WSR 03-23-135

EXPEDITED RULES

DEPARTMENT OF HEALTH


[ Filed November 19, 2003, 10:51 a.m. ]

Title of Rule: Chapter 246-50 WAC, Coordinated quality improvement program.

Purpose: Chapter 246-50 WAC establishes the criterial and approval process that health care entities must meet to apply for and maintain status as a coordinated quality improvement program.

Statutory Authority for Adoption: RCW 43.70.510.

Statute Being Implemented: RCW 43.70.510.

Summary: The proposed revisions to chapter 246-50 WAC retain most of the language and intent of the original chapter. The proposed changes clarify existing rules, and repeals the language requiring programs must be consistent with principles for continuous improvement published by the Health Care Policy Board. In 1996 the Health Care Policy Board was abolished through legislative action and is no longer in existence.

Reasons Supporting Proposal: The restructuring of the rules provide clearer guidance and reflect the current law.

Name of Agency Personnel Responsible for Drafting: Anh Berry, P.O. Box 47890, Olympia, WA 98504-7879 [7890], (360) 236-4028; Implementation and Enforcement: Patti Rathbun, P.O. Box 47890, Olympia, WA 98504-7879 [7890], (360) 236-4627.

Name of Proponent: Department of Health, governmental.

Rule is not necessitated by federal law, federal or state court decision.

Explanation of Rule, its Purpose, and Anticipated Effects: The proposed rules outline the process and the required criteria the department uses to evaluate applications for the coordinated quality improvement program. The purpose of the proposed changes is to delete the outdated sections, update the current reference RCW, and to improve the clarity and readability of the rules. It is anticipated that applicants will find the proposed rules easier to read and to understand.

Proposal Changes the Following Existing Rules: The proposal updates WAC 246-50-001 Purpose and scope, by eliminating the outdated language requiring programs must be consistent with principles for continuous improvement published by the Health Care Policy Board. In 1996 the Health Care Policy Board was abolished through legislative action and is no longer in existence; updates WAC 246-50-010 Definitions, to accurately reflect the current CQIP statute reference instead of the hospital statute; updates WAC 246-50-020 by eliminating the redundant responsibilities of the quality committee and replacing lengthy language of assuring patient confidentiality with a concise description of the criteria; streamlines WAC 246-50-030 Approval process -- Public disclosure, by replacing lengthy approval process with a concise description on how a health care entity can apply for the program and the approval process and by removing the public disclosure paragraph to the new section WAC 246-50-035 Is submitted program plan subject to public disclosure law; and eliminates WAC 246-50-040 Alternative program, because the information is best reflected under WAC 246-50-030. The proposal also creates WAC 246-50-005 Who is eligible to apply for the coordinated quality improvement program, to help stakeholders to determine their eligibility to apply for the program.

NOTICE

THIS RULE IS BEING PROPOSED UNDER AN EXPEDITED RULE-MAKING PROCESS THAT WILL ELIMINATE THE NEED FOR THE AGENCY TO HOLD PUBLIC HEARINGS, PREPARE A SMALL BUSINESS ECONOMIC IMPACT STATEMENT, OR PROVIDE RESPONSES TO THE CRITERIA FOR A SIGNIFICANT LEGISLATIVE RULE. IF YOU OBJECT TO THE USE OF THE EXPEDITED RULE-MAKING PROCESS, YOU MUST EXPRESS YOUR OBJECTIONS IN WRITING AND THEY MUST BE SENT TO Patti Rathbun, Department of Health, P.O. Box 47890, Olympia, WA 98504-7890 , AND RECEIVED BY January 20, 2004.


November 18, 2003

M. C. Selecky

Secretary

OTS-6145.4


AMENDATORY SECTION(Amending WSR 96-09-042, filed 4/11/96, effective 5/12/96)

WAC 246-50-001   ((Purpose and scope.)) What is the purpose of the coordinated quality improvement program?   (((1) 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 pursuant to RCW 43.70.510. Coordinated quality improvement programs approved by the department are provided discovery limitations pursuant to RCW 43.70.510 (3) and (4).)) The purpose of the coordinated quality improvement program is to improve the quality of health care services by identifying and preventing health care malpractice. This is a voluntary program that protects the confidentiality of information and documents that are collected for the purpose of improving the quality of health care as defined in RCW 43.70.510 (3) and (4). Information and documents specifically created ((specifically for, and collected)), and maintained by an approved quality improvement committee are ((also)) exempt from disclosure under chapter 42.17 RCW.

(((2) This chapter allows health care provider groups, 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 and health care institutions and medical facilities other than hospitals, to maintain a department-approved coordinated quality improvement program for the purpose of improving the quality of health care and identifying and preventing health care malpractice.

(3) Programs submitted for department approval should be consistent with the principles for the continuous improvement of the Washington state health care system published by the health care policy board.

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

[Statutory Authority: RCW 43.70.510. 96-09-042, 246-50-001, filed 4/11/96, effective 5/12/96; 94-24-001, 246-50-001, filed 11/23/94, effective 12/24/94.]


NEW SECTION
WAC 246-50-005   Who is eligible to apply for the coordinated quality improvement program?   (1) The following health care entities can apply for the coordinated quality improvement program:

(a) Provider groups of ten or more providers;

(b) Health care professional societies or organizations, including, but not limited to, state or local health care professional associations;

(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 as defined in RCW 48.43.005;

(f) Health care institutions or medical facilities other than hospitals; and

(g) Any person or entity providing personal coverage under chapter 48.42 RCW, and is subject to the jurisdiction and regulation of any state agency or subdivision.

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

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AMENDATORY SECTION(Amending WSR 96-09-042, filed 4/11/96, effective 5/12/96)

WAC 246-50-010   ((Definitions.)) What are the meanings of words and phrases used in this chapter?   The words and phrases in this chapter have the following meanings ((unless the context clearly indicates otherwise.)):

(1) "Alternative program" means a coordinated quality improvement program ((determined by)) that the department ((to be substantially equivalent to RCW 70.41.200(1))) determines sufficiently meets the components in WAC 246-50-020.

(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 ((to be)) is responsible for the coordinated quality improvement program.

(4) (("Health care entity" means a health care institution, medical facility, provider group, professional society or organization, 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 of any state agency or any subdivision thereof, authorized by RCW 43.70.510 to have a department-approved coordinated quality improvement program.

(5))) "Health care institution" or "medical facility" includes the following:

(a) ((Adult residential rehabilitation centers regulated pursuant to chapter 71.12 RCW;

(b) Alcoholism)) Alcohol and drug treatment facilities, or hospitals, regulated ((pursuant to chapters 71.12 and)) under chapter 70.96A RCW;

(((c) Alcoholism hospitals regulated pursuant to chapters 71.12 and 70.96A RCW;

(d) Ambulance and aid services regulated pursuant to chapter 18.73 RCW;

(e))) (b) Boarding homes regulated ((pursuant to)) under chapter 18.20 RCW;

(((f))) (c) Childbirth centers regulated ((pursuant to)) under chapter 18.46 RCW;

(((g))) (d) Community mental health centers regulated ((pursuant to)) under chapter 71.05 or 71.24 RCW;

(((h) Eye banks regulated pursuant to RCW 68.50.630;

(i) Home health agencies regulated pursuant to chapter 70.127 RCW;

(j) Hospice care centers regulated pursuant to chapter 70.41 RCW;

(k))) (e) Emergency medical care and transportation services regulated under chapter 18.73 RCW;

(f) Home health, hospice ((agencies)), and home care agencies regulated ((pursuant to)) under chapter 70.127 RCW;

(((l))) (g) Medical test sites regulated ((pursuant to)) under chapter 70.42 RCW;

(((m))) (h) Nursing homes regulated ((pursuant to)) under chapter 18.51 RCW;

(((n))) (i) Pharmacies regulated ((pursuant to)) under chapter 18.64 RCW;

(((o))) (j) Private establishments regulated under chapter 71.12 RCW include:

(i) Private psychiatric hospitals ((regulated pursuant to chapter 71.12 RCW)); and

(((p))) (ii) Residential treatment facilities for psychiatrically impaired children and youth ((regulated pursuant to chapter 71.12 RCW));

(((q))) (k) Rural health care facilities regulated ((pursuant to)) under chapter 70.175 RCW;

(((r))) (l) Organizations that provide designated trauma care services individually or jointly under chapter 70.168 RCW;

(m) Facilities owned and operated by a political subdivision or instrumentality of the state, including, but not limited to:

(i) Public health departments;

(ii) Fire districts and departments;

(iii) Soldiers' and veterans' homes;

(iv) State mental health institutions;

(v) Health clinics operated by educational institutions;

(vi) Department of corrections health care facilities;

(vii) County jail health clinics; and

(viii) County drug and alcohol treatment facilities;

(((s))) (n) Facilities required by federal law and implementing regulations, including, but not limited to:

(i) Native American health facilities; ((and))

(ii) Veterans' affairs health services; and

(((t))) (o) Other facilities determined by the department to be within the parameters of the definition of "health care facility" in RCW ((43.72.010)) 48.43.005.

(6) "Health care provider" or "provider" means:

(a) A person regulated under Title 18 RCW to practice health or health related services or otherwise practicing health care services in this state consistent with state law; or

(b) An employee or agent of a person described in (a) of this subsection, acting in the course and scope of ((the employee's or agent's employment performing health care or auxiliary services)) his or her employment.

(7) "Health care provider group" or "provider group" means an organized body of ten or more providers.

(8) "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.

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

(10))) "Program" means coordinated quality improvement program pursuant to RCW 43.70.510.

[Statutory Authority: RCW 43.70.510. 96-09-042, 246-50-010, filed 4/11/96, effective 5/12/96; 94-24-001, 246-50-010, filed 11/23/94, effective 12/24/94.]

Reviser's note: The typographical error in the above section occurred in the copy filed by the agency and appears in the Register pursuant to the requirements of RCW 34.08.040.
AMENDATORY SECTION(Amending WSR 94-24-001, filed 11/23/94, effective 12/24/94)

WAC 246-50-020   ((Coordinated quality improvement program -- Components.)) What are the components for a coordinated quality improvement program?   (1) A coordinated quality improvement program ((under the provisions of RCW 43.70.510 shall)) must include((, at a minimum:

(1))) the following components:

(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;)) Overseeing and coordinating the program;

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

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

(iv) Reviewing categories, methodologies, services offered currently, and services to be offered in the future to ensure the quality of health care outcomes.

(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;)) A process assuring patient confidentiality when the program gathers provider's personnel or credential information;

(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 specifically created ((specifically for and)), collected, and maintained by the quality improvement committee;

(j) Educational or informational 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 subsection (1) of this section.

[Statutory Authority: RCW 43.70.510. 94-24-001, 246-50-020, filed 11/23/94, effective 12/24/94.]


AMENDATORY SECTION(Amending WSR 94-24-001, filed 11/23/94, effective 12/24/94)

WAC 246-50-030   ((Approval process -- Public disclosure.)) How do I apply for the coordinated quality improvement program?   (1) ((A health care entity seeking department approval of a program shall submit to the department:)) To apply for an original program, an applicant must submit the following items to the department:

(a) An official department application ((on)) form((s provided by the department));

(b) The program plan, printed on 8 1/2 by 11 inch paper, including:

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

(ii) A detailed description of ((every aspect of the program)) each required component;

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

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

(2)((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 subsection (1) of this section; and

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

(3) The department shall review each application package submitted pursuant to this section, and:

(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) Provide the health care entity an opportunity for a brief adjudicative proceeding according to RCW 34.05.482 when the department declines to approve a program.

(4) The department shall retain a copy of the program plan. Material received by the department will be subject to the public disclosure law, chapter 42.17 RCW. Health care entities submitting material that they believe is exempt from public disclosure should conspicuously mark the portion or portions and state the basis for exemption. The department will give notice to the submitting entity of any request under the Public Disclosure Act for public disclosure of material that has been marked in accordance with this subsection at least ten working days in advance of releasing the information. This will allow the submitting party to invoke the provisions of RCW 42.17.330.)) To apply for an alternative program, an applicant must submit the following items to the department:

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

(b) Verification of accreditation or certification by an organization approved by the department.

(3) To apply for modification of an approved program, an applicant must submit the following items to the department:

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

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

(4) Upon approval or disapproval of the application, the department will send written notification to the applicant. A notification of disapproval will specify the reasons for denial, and offer the applicant an opportunity for a brief adjudicative proceeding according to RCW 34.05.482.

[Statutory Authority: RCW 43.70.510. 94-24-001, 246-50-030, filed 11/23/94, effective 12/24/94.]


NEW SECTION
WAC 246-50-035   Is submitted program plan subject to public disclosure law?   A program plan submitted to the department is subject to the public disclosure law, chapter 42.17 RCW. If an entity considers submitting material that is exempt from public disclosure, then the entity must clearly mark those portions as exempt and state the basis for the exemption. The department will notify the entity of any request of record that has been marked as exempt at least ten working days before releasing the record. The entity must seek an injunction under RCW 42.17.330 to prohibit the department from releasing the record that has been marked as exempt.

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AMENDATORY SECTION(Amending WSR 94-24-001, filed 11/23/94, effective 12/24/94)

WAC 246-50-990   Fees.   ((A health care entity shall submit a fee with each application for department approval as follows:

(1) A coordinated quality improvement program pursuant to WAC 246-50-030(1) -- two hundred fifty dollars;

(2) An alternative program pursuant to WAC 246-50-040 --forty dollars; and

(3) Modification of a department-approved program pursuant to WAC 246-50-030(2) -- sixty-five dollars.)) An entity must submit the following fee to the department at the time of the application:

Title of Fee Fee
Original application $250.00
Alternative application 40.00
Modification application of a department-approved program 65.00

[Statutory Authority: RCW 43.70.510. 94-24-001, 246-50-990, filed 11/23/94, effective 12/24/94.]


REPEALER

     The following section of the Washington Administrative Code is repealed:
WAC 246-50-040 Alternative programs.

Legislature Code Reviser 

Register

Washington State Code Reviser's Office