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NerveCenter Are federal laboratory regulations a double-edged sword.

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November 2011
tens of thousands of diagnostic tests used
every day. Its goal, according to CMS, is to
establish “quality standards for all laboratory
testing to ensure the accuracy, reliability, and
timeliness of patient test results, regardless of
where the test was performed.” These rules,
along with state standards, regulate the performance and reporting of clinical laboratory tests. By requiring laboratories to meet
certain standards there is more conformity
across laboratories.
Are Federal Laboratory Regulations a
Double-edged Sword?
he Clinical Laboratory Improvements
Act of 1988 (CLIA) established standards to improve the accuracy, reliability,
and timeliness of patient test results. Although the standards were established to improve the process of delivering test results to
patients, some suggest that CLIA regulations
November 2011
may be too restrictive and may actually hurt
care for some patients with rare neurological
disorders and other uncommon conditions.
Managed by the Centers for Medicare
and Medicaid Services (CMS), CLIA is funded by fees paid by approximately 190,000
laboratories that are certified to conduct the
However, some of the CLIA regulations may
potentially impede care for patients participating in research trials, particularly when
the research concerns diseases that require
quick intervention and the laboratory conducting the research is not CLIA certified.
After a laboratory makes a genetic or
immunologic discovery, for example, it can
take years for clinical tests to be developed
and even longer to commercialize the tests
and begin using them in CLIA-approved
Under CLIA, all testing of specimens to
be used in diagnosing, preventing, or treating
a disease must be performed by a CLIA-certified facility. Research laboratories may obtain
an exemption from CLIA certification—but
when they do, their patient-specific results
can’t ever be reported to the patient’s clinical
care physician. CMS is also very restrictive in
issuing waivers for non-CLIA certified labs.
According to its website page devoted to its
“Certificate of Waiver Project” (current as
of September 16, 2011), “To receive a certificate of waiver under CLIA, a lab must
only perform tests like the glucose meter test
which the Food and Drug Administration
(FDA) and the Centers for Disease Control
and Prevention (CDC) have determined to
be so simple that there is little risk of error.”
Alexander Raths, Chuck Rausin |, Troels Graugaard |
Implications for Patient Care
CLIA waivers for even these non-complex
tests require formal certification and adherence to specified procedures.
Some physician-scientists want the CLIA
rules to be less restrictive when it comes to
sharing results of experimental tests in rare
diseases where there is an incomplete level of
understanding of the disease and where the
results could lead to improved patient care.
“The question of whether CLIA potentially impedes care is very complex and, personally, I think it probably does, especially
for patients with rare diseases or for tests
that are novel and, in some cases, initially
performed by only one research lab,” says a
physician–scientist who specializes in paraneoplastic neurological disorders (PND) and
who asked that his name be withheld.
He questions the application of CLIA
during randomized clinical trials. “A clinical trial will randomize a subject to either
treatment A or B, based on the results of an
experimental blood test. In the past, CLIA
did not apply, but several years ago the rules
changed. Now CLIA does apply, since a
clinical decision is being made based on the
test results. It is possible that this test is novel
and only performed by the researcher doing
this clinical assay; in many cases the assay
would have difficulty in becoming a CLIA
approved test without external assistance. If
the whole point of informed consent is to let
the patient know what is, and what is not,
research, and if the patient consents, I do not
understand why CLIA has to be involved.”
Addendums to the CLIA in 2003 and 2005,
designed to bring the act into conformance
with Health Insurance Portability and Accountability Act (HIPAA) provisions, added
new restrictions to the release of clinical trial
data unless the tests were performed in a
CLIA lab.
Katherine Sims, MD, a specialist in
metabolic neurodegenerative disorders, is
Director of the Neurogenetics DNA Diagnostic Laboratory at Massachusetts General
Hospital, which conducts molecular DNA
diagnostic testing for more than 25 rare neurodegenerative disorders. The laboratory is
CLIA-certified by CMS to conduct immunology and cytogentic tests. The certification
involves lengthy surveys and inspections by
the Joint Commission of Hospital Accreditation, which may not have the expertise
needed to evaluate newer complex scientific
certified, laboratories could potentially save
Possible Solution:
CLIA Certification Assistance
Until such time as the Department of Health
and Human Services proposes a rule change
to CLIA requirements for experimental testing, institutions and researchers will have to
grapple with the current provisions.
While many university research labo-
Although the standards were established to improve the process of delivering test results to patients, some suggest that
Clinical Laboratory Improvements Act regulations may be too
restrictive and may actually hurt care for some patients with
rare neurological disorders and other uncommon conditions.
protocols. “Technical expertise is important
and this is adequately, but not very comprehensively, evaluated by CLIA inspectors,”
says Sims. “In my experience, the inspectors
are biochemically knowledgeable but not so
in molecular protocols and techniques, or
familiar with the quality control issues that
are really relevant to molecular DNA testing
and reporting.”
Sims says the CLIA regulations can influence patient care when research identifies
a gene or a mutation in a gene that researchers believe is clinically relevant. If the lab doing the clinical testing isn’t CLIA certified,
it would have to go through the application
and inspection process, Sims explained.
In the case of PND, classifying the
paraneoplastic antibodies present can help
identify the pathogenesis of the syndrome
and sometimes also the organ location of
an underlying tumor. Easier access to PND
test results from experimental, non CLIA-
ratories are not CLIA certified, some larger
institutions, including MD Anderson in
Houston, Texas, assist researchers in obtaining CLIA certification. Its clinical laboratory science program includes two semester-length courses focusing on laboratory
procedures and management and regulatory
and accreditation requirements, which are
designed to prepare staff for CLIA accreditation.
The physician-researcher says that
would be an ideal situation. “Researchers
want to focus on their research and not get
bogged down in all these administrative
tasks that we are not familiar with and for
which we have no funding,” he notes. “For
an individual researcher like myself it is difficult and expensive to incorporate CLIA
into research.”
DOI: 10.1002/ana.22660
Volume 70, No. 5
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