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CLIA QC Clearance Postponed Again & Again & Again & Again

An updated version of this essay appears on the Nothing but the Truth about Quality book.

For the third time in a row, the CLIA manufacturer clearance requirements for QC clearance have been postponed. What's taking so long? Why can't HCFA and DHSS come to a conclusion? Are the manufacturers exercising some undue influence? Better than answering these questions, Dr. Westgard suggests that we shouldn't wait for more CLIA rules. We have enough rules to go on right now - and here's how to use them to improve QC...

January 2001

On December 29, 2000, the Department of Health and Human Services (HSS) and the Health Care Financing Administration (HCFA) extended certain effective dates for clinical laboratory requirements under CLIA [1]. In particular, this extension postpones the original 2-year phase in period for the quality control requirements applicable to moderate and high complexity tests. The original CLIA rules, published in the Federal Register on February 28, 1992, were to be effective until September 1, 1994, after which laboratories were to meet all applicable quality control requirements or follow the manufacturer's instructions cleared by the FDA as meeting the CLIA requirements for quality control. During this phase in period, laboratories are in compliance with CLIA if they do the following:

  1. Follow the manufacturer's instructions for instrument or test system
    operation and test performance;
  2. Have a procedure manual describing the processes for testing and
    reporting patient test results;
  3. Perform and document calibration procedures at least once every six
    months;
  4. Perform and document contol procedures using at least two levels of
    control materials each day of testing;
  5. Perform and document applicable speciality and subspecialty control
    procedures, as specified under 493.1223; and
  6. Perform and document that remedial action has been taken when problems
    or errors are identified as specified in 493.1219.

This phase in period was first extended on December 6, 1994, again on May 12, 1997, again on October 14, 1998, and again on December 29, 2000. This 4th postponement provides a total of 10 years for the phase-in of the quality control requirements, or a total delay of 10 years in implementing the QC clearance provision of CLIA. Meanwhile, quality control has been coasting along, driven by the minimal requirement to run two levels of control each day.

Here's what the latest Federal Register postponement says:

"Section 493.1203, effective beginning December 31, 2000, establishes a mechanism for laboratories using commercial, unmodified tests to fulfill certain quality control requirements by following manufacturers' test system instructions that have been reviewed and determined by the FDA to meet applicable CLIA quality control requirements. Implementation of this review process, however, depended on the availability of sufficient additional resources necessary to meet the projected workload."

Excuses, excuses

The reason given for the postponements is that resource constraints that have prevented HSS from establishing a review process for manufacturers' test system quality control instructions for CLIA compliance. Amazing, isn't it! During this same period of time, HSS has been able to heap numerous new programs on laboratories to contain the cost of laboratory services, but doesn't have the resources to implement a key provision that assures the quality of laboratory tests.

Does anyone believe that HSS has more resource constraints than laboratories today? Wouldn't it be nice if laboratories were free to postpone their programs to comply with government regulations, in the same manner as manufacturers have been able to postpone compliance with the QC clearance provision of CLIA? HSS's selective inaction is more likely due to priorities and policies and politics, particularly being more "customer" friendly - to manufacturers, not to laboratories and the patients whose samples are being tested.

That said, here are some thoughts about what might be done to resolve the QC clearance issue.

QC Clearance

First, let's understand the intent of the QC clearance provision. Here's what section 493.1203 says:

"For each moderate or high complexity test performed, the laboratory will be in compliance with this section if it: (a) Meets all applicable quality control requirements specified in this subpart; or (b) Follows the manufacturer's instructions when using products (instruments, kits, or tests systems) cleared by the FDA as meeting the CLIA requirements for general quality control located at 493.1213, 493.1215, 493.1217 and applicable parts of 493.1205, 493.1211 and 493.1218. In addition, laboratories must comply with requirements within any section of this subpart that are unique to the laboratory facility and cannot be met by manufacturer's instructions."

The idea behind QC clearance is to be sure that the appropriate QC is being done and to simplify the requirements by allowing a laboratory to follow the manufacturer's instructions verbatim. But, the manufacturer must demonstrate the validity of its recommendations as part of the documentation submitted to FDA for review.

If the absence of QC clearance, a laboratory would be expected to comply with the following standard:

493.1218(b) "For each method that is developed in-house, is a modification of the manufacturer's test procedure, or is a method that has not been cleared by FDA as meeting the CLIA requirements for general quality control, the laboratory must evaluate the instrument and reagent stability and operator variance in determining the number, type, and frequency of testing calibration or control materials and establish criteria for acceptability used to monitor test performance during a run of patient specimen(s)."

That makes the laboratory responsible for determining how often controls should be analyzed, how many controls need to be analyzed, and what criteria (control rules) should be used to interpret the control results and judge the acceptability of an analytical run, taking into account the imprecision observed for the method in the laboratory (variance due to the instrument, reagents, and operators).

Truth in labeling

The QC clearance provision expands the FDA's role for reviewing manufacturers performance claims. QC becomes part of "truth in labeling", just like any other claim that is made by the manufacturer. The existing 510k review process would be used to verify that the manufacturer's claims for QC are backed by data, just like the claims for assay range, analytical sensitivity, analytical specificity, precision, accuracy, and expected values.

One critical shortcoming of product labeling is that there is NO claim for quality. All the claims are for the performance expected during stable operation. Quality depends also on unstable operation, but there is no documentation of how often problems occur and what QC is necessary to detect those problems. Those are issues that were to be addressed by the QC clearance provision. The net result is that a manufacturer's claims represent the best performance that can be expected if everything is working properly, but do not adequately address how to determine if things are working properly.

To do that, the manufacturer's QC instructions would need to address how often controls are analyzed, how many control measurements are made, and what criteria are used to judge the acceptance of a run. Few manufacturers provide that information today. Instead, the usual statement is to analyze two levels of quality control materials every 24 hours. The CLIA minimums have become the maximums for current QC practice. Manufacturers and laboratories hide behind the CLIA minimums to escape responsibility for the quality that is actually achieved in the daily production of test results.

Truth in regulations

Let's be honest, CLIA hasn't improved the quality of laboratory tests, only regulated the amount of effort in quality control to the minimum needed for compliance. The existence of the CLIA QC clearance provision and the continued lack of implementation challenges the "truth in regulations" and deceives the public. CLIA may be fundamentally sound if the QC clearance provision were implemented and if manufacturers and laboratories were held accountable for implementing appropriate and valid QC procedures, but that hasn't happened.

What's really happened is that manufacturers continue to raise issues that prevent the implementation of the QC clearance process. Evidence of that is found in the Federal Register itself[1].

"Following the publication of some of the previous extensions, we received comments that the current quality control requirements are not appropriate for some test methodologies, and that a comprehensive quality control regulation should be developed to address current quality control needs… Commenters also raised issues that stressed the need to ensure that the quality control requirements are practical and flexible enough to accommodate different testing sites and test systems that range from current methodologies to new and emerging technolgies, in order to not impede access. We must also, as the commeters suggest, base the requirements on technical considerations as well as their impact on patient care.

"Due to the complexity of the issues that must be addressed, we are extending the December 21, 2000 sunset date for quality control standards in Sec. 493.1203 to December 31, 2002, to allow laboratories to continue to meet the current regulations until we make further determinations regarding quality control issues."

Given the ongoing issues with point-of-care testing, the new issues with molecular diagnostics, and the new issues for new technologies that are yet to be discovered, etc., etc., etc., manufacturers will always resist the QC clearance provision. Manufacturers see QC instructions as a potential disadvantage because QC increases the apparent cost. They're reluctant to be truthful about the QC that needs to be done because it might imply their system is worse than their competitors, when the only difference is that their competitors aren't being honest. Manufacturers will continue to lobby and prevent the implementation of the CLIA QC clearance provision.

The final nail in the coffin comes from laboratories themselves. With all the pressure on cost reduction, efficiency, staffing vacancies, decreasing skills, etc., laboratories are generally happy to follow the manufacturer's QC instructions verbatim, whether validated or not. Laboratories no longer have the time to do things right! It saves time to follow the manufacturer's QC instructions and also transfers any blame for problems to the manufacturer. In other testing sites, the personnel would be happy to eliminate QC altogether - it's all a waste of time and effort and resources and furthermore confuses the nurses and interferes with patient care. Only the patients care about quality!

The truth is that regulations aren't the answer for assuring the quality of laboratory tests.

What is the answer?

CLIA QC Clearance may never happen. If the government can't get it done in ten years, there's no reason to believe it will get its act together soon. Certainly we can sit and wait, as we have for the last decade, but that's not going to improve things. All that will do is give us an excuse to complain.

The basis for a remedy lies in two new consensus documents on quality management [2] and quality control [3] that were published in 1999 and a consensus conference on quality specifications that was held in 1999 [4]. The recommendations or consensus positions represent the views of manufacturers, laboratory professionals, and regulators. No one is completely happy with these recommendations (which attests to the success of the consensus process), but they provide practical compromises for many of the issues that must be addressed to establish appropriate quality systems.

  • NCCLS EP-19P Quality Management for Unit-Use Testing provides a "source of errors" matrix that identifies potential problems throughout the total testing process. Manufacturers can use this matrix to identify potential problems and appropriate methods of control for any method or system, including unit use devices. Statistical QC is one method of control that is available to monitor many sources of errors, therefore it represents an efficient method of control that may be advantageous for monitoring several steps or variables in the total testing process.
  • NCCLS C24-A2 Statistical Quality Control for Quantitative Measurements: Principles and Definitions provides guidelines for planning statistical QC procedures on the basis of the quality required for a test and the performance (variance, bias) observed for a method.
  • Strategies to Set Global Analytical Quality Specifications in Laboratory Medicine describes a hierarchy of models that can be used to define the quality required for a test.

Here's how it should work!

  • Manufacturers should be responsible for applying the source of errors matrix from NCCLS EP-18P, identifying methods of control, and providing that documentation to users.
  • FDA should ensure that manufacturers include a source of errors matrix as part of their QC instructions and product labeling.
  • Users should be responsible for implementing the manufacturer's QC instructions and utilizing the manufacturer's claims for method imprecision and inaccuracy to establish statistical QC procedures that are appropriate for the quality required for tests in their laboratory, following the guidelines in NCCLS C24-A2. As routine performance data becomes available to characterize the varability observed in an individual laboratory, the statistical QC designs should be reassessed.
  • The Medical Director of a laboratory should define the quality required for the tests performance in the laboratory. The CLIA criteria for acceptable performance in proficiency testing provide minimum quality requirements that can be used by laboratories and manufacturers alike to design appropriate quality systems. Laboratories should also consider clinical requirements for quality when available and appropriate.
  • HCFA should amend the CLIA rules to remove all minimum QC requirements and recommend the sharing of responsibility for managing the quality of laboratory tests, as described above.

What will make this work? All the parties - manufacturers, laboratories, regulators - will share the responsibility for quality, rather than trying to distribute the blame to the other parties. A committment to quality by laboratories will drive the manufacturers to make improvements in response to customer demand. Regulators will play a descriptive role by formulating what needs to be achieved, rather than the prescriptive role of specifying how it should be done, thereby allowing manufacturers the flexibility they need to develop new technologies and approaches. Customer and laboratory acceptance in the marketplace will measure whether manufacturers provide quality systems, products, and services.

If that doesn't work, we can count on one last tried and true American solution - litigation. Laboratory customers, clients, and patients will end up taking the responsible parties to court to settle any grievances due to poor quality test results. Compliance to CLIA QC minimums will no longer be a defense for poor quality management. Evidence will be needed to demonstrate quality. Here's the ultimate situation where evidence-based medicine will be judged by a jury of consumers, not parties whose main interests are minimizing costs, maximizing reimbursements, and optimizing profits. And to be sure that the real quality issues aren't obscured, laboratory scientists will have a new opportunity to improve quality by testifying in court - a novel approach to quality improvement that is only possible in this litigious society of ours!

We have a choice between these futures. Which one will you choose?

References

  1. Medicare, Medicaid, and CLIA Regulations; Extension of certain effective dates for Clinical Laboratory Regulations under CLIA. Federal Register, December 29, 2000;65(251)82941-82944.
  2. NCCLS. Quality Management for Unit-Use Testing; Proposed Guideline. NCCLS Document EP18P. National Committee for Clinical Laboratory Standards, 940 West Valley Road, Suite 1400, Wayne, PA 19087.
  3. NCCLS. Statistical Quality Control for Quantitative Measurements: Principles and Definitions; Approved Guideline - Second Edition. National Committee for Clinical Laboratory Standards, 940 West Valley Road, Suite 1400, Wayne, PA 19087.
  4. Petersen PH, Fraser CG, Kallner A, Kenny D. Strategies to Set Global Analytical Quality Specifications in Laboratory Medicine. Scan J Clin Lab Invest 1999;59:475-586.

James O. Westgard, PhD, is a professor of pathology and laboratory medicine at the University of Wisconsin Medical School, Madison. He also is president of Westgard QC, Inc., (Madison, Wis.) which provides tools, technology, and training for laboratory quality management.