Journal of Gerontological Nursing

LEGAL ISSUES 

Changes in CLIA Limit Screening Tests

Christal L Arthur, RN, JD

Abstract

Prior to 1992, nurses could use moderately complex laboratory equipment to monitor the health status of patients. Using the equipment, nurses could frequently perform tests such as total cholesterol, hemoglobin, and blood sugar. Recently, rules implemented under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) restrict the nurse's use of the equipment unless a medical director is present, and periodic inspections of personnel, equipment, and lab results are performed.

In the past, nurses assumed a leadership role in the use of screening as a method for early recognition, referral, and treatment of disease. Nurses provided mass immunizations and screenings and ran campaigns for sewage control efforts, clean water, child safety, and improved housing and work settings (Sullivan, 1984).

The economic benefits of screening, prevention, and early treatment have been quantified per patient: inadequate immunization, $354,000; coronary artery disease, $30,000; alcoholism, $250,000; drug abuse, $63,000; lung cancer, $29,000; cervical cancer, $28,000; and infection with the human immunodeficiency virus, $75,000 (Healthy People, 1990). Noneconomic benefits for patients include a setting where patients can participate in health care decisions, choose a health care provider, and control their cost for wellness. In addition, a method was provided for patients to evaluate their wellness, health risks, concerns, and health practices.

CLIA was intended to affect every facility that tests human specimens to provide information ". . . for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of human beings. . ." (Federal Register). Facilities that fall within the purview of CLIA include health screening facilities, public schools, hospitals, private laboratories, home health agencies, blood centers, nursing homes, and private physician offices, among others.

The enactment of CLIA occurred after public and congressional sessions identified concerns about the quality of clinical laboratory testing (Hearings, 1988). There were three major areas of concern. Profit-oriented laboratories were more concerned about their profit margin than their diagnostic accuracy. Second, clinicians were unable to order the appropriate test, accurately interpret the results, and set up a proper course of treatment. Third, physicians and laboratories engaged in fraudulent practices by ordering medically unnecessary tests and overcharging patients, and the laboratories provided 25% to 50% kickbacks to the physicians (Hearings, 1988).

The consequences of the practices performed in laboratories (60% of which are located in physicians' laboratories) were the misdiagnosis and lack of detection of infections and cancers. To address concerns identified by the congressional sessions, CLIA modified the quality assurance requirements, personnel requirements, and proficiency testing requirements for agencies performing lab tests.

Rule makers anticipated that the implementation of the rules would increase the cost of lab tests, but they indicated that the direct increase in costs would fall on the laboratories themselves. Rule makers anticipated the following increases: 1% for hospitals and independent laboratories, 10% for physicianoperated laboratories, and an overall 25% in the cost of each lab test (Federal Register). They concluded within their cost/benefit analysis that non-poor American households were willing to pay 25% more for laboratory services (Federal Register).

Unfortunately, the consequences in the public health setting (ie, screening) were not considered by rule makers. Because there were no provisions within the statute to exempt public screening programs, patients will incur additional costs to obtain the same tests. For example, unless nurses' associations have a medical director (a sizable cost) managing their laboratory testing, they cannot meet the CLIA requirements to provide inhouse testing. Although associations can purchase laboratory testing from private laboratories, the cost for each test far exceeds the anticipated 25% increase by rule makers. Thus, under CLIA, patients can no longer use screenings as an inexpensive…

Prior to 1992, nurses could use moderately complex laboratory equipment to monitor the health status of patients. Using the equipment, nurses could frequently perform tests such as total cholesterol, hemoglobin, and blood sugar. Recently, rules implemented under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) restrict the nurse's use of the equipment unless a medical director is present, and periodic inspections of personnel, equipment, and lab results are performed.

In the past, nurses assumed a leadership role in the use of screening as a method for early recognition, referral, and treatment of disease. Nurses provided mass immunizations and screenings and ran campaigns for sewage control efforts, clean water, child safety, and improved housing and work settings (Sullivan, 1984).

The economic benefits of screening, prevention, and early treatment have been quantified per patient: inadequate immunization, $354,000; coronary artery disease, $30,000; alcoholism, $250,000; drug abuse, $63,000; lung cancer, $29,000; cervical cancer, $28,000; and infection with the human immunodeficiency virus, $75,000 (Healthy People, 1990). Noneconomic benefits for patients include a setting where patients can participate in health care decisions, choose a health care provider, and control their cost for wellness. In addition, a method was provided for patients to evaluate their wellness, health risks, concerns, and health practices.

CLIA was intended to affect every facility that tests human specimens to provide information ". . . for the diagnosis, prevention, or treatment of any disease or impairment of, or assessment of the health of human beings. . ." (Federal Register). Facilities that fall within the purview of CLIA include health screening facilities, public schools, hospitals, private laboratories, home health agencies, blood centers, nursing homes, and private physician offices, among others.

The enactment of CLIA occurred after public and congressional sessions identified concerns about the quality of clinical laboratory testing (Hearings, 1988). There were three major areas of concern. Profit-oriented laboratories were more concerned about their profit margin than their diagnostic accuracy. Second, clinicians were unable to order the appropriate test, accurately interpret the results, and set up a proper course of treatment. Third, physicians and laboratories engaged in fraudulent practices by ordering medically unnecessary tests and overcharging patients, and the laboratories provided 25% to 50% kickbacks to the physicians (Hearings, 1988).

The consequences of the practices performed in laboratories (60% of which are located in physicians' laboratories) were the misdiagnosis and lack of detection of infections and cancers. To address concerns identified by the congressional sessions, CLIA modified the quality assurance requirements, personnel requirements, and proficiency testing requirements for agencies performing lab tests.

Rule makers anticipated that the implementation of the rules would increase the cost of lab tests, but they indicated that the direct increase in costs would fall on the laboratories themselves. Rule makers anticipated the following increases: 1% for hospitals and independent laboratories, 10% for physicianoperated laboratories, and an overall 25% in the cost of each lab test (Federal Register). They concluded within their cost/benefit analysis that non-poor American households were willing to pay 25% more for laboratory services (Federal Register).

Unfortunately, the consequences in the public health setting (ie, screening) were not considered by rule makers. Because there were no provisions within the statute to exempt public screening programs, patients will incur additional costs to obtain the same tests. For example, unless nurses' associations have a medical director (a sizable cost) managing their laboratory testing, they cannot meet the CLIA requirements to provide inhouse testing. Although associations can purchase laboratory testing from private laboratories, the cost for each test far exceeds the anticipated 25% increase by rule makers. Thus, under CLIA, patients can no longer use screenings as an inexpensive method to monitor their health status, cannot monitor their health risks and their health concerns independently, and are limited in their choice of providers for testing. The rule makers acknowledge that the participant will incur higher out of pocket costs for tests. For the poor, this may be a burden too great to bear.

REFERENCES

  • Cancer Detection in Women. 1988 Hearing, Serial No.100-529.
  • Clinical Laboratories. 1988 Hearings, Serial No. 100-146.
  • Clinical Laboratory Improvement Act. 1988 Hearing, Serial No. 100-167.
  • Deadly Mistakes: Are Laboratory Results Reliable? 1988 Hearings, Serial No. 100-43.
  • 57 Federal Register No. 40 p. 7002-7243.
  • Health Care Financing Administration's Management of Medical Laboratories, 1988 Hearings, S. Hrg. 100-765.
  • Healthy People 2000, National Health Promotion and Disease Prevention Objectives, DHHS Publication No. (PHS) 9150213.
  • Sullivan, J. 1984 Directions in Community Health.

10.3928/0098-9134-19930101-09

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