Chapter 686 Oregon Laws 2003
AN ACT
HB 2349
Relating to patient safety; creating new provisions; amending ORS 182.454 and 182.456; and declaring an emergency.
Be It Enacted by the People of the State of
Oregon:
SECTION
1. As used in sections 1 to 12 of
this 2003 Act:
(1)
“Participant” means an entity that reports patient safety data to a patient
safety reporting program, and any agent, employee, consultant, representative,
volunteer or medical staff member of the entity.
(2)
“Patient safety activities” includes but is not limited to:
(a)
The collection and analysis of patient safety data by a participant;
(b)
The collection and analysis of patient safety data by the Oregon Patient Safety
Commission established in section 2 of this 2003 Act;
(c)
The utilization of patient safety data by participants;
(d)
The utilization of patient safety data by the Oregon Patient Safety Commission
to improve the quality of care with respect to patient safety and to provide
assistance to health care providers to minimize patient risk; and
(e)
Oral and written communication regarding patient safety data among two or more
participants with the intent of making a disclosure to or preparing a report to
be submitted to a patient safety reporting program.
(3)
“Patient safety data” means oral communication or written reports, data,
records, memoranda, analyses, deliberative work, statements, root cause
analyses or action plans that are collected or developed to improve patient
safety or health care quality that:
(a)
Are prepared by a participant for the purpose of reporting patient safety data
voluntarily to a patient safety reporting program, or that are communicated
among two or more participants with the intent of making a disclosure to or
preparing a report to be submitted to a patient safety reporting program; or
(b)
Are created by or at the direction of the patient safety reporting program,
including communication, reports, notes or records created in the course of an
investigation undertaken at the direction of the Oregon Patient Safety
Commission.
(4)
“Patient safety reporting program” includes but is not limited to the Oregon
Patient Safety Reporting Program created in section 4 of this 2003 Act and any
other patient safety reporting program established to improve the safety and
quality of patient care.
(5) “Serious adverse event” means an objective and definable negative consequence of patient care, or the risk thereof, that is unanticipated, usually preventable and results in, or presents a significant risk of, patient death or serious physical injury.
SECTION
2. (1) The Oregon Patient Safety
Commission is established as a semi-independent state agency subject to ORS
182.456 to 182.472. The commission shall exercise and carry out all powers,
rights and privileges that are expressly conferred upon it, are implied by law
or are incident to such powers.
(2)
The mission of the commission is to improve patient safety by reducing the risk
of serious adverse events occurring in Oregon’s health care system and by
encouraging a culture of patient safety in Oregon. To accomplish this mission,
the commission shall:
(a)
Establish a confidential, voluntary serious adverse event reporting system to
identify serious adverse events;
(b)
Establish quality improvement techniques to reduce systems’ errors contributing
to serious adverse events; and
(c)
Disseminate evidence-based prevention practices to improve patient outcomes.
(3)
ORS 192.410 to 192.505 do not apply to public records created or maintained by
the commission that contain patient safety data or to reports obtained by the
program.
(4) ORS 192.610 to 192.690 do not apply to portions of a meeting of the Oregon Patient Safety Commission Board of Directors, or subcommittees or advisory committees established by the board, to consider information that identifies a participant or patient and the written minutes of that portion of the meeting.
SECTION 3. The Oregon Patient Safety Commission may accept contributions of funds and assistance from the United States Government or its agencies or from any other source, public or private, and agree to conditions not inconsistent with the purposes of the commission. All funds received by the commission shall be deposited in the account established pursuant to ORS 182.470. The commission may apply for grants and foundation support and may compete for contracts consistent with the mission and goals of the commission.
SECTION
4. (1) The Oregon Patient Safety
Reporting Program is created in the Oregon Patient Safety Commission to develop
a serious adverse event reporting system. The program shall include but is not
limited to:
(a)
Reporting by participants, in a timely manner and in the form determined by the
Oregon Patient Safety Commission Board of Directors established in section 7 of
this 2003 Act, of the following:
(A)
Serious adverse events;
(B)
Root cause analyses of serious adverse events;
(C)
Action plans established to prevent similar serious adverse events; and
(D)
Patient safety plans establishing procedures and protocols.
(b)
Analyzing reported serious adverse events, root cause analyses and action plans
to develop and disseminate information to improve the quality of care with
respect to patient safety. This information shall be made available to
participants and shall include but is not limited to:
(A)
Statistical analyses;
(B)
Recommendations regarding quality improvement techniques;
(C)
Recommendations regarding standard protocols; and
(D)
Recommendations regarding best patient safety practices.
(c)
Providing technical assistance to participants, including but not limited to
recommendations and advice regarding methodology, communication, dissemination
of information, data collection, security and confidentiality.
(d)
Auditing participant reporting to assess the level of reporting of serious
adverse events, root cause analyses and action plans.
(e)
Overseeing action plans to assess whether participants are taking sufficient
steps to prevent the occurrence of serious adverse events.
(f)
Creating incentives to improve and reward participation, including but not
limited to providing:
(A)
Feedback to participants; and
(B)
Rewards and recognition to participants.
(g)
Distributing written reports using aggregate, de-identified data from the
program to describe statewide serious adverse event patterns and maintaining a
website to facilitate public access to reports, as well as a list of names of
participants. The reports shall include but are not limited to:
(A)
The types and frequencies of serious adverse events;
(B)
Yearly serious adverse event totals and trends;
(C)
Clusters of serious adverse events;
(D)
Demographics of patients involved in serious adverse events, including the
frequency and types of serious adverse events associated with language barriers
or ethnicity;
(E)
Systems’ factors associated with particular serious adverse events;
(F)
Interventions to prevent frequent or high severity serious adverse events; and
(G)
Appropriate consumer information regarding prevention of serious adverse
events.
(2)
Participation in the program is voluntary. The following entities are eligible
to participate:
(a)
Hospitals as defined in ORS 442.015;
(b)
Long term care facilities as defined in ORS 442.015;
(c)
Pharmacies licensed under ORS chapter 689;
(d)
Ambulatory surgical centers as defined in ORS 442.015;
(e)
Outpatient renal dialysis facilities as defined in ORS 442.015;
(f)
Freestanding birthing centers as defined in ORS 442.015; and
(g)
Independent professional health care societies or associations.
(3)
Reports or other information developed and disseminated by the program may not
contain or reveal the name of or other identifiable information with respect to
a particular participant providing information to the commission for the
purposes of sections 1 to 12 of this 2003 Act, or to any individual identified
in the report or information, and upon whose patient safety data, patient
safety activities and reports the commission has relied in developing and
disseminating information pursuant to this section.
(4) After a serious adverse event occurs, a participant must provide written notification in a timely manner to each patient served by the participant who is affected by the event. Notice provided under this subsection may not be construed as an admission of liability in a civil action.
SECTION
5. (1) Patient safety data
reported to the Oregon Patient Safety Commission and information developed
pursuant to the auditing and oversight described in section 4 (1) of this 2003
Act may not be disclosed to, subject to subpoena by or used by any state agency
for purposes of any enforcement or regulatory action in relation to a
participant.
(2)
Nothing in sections 1 to 12 of this 2003 Act may be construed to limit the
regulatory or enforcement authority of any state agency and, except for patient
safety data, state agencies have the same authority to access participant
records or other information in the same manner and to the same extent as if
sections 1 to 12 of this 2003 Act were not enacted.
(3) As used in this section, “state agency” has the meaning given that term in ORS 183.025.
SECTION
6. (1) Except as provided in
subsection (2) of this section, the Oregon Patient Safety Commission may assess
fees on the participating entities described in section 4 (2) of this 2003 Act
as determined by the Oregon Patient Safety Commission Board of Directors to
fund the Oregon Patient Safety Reporting Program.
(2) Independent professional health care societies or associations are exempt from fees assessed by the commission.
SECTION
7. (1) There is established the
Oregon Patient Safety Commission Board of Directors consisting of 17 members,
including the Public Health Officer and 16 directors who shall be appointed by
the Governor and who shall be confirmed by the Senate in the manner prescribed
in ORS 171.562 and 171.565.
(2)
Membership on the board shall reflect the diversity of facilities, providers,
insurers, purchasers and consumers that are involved in patient safety.
Directors shall demonstrate interest, knowledge or experience in the area of
patient safety.
(3)
The membership of the board shall be as follows:
(a)
The Public Health Officer;
(b)
One faculty member, who is not involved in the direct delivery of health care,
of the Oregon University System or a private Oregon university;
(c)
Two representatives of group purchasers of health care, one of whom shall be
employed by a state or other governmental entity and neither of whom may
provide direct health care services or have an immediate family member who is
involved in the delivery of health care;
(d)
Two representatives of health care consumers, neither of whom may provide
direct health care services or have an immediate family member who is involved
in the delivery of health care;
(e)
Two representatives of health insurers, including a representative of a
domestic not-for-profit health care services contractor, a representative of a
domestic insurance company licensed to transact health insurance or a
representative of a health maintenance organization;
(f)
One representative of a statewide or national labor organization;
(g)
Two physicians licensed under ORS chapter 677 who are in active practice;
(h)
Two hospital administrators or their designees;
(i)
One pharmacist licensed under ORS chapter 689;
(j)
One representative of an ambulatory surgical center or an outpatient renal
dialysis facility;
(k)
One nurse licensed under ORS chapter 678 who is in active clinical practice;
and
(L)
One nursing home administrator licensed under ORS chapter 678 or one nursing
home director of nursing services.
(4)
The term of office of each director appointed by the Governor is four years.
Before the expiration of the term of a director, the Governor shall appoint a
successor whose term begins on October 1 next following. A director is eligible
for reappointment for an additional term. If there is a vacancy for any cause,
the Governor shall make an appointment to become effective immediately for the
unexpired term. The board shall nominate a slate of candidates whenever a
vacancy occurs or is announced and shall forward the recommended candidates to
the Governor for consideration.
(5)
The board shall select one of its members as chairperson and another as vice
chairperson for the terms and with the duties and powers as the board considers
necessary for performance of the functions of those offices. The board shall
adopt bylaws as necessary for the efficient and effective operation of the
commission.
(6)
The Governor may remove any member of the board at any time at the pleasure of
the Governor, but not more than eight directors shall be removed within a
period of four years, unless it is for corrupt conduct in office. The board may
remove a director as specified in the commission bylaws.
(7)
The board may appoint subcommittees and advisory groups as needed to assist the
board, including but not limited to one or more consumer advisory groups and
technical advisory groups. The technical advisory groups shall include
physicians, nurses and other licensed or certified professional with specialty
knowledge and experience as necessary to assist the board.
(8) No voting member of the board may be an employee of the commission.
SECTION
8. Notwithstanding the term of
office specified by section 7 of this 2003 Act, of the directors first
appointed to the Oregon Patient Safety Commission Board of Directors under
section 7 of this 2003 Act:
(1)
Four shall serve for terms ending July 1, 2004;
(2)
Four shall serve for terms ending July 1, 2005;
(3)
Four shall serve for terms ending July 1, 2006; and
(4) Four shall serve for terms ending July 1, 2007.
SECTION
9. (1) Except as otherwise
provided in sections 1 to 12 of this 2003 Act, the Oregon Patient Safety
Commission Board of Directors, or officials of the Oregon Patient Safety
Commission acting under the authority of the board, shall exercise all the
powers of the commission and shall govern the commission. The board shall adopt
rules necessary for the implementation of the Oregon Patient Safety Reporting
Program, including but not limited to:
(a)
Developing a list of objective and definable serious adverse events to be
reported by participants. In developing this list, the board shall consider
similar lists developed in other states and nationally. The board may change
the list from time to time. The first list developed by the board shall focus
on serious adverse events that caused death or serious physical injury. Later
lists may include, in the discretion of the board, serious adverse events that
did not cause death or serious physical injury but posed a significant risk of
death or a risk of significant physical injury.
(b)
Developing a budget.
(c)
Establishing a process to seek grants and other funding from federal and other
sources.
(d)
Establishing a method to determine participant fees, if necessary.
(e)
Establishing auditing and oversight procedures, including a process to:
(A)
Assess completeness of reports from participants;
(B)
Assess credibility and thoroughness of root cause analyses submitted to the
program;
(C)
Assess the acceptability of action plans and participant follow-up on the
action plan; and
(D)
Obtain certification by the Public Health Officer on the completeness,
credibility, thoroughness and acceptability of participant reports, root cause
analyses and action plans.
(f)
Establishing criteria for terminating a participant from the program.
Incomplete reporting, failure to comply with section 4 (4) of this 2003 Act or
failure to adequately implement an action plan are grounds for termination from
the program.
(2)
The board may not use or disclose patient safety data reported, collected or
developed pursuant to sections 1 to 12 of this 2003 Act for purposes of any
enforcement or
regulatory action in relation to a
participant.
(3) The board shall maintain the confidentiality of all patient safety data that identifies or could be reasonably used to identify a participant or an individual who is receiving or has received health care from the participant.
SECTION
10. The Oregon Patient Safety
Commission Board of Directors shall report:
(1)
No later than September 30, 2004, to an interim committee of the Seventy-second
Legislative Assembly on the implementation of the Oregon Patient Safety
Commission and the serious adverse event reporting system developed by the
Oregon Patient Safety Reporting Program;
(2)
No later than September 30, 2005, to an interim committee of the Seventy-third
Legislative Assembly on preliminary results of a facility-based serious adverse
event reporting system;
(3)
No later than September 30, 2006, to an interim committee of the Seventy-third
Legislative Assembly on the implementation of a retail pharmacy serious adverse
event reporting system; and
(4) No later than September 30, 2007, to an interim committee of the Seventy-fourth Legislative Assembly regarding reporting results and whether performance goals have been met. The board shall offer recommendations for any changes to the system, including possible implementation of a mandatory serious adverse event reporting system.
SECTION 11. The Oregon Patient Safety Commission Board of Directors shall appoint an administrator of the Oregon Patient Safety Commission. Subject to the supervision of the board, the administrator has authority to direct the affairs of the commission. The administrator may not be a voting member of the board.
SECTION
12. (1) Patient safety data and
reports obtained by a patient safety reporting program from participants are
confidential and privileged and are not admissible in evidence in any civil
action, including but not limited to a judicial, administrative, arbitration or
mediation proceeding. Patient safety data, patient safety activities and
reports are not subject to:
(a)
Civil or administrative subpoena;
(b)
Discovery in connection with a civil action, including but not limited to a
judicial, administrative, arbitration or mediation proceeding; or
(c)
Disclosure under state public records law pursuant to section 2 (3) of this
2003 Act and, if permissible, federal public records laws.
(2)
The privilege established under this section does not apply to records of a
patient’s medical diagnosis and treatment and to records of a participant
created in the ordinary course of business.
(3)
Patient safety data, collected or developed for the purpose of and with the
intent to communicate with or to make a disclosure or report to the patient
safety reporting program, that are contained in the business records of the
participant are confidential and not subject to civil or administrative subpoena
or to discovery in a civil action, including but not limited to a judicial,
administrative, arbitration or mediation proceeding.
(4)
The following persons are not subject to an action for civil damages for
affirmative actions taken, acts of omission or statements made in good faith:
(a)
A person serving on the Oregon Patient Safety Commission Board of Directors;
(b)
A person serving on a committee established by the board;
(c)
A person communicating information to the Oregon Patient Safety Reporting
Program; or
(d)
A person conducting a study or investigation on behalf of the program.
(5)
A participant or a representative of the Oregon Patient Safety Reporting
Program may not be examined in any civil action, including but not limited to a
judicial, administrative, arbitration or mediation proceeding, as to whether a
communication of any kind, including oral and written communication, has been
made or shared with another participant or with the program regarding patient
safety data, patient safety activities, reports, records, memoranda, analyses,
deliberative work, statements or root cause analyses, provided the
communication was made with the intent of making a disclosure to or preparing a
report to be submitted to the Oregon Patient Safety Commission.
(6)
Nothing in this section may be construed to:
(a)
Limit or discourage patient safety activities of or among participants or the
voluntary reporting of patient safety data by one or more participants,
individually or jointly, to a patient safety reporting program;
(b)
Affect other privileges that are available under federal or state laws that
provide greater peer review or confidentiality protections than do the
protections afforded under sections 1 to 12 of this 2003 Act;
(c)
Preempt or otherwise affect mandatory reporting requirements under Oregon law
or licensing or certification requirements of state or federal law; or
(d)
Diminish obligations of participants to comply with state and federal laws
pertaining to quality assurance, personnel management and infection control
requirements.
(7) Reporting or sharing of patient safety data by a participant is not a waiver of any privilege or protection established under sections 1 to 12 of this 2003 Act or other Oregon law.
SECTION 13. ORS 182.454 is amended to read:
182.454. [On October 31, 1999,] The following semi-independent state agencies are [made] subject to ORS 182.456 to 182.472:
(1) The State Board of Architect Examiners.
(2) The State Landscape Architect Board.
(3) The State Board of Examiners for Engineering and Land Surveying.
(4) The State Board of Geologist Examiners.
(5) The Oregon Board of Optometry.
(6) The Oregon Patient Safety Commission.
SECTION 14. ORS 182.456 is amended to read:
182.456. As used in ORS 182.456 to 182.472:
(1) “Board” means a board established as a semi-independent state agency under ORS 182.451 or 182.452 or a board or commission listed under ORS 182.454.
(2) “License” includes licenses, registrations, certifications, permits or other forms of permission required by law to pursue an occupation or engage in a business regulated by a board.
SECTION 15. ORS 182.456, as amended by section 55, chapter 1084, Oregon Laws 1999, is amended to read:
182.456. As used in ORS 182.456 to 182.472:
(1) “Board” means a board established as a semi-independent state agency under ORS 182.451 or a board or commission listed under ORS 182.454.
(2) “License” includes licenses, registrations, certifications, permits or other forms of permission required by law to pursue an occupation or engage in a business regulated by a board.
SECTION 16. Sections 1, 4, 5, 6, 9, 10 and 12 of this 2003 Act are repealed on January 2, 2010.
SECTION 17. This 2003 Act being necessary for the immediate preservation of the public peace, health and safety, an emergency is declared to exist, and this 2003 Act takes effect July 1, 2003.
Approved by the Governor August 21, 2003
Filed in the office of Secretary of State August 21, 2003
Effective date August 21, 2003
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