osha bloodborne pathogens standard

OSHA Bloodborne Pathogens StandardR. W. Smith, CSP

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• R.W. Smith reports no actual or potential conflicts of interest associated with this course

Disclosure

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Upon successful completion of this course, learners should be able to:

1. Identify potential bloodborne pathogens and their modes of transmission

2. Discuss signs and symptoms of bloodborne pathogen exposure

3. List the Bloodborne Pathogens Standard compliance requirements for pharmacists

4. Recall procedures to prevent or reduce exposure to bloodborne pathogens, including vaccination requirements

5. Outline the appropriate elements of an Exposure Control Plan

6. Compare and contrast Universal Precautions and Body Substance Isolation

Learning Objectives

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• Occupational Safety and Health Act

• Occupational Safety and Health Administration

• Act passed in 1970

• Applies to any Employer who has Employees

• Various industries have standards: General Industry, Construction,

Agriculture, Shipyards

• Pharmacy falls into General Industry

OSHA

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• Covers occupational exposure to blood and other potentially infectious materials

• 1998 update ‐ Availability of new technology to prevent needlesticks was becoming more apparent

Bloodborne Pathogens Standard

Published 1991

Effective1992

Update1998

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http://www.osha.gov/SLTC/bloodbornepathogens/recognition.html

Why is this important?

5.6 Million HCW at Risk

385,000 Annual

Needlestick Injuries

62‐88% PREVENTABLE

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1. Have exposure control plan

2. Review and implement commercially available “safer medical devices”

3. Include procedures for documenting exposure incidents

4. Review and update plan annually

5. Follow universal precautions

6. Comply with most current CDC recommendations for post‐exposure evaluation and follow up

Common Violations: Failure to….

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Citations and Penalties

Serious: up to $7,000

Willful: up to $70,000

Repeat: up to $70,000

$92,500 Total:

• $22,500 for “serious deficiency in exposure control plan” including lack of documentation of yearly training

• $70,000 for failure to use safety devices

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• Each employer having employee(s) with occupational exposure shall establish a written Exposure Control Plan designed to eliminate or minimize employee exposure

• Written plan required• Plan must be reviewed at least annually to reflect changes in:• Tasks, procedures, or assignments which affect exposure, and

• Technology that will eliminate or reduce exposure

Exposure Control Plan

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• Engineering and Work Practice Controls

• Handwashing facilities• May use antiseptic hand cleanser if water not immediately available, but hands must be washed with soap and water ASAP

• Wash after removal of gloves or other personal protective equipment

• Wash immediately if contact with body fluid is made

• Other requirements as well

Elements of an Exposure Control Plan

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• Definition:• Pathogenic microorganisms that are present in human blood and can cause disease in humans

• More than 20 pathogens have been transmitted through sharps or needlestickinjuries (staphylococcus, streptococcus, syphilis, malaria, herpes, gonorrhea)

• Greatest risk• Human Immunodeficiency Virus (HIV)• Hepatitis B Virus (HBV)• Hepatitis C Virus (HCV)

Bloodborne Pathogens

Terms and Definitions

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• Exposure Incident• A specific eye, mouth, or 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

• Occupational Exposure• Reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infections materials that may result from the performance of an employee’s duties

Terms & Definitions

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• Engineering Controls• Mechanism to isolate or remove the bloodborne pathogens hazard

• Work Practice Controls• Controls that reduce the likelihood of exposure by altering the manner in which a task is preformed (e.g., prohibiting recapping of needles by a two‐handed technique).

Terms & Definitions

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• Contaminated• The presence or the reasonably anticipated presence of blood or other potentially infectious materials on an item or surface

• Decontamination• Use of physical or chemical means to remove, inactivate, or destroy bloodborne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface of item is rendered safe for handling, use or disposal

Terms & Definitions

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• SESIP (Sharps with Engineered Sharps Injury Protection)• Built‐in safety feature or mechanism that effectively reduces the risk of an exposure incident

• Needleless Systems• Device that does not use a needle

Terms & Definitions

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• Estimated number of Americans that have been infected• HIV – 1.2 million

• Hepatitis B – 0.7‐1.4 million• 20‐30% acquired in childhood

• >50% decrease in new cases from 2000‐2013

• Hepatitis C – 2.7 ‐ 3.9 million (1.8%)• >300% increase in new cases from 2005‐2013

Bloodborne Pathogen Prevalence

CDC HIV Surveillance Report 2013CDC Viral Hepatitis Statistics & Surveillance Report

Human Immunodeficiency Virus (HIV)

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• Men who have sex with men – 49%• Injection drug users – 13%• Heterosexual contact – 33%• Other – 4%• Transmission methods for Health Care Workers

• Needlesticks or cuts• Splashed in eyes, nose, mouth• Skin Contact

• 58 confirmed occupational transmissions in Health Care as of 2013

http://www.cdc.gov/hiv/resources/factsheets/us.htm

HIV Transmission Rates (2006)

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• 1 Milliliter of blood contains very few infectious particles

• Blood outside body can have viable infectious particles for 10 minutes to 48 hours

• Weak virus

• 1 in 276 people in U.S. have HIV

HIV Transmission

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• Risks following exposure to HIV‐infected patient• 0.3% (1 in 300) from needlestick• 0.1% (1 in 1000) from splash exposure (large volume)• 0.09% with exposure to non‐intact skin or mucous membrane

• Health care workers: 58 documented cases of seroconversion (only 1 since 1999)• 48 (84%) needlestick or cuts• 5 mucocutaneous exposure• 26 have developed AIDS

• 140 other cases of seroconversion but not documented immediately following exposure.

http://www.cdc.gov/ncidod/dhqp/pdf/bbp/Exp_to_Blood.pdf

Human Immunodeficiency Virus (HIV)

Other healthcare occupation ‐ 6

Physician, nonsurgical

Laboratory technician, nonclinical

Housekeeper/maintenance worker

Technician, surgical

Embalmer/morgue technician

Health aide/attendant

Respiratory therapist

Technician, dialysis

Dental worker, including dentist

Emergency medical technician/paramedic

Physician, surgical

Other technician/therapist

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24Nurse 37

Healthcare Personnel with Documented and Possible Occupationally Acquired AIDS/HIV Infection, by Occupation, 1981‐2013

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6353a4.htm Notes from the Field: Occupationally Acquired HIV Infection Among Health Care Workers —United States, 1985–2013

Occupation Documented

Laboratory worker, clinical

Possible

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TOTAL 58 140

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• Fever

• Headache

• Sore throat

• Swollen lymph glands

• Rash

www.mayoclinic.com

Signs of InfectionEarly Later

• Swollen lymph nodes — often one of the first signs of HIV infection

• Diarrhea

• Weight loss

• Fever

• Cough and shortness of breath

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• Soaking night sweats

• Shaking chills or fever higher than 100 F (38 C) for several weeks

• Dry cough and shortness of breath

• Chronic diarrhea

• Persistent white spots or unusual lesions on your tongue or in your mouth

www.mayoclinic.com

Signs of Infection – Still Later�Weight Loss

� Persistent unexplained fatigue

� Swelling of lymph nodes for more than 3 months

�Headaches

� Blurred and distorted vision

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Hepatitis

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http://www.cdc.gov/hepatitis/statistics.htm

Incidence of Reported Viral Hepatitis (USA)Hepatitis A(2013)

Hepatitis B(2007)

Hepatitis C(2007)

Acute Cases Reported 3,473 4,519 849

Estimated Acute Clinical Cases 13,000 13,000 2,800

Estimated New Infections (current) 25,000 43,000 17,000

Percent Ever Infected 29.1% ‐ 33.5% 4.3% ‐ 5.6% 1.3% ‐ 1.9%

Number living with Chronic Infection

N/A 800,000 ‐ 1.4 million

2.7–3.9 million

Annual Number of Chronic Liver Deaths assoc w/ Viral Hepatitis

N/A 3,000 12,000

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Viral HepatitisA B C D E

Source of virus

Feces Blood/Blood derived body fluids

Blood/Blood derived body fluids

Blood/Blood derived body fluids

Feces

Route of Transmission

Fecal‐oral Percutaneous permucosal

Percutaneous permucosal

Percutaneous permucosal

Fecal‐oral

Chronic Infection

No Yes Yes Yes No

Prevention Pre/post exposureimmunization

Pre/post exposureimmunization

Blood donor screening; risk behaviormodification

Pre/post exposureimmunization;risk behaviormodification

Ensure safedrinking water

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• Prevalence• 0.8‐1.4 million people in US are chronically infected• 4,758 reported acute cases in 2006• Health Care workers 3 to 5 times higher than US population

• Risks following exposure from needlestick injuries of HBV infected patient• 6 to 30%

• Health care workers• In 2001: <400 developed HBV infection• In 1983: 17,000 developed HBV

Hepatitis B Virus (HBV)

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• 1 Milliliter of blood can contain 30,000 Hepatitis B particles

• Blood outside body can have viable infectious particles for up to 6 days or more

• Strong Virus

Hepatitis B

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• Fever

• Fatigue

• Muscle or joint pain

• Loss of appetite

• Mild nausea and vomiting

www.hepcassoc.org

www.hepb.org

Hepatitis Signs• Severe signs: (1%)

• Nausea & vomiting

• Jaundice

• Bloated/swollen stomach

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• Incubation period: Average 90 days

• Range 60‐150 days

• Clinical illness (jaundice): <5 yrs, <10%

• 5 yrs or older, 30%‐50%

• Acute case‐fatality rate: 0.5%‐1%

• Chronic infection: <5 yrs, 30%‐90%

• 5 yrs or older, 2%‐10%

Hepatitis B – Clinical Features

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High Moderate Low/Not Detectable

Blood Semen Urine

Serum Vaginal Fluid Feces

Wound exudates Saliva from Dental Procedures

Sweat

Tears

Breast Milk

Vomit

Hepatitis B –Body Fluid Concentrations

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Hetero‐sexual, multiple partners39%

MSM24%

IDU16%

Other5%

Unknown16%

MMWR 2006;55(RR-16):6-7

Risk Factors for Hepatitis B

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• Incubation period Average 4‐12 weeks

• Range 2‐24 weeks

• Chronic infection 75%‐85%

• Acute illness (jaundice) Mild (<20%)

• Chronic Liver Disease 60‐70%

• Mortality from CLD 1%‐5%

Features of Hepatitis C Virus Infection

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• Transmission Rates• 0.4% to 1.8% (one in 55 to 250)

• Health care workers• In 1995, it was estimated that between 560 to 1120 developed HBC infection• 1‐2% of all cases in health care workers exposed to blood• Needlestick injuries most common cause of occupational HCV exposure• No vaccine available• Limited post‐exposure prophylaxis data

• Medication costly with many adverse effects

http://www.cdc.gov/ncidod/dhqp/pdf/bbp/Exp_to_Blood.pdf

Hepatitis C Virus (HBC)

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• Injectable drug use• Transfusion, transplant from infected donor

• Occupational exposure to blood• Mostly needle sticks

• Latrogenic (unsafe injections)• Birth to HCV‐infected mother

• Sex with infected partner• Multiple sex partners

Exposures Known to Be AssociatedWith HCV Infection, U.S.

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• Needlesticks

• Broken glass (contaminated)

• Splatter

• Rubbing eyes, nose, or mouth

• Sores, cuts, and rashes

Transmission

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• Most occur with hollow point needles

• Most occur during suturing, drawing blood, and administering injections

• Recapping needles (not allowed under the Bloodborne Pathogens Standard)

• Safety devices reduce the risk of injuries

Summary of Needlestick Injuries

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• Fingersticks

• Providing injections/immunizations

• Cleaning up blood

• Handling medical waste

• Handling contaminated protective gear

• Performing first aid and CPR

• Cleaning up broken contaminated glass

Exposure Risks for Pharmacists and Technicians

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• Treat all human blood and certain body fluids as if they are contaminated with bloodborne pathogens

• Must be observed in all situations where there is a potential for contact with blood or other potentially infectious materials

Universal Precautions

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You cannot tell if a person has a particular disease by looking at them

All body fluids

can transmit

bloodborne

pathogens!

Body Substance Isolation

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• This alone does not adequately protect the employee…most can be penetrated by a needle

• Provided to employee at no costs

• Use must be enforced by employer

• Accessible at worksite or issued to employee

• Cleaning, laundering, disposal, repair, and replacement responsibility of employer

Personal Protective Equipment

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• Eye protection and Nose/Mouth protection required if there is a risk of splash to the eyes, nose, or face

• GLOVES • Must be worn if hand contact with body fluid reasonably anticipated

• More complete body covering PPE would be required if there is a risk of splash to the body or clothing.

• All PPE should be removed in a manner that does not expose the employee to contamination

• Contaminated PPE is to be disposed of in appropriate Biohazard Disposal containers

• Non‐contaminated PPE is considered normal trash

Personal Protective Equipment

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• Outside of gloves are contaminated!

• If your hands get contaminated during glove removal, immediately wash your hands or use an alcohol‐based hand sanitizer

• Using a gloved hand, grasp the palm area of the other gloved hand and peel off first glove

• Hold removed glove in gloved hand

• Slide fingers of ungloved hand under remaining glove at wrist and peel off second glove over first glove

• Discard gloves in a waste container

http://www.cdc.gov/hai/pdfs/ppe/PPE‐Sequence.pdf

Personal Protective Equipment Removal

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How to Remove Gloves


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Prohibited in work areas with potential for exposure to

bloodborne pathogens:

• Eating, drinking, smoking, applying cosmetics or lip balm, handling contact lenses

• Food and drink storage in refrigerators, freezers, shelves, cabinets, countertops, or bench tops

Exposure Control Plan Elements

Recall procedures to prevent or reduce exposure to bloodborne pathogens

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• Employer must make available at no cost to employee, unless1. Employee has had the vaccination

2. Antibody testing reveals immunity

• Provide at reasonable time and place• Within 10 working days of assignment

Hepatitis B Vaccination

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• Intramuscular Injection • Efficacy

• 95% • Range 80% ‐ 100%

• Duration of Immunity • 20 years +• Booster doses NOT routinely recommended

• Schedule • 3 doses• Initial dose 30 Days 180 Days


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• Follow current USPHS recommendations, including boosters

• If refused:• Must be given at no charge if employee changes mind

• Must sign mandatory statement (exact wording)

• Contraindications


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“I understand that due to my occupational exposure to blood or other

potentially infectious materials I may be at risk of acquiring hepatitis B

virus (HBV) infection. I have been given the opportunity to be

vaccinated with hepatitis B vaccine, at no charge to myself. However, I

decline this vaccine, I continue to be at risk of acquiring hepatitis B, a

serious disease. If in the future I continue to have the occupational

exposure to blood or other potentially infectious materials and I want to

be vaccinated with hepatitis B vaccine, I can receive the vaccination

series at no charge to me.”

• Signed _________________________________ Date___________

http://www.immunize.org/


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• Develop a written schedule and procedure for cleaning

• Contaminated surfaces shall be disinfected after completion of procedure and at end of work shift• EPA approved disinfectant• 1:10 chlorine bleach and water solution

• Protective coverings shall be removed and replaced after contamination

Housekeeping

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• Regulated Waste

• Liquid or semi‐liquid blood or potentially infectious material

• Contaminated items that could release material if compressed

• Items caked with material

• Contaminated sharps

• Pathological or microbiological wastes

Housekeeping

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• Contaminated needles and sharps• Not bent, recapped or removed

• Sharps containers• Puncture resistant• Leakproof on sides and bottom• Labeled• Closed during transport

Engineering and Work Practice Controls

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• Safer Medical Devices

• Eliminate needles or use needleless systems when possible

• Sharps with engineered sharps injury protection

• Must involve frontline health care workers when evaluating and selecting devices and must be documented

• Must be evaluated regularly to reflect changes in technology

Exposure Control Plan Elements

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• Labels and signs

• Affixed to containers of wastes, refrigerators, freezers, and storage or transport containers

• Labels are to be fluorescent orange or orange‐red

• Must include word BIOHAZARD

https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051

Communication of Hazards

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• Training• All employees with exposure must complete

• At time of assignment to exposure area

• Retrain annually• Additional training when changes occur• Train during work hours• No cost to individual• Training material at appropriate educational level and language

Communication of Hazards

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• 1998: Availability of new technology to prevent needlesticks was becoming more apparent

• OSHA filed a Request for Information (RFI)• Results showed new technology and medical treatments had evolved since the standard was promulgated

• Indicated the importance of training and work practice controls

• Demonstrated a need to amend and update the Bloodborne Pathogens Standard

Update : Bloodborne Pathogens Standard

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• Public Law 106‐430• Signed into law November 6, 2000

• Effective as of April 18, 2001• Revised the Bloodborne Pathogens Standard to reduce needlesticks among healthcare workers

• Mandates:• Safer Devices• Sharps Injury Log• Employee Input

Needlestick Safety and Prevention Act

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• The following examples are a few of the marketed devices. This is not a complete list nor is it intended to recommend one device over the other.

• OSHA does not approve, endorse, register, or certify any medical devices.

• Many more devices are listed at:

http://www.healthsystem.virginia.edu/internet/epinet/.

Examples of Safety Devices

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http://www.cdc.gov/sharpssafety/pdf/sharpssafety_poster3.pdf

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https://www.osha.gov/SLTC/etools/hospital/hazards/sharps/sharps.html

Hypodermic syringes with“Self‐Sheathing” safety feature

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https://www.osha.gov/SLTC/etools/hospital/hazards/sharps/sharps.html

Hypodermic syringes with“Retractable Technology”

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Needle Glide Needles (NoSyringe) SafetyGlideTM (B‐D)

http://www.directlinemedical.com/needles‐with‐syringes/

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http://www.cdc.gov/sharpssafety/pdf/sharpssafety_poster3.pdf

Needle‐Pro Edge Safety Device

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http://jrtassociates.com/terumosurguard2safetysyringes.aspx

SurGuard2 Safety Syringe – Terumo Medical Corp.

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http://www.cdc.gov/injectionsafety/images/!Single‐use‐disposable‐fingerstickdevice.JPG

Single‐use, disposable fingerstick devices

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http://www.bd.com/vacutainer/pdfs/genie_lancet_VS5421.pdf

Genie Lancet Usage ‐ BD

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• Exposure PreventionInformation Network (EPINet™

http://www.healthsystem.virginia.edu/internet/epinet

• Centers For Disease Control and Prevention

http://www.cdc.gov/niosh/topics/bbp/

For more information about exposures

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1. Wash needlesticks and cuts with soap and water

2. Flush splashes to the nose, mouth, or skin with water

3. Irrigate eyes with clean water, saline, or sterile irrigants

4. Report the incident to your supervisor

5. Seek medical treatment according to your employers protocols

If an Exposure Occurs

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• US Public Health Service Management Recommendation:

• Must provide confidential medical examination and confidentiality must be assured

• Documentation of exposure

http://www.cdc.gov/mmwr/PDF/rr/rr5011.pdf

Post‐exposure Evaluation and Follow‐up

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• If you have an exposure incident:• Wash or flush the affected area immediately

• Report the incident to you supervisor• Identify the source of the exposure if possible• You will be tested “immediately”, then at 3, 6, and usually 12 month

• You may be offered the Hep B vaccine if you have not already had one

Incident Report

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• Provide to employee’s health care professional (written)

• Copy of the regulation

• Description of exposed employees duties as related to exposure

• Documentation of circumstances of exposure

• Results of source blood testing, if available

• Employees medical records as related to exposure, including vaccination status


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• Health Care Professionals Written Opinion

• Provide to employee with 15 days

• HCP’s written opinion for Hepatitis B vaccination

• HCP’s written opinion that:• Employee has been informed of results

• Employee has been told about medical conditions and recommendations for treatment and further evaluation

• All other findings shall not be included in this report


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• Sharps Injury Log

• Must include:• Detailed information on injury

• Type and brand of device involved in injury• Department of work area where incident occurred

• Explanation of how incident occurred

Record Keeping

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• Medical record for each employee with exposure• Name and SSN• Vaccination status/dates• Results of tests and follow‐ups• Written opinions of HCP• Copy of information provided to HCP• Keep for duration of employment plus 30 years

• Training records (keep for 3 years)• Dates• Contents• Name and qualifications of trainer• Names of Attendees

• Must be kept confidential

• Not required if employer has fewer than 10 employees

Record Keeping

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• For a copy of the OSHA Bloodborne Pathogens Standard go to:

www.osha.gov

• Use alphabetical search or type “bloodborne pathogens” in search line in upper right hand corner of window.

Bloodborne Pathogens Standard

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If you have further questions about Bloodborne Pathogens ask you supervisor and/or employer

Questions?

Click to edit

If You Would Like To Learn More About Bloodborne

Pathogens visit:

www.osha.gov

www.cdc.gov

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For further information:

www.osha.gov

www.cdc.gov

If You Would Like To Learn More About Bloodborne Pathogens:

THANK YOU

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osha bloodborne pathogens standard

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