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Should the public have direct access to lab services?

A generation ago, clinical medicine was strictly paternalistic. Physicians were taught by word and deed throughout their training and beyond that patients were uniformly unsophisticated about medical matters. The physician's function was to think for them and make all their health care decisions for them.

While physicians of this era generally explained diseases to their patients, they often kept the diagnosis secret if they felt patients could not "deal with" the information-whatever that meant. Sometimes physicians refused to explain the results of laboratory or x-ray tests on the grounds that patients were unable to comprehend the information. Many times doctors would simply inform patients that they were to undergo surgery the following morning. Characteristically, the patients would acquiesce without dissent.

Medicine was prescribed with no accompanying explanation of potential ramifications or available alternatives. Often the medication served only to make the patient sicker. Patients were recruited into clinical studies of new forms of therapy without their knowledge. These were the so called good old days. * The 1990s. The situation has changed, and very much for the better. Physicians have largely shed their paternalistic approach, narrowing the gulf between themselves and their patients. The magical aura is gone, although the long white coat and certain other trappings remain.

Consumer awareness, marketplace economics, high technology, and plaintiffs' attorneys have transformed medical practice. The family practitioner in the Norman Rockwell mode has been transformed into the businesslike, regulation-minded, technically oriented specialist of today.

At least one vestige of the old paternalism lingers: The physician remains the gatekeeper to testing. Even this is beginning to change, however, as patients increasingly demand direct access to testing services and to test results that pertain to their own well-being.

The trend is unmistakable. At one time virtually all laboratory testing was ordered by physicians. Now tests are ordered not only by allied health professionals, such as nurse epidemiologists and nurses in intensive- and critical-care units and emergency departments, but also by prison officials, nursing home personnel, insurance companies, military authorities, prospective employers, adoption agencies, judges, attorneys, and of course patients themselves. 9 Gaining access. Patients gain direct access to testing through health fairs in shopping malls, cholesterol screenings in pharmacies, and other nontraditional settings. Popularity is growing for FDA-approved self-test kits for pregnancy, fecal occult blood, and ovulation as well as those used to monitor urine and whole blood glucose. Other self-test kits are certain to follow.

Many states already permit-or at least do not forbid-direct consumer access to clinical laboratories for testing. California and Nevada recently enacted legislation permitting limited direct access to the services of licensed laboratories if the type of test requested is also available as a self-test kit approved by the FDA. o Meeting public demand. Pharmacies appear to be heavily involved in direct access screening programs. Drugstores sell self test kits to consumers and perform tests for patients on site as well.

According to the Inspector General's November 1989 report on cholesterol screening,' a recent survey of the top 100 pharmacy chains conducted by Drug Store News revealed that four times as many chains were offering screenings in 1988 as in 1986. On average, I I I customers were being screened per day in each such drugstore. Half of respondents said they performed screening to contribute to their health care image and to " bu i id traffic. "

Nearly half of the chains said they offered screening four or more times per year; more than half said they collaborated with an outside group to provide screening. Most respondents reported charging a fee, usually to cover costs rather than to make a profit. The average fee was about $6.00. 9 Numbers speak. Statistics in an October 1989 report on home testing devices from the Office of the Inspector General underscore the public demand for self-test kits. The document states that an estimated 20 per cent of U.S. households have used at least one home testing product, for total annual industry sales of $600 million to $800 million. "Analysts have predicted, " the report states, "that all American households will engage regularly in home testing of some sort by the year 2000. "

The IG report presents results of a public poll conducted by the Roper Organization in 1986. Of the 1,997 adults contacted, 12 per cent had used a blood pressure test device at home and 7 per cent had used a blood sugar measurement device at home. Nine per cent of female respondents had used a home kit to determine pregnancy.

All 34 pharmacies visited for the IG study carried in vitro self test kits. All but one of the stores sold home pregnancy test kits; 28 (82 per cent) sold ovulation monitoring tests. Eighty-two per cent sold blood glucose or blood sugar testing kits and half sold colorectal screening kits. Many sold glucose monitoring devices and blood pressure monitors.

Additional findings from the IG report can be found in "Statistics on the popularity of self-testing devices" elsewhere in this article. o Hesitant steps. While the public clamors for easy access to health testing, remnants of the old paternalism persist. The November 1989 IG report on cholesterol screening states: "The majority of respondents in this study, as well as the NCEP [National Cholesterol Education Program], say that effective screening programs must provide education, counseling and referral of screenees. To ensure that providers include these elements in their programs, we recommend that the Department consider using the NCEP guidelines as a starting point to establish regulatory standards under CLIA 1988.

The IG report on home testing reveals that American Public Health Association officials have written to the FDA expressing strong reservations about self testing. APHA suggests, "Home testing by consumers should be limited to on-going monitoring activities under the supervision of a physician." The American Pharmaceutical Association suggests that certain types of home testing devices be distributed only through licensed health care professionals, such as pharmacists or physicians.2

Others have observed that "the accuracy and usefulness of public cholesterol screening are compromised by poor quality assurance, inadequate on-site counseling, and lack of referral to a physician when appropriate. " Some find a danger in that the accuracy of results of home pregnancy test kits depends on the user's technical skill. In addition, the instructions in most kits fail to warn women who may be pregnant to refrain from smoking, drinking, and other activities known to be hazardous during pregnancy. o Ongoing studies. Laboratory professional societies are carefully monitoring the direct access trend. In 1989 the American Society of Clinical Pathologists appointed a committee to study ethical and scientific aspects of this emerging health care trend.

On March 24, 1990, the ASCP board of directors endorsed the following position statement, reflecting the association's consensus that direct access to health testing is in the public interest: "Direct patient access to testing performed by licensed laboratories offers a scientifically sound and medically appropriate alternative to home testing. " In addition, "Home testing and public health 'shopping mall') screening are responses to consumer interest in improving their health care. The alternative to home testing is direct patient access to licensed testing facilities. "

Many questions remain to be answered. Should consumers be permitted to perform and order every lab test themselves, or should the menu of options be restricted? If the menu is restricted, what rules or protocols will be used to determine whether direct access to these tests will be permitted?

is it anyone's concern besides the consumer's whether he or she is able perform a given self-test correctly? How much interpretive information should consumers receive with results of self-tests? Finally, should mandatory counseling accompany some or all tests requested directly by consumers, to insure public health and safety?

Finding the answers to these questions will take time and experience. How many of the answers will be found through planning and how many through mistakes and legal recourse has yet to be seen. Without question is that the burgeoning of direct access will reshape the way consumers determine whether and when to seek medical care. The resulting impact on the laboratory community is likely to be a substantial one that will warrant careful watching and monitoring. n
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Author:Soloway, Henry B.
Publication:Medical Laboratory Observer
Date:Jun 1, 1990
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