Liability for and Prevention of Transplant-Transmitted Infections
By Sara J. Agne, Snell & Wilmer L.L.P., Phoenix, Arizona
The Centers for Disease Control and Prevention (“CDC”) estimates that one in 20 hospitalized patients will contract a nosocomial, or healthcare-associated, infection (“HAI”).1 With the risks even greater and the effects more devastating for immunocompromised organ-transplant patients, providers who work in or near transplant programs should take special note of prevention and liability issues related to transplant-transmitted infections.
Rare, But on the Rise
Though considered rare overall, transplant-transmitted or solid organ transplant-associated infections have made the news several times in recent years. Clusters of donor-to-recipient, transplant-transmitted West Nile virus, lymphocytic choriomeningitis virus, rabies, even Balamuthia mandrillaris (a free-living ameba found in soil), have all been reported tragedies in the past decade.2 CDC officials estimate that as many as one percent of recipients may contract a transplant-transmitted infection of some type.3 It is a rough estimate, however, as the United States lacks a uniform, national mandatory reporting or monitoring system for transplant-transmitted infections.
Transplants of all types are thought to be generally increasing, with the Organ Procurement and Transplantation Network’s (“OPTN”) paired donation pilot program in full swing for kidney transplants4 and social media drawing attention to recipient need and donor opportunities.5 Recognition of transplant-transmitted infections, including rare zoonotic infections, is also on the rise.6 Societal factors such as increased immigration, “transplant tourism,” travel abroad, and exotic pet ownership may increase exposure. Potential donors with evidence of unexplained encephalitis at death have received additional scrutiny in recent years.7
Similar to newborn screening procedures, though, the extent and variety of pathogen screenings for donors and their organs may vary by state and by individual organ procurement organization. Sometimes the provider charged with performing the transplant is the only one who can prevent a mismatch between the condition of a donor’s organ and a patient’s wishes or protect the patient from undue risk. Failure to do so may give rise to liability.
For example, a pediatric surgeon’s concerns about transplant matches made before completion of donor serologies were recently raised to the OPTN/United Network for Organ Sharing’s (“UNOS”) disease transmission advisory committee. A discussion with a transplant coordinator revealed to the surgeon instances in which his recipient patients were being offered Hepatitis C-positive organs when the patients were listed as not willing to receive such organs.
The OPTN/UNOS committee acknowledged that “[n]o transplants took place in these instances, but potential for harm was present in these near miss situations.”8 Its interim conclusions included that in the event of inconsistent or pending test results, organs should be treated as positive for the tested antibody until proven otherwise, to minimize the risk of disease transmission.9 In other words, the most conservative approach should be used in the interest of patient safety over the desirability of a quick match and transplant.
Liability can attach for providers and organizations who fail to ensure safe and sanitary conditions for transplants. Widespread failures of infection precautions may be characterized as patient neglect. Failure to confirm and document full informed consent regarding transplant procedures may give rise to malpractice litigation or even federal allegations of healthcare fraud, if substandard care is alleged to have led to infection.10
Implementing simple best practices may help keep transplant patients infection-free and providers out of litigation. As with any procedure, informed consent is key. Providers should discuss the risks of transplant-transmitted infections with their patients and take special care to ensure patient comprehension. Risks should not be glossed over due to the prospect of an available organ. Patient directives regarding the types and conditions of organs that will or will not be offered, if available, must be clarified and honored.11
In its 2011 draft Public Health Service Guideline for Reducing Transmission of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) Through Solid Organ Transplantation, a panel of CDC experts strongly recommended that provider-patient informed consent discussions involve an ongoing process from the time of listing the patient for transplant.12 The discussion should continue to be reopened at any time the patient remains on the waiting list to account for potentially changed patient circumstances and due to the length of time most patients remain on the list before transplant. At the time of an organ offer, specifics regarding potential for HIV-, HBV-, or HCV-infection from the prospective donor should be discussed and supported by evidence of donor history and blood test results.
The draft notes that a separate informed consent discussion by the transplant center team and patient may be needed for vessel conduits, which may originate from a different donor. Conservative donor risk assessments and screenings should be conducted and verified, involving reviews of medical/behavioral history, physical examinations, and blood tests, including the most sensitive tests available for certain conditions. OPTN develops and maintains specific guidance for best practices in screening and recognizing donors with certain conditions, including tuberculosis and central nervous system infections like rabies, and for obtaining follow-up information from living donors.13
Congress funded states to devote time and resources to prevent nosocomial infections in both the American Recovery and Reinvestment Act of 2009 and the Patient Protection and Affordable Care Act of 2010.14 Particularly notable is the ongoing coalescence of reporting requirements, which can implicate federal healthcare incentives and state public records laws. Accurate and timely reports of transplant-transmitted and any nosocomial infections aid transparency and may reduce the specter of liability.
Of additional concern are the more common nosocomial infections to which immunosuppressed recipients can be especially vulnerable during their hospital stays. These include urinary tract infections, ventilator-assisted pneumonia, surgical site infections, intravascular-device-related infections, and Clostridium difficile-associated diarrhea. The rate of nosocomial infections in an organ transplant unit was reported in a 2006 article to be 62 percent for patients who received a kidney from a deceased donor and 40 percent for those who received a kidney from a living, related donor.15 Studies have shown that adequate cleaning of equipment may prevent as many as one-third of HAIs.16
There are also the cases where providers themselves are the vectors — a California heart surgeon unwittingly infected five patients with staph infections during valve replacement operations last year, due to microscopic tears in his surgical gloves. Four of the patients required second operations, paid for by the hospital. Ignoring the potential for certain procedures to place additional stress on surgical gloves or other equipment, or even excessive use of hot water for provider hand hygiene, can increase the risk of infection for transplant patients.17
A Balancing Act
The risks of infection should always be weighed against the benefit of a transplant by both providers and patient. Not all patients on the waitlist for an organ transplant are in equal need — hence the ranking of the list — and not all patients are willing to accept the same types of organs. As the CDC’s Director of the Office of Blood, Organ, and Other Tissue Safety, Matthew J. Kuehnert, MD, wrote in a blog post about Balamuthia infections and deaths, “a kidney patient medically stable while living on dialysis may not be as accepting of elevated risk as a heart failure patient without any hope for survival.”18 Kuehnert’s team at the CDC investigated more than 200 reports of unexpected transplant-transmitted infections from 2007 through 2010.19
Similarly, providers need to assess their professional and personal levels of comfort with elevated risks for their patients. When a rabies outbreak from 2011 transplants came to light in 2013, a New York transplant surgeon, Amy L. Friedman, MD, explained to CNN that she refuses to transplant organs from a donor who died of encephalitis of unknown origin.20 Her comments came with the caveat that she does kidney transplants with patients who can survive on dialysis in the immediate term, so, compared to patients in need of other organs, her patients may have the luxury of additional time. Dr. Friedman’s decision to decline certain organs in the interest of the safety of her relatively stable patients exemplifies the balancing calculations inherent to transplant medicine.
Yet the emergent nature of recipients’ needs combined with the limited window of organ viability for transplant will likely always mean that some conditions simply must remain unscreened for. Providers engaged in the balancing act inherent to transplants, however, may wish to take the steps outlined above to prioritize safety and minimize risk and potential liability.
Sara Agne is an associate at Snell & Wilmer L.L.P. in Phoenix, Arizona. She tweets about organ and transplant law and news on Twitter as @transplantlaw and can be reached at email@example.com.
Centers for Disease Control and Prevention,Healthcare-associated Infections (HAIs): The Burden, http://www.cdc.gov/hai/burden.html (last visited June 17, 2013).
See,e.g., Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report (“CDC MMWR”), West Nile Virus Infections in Organ Transplant Recipients --- New York and Pennsylvania, August—September, 2005, http://www.cdc.gov/mmwr/preview/mmwrhtml/mm54d1005a1.htm (last visited June 17, 2013); CDC MMWR, Brief Report: Lymphocytic Choriomeningitis Virus Transmitted Through Solid Organ Transplantation --- Massachusetts, 2008, http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5729a3.htm (last visited June 17, 2013); CDC MMWR, Update: Investigation of Rabies Infections in Organ Donor and Transplant Recipients --- Alabama, Arkansas, Oklahoma, and Texas, 2004, http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5327a5.htm (last visited June 17, 2013); CDC MMWR, Balamuthia mandrillaris Transmitted Through Organ Transplantation --- Mississippi, 2009, http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5936a1.htm?s_cid=mm5936a1_w (last visited June 17, 2013).
William Check, Ph.D., Lowering infectious disease risks for transplants, October 2012 Feature Story, College of American Pathologists Today, http://capatholo.gy/14eE3xz (last visited June 17, 2013) (quoting CDC’s Matthew J. Kuehnert, M.D.).
See, e.g., Facebook, Donate a lung to Sarah Murnaghan, https://www.facebook.com/DonateALungToSarahMurnaghan (last visited June 17, 2013).
Camille N. Kotton, Zoonoses in Solid-Organ and Hematopoietic Stem Cell Transplant Recipients, Clinical infectious Diseases, http://cid.oxfordjournals.org/content/44/6/857.long (last visited June 17, 2013) (“The studies of zoonoses and transplantation-associated infectious diseases are evolving fields that are receiving increased recognition.”).
OPTN issued guidance in June 2012 highlighting the risks that can be associated with such donors: OPTN, Guidance for Recognizing Central Nervous System Infections in Potential Deceased Organ Donors: What to Consider During Donor Evaluation and Organ Offers, http://optn.transplant.hrsa.gov/ContentDocuments/Guidance_DTAC_CNS_Infections_07-2012.pdf (last visited June 17, 2013).
OPTN/UNOS Ad Hoc Disease Transmission Advisory Committee, Interim Reports, March 20, 2013, Chicago, Illinois, at 3.
|9||Id. at 4.|
Shawn Mathis, Esq., Legal Responsibility and Accountability for Healthcare-Associated Infections in the ASC, The Health Lawyer, Vol. 24, No. 6, August 2012, at 34 ([Healthcare fraud] “can also include ‘quality of care cases involving allegations of substandard care’”) (quoting Dan Levinson, Inspector General of the U.S. Department of Health and Human Services).
|11||See supra note 8 and accompanying text.|
|12||Centers for Disease Control and Prevention, Notice of availability and request for public comment, PHS Guideline for Reducing Transmission of HIV, HBV, and HCV Through Solid Organ Transplant, 76 F.R. 58517-18 (September 13, 2011); full Draft Guideline available athttp://www.regulations.gov/#!documentDetail;D=CDC-2011-0011-0002, at 15.|
|13||See, e.g., supra note 7 and accompanying text.|
|14||See, e.g., Centers for Disease Control and Prevention, State-based HAI prevention: Affordable Care Act (ACA) Activities Funded, http://www.cdc.gov/hai/stateplans/aca/aca-funded.html (last visited June 17, 2013); Centers for Disease Control and Prevention, State-based HAI prevention: Performance Measures, Recovery Act Reporting Requirements, http://www.cdc.gov/hai/state-resources/ARRA_archive/ (last visited June 17, 2013).|
|15||Dantas SR, Kuboyama RH, Mazzali M, Moretti ML, Nosocomial infections in renal transplant patients: risk factors and treatment implications associated with urinary tract and surgical site infections, J. Hosp. Infect., Vol. 62, No. 2, 117-23 (June 2006).|
|16||See, e.g., Schabrun, S, Chipchase L, Healthcare equipment as a source of nosocomial infection: a systematic review, J. Hosp. Infect., Vol. 63, No. 3, 239-45 (2006).|
|17||CDC MMWR, Guideline for Hand Hygiene in Health-Care Settings, http://www.cdc.gov/mmwr/PDF/rr/rr5116.pdf, at 32 (“Avoid using hot water, because repeated exposure to hot water may increase the risk of dermatitis”) (last visited June 17, 2013).|
|18||Matthew J. Kuehnert, M.D., Investigating Rare Transplant-Transmitted Infections, http://blogs.cdc.gov/safehealthcare/2010/11/04/investigating-rare-transplant-transmitted-infections/ (last visited June 17, 2013).|
|19||Matthew J. Kuehnert, M.D., CDC: Protect Organ Transplant Patients from Unintended Disease Transmission, http://blogs.cdc.gov/safehealthcare/2011/09/21/cdc-protect-organ-transplant-patients-from-unintended-disease-transmission/ (last visited June 17, 2013).|
|20||Elizabeth Cohen and John Bonifield, CDC: Man died of rabies from kidney transplant, http://www.cnn.com/2013/03/15/health/organ-transplant-rabies-death (last visited June 17, 2013).|
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