(Clinical Chemistry. 1998;44:833-838.)
© 1998 American Association for Clinical Chemistry, Inc.
Clinical laboratory test menu changes in the Pacific Northwest: 1994 to 1996
Kathleen M. LaBeau1,a,
Marianne Simon2,
and Steven J. Steindel2
1
Office of Laboratory Quality Assurance, Washington State Department of Health, Seattle, WA 98155.
2
Centers for Disease Control and Prevention, Public
Health Practice Program Office, Division of Laboratory Systems,
Laboratory Practice Assessment Branch (M/S G-23), Atlanta, GA 30341.
a Address correspondence to this author at: Office of Laboratory Quality Assurance, Washington State Department of Health, 1610 NE 150th Street, Seattle, WA 98155. Fax 206-361-2813.
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Abstract
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Laboratory testing services are presently undergoing dynamic changes in
response to a wide range of external factors. Government regulations,
reimbursement, and managed care are only a few of the influences
affecting the availability of testing services and on-site testing
capabilities in hospital, independent, and physician office
laboratories. Medical practice changes, marketplace influences, test
technologies, and costs also play a role in determining where testing
is being performed. To better understand the factors influencing
clinical laboratory test volumes and menus and to identify on-site
testing deemed essential in physician office laboratories, we gathered
information from a network of clinical laboratories in the Pacific
Northwest. Questionnaires were sent to 257 Laboratory Medicine Sentinel
Monitoring Network participants in March 1996. In the past 2 years,
changes in on-site test volumes and test menus have been primarily due
to medical practice changes and marketplace influences. When
laboratories had a decrease in test volumes or test menu choices, the
size of the patient workload and the volumes of test orders have had
the greatest impact. Laboratory regulations and managed care contracts
have played a role in shifting on-site testing to outside sources;
however, these factors did not appear to be primary influences. Only
5% of physician office laboratories identified tests that they
believed were essential for optimal patient care but did not perform
on-site.
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Introduction
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Laboratory testing services are presently undergoing dynamic
changes in response to a wide range of external factors. Government
regulations, reimbursement, and managed care are only a few of the
influences that impact access to laboratory testing. Medical practice
changes, marketplace influences, test technologies, and costs also play
a role in determining laboratory testing menus.
When the Clinical Laboratory Improvement Amendments of 1988 (CLIA) were
implemented in 1992, federal regulation was extended to previously
unregulated laboratories, many of which were physician office
laboratories (POLs). Since then, considerable attention has been
focused on the perceived limitations of POLs to perform laboratory
testing on-site and the adverse impact these regulations may have had
on patient access to laboratory testing. As a result, legislation has
been introduced into the US House of Representatives and Senate to
exempt POLs from the majority of current laboratory testing regulations
(1)(2).
Recent studies on patient and physician access to laboratory testing
and changes in testing capabilities have produced conflicting results.
Some studies have indicated that on-site testing has been reduced or
discontinued as a result of CLIA (3)(4), whereas
one study showed no significant (P 
0.05) differences in
test menus or volumes before and after CLIA was implemented
(5).
A 1995 report by the US Department of Health and Human Services
identified the nongovernmental factors that impact testing capabilities
in POLs (6). Mergers and acquisitions are on the rise, the
number of managed care contracts are increasing rapidly (7),
capitation is replacing fee-for-service, and reimbursement is on the
decline; therefore, nonregulatory issues must also be considered when
studying changes in on-site laboratory testing menus.
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The Laboratory Medicine Sentinel Monitoring Network
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CLIA regulations provide authority to conduct studies related to
the quality of clinical laboratory testing, to identify factors that
may influence the accuracy and reliability of test results, and to
characterize present and future trends in the practice of clinical
laboratory medicine (8). To address these issues, the
Washington State Office of Laboratory Quality Assurance and the Centers
for Disease Control and Prevention collaborated to de velop a data
collection network in the Pacific Northwest and to provide ongoing
information about practices in hospital, independent laboratories, and
POLs. Through a series of surveys, which have been useful as screening
tools, the network provides a clearer understanding of current issues
related to laboratory testing quality, the extent and nature of
laboratory problems, and factors affecting access to laboratory
testing.
The Laboratory Medicine Sentinel Monitoring Network was created in
January 1995. A letter soliciting voluntary participation was mailed to
laboratory directors in all 950 licensed laboratories performing
moderate and high complexity testing, as defined by CLIA, in Washington
state, and 90 randomly selected laboratories in Alaska, Idaho, and
Oregon. At the time of this study, the network included 257
laboratories. Demographic information for network laboratories was
obtained through the Washington State Medical Test Site and CLIA
databases and from a questionnaire mailed to all participants in June
1995. Characteristics of the network laboratories are described in
Table 1
. Investigators primarily targeted laboratories in Washington,
where enrollment was expected to be optimal because of previous
interactions between the state agency staff and those testing sites. A
sampling of laboratories in the other three states was made to
determine the potential response rate of testing sites unfamiliar with
Washington state agency staff. The network was subsequently expanded in
1997 by the addition of more than 200 laboratories from these Pacific
Northwest states and presently includes 436 participants.
We recognize that there are some inherent biases in our population
because participants voluntarily joined the network and are limited to
one geographic location. Most of the laboratories are in Washington
state, which has a unique history with respect to the regulation of
medical testing sites. Washington was the first state to regulate
laboratories under a state program exempt from CLIA. Inspections of
previously unregulated laboratories began in February 1991, under a
state law enacted in November 1990 (9). This preceded the
implementation of CLIA inspections, which began nationwide in September
1992.
This study evaluated changes in on-site testing capabilities between
March 1994 and March 1996, thereby assessing the impact of regulations
that had been in effect for several years rather than the impact of
initial implementation. This network consists of laboratories that
perform at least moderate or high complexity testing. Because the
network does not include sites performing only waived testing,
laboratories that discontinued all moderate and high complexity testing
before this time period would not be included in the study.
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Materials and Methods
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In March 1996, a questionnaire was mailed to the director (or a
director-specified contact person) of each network laboratory. This
questionnaire was designed to learn about specific laboratory tests
that were added or deleted from on-site testing menus and the various
factors respondents perceived as influencing their on-site testing
menus. We also asked POLs to indicate which tests they felt must be
performed on-site for optimal patient care. To optimize the
response rate, the questionnaire, consisting of five multiple-choice
questions, was designed to be completed in ~20 min. The questionnaire
was not field-tested before use.
One hundred ninety-three laboratories returned completed questionnaires
(75% response rate). The demographic characteristics of respondent
laboratories are described in Table 1
. Nonrespondent laboratories were
not contacted to determine their reasons for not returning the
questionnaire. Significant (P 0.05) differences were not
found between the responders and the nonresponders with respect to
location, type of laboratory, or accreditation status. A significantly
higher percentage of respondent laboratories (72%) employed personnel
with formal laboratory training (at least one medical technologist or
medical laboratory technician) than did the nonrespondent laboratories
(55%).
Tests of significance were performed using Student's t-test
at 95% confidence limits (P = 0.05). Final reports of the
survey findings were mailed to network participants in June 1996.
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Findings
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changes in on-site test volumes
Network laboratories were asked, "In the past two years, has the
total number of patient tests performed on-site increased, decreased,
or remained the same?" In this question, the total patient test
volume was considered essentially the same if it remained within
± 10%. Total patient test volume remained essentially the same at
46% of the respondent laboratories. The total test volume had
increased at 35% of the respondent laboratories and had decreased at
18%. No significant differences were found in test volume increases or
decreases between POLs, hospital, and independent laboratories or
between urban and rural laboratories (P 0.05).
Reasons for test volume increases.
Laboratories that recorded
an increase or decrease in test volume were asked to choose one primary
and up to three secondary reasons for the change from a list of 18
possible reasons. The primary reasons given most frequently for a test
volume increase were changes in the practice (the number of providers,
the number of patients seen, or the case mix of patients seen; 69%)
and as a result of mergers/acquisitions (10%).
When individual reasons were grouped into categories of interest, those
related to practice changes and marketplace issues accounted for 95%
of the primary reasons given. When all secondary reasons given were
grouped, marketplace issues comprised 36% of the responses, test
technology-related issues accounted for 16%, and practice changes
accounted for 13% of the reasons (Fig. 1
).
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Figure 1. Reasons for test volume increases.
Practice changes, number of providers, number of
patients seen, case mix of patients; Marketplace
issues, changes to meet community needs, changes in
marketing efforts, result of mergers/acquisitions, better able to
compete in marketplace; Test technology,
availability of new testing technologies; Managed
care, testing performed on site due to a managed care or
insurance contract agreement.
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Reasons for test volume decreases.
Of the 18% of laboratories
that had a decrease in total test volume in the last 2 years, the
primary reasons given most frequently were changes in practice (number
of providers, number of patients seen, and case mix of patients seen;
37%); because of mergers/acquisitions (14%); and changes in
reimbursement for on-site testing (11%). The most common secondary
reasons given were changes in overall efficiency (overhead costs or
billable procedures; 11%), changes in reimbursement for on-site
testing (11%), compliance with laboratory regulations (CLIA or state
regulations; 11%), testing sent out because of managed care or
insurance contract agreements (11%), and changes in managed care
guidelines (11%). When individual reasons were grouped into categories
of interest, practice changes and marketplace issues accounted for 60%
of all primary reasons given. Issues related to costs comprised 30% of
the secondary reasons given, with marketplace issues and regulatory
issues comprising an additional 17% each (Fig. 2
).
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Figure 2. Reasons for test volume decreases.
Practice changes, number of providers, number of
patients seen, case mix of patients; Marketplace
issues, to meet community needs, changes in marketing
efforts, result of mergers/acquisitions, less able to compete in
marketplace; Costs, changes in reimbursement for on-site
testing, changes in overall efficiency (overhead costs, billable
procedures), changes in cost of testing equipment, reagents, supplies;
Managed care, testing sent out due to a managed
care or insurance contract agreement; Regulatory
issues, complying with laboratory regulations (CLIA, state),
complying with Occupational Safety and Health Administration
regulations, complying with physician self-referral regulations,
proficiency testing too expensive.
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changes in on-site testing menus
Laboratories were asked to indicate which tests on a list of tests
categorized by test specialties, as defined by CLIA, had been
discontinued in the last 2 years. The test list consisted of individual
analytes, except for "chemistry profile or panel" and "complete
blood count," which could be chosen as one test. If laboratories
discontinued any test that did not appear on this list, they could
write in the name of the test.
Discontinued tests.
Over the last 2 years, 107 laboratories
(55%) discontinued at least one test. Chemistry tests were
discontinued by the highest percentage of laboratories, followed in
decreasing order by those dropping tests from diagnostic immunology,
microbiology, hematology, waived, and immunohematology. Forty-five
percent of laboratories had discontinued testing from more than one
specialty. No significant differences were observed between the
percentages of POLs, hospital, or independent laboratories that
discontinued testing nor between urban and rural laboratories
(P 0.05). The tests that were discontinued are summarized
in Table 2
.
For each test listed, laboratories were asked to give one primary
reason and up to three secondary reasons for discontinuing the test.
When individual reasons for discontinuing testing were grouped by
categories of interest, those related to practice changes and to test
technology/accuracy issues accounted for 75% of all primary reasons.
Of the secondary reasons, 31% were related to regulatory issues.
Practice-related issues and nonregulatory cost issues each comprised
another 30% of the secondary reasons (Fig. 3
).
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Figure 3. Reasons that tests were discontinued.
Practice changes, change in patient load or case
mix, test volume was too low to be cost effective, determined that it
was not essential to perform test on site, another laboratory could
perform test on a STAT basis; Test technology, method was
too complicated or problematic, results do not match an outside
laboratory, could not achieve acceptable scores on proficiency testing,
results did not agree with clinical impression, patient history or
outcome, replaced with better technology; Regulatory
issues, quality control requirements made test too costly,
laboratory license fees were too costly, proficiency testing was too
costly, could not find personnel with necessary training or
qualification, concerned with meeting Occupational Safety and Health
Administration requirements; Costs, reimbursement was too
low to justify doing on site, instrument or reagent costs were too
high, another laboratory could perform less expensively;
Managed care, mandated by a managed care or
insurance contract agreement.
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Added tests.
In the last 2 years, 75 laboratories (39%) added
at least one test to their on-site testing menu. Chemistry tests were
added by the highest percentage of laboratories, followed by those
laboratories adding tests for diagnostic immunology, hematology,
microbiology, waived, and immunohematology. Thirty-seven percent of all
laboratories added testing from more than one specialty. Hospital
(70%) and independent laboratories (47%) added testing at
significantly higher frequencies (P =0.002 and P
=0.01, respectively) than did POLs (24%). Rural laboratories (53%)
added tests more frequently than did urban laboratories (33%;
P =0.01). The tests that were added are summarized in Table 3
.
The most common primary reasons for adding tests were as follows: test
is deemed necessary to perform on-site for optimal patient management
(22%); meets the needs of the community/clients (19%); better
technology available, improved quality of kits or instruments (13%);
and new medical knowledge that test is appropriate (11%). The most
frequent secondary reasons given were as follows: patient convenience
is enhanced (13%), patient outcomes are improved (12%), and meets the
needs of the community/clients (11%). When individual primary reasons
were grouped according to categories of interest, 30% related to
patient outcome/convenience. When all secondary reasons were grouped,
the highest percentage (34%) related to patient outcome/convenience.
Issues related to testing costs/revenue ranked next, comprising 24% of
all secondary reasons (Fig. 4
).
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Figure 4. Reasons that tests were added.
Patient outcome, patient convenience is enhanced,
patient outcomes are improved, test is deemed necessary for optimal
patient management; Marketplace issues, meets the
needs of the community or clients, marketing efforts, marketing
agreement/consolidation; Test technology,
improved quality of kits or instruments, kits or instruments are easier
to use; Practice issues, change in patient
workload or case mix of patients, office efficiency is enhanced, new
medical knowledge that test is appropriate; Costs, cost of
kits or instruments are less expensive, cost to patient is reduced when
performed on site, reimbursement is better when performed on site,
provides a source of revenue for the practice.
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tests performed by POLS
Network participants (excluding those in hospital and independent
laboratories) were asked to indicate which tests, on a list of 45 tests
commonly performed in POLs, they presently performed on-site.
Participants were also asked to indicate the tests, from the same list
of tests, whose performance on-site they considered essential for
optimal patient management and/or care. Responses from 93 laboratories
(categorized as POL, clinic, or health maintenance organization) were
evaluated.
The most common tests, performed by >75% of these laboratories, were
urinalysis, fecal occult blood, and urine sediment and other direct
microscopic examinations. Between 50% and 75% perform urine pregnancy
tests, microhematocrits, erythrocyte sedimentation rates, direct Strep
antigen tests, complete blood counts, and leukocyte differentials. The
following tests were deemed essential for optimal patient management by
>90% of the laboratories that performed them on-site: urinalysis,
urine sediment and other direct microscopic examinations;
urine pregnancy tests; microhematocrits; complete blood counts; whole
blood glucose concentrations; leukocyte counts; and hemoglobin
concentrations and/or hematocrits.
Tests deemed essential but not performed.
In addition to
determining which tests are performed in these POLs, we also hoped to
determine which tests they consider essential for optimal patient care
but do not perform. Laboratories were asked to indicate any tests that
they do not presently perform but that they felt were essential to be
done on site. For any tests listed, assumptions could be made that some
barrier existed that prevented the POL from performing the tests
on-site. The data gathered from this question indicated that this was
not occurring at a high frequency. Only five laboratories (5%) listed
tests that they were not presently performing but believed were
essential for optimal patient care. Four of the five laboratories had,
in the last 2 years, discontinued some of the tests listed as
essential. The reasons given for discontinuing these tests were that
the test volume was too low to be cost effective, that instruments
needed parts or repairs, and that proficiency testing was too costly.
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Discussion
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We investigated a wide range of factors believed to influence
recent changes in laboratory testing capabilities. This study
illustrates the basic reasons why network laboratories changed testing
services. We found that, in most cases, they do so for business reasons
or in response to changes in medical practice needs. In instances where
laboratories had a decrease in test volumes or test menu choices, the
size of the patient workload and volumes of test orders had the largest
impact. In addition, marketplace competition, testing costs, and
reimbursement appear to have further eroded the capabilities of
laboratories to retain and perform testing on site. Laboratory
regulations and managed care contracts did not feature prominently
among the primary reasons given for these changes. Only rarely could a
POL not do tests considered essential for the medical practice served.
We also note that laboratories have responded in a positive fashion to
changes in medical practice guidelines, trends in appropriate test
ordering patterns, and improvements in testing technologies by adding
to their test menus. One example is the change in thyroid testing in
response to presently recognized guidelines: network laboratories
shifted from T3 uptake and thyroxine
(T4) tests to thyroid-stimulating hormone, free
T3, and free T4 tests (10). We also
found laboratories adding the glycohemoglobin (hemoglobin A1C)
test, an addition that parallels the present emphasis on including this
as a quality indicator for optimal management of diabetes mellitus
(11). Network laboratories added Helicobacter
pylori antibody testing at the same time that diagnostic kits
became readily available, providing a simple, minimally invasive,
cost-effective screening device for this organism.
We have shown the utility of this network as a data collection
mechanism. It has allowed us to conclude that, at present, the primary
agents for changes in testing are factors that have always existed
within the practice of laboratory medicine. We have used the network to
undertake additional studies on issues related to quality assurance
practices, laboratory-related problems and errors, personnel changes,
and proficiency testing participation. The network successfully
provides an insight into the dynamics of change in laboratory medicine
and identifies areas for more rigorous studies.
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Acknowledgments
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We thank the following staff of the Washington State Office of
Laboratory Quality Assurance for their contributions: Susan
Bourne-Walker, Leonard Kargacin, Joan Carlson, and Gail Neuenschwander.
This project was funded by the Centers for Disease Control and
Prevention, Atlanta, GA (Cooperative Agreement U47/CCU011447).
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Abstract
Introduction
