# Presentation: 723786

## OSHA’s Revised Bloodborne Pathogens Standard

- Outreach and Education Effort 2001

## Bloodborne Pathogens Standard

- 29 CFR 1910.1030, Occupational Exposure to Bloodborne Pathogens
- Published December 1991
- Effective March 1992
- Scope
- ALL occupational exposure to blood and other potentially infectious material (OPIM)

**Notes:**
The BBP Standard applies to all employers with employees with reasonably anticipated occupational exposure to blood or OPIM.  It 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. 

## Bloodborne Pathogens Standard

- 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:**
This presentation will focus on 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.

## Methods of Compliance

- 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.

## Since 1991...

- Advancements in medical technology
- September 1998, OSHA’s _Request for Information_ (RFI)
- Findings of RFI
- Union and Congressional involvement
- November 1999, CPL 02-02-069

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

The information gathered from the RFI demonstrated feasibility and availability of safer medical devices, and the importance of training and work practices controls.

In May of 1999, the Stark Boxer Healthcare Worker Needlestick Prevention Act was introduced to Congress.  This was also designed as an attempt to reduce needlesticks.

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

## Needlestick Safety and Prevention Act, P.L. 106-430

## The Needlestick Safety and Prevention Act mandated...  OSHA clarify and revise 29 CFR 1910.1030, the Bloodborne Pathogens Standard

**Notes:**
This indicates the intent of the Needlestick Safety and Prevention Act, which was to 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 (Rep. Ballenger, HR5178)

## Needlestick Safety and Prevention Act Timeline

- 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 Standard

- Additional definitions, paragraph (b)
- New requirements in the Exposure Control Plan, paragraph (c)
- Solicitation of input from non-managerial employees, paragraph (c)
- Sharps injury log, paragraph (h)

**Notes:**
This is just an overview of the new provisions, these will be discussed in detail as the presentation progresses.

## Additional Definitions1910.1030(b)

*Engineering Controls** - *includes additional definitions and examples:
*Sharps with Engineered Sharps Injury Protections** - *[SESIP]
*Needleless Systems*

**Notes:**
Specific definitions in slides that follow.

## Engineering ControlsNew Definition

-    “... means controls (e.g., sharps disposal containers, self-sheathing needles, safer medical devices, such as sharps with engineered sharps injury protections and needleless systems) that isolate or remove the bloodborne pathogens hazard from the workplace.”

## Needleless SystemsNew Definition

- Device that does not use a needle for:
- Collection of bodily fluids
- Administration of medication/fluids
- Any other procedure with potential percutaneous exposure to a contaminated sharp

## “SESIP”New Definition

- 	Non-needle sharp or a needle with a built-in safety feature or mechanism that effectively reduces the risk of an exposure incident.

## Hypodermic syringes with “Self-Sheathing” safety feature

- Self-sheathed protected position

**Notes:**
NOTE:  The devices pictured in the next few slides are meant 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.

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.

[Device drawings courtesy of International Health Care Worker Safety Center, University of Virginia]

## Hypodermic syringes with “Retractable Technology” safety feature

- Retracted protected position

**Notes:**
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

- Blunted protected position

**Notes:**
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

**Notes:**
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

- Before        During         After

- Before    During     After

- In use     After use

**Notes:**
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

**Notes:**
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.med.virginia.edu/~epinet](http://www.med.virginia.edu/~epinet)_
- _www.tdict.org_
- Examples of two sources

**Notes:**
These websites include information about particular devices, as well as information about how to effectively evaluate devices.  These websites are electronically linked to CPL 2-2.44D on OSHA’s website, www.osha.gov.

## Exposure Control Plan:1910.1030(c)New Provisions

- 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

**Notes:**

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

## Solicitation of Non-Managerial EmployeesNew Provision

- Identification, evaluation, and selection of engineering controls
- Must select employees that are:
- Responsible for direct patient care
- Representative sample of those with potential exposure

**Notes:**
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.

## Engineering and Work Practice Controls: 1910.1030(d)

- 	Employers must _select_ and _implement_ appropriate engineering controls to reduce or eliminate employee exposure.

**Notes:**
This is an original requirement of the 1991 standard.  The Needlestick Safety and Prevention Act merely amplifies and specifies this requirement.  (Further discussion follows)

## “Where engineering controls will reduce employee exposure either by removing, eliminating, or isolating the hazard, they must be used.”

					CPL 02-02-069

- 					CPL 02-02-069

**Notes:**
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.

Much of the Needlestick Safety and Prevention Act was modeled after the November 1999 directive.  

## Engineering and Work Practice Controls

- 	Selection of engineering and work practice controls is dependent on the employer’s _exposure determination_.

**Notes:**
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

- 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

**Notes:**
This serves as the basis for determining when and where the use of engineering and work practice controls must be implemented.

## Engineering and Work Practice Controls (con’t)

- The employer must:
- Evaluate available engineering controls (safer medical devices)
- Train employees on safe use and disposal
- Implement appropriate engineering controls/devices

**Notes:**
Engineering controls must be appropriate for each process and procedure, independently. 

Employee training is key.  Devices will not be effective if employees do not feel comfortable using them.  Employees must receive training on new devices and/or new medical procedures.

## Engineering and Work Practice Controls (con’t)

- The employer must:
- 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

## Engineering and Work Practice Controls (con’t)

- The employer must:
- Train employees to use new devices and/or procedures
- Document in ECP

**Notes:**
Note:  This entire process (review and implementation of engineering controls) must be documented in the employer’s Exposure Control Plan.  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.

## Recordkeeping: 1910.1030(h)

- Sharps Injury Log
- Only mandatory for those keeping records under 29 CFR 1904
- Confidentiality
- Maintained independently from OSHA 300

**Notes:**
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.

## Sharps Injury Log

- At a minimum, the log must contain, for _each_ incident:
- Type and brand of device involved
- Department or area of incident
- Description of incident

**Notes:**
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.

## Summary of New Provisions

- 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)

**Notes:**
Again, this is just a summation of the new provisions of the Bloodborne Pathogens standard.

## U.S. Department of Labor, OSHA
 200 Constitution Avenue NW, Room N-3603
Washington, DC 20210
(202) 693-2190
Or contact your Regional, Area, or State-Plan Office

-  200 Constitution Avenue NW, Room N-3603
- Washington, DC 20210
- (202) 693-2190
- Or contact your Regional, Area, or State-Plan Office

## www.osha.gov