Appendix A

Post Exposure Prophylaxis, Counseling and Follow-up10/13/15

A.Management of Potentially Exposed Employees

The City of Philadelphia will make available to their employees a system that includes written protocols for prompt reporting, evaluation, counseling, treatment, and follow-up of occupational exposures that may place employees at risk for acquiring any bloodborne infection, including HIV. The City has also established Risk Management Safety Directive #P-3 Bloodborne Pathogens Prevention & Response Program, including post-exposure follow-up for their employees. Access to clinicians who can provide post-exposure care is available during all working hours, including nights and weekends through the City of Philadelphia’s network of Employees’ Compensation, Regulation 32 and Heart and Lung treatment sites. The hospitals that are currently participating are found in the Risk Management Safety Directive #P-4, Communicable Disease Policy for the City of Philadelphia. Anti-retroviral agents for post exposure prophylaxis (PEP) are available for timely administration (i.e., either by providing access to PEP drugs on site or creating links with other facilities or providers to make them available offsite). Persons responsible for providing post-exposure counseling are familiar with evaluation and treatment protocols and the facility’s procedures for obtaining drugs for PEP.

B. Exposure Report Form

Occupational exposures shall be recorded on the City of Philadelphia, Bloodborne Pathogens Exposure Report Form (see Appendix B) in addition to the City of Philadelphia Accident Injury & Illness (COPA II) form. Post-exposure management shall be recorded in the employee’s confidential occupational medical record.

C.Exposure Management

  1. The management of occupational exposure to potential bloodborne pathogens should be consistent with the Centers for Disease Control and Prevention:

a)Updated US Public Health Service Guidelines for the Management of OccupationalExposures to HIV and Recommendations for Post-exposure prophylaxis” (2005).

b)Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV and HIV and Recommendations for Post exposure Prophylaxis (2001)

c)The following procedures are consistent with the above referenced CDC guidelines.

  1. Treatment of an Exposure Site:

When possible or available, wounds and skin sites that have been in contact with blood or body fluids should be immediately washed with soap and water; mucous membranes should be flushed with copious amounts of water. There is no evidence that the use of antiseptics for wound care or expressing fluid by squeezing the wound further reduces the risk for HIV transmission. However, the use of antiseptics is not contraindicated. The application of caustic agents (e.g., bleach) or the injection of antiseptics or disinfectants into the wound is not recommended.

D.Healthcare Provider Assessment of BBP Infection Risk

After an occupational exposure, the source-person and the exposed employeeshall be evaluated to determine the need for BBP PEP immediately within hours of exposure rather than days. This includes follow-up for HIV, hepatitis B virus and hepatitis C virus in accordance with published CDC recommendations and the Risk Management Safety Directive #P-4 Communicable Disease Policy for the City of Philadelphia

  1. Evaluation of Bloodborne Pathogens Exposure.

a)The exposure should be evaluated for potential to transmit BBP based on the type of body substance involved and the route and severity of the exposure. Exposures to blood, fluid containing visible blood, or other potentially infectious material (including semen; vaginal secretions; and cerebrospinal, synovial, pleural, peritoneal, pericardial, and amniotic fluids) or tissue through a percutaneous injury (i.e., needle stick or other penetrating sharps-related event) or through contact with a mucous membrane are situations that pose a risk for bloodborne pathogens transmission and require medical evaluation..

b)In addition, any direct contact with human blood or serum in a research laboratory or production facility is considered an exposure that requires medical evaluation to assess the need for PEP.

c)For skin exposures, medical evaluation is indicated if it involves direct contact with a body fluid listed above and there is evidence of compromised skin integrity (e.g., dermatitis, abrasion, or open wound). However, if the contact is prolonged or involves a large area of intact skin, post-exposure follow-up shall be considered on a case-by-case basis by the City’s panel healthcare provider.

d)For human bites, the medical evaluation must consider for both the bite recipient and the person who inflicted the bite as potential exposure.

  1. Evaluation and testing of an exposure source

a)The evaluation and testing of an exposure source shall be in compliance with the Pennsylvania, Confidentiality of HIV –Related Information Act (Act of Nov. 29, 1990, P.L. 585, No. 148)

b)The Department shall request the source patient provide his/her medical records for review by the healthcare provider(See Appendix H for an example request for source patient information). The health care provider will use the source patient medical records in choosing an appropriate PEP regimen. Information available in the medical record at the time of exposure (e.g., laboratory test results, admitting diagnosis, or past medical history) or from the source person may suggest or rule out possible bloodborne pathogens infection.

c)If source patient information is not immediately available, the health care provider may recommend initiation of PEP for the employee, should not be delayed; changes in the PEP regimen can be made after PEP has been started, as appropriate.

d)If informed consent cannot be obtained (e.g., patient is unconscious), procedures should be followed for testing source patient according to Pennsylvania Act 148 applicable state and local laws.

  1. Unknown Source Patient:

a)When the source patient is unknown, information about where and under what circumstances the exposure occurred should be assessed for risk for transmission of BBP by the supervisor or safety officer / infection control officer via BBP report form and COPA II.

b)This assessment shall be provided to the healthcare provider at the time of the employee’s initial medical evaluation.

  1. Unknown Source Patient Assessment Considerations

Certain situations, as well as the type of exposure, may suggest an increased or decreased risk; an important consideration is the prevalence of HIV in the population group (i.e., institution or community) from which the contaminated source material is derived.

a)For example, an exposure that occurs in a geographic area where injecting-drug use is prevalent or on an AIDS unit in a health-care facility would be considered epidemiologically to have a higher risk for transmission. An exposure that occurs in a nursing home for the elderly where no known HIV-infected residents are present would be considered a low risk. Decisions regarding appropriate management should be individualized based on the risk assessment.

  1. HIV testing of needles or other sharp instruments associated with an exposure, regardless of whether the source is known or unknown, is not recommended. The reliability and interpretation of findings in such circumstances are unknown.

E.Clinical Evaluation and Baseline Testing of Exposed Employees

1.Exposed employees shall be informed for consent to a baseline evaluation for existing bloodborne pathogen infections. Baseline testing (i.e., testing to establish aerostats at the time of exposure) for the employee’s HIV antibody, Hepatitis panel) shall be performed in order to proceed with obtaining source patient information.

2.If the employee does not provide informed consent for baseline testing, source patient information shall not be provided to the panel healthcare provider to be shared with the employee. The employee shall be notified of confidentiality requirements regarding the source patient.

3.Results of the source patient’s blood tests for HIV and the hepatitis panel, will used by the health care provider in determining further follow up care of the employee.

4.Pregnant employeeevaluation for BBP exposure

a)Pregnancy testing should be offered to all non-pregnant women of childbearing age whose pregnancy status is unknown at the time of the BBP exposure.

b)Pregnant employees that sustain a BBP exposure while performing the scope of their duties are to be instructed to inform the healthcare provider at the City’s treatment panel

5.Evaluation of employee’s with pre-existing medical conditions for BBP exposure.

a)Employees who know they have a pre-existing medical condition are encouraged to inform the City’s treatment panel provider to ensure appropriate medical care is given.

F.Post Exposure Prophylaxis (PEP)

The following protocol applies to occupational exposures where anemployee has had an exposure to a source patient with a BBP (i.e. HIV, HBV, HCV or where information suggests that there is likelihoodthat the source person is infected). PEP protocols are administered by the City’s treatment panel of providers.

  1. Explanation and Recommendation of PEP to Employees

a)Explanations and recommendations for PEP treatment will be provided by the designated City’s treatment panel provider.

  1. Timeliness of PEP Initiation

a)PEP should be initiated as soon as possible.

b)To assure timely access to PEP, an occupational exposure should be regarded as an urgent medical concern and PEP started as soon as possible after the exposure (i.e., within a hours rather than days).

  1. Obtaining Prescribed PEP

a)If the City’s treatment panel provider issues PEP prescription(s) to the employee, the following information can be used to fill the prescription :

  1. Prescriptions can only be filled by an approved City network pharmacy. A listing can be can be obtained from the City’s third party administrator (currently for FY 13-FY16 - Comp Services Inc. at 215-587-1295)or contracted vendor (currently Scriptnetfor FY 13-FY16can also be contacted at 1-888-880-8562 or website for a current listing.

b)Exposed employees shall inform the network pharmacy of their work-related injury/illness and employment with the City of Philadelphia.

  1. Under no circumstance shall the employee provide his/her personal healthcare medical information to the pharmacy to fill the prescription
  2. All work-related prescriptions are covered under the City’s disability program (i.e. Regulation 32 – Employee Disability).
  1. In addition to PEP the healthcare provider will evaluate whether the patient should receive the hepatitis B vaccination series. (CDC Immunization of Health-Care Personnel, Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR;60 (No. RR-7))

G.Treatment Follow-up of Employees Exposed to BBP

Employees with occupational exposure to BBP are required to follow-up with the City’s treatment panel provider for counseling, post-exposure testing, and medical evaluation regardless of whether they receive PEP

  1. Post-exposure Testing

a)Employees shall be periodically monitored for his/her serostatus as determined by the City’s treatment panel provider.

b)Serostatus testing can range from 6 months post-exposure up to 2 years or more.

  1. Monitoring and Management of PEP Toxicity

a)If PEP is used, drug-toxicity monitoring will be provided at baseline and again 2 weeks after starting PEP by the City’s treatment panel. Clinical judgment, based on medical conditions that may exist in the employee and any toxicity associated with drugs included in the PEP regimen, should determine the scope of testing.

b)Employees who experience side effects from PEP (e.g., nausea and diarrhea) that prevents them from performing their assigned work duties must contact their supervisor and Safety Officer for medical re-evaluation authorization at the City’s treatment panel (See City’s Medical Health Care Provider Referral Authorization and Employee Notification Form).

c)Employees who fail to complete the recommended regimen often do so because of the side effects they experience (e.g., nausea and diarrhea). These symptoms often can be managed without changing the regimen by prescribing anti-motility and anti-emetic agents or other medications that target the specific symptoms. In other situations, modifying the dose interval (i.e., administering a lower dose of drug more frequently throughout the day, as recommended by the manufacturer), may help promote adherence to the regimen.

  1. Counseling and Education

a)Initial Counseling and Education

Employees that sustain a potential BBP exposure shall be provided education and counseling by the City’s treatment panel upon initial medical evaluation.

b)Follow Up Counseling and Education

Follow up counseling, education, and treatment depends on the laboratory results obtained from the source patient. Due to confidentiality requirements and regulations, source blood laboratory results will only be communicated to the employee through the City’s treatment panel provider. Appropriate treatment, counseling, and education are determined by the provider based on laboratory results of the source blood patient.