Regulatory Profiles

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November 2013 Clinical Laboratory News: Volume 39, Number 11


In This Issue...

CMS Issues Second Proposal on PT Referral

CMS is inviting comments from the lab community on proposed regulations for how it would enforce the CLIA ban on proficiency testing (PT) referral. The proposal spells out how CMS will fully implement and interpret the Taking Essential Steps for Testing (TEST) Act of 2012. The TEST act fixed automatic penalties for labs that refer a PT specimen to an outside lab and gave CMS more flexibility in how to punish offenders.

The CMS proposal divides punishments for PT referral into three categories based on the severity of the violation. The first category encompasses cases of repeat PT referral or cases where a laboratory reports another laboratory’s test results as its own. In such cases, CMS would not use alternative sanctions, but revoke the lab’s CLIA certificate for at least 1 year, ban the owner and operator from owning or operating a CLIA-certified laboratory for at least 1 year, and potentially impose a civil monetary penalty.

The second category of sanctions would be applied when a lab refers PT samples to a lab that operates under a different CLIA number before the PT event close date, but still reports its own results to the PT program. In this case, CMS surveyors would investigate, and if they determine that the referral does not constitute a repeat PT referral, CMS would suspend or limit the CLIA certificate for less than 1 year rather than revoke the CLIA certificate, and include other alternative sanctions, such as training for the lab’s staff.

For the third, least serious category of offenses, CMS proposes using only alternative sanctions. Under alternative sanctions, the lab at a minimum pays a fee and must comply with a directed plan of correction, including training staff. This category covers a variety of cases where a lab may unintentionally refer a PT sample to another lab, but catches the error, reports its own results, and never receives any results back from the other lab. CMS notes this can happen if a reference lab courier mistakenly picks up PT samples along with patient samples.

The deadline for comments on the proposed rule is November 18. Comments may be submitted online.

Health Information Exchange Saves $1 Million in ED Costs

New research shows that having access to data from a health information exchange (HIE) improved the quality of emergency care and saved more than $1 million in patient charges, or nearly $2,000 per patient, according to a study presented in Seattle at the annual meeting of the American College of Emergency Physicians. Since 2010, the federal government has issued millions of dollars in grants to help states launch HIEs, and use of HIEs will be required under electronic medical record “meaningful use” regulations.

“Nearly 90 percent of participants said that quality of patient care was improved, and 82 percent of participants said that valuable time was saved, reporting a mean time savings of 105 minutes per patient,” according to study author Christine Carr, MD, of the Medical University of South Carolina.

The study found that having access to an HIE for emergency patients resulted in savings from avoiding several types of services, including a laboratory savings of $2,073. The biggest savings came from the hospital admissions category, $551,282. The total of savings for patients in the sample was $1,035,654, based on Medicare-allowable charges, or $1,947 per patient.

More information is available online from the American College of Emergency Physicians.

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