Background: In 2007 and 2008, 115 patients were found to be either certainly or presumptively infected with the hepatitis C virus through the reuse of contaminated medication vials at two southern Nevada endoscopy clinics. A subsequent joint investigation by federal and state agencies found multiple breaches of infection control protocols. There was also strong anecdotal evidence that among clinic staff, unsafe patient care conditions often went unreported because of a general fear of retaliation. At the request of the Nevada legislature's Legislative Committee on Health Care, a study was conducted to examine Nevada RNs' experiences with workplace attitudes toward patient advocacy activities. This article presents the study findings and reviews how one public health tragedy led to the creation of effective health care policy.

Results: The response rate was modest at 33% (564 respondents). Of those who responded, 34% indicated that they'd been aware of a patient care condition that could have caused harm to a patient, yet hadn't reported it. The most common reasons given for nonreporting included fears of workplace retaliation (44%) and a belief that nothing would come of reports that were made (38%).

Conclusions: The study findings underscore the need for a shift in organizational culture toward one that encourages clear and open communication when patient safety may be in jeopardy. These findings were ultimately used to support the passage of whistleblower protection legislation in Nevada.

Although the Centers for Disease Control and Prevention (CDC) reports that an estimated 3.2 million Americans are living with chronic hepatitis C, in southern Nevada fewer than four cases of acute hepatitis C are confirmed annually.1, 2 So when six people who had recently undergone endoscopic procedures were diagnosed with acute hepatitis C within a six-month period (July 2007 to December 2007), alarms were sounded.1 Ultimately, more than 62,000 patients who had undergone endoscopic procedures at either of two southern Nevada endoscopy clinics would be notified that they might have been exposed to bloodborne pathogens, including hepatitis B virus, hepatitis C virus (HCV), and HIV, as a result of unsafe injection practices.3 In total, seven patients would be confirmed as having clinic-associated HCV infections that were genetically linked to source patients; two more had clinic-associated HCV infections that could not be so genetically linked; and an additional 106 patients were presumptively diagnosed with "possible clinic-associated HCV infection."3, 4 This appears to be the largest nosocomial patient exposure to a bloodborne pathogen in the United States ever documented in the literature.

BACKGROUND

In January 2008, the CDC, the Nevada State Health Division, and the Southern Nevada Health District began a joint epidemiologic investigation. The investigators found multiple breaches of infection control and record-keeping protocols at the two Las Vegas-area clinics, including the reuse of syringes, medication vials, bite blocks (devices placed in the mouth during upper endoscopies), and other equipment intended for single use.4, 5 At one clinic, the staff reported that "the rule was to reuse single-use equipment three times if possible."5 The clinic staff also reported that they were "only allowed to use four bite blocks per day per procedure room," regardless of the number of procedures performed, and were "directed to reuse syringes"; purchasing records supported both statements. The investigators themselves observed "the reuse of 'single-use' [medication] vials for multiple patients."

It bears emphasizing that single-use items aren't designed for reuse on another patient. The Society of Gastroenterology Nurses and Associates has stated that "critical medical devices" (devices introduced into the bloodstream or other sterile areas of the body) that are intended for single use should not be reused.6 They note that original equipment manufacturers must conduct rigorous testing to verify that a reusable item can be reliably cleaned and if necessary sterilized; and that the Food and Drug Administration requires equipment reprocessors to demonstrate that a reprocessed device is "substantially equivalent" to a newly manufactured device.6, 7

The investigators concluded that the Las Vegas-area nosocomial hepatitis C outbreak likely resulted from the use of contaminated syringes to reaccess single-use medication vials; the syringes were then used to administer procedural sedation to subsequent patients.4

The specific failures in this situation didn't seem to stem from a lack of knowledge about proper infection control practices. On the contrary, one RN reported to the investigators that he had observed the reuse of contaminated syringes on multiple occasions and had complained to clinic management about the practice.5 Another RN reported quitting after one day of work because of concerns about equipment reuse.5 She stated that when she voiced complaints about this and faulty record-keeping practices at the clinic to other staff members, she was told that was "how things were done there."

Nurses who were employed at the clinics told the executive director of the Nevada Hepatitis C Task Force that they feared being "fired, mistreated, or black-balled" if they were to report unsafe practices.8 Because the events at the clinics remain the subject of ongoing civil, administrative, and criminal proceedings, many details aren't publicly available; whether direct retaliatory activities were taking place at the clinics cannot yet be verified. That said, there's strong anecdotal evidence that a general fear of retaliation existed such that unsafe practices were not reported.8

WHAT THE LITERATURE REVEALS

While several government reports have urged the open reporting of concerns about the quality and safety of patient care,9-11 underreporting of quality problems and adverse events is common.12-17 The antecedents and consequences of whistleblowing, as well as the beliefs and values of whistleblowers, haven't been well described in the literature. Nor is there a single accepted definition of whistleblowing. Bolsin and colleagues offer this: "the attempt, in good faith and in the public interest, to disclose and resolve in a reasonable and non-vexatious manner, but in the face of significant institutional or professional opposition, a significant deficiency in the quality or safety of health care."13

McDonald and Ahern noted in 2000 that the bulk of nursing research specific to whistleblowing has been theoretical in nature rather than empirical,18 and that has remained true over the past decade. Still, there are some valuable findings. McDonald and Ahern's survey of nurses in western Australia found numerous negative professional consequences of whistleblowing, including demotion, pressure to resign, and referral to mental health providers.18 A study by Attree, conducted with British RNs, identified fear of re-percussions, an unsupportive organizational climate, labeling, and blame as barriers to nurses' reporting both actual and potential threats to patient safety.12 Nurses also risk what's been termed "moral compromise" when there's a conflict between their duty to advocate patient safety and real or perceived pressure from an employer to do otherwise in order to remain employed.12, 19 Studies also indicate that nurses have not reported patient safety threats because they believed their concerns would be ignored.20 And Ray attributed an instance of external whistleblowing to the organization's failure to meet its ethical obligations, and argued for an organizational infrastructure that fosters ethical and effective policymaking.21

Fears of reprisal are frequently described in the literature that discusses professional consequences of whistleblowing18, 22 and explores nurses' reasons both for reporting poor practice and for failing to so report.20, 23, 24 Such fears may be further fueled by media coverage of nurses who have been persecuted and even prosecuted for reporting practices and situations potentially dangerous to patients. One striking recent example was the case of Texas whistleblowers Vicki Galle and Anne Mitchell, two RNs who were criminally prosecuted in 2009 for "misuse of official information," a felony, after they reported a physician to the Texas Medical Board out of concern that his practices were below the acceptable standard of care. Although the charges against Vicki Galle were dismissed one week before the February 8, 2010, trial date, and although Anne Mitchell was swiftly acquitted, they told the New York Times that the case had "derailed" their careers and "stained their reputations and drained their savings."25 The expenses they incurred and the damages to their reputations and employment prospects understandably give other nurses reason to be wary when making similar reports. (For details of the case and its aftermath, see Winkler County Nurses Update at http://bit.ly/hIy9kE.)

The American Nurses Association's Code of Ethics for Nurses with Interpretive Statements calls on nurses to be accountable professionals; yet it fails to acknowledge that few protections exist for those who report unsafe patient care conditions.26 Indeed, although the Texas case marks the first time that nurses have been criminally prosecuted for reporting patient care concerns, cases in which nurses have been sanctioned, fired, or otherwise retaliated against have been commonly reported.12, 18 Such reports notwithstanding, nurses remain under mandate to protect patients from threats of which they are aware. Failure to do so is often considered to be unprofessional conduct by state boards of nursing.27

A catch-22. While nurses have a legal and moral imperative to protect patients from harm, they may also face the very real threat of employment loss for reporting unsafe practices. This is particularly true in states like Nevada where employment is "at will." Under the employment-at-will doctrine, employment is noncontractual and of indefinite duration; employees can be terminated for "good cause, bad cause, or no cause at all."28 Such terms place nurses who witness unsafe practices in a difficult catch-22: if they report unsafe practices, they risk losing their jobs; if they don't, they risk losing their licenses. Nurses can find themselves forced to gamble with patient safety in order to keep their jobs and reputations, especially when they lack confidence in their facility's reporting system.12

The findings of the joint investigation into the Las Vegas hepatitis C outbreak strongly suggest that many nurses were aware of unsafe practices that hadn't been reported.1, 5 Ultimately, 22 RNs and LPNs were investigated in connection with the outbreak; several are still under investigation by the Nevada State Board of Nursing (NSBN) for alleged violations that included failure to safeguard a patient, failure to properly document care, falsification of documentation, and failure to conform to customary standards of practice (Debra Scott, NSBN executive director, e-mail communication, September 7, 2010). At least two certified registered nurse anesthetists were also found to have actively engaged in unsafe practices.3 Nurses who knowingly failed to safeguard patients from the "incompetent, abusive or illegal practice of any person" were in violation of the Nevada Nurse Practice Act's Unprofessional Conduct Regulation,29 and were subject to licensure sanction by the NSBN. It remains unclear exactly how many nurses were aware of unsafe practices, which practices they were aware of, and when they became so aware, but the lives of these nurses and their patients have been forever changed.

WHISTLEBLOWER PROTECTIONS

Patient advocacy policies and statutes that protect nurses who report illegal or unsafe patient care practices or situations are commonly known as "whistleblower protections." At this writing, 21 states have legislated some form of whistleblower protection, though the laws vary from state to state in terms of their enforcement mechanisms and levels of recourse for employees who have experienced reprisals.30 To protect whistleblowers, legislation "should provide mechanisms to report unsafe practices without reprisal, allow for adequate response time internally, allow for an external process when internal processes fail, and deter false claims."31

WHAT PROMPTED THIS STUDY

To ascertain whether this study sample was demographically representative of Nevada nurses, its demographic data were compared with such data for Nevada nurses from the 2004 National Sample Survey of Registered Nurses (NSSRN).32 (The NSSRN is the most extensive and comprehensive source of statistics for RNs in the United States. It uses a very large sample, which minimizes sampling error, nonresponse error, and sampling bias; this contributes substantively to the validity of the data derived from its analysis.) The demographic data for this study's sample generally mirrored the Nevada-specific 2004 NSSRN data, which suggests that this study's sample is reasonably representative of the Nevada RN population. Reliability testing of the study tool demonstrated a high degree of internal consistency (r = 0.93) for the Likert-scaled items (items 21 through 33). This suggests that, taken together, these items measure a single unidimensional construct: specifically, whether the participant believed she or he could report threats to patient safety without fear of reprisal.

Demographic data for the study sample are reported in Table 1 and in questions 1, 2, 19, and 20 in Table 2. The average respondent was 49 years old and had graduated from a basic (prelicensure) program of nursing education 23 years before data collection. On average, respondents worked slightly less than 38 regularly scheduled hours and three unscheduled overtime hours each week. Ninety-one percent (513) of the respondents were female, 79% (448) identified as white, 72% (403) were married or had a domestic partner, and just over half (322) had at least one dependent living in their home. Ninety-four percent (529) of the respondents reported that they worked in a position that required an RN license, and 62% (349) worked in an acute care facility. Forty percent (223) of the respondents reported holding certification in their practice specialty, 31% (173) reported being represented by a labor union in their primary nursing work setting, and 39% (218) worked in a facility that was seeking designation as a magnet facility.

Table 1. Sample Demographics (N = 564)

Table 2. Responses to Yes-or-No Questions About Reporting Activities (N = 564

Reporting activities. Responses to yes-or-no questions about previous reporting activities are shown in Table 2. While 73% (412) of respondents stated that they'd previously reported an unsafe patient care situation to people whom they felt would be able to correct it (question 3), 34% (194) stated that they'd been aware of a situation that could have caused harm to a patient, yet did not report it (question 5). Whether a participant had been aware of an unsafe patient care situation that wasn't reported differed by work setting ([chi]² = 62.3; P < 0.001): 38% of nurses working in acute care settings (134 of 349 nurses) and 29% of nurses working in non-acute care settings (60 of 210 nurses) responded that they were aware of an unsafe patient care situation that wasn't reported. Responses to questions 3 and 5 did not significantly differ according to a nurse's educational level.

Results for items that were answerable using a Likert agreement scale are shown in Table 3. Nearly all of the respondents (90%; 508) agreed or strongly agreed with the statement "I know how to report an unsafe patient care situation." Sixty-two percent (351) felt that the facilities they worked in were supportive of nurses, and 76% (429) felt their facilities encouraged nurses to report conditions that might cause harm to patients. Yet more than a third of respondents (36%; 200) felt that their facilities were not supportive of nurses, and nearly a quarter (23%; 127) felt their facilities did not encourage nurses to report conditions that might cause harm to patients. More than one-quarter of respondents didn't feel that they could report the actions of another nurse to either the facilities' administration (28%; 158) or the NSBN (27%; 154) without experiencing workplace retaliation.

Table 3. Responses to Statements Using a Likert Agreement Scale (N = 564

Both the Las Vegas-area hepatitis C outbreak that prompted this study and the study findings have clear implications for nursing practice. First, the nosocomial spread of hepatitis C to what might have been as many as 115 patients serves as a sobering reminder of the importance of safe injection practices. In particular, in accordance with CDC guidelines, nurses and other health care providers are cautioned to remember that single-use syringes and vials must be disposed of immediately after use and must never be used on more than one patient.33, 34

Second, the findings of this study illustrate the importance of a workplace culture based on openness, not fear. The study found that many nurses are afraid of workplace retaliation if they report patient safety concerns, and that a sizable number had already either personally experienced such retaliation or knew a nurse who had. This is consistent with the findings of McDonald and Ahern, who found that whistleblowing nurses experienced "severe professional reprisals" for reporting misconduct that posed a risk to patient safety.18 That more than a third of RNs in our study indicated that they'd been aware of a situation that might have harmed a patient and had not reported it is of grave concern and must be addressed.

Although not all of the nurses in this study who reported an unsafe patient care situation experienced workplace retaliation, the fact that about one in six did cannot be dismissed. Moreover, nearly half of the respondents in this study knew of a nurse who had experienced such retaliation. These results provide support for the existence of what has been called a "culture of fear" in the workplace22-one that influences nurses not to report known safety violations that could (and sometimes do) result in direct and irrevocable patient harm. This culture of fear is a consistent theme in the whistleblowing literature and has been described by various authors who have explored the reasons nurses do and do not report unsafe patient care practices20, 23, 24 and the professional consequences nurses often face when they do.18, 22 Our findings underscore the need for a shift in organizational culture toward one that encourages clear and open communication when patient safety may be in jeopardy.

While some progress has been made toward fostering organizational cultures that encourage open reporting of patient safety threats, much remains to be done. As the Institute of Medicine's 2004 report Keeping Patients Safe: Transforming the Work Environment of Nurses noted, there have been incidents "in which nurses who were involved in the commission of an error but found blameless by a number of independent authoritative bodies were unjustly disciplined by state regulatory agencies."11 It's crucial that health care organizations and regulatory agencies address the systemic flaws that permit such injustice. If we accept the proposition that external whistleblowing marks an organization's failure to meet its ethical obligations,21 then creating organizational infrastructures that support whistleblowers and foster ethical decision making must be part of any solution. Internal reports of unsafe patient care practices must be encouraged and welcomed, in order to identify opportunities for systemic, as well as individual, improvement.

More than a third of the respondents who had known about but not reported a patient safety concern indicated that they "didn't think anything would come of [such] report." This finding is supported by the results of a survey of British nurses, which found that 58% cited "nothing will be done" as a top reason for not reporting a patient safety concern.20 The same survey also found that of nurses who had reported a patient safety concern, 47% felt that "the matter had been handled 'badly', with their concern being overlooked" and 23% said that the reported concern had gone on to cause harm to patients. Greater organizational transparency is needed so that nurses can see their facility's commitment to addressing patient safety concerns, as evidenced by its support for whistleblowers and swift response to any contributing systems failures.

Representatives from the NNA met with key stakeholders over the months preceding and during the legislative session to garner support for the bill (AB10; for details, visit http://bit.ly/hPQLHd). The bill was actively supported by the NSBN and by all labor unions in Nevada that were legislatively active. The NSBN is charged with protecting the public; providing nurses with a mechanism by which they can advocate the public's safety certainly falls within the realm of that charge. The support of the labor unions was also crucial. Other key supporters included the Nevada State Medical Association and the Nevada Department of Health and Human Services. Over the months that the bill was debated in both the state assembly and the state senate, the NNA and other stakeholders worked closely with key legislators to reach consensus on the final language of the bill. The NNA also worked closely with the Nevada Hospital Association to ensure that hospitals had a mechanism to protect patients in the event that a nurse was found to be practicing unsafely. After five months of negotiations, consensus on the final legislative language was reached. The bill provides the means for supporting nurses in a workplace environment that encourages "good faith" reporting of patient safety concerns; it also supports the employers' need to protect patients by retaining the means by which employers can discipline nurses whose actions pose a threat to patient safety. The bill was passed unanimously by the Nevada Assembly and with only one dissenting vote in the Nevada State Senate, and was signed into law on May 29, 2009.

In the event that a nurse does experience workplace retaliation after having made a report to any external agency, NRS 449.207 stipulates that the victim can file a civil action and may be awarded compensatory and punitive damages. (For the full text of both statutes, visit http://www.leg.state.nv.us/nrs/NRS-449.html.)

CONCLUSIONS

1. Centers for Disease Control and Prevention (CDC). Acute hepatitis C virus infections attributed to unsafe injection practices at an endoscopy clinic-Nevada, 2007. MMWR Morb Mortal Wkly Rep 2008;57(19):513-7. [Context Link]

2. Centers for Disease Control and Prevention (CDC). The ABCs of hepatitis. Atlanta; 2010. [Context Link]

3. Labus B. Outbreak of hepatitis C at outpatient surgical centers. Public health investigation report. Las Vegas, NV; 2009 Dec. http://www.southernnevadahealthdistrict.org/download/outbreaks/final-hepc-invest. [Context Link]

4. Fischer G, Schaefer M. Epi-Aid trip report (2008-019): investigation of acute hepatitis C among patients who underwent procedures at clinic A: Nevada 2007. Carson City, NV; 2008 May 15. http://health.nv.gov/PDFs/Hepatitis/FinalEpi2_20080515.pdf. [Context Link]

5. Southern Nevada Health District Outbreak Investigation Team. Interim report on the Endoscopy Center of Southern Nevada hepatitis C investigation. Las Vegas, NV; 2008 Mar 28. http://www.southernnevadahealthdistrict.org/download/outbreaks/interim-hepc-inve. [Context Link]

6. Society of Gastroenterology Nurses and Associates. Position statement: reuse of single-use critical medical devices. Chicago; 2008 Aug. http://www.sgna.org/Portals/0/Education/Position%20Statements/SUDPositionStateme. [Context Link]

7. Schultz D. Statement of Daniel Schultz, M.D., Director, Center for Devices and Radiological Health, before the Committee on Government Reform, House of Representatives Sep 26, 2006. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSing. [Context Link]

8. Assembly Committee on Health and Human Services, Senate Committee on Health and Education. Minutes of the joint meeting, seventy-fifth session, February 21, 2009. Las Vegas, NV: State of Nevada 2009. [Context Link]

9. Committee on Identifying and Preventing Medication Errors, et al., editors. Preventing medication errors. Washington, DC: National Academies Press; 2007. Quality Chasm series http://www.nap.edu/catalog.php?record_id=11623. [Context Link]

10. Kohn LT, et al., editors. To err is human: building a safer health system. Washington, DC: National Academy Press; 2000. http://books.nap.edu/openbook.php?isbn=0309068371. [Context Link]

11. Page A, editor. Keeping patients safe: transforming the work environment of nurses. Washington, DC: National Academies Press; 2004. http://www.nap.edu/catalog.php?record_id=10851. [Context Link]

12. Attree M. Factors influencing nurses' decisions to raise concerns about care quality. J Nurs Manag 2007;15(4):392-402. [Context Link]

13. Bolsin S, et al. Practical virtue ethics: healthcare whistleblowing and portable digital technology. J Med Ethics 2005;31(10):612-8. [Context Link]

14. Firth-Cozens J, et al. Confronting errors in patient care. Report on focus groups; 2002. http://www.haps.bham.ac.uk/publichealth/psrp/documents/PS002_Final_Report_Firth_. [Context Link]

15. Meurier CE. Understanding the nature of errors in nursing: using a model to analyse critical incident reports of errors which had resulted in an adverse or potentially adverse event. J Adv Nurs 2000;32(1):202-7. [Context Link]

16. Nuckols TK, et al. Contributing factors identified by hospital incident report narratives. Qual Saf Health Care 2008;17(5):368-72. [Context Link]

17. Nuckols TK, et al. Comparing process- and outcome-oriented approaches to voluntary incident reporting in two hospitals. Jt Comm J Qual Patient Saf 2009;35(3):139-45. [Context Link]

18. McDonald S, Ahern K. The professional consequences of whistleblowing by nurses. J Prof Nurs 2000;16(6):313-21. [Context Link]

19. Joel LA. Moral compromise: burnout revisited. Am J Nurs 1997;97(10):7. [Context Link]

20. Waters A. Nurses fear their concerns about care will be ignored. Nurs Stand 2008;22(37):12-3. [Context Link]

21. Ray SL. Whistleblowing and organizational ethics. Nurs Ethics 2006;13(4):438-45. [Context Link]

22. Independent Nurse. Culture of fear over whistleblowing. 2009 May 15;12. [Context Link]

23. Gallagher A. Whistleblowing: what influences nurses' decisions on whether to report poor practice? Nurs Times 2010;106(4):22-5. [Context Link]

24. Lachman VD. Whistleblowers: troublemakers or virtuous nurses? Dermatol Nurs 2008;20(5):390-3. [Context Link]

25. Sack K. Nurse to stand trial for reporting doctor. New York Times 2010 Feb 6. https://www.nytimes.com/2010/02/07/us/07nurses.html. [Context Link]

26. American Nurses Association. Code of ethics for nurses with interpretive statements. Silver Spring, MD; 2001. [Context Link]

27. National Council of State Boards of Nursing. NCSBN model nursing practice act and model nursing administrative rules. Chicago; 2010 Aug. https://www.ncsbn.org/Model_Nursing_Practice_Act_081710.pdf. [Context Link]

28. Muhl CJ. The employment-at-will doctrine: three major exceptions. Monthly Labor Review 2001;124(1):1-11. [Context Link]

29. Nevada State Board of Nursing. NAC 632.890. Unprofessional conduct regulation. Reno, NV n.d. [Context Link]

30. American Nurses Association. Whistleblower protection. 2009. http://www.nursingworld.org/MainMenuCategories/ANAPoliticalPower/State/StateLegi. [Context Link]

31. Black L. Testimony before the Nevada Assembly Committee on Health and Human Services in support of Assembly Bill 10. Nevada Nurses Association; Feb 21, 2009. http://www.leg.state.nv.us/75th2009/Exhibits/Assembly/HH/AHH184D.pdf. [Context Link]

32. Health Resources and Services Administration, Bureau of Health Professions. The registered nurse population: findings from the 2004 National Sample Survey of Registered Nurses. Washington, DC: U.S. Department of Health and Human Services 2006 Jun. http://bhpr.hrsa.gov/healthworkforce/rnsurvey04. [Context Link]

33. One and Only Campaign. Safe injection practices under standard precautions. 2009. [Context Link]

34. Siegel JD, et al. 2007 guideline for isolation precautions: preventing transmission of infectious agents in healthcare settings; 2007. http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf. [Context Link]

For 18 additional continuing nursing education articles on professional issues, go to http://www.nursingcenter.com/ce.