLA and/or the state may not follow suit. Also be aware that if your lab fails to maintain accreditation with one of the agencies other than CLIA, they will lose their CLIA Certificate as well unless they can pass a CLIA inspection. The accrediting agencies carry just as much weight as does CLIA.

Whenever I am asked which agency I recommend for a new lab, my answer is “it depends”¦” In some states, CLIA is absolutely the best choice (North Carolina is one of those states) because the department is very well run and the inspectors are very well trained and highly accessible when assistance is needed. In other states, CLIA is a disaster and COLA is absolutely the best choice (California and Louisiana being two examples). In the great majority of states, it really doesn’t matter which agency is chosen because overall they both do excellent jobs.

Guest Author Libby Knollmeyer

Consultant Elizabeth Knollmeyer, B.S., MT (ASCP) has over 40 years experience in the laboratory industry. She specializes in financial, operational management and compliance issues for both hospital and physician office laboratories.  Libby has a wide variety of experience with her areas of special expertise including financial review and management, Quality Management protocols, Outreach development, compliance and regulatory assistance, lab design and up fitting, lab remodeling, and market research for IVD manufacturers. She works independently and with large consulting groups to provide interim management for hospitals, and serves as adviser to lab equipment and supply distributors.  She can be reached at (336) 288-5823 or at eknollmeyer@triad.rr.com.