CEO SUMMARY: News that a phlebotomist employed by SmithKline Beecham Clinical Laboratories (SBCL) was discovered to be washing and reusing needles got national media attention last week. During her 22-month employment at SBCL, this phlebotomist apparently reused butterfly needles on “difficult to draw” patients. Ramifications of this discovery will affect not only SBCL, but the entire lab.
ON APRIL 15, the San Francisco Chronicle broke a major story about the discovery by SmithKline Beecham Clinical Laboratories (SBCL) that one of its phlebotomists had washed and reused butterfly needles on “difficult to draw” patients.
Several thousand people were potentially exposed to HIV and hepatitis. The grisly news was immediately picked up by newspapers, radio stations, and television news programs throughout the United States. SmithKline, a company proud of its reputation for quality and patient care, found itself in an unwanted spotlight.
On April 16, SmithKline Beecham responded to the San Francisco Chronicle story. SmithKline and the California Department of Health Services (DHS) issued a joint statement about the situation at a press conference in Berkeley, California.
According to SmithKline, a co-worker had observed the SBCL phlebotomist reusing needles at the SBCL phlebotomy station in Palo Alto on March 22. When SBCL managers interviewed this phlebotomist later that day, she admitted to reusing needles.
State Health Investigators
She was suspended the same day and subsequently terminated. During interviews with state health investigators, she again admitted that she reused needles when drawing patients at the SBCL phlebotomy station.
The woman was identified by the press as Elaine Giorgi. She started work with SBCL on June 1, 1997. It is believed that she drew some 3,600 patients between that date and her suspension and subsequent termination.
Santa Clara County’s health officer, Martin Fensterscheib, M.D. interviewed Ms. Giorgi and said that she told him she reused needles because “she was running out of butterfly needles and it was important that she not run out.”
Although Giorgi claimed to have only done this for a short period of time, perhaps only two weeks in late February and early March, Dr. Fensterscheib was skeptical. He said he “found inconsistencies in her story…I can’t believe that there was a very limited use.”
SBCL responded to those comments. “Cost is not the consideration. Patient care is,” said SBCL Public Information Officer Toby Dichter. “We don’t go out and say ‘Don’t use too many butterfly needles.’ (Phlebotomists) have absolutely unrestricted access to anything they need.”
Many phlebotomists would take exception to Dichter’s statements. Because of their cost relative to syringe needles, butterfly needles are widely recognized to be an item ever in “short supply” in hospital labs and commercial labs from coast to coast.
It is not uncommon in the lab industry for phlebotomists who use “too many” butterfly needles to find themselves evaluated negatively for the practice.
Giorgi worked worked alone in an SBCL draw station located in a physicians’ office tower next to the Stanford University Medical Center. She described to investigators a practice where she would wash used butterfly needles in a sink with water and diluted hydrogen peroxide. She then put the needles into clean needle containers to be used when drawing patients with difficult-to-pierce veins.
The woman completed her training as a phlebotomist in 1994. She worked at other laboratories before coming to SBCL in 1997. She further completed the SBCL phlebotomy certification before starting to draw blood on patients referred to SBCL. Officials stated that “it is not known when the woman began reusing needles, how often she reused them, or if she reused them at any other facility where she worked.”
“Clearly we are shocked and baffled by this practice. It’s a breach of medical care,” stated Edward Kaufman, M.D., National Medical Director at SBCL at the joint news conference with DHS officials. “She can’t explain why she did it.”
Both health officials and SBCL executives agree that risk of infection was minimal, but possible. “Although we believe the risk is very low,” stated Jon Rosenberg, M.D., a DHS specialist in disease transmission and control, “we can’t assume that it’s nonexistent or negligible.”
Certified letters were mailed last week to the 3,600 patients who were drawn by Giorgi during her employment with SBCL, and to the patients’ doctors. The letters notify the patients about the situation. A toll-free hotline was also established, and got 4,200 calls in its first day of operation.
Dr. Kaufman stated that SmithKline Beecham is “fully prepared to assume appropriate responsibility for costs associated with retesting, counseling, and treating patients who may have contracted a disease.”
SmithKline Beecham, PLC now finds itself in the eye of a complex hurricane. Although the facts of this case are relatively simple, it is the consequences and ramifications that will prove complex and long-lasting.
SmithKline Beecham, PLC now finds itself in the eye of a complex hurricane. Although the facts of this case are relatively simple, it is the consequences and ramifications that will prove complex and long-lasting. It is the type of bad-news story that all clinical laboratories wish to avoid.
From that perspective, lab executives and pathologists should watch how SmithKline handles itself during this crises. There are several levels of management action involved in this case.
One, SmithKline must react to the patients placed at risk by the actions of its employee phlebotomist. This means identifying all individuals who were potentially affected and insuring that they get appropriate medical tests, counseling, and healthcare.
Two, SmithKline must deal with public relations disaster as it affects patients and physicians in the medical community, both in the San Francisco Bay Area and throughout the nation. It must reestablish confidence in the quality of its medical services.
Three, SmithKline has issues, and possible legal exposure, with public health agencies. It is certain that all government health regulators will want to be seen as “doing their jobs” and properly enforcing public health regulations. In this high profile case, it is easy for bureaucrats to characterize a corporation as the “bad guy.”
Four, there is already a civil suit filed against SmithKline. More should be expected. SBCL’s full exposure to civil suits cannot be evaluated until the health status of the affected patients is determined.
Five, this crises may lead to changes in the way SBCL manages its laboratory services, both clinically and operationally. As more is learned about why this phlebotomist became motivated to reuse butterfly needles, there may be changes in the way cost-cutting initiatives are allowed to control access to supplies required for the provision of clinical services.
Laboratory executives and pathologists should not underestimate the impact this crises will have on the entire laboratory industry. They should carefully follow this story and how it unfolds. What happens to SBCL, and how SBCL copes with this situation will teach valuable management lessons for other labs which may find themselves in a similar situation sometime in the future.
First Lawsuit Filed As More Expected
Within days of the announcement that an SBCL phlebotomist had reused needles for blood draws, the first class action lawsuit against the laboratory was filed in Santa Clara County Superior Court by the law offices of Stephen Blick and Charles Hawkins.
Additional lawsuits are expected. Palo Alto is a wealthy suburban community. On the plus side for SBCL, it means that the incidence of hepatitis and HIV infections is very low. On the minus side, it means that most patients drawn by Giorgi are intelligent, aware, and have the financial capability to finance lawsuits.
There is also the possibility of criminal charges. Although no law in California prevents the reuse of needles for blood draws, a number of statutes can apply to the situation. The Santa Clara District Attorney’s office and the Palo Alto Police are investigating the situation.
In addition to the possibility of civil claims and criminal charges, both SBCL and the phlebotomist are subject to regulatory scrutiny. A variety of government agencies can investigate the actions of SBCL and its phlebotomist to identify violations of regulations. If it is determined that regulations were not followed, appropriate fines, citations, and sanctions could be assessed.