A description of the proposed changes are as follows:

1. TITLE 8:

GENERAL INDUSTRY SAFETY ORDERS
Chapter  4, Subchapter 7, Article 100
Section 5193
Bloodborne Pathogens/Sharps Injury Prevention

INITIAL STATEMENT OF REASONS


INFORMATIVE DIGEST OF PROPOSED ACTION/PLAIN ENGLISH OVERVIEW

Please take notice that the Occupational Safety and Health Standards Board proposes to adopt revisions to section 5193, Bloodborne Pathogens of Title 8 of the California Code of Regulations. These proposed revisions are authorized by Labor Code section 142.3 and required by Labor Code section 144.7, which will become effective on January 1, 1999.

The purpose of this proposal is to clarify and add protections to the existing standard. The bloodborne pathogens standard was originally promulgated pursuant to Labor Code section 142.3(a)(2) and, therefore, is required by law to be at least as effective as its federal equivalent, 29 CFR section 1910.1030. The effect of the proposed amendments is, in some parts, to clarify and reorganize existing requirements without changing them substantively, and in other parts, to increase protection to covered employees and thereby make the standard more effective than its federal equivalent.

Section 5193(b), Definitions.

The following definitions in existing section 5193(b) are proposed to be revised:

bloodborne pathogens
decontamination
engineering controls
licensed healthcare professional
one-hand technique
other potentially infectious materials
parenteral
production facility
regulated waste
research laboratory
source individual
universal precautions
work practice controls

The proposed revisions to these definitions increase clarity and make the definitions consistent with the new requirements added to existing section 5193.

The following words with definitions, which are not found in existing section 5193(b), are proposed to be added:

engineered sharps injury protection
HCV
needle or needle device
needleless system
OPIM
sharp
sharps injury
sharps injury log

These newly defined terms increase clarity and facilitate the addition of the new requirements to section 5193.

The following words with definitions in existing section 5193(b) are proposed to be deleted:

contaminated sharps
sterilize

These words with definitions are proposed to be deleted because they are not referred to in the body of either existing section 5193 or section 5193 as proposed to be amended, and therefore are surplusage.

Section 5193(c), Exposure Response, Prevention and Control.

The title of this subsection is proposed to be changed from "Exposure Control" to "Exposure Response, Prevention and Control."

Subsection (c)(1), Exposure Control Plan.

Subsection (c)(1)(A) This subsection is proposed for revision to make the wording more consistent with the requirements of the "Injury and Illness Prevention Plan" requirements contained in 8 CCR section 3203.

Subsection (c)(1)(B) Existing subsection (c)(1)(B) of section 5193 is proposed to be amended to require the Exposure Control Plan to be in writing and to make it clear that the bloodborne pathogens it addresses include the Hepatitis C virus.

New subsections (c)(1)(B)4. through (c)(1)(B)8. are proposed to be added to require the following:

--a procedure for gathering the information required in the sharps injury log.

--periodic determination of the frequency of use of the types and brands of sharps involved in exposure incidents documented on the employer's sharps injury log;

--a procedure for identifying and selecting currently available engineering controls;

--a procedure for documenting circumstances in which engineering controls are not used because of patient safety determinations; and

--a procedure for obtaining the active involvement of employees in reviewing and updating the exposure control plan.

Subsection (c)(1)(D) In addition to editorial revisions, two new provisions are proposed to be added to this subsection to require updating the employer's Exposure Control Plan. New subsection (c)(1)(D)2. requires the employer’s plan to reflect progress in implementing the use of needleless systems and sharps with engineered sharps injury protection. New subsection (c)(1)(D)5. is proposed to require the employer to review and respond to information indicating that the existing plan is deficient.

Subsection (c)(2), Sharps Injury Log.

This subsection is titled "Exposure Determination" in existing section 5193(c)(2), and is proposed to be retitled as "Sharps Injury Log." This subsection is proposed to create an immediate requirement for employers to establish and maintain a sharps injury log, which is a record of sharps injuries that result in exposure incidents. The sharps injury log must record the date and time of the sharps injury as well as the type and brand of sharp involved, consistent with Health and Safety Code section 105330.

In addition, this subsection is proposed to include several additional items of information that must be recorded in the sharps injury log. These additional items will maximize the utility of the sharps injury log as a source of information that supports effective selection of sharps with engineered sharps injury protection.

Subsection (c)(3), Exposure Determination.

The language in existing subsection (c)(2) is proposed to be relocated to subsection (c)(3) and internal referencing is revised accordingly.

Section 5193(d), Methods of Compliance.

Subsection (d)(2), Engineering and Work Practice Controls – General Requirements.

The title of this subsection is proposed for revision from "Engineering and Work Practice Controls" to "Engineering and Work Practice Controls--General Requirements."

Subsection (d)(2)(A) The second sentence related to the use of personal protective equipment is proposed to be relocated to subsection (d)(4). As described below, proposed subsection (d)(4) is proposed to be renumbered from existing subsection (d)(3).

Subsection (d)(2)(C) It is proposed to revise this subsection to contain a new requirement to evaluate and update work practice controls, and relocate the language in existing subsection (d)(2)(C) to proposed subsection (d)(3)(I), which deals only with hygiene-related requirements.

Subsection (d)(2)(D) It is proposed to revise this subsection to contain the language in existing subsection (d)(2)(K), related to minimizing exposure to droplets of blood or other potentially infectious materials (OPIM). The language in existing subsection (d)(2)(D) is proposed to be relocated to proposed subsection (d)(3)(I), which deals only with hygiene-related requirements.

Subsections (d)(2)(E) through (d)(2)(N) It is proposed to relocate and in some cases revise these provisions, as described in subsections (d)(2)(D) and (d)(3).

Subsection (d)(3), Engineering and Work Practice Controls – Specific Requirements.

This subsection is proposed to be titled "Engineering and Work Practice Controls--Specific Requirements." In existing section 5193, this subsection is titled "Personal Protective Equipment." This title and the provisions of existing subsection (d)(3) are proposed to be relocated to subsection (d)(4). The following is a description of the provisions proposed to be added or relocated into new subsection (d)(3):

Subsection (d)(3)(A) This subsection is proposed to be titled "Needleless Systems, Needle Devices, and Non-Needle Sharps," and these new requirements are proposed to require the use of needleless systems, needle devices with engineered sharps injury protection, and non-needle sharps with engineered sharps injury protection. These proposed requirements are subject to 4 exceptions, so that a particular engineering control, e.g., a self-sheathing needle, is not required if it is not available on the market, if it jeopardizes patient safety or care, if the employer's information indicates that the control measure is ineffective, or if sufficient information on the effectiveness of the control measure is not available.

Subsection (d)(3)(B) This subsection is proposed to be titled "Prohibited Practices" and is intended to collect together all prohibited practices specified in existing section 5193, except for those contained in existing subsection (e), which applies specifically to research laboratories and production facilities. Proposed subsection (d)(3)(B) contains the language from the following subsections of existing section 5193, edited for clarity: subsections (d)(2)(G), (d)(2)(H) (first sentence only), (d)(2)(I), (d)(2)(J), (d)(2)(L), and (d)(4)(B)4. Language from existing subsections (d)(4)(B)5. and (d)(4)(C)1.d. have been combined, edited for clarity, and placed in proposed subsection (d)(3)(B)6., with the effect that there is a uniform requirement applicable to accessing all sharps containers, regardless of whether they contain disposable or reusable sharps. New subsection (d)(3)(B)4. is proposed to be added to forbid the reuse of disposable sharps.

Subsection (d)(3)(C) This subsection is proposed to be titled "Requirements for Handling Contaminated Sharps" and contains all affirmative requirements for handling contaminated sharps in existing section 5193. These requirements are the procedures for disposing of reusable sharps in existing subsection (d)(2)(H) and requirements applicable to sharps to be disposed of in existing subsection (d)(4)(C)1.b.

In addition, a new requirement is proposed to be placed in subsection (d)(3)(C)1. to ensure that all procedures involving the use of sharps in connection with patient care are performed using methods designed to reduce the risk of a sharps injury.

Subsection (d)(3)(D) This subsection is proposed to be titled "Sharps Containers for Contaminated Sharps" and contains all requirements specifying what characteristics sharps containers must have. It combines the sharps container specification provisions from existing subsections (d)(4)(C)1.a. and (d)(2)(H). In addition, proposed subsection (d)(3)(D) contains a requirement for the container to be rigid, as well as a requirement for it to be portable under certain circumstances. Proposed subsection (d)(3)(D) eliminates the distinction that existing section 5193 draws between sharps containers for reusable sharps and sharps containers for sharps being disposed of, except for a new proposed requirement that containers for sharps being disposed of must be closeable and sealable so that it is leak resistant and difficult to reopen.

Subsection (d)(3)(E) This subsection is proposed to be titled "Regulated Waste" and is proposed to contain provisions related to handling, storage, treatment, and disposal of regulated waste. It consists of language, edited for clarity, from existing subsections (d)(4)(C)1.c., (d)(4)(C)2., and (d)(4)(C)3. Provisions pertaining to "Other Regulated Waste" in existing subsection (d)(4)(C)2. are included in proposed subsection (d)(3)(E)3., but are proposed to be amended for the purpose of clarification to state that they apply to "disposal" rather than temporary "placement" in a container.

Subsection (d)(3)(F) This subsection is proposed to be titled "Handling Specimens of Blood or OPIM" and is proposed to contain the provisions in existing section 5193(d)(2)(M).

Subsection (d)(3)(G) This subsection is proposed to be titled "Servicing or Shipping Contaminated Equipment" and is proposed to contain the provisions in existing subsection (d)(2)(N), edited for clarity.

Subsection (d)(3)(H) This subsection is proposed to be titled "Cleaning and Decontamination of the Worksite" and is proposed to contain the provisions in existing subsections (d)(4)(A) and (d)(4)(B)1. through (d)(4)(B)3., edited for clarity.

Subsection (d)(3)(I) This subsection is proposed to be titled "Hygiene" and is proposed to contain the provisions in existing subsection (d)(2)(C) through (d)(2)(F).

Subsection (d)(3)(J) This subsection is proposed to be titled "Laundry" and is proposed to contain the provisions in existing subsection (d)(4)(D), edited for clarity.

Subsection (d)(4) As stated above, the title of this subsection is proposed to be "Personal Protective Equipment" and this proposed subsection is the equivalent of existing subsection (d)(3). The substance of the language in proposed subsection (d)(4) is the same as that of existing subsection (d)(3), with the following exceptions:

--Proposed subsection (d)(4)(A) begins with the second sentence of existing subsection (d)(2)(A), edited for clarity and pertaining to the use of personal protective equipment.

--The requirement in existing subsection (d)(3)(J) to comply with 8 CCR section 5144 is proposed to be expanded in proposed subsection (d)(4) to require compliance with the recently adopted 8 CCR section 5147, where applicable.

--The regulatory language, including titles, are proposed to be edited for clarity.

Existing Subsection (d)(4), Housekeeping is proposed for relocation as stated above.

Section 5193(e), HIV, HBV and HCV Research Laboratories and Production Facilities.

Proposed section 5193(e) is the equivalent of existing section 5193(e) and contains the same regulatory language with the following exceptions:

Where reference is made to HIV and HBV, a reference to HCV is proposed to be added so that it is clear that this subsection is intended to protect against Hepatitis C in the same manner as it protects against Hepatitis B.

References to Health and Safety Code Chapter 6.1 and section 25090 are proposed to be revised to section 118215 to reflect amendments to the Health and Safety Code that have taken place since section 5193 was adopted.

The regulatory language is proposed to be edited for clarity.

Section 5193(f), Hepatitis B Vaccination and Bloodborne Pathogen Post-exposure Evaluation and Follow-up.

Proposed section 5193(f) is the equivalent of existing section 5193(f) and is proposed to contain the same language with the following exceptions:

Where reference is made to HIV and HBV, a reference to HCV is added, so that it is clear that this subsection is intended to protect against Hepatitis C in the same manner as it protects against Hepatitis B.

The regulatory language is proposed to be edited for clarity.

Section 5193(g), Communication of Hazards to Employees.

This subsection is the equivalent of section 5193(g) and is proposed to contain the same language with the following exceptions:

Reference to Health and Safety Code sections 25080 to 25082 is proposed to be revised to sections 118275 to 118320 to reflect amendments to the Health and Safety Code that have taken place since section 5193 was adopted.

Provisions pertaining to labeling in existing subsection (g)(1)(A)2. are proposed to be revised to make them consistent with recent amendments to the Health and Safety Code.

Where reference is made to HIV and HBV, a reference to HCV is added, so that it is clear that this subsection is intended to protect against Hepatitis C in the same manner as it protects against Hepatitis B.

The existing regulatory language is proposed to be edited for clarity.

A requirement has been added to provide training on the employer's procedure for recording exposure incidents on the sharps injury log.

Section 5193(h), Recordkeeping.

Proposed section 5193(h) is the equivalent of existing section 5193(h) and is proposed to contain the same language with the following exceptions:

Provisions are proposed to require a minimum retention period for the sharps injury log, and to require the sharps injury log to be provided upon request to employees, employee representatives, the Chief of the Division of Occupational Safety and Health, and the Department of Health Services.

Existing Section 5193(i), Dates.

The regulatory language from existing section 5193(i) is proposed to be deleted because it consists solely of outdated compliance phase-in dates for various subsections of existing section 5193.

Section 5193(i), Appendix.

Proposed section 5193(i) is the equivalent of existing section 5193(j) and is proposed to contain no changes to that subsection except editorial revisions for consistency.

DOCUMENTS INCORPORATED BY REFERENCE

None.