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Stuck in the Middle

A clinician sustains a needlestick from a patient who refuses HIV testing. An HIV physician, an attorney, and an ethicist weigh provide weigh in on how best to manage.

A 36-year-old man was admitted to the intensive care unit after being found confused and febrile on the street. Admission evaluation revealed evidence of multiple trauma, waxing and waning mental status, and leukocytosis; a urine toxicology screen was positive for opiates and cocaine.

While placing a central line in this patient, the intensivist stuck himself with the hollow-bore needle being used for the procedure. He experienced slight bleeding but did not recall any visible blood on the device. According to state law where the case occurred, written informed consent is required for HIV testing in the source patient. However, the patient refused to sign the consent form and became angry because he felt the healthcare team was threatening him. During the next 24 hours, he became increasingly obtunded and required intubation for airway control. The only person visiting him in the hospital was his girlfriend; no healthcare proxy or family member was available.

How would you manage the intensivist who sustained the injury? Would you give postexposure prophylaxis (PEP)? If so, what specifically would you give, and for how long? How would you determine whether the source patient is HIV-infected? Would you perform surrogate testing (for example, obtain a CD4-cell count) to assess this? Would you consider testing him without written informed consent? Would you ask his girlfriend to provide consent for him? If he is tested, would you give him the results after he recovers if the test is negative? If the test is positive?

Addendum: When we originally published this case, we asked readers what they would do (see responses below). Now, we have updated the case to provide the opinions of three experts.

Response 1

Raphael J. Landovitz, MD

According to CDC surveillance data, the average risk for HIV infection following percutaneous exposure to HIV-infected blood is approximately 0.3% (Am J Med 1997; 102:9). An exacerbating factor in this case is the involvement of a hollow-bore needle that (presumably) had been intravascular in the source patient; thus, blood might have been present in the lumen of the needle, even if it was not visible on the needle's exterior. Most guidelines and many experts would recommend PEP for such an exposure, based on a single case-control study suggesting that it leads to a >80% reduction in the likelihood of HIV infection following a needlestick injury (N Engl J Med 1997; 337:1485).

In an ideal situation, the source individual would agree to HIV testing, and the results would determine the need for PEP. For example, if rapid testing for HIV antibodies was available and the results were negative, PEP could be deferred, assuming the source was not at risk for being in the acute "window period" of HIV infection (when viremia levels are extremely high, but antibodies are not yet present). If rapid testing was not available, PEP could be initiated while the source patient was tested conventionally (ELISA with confirmation from a Western blot or an immunofluorescent assay) — and then if a negative result was obtained, the PEP could be discontinued (again, with the same caveats regarding acute infection risk).

Laws around HIV testing and consent are evolving. CDC guidelines published in 2006 recommended dropping the requirement for written consent, to destigmatize and facilitate such testing. Although state laws are increasingly coming into concordance with CDC recommendations, such laws differ widely from state to state (Ann Intern Med 2009; 150:263). Even in states that have adopted "opt-out" HIV testing policies and dropped the requirement for written consent, the situation remains extremely complicated and relatively untested against legal challenge: If the source patient is unwilling to be tested, there are no ethical options to get around the refusal. Surrogate testing (of CD4-cell counts, viral loads, or p24 antigenemia) violates the spirit of informed consent for HIV testing and is not considered acceptable. The source patient's girlfriend cannot provide informed consent unless she has been specifically designated as his healthcare proxy.

The clinician then is left to balance the likelihood of HIV acquisition in this case against the potential toxicities of PEP. In the current HIV treatment era, the toxicity of a 28-day course of PEP is significantly less than it was in the not-too-recent past, and therefore the risk–benefit ratio for PEP is improving. Given the lack of data showing that a three-drug regimen for PEP is superior to a two-drug one, I would provide the intensivist with a 28-day course of tenofovir/FTC (Truvada) to be started as quickly as possible after the exposure, with baseline and follow-up ELISA testing at 4 to 6 weeks, 12 weeks, and 24 weeks.

In addition, I would consider the possibility that the intensivist was exposed to hepatitis B or C virus (HBV and HCV, respectively) from the needlestick. If the intensivist has somehow escaped HBV vaccination, a first dose of vaccine should be given immediately; if the source patient has evidence of circulating HBV surface antigen, hepatitis B immune globulin, too, could be considered for the intensivist. HCV testing of the source should be performed, and baseline and serial EIA testing of the intensivist should be considered to assess for acute HCV seroconversion, which would warrant early treatment with pegylated interferon. Notably, hepatitis testing in the source patient would not be considered a surrogate for HIV testing in the same way that testing for viral load, CD4-cell count, or p24 antigenemia would be.

Response 2

Catherine Hanssens, Esq.

Any version of involuntary testing in this scenario is inappropriate — medically, legally, and ethically. Individual privacy rights do not operate in isolation from medical and public health needs, but a provider's desire to know a piece of information is very different from the need for, or even usefulness of, that information — in this case, the HIV status of the patient.

The patient did not, and does not, have the legal capacity to consent to an HIV test, and without a medical power of attorney, the girlfriend has no legal authority to consent on his behalf. Equally important, however, is that the testing under consideration would not provide information sufficiently conclusive to alter the recommended course of prophylaxis.

None of the tests suggested could rule out HIV infection or the possibility of exposure. A negative antibody test does not rule out recent infection. A CD4-cell count is useless, because it reveals immunocompetence or suppression, not the cause, and many HIV-positive individuals retain healthy immune systems for at least a short period following infection. Even a negative viral-load test is not conclusive in ruling out the presence of HIV.

The risk for infection from the needlestick accident described is extremely low, even if the exposure involved HIV-infected blood. That said, a 4-week course of tenofovir/FTC (Truvada), with its relatively tolerable side effects, would generally be worthwhile to diminish the remote risk for infection. Although the scenario makes no reference to the HIV status or testing of the intensivist, he himself should receive initial and repeat HIV testing.

This recommendation for PEP should be considered in the context of current HIV therapy trends, in which growing numbers of doctors are calling for lifelong antiretroviral therapy (ART) soon, or even immediately, after an individual is infected with HIV. If physicians and researchers thought a short course of treatment was too toxic or risky to endure without proof of HIV exposure, would they be recommending earlier initiation of ART to their patients in advance of clear clinical need and conclusive evidence that it improves long-term health and survival?

Finally, if the patient were tested, not revealing that fact would be unethical, regardless of the test result. However, the question is irrelevant because involuntary testing itself would be unethical under the circumstances described.

Response 3

Lisa Lehmann, MD, PhD, MSc

The ethics of testing patients for HIV without their consent must be distinguished from the legal question of whether the law requires informed consent. From an ethical perspective, even in states with no requirement for written informed consent, we would still almost always need to obtain verbal consent from patients before testing them for HIV.

Consent may be waived if not knowing a patient's HIV status would cause serious harm to another person. In the present case, however, not knowing the patient's HIV status does not pose a threat of serious harm to the intensivist. The intensivist can prevent infection by taking PEP without knowing the patient's HIV status. In doing so, the intensivist may incur unnecessary toxicity and adverse effects from the medications. This potential harm must be balanced against the harm to the patient of testing without consent.

In this case, I see no compelling reason to test the patient without his consent. Testing the patient would not be for diagnostic purposes, to provide him with appropriate medical care, but rather for the intensivist's benefit. Furthermore, testing is not absolutely necessary to protect the health of the physician and has the potential to harm the patient. If the intensivist is concerned about his risk for HIV infection, he can begin PEP immediately, and when the patient regains his capacity to provide consent, he can be asked again about testing. However, even if the patient were tested after the needlestick, he could be in a window period during which he could transmit the virus without testing positive. Thus, a negative HIV test for the patient would not guarantee that the intensivist has no risk for HIV infection. If the patient never regains the capacity to consent because he dies, postmortem testing would be reasonable even without consent because concerns about potential harm to him would have disappeared.

Surrogate testing for HIV is ethically unjustified in that it represents a duplicitous attempt to circumvent both the patient's autonomy and state law. It is also clinically problematic because a CD4-cell count is unreliable in critically ill patients and therefore should not be used to guide clinical decisions.

The patient's girlfriend in this case is not an appropriate surrogate to provide informed consent for testing. Some states that require written informed consent mandate that the consent be from the patient, not from a surrogate. Even if the girlfriend could legally provide consent, disregarding her own motivations for wanting the patient tested might be difficult for her.

The intensivist's preferences with regard to PEP should guide the decision about how to proceed. The risk for HIV transmission from needlestick injuries should be explained, as well as the increased risk associated with a needlestick involving a large-bore needle that was in a vein.

Tell us what you would do

How would you manage this patient? Submit your comments below.

Dr. Landovitz is Assistant Professor, Division of Infectious Diseases, Center for Clinical AIDS Research and Education, University of California, Los Angeles.

Ms. Hanssens is Executive Director, Center for HIV Law and Policy, New York City.

Dr. Lehmann is director of the Center for Bioethics at Brigham and Women's Hospital, a practicing internist in Brigham Internal Medicine Associates, and Assistant Professor of Medicine and Medical Ethics at Harvard Medical School. She reports no potential conflicts of interest.

Published in Journal Watch HIV/AIDS Clinical Care July 27, 2009

Reader Remarks:

Read all Reader Remarks on this article

• Middle managment
  Peter J. Waldman, Vermont, 28 Jul 2009 2:37 PM EST
  I woud definitely treat the intensivist with PEP, would absolutely consider testing the source patient without consent, and I would... [more]
• HIV
  Joalie Davie, New Mexico, 28 Jul 2009 2:33 PM EST
  I assume that the patient will not be available for a follow up HIV test as well so even if... [more]
• Stuck in the Middle
  NSKE NSKE, 28 Jul 2009 1:29 PM EST
  Without a doubt if it was me - obtain baseline test for HIV both HIV antibody and vL. Then immediately... [more]
• HIV refusal / internist needlestick
  Mariah Haley, ICU Nurse, 28 Jul 2009 12:49 PM EST
  Patients shouldn't be the ONLY people with rights in this situation!
  
  Yes, they have the right to refuse to consent... [more]
• treatment of accidental needle stick in healthcare provider.
  GB Howell, Outpatient clinic, 28 Jul 2009 12:41 PM EST
  I would test and I would treat.
• Intensivist Needle Stick from ?able pt.
  Ruth H. Strauss MD, 28 Jul 2009 12:22 PM EST
  To be honest, I would ask the girlfriend, and if she said "no" I would probably either have 2 physicians... [more]
• cerd
  carlos e. rojas, 28 Jul 2009 12:21 PM EST
  The same principle of law, that you may breech information about pt condition, in case of life threatening event involving... [more]
• stuck in the middle
  Herschel V. Murdaugh, retired, 28 Jul 2009 12:15 PM EST
  My first responsibility is to the patient, then the physician stuck with the needle. Clinical experience suggests that the patient... [more]
• Intensivist with needle-stick
  Vickie L Becker, 28 Jul 2009 12:07 PM EST
  I would test the patient and give the intensivist PEP, according the most recent guidelines: Hep B- HBig + vaccinate;... [more]
• about Stuck in the Middle
  Daniela G Nikolova, Clinic of infectious diseases-Varna,Bulgaria, Europe, 28 Jul 2009 12:05 PM EST
  On all questions my answers are- yes. PEP will be 3-component therapy-for example- Combivir and Viramune or Kivexa and Kaletra... [more]
• Manage the intensivist
  V Sanders, 28 Jul 2009 11:52 AM EST
  Follow post-exposure guidelines for unknown source. Do not test the patient against his will. Provide postexposure prophylaxis. Intitial lab test... [more]
• HIV Exposure risk
  Deepak Bhagwandas,MD.PT, 28 Jul 2009 11:35 AM EST
  Start antiretrovirals ppx
• Stuck in the middle
  Benjamin D. Gordon, M.D., retired, 28 Jul 2009 11:12 AM EST
  A patient whose mental status is "waxing and waning" and who has evidence of cocaine and opiate use is not... [more]
• stuck in the middle
  ROBERT A MAXWELL, 28 Jul 2009 11:04 AM EST
  1. Ask him again, even though he is intubated, and inform him that the physician suffered needlestick, for permission. Also... [more]
• HIV Test
  Dr, Cornelius Reinhard Weerts, Germany, 28 Jul 2009 10:43 AM EST
  Undergo an HIV Test twice -in different times - on your own cost.
• HIV testing
  Paul H King, 28 Jul 2009 10:03 AM EST
  test the subject....period..no discussion required
• Stuck in the Middle
  Jean Yared, 28 Jul 2009 9:49 AM EST
  I would start by testing the intensivist for ELISA HIV at D0 (and every 6 weeks up to 6 months),... [more]
• Patient Testing for HIV
  Lawrence E. Plaskett, 28 Jul 2009 9:38 AM EST
  In view of the circumstances under which he was admitted, I would evaluate his HIV status. Additionally, I would inform... [more]
• Stuck in the Middle
  Humberto Olivencia, 28 Jul 2009 9:35 AM EST
  In my hospital we have a consent that is firmed by most of the patients when they are hospitalize (... [more]
• "informed consent"
  Mel Breite, 28 Jul 2009 8:38 AM EST
  our beloved patient is having all kinds of things done without real "informed consent" to possibly save his life. We... [more]
• needlestick patient refuses HIV test
  Ste..a J. Fitzgibbons, IPC, 28 Jul 2009 8:09 AM EST
  Hospitals all over the world have policies for this, what's the big puzzle? The patient's blood is sent for testing... [more]
• Nature heals
  Martín G. Murman, 28 Jul 2009 7:59 AM EST
  Primum non nocere
• Stuck in the middle
  Maria Mohammed Satti, 28 Jul 2009 7:44 AM EST
  I will test the patient without his consent & will not give him the results either way they are. He... [more]
• Non-consented test for the patient.
  Krispin Hajkowicz, Australia, 28 Jul 2009 12:43 AM EST
  I would perform a non-consented HIV test on the patient for his own wellbeing in an emergency. A positive or... [more]
• Testing the patient
  Harvey A. Elder, San Bernardino Co. P.H.D. Early Intervention Clinic, 27 Jul 2009 11:47 PM EST
  I would have drawn the blood for the test before receiving the patient's permission. If refused, I would identify the... [more]
• needle stick
  howard zhang, UMMC, 27 Jul 2009 10:10 PM EST
  I would prophylactically treat the physician, and test the patient for HIV even though he refused. I think the consent... [more]
• Stuck in the Middle
  Bettina Bernstein, 28 Jul 2009 4:34 PM EST
  postexposure prophylaxis if the intensivist was not allergic HIV test on the blood already drawn as the test result is... [more]
• HIV
  James S. Long, 28 Jul 2009 4:49 PM EST
  Start PEP on the intensivist, test for HIV, even without consent, and inform him of the results after he recovers.... [more]
• Stuck in the Middle
  Samuel S Zagarella, Australia, 28 Jul 2009 7:45 PM EST
  Doctors have rights too. The intensivist has an obligation to save this patient AND an obligation to their own health... [more]
• Stuck in the Middle
  SUDHIR REGMI, KMCTH,Kathmandu,NEPAL, 29 Jul 2009 12:21 AM EST
  Certainly, the first step from my side would be post-exposure prophylaxis for the intensivist. In view of patient's toxicology screening,he... [more]
• Stuck in the Middle
  Tania Acevedo, Danbury Hospital, 29 Jul 2009 5:00 PM EST
  Treat the intensivist, with prophylaxis and test the patient. There 2 human lives that can be seriously affected by this... [more]
• Implied Consent
  KS Kahlon, Community Hospital, San Diego, California, 29 Jul 2009 7:58 PM EST
  At our institution, patients who are able or a legal surrogate sign a form at the time of hospital presentation... [more]
• testing with no consent
  José Manuel Ferreira, 31 Jul 2009 7:17 PM EST
  in portugal the patient would be testede because in our understanding the patient admited to hospital is in the ritgh... [more]
• stuck in the middle
  E Kunka, 1 Aug 2009 1:11 PM EST
  I would start PEP for the Doctor and then go ahead to collect blood for an HIV testing from the... [more]
• What I would do, Stuck in the Middle
  Elsa J. Aguilera, VA Boston Healthcare System, 31 Jul 2009 12:02 PM EST
  1) After taking blood from the intensivist for HIV, HBsAg, HCV treat him on emergency basis
  
  2) Ask the girlfriend... [more]
• postexposure prophylaxis
  khaled hamad, afh oman, 3 Aug 2009 3:42 PM EST
  after reviewing the hx and the circumstance of the injury and taking in consederation that the pat. was found in... [more]
• Dilema Do or Dont
  Rabia Akbar Vali, Central Private Hospital, 6 Aug 2009 11:42 AM EST
  the patient is admitted in a confused state and preferably i will take the consent of his girl friend and... [more]
• Have Patient Pre-sign before receiving any treatment
  Rochelle Y. Odell, Disabled W/CRPS, but worked at USC University Hospital in Los Angeles before becoming disabled., 8 Aug 2009 2:25 AM EST
  Being a former Critical Care Tech at a community hospital in Georgia, I received a needle stick. Fortunately, it was... [more]
• stuck in the middle
  Doanh Lu, Vietnam, 11 Aug 2009 1:35 AM EST
  The responses from the experts clearly showed that they have never had a needle stick from a high-risk patient, nor... [more]
• I will test the patient,for his benefit
  Rabia Akbar Vali, Central Private Hospital,Sharjah,U.A.E., 11 Aug 2009 2:19 AM EST
  both the patient and the treating doctor are important and both need to be taken care of and as the... [more]
• Needle stick from high risk source
  Peter T Comfort, Overberg Hospice, South Africa., 11 Aug 2009 5:50 AM EST
  If HIV +ve, the patient endangers medical staff, their families,their own future health and all those whom they may come... [more]
• Needle Stick
  Melissa Hawthorn, Clinical Research, 11 Aug 2009 8:14 AM EST
  Is that lawyer high? Since when do the rights of one always trump the rights of another? By this I... [more]
• Post-exposure prophylaxis
  Suleiman ibrahim Kuranga, University of ilorin teaching Hospital, ilorin, 11 Aug 2009 9:44 AM EST
  From the history given, there is no need the intervist insist on the patient doing the test againt his will,... [more]
• Ethics
  Deborah May, 11 Aug 2009 9:54 AM EST
  So breaking the law whenever it is deemed to be in the best interest of the physician is an acceptable... [more]
• Put yourself in the intensivist shoes
  Thabisa Sibanda MBchB, PG diploma in Clinical trials, 11 Aug 2009 10:16 AM EST
  Firstly it is unethical to test this patient. Surrogate markers are equally unethical and also unhelpful. Unfortunately this situation is... [more]
• Arrest 'em and test 'em
  Charles E Walsh, 11 Aug 2009 10:20 AM EST
  Charge: attempted murder, of intensivist by patient. Subpeona HIV status. Treat intensivist per results. Golf.
• hiv consent
  Anne M. Pennisson,MD, gov., 11 Aug 2009 1:26 PM EST
  Other tests could be used p24 antigen,cd4 counts but the pt should be tested for rapid HIV and vl. The... [more]
• Ethical Relativism
  A W P, MD JD, 11 Aug 2009 6:43 PM EST
  The Canons of legal ethics provide for an attorney who has not been paid by their client the leeway to... [more]
• Stuck in the Middle
  Emily Mawdsley, 29 Dec 2009 11:00 AM EST
  Wouldn't we adjust the PEP regimen based on the source patient's results? For example, if the pt tests positive for... [more]
• patient autonomy
  James H Avruch, Tufts Mwedical Center, 22 Jan 2010 8:50 AM EST
  I'm not an intensivist and i have not had a needlestick from a high- risk patient. Some have argued that... [more]