HIV, hepatitis tests urged for thousands after stunning admission of needle reuse
Lab worker also had difficulty drawing blood in prior hospital job
Some 3,600 people have been advised to be tested for bloodborne viruses after a phlebotomist in a Palo Alto, CA, clinical laboratory recently shocked health officials and outraged patients by admitting to an infection control breach of striking severity: reusing needles to draw blood.
The admission and several other potentially significant findings about the case were documented in court records obtained by Hospital Infection Control, including reports by public health officials who investigated the case and submitted "declarations" in support of a court order temporarily barring the phlebotomist from doing any other patient care or blood work. The documents in the injunction application were filed in the state Superior Court of San Mateo County in Redwood City, CA, on April 29, 1999. The phlebotomist has not been charged with a crime. (See related story on court action, p. 76.)
The case is under criminal investigation by Dale Sanderson, JD, Santa Clara County deputy district attorney in San Jose. Sanderson declined to comment regarding which criminal statutes might be used to prosecute the phlebotomist. "It is an ongoing criminal investigation," he tells HIC. "It is by no means complete." Efforts to reach the phlebotomist by phone were not successful. Her attorney in the civil case, James Lenninger, JD, in San Jose, tells HIC, "Until such time as we are clear of any criminal investigation, there isn’t going to be any comment on it." The considerable fallout from the case includes a class action lawsuit against the lab’s operator, SmithKline Beecham Clinical Laboratories in Philadelphia; a separate lawsuit by a patient who claims to have been infected with hepatitis C virus at the lab; and a proposed new state law to toughen phlebotomy training and oversight in California. (See related stories, pp. 77-78.)
Public health officials are at a loss to explain such a gross violation of standard medical practice, particularly because the 52-year-old female phlebotomist had been working in the field as a certified blood-drawer since 1994.
"She had a lot more training than most, and she had been working as a phlebotomist for several years," says Sara H. Cody, MD, who interviewed the phlebotomist and filed a court report as communicable disease control officer for the Santa Clara County Public Health Department in San Jose. "In her case, I don’t think that training was the issue. We are all just absolutely stunned — jaws on the floor — and really do not know [why she did it]. It is so bizarre."
According to court documents, a co-worker who blew the whistle in the case reported the phlebotomist allegedly said she was cleaning and reusing "expensive" butterfly phlebotomy needles at the SmithKline Patient Service Center lab to avoid any "problems" with the company. Butterfly phlebotomy needles, which are available in conventional and safety designs to prevent needlesticks, often are selected for more difficult blood draws because they have tabs that ease grip and placement. SmithKline adamantly denies that any cost or supply problems were an issue in such a flagrant violation of its basic infection control policies. The court documents also indicate that the phlebotomist had a record of "termination" from a previous hospital job after some six weeks for problems that included making "numerous errors" and having "extraordinary difficulty" doing blood draws. There was no indication of needle reuse at that site.
Phlebotomist cited supply concerns
According to court records, the lab co-worker who tipped off authorities about the case reported seeing a white plastic basket containing butterfly needles that were soiled with visible blood. When the co-worker asked the phlebotomist whether she should dispose of the needles in a sharps container, the co-worker reported that the phlebotomist allegedly said the butterfly needles could be reused two or three times, according to the court report filed by Donald Newbold, MT, a laboratory field services examiner for the state Department of Health Services (DHS) in Berkeley. The court reports do not imply any reuse of needles by the co-worker, a temporary employment service worker who reported the reuse incidents to her employer and subsequently described the lab practices to public health investigators.
In her comments to investigators, the phlebotomist who confessed to reusing single-use needles cited supply concerns as her rationale. When asked why she didn’t simply call another lab or her supervisor regarding her concerns about running short of the needles, "she responded that she just didn’t. She said the butterflies were like gold,’ which I understood to mean that they were highly prized," Newbold reported in court documents. Newbold declined through a department spokesman to be interviewed for this report.
A SmithKline Beecham spokesman denied that any supply problems or cost pressures contributed to the phlebotomist’s actions. Though such butterfly designs can cost an estimated 50 cents each as compared to conventional equipment in the range of 10 cents apiece, cost would not have been a roadblock to her simply ordering more of the needles, says Thomas Johnson, spokesman for SmithKline.
"She has stated that she was concerned about running out of needles and that is why she was reusing them," Johnson tells HIC. "But there are no restrictions on any of our phlebotomists for ordering or using supplies when it comes to collecting blood samples. So there is really no rational explanation for why she did what she did."
According to court records, the phlebotomist admitted to Cody and another investigator that she reused approximately five butterfly needles during the first week or two of March 1999. She also admitted to Newbold that she reused butterfly needles on five to 10 patients during a two-week period when she claimed she could not get butterfly needles because of a supply disruption due to the supply department moving. However, state health investigators and prosecutors in the civil case concluded in the court documents that her "reason for reusing butterfly needles is not substantiated, nor is her report of her frequency of reusing needles."
Some 3,600 patients visited the lab while the phlebotomist worked there from June 1, 1997, to March 22, 1999, after which her employers suspended and then fired her. Because she was the primary phlebotomist at the lab, it is thought that the majority of the blood draws done at the lab during that period were done by her with the exception of sick days, vacations, and periods when other workers joined her in the lab, says Ken August, spokes man for the state DHS in Sacramento. As a result, SmithKline sent certified letters offering free testing and follow-up for HIV and hepatitis B and C for all 3,600 patients. They also sent letters to patients’ physicians of record and set up a hotline for patients to seek information on the case. The lab drew patients from a variety of sources, including referrals from internal medicine physicians, obstetricians, and surgeons. Additional patients came on research protocols from Stanford University, Cody adds.
In admitting to reusing the needles in limited instances, the phlebotomist described a "disinfection" and repackaging method that was recorded in court documents as follows:
"To disinfect’ the needle she placed it immediately in the sink behind her after removing it from the patient. She stated that she then took a small disposable cup, filled it halfway with water and added a small amount of hydrogen peroxide. She then placed the needle and tubing in the cup, and used a vacutainer to clear the solution. She said that both the needle and tubing were very clean when she was done. She stated that she slid the plastic protective cover back up over the bevel of the needle, wrapped up the tubing and placed the needle and tubing back in the original wrapping," the court report states.
"This is an absolutely inadequate method," Cody tells HIC. "It is not sterilization, it is not disinfection, and it’s barely cleaning. To be honest, when she described what she did, there was some internal consistency in her story. So if she really believed hydrogen peroxide was an adequate disinfectant, maybe she was trying to do right, to do good. I don’t know whether the whole story was constructed after some thinking, or whether she really felt that way. I am not sure how someone could have such a grave misunderstanding about infection control."
Though some flushing of pathogens may have been accomplished with the diluted antiseptic, even needles designed for reuse must be thoroughly cleaned and then heat-sterilized, according to guidelines by the Centers for Disease Control and Prevention. More to the point, any attempt to reprocess single-use needles "may not sterilize the internal surfaces and may compromise the integrity of the device," the CDC states.1 Indeed, Newbold noted in his report that upon examining some of the repackaged devices, "a reddish substance that appeared to be blood" was visible to the naked eye on several of the butterflies on the end of the tubing and on the needle that is inserted into the vacutainer.
At least some of the butterfly needles at the lab were a winged steel design that uses a safety shield that locks in place after use to prevent needlesticks, Newbold found. But investigators did not report that the worker’s actions were motivated by a desire to protect herself from injuries and exposures. Instead, the court documents cite a "cavalier" attitude toward basic asepsis that included rarely wearing gloves, according to the co-worker’s account. Butterfly needles also are generally used for more challenging blood draws, Johnson says.
"They are used for patients that are more difficult to draw, either the very young or very old, or patients with veins that are difficult to draw from," he says.
Johnson says he was not aware of the phlebotomist having any difficulty with blood draws, but notes that she may have had a "preference" to use the devices.
Questions of competence
However, considerable evidence that the phlebotomist had past difficulties in collecting blood specimens was cited in hospital records and public health interviews with the phleboto mist’s former supervisors at Mills-Peninsula Health Services in Burlingame, CA. She worked at the hospital "from Sept. 3, 1996 until her termination on Oct. 15, 1996," Newbold reported. Dated that same day, a hospital letter explaining the action to the phlebotomist said, "You have made numerous errors, such as misdrawing patients, leaving orders uncollected, [and] creating or drawing specimens that need to be recollected due to poor quality," according to court documents.
Another supervisor at the same facility told the investigator that the phlebotomist "had extraordinary difficulty getting patients’ blood. Some times, [she] would be unable to obtain the blood specimen and would not tell the laboratory. The laboratory would learn of the problem when the physician would call for the test results." The reason given for the termination was "work performance not up to established standards regarding phlebotomy."
Margie O’Clare, director of communications at Mills-Peninsula, confirmed that the phlebotomist worked on the aforementioned dates in a probationary status. She did not "successfully complete" her probation, which is normally six months. Regarding questions about alerting subsequent employers to the action, O’Clare says hospital policy permits only release of employee dates of service. Regardless, court records reveal that the phlebotomist worked for a temporary service that found her a job at another SmithKline lab in San Carlos in 1995. Mills-Peninsula records also indicate she was reportedly an "on-call" employee for SmithKline at the time of the probationary hire, O’Clare says. The phlebotomist had three certificates of training and a recommendation, she says. Johnson says he is not sure specifically what referral and background information SmithKline had on the worker when she went to the Palo Alto lab, "but I can say for certain that if the company had received any information indicating that she was not fit to perform her duties as a phlebotomist, then she would not have been hired."
Mills-Peninsula sent letters offering free follow-up testing to 272 patients who may have had "contact" with the phlebotomist. Needle reuse is considered unlikely because she was closely supervised as a probationary employee at the facility, according to a hospital statement. The DHS is investigating other job sites where the phlebotomist worked to try to identify any other infection control breaches, August says. The department also is investigating allegations in the court documents that the phlebotomist reused lab equipment such as pipettes and mislabeled blood samples at the Palo Alto facility, he adds.
Still, there was no indication of criminal intent when the phlebotomist was questioned about reusing the needles, he notes. "In talking with investigators from the Santa Clara County Health Department and representatives from SmithKline, they [all] said that she did not show any malice or any ill intent," August says. Nevertheless, as part of the aforementioned criminal investigation, Palo Alto police have set up a "tip line" seeking information from any of the patients who specifically saw a staff worker reuse a needle to conduct a blood draw at the lab. In addition, they are seeking additional information from all patients who report that they tested positive for a disease they didn’t have prior to having their blood drawn at the lab.
Cody reported in her court statement that the phlebotomist "knows the practice was wrong and that she should not have done it. She admitted that she made a mistake. She was directly asked if she had done anything like this before and she emphatically denied ever having re-used needles, except for this instance."
Such blatant violations of basic asepsis are rare but not unprecedented. The CDC took the unusual step of reiterating the aforementioned guidelines for proper use of needles and syringes in 1993 after a physician administering group immunizations was observed wiping the needle with an alcohol swab and using it on the next patient.1 Though uncommonly reported, reuse of needles has resulted in patient-to-patient transmission of HIV.2,3 Indeed, Cody concluded the phleboto mist’s actions constituted a threat to public health, and Newbold recommended that she be barred for life from working in the laboratory sector of health care. While the state has regulatory authority over labs and could take action against the Palo Alto facility, no larger program of inspection or oversight of state clinical labs is currently planned, August says. "To our recollection," he says, "this is unique."
References
1. Centers for Disease Control and Prevention. Improper infection control practices during employee vaccination programs — District of Columbia and Pennsylvania, 1993. MMWR 1993; 42:969-971.
2. Hersh BS, Popovici F, Apetrei RC, et al. Acquired immunodeficiency syndrome in Romania. Lancet 1991; 338:645-649.
3. Centers for Disease Control and Prevention. Patient exposures to HIV during nuclear medicine procedures. MMWR 1992; 15:110-126.
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