BILL NUMBER: SB 1301	CHAPTERED
	BILL TEXT

	CHAPTER  647
	FILED WITH SECRETARY OF STATE  SEPTEMBER 29, 2006
	APPROVED BY GOVERNOR  SEPTEMBER 29, 2006
	PASSED THE SENATE  AUGUST 31, 2006
	PASSED THE ASSEMBLY  AUGUST 30, 2006
	AMENDED IN ASSEMBLY  AUGUST 28, 2006
	AMENDED IN ASSEMBLY  AUGUST 24, 2006
	AMENDED IN ASSEMBLY  AUGUST 21, 2006
	AMENDED IN ASSEMBLY  AUGUST 7, 2006
	AMENDED IN ASSEMBLY  JUNE 29, 2006
	AMENDED IN ASSEMBLY  JUNE 13, 2006
	AMENDED IN SENATE  MAY 1, 2006
	AMENDED IN SENATE  APRIL 6, 2006
	AMENDED IN SENATE  MARCH 27, 2006

INTRODUCED BY   Senator Alquist

                        FEBRUARY 16, 2006

   An act to add Sections 1279.1, 1279.2, 1279.3, and 1280.4 to, the
Health and Safety Code, relating to health facilities.


	LEGISLATIVE COUNSEL'S DIGEST


   SB 1301, Alquist  Health facilities: reporting and inspection
requirements.
   Existing law provides for the inspection, licensure, and
regulation of health care facilities by the State Department of
Health Services, including, among other facilities, general acute
care hospitals, acute psychiatric hospitals, special hospitals, and
long-term health care facilities, some of which are collectively
referred to as nursing homes. Existing law requires that all licensed
general acute care hospitals maintain a medical records system, as
specified, that organizes all medical records for each patient under
a unique identifier, and develop and implement policies and
procedures to ensure that relevant portions of patients' medical
records can be made available within a reasonable period of time to
respond to the request of a treating physician, other authorized
medical professionals, authorized representatives of the department,
or any other person authorized by law to make such a request, taking
into consideration the physical location of the records and hours of
operation of the facility where those records are located, as well as
the interests of the patients.
   Existing law establishes licensing and certification fees
applicable to various clinics, health care providers, and health
facilities, for the 2006-07 fiscal year, and requires the department,
commencing February 1, 2007, and every February 1 thereafter, to
publish a list of estimated fees, based on specified calculations and
cost estimates.  Existing law also requires the department, by
February 1 of each year, among other reports, to prepare and make
available to interested persons a staffing and systems analysis to
ensure efficient and effective utilization of fees collected, proper
allocation of departmental resources to licensing and certification
activities, survey schedules, complaint investigations, enforcement
and appeal activities, data collection and dissemination, surveyor
training, and policy development, including specified information.
   This bill would require that information on the number and
timeliness of adverse event investigations related to reports of
adverse events also be included in that analysis.
   This bill would require the department to take various actions
related to the reporting to, and the investigation by, the department
of any adverse event, as defined, that occurs at a general acute
care hospital, acute psychiatric hospital, or special hospital. The
bill would require a general acute care hospital, acute psychiatric
hospital, or special hospital to report to the department any adverse
event, as defined, within 5 days of its discovery, unless the
adverse event is an ongoing urgent or emergent threat to the welfare,
safety, or health of patients, personnel, or visitors, in which case
the event shall be reported to the department within 24 hours of its
discovery. The bill would authorize the department to assess
specified civil penalties against a licensee for failure to report an
adverse event as required by the bill.
   This bill would require the department to conduct an onsite
inspection or investigation within 48 hours or 2 business days of a
complaint that indicates an ongoing threat of imminent danger of
death or serious bodily harm at a general acute care hospital, an
acute psychiatric hospital, or a special hospital. The bill would
require information about the reported adverse event and the outcome
of investigations or inspections of substantiated adverse events
reported conducted in accordance with these provisions to be posted
on the department's Internet Web site and available in written form,
by January 1, 2015. The bill would require the department to make
this information readily accessible to consumers between January 1,
2009, and January 1, 2015. The bill would require the department to
make related data available to entities deemed appropriate by the
department, to be posted on the entities' Internet Web sites.
   The bill would require the costs of administering and implementing
certain of its provisions to be paid from funds derived from
licensing fees paid by general acute care, acute psychiatric, and
special hospitals.
   This bill would make its provisions operative on July 1, 2007.
   Violation of provisions relating to the operation of health
facilities is a crime. Therefore, by imposing new and revised
requirements on health facilities, 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.  Section 1279.1 is added to the Health and Safety Code,
to read:
   1279.1.  (a) A health facility licensed pursuant to subdivision
(a), (b), or (f) of Section 1250 shall report an adverse event to the
department no later than five days after the adverse event has been
detected, or, if that event is an ongoing urgent or emergent threat
to the welfare, health, or safety of patients, personnel, or
visitors, not later than 24 hours after the adverse event has been
detected. Disclosure of individually identifiable patient information
shall be consistent with applicable law.
   (b) For purposes of this section, "adverse event" includes any of
the following:
   (1) Surgical events, including the following:
   (A) Surgery performed on a wrong body part that is inconsistent
with the documented informed consent for that patient. A reportable
event under this subparagraph does not include a situation requiring
prompt action that occurs in the course of surgery or a situation
that is so urgent as to preclude obtaining informed consent.
   (B) Surgery performed on the wrong patient.
   (C) The wrong surgical procedure performed on a patient, which is
a surgical procedure performed on a patient that is inconsistent with
the documented informed consent for that patient. A reportable event
under this subparagraph does not include a situation requiring
prompt action that occurs in the course of surgery, or a situation
that is so urgent as to preclude the obtaining of informed consent.
   (D) Retention of a foreign object in a patient after surgery or
other procedure, excluding objects intentionally implanted as part of
a planned intervention and objects present prior to surgery that are
intentionally retained.
   (E) Death during or up to 24 hours after induction of anesthesia
after surgery of a normal, healthy patient who has no organic,
physiologic, biochemical, or psychiatric disturbance and for whom the
pathologic processes for which the operation is to be performed are
localized and do not entail a systemic disturbance.
   (2) Product or device events, including the following:
   (A) Patient death or serious disability associated with the use of
a contaminated drug, device, or biologic provided by the health
facility when the contamination is the result of generally detectable
contaminants in the drug, device, or biologic, regardless of the
source of the contamination or the product.
   (B) Patient death or serious disability associated with the use or
function of a device in patient care in which the device is used or
functions other than as intended. For purposes of this subparagraph,
"device" includes, but is not limited to, a catheter, drain, or other
specialized tube, infusion pump, or ventilator.
   (C) Patient death or serious disability associated with
intravascular air embolism that occurs while being cared for in a
facility, excluding deaths associated with neurosurgical procedures
known to present a high risk of intravascular air embolism.
   (3) Patient protection events, including the following:
   (A) An infant discharged to the wrong person.
   (B) Patient death or serious disability associated with patient
disappearance for more than four hours, excluding events involving
adults who have competency or decisionmaking capacity.
   (C) A patient suicide or attempted suicide resulting in serious
disability while being cared for in a health facility due to patient
actions after admission to the health facility, excluding deaths
resulting from self-inflicted injuries that were the reason for
admission to the health facility.
   (4) Care management events, including the following:
   (A) A patient death or serious disability associated with a
medication error, including, but not limited to, an error involving
the wrong drug, the wrong dose, the wrong patient, the wrong time,
the wrong rate, the wrong preparation, or the wrong route of
administration, excluding reasonable differences in clinical judgment
on drug selection and dose.
   (B) A patient death or serious disability associated with a
hemolytic reaction due to the administration of ABO-incompatible
blood or blood products.
   (C) Maternal death or serious disability associated with labor or
delivery in a low-risk pregnancy while being cared for in a facility,
including events that occur within 42 days postdelivery and
excluding deaths from pulmonary or amniotic fluid embolism, acute
fatty liver of pregnancy, or cardiomyopathy.
   (D) Patient death or serious disability directly related to
hypoglycemia, the onset of which occurs while the patient is being
cared for in a health facility.
   (E) Death or serious disability, including kernicterus, associated
with failure to identify and treat hyperbilirubinemia in neonates
during the first 28 days of life. For purposes of this subparagraph,
"hyperbilirubinemia" means bilirubin levels greater than 30
milligrams per deciliter.
   (F) A Stage 3 or 4 ulcer, acquired after admission to a health
facility, excluding progression from Stage 2 to Stage 3 if Stage 2
was recognized upon admission.
   (G) A patient death or serious disability due to spinal
manipulative therapy performed at the health facility.
   (5) Environmental events, including the following:
   (A) A patient death or serious disability associated with an
electric shock while being cared for in a health facility, excluding
events involving planned treatments, such as electric countershock.
   (B) Any incident in which a line designated for oxygen or other
gas to be delivered to a patient contains the wrong gas or is
contaminated by a toxic substance.
   (C) A patient death or serious disability associated with a burn
incurred from any source while being cared for in a health facility.

   (D) A patient death associated with a fall while being cared for
in a health facility.
   (E) A patient death or serious disability associated with the use
of restraints or bedrails while being cared for in a health facility.

   (6) Criminal events, including the following:
   (A) Any instance of care ordered by or provided by someone
impersonating a physician, nurse, pharmacist, or other licensed
health care provider.
   (B) The abduction of a patient of any age.
   (C) The sexual assault on a patient within or on the grounds of a
health facility.
   (D) The death or significant injury of a patient or staff member
resulting from a physical assault that occurs within or on the
grounds of a facility.
   (7) An adverse event or series of adverse events that cause the
death or serious disability of a patient, personnel, or visitor.
   (c) The facility shall inform the patient or the party responsible
for the patient of the adverse event by the time the report is made.

   (d) "Serious disability" means a physical or mental impairment
that substantially limits one or more of the major life activities of
an individual, or the loss of bodily function, if the impairment or
loss lasts more than 7 days or is still present at the time of
discharge from an inpatient health care facility, or the loss of a
body part.
   (e) Nothing in this section shall be interpreted to change or
otherwise affect hospital reporting requirements regarding reportable
diseases or unusual occurrences, as provided in Section 70737 of
Title 22 of the California Code of Regulations. The department shall
review Section 70737 of Title 22 of the California Code of
Regulations requiring hospitals to report "unusual circumstances" and
consider amending the section to enhance the clarity and specificity
of this hospital reporting requirement.
  SEC. 2.  Section 1279.2 is added to the Health and Safety Code, to
read:
   1279.2.  (a) (1) In any case in which the department receives a
report from a facility pursuant to Section 1279.1, or a written or
oral complaint involving a health facility licensed pursuant to
subdivision (a), (b), or (f) of Section 1250, that indicates an
ongoing threat of imminent danger of death or serious bodily harm,
the department shall make an onsite inspection or investigation
within 48 hours or two business days, whichever is greater, of the
receipt of the report or complaint and shall complete that
investigation within 45 days.
   (2) Until the department has determined by onsite inspection that
the adverse event has been resolved, the department shall, not less
than once a year, conduct an unannounced inspection of any health
facility that has reported an adverse event pursuant to Section
1279.1.
   (b) In any case in which the department is able to determine from
the information available to it that there is no threat of imminent
danger of death or serious bodily harm to that patient or other
patients, the department shall complete an investigation of the
report within 45 days.
   (c) The department shall notify the complainant and licensee in
writing of the department's determination as a result of an
inspection or report.
   (d) For purposes of this section, "complaint" means any oral or
written notice to the department, other than a report from the health
facility, of an alleged violation of applicable requirements of
state or federal law or an allegation of facts that might constitute
a violation of applicable requirements of state or federal law.
   (e) The costs of administering and implementing this section shall
be paid from funds derived from existing licensing fees paid by
general acute care hospitals, acute psychiatric hospitals, and
special hospitals.
   (f) In enforcing this section and Sections 1279 and 1279.1, the
department shall take into account the special circumstances of small
and rural hospitals, as defined in Section 124840, in order to
protect the quality of patient care in those hospitals.
   (g) In preparing the staffing and systems analysis required
pursuant to Section 1266, the department shall also report regarding
the number and timeliness of investigations of adverse events
initiated in response to reports of adverse events.
  SEC. 3.  Section 1279.3 is added to the Health and Safety Code, to
read:
   1279.3.  (a) By January 1, 2015, the department shall provide
information regarding reports of substantiated adverse events
pursuant to Section 1279.1 and the outcomes of inspections and
investigations conducted pursuant to Section 1279.1, on the
department's Internet Web site and in written form in a manner that
is readily accessible to consumers in all parts of California, and
that protects patient confidentiality.
   (b) By January 1, 2009, and until January 1, 2015, the department
shall make information regarding reports of substantiated adverse
events pursuant to Section 1279.1, and outcomes of inspections and
investigations conducted pursuant to Section 1279.1, readily
accessible to consumers throughout California. The department shall
also compile and make available, to entities deemed appropriate by
the department, data regarding these reports of substantiated adverse
events pursuant to Section 1279.1 and outcomes of inspections and
investigations conducted pursuant to Section 1279.1, in order that
these entities may post this data on their Internet Web sites.
Entities deemed appropriate by the department shall enter into a
memorandum of understanding with the department that requires the
inclusion of all data and all hospital information provided by the
department. These entities may include universities, consumer
organizations, or health care quality organizations.
   (c) The information required pursuant to this section shall
include, but not be limited to, information regarding each
substantiated adverse event, as defined in Section 1279.1, reported
to the department, and may include compliance information history.
The names of the health care professionals and health care workers
shall not be included in the information released by the department
to the public.
  SEC. 4.  Section 1280.4 is added to the Health and Safety Code, to
read:
   1280.4.  If a licensee of a health facility licensed under
subdivision (a), (b), or (f) of Section 1250 fails to report an
adverse event pursuant to Section 1279.1, the department may assess
the licensee a civil penalty in an amount not to exceed one hundred
dollars ($100) for each day that the adverse event is not reported
following the initial five-day period or 24-hour period, as
applicable, pursuant to subdivision (a) of Section 1279.1. If the
licensee disputes a determination by the department regarding alleged
failure to report an adverse event, the licensee may, within 10
days, request a hearing pursuant to Section 100171. Penalties shall
be paid when appeals pursuant to those provisions have been
exhausted.
  SEC. 5.  This act shall become operative on July 1, 2007.
  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.