2015 - Exposure Prevention and Post Exposure Management Exposure Prevention, Postexposure Management and Recordkeeping Kathy Eklund, RDH MHP The Forsyth Institute
Disclosure Kathy Eklund is an employee of the Forsyth Institute, a member of the Board of Directors of OSAP, and an author of the Interact Training System. Other than her work with the Interact Training System, Ms. Eklund, nor any member of her immediate family have any commercial interests relevant to this presentation. Visuals of products and devices are not an endorsement.
Today s Agenda Exposure Risk Determination, Postexposure Management, Workrelated Injury & Illness Record-Keeping After attending this session, the participant will be able to: 1.Describe strategies and tools to prevent occupational exposure incidents. 2. Explain the processes of postexposure management to reduce the risk of bloodborne disease transmission. 3. Identify the relevant OSHA regulations and CDC guidance documents to develop and implement a site-specific postexposure management program.
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Exposure Determination Who has occupational exposure to blood and other potentially infectious materials (OPIM)?
OSHA Regulations BBP Standard Each employer who has an employee(s) with occupational exposure as defined by paragraph (b) of this section shall prepare an exposure determination. This exposure determination shall contain the following: Job classifications with occupational exposure to Blood and OPIM A list of all tasks and procedures or groups of closely related task and procedures in which occupational exposure occurs and that are performed by employees in job classifications listed in accordance with the provisions of paragraph (c)(2)(i)(b) of this standard. The Bloodborne Pathogens Standard (29 CFR 1910.1030) https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_ta ble=standards&p_id=10051
Bloodborne : Exposure Prevention and Management
CDC Recommendations for Hepatitis B Protection among HCP (2013) www.cdc.gov/mmwr/preview/mmwrhtml/rr6210a1.htm?s_cid=rr6210a1_w 8
Post-Exposure Serologic Assessment Because vaccine-induced anti-hbs wanes over time, testing HCP for anti-hbs years after vaccination might not distinguish vaccine nonresponders from responders. NEW Giudance: Pre-exposure assessment of current or past anti-hbs results upon hire or matriculation, followed by one or more additional doses of HepB vaccine for HCP with anti-hbs <10 miu/ml, if necessary, helps to ensure that HCP will be protected if they have an exposure to HBV-containing blood or body fluids. CDC Guidance for Evaluating Health-Care Personnel for Hepatitis B Virus Protection and for Administering Postexposure Management Recommendations and Reports December 20, 2013 / 62(rr10);1-19 http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6210a1.ht m?s_cid=rr6210a1_w
OSHA: Hepatitis B Vaccine 29 CFR 1910.1030(f)(1)(ii)(D) takes into consideration the changing nature of medical treatment relating to hepatitis B. OSHA requires use of the U.S. Public Health Service (USPHS) guidelines current at the time of the evaluation or procedure. The hepatitis B vaccination must be given in the standard dose and through the standard route of administration, as recommended in the most current USPHS guidelines.
Types of Occupational Exposures to Blood Percutaneous injury Mucous membrane exposure Non-intact (broken) skin exposure Bites
Evaluate Alternative Practices and Devices
Engineered Safety Sharps
Sharps Safety Devices OSHA requires employer to consider procedures and technology that reduce the risk of needlesticks Must document consideration and use of appropriate, and effective safer devices Description of devices identified as candidates Method(s) used to evaluate those devices Justification for the eventual selection (or rejection) Cannot use cost as a justification for non-selection of a safer device Non-managerial employee input must be documented but can be informal in nature
Traditional Scalpel with Blade
Blade remover
Modify Unsafe Behavior : Use a Device with an Engineered Safety Feature
Dental Safety Needles and Syringes
Needle recapping options Local Anesthesia for Dental Professionals, Bassett et al, 2010
Removal of the capped needle from the syringe Risks When a capped needle is removed from the syringe by hand, the cap can come off and a percutaneous injury/ exposure incident can occur.
Behaviors and Risks of Needle Stick
One-handed needle disposal method using the CARD Local Anesthesia for Dental Professionals, Bassett et al, 2010
Removing the Capped Needle from a Reusable Syringe
Postexposure Management
OSHA DEFINITION Exposure Incident means a specific eye, mouth, other mucous membrane, nonintact skin, or parenteral contact with blood or other potentially infectious materials that results from the performance of an employee's duties.
Postexposure Management Program Develop clear policies and procedures that reflect Employer Obligations un OSHA BBP Standard Current CDC Guidance Other Considerations (temporary workers, volunteers, etc.) Educate dental health care personnel (DHCP) Education and training strategies Provide rapid response following an exposure incident: Facilitate appropriate exposure response/first aid, Complete initial exposure report Refer DHCP to qualified HCP (risk assessment, baseline testing, and post-exposure prophylaxis) Document source patient and request testing for HIV, HBV, and HCV, unless +sero-status known
Exposure Incident Management Percutaneous Expousre Incident Remove instrument or syringe/needle Report Injury to designated on-site manager Provide exposure response first aid Complete initial report Refer exposed DHCP to qualified HCP Request source patient testing Post-exposure site specific evaluation Obtain written report from HCP
Do not reuse instrument or device on patient If exposure occurs with sterile item, it must be re-sterilized If accidental reuse occurs, inform patient and evaluating health care provider (occupational health physician or nurse) Remove Instrument/Needle
Provide Exposure Response First Aid Wound management for percutaneous exposures Eyewash for blood exposures to the eyes
Wound Care Dos and Don ts
Wash the Wound Do Wash Wound with Soap and Water Do Not
Do Not Do not squeeze or milk wound. Do not apply a tourniquet
Flush Mucous Membranes of the Eyes
Eye Wash Use and Maintenance
Elements of the Exposure Report Date and time of exposure Procedure details: where, when, how, with what device Exposure details: route, body substance involved, volume and duration of contact Information about source patient Exposure management details
http://www.cdc.gov/mmwr/preview/mmwrht ml/rr5011a1.htm 2001
Request Source Patient Testing Documentation of the source patient Where should this be documented? What information, if source is infected? What tests? (HIV, HBV, HCV) Who should do the testing? Who pays? Informed consent and patients rights What are the state specific statutes and regulations?
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5011a1.htm 2001
Refer Exposed DHCP to Qualified HCP HCP should be selected in advance of an exposure Qualified to do post-exposure management and medical follow-up Open and available during dental practice hours Familiar with dentistry and types of exposure
Risk of Infection after Needlestick Source HBV HBeAg+ HBeAg- Risk 6.0-30.0% 22.0-30.0% 1.0-6.0% 1/3 HCV HIV 1.8% 0.3% 1/30 1/300
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5011a1.htm
CDC Recommendations for Hepatitis B Protection among HCP (2013) www.cdc.gov/mmwr/preview/mmwrhtml/rr6210a1.htm?s_cid=rr6210a1_w 46
Recommended Postexposure Management: PEP for Exposure to HBV Exposed person Treatment Vaccinated Documented responder Documented Nonresponder 1 series/3 doses Documented Nonresponder 2 series/6 doses Unvaccinated/incompletely vaccinated or vaccine refusers No action needed HBIG x 1 and initiate revaccination, positive/unknown source no action if the source patient is negative for HBsAg HBIG x 2, separated by 1 month, positive/unknown source. No action if the source patient is negative for HBsAg HBIG x 1 and initiate revaccination, no HBIC if source patient is HBsAg negative
Management of Exposures to Hepatitis C Virus (HCV) For source patient, testing for antibodies to HCV Rapid HCV antibody test may be available. For exposed person, baseline and followup testing for anti-hcv and liver enzyme activity Immunoglobulin prophylaxis is not effective nor recommended. New HCV treatment drugs, used for acute HCV infection, are currently not recommended for HCV post-exposure prophylaxis.
No Recommended HCV Prophylaxis Preexposure or postexposure prophylaxis with antiviral therapy is NOT recommended. Although new antiviral treatment regimens are highly efficacious and more tolerable than IFNbased therapy, there are no data on the efficacy or cost-effectiveness of antiviral therapy for pre-exposure or post-exposure prophylaxis of HCV infection. Some studies have shown that post-exposure treatment with IFN-based regimens does not prevent infection. (Nakano, 1995 [17]); (Arai, 1996 [18])
Postexposure Management: Follow-up of Hepatitis C Virus (HCV) Exposed HCP Test for anti-hcv and amino alanine transferase (ALT) 4-6 months after exposure. Test for HCV- ribonucleic acid (RNA) at 4-6 weeks for earlier diagnosis of HCV infection. Confirm anti-hcv enzyme immunoassay (EIA) positive results with recombinant immunoblot assay (RIBA). Guidelines for therapy during acute HCV are to refer to a specialist for proper management. Select an HCP who follows current HCV postexposure recommendations.
Interpretation of Blood Testing During Diagnosis of Acute HCV Infection Test Interpretation for Diagnosis of Acute HCV Infection HCV antibody [test baseline, 4-6 weeks and 4-6 months after the exposure] HCV Ribonucleic Acid( RNA) [test 4-6 weeks after the exposure] May be negative in the first 6 weeks after exposure May be delayed or absent when the individual is immunosuppressed Presence alone does not distinguish between acute and chronic infection Low signal-to-cutoff ratio may be present during acute HCV infection or represent a false-positive result Viral fluctuations greater than 1 log10 IU/mL may indicate acute HCV infection May be transiently negative during acute HCV infection Alone does not distinguish between acute and chronic infection Alanine aminotransferase (ALT) [test 4-6 months after the exposure] Fluctuating peaks during acute HCV infection suggest acute infection May be normal during acute HCV infection May be elevated due to other liver insults such as alcohol consumption AASLD and IDSA; http://www.hcvguidelines.org/fullreport/management-acute-hcv-infection
HIV Postexposure Prophylaxis Updated US Public Health Service Guidelines for the Management of Occupational Exposures to Human Immunodeficiency Virus and Recommendations for Postexposure Prophylaxis David T. Kuhar, MD; David K. Henderson, MD; Kimberly A. Struble, PharmD; Walid Heneine, PhD; Vasavi Thomas, RPh, MPH; Laura W. Cheever, MD, ScM; Ahmed Gomaa, MD, ScD, MSPH; Adelisa L. Panlilio, MD and for the US Public Health Service Working Group Infection Control and Hospital Epidemiology, Vol. 34, No. 9 (September 2013), pp. 875-892 Published by: The University of Chicago Press on behalf of The Society for Healthcare Epidemiology of America Article DOI: 10.1086/672271 Article Stable URL: http://www.jstor.org/stable/10.1086/67227 52
HIV PEP Recommendations (1) PEP is recommended when occupational exposures to HIV occur; (2) the HIV status of the exposure source patient should be determined, if possible, to guide need for HIV PEP; (3) PEP medication regimens should be started as soon as possible after occupational exposure to HIV, and they should be continued for a 4-week duration; (4) new recommendation-pep medication regimens should contain 3 (or more) antiretroviral drugs (listed in Appendix A ) for all occupational exposures to HIV;
HIV PEP Recommendations (5) expert consultation is recommended for any occupational exposures to HIV and at a minimum for situations described in Box 1 ; (6) close follow-up for exposed personnel ( Box 2 ) should be provided that includes counseling, baseline and follow-up HIV testing, and monitoring for drug toxicity; follow-up appointments should begin within 72 hours of an HIV exposure; and (7) new recommendation-if a newer fourth-generation combination HIV p24 antigen-hiv antibody test is utilized for follow-up HIV testing of exposed HCP, HIV testing may be concluded 4 months after exposure ( Box 2 ); if a newer testing platform is not available, follow-up HIV testing is typically concluded 6 months after an HIV exposure.
PEPline National Clinicians Post-Exposure Prophylaxis Hotline (PEPline) Free consultation for clinicians treating occupational exposures to HIV and other bloodborne pathogens 24 hours a day 7 days a week 1-888-HIV-4911 http://pepline.ucsf.edu/peplin e a joint program of UCSF/SFGH CPAT / EPI Center supported by HRSA and CDC
Postexposure Management Takeaway Select a designated HCP who follows current CDC recommendations for post-exposure management. Because of the rapidly changing field of HIV, HCV and HBV care, this information could become out of date quickly.
Obtain Written Report from HCP Scope of report information File in the DHCP s confidential health record Who has legal access?
Recordkeeping Requirements Recordkeeping Requirements OSHA Injury and Illness Recordkeeping and Reporting Requirements Web Page. https://www.osha.gov/recordkeeping/index.html 1904.39 Recording and Reporting Occupational Injuries and Illness https://www.osha.gov/pls/oshaweb/owadis p.show_document?p_table=standards &p_id=12783
Who is not required to use the OSHA injury and illness recordkeeping forms to document exposure incidents? Audience Participation A.Small employers 10 or fewer employees at all times during the year? B.Dental and medical offices C.Both A and B D.There are no exemptions for sharps injury recordkeeping for healthcare employers
Who has to complete the OSHA injury and illness recordkeeping forms? Many, but not all employers. Exceptions are based on: Small employer exemption 10 or fewer employees at all times during the year Low-hazard industry exemption see list of Partially Exempt Industries (PDF) Fatality and other serious event reporting as well as injury and illness surveys involve other considerations. 2 3
Exemptions Dental Offices (NAICS #6212 Offices of Dentist) Employers are not required to keep OSHA injury and illness records for any establishment classified in the following North American Industry Classification System (NAICS), unless they are asked in writing to do so by OSHA, the Bureau of Labor Statistics (BLS), or a state agency operating under the authority of OSHA or the BLS. All employers, including those partially exempted by reason of company size or industry classification, must report to OSHA any workplace incident that results in a fatality, in-patient hospitalization, amputation, or loss of an eye
What are the severity criteria for recording a work-related injury or illness? Death Loss of consciousness Days away from work Restricted work activity or job transfer Medical treatment beyond first aid 7 8
What forms must be completed? OSHA Form 300 Log of Work-Related Injuries and Illnesses OSHA Form 301 Injury and Illness Incident Report OSHA Form 300A Summary of Work- Related Injuries and Illnesses 3 4
OSHA Form 300: Recording a Case with Medical Treatment beyond First Aid (For a list of specific treatments considered to be first aid, see section 1904.7(b)(5) [PDF].) 11 12
Other Recording Criteria Significant diagnosed injury or illness Needlestick and sharps injuries section 1904.8 (PDF) Medical removal section 1904.9 (PDF) Hearing loss section 1904.10 (PDF) Tuberculosis section 1904.11 (PDF) It s important and required. 12 13
OSHA Form 301: Injury and Illness Incident Report 13 14
OSHA Form 300A: Summary of Work-Related Injuries and Illnesses It s easy and beneficial. 14 15
OSHA Form 300A: Summary of Work-Related Injuries and Illnesses (continued) 15 16
Keep the Forms on File Do not send copies to OSHA unless asked to do so Allow access to the records File and update for 5 years (For details on access provisions, see section 1904.35 [PDF] and 1904.40 [PDF].) It s important and required. 16 17
OSHA Resources Recordkeeping web page (https://www.osha.gov/recordkeeping) Q&A Search web page (https://www.osha.gov/recordkeeping/faq_search/index.html) Local OSHA Offices https://www.osha.gov/html/ramap.html) E-correspondence/Contact us (https://www.osha.gov/html/feed_back.html) 17 18
Postexpousre Site Specific Follow-Up Review all documentation for completeness Assess the circumstances of the incident Determine if there is a need to: modify policies, procedures, devices, etc. provide further education and training other