WSR 06-03-123

PERMANENT RULES

DEPARTMENT OF HEALTH


[ Filed January 18, 2006, 7:38 a.m. , effective February 18, 2006 ]


Effective Date of Rule: Thirty-one days after filing.

Purpose: To amend chapter 246-50 WAC in order to comply with chapter 145, Laws of 2004. Amendments reflect the number of providers who can apply and maintain a coordinated quality improvement program by reducing the number of provider groups from ten or more to five or more providers. In addition, the rule combines definitions with the same statutory authority, separates sections resulting in three new sections, and clarifies language.

Citation of Existing Rules Affected by this Order: Amending chapter 246-50 WAC.

Statutory Authority for Adoption: RCW 43.70.510, 70.41.200, 4.24.250.

Adopted under notice filed as WSR 05-21-127 on October 19, 2005.

Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 0, Amended 1, Repealed 0.

Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 1, Repealed 0.

Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 0, Repealed 0.

Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 3, Amended 4, Repealed 0.

Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 3, Amended 4, Repealed 0.

Date Adopted: January 17, 2006.

Mary C. Selecky

Secretary

OTS-8158.4


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

WAC 246-50-001   Purpose and scope.   (1) The purpose of the coordinated quality improvement program is to improve the quality of health care services by identifying and preventing health care 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 ((pursuant to)) under RCW 43.70.510. Coordinated quality improvement programs approved by the department are provided discovery limitations ((pursuant to)) under RCW 43.70.510 (3) and (4). Information and documents ((created)) specifically created 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)) under 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)) authority and ((regulation)) rules of any state agency or any subdivision ((thereof and)) such as 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   Applicant eligibility.   (1) The following health care entities may apply for the coordinated quality improvement program:

(a) Provider groups of five 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 authority and rules 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.   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 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 ((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)) under 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)) under chapter 71.12 RCW;

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

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

(d) Ambulance and aid services regulated pursuant to)) Emergency medical care and transportation services regulated under chapter 18.73 RCW;

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

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

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

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

(k) Hospice agencies regulated pursuant to chapter 70.127 RCW;

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

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

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

(((o))) (k) Private psychiatric hospitals and residential treatment facilities for psychiatrically impaired children and youth regulated ((pursuant to)) under chapter 71.12 RCW;

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

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

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

(n) 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; and

(ix) Public hospital districts;

(((s))) (o) 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))) (p) Other facilities ((determined by)) that the department ((to be within the parameters of the)) determines meet 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.

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

(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)) under 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.]


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

WAC 246-50-030   Application and approval process(( -- Public disclosure)).   (((1))) A health care entity seeking department approval of a program shall submit to the department:

(((a))) (1) An application on forms provided by the department;

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

(((i))) (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; and

(((ii))) (b) A detailed description of every aspect of the program;

(((c))) (3) The fee specified in WAC 246-50-990; and

(((d))) (4) 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.))

[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   Modification of an approved plan.   (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); and

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

(2) The department shall review each application package submitted under 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) deny the application and 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.

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

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NEW SECTION
WAC 246-50-060   Public record disclosure.   A program plan and all supplemental material are public records and are subject to the public record disclosure law, chapter 42.17 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 subsection. 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 42.17.330. Upon receiving such proof, the department will notify the public record requester of the action the health care entity initiated under RCW 42.17.330, 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 42.17.330. Absent proof from the health care entity that it has initiated action under RCW 42.17.330, the department will disclose the records consistent with state and federal law.

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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)) must 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.))


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.]