Some things aren’t a matter of whether but of when. And national quality
measures for laboratories that can be linked to payment incentives or
inspection penalties or both are likely to be one of them.
The Institute for Quality in Laboratory Medicine—a public-private
partnership with more than 65 stakeholders, including the CAP, and supported
by the Centers for Disease Control and Prevention— unveiled at its
April conference a set of 12 quality indicators as a potential starting
point for measuring laboratory performance.
The institute’s consensus-driven effort to define laboratory quality
standards and metrics is just out of the gate and aimed at encouraging
labs’ voluntary participation. But many in the field expect clinical
laboratories eventually to join other health care sectors that publicly
report national quality measures.
Yet the ultimate message coming out of the institute’s endeavor
may be that laboratory medicine is even more of a driver of overall health
care quality than realized previously. Lee Hilborne, MD, MPH, co-chair
of the institute’s Quality Indicator Workgroup that developed the
initial set of indicators for further investigation, predicts that “over
the next decade, laboratory testing will be increasingly used to assess
the quality of care and the extent to which pathologists’ clinical
colleagues practice evidence-based medicine.”
To identify and develop national quality measures, the CDC is working
with the National Quality Forum, an independent organization with more
than 260 public and private stakeholders, including the CAP, created to
forge a national strategy for health care quality measurement and reporting.
The CDC’s Joe Boone, PhD, says the institute’s goal is to
collaborate with the forum and its own partners to bring a spectrum of
stakeholders to the table to hammer out a set of national quality indicators.
“The goal is to develop something that will be useful not just to
labs but to the whole health care field,” Dr. Boone says.
As a first step in that direction, the institute workgroup’s 12
candidate quality indicators are a blend of preanalytical, analytical,
and postanalytical measures, as well as systems measures that extend before
and after the traditional beginning and end of the process. “There’s
a very clear understanding that the IQLM should examine the entire testing
process from the ‘pre-pre’ analytical to the ‘post-post’
analytical phases,” explains Robin Stombler, president of Auburn
Health Strategies, Arlington, Va., which is helping the CDC develop the
institute, or IQLM.
The institute’s Quality Indicator Workgroup culled the indicators
from a much larger pool of potential measures as a “first pass”
at a core set, said the workgroup’s co-chair Frederick Meier, MD,
in a presentation titled “Coming Soon to Your Lab: National Quality
Indicators for Laboratory Testing,” at this year’s Executive
War College, sponsored by The Dark Report.
In his presentation, Dr. Meier, who is division head of system laboratories
for the Henry Ford Health System in Detroit, analyzed the strengths and
weaknesses of the 12 initial quality indicators and discussed some of
the directions in which a quality reporting initiative might take labs
and the health care system.
The candidate quality indicators are as follows:
- Diabetes monitoring (system)
- Hyperlipidemia screening (system)
- Test order accuracy (preanalytic)
- Patient identification (preanalytic)
- Blood culture contamination (preanalytic)
- Adequacy of specimen information (system/preanalytic)
- Accuracy of point-of-care testing (analytic)
- Cervical cytology/biopsy correlation (analytic)
- Critical value reporting (post analytic)
- Turnaround time (postanalytic)
- Clinician satisfaction (system/postanalytic)
- Clinician followup (system/postanalytic)
The list includes a number of process quality indicators that testify
to the accuracy and efficiency of laboratory testing, Dr. Meier said.
“These include doing the right test, identifying patients and specimens
correctly, reporting critical values, and getting test results back rapidly.”
Blood culture contamination is a particularly good measure of specimen
collection quality that is linked directly to patient outcomes. “Published
studies have demonstrated that people with contaminated blood culture
samples have longer hospital lengths of stay and more nosocomial infections,”
Dr. Meier told CAP TODAY. The infections result from unnecessary intravenous
access, antibiotic-induced super infections, and antibiotic-associated
The CDC championed the diabetes monitoring with hemoglobin A1c and hyperlipidemia
screening indicators because they focus on measures that assess and monitor
heart disease and diabetes, which are the two major causes of morbidity
for Medicare and Medicaid populations, Dr. Meier says. Hyperlipidemia
screening would include cholesterol, LDL, HDL, and triglycerides, which
are part of the Health Plan Employer Data Information Set, or HEDIS, used
by the National Commission on Quality Assurance to evaluate health plans.
The CDC’s Dr. Boone says diabetes monitoring and hyperlipidemia
screening are health care rather than lab-service measures. “But
because health care payers use the measures so broadly to evaluate quality
of care—and labs play a key role in providing the basic information
for that evaluation—the measures really provide a nice link between
lab services and health care.”
Several of the candidate measures have been validated in the CAP’s
Q-Tracks program, which offers continuous quality monitoring for clinical
and anatomic pathology laboratories with longitudinal tracking of key
- Patient and specimen identification. “Measurement of patient
identification is a Q-Track-validated QI that can clearly be done,”
one associated with improvements related to specific institutional practices,
Dr. Meier says. Labeling specimens at the bedside or point of care has
also been shown to reduce patient ID errors.
- Test order accuracy, if the indicator simply involves detecting transcription
errors. The Q-Tracks program has shown that redundant order-entry approaches
reduce errors in test order accuracy, Dr. Meier says. There are also
feasible monitors for duplicate test orders. But if the measure is defined
as monitoring whether the right test for an indication is ordered, he
says, most laboratorians are at a loss as to how to monitor that as
a quality indicator.
- Blood culture contamination. The blood contamination Q-Tracks study
found that institutions have significantly less blood culture contamination
when dedicated phlebotomists under direct supervision of the laboratory
collect the blood culture samples, says Dr. Meier.
- Adequacy of specimen information, if the indicator is limited to
specimen labeling, which has yet to be determined. “But nonlaboratorians
in the IQLM Quality Indicator Workgroup say there is often other information
that should be submitted with specimens to help labs and clinicians
interpret the results,” Dr. Meier says. “They want labs
to monitor that information to reduce omissions.”
- Turnaround time. This indicator is also “Q-Track-able,”
Dr. Meier says, and shows modest improvement just by virtue of tracking
- Critical value reporting. “This quality indicator would involve
an institution measuring how quickly it delivered critical values and
how infrequently it was unable to deliver a result designated as critical,”
Dr. Meier says. He predicts that the critical value reporting indicator,
if implemented, could hasten consensus among pathologists and clinical
labs on which values are critical in various settings.
- Clinician satisfaction. The College has also done Q-Probes studies
on clinician satisfaction. (Q-Probes studies take a statistical snapshot
in time of a single primary performance indicator and possible influencing
variables at participating institutions.) “CAP’s Laboratory
Accreditation Program already requires a satisfaction survey at least
every two years,” Dr. Meier adds, noting that satisfaction is
itself a measurable outcome.
In Dr. Meier’s view, two of the candidate indicators are problematic.
These are accuracy of POC testing and cervical cytology-histology correlation.
“The former is a nebulous monitor,” he says. “And evidence
shows that the latter does not improve process, let alone outcome quality.”
Yet the Centers for Medicare and Medicaid Services and the CDC have experienced
serious problems with waived test accuracy, most of which is point of
care, and with the CLIA-mandated cervical cytology/histology correlation,
Dr. Meier notes. “So these federal agencies would like to use the
National Quality Forum consensus process to figure out how they can discharge
these two regulatory responsibilities in a useful way,” though he’s
not sure such a solution will be forthcoming.
How might a quality indicator for POC accuracy be reported? Judy Yost,
director of the CMS Division of Laboratory Services, says she’ll
leave the design of the indicator to the experts. But she speculates that
the measure may be able to be reported in the number of labs within a
total population or incidents in which specific problems or indicators
are identified as having an actual or potential impact on the quality
of testing. “To monitor, you might do some sort of self-survey crafted
to tease out these issues, or conduct focused on-site visits,” she
says. She sees POC testing accuracy as an important indicator “since
so much testing is moving in that direction and test quality should be
assured regardless of where the test is performed.”
As a candidate indicator, clinician followup for lab test results is
also still nebulous, Dr. Meier says: “A quality indicator looking
at clinician followup would require evidence-based protocols for acting
on specific sorts of test results. And laboratorians fear that if the
clinician followup index were to require laboratories to ensure that clinicians
‘do something’ with abnormal test results, laboratorians would
be placed in a policing role that would set labs up to fail” on
Addressing clinician followup is one of those “cross-cutting issues”
that requires laboratorians and nonlaboratorians to work together, agrees
the CDC’s Dr. Boone, who adds that one of the institute’s
goals is to bring stakeholders with different perspectives to the table.
Computerized systems that link test results to evidence-based clinical
protocols could play a role in helping ensure clinicians do what’s
best for patients. Such systems are, in fact, already in play in some
large health care systems. As an example, Vanderbilt University Medical
Center’s computerized physician order-entry system includes dozens
of care protocols for clinician followup of inpatient lab testing.
“The CPOE system includes protocols such as an anticoagulation
adviser that suggests optimal therapy for patients with clots in their
legs or lungs,” says Randolph A. Miller, MD, an internist and university
professor of biomedical informatics, medicine, and nursing at Vanderbilt.
Robert Michel, editor of The Dark Report, predicts that the
more that ordering physicians feel pressure to improve their own quality
performance on standardized measures, the more motivation they will have
to consult pathologists for help in selecting the right lab tests and
using test results to improve outcomes.
Some experts predict that implementing valid national lab quality indicators
could reduce the volume of ineffective laboratory testing. Dr. Meier explained
the backdrop for this concept at the Executive War College by pointing
to two ostensibly conflicting hypotheses about the impact of lab testing
on patient care.
“The Wennberg-Fisher model presents data that lab testing, at best,
has no impact on health care outcomes,” Dr. Meier said. In fact,
more testing, in some cases, may actually cause harm. In that sense, less
lab testing is better. According to this model, lab testing is what’s
known as a “supply-sensitive service,” which means the more
lab testing is available, the more it’s done, even though the services
do not have any measurable impact on patient outcomes. “Supply-sensitive
services account for about 30 percent of CMS’ costs, so they have
the payer’s attention,” Dr. Meier said.
For example, “the amount of lab testing done in the most consumptive
one-fifth of Medicare regions is almost twice the test volume done in
the least consumptive quintile, so the difference is dramatic,”
he added. “Yet these differences in testing are not affected by
differences in diagnoses or different measures of illness severity among
patients.” (The Wennberg-Fisher data are summarized in a special
edition of Health Affairs published in fall 2004.)
By contrast, another economic analysis, by Frank Lichtenberg of the National
Bureau of Economic Research, who was at the institute meeting in April,
“shows that the amount of money spent on developing and providing
certain new tests is less than the savings produced by using these tests
in patient management,” Dr. Meier says. Examples are tests for hemoglobin
A1c and hyperlipidemia that are used to monitor patients with diabetes
mellitus and those with hyperlipidemia who are treated with effective
While not cited in the candidate quality indicators, testing for microalbuminuria
at levels below that detected by urine dipsticks can also be linked to
measurable positive patient outcomes in diabetic or hypertensive patients
when the testing triggers appropriate medical intervention, Dr. Meier
says. Better diabetic control or use of ACE inhibitors in such cases,
for example, has been shown to stave off progression of chronic kidney
disease or at least delay the need for dialysis.
To explain how both of the hypotheses about the impact of lab testing
could be valid, Dr. Meier postulates that the positive impact of effective
cost-saving testing described by Lichtenberg may be diluted by the huge
volume of ineffective testing that’s done routinely.
That is, “the ineffective testing can be thought of as ‘noise,’
whereas the effective testing is the ‘signal,’” Dr.
Meier explains. Laboratory quality indicators can lessen the distracting
noise and enhance the signal that leads to positive outcomes. “By
increasing process quality in clinical lab testing that monitors and reduces
defects, health care systems can dampen or reduce the noise of ineffective
testing,” he says. “The effort to link testing practices to
beneficial outcomes is an attempt to amplify the signal that the noise
has been obscuring.”
Unnecessary tests, of course, can result in increased morbidity or mortality,
says Vanderbilt’s Dr. Miller. Vanderbilt has found that using a
peer-management resource-use approach to ordering of serum chemistry panels
has reduced testing for all components in the panel by 30 percent without
a concomitant increase in patient morbidity or mortality.
Before the new system went into effect, many Vanderbilt physicians were
ordering the basic metabolic panel every morning (all seven tests daily)
in an “automatic” way, says Dr. Miller. Those physicians can
now order the panels only one day at a time, and even then, they must
order the seven components separately. The ordering physician must view
a Web page within the computerized physician order-entry system that graphs
the patient’s last week of results for each component of the panel.
If the graph shows unchanging or normal results for a given component
test, the physician has a strong incentive to not order another test instance.
A study by Dr. Miller and his colleagues published in August 2004 in
the Annals of Internal Medicine showed that when Vanderbilt physicians
ordered serum chemistry panels in recurring, “autopilot” mode,
they discontinued the testing, on average, one or two days later than
they did after the intervention that made them decide daily whether to
order any tests at all. A net decrease in testing of even 20 percent (one
day out of an average hospital stay of five days) could translate into
millions of tests not done each week at the national level, Dr. Miller
Implementing process quality measures may also lower labs’ costs.
Lean labs cut their costs by adopting the single-flow manufacturing principles
that catapulted Japanese automakers to world-class status. “And
Lean principles used by labs address the same issues as do the Q-Tracks-validated
quality measures,” says Dr. Meier. For example, Lean labs have systems
to verify test orders and stop the flow of misidentified specimens.
The government is counting on quality measures to lower health care costs
by improving patient outcomes and tying provider reimbursement to performance.
Pay-for-performance (P4P) is the background against which the CMS sees
efforts to set quality standards and indicators to monitor them, Dr. Meier
said at the Executive War College. “The P4P penalties for providers
in the lowest or 10th percentile performance stratum are there to keep
the P4P initiative ‘cost-neutral,’” he adds.
If you listen to CMS administrator Mark McClellan, pay-for-performance
is a major part of the agency’s agenda, says Kenneth W. Kizer, MD,
MPH, president and CEO of the National Quality Forum, Washington, DC,
who notes that CMS plans to start pay-for-performance in ambulatory settings
next year. Acute-care hospitals that voluntarily report their performance
on selected quality measures will receive the full Medicare rate hike
again this year, or 0.4 percent more than their nonreporting counterparts.
Pay-for-performance extends beyond government payers: There are currently
more than 100 P4P initiatives in the private sector. Though none involves
labs as far as Dr. Kizer knows, “one has to think that private payers
are considering that approach for labs.
“Labs may be less visible than hospital care, but labs are part
of the health care system and are certainly important from a quality perspective.”
Even if quality indicators do not play an immediate role in laboratory
pay-for-performance, they may soon become a part of laboratory inspection,
Dr. Meier predicts. “Inspectors already get laboratories’
proficiency testing information before they inspect laboratories; certainly
indicators about lab performance will be another item that surveyors can
use as context for their on-site examination of laboratory performance.”
Some say the CMS applies a back-door form of pay-for-performance through
survey fines and decertification from government payer programs triggered
by poor performance on quality indicators. “In some ways, I suppose
you could characterize it that way,” Dr. Kizer says. By contrast,
the government’s new vision of pay-for-performance is more of a
reward system. “The potential value of pay-for-performance is that
it provides incentives and rewards for doing better, so it’s not
just a big stick. Big sticks only go so far, since human beings respond
better to positive rewards and feedback,” Dr. Kizer says.
That’s not to say the government shouldn’t levy fines and
penalties on providers that do egregious things, he adds. “But using
a punitive approach toward long-term care facilities, for example, over
the past two decades hasn’t produced the quality improvements the
government would like to see. One of the lessons we have learned and which
is being stressed by the National Commission for Quality Long-Term Care,
which the NQF sponsors, is that we need a new approach to promoting quality.”
Standardized national quality measures may hold some unexpected perks
for laboratories competing for contracts with payers based on quality
performance. CDC’s Dr. Boone notes that some laboratories have expressed
concerns about payers demanding certain quality measure information which,
in some cases, the labs hadn’t collected.
“And it’s hard to compete if you don’t have what payers
are asking for,” Dr. Boone says. “If a common set of performance
measures were developed that all payers could agree to, the laboratories
would at least know what to expect.”
Karen Lusky is a writer in Brentwood, Tenn.