With the H1N1 flu virus rapidly spreading across the
United States, the Centers for Disease Control and Prevention (CDC), as
well as the Centers for Medicare and Medicaid Services (CMS), are
working to improve the standards by which laboratories report and test
for infectious diseases. A major focus of these efforts is to improve
communication between federal agencies, medical laboratories, and the
general public. In addition, existing guidelines pertaining to
infectious diseases are in various stages of revision.
The more you plan,
the better you can cope when a pandemic hits.
Retooling standards
In February, CMS reported it was working with the CDC
to review and modernize the proficiency testing (PT) regulations in CLIA
subparts H and I. According to Judith Yost, MA, MT(ASCP), director of
the Division of Laboratory Services at CMS, these updates will be
spearheaded by a work group formed from Clinical Laboratory Improvement
Advisory Committee (CLIAC) members. “CMS and CDC hope to assemble this
distinguished work group in early 2010 to begin its extensive
deliberations. It is our sincere desire that by utilizing the expertise
of these individuals on the front end of the process, we can avoid
controversy in the future over the revised standards following
publication. The regulatory process,, however, will still require a
proposed rule that solicits public comments prior to any final standards
being published and implemented,” she notes.
In addition to CLIAC, input also will come from
laboratories, PT programs, accrediting organizations, exempt states, the
Veterans Administration, Department of Defense, the Food and Drug
Administration (FDA), and other government agencies, she says.
Yost says that because the healthcare environment is
so drastically different now than it was in 1992 when these regulations
were published, changes need to be made. “This means that we will
re-evaluate the requirements for laboratories, PT programs, grading
criteria, targets; and develop a technically sound mechanism for analyte
selection and PT referral, just to name a few.”
Of particular interest are labs that send PT samples
to reference labs. “CMS recognizes that some laboratories were doing so
by following their own internal policies, but some were purposely trying
to obtain results to turn in for PT grading purposes,” Yost explains.
“PT referral is considered cheating; and Congress, when it wrote the
CLIA law, assumed if a lab cheated in PT, it must also misrepresent its
patient results. Thus, it has the most stringent penalties.” Some cases
actually have been determined to be accidental, Yost says; and in those
instances, the lab does not receive strong sanctions.
Genetic tests addressed
Due to advances in technology, another area under
scrutiny is genetic testing. “We regulate genetic testing just like we
do any other testing that meets the definition of a lab at 42 CFR 493.2.
It is subject to all of the CLIA quality standards,” she says. “Most
genetic tests are high complexity under CLIA and, so, are subject to
these requirements as they apply to genetic tests. The CDC recently
published a Morbidity and Mortality Weekly Report (MMWR)
on CLIA compliance for genetic (molecular) labs. It is a great reference
since many more labs are performing these tests. You can obtain the
MMWR on the CDC website under the division of lab systems. Be aware
that since there is no generally agreed-upon definition of a genetic
test; and since CLIA does not have specific standards, it is hard to
know what might be called a genetic test.”
CLIA-waived tests on the rise
Yet another area of concern involves CLIA-waived
tests. These tests have increased from eight in 1992 to approximately
100 today, representing over 1,000 test systems. And the number of labs
that have been issued a Certificate of Waiver is about 63% of the more
than 206,000 CLIA-registered laboratories, according to Yost. “CMS/CLIA
is evaluating possible mechanisms to facilitate better quality testing
in waived laboratories in collaboration with CDC/CLIAC, accrediting
organizations, professional organizations, and the FDA which categorizes
these tests,” she says.
“We have evidence from our visits to waived labs that
testing personnel are not trained and may not follow manufacturers’
instructions or do quality control. This has a great potential for
inaccurate results.”
CLIA and electronic health records
On a more positive note, Yost says a major initiative
that, ultimately, will affect clinical laboratories are the continued
efforts to adopt electronic health records, or EHR. But she cautions,
“There are, of course, CLIA requirements for certain data elements to be
contained in laboratory reports; a requirement that the reports be
accurate, reliable, timely, and confidential; and that they only be
transmitted to the person authorized by the state in which the
laboratory is located or to the individual who will use that information
to treat that patient.”
Improved communication
This year’s flu season, with its initial threat of a
possible H1N1 pandemic, the CDC has attempted to improve the way it
communicates with labs and the general public. John Ridderhof, DrPH,
associate director for laboratory science, National Center for
Preparedness, Detection and Control of Infectious Diseases, Coordinating
Center for Infectious Diseases (formerly known as the National Center
for Infectious Diseases) at the CDC, points to the increased use of the
CDC’s Laboratory Outreach and Communication Systems (LOCS) during the
H1N1 outbreak. “We send e-mails on new or updated guidance to most of
the major laboratory organizations that then may decide to forward the
updates to member listservs or post those on their websites,” he says.
LOCS messages are categorized as to their importance:
- LOCS Alert: Conveys the highest level of
importance and warrants immediate action or attention. - LOCS Advisory: Provides important information for
a specific incident or situation that may not require immediate
action. - LOCS Update: Provides updated information
regarding an incident or situation that is unlikely to require
immediate action.
In addition to information contained in e-mails, the
messages also provide links to related government and non-government
websites.
Pandemic-planning program
The need for enhanced communication systems led the
CDC to develop “FluLabSurge” — a spreadsheet-based program designed to
assist lab directors in forecasting the demand for specimen testing
during an influenza pandemic and to develop response plans.
“It became apparent that lab directors were not aware
of what to do if there was a flu pandemic,” explains Martin Meltzer,
senior health economist and distinguished consultant at the CDC. “The
more you plan, the better you can cope when a pandemic hits.”
FluLabSurge is able to produce estimates of the daily
number of specimens that may be delivered to a lab for testing, and the
testing capacity of that lab. At the peak of the 1968 flu pandemic, for
example, 1 million samples per week were arriving at labs throughout the
country, Meltzer says. The full version of FluLabSurge consists of three
separate modules:
- Workload Demand: Predicts the daily number of
specimens that may be delivered over the course of a pandemic. The
number of specimens sent to a lab for testing will depend upon the
total number of cases, hospitalizations, and deaths. A user can also
choose a scenario representing a 1968-type or 1918-type pandemic. - Laboratory Capacity: Predicts the average and
maximum laboratory testing capacities, using data regarding the
number of available personnel and diagnostic machines. The module
also allows the user to extensively explore “what if” scenarios,
such as “What if we added more personnel; how many additional tests
could we run in a given time period?” - Pandemic Planning: Utilizes the data from the
other two modules to assist in planning for the next pandemic. The
output from this module can be pasted into presentation material
and/or reports.
FluLabSurge uses the Windows operating system and
Microsoft Excel. The software is free and can be downloaded at
www.cdc.gov/flu/tools/flulabsurge.
Richard R. Rogoski is a freelance journalist based in
Durham, NC. Contact him at [email protected].
