ESHB 1414 -
By Committee on Health & Long-Term Care
ADOPTED 04/11/2007
Strike everything after the enacting clause and insert the following:
"NEW SECTION. Sec. 1 The definitions in this section apply
throughout this chapter unless the context clearly requires otherwise.
(1) "Ambulatory surgical facility" means any distinct entity that
operates for the primary purpose of providing specialty or
multispecialty outpatient surgical services in which patients are
admitted to and discharged from the facility within twenty-four hours
and do not require inpatient hospitalization, whether or not the
facility is certified under Title XVIII of the federal social security
act.
(2) "Department" means the department of health.
(3) "General anesthesia" means a state of unconsciousness
intentionally produced by anesthetic agents, with absence of pain
sensation over the entire body, in which the patient is without
protective reflexes and is unable to maintain an airway.
(4) "Person" means an individual, firm, partnership, corporation,
company, association, joint stock association, and the legal successor
thereof.
(5) "Practitioner" means any physician or surgeon licensed under
chapter 18.71 RCW, an osteopathic physician or surgeon licensed under
chapter 18.57 RCW, or a podiatric physician or surgeon licensed under
chapter 18.22 RCW.
(6) "Secretary" means the secretary of health.
(7) "Surgical services" means invasive medical procedures that:
(a) Utilize a knife, laser, cautery, cryogenics, or chemicals; and
(b) Remove, correct, or facilitate the diagnosis or cure of a
disease, process, or injury through that branch of medicine that treats
diseases, injuries, and deformities by manual or operative methods by
a practitioner.
NEW SECTION. Sec. 2 The secretary shall:
(1) Issue a license to any ambulatory surgical facility that:
(a) Submits payment of the fee established in section 7 of this
act;
(b) Submits a completed application that demonstrates the ability
to comply with the standards established for operating and maintaining
an ambulatory surgical facility in statute and rule. An ambulatory
surgical facility shall be deemed to have met the standards if it
submits proof of certification as a medicare ambulatory surgical
facility or accreditation by an organization that the secretary has
determined to have substantially equivalent standards to those of the
department; and
(c) Successfully completes the survey requirements established in
section 11 of this act;
(2) Develop an application form for applicants for a license to
operate an ambulatory surgical facility;
(3) Initiate investigations and enforcement actions for complaints
or other information regarding failure to comply with this chapter or
the standards and rules adopted under this chapter;
(4) Conduct surveys of facilities, including reviews of medical
records and documents required to be maintained under this chapter or
rules adopted under this chapter;
(5) By March 1, 2008, determine which accreditation organizations
have substantially equivalent standards for purposes of deeming
specific licensing requirements required in statute and rule as having
met the state's standards; and
(6) Adopt any rules necessary to implement this chapter.
NEW SECTION. Sec. 3 Except as provided in section 4 of this act,
after June 30, 2009, no person or governmental unit of the state of
Washington, acting separately or jointly with any other person or
governmental unit, shall establish, maintain, or conduct an ambulatory
surgical facility in this state or advertise by using the term
"ambulatory surgical facility," "day surgery center," "licensed
surgical center," or other words conveying similar meaning without a
license issued by the department under this chapter.
NEW SECTION. Sec. 4 Nothing in this chapter:
(1) Applies to an ambulatory surgical facility that is maintained
and operated by a hospital licensed under chapter 70.41 RCW;
(2) Applies to an office maintained for the practice of dentistry;
(3) Applies to outpatient specialty or multispecialty surgical
services routinely and customarily performed in the office of a
practitioner in an individual or group practice that do not require
general anesthesia; or
(4) Limits an ambulatory surgical facility to performing only
surgical services.
NEW SECTION. Sec. 5 (1) An applicant for a license to operate an
ambulatory surgical facility must demonstrate the ability to comply
with the standards established for operating and maintaining an
ambulatory surgical facility in statute and rule, including:
(a) Submitting a written application to the department providing
all necessary information on a form provided by the department,
including a list of surgical specialties offered;
(b) Submitting building plans for review and approval by the
department for new construction, alterations other than minor
alterations, and additions to existing facilities, prior to obtaining
a license and occupying the building;
(c) Demonstrating the ability to comply with this chapter and any
rules adopted under this chapter;
(d) Cooperating with the department during on-site surveys prior to
obtaining an initial license or renewing an existing license;
(e) Providing such proof as the department may require concerning
the ownership and management of the ambulatory surgical facility,
including information about the organization and governance of the
facility and the identity of the applicant, officers, directors,
partners, managing employees, or owners of ten percent or more of the
applicant's assets;
(f) Submitting proof of operation of a coordinated quality
improvement program in accordance with section 9 of this act;
(g) Submitting a copy of the facility safety and emergency training
program established under section 6 of this act;
(h) Paying any fees established under section 7 of this act; and
(i) Providing any other information that the department may
reasonably require.
(2) A license is valid for three years, after which an ambulatory
surgical facility must submit an application for renewal of license
upon forms provided by the department and the renewal fee as
established in section 7 of this act. The applicant must demonstrate
the ability to comply with the standards established for operating and
maintaining an ambulatory surgical facility in statutes, standards, and
rules. The applicant must submit the license renewal document no later
than thirty days prior to the date of expiration of the license.
(3) The applicant may demonstrate compliance with any of the
requirements of subsection (1) of this section by providing
satisfactory documentation to the secretary that it has met the
standards of an accreditation organization or federal agency that the
secretary has determined to have substantially equivalent standards as
the statutes and rules of this state.
NEW SECTION. Sec. 6 An ambulatory surgical facility shall have
a facility safety and emergency training program. The program shall
include:
(1) On-site equipment, medication, and trained personnel to
facilitate handling of services sought or provided and to facilitate
the management of any medical emergency that may arise in connection
with services sought or provided;
(2) Written transfer agreements with local hospitals licensed under
chapter 70.41 RCW, approved by the ambulatory surgical facility's
medical staff; and
(3) A procedural plan for handling medical emergencies that shall
be available for review during surveys and inspections.
NEW SECTION. Sec. 7 The department of health shall convene a
group of interested stakeholders to identify relevant regulatory issues
related to the implementation of this act, including a reasonable fee
schedule for licenses and renewal licenses. The group shall report to
the department on their recommendations no later than December 15,
2007.
NEW SECTION. Sec. 8 (1) The secretary may deny, suspend, or
revoke the license of any ambulatory surgical facility in any case in
which he or she finds the applicant or registered entity knowingly made
a false statement of material fact in the application for the license
or any supporting data in any record required by this chapter or matter
under investigation by the department.
(2) The secretary shall investigate complaints concerning operation
of an ambulatory surgical facility without a license. The secretary
may issue a notice of intention to issue a cease and desist order to
any person whom the secretary has reason to believe is engaged in the
unlicensed operation of an ambulatory surgical facility. If the
secretary makes a written finding of fact that the public interest will
be irreparably harmed by delay in issuing an order, the secretary may
issue a temporary cease and desist order. The person receiving a
temporary cease and desist order shall be provided an opportunity for
a prompt hearing. The temporary cease and desist order shall remain in
effect until further order of the secretary. Any person operating an
ambulatory surgical facility under this chapter without a license is
guilty of a misdemeanor, and each day of operation of an unlicensed
ambulatory surgical facility constitutes a separate offense.
(3) The secretary is authorized to deny, suspend, revoke, or modify
a license or provisional license in any case in which it finds that
there has been a failure or refusal to comply with the requirements of
this chapter or the standards or rules adopted under this chapter. RCW
43.70.115 governs notice of a license denial, revocation, suspension,
or modification and provides the right to an adjudicative proceeding.
(4) Pursuant to chapter 34.05 RCW, the secretary may assess
monetary penalties of a civil nature not to exceed one thousand dollars
per violation.
NEW SECTION. Sec. 9 (1) Every ambulatory surgical facility shall
maintain a coordinated quality improvement program for the improvement
of the quality of health care services rendered to patients and the
identification and prevention of medical malpractice. The program
shall include at least the following:
(a) The establishment of a quality improvement committee with the
responsibility to review the services rendered in the ambulatory
surgical facility, both retrospectively and prospectively, in order to
improve the quality of medical care of patients and to prevent medical
malpractice. The committee shall oversee and coordinate the quality
improvement and medical malpractice prevention program and shall ensure
that information gathered pursuant to the program is used to review and
to revise the policies and procedures of the ambulatory surgical
facility;
(b) A medical staff privileges sanction procedure through which
credentials, physical and mental capacity, and competence in delivering
health care services are periodically reviewed as part of an evaluation
of staff privileges;
(c) The periodic review of the credentials, physical and mental
capacity, and competence in delivering health care services of all
persons who are employed or associated with the ambulatory surgical
facility;
(d) A procedure for the prompt resolution of grievances by patients
or their representatives related to accidents, injuries, treatment, and
other events that may result in claims of medical malpractice;
(e) The maintenance and continuous collection of information
concerning the ambulatory surgical facility's experience with negative
health care outcomes and incidents injurious to patients, patient
grievances, professional liability premiums, settlements, awards, costs
incurred by the ambulatory surgical facility for patient injury
prevention, and safety improvement activities;
(f) The maintenance of relevant and appropriate information
gathered pursuant to (a) through (e) of this subsection concerning
individual practitioners within the practitioner's personnel or
credential file maintained by the ambulatory surgical facility;
(g) Education programs dealing with quality improvement, patient
safety, medication errors, injury prevention, staff responsibility to
report professional misconduct, the legal aspects of patient care,
improved communication with patients, and causes of malpractice claims
for staff personnel engaged in patient care activities; and
(h) Policies to ensure compliance with the reporting requirements
of this section.
(2) Any person who, in substantial good faith, provides information
to further the purposes of the quality improvement and medical
malpractice prevention program or who, in substantial good faith,
participates on the quality improvement committee is not subject to an
action for civil damages or other relief as a result of such activity.
Any person or entity participating in a coordinated quality improvement
program that, in substantial good faith, shares information or
documents with one or more other programs, committees, or boards under
subsection (8) of this section is not subject to an action for civil
damages or other relief as a result of the activity. For the purposes
of this section, sharing information is presumed to be in substantial
good faith. However, the presumption may be rebutted upon a showing of
clear, cogent, and convincing evidence that the information shared was
knowingly false or deliberately misleading.
(3) Information and documents, including complaints and incident
reports, created specifically for, and collected and maintained by, a
quality improvement committee are not subject to review or disclosure,
except as provided in this section, or discovery or introduction into
evidence in any civil action, and no person who was in attendance at a
meeting of such committee or who participated in the creation,
collection, or maintenance of information or documents specifically for
the committee shall be permitted or required to testify in any civil
action as to the content of such proceedings or the documents and
information prepared specifically for the committee. This subsection
does not preclude: (a) In any civil action, the discovery of the
identity of persons involved in the medical care that is the basis of
the civil action whose involvement was independent of any quality
improvement activity; (b) in any civil action, the testimony of any
person concerning the facts which form the basis for the institution of
such proceedings of which the person had personal knowledge acquired
independently of such proceedings; (c) in any civil action by a health
care provider regarding the restriction or revocation of that
individual's clinical or staff privileges, introduction into evidence
of information collected and maintained by quality improvement
committees regarding such health care provider; (d) in any civil
action, disclosure of the fact that staff privileges were terminated or
restricted, including the specific restrictions imposed, if any, and
the reasons for the restrictions; or (e) in any civil action, discovery
and introduction into evidence of the patient's medical records
required by rule of the department to be made regarding the care and
treatment received.
(4) Each quality improvement committee shall, on at least a
semiannual basis, report to the management of the ambulatory surgical
facility, as identified in the facility's application, in which the
committee is located. The report shall review the quality improvement
activities conducted by the committee, and any actions taken as a
result of those activities.
(5) The department shall adopt such rules as are deemed appropriate
to effectuate the purposes of this section.
(6) The medical quality assurance commission, the board of
osteopathic medicine and surgery, or the podiatric medical board, as
appropriate, may review and audit the records of committee decisions in
which a practitioner's privileges are terminated or restricted. Each
ambulatory surgical facility shall produce and make accessible to the
commission or board the appropriate records and otherwise facilitate
the review and audit. Information so gained is not subject to the
discovery process and confidentiality shall be respected as required by
subsection (3) of this section. Failure of an ambulatory surgical
facility to comply with this subsection is punishable by a civil
penalty not to exceed two hundred fifty dollars.
(7) The department and any accrediting organization may review and
audit the records of a quality improvement committee or peer review
committee in connection with their inspection and review of the
ambulatory surgical facility. Information so obtained is not subject
to the discovery process, and confidentiality shall be respected as
required by subsection (3) of this section. Each ambulatory surgical
facility shall produce and make accessible to the department the
appropriate records and otherwise facilitate the review and audit.
(8) A coordinated quality improvement program may share information
and documents, including complaints and incident reports, created
specifically for, and collected and maintained by, a quality
improvement committee or a peer review committee under RCW 4.24.250
with one or more other coordinated quality improvement programs
maintained in accordance with this section or RCW 43.70.510 or
70.41.200, a quality assurance committee maintained in accordance with
RCW 18.20.390 or 74.42.640, or a peer review committee under RCW
4.24.250, for the improvement of the quality of health care services
rendered to patients and the identification and prevention of medical
malpractice. The privacy protections of chapter 70.02 RCW and the
federal health insurance portability and accountability act of 1996 and
its implementing regulations apply to the sharing of individually
identifiable patient information held by a coordinated quality
improvement program. Any rules necessary to implement this section
shall meet the requirements of applicable federal and state privacy
laws. Information and documents disclosed by one coordinated quality
improvement program to another coordinated quality improvement program
or a peer review committee under RCW 4.24.250 and any information and
documents created or maintained as a result of the sharing of
information and documents are not subject to the discovery process and
confidentiality shall be respected as required by subsection (3) of
this section, RCW 18.20.390 (6) and (8), 70.41.200(3), 74.42.640 (7)
and (9), and 4.24.250.
(9) An ambulatory surgical facility that participates in a
coordinated quality improvement program under RCW 43.70.510 shall be
deemed to have met the requirements of this section.
(10) Violation of this section shall not be considered negligence
per se.
NEW SECTION. Sec. 10 The department shall establish and adopt
such minimum standards and rules pertaining to the construction,
maintenance, and operation of ambulatory surgical facilities and
rescind, amend, or modify such rules, as are necessary in the public
interest, and particularly for the establishment and maintenance of
standards of patient care required for the safe and adequate care and
treatment of patients. In establishing the format and content of these
standards and rules, the department shall give consideration to
maintaining consistency with such minimum standards and rules
applicable to ambulatory surgical facilities in the survey standards of
accrediting organizations or federal agencies that the secretary has
determined to have substantially equivalent standards as the statutes
and rules of this state.
NEW SECTION. Sec. 11 (1) The department shall make or cause to
be made a survey of all ambulatory surgical facilities every eighteen
months. Every survey of an ambulatory surgical facility may include an
inspection of every part of the surgical facility. The department may
make an examination of all phases of the ambulatory surgical facility
operation necessary to determine compliance with all applicable
statutes, rules, and regulations. In the event that the department is
unable to make a survey or cause a survey to be made during the three
years of the term of the license, the license of the ambulatory
surgical facility shall remain in effect until the state conducts a
survey or a substitute survey is performed if the ambulatory surgical
facility is in compliance with all other licensing requirements.
(2) An ambulatory surgical facility shall be deemed to have met the
survey standards of this section if it submits proof of certification
as a medicare ambulatory surgical facility or accreditation by an
organization that the secretary has determined to have substantially
equivalent survey standards to those of the department. A survey
performed pursuant to medicare certification or by an approved
accrediting organization may substitute for a survey by the department
if:
(a) The ambulatory surgical facility has satisfactorily completed
a survey by the department in the previous eighteen months; and
(b) Within thirty days of learning the result of a survey, the
ambulatory surgical facility provides the department with documentary
evidence that the ambulatory surgical facility has been certified or
accredited as a result of a survey and the date of the survey.
(3) Ambulatory surgical facilities shall make the written reports
of surveys conducted pursuant to medicare certification procedures or
by an approved accrediting organization available to department
surveyors during any department surveys, upon request.
NEW SECTION. Sec. 12 The department shall require ambulatory
surgical facilities to submit data related to the quality of patient
care for review by the department. The data shall be submitted every
eighteen months. The department shall consider the reporting standards
of other public and private organizations that measure quality in order
to maintain consistency in reporting and minimize the burden on the
ambulatory surgical facility. The department shall review the data to
determine the maintenance of quality patient care at the facility. If
the department determines that the care offered at the facility may
present a risk to the health and safety of patients, the department may
conduct an inspection of the facility and initiate appropriate actions
to protect the public. Information submitted to the department
pursuant to this section shall be exempt from disclosure under chapter
42.56 RCW.
NEW SECTION. Sec. 13 (1) The chief administrator or executive
officer of an ambulatory surgical facility shall report to the
department when the practice of a health care provider licensed by a
disciplining authority under RCW 18.130.040 is restricted, suspended,
limited, or terminated based upon a conviction, determination, or
finding by the ambulatory surgical facility that the provider has
committed an action defined as unprofessional conduct under RCW
18.130.180. The chief administrator or executive officer shall also
report any voluntary restriction or termination of the practice of a
health care provider licensed by a disciplining authority under RCW
18.130.040 while the provider is under investigation or the subject of
a proceeding by the ambulatory surgical facility regarding
unprofessional conduct, or in return for the ambulatory surgical
facility not conducting such an investigation or proceeding or not
taking action. The department shall forward the report to the
appropriate disciplining authority.
(2) Reports made under subsection (1) of this section must be made
within fifteen days of the date of: (a) A conviction, determination,
or finding by the ambulatory surgical facility that the health care
provider has committed an action defined as unprofessional conduct
under RCW 18.130.180; or (b) acceptance by the ambulatory surgical
facility of the voluntary restriction or termination of the practice of
a health care provider, including his or her voluntary resignation,
while under investigation or the subject of proceedings regarding
unprofessional conduct under RCW 18.130.180.
(3) Failure of an ambulatory surgical facility to comply with this
section is punishable by a civil penalty not to exceed two hundred
fifty dollars.
(4) An ambulatory surgical facility, its chief administrator, or
its executive officer who files a report under this section is immune
from suit, whether direct or derivative, in any civil action related to
the filing or contents of the report, unless the conviction,
determination, or finding on which the report and its content are based
is proven to not have been made in good faith. The prevailing party in
any action brought alleging that the conviction, determination,
finding, or report was not made in good faith is entitled to recover
the costs of litigation, including reasonable attorneys' fees.
(5) The department shall forward reports made under subsection (1)
of this section to the appropriate disciplining authority designated
under Title 18 RCW within fifteen days of the date the report is
received by the department. The department shall notify an ambulatory
surgical facility that has made a report under subsection (1) of this
section of the results of the disciplining authority's case disposition
decision within fifteen days after the case disposition. Case
disposition is the decision whether to issue a statement of charges,
take informal action, or close the complaint without action against a
provider. In its biennial report to the legislature under RCW
18.130.310, the department shall specifically identify the case
dispositions of reports made by ambulatory surgical facilities under
subsection (1) of this section.
NEW SECTION. Sec. 14 Each ambulatory surgical facility shall
keep written records of decisions to restrict or terminate privileges
of practitioners. Copies of such records shall be made available to
the medical quality assurance commission, the board of osteopathic
medicine and surgery, or the podiatric medical board, within thirty
days of a request, and all information so gained remains confidential
in accordance with sections 9 and 13 of this act and is protected from
the discovery process. Failure of an ambulatory surgical facility to
comply with this section is punishable by a civil penalty not to exceed
two hundred fifty dollars.
NEW SECTION. Sec. 15 (1) Prior to granting or renewing clinical
privileges or association of any practitioner or hiring a practitioner,
an ambulatory surgical facility approved pursuant to this chapter shall
request from the practitioner and the practitioner shall provide the
following information:
(a) The name of any hospital, ambulatory surgical facility, or
other facility with or at which the practitioner had or has any
association, employment, privileges, or practice;
(b) If such association, employment, privilege, or practice was
discontinued, the reasons for its discontinuation;
(c) Any pending professional medical misconduct proceedings or any
pending medical malpractice actions in this state or another state, the
substance of the allegations in the proceedings or actions, and any
additional information concerning the proceedings or actions as the
practitioner deems appropriate;
(d) The substance of the findings in the actions or proceedings and
any additional information concerning the actions or proceedings as the
practitioner deems appropriate;
(e) A waiver by the practitioner of any confidentiality provisions
concerning the information required to be provided to ambulatory
surgical facilities pursuant to this subsection; and
(f) A verification by the practitioner that the information
provided by the practitioner is accurate and complete.
(2) Prior to granting privileges or association to any practitioner
or hiring a practitioner, an ambulatory surgical facility approved
under this chapter shall request from any hospital or ambulatory
surgical facility with or at which the practitioner had or has
privileges, was associated, or was employed, the following information
concerning the practitioner:
(a) Any pending professional medical misconduct proceedings or any
pending medical malpractice actions, in this state or another state;
(b) Any judgment or settlement of a medical malpractice action and
any finding of professional misconduct in this state or another state
by a licensing or disciplinary board; and
(c) Any information required to be reported by hospitals or
ambulatory surgical facilities pursuant to RCW 18.130.070.
(3) The medical quality assurance commission, board of osteopathic
medicine and surgery, podiatric medical board, or dental quality
assurance commission, as appropriate, shall be advised within thirty
days of the name of any practitioner denied staff privileges,
association, or employment on the basis of adverse findings under
subsection (1) of this section.
(4) A hospital, ambulatory surgical facility, or other facility
that receives a request for information from another hospital,
ambulatory surgical facility, or other facility pursuant to subsections
(1) and (2) of this section shall provide such information concerning
the physician in question to the extent such information is known to
the hospital, ambulatory surgical facility, or other facility receiving
such a request, including the reasons for suspension, termination, or
curtailment of employment or privileges at the hospital, ambulatory
surgical facility, or facility. A hospital, ambulatory surgical
facility, other facility, or other person providing such information in
good faith is not liable in any civil action for the release of such
information.
(5) Information and documents, including complaints and incident
reports, created specifically for, and collected and maintained by, a
quality improvement committee are not subject to discovery or
introduction into evidence in any civil action, and no person who was
in attendance at a meeting of such committee or who participated in the
creation, collection, or maintenance of information or documents
specifically for the committee shall be permitted or required to
testify in any civil action as to the content of such proceedings or
the documents and information prepared specifically for the committee.
This subsection does not preclude: (a) In any civil action, the
discovery of the identity of persons involved in the medical care that
is the basis of the civil action whose involvement was independent of
any quality improvement activity; (b) in any civil action, the
testimony of any person concerning the facts which form the basis for
the institution of such proceedings of which the person had personal
knowledge acquired independently of such proceedings; (c) in any civil
action by a health care provider regarding the restriction or
revocation of that individual's clinical or staff privileges,
introduction into evidence information collected and maintained by
quality improvement committees regarding such health care provider; (d)
in any civil action, disclosure of the fact that staff privileges were
terminated or restricted, including the specific restrictions imposed,
if any, and the reasons for the restrictions; or (e) in any civil
action, discovery and introduction into evidence of the patient's
medical records required by rule of the department to be made regarding
the care and treatment received.
(6) Ambulatory surgical facilities shall be granted access to
information held by the medical quality assurance commission, board of
osteopathic medicine and surgery, or podiatric medical board pertinent
to decisions of the ambulatory surgical facility regarding
credentialing and recredentialing of practitioners.
(7) Violation of this section shall not be considered negligence
per se.
NEW SECTION. Sec. 16 Ambulatory surgical facilities shall have
in place policies to assure that, when appropriate, information about
unanticipated outcomes is provided to patients or their families or any
surrogate decision makers identified pursuant to RCW 7.70.065.
Notifications of unanticipated outcomes under this section do not
constitute an acknowledgement or admission of liability, nor may the
fact of notification, the content disclosed, or any and all statements,
affirmations, gestures, or conduct expressing apology be introduced as
evidence in a civil action.
NEW SECTION. Sec. 17 Every ambulatory surgical facility shall
post in conspicuous locations a notice of the department's ambulatory
surgical facility complaint toll-free telephone number. The form of
the notice shall be approved by the department.
NEW SECTION. Sec. 18 Information received by the department
through filed reports, inspection, or as otherwise authorized under
this chapter may be disclosed publicly, as permitted under chapter
42.56 RCW, subject to the following provisions:
(1) Licensing inspections, or complaint investigations regardless
of findings, shall, as requested, be disclosed no sooner than three
business days after the ambulatory surgical facility has received the
resulting assessment report;
(2) Information regarding administrative action against the license
shall, as requested, be disclosed after the ambulatory surgical
facility has received the documents initiating the administrative
action;
(3) Information about complaints that did not warrant an
investigation shall not be disclosed except to notify the ambulatory
surgical facility and the complainant that the complaint did not
warrant an investigation; and
(4) Information disclosed under this section shall not disclose
individual names.
NEW SECTION. Sec. 19 The ambulatory surgical facility account is
created in the custody of the state treasurer. All receipts from fees
and penalties imposed under this chapter must be deposited into the
account. Expenditures from the account may be used only for
administration of this chapter. Only the secretary or the secretary's
designee may authorize expenditures from the account. The account is
subject to allotment procedures under chapter 43.88 RCW, but an
appropriation is not required for expenditures.
Sec. 20 RCW 70.56.010 and 2006 c 8 s 105 are each amended to read
as follows:
The definitions in this section apply throughout this chapter
unless the context clearly requires otherwise.
(1) "Adverse health event" or "adverse event" means the list of
serious reportable events adopted by the national quality forum in
2002, in its consensus report on serious reportable events in health
care. The department shall update the list, through adoption of rules,
as subsequent changes are made by the national quality forum. The term
does not include an incident.
(2) "Ambulatory surgical facility" means ((any distinct entity that
operates exclusively for the purpose of providing surgical services to
patients not requiring hospitalization, whether or not the facility is
certified under Title XVIII of the federal social security act)) a
facility licensed under chapter 70.-- RCW (sections 1 through 19 of
this act).
(3) "Childbirth center" means a facility licensed under chapter
18.46 RCW.
(4) "Correctional medical facility" means a part or unit of a
correctional facility operated by the department of corrections under
chapter 72.10 RCW that provides medical services for lengths of stay in
excess of twenty-four hours to offenders.
(5) "Department" means the department of health.
(6) "Health care worker" means an employee, independent contractor,
licensee, or other individual who is directly involved in the delivery
of health services in a medical facility.
(7) "Hospital" means a facility licensed under chapter 70.41 RCW.
(8) "Incident" means an event, occurrence, or situation involving
the clinical care of a patient in a medical facility that:
(a) Results in unanticipated injury to a patient that is not
related to the natural course of the patient's illness or underlying
condition and does not constitute an adverse event; or
(b) Could have injured the patient but did not either cause an
unanticipated injury or require the delivery of additional health care
services to the patient.
"Incident" does not include an adverse event.
(9) "Independent entity" means that entity that the department of
health contracts with under RCW 70.56.040 to receive notifications and
reports of adverse events and incidents, and carry out the activities
specified in RCW 70.56.040.
(10) "Medical facility" means a childbirth center, hospital,
psychiatric hospital, or correctional medical facility. An ambulatory
surgical facility shall be considered a medical facility for purposes
of this chapter upon the effective date of any requirement for state
registration or licensure of ambulatory surgical facilities.
(11) "Psychiatric hospital" means a hospital facility licensed as
a psychiatric hospital under chapter 71.12 RCW.
Sec. 21 RCW 43.70.510 and 2006 c 8 s 113, 2005 c 291 s 2, 2005 c
274 s 302, and 2005 c 33 s 6 are each reenacted and amended to read as
follows:
(1)(a) Health care institutions and medical facilities, other than
hospitals, that are licensed by the department, professional societies
or organizations, health care service contractors, health maintenance
organizations, health carriers approved pursuant to chapter 48.43 RCW,
and any other person or entity providing health care coverage under
chapter 48.42 RCW that is subject to the jurisdiction and regulation of
any state agency or any subdivision thereof may maintain a coordinated
quality improvement program for the improvement of the quality of
health care services rendered to patients and the identification and
prevention of medical malpractice as set forth in RCW 70.41.200.
(b) All such programs shall comply with the requirements of RCW
70.41.200(1) (a), (c), (d), (e), (f), (g), and (h) as modified to
reflect the structural organization of the institution, facility,
professional societies or organizations, health care service
contractors, health maintenance organizations, health carriers, or any
other person or entity providing health care coverage under chapter
48.42 RCW that is subject to the jurisdiction and regulation of any
state agency or any subdivision thereof, unless an alternative quality
improvement program substantially equivalent to RCW 70.41.200(1)(a) is
developed. All such programs, whether complying with the requirement
set forth in RCW 70.41.200(1)(a) or in the form of an alternative
program, must be approved by the department before the discovery
limitations provided in subsections (3) and (4) of this section and the
exemption under RCW 42.56.360(1)(c) and subsection (5) of this section
shall apply. In reviewing plans submitted by licensed entities that
are associated with physicians' offices, the department shall ensure
that the exemption under RCW 42.56.360(1)(c) and the discovery
limitations of this section are applied only to information and
documents related specifically to quality improvement activities
undertaken by the licensed entity.
(2) Health care provider groups of five or more providers may
maintain a coordinated quality improvement program for the improvement
of the quality of health care services rendered to patients and the
identification and prevention of medical malpractice as set forth in
RCW 70.41.200. For purposes of this section, a health care provider
group may be a consortium of providers consisting of five or more
providers in total. All such programs shall comply with the
requirements of RCW 70.41.200(1) (a), (c), (d), (e), (f), (g), and (h)
as modified to reflect the structural organization of the health care
provider group. All such programs must be approved by the department
before the discovery limitations provided in subsections (3) and (4) of
this section and the exemption under RCW 42.56.360(1)(c) and subsection
(5) of this section shall apply.
(3) Any person who, in substantial good faith, provides information
to further the purposes of the quality improvement and medical
malpractice prevention program or who, in substantial good faith,
participates on the quality improvement committee shall not be subject
to an action for civil damages or other relief as a result of such
activity. Any person or entity participating in a coordinated quality
improvement program that, in substantial good faith, shares information
or documents with one or more other programs, committees, or boards
under subsection (6) of this section is not subject to an action for
civil damages or other relief as a result of the activity or its
consequences. For the purposes of this section, sharing information is
presumed to be in substantial good faith. However, the presumption may
be rebutted upon a showing of clear, cogent, and convincing evidence
that the information shared was knowingly false or deliberately
misleading.
(4) Information and documents, including complaints and incident
reports, created specifically for, and collected and maintained by, a
quality improvement committee are not subject to review or disclosure,
except as provided in this section, or discovery or introduction into
evidence in any civil action, and no person who was in attendance at a
meeting of such committee or who participated in the creation,
collection, or maintenance of information or documents specifically for
the committee shall be permitted or required to testify in any civil
action as to the content of such proceedings or the documents and
information prepared specifically for the committee. This subsection
does not preclude: (a) In any civil action, the discovery of the
identity of persons involved in the medical care that is the basis of
the civil action whose involvement was independent of any quality
improvement activity; (b) in any civil action, the testimony of any
person concerning the facts that form the basis for the institution of
such proceedings of which the person had personal knowledge acquired
independently of such proceedings; (c) in any civil action by a health
care provider regarding the restriction or revocation of that
individual's clinical or staff privileges, introduction into evidence
information collected and maintained by quality improvement committees
regarding such health care provider; (d) in any civil action
challenging the termination of a contract by a state agency with any
entity maintaining a coordinated quality improvement program under this
section if the termination was on the basis of quality of care
concerns, introduction into evidence of information created, collected,
or maintained by the quality improvement committees of the subject
entity, which may be under terms of a protective order as specified by
the court; (e) in any civil action, disclosure of the fact that staff
privileges were terminated or restricted, including the specific
restrictions imposed, if any and the reasons for the restrictions; or
(f) in any civil action, discovery and introduction into evidence of
the patient's medical records required by rule of the department of
health to be made regarding the care and treatment received.
(5) Information and documents created specifically for, and
collected and maintained by, a quality improvement committee are exempt
from disclosure under chapter 42.56 RCW.
(6) A coordinated quality improvement program may share information
and documents, including complaints and incident reports, created
specifically for, and collected and maintained by, a quality
improvement committee or a peer review committee under RCW 4.24.250
with one or more other coordinated quality improvement programs
maintained in accordance with this section or with RCW 70.41.200, a
coordinated quality improvement committee maintained by an ambulatory
surgical facility under section 8 of this act, a quality assurance
committee maintained in accordance with RCW 18.20.390 or 74.42.640, or
a peer review committee under RCW 4.24.250, for the improvement of the
quality of health care services rendered to patients and the
identification and prevention of medical malpractice. The privacy
protections of chapter 70.02 RCW and the federal health insurance
portability and accountability act of 1996 and its implementing
regulations apply to the sharing of individually identifiable patient
information held by a coordinated quality improvement program. Any
rules necessary to implement this section shall meet the requirements
of applicable federal and state privacy laws. Information and
documents disclosed by one coordinated quality improvement program to
another coordinated quality improvement program or a peer review
committee under RCW 4.24.250 and any information and documents created
or maintained as a result of the sharing of information and documents
shall not be subject to the discovery process and confidentiality shall
be respected as required by subsection (4) of this section and RCW
4.24.250.
(7) The department of health shall adopt rules as are necessary to
implement this section.
Sec. 22 RCW 70.41.200 and 2005 c 291 s 3 and 2005 c 33 s 7 are
each reenacted and amended to read as follows:
(1) Every hospital shall maintain a coordinated quality improvement
program for the improvement of the quality of health care services
rendered to patients and the identification and prevention of medical
malpractice. The program shall include at least the following:
(a) The establishment of a quality improvement committee with the
responsibility to review the services rendered in the hospital, both
retrospectively and prospectively, in order to improve the quality of
medical care of patients and to prevent medical malpractice. The
committee shall oversee and coordinate the quality improvement and
medical malpractice prevention program and shall ensure that
information gathered pursuant to the program is used to review and to
revise hospital policies and procedures;
(b) A medical staff privileges sanction procedure through which
credentials, physical and mental capacity, and competence in delivering
health care services are periodically reviewed as part of an evaluation
of staff privileges;
(c) The periodic review of the credentials, physical and mental
capacity, and competence in delivering health care services of all
persons who are employed or associated with the hospital;
(d) A procedure for the prompt resolution of grievances by patients
or their representatives related to accidents, injuries, treatment, and
other events that may result in claims of medical malpractice;
(e) The maintenance and continuous collection of information
concerning the hospital's experience with negative health care outcomes
and incidents injurious to patients, patient grievances, professional
liability premiums, settlements, awards, costs incurred by the hospital
for patient injury prevention, and safety improvement activities;
(f) The maintenance of relevant and appropriate information
gathered pursuant to (a) through (e) of this subsection concerning
individual physicians within the physician's personnel or credential
file maintained by the hospital;
(g) Education programs dealing with quality improvement, patient
safety, medication errors, injury prevention, staff responsibility to
report professional misconduct, the legal aspects of patient care,
improved communication with patients, and causes of malpractice claims
for staff personnel engaged in patient care activities; and
(h) Policies to ensure compliance with the reporting requirements
of this section.
(2) Any person who, in substantial good faith, provides information
to further the purposes of the quality improvement and medical
malpractice prevention program or who, in substantial good faith,
participates on the quality improvement committee shall not be subject
to an action for civil damages or other relief as a result of such
activity. Any person or entity participating in a coordinated quality
improvement program that, in substantial good faith, shares information
or documents with one or more other programs, committees, or boards
under subsection (8) of this section is not subject to an action for
civil damages or other relief as a result of the activity. For the
purposes of this section, sharing information is presumed to be in
substantial good faith. However, the presumption may be rebutted upon
a showing of clear, cogent, and convincing evidence that the
information shared was knowingly false or deliberately misleading.
(3) Information and documents, including complaints and incident
reports, created specifically for, and collected and maintained by, a
quality improvement committee are not subject to review or disclosure,
except as provided in this section, or discovery or introduction into
evidence in any civil action, and no person who was in attendance at a
meeting of such committee or who participated in the creation,
collection, or maintenance of information or documents specifically for
the committee shall be permitted or required to testify in any civil
action as to the content of such proceedings or the documents and
information prepared specifically for the committee. This subsection
does not preclude: (a) In any civil action, the discovery of the
identity of persons involved in the medical care that is the basis of
the civil action whose involvement was independent of any quality
improvement activity; (b) in any civil action, the testimony of any
person concerning the facts which form the basis for the institution of
such proceedings of which the person had personal knowledge acquired
independently of such proceedings; (c) in any civil action by a health
care provider regarding the restriction or revocation of that
individual's clinical or staff privileges, introduction into evidence
information collected and maintained by quality improvement committees
regarding such health care provider; (d) in any civil action,
disclosure of the fact that staff privileges were terminated or
restricted, including the specific restrictions imposed, if any and the
reasons for the restrictions; or (e) in any civil action, discovery and
introduction into evidence of the patient's medical records required by
regulation of the department of health to be made regarding the care
and treatment received.
(4) Each quality improvement committee shall, on at least a
semiannual basis, report to the governing board of the hospital in
which the committee is located. The report shall review the quality
improvement activities conducted by the committee, and any actions
taken as a result of those activities.
(5) The department of health shall adopt such rules as are deemed
appropriate to effectuate the purposes of this section.
(6) The medical quality assurance commission or the board of
osteopathic medicine and surgery, as appropriate, may review and audit
the records of committee decisions in which a physician's privileges
are terminated or restricted. Each hospital shall produce and make
accessible to the commission or board the appropriate records and
otherwise facilitate the review and audit. Information so gained shall
not be subject to the discovery process and confidentiality shall be
respected as required by subsection (3) of this section. Failure of a
hospital to comply with this subsection is punishable by a civil
penalty not to exceed two hundred fifty dollars.
(7) The department, the joint commission on accreditation of health
care organizations, and any other accrediting organization may review
and audit the records of a quality improvement committee or peer review
committee in connection with their inspection and review of hospitals.
Information so obtained shall not be subject to the discovery process,
and confidentiality shall be respected as required by subsection (3) of
this section. Each hospital shall produce and make accessible to the
department the appropriate records and otherwise facilitate the review
and audit.
(8) A coordinated quality improvement program may share information
and documents, including complaints and incident reports, created
specifically for, and collected and maintained by, a quality
improvement committee or a peer review committee under RCW 4.24.250
with one or more other coordinated quality improvement programs
maintained in accordance with this section or RCW 43.70.510, a
coordinated quality improvement committee maintained by an ambulatory
surgical facility under section 8 of this act, a quality assurance
committee maintained in accordance with RCW 18.20.390 or 74.42.640, or
a peer review committee under RCW 4.24.250, for the improvement of the
quality of health care services rendered to patients and the
identification and prevention of medical malpractice. The privacy
protections of chapter 70.02 RCW and the federal health insurance
portability and accountability act of 1996 and its implementing
regulations apply to the sharing of individually identifiable patient
information held by a coordinated quality improvement program. Any
rules necessary to implement this section shall meet the requirements
of applicable federal and state privacy laws. Information and
documents disclosed by one coordinated quality improvement program to
another coordinated quality improvement program or a peer review
committee under RCW 4.24.250 and any information and documents created
or maintained as a result of the sharing of information and documents
shall not be subject to the discovery process and confidentiality shall
be respected as required by subsection (3) of this section, RCW
18.20.390 (6) and (8), 74.42.640 (7) and (9), and 4.24.250.
(9) A hospital that operates a nursing home as defined in RCW
18.51.010 may conduct quality improvement activities for both the
hospital and the nursing home through a quality improvement committee
under this section, and such activities shall be subject to the
provisions of subsections (2) through (8) of this section.
(10) Violation of this section shall not be considered negligence
per se.
Sec. 23 RCW 18.130.070 and 2006 c 99 s 2 are each amended to read
as follows:
(1)(a) The secretary shall adopt rules requiring every license
holder to report to the appropriate disciplining authority any
conviction, determination, or finding that another license holder has
committed an act which constitutes unprofessional conduct, or to report
information to the disciplining authority, an impaired practitioner
program, or voluntary substance abuse monitoring program approved by
the disciplining authority, which indicates that the other license
holder may not be able to practice his or her profession with
reasonable skill and safety to consumers as a result of a mental or
physical condition.
(b) The secretary may adopt rules to require other persons,
including corporations, organizations, health care facilities, impaired
practitioner programs, or voluntary substance abuse monitoring programs
approved by a disciplining authority, and state or local government
agencies to report:
(i) Any conviction, determination, or finding that a license holder
has committed an act which constitutes unprofessional conduct; or
(ii) Information to the disciplining authority, an impaired
practitioner program, or voluntary substance abuse monitoring program
approved by the disciplining authority, which indicates that the
license holder may not be able to practice his or her profession with
reasonable skill and safety to consumers as a result of a mental or
physical condition.
(c) If a report has been made by a hospital to the department
pursuant to RCW 70.41.210 or by an ambulatory surgical facility
pursuant to section 12 of this act, a report to the disciplining
authority is not required. To facilitate meeting the intent of this
section, the cooperation of agencies of the federal government is
requested by reporting any conviction, determination, or finding that
a federal employee or contractor regulated by the disciplining
authorities enumerated in this chapter has committed an act which
constituted unprofessional conduct and reporting any information which
indicates that a federal employee or contractor regulated by the
disciplining authorities enumerated in this chapter may not be able to
practice his or her profession with reasonable skill and safety as a
result of a mental or physical condition.
(d) Reporting under this section is not required by:
(i) Any entity with a peer review committee, quality improvement
committee or other similarly designated professional review committee,
or by a license holder who is a member of such committee, during the
investigative phase of the respective committee's operations if the
investigation is completed in a timely manner; or
(ii) An impaired practitioner program or voluntary substance abuse
monitoring program approved by a disciplining authority under RCW
18.130.175 if the license holder is currently enrolled in the treatment
program, so long as the license holder actively participates in the
treatment program and the license holder's impairment does not
constitute a clear and present danger to the public health, safety, or
welfare.
(2) If a person fails to furnish a required report, the
disciplining authority may petition the superior court of the county in
which the person resides or is found, and the court shall issue to the
person an order to furnish the required report. A failure to obey the
order is a contempt of court as provided in chapter 7.21 RCW.
(3) A person is immune from civil liability, whether direct or
derivative, for providing information to the disciplining authority
pursuant to the rules adopted under subsection (1) of this section.
(4)(a) The holder of a license subject to the jurisdiction of this
chapter shall report to the disciplining authority:
(i) Any conviction, determination, or finding that he or she has
committed unprofessional conduct or is unable to practice with
reasonable skill or safety; and
(ii) Any disqualification from participation in the federal
medicare program, under Title XVIII of the federal social security act
or the federal medicaid program, under Title XIX of the federal social
security act.
(b) Failure to report within thirty days of notice of the
conviction, determination, finding, or disqualification constitutes
grounds for disciplinary action.
Sec. 24 RCW 18.71.0195 and 2005 c 274 s 227 are each amended to
read as follows:
(1) The contents of any report filed under RCW 18.130.070 shall be
confidential and exempt from public disclosure pursuant to chapter
42.56 RCW, except that it may be reviewed (a) by the licensee involved
or his or her counsel or authorized representative who may submit any
additional exculpatory or explanatory statements or other information,
which statements or other information shall be included in the file, or
(b) by a representative of the commission, or investigator thereof, who
has been assigned to review the activities of a licensed physician.
Upon a determination that a report is without merit, the
commission's records may be purged of information relating to the
report.
(2) Every individual, medical association, medical society,
hospital, ambulatory surgical facility, medical service bureau, health
insurance carrier or agent, professional liability insurance carrier,
professional standards review organization, agency of the federal,
state, or local government, or the entity established by RCW 18.71.300
and its officers, agents, and employees are immune from civil
liability, whether direct or derivative, for providing information to
the commission under RCW 18.130.070, or for which an individual health
care provider has immunity under the provisions of RCW 4.24.240,
4.24.250, or 4.24.260.
Sec. 25 RCW 42.56.360 and 2006 c 209 s 9 and 2006 c 8 s 112 are
each reenacted and amended to read as follows:
(1) The following health care information is exempt from disclosure
under this chapter:
(a) Information obtained by the board of pharmacy as provided in
RCW 69.45.090;
(b) Information obtained by the board of pharmacy or the department
of health and its representatives as provided in RCW 69.41.044,
69.41.280, and 18.64.420;
(c) Information and documents created specifically for, and
collected and maintained by a quality improvement committee under RCW
43.70.510, section 9 of this act, or 70.41.200, or by a peer review
committee under RCW 4.24.250, or by a quality assurance committee
pursuant to RCW 74.42.640 or 18.20.390, and notifications or reports of
adverse events or incidents made under RCW 70.56.020 or 70.56.040,
regardless of which agency is in possession of the information and
documents;
(d)(i) Proprietary financial and commercial information that the
submitting entity, with review by the department of health,
specifically identifies at the time it is submitted and that is
provided to or obtained by the department of health in connection with
an application for, or the supervision of, an antitrust exemption
sought by the submitting entity under RCW 43.72.310;
(ii) If a request for such information is received, the submitting
entity must be notified of the request. Within ten business days of
receipt of the notice, the submitting entity shall provide a written
statement of the continuing need for confidentiality, which shall be
provided to the requester. Upon receipt of such notice, the department
of health shall continue to treat information designated under this
subsection (1)(d) as exempt from disclosure;
(iii) If the requester initiates an action to compel disclosure
under this chapter, the submitting entity must be joined as a party to
demonstrate the continuing need for confidentiality;
(e) Records of the entity obtained in an action under RCW 18.71.300
through 18.71.340;
(f) Except for published statistical compilations and reports
relating to the infant mortality review studies that do not identify
individual cases and sources of information, any records or documents
obtained, prepared, or maintained by the local health department for
the purposes of an infant mortality review conducted by the department
of health under RCW 70.05.170; and
(g) Complaints filed under chapter 18.130 RCW after July 27, 1997,
to the extent provided in RCW 18.130.095(1).
(2) Chapter 70.02 RCW applies to public inspection and copying of
health care information of patients.
Sec. 26 RCW 18.71.017 and 2000 c 171 s 23 are each amended to
read as follows:
(1) The commission may adopt such rules as are not inconsistent
with the laws of this state as may be determined necessary or proper to
carry out the purposes of this chapter. The commission is the
successor in interest of the board of medical examiners and the medical
disciplinary board. All contracts, undertakings, agreements, rules,
regulations, and policies continue in full force and effect on July 1,
1994, unless otherwise repealed or rejected by this chapter or by the
commission.
(2) The commission may adopt rules governing the administration of
sedation and anesthesia in the offices of persons licensed under this
chapter, including necessary training and equipment.
Sec. 27 RCW 18.57.005 and 1986 c 259 s 94 are each amended to
read as follows:
The board shall have the following powers and duties:
(1) To administer examinations to applicants for licensure under
this chapter;
(2) To make such rules and regulations as are not inconsistent with
the laws of this state as may be deemed necessary or proper to carry
out the purposes of this chapter;
(3) To establish and administer requirements for continuing
professional education as may be necessary or proper to insure the
public health and safety as a prerequisite to granting and renewing
licenses under this chapter: PROVIDED, That such rules shall not
require a licensee under this chapter to engage in continuing education
related to or provided by any specific branch, school, or philosophy of
medical practice or its political and/or professional organizations,
associations, or societies;
(4) To adopt rules governing the administration of sedation and
anesthesia in the offices of persons licensed under this chapter,
including necessary training and equipment;
(5) To keep an official record of all its proceedings, which record
shall be evidence of all proceedings of the board which are set forth
therein.
Sec. 28 RCW 18.22.015 and 1990 c 147 s 5 are each amended to read
as follows:
The board shall:
(1) Administer all laws placed under its jurisdiction;
(2) Prepare, grade, and administer or determine the nature,
grading, and administration of examinations for applicants for
podiatric physician and surgeon licenses;
(3) Examine and investigate all applicants for podiatric physician
and surgeon licenses and certify to the secretary all applicants it
judges to be properly qualified;
(4) Adopt any rules which it considers necessary or proper to carry
out the purposes of this chapter;
(5) Adopt rules governing the administration of sedation and
anesthesia in the offices of persons licensed under this chapter,
including necessary training and equipment;
(6) Determine which schools of podiatric medicine and surgery will
be approved.
NEW SECTION. Sec. 29 Except for section 7 of this act, this act
takes effect July 1, 2009.
NEW SECTION. Sec. 30 The secretary of health may take the
necessary steps to ensure that this act is implemented on its effective
date.
NEW SECTION. Sec. 31 Sections 1 through 6 and 8 through 19 of
this act constitute a new chapter in Title
ESHB 1414 -
By Committee on Health & Long-Term Care
ADOPTED 04/11/2007
On page 1, line 1 of the title, after "facilities;" strike the remainder of the title and insert "amending RCW 70.56.010, 18.130.070, 18.71.0195, 18.71.017, 18.57.005, and 18.22.015; reenacting and amending RCW 43.70.510, 70.41.200, and 42.56.360; adding a new chapter to Title 70 RCW; creating new sections; prescribing penalties; and providing an effective date."