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Public Statements

Taking Essential Steps for Testing Act of 2012

Floor Speech

Location: Washington, DC


Mrs. CAPPS. Mr. Speaker, I yield myself 5 minutes.

Mr. Speaker, the Taking Essential Steps for Testing Act is a bipartisan, sensible bill which will provide the Centers for Medicare and Medicaid Services the flexibility it needs in imposing penalties on clinical laboratories that violate certain recertification procedures. While not commonly discussed, the Clinical Laboratory Improvement Amendments of 1988, or CLIA, is an important law that ensures all labs operating in the United States can be trusted. Under CLIA, all labs must be certified to prove they are qualified to perform clinical tests while meeting quality and safety standards. We can all agree this is a good thing.

Labs are periodically retested to keep their CLIA certification. To do this, labs are required to perform proficiency tests which measure the quality and competency of a lab's work. Unlike some tests that come to a lab that can be sent out to other labs, proficiency tests must be performed in-house. Currently, if a lab is found to have referred a proficiency test to another lab, the Secretary of HHS must revoke that lab's certificate for at least 1 year. This prevents it from participating in Medicare or Medicaid for that period. In addition, the operator of any lab that has had its certificate revoked is barred from owning or operating any certified labs for 2 years.

However, current law does not allow the Secretary any flexibility in imposing these penalties for labs that improperly refer proficiency tests--even when it's an unintentional referral. This has led to labs that are being shut down across the country, potentially affecting patient care and access, even when their actions are not worthy of such a sanction. This is especially pronounced when the sanction occurs on just one lab that is part of a larger health care system, as the penalties apply to the entire system, even if all the other labs happen to be in compliance.

So this legislation would help address these problems by allowing CMS the flexibility to institute lesser sanctions to really address the problem instead of penalizing an entire system for unintentional proficiency test referrals. The bill does so without changing the accountability within the law or making our labs less reliable. And CMS still will be required and able to hold so-called ``bad actors'' accountable.

This bill is a very commonsense reform to CLIA, and I'm pleased to support it. I urge my colleagues to do so as well.

I reserve the balance of my time.


Mrs. CAPPS. Mr. Speaker, in closing, the Taking Essential Steps for Testing Act is a straightforward bill with bipartisan support. It will give CMS tools to effectively deal with labs that unintentionally refer out their proficiency tests, maintain sanctions for labs that intentionally flaunt the law, and ensure that certified clinical labs are there for us when we need them.

I urge support for this bill, and I yield back the balance of my time.


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