INITIAL STATEMENT OF REASONS

CALIFORNIA CODE OF REGULATIONS
TITLE 8: GENERAL INDUSTRY SAFETY ORDERS
Chapter  4, Subchapter 7, Article 109, Section 5193

Bloodborne Pathogens/Sharps Injury Prevention


PROBLEM ADDRESSED BY PROPOSED ACTION

Labor Code section 144.7, which takes effect on January 1, 1999, requires the Division of Occupational Safety and Health (Division) to develop and the Occupational Safety and Health Standards Board (Standards Board) to adopt amendments to the existing bloodborne pathogens standard, 8 CCR section 5193, on an emergency basis by January 15, 1999, and on a permanent basis by August 1, 1999. This Initial Statement of Reasons addresses the amendments proposed to be adopted on a permanent basis.

The existing bloodborne pathogens standard is designed to reduce the incidence of workplace transmission of diseases caused by bloodborne pathogens. The existing standard identifies the principal bloodborne pathogens of concern as the Human Immunodeficiency Virus (HIV), which results in AIDS and related disorders, and the Hepatitis B virus (HBV), which causes Hepatitis B.

Required Amendments.

The amendments required by Labor Code section 144.7 are as follows:

(1) A revised definition of "engineering controls" that includes sharps injury prevention technology. Sharps prevention technology is to include, but not be limited to, needleless systems and sharps with engineered sharps injury protection, which are defined in the proposed standard.

(2) A requirement that sharps prevention technology be included as engineering or work practice controls, except in cases where the employer or other appropriate party can demonstrate that the technology does not promote employee or patient safety, or interferes with a medical procedure. Those cases are to be specified in the proposed standard, and must include, but not be limited to, circumstances where the technology is medically contraindicated or not more effective than alternative measures used by the employer to prevent exposure incidents.

(3) A requirement that written exposure control plans include an effective procedure for identifying and selecting existing sharps injury prevention technology.

(4) A requirement that written exposure control plans be updated when necessary to reflect progress in implementing sharps injury prevention technology.

(5) A requirement that information concerning exposure incidents be recorded in a "sharps injury log", including, but not limited to, the type and brand of device involved in the incident.

Authorized Amendments.

Section 144.7 authorizes the Division to consider and propose for adoption by the Standards Board additional revisions to the bloodborne pathogen standards to prevent sharps injuries or exposure incidents including, but not limited to, training requirements and measures to increase vaccinations.

In addition, the Division is authorized to propose and the Standards Board is authorized to adopt amendments to occupational safety and health standards in general under Labor Code section 142.3.

A New Bloodborne Pathogen Has Been Identified.

In recent years, the Hepatitis C virus has been identified as being a major public health threat. At the time the bloodborne pathogens standard was originally promulgated, this virus was poorly understood and designated as a "Non A, Non B Hepatitis virus. (See Document No. 1.) There is sufficient information now available to warrant specific reference to this virus in the standard and to include it in those parts of the standard that refer to HIV and HBV. (See Document No. 14.)

The Problem of Sharps Injuries in Healthcare Settings.

The major problem these amendments and Labor Code section 144.7 are designed to address is the problem of needlesticks and other "sharps injuries" resulting in bloodborne pathogens exposure incidents. Sharps injuries are a problem in healthcare delivery settings and typically occur when a healthcare worker inadvertently punctures his or her skin with a hypodermic syringe or other sharp device (the term "sharps" is used to refer to these devices collectively) that has been used on a patient and become contaminated with the patient's blood or other body fluids. Sharps injuries are the primary mode of transmission of bloodborne pathogens in the workplace. (See Documents No. 3 and 18.)

In recent years, needle devices specially designed to minimize the risk of a needlestick have entered the market. Some of these needle devices are of a design that can be described as "self-sheathing," but others employ different design strategies to protect against needlesticks. (See Documents No. 3, 4, 8, and 11.)

In addition, systems without needles (needleless systems) designed to fully or partially replace needle systems have become available. The effectiveness of these devices in preventing needlesticks varies from significantly more effective to significantly less effective than the traditional devices they are meant to replace. Moreover, the specific medical procedure for which a device is used has an impact on the degree of the device's effectiveness in preventing needlesticks as well as its appropriateness for use from the perspective of medical efficacy.

Lack of Specific Focus on Prevention of Sharps Injuries in the Engineering and Work Practice Control Requirements of the Existing Bloodborne Pathogens Standard.

The existing bloodborne pathogens standard requires employers to use engineering and work practice controls "to eliminate or minimize employee exposure." The standard does not define "employee exposure." However, it does coin the term "occupational exposure", which it defines as "reasonably anticipated skin, eye, mucous membrane or parenteral contact with blood or other potentially infectious materials that may result from an employee's duties." Engineering controls are defined as "controls (e.g., sharps disposal containers, self-sheathing needles) that isolate or remove the bloodborne pathogens hazard from the workplace."

The engineering control requirements cited above lack a clear assignment to employers of affirmative responsibility to address the use of sharps injury prevention technology. This results in insufficient notice to employers as to what behavior is expected of them, and builds an inherent weakness into any Division enforcement action directed at this issue.

Miscellaneous Changes Needed to Clarify Existing Requirements.

A number of provisions are outdated, or are worded in such a way as to make it difficult to understand the underlying requirement. For example, the definition of the term "regulated waste" in the existing standard does not clearly limit itself to waste, and could be read to apply to all potentially infectious materials, including tissue or blood samples to be shipped out of the generating institution to a receiving institution for use or testing. This was not the intent of the existing standard (see e.g., subsection (g)(1)(A)1., which lists storage containers for transport of blood or other potentially infectious materials as a category separate from "regulated waste"), and creates significant potential for confusion in understanding the requirements that apply to regulated waste.

PURPOSE OF PROPOSED ACTION

Section 5193(b), Definitions.

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

Bloodborne Pathogens: It is proposed to add Hepatitis C to the list of examples of bloodborne pathogens, so that the hazard of exposure to and infection by Hepatitis C will be appropriately addressed under the applicable requirements of the bloodborne pathogens standard.

Decontamination: It is proposed to revise an outdated reference to the Health and Safety Code.

Engineering Controls: It is proposed to remove the specific reference to self-sheathing needles and replace it with a reference to needleless systems and sharps with engineered sharps injury protection. This proposal is necessary to comply with Labor Code section 144.7 and to clarify provisions in the text which use these terms.

Licensed Healthcare Professional: It is proposed to reword this definition to make it clear that, where the standard authorizes or requires an activity to be performed by a licensed healthcare professional, it is the scope of the healthcare professional's license that determines whether he or she may perform the activity under the standard. This proposal is necessary to clarify the existing definition, and to extend it to new provisions in the standard which refer to this term.

One Hand Technique: It is proposed to include the word "a" before the word "procedure" to editorially correct the language in the definition.

Other Potentially Infectious Materials: It is proposed to reword this definition to make it more clear.

Parenteral: It is proposed to clarify this definition by enlarging the term to "parenteral contact," which is the exact context in which the term is used in the body of the existing and proposed regulations.

Production Facility: It is proposed to add the Hepatitis C virus to the list of bloodborne pathogens to which the definition of this term refers.

Regulated Waste: It is proposed to reword this definition for clarity and to add language making it more clear that the definition applies only to material that is "waste," as opposed to other materials which are not to be intended to be disposed of.

Research Laboratory: It is proposed to add the Hepatitis C virus to the list of bloodborne pathogens to which the definition of this term refers.

Source Individual: It is proposed to edit this definition to consistently refer to "other potentially infectious materials" as "OPIM".

Universal Precautions: It is proposed to add the Hepatitis C virus to the list of bloodborne pathogens to which the definition of this term refers.

Work Practice Controls: It is proposed to reword this definition for clarity and to add a reference to patient handling techniques as an example. This proposal is necessary to clarify the use of the term in the standard.

The following terms with definitions are proposed to be added to section 5193 to increase clarity and facilitate the addition of the new requirements of section 5193.

Engineered Sharps Injury Protection: This term is proposed to be added to comply with Labor Code section 144.7, which requires this term to be defined.

HCV: This term is proposed to be added to simplify references to the Hepatitis C virus.

Needle or Needle Device: This term is proposed to be added to comply with Labor Code section 144.7 and to clarify requirements applicable to these devices.

Needleless System: This term is proposed to be added to comply with Labor Code section 144.7 and to clarify requirements applicable to these devices.

OPIM: This term is proposed to be added to simplify references to "other potentially infectious materials."

Sharp: This definition is proposed to be added to clarify requirements applicable to sharps.

Sharps Injury: This definition is proposed to be added to clarify the requirements directed toward preventing sharps injuries.

Sharps Injury Log: This definition is proposed to be added to comply with Labor Code section 144.7 and to clarify requirements applicable to the logging of sharps injury events.

The following words with definitions which are currently found in section 5193(b) are proposed to be deleted as these definitions are no longer referred to in proposed section 5193(b) and, therefore, these definitions are not necessary.

Contaminated Sharps: This term is proposed to be deleted because the proposed definitions of                   "contaminated" and "sharp" make a definition of the two words together unnecessary.

Sterilize: This term is proposed to be deleted because it is not referred to in either existing section or proposed section 5193.

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," to clarify the purpose of the subsection.

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

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

Subsection (c)(1)(B) This subsection is proposed to be changed to make it more consistent with the wording of the "Injury and Illness Prevention Plan" requirements contained in 8 CCR section 3203 and to add requirements via amended subsection (c)(1)(B)2. and new subsections (c)(1)(B)4. through (c)(1)(B)8., as follows:

--add a reference to HCV, which will make subsection (c)(1) consistent with changes proposed for subsection (e);

--require an effective procedure for gathering the information required by the Sharps Injury Log; (See proposed subsection (c)(2).)

--require 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;

--require an effective procedure for identifying and selecting currently available engineering controls;

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

--require an effective procedure for obtaining the active involvement of employees reviewing and updating the exposure control plan.

These proposed additions are necessary, as determined by the Advisory Committee established by the Division of Occupational Safety and Health, to generate and review proposed amendments to the bloodborne pathogens standard to make this provision consistent with changes proposed for subsection (e); to establish an information gathering and documentation procedure upon which the employer can base utilization decisions regarding needleless systems and sharps with engineered sharps injury protection, as required by Labor Code section 144.7. (See Attachment 4.)

Subsection (c)(1)(D) Two new provisions are proposed to be added to this subsection to require updating the employer's exposure control plan to reflect progress in implementing the use of needleless systems and sharps with engineered sharps injury protection, and to review and respond to information indicating that the plan is deficient. These provisions are necessary, as determined by the Advisory Committee established by the Division of Occupational Safety and Health, to complete information gathering and documentation procedures which support utilization decisions regarding needleless systems and sharps with engineered sharps injury protection, as required by Labor Code section 144.7. (See Attachment 4.)

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

This subsection is titled "Exposure Determination" in existing section 5193(c)(2). It is proposed to be titled "Sharps Injury Log" in amended section 5193(c)(2). Subsection (c)(2) is proposed to be completely reworded to create a requirement for establishing and maintaining a sharps injury log, which is a record of sharps injuries that result in exposure incidents, and to specify the types of information that must be logged. This information is to include the following:

--The date and time of the exposure incident

--The type and brand of sharp involved in the exposure incident

--A description of significant details of the circumstances of the exposure incident.

These provisions are required and authorized by Labor Code section 144.7 and were found to be necessary by the Advisory Committee as a means of ensuring that employers will document their own sharps injury experience with sufficient detail to support effective exposure-control strategies.

Subsection (c)(3), Exposure Determination.

This subsection is proposed to consist of the language in existing section 5193(c)(2).

Section 5193(d), Methods of Compliance.

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

The title of this subsection is proposed to be changed from "Engineering and Work Practice Controls" to "Engineering and Work Practice Controls--General Requirements." The purpose of this change is to provide greater clarity.

Subsection (d)(2)(A) The second sentence of this subsection in existing section 5193 is related to the use of personal protective equipment. It is therefore proposed to be relocated and included as the first sentence to the subsection dealing with personal protective equipment, which is subsection (d)(3) in existing section 5193, but renumbered as subsection (d)(4) in proposed section 5193.

Subsection (d)(2)(C) This subsection in existing 5193 contains a hygiene-related requirement. This requirement is proposed to be relocated to subsection (d)(3)(I), which deals strictly with hygiene-related requirements. Subsection (d)(2)(C) is now proposed to contain a new requirement to evaluate and update work practice controls.

This requirement is necessary to ensure that work practice controls are kept current in the same fashion as engineering controls, which are required to be current by existing subsection (d)(2)(B). Because engineering controls such as sharps with engineered sharps injury protection cannot provide any protection to employees unless they are actually used, and it is only through work practice controls that the use of engineering controls can be assured, the requirement to keep work practice controls current is a necessary adjunct to the requirement to keep engineering controls current. This proposal was found to be necessary by the Advisory Committee.

Subsection (d)(2)(D) This subsection in existing section 5193 contains a hygiene-related requirement. This requirement is proposed to be relocated to subsection (d)(3)(I), which deals strictly with hygiene-related requirements. Subsection (d)(2)(D) is proposed to contain the language currently found in subsection (d)(2)(K), related to minimizing exposure to droplets of blood or other potentially infectious materials (OPIM). The purpose of this change is to increase clarity.

Subsections (d)(2)(E) through (d)(2)(N) These subsection designations are proposed to be eliminated and the regulatory language in them relocated to other subsections in proposed section 5193, as described below.

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

This subsection is proposed to be titled "Engineering and Work Practice Controls--Specific Requirements." The purpose of this title is to increase clarity. The contents of existing subsection (d)(3) are proposed to be renumbered as subsection (d)(4).

Subsection (d)(3)(A) This subsection is proposed to be titled "Needleless Systems, Needle Devices, and Non-Needle Sharps," and has no equivalent in existing section 5193. This subsection is 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 new provisions are required by Labor Code section 144.7 and were found to be necessary by the Advisory Committee to prevent sharps injuries.

The requirements of proposed subsection (d)(3)(A) are subject to 4 exceptions, so that a particular engineering control, e.g., a self-sheathing needle, is not required if (1) it is not available on the market, (2) if it jeopardizes patient safety or care, (3) if the employer's information indicates that the control measure is ineffective, or (4) if sufficient information on the effectiveness of the control measure is not available.

Exceptions 2 and 3 are required by Labor Code section 144.7. Exceptions 1 and 4 are authorized by section 144.7 and are necessary to avoid forcing employers to use equipment which information indicates is not effective, or about which insufficient information exists to determine effectiveness. These proposed exceptions were also found to be necessary by the Advisory Committee.

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 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. The 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. In addition, a new prohibition is added to forbid the reuse of disposable sharps. This prohibition is necessary because disposable devices are subject to failure upon reuse, which increases the chances of a sharps injury occurring.

Subsection (d)(3)(C) This subsection is proposed to be titled "Requirements for Handling Contaminated Sharps" and is proposed to contain all affirmative requirements for handling contaminated sharps currently found in existing section 5193. These are the procedures for disposing of reusable sharps in existing subsection (d)(2)(H), and the requirements applicable to sharps to be disposed of in existing subsection (d)(4)(C)1.b. Language from subsection (d)(4)(B)5. has been added as well, so that it now applies to all contaminated sharps rather than contaminated reusable sharps. This merging of requirements is necessary to ensure that the handling of all contaminated sharps is carried out subject to the principles of universal precautions, consistent with existing and proposed subsection (d)(1), and to eliminate inconsistency in the language of the existing standard.

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. This requirement was found to be a necessary component of sharps injury prevention by the Advisory Committee because the manner in which a patient is handled, particularly a struggling patient, has a significant impact on the potential for occurrence of a sharps injury.

Subsection (d)(3)(D) This subsection is proposed to be titled "Sharps Containers for Contaminated Sharps" and is proposed to contain all the 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) is proposed to contain a requirement for the container to be rigid, consistent with a recommendation by the National Institute of Occupational Safety and Health (NIOSH--See Document No. 23.) A requirement for The sharps container to be portable under certain circumstances is also proposed to be added which was found to be necessary by the Advisory Committee.

Proposed subsection (d)(3)(D) contains uniform requirements for all sharps containers, consistent with the universal precautions rationale described above in connection with proposed subsection (d)(3)(C). However, as required by the 1995 addition of section 117750 to the Health and Safety Code which is applicable to medical waste, a new requirement applicable only to containers for sharps to be disposed of is proposed. This proposed requirement states that the sharps container must be closeable and sealable so that they are 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 have been amended to state that they apply to "disposal" rather than temporary "placement" in a container. The purpose and effect of this proposal is to increase clarity and prevent confusion concerning the distinction between requirements applicable to infectious materials intended to be disposed of and requirements applicable to infectious materials destined for procedures and/or handling other than disposal.

Subsection (d)(3)(F) This subsection is proposed to be titled "Handling Specimens of Blood or OPIM" and is proposed to contain the provisions found in existing subsection (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 found 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 found 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 found in existing subsections (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 found in existing subsection (d)(4)(D), edited for clarity.

Subsection (d)(4) As stated above, the title of this proposed subsection is "Personal Protective Equipment," and is the equivalent of existing section 5193(d)(3). The substance of the language for 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), which pertains to the use of personal protective equipment, and this language has been relocated in proposed subsection (d)(4)(A) for the purpose of increased clarity.

--The requirement of existing subsection (d)(3)(J) to comply with section 8 CCR section 5144 has been expanded in proposed subsection (d)(4) to require compliance with the recently adopted 8 CCR section 5147, where applicable. This proposal has been made necessary by recent amendments to section 5144, which occurred in conjunction with the adoption of new section 5147. The effect of those two regulatory actions was to exclude respiratory protection from tuberculosis from section 5144 and to address it specifically in section 5147. Thus, it is now necessary to amend section 5193 now to preserve its applicability to situations in which respirators are used for protection from tuberculosis. Without this amendment, section 5193 would be less protective than it was before section 5147 was adopted and section 5144 was amended, as section 5144 did not exclude tuberculosis respirators previously.

--The 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 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.

--Reference 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 originally adopted.

--The language is proposed to be edited for clarity.

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

Proposed section 5193(f) is the equivalent of existing section 5193(f) and contains the same regulatory 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.

Proposed section 5193(g) is the equivalent of existing section 5193(g) and contains the same regulatory 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 originally adopted.

--Provisions pertaining to labeling in existing subsection (g)(1)(A)2. are proposed to be amended for clarity and to keep them consistent with recent amendments to the Health and Safety Code.

--Reference to 8 CCR section 6003 has been changed to 8 CCR section 3340 to reflect amendments to Title 8 that have taken place since section 5193 was originally adopted.

--Provisions in subsections (g)(1)(A)7., (g)(2)(E), and (g)(2)(G) are proposed to be edited for clarity.

--The NOTE in subsection (g)(2)(G)14. is proposed to be amended to include a reference to Hepatitis C.

Section 5193(h), Recordkeeping.

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

--Provisions are proposed to be added 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. This proposal is necessary to ensure that the required information will be kept for a period of time sufficient for its effective use, and was found to be necessary by the Advisory Committee.

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

Existing Section 5193(i), Dates.

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 as originally adopted.

Section 5193(i), Appendix.

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

 DOCUMENTS INCORPORATED BY REFERENCE

None.

SPECIFIC TECHNOLOGY OR EQUIPMENT

This proposal will not mandate the use of specific technologies or equipment.

COST ESTIMATES OF PROPOSED ACTION

In 1991, federal OSHA estimated that the original bloodborne pathogen standard affected nearly one-half million businesses nationwide (1). Approximately 12 percent or 60,000 of those businesses were located in California. A majority of the affected businesses are healthcare facilities in the Standard Industrial Classification (SIC) 80. Non-healthcare industries where employees are potentially exposed to blood are also covered by the standard. Some of the industries include: law enforcement, research labs, funeral services, and personal services. Currently, it is estimated that there are over 84,000 California businesses covered by the proposed regulation. This estimate is based on a number of staff contacts with healthcare facilities and government agencies and is summarized in Table 1.

The problem addressed by the proposed action is that the existing bloodborne pathogen standard does not adequately prevent the growing number of occupational sharps injuries. According to a survey of the healthcare industry, it is estimated that healthcare workers suffer 96,000 needlestick injuries per year in the state of California-Table 2 (18). The figures provided for needlestick injuries by the scientific research literature, regulatory agencies, government service agencies, and affected business associations vary considerably. This analysis is within the generally acknowledged view that needlesticks and other occupational exposure incidents to bloodborne pathogens such as sharps injuries are significantly under-reported in the healthcare industry. Reference to under-reporting of sharps injuries is common in nearly every periodical attempting to analyze needlesticks injuries. Examples of underreporting these injuries may be found in the following Documents Relied Upon: (8), Culver, J., Preventing transmission of Blood-borne pathogens: A compelling argument for effective device-selection strategies, Am. J. Infect. Control, Vol. 25, 430-433, 1997; (9), Gershon, R.M., Byrns, G.E., Dunleavy, M.L., Occupationally Acquired HIV In Health Care Workers, Nurse Practitioner, Am. J. of Primary Health Care, Vol. 21, #9, September 1996; (13), Patel, N., Tignor, G.H., Device-specific sharps injury and usage rates: An analysis by hospital department, Am. J. Infect. Control, 25, 77-84, 1997. Therefore, the under-reporting of exposure incidents result in under-estimating the cost of sharps injuries and the benefits derived from the proposed amendments. Consequently, the estimated benefits resulting from the proposal is conservative.

The proposal has two major requirements that become effective on August 1, 1999 and are anticipated to impose significant costs. The first requirement is for all businesses to switch from unprotected sharps devices to engineered sharps prevention devices. These new devices are currently available and are estimated to cost an additional $104 million per year. Table 3 summarizes the estimated number of devices and cost for five of the most commonly used sharps. This data was supplied by two manufacturers of devices that prevent sharps injuries and the costs are also displayed on a per-unit cost basis. For example, with approximately 500 million sharps devices used per year approximately 24 percent are syringes equipped with needles. The cost to convert to syringes with sharps protection will be between $22.7 and $29.7 million (3 & 4). Additional costs will be incurred from conversion of other sharps devices that can be modified to provide engineered protection. These devices include blood collection units, lancets, IV line ports, and IV catheters.

The second major requirement that is expected to impose a significant cost is the recordkeeping additions to the Sharps Injury Log. As estimated in Table 4, the additional recordkeeping costs are anticipated to be over $70 million per year based on the number of establishments. These costs were estimated based on contacting staff from various healthcare facilities and asking how much additional time it would take them to gather the additional information required by the proposal. These individuals provided an estimate of the number of hours required for collecting the additional information at the different types of facilities. A high and low estimate was then determined based on an hourly salary range from $22.66 to $30 for a nursing professional. These costs are anticipated to be reduced as the number of needlestick cases decline. Therefore, using an average of the high and low estimate is very conservative and possibly an overestimation of costs in future years.

The following are some of the anticipated benefits of the proposal:

Just as this proposed regulation emphasizes HCV in addition to the HIV and HBV, other bloodborne diseases exist and the changes in the proposed regulation will afford some additional measure of protection. Non-A non-B Hepatitis was cited in the 1991 Federal Preamble (1) and it is now known that Hepatitis C was one of the viruses in that category. However, also cited therein were: Syphilis, Malaria, Babesiosis, Brucellosis, Leptospirosis, Arboviral infections, Relapsing Fever, Creutzfeldt-Jakob Disease, Human T-lymphotropic Virus Type I, and Viral Hemorrhagic Fever. Although these diseases do not have the prevalence of HIV, HBV and HVC in the population, they still pose a potential risk to healthcare workers. The reduction in the risk of any one of these diseases by the proposed regulation is an additional significant benefit.

One manufacturer estimated an annual saving of $444 million in California medical costs. Their estimate consisted of $228 million per year by eliminating new cases of HIV and savings of $216 million resulting from the reduction in hepatitis due to eliminating the reuse of syringes. The cost estimate for the conversion to new devices was $124 million. This would result in net savings to California of $320 million (3).

Quantifying all the potential benefits is not possible due to the range of reported costs and the varying potential for morbidity and litigation. Table 6 lists various potential benefits and savings that could result from this proposed regulation. A conservative estimate of the immediate benefits that would result from the proposal was obtained from two manufacturers (4, 10). The data submitted on medical costs associated with a needlestick project significant savings that could be realized annually from eliminating 96,000 needlestick injuries, which is an underestimate of the over 200,000 needlesticks that have been estimated by others in the healthcare industry. Whenever an employee is stuck by a contaminated sharp, the average total cost of immediate diagnosis and treatment to a healthcare worker for sharps injuries is between $2,234 and $3,832, which includes prophylaxis. Treatment for needlestick injuries have additional costs besides the basic medical costs estimated in Table 6. Some of the following additional costs, although not quantified, could result in even further savings:

Although the latter are difficult to quantify and are outside the scope of occupational safety and health regulation, currently such costs have a significant impact when sharps injuries occur. Table 7 lists the estimated costs from Tables 3 and 4 and the estimated benefits for Table 6. The net result is an average annual estimated savings of over $100 million per year for all affected businesses.

Costs or Savings to State Agencies

Based on the standard assumption that state government accounts for approximately 1% of all California employment, it is estimated that the state would have approximately 1% of the costs and benefits from the proposed regulation. This percentage is based on the assumption that needlesticks are correlated to overall employment, not to the low number of state facilities as summarized in Table 1. Therefore, based on the above cost estimates, state agencies will incur $1.9 million in annual costs and $2.9 million in annual savings with a net overall savings estimated to be over $1 million per year.

As summarized in Table 1, the following are examples of the state agency services that will affected to varying degrees:

Impact on Housing Costs

The proposal will not significantly effect housing costs.

Impact on Businesses

Based on the above cost estimates and the standard assumption that private businesses make up approximately 90% of all California employment, the 75,000 affected businesses will incur an annual cost of $166 million which will be offset by an annual savings of $262 million, resulting in an estimated net annual savings of $95 million. As summarized in Table 1, the types of businesses affected by the proposal include:

This proposal will result in a significant economic impact on businesses, but will not effect the ability of California businesses to compete with businesses in other states. There may be a small net increase in the number of healthcare personnel available to the medical community. This may be anticipated, as it becomes known that the California healthcare industry provides better worker protection than the rest of the nation as presented in the proposed regulation.

The number of businesses and jobs that will be created or eliminated is negligible. Businesses that make, design or market new devices and consultants that may evaluate devices or consult on recordkeeping may experience an increase in activities. Businesses that market devices for which their use may be reduced or eliminated would be adversely affected. Consequently, the effect of the proposed regulation on the existing needle device market will be to shift production from devices without engineered sharps protection to safety enhanced devices. This may provide new opportunities for new products to be introduced into the market.

It is assumed that small businesses comprise the majority of establishments in the healthcare industry, encompassing 97 percent of the healthcare community. Physicians' and dentists' offices numerically dominate the healthcare industry and typify the small businesses impacted by the proposed regulation. Table 5 summarizes the typical costs anticipated for an average dentist’s office. These costs are estimates provided by the University of the Pacific (2) and rates of injuries reported in the literature (14), and do not reflect the potential savings of reduced medical costs that would more than offset such costs, as summarized in Table 7.

Cost Impact on Private Persons or Entities

The proposed regulation will impact private persons or entities in that the above costs and savings are anticipated to be passed on to consumers and insurers. An example of a cost that would be passed on is a phlebotomy that would increase by $0.21 over existing costs due to increased cost of needle devices with sharps injury protections. This is approximately 1% of the cost of the phlebotomy itself. When averaged over the costs of the testing, for which the phlebotomy was an integral part, the cost increase may be as low as 0.04%. This additional cost is expected to decrease over time, since the unit cost of engineered sharps protection devices mandated by the proposed regulation should decrease as supply and demand increases. Second, the relative need to provide services for sharps injuries and associated diseases, for which the proposed regulation provides protection, should decrease. This would yield a net savings to the insurance industry and private persons in the long term. It should be noted that the overall cost of medical services will increase irrespective of the potential cost of the proposed amendment to the regulation (22).

There are additional cost factors to individuals who may be impacted by illnesses derived from occupational exposure to bloodborne pathogens. For example, the maximum wage replacement benefit under California Workers' Compensation is currently $490 per week. This corresponds to two-thirds of an average $735 weekly wage of a healthcare employee (See the average wage for healthcare providers listed in Table 6). Thus, many healthcare workers would not be able to replace their full lost wages by Worker's Compensation disability indemnity. There is also no compensation for lost overtime, as many healthcare workers work in excess of 40 hours per week. This determination does not include the impact on physicians and certain other medical care professionals, whose compensation is considerably higher.

Costs or Savings in Federal Funding to the State

The proposed amendment will not result in costs or savings in federal funding to the state.

Costs or Savings to Local Agencies or School Districts Required to be Reimbursed

No costs to local agencies or school districts are required to be reimbursed. See explanation under "Determination of Mandate."

Other Nondiscretionary Costs or Savings Imposed on Local Agencies

This proposed regulation imposes nondiscretionary costs that will ultimately result in lower medical costs and a savings to local agencies. It is estimated that local agencies make up approximately 9% of all California employment. Therefore, local agencies would incur 9% of the above costs and savings resulting in a net annual savings of over $9 million. Public health facilities operated by local agencies will incur a cost due to the increased cost of devices that provide protection from sharps injuries. However, the decreased incidence of disease in the general population should yield a net benefit and reduction in costs to local agencies.

DETERMINATION OF MANDATE

The Occupational Safety and Health Standards Board has determined that the proposed regulation does not impose a mandate requiring reimbursement by the state pursuant to Part 7 (commencing with Section 17500) of Division 4 of the Government Code because this regulation does not constitute a "new program or higher level of service of an existing program within the meaning of Section 6 of Article XIII B of the California Constitution."

The California Supreme Court has established that a "program" within the meaning of Section 6 of Article XIII B of the California Constitution is one which carries out the governmental function of providing services to the public, or which, to implement a state policy, imposes unique requirements on local governments and does not apply generally to all residents and entities in the state. (County of Los Angeles v. State of California (1987) 43 Cal.3d 46.)

The proposed regulation does not require local agencies to carry out the governmental function of providing services to the public. Rather, the regulation requires local agencies to take certain steps to ensure the safety and health of their own employees only. Moreover, the proposed regulation does not in any way require local agencies to administer the California Occupational Safety and Health program. (See City of Anaheim v. State of California (1987) 189 Cal.App.3d 1478.)

The proposed regulation does not impose unique requirements on local governments. All employers - state, local and private - will be required to comply with the prescribed standard.

PLAIN ENGLISH STATEMENT

It has been determined that the proposal may affect small business. The express terms of the proposal written in plain English have been prepared by the Board pursuant to Government Code sections 11342(e) and 11346(a)(1) and the informative digest for this proposal constitutes a plain English overview.

ASSESSMENT

The adoption of the proposed amendments to this regulation will only marginally create or eliminate jobs in the State of California and will not result in the elimination of existing businesses. The creation or expansion of businesses in the State of California is anticipated to be minor.

ALTERNATIVES THAT WOULD AFFECT PRIVATE PERSONS

No alternatives considered by the Board would be more effective in carrying out the purpose for which the action is proposed or would be as effective and less burdensome to affected private persons than the proposed action.


TABLE 1 - ESTIMATED NUMBER AND TYPES OF FACILITIES AFFECTED BY THE PROPOSAL

Type of Facility

Number

All

State

Local

Private

Small

of Facilities

Business

Business*

Healthcare

Hospitals

597

597

482

Hospitals, State

10

10

Hospitals, Local

105

105

Doctor's Offices

30,224

30,224

30,224

30,224

Dentist's Offices

15,530

15,530

15,530

15,530

Laboratory

2,500

2,500

2,500

2,500

Home Care

1,587

1,587

1,587

1,587

Nursing Facilities

1,547

1,547

1,547

1,547

Bloodbanks, etc.

153

153

153

153

Public Health Clinics

98

98

98

Emergency, State

1

1

1

Emergency, Local

569

569

569

Emergency, Private

194

194

194

194

TOTAL HEALTHCARE

53,000

11

772

52,217

51,735

Nonmedical

Veterinary Services

3,660

3,660

3,660

3,660

Research

174

174

174

Manufacturing

24,305

24,305

24,305

Law Enforcement, State

1

1

1

Law Enforcement, Local

517

517

517

Funeral Parlors

2,587

2,587

2,587

2,587

Corrections Facilities

91

91

Corrections, State

33

33

Corrections, Local

58

58

58

TOTAL NONMEDICAL

31,426

266

575

30,552

6,247

GRAND TOTAL

84,426

277

1,347

82,769

57,982

*Small businesses are also included in the Private Business column.


TABLE 2 - HOSPITAL SURVEY OF NEEDLESTICK INJURIES AMONG
HEALTHCARE PROVIDERS
- 77 HOSPITALS 1993-95

Employee

Needlesticks

Percentage of

Distribution of

Estimated

Classifications

Incidents

Needlestick Distribution

Total Number of

Needlesticks

Among Types

Needlesticks in US

per Year in

Shown

California

Physician

1,319

12.4

99,266

11,912

Medical Student

91

0.9

6,849

822

Nurse: RN, LPN

5,185

48.8

390,216

46,826

Nursing Student

79

0.7

5,945

713

Respiratory Therapist

171

1.6

12,869

1,544

Surgery Attendant

575

5.4

43,274

5,193

Other Attendant

423

4.0

31,834

3,820

Phlebotomist

546

5.1

41,091

4,931

Clinical Lab Worker

388

3.7

29,200

3,504

Technologist

528

5.0

39,737

4,768

Dentist

44

0.4

3,311

397

Dental Hygienist

36

0.3

2,709

325

Housekeeper/Laundry

499

4.7

37,554

4,506

Paramedic

18

0.2

1,355

163

Other, Student

84

0.8

6,322

759

Other

644

6.1

48,467

5,816

Total

10,630

100

800,000

96,000

Estimated Based on

Estimated Based on

Percent of Total

12% for California

* EPINet, Uniform Needlestick and Sharp Object Injury Report, 77 Hospitals, 1993-95, International Health-care- worker Safety Center, University of Virginia.


TABLE 3 - POTENTIAL COST OF SHARPS INJURY PREVENTION DEVICES

Syringes With

Blood

Lancets

IV Line

IV Line

Total

Total

Needles

Collection

Ports

Catheters

Sharps

Cost

Total Units

Units

Units

Units

Units

108,000,000

77,280,000

31,800,000

120,000,000

24,000,000

361,080,000

Cost Increase

Incremental Cost

$ 22,680,000

$13,137,600

$ 2,544,000

$48,000,000

$18,000,000

$104,361,600

% Currently Converted

21

22.5

45

70

20

Net Cost Increase

Net Cost

$ 17,917,200

$10,181,640

$ 1,399,200

$14,400,000

$14,400,000

$ 58,298,040

Median Unit Cost

Engineered Device

$ 0.30

$ 0.42

$ 0.15

$ 0.60

$ 1.40

Conventional

$ 0.09

$ 0.25

$ 0.07

$ 0.20

$ 0.65

Cost Increase

$ 0.21

$ 0.17

$ 0.08

$ 0.40

$ 0.75

Source: T. Juraschek, Becton Dickinson and Company, August 6, 1998.

Total Number

Syringes With

% Currently

Cost Increase

Net Cost

Unit Cost

Of Syringes

Needles

Converted

Increase

Total Units

516,000,000

123,840,000

21

$29,721,600

$23,480,064

Engineered Device

$ 0.30

Conventional

$ 0.06

Median Cost Increase

$ 0.24

Source: Retractable Technologies, Inc., July 8, 1998.


TABLE 4 - ESTIMATES OF ADDITIONAL RECORDKEEPING COSTS FOR IMPLEMENTING THE PROPOSED STANDARD

Type of Facility

Number

Time

Recordkeeping

Recordkeeping

Recordkeeping

of Facilities

Required

Cost By Facility

Cost By Facility

$30/Hr

@ $ 30/hour

@ $ 22.66/hour

Hospitals, High

597

2 hr/wk

$ 1,862,640

$ 1,862,640

1,406,914

Hospitals, State

10

2 hr/wk

$ 31,200

Hospitals, Local

105

2 hr/wk

$ 327,600

Hospitals, Private

482

2 hr/wk

$ 1,503,840

Doctor's Offices, High

30,224

2 hr/mo

$ 21,761,280

$ 21,761,280

16,437,020

Doctor's Offices, Low

13,652

2 hr/mo

$ 9,829,440

Doctor's Offices

1

2 hr/mo

$ 720

Dentist's Offices, High

15,530

2 hr/mo

$ 11,181,600

Dentist's Offices, Low

12,021

2 hr/mo

$ 8,655,120

Dentist's Offices

1

2 hr/mo

$ 720

Emergency, Total

764

2 hr/wk

$ 2,383,680

$ 2,383,680

1,800,473

Emergency, State

1

2 hr/wk

$ 3,120

Emergency, Local

569

2 hr/wk

$ 1,775,280

Emergency, Private

194

2 hr/wk

$ 605,280

Laboratory

2,500

1 hr/wk

$ 3,900,000

3,900,000

2,945,800

Laboratory

1

1 hr/wk

$ 1,560

Nursing Facilities

1,464

2 hr/wk

$ 4,567,680

$ 4,567,680

3,450,121

Nursing Facilities

1

2 hr/wk

$ 3,120

Bloodbanks

153

1 hr/wk

$ 238,680

$ 238,680

360,566

Bloodbanks, etc.

1

1 hr/wk

$ 1,560

Corrections, State

33

2 hr/wk

$ 102,960

$ 102,960

77,769

Corrections, County

58

2 hr/wk

$ 180,960

$ 180,960

136,685

Corrections

1

2 hr/wk

$ 3,120

$ 3,120

2,357

Public Health Clinics

98

2 hr/wk

$ 305,760

$ 305,760

230,951

Public Health Clinics

1

2 hr/wk

$ 3,120

Veterinary Clinics

10,038

1 hr/wk

$ 15,659,280

$ 15,659,280

11,827,976

Veterinary Clinics

1

1 hr/wk

$ 1,560

Home Care

1,587

1 hr/wk

$ 2,475,720

$ 2,475,720

1,869,994

Home Care

1

1 hr/wk

$ 1,560

Research

174

1 hr/wk

$ 271,440

$ 271,440

205,028

Research

1

1 hr/wk

$ 1,560

Law Enforcement

544

1 hr/wk

$ 848,640

$ 848,640

641,006

Law Enforcement

1

1 hr/wk

$ 1,560

Manufacturing

24305

1 hr/wk

$ 37,915,800

$ 37,915,800

28,639,068

Manufacturing

1

1 hr/wk

$ 1,560

Total Recordkeeping Cost

$ 92,477,640

70,031,727


TABLE 5 - COST TO A TYPICAL SMALL BUSINESS "DENTIST"
CALIFORNIA

Number

Employees

Patients

Needle

Syringes

Cost, Low

Cost, High

Cost,

2000/year

Sticks

Total

$0.22

$0.83

Average

COST OF

SHARPS UTILIZATION

Dentist's Offices, High

15,530

83,420

31,060,000

61,499

31,060,000

$ 6,833,200

$ 25,779,800

16,306,500

Dentist's Offices, Low

12,021

37,948

24,042,000

47,603

24,042,000

$ 5,289,240

$ 19,954,860

12,622,050

Dentist's Office, One

1

2000

2000

$ 440

$ 1,660

1,050

COST OF

SHARPS INJURY LOG

Dentist's Offices, High

15,530

83,420

$ 11,181,600

Dentist's Offices, Low

12,021

37,948

$ 8,655,120

Dentist's Office, One

1

$ 720

Average Cost--Sharps and Log

1,770

Source E. Cuny, University of the Pacific, August 7, 1998

TABLE 6 - ESTIMATED BENEFITS FROM REDUCTIONS IN SHARP'S INJURIES

Time

Rate

Potential Savings

Total Cost, per 96,000

Cases per Year

TREATMENT PROGRAMS

Screening and Initial

Treatment per J&J Estimates

$ 2,234

$ 214,464,000

Screening and Initial

Treatment per B&D Estimates

$ 3,832

$ 367,872,000

FURTHER POTENTIAL SAVINGS

Follow-up cost of treatment, per

J&J estimates

$ 595

*

Lost Productivity (employer)

6 months

$735/week

$ 19,110

*

Workers' Compensation

6 months

$490/week

$ 12,740

*

Lost Wages (Difference Between

Workers' Comp. and Employee Wages)

6 months

$ 6,370

*

Liability Costs, (examples include

lawsuit settlements over $1 million).**

Variable

*

Death per Case

Variable

*

Potential Benefits, Low

$ 214,464,000

Potential Benefits, High

$ 367,872,000

*    Potential savings were not quantified
**  Source: Hospitals Should Prepare for AIDS Liability Problems, Hospitals, May 5, 1990, Pages 33 -34


TABLE 7 - SUMMARY OF ESTIMATED COSTS AND BENEFITS OF THE PROPOSAL

Total Cost of Conversion

To Safety Devices & Recordkeeping

Low

High

Average

Conventional Needles to Needleless Systems

$ 104,361,600

$ 104,361,600

$ 104,361,600

Record Keeping Cost

$ 70,031,727

$ 92,477,640

$ 81,254,684

Total Cost

$ 174,393,327

$ 196,839,240

$ 185,616,284

Benefits Due to Reductions in Needlestick Treatment

Savings on Screening and Treatment Cost

$ 214,464,000

$ 367,872,000

$ 291,168,000

Net Savings. (Benefits - Cost)

$ 40,070,673

$ 171,032,760

$ 105,551,717

Cost / Benefit Ratio

0.81

0.54

0.64