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Seven forces reshaping the clinical laboratory.

Imagine the laboratory as a large ring pulled in many directions. The location of this ring in the future will depend on the relative force of many influences. What are these influences?

Until recently, technology and financial concerns were the major factors influencing the clinical laboratory. Technical advances include automation of fluid dispensing, data processing, antibody-based methodology, and ion-selective electrodes. The laboratory of the future will contend with new oppurtunities in quality management.[1]

In this article I will deal with seven of the major concerns influencing the future laboratory: the supply of technologists, uncertain reimbursement, public health issues, the new demographics, laboratory regulation, medicolegal issues, and biomedical ethics. Once we have have examined these influences we can answer the following questions: What new test will we perform 10 years from now? What test will no longer be performed? Where will we perform test? Who will doo the testing? Who will regulate testing? What new regulations will be enforced? Who will pay for testing? What will be the patient's role in testing? As we answer these questions, we begin to make plans for the future.

Changes in the laboratory are a direct result of changes in clinical medicine. Clinical medicine will become more concerned with maintaining health and preventing disease. So too will tha laboratory. Clinical medicine will change its payment systems. So too will the laboratory. Clinical medicine will be more subject to medicolegal questions and ethical issues. So too will the laboratory. Clinical medicine will become more dependent upon artificial intelligence and other expert systems. Sotoo will the clinical lab.

* Technologisst shortage. Various think tanks and consultants groups assert that oyr field will face a personnel shortage for many reasons. Fluctuations in the birthrate will result in a generally older population. The proportion of the work force older than 65 years of age will expand while the proportion of those who are 18 to 65 will decrease.

The feminist movement has made a significant impact on women's career choices. thirty years ago, the brightest women students went into nursing, medical technology, and teaching. today their counterparts often choose business law, and medicine.

The shortage of supervisory and managerial personnel will continue. This is especially evident today in cytogenetics, cytopathology, and toxicology. The regulations on testing for drugs of abuse and Pap smear cytology as well as heightened interest in cytogenetics will lead to graeter demand for trained personnel in this specialties.

The shortage of technologists will result in the following:

[paragraph] We will raise lab salaries to attract workers.

[paragraph] We will develop more automated instrumentation.

[paragraph] We will establish large referral laboratories. These labs allow greater efficiency than is possible in the hospital laboratory.

I encourage industry and hospital laboratories to looby for our profession and to recruit into our field. Now is the time for us to sing the praises of medical technology in our high schools and junior high schools. It is urgent that we tell students about the opportunities available in our specialty.

* Uncertain reimbursement. Traditionally, changes in health care economics were relatively independent independent of the trends in our national economy. In recession or in inflation, in a growing market or in a diminishing market, health care expenses continued to rise.

This situation is now changing. Congress, looking closely at spiraling budget deficits, targets health care expenses. The state of Massachusetts is a prime example. When its economy was apparently booming, the governor signed a universal health care reimbursement plan. Later, when the state economy suffered, so did reimbursement for health care. This scenario will be repeated on the national scene.

* Enter the RVS. Pathologists and all other medical specialists will be paid for services given to Medicare patients according to the Relative Value Scale (RVS) fee schedule. The RVS represents a single value scale across the nation with geographic adjustment factors built in for all procedures that are performed by physicians. The scale is computed as a function of the time worked, practice expenses, malpractice considerations, and a conversion factor.

This year the RVS for pathologists will result in a 6% drop in fees paid from the amount granted in 1991. Moreover, it will lead to a 30% decrease in payments per service by 1996. RVS will lead to similar reductions in other procedure-based specialties, including radiology, anesthesiology, and various surgical subspecialties. Family practice, general practice, and internal medicine will see a modest expansion in payments per service under RVS.

We will have a national health insurance plan by the year 2001. Preferred provider organizations (PPOs) and health maintenance organizations (HMOs) will continue to receive substantial portions of reimbursement.

Third-party payers such as Blue Cross/Blue Shield and other private insurance companies will monitor test ordering according to clinical diagnosis. In the future, insurance companies may refuse to pay for routine laboratory testing in the healthy person or even the worried well. Many insurance policies have an obligatory deductible; beyond that amount, the insured must pay a percentage, typically 20%, of expenses. These factors will discourage patients from asking for excessive laboratory testing. In PPOs and in HMOs today, clinicians already feel pressure to order fewer tests. Some of this is done implicitly as the physicians receive bonuses for "more efficient" practice of laboratory medicine-even though in some cases, ordering more tests may decrease the patient's total medical expenses for that illness.

Finally, competition based upon test price will grow. Laboratories that provide tests at lower cost will have an advantage. We will look at laboratory testing more as a commodity than as a specialty offering. We will consider testing as a "generic" rather than as a "brandname" product.

The diagnosis related group (DRG) system that has been present in the hospital setting since 1983 will expand to the outpatient setting, where it is now called the "roll-in." The clinician will receive a preestablished fee based upon type of visit, type of patient, and diagnosis. For example, an initial evaluation of a patient with hypertension may provide $180. For monitoring a patient with hypertension during a follow-up office visit, the physician may receive $40. The clinician may keep or dispense part or all of either amount however he or she chooses. What percentage will go to the laboratory? for radiology? for the physician's time and effort? What will be the incentive for doing a test in the doctor's office when it would be cheaper to send it to a referral laboratory? Clinicians will have to make this kind of analysis if the outpatient DRG roll-in becomes part of our reimbursement system.

Medicare supports a per capita reimbursement approach. Thus, a PPO or an HMO would receive a defined payment per subscriber per year. Such a system would tend to lower extra expenses and encourage more efficient use of the clinical laboratory.

Clearly, laboratory testing is necessary for most clinical problems. It is also clear, however, that the low-cost producer will have an advantage in the future. To define the cost of laboratory testing, laboratories will institute automated cost-accounting systems. We will consider the elements of labor, supplies, depreciation, equipment maintenance, quality-related expenses, and marketing expenses. We will add indirect expenses consisting of overhead on the building, medicolegal expenses, and transportation expenses. The result will be a true understanding of the relationship of cost to charge and the relationship of cost to volume of testing.

* Public health issues. Public health will play an important role in the clinical laboratory of the future. Interest is growing rapidly in the study of disposal of biological waste and hazardous chemicals used in the laboratory. OSHA standards issued late last year on AIDS protection are now in force. The same public health concerns within the laboratory will play a role in industry. The practice of occupational medicine will make greater demands on the clinical laboratory. Exposure to chemicals, rare metals, and environmental hazards will require additional laboratory testing. Already testing has grown for blood lead and free erythrocyte protoporphyrin, especially in young children living where they are exposed to paint containing lead.

Attention to drug and alcohol abuse will become more acute. We will see greater interest in supporting the drug-free workplace through National Institute on Drug Abuse (NIDA) testing. As knowledge grows about risk factors for disease, such as hypercholesterolemia as a precursor of heart disease, more individuals will undergo routine screening tests for cholesterol and triglycerides. Laboratories will perform more Pap smears for cervical cancer, CA 125 tests 125 for ovarian cancer in highrisk groups, and prostate-specific antigen (PSA) assays in older men. Blue Cross/Blue Shield recently supported reimbursement for laboratory tests in cancer screening.

* The new demographics. The aged consume a disproportionate part of the health care dollar. As the population ages, the number of individuals who are older than 80 or even 90 years will mushroom. The incidence of chronic disease will rise. Factors demanding greater attention will include the dissipation of health as the body ages, extra time to avail the elderly of the health care opportunities available, and the right of the retiree to enjoy the benefits of Medicare. Older people have a higher incidence of prostate cancer, osteoarthritis, osteoporosis, and diabetes. Laboratory testing in this group will escalate. Testing for geriatrics-associated diseases will become more prevalent.

We cannot ignore the AIDS epidemic. Undoubtedly new viral diseases will surface over the coming decade. Testing in this arena will involve more sophisticated antibody-related assays and recombinant DNA-based testing.

* Laboratory regulation. No law passed in the last 25 years has had a more profound effect on laboratory testing than the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88). This bill places all laboratories on alert. The Government will be able to penalize or even to disqualify a laboratory if it consistently fails proficiency testing challenges, if it lacks qualified personnel, or if it performs too many tests per cytotechnologist per day.

In CLIA '88, tests are classified under a three-tiered model. The categories are based on complexity of methodology. The first tier consists of certificate of waiver tests, including simple tests such as dipstick urinalysis, fecal occult blood, and urine pregnancy tests. Next come tests of moderate complexity, which include various microbiology culture assays, immunoassay procedures, automated chemistry analyses, automated hematology assays, and ABO/Rh Rh grouping. The third tier covers tests of high complexity: cytology, histopathology, histocompatibility, and cytogenetics. Distinct personnel requirements have been outlined for each category.

As of this writing, the personnel standards for the three categories are less stringent than originally proposed. Nonetheless, they will probably affect everyone who performs tests in physicians' office labs and in point-of-care areas of the hospital.

The major impact of CLIA '88 will be to require labs to pass proficiency testing challenges as a minimum criterion for certification. The same approach is being used by NIDA in certifying laboratories to perform testing for drugs of abuse.2

The next 10 years will witness heavier regulation of the laboratory industry. The consequences of poor quality will ultimately lead to sanctions against laboratories that fail to correct analytical problems quickly.

* Medicolegal issues. Plaintiffs today sue for "poor result" and "poor outcome" as well as for errors in judgment, the predominant trigger of lawsuits in the past. The presumption is that if the outcome was unexpected and unsatisfactory, a physician must have made an error in judgment. Although the clinical laboratory is not often involved, it is no longer immune to such litigation. Why was a certain test not ordered? How often should one order tests for potassium, sodium, or other electrolytes for a patient receiving intravenous fluids? Was the critical value called to the ward in a timely manner? Did the physician respond to an abnormal result? In a NIDA case, was the chain of custody followed? Did the patient give permission to use the specimen for research purposes? Was the specimen labeled appropriately?

Concern for the medicolegal implications of laboratory testing has resulted in overutilization. We document every call of critical values to the wards. We stress chain-of-custody considerations for all drug testing, NIDA and non-NIDA alike.

* Biomedical ethics. How vigorously should one treat the terminally ill patient? Can we use fetal tissue for therapeutic purposes? What will be the Supreme Court's opinion on abortion by the year 2001? Should health insurance cover therapies and diagnostic procedures that provide only limited clinical benefit?

In Oregon the legislature passed a law rationing the health care dollar. The basis of the determination is the benefit-cost ratio of various therapies for a number of diseases. When a therapy has very little value in a particular disease, its benefit-cost ratio is low; therefore, state medical insurance probably will not reimburse for it. Will we as a nation adopt an approach similar to the Oregon experiment? Will we refuse to reimburse for tests that have limited clinical value?

Currently we are spending 11% of the gross national product on medicine and health care. Will this grow to 12%, 15%, or 20% by 2001? If given a choice between spending a tax dollar on health care, the environment, or our children's education, which should we choose? These are among the ethical questions our country faces. Good economic times provide enough money for all these worthy causes. In tough times with limited resources, we have to assign priorities. Until now the health care lobby has succeeded in encouraging Congress to spend more and more money on medicine-related expenses. This may not always be the case.

The patient in the year 2001 will be more knowledgeable about his or her own health. People will be more concerned about their physical fitness, mental fitness, and nutrition. Patients will be able to see their laboratory results on request. The end user will be a more demanding customer.

What tests will we offer? Who will do the tests? Where will they be done? More and more tests will be done near the patient in the hospital and in large referral laboratories. A comparable expansion of choices--depending on time of day, convenience, and expense--is evident in the food industry. At 3 a.m., a piece of cheese is available in the hotel mini-bar at a highly inflated price, at 10 p.m. in the all-night grocery at a fairly inflated price, and at any time during the week in the bargain-priced megamarket.

The near future will bring similar options for laboratory testing, depending on the urgency of the test order and the cost to be expended. Tests for blood gases and electrolytes will be available 24 hours a day at the bedside for the critically ill patient, for whom receiving results in a timely manner is paramount. Esoteric testing will be done by large referral laboratories with a one- or two-day turnaround time, including nationwide air transport.

What tests will we offer? Testing will rise for immunology, virology, and tumor markers. Cytogenetics will grow in importance to include various DNA probe-based technologies. We will see more automation of antibody-based testing.

Who will do the testing in the future? That is the most difficult question to answer. We must spend more resources to educate and train those who will perform tests. There is a high likelihood that many people reading this article today will need health care in the year 2001. Those we train today will serve us tomorrow. [1.] Statland, B.E. Quality management Watchword for the '90s. MLO 21(7): 33-40, July 1989. [2.] Armbruster, D.A. A guide to NIDA certification for workplace drug testing. MLO 24(2): 31-36, February 1992.
COPYRIGHT 1992 Nelson Publishing
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1992 Gale, Cengage Learning. All rights reserved.

Article Details
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Author:Statland, Bernard E.
Publication:Medical Laboratory Observer
Article Type:Cover Story
Date:May 1, 1992
Previous Article:With more questions than answers, industry studies impact of CLIA '88.
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