Employer Responsibilities in PEP Management to Prevent HIV Infection Following an Occupational Exposure
NYSDOH AIDS Institute, June 2020
Requirements: Organizations that employ health professionals or others who are at risk for occupational exposure to blood, body fluids, or other potentially infectious materials are generally required to establish policies and procedures that guide the management of such exposures.
Employers must conform to the OSHA Bloodborne Pathogens Standard (OSHA Bloodborne Pathogens Standard 29 CFR § 1910.1030 and Compliance Directive CPL 02-02-069, 11/27/01, Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens), which are applicable to New York public employers under the New York Public Employee Safety and Health (PESH) Act (Labor Law § 27-a) and regulations (12 NYCRR Part 800). OSHA and PESH standards regarding occupational exposure to bloodborne pathogens are identical. These regulations require that a management plan is in place.
Employee access to post-exposure services: The employer should ensure that any employee who sustains an occupational exposure has access to post-exposure services within 1 to 2 hours of a reported event. Services must be available 24 hours per day, 7 days per week. Organizations that do not have onsite occupational health services are encouraged to form agreements or contracts with another facility, Emergency Department, or private practitioner for such services.
Definition of individuals covered: New York State regulations apply to staff, employees, or volunteers in the performance of employment or professional duties who work in:
- A medical or dental office.
- A facility regulated, authorized, or supervised by the Department of Health, Office of Mental Health, Office of Mental Retardation and Developmental Disabilities, Office of Children and Family Services, Office of Alcoholism and Substance Abuse Services, or the Department of Correctional Services.
- Emergency response employee (paid or volunteer, including an emergency medical technician, a firefighter, a law enforcement officer or local correctional officer, or medical staff).
Post-exposure policies should define who is included as an “employee” for purposes of providing care. In addition to staff who are employed by an organization (e.g., nurses, laboratory personnel, housekeepers), consideration must be given to whether other individuals (e.g., medical/nursing students, house staff, attending physicians, volunteers, and pre-hospital care personnel) will be covered by the institution’s policy. In addition, the scope of services that will be provided must be delineated (e.g., laboratory testing, occupational health services, prophylactic drugs or vaccines), including whether there are limitations within the categories of individuals covered, particularly regarding workers’ compensation benefits.
Access to services: Exposed workers who sustain an occupational exposure should be ensured access to post-exposure services within 1 or 2 hours of a reported event. This may require 24-hour and weekend coverage. Procedures should identify how workers access services during regular work hours and, if different, how they access services during evening, night, or weekend shifts. Organizations that do not have onsite occupational health services should consider forming agreements or contracts with another facility or private practitioner for such services.
Post-exposure services for exposures to all bloodborne pathogens include but are not limited to:
- Post-exposure evaluation and follow-up post-exposure vaccinations.
- Arrangements for a full course of PEP medications, at no cost to the employee.
- Care provided under the supervision of a licensed physician or other licensed healthcare professional.
- Availability of a rapid HIV test for source testing.
- Supportive counseling.
Federal law requires covered employers to ensure that all medical evaluations and procedures, vaccines, and post-exposure prophylaxis are made available to the employee within a reasonable time and at a reasonable location and are made available at no cost to the employee (OSHA, 29 CFR, Part 1910.2030, CPL 2-02.069, 11/27/01, Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens).
PESH and OSHA’s Bloodborne Pathogens Standards indicate that the covered employer is responsible for all costs associated with an exposure incident. An employer may not require any out-of-pocket expenditures on behalf of the employee, such as requiring the employee to utilize workers’ compensation if prepayment is required or compelling an employee to use health insurance to cover these expenses unless the employer pays all premiums and deductible costs associated with the employees’ health insurance. In addition to services listed above, the NYSDOH AI guideline Post-Exposure Prophylaxis (PEP) to Prevent HIV Infection states that the following should be considered by the employer when establishing plans for providing PEP for HIV exposure:
- Who will perform the post-exposure evaluation.
- Who will provide counseling to the exposed worker regarding the exposure and indications for PEP (for off-hour exposures as well).
- How PEP will be made available within 2 hours of an exposure.
- How a 7-day supply of PEP will be made available for urgent use.
- Who will be given authority for releasing drugs for this purpose.
- How the exposed worker will obtain PEP medications to complete the 28-day regimen.
Determining the HIV status of the exposure source: Procedures to facilitate rapid evaluation and voluntary testing for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and other bloodborne pathogens and disclosure of related information of the source individual should be in place.
The employer is responsible for establishing and implementing policies to protect the confidentiality of both the exposed employee and the exposure source (New York Public Health Law §§ 2135, 2782; 10 NYCRR § 63.6).
Access to source HIV-related information: New York law and regulations (Public Health Law § 2781(6)(e); 10 NYCRR § 63.8(m)) authorize disclosure of existing HIV-related information to healthcare providers of those who have been exposed in the workplace when significant risk exposure has occurred.
When the source is already known to be infected with HBV, HCV, or HIV, testing for the source individual’s known HBV, HCV, or HIV status does not need to be repeated. Testing for other bloodborne pathogens should still occur.
If the exposed worker is part of the healthcare team, he/she may have access to the medical record and know the HIV status of the source, as well as information about drug resistance. Information related to drug regimens, and, if available, resistance information should be made available to the exposed employee’s healthcare provider to determine the best regimen for the employee. However, initiation of PEP should not be delayed while awaiting this information.
HIV testing of the source: Consistent with recommendations by the Centers for Disease Control and Prevention (CDC), and the U.S. Department of Labor, OSHA mandates that medical facilities subject to OSHA authority use rapid HIV antibody tests when testing the source after potential exposure to a bloodborne pathogen. The CDC recommends testing with a 4th-generation antibody/antigen combination assay.
- The source should be tested as soon as possible to determine HIV infectivity.
- Results of the source individual’s HIV testing should be made available to the exposed worker’s healthcare provider. Patient authorization for the release of this information is not required for necessary communication of information between care providers for timely treatment of the exposed worker.
Source has the capacity to consent for HIV testing: Informed consent from the source should be obtained. If consent is not obtained for HIV testing, the employer should document that consent cannot be obtained and testing cannot be performed. See Box 7: HIV Testing When the Source of an Occupational Exposure Is Unable to Consent.
Source does not have the capacity to consent for HIV testing: If the source is comatose or is determined by his or her attending professional to lack the mental capacity to consent, and the source is not expected to recover in time for the exposed individual to receive appropriate medical treatment, the Health Care Proxy Law and Family Health Care Decisions Act (FHCDA) give healthcare providers the ability to locate someone who has the legal authority to consent to HIV testing (the healthcare agent or FHCDA Surrogate).
New York regulations [§§ 63.3(d)(7), 63.8(n)] also authorize anonymous testing when no individual authorized to consent on behalf of the source is immediately available.
An anonymous test* may be performed if: The healthcare agent or FHCDA Surrogate, who has the legal authority to consent, is not available or reasonably likely to become available in time for the exposed individual to receive appropriate medical treatment and the exposed individual will benefit medically by knowing the source’s HIV test results or the source is deceased.
*The law requires that results of anonymous source testing are given only to the healthcare provider of the exposed individual solely for assisting the exposed individual in making appropriate decisions regarding post-exposure medical treatment. The results of the test cannot be disclosed to the source or placed in the source’s medical record. The source may be told that the exposure occurred and that an HIV test was performed. The source should be offered confidential testing so that they may have access to information about his/her own HIV status.
Worker’s compensation program: The Workers’ Compensation Law has specific implications for employees exposed to HIV, as well as those rare cases that result in seroconversion. Individuals who manage such exposures should be familiar with these implications because they should be able to counsel employees and refer them for legal and medical assistance accordingly. The organization’s workers’ compensation provider should be contacted as situations arise.
NYS Worker’s Compensation Board:
- Website: http://www.wcb.ny.gov/
- Worker benefits and information regarding how to file a claim: http://www.wcb.ny.gov/content/main/Workers/Workers.jsp
- Advocate for Injured Workers, for questions related to injured workers:
Preventing transmission of bloodborne pathogens: As part of the employer’s plan to prevent transmission of bloodborne pathogens, the following measures can be taken to avoid injuries:
- Elimination of unnecessary use of needles or other sharps.
- Use of devices with safety features.
- Verification of training and compliance with safety features.
- Avoidance of needle recapping.
- Planning before beginning any procedure using needles or other sharps for safe handling and prompt disposal in sharps disposal containers.
- Promotion of education and safe work practices for handling needles and other sharps.
For more information about prevention of needlestick injuries, refer to the National Institute for Occupational Safety and Health Alert: Preventing Needlestick Injuries in Health Care Settings.
Even when effective prevention measures are implemented, exposures to blood and bodily fluid still occur. Employers of personnel covered by the OSHA Bloodborne Pathogens Standard are obligated to provide post-exposure care, including prophylaxis, at no cost to the employee. The employer may subsequently attempt to obtain reimbursement from workers’ compensation.
Documentation: Information that should be recorded after an occupational exposure to HIV has occurred includes the following, which the clinician should record in the exposed worker’s confidential medical record:
- Date and time of the exposure.
- Details of the procedure being performed and the use of protective equipment at the time of the exposure.
- Type, severity, and amount of fluid to which the worker was exposed.
- Details about the source individual.
- Whether HIV testing of the source was performed.
- Medical documentation that provides details about post-exposure management.
- If the occupationally exposed individual declines PEP, the clinician should document this decision in the individual’s medical record.
Specific OSHA requirements regarding documentation may be found at Safety and Health Topics: Bloodborne Pathogens and Needlestick Prevention.
Services for Sexual Assault Patients
NYSDOH AIDS Institute, June 2020
New York State (NYS) Public Health Law 2805-i requires that hospitals providing treatment to survivors of sexual assault advise the patient of the availability of services provided by the local rape crisis or victim assistance organization and secure such services as requested by the patient.
Role of the rape crisis advocate: The primary role of the rape crisis advocate is to provide the patient with emotional support, advocacy, information, counseling, and accompaniment services, and to facilitate informed decision-making at a time when the patient may be in crisis. Advocates do not provide healthcare or collect evidence; however, they can enhance the efforts of healthcare staff through the provision of information regarding medical and legal options. For information about rape crisis services, see NYSDOH Sexual Violence Prevention Program. The NYSDOH, with other State agencies, healthcare facilities, and professional organizations, provides technical assistance on sexual assault issues.
Sexual Assault Forensic Examiner (SAFE): The initial response that a survivor of rape or sexual assault receives when seeking healthcare or reporting the crime has a profound influence on that individual’s subsequent recovery. Engagement of healthcare practitioners from the SAFE program helps improve the care that survivors of sexual assault receive. The NYSDOH certifies all appropriately qualified individuals as SAFEs. A SAFE is a specially trained registered nurse, nurse practitioner, physician, or physician’s assistant.
NYS public health law requires that the NYSDOH establish standards for and certify SAFE hospital programs. All SAFE Designated Hospitals have a SAFE available either on site or on-call within 60 minutes of the sexual assault patient’s arrival at the hospital, except under exigent circumstances (NYS Public Health Law 2805-i). In NYS, the standard of care for survivors of rape and sexual assault presenting at healthcare settings includes comprehensive high-quality medical care, collection of forensic evidence, and respectful and sensitive treatment. The NYSDOH recommends the use of SAFEs in all hospitals to assist in meeting this standard. The SAFE should be an active participant in the discussion regarding initiation of HIV post-exposure prophylaxis (PEP). SAFEs help to ensure the best medical, legal, and psychological outcomes for the adult survivor of sexual assault and provide compassionate emotional support. They are trained to provide care to survivors of sexual assault and to collect and preserve forensic evidence to support prosecution if the patient decides to report the crime to law enforcement.
Reimbursement for SAFE services: Provider reimbursement under the Office of Victim Services (OVS) FRE Direct Reimbursement Program is intended to cover the forensic examiner’s services, including pharmaceuticals related to a sexual assault forensic examination. This reimbursement includes the cost of the initial 7-day starter pack of PEP if the care provider determines a risk of HIV exposure. Claim forms for reimbursement under the Direct Reimbursement Program can be found in each Sexual Offense Evidence Collection Kit and be downloaded from the OVS website.
Documentation of a visit to a facility that provides a forensic medical examination satisfies the OVS reporting requirement, thereby providing survivors who are either unwilling or unable to report the crime to the police the opportunity to file a regular compensation claim. Survivors of sexual assault may also contact a Rape Crisis Center or Victim Advocate Program in their county or region for assistance in filing regular compensation claims with OVS, particularly when an emergency award is needed from the OVS (see below). Many of these agencies have 24-hour hotlines. For more information and a list of Victim Advocate Programs and other resources, consult the OVS website.
The OVS has an “emergency award” procedure in addition to its normal compensation process to ensure continued availability of PEP for survivors of sexual assault beyond the initial 7-day starter pack supply. Advocates who know the community connections and procedures to expedite the process should work with the exposed individual. The process for requesting an emergency award is as follows: 1) Claimant files a regular claim application with the OVS, indicating that medication for HIV PEP is necessary, and requests an emergency award. 2) OVS makes an expedited determination for the purposes of the emergency award. 3) If the OVS determines it can grant an emergency award, up to $2,500, then OVS directly reimburses pharmacy providers on behalf of the claimant.