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Controlling overutilization of the lab.

Computers can be a useful tool in trying to reduce overutilization of the laboratory by clinicians.

This was indicated in a study conducted by a team from the Indiana University School of Medicine and reported in the May 24 issue of the New England Journal of Medicine.'

Physician orders for outpatient diagnostic tests were 14 per cent lower per patient visit when charges were displayed at a microcomputer workstation used for ordering the tests. "The computer-display message about the charges for specific tests, delivered when the tests were ordered, seemed to make the physician generally more aware of the co involved," said William M. Tierney, M.D., and his coauthors.

The elaborate study was carried out at an academic primary care medical practice in Indianapolis. It involved 121 physicians and more than 15,000 patient visits. All tests were ordered at microcomputer workstations by the physicians. For half (the intervention group), the charge for the test being ordered and the total charge for tests for that patient on that day were displayed on the computer screen. The remaining physicians control group) also used the computers but received no message about charges.

During the 14 weeks before the study, the number of tests ordered and the average charge for tests per patient visit were similar for both physician groups.

In the 26-week study period, physicians in the intervention group ordered 14 per cent fewer tests per patient visit than their control group counterparts, resulting in test charges 13 per cent, or $6.68 per visit, lower. The differences were greater for scheduled visits (17 per cent fewer tests and 15 per cent lower charges) than for unscheduled, urgent visits (I I per cent fewer tests and 10 per cent lower charges).

Alas, the reduced ordering patterns were not permanent, however. During the 19-week post intervention period, the difference between the two physician groups narrowed. The number of tests ordered by the intervention group was only 7.7 per cent lower than the control group, with test charges only 3.5 per cent lower.

"It appears that physicians may need to be continually reminded of the charges for tests if they are to maintain their cost-consciousness," the authors suggested.

The researchers considered the possibility that the savings resulting from their intervention might be offset by increases in the patients' use of other resources or by worse outcomes. For the 26-week intervention period and the following 26 weeks, they counted the number of hospitalizations, ER visits, and visits to all other outpatient clinics for the 8,392 patients who visited the studied facility during the intervention period. There were no significant differences in these possible adverse outcomes for the patients seen by the two physician groups.

The study also evaluated the effect of intervention on physicians' knowledge of the charges for 13 tests. Before the intervention, the physicians' absolute error rate was substantial; the mean error was 44 per cent for the intervention group and 45.6 per cent for the control group.

Questioned again at the end o the intervention period, the physicians showed little imp The mean error was 42.4 per cent for the intervention group and 42 per cent for the control group. Erroneous estimates of charges were both high and low; the overall average estimate of the physicians was 10 per cent higher than the actual charges for all 13 tests. The degree of error did not differ between the intervention and control groups, and accuracy did not improve after the intervention for those in the intervention group.

Despite the short-lived benefits of their protocol, the authors were optimistic about it. "Our intervention," they said, "significantly reduced outpatient testing for all patients in a busy academic medical practice. We intervened while the physician was dealing with an individual patient-a strategy that is more effective than providing feedback after the visit.... Our contention [is] that physicians will alter their behavior when given information about the cost side of the cost-benefit equation. " Long-awaited regulations to implement the Clinical Laboratory Improvement Amendments of 1988 were finally published May 21, but it appears the proposed rules will have a long and arduous trek toward industry compliance. As expected, the CLIA 88 proposals outlined in the Federal Register represent a first-ever attempt to regulate all laboratories by test complexity and risk factors rather than by location or type of lab. Rules would apply to all facilities and individuals performing tests on human specimens for diagnosis and health assessment, except for forensic drug testing at labs certified by the National Institute on Drug Abuse.

In the proposed regulatory structure, the Department of Health and Human Services has divided all testing into three categories: Exempt, Level I, and Level 11 (see breakdown in Figure 1). Officials determined that 28 procedures are so simple and low-risk that they require only minimal Federal oversight. Eleven procedures were designated for Level 1, and the remainder fall into Level 11.

Labs performing only exempted tests would qualify for a certificate of waiver, meaning the facilities would only need to register with HHS and submit to random inspections.

Labs conducting any of the Level I or 11 tests would require certification and would have to conform to comparable standards for quality control and proficiency testing. The main difference between these two categories is that Level II carries more stringent personnel requirements.

Uncertainty over the proper placement of various tests was a key impediment to formulating the regulations for the two-year-old law. And it appears likely that issue will remain a bone of contention throughout the public comment period ending Aug. 20.

The American Medical Association, for example, had previously expressed concern that the new structure would force physicians to abandon much of their in-office testing. And while many of the most common, uncomplicated tests are included in the exempt category, it remains to be seen how many physician labs would fall subject to more stringent requirements. Regulators are considering some mechanism to allow doctors to perform tests outside their scope of approval in emergency situations.

HHS is inviting industry comment on its designation of tests among the three categories. Over the longer term, the department will form a technical advisory committee to consider changes that account for advances in test technology, equipment, and methodology.

Because of the implementation lag, HHS is, in essence, proposing a phase-in of compliance. This involves issuance of certain

provisional" certifications for approximately two years.

Labs licensed under CLIA 67 must have provisional certificates as of this month, the period in which most existing licenses were due to expire. At press time, HHS was preparing instructions on how those laboratories should apply for certification.

When the proposed rules are finalized, perhaps late this year or early next, HHS will begin issuing provisional certificates for all non-waivered, non-CLIA 67 labs. That will allow those facilities to continue operating while their level of compliance is determined. Regular certificates will also be issued to interstate labs when the rules are final. Bottom line: All affected test sites will require certification for regulatory compliance sometime during 1992 or 1993. The requirements may be met by a certificate of accreditation from approved programs, a list of which HHS will publish shortly.

Most of the performance standards in the new proposals were taken wholesale from final rules for CLIA 67 labs and Medicare/ Medicaid vendors published March 14 (see Washington Report, May MLD).

As previously outlined, passing scores for proficiency testing (PT) would be 100 per cent for the ABO group, Rho(D) group, and compatibility testing subspecialties of immunohematology. Passing scores for all other specialties and subspecialties would be 80 per cent.

Despite ongoing protests from organized pathology, HHS has maintained its tough stance on cytology PT, including requirements for unannounced, on-site testing events.

Quality assurance provisions are also comparable to those outlined in March. Facilities must implement plans to insure quality in areas such as lab construction, environment, methodology, and equipment and procedure instructions. New requirements for Level I and II labs include: *Adequate ventilation to remove toxic fumes and filter air exhausted from areas where infectious material is handled. * A stable electrical power source that protects equipment from power surges. * Procedure manual additions for specimen storage criteria in each test procedure. * For electrophoresis procedures, a limit of one control in each electrophoresis cell with each test run.

In terms of personnel requirements, HHS says Level I and II labs would have to be directed by a licensed M.D. or D.O.; a Ph.D. in chemical, physical, or biological science; or an individual qualified under state law or a Medicare

grandfather" provision. No bench-level requirements for Level I are given, but the director must insure that personnel have appropriate education, experience, and training to perform their respective test procedures.

For Level 11 facilities, HHS would further impose the same personnel qualifications for MTs and MLTs as in Medicare independent labs.

Officials propose, however, that most Level 11 testing could be done by technicians with specific specialty/subspecialty training and experience. Qualified technologists would still be required for cytology, microbiology, and immunohematology. HHS seeks comments on ways to qualify experienced cytotechnologists who do not meet the full requirements for independent labs.

All personnel requirements would take effect for certified and provisionally certified labs on July 1, 199 1.

Although exhaustive, the May 21 proposals were not a complete work. At this writing, HHS was expected to issue additional plans soon regarding penalties for noncompliance, recognition of accreditation groups and state programs, and responsibilities of state agencies.

The new regulatory framework is intended to be self-financing, which means the lab industry will pay various fees for certification, PT, and inspection. These charges will be detailed by HHS at a later date, but for now officials concede they have no idea what the overall costs will be. Some sources estimate labs applying for certificate of waiver will pay around $500. Level I or 11 certificates may cost $2,000 every two years. Interested parties should submit their written comments to: Health Care Financing Administration, Department of Health and Human Services, Attention HSQ- 176-P, P.O. Box 26676, Baltimore, MD 21207. In such comments, refer to file code HSQ- 176-P. Deadline is Aug. 20; no faxed comments will be accepted. For additional information, contact Rhonda Whalen at (301) 966-6801. n
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Article Details
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Author:Fitzgibbon, Robert J.
Publication:Medical Laboratory Observer
Article Type:editorial
Date:Jul 1, 1990
Previous Article:Creating Levey-Jennings charts on a PC.
Next Article:CLIA '88 regs issued; all labs affected.

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