Appendix B - New York State Department of Health Policy Statement and Guidelines to Prevent Transmission of Bloodborne Pathogens from Infected Health Care Personnel through Medical/Dental Procedures
Hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) are the three most common bloodborne pathogens. All three can be transmitted either parenterally or by mucous membrane exposure. Experts agree that the risk for transmission of these viruses from infected health care personnel (HCP) to a patient during the provision of routine health care that does not involve invasive procedures is negligible. In instances in which invasive procedures and exposure-prone noninvasive procedures are being conducted, these risks are still quite small, but are clearly elevated when compared with other routine patient-care activities that do not involve invasive procedures (Henderson, et al, 2010).
Despite the widespread use of the hepatitis B vaccine, HBV remains the most commonly transmitted bloodborne pathogen in the health care setting. Given the lack of a hepatitis C vaccine, and with the prevalence of HCV infection rising around the world, HCV might be more frequently transmitted through health care in the years ahead. HCP-to-patient transmission of HIV has been extremely rare, with no cases reported worldwide since 2003 (Henderson, et al, 2010). Nonetheless, the first instance of transmission of HIV from an infected provider to a patient in 1990 was the driving force for the creation of guidelines and recommendations regarding providers infected with bloodborne pathogens.
In 1991, the Centers for Disease Control and Prevention (CDC) published guidelines for the prevention of HCP-to-patient transmission of HBV and HIV. At that same time the New York State Department of Health (NYSDOH) issued a policy statement and guidelines concerning HIV-infected medical personnel. In 1992, legislation formally codified New York's policies and guidelines to protect all citizens from exposure to HIV, HBV and other bloodborne pathogens during medical/dental procedures and to safeguard the rights of infected HCP. Since that time, much knowledge has been gained regarding health care-associated transmission, management, and prevention of infection with these viruses. This current document was reviewed and revised in 2011 by NYSDOH. It includes an update of applicable laws and regulations and adds HCV to the list of bloodborne pathogens.
The updated NYSDOH policy statement and guidelines concerning bloodborne pathogen-infected HCP continue to emphasize voluntary testing of HCP and case-by-case evaluation of bloodborne pathogen-infected HCP who perform invasive procedures to determine if they pose a significant risk to patients. Bloodborne pathogen infection alone is not sufficient justification to limit the professional duties of HCP unless specific factors compromise an HCP's ability to meet infection prevention and control standards or to provide quality patient care.
Based on currently-accepted medical and scientific evidence, the NYSDOH recommends the following policies to prevent infected health care personnel (HCP)-related bloodborne pathogen transmission (HIV, HBV, HCV):
- The most effective means of preventing bloodborne pathogen transmission in health care settings is through strict adherence to Standard Precautions (Siegel, et al, 2007), and established infection prevention and control practices that decrease the opportunity for direct exposure to blood and body fluids for both health care workers and patients.
- Voluntary testing without fear of disclosure or discrimination is the best means of encouraging people at risk for bloodborne pathogens to seek counseling and testing.
- Mandatory screening of New York HCP for bloodborne pathogens is not recommended. Such a program would cost millions of dollars and would not produce any appreciable gain in public safety. Negative antibody tests for HIV, HBV, and HCV do not rule out the presence of infection since it can take some time for measurable antibodies to appear.
- All patients and health care workers who have been potentially exposed to bloodborne pathogens should be strongly counseled to seek testing so they may benefit from medical management. Health care workers should also seek screening for bloodborne diseases per CDC recommendations as part of their own health care. CDC recommends that all persons aged 13–64 have routine screening for HIV (CDC, 2006). Persons of all ages with ongoing risk factors for HIV should have periodic repeat screening and seek medical care if they are found to be HIV-infected. HBV and HCV screening recommendations are based on an assessment of individual risks (CDC, 2001).
- Bloodborne pathogen infection alone does not justify limiting a health care worker's professional duties. Limitations, if any, should be determined on a case-by-case basis after consideration of the factors that influence transmission risk, including inability or unwillingness to comply with infection prevention and control standards or functional impairment that interferes with job performance.
- Health care workers are not required to inform patients or employers that they have a bloodborne pathogen infection. Such disclosure might serve as a deterrent to workers seeking voluntary testing and medical evaluation. Strict adherence to Standard Precautions is an effective means of preventing transmission of bloodborne pathogens.
The NYSDOH has identified measures that enhance public safety and guard against discrimination for bloodborne pathogen-infected health care personnel (HCP).
1. Mandatory Infection Prevention and Control Training for HCP
New York State regulation (10 N.Y.C.R.R. § 405.11) requires all licensed health care facilities to train their staff in infection prevention and control techniques, to provide appropriate equipment, and to enforce use of Standard Precautions in situations involving potential exposure to blood or other body fluids. The NYSDOH also provides detailed infection prevention and control guidelines to all physicians and dentists practicing in New York State and makes such guidelines publicly available on the NYSDOH website.
In addition, Public Health Law (PHL) § 239 and Education Law (EdL) § 6505-b require licensed health care professionals (including physicians, physician assistants, specialist assistants, registered nurses, licensed practical nurses, dentists, dental hygienists, podiatrists, and optometrists) to complete a course in infection control and barrier precautions on or before July 1, 1994, and every four years thereafter. As of 2008, PHL § 239 also requires medical students, medical residents, and physician assistant students to complete coursework or training in infection control practices. Required courses, tailored to the infection prevention and control training needs of specific health care specialties, include work practices and engineering controls, safe injection practices, and disinfection and sterilization procedures. The NYSDOH or New York State Education Department (NYSED) must approve the course syllabus and course providers.
Health care professionals must submit proof of completion of required infection prevention and control training to either the NYSDOH or NYSED. Physicians with hospital privileges will present the necessary training documentation to the facility (in lieu of the NYSDOH) during the process of renewing facility privileges. The NYSDOH or NYSED will grant an exemption from this training requirement to health care professionals who demonstrate that such training is not needed because of the nature of their clinical practice, or that they have completed equivalent training or coursework. A health care professional who receives an exemption must apply to the NYSDOH or NYSED to continue such exemption every four years.
2. Enforcement of Infection Prevention and Control Standards
All licensed health care facilities are responsible under existing regulations (see 10 N.Y.C.R.R. § 405.11) for monitoring and enforcing proper use of infection prevention and control practices and Standard Precautions by health care workers functioning under their jurisdiction. Failure to comply with this requirement will result in NYSDOH citation, potential fines, and other disciplinary action against the facility.
Any licensed health care worker who fails to use appropriate infection prevention and control techniques to protect patients or fails to ensure that health care workers under his or her supervision do so may be subject to charges of professional misconduct and disciplinary action (e.g., Education Law § 6530(47); 8 N.Y.C.R.R. § 29.2(a)(13)).
Any patient or employee report regarding lax infection prevention and control practices in a private medical or dental office may prompt an investigation by the appropriate authorities. Substantiated lapses in infection prevention and control in a private practice setting may result in charges of professional misconduct against any licensed professional in the practice who was involved or who has responsibility for ensuring that office staff are adequately trained and follow patient protection measures.
The NYSDOH and NYSED have promulgated regulations and/or statutory amendments to implement these enforcement provisions.
3. Protecting HCP from Infection
All health care facilities should take the following steps to protect HCP from occupational exposure to bloodborne pathogens (for more details, refer to the Occupational Safety and Health Administration's website):
- All HCP should receive appropriate training for their job titles in infection prevention and control techniques, including engineering and work practice controls, Standard Precautions, and work practices that help prevent sharps or other injuries and splashes of blood and body fluids.
- All HCP should be provided a safe work environment, including protective equipment, clothing, and devices to reduce the risk of occupational exposure to blood and body fluids.
- All HCP whose job responsibilities involve contact with blood or sharp objects likely to be contaminated with blood should be offered and encouraged to receive the hepatitis B vaccine.
- All HCP should receive information about the risks associated with bloodborne pathogen transmission and the merits of knowing their status if they have personal or occupational risks so they may benefit from medical management.
- All HCP should be informed that if they have an impaired immune system, they are at risk of acquiring potentially life-threatening infections, including tuberculosis, from patients.
- Information on the availability of voluntary and confidential or anonymous (in the case of HIV) counseling and testing for bloodborne pathogens should be made available to health care workers.
4. Evaluating Infected HCP
A health care facility should base its evaluation of HCP on the premise that bloodborne pathogen infection alone is not sufficient justification to limit the professional duties of HCP. The determination of whether an individual HCP poses a significant risk to patients that warrants job modification, limitation, or restriction requires a case-by-case evaluation that considers the multiple factors that can influence risk. Periodic re-evaluation of HCP with bloodborne pathogen infection may be appropriate if physical or mental functioning changes.
Factors that may bear on the ability of HCP, including those with bloodborne infections, to provide quality health care include:
- Physical or mental condition that may interfere with the worker's ability to perform assigned tasks or regular duties;
- Lack of compliance with established guidelines to prevent transmission of disease and/or documentation or evidence of previous transmission of bloodborne pathogens;
- Lack of appropriate infection prevention and control techniques as related to performance of procedures (e.g., poor hand hygiene practices or lack of attention to Standard Precautions);
- Any health condition that would pose a significant risk to others.
Institutional Review Process:
Under NYSDOH regulations (10 N.Y.C.R.R. § 405.3(b)), all licensed health care facilities are responsible for ensuring that their employees, medical staff, and volunteers do not have physical or mental impairments related to bloodborne pathogen infection or any other condition that would interfere with the performance of their duties or pose a risk to patients.
Consistent with this regulation, health care facilities are responsible for establishing a mechanism for evaluating HCP with bloodborne pathogen infection to ensure that they do not pose a risk. This requirement should not be misconstrued to condone involuntary or mandatory screening of employees for bloodborne pathogens by health care facilities.
Except as otherwise authorized in state or federal law, PHL § 2781 prohibits HIV testing of any person without written, informed consent. All HCP should be counseled about the importance of learning their bloodborne pathogen status.
Institutional evaluations of individual workers known to be infected with bloodborne pathogens should involve consultation with experts who can provide a balanced perspective. Such experts may include an infectious disease physician and/or hospital epidemiologist with an understanding of bloodborne pathogens, a representative from the infected health care worker's specialty area, and the infected worker's primary care provider. All matters related to such evaluations must be handled confidentially.
Any modifications of work practice must seek to impose the least restrictive alternative in accordance with disability laws. Any worker who believes that his/her employment has been restricted or terminated without just cause may ask for a second opinion from a NYSDOH review panel and/or file a complaint with the State Human Rights Commission.
State-Appointed Review Panels:
Pursuant to PHL § 2760, the NYSDOH may convene a state advisory panel that provides guidance to bloodborne pathogen-infected health care workers who seek consultation. Access to state-appointed panel review is available on request to infected health care workers who perform procedures that might increase the risk of worker-to-patient blood exposure. State panels function as an evaluation resource for practitioners who are not affiliated with institutions, or as a second opinion for workers affiliated with health care facilities who have been evaluated by their facilities.
Each panel would include a state or local public health officer, an infectious disease expert, and an expert in infection control/epidemiology. In addition, an individual from the infected health care worker's specialty area and the individual's primary care provider may be asked to serve as members of the panel. The purpose of such panels is to provide timely advice and consultation on an individual's risk of bloodborne disease transmission through his/her professional practice and to recommend practice limitations, modifications, or restrictions where the evidence suggests there is a significant risk to patients.
The evaluation process will be confidential except for the following circumstances:
- To adequately evaluate health care workers who are institutionally based, the panel – directly or through its designees – may request information about the health care worker's practice from the facility.
- If practice restrictions are recommended, the individual involved shall verify to the panel that all health care facilities in which the health care worker practices are informed. If verification is not forthcoming, the panel will inform such facilities. Within all facilities, the usual rules of confidentiality apply.
The NYSDOH is available to any individual, institution, or organization to discuss concerns about the management of employees with bloodborne pathogens. In addition, the NYSDOH will provide information, confidentiality or anonymously, on the process for accessing the state review panels described above. For information, contact the NYSDOH Bureau of Healthcare-Associated Infections Healthcare Epidemiology and Infection Control program at 518-474-1142 or visit the Bureau's website.
Enforcement of Practice Restrictions:
Health care facilities must ensure that health care workers who are in their employ or who provide patient care from their facilities follow any practice limitations recommended by institutional panels. If practice limitations are recommended for a community-based health care worker, the NYSDOH or NYSED (depending upon the license held by infected HCP) will perform periodic monitoring with the professional's consent to ensure compliance. If a health care worker does not follow the practice restrictions or if compliance is uncertain, the appropriate state licensing/certification/permit board will be notified.
Confidentiality of a Health Care Worker's HIV Status:
PHL § 2782 protects the confidentiality of HIV-related information by limiting who may obtain the information and for what purpose. The Human Rights Law §296 prohibits discriminatory employment practices based on a person's disability. In accordance with the law, HIV-infected health care workers may not be required as a condition of employment to disclose their HIV status to patients. Similarly, health care facilities are under no general obligation under New York State law to disclose to patients the status of an infected health care worker in their employ. Issues related to possible employment discrimination should be directed to the NYS Division on Human Rights (718-741-8400) or to the NYC Commission on Human Rights (212-306-5070).
Notification of patients that they were exposed to the blood of a health care worker should be based on documentation of an injury to a health care worker or negligent practice that could have resulted in the health care worker's blood coming into direct contact with a patient's bloodstream or mucous membranes. In such circumstances, the patient should be advised to receive testing for potential bloodborne pathogen exposure. The NYSDOH will be available to assist health care facilities in determining if a significant risk of exposure to bloodborne pathogens warrants notification to patients.
5. Quality Assurance Protections
Health care facility quality assurance programs and, under their umbrella, infection prevention and control policies and procedures, are key mechanisms for preventing disease transmission within health care settings. To further reduce the low risk of bloodborne pathogen transmission from infected HCP through medical procedures, health care facilities should take the following actions:
- Ensure policies and procedures for the prevention of bloodborne pathogen infections are in place and being monitored for compliance.
- Review existing policies and procedures to ensure that mechanisms are in place for reporting and managing circumstances where an HCP is exposed to a patient's blood and/or body fluids or there has been blood exposure between a patient and an HCP (e.g., during a procedure where injury to a health care worker resulted in both parties having contact with the other person's blood).
- Form cooperative work groups to review surgical techniques (in the case of an infected HCP) to identify changes in practice or other alternatives to reduce any risk of potential injury to a health care worker that could result in blood exposure to patients.
- Bloodborne pathogens
- microorganisms in blood that can cause illness in humans. Of primary concern are the human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV).
- Health care worker
- a person (e.g., employee, student, contractor, independent licensed practitioner, public-safety worker, or volunteer) whose activities involve contact with patients or with blood or other body fluids from patients in a health care, laboratory, or public safety setting.
- introduced into the body by a route other than the digestive tract (i.e., as by intravenous or intramuscular injection).
- Standard Precautions
- a set of infection prevention guidelines that combine the major features of Universal Precautions and Body Substance Isolation guidelines and are based on the principle that all blood, body fluids, secretions, excretions except sweat, nonintact skin, and mucous membranes may contain transmissible infectious agents. Standard Precautions include a group of practices that apply to all patients, regardless of suspected or confirmed infection status, in any setting in which health care is delivered. These include: hand hygiene; use of gloves, gown, mask, eye protection, or face shield, depending on the anticipated exposure; and safe injection practices. Also, 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 (e.g. wear gloves for direct contact, contain heavily soiled equipment, properly clean and disinfect or sterilize reusable equipment before use on another patient).
- CDC. Updated U.S. Public Health Service guidelines for the management of occupational exposures to HBV, HCV, and HIV and recommendations for postexposure prophylaxis. MMWR 2001;50(RR11);1-42.
- CDC. Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR 2006;55(RR14);1-17.
- Henderson, D., et al (2010). SHEA guideline for management of healthcare workers who are infected with hepatitis B Virus, hepatitis C Virus, and/or human immunodeficiency virus. Inf Cont and Hosp Epi 31, 13 (pp 203-32).
- Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the Healthcare Infection Control Practices Advisory Committee, 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Setting http://www.cdc.gov/ncidod/dhqp/pdf/isolation2007.pdf
- CDC. Updated Recommendations for the Management of Hepatitis B Virus-Infected Health-Care Providers and Students. MMWR 2012:61(RR-12):1-12.