BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | AB 614|
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THIRD READING
Bill No: AB 614
Author: Brown (D)
Amended: 6/2/15 in Senate
Vote: 21
SENATE HEALTH COMMITTEE: 8-0, 6/24/15
AYES: Hernandez, Nguyen, Mitchell, Monning, Nielsen, Pan,
Roth, Wolk
NO VOTE RECORDED: Hall
SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8
ASSEMBLY FLOOR: 77-0, 5/7/15 (Consent) - See last page for
vote
SUBJECT: Health care standards of practice
SOURCE: California Department of Public Health
DIGEST: This bill permits the Department of Public Health
(DPH), without taking regulatory action, to update references in
the California Code of Regulations (CCR) to health care
standards of practice adopted by a recognized state or national
association when the state or national association and its
outdated standards are already named in the CCR.
ANALYSIS:
Existing law:
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1)Requires DPH's Licensing and Certification Division (L&C) to
inspect and license health facilities, including, but not
limited to, clinics, skilled nursing facilities, acute care
hospitals, and psychiatric hospitals.
2)Requires DPH to adopt, amend, or repeal, any reasonable rules
and regulations necessary or proper to carry out the purposes
and intent of existing law related to the licensing of health
facilities and to enable DPH to exercise the powers and
perform the duties conferred upon it by that law, as
specified.
3)Establishes, under the Administrative Procedures Act (APA), a
process for adopting, amending, or repealing regulations
through the Office of Administrative Law (OAL).
This bill:
1)Permits DPH, without taking regulatory action, to update
references in the CCR to health care standards of practice
adopted by a recognized state or national association when the
state or national association and its outdated standards are
already named in the CCR.
2)Requires DPH, when updating these references, to:
a) Post notice of their proposed adoption of the state or
national association's health care standards of practice
on its Web site for at least 45 days. Requires the notice
to include the name of the state or national association,
the title of the health care standards of practice, and
the version of the updated health care standards of
practice to be adopted.
b) Notify stakeholders that the proposed standards have
been posted on the Web site by issuing a mailing to the
most recent stakeholder list on file with the DPH's Office
of Regulations.
c) Submit the required notice to the OAL. Requires the
OAL to publish in the California Regulatory Notice
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Register any notice received; and,
d) Accept public comment for at least 30 days after the
conclusion of the 45-day posting period. Specifies that
written responses to public comments are not required.
3)Requires a public hearing to be held if a member of the public
requests one during the public comment period.
4)Requires DPH to consider any comments received during the
public comment period prior to the adoption of the health care
standards whether or not a public hearing is requested.
5)Requires DPH to seek adoption of new standards using the
regulatory process if public comments are submitted in
opposition to the adoption of the proposed standards, or the
state or national association named in the CCR no longer
exists. Specifies that a state or national association named
in the CCR that has changed its name does not constitute an
association that no longer exists.
6)Requires DPH to update its Internet Web site to notify the
public that the standard has been adopted and the effective
date of that standard if no opposition to the change is
received.
7)Makes technical, clarifying changes to existing law related to
the inpatient treatment of eating disorders.
Comments
1)Author's statement. According to the author, this bill
streamlines DPH's process used to update health care standards
of practice in health facilities and clinics. Currently,
DPH's L&C Program has a substantial backlog of regulations
that are subject to the APA. The APA requires a full
rulemaking process in order to update these standards, taking
up to three years or longer for each regulation update to
complete. AB 614 will also improve the quality of patient
care provided in licensed health facilities by eliminating the
need to revise regulations through the full APA process simply
to update references to the most recent standards of practice.
This change will lead to a more efficient and cost effective
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method for ensuring that health facilities and DPH are
referencing standards and providing care that is consistent
with the most current nationally recognized professional
standards.
2)L&C Division. According to the L&C Annual Report for Fiscal
Year 2015-16, it is responsible for regulatory oversight of
licensed health care facilities and health care professionals
to ensure safe, effective, and quality health care for all
Californians. L&C licenses and certifies over 7,500 health
care facilities and agencies in California in 30 different
licensure and certification categories. In order to ensure
compliance with federal and state laws, they conduct periodic
inspections and complaint investigations of health care
facilities. Facilities regulated by L&C include, but are not
limited to, nursing homes, general and psychiatric hospitals,
acute care hospitals, special hospitals, community clinics,
congregate living health facilities, skilled nursing
facilities, surgical clinics, rehabilitation clinics, dialysis
clinics, correctional treatment centers and intermediate care
facilities. L&C also certifies nurse assistants, home health
aides, and hemodialysis technicians and licenses nursing home
administrators.
3)Regulatory process. According to the OAL, the regulatory
process is designed to provide the public with a meaningful
opportunity to participate in the adoption of regulations or
rules that have the force of law and to ensure the creation of
an adequate record for the public, OAL, and judicial review.
The OAL is responsible for reviewing administrative
regulations proposed by over 200 state agencies for compliance
with the standards set forth in the APA. To initiate a
rulemaking action, an agency first issues a public notice, and
has one year within which to complete the rulemaking and
submit to OAL. The APA requires a minimum of 45-days comment
to the agency, in writing, on the proposed regulation. After
the initial public comment period, changes to the initial
proposal may be made. Agencies must make each substantial,
sufficiently related change available for public comment for
at least 15 days before adoption. Upon receipt of a proposed
regulation, OAL has 30 working days to conduct its review and
determine whether it demonstrates that the agency satisfied
the procedural requirement of the APA, and review the proposed
regulations for compliance with the six legal standards set
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forth in the APA. According to DPH, their experience is that
a relatively simple regulation packet could move through the
process in as few as 15-18 months, while regulations
pertaining to more complicated subject matter can sometimes
take several years, depending on the volume of public
comments.
4)Standards of practice. Nationally recognized professional
organizations use industry expertise, information gathered
through research, patient outcomes, and best practices to
develop standards that are used by various health care
professions in an effort to provide quality care. For
example, the American Academy of Pediatrics publishes clinical
practice guidelines on a range of subjects including: The
Diagnosis, Management, and Prevention of Bronchiolitis,
Management of Newly Diagnosed Type 2 Diabetes Mellitus in
Children and Adolescents, and Treatment of the School-Aged
Child With Attention-Deficit/Hyperactivity Disorder.
Additionally, a number of national organizations publish
standards intended to guide the profession in day-to-day
practice, including the American Association of Nurse
Practitioners, the American Nurses Association, and the
American Association of Nurse Anesthetists. In addition,
there are other documents relevant to specialties. For
example, Pediatric Nursing: Scope and Standards of Practice
is a collaborative effort of the ANA, the Society for
Pediatric Nurses, and the National Association of Pediatric
Nurse Practitioners and is meant to define the scope of
practice and standards of practice for pediatric nursing.
5)DPH and outdated regulations. The author states that this
bill is necessary because L&C has a substantial backlog of
regulations that are subject to the APA. This is not the only
case of outdated regulations not being addressed by DPH. In
the fall of 2014, the Senate Health Committee asked the Senate
Office of Research to identify outdated regulations under the
purview of DPH. Working with DPH, there are approximately 25
instances in which statute required a regulation be
promulgated or updated, but that had not completed (most of
these in L&C - see Senate Health Committee analysis for
detail). According to DPH, there are approximately 30
references to outdated standards of practice in Title 22 of
the CCR (which apply to up to 30 types of health facilities,
including clinics, and general acute care hospitals), some of
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which are referenced in more than one place, and dating as far
back as 1961. DPH is currently in the process of updating
Title 22. Some of the regulatory packets could be completed
later this year, other more complex packets will take several
years to complete, and due to the volume, DPH estimates that
the entire update will not be complete until sometime in 2025.
Currently, health facilities affected by regulations which
reference outdated standards of practice are requesting
program flexibility from DPH to allow them to operate using
more current medical standards.
6)Policy comment. According to the Senate Health Committee,
"There are numerous instances in which a regulated entity
cannot operate effectively because factors in today's world
conflict with regulations that have not been updated by DPH in
20 to 30 years. This problem has affected health care
facilities, labs, pharmacies, and narcotic treatment
facilities, among others. There have been a number of bills
that have come through the Health Committee to work around
outdated regulations, without leaving facilities unregulated
entirely. Those bills have been drafted to address specific
instances in which an outdated regulation was limiting the
ability of providers to practice in the most effective manner.
For example, federal regulations were amended in 2001 to allow
for Sunday or holiday closure of methadone clinics in certain
cases while state regulations have not been updated for over
20 years and require methadone clinics to be open seven days a
week. There are take-home doses of methadone available that
are safe to use, ensuring that patients do not have a break in
treatment if a facility were closed one day a week. Another
bill heard by this Committee permits pharmacy technicians,
rather than pharmacists, to check expiration dates on the
labels of drugs in a hospital pharmacy - something currently
prohibited by a regulation not updated since its promulgation
in 1986. While the Health Committee has approved a piecemeal
approach to the problem of outdated regulations, the
longstanding reluctance of DPH to utilize the standard
rulemaking process is troubling. It is encouraging that DPH
is currently engaged in an effort to update Title 22 regs.
DPH should also examine what the barriers have been to using
the APA process in an effort to make that a more routine part
of their role as a regulator."
FISCAL EFFECT: Appropriation: No Fiscal
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Com.:YesLocal: Yes
SUPPORT: (Verified7/8/15)
California Department of Public Health (source)
American Federation of State, County and Municipal Employees
Arc and United Cerebral Palsy California Collaboration
California Commission on Aging
California Senior Legislature
Congress of California Seniors
OPPOSITION: (Verified7/8/15)
None received
ASSEMBLY FLOOR: 77-0, 5/7/15
AYES: Achadjian, Alejo, Travis Allen, Baker, Bigelow, Bloom,
Bonilla, Bonta, Brough, Brown, Burke, Calderon, Chang, Chau,
Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle, Daly,
Dodd, Eggman, Frazier, Beth Gaines, Gallagher, Cristina
Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez,
Gordon, Gray, Grove, Hadley, Harper, Holden, Irwin, Jones,
Jones-Sawyer, Kim, Lackey, Levine, Linder, Lopez, Low,
Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin,
Nazarian, Obernolte, O'Donnell, Olsen, Patterson, Perea,
Quirk, Rendon, Ridley-Thomas, Rodriguez, Salas, Santiago, Mark
Stone, Thurmond, Ting, Wagner, Waldron, Weber, Wilk, Williams,
Wood, Atkins
NO VOTE RECORDED: Campos, Roger Hernández, Steinorth
Prepared by:Melanie Moreno / HEALTH /
7/8/15 11:52:16
**** END ****
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