San Francisco Chronicle - Saturday, April 17, 1999
Sabin Russell, Henry K. Lee, Lisa Fernandez, Chronicle Staff Writers

The ensuing outcry is certain to focus attention on state training requirements under which a technician can be certified to draw blood after as little as two days of classes.

Warning letters will be mailed today to 3,600 patients who may have had their blood work done since June 1997 at the small SmithKline Beecham Clinical Laboratory in Palo Alto.

Similar letters will be sent to patients who may have had their blood drawn by the same lab technician at up to 10 other yet-to-be named locations. Two of the sites are in San Francisco and the others are in San Mateo and Santa Clara counties.

The lab technician, who has not been publicly identified, has admitted to occasionally washing and then reusing disposable needles. The needle-cleaning activity was spotted by a SmithKline co-worker who had been assigned temporarily to help the technician because of a heavy workload. The co-worker quickly alerted lab supervisors.

Patients are being advised to take precautionary blood tests to rule out the remote possibility that they may have been exposed to deadly viruses carried by others who had blood drawn at the lab.

Dr. Jon Rosenberg, who is in charge of the state's investigation, said health investigators are less concerned about the other 10 sites because the phlebotomist did not work alone in any of them -- the practice of needle cleaning would have sent up a red flag among any of her co-workers.

Jesse Moon of Palo Alto and her two teenage sons showed up at the laboratory angry and frightened yesterday.

Moon's sons, Brendan, 13, and Noah, 17, both had their blood drawn from the lab in October 1997 and March 1998, she said. The two boys were taking acne medication and were having their cholesterol levels checked when they visited. They have now taken HIV tests as a precaution and will learn the results Monday.

"They're going to pay for every penny of this," Moon said from the tree-lined parking lot outside the small, one-technician lab at 1101 Welch Road. "This is very scary."

While health experts puzzle over why a trained blood-lab worker -- known as a phlebotomist -- would violate a fundamental ground rule of blood-drawing techniques, the answer may lie in training. Any high school graduate can become a phlebotomist in California after just 10 hours of classes and three successful punctures on a human subject.

"The California curriculum is a joke. Actually, it's criminal," said Nina Breinig, a phlebotomy instructor in Walnut Creek. Students at Phlebotomy Plus, where Breinig teaches, must complete 100 hours of classes and hands-on experience -- standards set by a national phlebotomist association.

"The first portion is a week of classes on infection control and safety. No one is allowed to draw blood until they have it right," she said. But California's woefully lax requirements for a state blood-drawing certificate has spawned an industry of weekend phlebotomy schools that churn out graduates who learn to draw blood by sticking hypodermic needles into bananas and oranges.

The 10-hour standard was established in 1971, when most blood draws were done by experienced nurses, who took the training as a refresher course. Efforts to improve the state standard have gone nowhere.

William Bigler, director of the Center for Biomedical Laboratory Science at San Francisco State University, said the SmithKline Beecham technician's behavior was inexcusable, but not the whole story. "I don't think she's at fault as much as her training," he said. "We need to get that improved."

At a news conference held by the state Department of Health Services in Berkeley yesterday, the national medical director for SmithKline Beecham apologized to concerned clients.

"I want to express our genuine regret that a SmithKline Beecham employee may have exposed patients," said Dr. Edward Kaufman. "Clearly, we are both shocked and baffled by this practice," Kaufman said.

Kaufman said SmithKline Beecham is "fully prepared to assume appropriate responsibility" for costs associated with retesting, counseling and treating patients who may have contracted a disease.

State and county health officials agreed that the chance that any patient may have actually been exposed to deadly viruses was remote. The lab technician who reused needles has told authorities she did not do it often. And her technique of cleaning needles with a diluted solution of hydrogen peroxide may have killed any viruses.

In addition, the patients tested at the lab, as a group, had a low percentage of diseases such as hepatitis and AIDS.

The disclosure has created an enormous headache for the nearby Palo Alto Medical Foundation, which is known by its old name, the Palo Alto Clinic, but does not send patients to the SmithKline Beecham lab.

David Druker, chief operating officer of the Palo Alto Medical Clinic, said yesterday his facility had received hundreds of phone calls from "panicked" patients who mistakenly thought the clinic was involved.

Health officials also stressed the need for caution yesterday. "Although we believe that the risk is very low, we can't assume that it's nonexistent or negligible," said Rosenberg.

Investigators said the SmithKline Beecham employee, a woman about 50 years old, was trained as a phlebotomist in 1994. Before that, she was working outside of the health-care industry.
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