BILL NUMBER: SB 1318	ENROLLED
	BILL TEXT

	PASSED THE SENATE  AUGUST 30, 2012
	PASSED THE ASSEMBLY  AUGUST 28, 2012
	AMENDED IN ASSEMBLY  AUGUST 24, 2012
	AMENDED IN ASSEMBLY  AUGUST 8, 2012
	AMENDED IN ASSEMBLY  AUGUST 7, 2012
	AMENDED IN ASSEMBLY  JUNE 14, 2012
	AMENDED IN SENATE  MAY 25, 2012
	AMENDED IN SENATE  APRIL 11, 2012

INTRODUCED BY   Senator Wolk
   (Coauthor: Senator Anderson)

                        FEBRUARY 23, 2012

   An act to amend Section 1248.15 of, to add Section 1228.5 to, and
to repeal and add Section 1288.7 of, the Health and Safety Code,
relating to infectious diseases.


	LEGISLATIVE COUNSEL'S DIGEST


   SB 1318, Wolk. Health facilities: influenza vaccinations.
   Existing law imposes on the State Department of Public Health
various duties and responsibilities regarding the regulation of
clinics and health facilities, including general acute care
hospitals, as defined.
   Existing law requires a general acute care hospital to annually
offer onsite influenza vaccinations, if available, to all hospital
employees. Existing law requires a general acute care hospital to
require its employees to be vaccinated, or if the employee elects not
to be vaccinated, to declare in writing that he or she declined the
vaccination. A violation of these provisions is punishable as a
misdemeanor.
   This bill would require clinics, as defined, and health facilities
to institute measures, including aerosol transmissible diseases
training, designed to maximize influenza vaccination rates and to
prevent onsite health care workers affiliated with the clinic or
health facility and persons with privileges on the medical staff from
contracting, and transmitting to patients, the influenza virus. This
bill would provide that a clinic includes a licensed clinic, a
clinic conducted, operated, or maintained as an outpatient department
of a hospital, or an outpatient setting, as defined.
   This bill would require each clinic and health facility to
annually offer onsite influenza vaccinations to its employees and to
require its onsite health care workers affiliated with the clinic or
health facility, as defined, and persons with privileges on the
medical staff, as defined, to be vaccinated. This bill would require
each clinic and health facility to annually record its vaccination
rate, as defined, for each year and to make those records available
online or upon request. This bill would require clinics and health
facilities to maintain vaccination records of their employees and
permit clinics and health facilities to require documentation of
vaccination or vaccination refusal from an onsite health care worker
or person with privileges on the medical staff. By increasing the
responsibilities of clinics and health facilities, and adding
instances where a clinic or health facility could be subject to a
misdemeanor, this bill would expand the definition of a crime and
would impose a state-mandated local program.
   This bill would also require each clinic and health facility to
develop policies to implement these provisions and to ensure
nonmedical staff, as defined, compliance with vaccination
requirements. This bill would require the medical staff to develop
separate policies to ensure compliance with vaccination requirements
imposed by the clinic or health facility.
   This bill would require, commencing January 1, 2015, each clinic
and health facility to have a 90% or higher vaccination rate. The
bill would require the department, by July 1, 2015, to develop a
model mandatory vaccination policy, as specified, and for each year a
clinic or health facility does not achieve the 90% or higher
vaccination rate, would require the clinic or health facility to
adopt the model mandatory vaccination policy for the following
influenza season.
   Existing law establishes the Medical Board of California which
approves accrediting agencies of outpatient settings. Existing law
permits outpatient settings to apply to an accreditation agency for a
certificate of accreditation. Existing law requires every outpatient
setting which is accredited to be inspected by the accreditation
agency.
   This bill would require an accrediting agency to ensure that an
outpatient setting to which it has issued a certificate is in
compliance with these provisions.
   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.


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:

  SECTION 1.  The Legislature declares that influenza can be a
serious disease that can lead to hospitalization and even death, and
that increased access to vaccinations is a critical component in the
promotion of health and wellness. Because of their contact with
patients, many health care workers are at risk for exposure to, and
possible transmission of, vaccine-preventable diseases. By getting
vaccinated, health care workers can protect themselves, their
families, and patients from contracting the influenza virus. It is
the intent of the Legislature in enacting this statute to protect the
health, safety, and welfare of health care workers and patients who
enter a clinic or health care facility. It is also the intent of the
Legislature that health care facilities and clinics institute
measures designed to maximize influenza vaccination rates and
increase vaccination among health care workers. It is also the intent
of the Legislature that the State Department of Public Health
develop a model mandatory vaccination policy through a stakeholder
process to achieve a 90-percent influenza vaccination compliance rate
requirement for health care workers.
  SEC. 2.  Section 1228.5 is added to the Health and Safety Code, to
read:
   1228.5.  (a) A clinic shall institute measures designed to
maximize influenza vaccination rates and to prevent persons with
privileges on the medical staff and onsite health care workers
affiliated with the clinic from contracting, and transmitting to
patients, the influenza virus. These measures shall include, but not
be limited to, aerosol transmissible diseases training as described
in subdivision (i) of Section 5199 of Title 8 of the California Code
of Regulations, as in effect on January 1, 2013.
   (b) A clinic shall annually offer its employees onsite influenza
vaccinations, if available, at no cost to the employee.
   (c) A clinic shall require all onsite health care workers
affiliated with the clinic and persons with privileges on the medical
staff to either annually receive an influenza vaccination or, as an
alternative to the annual influenza vaccination if an onsite health
care worker affiliated with the clinic or person with privileges on
the medical staff elects not to be vaccinated, he or she shall agree,
in writing, to adhere to the most effective measures determined by
the clinic in preventing health care workers from contracting and
transmitting the influenza virus.
   (d) (1) A clinic shall annually record its vaccination rate, as
defined in paragraph (4) of subdivision (i), for that year, and make
those records available online or upon request of a government
agency, organization, or individual.
   (2) The records described in paragraph (1) shall be maintained and
made available during any inspection made by the department or an
accrediting agency.
   (e) (1) Commencing January 1, 2015, a clinic shall have a
90-percent or higher vaccination rate. For each year that a clinic
does not achieve the 90-percent or higher vaccination rate, the
clinic shall adopt for the following influenza season, as defined by
the State Public Health Officer, the model mandatory vaccination
policy described in paragraph (2), to achieve the 90-percent or
higher goal. The department or an accrediting agency may waive the
90-percent vaccination rate requirement for a clinic that is in
substantial compliance.
   (2) The department, in consultation with the California Conference
of Local Health Officers, shall develop a model mandatory
vaccination policy, which has been determined to achieve the
90-percent or higher goal, through a stakeholder process to be issued
through an all facilities letter no later than July 1, 2015.
   (3) The department or an accrediting agency may waive the
90-percent vaccination rate requirement for a clinic during any
particular year if the clinic is able to show that it is reasonably
unable to access the appropriate amount of influenza vaccines
necessary to achieve the 90-percent goal for that year.
   (f) (1) In meeting the requirements of subdivisions (c), (d), and
(e), the clinic shall maintain influenza vaccination records of
employees and may maintain influenza vaccination records of the other
onsite health care workers who are affiliated with, but are not
employees of, the clinic and of persons with privileges on the
medical staff. If the clinic does not have records of an onsite
health care worker or person with privileges on the medical staff
being vaccinated onsite, the clinic may require the worker or medical
staff person to either provide documentation of vaccination or
documentation that he or she refused the vaccination.
   (2) The clinic may include language in its business contracts to
require a contract worker to maintain records of the verification of
offsite vaccination or documentation that he or she refused the
vaccination, which shall be available to the clinic upon request.
Nothing in this section shall be construed to require a clinic to
maintain separate vaccination records or to provide vaccinations at
no cost to a contract worker who is not an employee of the clinic.
   (g) Each clinic shall develop policies to implement this section
and to ensure its onsite health care workers affiliated with the
clinic are in compliance with the vaccination requirements imposed by
this section. The medical staff shall also develop policies to
ensure that persons who have privileges on the medical staff are in
compliance with the vaccination requirements of this section that
have been implemented by the clinic.
   (h) Subdivisions (f) and (g) shall not be applicable to a dialysis
clinic which maintains an influenza immunization log for its
patients, health care workers, and medical staff pursuant to an
infection control program in compliance with the Medicare "Conditions
for Coverage for End-State Renal Disease Facilities," conditions
that are promulgated by the federal Centers for Medicare and Medicaid
Services, if the immunization log addresses influenza vaccination
and is available for review during routine department inspections or
during an inspection in response to a complaint.
   (i) For purposes of this section, the following definitions shall
apply:
   (1) "Employee" means an individual who works for the clinic, is
listed on the clinic's payroll records, and is under the clinic's
direction and control.
   (2) "Medical staff" means professional medical personnel who are
approved and given privileges to provide health care to patients
while onsite in a clinic and who are responsible for the adequacy and
quality of care rendered to patients. Medical staff includes, but is
not limited to, physicians and surgeons, and, if dental or podiatric
services are provided, dentists or podiatrists.
   (3) "Onsite health care worker affiliated with the clinic" means a
person who is either a volunteer or is employed by, paid by, or
receives credit or any other form of compensation from the clinic,
who performs some or all of his or her duties in a patient care area
of the facility. The patient care area of the facility shall be
determined by the clinic and is where onsite health care workers and
medical staff are within close proximity to patients receiving care.
An onsite health care worker affiliated with the clinic includes, but
is not limited to, employees, physicians, nurses, nursing
assistants, therapists, technicians, emergency medical service
personnel, dental personnel, pharmacists, laboratory personnel,
autopsy personnel, students and trainees, contractual staff, and
registry staff who perform direct patient care duties but are not
employed by the clinic.
   (4) "Vaccination rate" means the percentage of a clinic's onsite
health care workers who are employees and persons with privileges on
the medical staff who receive influenza vaccination during a specific
year or influenza season.
   (j) Notwithstanding Chapter 3.5 (commencing with Section 11340) of
Part 1 of Division 3 of Title 2 of the Government Code, the
department may implement this section by sending letters or similar
instruction to all applicable facilities without taking regulatory
action.
   (k) This section does not prevent a clinic or local jurisdiction
from instituting additional measures or policies to maximize
influenza vaccination rates and to prevent health care workers
affiliated with the clinic from contracting and transmitting the
influenza virus.
   (l) This section does not require the department to perform any
additional surveillance for the purpose of ensuring compliance with
this section that is above and beyond its routine licensing survey
schedule or other statutory requirements.
   (m) Clinic, for purposes of this section, includes a clinic
licensed pursuant to this chapter, a clinic that is conducted,
operated, or maintained as an outpatient department of a hospital, as
defined in Section 1250, and an outpatient setting, as defined in
Section 1248.
   (n) Accrediting agencies approved by the Medical Board of
California shall be solely responsible for ensuring that outpatient
settings, as defined in Section 1248, are in compliance with this
section.
   (o) Implementation of this section is exempt from the rulemaking
provisions of the Administrative Procedure Act (Chapter 3.5
(commencing with Section 11340) of Part 1 of Division 3 of Title 2 of
the Government Code).
  SEC. 3.  Section 1248.15 of the Health and Safety Code is amended
to read:
   1248.15.  (a) The board shall adopt standards for accreditation
and, in approving accreditation agencies to perform accreditation of
outpatient settings, shall ensure that the certification program
shall, at a minimum, include standards for the following aspects of
the settings' operations:
   (1) Outpatient setting allied health staff shall be licensed or
certified to the extent required by state or federal law.
   (2) (A) Outpatient settings shall have a system for facility
safety and emergency training requirements.
   (B) There shall be onsite equipment, medication, and trained
personnel to facilitate handling of services sought or provided and
to facilitate handling of any medical emergency that may arise in
connection with services sought or provided.
   (C) In order for procedures to be performed in an outpatient
setting as defined in Section 1248, the outpatient setting shall do
one of the following:
   (i) Have a written transfer agreement with a local accredited or
licensed acute care hospital, approved by the facility's medical
staff.
   (ii) Permit surgery only by a licensee who has admitting
privileges at a local accredited or licensed acute care hospital,
with the exception that licensees who may be precluded from having
admitting privileges by their professional classification or other
administrative limitations, shall have a written transfer agreement
with licensees who have admitting privileges at local accredited or
licensed acute care hospitals.
   (iii) Submit for approval by an accrediting agency a detailed
procedural plan for handling medical emergencies that shall be
reviewed at the time of accreditation. No reasonable plan shall be
disapproved by the accrediting agency.
   (D) In addition to the requirements imposed in subparagraph (C),
the outpatient setting shall submit for approval by an accreditation
agency at the time of accreditation a detailed plan, standardized
procedures, and protocols to be followed in the event of serious
complications or side effects from surgery that would place a patient
at high risk for injury or harm or to govern emergency and urgent
care situations. The plan shall include, at a minimum, that if a
patient is being transferred to a local accredited or licensed acute
care hospital, the outpatient setting shall do all of the following:
   (i) Notify the individual designated by the patient to be notified
in case of an emergency.
   (ii) Ensure that the mode of transfer is consistent with the
patient's medical condition.
   (iii) Ensure that all relevant clinical information is documented
and accompanies the patient at the time of transfer.
   (iv) Continue to provide appropriate care to the patient until the
transfer is effectuated.
   (E) All physicians and surgeons transferring patients from an
outpatient setting shall agree to cooperate with the medical staff
peer review process on the transferred case, the results of which
shall be referred back to the outpatient setting, if deemed
appropriate by the medical staff peer review committee. If the
medical staff of the acute care facility determines that
inappropriate care was delivered at the outpatient setting, the acute
care facility's peer review outcome shall be reported, as
appropriate, to the accrediting body or in accordance with existing
law.
   (3) The outpatient setting shall permit surgery by a dentist
acting within his or her scope of practice under Chapter 4
(commencing with Section 1600) of Division 2 of the Business and
Professions Code or physician and surgeon, osteopathic physician and
surgeon, or podiatrist acting within his or her scope of practice
under Chapter 5 (commencing with Section 2000) of Division 2 of the
Business and Professions Code or the Osteopathic Initiative Act. The
outpatient setting may, in its discretion, permit anesthesia service
by a certified registered nurse anesthetist acting within his or her
scope of practice under Article 7 (commencing with Section 2825) of
Chapter 6 of Division 2 of the Business and Professions Code.
   (4) Outpatient settings shall have a system for maintaining
clinical records.
   (5) Outpatient settings shall have a system for patient care and
monitoring procedures.
   (6) (A)  Outpatient settings shall have a system for quality
assessment and improvement.
   (B) Members of the medical staff and other practitioners who are
granted clinical privileges shall be professionally qualified and
appropriately credentialed for the performance of privileges granted.
The outpatient setting shall grant privileges in accordance with
recommendations from qualified health professionals, and
credentialing standards established by the outpatient setting.
   (C) Clinical privileges shall be periodically reappraised by the
outpatient setting. The scope of procedures performed in the
outpatient setting shall be periodically reviewed and amended as
appropriate.
   (7) Outpatient settings regulated by this chapter that have
multiple service locations shall have all of the sites inspected.
   (8) Outpatient settings shall post the certificate of
accreditation in a location readily visible to patients and staff.
   (9) Outpatient settings shall post the name and telephone number
of the accrediting agency with instructions on the submission of
complaints in a location readily visible to patients and staff.
   (10) Outpatient settings shall have a written discharge criteria.
   (b) Outpatient settings shall have a minimum of two staff persons
on the premises, one of whom shall either be a licensed physician and
surgeon or a licensed health care professional with current
certification in advanced cardiac life support (ACLS), as long as a
patient is present who has not been discharged from supervised care.
Transfer to an unlicensed setting of a patient who does not meet the
discharge criteria adopted pursuant to paragraph (10) of subdivision
(a) shall constitute unprofessional conduct.
   (c) An accreditation agency may include additional standards in
its determination to accredit outpatient settings if these are
approved by the board to protect the public health and safety.
   (d) No accreditation standard adopted or approved by the board,
and no standard included in any certification program of any
accreditation agency approved by the board, shall serve to limit the
ability of any allied health care practitioner to provide services
within his or her full scope of practice. Notwithstanding this or any
other provision of law, each outpatient setting may limit the
privileges, or determine the privileges, within the appropriate scope
of practice, that will be afforded to physicians and allied health
care practitioners who practice at the facility, in accordance with
credentialing standards established by the outpatient setting in
compliance with this chapter. Privileges may not be arbitrarily
restricted based on category of licensure.
   (e) The board shall adopt standards that it deems necessary for
outpatient settings that offer in vitro fertilization.
   (f) The board may adopt regulations it deems necessary to specify
procedures that should be performed in an accredited outpatient
setting for facilities or clinics that are outside the definition of
outpatient setting as specified in Section 1248.
   (g) As part of the accreditation process, the accrediting agency
shall conduct a reasonable investigation of the prior history of the
outpatient setting, including all licensed physicians and surgeons
who have an ownership interest therein, to determine whether there
have been any adverse accreditation decisions rendered against them.
For the purposes of this section, "conducting a reasonable
investigation" means querying the Medical Board of California and the
Osteopathic Medical Board of California to ascertain if either the
outpatient setting has, or, if its owners are licensed physicians and
surgeons, if those physicians and surgeons have, been subject to an
adverse accreditation decision.
   (h) An outpatient setting shall be subject to the reporting
requirements in Section 1279.1 and the penalties for failure to
report specified in Section 1280.4.
   (i) An accrediting agency shall ensure that an outpatient setting
to which it has issued an accreditation certificate is in compliance
with Section 1228.5.
  SEC. 4.  Section 1288.7 of the Health and Safety Code is repealed.
  SEC. 5.  Section 1288.7 is added to the Health and Safety Code, to
read:
   1288.7.  (a) A licensed health facility shall institute measures
designed to maximize influenza vaccination rates and to prevent
persons with privileges on the medical staff and onsite health care
workers affiliated with the health facility from contracting, and
transmitting to patients, the influenza virus. These measures shall
include, but not be limited to, aerosol transmissible diseases
training as described in subdivision (i) of Section 5199 of Title 8
of the California Code of Regulations, as in effect on January 1,
2013.
   (b) A licensed health facility shall annually offer its employees
onsite influenza vaccinations, if available, at no cost to the
employee.
   (c) A licensed health facility shall require all onsite health
care workers affiliated with the health facility and persons with
privileges on the medical staff to either annually receive an
influenza vaccination or, as an alternative to the annual influenza
vaccination if the onsite health care worker affiliated with the
health facility or person with privileges on the medical staff elects
not to be vaccinated, he or she shall agree, in writing, to adhere
to the most effective measures determined by the health facility in
preventing health care workers from contracting and transmitting the
influenza virus.
   (d) (1) A health facility shall annually record its vaccination
rate, as defined in paragraph (4) of subdivision (i), for that year,
and make those records available online or upon request of a
government agency, organization, or individual.
   (2) The records described in paragraph (1) shall be maintained and
made available during any inspection made by the department.
   (e) (1) Commencing January 1, 2015, a health facility shall have a
90-percent or higher vaccination rate. For each year that a health
facility does not achieve the 90-percent or higher vaccination rate,
the health facility shall adopt for the following influenza season,
as defined by the State Public Health Officer, the model mandatory
vaccination policy described in paragraph (2), to achieve the
90-percent or higher goal. The department may waive the 90-percent
vaccination rate requirement for a health facility that is in
substantial compliance.
   (2) The department, in consultation with the California Conference
of Local Health Officers, shall develop a model mandatory
vaccination policy, which has been determined to achieve the
90-percent or higher goal, through a stakeholder process to be issued
through an all facilities letter no later than July 1, 2015.
   (3) The department may waive the 90-percent vaccination rate
requirement for a health facility during any particular year if the
health facility is able to show that it is reasonably unable to
access the appropriate amount of influenza vaccines necessary to
achieve the 90-percent goal for that year.
   (f) (1) In meeting the requirements of subdivisions (c), (d), and
(e), the health facility shall maintain influenza vaccination records
of employees and may maintain influenza vaccination records of the
other onsite health care workers who are affiliated with, but are not
employees of, the health facilities and of persons with privileges
on the medical staff. If the health facility does not have records of
an onsite health care worker or person with privileges on the
medical staff being vaccinated, the health facility may require the
worker or medical staff person to either provide documentation of
vaccination or documentation that he or she refused the vaccination.
   (2) The health facility may include language in its business
contracts to require a contract worker to maintain records of the
verification of offsite vaccination or documentation that he or she
refused the vaccination, which shall be available to the health
facility upon request. Nothing in this section shall be construed to
require a health facility to maintain separate vaccination records or
to provide vaccinations at no cost to a contract worker who is not
an employee of the health facility.
   (g) Each licensed health facility shall develop policies to
implement this section and to ensure its onsite health care workers
affiliated with the health facility are in compliance with the
vaccination requirements imposed by this section. The medical staff
shall develop policies to ensure that persons who have privileges on
the medical staff are in compliance with the vaccination requirements
of this section that have been implemented by the health facility.
   (h) In addition to other requirements of this section, general
acute care hospitals shall take all of the following actions:
   (1) Institute respiratory hygiene and cough etiquette protocols,
develop and implement procedures for the isolation of patients with
influenza, and adopt a seasonal influenza plan.
   (2) Revise an existing or develop a new disaster plan that
includes a pandemic influenza component. The plan shall also document
any actual or recommended collaboration with local, regional, and
state public health agencies or officials in the event of an
influenza pandemic.
   (i) For purposes of this section, the following definitions shall
apply:
   (1) "Employee" means an individual who works for the health
facility, is listed on the health facility's payroll records, and is
under the health facility's direction and control.
   (2) "Medical staff" means professional medical personnel who are
approved and given privileges to provide health care to patients in a
health facility and who are responsible for the adequacy and quality
of care rendered to patients. Medical staff includes, but is not
limited to, physicians and surgeons, and, if dental or podiatric
services are provided, dentists or podiatrists.
   (3) "Onsite health care worker affiliated with the health facility"
means a person who is either a volunteer or is employed by, paid by,
or receives credit or any other form of compensation from the health
facility, who performs some or all of his or her duties in a patient
care area of the facility. The patient care area of the facility
shall be determined by the health facility and is where onsite health
care workers and medical staff are within close proximity to
patients receiving care. An onsite health care worker affiliated with
the health facility includes, but is not limited to, physicians,
nurses, nursing assistants, therapists, technicians, emergency
medical service personnel, dental personnel, pharmacists, laboratory
personnel, autopsy personnel, students and trainees, contractual
staff, and registry staff performing direct patient care duties but
are not employed by the health facility.
   (4) "Vaccination rate" means the percentage of a health facility's
onsite health care workers who are employees and persons with
privileges on the medical staff who receive an influenza vaccination
during a specific year or influenza season.
   (j) Notwithstanding Chapter 3.5 (commencing with Section 11340) of
Part 1 of Division 3 of Title 2 of the Government Code, the
department may implement this section by sending letters or similar
instruction to all applicable facilities without taking regulatory
action.
   (k) This section does not apply to correctional treatment centers
as defined in subdivision (j) of Section 1250.
   (l) This section does not prevent a health facility or local
jurisdiction from instituting additional measures or policies to
maximize influenza vaccination rates and to prevent health care
workers affiliated with the health facility from contracting and
transmitting the influenza virus.
   (m) This section does not require the department to perform any
additional surveillance for the purposes of ensuring compliance with
this section that is above and beyond its routine licensing survey
schedule or other statutory requirements.
   (n) Implementation of this section is exempt from the rulemaking
provisions of the Administrative Procedure Act (Chapter 3.5
(commencing with Section 11340) of Part 1 of Division 3 of Title 2 of
the Government Code).
  SEC. 6.  No reimbursement is required by this act pursuant to
Section 6 of Article XIII B of the California Constitution because
the only costs that may be incurred by a local agency or school
district will be incurred because this act creates a new crime or
infraction, eliminates a crime or infraction, or changes the penalty
for a crime or infraction, within the meaning of Section 17556 of the
Government Code, or changes the definition of a crime within the
meaning of Section 6 of Article XIII B of the California
Constitution.