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Bloodborne Pathogens and OPIM Principles Allen Yee, FACEP

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Bloodborne Pathogens and OPIM Principles

Allen Yee, FACEP

Objectives

Review OSHA and Federal regulationsReview Code of Virginia Review transmission ratesReview nuances of human bitesReview administrative issues that

physicians may face

As mandated by the Needlestick Safety and Prevention Act, OSHA revised the Bloodborne Pathogens Standard (29 CFR 1910.1030), effective April 18, 2001. Definitions for bloodborne pathogens, other potentially infectious materials (OPIM), and occupational exposure are found in 29 CFR 1910.1030(b).

29 CFR 1910.1030

What is a bloodborne pathogen? Bloodborne Pathogens means pathogenic

microorganisms that are present in human blood and can cause disease in humans. These pathogens include, but are not limited to, hepatitis B virus (HBV) and human immunodeficiency virus (HIV).

29 CFR 1910.1030 What is OPIM (Other Potentially Infectious

Material)? The following human body fluids: semen, vaginal

secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids

Any unfixed tissue or organ (other than intact skin) from a human (living or dead)

HIV-containing cell or tissue cultures, organ cultures, and HIV- or HBV-containing culture medium or other solutions

Blood, organs, or other tissues from experimental animals infected with HIV or HBV.

29 CFR 1910.1030

What is an exposure incident? Exposure Incident means a specific eye,

mouth, other mucous membrane, non-intact skin, or parenteral contact with blood or other potentially infectious materials that results from the performance of an employee's duties.

Ryan White CARE Act

Originally for HIV April 1994

Repealed in 2006Reinstated 2009

Ryan White Covered Diseases

HIVHep BHep C

Other Covered Diseases Measles TB Chicken Pox Avian Influenza Diptheria Meningitis Mumps Plague SARS VHF Rubella

Bloodborne Exposures Public Safety employee should report the

exposure to their agency’s designated infection control officer (DICO)

The DICO should investigate and determine if there was an exposure. If incident was deemed and exposure, the DICO should request the hospital to perform appropriate testing as outlined in state law and Ryan White Act

The results are given back to the exposed individual and the DICO “As soon as possible” but no later than 48 hours

Current guidelines of the Centers for Disease Control and Prevention Most current CDC recommendations

Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HIV and Recommendations for Postexposure Prophylaxis –Sept 2005

Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis – June 2001

Bloodborne Exposures and HIPAA

It is not a HIPAA violation for the exposed patient to receive the information on the source employee

It is not a HIPAA violation for the employee and his/her employer to receive the information on the source patient

Bloodborne Pathogens Contaminated needle sticks (blood) Gross blood Blood and other potentially infections materials

(OPIM) CSF Synovial fluid Amniotic fluid Peritoneal fluid Pleural fluid Any fluid with visible blood

Bloodborne Pathogens

No risk fluids (assuming no visible blood is present) Tears Sweat Saliva Urine Stool Vomit Sputum

Risks of HIV Transmission The average risk for HIV transmission after a

percutaneous exposure to HIV-infected blood has been estimated to be approximately 0.3%

The average risk for HIV transmission after a mucous membrane exposure is approximately 0.09%

Although episodes of HIV transmission after nonintact skin exposure have been documented, the average risk for transmission by this route has not been precisely quantified but is estimated to be less than the risk for mucous membrane exposures.

The risk for transmission after exposure to fluids or tissues other than HIV-infected blood also has not been quantified but is probably considerably lower than for blood exposures.

Risks of HIV Transmission

The CDC documented 55 cases and 136 possible cases of occupational HIV transmission to US healthcare workers between 1985 and 1999

Risks of Hep B Transmission Hepatitis is much more transmissible than HIV. Risk of infection from a single needlestick is 6%-30%.

The risk of HBV infection is primarily related to the degree of contact with blood and also to the hepatitis B e antigen (HBeAg) status of the source person. In studies of HCP who sustained injuries from needles contaminated with blood containing HBV, the risk of developing clinical hepatitis if the blood was both hepatitis B surface antigen (HBsAg) and HBeAg-positive was 22%--31%; the risk of developing serologic evidence of HBV infection was 37%--62%. By comparison, the risk of developing clinical hepatitis from a needle contaminated with HBsAg-positive, HBeAg-negative blood was 1%--6%, and the risk of developing serologic evidence of HBV infection, 23%--37%

Risks of Hep B Transmission

50% of the people with HBV infection are unaware that they have the virus.

The CDC states that HBV can survive for at least one week in dried blood on environmental surfaces or contaminated needles and instruments.

Risks of Hep C Transmission Risk of HCV infection after needlestick is 1.8% HCV is not transmitted efficiently through

occupational exposures to blood. One study indicated that transmission occurred only from hollow-bore needles compared with other sharps.

Transmission rarely occurs from mucous membrane exposures to blood, and no transmission in HCP has been documented from intact or nonintact skin exposures to blood

HIV Post Exposure Testing

HIV Whole blood rapid HIV test Availability of quick test results on the source

patient in an exposure situation may prevent the unnecessary administration of chemoprophylaxis to the health care worker

• CDC, May 1998, 2005 If source patient is negative, no further testing

of the exposed health care is needed

HIV Post Exposure Testing

HIV OSHA has stated in a letter dated July 21,

2006• “an employer failure to use rapid HIV testing when

testing is required by paragraph (f)(3)(ii)(A) would usually be considered a violation of that provision”

Hep B Post Exposure Testing

Hep B HBV surface antigen of source patient No employee testing

For further source patient ordering, contact your employee health vendor

Hep C Post Exposure Testing

Hep C Rapid Hep C tests (for anti-HCV) For further source patient ordering, contact

your employee health vendor

Human Bites

If a patient bites an employee and breaks the skin, it is the patient who is exposed to bloodborne pathogens! If the employee was bit during a dental procedure,

both the patient and the employee must be tested and results shared accordingly

• Guidelines for Infection Control in Dental Health-Care Settings – CDC – December 2003

Human Bites

If a patient bites an employee and breaks the skin of the employee and there was visible blood in the patient’s mouth prior to the incident, there is exposure of bloodborne pathogens to the employee Exposures are to both patient and employee Both must be tested and results shared

Human Bites

If a patient bites an employee and breaks the skin of the employee and there was no visible blood in the patient’s mouth, there is no exposure of bloodborne pathogens to the employee The risk of transmission is extremely low There is no deemed consent to test the patient and

no protections under the law to do so We can ask the patient for permission to test and

share test results

Human Bites

If a patient bites an employee and does not break the skin, there is no exposure to bloodborne pathogens! The risk of transmission is extremely low There is no deemed consent to test and no

protections under the law to do so

Bloodborne Exposures

It is not a HIPAA violation for the DICO to received the information on the source patient

Administrative Issues

Exposure Control plan Must be available/accessible to all employees

• Available on intranet

Administrative Issues

Exposure Control Plan “Remains current with the latest information

and scientific knowledge pertaining to bloodborne pathogens”

• (1)(iv), CPL 2-2.69 OSHA CDC Morbidity and Mortality OSHA press releases

Administrative Issues

Are volunteers “employees”? No definitive answer from OSHA Depends on “compenstion”

• Stipend• Tax breaks• Retirement• Non monetary compensation

Administrative Issues

Files needed Individual employee files Monthly reports Compliance monitor/updates OSHA 300 Log/sharps log Training records

Administrative Issues

Employee Medical record Health history form Hep B vaccination record TB testing Consent/denial forms Exposure report forms

Administrative Issues

OSHA requires training for New hires Employees with potential for exposures

Annual retraining is required

Administrative Issues

Exposure Control plan Must be developed

Administrative Issues Elements in Exposure Control Plan

Criteria to determine what is an exposure Implementation schedule Training Hep B program Injury reduction/work practice controls Cleaning/disinfection Waste disposal Post exposure management Record keeping Compliance monitoring

Administrative Issues

Exposure Control Plan Readily available at worksite Must be able to produce copy within 15 days

if requested Must be reviewed annually Reviewed when new procedures, tasks, or

changes in practice occur (i.e N95, SARS)

Administrative Issues

Hepatitis B Vaccine No cost to employee Made available at reasonable time and place Provided as per CDC guidlines

Administrative Issues

Hep B vaccinations To be administered within 10 days of

assignment to a at risk position Series

• Initial dose• Second dose 4 weeks later• Third dose 6 months after the first

Interruption of the series does not require starting over a new series

• CDC 1992

Administrative Issues

Hep B vaccinations Post vaccination titers

• Should be considered for persons at risk for occupational exposure

Should be done between 1 and 2 months following completion of vaccine series

Once a positive titer has been established, there is no need to re-titer

If no response, repeat 3 dose series and re-titer If still no response, no further doses and advise

employee of status

Administrative Issues

Training on bloodborne pathogens Based on frequency

• Epidemiology• Mode of transmission• Symptoms

How to recognize potential for exposures Exposure control plan compenents and

location

Administrative Issues

Additional Training Work restriction guidelines HIV post exposure Issues Hand hygiene

• No artificial nails or extentions

Administrative Issues

Engineering/work practice controls Used to minimize or eliminate exposure

• Sharp risk assessments• Needle safe systems

Must be evaluated on a regular basis

Administrative Issues

Needle Safe Devices Needle stick safety and prevention act

• P/L. 106-430 IV catheters Lancets Syringes Vaccutainers

Administrative Issues

PPE Employer must provide to all employees who

face occupational exposure and ensure employee use

Must be readily accessible and in appropriate sizes

Administrative Issues

Latex allergies Need to provide PPE

Administrative Issues

Cleaning and disinfection All equipment and working areas must be

cleaned and decontaminated after contact with blood or OPIM

Cleaning routines and schedule Product specifics Cleaning of EMS equipment left at healthcare

facility• Responsibility of the facility or the equipment must

be bagged for transport

Administrative Issues

Waste handing Contaminated sharps must be placed in

appropriate sharps container immediately or as soon as it is feasible

Blood or OPIM• Red bag

Administrative Issues - Records

Medical Records (1910.130) Name and social security number Hep B vaccination records Source patient blood tests if available Post exposure examinations, testing, and

follow up Other relevant records

• Vaccinations

Administrative Issues - Records

Medical records Confidentiality Duration of employment plus 30 years

Administrative Issues - Records

Medical Records When copy is requested, employer must

• Provide copy at no cost• Allow employee to copy

Administrative Issues - Records

Sharps Injury Logs Employee name Device used

Location of incident How exposure occurred

Administrative Issues

TB risk assessment Based on number of TB patients encountered

• Untreated• Meds on 2 days about 10% non communicative• Meds on 14 days essentially non communicative

Administrative Issues

TB risk assessment Low risk

• Three or less TB patients per year Medium risk

• More than 3 TB patients per year

Administrative Issues

TB risk assessment Low risk TB testing

• On hire• Post exposure

Medium risk TB testing• On hire• Annual• Post exposure

Administrative Issues

Fit testing Initial and annual fit testing Change in facial features

Administrative Issues

Other Vaccinations TDAP Annual influenza

• Declination forms should be signed ? Hep C ? MMR

Administrative Issues

Immunization Recommendation for disaster workers Tetanus Hep B No indications for

• Hep A• Typhoid• Cholera• Meningococcal• Rabies