Dr. Peter M. DiChiara used to send his patients off to the local hospital to get medical tests. But today, with $40,000 worth of testing equipment, he does most procedures--from blood glucose tests to urinalysis--in his Troy, Ala., office.
Like thousands of other doctors across the country, DiChiara set up his in-office test equipment to offer patients a convenient, lower-cost alternative to the hospital lab.
But unlike many hospital labs, DiChiara's laboratory and those of most other physicians across the country are subject to little regulatory scrutiny. Even in California, which does regulate such labs, officials say they lack the resources necessary to oversee the industry.
DiChiara, equipment manufacturers and some physicians say regulation is unnecessary because technological advances have made in-office testing virtually foolproof.
But as doctors increasingly rely on such in-office tests to help detect certain kinds of cancer, infectious diseases, genetic flaws and a host of other maladies, some experts say inaccurate and unreliable testing is itself a health hazard.
These concerns come at a time when advances in computer science and biotechnology have increased Americans' confidence in the ability of various medical tests to accurately ascertain the state of patients' health.
Too Much Trust
The accuracy and reliability of tests increasingly affect important aspects of American life. In order to join the U.S. armed forces recruits now must take a test to detect AIDS antibodies. To get a job, many applicants must take tests designed to detect illegal drugs. To obtain health insurance, applicants are often asked to undergo physical exams that may involve a host of clinical tests; and failing a blood alcohol test can land a driver in jail.
Medical tests, which range from a $1 pregnancy or simple AIDS antibody test to $20,000 machines that examine human blood, can indeed be important tools to aid in the diagnosis and treatment of disease. But critics say they are alarmed that Americans have come to regard lab work as nearly infallible.
For more than a decade, the federal government and the state of California have regulated big medical labs that test body tissues and fluid, but it is the smaller labs in physicians' offices that are now the focus of many concerns.
"Most patients have blind faith that all tests are perfect and will reveal a vast store of knowledge about them to the doctor," said Edward R. Pinckney, a Los Angeles physician and expert who has written a book on the subject.
"Technology has given us a false sense of security. People should realize that every lab produces some error. If nothing else, patients should demand to know the accuracy and risk factors of each test," he said.
Pinckney isn't the only one concerned.
"With Medicare spending almost $2 billion a year for laboratory testing and the (federal) government calling for mandatory testing in areas such as drug abuse and AIDS, it seems the government has an obligation to see that this testing is as accurate as possible," said Sen. William S. Cohen (R-Me.), who is chairman of the Senate subcommittee on oversight of government management. He said his subcommittee hopes to hold hearings on the issue this fall.
While sloppy lab work isn't as obviously dangerous as such other medical errors as incompetent surgery or excessive radiation, it can do great harm. For instance, cancer spread rapidly through the body of a 34-year-old Virginia woman in 1981 and killed her after a hospital laboratory in Arlington, Va., erroneously reported two successive Pap tests as noncancerous.
The surge of testing in doctor's offices is dramatic. Manufacturers' sales of clinical chemistry and rapid diagnostic tests to American physicians practicing alone or in small groups has more than doubled in recent years. Manufacturers' sales went from $168 million in 1981 to $390 million last year and are expected to rise to $936 million by 1991, according Boston Biomedical Consultants Inc.
The burgeoning market prompted Congress last year to ask the Department of Health and Human Services to study "standards that might be established under the Medicare program for clinical laboratories which are part of or associated with a physician's office to assure the health and safety of individuals."
The report was due to be submitted in April but is several more months away from release, according to department officials and congressional aides.
Congress need not look far to find evidence of widespread testing error.
Nearly one in six labs tested recently by the Centers for Disease Control (CDC) didn't properly identify several common strains of bacteria, according to Joe Boone, a chemist with the laboratories systems branch of CDC, which until last year conducted proficiency testing of the 7,000 labs regulated under federal law. One in seven failed to identify various fungal growth properly, he said.