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CLIA Final Rule

A Scientific Rationale for Equivalent QC?

CLIA Final Rule:
An Open Letter Regarding
the Scientific Rationale for Equivalent QC

For those wondering about the new "Equivalent QC" procedures, the AACC POC listserve has been a must-read. Arguments about the validity, acceptability, and practicality of "eQC" have been raging back and forth. Recently, someone posted an open letter to CMS, asking for the scientific rationale behind eQC. CMS replied with a statement. For those who don't subscribe to the AACC POC listserve, we're happy to post the entire conversation here.

October 2004

Editor's note: There have been interesting posts on the AACC-POCC-Div listserve regarding the CLIA Final Rule and Equivalent QC. Partly by request, we are reposting some of the questions and responses:

An Open Letter Regarding Equivalent QC

Would one of you please explain the scientific rationale behind the new equivalent QC recommendations. Before a company can release an instrument and the liquid and electronic QC that go with it, they have to do extensive studies and present them to the FDA to prove that the instrument does what they say it does.

Before we can put an instrument in place in the hospital, we have to do an extensive workup, including precision (two levels of QC and two levels of patient samples when possible), accuracy, linearity, calibration verification, method comparison (to reference instrument and instrument to instrument).

Additionally, we do patient comparisons every six months, calibration verification and linearity every six months, proficiency testing 3 times a year, user competencies (initial, six month and annual), and the usual ongoing QC.

How do the new recommendations for equivalent QC improve our processes and improve patient care?

What they do is increase the cost of health care, as the cost of these controls (10, 30 or 60 days worth) have to be paid for some how, to say nothing cost of the personnel time to do this testing.

I understand that, right now, these are recommendations and voluntary, but the obvious intention is to make these required standards.

Thank you for your time to explain this to me. Also, would you please post your response to all on the POCT listserv, as I'm sure that everyone would be interested in your response.

Thank you,
Patricia M. White, M.T. (ASCP)
Point of Care Coordinator
Riverside Methodist Hospitals
Columbus, OH

CMS Response:

Response to Patricia M. White’s Correspondence Regarding the Rationale Behind the Equivalent QC Recommendations

Please recall the implementation history of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) requirements. Initially, there were major concerns about the cost and burden of CLIA expressed by previously unregulated entities. Due to these concerns, the 1992 CLIA regulations included “phase-in” QC requirements to enable these previously unregulated facilities performing unmodified, moderate complexity testing the opportunity to understand and meet the very simple QC requirements. During the phase-in, laboratories performing unmodified, moderate complexity testing were allowed to follow the manufacturer’s instructions to meet the requirement to perform control procedures (test two levels of control material) each day of testing. In many cases, the manufacturer provided function or electronic checks or internal controls that monitored only limited portions of the test system and did not monitor the complete analytic process. On numerous occasions during the phase-in, concerns were raised by professional organizations and laboratory professionals about these limited control procedures and their impact on the quality of testing. We shared these concerns. CMS frequently identified significant problems in these previously unregulated laboratories that warranted more stringent standards. Both the survey data and PT performance data confirm these findings.

To address these quality concerns and complete the plan outlined in the 1992 regulations, the final rule published in January 24, 2003, combined the moderate and high complexity QC requirements into one set of standards applicable to nonwaived testing. These regulations include a provision requiring daily testing of two levels of control material, unless CMS approves an equivalent procedure in the SOM guidelines. As noted in the 2003 regulation, the control procedures requirements were developed to monitor the accuracy and precision of the complete analytic process. As we were developing the 2003 regulation, we had discussions with QC experts (e.g., manufacturers, physicians, laboratory professionals and government agency representatives) who repeatedly emphasized that test systems, as well as internal, built-in controls/checks, vary greatly and not all test systems need the same external QC monitoring. The challenge was to ensure the requirements reasonably balance the need to appropriately monitor the complete analytic process to assure quality testing with the goal of establishing cost-effective minimal standards. Although the current regulations are more stringent than the previous phase-in requirements, the guidelines were developed to mitigate the impact, provide flexibility for certain test systems and provide accommodation for future changes in technology. The guidelines focus on the importance of having control procedures that monitor the three sources of errors: test system; environment; and testing personnel. Unlike the previous guidelines, the revised guidelines acknowledge that not all internal, electronic or procedural controls are the same. Although options are presented in the guidelines permitting reductions in external QC testing, this testing is still required at specified intervals and when an EQC problem is identified.

The concept of using the SOM guidelines to establish equivalent procedures to provide flexibility for CLIA compliance is not new. In the Medicare, Medicaid and CLIA regulations published in the Federal Register March 14, 1990, laboratories were permitted to deviate from the published requirements, if they followed the equivalent procedures that were specified in the SOM guidelines. For example:

  • Laboratories following CLSI Standard M2-A: Performance Standards for Antimicrobial Disk Susceptibility Tests and demonstrating satisfactory performance were allowed to change from daily to weekly QC testing of the antimicrobial disk diffusion test.
  • For assays and procedures that did not have QC available, such as chromosome studies in cytogenetics, laboratories were required to have an alternative mechanism to assure the validity of patient results.

The current guidelines include these previous variations from the mandated testing of two levels of external QC each day of use, as well as the newly developed EQC procedures. The evaluation process for determining eligibility for EQC procedures, in lieu of daily external QC testing, is based on the process outlined in the CLSI standards for susceptibility testing procedures. Performing and documenting these types of evaluations appears to be standard practice in many accredited laboratories.

Establishment of the EQC procedures was based on the information provided by many laboratory directors and supervisors who shared their experiences in evaluating test systems and instruments to determine control procedures. For example, the American Association for Clinical Chemistry identified contacts in large, accredited laboratories performing point-of-care tests and provided the opportunity for discussions about the ability of built-in controls/monitors to replace daily external QC testing. Prior to making decisions about decreasing the frequency of external control testing, a critical factor repeatedly mentioned was the need to conduct an evaluation to verify the test system’s stability and the ability of internal controls/monitors to reliably detect errors and alert the operator to test system problems.

The EQC procedures are not intended to be “stand alone” mechanisms for evaluating test system performance. The EQC procedures are only one component of the Quality System requirements established to monitor a test system’s performance and ensure quality testing. Quality System requirements are over-arching requirements that include:

  • The laboratory’s responsibility for determining the appropriate test systems for the patient population served.
  • The laboratory director’s responsibility for the QC and quality assessment activities
  • Establishment of an appropriate QC program that includes verification/establishment of performance specifications; calibration, calibration verification procedures; performance of maintenance/function checks and adherence to manufacturer’s instructions for test performance.
  • Enrollment and successful participation in an approved PT program. Demonstration of accuracy for tests for which PT is not required or for which PT samples are not available.
  • Annual competency assessments demonstrating all testing personnel are accurately performing testing.
  • Establishment of an ongoing assessment program that monitors and evaluates the laboratory’s policies and procedures to ensure quality improvement.
  • Documentation of all quality system activities.

We plan to collect information as we monitor the use and implementation of the initial EQC procedures. As we gather more data, modifications, additions and/or deletions may be made to the EQC procedures. Our intent is to ensure the CLIA requirements are appropriate and to maintain flexibility to accommodate technical innovations that promote quality testing. In that effort, CMS will continue to work with, and seek input from, accrediting organizations, manufacturers, laboratory experts and the other government agencies with CLIA responsibilities. In the near future, we hope to convene a meeting with representatives of all these entities to discuss current and future technologies and reasonable, cost-effective QC protocols that ensure quality laboratory services.

See an analysis of the the CMS Response and proposed scientific rationale for equivalent QC

A Final Note

Westgard QC has posted this as a courtesy to its readers as well as those of the AACC-POC listserve. Ms. White has been inundated with requests for copies of the CMS letter.

We should be clear, however: Westgard QC is not an impartial observer of the CLIA Final Rule and "Equivalent QC" controversy. This website has strong and definite opinions about the validity of these procedures. In the near future, we will provide additional analysis of this letter and its response.

For anyone wishing to find out more about our position on the CLIA Final Rules, review the many articles, displayed on the column at right.

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