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Coming soon: more changes to the CLIA regulations

A look at how the latest revisions might make life easier for physicians with labs

From the February ACP-ASIM Observer, copyright 2003 by the American College of Physicians-American Society of Internal Medicine.

By Connie Laubenthal

Since Ronald Reagan signed the Clinical Laboratory Improvement Amendments (CLIA) into law in 1988, the federal regulations designed to improve and regulate the quality of clinical labs have changed sporadically every few years. Late last month, however, the Centers for Medicare and Medicaid Services (CMS) released final revisions to the regulations that will change the way some physicians operate their office labs. These regulations will take effect on April 24 of this year.

That's good news for most physicians, because the changes will be fairly easy to comply with. The revisions should also help reduce the costs of CLIA compliance and make running your lab easier.

While the final regulations were just published, the CMS issued a briefing document late last year that previews the expected changes. Here is an overview of the major changes that will affect physicians with clinical labs.

  • Frequency of quality control testing. The latest version of the CLIA regulations reduce the frequency with which most specialty and subspecialty practices must perform quality control testing. Less frequent monitoring should reduce staff workload and overall costs.

  • Quality control phase-in for moderate complexity tests. The gradual phasing in of quality control measures for lab tests of moderate complexity will end on April 24. Once the change is finalized, CMS will use one set of quality control standards for facilities that perform both moderate and high complexity tests. As a result, moderate complexity laboratories will now have to perform one quality control validation study to validate a new test before engaging in patient specimen testing. Moderate complexity labs will also have to take some additional quality steps, but the extra requirements are not extensive.

  • Board certification of laboratory directors at high complexity testing facilities. The phase-in period allowing personnel who have a doctoral degree but not board certification to be "grandfathered" into the role of laboratory director will end Feb. 24. Individuals with a doctoral degree who become directors of high complexity laboratories after Feb. 24 must be board certified.

  • The requirements for existing subparts J (patient test management), K (quality control) and P (quality assurance) will be combined. These subparts will be combined into two new subparts: J (facility administration) and K (quality systems).

    This change involves a reorganization of the regulations to better follow the flow of actual laboratory procedures. These new requirements are ordered according to the standard system for routing patient specimens from collection, identification, receiving and processing through the testing procedures to final report generation and posting.

This article gives an overview of some of the more important regulatory changes that will affect clinical laboratories. For a full explanation of the changes, see the Jan. 24, 2003, Federal Register. Final changes to the CLIA regulations will also appear on the CMS Web site.

The College's Medical Laboratory Evaluation (MLE) Program has published an online guide to the changes. The MLE's compliance specialists have kept abreast of the changes and will be available to help College members understand exactly what is required for their laboratories and how the changes will affect in-house quality assurance programs and quality control procedures.

Connie Laubenthal, MS, CLS (NCA), is Program Director for the College's Medical Laboratory Evaluation Program.

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