(1)Under the existing law, the Dental Practice Act, the Dental Board of California, among other things, establishes requirements pursuant to which an California licenses and regulates the practice of dentistry. The act provides that an applicant may obtain an initial 2-year license to practice dentistry and a 2-year renewal license, including that the board may require successful completion of continuing education as a condition to license renewal. license. The act also makes certain conduct unprofessional conduct and authorizes the board to revoke or suspend a license or reprimand or place on probation a dentist for that unprofessional conduct.

Under the existing law, the Medical Practice Act, the Medical Board of California, the Osteopathic Medical Board of California, and the California Board of Podiatric Medicine establish requirements pursuant to which an applicant may obtain an initial 2-year license or subsequent 2-year renewal license to practice medicine as a podiatrist, as a physician and surgeon, osteopathic medicine as an osteopathic physician and surgeon, or podiatric medicine as a podiatrist, respectively. Under existing law, the Medical Board of California is required to adopt and administer standards for the continuing education of physicians and surgeons and each year audits a random sample of physicians and surgeons who have reported compliance with those requirements and requires a noncompliant licensee to make up the deficiency during the next renewal period. Under existing law, a licensee who fails to so comply is ineligible for a subsequent renewal license until he or she documents compliance to the board. Existing law provides for similar continuing education requirements as a condition of obtaining a renewal license to practice osteopathic medicine and podiatric medicine. The act authorizes these boards to discipline a licensee for specified unprofessional conduct.

This bill would require a covered licensee, defined as a dentist, physician and surgeon, osteopathic physician and surgeon, or person licensed to practice podiatric medicine, who practices in a setting other than a clinic, general acute care hospital, or skilled nursing facility, to adopt and implement an antimicrobial stewardship policy consistent with specified guidelines or methods of intervention, as defined, before applying for a renewal license and, upon applying for a renewal license, to certify in writing, on a form prescribed by the respective licensing board, that he or she has both adopted an antimicrobial stewardship policy and is in compliance with that policy. The bill would require those licensing boards to audit, during each year, a random sample of covered licensees who have certified compliance with these requirements and would limit the audit of an individual covered licensee to once every 4 years. The bill would require a covered licensee who is selected for audit to submit to the board, on a form prescribed by the board, a copy of his or her antimicrobial stewardship policy. The bill would require the respective licensing board, that determines that its audited covered licensee has failed to comply with these requirements, to require that covered licensee to comply with these requirements during the following renewal period. The bill would provide that the failure of a covered licensee who fails to comply is ineligible for license renewal until he or she has documented compliance. to comply with those requirements during the renewal period constitutes unprofessional conduct.

(2)Under existing law, health facilities, including, among others, general acute care hospitals, skilled nursing facilities, primary care clinics, and specialty clinics, are licensed and regulated by the State Department of Public Health, and a violation of those provisions is a crime. Existing law requires that each general acute care hospital, on or before July 1, 2015, adopt and implement an antimicrobial stewardship policy in accordance with guidelines established by the federal government and professional organizations that includes a process to evaluate the judicious use of antibiotics, as specified. Existing law requires each skilled nursing facility, on or before January 1, 2017, to adopt and implement an antimicrobial stewardship policy consistent with guidelines developed by the federal Centers for Disease Control and Prevention and other specified entities.

This bill would, beginning January 1, 2018, require a clinic to adopt and implement an antimicrobial stewardship policy consistent with specified guidelines or methods of intervention, as defined. Because this bill would create new crimes, the bill would impose a state-mandated local program.

(3)The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this act for a specified reason.

(2)Under existing law, health facilities, including, among others, general acute care hospitals, skilled nursing facilities, primary care clinics, and specialty clinics, are licensed and regulated by the State Department of Public Health, and a violation of those provisions is a crime. Existing law requires that each general acute care hospital, on or before July 1, 2015, adopt and implement an antimicrobial stewardship policy in accordance with guidelines established by the federal government and professional organizations that includes a process to evaluate the judicious use of antibiotics, as specified. Existing law requires each skilled nursing facility, on or before January 1, 2017, to adopt and implement an antimicrobial stewardship policy consistent with guidelines developed by the federal Centers for Disease Control and Prevention and other specified entities.

This bill would state the intent of the Legislature to enact legislation that would promote the establishment of antimicrobial stewardship programs or policies in outpatient health facilities. The bill makes related findings and declarations. would, beginning January 1, 2018, require a clinic to adopt and implement an antimicrobial stewardship policy consistent with specified guidelines or methods of intervention, as defined. Because this bill would create new crimes, the bill would impose a state-mandated local program.

Under existing law, health facilities, including, among others, general acute care hospitals, skilled nursing facilities, primary care clinics, and specialty clinics, are licensed and regulated by the State Department of Public Health, and a violation of those provisions is a crime. Existing law requires that each general acute care hospital, on or before July 1, 2015, adopt and implement an antimicrobial stewardship policy in accordance with guidelines established by the federal government and professional organizations that includes a process to evaluate the judicious use of antibiotics, as specified. Existing law requires each skilled nursing facility, on or before January 1, 2017, to adopt and implement an antimicrobial stewardship policy consistent with guidelines developed by the federal Centers for Disease Control and Prevention and other specified entities.

This bill would state the intent of the Legislature to enact legislation that would promote the establishment of antimicrobial stewardship programs or policies in outpatient health facilities. The bill makes related findings and declarations.

 THIRD READING  

Bill No: SB 994

Author:

:

Vote:

SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 7-0, 4/11/16

AYES: Hill, Berryhill, Block, Galgiani, Jackson, Mendoza, Wieckowski

NO VOTE RECORDED: Bates, Hernandez

SENATE HEALTH COMMITTEE: 6-1, 4/20/16

AYES: Hall, Mitchell, Monning, Pan, Roth, Wolk

NOES: Hernandez

NO VOTE RECORDED: Nguyen, Nielsen

SENATE GOVERNANCE & FIN. COMMITTEE: 7-0, 6/29/16

AYES: Hertzberg, Nguyen, Beall, Hernandez, Lara, Moorlach, Pavley

SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8

SUBJECT:

SOURCE: Author

DIGEST: This bill allows the boards of directors of the Beach Cities Health Care District and the Peninsula Health Care District to use design-build contracting for the construction of buildings in those districts.

ANALYSIS:

Existing law:

1. Requires, pursuant to the Local Agency Public Construction Act, that local officials must invite bids for construction projects and then award contracts to the lowest responsible bidder.
2. Allows some state and local officials to use the “design-build” method to procure both design and construction services from a single company before the development of complete plans and specifications.

This bill:

1. Allows, until January 1, 2022, the Beach Cities and Peninsula Health Care Districts’ board of directors, notwithstanding any other law, to use the design-build procedure to construct facilities or other buildings in those districts.
2. Specifies that a health care district must use the design-build procedure that current law establishes for local agencies and provides that statutory references to a “local agency” means a health care district and its board of directors.
3. Requires that, to the extent any project using the design-build process authorized by this bill must be reviewed and inspected in accordance with the standards and requirements of the Alfred E. Alquist Hospital Facilities Seismic Safety Act of 1983, the bill’s provisions must not be construed as an exemption from that act.

Background

The Local Agency Public Construction Act requires local officials to invite bids for construction projects and then award contracts to the lowest responsible bidder. This design-bid-build method is the traditional, and most widely-used, approach to public works construction. This approach splits construction projects into two distinct phases: design and construction. During the design phase, the local agency prepares detailed project plans and specifications using its own employees or by hiring outside architects and engineers. Once project designs are complete, local officials invite bids from the construction community and award the contract to the lowest responsible bidder.

State law also allows some state and local officials to use the design-build method to procure both design and construction services from a single company before the development of complete plans and specifications. Under design-build, a public agency contracts with a single entity - which can be a single firm, a consortium, or a joint venture - to design and construct a project. Before inviting bids, the agency prepares documents that describe the basic concept of the project, as opposed to a complete set of drawings and specifications of what will be constructed. In the bidding phase, the agency typically evaluates bids on a best-value basis, incorporating technical factors, such as qualifications and design quality, in addition to price.

Until January 1, 2025, all counties and cities can use the design-build method to construct buildings and related improvements and other specified types of public works that cost more than $1 million (SB 785, Wolk, Chapter 931, Statutes of 2014). The Legislature also has authorized some special districts to construct projects using the design-build method, including four local health care districts:

• The Sonoma Valley Healthcare District can use the design-build process when contracting for the construction of a building and improvements directly related to a hospital or health facility building at the Sonoma Valley Hospital (SB 1699, Wiggins, Chapter 415, Statutes of 2008). Following SB 1699’s enactment, the Sonoma Valley Health Care District’s voters approved a $35 million bond to finance earthquake safety improvements to bring the hospital’s emergency room into compliance with the state’s seismic safety standards for hospitals. The District’s upgraded facility, which was constructed using design-build contracts, opened in 2013.
• The Last Frontier Healthcare District can use the design-build process when contracting for the construction of a building and improvements directly related to a hospital or health facility building at the Modoc Medical Center (SB 268, Gaines, Chapter 18, Statutes of 2014).
• The Marin Healthcare District can use the design-build process when contracting for the construction of a building and improvements directly related to a hospital or health facility building at the Marin General Hospital (SB 785, Wolk, Chapter 931, Statutes of 2014).
• The Mayers Memorial Hospital District can use the design-build process when contracting for the construction of a building and improvements directly related to a hospital or health facility building at the Mayers Memorial Hospital District (AB 1290, Dahle, Chapter 34, Statutes of 2015).

The Beach Cities Health Care District was established in 1955 to serve residents in the Los Angeles County communities of Hermosa Beach, Manhattan Beach, and Redondo Beach. The district is governed by a five-member board of directors elected by voters within the district’s boundaries to serve four-year terms. Subsequent to the closure of the District’s South Bay Hospital in 1998, the District has focused on providing its more than 120,000 residents with a variety of health and wellness programs promoting healthy lifestyles, physical fitness, and emotional health.

The Peninsula Health Care District serves more than 200,000 residents in San Mateo County, including the communities of San Bruno, Millbrae, Burlingame, Hillsborough, and parts of San Mateo and Foster City. The District is governed by a five-member board of directors elected by voters within the District’s boundaries to serve four-year terms. The District was established in 1947 and completed the construction of Peninsula Hospital in 1954. A newly-constructed replacement for Peninsula Hospital operated by Mills Peninsula Health Services/Sutter Health opened in May 2011. That facility is located on land owned by Peninsula Healthcare District, pursuant to a long-term lease agreement. In addition to managing property, the District supports a variety of community-based health programs and partnerships, provides health-related community grants, and invests in health care facilities.

This year, the Legislature is considering SB 957 (Hueso), which extends the authority to use the design-build contracting method to any local health care district that own or operates either a hospital or medical clinic. Because the Beach Cities Health Care District and the Peninsula Health Care District do not own or operate hospitals or medical clinics, district officials want the Legislature to grant separate authority for the two districts to use design-build contracting to build buildings within their districts’ boundaries.

Comments

Purpose of the bill. The Beach Cities Health Care District is home to a rapidly growing senior population. This bill’s grant of design-build authority allows the district to further improve the health of older adults through the construction of a therapeutic senior living community. This much-needed community work would consolidate vital social services for older adults - including rehabilitation and fitness facilities, pharmacies, medical offices, social workers and grocery stores - onto a single, accessible campus. The planning process is already underway for these development projects, and design-build authority will help to keep costs down, expedite the design and construction process, and save taxpayer dollars while fulfilling community health care needs. Similarly, the Peninsula Health Care District plans to develop the Peninsula Wellness Community, which is envisioned as a “gathering place” that will engage all ages and levels of wellness with services and activities. The community will offer housing for older adults, health support across generations, and working spaces for professionals and researchers. It will become a hub for wellness and medical services, and a catalyst for intergenerational connections. The design-build authority granted by this bill will allow for more cost-effective development of the Peninsula Wellness Community by fostering more competition among general contractors and allowing a general contractor to provide earlier input in the design process.

Non-provider districts. The four health care districts that have design-build authority under existing law all own and operate hospitals and were granted authority to use design-build contracting for construction projects that are associated with those hospitals. Like several other local healthcare districts throughout California, the Beach Cities and Peninsula Health Care Districts no longer own or operate hospitals. Peninsula Health Care District does not provide any direct health care services to its residents. Instead, the districts rely largely on property tax revenues and rental income to make grants to support health care-related activities. By allowing district officials to award construction contracts based on a “best value” determination, this bill makes the procurement process for the districts’ construction projects more subjective. More subjectivity increases the chances that inappropriate factors could influence which bidders are awarded some contracts. For some local governments, this additional subjectivity may be justified by the time and cost savings associated with integrating the design and construction process for complex infrastructure, like hospitals or medical clinics. It is less clear why a health care district that is only responsible for managing property should be allowed to use the design-build contracting model to construct medical office buildings, market-rate housing units, or other common infrastructure that will serve only to generate rental income for the district.

Mandate. The design-build procedures that this bill authorizes the Beach Cities and Peninsula Health Care Districts to use requires that specified information provided by bidders in response to a request for qualifications must be certified under penalty of perjury. By creating a new crime, this bill also creates a new state-mandated program. But the bill disclaims the state's responsibility for reimbursing local governments for enforcing these new crimes. That's consistent with the California Constitution, which says that the state does not have to reimburse local governments for the costs of new crimes (Article XIIIB, 6[a][2]).

Urgency. Regular statutes take effect on January 1 following their enactment; bills passed in 2016 take effect on January 1, 2017. The California Constitution allows bills with urgency clauses to take effect immediately if they're needed for the public peace, health, and safety. This bill contains an urgency clause declaring that it is necessary for its provisions to go into effect immediately to facilitate construction of facilities or other buildings in the two districts at the earliest possible time pursuant to design-build authority.

Special legislation. The California Constitution prohibits special legislation when a general law can apply (Article IV, §16). This bill contains findings and declarations explaining the need for legislation that applies only to the Beach Cities Health Care District and the Peninsula Health Care District.

FISCAL EFFECT: Appropriation: Fiscal Com.: Local:

SUPPORT: (Verified 8/1/16)

Association of California Healthcare Districts

Beach Cities Health Care District

Peninsula Health Care District

State Building and Construction Trades Council

OPPOSITION: (Verified 8/1/16)

None received

Prepared by:

8/3/16 19:14:36

**** END ****

SENATE COMMITTEE ON GOVERNANCE AND FINANCE

Senator Robert M. Hertzberg, Chair

2015 - 2016 Regular

Health care districts: design-build

Allows the boards of directors of the Beach Cities Health Care District and the Peninsula Health Care District to use design-build contracting for the construction of buildings in those districts.

Background

The Local Agency Public Construction Act requires local officials to invite bids for construction projects and then award contracts to the lowest responsible bidder. This design-bid-build method is the traditional, and most widely-used, approach to public works construction. This approach splits construction projects into two distinct phases: design and construction. During the design phase, the local agency prepares detailed project plans and specifications using its own employees or by hiring outside architects and engineers. Once project designs are complete, local officials invite bids from the construction community and award the contract to the lowest responsible bidder.

State law also allows some state and local officials to use the design-build method to procure both design and construction services from a single company before the development of complete plans and specifications. Under design-build, a public agency contracts with a single entity - which can be a single firm, a consortium, or a joint venture - to design and construct a project. Before inviting bids, the agency prepares documents that describe the basic concept of the project, as opposed to a complete set of drawings and specifications of what will be constructed. In the bidding phase, the agency typically evaluates bids on a best-value basis, incorporating technical factors, such as qualifications and design quality, in addition to price.

Until January 1, 2025, all counties and cities can use the design-build method to construct buildings and related improvements and other specified types of public works that cost more than $1 million (SB 785, Wolk, 2014). The Legislature also has authorized some special districts to construct projects using the design-build method, including four local health care districts:

• The Sonoma Valley Healthcare District can use the design-build process when contracting for the construction of a building and improvements directly related to a hospital or health facility building at the Sonoma Valley Hospital (SB 1699, Wiggins, 2008). Following SB 1699’s enactment, the Sonoma Valley Health Care District’s voters approved a $35 million bond to finance earthquake safety improvements to bring the hospital’s emergency room into compliance with the state’s seismic safety standards for hospitals. The District’s upgraded facility, which was constructed using design-build contracts, opened in 2013.
• The Last Frontier Healthcare District can use the design-build process when contracting for the construction of a building and improvements directly related to a hospital or health facility building at the Modoc Medical Center (SB 268, Gaines, 2014).
• The Marin Healthcare District can use the design-build process when contracting for the construction of a building and improvements directly related to a hospital or health facility building at the Marin General Hospital (SB 785, Wolk, 2014).
• The Mayers Memorial Hospital District can use the design-build process when contracting for the construction of a building and improvements directly related to a hospital or health facility building at the Mayers Memorial Hospital District (AB 1290, Dahle, 2015).

The Beach Cities Health Care District was established in 1955 to serve residents in the Los Angeles County communities of Hermosa Beach, Manhattan Beach, and Redondo Beach. The district is governed by a five-member board of directors elected by voters within the district’s boundaries to serve four-year terms. Subsequent to the closure of the District’s South Bay Hospital in 1998 the District has focused on providing its more than 120,000 residents with a variety of health and wellness programs promoting healthy lifestyles, physical fitness, and emotional health.

The Peninsula Health Care District serves more than 200,000 residents in San Mateo County, including the communities of San Bruno, Millbrae, Burlingame, Hillsborough, and parts of San Mateo and Foster City. The District is governed by a five-member board of directors elected by voters within the District’s boundaries to serve four-year terms. The District was established in 1947 and completed the construction of Peninsula Hospital in 1954. A newly-constructed replacement for Peninsula Hospital operated by Mills Peninsula Health Services/Sutter Health opened in May 2011. That facility is located on land owned by Peninsula Healthcare District, pursuant to a long-term lease agreement. In addition to managing property, the District supports a variety of community-based health programs and partnerships, provides health-related community grants, and invests in health care facilities.

This year, the Legislature is considering SB 957 (Hueso), which would extend the authority to use the design-build contracting method to any local health care district that own or operates either a hospital or medical clinic. Because the Beach Cities Health Care District and the Peninsula Health Care District do not own or operate hospitals or medical clinics, district officials want the Legislature to grant separate authority for the two districts to use design-build contracting to build buildings within their districts’ boundaries.

Proposed Law

Senate Bill 994 allows, until January 1, 2022, the Beach Cities and Peninsula Health Care Districts’ board of directors, notwithstanding any other law, to use the design-build procedure to construct facilities or other buildings in those districts.

SB 994 specifies that a health care district must use the design-build procedure that current law establishes for local agencies and provides that statutory references to a “local agency” means a health care district and its board of directors.

SB 994 requires that, to the extent any project using the design-build process authorized by the bill must be reviewed and inspected in accordance with the standards and requirements of the Alfred E. Alquist Hospital Facilities Seismic Safety Act of 1983, the bill’s provisions must not be construed as an exemption from that act.

State Revenue Impact

No estimate.

Comments

1. Purpose of the bill. The Beach Cities Health Care District is home to a rapidly growing senior population. SB 994’s grant of design-build authority would allow the district to further improve the health of older adults through the construction of a therapeutic senior living community. This much-needed community work would consolidate vital social services for older adults - including rehab and fitness facilities, pharmacies, medical offices, social workers and grocery stores - onto a single, accessible campus. The planning process is already underway for these development projects, and design-build authority will help to keep costs down, expedite the design and construction process, and save taxpayer dollars while fulfilling community health care needs. Similarly, the Peninsula Health Care District plans to develop the Peninsula Wellness Community, which is envisioned as a “gathering place” that will engage all ages and levels of wellness with services and activities. The community will offer housing for older adults, health support across generations, and working spaces for professionals and researchers. It will become a hub for wellness and medical services, and a catalyst for intergenerational connections. The design-build authority granted by SB 994 will allow for more cost-effective development of the Peninsula Wellness Community by fostering more competition among general contractors and allowing a general contractor to provide earlier input in the design process.

2. Non-provider districts. The four health care districts that have design-build authority under existing law all own and operate hospitals and were granted authority to use design-build contracting for construction projects that are associated with those hospitals. Like several other local healthcare districts throughout California, the Beach Cities and Peninsula Healthcare Districts no longer own or operate hospitals. Peninsula Health Care District does not provide any direct health care services to its residents. Instead, the districts rely largely on property tax revenues and rental income to make grants to support health care-related activities. By allowing district officials to award construction contracts based on a “best value” determination, SB 994 makes the procurement process for the districts’ construction projects more subjective. More subjectivity increases the chances that inappropriate factors could influence which bidders are awarded some contracts. For some local governments, this additional subjectivity may be justified by the time and cost savings associated with integrating the design and construction process for complex infrastructure, like hospitals or medical clinics. It is less clear why a health care district that is only responsible for managing property should be allowed to use the design-build contracting model to construct medical office buildings, market-rate housing units, or other common infrastructure that will serve only to generate rental income for the district.

3. Mandate. The design-build procedures that SB 994 authorizes the Beach Cities and Peninsula Health Care Districts to use requires that specified information provided by bidders in response to a request for qualifications must be certified under penalty of perjury. By creating a new crime, SB 994 also creates a new state-mandated program. But the bill disclaims the state's responsibility for reimbursing local governments for enforcing these new crimes. That's consistent with the California Constitution, which says that the state does not have to reimburse local governments for the costs of new crimes (Article XIIIB, 6[a][2]).

4. Urgency. Regular statutes take effect on January 1 following their enactment; bills passed in 2016 take effect on January 1, 2017. The California Constitution allows bills with urgency clauses to take effect immediately if they're needed for the public peace, health, and safety. SB 994 contains an urgency clause declaring that it is necessary for its provisions to go into effect immediately to facilitate construction of facilities or other buildings in the two districts at the earliest possible time pursuant to design-build authority.

5. Special legislation. The California Constitution prohibits special legislation when a general law can apply (Article IV, §16). SB 994 contains findings and declarations explaining the need for legislation that applies only to the Beach Cities Health Care District and the Peninsula Health Care District.

6. Related legislation. SB 994 is not the first legislative effort to allow all health care districts to use design-build contracting. Early versions of SB 1699 (Wiggins, 2008) would have granted all health care districts the authority to use the design-build method, but the bill was subsequently narrowed to grant the authority only to the Sonoma Valley Health Care District. Similarly, an early version of SB 1005 (Cox, 2010) would have allowed all health care districts to construct projects using the design-build contracting method. That bill died in the Assembly Appropriations Committee. SB 957 (Hueso, 2016) would authorize all health care districts that own or operate a hospital or clinic to use design-build contracting authority. The Senate Governance and Finance Committee approved SB 957 at its April 13, 2016 hearing on a 6-0 vote.

Support and Opposition

(6/23/16)

Support: Association of California Healthcare Districts; Beach Cities Health Care District; Peninsula Health Care District; State Building and Construction Trades Council.

Opposition: Unknown.

-- END --

SENATE COMMITTEE ON HEALTH

Senator Ed Hernandez, O.D., Chair

BILL NO: SB 994

SUBJECT: Antimicrobial stewardship policies

SUMMARY:

Requires primary care clinics and specialty clinics, by January 1, 2018, and physicians, podiatrists and dentists when applying for their next renewal license, to adopt and implement an antibiotic stewardship policy, as defined.

Existing law:

1. Requires general acute care hospitals, by July 1, 2015, to adopt and implement an antimicrobial stewardship policy (ASP) in accordance with guidelines established by the federal government and professional organizations; develop a physician supervised multidisciplinary antimicrobial stewardship committee, subcommittee, or workgroup; and report antimicrobial stewardship program activities to each appropriate hospital committee undertaking clinical quality improvement activities.
2. Requires skilled nursing facilities (SNFs), by January 1, 2017, to adopt and implement an ASP that is consistent with antimicrobial stewardship guidelines developed by the federal Centers for Disease Control and Prevention (CDC), the federal Centers for Medicare and Medicaid Services, the Society for Healthcare Epidemiology of America, or similar recognized professional organizations. Specifies that failure of a SNF to comply with this requirement is subject to citation and civil penalty provisions in existing law.
3. Requires, on or after January 1, 2018, a licensed veterinarian who renews his or her license to complete a minimum of one credit hour of continuing education on the judicious use of medically important antimicrobial drugs, as defined, every four years as part of his or her continuing education requirements.
4. Licenses and regulates primary care clinics and specialty clinics by the Department of Public Health (DPH). Specialty clinics include surgical clinics, chronic dialysis clinics, rehabilitation clinics, and alternative birth centers. Requires clinics, unless accredited by a recognized accrediting organization or unless it meets other specified exceptions, to be periodically inspected for compliance with licensing laws and regulations no less than once every three years, and as often as necessary to ensure the quality of care being provided.
5. Licenses and regulates physicians through the Medical Board of California, osteopathic physicians through the Osteopathic Medical Board, podiatrists through the Board of Podiatric Medicine, and dentists through the Dental Board of California.

This bill:

1. Requires a primary care clinic or a specialty clinic, as defined, on or before January 1, 2018, to adopt and implement an ASP, as defined.
2. Requires physicians, osteopathic physicians, podiatrists, and dentists, who practice in a setting other than a licensed primary care or specialty clinic, general acute care hospital, or SNF, to adopt and implement an ASP, as defined, before applying for a renewal license.
3. Requires physicians, osteopathic physicians, podiatrists, and dentists, upon filing an application with their respective licensing board for a renewal license, to certify in writing, on a form prescribed by their respective board, that he or she has both adopted an ASP and is in compliance with that policy.
4. Requires the licensing boards for physicians, osteopathic physicians, podiatrists, and dentists, to audit during each year a random sample of licensees who have certified compliance with the ASP policy, but prohibits the boards from auditing an individual licensee more than once every four years. Requires licensees selected for an audit to submit to his or her respective licensing board, on a form prescribed by that board, a copy of his or her ASP.
5. Requires a licensing board of a physician, osteopathic physician, podiatrist, or dentist, if the board determines that an audited licensee has failed to comply with the ASP requirement, to require that licensee to comply during the following renewal period. Specifies that failure to comply within the following renewal period constitutes unprofessional conduct, as specified.
6. Defines an ASP as efforts to promote the appropriate prescribing of antimicrobials for patients, with the goal of reducing antimicrobial overuse and misuse and minimizing the development of antimicrobial resistant infections, that is consistent with one of the following parameters:
   1. Antimicrobial stewardship guidelines published by the CDC, the federal Centers for Medicare and Medicaid Services, the Society for Healthcare Epidemiology, the Infectious Disease Society of America, or similar recognized professional organizations; or,
   2. Evidence-based methods. Requires, to the extent practicable, evidence-based antimicrobial stewardship policies to include more than one intervention or component. Defines “evidence-based methods” as antimicrobial prescribing intervention methods that have been proven effective through outcome evaluations or studies, including, but not limited to, audit and feedback, academic detailing, clinical decision support, delayed prescribing practices, poster-based interventions, accountable justification, and peer comparison.
7. Makes various legislative findings and declarations, including that the CDC estimates that at least two million Americans are infected with, and 23,000 Americans dies as a result of, antibiotic-resistant infections, and that in one year, 262.5 million courses of antibiotics are written in outpatient settings, with the CDC estimating that over one-half of the antibiotics prescribed in outpatient settings are unnecessary. Also finds and declares that the President’s National Action Plan for Combating Antibiotic-Resistant Bacteria calls for the establishment of antibiotic stewardship activities in all healthcare delivery settings, including outpatient settings, by 2020.

FISCAL EFFECT:

This bill has not been analyzed by a fiscal committee.

COMMENTS:

1. Author’s statement. According to the author, the CDC estimates that at least 23,000 Americans die as a result of antibiotic resistant infections every year and the threat is a growing. A recent study commissioned by the United Kingdom determined that by 2050, worldwide, more people will die from antibiotic resistant infections than from cancer. While not the only cause, the overuse and misuse of antibiotics in medicine is a significant contributing factor driving the development of antibiotic resistance and if we are to truly solve the problem, among other things, we need to focus on promoting more judicious antibiotic prescribing. A majority of antibiotics are prescribed in non-hospital health care settings, such a medical offices where physicians, physician assistants and nurse practitioners work. Based on data from other countries, an estimated 80% of antibiotic prescriptions are written in the outpatient setting. The CDC estimates at least 50% of the antibiotic prescribing in outpatient settings is unnecessary or inappropriate. SB 994 will promote better antibiotic prescribing and ultimately help reduce the burden of antibiotic resistant infections by requiring antibiotic stewardship policies in outpatient healthcare settings. Antibiotic stewardship improves prescribing decisions through educational interventions.
2. Background. According to the CDC, antibiotic resistance is a quickly growing, extremely dangerous problem. World health leaders have described antibiotic-resistant bacteria as "nightmare bacteria" that "pose a catastrophic threat" to people in every country in the world. Most infections occur in the community, like skin infections with Methicillin-resistant Staphylococcus aureus (MRSA) and sexually transmitted diseases. However, most deaths related to antibiotic resistance occur from drug-resistant infections picked up in healthcare settings, such as hospitals and nursing homes. According to a February 2013 joint letter from the Infectious Diseases Society of America (IDSA) and the Society for Health Epidemiology of America (SHEA) to the National Quality Forum, ample data exist from both inpatient and outpatient settings demonstrating that antibiotics are often prescribed sub-optimally or inappropriately. Antibiotics are misused in a variety of ways. They are often administered when they are not needed, continued when they are no longer necessary, or prescribed at the wrong dose. Broad-spectrum agents may be used unnecessarily against bacteria that are very susceptible or the wrong antibiotic may be given to treat a particular infection. Over the past 30 years, bacteria that are extremely resistant to traditional treatments or resistant to multiple drugs have spread widely among patients in healthcare settings. In some cases these pathogens have been pan-resistant, meaning that they are resistant to all available antibiotics. The unique nature of antibiotics, in which the use of the drugs in one patient can impact the effectiveness of the drug in a different patient, make antibiotic overuse a serious patient safety issue and public health threat. The World Health Organization has characterized antibiotic resistance as “a crisis that has been building up over decades, so that today common and life-threatening infections are becoming difficult or even impossible to treat.” Resistant infections not only result in increased morbidity and mortality, but increased economic burdens. For example, studies have shown that antibiotic-resistant infections are associated with longer lengths of stay and increased mortality, both in the hospital and in intensive care units.
3. Presidential Executive Order and Action Plan. In September of 2014, President Obama issued an executive order, titled “Combating Antibiotic-Resistant Bacteria.” Among other things, this executive order requires the Health and Human Services Agency, by the end of calendar year 2016, to review existing regulations and propose new regulations or other actions, as appropriate, that require hospitals and other inpatient healthcare delivery facilities to implement robust antibiotic stewardship programs that adhere to best practices, such as those identified by the CDC. The executive order also established a federal task force that is required to, as appropriate, define, promulgate, and implement stewardship programs in other healthcare settings, including office-based practices, outpatient settings, emergency departments, and institutional and long-term care facilities, such as nursing homes, pharmacies, and correctional facilities. In March 2015, the White House issued the National Action Plan for Combating Antibiotic-Resistant Bacteria (Action Plan). The Action Plan lays out a five-year plan to achieve five distinct goals by 2020: 1) slow the emergence of resistant bacteria, 2) strengthen One-Health surveillance efforts, 3) advance the development and use of rapid diagnostic tests to identify resistant bacteria, 4) accelerate the development of new antibiotics, other treatments, and vaccines, and 5) improve international collaboration to achieve these goals.
   
4. California’s program.  In February 2010, the DPH Healthcare Associated Infection (HAI) Program developed a statewide antimicrobial stewardship program (ASP) initiative in order to strengthen and promote optimization of antimicrobial utilization in California health care facilities. According to DPH, the purpose of an antimicrobial stewardship program in a healthcare facility is to measure and promote the appropriate use of antimicrobials by selecting the appropriate agent, dose, duration and route of administration in order to improve patient outcomes, while minimizing toxicity and the emergence of antimicrobial resistance. Although guidelines exist for developing ASPs, there is limited information on practical implementation of these guidelines, particularly in resource-limited settings.  According to DPH, its partners in this statewide initiative include the Division of Healthcare Quality and Promotion at CDC, Infectious Disease Association of California, and SHEA. According to the DPH website, current program activities include:
   1. The HAI Program has launched a statewide Antimicrobial Stewardship Program Collaborative, with the goal of ensuring that all California hospitals have a functional and robust ASP to promote patient safety and to decrease antimicrobial resistance. The Collaborative will extend for one year from January through December 2015;
   2. Spotlight on ASP Project, which helps define antimicrobial stewardship programs and activities, and spotlights volunteer hospitals that want to highlight and share with others their ASP progress;
   3. Utilization of a statewide assessment of ASPs present in California healthcare facilities (May 2010 - March 2011) to develop evidence-based recommendations on how to implement or strengthen ASPs given available resources and facility attributes;  
   4. Developing recommendations with the Antimicrobial Stewardship Subcommittee of the California HAI Advisory Committee;
   5. Defining activities that comprise ASPs in California hospitals; and,
   6. The California Antibiogram Project, which collects information on specific antimicrobial-organism combinations across California general acute care hospitals.
5. Double referral. This bill was heard in the Senate Business, Professions and Economic Development Committee on April 11, 2016, and passed with a 7-0 vote.
6. Prior legislation. SB 361 (Hill, Chapter 764, Statutes of 2015), required SNFs to adopt and implement an antimicrobial stewardship policy by January 1, 2017.

SB 27 (Hill, Chapter 758, Statutes of 2015), restricted the use of antimicrobial drugs in livestock, required a veterinarian’s prescription or feed directive for use, eliminated the over-the-counter availability of these drugs, required the CDFA to develop antimicrobial stewardship guidelines and best management practices for veterinarians, as well as livestock owners and their employees on the proper use of antimicrobial drugs, and to develop a program to track antimicrobial drug use in livestock.

SB 1311 (Hill, Chapter 843, Statutes of 2014), required general acute care hospitals, by July 1, 2015, to adopt and implement an antimicrobial stewardship policy, as specified; develop a physician supervised multidisciplinary antimicrobial stewardship committee, subcommittee, or workgroup; appoint at least one physician or pharmacist who has attended training specifically on antimicrobial stewardship to the committee, subcommittee, or workgroup, as specified; and, report antimicrobial stewardship program activities to appropriate hospital committees, as specified.

SB 158 (Florez, Chapter 294, Statutes of 2008), established an infection surveillance, prevention, and control program within DPH to provide oversight of hospital prevention and reporting of general acute care hospital-associated infections, expanded the responsibilities of DPH’s HAI Advisory Committee, and requires all hospitals to institute a patient safety plan for the purpose of improving the health and safety of patients and reducing preventable patient safety events.

SB 1058 (Alquist, Chapter 296, Statutes of 2008), established the Medical Facility Infection Control and Prevention Act, which requires hospitals to implement specified procedures for screening, prevention, and reporting specified health care associated infections also known as HAIs. Requires hospitals to report positive MRSA and other HAI test results to DPH and requires DPH to make specified information public on its website.

SB 739 (Speier, Chapter 526, Statutes of 2006), created a state HAI advisory committee to make recommendations regarding reporting cases of HAI in hospitals. Requires each general acute care hospital, after January 1, 2008, to implement and annually report to DPH its implementation of infection surveillance and infection prevention process measures that have been recommended by CDC Healthcare Infection Control Practices Advisory Committee, as suitable for a mandatory public reporting program. Required, initially, these process measures to include the CDC guidelines for central line insertion practices, surgical antimicrobial prophylaxis, and influenza vaccination of patients and healthcare personnel. Requires DPH, in consultation with the HAI advisory committee, to make this information public no later than six months after receiving the data. Required that general acute care hospitals develop a process for evaluating the judicious use of antibiotics, the results of which shall be monitored jointly by appropriate representatives and committees involved in quality improvement activities.

SB 1487 (Speier, 2004), would have required specified hospitals to have written infection control plans and report to Office of Statewide Health Planning and Development (OSHPD) data, including the rate of HAIs and risk-adjusted infection rate data according to the risk-adjustment methodology determined by CDC. SB 1487 was vetoed by then Governor Schwarzenegger, whose veto message suggested that it was unnecessary because of other national efforts, which could call into question the quality and validity of the data without proper auditing, and because it would impose significant costs to hospitals and OSHPD.

1. Support. The Alliance for the Prudent Use of Antibiotics (APUA) states in support, a majority of antibiotics are prescribed in non-hospital health care settings, such as medical offices where physicians, physician assistants and nurse practitioners work, dentist offices, and podiatric offices. APUA states that many different solutions are needed, but one of the most important actions that can be taken to slow the development of antibiotic resistance is to ensure that antibiotics are used judiciously and only when needed. The California Hospital Association also supports this bill, stating that ASPs are already required in hospitals and nursing homes, and this bill will require ambulatory health care settings that serve non-hospitalized patients to establish an ASP.
2. Opposition. The California Medical Association (CMA) states in opposition that the most recent data from the CDC suggests that California is ahead of the curve as it relates to the issue of excessive antibiotic prescribing, and that California is one of the states at the low end of per capita antibiotic prescribing. CMA states that although well-intentioned, this bill would be onerous and confusing to comply with, and that the criteria for successfully meeting the bill’s requirements are unclear and ripe for misinterpretation. CMA also points out that requiring licensing boards to ensure, though an annual audit of a random sample, that licensees have both adopted and are in compliance with an ASP has the potential to create significant workload for the licensing board. The American Academy of Pediatrics (AAP) states in opposition that while the language seeks to exempt people who only practice in licensed facilities, it is unlikely to significantly reduce the bill’s reach since may physicians practice in several settings, with both hospital privileges and a private practice. AAP argues that a physician may then be subject to multiple different ASPs, resulting in confusion. This bill is also opposed by the California Dental Association (CDA), which states that this bill is premature, confusing, and raises enforcement feasibility questions. CDA states that just five months ago, the CDC presented to the American Dental Association on antibiotic stewardship, and detailed the lack of data or evidence on the prescribing behaviors of dentists. According to CDA, the CDC discussed the challenges of implementing any interventions without the data from which to develop them, and stated that the next steps would be to measure and characterize antibiotic prescribing by dentists.
3. Inclusion of dentists and podiatrists. The concern over the inappropriate prescribing of antibiotics in outpatient settings has historically focused on the use of antibiotics in primary care settings to treat what are often viral infections, rather than bacterial infections. The data on dental and podiatric prescribing behavior is less robust. With regard to dental prescribing, the author cites a review of studies published in July of 2010 in the journal Therapeutics and Clinical Risk Management (TCRM report), which reviewed studies on dental prescribing published worldwide. According to the TCRM report, dentists prescribe between 7% and 11% of all common antibiotics, mainly for the treatment of infections that originate in the tooth or surrounding tissue. The TCRM report concluded that the prescribing practices of dentists are inadequate and this is manifested by over-prescribing, and recommended improving antibiotic prescribing practices in dental offices. However, this was a review of literature worldwide, and there does not appear to be much data specific to the United States. The American Dental Association, in a statement that it made supporting the responsible use of antibiotics, pointed to a study published in March of 2015 in the journal Clinical Infectious Diseases which looked at oral antibiotic prescribing data among all outpatients, and it found that after family practitioners, pediatricians and internists, dentists were the next most-frequent prescriber of oral antibiotics in an outpatient setting at 10% of all prescriptions.
4. Policy Comment. Currently, the CDC and other organizations have only published antibiotic stewardship guidelines for hospitals and other institutional settings. According to the author, the CDC is expected to publish antibiotic stewardship guidelines for outpatient settings later this year. While this bill allows compliance through “evidence-based methods,” such as poster-based interventions or accountable justification (writing justifications for prescribing antibiotics in the patient’s medical record), given the lack of published guidelines specific to outpatient settings, the author may wish to consider a delayed implementation to allow for these guidelines to be published.

SUPPORT AND OPPOSITION:

Support: Alliance for the Prudent Use of Antibiotics

California Hospital Association

County Health Executives Association of California

Oppose: American Academy of Pediatrics

California Dental Association

California Medical Association

-- END --

SENATE COMMITTEE ON

BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT

Senator Jerry Hill, Chair

2015 - 2016 Regular

Bill No: Hearing Date: April 11, 2016

Subject:

SUMMARY:

Specifies that a covered licensee, as defined, that includes physicians and surgeons, osteopathic physicians and surgeons, podiatrists and dentists must adopt and implement an antimicrobial stewardship policy, as defined, before applying for a renewal license. Requires the covered licensee to certify in writing upon renewal of their license with the board that regulates and licenses the practitioner, that he or she has the adopted the policy as specified, and is in compliance with that policy. Requires the board to audit a random sample of covered licensees and for each audited licensee to provide a copy of his or her antimicrobial stewardship policy. If the covered licensee fails to provide a copy of their policy then they will have until their next renewal to comply or be ineligible to receive their license. Also requires a primary care clinic or specialty clinic, on or after January 1, 2018, to adopt and implement an antimicrobial stewardship policy.

Existing law:

1. Specifies that the Department of Public Health (DPH) shall require that general acute care hospitals, as defined, develop a process for evaluating the judicious use of antibiotics, the results of which shall be monitored jointly by appropriate representatives and committees involved in quality improvement activities.
   (Health and Safety Code (HSC) § 1288.8)
2. Requires each general acute care hospital to adopt and implement an antimicrobial stewardship policy in accordance with guidelines established by the federal government and professional organizations and that this policy shall include a process to evaluate the judicious use of antibiotics in accordance with the requirements in Item #1), above. (HSC § 1288.85 (a))
3. Requires the general acute care hospital to develop a physician supervised multidisciplinary antimicrobial stewardship committee, subcommittee, or workshop and appoint to the entity at least one physician or pharmacist who is knowledgeable about the subject of antimicrobial stewardship, as specified, and to report antimicrobial stewardship program activities to each appropriate hospital committee undertaking clinical quality improvement activities.
   (HSC § 1288.85 (b), (c) and (d))
4. Requires on or after January 1, 2017, each skilled nursing facility, as defined, to adopt and implement an antimicrobial stewardship policy that is consistent with antimicrobial guidelines developed by the federal Centers for Disease Control (CDC) and Prevention, the federal Centers for Medicare and Medicaid Services, the Society for the Healthcare Epidemiology of America, or similar recognized professional organizations. (HSC § 1275.4)
5. Restricts the use of medically important antimicrobial drugs in livestock for specified purposes beginning January 1, 2018, requires a veterinarian’s prescription or feed directive for use, and eliminates the over-the-counter availability of these drugs; requires the California Department of Food and Agriculture (CDFA) to, in coordination with federal programs and state agencies, to develop a program to track antimicrobial drug use in livestock and the emergence of antimicrobial-resistant bacteria; requires CDFA to develop antimicrobial stewardship guidelines and best management practices on the proper use of these drugs; clarifies when medically important antimicrobial drugs may be used for preventative purposes; provides details regarding the CDFA antimicrobial monitoring program; and provides for penalties for those who violate the provisions of these new requirements as specified. (Food and Agriculture Code §§ 14400-14408)
   
6. Requires on or after January 1, 2018, a licensed veterinarian who renews his or her license to complete a minimum of one credit hour of continuing education on the judicious use of medically important antimicrobial drugs, as defined, every four years as part their continuing education requirements. (Business and Professions Code (BPC) § 4846.5)
   
7. Provides for the licensure and regulation of physicians and surgeons by the Medical Board of California (MBC), for osteopathic physicians and surgeons by the Osteopathic Medical Board (OMB), for podiatrists by the California Board of Podiatric Medicine (BPM) and for dentists by the Dental Board of California (DBC) under the Department of Consumer Affairs.
   
8. Provides that a “clinic” means an organized outpatient health facility that provides direct medical, surgical, dental, optometric, or podiatric advice, services, or treatment to patients who remain less than 24 hours, and that may also provide diagnostic or therapeutic services to patients in the home as incident to care provided at the clinic facility. (HSC § 1200)
   
9. Provides that a primary care clinics and specialty clinics, as defined, shall be eligible for licensure with the DPH. (HSC § 1204 (b))
   
10. Defines a “general acute care hospital” generally as a facility having a duly constituted governing body with overall administrative and professional responsibility and an organized medical staff that provides 24-hour inpatient care, including the following basic services: medical, nursing, surgical, anesthesia, laboratory, radiology, pharmacy, and dietary. (HSC § 1250 (a))
    
11. Defines a “skilled nursing facility” as a health facility that provides skilled nursing care and supportive care to patients whose primary need is for the availability of skilled nursing care on an extended basis. (HSC § 1250 (c))

This bill:

1. Defines “antimicrobial stewardship policy” as efforts to promote the appropriate and optimal selection, dosage, and duration of antimicrobials for patients, with the goal of reducing antimicrobial overuse and misuse and minimizing the development of antimicrobial resistant infections, that is consistent with one of the following parameters:
   
   1. Antimicrobial stewardship guidelines published by the federal Centers for Disease Control and Prevention, the federal Centers for Medicare and Medicaid Services, the Society for Healthcare Epidemiology of America, the Infectious Diseases Society of American, or similar recognized, professional organizations.
      
   2. Evidence-based methods. To the extent practicable, antimicrobial stewardship policies based on proven, evidence-based methods should include more than one intervention or component.
      
2. Provides that a “covered license” means a physician and surgeon who practices medicine in a setting other that a clinic licensed pursuant to Section 1204 of the BPC, a general acute care hospital, as defined in Item # 10) above, or a skilled nursing facility , as defined in Item # 11) above.
   
3. Defines “evidence-based methods” as antimicrobial prescribing intervention methods that have been proven effective through outcome evaluations or studies, including, but not limited to, audit and feedback, academic detailing, clinical decision support, delayed prescribing practices, poster-based interventions, accountable justification, and peer comparison.
   
4. Requires a covered licensee to adopt and implement an antimicrobial stewardship policy before applying for a renewal license.
   
5. Requires a covered licensee, upon filing an application with the MBC for a renewal license, to certify in writing, on a form prescribed by the MBC, that he or she has both adopted an antimicrobial stewardship policy as specified, and is in compliance with that policy.
   
6. Requires the MBC to audit each year a random sample of covered licensees who have certified compliance as specified, but that the MBC shall not audit an individual covered licensee more than once every four years.
   
7. Provides that a covered licensee who is selected for an audit shall submit to the MBC, on a form prescribed by the Board, a copy of his or her antimicrobial stewardship policy.
   
8. Provides that if the MBC determines that an audited covered licensee has failed to comply with the requirements to adopt and implement an antimicrobial stewardship policy, then the MBC shall require the covered licensee to comply during the following renewal period and if the covered licensee fails to comply within that
   
   
   period, he or she is ineligible for a subsequent license renewal until he or she has documented compliance.
   
9. Specifies that a covered licensee also includes osteopathic physicians and surgeons licensed and regulated by the OMB, podiatrists licensed and regulated by the BPM and dentists licensed and regulated by the DBC, and subjects these practitioners to the same requirements as those specified in Items #4) through # 8), above.
   
10. Requires a primary care clinic or specialty clinic, on or after January 1, 2018, to adopt and implement an antimicrobial stewardship policy, as defined, and meets that is consistent with one of the following parameters as specified in Items # 1) and # 3), above; published antimicrobial stewardship guidelines published by specified entities or evidence-based methods, as defined.
    

FISCAL EFFECT:

Unknown. This bill is keyed “fiscal” by Legislative Counsel.

COMMENTS:

1. Purpose. This measure is sponsored by the Author and is intended to promote the appropriate antibiotic prescribing for non-hospitalized patients in ambulatory healthcare settings. The Author indicates that according to the CDC at least 2 million Americans are infected with – and at least 23,000 Americans die as a result of – antibiotic resistant infections every year, resulting in at least $20 billion in direct health care costs and at least $35 billion in productivity loss nationwide. In California alone, the DPH estimates that antibiotic resistant infections are responsible for at least 3,000 deaths and 260,000 illnesses every year.
   
   Antibiotic resistance is a growing threat, as stated by the Author. “A recent study commissioned by the United Kingdom determined that by 2050, worldwide, more people will die from antibiotic resistant infections than from cancer. While not the only cause, the overuse and misuse of antibiotics in medicine is a significant contributing factor driving the development of antibiotic resistance and if we are to truly solve the problem, among other things, we need to focus on promoting more appropriate and judicious antibiotic prescribing.”
   
   A majority of antibiotics are prescribed in non-hospital health care settings, as pointed out by the Author, such as medical offices where physicians, physician assistants and nurse practitioners work, dentist offices, and podiatric offices. Based on data from other countries, it can be estimated that up to 80% of all antibiotic prescriptions are written in the outpatient setting.
   
   For example, according to the CDC, across the country in 2013, healthcare providers prescribed 268.6 million courses of antibiotics in outpatient settings. Primary care physicians were responsible for 121.7 million prescriptions, physician assistants and nurse practitioners were responsible for 48.4 million prescriptions and dentists were responsible for 24.5 million prescriptions. The CDC estimates that 50% of these prescriptions are unnecessary and contributes to the development of antibiotic resistant infections.
   
   The Author further points out that worldwide antibiotic consumption is rising. Between 2000 and 2010, global consumption of antibiotics increased by 30%, according to the Center for Disease Dynamics, Economics, & Policy. The United States has the highest per capita consumption of antibiotics and consumes the third highest amount of antibiotics overall, preceded only by China and India. Inappropriate antibiotic use means using antibiotics when no benefit is possible (e.g. to treat a viral infection), or using the wrong antibiotic, or prescribing the wrong dosage.
   
   The Author believes that many different solutions are needed, but one of the most important actions that can be taken to slow the development of antibiotic resistance is to ensure that antibiotics are used judiciously and only when needed. To promote judicious use the CDC recommends the establishment of antibiotic stewardship programs, which represent a “commitment to always use antibiotics only when they are necessary to treat and in some cases prevent, disease; to choose the right antibiotics; and to administer them in the right way in every case. Effective stewardship ensures that every patient gets the maximum benefit from the antibiotics, avoids unnecessary harm from allergic reaction and side effects, and helps preserve the life-saving potential of these drugs for the future.” Antibiotic stewardship programs in outpatient settings can help decrease inappropriate prescribing and decrease the development of antibiotic resistance.
2. Background. Antimicrobial drugs were first developed in 1928 and became widely used in human medicine in the 1940s. These new drugs quickly proved to have significant health benefits in both human and animal medicine and to this day are extremely valuable tools used to treat and prevent illness and infection. However, incidences of antimicrobial resistance have been recorded over time and, if not addressed, pose a serious threat to public health.
   
   Antimicrobial resistance may develop for several reasons. One of the most widely accepted contributors to antimicrobial resistance is the misuse of antimicrobial drugs. When bacteria are exposed to an antimicrobial drug, it provides the opportunity for “survival of the fittest” where only the strongest, most immune bacteria survive. These surviving, antimicrobial-resistant bacteria then multiply to form new colonies of resistant bacteria that may spread and infect other individuals. For this reason, it is important to use antimicrobial drugs judiciously in both human and animal medicine as one method to mitigate resistance.
   
   According to a February 2013 joint letter from the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of American (SHEA) to the National Quality Forum, ample data exist from both inpatient and outpatient settings demonstrating that antibiotics are often prescribed sub-optimally or inappropriately. Antibiotics are misused in a variety of ways. They are often administered when they are not needed, continued when they are no longer necessary, or prescribed at the wrong dose. Broad-spectrum agents may be used unnecessarily against bacteria that are very susceptible or the wrong antibiotic may be given to treat a particular infection. Over the past 30 years, bacteria that are extremely resistant to traditional treatments or resistant to multiple drugs have spread widely among patients in health care settings. In some cases these pathogens have been pan-resistant, meaning that they are resistant to all available antibiotics. The unique nature of antibiotics, in which the use of the drugs in one patient can impact the effectiveness of the drug in a different patient, make antibiotic overuse a serious patient safety issue and public health threat. The World Health Organization has characterized antibiotic resistance as “a crisis that has been building up over decades, so that today common and life-threatening infections are becoming difficult or even impossible to treat.” Resistant infections not only result in increased morbidity and mortality, but increased economic burdens. For example, studies have shown that antibiotic-resistant infections are associated with longer lengths of stay and increased mortality, both in the hospital and in intensive care units.
   
   The Centers for Disease Control and Prevention (CDC) issued a report titled, Antibiotic Resistance Threats in the United States, 2013. The CDC estimates that in the United States more than 2 million people are sickened every year with antibiotic-resistant infections with at least 23,000 Americans who die as a result of antibiotic infections every year. In its report, the CDC lists four core actions that fight the spread of antibiotic resistance: 1) preventing infections from occurring and preventing resistant bacteria from spreading, 2) tracking resistant bacteria, 3) improving the use of antibiotics, and 4) promoting the development of new antibiotics and new diagnostic tests for resistant bacteria. The CDC notes that the use of antibiotics is the single most important factor leading to antibiotic resistance around the world. Up to 50% of all antibiotics prescribed for people are either not needed or not optimally effective as prescribed.
   
   On September 18, 2014, President Obama issued Executive Order 13676: Combating Antibiotic-Resistant Bacteria, which states that this is an issue of national security and that “the Federal Government will work domestically and internationally to detect, prevent, and control illness and death related to antibiotic-resistant infections by implementing measures that reduce the emergence and spread of antibiotic-resistant bacteria and help ensure the continued availability of effective therapeutics for the treatment of bacterial infections.” Later that same month, the White House issued the National Strategy for Combating Antibiotic-Resistant Bacteria, and in March 2015, the White House issued the National Action Plan for Combating Antibiotic-Resistant Bacteria (Action Plan).
   
   The Action Plan lays out a five-year plan with five distinct goals: 1) slow the emergence of resistant bacteria, 2) strengthen One-Health surveillance efforts, 3) advance the development and use of rapid diagnostic tests to identify resistant bacteria, 4) accelerate the development of new antibiotics, other treatments, and vaccines, and 5) improve international collaboration to achieve these goals.
   
   California’s program. In February 2010, the DPH Healthcare Associated Infection (HAI) Program developed a statewide antimicrobial stewardship program (ASP) initiative in order to strengthen and promote optimization of antimicrobial utilization in California health care facilities. According to DPH, the purpose of an antimicrobial stewardship program in a health care facility is to measure and promote the appropriate use of antimicrobials by selecting the appropriate agent, dose, duration and route of administration in order to improve patient outcomes, while minimizing toxicity and the emergence of antimicrobial resistance. Although guidelines existed for developing ASPs, there was limited information on practical implementation of these guidelines, particularly in resource-limited settings. According to DPH, its partners in this statewide initiative included the Division of Healthcare Quality and Promotion at CDC, Infectious Disease Association of California, and SHEA. SB 1311 (Hill, Chapter 843, Statutes of 2014) more specifically required acute care hospitals to adopt and implement antimicrobial stewardship policy (ASP) in accordance with guidelines established by the federal government and professional organizations. Prior to SB 1311, only 50 percent of hospitals had actually established an ASP and only 22 percent said they were influenced by the current requirement to develop a stewardship program.
   
3. Prior Related Legislation. SB 27 (Hill, Chapter 758, Statutes of 2015) restricts the use of antimicrobial drugs in livestock, requires a veterinarian’s prescription or feed directive for use, eliminate the over-the-counter availability of these drugs, requires the CDFA to develop antimicrobial stewardship guidelines and best management practices for veterinarians, as well as livestock owners and their employees on the proper use of antimicrobial drugs, and to develop a program to track antimicrobial drug use in livestock.
   
   SB 361 (Hill, Chapter 764, Statutes of 2015) requires, on or after January 1, 2017, each skilled nursing facility, as defined, to adopt and implement an antimicrobial stewardship policy consistent with guidelines development by federal or professional organizations, as specified. Requires a veterinarian upon renewal of their license to have completed a continuing education course in the judicious use of medically important antimicrobial drugs, as specified.
   
   SB 1311 (Hill, Chapter 843, Statutes of 2014) requires each general acute care hospital, as defined, to adopt and implement an antimicrobial stewardship policy in accordance with guidelines established by the federal government and professional organizations and that this policy shall include a process to evaluate the judicious use of antibiotics, as specified.
   
   SB 158 (Florez, Chapter 294, Statutes of 2008) established an infection surveillance, prevention, and control program within DPH to provide oversight of hospital prevention and reporting of general acute care hospital-associated infections, expanded the responsibilities of DPH’s Healthcare Associated Infection (HAI) Advisory Committee, and requires all hospitals to institute a patient safety plan for the purpose of improving the health and safety of patients and reducing preventable patient safety events.
   
   SB 1058 (Alquist, Chapter 296, Statutes of 2008) established the Medical Facility Infection Control and Prevention Act, which requires hospitals to implement specified procedures for screening, prevention, and reporting specified health care associated infections also known as HAIs. Requires hospitals to report positive MRSA and other HAI test results to DPH and requires DPH to make specified information public on its Internet Web site.
4. Arguments in Support. The California Hospital Association (CHA) is in support of this bill and indicates that “the overuse and misuse of antibiotics in medicine is a significant contributing factor driving the development of antibiotic resistance and if we are to truly solve the problem, among other things, we need to focus on promoting more appropriate and judicious antibiotic prescribing. The CHA goes on to state that a majority of antibiotics are prescribed in non-hospital health care settings, such as medical offices where physicians, physician assistants and nurse practitioners work, dentist offices, and podiatric offices. CDC estimates at least
   50 percent of the antibiotic prescribing in outpatient settings is unnecessary or inappropriate. The CHA believes this measure is important because it will require ambulatory health care settings that serve non-hospitalized patients to establish an antibiotic stewardship policy that is similar to the requirements for hospitals and nursing homes.
   
   The Society of Infectious Diseases Pharmacists (SIDP) is also in support of this measure. SIDP indicates that growing bacterial resistance is contributing to increased morbidity and mortality of patients across California and the county as a whole. Overuse and inappropriate use of antibiotics is common, and contributing to this increasing resistance, therefore expanding the reach of microbial stewardship to reduce unnecessary and inappropriate use in primary clinics is important. SIDP believes that directing primary care clinics to initiate antimicrobial stewardship efforts can help to educate the public and prescribers regarding the appropriate antibiotic use and thus have meaningful impacts on society.
   
5. Policy Issue. Should the “Covered Licensee” be ineligible for a subsequent license renewal until he or she has documented compliance with adopting the antimicrobial policy? The Author may want to consider rather than subjecting the practitioner to possible loss of their license for non-compliance with adopting the antimicrobial policy, that instead provide that it would be unprofessional conduct on the part of the licensee if they did not adopt the policy. This would allow some latitude with the individual licensing board as to what appropriate action to take to assure compliance with the requirement to have an antimicrobial stewardship policy in place. The board could determine that they could do anything from cite and fine the licensee for non-compliance to more formal disciplinary action if determined necessary.
   
6. Suggested Technical Amendment. On page 10, line 29, after “specialty clinic” insert the following: ,licensed pursuant to Section 1204,
   
7. Author’s Amendment. The Author would like to clarify the definition of antimicrobial stewardship policy by making the following change:
   
   On Page 6, line 19, strike the following, and optimal selection, dosage, and duration of and insert prescribing of
   
   The definition would then read as follows: “Antimicrobial stewardship policy” as efforts to promote the appropriate prescribing of of antimicrobials for patients, with the goal of reducing antimicrobial overuse and misuse and minimizing the development of antimicrobial resistant infections, that is consistent with one of the following parameters:
   
   1. Antimicrobial stewardship guidelines published by the federal Centers for Disease Control and Prevention, the federal Centers for Medicare and Medicaid Services, the Society for Healthcare Epidemiology of America, the Infectious Diseases Society of American, or similar recognized, professional organizations.
      
   2. Evidence-based methods. To the extent practicable, antimicrobial stewardship policies based on proven, evidence-based methods should include more than one intervention or component.
      

NOTE:

Double-referral to Health Committee.

SUPPORT AND OPPOSITION:

Support:

California Hospital Association

Society of Infectious Diseases Pharmacists

Opposition: None on file as of April 5, 2016.

-- END --