| R. Lewis Dark:
Time for Congress to Properly Fix CLIA PT Issue
THIS TIME, THE PROVERBIAL CAT MAY BE OUT OF THE BAG when it comes to longstanding
dissatisfaction with how federal regulators interpret and enforce
CLIA (Clinical Laboratory Improvement Amendments) regulations as they
relate to inadvertent errors in the referral of proficiency tests (PT).
For many in the clinical laboratory profession, this issue of THE DARK REPORT
will be their first news about the situation at the Ohio State University Wexner
Medical Center (OSUWMC), where CLIA officials have sent notice that the laboratory’s
CLIA license could be revoked, effective August 10, 2012, and subject
to appeal. The sanction is the result of the unintended referral of proficiency testing
specimens. It was a situation that the OSUWMC lab self-reported to the
Centers for Medicare & Medicaid Services (CMS). (See pages 3-7.)
Can you remember the last time it was publicly known that a major, respected
laboratory organization had its CLIA license revoked? The closest episode to
cancellation that I can recall would be on February 23, 2002. That was when CMS
officials issued to Specialty Laboratories, Inc., a "cancellation of approval to
receive Medicare payment for all laboratory services." So, even in that dramatic
case, Specialty’s CLIA license was not revoked. In fact, Specialty's CLIA license
cancellation only lasted until June 18, 2002—just 116 days!
So now the entire clinical lab profession will watch as the laboratory of a
respected academic medical center could be stripped of its CLIA license because
of the inadvertent referral of six proficiency testing specimens since 2009. In the
event that CMS prevails at appeal, it could leave OSUWMC officials no option but
to transfer ownership of the lab to a new entity and find a new lab director.
This process will likely cost millions of dollars for a lab organization the
size of OSUWMC. And what will be achieved by this particular CLIA sanction?
The same lab facility will operate with the same lab instruments, manned
by the same staff following the same protocols—except as modified in the
wake of the root cause analysis for the PT specimen referrals. The only difference
will be that the lab will have a new owner and a new laboratory director.
This and similar CLIA license revocations are why members of Congress
sponsored bills in both houses to address the CLIA statute's proficiency testing
"Catch 22" language that is the cause of this situation. It would be timely for all of
us to contact our members of Congress and urge passage of these bills.
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CLIA PT Enforcement
Ensnares Top Labs
Ohio State University Wexner Medical Center
faces loss of its laboratory's Medicare license
CEO SUMMARY: Think it can't happen to you? Think again.
Following self-disclosure of inadvertent referrals of proficiency
testing (PT) specimens, the laboratory at Ohio State University
Wexner Medical Center (OSUWMC) was visited by officials from
the Ohio Department of Health and the Centers for Medicare &
Medicaid Services (CMS). Following that survey, CMS sent
notice to the OSUWMC laboratory that its CLIA license would be
revoked, on August 10, 2012, in the absence of an appeal.
CMS Proposes Sanctions
Against OSU Laboratory
Procedural PT errors cause CMS to send
notice of revocation of lab’s CLIA license
CEO SUMMARY: As its reward for self-reporting the referral
of six proficiency testing (PT) specimens in three years, the
laboratory at Ohio State University Wexner Medical Center
(OSUWMC) has been told by the Centers for Medicare &
Medicaid Services (CMS) that its CLIA license could be
revoked, subject to appeal by the laboratory. Here are the
details of this story, as presented in a letter prepared by
OSUWMC’s laboratory director and sent to CMS officials.
Existing CLIA Language
Drives PT Enforcement
CMS officials interpret CLlA law in a manner
that some say does not meet the intent of Congress
CEO SUMMARY: Revocation of a lab's CLIA license as
penalty for inadvertent errors in handling proficiency tests (PT)
is not a new problem. As explained here, most clinical laboratories
have appropriate protocols for handling PT samples. But,
when errors occur, the Centers for Medicare & Medicaid
Services (CMS), based on its current interpretation of the CLIA
law, does not distinguish between an intentional effort to cheat
the proficiency test process and an inadvertent PT error.
CMS and CAP Comment
On CLIA PT Matters
CLIA statute is enforced by CMS based
on strict interpretation of the law's language
CEO SUMMARY: Federal regulators rely on interpretations
from administrative law judges (ALJ) for guidance in how to
apply the Clinical Laboratory Improvement Amendments (CLIA)
as they pertain to proficiency testing (PT) and the issue of inadvertent
PT referrals. Representatives of the Centers for Medicare
& Medicaid Services (CMS) and the College of American
Pathologists (CAP) provide comments about this issue and offer
insight as to how laboratories can comply with the law.
Lawyer Questions CMS
Over Inadvertent PT Errors
Revoking Medicare license and suspending
lab’s medical director not likely intent of Congress
CEO SUMMARY: In the case of the Ohio State University Wexner
Medical Center (OSUWMC) clinical lab, one attorney with long
experience in CLIA regulatory matters says that the facts do not
support the severe sanctions that CLIA officials may impose on a
healthcare organization that is widely-respected nationally. While
the lab did commit errors in its handling of PT specimens, the
errors were inadvertent; it self-reported the errors; then instituted
systemic changes to prevent recurrence of the same errors.
Congress May Respond to
Tough CLIA PT Penalties
Two bills are a response to laboratory sanctions
imposed for inadvertent PT violations under CLIA
CEO SUMMARY: For years, severe penalties in cases where a
laboratory has inadvertently erred in handling proficiency testing
(PT) specimens have been a point of contention between the
Centers for Medicare & Medicaid Services (CMS) and the clinical
laboratory profession. Two bills proposed in Congress would give
CMS more discretion in how it interprets the language in the
Clinical Laboratory Improvement Amendments (CLIA).
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