Legal Review & Commentary
Mislabeled blood sample leads to inappropriate diagnosis of HIV, $20,000 settlement, and $52,000 verdict
By Blake J. Delaney, Esq., Buchanan Ingersoll & Rooney PC, Tampa, FL
News: A woman who was eight months pregnant was informed by her obstetrician that recent bloodwork had tested positive for HIV. The woman went into labor within 24 hours of hearing the news, and hospital personnel administered antiretroviral therapy to the woman and, following the delivery, to her newborn son. Two weeks later, the woman was informed that there was a mix-up at the laboratory and that the woman was not, in fact, HIV-positive. The woman sued the hospital and the laboratory for negligence. The laboratory settled the case for $20,000, and a jury returned a verdict against the hospital for $52,000.
Background: A woman in her eighth month of pregnancy decided to switch obstetricians. At her first visit with the new doctor, the obstetrician ordered a complete round of baseline tests, including HIV, hepatitis C, and CBC. The woman's blood was drawn at the hospital, which served as the site collection for the laboratory interpreting the results.
Ten days later, the obstetrician advised the woman that she had tested positive for HIV. She was referred to an infectious disease OB/GYN, who instructed her to begin taking antiretroviral medication to lessen the chances of the unborn baby contracting HIV during the birth. Within 24 hours of hearing the news, the woman went into premature labor. She was rushed to the nearest hospital, which was different from the hospital where her bloodwork had been performed. Because the OB/GYN had informed the woman that no one could be in the delivery area at the time of birth unless they knew of the woman's HIV-positive status, the expectant mother told her parents and in-laws that she had tested HIV-positive. At the hospital, personnel began intravenous antiretroviral therapy and administered additional blood tests. Following the delivery, the newborn was taken to the ICU and given antiretroviral medication as well.
Two weeks later, the woman's obstetrician called to inform her that there had been a mix-up at the laboratory and that she was not HIV-positive. The physician informed the new mother that the results of all of the follow-up HIV tests were negative and that he believed her blood sample had been mislabeled at the laboratory. The antiretroviral treatment immediately was stopped.
The woman, her husband, and their son sued the hospital and the laboratory for negligence. The woman sought damages for mental anguish and physical pain, and she feared what effects her baby would experience as a result of the unnecessary administration of antiretroviral treatment following his birth. The woman claimed that she was not mad about the laboratory mix-up until it was clear to her that no one cared about the anguish she had been through during those two weeks.
The laboratory settled with the plaintiffs for $20,000 before trial, but the hospital denied liability. It claimed that on the same day that the woman learned of the positive result, her physician had told her that the test result was not confirmed and that additional tests were needed to verify that the initial result was accurate. The defendant hospital pointed out that an HIV test taken less than 24 hours after the woman initially was informed that she was HIV-positive had returned with negative results, and that the woman's HIV-negative status was confirmed over the next several days by additional tests. The woman claimed in response that she was not informed of these test results until two weeks had passed. After trial, the jury returned a verdict of $52,000 for the plaintiffs to compensate them for their mental anguish and physical pain.
What this means to you: "Patient identification is the very first step in providing safe care," says Cheryl Whiteman, RN, MSN, HCRM, clinical risk manager for Baycare Health System in Clearwater, FL.
Although many health care providers think of the administration of a medication or the verification before a surgical procedure as "patient identification," Whiteman is mindful that the term also ensures that an order is entered into the computer on the right patient, the right test results are entered on the correct medical record, and — as in this case — specimens are correctly labeled. Indeed, The Joint Commission has recommended a National Patient Safety Goal (NPSG) for 2008 mandating that specimens are labeled in the presence of the patient to help avoid errors such as this one.
Whiteman notes that risk managers should evaluate their facility's process and policy of labeling specimens. In anticipation of the NPSG, risk managers should consider how to implement the policy of labeling all specimens in the presence of the patient. Whiteman recognizes that staff education may be needed and that, in accordance with the risk management process, a monitor should be utilized to verify staff compliance with the policy.
Continuity of care in this case was confounded by the multiple practitioners involved with the patient in a very short period of time. The patient electively changed obstetricians late in her pregnancy, was subsequently referred to an infectious disease obstetrician based on the incorrect HIV result, and was admitted to a hospital other than the one where previous care and testing had been provided. "But even though the various personnel involved may have contributed to the confusing situation, it still appears that there was a delay in informing the patient of a confirmed negative HIV status. It is easy to see how the patient may have been left with no loyalty to any of the providers, which could easily lead to the perception that no one cared about her plight," says Whiteman.
In conclusion, Whiteman emphasizes the movement in health care toward transparency and providing honest information in a timely manner. "The principles of disclosure include a caring attitude, as well as a since apology when warranted," notes Whiteman.
- Texas District Court, Harris County, Case No. 2003-47465-A.