The American Hospital Association is supporting legislation that gives CMS more discretion when enforcing the Clinical Laboratory Improvement Amendments to preserve patient access to laboratory services, according to an AHA News Now report.
U.S. Senate Bill 3391, House Bill 6118 — known as the Taking Essential Steps for Testing Act — would amend the Public Health Service Act so that laboratories would not have their CLIA certificates revoked for an unintentional referral of proficiency samples — samples used in proficiency testing — or laboratory referrals that are not intended to subvert rules. The Public Health Service Act permits a one-year certificate suspension on labs that intentionally refer proficiency testing samples to another laboratory. The amendment would give CMS more discretion in cases involving improper referrals.
Here’s another specific change called for in both the House and Senate bills. A sentence in Section 353 of the Public Health Service Act states that
No person who has owned or operated a laboratory which has had its certificate revoked may, within 2 years of the revocation of the certificate, own or operate a laboratory for which a certificate has been issued under this section.
The amendment would insert this clause to the end of the sentence:
Except that if the revocation occurs pursuant to paragraph (4) the Secretary may substitute intermediate sanctions under subsection (h) instead of the 2-year prohibition against ownership or operation which would otherwise apply under this paragraph.
Intermediate sanctions include “directed plans of correction,” civil money penalties or payment for the cost of onsite laboratory monitoring.
AHA Executive Vice President Rick Pollack said in a letter to the senators sponsoring the bill that “It is important that laboratories not be unfairly punished for following their usual protocols, which sometimes result in the unintentional referral of a proficiency test specimen to another laboratory.”
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