Bill Text: CA SB303 | 2009-2010 | Regular Session | Enrolled
Bill Title: Nursing facility residents: informed consent.
Spectrum: Partisan Bill (Democrat 4-0)
Status: (Vetoed) 2010-01-19 - Stricken from Senate file. [SB303 Detail]
Download: California-2009-SB303-Enrolled.html
BILL NUMBER: SB 303 ENROLLED
BILL TEXT
PASSED THE SENATE SEPTEMBER 10, 2009
PASSED THE ASSEMBLY SEPTEMBER 8, 2009
AMENDED IN ASSEMBLY SEPTEMBER 2, 2009
AMENDED IN ASSEMBLY AUGUST 17, 2009
AMENDED IN ASSEMBLY JULY 7, 2009
AMENDED IN SENATE APRIL 27, 2009
AMENDED IN SENATE APRIL 16, 2009
AMENDED IN SENATE APRIL 14, 2009
INTRODUCED BY Senator Alquist
(Coauthor: Senator Florez)
(Coauthors: Assembly Members Ammiano and Hall)
FEBRUARY 25, 2009
An act to amend Sections 1418.9 and 1599.1 of, and to add Section
1599.15 to, the Health and Safety Code, relating to nursing facility
residents.
LEGISLATIVE COUNSEL'S DIGEST
SB 303, Alquist. Nursing facility residents: informed consent.
Existing law provides that patients of skilled nursing facilities
and intermediate care facilities have prescribed rights.
This bill would add to these rights the right of every resident to
receive all information that is material to an individual's decision
concerning whether to accept or refuse any proposed treatment or
procedure. This bill would make the physician responsible for
disclosing the material information to the resident and obtaining his
or her informed consent.
This bill would require that informed consent, as defined, be
obtained in accordance with the above requirements of the bill, with
respect to a resident's decision to accept or reject the
administration of a psychotherapeutic drug.
This bill would also require the State Department of Public Health
to inspect for compliance with this requirement during prescribed
inspections.
Under existing law, the Long-Term Care, Health, Safety, and
Security Act of 1973, an attending physician and surgeon who seeks to
prescribe, order, or increase an order for an antipsychotic
medication for a resident of a skilled nursing facility is required
to obtain the informed consent of that resident. A violation of this
provision is a misdemeanor.
This bill would extend these requirements to a physician and
surgeon of a resident in an intermediate care facility.
This bill would apply the definition of "informed consent"
contained in the bill to this provision. Because this bill would
change the definition of a crime, this bill would impose a
state-mandated local program.
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. This act shall be known, and may be cited, as the
Nursing Facility Resident Informed Consent Protection Act of 2009.
SEC. 2. The Legislature finds and declares all of the following:
(a) The protection of residents in California's nursing facilities
is of paramount importance to the citizens of California.
(b) Almost 60 percent of California nursing facility residents are
prescribed psychotherapeutic drugs, many of which have dangerous
side effects.
(c) Nearly 20 percent of California nursing facility residents are
receiving powerful antipsychotic drugs that are not intended or
approved for the resident's underlying medical condition.
Antipsychotic drugs are a subclass of psychotherapeutic drugs.
(d) The United States Food and Drug Administration (FDA) has
issued black box warnings for the antipsychotic drugs most commonly
provided to nursing facility residents. The warnings state that these
antipsychotic drugs greatly increase the risk of death for seniors
with dementia.
(e) Nursing facility residents and resident's representatives
rarely see the medication inserts that provide the black box warnings
and often do not receive sufficient information about the side
effects of medications.
(f) Nursing facility residents and resident's representatives must
be well-informed in advance about the risks of proposed
antipsychotic drugs and their consent must be obtained before
medications are used.
(g) California's existing regulations on informed consent for
nursing facility residents are rarely enforced.
(h) It is, therefore, the intent of the Legislature to enact
legislation that would do all of the following:
(1) Codify provisions that establish a resident's right to
informed consent concerning the use of psychotherapeutic drugs.
(2) Specify that residents and their representatives must be
informed in writing about the content of black box warnings for
proposed drugs and whether the drug's proposed use has been approved
by the FDA.
(3) Require the State Department of Public Health to evaluate
nursing facility compliance with these provisions during periodic
state licensing inspections.
SEC. 3. Section 1418.9 of the Health and Safety Code is amended to
read:
1418.9. (a) If the attending physician and surgeon of a resident
in a skilled nursing facility or intermediate care facility
prescribes, orders, or increases an order for an antipsychotic
medication for the resident, the physician and surgeon shall do both
of the following:
(1) Obtain the informed consent, in accordance with the
requirements of subdivision (j) of Section 1599.1 and Section
1599.15, of the resident for purposes of prescribing, ordering, or
increasing an order for the medication.
(2) Seek the consent of the resident to notify the resident's
interested family member, as designated in the medical record. If the
resident consents to the notice, the physician and surgeon shall
make reasonable attempts, either personally or through a designee, to
notify the interested family member, as designated in the medical
record, within 48 hours of the prescription, order, or increase of an
order.
(b) Notification of an interested family member is not required
under paragraph (2) of subdivision (a) if any of the following
circumstances exist:
(1) There is no interested family member designated in the medical
record.
(2) The resident has been diagnosed as terminally ill by his or
her physician and surgeon and is receiving hospice services from a
licensed, certified hospice agency in the facility.
(3) The resident has not consented to the notification.
(c) As used in this section, the following definitions shall
apply:
(1) "Resident" means a patient of a skilled nursing facility or an
intermediate care facility who has the capacity to consent to make
decisions concerning his or her health care, including medications.
(2) "Designee" means a person who has agreed with the physician
and surgeon to provide the notice required by this section.
(3) "Antipsychotic medication" means a medication approved by the
United States Food and Drug Administration for the treatment of
psychosis.
(4) "Increase of an order" means an increase of the dosage of the
medication above the dosage range stated in a prior consent from the
resident.
(d) This section shall not be construed to require consent from an
interested family member for an attending physician and surgeon of a
resident to prescribe, order, or increase an order for antipsychotic
medication.
SEC. 4. Section 1599.1 of the Health and Safety Code is amended to
read:
1599.1. Written policies regarding the rights of patients shall
be established and shall be made available to the patient, to any
guardian, next of kin, sponsoring agency or representative payee, and
to the public. Those policies and procedures shall ensure that each
patient admitted to the facility has the following rights and is
notified of the following facility obligations, in addition to those
specified by regulation:
(a) The facility shall employ an adequate number of qualified
personnel to carry out all of the functions of the facility.
(b) Each patient shall show evidence of good personal hygiene and
be given care to prevent bedsores, and measures shall be used to
prevent and reduce incontinence for each patient.
(c) The facility shall provide food of the quality and quantity to
meet the patients' needs in accordance with physicians' orders.
(d) The facility shall provide an activity program staffed and
equipped to meet the needs and interests of each patient and to
encourage self-care and resumption of normal activities. Patients
shall be encouraged to participate in activities suited to their
individual needs.
(e) The facility shall be clean, sanitary, and in good repair at
all times.
(f) A nurses' call system shall be maintained in operating order
in all nursing units and provide visible and audible signal
communication between nursing personnel and patients. Extension cords
to each patient's bed shall be readily accessible to patients at all
times.
(g) (1) If a facility has a significant beneficial interest in an
ancillary health service provider or if a facility knows that an
ancillary health service provider has a significant beneficial
interest in the facility, as provided by subdivision (a) of Section
1323, or if the facility has a significant beneficial interest in
another facility, as provided by subdivision (c) of Section 1323, the
facility shall disclose that interest in writing to the patient, or
his or her representative, and advise the patient, or his or her
representative, that the patient may choose to have another ancillary
health service provider, or facility, as the case may be, provide
any supplies or services ordered by a member of the medical staff of
the facility.
(2) A facility is not required to make any disclosures required by
this subdivision to any patient, or his or her representative, if
the patient is enrolled in an organization or entity that provides or
arranges for the provision of health care services in exchange for a
prepaid capitation payment or premium.
(h) (1) If a resident of a long-term health care facility has been
hospitalized in an acute care hospital and asserts his or her rights
to readmission pursuant to bed hold provisions, or readmission
rights of either state or federal law, and the facility refuses to
readmit him or her, the resident may appeal the facility's refusal.
(2) The refusal of the facility as described in this subdivision
shall be treated as if it were an involuntary transfer under federal
law, and the rights and procedures that apply to appeals of transfers
and discharges of nursing facility residents shall apply to the
resident's appeal under this subdivision.
(3) If the resident appeals pursuant to this subdivision, and the
resident is eligible under the Medi-Cal program, the resident shall
remain in the hospital and the hospital may be reimbursed at the
administrative day rate, pending the final determination of the
hearing officer, unless the resident agrees to placement in another
facility.
(4) If the resident appeals pursuant to this subdivision, and the
resident is not eligible under the Medi-Cal program, the resident
shall remain in the hospital if other payment is available, pending
the final determination of the hearing officer, unless the resident
agrees to placement in another facility.
(5) If the resident is not eligible for participation in the
Medi-Cal program and has no other source of payment, the hearing and
final determination shall be made within 48 hours.
(i) Effective July 1, 2007, Sections 483.10, 483.12, 483.13, and
483.15 of Title 42 of the Code of Federal Regulations in effect on
July 1, 2006, shall apply to each skilled nursing facility and
intermediate care facility, regardless of a resident's payment source
or the Medi-Cal or Medicare certification status of the skilled
nursing facility or intermediate care facility in which the resident
resides, except that a noncertified facility is not obligated to
provide notice of Medicaid or Medicare benefits, covered services, or
eligibility procedures.
(j) The resident shall have the right to receive all information
that is material to an individual's decision concerning whether to
accept or refuse any proposed treatment or procedure. The disclosure
of material information for administration of psychotherapeutic drugs
shall include the disclosures required by Section 1599.15.
SEC. 5. Section 1599.15 is added to the Health and Safety Code, to
read:
1599.15. (a) As used in this section, the following definitions
shall apply:
(1) "Attending physician" means the physician chosen by the
resident or the resident's representative to be responsible for the
medical treatment of the resident in the facility.
(2) "Informed consent" means the voluntary agreement of a patient
or a resident's representative to accept a treatment or procedure
after receiving information in accordance with subdivisions (b) to
(f), inclusive, of this section and subdivision (j) of Section
1599.1.
(3) "Psychotherapeutic drug" means a medication to control
behavior or to treat thought disorder processes.
(b) It is the responsibility of the attending physician to
determine what information a reasonable person in the resident's
condition and circumstances would consider material to a decision to
accept or refuse a proposed treatment or procedure. Information that
is commonly appreciated need not be disclosed. The disclosure of the
material information and obtaining informed consent shall be the
responsibility of the physician.
(c) The information material to a decision concerning the
administration of a psychotherapeutic drug shall include, but not be
limited to, the following:
(1) The reason for the treatment and the nature and seriousness of
the resident's illness.
(2) The nature of the procedure to be used in the proposed
treatment, including the procedure's probable frequency and duration.
(3) The probable degree and duration, whether temporary or
permanent, of improvement or remission expected with or without the
proposed treatment.
(4) The nature, degree, duration, and probability of the side
effects and significant risks that are commonly known by the health
professions. Information on risks associated with psychotherapeutic
drugs shall include, but not be limited to, whether a proposed
medication is being prescribed for a purpose or medical condition
other than the purpose or medical condition for which the United
States Food and Drug Administration (FDA) has specifically approved
that medication. Information on risks of a proposed medication shall
also include, in writing, any current boxed warning labels and
accompanying detailed information regarding contraindications,
warnings, and precautions required by the FDA.
(5) The reasonable alternative treatments and risks, and why the
health professional is recommending a particular treatment.
(6) That the resident has the right to accept or refuse the
proposed treatment, and, if he or she consents, the right to revoke
his or her consent for any reason at any time.
(d) Before initiating the administration of psychotherapeutic
drugs, facility staff shall verify that the resident's health record
contains a notation by the attending or prescribing physician and
surgeon that the physician and surgeon has obtained the informed
consent of the resident to the proposed treatment or procedure.
Facility staff shall also verify with the resident or the resident's
representative that the resident has voluntarily agreed to accept the
proposed treatment or procedure after receiving information from the
attending physician and surgeon and shall document this verification
in the resident's health record. If the resident or the resident's
representative indicates to facility staff that he or she did not
voluntarily agree to accept the proposed treatment or procedure, or
that he or she is now refusing treatment, the treatment shall be
withheld from the resident. If the resident or the resident's
representative has questions or concerns about the risks or benefits
of, or alternatives to, the treatment, the facility staff shall
immediately refer those questions or concerns to the resident's
attending or prescribing physician and surgeon. The facility shall
also ensure that all decisions concerning the withdrawal or
withholding of life sustaining treatment are documented in the
resident's health record.
(e) Residents' rights policies and procedures established under
this section concerning consent, informed consent, and refusal of
treatments or procedures shall specify how the facility will verify
that the resident provided informed consent or refused treatment or
procedure pertaining to the administration of psychotherapeutic
drugs.
(f) This section shall not be construed to require obtaining
informed consent each time a treatment or procedure is administered
unless material circumstances or risks change.
(g) The State Department of Public Health shall inspect skilled
nursing facilities as defined in subdivision (c) of Section 1250 and
intermediate care facilities as defined in subdivision (d) of Section
1250 for compliance with this section during the periodic
inspections required under Section 1422 and, as appropriate, during
complaint investigations required under Section 1420. This inspection
requirement shall not limit the department's authority in other
circumstances to cite for violations of this section or to inspect
for compliance with this section.
(h) A violation of the informed consent rights provided for in
this section may constitute a class "B," "A," or "AA" violation
pursuant to the standards established in Section 1424.
(i) Nothing in this section shall impair or otherwise alter other
nonconflicting statutory or regulatory requirements, including, but
not limited to, requirements contained in paragraphs (e) to (h),
inclusive, of Section 72528 of Title 22 of the California Code of
Regulations or otherwise related requirements for informed consent
for the administration of psychotherapeutic drugs.
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.
