Background
Subsequent to the well‐publicized case of transmission of Human Immunodeficiency Virus (HIV) to a cluster of patients in a Florida dentist’s practice, the Centers for Disease Control and Prevention (CDC) published Recommendations for Preventing Transmission of Human Immunodeficiency Virus and Hepatitis B Virus to Patients During Exposure-Prone Invasive Procedures in 1991.1 The document was prefaced with the statements that:
• Infected health care workers (HCWs) who adhere to universal precautions and who do not perform invasive procedures (see glossary) pose no risk of transmitting Human Immunodeficiency Virus (HIV) or Hepatitis B Virus (HBV) to patients.
• Infected HCWs who adhere to universal precautions and who perform certain exposure-prone procedures (EPP) (see glossary) pose a small risk of transmitting HBV to patients.
• HIV is transmitted much less readily than HBV.
They conclude, “precautions are prudent to prevent HIV and HBV transmission during procedures that have been linked to HCW‐to‐patient HBV transmission or that are considered exposure‐prone.”
The following specific recommendations were made:
• Current guidelines regarding disinfection and sterilization of reusable equipment should be followed.
• All HCWs should adhere to universal precautions at all times.
• All HCWs should refrain from direct patient care if they have exudative lesions or weeping dermatitis.
• Medical, surgical, and dental organizations and institutions should compile lists of exposure‐prone procedures specific to their specialties.
• HCWs who perform EPP should know their serologic status. HBV infected HCWs should further know if they are HBeAg positive.
• HIV and HBV (HBeAg+) positive HCWs should not perform EPPs unless and until it is approved by an expert review panel (ERP) (see glossary). The ERP will determine if any restrictions should be placed on practice.
• HIV and HBV (HBeAG+) positive HCWs should prospectively notify patients regarding their seropositivity prior to performing EPPs.
Of note, there were no restrictions placed on infected HCWs who perform invasive procedures that have not been identified as exposure‐prone. Also mandatory serologic testing of all HCWs for HIV, HBV, and HBeAg was not recommended.
These recommendations took on the force of a guideline when later in 1991 the U.S. Congress mandated that states receiving Public Health Service funds either adopt the CDC recommendations or their equivalent.2 The CDC subsequently announced that any state that mandated the use of universal precautions would be in compliance with the recommendations.3 States have variously interpreted the CDC document regarding the definition of invasive and exposure‐prone procedures, the requirement for serologic testing of HCWs, the necessity to disclose to patients and fellow workers, and restrictions on practice (Table 1).4
Legal Issues
The legal issues that have arisen regarding the scope of practice of HCWs infected with blood borne pathogens have been based on the often conflicting rights of the HCW to be free of discrimination versus that of the patient to be free of unnecessary risk. The HCW is protected by two federal laws that prohibit discrimination based on disability. The Rehabilitation Act of 1973, section 504, prohibits discrimination by federal agencies and by recipients of federal financial assistance, i.e. all hospitals and medical offices receiving Medicare or Medicaid funding. Title I of the Americans with Disabilities Act (AwDA) (42 U.S.C. § 12101), as enacted by congress in 1990, prohibits discrimination against otherwise qualified individuals based on disability by both public and private employers with 15 or more employees (excluding the federal government). 5 In 1988, the U.S. Dept. of Justice declared that HIV infection is a disability under Section 504 of the Rehabilitation Act.6 The U.S. Supreme Court held that all stages of HIV infection are covered disabilities under the ADA in 1998.7
A qualified individual is one who can perform the essential job functions with or without reasonable accommodation by the employer so long as they do not impose an undue hardship. The employer may, however, deny a job to someone who poses a “direct threat to ………. other individuals in the workplace.” A direct threat is defined as “ a significant risk of substantial harm to the health or safety of other individuals in the workplace.” Courts have ruled on what constitutes a significant risk based on the following factors: 1) duration of the risk, 2) nature and severity of the potential harm, 3) likelihood that the potential harm will occur, and 4) imminence of the potential harm. The Equal Employment Opportunity Commission, which is responsible for enforcing Title 1, has stated that the (significant) risk need only be reduced to an acceptable level, not eliminated altogether.
Courts, however, have variously interpreted what characterizes a significant risk. One successful argument has been that, in the case of HIV, because infection is usually fatal, any risk of transmission makes the risk “significant.” 5 Some courts have relied on the severity of harm should the risk materialize. Neither have the recommendations of expert review panels (ERPs) always protected HCWs from liability as courts have upheld sanctions contrary to their advice. Some courts and state statutes have mandated restrictions that are more stringent than those set forth by the CDC, in part because they have not always differentiated between invasive procedures and exposure‐prone procedures as set forth in the original CDC document.8
Other lawsuits against infected HCWs have been successfully argued using the informed consent doctrine that necessitates that all material risks, but not remote risks, be disclosed. The law in some states is predicated on what a reasonable physician considers a material risk, some on what a reasonable patient would expect to be disclosed, and some are a hybrid.4 To prevail in a suit, the patient must show that there was a duty to disclose the risk, that there was a failure of disclosure, and as a result, the patient sustained a legally compensable injury. There have even been successful lawsuits against HIV‐infected HCWs under informed consent law that did not involve transmission of the virus. Courts have assigned damages based on emotional distress for the period of time between when the patient learned about the HIV status of the HCW and when the patient definitively tested negative for the virus.6
Transmission Risks
Three events must occur simultaneously for successful transmission of blood borne pathogens from a HCW to a patient during an exposure‐prone procedure. 1) The HCW must be viremic with an infectious virus. 2) The HCW must sustain a percutaneous injury or have an exposed cutaneous lesion. 3) The HCW’s blood/body fluid must contact the patient’s mucous membranes, wound, or otherwise exposed tissue (recontact). It has been estimated that the incidence of recontact after an intraoperative percutaneous injury is 11.4 ‐ 29 percent, the majority of which are preventable.9
The probability of seroconversion after exposure is dependent on factors such as the route of exposure, the concentration of infectious viral particles, and the amount of infectious material transferred. HBV carries the greatest risk of transmission after percutaneous injury (23‐ 37 percent for HBsAg‐ exposure, 37 ‐ 62 percent after exposure to HBeAg+ or HBV pre‐core mutant source). Hepatitis C virus (HCV) carries an intermediate transmission risk of 1.8 percent (0 ‐7 percent). HIV has the lowest risk, shown to be 0.3% after a percutaneous injury, and 0.09 percent after a mucous membrane exposure.10, 11 Post‐exposure prophylaxis is available for both HBV and HIV, the efficacy of which depends on initiating treatment early (within hours for HIV and as early as possible, but not greater than a week, for HBV). There are inadequate data to support post‐ exposure prophylaxis (PEP) after HCV exposure. However, testing for seroconversion and liver function is advised for later care. Guidelines for PEP may be found at: http://www.nccc.ucsf.edu/hiv_clinical_resources/pep_guidelines.
Safe Practices
Transmission of bloodborne pathogens from HCWs to patients in the United States is an infrequent occurrence. Those directly attributable to anesthesiologists have predominantly been associated with unsafe injection practices (frequently in the setting of drug abuse), or inadequate disinfection practices. The CDC makes the following recommendations for all HCWs, including those with bloodborne infections, to improve patient safety:
• All needles and syringes should be sterile and single use. A used syringe should not be refilled with the same or different medication even when it has been associated with inadvertent use on a subsequent patient.
• All used needles and syringes should be disposed of between patients.
• Recapping of needles is highly discouraged. When necessary, a technique where the sharp is never pointed toward any part of the operator’s body (single hand scoop technique) should be utilized.
• Sharps should be discarded in an appropriate puncture resistant container as soon as possible after use. Sharps containers should be located so as to minimize the distance that a sharp needs to be transported for disposal.
• Single dose vials are preferred and are single patient use items. The vial top should be disinfected with an alcohol swab prior to entry.
• Multi‐dose vials are also considered single patient use items, unless they have been aliquoted away from the patient care area. The vial top should be disinfected with an alcohol swab prior to use.
• Bags and bottles should not be shared as diluents for medications to be used on multiple patients.
• Aseptic technique should be used in the preparation of medications. Medications should be prepared separate from areas of blood contaminated areas should be maintained.
• Equipment and environmental surfaces must be appropriately cleaned between patients.
• Gloves and hand hygiene should be utilized according to standard precautions.12
Recommendations of Other Professional Societies
The American Medical Association’s (AMA) position on HIV‐Infected Physicians13, 14 restates the recommendations of the 1991 CDC document. The AMA supports disclosure to patients of a physician’s seropositivity prior to performing EPPs, but also advocates for confidentiality. This would appear to necessitate that HCWs either discontinue performing EPPs or forfeit their privacy rights regarding personal health information.
The American College of Surgeons’ most recent Statement on the Surgeon and HIV Infection (2004)15 does not place limits on scope of practice based on procedures performed. The only recommend restrictions are in circumstances where the physician is unable to comply with recognized infection control practices or is functionally unable to perform the procedure. The surgeon, their personal physician, and/or an ERP would make any determination of practice restrictions.
The American Dental Association has published a resource manual for support of dentists with HBV, HIV, TB and other infectious diseases16 in addition to a policy statement on blood borne pathogens, infection control and the practice of dentistry.17 The recommendations advocate adhering to current CDC recommendations. They emphasize that there is not a significant risk of disease transmission if appropriate infection control measures are followed. They recognize the impact of state laws requiring disclosure of the dentist’s serostatus. They advocate that those who discontinue practice for this reason should be deemed totally disabled and eligible for disability benefits.
The American College of Obstetricians and Gynecologists18 sets forth the following: testing should be voluntary, physicians have the same privacy rights as patients, and practice decisions should be made by the clinician in consultation with their personal physician and perhaps an ERP. They reject disclosure requirements.
The American Academy of Orthopaedic Surgeons advisory statement on preventing the transmission of blood borne pathogens19 emphasizes the adherence to recommended infection control practices and the avoidance of recontact of contaminated instruments with the patient. They advise against HIV and/or HBV (HBeAg+) infected surgeons performing EPP except as allowed by an ERP.
Recommendations of the Committee on Occupational Health
The current practice of surgical anesthesiology does not routinely include procedures that meet criteria for exposure‐prone as defined by the CDC. Neither is the Committee aware of any procedures performed by anesthesiologists that have been linked to transmission when currently recommended infection control practices are followed. Therefore, no arbitrary restrictions should be imposed on the practice of anesthesiology based solely on the physician’s serologic status. Restrictions should only be imposed if the anesthesiologist has previously been linked to the transmission of blood borne pathogens despite adherence to recommended infection control practices, is unable to perform regular duties despite reasonable accommodations, or refuses to comply with recommended practice.
All anesthesiologists who are at risk of occupational exposure to blood borne pathogens should be immunized against HBV, unless otherwise contraindicated.
The anesthesiologist’s serologic status need not be disclosed as an element of informed consent. This assertion is based on the fact that the serologic status of an individual is protected information under the Health Insurance Portability and Accountability Act and that appropriately performed anesthesia procedures do not bear a significant risk of transmission of blood borne pathogens. Anesthesiologists should know their serostatus and undergo testing after sustaining a significant exposure in order to properly manage their own health conditions.
An anesthesiologist who is the source of a significant exposure to a patient should initiate an exposure investigation. Disclosure of the risk of specific disease transmission should be revealed, but the identity of the source HCW should remain confidential.
Anesthesiologists who discontinue anesthesia practice because of a legal obligation to disclose their infectious status to patients should be considered disabled under the AwDA and the Rehabilitation Act of 1973, and therefore eligible or full disability benefits.
Glossary
Exposure-prone procedure. An invasive procedure with characteristics that include: digital palpation of a needle tip in a body cavity or the simultaneous presence of the HCW’s fingers and a needle or other sharp instrument or object in a poorly visualized or highly confined anatomic site. Performance of exposure‐prone procedures presents a recognized risk of percutaneous injury to the HCW, and - if such an injury occurs - the HCW’s blood is likely to contact the patient’s body cavity, subcutaneous tissues, and/or mucous membranes.1
Expert review panel. May include: HCW’s personal physician, specialist in HIV and HBV, specialist in EPPs performed by the HCW, state or local health officials. The panel should recognize the importance of HCW confidentiality and privacy rights. 1
Invasive procedure. Surgical entry into tissues, cavities, or organs or repair of major traumatic injuries associated with any of the following: 1) an operating or delivery room, emergency department, or outpatient setting, including both physicians’ and dentists’ offices; 2) cardiac catheterization and angiographic procedures; 3) a vaginal or cesarean delivery or other invasive obstetric procedure during which bleeding may occur; or 4) the manipulation, cutting, or removal of any oral or perioral tissues, including tooth structure, during which bleeding occurs or the potential for bleeding exists.20
Standard precautions (previously universal + body substance precautions). These include hand hygiene; use of gloves, gown, mask, eye protection, or face shield, depending on the anticipated exposure; safe injection practices; and respiratory hygiene/cough etiquette. Equipment or items in the patient environment likely to have been contaminated with infectious body fluids must be handled in a manner to prevent transmission of infectious agents.21
Universal precautions. Appropriate use of hand washing, protective barriers, and are in the use and disposal of needles and other sharp instruments.22
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1 CDC. Recommendations for Preventing Transmission of Human Immunodeficiency Virus and Hepatitis B Virus to Patients During Exposure‐Prone Invasive Procedures, MMWR 1991; 40(RR08): 1‐9. 2b.
2Treasury, Postal Service and General Government Appropriations act of 1992, PuL. 102‐141, § 633, 105 Stat. 876 (1991), 42 U.S.C. § 300ee‐2, note (Supp.III 1991).
3 AIDSLaw of Louisiana, Inc. Living with HIV Disease: Employment Discrimination and Medical Examinations http://www.lawhelp.org/LA/showdocument.cfm/County/%20/City/%20/demoMode/=%201/Language/1/State/LA/TextOnly/N/ZipCode/%20/LoggedIn/0/doctypnelID/e/faq/ichannelprofileid/5036/iorganizationid/937/iquestionid/685/iChan140/Search/1/searchterm/HIV
4 The Center for HIV Law and Policy, Guidelines for HIV‐Positive Health Care Workers. http://www.nccc.ucsf.edu/hiv_clinical_resources/pep_guidelines. Accessed 7/14/2011.
5 Gautier E. The Legal Rights and Obligations of HIV‐Infected Health Care Workers. American Association of Physicians for Human Rights and the National Lawyers Guild 1993
6 Zazzali M. HIV‐Infected Health Care Workers Who Perform Invasive, Exposure‐Prone Procedures: Defining the Risk and Balancing the Interests of Health Care Workers and Patients. Seton Hall Law Review 1998; 28(3): 1000‐42.
7 Bragdon v Abbott, 524 US 624 (1998). Gostin LO. A Proposed National Policy on Health Care Workers Living with IV/AIDS and Other Blood‐borne Pathogens. JAMA 2000; 284(15): 1965‐70.
8 Gostin LO. A Proposed National Policy on Health Care Workers Living with HIV/AIDS and Other Blood-borne Pathogens. JAMA 2000; 284 (15): 1865-70.
9 Chiarello LA, Cardo DM, Panlilio A, Alter MJ, Gerberding JL. Risks and Prevention of Bloodborne Virus Transmission from Infected Healthcare Providers. Seminars in Infection Control 2001; 1(1): 61‐72.
10 Centers for Disease Control and Prevention. Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HIV and Recommendations for Postexposure Prophylaxis. MMWR Sept.30, 2005; 54(RR09); 1‐17. http://www.cdc.gov/hiv/resources/guidelines/index.htm. Accessed 10/4/2008.
11 Centers for Disease Control and Prevention. Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis. MMWR June 29, 2001; 50(RR11); 1‐52. http://www.cdc.gov/hiv/resources/guidelines/index.htm. Accessed 10/4/2008.
12 Williams IT, Perz JF, Bell BP. Viral Transmission in Ambulatory Health Care Settings. Clinical Infectious Diseases 2004; 38:1592‐98.
13 American Medical Association. H‐20.912 Guidance for HIV‐Infected Physicians and other Health Care Workers. http://www0.ama‐assn.org/apps/pf_new/pf_online?f_n=browse&doc=policyfiles/HnE/H‐20.912.HTM&&s_t=&st_p=&nth=1&prev_pol=policyfiles/HnE/H‐15.999.HTM&nxt_pol=policyfiles/HnE/H‐20.898.HTMAccessed (10/3/2008)
14 American Medical Association. E‐9.131 HIV‐Infected Patients and Physicians. http://www0.ama‐assn.org/apps/pf_new/pf_online?f_n=browse&doc=policyfiles/HnE/E‐9.131.HTM&&s_t=&st_p=&nth=1&prev_pol=policyfiles/HnE/E‐8.21.HTM&nxt_pol=policyfiles/HnE/E‐9.01.HTM&. Accessed (10/3/2008).
15 American College of Surgeons. Statement on the Surgeon and HIV Infection 2004. [ST‐13]. http://www.facs.org/fellows_info/statements/st‐13.html. Accessed 10/4/2008.
16 American Dental Association. Resource manual for Support of Dentists with HBV, HIV, TB and other Infectious Diseases. http://www.ada.org/prof/resources/topics/hiv/intro.asp. Accessed 10/4/08.
17American Dental Association. Policy Statement on Bloodborne Pathogens, Infection Control and the Practice of Dentistry. Adopted Oct. 1999. Amended Oct. 2004. http://www.ada.org/prof/resources/positions/statements/blood.asp. Accessed 10/4/2008. Accessed 10/4/2008.
18 American College of Obstetricians and Gynecologists. ACOG Committee Opinion No. 389. Dec. 2007. Human Immunodeficiency Virus. http://www.acog.org/from_home/publications/ethics/co389.pdf. Accessed 10/4/2008.
19 American Academy of Orthopaedic Surgeons. Information Statement. Preventing the Transmission of Bloodborne Pathogens. Http://www.aaos.org/about/papers/advistmt/1018.asp. Accessed 10/4/2008.
20CDC. Recommendations for Prevention of HIV Transmission in Health‐Care Settings. MMWR 1987;36 (suppl. No. 2S):6S‐7S.
21 Centers for Disease Control and Prevention. Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings 2007. http://www.cdc.gov/ncidod/dhqp/gl_isolation_standard.html. Accessed 10/4/2008.
22 Centers for Disease Control and Prevention. Universal Precautions for Prevention of Transmission of HIV and Other Bloodborne Infections. http://www.cdc.gov/ncidod/dhqp/bp_universal_precautions.html. Accessed 10/11/08.