Clinical Guidelines for the Medical Management of Hepatitis C

Appendix B - New York State Department of Health Policy Statement and Guidelines to Prevent Transmission of HIV and Hepatitis B through Medical/Dental Procedures

Background

All medical and scientific data confirm that the risk of transmission of human immunodeficiency virus (HIV) and hepatitis B (HBV) through medical/dental procedures is remote and largely preventable through strict adherence to barrier precautions and infection control practices that decrease the opportunity of blood-to-blood exposure for both healthcare personnel and patients.

After more than 10 years of experience and millions of procedures, there is still only one documented case in which a healthcare worker with HIV transmitted the virus to patients. Ongoing and completed studies involving more than 15,000 patients of healthcare personnel infected with HIV, including surgeons and dentists, have revealed no infection of patients through medical procedures. Evaluation of AIDS cases that have no identified risk also has not implicated an infected healthcare worker in transmission.

The risk of hepatitis B virus (HBV) transmission through medical/dental procedures is several times greater than HIV. Twenty dusters of hepatitis B transmission to patients have been reported and investigated over the past 20 years. These cases commonly involved a breakdown in infection control during procedures where the healthcare worker's hands were within a body cavity and injury to the worker caused bleeding into the patient. Most reported dusters of hepatitis B in the U.S. occurred prior to 1985. The decrease in such reports in recent years may reflect the adoption of universal precautions and increased use of hepatitis B vaccine among healthcare workers.

Since the advent of the AIDS epidemic, both the Centers for Disease Control (CDC) and the New York State Department of Health have issued recommendations to healthcare workers and healthcare facilities emphasizing the importance of strict adherence to infection control standards and universal barrier precautions to minimize exposure to bloodbome pathogens in medical/ dental settings.

In January 1991, the Department of Health issued a policy statement and guidelines concerning HIV-infected medical personnel. This policy emphasizes voluntary testing of healthcare workers and case-by-case evaluation of HIV-infected personnel who perform invasive procedures to determine if they pose a significant risk to patients. The policy states that HIV infection alone is not sufficient justification to limit the professional duties of healthcare professionals unless specific factors compromise a worker's ability lo meet infection control standards or to provide quality patient care.

In July 1991, the CDC issued "Recommendations for Preventing the Transmission of HIV and Hepatitis B to Patients During Exposure-prone Invasive Procedures." In September, Congress passed a law directing all states to adopt the CDC recommendations or equivalent standards. These actions prompted the New York State Department of Health to again review all scientific and medical data bearing on the risk of HIV transmission through medical/ dental procedures. In conducting this evaluation, the department consulted widely with infection control experts and with representatives of medical, dental and hospital associations, and consumer groups.

On October 8, 1991, the department issued for public comment a proposed "Policy Statement and Action Plan to Prevent Transmission of HIV through Medical/Dental Procedures." The document reaffirmed the state's existing HIV-prevention/protection policies. It also outlined proposed state initiatives to strengthen infection control training and practice for healthcare practitioners. A total of 36 interested groups or individuals representing a broad range of interests provided written comment or testified at a public hearing held on November 4, 1991. The overwhelming majority of those providing comment endorsed the state's policy and action plan; some also provided specific suggestions for modifications or adjustments.

On August 11, 1992, Governor Cuomo signed legislation that formally codifies New York's policies and guidelines to protect all citizens from exposure to HIV, HBV and other bloodbome pathogens during medical/dental procedures, and to safeguard the rights of infected workers.

August 1992 - FINAL

Policy Statement

Based on evaluation of all available medical and scientific data, the Department of Health believes the following HIV and HBV-related policies best safeguard New York's citizens and protect the viability of our healthcare system.

  1. The most effective means of preventing HIV and HBV transmission in healthcare settings is through strict adherence to universal barrier precautions and established infection control practices which decrease the opportunity of direct exposure to blood and body fluids for both workers and patients.
  2. Voluntary testing without fear of disclosure or discrimination is the best means of encouraging people at risk for HIV or HBV to seek counseling and testing.
  3. All patients and healthcare personnel who have been potentially exposed to HIV or HBV through personal risk behavior, blood products or occupational accidents should be strongly counseled to seek testing so they may benefit from medical management
  4. Mandatory HIV screening of New York healthcare workers would cost millions of dollars and would not produce any appreciable gain in public safety. A negative antibody test does not rule out the presence of infection since it can take some time for measurable antibodies to appear.
  5. HIV or HBV infection alone does not justify limiting a healthcare 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 control standards or functional impairment which interferes with job performance.
  6. Requiring healthcare workers to inform patients or employers that they are HIV or HBV positive would only serve as a deterrent to workers seeking voluntary testing and medical evaluation. It also would endanger the professional careers of competent and needed health personnel who pose no risk to patients.

Guidelines

In its ongoing evaluation of the risk associated with potential exposure to HIV and HBV in healthcare settings, the Department of Health has identified measures the state can take to enhance public safety and to guard against discrimination for HIV- or HBV-infected healthcare personnel.

  1. Mandatory Infection Control Training for Healthcare Personnel

    New York State has been in the forefront of promoting infection control training and practice to prevent bloodborne disease exposure to healthcare workers or patients. All hospitals are required by regulation to train their staffs in infection control techniques, to provide appropriate equipment and to enforce use of universal barrier precautions in'situations involving potential exposure to blood or other body fluids. The department also has provided detailed infection control guidelines to all physicians and dentists practicing in New York State.

    To increase public safety, New York State has passed legislation to require licensed healthcare professionals (including physicians, physicians' assistants, specialists' assistants, registered nurses, licensed practical nurses, dentists, dental hygenists, podiatrists, optometrists) to complete a course in infection control and barrier precautions on or before July 1, 1994, and every four years thereafter. Required courses, tailored to the infection control training needs of specific medical and dental specialties, will include work practices and engineering controls, disinfection and sterilization procedures. Course content must be approved by the State Department of Health and/or Education.

    Proof of completion of required infection control training must be submitted by health professionals to either the State Department of Health or the Education Department. Physicians with hospital privileges will present the necessary training documentation to the hospital (in lieu of the Department of Health) during the process of renewing hospital privileges. A waiver of this training requirement may be granted by the Department of Health to health professionals who demonstrate that such training is not needed due to the nature of their work, or that they have met criteria for equivalency.

  2. Enforcement of Infection Control Standards

    All licensed healthcare facilities are responsible under existing regulations for monitoring and enforcing proper use of infection control practices and universal precautions by healthcare personnel functioning under their jurisdiction. Failure to comply with this requirement will result in Department of Health citation, potential fines and other disciplinary action against the institution.

    Any licensed healthcare professional who fails to use appropriate infection control techniques to protect patients or fails to ensure that healthcare workers under his/her supervision do so may be subject to charges of professional misconduct and disciplinary action.

    Any patient or employee complaint regarding lax infection control practices in a private medical or dental office will prompt an investigation by the departments of Health and/or Education. Substantiated lapses in infection control in a private practice setting may result in charges of professional misconduct against any licensed professional in the practice who was directly involved, was aware of the violation or who has responsibility for ensuring that office staff are adequately trained and follow patient protection measures.

    The state departments of Health and Education will promulgate regulations and/or statutory amendments to implement these more stringent enforcement provisions.

  3. Protecting Healthcare Workers from Infection

    Each healthcare facility should take the following steps to protect workers from occupational exposure to HIV, HBV and other bloodborne pathogens.

    1. All healthcare workers should receive appropriate training for their job titles in infection control techniques, including engineering and work practice controls, universal precautions and work practices that help prevent needle-sticks or other injuries and splashes of blood and body fluids.
    2. All healthcare personnel 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.
    3. All healthcare workers 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.
    4. All healthcare personnel should receive information about the risks associated with HIV and HBV transmission and the merits of knowing their status if they have personal or occupational risks so they may benefit from medical management.
    5. All healthcare workers should be informed that if they have an impaired immune system due to HIV infection or other medical condition, they are at risk of acquiring potentially life-threatening infections, including TB, from patients.
    6. Information on the availability of voluntary, confidential or anonymous counseling and testing for HIV and HBV should be made available to healthcare workers.
  4. Process for Evaluating Infected Healthcare Workers

    To ensure that public protection is a primary consideration and that healthcare personnel are afforded appropriate and equitable treatment, the Department of Health will establish a uniform process and criteria for evaluating HIV/HBV-infected healthcare workers to determine if practice limitations are warranted.

    Evaluation Criteria

    The evaluation of a healthcare worker should be based on the premise that HIV or HBV infection alone is not sufficient justification to limit a healthcare worker's professional duties. The determination of whether an individual healthcare worker poses a significant risk to patients which warrants job modification, limitation or restriction requires a case-by-case evaluation which considers the multiple factors that can influence risk. Periodic reevaluation of an HIV-infected healthcare worker may be appropriate if physical or mental functioning changes due to disease progression.

    Factors that may have a bearing on the ability of healthcare workers, including those with bloodbome infections, to provide quality healthcare 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;
    • the appropriateness of techniques as related to performance of procedures; any health condition that would pose a significant risk to others.

    Institutional Review Process

    Under State Health Department regulations, all licensed healthcare institutions are responsible for ensuring that their employees, medical staff and volunteers do not have physical or mental impairments related to HIV or HBV infection or any other condition that would interfere with the performance of their duties or pose a risk to patients. Consistent with this regulation, healthcare facilities are responsible for establishing a mechanism for evaluating healthcare workers with HIV or HBV infection. This requirement should not be misconstrued to foster or condone involuntary screening of employees for HIV or HBV by healthcare institutions. New York State law prohibits HIV testing of any citizen without written, informed consent. All healthcare workers should be counseled about the importance of learning their HIV and HBV status if they have been potentially infected through personal behavior or occupational exposure.

    Institutional evaluations of individual workers known to be infected with HIV or HBV shall be based on the Department of Health criteria, and shall involve consultation with experts who can provide a balanced perspective. Such experts include an infectious disease physician and/or hospital epidemiologist with an understanding of HIV and HBV, a representative from the infected healthcare worker's practice area and the personal physician of the infected worker. All matters related to such evaluations must be handled confidentially.

    Any modification of work practice must seek to impose the least restrictive alternative in accordance with federal 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 Department of Health review panel and/or file a complaint with the State Human Rights Commission.

    State-Appointed Review Panels

    The State Health Department will establish and oversee a voluntary evaluation process to provide guidance to HIV/HBV-infected healthcare workers who seek consultation. Access to state-appointed panel review will be available to infected healthcare workers who perform procedures that might increase the risk of worker-to-patient blood exposure. State panels will function as a primary evaluation resource for practitioners who are not affiliated with institutions, or as a second opinion for workers affiliated with health facilities who have been evaluated by their institutions. Each panel will include a public health official, an infectious disease expert, an expert in infection control/ epidemiology. In addition, an individual from the infected practitioner's area of practice and the individual's private physician 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 workers who are institutionally based, the panel — directly or through its designees — may need to request information about the worker's practice from the facility.
    • If practice restrictions are recommended, the individual involved shall assure - and verify to the panel - that all health facilities where he/she practices are informed. If assurance is not forthcoming, the panel will inform such facilities. Within all facilities, the normal rules of confidentiality apply.

    DOH Consultation

    Staff of the Department of Health will be available to any individual, institution or organization to discuss concerns about the management of employees with HIV or HBV. In addition, the department will provide information, confidentially or anonymously, on the process for accessing the state review panels described above.

    Enforcement of Practice Restrictions

    Healthcare institutions will be responsible for ensuring that any practice limitations recommended by institutional panels are followed in the facility by healthcare workers who are in their employ or who provide patient care from their facilities. If practice limitations are recommended for a community-based physician or dentist, periodic monitoring to ensure compliance will be performed by the State Department of Health or Education with the professional's consent. If a healthcare professional does not follow the practice restrictions or if compliance is uncertain, the appropriate state licensing/certification/permit board will be notified. The professional may be' charged with professional misconduct for negligent practice in violation of the State Education Law.

    Confidentiality of a Healthcare Worker's HIV Status

    HIV-infected healthcare workers are entitled to protections under the New York State HIV Confidentiality Law as are all citizens. Such workers are not required to disclose their HIV status to patients or employers. Healthcare facilities are under no obligation under New York law to disclose to patients the status of an infected healthcare worker in their employ; such disclosure, without the consent of the worker, would likely violate New York's HIV Confidentiality Law.

    Notification of patients that they were exposed to the blood of a healthcare worker should be based on documentation of an injury to a worker that could have resulted in the 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 HIV or HBV exposure. The Department of Health will be available to assist hospitals in determining if a significant risk of exposure to bloodborne pathogens warrants notification to patients.

  5. Quality Assurance Protections
    1. Hospital quality assurance programs, and under their umbrella, infection control policies and procedures, are key mechanisms for preventing disease transmission within healthcare settings. To further reduce the low risk of HIV or HBV transmission through medical procedures, hospitals should take the following actions:
    2. Assure that infection control policies and procedures for the prevention of bloodborne infections are in place and being monitored for compliance.
    3. Review existing policies and procedures to assure that mechanisms are in place for reporting and managing circumstances where an employee is exposed to a patient's blood or there has been mutual blood exposure between a patient and employee (i.e., during a procedure where injury to a worker resulted in both parties having contact with the other person's blood).
    4. Form cooperative work groups to review surgical techniques to identify changes in practice or other alternatives to reduce any risk of potential injury to a healthcare worker that could result in blood exposure to patients.

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