U.S. May Require Medical Labs to Improve Accuracy

The Department of Health and Human Services has drafted a regulation to force hospital and independent laboratories--but not labs in doctors’ offices--to improve the accuracy and quality of clinical tests or be tossed out of the Medicare and Medicaid programs, documents indicate.

The proposed regulation would apply to common diagnostic tests such as Pap smears, blood tests and urinalysis checks for illegal drug use.

Rep. Ron Wyden (D-Ore.) and aides to House Commerce Committee Chairman John D. Dingell (D-Mich.) charged that the proposal is inadequate because it does not cover the labs in doctors’ offices.

“The fact is that thousands of people are given millions of medical tests today in labs with little or no accountability--and many are in doctors’ offices,” Wyden said.

Wyden and Dingell have introduced bills aimed at improving the accuracy and quality of tests in all medical laboratories, including doctors’ offices.

HHS Inspector General Richard P. Kusserow testified last week that “each year between 4 (billion) and 6 billion tests are performed” at a cost of up to $25 billion a year, with a fifth of the cost paid for by Medicare. “Approximately 50% are performed in the nation’s 6,600 hospital laboratories, while another 25% are performed in the 4,500 independent laboratories. The final 25% are performed in what we estimate to be the 98,400 physician-office laboratories operating in this country.”

The key feature of the regulation would be a shift from emphasizing various types of staffing requirements to focusing more on the outcome of tests. The proposal would:

--Establish a uniform national system of proficiency tests, under which various professional organizations such as the College of American Pathologists periodically submit slides with blood samples, urine and other materials to the laboratories, and then rate them on how well they analyzed the materials. Labs with unsatisfactory ratings could face bans on handling certain tests or exclusion from the Medicare program and from interstate commerce.

--Forbid technicians to handle more than 80 to 100 Pap smear slides a day, with the final figure to be decided later.

--Require labs to set up stronger internal quality-control systems.

--Require hospitals to have a trained supervisor on the premises when testing is performed.