The San Francisco Chronicle - Friday, July 23, 1999
Julie N. Lynem, Chronicle Staff Writer

The state Department of Health Services said it will fine SmithKline $50,000 based on Elaine Giorgi's admission that she reused needles on five to 10 patients.

In addition, the company will be fined $40,000 because the former phlebotomist mixed serum samples from two patients, mislabeled patient specimens and failed to label test specimens properly in a timely manner.

The company was also slapped with a $6,000 penalty for not monitoring employees at the Welch Road laboratory. Another $6,000 fine was assessed because the lab director did not ensure that phlebotomists hired on a temporary basis were qualified.

SmithKline will have 15 days to respond to the sanction, which comes nearly two months after the department found that the company's Palo Alto lab created a state of "immediate jeopardy" for the community and that SmithKline's responsibility went beyond the actions of Giorgi.

The penalty was the maximum allowed under state guidelines, a department spokesman said yesterday. The state also could have suspended or revoked SmithKline's laboratory license, but it chose not to do so because the company "acted promptly and appropriately" to remedy the situation, said Ken August, a spokesman for the Department of Health Services.

"This was a unique case in that the actions of the phlebotomist were unprecedented and inexplicable," August said. "We've never investigated such a case."

But some people said the sanction should have been more severe. Stephen Blick, a San Jose attorney whose law firm filed a class-action suit against SmithKline on April 16, said he wishes the state could penalize the lab even more.

"I'm pleased that they have fined SmithKline Beecham to the extent permitted under their guidelines," he said. "But if there were guidelines that would have permitted a higher fine, it should have been in excess of $10 million. Based on the egregious nature of SmithKline's conduct, it would have been befitting."

Assemblywoman Carole Migden, D-San Francisco, approved of the state's decision to fine SmithKline but said higher fines may be warranted in such cases. Migden has written a bill that would require unlicensed phlebotomists to receive 80 hours of classroom and clinical training to earn a state certificate.

Currently, obtaining a phlebotomy certificate requires a high school diploma, 10 hours of class time and three successful blood draws on human subjects. "Perhaps it bears examination to lift the ceilings on those fines," she said.

In a letter to the company's lab director in Dublin, the department said it determined the amount of the penalty by looking at the severity of violations at the Palo Alto lab where Giorgi drew blood.

After the disclosure that Giorgi had reused needles, about 3,600 people from the Palo Alto blood- drawing station were notified that they could have been exposed to HIV, hepatitis B and hepatitis C. An additional 11,700 residents of San Francisco, San Mateo and Santa Clara counties who had had blood drawn at sites where Giorgi worked also were notified.

Giorgi was fired after another employee at SmithKline's Palo Alto lab reported seeing her wash needles for reuse. The San Mateo woman, who worked at the Palo Alto site from mid-June 1997 to March 22, has been temporarily barred from practicing phlebotomy.

In a statement released yesterday, SmithKline said it disagreed with the monetary penalty, noting that it took the necessary steps to notify state health officials and patients.

Tom Johnson, a company spokesman, said SmithKline has continued to follow through with its promise to contact all of the patients and offer free testing. Testing should be completed by this fall, he said.

"From the beginning, our concern has been for the well-being of our patients, and we are encouraged by the state's previously announced assessment that any risk of infection is low," the company's statement said.

William Audet, a San Jose attorney involved in a second class action against the company, said the state's fine is substantial.

"I don't know of any fines that are over and above that for this type of contact," he said. "But in my view, it establishes what we've been complaining about all along -- that SmithKline has had a questionable operation at the Palo Alto site for some time and have been putting people's health at risk due to lack of supervision."
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