BILL NUMBER: SB 1169	AMENDED
	BILL TEXT

	AMENDED IN SENATE  MAY 15, 2001

INTRODUCED BY   Senator Alpert

                        FEBRUARY 23, 2001

    An act to add and repeal Section 1157.8 of the Evidence
Code, and to add and repeal Part 5.5 (commencing with Section 128850)
to Division 107 of the Health and Safety Code, relating to health.
  An act to amend Section 4052 of the Business and
Professions Code, relating to pharmacy. 


	LEGISLATIVE COUNSEL'S DIGEST


   SB 1169, as amended, Alpert.   Patient safety data
reporting and analysis   Pharmacy  . 
   Under existing law, a pharmacist may not, in general, furnish a
dangerous drug except upon the prescription of a physician, dentist,
podiatrist, optometrist, or veterinarian.  However, existing law
provides for certain exemptions.
   This bill would authorize a pharmacist to initiate emergency
contraception drug therapy in accordance with written guidelines or
protocols previously established and approved for his or her practice
by a practitioner authorized to prescribe drugs.  
   Under existing law, the Office of Statewide Health Planning and
Development is vested with responsibilities in the areas of health
planning and data reporting.
   This bill would require the office to contract with an
organization recognized as operating a quality-oriented data base
program to create a central reporting data base and to receive and
analyze information relating to medical events involving the
occurrence or near occurrence of compromises of patient safety or of
the quality of health care delivery by any health care professional,
facility, or organization licensed by the state.
   This bill would provide for the making of voluntary reports to
this contractor, and for the analysis of reports by the contractor to
attempt to determine safeguards to prevent future occurrences of the
conduct reported. It would provide for summary quarterly reports to
be made by the contractor to the office and the State Department of
Health Services.
   The bill would contain various safeguards for the identity of
reporters and the subjects of reports.
   The bill would provide for the repeal of its provisions on January
1, 2006. 
   Vote:  majority.  Appropriation:  no.  Fiscal committee: 
yes   no  . State-mandated local program:  no.


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

  
  SECTION 1.  This act shall be known, and may be cited, as the
 
  SECTION 1.  Section 4052 of the Business and Professions Code is
amended to read: 
   4052.  (a) Notwithstanding any other provision of law, a
pharmacist may:
   (1) Furnish a reasonable quantity of compounded medication to a
prescriber for office use by the prescriber.
   (2) Transmit a valid prescription to another pharmacist.
   (3) Administer, orally or topically, drugs and biologicals
pursuant to a prescriber's order.
   (4) Perform the following procedures or functions in a licensed
health care facility in accordance with policies, procedures, or
protocols developed by health professionals, including physicians,
pharmacists, and registered nurses, with the concurrence of the
facility administrator:
   (A) Ordering or performing routine drug therapy-related patient
assessment procedures including temperature, pulse, and respiration.

   (B) Ordering drug therapy-related laboratory tests.
   (C) Administering drugs and biologicals by injection pursuant to a
prescriber's order (the administration of immunizations under the
supervision of a prescriber may also be performed outside of a
licensed health care facility).
   (D) Initiating or adjusting the drug regimen of a patient pursuant
to an order or authorization made by the patient's prescriber and in
accordance with the policies, procedures, or protocols of the
licensed health care facility.
   (5) (A) Perform the following procedures or functions as part of
the care provided by a health care facility, a licensed home health
agency, a licensed clinic in which there is a physician oversight, a
provider who contracts with a licensed health care service plan with
regard to the care or services provided to the enrollees of that
health care service plan, or a physician, in accordance, as
applicable, with policies, procedures, or protocols of that facility,
the home health agency, the licensed clinic, the health care service
plan, or that physician, in accordance with subparagraph (C):
   (i) Ordering or performing routine drug therapy-related patient
assessment procedures including temperature, pulse, and respiration.

   (ii) Ordering drug therapy related laboratory tests.
   (iii) Administering drugs and biologicals by injection pursuant to
a prescriber's order (the administration of immunizations under the
supervision of a prescriber may also be performed outside of a
licensed health care facility).
   (iv) Adjusting the drug regimen of a patient pursuant to a
specific written order or authorization made by the patient's
prescriber for the individual patient, and in accordance with the
policies, procedures, or protocols of the health care facility, home
health agency, licensed clinic, health care service plan, or
physician.  Adjusting the drug regimen does not include substituting
or selecting a different drug, except as authorized by Section 4073.

   (B) A patient's prescriber may prohibit, by written instruction,
any adjustment or change in the patient's drug regimen by the
pharmacist.
   (C) The policies, procedures, or protocols referred to in this
paragraph shall be developed by health care professionals, including
physicians, pharmacists, and registered nurses, and, at a minimum,
meet all of the following requirements:
   (i) Require that the pharmacist function as part of a
multidisciplinary group that includes physicians and direct care
registered nurses.  The multidisciplinary group shall determine the
appropriate participation of the pharmacist and the direct care
registered nurse.
   (ii) Require that the medical records of the patient be available
to both the patient's prescriber and the pharmacist.
   (iii) Require that the procedures to be performed by the
pharmacist relate to a condition for which the patient has first been
seen by a physician.
   (iv) Except for procedures or functions provided by a health care
facility, a licensed clinic in which there is physician oversight, or
a provider who contracts with a licensed health care plan with
regard to the care or services provided to the enrollees of that
health care service plan, require the procedures to be performed in
accordance with a written, patient-specific protocol approved by the
treating or supervising physician.  Any change, adjustment, or
modification of an approved preexisting treatment or drug therapy
shall be provided in writing to the treating or supervising physician
within 24 hours.
   (6) Manufacture, measure, fit to the patient, or sell and repair
dangerous devices or furnish instructions to the patient or the
patient's representative concerning the use of those devices.
   (7) Provide consultation to patients and professional information,
including clinical or pharmacological information, advice, or
consultation to other health care professionals.  
   (8) Initiate emergency contraception drug therapy in accordance
with written guidelines or protocols previously established and
approved for his or her practice by a practitioner authorized to
prescribe drugs. 
   (b) Prior to performing any procedure authorized by paragraph (4)
of subdivision (a), a pharmacist shall have received appropriate
training as prescribed in the policies and procedures of the licensed
health care facility.  Prior to performing any procedure authorized
by paragraph (5) of subdivision (a), a pharmacist shall have either
(1) successfully completed clinical residency training or (2)
demonstrated clinical experience in direct patient care delivery.
   (c) Nothing in this section shall affect the requirements of
existing law relating to maintaining the confidentiality of medical
records.
   (d) Nothing in this section shall affect the requirements of
existing law relating to the licensing of a health care facility.
 California Patient Safety Act.
  SEC. 2.  The Legislature finds and declares all of the following:
   (a) It is important to identify deficiencies in, and opportunities
for, improving health care patient safety systems, for the purpose
of identifying and encouraging the adoption of structural safeguards.

   (b) The establishment of a voluntary, confidential, anonymous
nonregulatory system to accept reports of these deficiencies and
opportunities will maximize the number of reports and best encourage
a systems approach to error reduction.
   (c) Human factors research strongly supports the creation of such
a forum for analysis, education, and the improvement of health care
quality and safety.  The data collected under such a reporting system
can be used to evaluate medical equipment and procedures and aid in
the development and improvement of medical equipment, procedures, and
systems to strengthen the foundation of health care patient safety.

   (d) Effective reduction of unintended adverse patient outcomes in
any health care organization or setting requires a reporting system
in which patients, their families, and health care providers can
report detailed descriptions of medical events related to safety or
quality assurance without fear of regulatory or punitive
consequences.
   (e) To promote the confidence that the system will be used to
improve patient safety systems, rather than to punish or regulate,
the collection and analysis should be carried out by a single entity
which does not have existing regulatory or oversight
responsibilities.
   (f) Although numerous administrative, civil, and criminal
mechanisms exist for disciplining health care professionals and
facilities who fail to meet the standard of care, these systems, by
themselves, have failed to create optimal patient safety.  Recent
research into the issue indicates that these punitive systems will
not suffice in improving patient safety and that voluntary reporting
systems acknowledge the inevitability of human error and understand
that errors occur because individual health care professionals cannot
consistently outperform unsafe or potentially unsafe systems
operating within health care delivery.  Under these voluntary systems
of reporting, medical event analysis is system or process oriented
rather than focused on individual blame.
   (g) This collecting entity will have responsibility for managing
reports related to the data collected under this reporting system,
and will create data base structures for the purpose of providing
patient safety hazard alerts, distributing safety information,
without identifying specific facilities or individuals, and
effectively communicating aggregate information in the form of
quarterly reports to the State Department of Health Services, the
Office of Statewide Health Planning and Development, and the public.

   (h) Data reported and collected pursuant to this reporting system
will be provided with protection from subpoena, discovery, or use for
other purposes, such as civil litigation, arbitration, or other
administrative actions.
   (i) To ensure continued attention to the effectiveness of this
system, this reporting system will be eliminated on January 1, 2006,
unless extended by the Legislature.
  SEC. 3.  Section 1157.8 is added to the Evidence Code, to read:
   1157.8.  (a) The identity of a medical event reporter, the reports
made, and the data regarding medical events reported and collected,
under Part 5.5 (commencing with Section 128850) of Division 107 of
the Health and Safety Code, shall not be subject to subpoena, nor
shall it be disclosed or compelled to be produced in any civil,
administrative, or other noncriminal proceeding, or be deemed
admissible as evidence in any civil, administrative, or other
tribunal or court for any reason, with the exception of information
upon which the report is based, and if and only if that information
exists independent of the reporting process mandated by that part and
is otherwise discoverable under any other provision of law.  No
person involved in the investigation, collection, review,
development, or submission of the data under Part 5.5 (commencing
with Section 128850) of Division 107 of the Health and Safety Code
shall be subject to subpoena or compelled or allowed to testify
regarding the data.
   (b) This section shall remain in effect only until January 1,
2006, and as of that date is repealed, unless a later enacted
statute, that is enacted before January 1, 2006, deletes or extends
that date.
  SEC. 4.  Part 5.5 (commencing with Section 128850) is added to
Division 107 of the Health and Safety Code, to read:

      PART 5.5.  PATIENT SAFETY DATA REPORTING AND ANALYSIS
REQUIREMENTS

   128850.  The Office of Statewide Health Planning and Development
shall contract with an organization recognized as operating a
quality-oriented data base program, such as the Institute of Medical
Quality, to create a central reporting data base and to receive and
analyze information relating to medical events involving the
occurrence or near occurrence of compromises of patient safety or of
the quality of health care delivery by any health care professional,
facility, or organization licensed by the state.
   128851.  For purposes of this part:
   (a) "Medical events involving the occurrence or near occurrence of
compromises of patient safety or of the quality of health care
delivery by any health care professional, facility, or organization
licensed by the state" means any occurrence that the reporter
believes did result, or could have resulted, in a compromise of
patient safety or of the quality of health care delivery.
   (b) "Reporter" means any health care facility, health care
professional, patient, or person who is involved in any manner in a
medical event described in subdivision (a) and who reports the event
to the contractor.
   128852.  The contractor provided for pursuant to Section 128850
shall develop a medical event reporting form for voluntary submission
to the contractor.  The report form shall include, but not be
limited to, the date of the event and a summary of the event.  The
report form shall contain a tear-off portion that contains the
information that identifies the person or entity submitting the
report.
   128853.  Within 72 hours of receipt of a report, the contractor
shall review the report, contact the medical event reporter, if
necessary, to obtain additional information about the event for
purposes of evaluating potential systems safeguards that would reduce
the likelihood of the medical event reoccurring, detach that portion
of the report which contains identifying information and return it
to the reporting individual or entity by United States mail.  The
contractor shall delete any identifying information as to the person
or entity submitting the report, or the health care professional or
institution that is the subject of the report.
   128854.  On or before January 1, 2003, and quarterly thereafter,
the contractor shall submit to the office and the State Department of
Health Services and prepare for distribution to the public, a
summary report regarding the information received and analyzed
pursuant to the central reporting system, without any identifying
information concerning the reporters or the subjects of the reports.
This report shall include an analysis and interpretation of the data
received by the contractor and recommendations for improvement of
patient safety and quality of care related thereto.
   128855.  A reporter who reports pursuant to this chapter shall not
be civilly or criminally liable for any report authorized by this
part.
   128856.  A supervisor or administrator for any health care
professional, facility, or organization shall not impede or inhibit
the making of a report authorized by this part.  A person making a
report pursuant to this part shall not be subject to any sanction for
making the report.
   128857.  It is the intent of the Legislature that the
administrative cost incurred by the office in administering this
part, including the cost incurred by the organization contracting
with the office, be funded pursuant to the Budget Act.
   128858. This part shall remain in effect only until January 1,
2006, and as of that date is repealed, unless a later enacted
statute, that is enacted before January 1, 2006, deletes or extends
that date.