CEO SUMMARY: As many as 15,000 people have been offered free blood testing because they may have been drawn by this phlebotomist since 1994. Regulatory action, private lawsuits, and media coverage are subjecting laboratories to unwelcome, even unwarranted, scrutiny. As the ramifications of this phlebotomist’s decision to reuse needles ripples through the healthcare system, lab administrators should heed the lessons to be learned.
NEWS THAT A PHLEBOTOMIST reused needles created shock waves in the San Francisco Bay Area. Since the public announcement on April 16, there have been ongoing disclosures.
To date, at least 15,000 people have been offered free blood testing because they had some chance, however slim, of being exposed to infection by phlebotomist Elaine Giorgi. This covers most sites and companies where she has worked since 1994.
Reused Butterfly Needles
The matter became public when SmithKline Beecham Clinical Laboratories (SBCL) and the California Department of Health Services (DHS) conducted a joint press conference to announce the discovery that a phlebotomist had reused butterfly needles on “difficult to draw” patients.
The facts are simple. Elaine Giorgi, a phlebotomist working for SBCL in its Palo Alto patient service center, was terminated after a co-worker reported seeing her washing disposable needles in a sink on March 22.
She admitted to SBCL managers, and later to public health agency officials, that she had reused butterfly needles. “She believed she needed to reuse needles to conserve those needles,” reported state health investigator John Rosenberg. “She recognized they are more expensive than the usual needles.”
For clinical laboratory executives, the affair of the “Palo Alto Phlebotomist” provides invaluable insight as to the consequences of breaching the public’s confidence in health services.
SmithKline Beecham Clinical Laboratories was the first laboratory in the hot seat. Although national media coverage died down relatively quickly, there remains high awareness of this matter throughout the San Francisco area. In the seven weeks since the news became public, past employers of Ms. Giorgi were identified and brought into the story.
Starting in 1994, it is known that Elaine Giorgi worked at Unilab (then called PathLabs), Mills Peninsula Health Services, and Laurel Medical Group before taking a position at SBCL in June 1997.
Unilab no longer has patient records for these sites and dates. It is estimated that about 350 patients will get offers of free testing from Mills and Laurel. SBCL offered 3,700 patients served at the Palo Alto draw site free testing and counseling. It has since offered another 11,700 patients free testing and counseling.
On May 14, Ms. Giorgi agreed to a preliminary court injunction requested by the state attorney general’s office. It bars her from drawing blood, doing injections of any kind and, preparing labels or medical specimens pending further court action.
Risk of contracting one of the three most serious blood-borne diseases through transmission by dirty needles:
Hepatitis B: 20%-30%
Hepatitis C: 3%
Source: Calif. Dept. of Health Services
Lab executives familiar with this case have wondered what kind of exposure SBCL faces from claims by patients that they became infected with HIV or hepatitis as a result of the phlebotomist’s actions. It didn’t take long for that problem to surface.
In Santa Clara County Superior Court, “Jane Doe 7659” filed a lawsuit against Elaine Giorgi and SBCL on May 6. The plaintiff claims she was told by county health officials on October 29, 1997 that she tested positive for hepatitis C.
According to her attorney, Richard Alexander of Alexander Hawes & Audet, this woman had never tested positive before that date. The attorney said Jane Doe 7659 had blood drawn at SBCL’s Palo Alto site in June, July, and September 1997.
Here’s where laboratories will get a first-hand lesson on the legal system versus medical reality. Once the lawsuit was filed, health officials were quick to point out that linking any individual infection to this phlebotomist will be difficult.
Exposed To Hepatitis
“There is a certain percentage of the population that has been exposed to hepatitis and we would expect some people to test positive,” said DHS spokesman Ken August. “We may never be able to ascertain definitively whether someone was exposed to a virus through unsafe medical practices or some other risk factor.”
Besides shared needles, August was referring to transmission of hepatitis through sexual activity and other unidentified means. Most laboratorians are familiar with the incidence of HIV and hepatitis among the wider population.
Scott Morrow, M.D. Medical Officer for San Mateo County, stated that the incidence rate of hepatitis C is between 1.2% and 1.8% for the population of the United States.
Some Will Test Positive
Epidemiologists at DHS believe that, of the 1,500 patients already screened for infection as a result of this matter, as many as 20 will test positive for hepatitis C, with most learning about it for the first time. “Studies show that between 50% and 70% of people with hepatitis C don’t know it,” said Dr. Morrow.
What complicates any court determination of liability from hepatitis C infection is the fact that, in 20% of all cases diagnosed, no risk factor is ever identified. This is expected to be true for some individuals drawn by Ms. Giorgi and now undergoing precautionary blood testing.
Seven weeks after the public learned about this problem, SmithKline Beecham Clinical Laboratories continues to find itself in the headlines. The fears and emotional distress caused by this situation will not disappear overnight. For example, there are many people who still recall the 60 Minutes’ expose of the “Pap smear industry” during the mid 1980s…and that was almost 15 years ago!
SBCL’s Unfortunate Luck
Laboratory executives in all parts of the country should consider SBCL’s unfortunate luck as a warning. Every laboratory in the United States could experience a similar situation if any single employee took a rogue action like that of phlebotomist Elaine Giorgi.
It is evidence of the clinical lab- oratory industry’s stellar record for safety and patient care that this is the first such case in decades to attract wide-spread public attention. Laboratories should be justifiably proud of this accomplishment.
On the other hand, Ms. Giorgi’s actions, and the consequences to a well-respected laboratory company, demonstrate how easy it can be for one employee to erode an honorable company’s goodwill with the public.
THE DARK REPORT recommends that laboratory executives and pathologists meet with their management team and evaluate existing policies, procedures and management oversight of phlebotomy and other lab operations which could compromise patient care.
Anticipating such crises costs a laboratory a lot less time and money than dealing with the disaster after it occurs.
Timeline For SBCL Phlebotomist Affair
March 22—Co-worker observes phlebotomist Elaine Giorgi washing disposable needles in the sink at SBCL’s Palo Alto service center. SBCL suspends Giorgi that day. She is later terminated.
April 15—San Francisco Chronicle discloses story about SBCL’s phlebotomist reusing disposable needles.
April 16—SBCL and California Department of Health Services hold joint press conference to release details of the situation and offer blood testing to 3,700 patients affected by this situation.
April 23—First class action lawsuit filed against SBCL in Santa Clara County Superior Court. Palo Alto police begin investigation to determine if criminal actions occurred.
April 26—State Representative Carole Migdon introduces bill to increase certification requirements for phlebotomists, including 80 hours of training.
May 5—”Jane Doe 7659” files lawsuit in Santa Clara County Superior Court claiming her hepatitis C infection was caused by the phlebotomist’s actions at the Palo Alto draw station.
May 7—Minor “Ryan K.” files suit, claims he fears he may have contracted a disease from Giorgi, although the disease is undiagnosed.
May 8—UCSF Stanford Health Care officials disclose that several HIV-positive patients had blood drawn at the SBCL phlebotomy site in Palo Alto.
May 13—Giorgi accepts court injunction preventing her from drawing blood.
May 24—SBCL discloses all locations and dates where Giorgi worked. Offers free testing and counseling to 11,700 more people.