ONE CHAPTER HAS CONCLUDED in the story about the phlebotomist who was discovered last March to be reusing butterfly needles in Palo Alto, California.
California’s Department of Health Services (DHS) fined SmithKline Beecham Clinical Laboratories (SBCL) a total of $102,00 for its part in the episode. SBCL’s license could have been revoked or suspended.
Phlebotomist Elaine Georgi, while an employee of SBCL, has admitted that she reused needles to draw patients in February 1999. Evidence indicates she may have started this practice as early as August 1998.
Authorities publicly downplayed the risk of exposure to HIV and hepatitis as a result of Ms. Georgi’s actions. But a number of lawsuits were filed. At least one plaintiff now claims to have contracted hepatitis C as a consequence of having her blood drawn by Ms. Georgi at SBCL’s Palo Alto draw site.
Fine Against SBCL
Formal legal action is still pending against Elaine Georgi. Meanwhile, the Department of Health Services’ fine against SBCL apparently resolves the lab’s involvement in this matter.
For laboratory administrators throughout the country, this issue has highlighted the risks of offering phlebotomy services to the public. When the story broke on April 15, it focused unwelcome national media attention on SBCL.
SBCL received a Statement of Deficiencies from DHS at its Dublin, California laboratory on May 12, 1999. SBCL responded with a Plan of Correction on May 26, 1999.
DHS assessed a $50,000 fine for SBCL’s failure to properly manage the phlebotomist. This is based on the phlebotomist’s admission that she reused needles on five to ten patients in February 1999.
Mixing Or Mislabeling
Another $40,000 fine was assessed for failure to insure specimen integrity. This was based on four instances where Elaine Georgi mixed serum specimens from two patients and/or mislabeled specimens.
Two $6,000 fines were assessed for failure to adhere to a quality control procedure at the Palo Alto site and failure of the laboratory director to ensure that “phlebotomists hired on a temporary bases were qualified and competent.”
Laboratory executives and pathologists should consider this a wake-up call to review their own laboratory’s crises management plan. Every clinical laboratory is vulnerable to the actions of a rogue employee.
As SBCL discovered, any laboratory can find itself in the middle of public controversy at the most unexpected moment. In such an event, a well-designed crises management plan is essential to restore public confidence in that laboratory’s competence, safety, and professionalism.