This standard limits occupational exposure to blood and other potentially infectious materials since any exposure could result in transmission of bloodborne pathogens, which could lead to disease or death. Acquired Immunodeficiency Syndrome (AIDS), Hepatitis B and Hepatitis C are serious concerns for workers exposed to blood and other potentially infectious materials. Bloodborne pathogen exposure may occur in many ways, but needlestick injuries are the most common cause. Exposure may also occur through contact of contaminants with the nose, mouth, eyes, or skin.

• Approximately 5.6 million workers in health care and other facilities are at risk of exposure to bloodborne pathogens such as human immunodeficiency virus (HIV – the virus that causes AIDS), the hepatitis B virus (HBV), and the hepatitis C virus (HCV)

• OSHA’s Bloodborne Pathogens standard prescribes safeguards to protect workers against the health hazards from exposure to blood and other potentially infectious materials, and to reduce their risk from this exposure

29 CFR 1910.1030, does not apply to construction, agriculture or maritime, but does include all employees who could be “reasonably anticipated”, as the result of performing their job duties, to face contact with blood and other potentially infectious materials.

OSHA’s Bloodborne Pathogens standard, 29 CFR 1910.1030, does not apply to construction, agriculture or maritime employees. Additionally, “Good Samaritan” acts such as assisting a co-worker with a nosebleed would not be considered occupational exposure.

• Physicians, nurses and emergency room personnel

• Orderlies, housekeeping personnel, and laundry workers

• Dentists and other dental workers

• Laboratory and blood bank technologists and technicians

• Medical examiners

• Morticians

• Law enforcement personnel

• Firefighters

• Paramedics and emergency medical technicians

• Anyone providing first-response medical care

• Medical waste treatment employees

• Home healthcare workers

How does exposure occur?

• Most common: needlesticks

• Cuts from other contaminated sharps (scalpels, broken glass, etc.)

• Contact of mucous membranes (for example, the eye, nose, mouth) or broken (cut or abraded) skin with contaminated blood

Exposure Control Plan

• Identifies jobs and tasks where occupational exposure to blood or other potentially infectious material occurs

• Describes how the employer will:

  • Use engineering and work practice controls

  • Ensure use of personal protective equipment

  • Provide training

  • Provide medical surveillance

  • Provide hepatitis B vaccinations

  • Use signs and labels

• 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

• Annual review must document employer’s consideration and implementation of safer medical devices

• Must solicit input from potentially exposed employees in the identification, evaluation and selection of engineering and work practice controls

• Plan must be accessible to employees

Universal Precautions

• Treat all human blood and certain body fluids as if they are infectious

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

Engineering and Work Practice Controls

• These are the primary methods used to control the transmission of HBV and HIV
• When occupational exposure remains after engineering and work practice controls are put in place, personal protective equipment (PPE) must be used

Engineering Controls

• reduce employee exposure by either removing the hazard or isolating the worker
• Examples include:
  • Sharps disposal containers
  • Self-sheathing needles
  • Safer medical devices
    • Needleless Systems: a device that does not use needles for the collection or withdrawal of body fluids, or for the administration of medication or fluids
    • Sharps with Engineered Sharps Injury Protections: a non-needle sharp or a needle device used for withdrawing body fluids, accessing a vein or artery, or administering medications or other fluids, with a built-in safety feature or mechanism that effectively reduces the risk of an exposure incident

Work Practice Controls

• reduce the likelihood of exposure by altering how a task is performed
• Examples include:

  • Wash hands after removing gloves and as soon as possible after exposure

  • Do not bend or break sharps

  • No food or smoking in work areas

Personal Protective Equipment (PPE)

• Refers to specialized clothing or equipment worn by an employee for protection against infectious materials
• Must be properly cleaned, laundered, repaired, and disposed of at no cost to employees
• Must be removed when leaving area or upon contamination
• Examples Include: gloves, gowns, face shields, eye protection, mouthpieces, resuscitation devices

Housekeeping

• Must develop a written schedule for cleaning and decontamination at the work site based on the:

  • Location within the facility

  • Type of surface to be cleaned

  • Type of soil present

  • Tasks or procedures being performed

• Work surfaces must be decontaminated with an appropriate disinfectant:

  • after completion of procedures,

  • when surfaces are contaminated

  • at the end of the work shift

Regulated Waste

• must be placed in closeable, leak-proof containers built to contain all contents during handling, storing, transporting or shipping
• must be appropriately labeled or color-coded

Laundry

• If contaminated handle as little as possible and use PPE

• Must be bagged or containerized at location where used

• No sorting or rinsing at location where used

• Must be placed and transported in labeled or color-coded containers

Hepatitis B Vaccination Requirements

• Must make available, free of charge at a reasonable time and place, to all employees at risk of exposure within 10 working days of initial assignment unless:
  • employee has had the vaccination
  • antibody testing reveals immunity
• The vaccination must be performed by a licensed healthcare professional

• Must be provided even if employee initially declines but later decides to accept the vaccination

• Employees who decline the vaccination must sign a declination form

• Employees are not required to participate in antibody prescreening program to receive vaccination series

• Vaccination booster doses must be provided if recommended by the U.S. Public Health Service

What to do if an exposure occurs

• Wash exposed area with soap and water

• Flush splashes to nose, mouth, or skin with water

• Irrigate eyes with water or saline

• Report the exposure

• Direct the worker to a healthcare professional

Post-exposure Follow-up

• Document routes of exposure and how exposure occurred

• Record injuries from contaminated sharps in a sharps injury log, if required

• Obtain consent from the source individual and the exposed employee and test blood as soon as possible after the exposure incident

• Provide risk counseling and offer post-exposure protective treatment for disease when medically indicated in accordance with current U.S. Public Health Service guidelines

• Provide written opinion of findings to employer and copy to employee within 15 days of the evaluation

Biohazard Warning Labels

• Warning labels required on:
  • containers of regulated waste
  • refrigerators and freezers containing blood and other potentially infectious materials
  • other containers used to store, transport, or ship blood or other potentially infectious materials
• Red bags or containers may be substituted for labels

Training Requirements

• Provide at no cost to employees during working hours

• Provide at time of initial assignment to a job with occupational exposure and at least annually thereafter

• Additional training needed when existing tasks are modified or new tasks are required which affect the worker’s occupational exposure

• Maintain training records for 3 years

Training Elements

• Copy of the standard

• Modes of transmission

• Site-specific exposure control plan

• Hazard recognition

• Use of engineering controls, work practices and PPE

• Live question and answer sessions

Medical Record-Keeping Requirements

• Employee’s name and social security number

• Employee’s hepatitis B vaccination status

• Results of examinations, medical testing, and post-exposure evaluation and follow-up procedures

• Health care professional’s written opinion

• Information provided to the health care professional

• Employee medical records must be kept confidential and not disclosed or reported without the employee’s written consent (unless required by law)

• Records must be maintained for duration of employment plus 30 years according to OSHA’s rule governing access to employee exposure and medical records

Sharps injury log

• Employers must maintain a sharps injury log for the recording of injuries from contaminated sharps

• The log must be maintained in a way that ensures employee privacy and must contain, at a minimum:

  • Type and brand of device involved in the incident

  • Location of the incident

  • Description of the incident

• OSHA’s Bloodborne Pathogens standard prescribes safeguards to protect workers against the health hazards from exposure to blood and other potentially infectious materials, and to reduce their risk from this exposure

• Implementation of this standard not only will prevent hepatitis B cases, but also will significantly reduce the risk of workers contracting AIDS, Hepatitis C, or other bloodborne diseases

• 29 CFR 1910.1030, Occupational Exposure to Bloodborne Pathogens

• Published December 1991

• Effective March 1992

• Scope includes ALL occupational exposure to blood and other potentially infectious material (OPIM)

• Applies not just in healthcare, but in general industry as well (e.g., first aiders).

• The BBP standard does NOT apply in construction, agriculture, or maritime; as those industries have adopted different standards.

Major Provisions by Paragraph

(b) Definitions

(c) Exposure Control Plan (ECP)

(d) Engineering and Work Practice Controls

- Personal Protective Equipment (PPE)

(e) HIV and HBV Research Labs

(f) Vaccination, Post-Exposure Follow-up

(g) Labeling and Training

(h) Recordkeeping

NOTES:

Requirements for (1) Exposure Control Plan, (2) Engineering Controls, (3) Recordkeeping, as these are the areas where new requirements have been mandated.

The remaining sections of the standard have been in place since 1991. If you have questions on these sections, feel free to call your OSHA Area or Regional Office. Contact information is available on OSHA’s website at www.osha.gov.

• Universal Precautions

• Engineering and Work Practice Controls

• Personal protective equipment

• Housekeeping

NOTES: Since paragraph (d) of the standard is exceptionally important in reducing and eliminating occupational exposure to blood and OPIM, it is important to note all of the major methods of compliance (indicated on this slide).

Universal precautions is an approach to infection control where all human blood and certain human body fluids are treated as if they are known to be infected by HIV, HBV, HCV, and other bloodborne pathogens. The Centers for Disease Control and Prevention (CDC) and local Departments of Health have numerous resources regarding proper infection control practices. Documents are available from the CDC at www.cdc.gov.

Engineering and work practice controls must be used to eliminate or minimize employee exposure. Where occupational exposure remains after the institution of these controls, personal protective equipment must also be used.

Housekeeping ensures that a worksite is maintained in a clean and sanitary condition.

• Advancements in medical technology

  • Nearly 10 years of new technology, medical treatments, and interpretations since publication of 1991 BBP Standard

• September 1998, OSHA’s Request for Information (RFI)

  • Findings of RFI demonstrated feasibility and availability of safer medical devices, and importance of training and work practices controls.

• Union and Congressional involvement

  • May 1999: Stark Boxer Healthcare Worker Needlestick Prevention Act introduced to Congress.

    • designed as an attempt to reduce needlesticks

  • Needlestick Safety and Prevention Act passed unanimously in House and Senate (introduced by Congressman Cass Ballenger (NC) as HR 5178)

    • Purpose: modify the Bloodborne Pathogens standard to set forth in greater detail its requirement that employers identify, evaluate, and make use of effective safer medical devices

• November 2001, OSHA Directive # CPL 02-02-069

  • Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens

• This act mandated that OSHA clarify and revise 29 CFR 1910.1030, the Bloodborne Pathogens Standard.
• Under the act, employers were required to identify, evaluate, and make use of effective safer medical devices. (Rep. Ballenger, HR5178)
• The Timeline for the Act was as follows:

  • P. L. 106-430 signed; November 6, 2000

  • Revised Standard published in Federal Register; Jan. 18, 2001

  • Effective date; April 18, 2001

  • Enforcement of new provisions; July 17, 2001

  • Adoption in OSHA state-plan states; October 18, 2001

Revisions to the Standard (Overview)

Additional Definitions - 1910.1030(b)

NOTE: The devices pictured in the next few sections are intended to serve as examples of devices that are currently available. This is not an exhaustive list, nor is it meant to favor one device over another. OSHA does not approve, endorse, register, or certify any medical devices.

• Hypodermic syringes with “Self-Sheathing” safety feature

Needle guard has protected sliding sheath (with some designs the shield must be twisted to engage the lock).

To safely activate the sheath, hold back of syringe in one hand, hold external sheath with other and pull back on the syringe so the sheath is left covering needle. This is better than advancing the sheath forward; if hands slip, a stick may result.

Activated (used) syringe must then be placed in a sharps box, as device activation is considered to be a temporary safety measure, and treated as regulated waste.

• Hypodermic syringes with “Retractable Technology” safety feature

After injecting medication, further depression of the plunger activates a mechanism that retracts needle into the syringe.

Activated (used) syringe must then be placed in a sharps box and treated as regulated waste.

• Phlebotomy needle with “Self-Blunting” safety feature

After final tube of blood is drawn, blunt internal hub is activated by forward pressure of vacuum tube, blunting needle before it is removed from patient.

Blunting may occur accidentally or deliberately with the first tube, if pushed into the blunting activation mechanism.

If the needle is blunted prematurely, it cannot be used again or repositioned.

Activated (used) syringe must then be placed in sharps box and treated as regulated waste.

Note: The standard prohibits the removal of a needle, unless it is medically necessary. After single use, the device must be deposited in a sharps container.

• “Add-on” safety feature

Attached to Syringe Needle

Attached to Blood Tube Holder

The hinged safety device can either be purchased separately to add on to an existing syringe or purchased pre-attached to a syringe or blood tube holder.

Once the needle is used, the hinge should be clicked into place using a tabletop-- NOT the other hand.

The activated (used) device must then be placed in a sharps box and treated as regulated waste.

• Retracting lancets with safety features

Left to Right: Before / During / After

Left to Right: Before / During / After

Left to Right: In Use / After Use

These devices are used for finger pricks, most often to test blood sugar in people with diabetes.

When these devices are triggered, the lancet instantly protracts and cannot be used again.

After use, the device must be placed in a sharps box and treated as regulated waste.

• Disposable scalpels with safety features

Retracted Position

Protracted Position

Protracted Position

Single use disposable scalpels with blades that retract or sheath. Most of these devices do not lock. Be careful. After use, safely place the scalpel in a sharps box.

Additional information about safety devices available at... www.tdict.org.

The ECP must be updated to include:

• changes in technology that reduce/eliminate exposure

• annual documentation of consideration and implementation of safer medical devices

• solicitation of input from non-managerial employees

The plan must be updated annually and whenever necessary to reflect any changes.

New provision for Solicitation of input from non-managerial employees

• Identification, evaluation, and selection of engineering controls

• Must select employees that are:

  • Responsible for direct patient care

  • Representative sample of those with potential exposure

NOTE: Small medical offices may want to seek input from all employees when making their decisions. Larger facilities are not required to request input from all exposed employees; however, the employees selected should represent the range of exposure situations encountered in the workplace (e.g., pediatrics, emergency department, nuclear medicine, etc.). The solicitation of employees who have been involved in the input and evaluation process must be documented in the Exposure Control Plan.

Employers must select and implement appropriate engineering controls to reduce or eliminate employee exposure.

NOTE: This is an original requirement of the 1991 standard. The Needlestick Safety and Prevention Act merely amplifies and specifies this requirement.

Selection of engineering and work practice controls is dependent on the employer’s exposure determination.

NOTE: Exposure Determination is (and has been) required by the original standard. Further discussion about the elements of an exposure determination can be found in the 1991 standard and in CPL 2-2.44D (Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens Compliance Directive).

• EXPOSURE DETERMINATION (basis for determining when and where the use of engineering and work practice controls must be implemented.
  • The Employer Must
    • Identify worker exposures to blood or OPIM
    • Review all processes and procedures with exposure potential
    • Re-evaluate when new processes or procedures are used
    • Evaluate available engineering controls (safer medical devices)
    • Train employees on safe use and disposal
    • Implement appropriate engineering controls/devices
    • Document evaluation and implementation in ECP
    • Review, update ECP at least annually
    • Review new devices and technologies annually
    • Implement new device use, as appropriate and available
    • Train employees to use new devices and/or procedures
    • Document in ECP

Note: This entire process (review and implementation of engineering controls) must be documented in the employer’s Exposure Control Plan (ECP). It is not necessary to include all supporting documents in the ECP, as long as there is reference in the ECP to where the original documents can be found. The ECP must be available to employees.

Quote from OSHA Directive CPL 02-02-069: “Where engineering controls will reduce employee exposure either by removing, eliminating, or isolating the hazard, they must be used.”

This quote is taken from CPL 2-2.44D Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens (November 1999 compliance directive). The directive lends specificity to the standard, setting forth the methods by which employers must protect their employees from the hazards of blood and OPIM with regard to the implementation of engineering and work practice controls.

The directive further explains OSHA’s expectation for preventing exposures includes a comprehensive programs, including engineering controls (e.g., needleless systems, SESIPs, etc.) and proper work practices (e.g., immediately disposing of a contaminated sharp in a sharps box). If engineering and work practice controls do not eliminate exposure, the use of PPE (e.g., eye protection) is required.

• Sharps Injury Log

  • Only mandatory for those keeping records under 29 CFR 1904

  • Confidentiality

  • Maintained independently from OSHA 300

Sharps Injury Logs must be kept by those required to keep records under 29 CFR 1904, Occupational Injury and Illness Recording and Reporting Requirements (may exclude select Standard Industry Classification (SIC) codes and employers with 10 or fewer employees).

The log must be maintained confidentially, as required by paragraph (h)(1)(iii) of the standard. (Personal identifiers must be removed from any list when posting or copying.)

Procedures for maintaining confidentiality for employers are listed in 29 CFR 1904.

Procedures for maintaining confidentiality for CSHOs are listed in 1913.10.

For CSHOs: If additional medical records are needed to ensure compliance, may be necessary to obtain a Medical Access Order under 1913.10. Check with Area Director.

At a minimum, the log must contain, for each incident:

• Type and brand of device involved

• Department or area of incident

• Description of incident

NOTE: Type and brand must be documented if it is known. [“If known”, refers to situations where a stick occurred through trash or bedding; mostly in housekeeping and maintenance. If attempting to determine the type and brand of a device would increase the potential for an exposure, do not proceed (i.e., do not attempt to remove it from sharps container). Simply list the area of occurrence and a description of the incident.]

As employers, it is important to review your log frequently to determine where needlesticks are occurring and why. This is the rationale behind logging specific information about each incident, as required by the revised standard.

• Additional definitions, paragraph (b)

• New requirements in the Exposure Control Plan, paragraph (c)

• Non-managerial employees involved in selection of controls, paragraph (c)

• Sharps injury log, paragraph (h)

OSHA Standard

· 29 CFR 1910 Subpart Z (1910.1030)

Ø http://www.osha-slc.gov/OshStd_data/1910_1030.html

· 29 CFR 1910 Subpart Z (1910.1030 App A) Hepatitis B Vaccine Declination

Ø http://www.osha-slc.gov/OshStd_data/1910_1030_APP_A.html

OSHA Publications

Ø http://www.osha-slc.gov/OshDoc/Additional.html

· 3128 Bloodborne Pathogens and Acute Care Facilities

· 3129 Controlling Occupational Exposure to Bloodborne Pathogens in Dentistry

· 3130 Occupational Exposure to Bloodborne Pathogens – Precautions for

Emergency Responders

· 3131 Bloodborne Pathogens and Long-Term Care Workers

OSHA References/Resources

· CPL 02-02-069, Enforcement Procedures for the Occupational Exposure to

Bloodborne Pathogens, Appendix C – Web Site Resource List

Ø http://www.osha-slc.gov/OshDoc/Directive_pdf/CPL_2-2_69.pdf

· OSHA Technical Links – Bloodborne Pathogens

Ø http://www.osha-slc.gov/SLTC/bloodbornepathogens/index.html

· OSHA Technical Links – Needlestick Prevention

Ø http://www.osha-slc.gov/SLTC/needlestick/index.html

· Protecting Nursing Home Workers: OSHA’s Safety and Health Program Approach

Ø http://www.osha-slc.gov/SLTC/nursinghome/training/nursing/index.html

· Video: As It Should be Done: Workplace Precautions Against Bloodborne Pathogens

Ø http://www.osha-slc.gov/SLTC/video/asitshouldbedone/video.html