BILL ANALYSIS Ó
AB 614
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Date of Hearing: April 14, 2015
ASSEMBLY COMMITTEE ON HEALTH
Rob Bonta, Chair
AB 614
(Brown) - As Introduced February 24, 2015
SUBJECT: Health care standards of practice.
SUMMARY: Authorizes the California Department of Public Health
(DPH) to use a streamlined administrative process to update
regulatory references to health care standards of practice
adopted by a state or national association when outdated
standards are referenced in the California Code of Regulations
(CCR). Specifically, this bill:
1)Requires DPH, when updating regulatory references to health
care standards in the CCR to:
a) Post 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 on DPH's Internet Website;
b) Post notice of DPH's proposed adoption of the state or
national association's health care standards of practice on
it's on its Internet Website for at least 45 days;
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c) Notify stakeholders that the proposed standards have
been posted on DPH's Internet Website by issuing a mailing
to the most recent stakeholder list on file with DPH's
Office of Regulations; and,
d) Accept public comment for at least 30 days after the
conclusion of the 45-day posting period.
2)Requires DPH to hold a public hearing during the public
comment period if a member of the public requests one, and to
consider comments prior to the adoption of the standards.
3)Specifies that written responses to public comments are not
required of DPH.
4)Specifies that if comments in opposition to the adoption of
the proposed standards are received, DPH cannot use the
streamlined process, and must instead seek adoption of the
standards using the regulatory process established in the
Administrative Procedures Act (APA).
EXISTING LAW: Establishes DPH to license health facilities and
requires DPH to adopt, amend or repeal, as specified, any
reasonable rules and regulations as may be necessary or proper
to carry out the exercise of its power. Establishes, under the
APA, a process for adopting, amending, or repealing regulations.
FISCAL EFFECT: This bill has not been analyzed by a fiscal
committee.
COMMENTS:
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1)PURPOSE OF THE BILL. According to the author, this bill will
eliminate the need to revise regulations simply to update
references to the most recent standards of practice when
applicable. The author states that this will result in an
efficient and cost effective 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, improving the quality of
patient care provided in licensed health facilities.
2)BACKGROUND.
a) Regulatory Process. The regulatory process, governed by
the APA and enforced by the Office of Administrative Law
(OAL) 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.
Generally, there are two types of rulemaking procedures that
a state agency can pursue: regular or emergency. The
regular rulemaking process requires that a state agency
meet certain public hearing and notice requirements. The
emergency rulemaking process has different requirements,
which generally include a brief public notice period, a
finding of emergency, a brief public comment period, review
by OAL and an OAL decision. For the regular rulemaking
process, once a state agency decides to conduct a
rulemaking action, it develops four documents required
during the preliminary stage: a) the proposed text; b) the
Initial Statement of Reasons; c) the Fiscal Impact
Statement; and, d) the Notice of Proposed Regulatory Action
(notice).
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To initiate a rulemaking action, an agency issues a notice by
having it published in the California Regulatory Notice
Register (Register), by mailing the notice to those persons
who have filed a request for notice of regulatory action,
and by posting the notice, text, and Initial Statement of
Reasons on the agency's Website. Once the notice is
published in the Register, the APA rulemaking process is
officially started and the agency has one year within which
to complete the rulemaking and submit the rulemaking file
to OAL.
The APA requires at a minimum a 45-day opportunity to
comment to the agency, in writing, on the proposed
regulation. An agency has the option as to whether it will
hold a public hearing on a proposed rulemaking action.
However, if an agency does not schedule a public hearing,
any interested person can submit a written request within a
specified timeframe requesting one to be held, and the
agency must then give notice and hold a public hearing.
After the initial public comment period, a rulemaking
agency may decide to change its initial proposal either in
response to public comments received or on its own
initiative. The agency must then decide whether a change
is: a) nonsubstantial; b) substantial and sufficiently
related; or, c) substantial and not sufficiently related.
A rulemaking agency must make each substantial,
sufficiently related change to its initial proposal
available for public comment for at least 15 days before
adopting such a change. Thus, before a rulemaking agency
adopts such a change, it must mail a notice of opportunity
to comment on proposed modifications along with a copy of
the text of the proposed changes to each person who has
submitted written comments on the proposal, testified at
the public hearing, or asked to receive a notice of
proposed modifications. The agency must also post the
notice on its Website. No public hearing is required. The
public may comment on the proposed modification in writing.
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The agency must then consider the comments received during
the 15-day comment period which are specifically directed
to the proposed modifications. An agency may conduct more
than one 15-day opportunity to comment on modifications.
A rulemaking agency must summarize and respond on the
record to timely comments that are directed at the proposal
or at the procedures followed by the agency during the
regulatory action. With each comment, the agency must
either: a) explain how it has amended the proposal to
accommodate the comment; or, b) explain the reasons for
making no change to the proposal. The summary and response
to comments is included as part of the rulemaking file in
the Final Statement of Reasons.
Finally, a rulemaking agency must transmit a rulemaking
action to OAL for review within one year from the date that
the notice was published in the Regulatory Notice Register.
OAL then has 30 working days to conduct its review. OAL
must review the rulemaking record to determine whether it
demonstrates that the rulemaking agency satisfied the
procedural requirement of the APA, and review the proposed
regulations for compliance with the six legal standards set
forth in the APA: Authority; Reference; Consistency;
Clarity; Nonduplication; and, Necessity. OAL may not
substitute its judgment for that of the rulemaking agency
with regard to the substantive content of the regulations.
According to DPH, their experience is that a relatively
simple regulation packet could move through the process in
as few as 15-18 months, regulations pertaining to more
complicated subject matter can sometimes take several
years, depending on the volume of public comments.
b) Health care standards of practice. Nationally
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recognized professional organizations use industry
expertise, information gathered through research, patient
outcomes, and best practices to develop standards that are
accepted in various medical professions for providing the
highest quality of care possible. For example, the
American Academy of Pediatrics publishes a wide variety of
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, to name a few.
c) Obsolete references to standards of practice in CCR.
There are approximately 30 references to outdated standards
of practice in Title 22 of the CCR (which apply to various
health facilities, including clinics, and general acute
care hospitals), some of which are referenced in more than
one place, and dating as far back as 1961. The American
Dietetic Association standards of practice referenced for
educational programs for dietetic service staff in general
acute care hospitals were adopted in June 1974. 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 (Title 22 effects up to 30
different types of health facilities) 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.
3)SUPPORT. DPH is the sponsor of this bill and notes they are
the enforcement and regulatory agency for approximately 30
different types of health care facilities and clinics, and
they have a backlog of regulations that are subject to the
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APA. DPH contends that in order to remain compliant with
up-to-date clinical practices instead of being errantly held
to antiquated practices in state regulations, facilities must
request program flexibility from DPH, and this additional step
creates hurdles for health facilities and clinics. DPH
concludes that this bill will eliminate the need to revise
regulations simply to update references to the most recent
standards of practice.
The California Long-Term Care Ombudsman Association supports
this bill because it helps to create a more efficient and cost
effective method for ensuring skilled nursing facilities are
referencing standards and providing care that is consistent
with the most current nationally recognized professional
standards.
4)PREVIOUS LEGISLATION.
a) AB 1312 (Brown) of 2013 would have authorized DPH to,
without taking any regulatory action, update references in
the CCR to health care standards of practice adopted by a
recognized state or national association when the same
state or national association and its outdated standards
are already named in the CCR. AB 1312 was held in Assembly
Health Committee.
b) AB 1487 (Hill), Chapter 444, Statutes of 2010, allows
DPH to adopt initial regulations based on the "Guidelines
for Reducing Risk of Viral Transmission During Fertility
Treatment" using a streamlined process.
5)SUGGESTED AMENDMENTS. In order to insure that stakeholders
and the public are kept apprised of which professional
standards are being updated in CCR, this bill should be
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amended to clarify and strengthen the manner in which DPH
notifies the public in advance of any proposed update by
requiring DPH 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. This bill should also be amended
to require DPH to publish a notice in the Register when
updating references to standards of practice in CCR.
This bill should be amended to clarify that if the state or
national association whose standards of practice are currently
referenced no longer exists, DPH must adopt new standards
pursuant to the full regulatory process, and to clarify that
if no opposition is received by DPH, the Website must be
updated to notify the public that the standard has been
adopted and the effective date of that standard.
REGISTERED SUPPORT / OPPOSITION:
Support
California Department of Public Health (sponsor)
California Long-Term Care Ombudsman Association
Opposition
None on file.
Analysis Prepared by:Lara Flynn / HEALTH / (916) 319-2097
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