BILL NUMBER: AB 822 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY MARCH 25, 2009
INTRODUCED BY Assembly Member Fletcher
( Coauthor: Senator Wyland
)
FEBRUARY 26, 2009
An act to amend Section 1276 of, and to add Chapter 2 (commencing
with Section 101990) to Part 6 of Division 101 of the Heath and
Safety Code, relating to health facilities.
LEGISLATIVE COUNSEL'S DIGEST
AB 822, as amended, Fletcher. Health facilities: program
flexibility.
Under existing law, the State Department of Public Health has
licensing authority over several categories of clinics and health
facilities, including hospital. Existing law requires the building
standards published in the California Building Standards Code and the
regulations adopted by the department to prescribe standards for
adequacy, safety, and sanitation of the physical plant, of
appropriate staffing, and of services, based on the type of health
facility and the needs of the persons served. These regulations are
required to permit program flexibility in various contexts, as long
as statutory requirements are met, and the use has the prior written
approval of the department or of the Office of Statewide Health
Planning and Development.
Existing law requires the department to develop a standardized
form and format for requests by health facilities for program
flexibility. Health facilities shall thereafter apply to the
department for program flexibility in the prescribed manner. After
the department receives a complete application requesting program
flexibility, it is required to approve, approve with conditions or
modifications, or deny the application within 60 days. Denials and
approvals with conditions or modifications are required to be
accompanied by an analysis and a detailed justification for any
conditions or modifications imposed.
This bill would require the department to approve or approve with
conditions or modifications a complete application requesting program
flexibility for the use of alternate concepts, methods, procedures,
techniques, or equipment by a general acute care hospital whenever
the hospital demonstrates to the department that this use meets or
exceeds the quality of care and patient safety in effect on January
1, 2010.
The bill would also require the department to establish a pilot
program to gather clinical data on, and provide general acute care
hospitals experience with, the use of alternate concepts, methods,
procedures, techniques, equipment, and care from what is authorized
pursuant to specified regulations, but meet certain statutory
requirements. It would require, by January 1, 2012
2014 , the department to prepare a specified
report to the Legislature on the pilot program .
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. (a) The Legislature hereby finds and declares all of
the following:
(1) The provision of health care in general acute care hospitals
has improved dramatically in recent years, due in part to
technological and methodological advances in health care that have
greatly improved patient outcomes.
(2) California's hospital licensing regulations, found in Division
5 of Title 22 of the California Code of Regulations, were adopted in
1976. Although there have been limited revisions over the past
decades, the regulations have not kept pace with state-of-the art
technology, equipment, and practices now available to provide optimum
patient care.
(3) Due to these outdated regulations, California hospitals are
not able to provide patients with some of the cutting-edge
technology, equipment, procedures, and care that are available
elsewhere.
(4) It is appropriate to gather clinical data and experience in
California regarding the state-of-the-art technology, equipment,
procedures, and care now available.
(b) It is the intent of the Legislature that the State Department
of Public Health develop and implement a pilot program for the
purposes specified in subdivision (a).
SEC. 2. Section 1276 of the Health and Safety Code is amended to
read:
1276. (a) The building standards published in the State Building
Standards Code by the Office of Statewide Health Planning and
Development, and the regulations adopted by the department shall, as
applicable, prescribe standards of adequacy, safety, and sanitation
of the physical plant, of staffing with duly qualified licensed
personnel, and of services, based on the type of health facility and
the needs of the persons served thereby.
(b) These regulations shall permit program flexibility by the use
of alternate concepts, methods, procedures, techniques, equipment,
personnel qualifications, bulk purchasing of pharmaceuticals, or
conducting of pilot projects as long as statutory requirements are
met and the use has the prior written approval of the department or
the office, as applicable. The approval of the department or the
office shall provide for the terms and conditions under which the
exception is granted. A written request plus supporting evidence
shall be submitted by the applicant or licensee to the department or
office regarding the exception, as applicable.
(c) While it is the intent of the Legislature that health
facilities shall maintain continuous, ongoing compliance with the
licensing rules and regulations, it is the further intent of the
Legislature that the department expeditiously review and approve, if
appropriate, applications for program flexibility. The Legislature
recognizes that health care technology, practice, pharmaceutical
procurement systems, and personnel qualifications and availability
are changing rapidly. Therefore, requests for program flexibility
require expeditious consideration.
(d) (1) The department shall, on or before April 1, 1989, develop
a standardized form and format for requests by health facilities for
program flexibility. Health facilities shall thereafter apply to the
department for program flexibility in the prescribed manner. After
the department receives a complete application requesting program
flexibility, it shall have 60 days within which to approve, approve
with conditions or modifications, or deny the application. Denials
and approvals with conditions or modifications shall be accompanied
by an analysis and a detailed justification for any conditions or
modifications imposed. Summary denials to meet the 60-day timeframe
shall not be permitted.
(2) Notwithstanding paragraph (1), the department shall approve or
approve with conditions or modifications a complete application
requesting program flexibility for the use of alternate concepts,
methods, procedures, techniques, or equipment by a general acute care
hospital whenever the hospital demonstrates to the department that
this use meets or exceeds the quality of care and patient safety in
effect on January 1, 2010.
(e) Notwithstanding any other provision of law or regulation, the
department shall provide flexibility in its pharmaceutical services
requirements to permit any state department that operates state
facilities subject to these provisions to establish a single
statewide formulary or to procure pharmaceuticals through a
departmentwide or multidepartment bulk purchasing arrangement. It is
the intent of the Legislature that consolidation of these activities
be permitted in order to allow the more cost-effective use and
procurement of pharmaceuticals for the benefit of patients and
residents of state facilities.
SEC. 3. Chapter 2 (commencing with Section 101990) is added to
Part 6 of Division 101 of the Health and Safety Code, to read:
CHAPTER 2. HEALTH FACILITY INNOVATION
101990. (a) The State Department of Public Health shall establish
a pilot program to gather clinical data on, and provide general
acute care hospitals, as defined in subdivision (a) of Section 1250,
experience with, the use of alternate concepts, methods, procedures,
techniques, equipment, and care to what is authorized pursuant to
regulations adopted pursuant to Chapter 2 (commencing with Section
1250) of Division 2 in effect on January 1, 2010, but otherwise meet
the statutory requirements of that chapter.
(b) The department shall identify alternate concepts, methods,
procedures, techniques, equipment, or care that the department
determines will promote innovation and improvements in services and
patient care. The department shall also solicit and receive proposals
from general acute care hospitals to use alternate concepts,
methods, procedures, techniques, equipment, and care that will
promote innovation and improvements in services and patient care.
(c) The department shall, by July 1, 2010
2011 , authorize at least two, but not more than 10, general
acute care hospitals to use an alternate concept, method, procedure,
technique, equipment, or care that was identified by the department
or proposed by a hospital pursuant to subdivision (b). At least one
general acute care hospital shall be located within the County of San
Diego and shall be associated with a two-hospital system operated by
a health care district. A general acute care hospital participating
in the pilot program shall staff the alternate concepts, methods,
procedures, techniques, equipment, and care with licensed nurses
pursuant to the requirements of Section 1276.4.
(d) The department may charge a general acute care hospital
authorized to participate in the program an annual fee to participate
in the pilot program that does not exceed the amount of the direct
costs to the department of overseeing and evaluating the pilot
program. The moneys collected from this fee shall be deposited in the
State Department of Public Health Licensing and Certification
Program Fund.
(e) By January 1, 2012 2014 , the
department shall prepare and submit a report to the Legislature on
the results of the pilot program and its impact upon the quality of
service and patient care.