0990-Clinical Laboratories_Attachment D - ACLA Comments

August 17, 2012

COMMENTS OF
THE AMERICAN CLINICAL LABORATORY ASSOCIATION ON
OFFICE OF THE NATIONAL COORDINATOR FOR HEALTH INFORMATION TECHNOLOGY
PROPOSED INFORMATION COLLECTION REQUEST
REGARDING HEALTH INFORMATION EXCHANGE IN CLINICAL LABORATORIES
The American Clinical Laboratory Association (“ACLA”) appreciates the opportunity to
offer its comments on the Office of the National Coordinator for Health Information Technology
(“ONC”) proposed project, “National Survey on Health Information Exchange in Clinical
Laboratories,” OS—0990—New; 60 Day Notice. ACLA is an association representing clinical
laboratories throughout the country, including local, regional, and national laboratories. As
providers of millions of clinical diagnostic laboratory services for patients each year, ACLA
member companies will be impacted directly by the proposed information collection activity.
The proposed questionnaire refers repeatedly to “billable tests” that a laboratory may
send (e.g., questions 11, 12, 13, and 14). ACLA does not object to the definition proposed for
“billable test” (“a laboratory test that is ordered by an approved provider, has an associated CPT
code, and produces a result”), but we believe that ONC should use the term “test” throughout and
it should apply the aforementioned definition to “test,” rather than “billable test.” This is
because whether or not a test is “billable” is not relevant to the exchange of health information
with ordering physicians and others.
ACLA does not believe that proposed questions 7, 8, 9, and 10 about Laboratory
Information Systems (“LIS/LIMS”) are relevant to ONC’s stated purpose of assessing and
evaluating the electronic transfer of health information from clinical laboratories to ordering
physicians.
Some of ACLA’s members would object to answering proposed question 11, which asks
how many total tests the lab sent to ordering physicians during calendar year 2011. However,
these same members would not object to answering proposed question 11.a, which asks the range
of the number of tests a laboratory sent in a given year.
The questionnaire should ask separate questions about LOINC and SNOMED (see
Section 3 of the proposed questionnaire) because they are unique terminologies and they are used
for different purposes. A few of the questions seem to imply that both are used for results
reporting; however, SNOMED in particular is not appropriate for reporting results on a
widespread basis. Information gathered in this way, without differentiation, will not provide an
accurate picture of adoption and appropriate use of LOINC versus SNOMED.
ACLA’s members would like to know whether ONC’s proposed survey would take the
place of or complement State-based surveys to which they have been asked to respond in recent
years. Section 13301 of the American Recovery and Reinvestment Act, Pub. L. 111-5, provided

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for federal grants to States to promote health information technology (“HIT”), and a State
receiving such a grant is required to report to the Secretary of Health and Human Services on the
effectiveness of its HIT promotion activities as compared to its goals. In service of this grant
condition, many States have conducted surveys of laboratories in particular to gauge their use of
HIT and their exchange of health information with providers. It is ACLA’s hope that the results
of ONC’s proposed survey would serve as the means to measure HIT adoption within the
laboratory community, both now and in the future.
One additional general comment that ACLA has is, for the information collection to be
most useful, the same clinical laboratories should be surveyed in both “Wave 1” and “Wave II.”
This would be the best way to measure progress in exchange of health information between
clinical laboratories and ordering providers.
Thank you for your consideration of our comments. If you have any questions, please
contact Jason DuBois at 202-637-9466.