Doctors’ Labs Don’t Always Pass the Test

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.

Several private professional groups, such as the College of American Pathologists, now conduct proficiency testing on behalf of the CDC. They have also found the accuracy level of medical laboratories wanting.

When the College of American Pathologists asked the 5,000 labs across the country to run cholesterol tests on identical samples in 1985, nearly 50% produced unacceptable results. “I was surprised; we were all caught unaware,” said Howard Robin, chief of medicine at Sharp Cabrillo Hospital in San Diego and West coast spokesman for the pathologists group.

It was concern over errors that prompted Congress to approve the Clinical Laboratories Improvement Act in 1967.

That law, however, covers only a fraction of the nation’s labs: the estimated 7,000 that seek reimbursement under the federal Medicare program or conduct interstate business. In addition, the law does not cover diagnostic machinery itself, such as stress monitors, electrocardiograms, blood analyzers and the like. California passed a similar law 15 years ago.

Since then, California and 12 other states have extended those laws to regulate labs in physicians’ offices.

Most of these laws require labs be regularly tested by proficiency testing services. The test involves periodically sending specimens to physicians’ labs to be examined and evaluated. The doctors’ labs then evaluate the samples and send the results back to the testing service.

The proficieny testing services then determine how well the doctors’ labs performed the testing and evaluation. The results of those tests are also shared with state and federal regulatory officials.

However, most of those states, including California, admit that they lack the money and personnel to police the industry.

Can’t Monitor Results

In California, officials say they only know whether the physicians’ labs are enrolled in the proficiency testing programs, but not how well they do.

“We don’t have the ability to monitor results; we can only monitor enrollment in (the testing) programs,” said Ronald Harkey, an examiner with the laboratory division of the California Department of Health. Harkey says he only has a part-time examiner and clerk to assist him in overseeing the proficiency test scores submitted four times a year by thousands of physicians’ office labs.

He says his office is developing a computer program to facilitate the task.

For its part, the federal government has balked at extending its regulatory reach to the estimated 80,000 to 100,000 small labs in physicians’ offices. Government officials have argued that regulating physicians’ labs would be prohibitively expensive. They also say testing accuracy has improved.

“There has been a steady improvement in testing accuracy,” said CDC’s Boone. “There are mistakes being made, but they are relatively small in number.”

“There are some indications that quality has improved over time,” added Stanley Edinger, senior scientist in the survey and certification division of the federal Public Health Service. But, he admits, “it’s difficult to draw any conclusion because there is a lack of data.”

Many manufacturers also argue that further regulation is unnecessary. They say advances in technology have made administration and interpretation of tests virtually foolproof.

“I’m against a lot of regulation,” said David Thompson, vice president of the diagnostic division of Abbott Laboratories in Chicago. “I think that we as manufacturers have an obligation to produce quality instrumentation and tests that will give highly accurate results even when used by untrained people. Certainly there are some tests out there today that aren’t providing that level of quality. But I think in the end the quality manufacturers will win out.”

Many Causes of Errors

Faulty tests can occur for many reasons: a machine loses its calibration; test chemicals age; human specimens are mislabeled; fatigue, inexperience or lack of training cause an examiner to misidentify a microorganism under the microscope.

Responsible labs try to avoid those problems by testing chemical and calibrating equipment daily. They frequently test reference specimens to uncover problems with the equipment or procedures. And the labs are usually operated by trained scientists and technicians--all significant differences from most physicians’ labs.

“Surveys consistently indicate that physician-owned laboratories score lower than most other labs on proficiency tests,” James R. Wood, director of the training program at Lab-Net Inc., a network of lab consultants based in San Diego. “New technology may be starting to make office testing more automated, but the possibility of errors still exists . . . because of things like outdated reagents and the level of training of the medical staff.”

“I haven’t seen a foolproof product on the market yet,” said Anthony D. Fiorillo, executive vice president of the Ames division of Miles Laboratories and one of the few manufacturers that supports additional testing regulations. “We have a cadre of people who do nothing but train and retain assistants in doctors’ offices.”

Even more troublesome, say some experts, is that testing is beginning to spread beyond even the oversight of doctors and scientists.

Instant Medical Test Inc. of Denver recently signed a contract to offer medical tests in Osco Drugs’ 666 stores in 30 states. The tests, administered by non-physicians, range from a $5 lung test to $35 for a complete blood chemistry.

Osco and Instant Medical Test officials could not be reached for comment. But in an interview with The Times last month, a vice president at Medical Tests noted that the technicians who conduct the tests have at least a year’s experience in a physician’s office or hospital and receive a 30- to 40-hour training course.

“A lot of doctors come out and see us, and they feel better when they see our personnel and they see our training,” Nancy Landauer, vice president of Medical Tests, told The Times.

But testing expert Pinckney says he doesn’t feel comfortable about the development.

“Only regular proficiency testing from an outside, unbiased source can improve testing accuracy,” Pinckney said. “There should be no double standard when it comes to in-office medical testing.”