The purpose of a coordinated quality improvement program is to improve the quality of health care services and identify and prevent medical malpractice under RCW 43.70.510. This chapter establishes the criteria and approval process for health care entities who choose to apply for a department of health-approved coordinated quality improvement program under RCW 43.70.510. A coordinated quality improvement program plan must be approved by the department before the discovery limitations provided in RCW 43.70.510 (3) and (4) and the exemptions under RCW 42.56.360 (1)(c) and 43.70.510(5) shall apply.

(1) The following health care entities may apply for the coordinated quality improvement program:

(a) Health care institutions and medical facilities other than hospitals, that are licensed by the department;

(b) Professional societies or organizations;

(c) Health care service contractors as defined in RCW 48.44.010;

(d) Health maintenance organizations as defined in RCW 48.46.020;

(e) Health carriers approved pursuant to chapter 48.43 RCW;

(f) 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 or any subdivision thereof; and

(g) Health care provider groups of five or more providers.

(2) This chapter does not apply to hospital coordinated quality improvement programs required by RCW 70.41.200.

The definitions in this section apply throughout this chapter unless the context clearly requires otherwise.

(1) "Alternative program" means a coordinated quality improvement program determined by the department to be substantially equivalent to RCW 70.41.200(1).

(2) "Department" means the Washington state department of health.

(3) "Governing body" means:

(a) The person, persons, or board responsible for the health care entity; or

(b) In the case of a provider group where no person, persons, or board is in charge of all providers, the person, persons, or group identified by the provider group is responsible for the coordinated quality improvement program.

(4) "Health care provider" or "provider" means a health care professional licensed under the chapters specified in RCW 18.130.040.

(5) "Health care provider group" or "provider group" means an organized body or consortium of five or more providers in total.

(6) "Negative health care outcome" means a patient death or impairment of bodily function other than those related to the natural course of illness, disease, or proper treatment in accordance with generally accepted health care standards.

(7) "Professional society or organization" means a group of health care professionals including, but not limited to, state or local health care professional associations.

(8) "Program" means coordinated quality improvement program under RCW 43.70.510.

A program under the provisions of RCW 43.70.510 shall include, at a minimum:

(1) The following components, as modified and approved by the department to reflect the structural organization of the health care entity:

(a) A governing body;

(b) A committee, appointed by the governing body, with a broad representation of the services offered, responsible for:

(i) Reviewing services rendered, both retrospectively and prospectively, to improve the quality of health care by measuring key characteristics such as effectiveness, accuracy, timeliness, and cost;

(ii) Reviewing categories and methodologies of services rendered and to be rendered with the goal of improving health care outcomes;

(iii) Overseeing and coordinating the program;

(iv) Ensuring information gathered for the program is reviewed and used to revise health care policies and procedures; and

(v) Reporting to the governing body, at least semiannually, on program activities and actions taken as a result of those activities;

(c) Periodic evaluation of each provider under the purview of the program, including mental and physical capacity, competence in delivering health care, and verification of current credentials;

(d) A procedure for promptly resolving all complaints pertaining to accidents, injuries, treatment and other events that may result in claims of health care malpractice;

(e) A method for continually collecting and maintaining information concerning:

(i) Experience with negative health care outcomes and injurious incidents; and

(ii) Professional liability premiums, settlements, awards, costs for injury prevention and safety improvement activities;

(f) A method for maintaining information gathered under the purview of the program concerning a provider in that provider's personnel or credential file, assuring patient confidentiality;

(g) A process for reporting accidents, injuries, negative health outcomes, and other pertinent information to the quality improvement committee;

(h) A process assuring compliance with reporting requirements to appropriate local, state, and federal authorities;

(i) A method for identifying documents and records created specifically for and collected and maintained by the quality improvement committee;

(j) Educational activities for personnel engaged in health care activities including, but not limited to:

(i) Quality improvement;

(ii) Safety and injury prevention;

(iii) Responsibilities for reporting professional misconduct;

(iv) Legal aspects of providing health care;

(v) Improving communication with health care recipients; and

(vi) Causes of malpractice claims; or

(2) Components determined by the department to be substantially equivalent to those listed in subsection (1) of this section.

(1) To obtain department approval of a program, an authorized representative of the health care entity shall submit to the department a completed application on forms provided by the department. A completed application must include at least the following:

(a) A table of contents clearly denoting, at a minimum, where each component specified in WAC 246-50-020 is located within the program plan;

(b) A program plan with detailed description of every aspect of the program including every component of the program required under WAC 246-50-020;

(c) The fee specified in WAC 246-50-990; and

(d) Other information as may be required by the department.

(2) The department may grant or deny approval of an application. If an application is denied, the health care entity may modify and resubmit its application or request a brief adjudicative proceeding according to RCW 34.05.482.

(3) A health care entity that maintains a department-approved program must renew every five years after the date of initial approval. An application for renewal must meet the requirements of subsection (1) of this section. A program remains approved during the renewal process. A health care entity must apply for renewal on or before the original expired due date, unless it has received written confirmation from the department that the applicant may apply at a later date. Failure to apply for renewal will mean that the approval is expired and no longer valid. A health care entity that does not apply for renewal and the approval expires must reapply for the initial department approval by meeting the requirements of subsection (1) of this section.

(4) The department may grant or deny approval or application for renewal. If an application for renewal is denied, the health care entity may modify and resubmit its application or request a brief adjudicative proceeding according to RCW 34.05.482. A program remains approved while an application for renewal is under review, including the time that a health care entity may use to modify and resubmit its application for renewal, until the adjudicative process is exhausted, or the health care entity indicates it does not intend to seek renewal.

(1) To maintain department approval, a health care entity modifying the scope, components or operation of an approved program, shall submit to the department:

(a) An application package specified in WAC 246-50-030(1), modified as appropriate; and

(b) A detailed description of the modification and how it affects the program.

(2) A health care entity shall modify its approved program to comply with any changes in requirements for program approval adopted by the department or the legislature. Any such modification shall be made using the procedure outlined in subsection (1) of this section.

(3) A health care entity shall notify the department of a change in authorized representative within thirty days of a change. The procedure outlined in subsection (1) of this section does not apply to this subsection. A health care entity shall modify its approved program to comply with any changes in requirements for program approval adopted by the department or the legislature within six months of notice from the department that, unless it has received written confirmation from the department that it may apply at a later date. Any such modification shall be made using the procedure outlined in subsection (1) of this section.

(4) The department shall review each application package submitted under this section and either:

(a) Send written notification of approval to a health care entity submitting a program with the components specified in WAC 246-50-020; or

(b) Deny the application. If denied, the health care entity may modify and resubmit its application package or request a brief adjudicative proceeding according to RCW 34.05.482.

(5) A program remains approved while an application to modify is under review, including the time that a health care entity may use to modify and resubmit its application under this section or the adjudicative process identified in subsection (4) of this section is exhausted.

(6) The department shall retain a copy of the program plan.

A health care entity seeking department approval of an alternative program shall submit to the department, in addition to the items specified in WAC 246-50-030(1), verification of certification or accreditation by an organization approved by the department.

All health care entities with currently approved programs must apply for renewal of their programs by December 31, 2021. An application for renewal must meet the requirements of WAC 246-50-030(1). A program remains approved while an application for renewal is under consideration by the department. Failure to apply for renewal by December 31, 2021, will mean the approval is expired and no longer valid.

A program plan and all supplemental material are public records and are subject to the Public Records Act, chapter 42.56 RCW, once the department receives them. Health care entities submitting material they believe is exempt from public record disclosure should clearly mark the portion or portions as "exempt" and state the specific statutory basis for exemption. The department will notify the health care entity of a public record disclosure request for material the entity marked "exempt" in accordance with this section. The department will allow the health care entity ten work days from when it receives department notice to deliver to the department proof that the entity has initiated formal action to secure an injunction under RCW 42.56.540. Upon receiving such proof, the department will notify the public record requester of the action the health care entity initiated under RCW 42.56.540, and take no further action pending a decision by the court. The health care entity must notify the department if it withdraws or takes any other action to terminate the judicial process under RCW 42.56.540. Absent proof from the health care entity that it has initiated action under RCW 42.56.540, the department will disclose the records consistent with state and federal law.

A health care entity must submit a fee with each application as follows: