Testing for Hepatitis C in Healthcare Workers Prior to a Known Occupational Exposure: A Reconsideration. By David M. Sine, ARM, CSP, OHST, CPHRM

Transcription

1 Testing for Hepatitis C in Healthcare Workers Prior to a Known Occupational Exposure: A Reconsideration By David M. Sine, ARM, CSP, OHST, CPHRM

2 Biography David M. Sine has been the state Safety Director of two Eastern states, the Senior Staff Engineer for the JCAHO, a Senior Consultant for the AHA and Vice Chair of the board of Brackenridge Hospital in Austin, Texas. Founding partner and one time contributing editor for Briefings on Hospital Safety, co-author of Quality Improvement Techniques for Hospital Safety, and the Design Guide for Behavior Heath Facilities, Mr. Sine is certified by the Joint Board of the American Board of Industrial Hygiene and Certified Safety Professionals and as a Certified Professional Healthcare Risk Manager by ASHRM. A health care risk management consultant since 1980 he has conducted over 1300 JCAHO compliance assessment surveys. He serves as a member of the NFPA 101 Life Safety Code Subcommittee on Health Care Occupancies, the JCAHO Committee on Healthcare Safety and acts as a risk management advisor to the National Association of Psychiatric Health Systems and is president and founder of SafetyLogic Systems, in Austin, Texas. Journal of SH&E Research Vol. 5, No. 1 Page 2 of 12

3 Abstract Objective: To briefly review and reject three of the most commonly advanced arguments against the testing of healthcare workers: risk of exposure, informed consent and/or duty to warn, and employee privacy. Methods: Arguments against the inclusion of HCV testing in healthcare worker (HCW) pre-employment physical cite the low risk of transmission of HCV from HCW to patient. The risk of transmission from a HCW infected with a blood borne pathogen infection to a patient is often described by those opposed to pre-employment testing as either small, remote, low, extremely low, or rare. This paper compares these estimated risks to other known risks for pathogens, applicable case law, and the standards for informed consent. Results: The research and discussion of this paper supports the inclusion of testing for hepatitis C (HCV) as a part of the post offer, pre-placement physical for healthcare workers (HCW) in a hospital setting. Conclusions: Current standards regarding the pre-employment testing of HCWs are not consistent with those that apply to other blood born pathogens and communicable diseases. This produces policies that are asymmetrical and place the patient at a disadvantage in both the informed consent process and in the management of their personal health. Journal of SH&E Research Vol. 5, No. 1 Page 3 of 12

4 Introduction National policies 1 regarding the testing of healthcare workers for transmissible blood borne pathogens have changed little since issued by the CDC in 1991[1] and no current federal policy recommends the testing of healthcare workers prior to an occupational exposure to hepatitis C laden blood. The research and discussion of this paper will support the inclusion of testing for hepatitis C (HCV) as a part of the post offer, preplacement physical for healthcare workers (HCW) in a hospital setting. Current law does not require testing and some laws, such as the ADA or the Fair Housing and Employment Act, may actually discourage determination of HCV status as a part of a healthcare worker employee pre-employment physical. This paper will briefly review and reject three of the most commonly advanced arguments against the testing of healthcare workers: risk of exposure, informed consent and/or duty to warn, and employee privacy. The benefits to HCWs, patients, and employers provided by a rejection of these three arguments are described and a policy of routine pre-exposure HCV testing is proposed. Background Prevalence of HCV in the General Population At present, over 4 million Americans have HCV antibodies of which about 2.7 million have active hepatitis C virus infection (HCV prevalence in the general population prevalence is estimated to be 1.6% to 1.8%).[2] Compared with an estimate of about 750,000 Americans infected with HIV hepatitis C is a far more prevalent disease. [3] there are 25,000 new HCV infections reported every year: HCV is the most common chronic blood-borne infection in the United States and the most frequently reported viral infection in Canada.[4] There are 170 million cases worldwide. Progression to chronic liver disease and other complications make end-stage liver disease due to HCV the most common underlying cause for liver transplantation in the United States.[5] HCV, attributable for 8,000 to 10,000 deaths per year, is the 10 th leading cause of death in the United States. 85% of those infected will develop chronic infection, however, the disease process is slow and it can take as many as 20 years for the disease to present symptoms in some victims.[6] 70% of all chronic cases will develop liver disease and the Association for Professionals in Infection Control and Epidemiology (APIC) states that HCWs account for 2% to 4% of known acute cases.[7] Transmission of the infection can be caused by exposure to infected blood, blood products, shared IV needles, shared tattoo needles, and through unprotected sex. The 1 Typically, a standard is a code, policy or rule that has been adopted by an authority having jurisdiction with enforcement capability. However, for the purposes of this paper the use of the term standard will be broadened to also include the recommendations of the CDC, OSHA, and NIOSH or similar standards writing bodies. Journal of SH&E Research Vol. 5, No. 1 Page 4 of 12

5 estimated seroprevalence of HCV is 2% to 3% among partners of HCV infected persons who are in long-term monogamous relationships.[8] Prevalence of HCV in the Healthcare Worker (HCW) HCW and emergency medical and public safety workers, such as firefighters or police officers, are at significant occupational risk of exposure to HCV.[9] The CDC estimates that two out of every 100 health-care workers will be infected with HCV after a needlestick or a similar type of exposure to HCV positive blood in the workplace.[9-11] A statistical study of 10,654 HCW in Scotland in 2001 indicated an overall rate of HCV infection of.28% (30/10,654) with sub group rates of 1.4% for surgeons and 1% for physicians.[12] In June of 2000, a CDC data review found that out of 2136 participants in an EMS focused study, 3% tested anti-hcv positive; this prevalence was twice as high as the national average of 1.8% for the general population.[2] Another study found 2.05 per 1000 HCWs positive for HCV compared with 0.7 per 1000 in a case controlled study of blood donors (who should be assumed to be at a lower risk for HCV infection than the general public). This is a similar finding to a study that found a 2.8 per 1000 rate in HCWs.[13] These study results were interpolated by APIC which, in a 1998 position paper, stated that 1% of U.S. HCWs are positive for HCV infection.[7] Healthcare workers with frequent or unprotected exposure to blood or blood products are at an even higher risk.[3, 12] In general, the prevalence of HCV infection in HCWs is assumed to be the same or even slightly less than that of the general population; however, certain sub-groups of healthcare workers, such as surgeons, have a higher rate of infection than the general population. Current Standard The current standards do not require nor do they recommend mandatory testing of HCWs prior to a known work related exposure.[6] However, current standards do clearly suggest that HCWs learn their own health status and take appropriate actions.[14] In 2006, as in 1991, mandatory testing for blood borne pathogens is not recommended by CDC but it remained a suggested ethical obligation of HCWs performing exposure prone procedures to know their health status and self report to the profession s regulatory body. Only if a HCW is determined to be HCV positive after an occupational exposure is a review of the high risk clinical procedures in which that particular HCW is likely to be engaged recommended to prevent HCW to patient transmission of blood borne pathogens. No practice restrictions are recommended between the time of the potential exposure to HCV laden blood and the determination of the HCW s HCV status.[14] This presents a conflict for employer and employee (HCW) alike: how (and when) to determine HCV status in the absence of pre-exposure HCV testing. This dichotomy in recommendation is seen when comparing the typical statements of authorities having Journal of SH&E Research Vol. 5, No. 1 Page 5 of 12

6 jurisdiction based upon the most recent CDC recommendations. The resulting conflict between recommendations given by state health departments is typified by the following recommendations from the Department of health from the state of Michigan: Routine or mandatory HIV, HBV, and HCV testing of all HCWs is not recommended, nor should it be a requirement for employment, credentialing, licensure, or insurance. HCWs are encouraged to be aware of their HIV, HBV, and HCV serologic status and seek treatment to reduce the risk of transmission blood-borne pathogens to sexual contacts and patients through unanticipated occupational exposures. [15] (emphasis added) Since the latency period of HCV is so long and the appearance of symptoms can be delayed for months if not years, in the absence of routine testing the HCW may not be aware of their serologic status and thus not in compliance with these vague recommendations for self testing. The above two statements beg the question: If healthcare workers (or certain sub-groups of healthcare workers) are at a greater risk of being and having been exposed to HCV than that of the general public, should not HCWs be routinely tested for HCV (as is only suggested by the second statement) and not wait, as is the current practice, until after a known and documented workplace exposure as a means to better protect themselves and their patients? Risk of transmission Pre-employment testing of HCWs for HCV would serve two significant purposes: alerting HCWs to their health status so that they may seek treatment and counseling, and to reduce the risk of HCW to patient HCV transmission through appropriate use of personal protective equipment and practice restrictions. Many arguments against the inclusion of HCV testing in a HCW pre-employment physical cite the low risk of transmission of HCV from HCW to patient. The risk of transmission from a HCW infected with a blood borne pathogen infection to a patient is often described by those opposed to pre-employment testing as either small, remote, low, extremely low, or rare[1, 8, 16, 17]. It is further argued that the risk, cost, and potential liability of pre-employment HCV testing returns insufficient benefit when placed in balance with the risk of HCW to patient transmission. Ross et al, have suggested in a 2002 study that the risk of a surgeon (gynecologist) with known HCV infection (i.e. HCV positive on PCR) transmitting HCV to their patients is as low as one in 1,750 operations.[18] In reality, the risk of HCW to patient transmission is not yet fully understood. However, more recent studies and events are beginning to give a better picture of the risk and how Journal of SH&E Research Vol. 5, No. 1 Page 6 of 12

7 it should be better managed. A more recent study concluded that a HCV positive cardiac surgeon transmitted HCV to as many as 14 of 937 patients (1.5% or 1500:100,000 ).[19] Since the 1991 CDC recommendations were issued there have been 132 documented HCW-to-patient transmissions of bloodborne pathogens, 38 of which were HCV related. Various retrospective studies of these nosocomial infections have placed the rate of transmission from HCW-to-patient during invasive procedures as high as 2.25%.[19] While the above referenced study of the HCV positive Long Island cardiac surgeon s patients for a ten year interval produced a rate of 1.5%, the risk of transmission may be influenced by type and duration of procedure as well as technique within the procedure, experience of the surgeon, and fatigue. The most common site of exposure (for percutaneous injury) for physicians is still the OR [20] yet operating room physicians have the lowest level of compliance in reporting their injuries, obviously a significant confounding factor for the available data.[21] As an example of underreporting, an anesthesiologist was diagnosed as having acute hepatitis C three days after providing anesthesia during the thoracotomy of a 64-year-old man. Eight weeks later that patient was diagnosed as having acute hepatitis C.[22] None of the surgical team, including the anesthesiologist, recalls any unusual events or incidents (e.g. needle stick injuries) that occurred during the patient's procedure and no incident reports were filed. Clearly, current infection control practices and the use of personal protective equipment is not failsafe. It is important to place these estimates of risk of HCV positive HCW to patient transmission in perspective by comparing them to other risks that garner much more public and regulatory concern. As of 2001, the risk of HCV infection from a unit of transfused blood is less than one per million transfused units.[23] The estimated risk of HIV transmission during unprotected sex varies greatly but a common figure often cited is 1:100,000 for male to female and 1:200,000 for female to male.[24] The risk for HCV transmission from a HCW to a patient (1500:100,000) is significantly higher than these comparative evidence based estimates referenced above.[19] The real question then becomes: by what reasonable ethical standard can these risks of HCW to patient transmission be considered so low that the healthcare community has no ethical duty to determine HCW health status and to warn patients of their risk during treatment? It remains an undisputed fact that the risk of transmission from a HCW to a patient is only zero in a HCW who is not HCV positive. Also undisputed is that the known risk of transmission is thought to be greater today than when the current standard was developed; the standards, therefore, should be strengthened accordingly. [19] Duty to Warn and Informed Consent In an article published in JAMA in 2000, Gostin concluded that there is no duty to inform a patient of a HCW s serological health status.[25] This is similar to the promulgated standards (recommendations) of the CDC which have been reinforced by public statements made by CDC executive leadership.[26] It is also believed that by revealing serostatus, that the HCW potentially places at risk their professional career due to Journal of SH&E Research Vol. 5, No. 1 Page 7 of 12

8 practice restriction and stigmatization. Because of these fears, many HCWs do not attempt to discover their HCV serologic status and assume that by not doing so they then have no duty to warn patients. However, the duty of a physician to warn a patient of their positive serostatus is established by cases such as Faya, Behringer and Kerins.[27-29] and patients have clearly indicated that they consider it well within their right (of informed consent) to know the serostatus of their healthcare providers (contra). Hospitals do sometimes acknowledge their duty to warn and respond after the serostatus of a HCW is brought to their attention. In a recent HCW-to-patient HCV exposure cluster in New York, the hospital (after consulting with federal officials) decided to actively notify all former patients of a cardiac surgeon infected with HCV (3,000 to 4,000 patients), a reversal of previous advice given by CDC and the New York State Department of Health. That surgeon is also now required to inform surgical patients of his HCV status prior to surgery, a significant change from previous policy.[30] The current more typical practice of either not informing the patient or waiting to inform him until after a potential blood borne pathogen exposure denies the patient access to important information upon which they could have based their informed consent. Thus, HCV serostatus and it s inclusion in the process of informed consent is not typically approached in same manner as other known healthcare risks. Many believe that that requiring health-care workers to inform patients or employers that they are HIV or HBV positive will only serve as a deterrent to workers voluntarily seeking testing and medical evaluation. It is also believed that serostatus disclosure would endanger the professional careers of competent and needed health care personnel who pose no risk to patients.[31] The current practice of don t ask and don t tell, however, places both the HCW and the patient at risk. By not determining their HCV status, the HCW potentially and needlessly delays the start of treatment of an insidious disease with a long latency period. By not communicating a seropositve status to a patient, the HCW denies the patient one of the pillars of informed consent: the actual known risks of a clinical procedure. Recent surveys of patient attitudes support the need to include patient notification of HCW serostatus before a medical procedure commences as a central value [32] of the healthcare profession. In a recent study involving U.S. households (2,353 respondents), 89% agreed that they would want to know if their dentist or doctor was infected with HCV and 82% agreed that disclosure of HBV or HCV infection in a provider should be mandatory.[17] Clearly, if central values of a profession are determined by a dialog between members of a profession and the community that the profession serves, then notification of patients of HCW serostatus is to be included as a component of informed consent. The duty to warn patients that may be or may have been exposed to a blood borne pathogen is clearly established in the informed consent process for blood transfusion as well as the national look-back programs for previous exposures to potentially HCV laden Journal of SH&E Research Vol. 5, No. 1 Page 8 of 12

9 blood or blood products. In both examples, the patient is informed of the potential for infection (and in the later encouraged to seek testing and, if indicated, treatment) Case law may also support the conclusion that both the hospital and the HCW have a duty to warn if there is a risk of unintended (and preventable) transmission of a (blood borne) disease to a third party. The Corpus Christi Court of Appeals in Garcia v. Santa Rosa Healthcare Corp. held that health care professionals who discover some disease or medical condition which their services or products have likely caused owe a duty to warn a third party.[33] In our application of this finding to our issue, the HCW and hospital owe that duty to a patient so that an unnamed third party at risk such as children or a sexual partner may be notified or protected. There is existing language in some state regulations that addresses the duty to warn in the case of other blood borne pathogens. The following language, adapted from the State of Michigan Department of Health, is typical: If an infected health-care worker s serostatus becomes known, a notification of patient(s) should be considered on a case-by-case basis.[15] Still, the CDC only recommends that HCWs be tested only after a known exposure (e.g. needle sticks or splashes to the eye) to HCV-positive blood.[10] A significant difference between the HCW and the patient is that the HCW generally knows that they have been exposed (through percutaneous injury) and can seek testing and treatment. Not so the patient no statutory provision exists that compels the HCW to inform the patient so that they may seek testing and treatment if an unintended exposure to blood occurs while in the care of a HCW. Thus, patients are not given the same opportunity as HCWs to be tested, seek early pre-symptomatic treatment, or to alter personal behaviors that may place sexual partners or children at risk. The current national policy of not testing HCWs and, therefore, not informing patients as a part of the consent process offers no reduction of risk to either patients or HCWs. The next question then becomes is the pre-employment test for HCV status of an HCW an invasion of privacy and, if so, does the right of privacy prevent the routine testing of the HCW for HCV serostatus? Privacy The privacy arguments against mandatory pre-employment testing of HCV serostatus take two tracks: first, that the health status of a HCW is of no concern to the patient and to reveal serostatus is a violation of HCW expectation for privacy, and, second, that the test itself is an invasion of HCW privacy. If the first argument is valid then it must be applied to more than only HCV status. However, the current CDC requirements do require that the HIV status of a HCW be disclosed before performing exposure-prone procedures.[1] As previously discussed in the above section, disclosure has become a cultural, ethical and legal expectation. In many states the standard of care (and case law) requires that HCWs disclose risks that a Journal of SH&E Research Vol. 5, No. 1 Page 9 of 12

10 reasonable patient would want to know. These norms should apply equally to all blood borne pathogens including HIV, HBV, and HCV. The second argument, that the test itself is an invasion of privacy, also fails when compared to current practices to test HCWs for other communicable diseases and to vaccinate against them. HCWs are required by law to submit to annual TB tests, annual vaccinations against influenza and HBV, and similar invasions of person and privacy to prevent or limit the spread of communicable disease in the public interest.[34-36] To not test and appropriately disclose the serostatus of a HCW creates asymmetrical policies in these matters of privacy as the HCV status of the patient is routinely probed and noted by the HCW. The CDC recommends that physicians routinely question their patients concerning risk factors for (HCV) infection.[5] How can it be ethical for some claim a right to privacy that others may not similarly claim when that right has been set aside specifically to benefit the public good and health as is the case in mandatory vaccinations?[36] The only available reasonable conclusion must be that such arbitrary claims of invasion of privacy are inconsistent and neither ethical nor in keeping with applicable case law. Conclusions Current standards regarding the pre-employment testing of HCWs are not consistent with those that apply to other blood born pathogens and communicable diseases. In application, this policy produces infection control practices that are asymmetrical and place the patient at a disadvantage in both the informed consent process and in the management of their personal health. A more aggressive approach to testing, in keeping with the recent change in the recommended testing protocol for HIV by the CDC and our growing understanding of the risk of HCV transmission, is now needed.[32] Without unfettered access by HCWs to their serostatus, and without knowledge of HCWs serostatus by patients, little else can be done to mitigate and manage the inadvertent but apparently inevitable percutaneous transmission of hepatitis C. The author concludes that HCW behavior regarding voluntary testing or inclusion of HCV serostatus as a part of an informed consent process will not change until the current standards for HCV preplacement testing are modified, adopted, and enforced by authorities having jurisdiction such as CMS, JCAHO, and state health departments. Journal of SH&E Research Vol. 5, No. 1 Page 10 of 12

11 References CDC, Recommendations for preventing transmission of human immunodeficiency virus and hepatitis B virus to patients during exposure prone invasive procedures. MMWR Morbidity Motality Weekly Reporter, : p CDC, Hepatitis C virus infection among firefighters, emergency medical technicians, and paramedics---selected locations, United States, 1991 through 2000, MMWR, Editor. 2000, CDC. Dulworth, S., S. Patel, and B. Pyenson, The hepatitis C epidemic: looking at the tip of the iceberg. 2000, Miliman & Robertson, Inc. Thompson, K., Pay Now, Save Later, in Living p CDC, Recommendations for prevention and control of hepatitis C virus infection and HCV related chronic disease, MMWR p CDC, National Hepatitis C Prevention Strategy. 2001, Division of Viral Hepatitis. APIC position paper: Hepatitis C exposure in the healthcare setting AJIC, (1): p Boyer, J. and e. al, Management of Hepatitus C: 2002, in NIH Concensus Confernce Statement. 2002, NIH. HealthAtoZ. Healthcare Workers and Hepatitis C [cited /26/2006]; Available from: CDC. Frequently asked questions about Hepatitis C [cited /26/2006]; Available from: Hepatitis C and Healthcare Workers [cited /26/20006]; Available from: Thorburn, D.e.a., A study of hepatitis C prevalence in healthcare workers in the West of Scotland Gut, (1): p Neal, K.R., J. Dorman, and W. Irving, Prevalence of hepatitis C antibodies amoung healthcare workers of two teaching hospitals. Who is at risk? BMJ, (179). CDC, Updated US public health service guidelines for the management of occupational exposures to HBV, HCV, and HIV and recommendations for postexposure prophylaxis, CDC, Editor Michigan recommendations on HIV, hepatitis B, and hepatitis C infected health-care workers, D.o.H. Michigan Department of Community Health, Wellness and Disease Control, Editor ACEP, Bloodborne Infections in Emrgency Medicine. 2004: ACEP Policy Statement, Journal of SH&E Research Vol. 5, No. 1 Page 11 of 12

12 Tuboku-Metzger, J., et al., Public attitudes and opinions toward physicians and dentists infected with blood-borne viruses: Results of a national survey. AJIC, (55): p Ross, R.S., S. Viazov, and M. Roggendorf, Risk of HCV transmission from infected medical staff to patients. Arch of Internal Medicine, : p Perry, J.L., MA, R.D. Pearson, and J. Jagger, Infected health care workers and patient safety: A double standard. AJIC, (5): p Hsieh, W.B., N.-C. Chiu, and e. al, Occupation what infectious body fluid exposures in a teaching hospital: A three-year review. Journal of microbiology, immunology and infection, : p Alvarado, F. and e. al, Percutanious injury reporting in U.S. hospitals, Infection Control Hospital Epidemiology, (106). Cody, S.H. and e. al, Hepatitis C virus transmission from an anesthesiologist to a patient. Arch of Internal Medicine, (3): p All About Hepatitis C [cited /12/07]; Available from: AIDS.ORG. Fact Sheets: How Risky Is It? 2006 [cited 11/6/2006; Available from: Gostin, L., The proposed national policy and health-care workers living with HIV AIDS and other blood-borne pathogens. JAMA, 2000(284): p Gerberding, J., Infected healthcare worker. New Englan Journal of Medicine, : p Faya v. Almaraz 620 A.2d , Maryland. Kerins v. Hartley, 17 Cal. App. 4th 713 (1993). Behringer v. The Medical Center at Princeton, 592 A.2nd, Dennis P. Whalen, D.C., Letter to Dennis Dowling D.o. Health, Editor. 2002: Albany. Health, N.Y.D.o., Policy Statement and Action Plan to Prevent Transmission of HIV through Medical/Dental Procedures, D.o. Health, Editor Ozar, D. and D. Sokol, The Central Values of Dental Practice, in Dental Ethics at Chairside. 2002, Georgetown University Press: Washington, D.C. Garcia v. Santa Rosa Health Care Corp. 1996, Tex. App.-- Corpus Christi. NLRB, Virgina Mason Hosptial vs Washington State Nurses Assn. 2006, NRLB. CPL CPL Enforcement Procedures and Scheduling for Occupational Exposure to Tuberculosis OSHA. JACOBSON v. MASSACHUSETTS, in 197 U.S. 11; 25 S. Ct. 358; 49 L. Ed SUPREME COURT OF THE UNITED STATES. Journal of SH&E Research Vol. 5, No. 1 Page 12 of 12