Office-based Laboratories Research Articles

The Cost of Implementation of the Clinical Laboratory Improvement Amendments of 1988—The Example of Pediatric Office-Based Cholesterol Screening

To measure the additional costs of office-based laboratory testing due to the implementation of the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88), using cholesterol screening for children as an example. Four- to ten-year-old children who received their well child care at one of seven participating pediatric practices were screened for hypercholesterolemia. The average number of analyses per day and days per month were derived from the volume of testing completed by the practices. Nurses and technicians time in the screening process were measured and personnel costs were calculated based on salary and fringe benefit rates. Costs of supplies, analyzing control samples, instrument calibration, and instrument depreciation were included. Costs estimates of screening were then completed. CLIA '88 implementation costs were derived from appropriate proficiency testing and laboratory inspection programs. In six practices completing a low volume of testing, 2807 children (5 to 6 children per week) were screened during the observation period, while 414 (about 25 children per week) were screened in one high-volume practice implementing universal screening over a 4-month period. For the six low-volume practices, the cost of screening was $10.60 per child. This decreased to $5.47 for the high-volume practice. Estimated costs of CLIA '88 implementation, including additional proficiency testing and laboratory inspection, added $3.20 per test for the low-volume practices, and $0.71 per test for the high-volume testing. Implementation of CLIA adds significantly to the cost of office-based chemistry laboratory screening. Despite these additional expenses, the cost of testing is still within a reasonable charge for laboratory testing, and is highly sensitive to the volume of tests completed.

The Office Laboratory

Few areas of medicine are experiencing such tremendous growth as the office-based laboratory. Recent advances in technology and changes in reimbursement practices have greatly expanded the potential of this segment of patient care. In the 1990s the physician has opportunity to introduce many testing procedures to the office laboratory that were not available 20 years ago. Requirements in the areas of quality assurance and quality control are constantly changing. These regulations vary from state to state and each laboratory should know what is required by their respective certifying agency. In today's market, the physician must choose between the referral laboratory or the resources in the office and consider which option provides the best in care and cost to the patient.

Regulatory Considerations in the Establishment and Expansion of Office-Based Laboratories

As a result of changing patterns of medical practice, technology, and reimbursement, office-based clinical laboratory testing is increasing substantially. This article reviews current federal and state regulations covering such laboratories and comments upon likely trends in these regulations. Various economic and political issues associated with office-based clinical laboratory regulation are also discussed.

Issues and Trends in the Regulation of Office-Based Clinical Laboratories

Office-based clinical laboratories are the least regulated of all laboratories as a result of familiar forces in the politics of the regulation of medicine. This article discusses the evolution of these regulations and summarizes the applicability and intent of federal and state rules. Counterbalancing forces in the present political and medical environment tending simultaneously toward greater and lesser regulation are discussed.

Effect of medicare/medicaid reimbursement policies on diagnostic methodology in the physician's office

The Deficit Reduction Act of 1984 has mandated the most significant change in Medicare payment for clinical laboratory testing services since the program's inception in 1965. The reasonable charge methodology previously used for determining payment for laboratory services under Medicare Part B has been replaced with a fee schedule applicable to laboratory services provided in physician's offices, independent laboratories, and hospital outpatient laboratories. Physicians are now prohibited from billing Medicare or Medicare patients for outside laboratory tests, including professional interpretation of these outside laboratory results. The new regulations appear to provide strong incentives for office-based laboratory testing, and the development of more sophisticated laboratory technology has allowed office labs to perform accurate and reliable analyses at realistic costs that are the equivalent of the services of independent laboratories. The exemption of physicians' office laboratories from licensure requirements has generated controversy among pathologists' groups and laboratory administrators.