In the Lab: Too Many Defective Tests

Matter-of-factly the doctor says:

"We'll send this to the lab and have the answer for you in a couple of days."

Just as matter-of-factly the patient imagines that his blood or urine sample will go to a laboratory filled with shiny, sterile stainless steel and glassware, to be worked over by skilled technicians in white coats. He has no doubt about the accuracy of the results, because his doctor shows none. That blind faith is unjustified, a succession of medical experts told the Senate antitrust subcommittee last week. In fact, Dr. David J.

Sencer of the National Communicable Disease Center declared that of the estimated 500 million medical lab tests done each year in the U.S., no less than 25%, or 125 million, produce defective or dangerously wrong results.

Dr. Sencer cited examples: > The wife of an Army sergeant was said by a hospital laboratory to have group-B Rh-positive blood and was given transfusions of that type. In reality, her blood was group 0; she suffered permanent kidney damage. -- Twin boys were born to a woman in Alabama whose blood had twice been typed as Rh-positive; actually it was negative, and the twins died of a blood-destroying anemia. Indeed, of 328 blood-disorder deaths in the newborn studied in California, 34.5% were associated with laboratory errors, and many could have been prevented. -- A newspaperman, 26, was being treated with anticoagulants for phlebitis. A laboratory reported that his blood had a normal clotting time, so the doctor kept up the treatment. The man's blood was actually slow to clot; he died of an internal hemorrhage.

>Blood specimens from 33 patients reported by laboratories as malaria victims were submitted to NCDC, which found no malaria in any. One such false-positive case was cited in a medical journal as due to drug resistance--a report that is still confusing doctors.

How is it possible for aseptic scientific laboratories, run by experts, to be so often wrong? The answer is that too many of them are neither aseptic nor scientific; nor are they run by experts. There are about 14,000 of them in the U.S. Half of these are in hospitals, and 400 are run by states and cities. That leaves almost 6,600 independent labs which, in 47 states, are under no effective control whatsoever. Only California, Illinois and New York require licensing of labs. Half a dozen other states require that the director of a lab must have some professional qualifications, but he need not be on the spot; this is an invitation for unscrupulous physicians to take well-paid figurehead positions. In more than 40 states, any high school dropout can set up a lab with no questions asked, although, as the committee chairman, Michigan's Democratic Senator Philip A. Hart noted, "they require a license for a fellow who cuts your hair."

Once in business, the lab can solicit doctors with profitable come-ons. It may offer "all the tests your patients require" for a flat fee of $75 a month--and subtly encourage the doctor who orders 100 tests a month to bill his patients for tests at $3 to $10 each. At whatever price, a test is worse than useless and may have fatal results unless the technicians know how to run it and have the right equipment. On this score also, Dr. Sencer had bad news. More than 20% of test materials examined by the NCDC were found faulty.

Not Necessarily Safe. As for results, several studies of laboratories that agreed to have their performance checked showed that up to 40% were unsatisfactory in testing for the presence of bacteria, up to 80% in identifying proportions of different blood cells, and up to 18% in such a standard and simple procedure as blood typing. The picture may be still worse in labs that refused to be checked.

The plight of the patient in the 47 states with no legal control is understandably bad, but the resident of well-regulated California or New York is not necessarily safe either. Dr. Howard L. Bodily of the California State Department of Public Health pointed out that there is no federal law to prevent a doctor's signing up with a cut-rate laboratory thousands of miles away from his consulting room and sending his specimens by mail--regardless of the fact that delay may make many of them useless. Some mail-order laboratories have been caught sending out test "results" on specimens that they had never examined, even in such life-and-death matters as cancer smears.

There is wide variation in the quality of testing done in laboratories within hospitals, largely as a result of the shortage of trained technicians. There is still greater variation in the backroom labs behind doctors' offices, but just how good or bad their work is, said Dr. Sencer, has never been surveyed. And in the best-regulated, best-run labs, mental obsolescence is a major problem--many doctors, as well as technicians, learned their skills 20 or more years ago, before most of the 1,000 testing procedures now known had been developed.

Senator Hart is determined to introduce a bill, not yet drafted, to regulate interstate laboratory business. How to control the labs inside those 47 unregulated states, no one knows. Leaving them unregulated, says Hart, "will keep the undertakers and the cemeteries busier than usual, earlier than usual."

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