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1
Clinical Chemistry Laboratory, Hartford Hospital, 80 Seymour St., Hartford, CT, 06102. Fax 860-545-5206.
2
Office of Biostatistical Consultation, University
of Connecticut Health Center, 263 Farmington Ave., Farmington, CT
06030.
a Author for correspondence.
| Abstract |
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Key Words: indexing terms: laboratory management turnaround times outcomes analysis Diagnosis Related Group random-access analysis creatine kinase isoenzymes
| Introduction |
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The practice of cardiology continues to evolve at a rapid rate, such
that utilization of cardiac markers for patients with ischemic heart
disease is one area in which outcomes analysis is particularly
warranted. Efficient testing policies will have a dramatic effect on
costs, given the high number of hospital admissions per year for
cardiac patients (>700 000 for Medicare alone). Moreover, Medicare
weighting factors for cardiac DRGs (Table 1
) are among the highest of all medical DRGs listed by the Health
Care Financing Administration (HCFA) (1). The clinical
chemistry laboratory has traditionally played a large role in triage,
diagnosis, and management of coronary artery disease. The assay for
creatine kinase (CK) MB isoenzyme has become standard practice for
serologic diagnosis of acute myocardial infarction (AMI). Guidelines
established by the American College of Physicians recommend use of CK
and lactate dehydrogenase isoenzymes at admission and at 12 and 24
h after admission (2). In uncomplicated AMI cases,
activities of total CK and CK-MB increase and return to normal limits
within 34 days, usually before the patient has been discharged. Some
AMI patients, however, develop complicationse.g., congestive heart
failure, postinfarction angina, cardiogenic shock, and
reinfarctioneither while hospitalized or within a few weeks or months
after discharge (3)(4)(5). Thus, it is typical practice for
cardiologists to continue ordering assays of total CK and CK-MB until
the day of discharge. Some laboratories have elected to use myoglobin
or CK-MB isoforms to detect new injury attributable to complications,
because these markers rapidly return to normal after the initial insult
(6)(7); however, use of these markers is not
yet as widespread as CK-MB testing. Although not specifically
documented, lactate dehydrogenase isoenzymes and cardiac troponins T
and I are not likely to be as useful as CK-MB for detecting
postinfarction ischemia because their concentrations remain abnormally
high for a week or more after AMI, obscuring the release of proteins
and enzymes from any subsequent injury (8)(9).
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The present study was designed to determine whether the frequency of CK-MB testing is associated with hospital lengths of stay (LOS) and laboratory charges for cardiac DRGs. A prospective placebo-controlled LOS triali.e., at a single hospital in which some patients would receive stat CK-MB results and others would receive batched resultscannot be justified on an ethical basis. Therefore, we compared retrospective data from one hospital with those from another for a homogeneously reimbursed patient population.
| Materials and Methods |
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Medicare patients were chosen because the reimbursement policies are prospective and because financial incentives to reduce LOS and test utilization costs are uniform across the state. We were not able to use the All Patient Refined DRGs classifications, because these data were not available until after 1994 (11). The All Patient Refined DRG index, which incorporates complexity subclasses for each DRG (ranked from minor to extreme), would have been useful to subclassify hospital and patient groups.
Total numbers of patients in each DRG were broken down into age categories of <25-44, 4564, 6590 (in 5-year increments), and >90 years. Because these were all Medicare patients, most of them were >65. We also obtained the discharge destination (to home, short-term hospital, skilled nursing home, intermediate medical care center, home health, or discharged against medical advice) information for these patients and their total associated laboratory charges.
Data from two hospitals were omitted because one is now closed (CK-MB testing policy was thus unavailable) and the other does not have an on-site laboratory. Data from the remaining 82 hospitals are the basis for this analysis.
hospital demographics
Massachusetts hospitals were broken down into bed sizes as listed
in the 1994 American Hospital Association Guide (12). For
this study, we classified hospitals with <150 beds as small. Those
with bed sizes between 150 and 300 were classified as medium, and those
with >300 beds were large. Hospitals were also classified according to
location, in terms of population area served (denoted by the US Census)
(13): Hospitals in rural areas served populations of
<250 000; hospitals in small cities (Springfield or Worcester areas)
served populations of 250 0001 000 000; and urban hospitals
(greater Boston area) served populations of >2.5 million (no areas in
Massachusetts contained a population between 1.0 and 2.5 million). The
DRG Case Mix Index for the individual providers was obtained from data
published by HCFA (1). This index is an average of
relative weights for medical and surgical DRGs admitted in each
hospital. The higher the average, the greater the number of complicated
cases seen by that provider. As shown in Table 1
, AMI DRGs have higher
weighting factors than do non-AMI DRGs.
laboratory policies for CK-MB testing
Using Massachusetts hospital addresses and telephone numbers
obtained from the American Hospital Association Guide
(12), we contacted chemistry laboratory supervisors and
appropriate bench technologists by telephone to determine what CK-MB
testing policies they used during all or most of fiscal year 1994. The
laboratories were accordingly categorized into one of four groups:
Those conducting CK-MB testing once or twice daily were classified into
group 1, slow; those conducting testing once per shift (three times
daily) were classified into group 2, intermediate; laboratories that
conducted testing as needed on a stat basis or in four or more
scheduled batched runs per day were classified into group 3, fast. We
classified into group 4 the laboratories that used immunoinhibition
(INH screen) to determine CK-B subunit activity and either did not
perform confirmation analysis (e.g., electrophoresis) or conducted
confirmations on a nonstat basis. Laboratories that screened with INH
and confirmed for CK-MB in real time were included in group 3. Although
stat results can be obtained with INH, this assay can produce falsely
high CK-MB values in the presence of interferences such as CK-BB and
macro CK (14). Thus, we put hospitals that used INH
without immediate confirmation into a separate group (group 4) to see
whether the occasional false-positive INH result led to enough
diagnostic ambiguity to affect LOS.
statistical analysis
For each group, the mean (and SD) LOS was calculated from the
total numbers of patients and LOS values reported for each hospital.
Patients whose LOS exceeded the HCFA outlier thresholds, as defined in
Table 1
, were removed from the database. The 95% confidence intervals
(CI) were computed from an established formula (15).
One-way analysis of variance (ANOVA) was used to compare means across
groups. Significant differences between LOS values were determined by
using the Tukey HSD test, with significance indicated by P
<0.05. We also conducted a correlation analysis with LOS as an outcome
measure and patient's age as a covariate; P <0.05 for
Pearson's correlation coefficient was considered significant. Data
were entered and evaluated by using a commercial PC-based package (Ver.
6.1; Statistical Package for the Social Sciences, Chicago, IL).
| Results |
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In general, surviving AMI patients with complications (DRG 121) had
longer mean LOS, 7.9 days (CI: 7.88.0, n = 5984, combining
results for all hospitals), than did those without complications (DRG
122), 5.9 days (CI: 5.86.0, n = 2820). The LOS for AMI patients
who died (DRG 123), 4.9 days (CI: 4.65.1, n = 1397), was
statistically lower than for either of the other AMI groups. For
patients in whom AMI was ruled out, those with a primary diagnosis of
angina pectoris (DRG 140) had longer LOS, 3.4 days (CI: 3.43.5,
n = 8198), than did those with chest pain (DRG 143), 2.5 days (CI:
2.42.5, n = 5122). These LOS results are similar to published
national means for 1994 (Table 1
).
Table 3
, comparing effect of hospital size on LOS, shows that AMI
patients (especially DRG 121) in small hospitals had significantly
shorter mean LOS times than those in medium-size and large hospitals.
An age breakdown of the DRG 121 cases showed that the numbers of
enrolled patients at ages 8590 and >90 years were identical for the
different hospital sizes: respectively 12.2% and 6.4% for small
hospitals, 12.0% and 6.5% for medium, and 11.7% and 5.5% for large.
However, there were some differences in discharge destinations
according to hospital sizes. For DRG 121 cases, small and medium-size
hospitals had a larger percentage of their patients transferred to
other short-term hospitals (25.5% and 24.3%, respectively) than did
large hospitals (14.1%), which are presumably able to handle the more
difficult referral cases. No consistent trend was observed between
hospital size for any of the other DRGs studied.
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Table 3
also shows the mean LOS as a function of the geographic area
serviced by the hospital. Although we saw significant differences
between some groups, there was no consistent trend: e.g., hospitals in
small cities had a longer LOS for DRG 121 than did hospitals in rural
and urban areas, whereas for DRG 143 the rural hospitals had slightly
longer LOS than did the small city and urban hospitals.
Table 4
lists the LOS for various AMI and AMI-rule-out DRGs, grouped
according to CK-MB testing policies. For DRGs 121, 122, and 123, there
were no significant differences in LOS between groups 2, 3, and 4
[i.e., intermediate assay frequency (at least every 8 h), fast
(stat analysis), and INH screen]. We therefore combined the data
for groups 24 and obtained an LOS for DRG 121 of 7.8 days (CI:
7.67.9, n = 4471). In contrast, laboratories who had slow CK-MB
reporting policies (once or twice per day; group 1) had significantly
longer LOS for DRG 121: 8.4 days (CI: 8.28.7, n = 1513). Except
for one marginal exception (DRG 143, group 1 vs 3), we observed no
significant difference between group 1 and any other group for DRGs
122, 123, 140, and 143.
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Table 4
also shows the average total laboratory charge per patient in
these various DRG groups. Although there was no direct correlation
between laboratory charges and CK-MB turnaround times, patients in
group 1 hospitals incurred more total laboratory charges for DRGs
121123 than did those in any of the other groups.
Factors such as hospital size, location, age distribution of patients,
discharge destination, and DRG Case Mix Index were computed (Table 5
) to determine whether these influenced the observation that
group 1 hospitals had longer mean LOS for DRG 121 patients. Mean bed
size had no significant effect because each test-frequency group
contained an approximately equal mix of small, medium, and large
hospitals (see group 1 vs combined groups 24). With regards to
geographic locations, group 1 had a higher percentage of hospitals
located in urban areas and a lower percentage located in rural areas
than did combined groups 24. For age of the patients presenting to
hospitals, group 1 had a slightly lower percentage of patients at
8590 (6.7%) and >90 years (3.1%) than did the composite of groups
24 (10.6% and 5.1%, respectively). However, the Pearson correlation
analysis between LOS and age (combining 8590 and >90 years groups)
for all hospitals showed no significant difference for any of the DRGs
(e.g., P = 0.7 for DRG 121). Discharge
destinations to short-term hospitals, and DRG Case Mix Index, were also
not significantly different between group 1 and any other individual
group or combined groups 24 (Table 5
).
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| Discussion |
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Previous outcomes studies for cardiac markers have focused on the selection of available tests, and the need and frequency of serial sample testing. For example, Fisher and Plotnick (18) suggested that aspartate aminotransferase has no useful role in AMI diagnosis. Lewandrowski et al. (19) instituted a mandatory approval program for lactate dehydrogenase isoenzymes and demonstrated a >99% decrease in testing. Saxena et al. (20), examining the appropriateness of the timing of serial tests relative to the time of admission, found that only a minority of tests were ordered according to recommended protocols. None of these studies reported the effect of changing test-ordering patterns on LOS. In the only study comparing random-access vs batch CK-MB testing, Anderson et al. (21) showed that changing the testing policy from batch to random-access reduced LOS for AMI patients with a nondiagnostic ECG from 8.2 to 6.3 days and laboratory costs from $2194 to $1924. These results were not statistically significant because the two groups studied contained only 23 patients; for patients in whom an AMI was ruled out, however, the LOS difference (4.4 vs 3.0 days) was significant. Their use of historic data for the control group may have biased results because the reductions in LOS may have been caused by increasing pressure in managed care to discharge all admitted patients.
Our study differs from the others because results are computed for
large numbers of patients and the lengths of stay are compared over one
period of time rather than sequentially. However, different medical
practices from one institution to another create many other
uncontrollable variables; a more ideal study would compare LOS from
matched cases from different institutions. Because such data were not
available to us, we attempted to characterize the CK-MB testing-policy
groups according to hospital and patient demographics. For example, one
might expect a shorter mean LOS for hospitals that had a
disproportionately high rate of patient transfers to tertiary
institutions; however, our data showed that this was not the case:
Because there were no differences in DRG mix, hospitals with an
infrequent CK-MB testing policy did not see inordinate numbers of
complicated cases in comparison with hospitals with more frequent
testing policies. Group 1 did have more patients <85 years, which
might favor a shorter LOS, but the Pearson correlation showed no
significant relation between these age groups and LOS. A rural hospital
might also be slower in adopting the new managed-care practices, but
Table 3
showed no consistent trend between LOS and geographic location.
It is possible that laboratories with liberal CK-MB testing policies practice at hospitals that are progressive and more responsive to changes in reimbursement polices. Such institutions might also be biased towards being more aggressive in reducing the LOS for all DRGs. Data for the chest pain DRG 143 were used as a control because this is a noncardiac DRG. Because the LOS for DRG 143 patients in group 1 institutions was no longer than for any other group, we suggest that the higher LOS for group 1 DRG 121 patients was not linked to the progressiveness of the individual hospitals.
We conclude that infrequent CK-MB testing policy is associated with a longer LOS (by 0.7 days) and higher laboratory costs for cardiac patients. The potential impact is tremendous when this difference is multiplied by the millions of cardiac patients seen in the US each year. LOS may be less affected by CK-MB testing policies in AMI-rule-out groups because, in most angina and chest pain cases, stat total CK results are available in all hospitalsand are usually within the normal range, which often obviates the need for further testing for CK-MB. Given that the clinical status of AMI patients is not generally made available to the laboratory, we suggest that all samples be tested on a frequent or stat basis (>3 times a day). The incremental expense for delivering the CK-MB results on a more timely basis does not outweigh the additional overall laboratory costs incurred by keeping patients in the hospital for the extra hours until the next testing run.
| Acknowledgments |
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| Footnotes |
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| References |
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The following articles in journals at HighWire Press have cited this article:
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R Bholasingh, R J de Winter, J C Fischer, R W Koster, R J G Peters, and G T Sanders Safe discharge from the cardiac emergency room with a rapid rule-out myocardial infarction protocol using serial CK-MBmass Heart, February 1, 2001; 85(2): 143 - 148. [Abstract] [Full Text] |
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A. H.B. Wu, F. S. Apple, W. B. Gibler, R. L. Jesse, M. M. Warshaw, and R. Valdes Jr. National Academy of Clinical Biochemistry Standards of Laboratory Practice: Recommendations for the Use of Cardiac Markers in Coronary Artery Diseases Clin. Chem., July 1, 1999; 45(7): 1104 - 1121. [Abstract] [Full Text] [PDF] |
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G. J. Kost, S. S. Ehrmeyer, B. Chernow, J. W. Winkelman, G. P. Zaloga, R. P. Dellinger, and T. Shirey The Laboratory-Clinical Interface: Point-of-Care Testing Chest, April 1, 1999; 115(4): 1140 - 1154. [Abstract] [Full Text] [PDF] |
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R. H. Christenson and H. M. E. Azzazy Biochemical markers of the acute coronary syndromes Clin. Chem., August 1, 1998; 44(8): 1855 - 1864. [Abstract] [Full Text] [PDF] |
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R. H. Christenson, F. S. Apple, D. L. Morgan, G. L. Alonsozana, K. Mascotti, M. Olson, R. T. McCormack, F. H. Wians Jr., J. H. Keffer, and S.-H. Duh Cardiac troponin I measurement with the ACCESS® immunoassay system: analytical and clinical performance characteristics Clin. Chem., January 1, 1998; 44(1): 52 - 60. [Abstract] [Full Text] [PDF] |
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J. R. Hedges Cardiac Enzyme Availability and Hospital Length of Stay Clin. Chem., February 1, 1997; 43(2): 249 - 250. [Full Text] [PDF] |
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