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Medicare Compliance & Reimbursement

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Labs Falling Under Increased Scrutiny

Published on Sun Nov 21, 2004

Proposed bill could mean new whistleblower protections, trickier inspections.

Tougher compliance measures for medical laboratories are brewing in Washington.
     
On the heels of a Medicare scandal in which Maryland General Hospital allegedly gave 450 patients questionable HIV and Hepatitis-C tests, U.S. Representative Elijah Cummings (D-MD) has introduced the Clinical Laboratory Compliance Improvement Act of 2004 aimed at ensuring all labs comply with federal standards.
     
The bill requires:

     

  • more protections for employees who alert authorities to violations;

         

  • labs to post a "conspicuous notice" informing employees how and to whom to report problems and what whistleblower protections apply to them under federal law;

         

  • more oversight and information sharing between the Centers for Medicare and Medicaid Services, state health agencies and private laboratory accrediting organizations regarding reports of deficiencies and investigative activity;
         
  • standard accreditation surveys conducted without prior notice; and

         

  • an annual report by the Secretary of the Department of Health and Human Services.

    During two congressional hearings in July, two former MGH employees testified that the fear of retaliation for reporting lab problems hindered immediate action on unsafe lab activities. The hearings also determined that miscommunication between various inspecting agencies, as well as advance warnings of impending inspections allowed the lab to cover up violations and perpetuate unsafe lab operations.
         
    "The hearing gave us little assurance that what was occurring at Maryland General was an isolated incident," Cummings said.
         
    Lesson Learned: Labs may need to prepare for tougher federal oversight coming down the pike.

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