OSHA’s Bloodborne Pathogens Standard Bonnie DiSalvo, MS ASHM USDA/ARS/NAA

BLOODBORNE PATHOGENS Pathogenic organisms that are present in human blood and can cause disease in humans. These include, but are not limited to: Hepatitis B Virus (HBV), HCV and Human Immunodeficiency Virus (HIV)

 “Occupational Exposed Worker” “Reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious material that may result from the performance of employee duties.”  “Occupational Exposed Worker” “Reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious material that may result from the performance of employee duties.”

OTHER POTENTIALLY INFECTIOUS MATERIAL (OPIM for short) Saliva in dental procedures Any body fluid visibly contaminated with blood All body fluids in situations where it is difficult or impossible to differentiate between body fluids

Standard Requirements Written Exposure Control Plan Universal Precautions Engineering and work practice controls

Standard Requirements (con’t) Basic housekeeping Medical prevention plan Training Labeling requirements and record keeping PPE

EXPOSURE CONTROL PLAN (c) Employee exposure determination The schedule and method of implementing paragraphs (d) to (h) of the standard The procedures for evaluating circumstances surrounding an exposure incident To eliminate or minimize employee exposure, the employer shall develop a written Exposure Control Plan that contains

EXPOSURE CONTROL PLAN Reviewed and updated annually Reflect changes in technology that would reduce or eliminate exposure Document consideration of devices

EXPOSURE CONTROL PLAN Solicit input from non-managerial employees –Identification –Evaluation –Selection Effective engineering and work practice controls Document (c)(1)(v)

The Written ECP Should* Include: Use of universal precautions Engineering and work practice controls PPE Medical evaluations and vaccinations Training *These elements are required by the standard, but not necessarily in the ECP

November 2000 Law Requires Sharps Injury Log Documented non-managerial employee input on safer medical devices Documented evaluation and implementation of “safer medical devices” at least annually

UNIVERSAL PRECAUTIONS An approach to infection control. According to the concept of Universal Precautions, all human blood and body fluids are treated as if known to be infectious for HIV, HBV, HCV and other bloodborne pathogens.

Universal/Standard Precautions:  This includes cell or tissue culture, culture medium, solutions or tissues from humans, experimental animals infected with HIV/HBV/HCV  For our research facilities, blood and tissue products are treated under the standard Universal/Standard Precautions:  This includes cell or tissue culture, culture medium, solutions or tissues from humans, experimental animals infected with HIV/HBV/HCV  For our research facilities, blood and tissue products are treated under the standard

ENGINEERING CONTROLS Controls that isolate or remove the hazard from the workplace Examples: –Sharps disposal containers, self- sheathing needles, safer medical devices, such as sharps with engineered sharps injury protection and needle-less systems

(d)(2)(i) ENGINEERING CONTROLS AND WORK PRACTICES Engineering and work practice controls to be instituted as the PRIMARY means of eliminating or minimizing exposure. –The employer MUST use engineering and work practice controls to eliminate exposure or reduce it to the lowest feasible extent.

(d)(2)(i) ENGINEERING CONTROLS AND WORK PRACTICES The employer should be using or at least have considered, and documented in the exposure control plan why he/she CANNOT use engineering and work practice controls for work operations involving exposure to blood or OPIM.

(d)  Work Practices:  Hand washing  Personal hygiene  Personal attire  Not wearing personal protective equipment (PPE) out of the work area  Changing PPE when contaminated  Decontaminating/cleaning regularly & after spills (d)  Work Practices:  Hand washing  Personal hygiene  Personal attire  Not wearing personal protective equipment (PPE) out of the work area  Changing PPE when contaminated  Decontaminating/cleaning regularly & after spills Work Practice Controls

Sharps Disposal Containers Must be labeled or color-coded, puncture resistant, leak-proof, and close-able Should have well marked fill line, be translucent or have translucent lid Classified as medical device (SMDA)

Sharps Disposal Containers Establish collection schedules Provide placement of containers Review disposal procedures

NEEDLE SHIELDS THAT CONTAIN THE HAZARD Attached to syringe needle Attached to holder Attached to needle

Housekeeping  Written schedule for cleaning and decontaminating  Documented eye wash checks  Material decontamination before exit from lab  Removal of PPE from lab is prohibited  Home laundering of PPE is prohibited  Segregated waste Housekeeping  Written schedule for cleaning and decontaminating  Documented eye wash checks  Material decontamination before exit from lab  Removal of PPE from lab is prohibited  Home laundering of PPE is prohibited  Segregated waste

Medical Prevention Plan (f) Vaccination, Post-Exposure Follow-up  Hepatitis B vaccine made available to all workers with potential risk of exposure  Offered within 10 days of employment  No cost to worker  “Declination” signed if employee declines vaccine; may accept at a later date Medical Prevention Plan (f) Vaccination, Post-Exposure Follow-up  Hepatitis B vaccine made available to all workers with potential risk of exposure  Offered within 10 days of employment  No cost to worker  “Declination” signed if employee declines vaccine; may accept at a later date

(f) Vaccination, Post-Exposure Follow-up  Report the incident immediately  Inform supervisor  Go to clinic/medical services provider  Confidential medical evaluation  Route of exposure  Circumstances of the incident  Source known  Important to start drug therapy within 2 hours  Testing of victim/source only with consent (baseline blood stored for 90 days) (f) Vaccination, Post-Exposure Follow-up  Report the incident immediately  Inform supervisor  Go to clinic/medical services provider  Confidential medical evaluation  Route of exposure  Circumstances of the incident  Source known  Important to start drug therapy within 2 hours  Testing of victim/source only with consent (baseline blood stored for 90 days) Medical Prevention Plan

Decontamination What needs to be? What does not need to be? Create a schedule Requirements for medical equipment EPA disinfectants, 1:10 dilutions bleach, 2% glutaraldehyde

(d)(3) PERSONAL PROTECTIVE EQUIPMENT (d)(3)(i) - PPE must be provided at NO COST to the employee (d)(3)(ii) This paragraph addresses that PPE must be used properly per training received (d)(3)(iii) - discusses provisions of appropriate PPE, including hypoallergenic gloves as readily available alternative to latex

Personal Protective Equipment (PPE ) Appropriate PPE –Testing standards ASTM ES 21 and ES 22 –Types –When used and by whom –Special needs –No respiratory protection required

(g)Labeling and Training  Labels must include universal biohazard symbol and the term “Biohazard”  Wherever BBP or OPIM are  Fluorescent orange-red  Secured with: string, tape, wire, adhesive  Exceptions: Blood products for clinical use, blood samples in containers, blood drawing tubes (g)Labeling and Training  Labels must include universal biohazard symbol and the term “Biohazard”  Wherever BBP or OPIM are  Fluorescent orange-red  Secured with: string, tape, wire, adhesive  Exceptions: Blood products for clinical use, blood samples in containers, blood drawing tubes Compliance

(g)Labeling and Training  Signs posted at all work area entrances:  Biohazard symbol  Infectious agent  Entry requirements  Name & telephone # of responsible person (g)Labeling and Training  Signs posted at all work area entrances:  Biohazard symbol  Infectious agent  Entry requirements  Name & telephone # of responsible person Compliance

(h)Record Keeping  Occupational exposure/sharps injury record  Confidential  Kept for duration of employment, + 30 years  Includes:  Name & social security number  Vaccination status  Examination results (h)Record Keeping  Occupational exposure/sharps injury record  Confidential  Kept for duration of employment, + 30 years  Includes:  Name & social security number  Vaccination status  Examination results Compliance

(h)Record Keeping  Training records  Kept for 3 years  Dates  Contents  Names & qualifications of instructors  Names & job titles of students  Annual documentation (h)Record Keeping  Training records  Kept for 3 years  Dates  Contents  Names & qualifications of instructors  Names & job titles of students  Annual documentation Compliance

Sharps Injury Log Information Type and brand of device involved Where incident occurred Description of how incident occurred Employee confidentiality must be maintained

Incident Reporting Set up a policy Record incidents in Sharps Injury Log Effective January 2002, Included on OSHA logs (positives only)

Postexposure Evaluation and follow-up Incident reports Document route of exposure Identify source Test source blood Give test results to worker Upon consent, test worker’s blood

Postexposure Evaluation(cont.) If no consent for HIV tests save blood for 90 days Advise worker to seek medical attention Provide counseling Evaluate test results to give treatment if needed

Physician's Written Opinion Complete within 15 days Worker must be informed of results and risks Employers have access to report

Types of Prophylaxis HBV –vaccine, serum immunoglobulin HIV –zidovudine –lamivudine (3TC) –Indinavir (IDV) when increased risk HCV –None

Needlestick Prevention Device Evaluation Program (NPD) Reasons for a program Program Components NPD Evaluation Criteria

Reasons for Program Regulatory Liability Ethics

Program Components Collect and Analyze Data Evaluate Devices Implementation Collect and Analyze Data

Review exposure records Target highest risk areas Determine device criteria and judgement scheme

Criteria to Consider Safety –Healthcare Worker (HCW) –Patient –Other Individuals

Evaluate Devices Involve multiple users in variety of locations Use devices “in the field” Prepare cost analysis

Criteria to Consider Human Factors –Ease of Use –Training –Patient Comfort

BIOHAZARD SYMBOL BIOHAZARD

Treat as regulated medical waste Follow State, federal and local regulations For perception issues on uncontaminated sharps and lab waste-discuss