New law would lessen penalties for medical laboratories from violations of CLIA regulations if they made inadvertent referrals of  proficiency tests to other clinical labs

Clinical laboratories may have to wait at least another month before the U.S. Senate returns from recess to vote on a bill to remove severe penalties for labs that inadvertently violate certain CLIA proficiency testing (PT) requirements. A similar bill was passed in the House in September.

The bill, S. 3391: Taking Essential Steps for Testing Act, was ready for a Senate vote in mid-October. It was set aside so that senators could return home while the campaign season entered its final weeks.

Bill Would Lessen Penalties for Clinical Laboratories Under CLIA

A companion bill passed the U.S. House of Representatives unanimously on September 19. That house bill, H.R. 6118, has the same name.

Both bills are designed to provide more precise guidance to resolve an issue under the Clinical Laboratory Improvement Amendments (CLIA) statute of 1988. (See The Dark Report “Congress May Respond to Tough CLIA PT Penalties,” August 6, 2012).

It was Representative Michael Grimm (R-NY), who first sponsored the House bill that would provide clarification on how the Clinical Laboratory Improvement Amendments should be interpreted and enforced on the issue of inadvertent referrals of proficiency testing specimens. This bill has passed in the House and a comparable bill awaits a vote by the Senate. Pathologists and medical laboratory managers are encouraged to contact their senators and urge passage of this bill in the Senate. (photo copyright Associated Press.)

It was Representative Michael Grimm (R-NY), who first sponsored the U.S. House bill that would provide clarification on how the Clinical Laboratory Improvement Amendments should be interpreted and enforced on the issue of inadvertent referrals of proficiency testing specimens. This bill has passed in the House and a comparable bill awaits a vote in the Senate. Pathologists and medical laboratory managers are encouraged to contact their senators and urge passage of this bill in the Senate. (photo copyright Associated Press.)

Federal regulators believe the CLIA regulations require them to levy the most severe penalties, even when CLIA-licensed medical laboratories have inadvertent PT errors. No patients may be harmed as a result of such errors, but federal regulators have imposed severe sanctions on multiple occasions. The severest penalties include revoking a clinical laboratory’s CLIA license, banning the medical director of the lab from directing a clinical laboratory for two years, and requiring new ownership of any medical laboratory found in violation of the CLIA rules for handling PT specimens.

Medical laboratories that had inadvertent PT errors and were cited for such violations were among the parties that asked their congressional representatives to address this matter. One recent case involved the clinical laboratory at Ohio State University Wexner Medical Center (OSUWMC).

It was The Dark Report that first published the details of the case involving OSUWMC.  (See The Dark Report, “CLIA PT Enforcement Ensnares Top Labs,” August 6, 2102). CMS regulators threatened to revoke the CLIA license of the clinical laboratory at OSUWMC as a result of unintentional PT errors. CMS notified the lab of its findings in a letter dated June 11, 2012. On August 3, 2012, every member of theOhio Congressional delegation wrote to federal Health and Human Services Secretary Kathleen Sebelius asking her to review the facts of the case and to ensure that the laboratory can continue to operate under the ownership and control of the Ohio State University and OSUWMC.

Sponsored by Representative Michael Grimm of New York State

H.R. 6118 was sponsored by Michael Grimm (R-N.Y.). “The TEST Act tweaks a well-intended law and rids it of the unintended negative consequences imposed by an overzealous regulation,” Grimm told The Staten Island Advance. “While the current regulation was well-intended to ensure reliable lab results from the most basic test to the most life-threatening, it can turn an honest mistake into a disaster for our healthcare providers.”

The bill that Grimm sponsored would revise sanctions for medical laboratories that refer PT samples to another laboratory for analysis by giving the HHS secretary discretion to substitute intermediate sanctions for such violations instead of the two-year prohibition against ownership or operation that would otherwise apply.  This bill would also make the certificate or revocation for such a laboratory optional rather than mandatory, according to GovTrack.US, a site that tracks bills in Congress.

Revoking Medical Laboratory’s CLIA Certificate

When a CLIA certificate is revoked, that medical laboratory cannot conduct human specimen testing. If it is a hospital laboratory, such a revocation  can lead a hospital either to shut down services—such as the emergency department and/or operating rooms—or pay substantial amounts of money  to bring in an outside laboratory for the two years of the CLIA penalty period.

The Clinical Laboratory Coalition of the College of American

Pathologists, and the American Clinical Laboratory Association, among other lab associations, support both H.R. 6118 and S. 3391.

“We have been working on this issue for most of this year and have had great support from the lab organizations, CMS, and the House and Senate,” said ACLA President Alan Mertz. “It’s unusual when you can get a bill passed in the House in such a short time, and we almost got the Senate bill passed as well. But it was held up for procedural reasons that had nothing to do with the bill itself.

Clinical Labs Can Make Inadvertent Proficiency Testing Errors

“We got so much support because these bills just make sense,” continued Mertz. “The enforcement penalties for unintentional PT mistakes were out of proposition with the alleged violations. Plus, the CLIA regulations can be confusing. Labs are supposed to treat all PT samples the same way they treat live specimens, but they must never refer a PT sample out to another lab. You can see why this rule is confusing.

“When the Senate returns in November or December, we expect the bill to pass,” he added. “In the meantime, pathologists and clinical laboratory directors should call their senators about this bill. It’s important to let them know that it shouldn’t fall through the cracks.”

House and Senate Co-Sponsors for Medical Lab Bill

The House bill has 13 co-sponsors: Steve Austria (R-OH), Michael Burgess (R-TX), Sean Duffy (R-WI), Tim Griffin (R-AR), Daniel Lipinski (D-IL), Ronald “Ron” Paul (R-TX), Reid Ribble (R-WI,) Peter Roskam (R-IL), Mike Ross (D-AR), Steve Stivers, (R-OH), Patrick “Pat” Tiberi (R-OH), Timothy Walz, (D-MN), and Steve Womack (R-AR).

The Senate bill was introduced by Amy Klobuchar (D-KN) and has six cosponsors: John Boozman, (R-AR), Sherrod Brown (D-OH), Richard Burr (R-NC), Al Franken (D-MN), Robert “Rob” Portman (R-OH), and Jeanne Shaheen (D-NH).

All pathologists, clinical chemists, medical technologists, and other medical laboratory scientists are encouraged to contact their Senators and urge passage of the senate bill.

—Joseph Burns

 

Related Information:

House passes bill from Staten Island’s Rep. Grimm aimed at aiding medical labs

ACLA Applauds Introduction of Bill Increasing Flexibility of Regulations that Currently Limit Access to Clinical Laboratory Tests

The Dark Report “Congress May Respond to Tough CLIA PT Penalties,” August 6, 2012

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