Kathleen M. Koechlin PhD, MPH, RN Hepatitis C Coordinator Ohio Department of Health

1. Ohio Department of Health Updated Recommendations for HIV, HCV, and HBV Infected Healthcare Workers, 2006 Kathleen M. Koechlin PhD, MPH, RN Hepatitis C Coordinator Ohio Department of Health Bureau of Infectious Disease Control kathleen.koechlin@odh.ohio.gov 614-644-2714

2. A page of acronyms • ODH = Ohio Department of Health • HCW = healthcare worker • HIV = human immunodeficiency virus • HCV = hepatitis C virus • HBV = hepatitis B virus • CDC = Centers for Disease Control and Prevention • OSHA = Occupational Safety and Health Administration • EPA = Environmental Protection Agency • JCAHO = Joint Commission on Accreditation of Healthcare Organizations

3. History – Federal Mandate • Section 633 of the Treasury, Postal Service, and General Appropriations Act of 1991 mandated that all states establish recommendations for the practice of HCWs infected with a bloodborne pathogen including HIV and HBV

4. History – State Mandate • Ohio House Bill 419 passed by the 119th General Assembly in 1992 • Mandated the Director of Health to create the Task Force on the Transmission of Bloodborne Pathogens by Healthcare Professionals • Establish and keep current guidelines/ recommendations in accordance with the CDC guidelines • Required the Ohio dental, medical, and nursing boards to adopt rules establishing that Universal Blood and Body Fluid Precautions be used by all persons licensed by these boards

5. CDC Recommendations - July 12, 1991 • Based on the following considerations: • Infected HCWs who adhere to Universal Precautions and do not perform invasive procedures pose no risk for transmitting HIV or HBV to patients • Infected HCWs who adhere to Universal Precautions and who perform certain exposure-prone procedures pose a small risk for transmitting HBV to patients • HIV is transmitted much less readily than HBV • Until further data are available, precautions must be taken to prevent HIV and HBV transmission during procedures that have been linked to HCW-to-patient HBV transmission or that are considered exposure-prone

6. Background – Previous Infection Control Practice Recommendations • Universal Precautions • Appropriately disinfected and sterilized instruments and other reusable equipment • Training of HCWs on infection control • HBV vaccine for all HCWs who might be exposed to blood in an occupational setting

7. Background –Transmission of HBV During Invasive Procedures • As of 1991, published reports of 20 clusters in which a total of over 300 patients were infected with HBV in association with treatment by an HBV-infected HCW • Of HCWs whose HBeAg status was determined (17 of 20), all were HBeAg positive • Each report indicated that the potential existed for contamination of surgical wounds or traumatized tissue, either from a major break in standard infection-control practices or from unintentional injury to the infected HCW during invasive procedures

8. Background –Transmission of HIV During Invasive Procedures • Cluster of HIV infections among patients in the practice of one dentist with AIDS (5 of 850 patients evaluated through June 1991) • Two studies when patients were cared for by a general surgeon and a surgical resident who had AIDS, all patients tested HIV negative • Of 143 patients treated by an HIV+ dental student, all were HIV- • 616 patients of an HIV+ general surgeon all tested HIV- except for one who had a history of injection drug use • Further evaluation of a substantially larger number of patients whose exposure-prone procedures have been performed by HIV-infected HCWs is needed

9. Exposure-Prone Procedures • Certain oral, cardiothoracic, colorectal, and OB/GYN procedures • Characteristics of exposure-prone procedures: • Digital palpation of a needle tip in a body cavity • 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

10. CDC Recommendations • All HCWs should adhere to Universal Precautions • No basis for recommendations to restrict the practice of HCWs infected with HIV or HBV who perform invasive procedures not identified as exposure-prone, provided they practice the recommended surgical or dental technique and comply with Universal Precautions and current recommendations for sterilization/ disinfection

11. CDC Recommendations, continued • Exposure-prone procedures should be identified by medical/surgical/dental organizations and institutions at which the procedures are performed • HCWs who perform exposure-prone procedures should know their HIV antibody status • HCWs who perform exposure-prone procedures and do not have serologic evidence of immunity to HBV from vaccination or previous infection should know their HBsAg status and, if positive, should know their HBeAg status

12. CDC Recommendations, continued • HCWs who are infected with HIV or HBV (and are HBeAg+) should not perform exposure-prone procedures unless they have sought counsel from an expert review panel and been advised under what circumstances, if any, they may continue to perform these procedures • Mandatory testing of HCWs for HIV, HBsAg, or HBeAg is not recommended

13. HCWs whose practices are modified because of HIV or HBV status…. • should, whenever possible, be provided opportunities to continue appropriate patient-care activities • should be given career counseling and ways to retain a job so that the continued use of the HCW’s talents, knowledge and skills can be maintained

14. HCWs whose practices are modified because of HBV status…. • Should be re-evaluated periodically to determine whether their HBeAg status changes

15. Notification of Patients • The public health benefit of notification of patients who have had exposure-prone procedures performed by HCWs infected with HIV or positive for HBeAg should be considered on a case-by-case basis, taking into consideration: • Specific risks • Confidentiality issues • Available resources

16. Additional Needs • Clearer definition of the nature, frequency, and circumstances of blood contact between patients and HCWs during invasive procedures • Development and evaluation of new devices, protective barriers, and techniques that may prevent such blood contact without adversely affecting the quality of patient care • More information on the potential for HIV and HBV transmission through contaminated instruments • Improvements in sterilization and disinfection techniques for certain reusable equipment and devices • Identification of factors that may influence the likelihood of HIV or HBV transmission after exposure to HIV or HBV infected blood

17. Ohio Department of Health Updated Recommendations for HIV, HCV, and HBV Infected Healthcare Workers, 2006 • In the early 1990s the original document (created in response to the federal and state mandates) developed recommendations for HCWs infected with HIV and HBV • Developed by a committee of Ohio’s medical and public health communities in conjunction with the ODH • Ohio State Medical Board • Ohio Board of Nursing • Ohio State Dental Board • Ohio Hospital Association • Ohio Dental Association • Ohio Osteopathic Association • Ohio State Medical Association • Ohio Nurses Association • Association of Ohio Health Commissioners • Physicians with expertise in HIV

18. Ohio Department of Health Updated Recommendations for HIV, HCV, and HBV Infected Healthcare Workers, 2006 • In 2004-2005, the ODH reviewed those recommendations given current science and a new understanding of HCV and its significance • The revision process solicited comments from: • Ohio State Medical Board • Ohio Board of Nursing • Ohio State Dental Board • Ohio Hospital Association • Ohio Dental Association • Ohio Osteopathic Association • Ohio State Medical Association • Ohio Nurses Association • Association of Ohio Health Commissioners • Infectious Diseases Society of Ohio

19. Principles Guiding Policy Development • Universal and/or Standard Precautions are the most effective means of preventing transmission of any bloodborne pathogen both to and from HCWs • Medical practices, including Universal or Standard Precautions and improved engineering controls, decrease the risk of bloodborne pathogen transmission • Mandatory HIV screening of all HCWs in Ohio is inappropriate • Risk of HCV transmission from an infected HCW to patients appears to be very low • There is some evidence that transmissibility of these viruses is reflected in certain biochemical markers (e.g., HBeAg, HIV-RNA viral load)

20. Ohio’s Policy Recommendations • CDC’s guidelines and OSHA’s Bloodborne Pathogen Standard are the basis • Universal Precautions and Standard Precautions • Infection Control • Training and Education • Hepatitis B Vaccination • Counseling and Testing • Infected HCWs • Review Panels

21. Universal Precautions and Standard Precautions • All HCWs must strictly adhere to the Universal Precautions set forth by the OSHA • All HCWs must follow CDC guidelines for Standard Precautions • Ohio medical, dental, and nursing boards have mandated the use of Universal Precautions for license holders who perform exposure-prone procedures • Employers must keep records of training, observe practices, and ensure compliance with Universal and/or Standard Precautions

22. Infection Control • All HCWs must strictly adhere to appropriate infection control procedures (guidelines set forth by the CDC and regulations of the EPA and OSHA) • HCWs who have exudative lesions or weeping dermatitis should refrain from all direct patient care and from handling patient care equipment and devices used in performing invasive procedures until the condition resolves

23. Training and Education • Proper infection control techniques • Comply with CDC guidelines concerning barrier techniques, Standard Precautions, and recommendations for ongoing training • OSHA requires training by employers for persons with occupational exposure to potentially infectious substances • Training should be required in professional and vocational schools • Training is recommended as part of continuing professional education programming • Training is encouraged to be performed in accordance with the OSHA and the JCAHO requirements but should include HCWs outside these employer domains

24. Hepatitis B Vaccination • HCWs susceptible to HBV infection and with the potential of coming into contact with blood or other potentially infectious materials while working should receive vaccination against HBV

25. Counseling and Testing • Mandatory testing of all HCWs for HIV, HCV, or HBV is NOT recommended • Testing should NOT be a condition of employment, licensure or certification • HCWs who perform exposure-prone invasive procedures should know their HIV, HCV and HBV status • HCWs should be acutely aware of incidents that pose a risk of acquiring a bloodborne pathogen during work duties and should immediately report any percutaneous or mucous membrane exposure to the blood or other potentially infectious material of a patient • All HIV, HCV and HBV test results are protected by medical confidentiality standards and should only be released to individuals who have a legitimate need to know

26. Infected HCWs • Infected HCWs who adhere to Universal and Standard Precautions and do not perform invasive procedures pose no risk for transmission of a bloodborne infection to a patient • Infected HCWs who adhere to Universal and Standard Precautions and do perform invasive procedures pose a small risk for transmission to a patient • HCWs who are infected with a bloodborne pathogen have an obligation to seek advice from their personal physician in evaluating their specific medical conditions, and to examine the possible need for assistance from a review panel • HCWs or their personal physician(s) should contact the appropriate review panel for advice and consultation regarding a HCW’s evaluation

27. Review Panels • Institutional Review Panels • Non-institutional review panel convened by the Director of the ODH

28. Institutional Review Panels – Composition (at a minimum) • An infectious disease physician or an advanced practice nurse in infectious diseases • A HCW who holds the same license and performs the same procedures as the infected HCW • An infection control specialist who has expertise in Standard Precautions and OSHA requirements • An occupational health/employee health expert from the facility where the HCW practices • The local health commissioner or designee • An attorney • An individual with expertise in legislative mandates impacting workplace obligations toward infected HCWs

29. Institutional Review Panels – Composition, continued • The HCW’s personal physician should be consulted by the panel, after appropriate authorization, about the HCW’s current functional status • All institutional review panels should include at least two individuals who are from outside the institution

30. Institutional Review Panels – other requirements: • All institutional panels making recommendations regarding HIV, HCV or HBV positive HCWs must receive approval from the Director of Health before the panel acts as the review panel • Institutions should have an employee testing policy consistent with CDC and ODH recommendations and not in violation of state or federal law

31. Institutional Review Panels – other requirements: • Any institutional panel must report to the Director of Health the status of compliance with panel recommendations by a HCW receiving guidance from the panel • The HCW shall be identified by an assigned case number for purposes of reporting to the Director of Health • The HCW’s name will only be associated with the case number if any action by a licensing board must be taken • The Director of Health will receive a timetable for the re-evaluation, progress and compliance of each HCW under the review of an institutional panel

32. Non-institutional Review Panels – Composition (at a minimum) • Members will be selected by the Director of Health on a case-by-case basis to ensure familiarity with the specific professional duties of the HCW • The composition of this panel must be equivalent to the composition of the institutional panel with the following exceptions: • The state epidemiologist or designee must be included • The occupational health specialist will be designated by the Director of Health if this panel relates to non-institutional workers and a non-institutional panel is convened

33. Review Panel Duties • Evaluate the HCW’s medical condition and ability to perform specific job duties • Make recommendations to the Director of Health concerning the circumstances under which the HCW may perform exposure-prone procedures • Recommendations shall be based on the HCW’s impairment and shall consider his or her likelihood of performing exposure-prone procedures

34. Institutional Panel Duties • Evaluate the HCW’s medical condition and ability to perform specific occupational duties • Monitor compliance with Universal Precautions, Standard Precautions and appropriate infection control techniques • Provide guidance and education to assist the infected HCW in achieving strict adherence to established standards • Modification of practice recommendations when appropriate

35. Institutional Panel Duties, continued • Render a decision regarding the HCW’s ability to perform occupational duties • Include a report of recommendations to be reviewed with and followed by the HCW • Copy of the report is filed with the Director of Health • If HCW accepts recommendations, the panel will establish a schedule to review the case and to re-evaluate the HCW’s adherence to recommendations and ability to continue specific occupational duties • Copies of re-evaluations filed with Director of Health • Should the HCW become non-compliant with the panel recommendations or become unfit for duty, the panel shall file a report with the Director of Health who will notify the appropriate licensing board

36. Non-institutional Panel Duties • Evaluate the HCW’s medical condition and ability to perform specific occupational duties • Monitor compliance with Universal Precautions, Standard Precautions and appropriate infection control techniques • Provide guidance and education to assist the infected HCW in achieving strict adherence to established standards • Modification of practice recommendations when appropriate

37. Non-institutional Panel Duties, continued • A decision regarding the HCW’s ability to perform occupational duties will be filed with the Director of Health • The panel will establish a schedule for periodic re-evaluation of the HCW • Copies of the re-evaluation reports will be filed with the Director of Health • Should the HCW become non-compliant with the panel recommendations or become unfit for duty, the panel shall file a report with the Director of Health who will notify the appropriate licensing board

38. Confidentiality • All information obtained by a review panel regarding HIV, HCV or HBV infected HCWs shall be held in confidence in accordance with all applicable federal and state laws • Members of the review panel must sign a statement of confidentiality regarding the information they receive as a member of a review panel

39. Enforcement • Noncompliance shall be reported immediately to the Director of Health and further action will be taken as necessary

40. Enforcement, continued • Upon completing review of all relevant information • The panel prepares a preliminary report of its findings and recommendations • A copy of this report is forwarded to the HCW • No later than 60 days after providing the copy to the HCW, the panel convenes informally to review the report with the HCW

41. Enforcement, continued • At the informal review: • The HCW may appear in person, with, or by such other representative as the HCW feels is appropriate • The HCW may, in advance of or at the informal review, present additional relevant information and his or her positions, arguments, or contentions in writing or verbally • The panel may adopt, reverse, or modify the preliminary report and notify the HCW within 30 days of the informal review in the panel’s final report and recommendation

42. Enforcement, continued • After the panel’s final report: • The HCW may, within 30 days, request the Director of Health review the panel’s final report and recommendations • The HCW may include written objections to the panel’s final report and recommendations along with the request for the Director’s review • The Director of Health may request such additional information the Director feels is appropriate to conduct the requested review • The Director shall affirm, reverse, or modify the panel’s final report and recommendations • The decision of the Director to affirm, reverse, or modify the panel’s report and recommendations is final and not subject to appeal

43. Articles of Interest • Harpaz R, Von Seidlein L, Averhoff FM, et al. Transmission of hepatitis B virus to multiple patients from a surgeon without evidence of inadequate infection control. N Engl J Med 1996;334:549-54. • AIDS/TB Committee of the Society for Healthcare Epidemiology of America. Management of healthcare workers infected with hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or other bloodborne pathogens. Infect Control Hosp Epidemiol 1997;18:349-63.

44. Articles of Interest • Reitsma AM, Closen ML, Cunningham M, et al. Infected physicians and invasive procedures: Safe practice management. Clinical Infectious Diseases 2005;40:1665-72. • Perry JL, Pearson RD, Jagger J. Infected health care workers and patient safety: A double standard. Am J Infect Control 2006;34:313-9.

45. References • Recommendations for Preventing Transmission of Human Immunodeficiency Virus and Hepatitis B Virus to Patients During Exposure-Prone Invasive Procedures. MMWR 40(RR08); 1-9. http://www.cdc.gov/mmwr/preview/mmwrhtml/00014845.htm • Ohio Department of Health Updated Recommendations for HIV, HCV, and HBV Infected Healthcare Workers, 2006. http://www.odh.ohio.gov/alerts/alerts.aspx