AN ACT Relating to prenatal testing for heritable and congenital disorders; adding a new chapter to Title 70 RCW; adding a new section to chapter 48.21 RCW; adding a new section to chapter 48.44 RCW; adding a new section to chapter 48.46 RCW; adding a new section to chapter 70.54 RCW; prescribing penalties; making an appropriation; providing effective dates; and declaring an emergency.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF WASHINGTON:

NEW SECTION. Sec. 1. The legislature finds that the care and competent performance of certain prenatal tests for congenital and heritable disorders is crucial to protect the health of both mothers and infants. The legislature further finds that the public health, safety, and welfare will be protected by regulating the performance of these tests.

NEW SECTION. Sec. 2. Unless the context clearly requires otherwise the definitions in this section apply throughout this chapter.

(1) "Department" means the department of social and health services.

(2) "Laboratory" means a private or public agency or organization performing prenatal tests for congenital and heritable disorders.

(3) "License holder" means a laboratory granted a license by the department.

(4) "Prenatal tests" means any test that predicts congenital or heritable disorders which: (a) As determined by the state health coordinating council performed by unregulated laboratories can clearly harm or endanger the health, safety, or welfare of the public, and the potential harm is easily recognizable and not remote or dependent upon tenuous argument, and (b) are enumerated by the department by rule.

(5) "Secretary" means the secretary of social and health services.

NEW SECTION. Sec. 3. A laboratory shall not perform specific prenatal tests without a license issued by the department.

NEW SECTION. Sec. 4. The department shall adopt rules by December 1, 1988, establishing requirements for the licensure required under section 3 of this act. The department shall adopt rules in accordance with the administrative procedure act, chapter 34.04 RCW. In adopting rules the department shall consult with the prenatal test advisory committee.

NEW SECTION. Sec. 5. (1) The prenatal test advisory committee is formed to advise the department on developing prenatal test laboratory licensure rules. The advisory committee shall develop recommendations to address:

(a) The minimum number of genetic screening examinations within a given unit of time which the laboratory shall perform;

(b) The requirements for internal and external laboratory quality control systems;

(c) The definition of a minimum data base and procedures to facilitate and encourage sharing laboratory data with the state;

(d) Suggested guidelines for laboratory capabilities to interpret data and provide follow-up counseling;

(e) Minimum educational, experience, and licensure requirements for personnel employed by laboratories for the purpose of analyzing and interpreting genetic tests; and

(f) Suggested guidelines to facilitate coordination with existing prenatal testing programs of the department.

(2) The prenatal test advisory committee shall be appointed by the governor whose members shall be comprised of the following specialists:

(a) A high-risk perinatal obstetrician;

(b) A practicing obstetrician;

(d) A pediatrician experienced with chronic impairing conditions;

(e) A representative of the developmentally disabled;

(f) Two representatives from the laboratories performing prenatal tests;

(g) A physician ultrasonographer; and

(h) A genetic counselor.

(3) The prenatal test advisory committee shall serve at the pleasure of the governor. The terms shall be staggered. Members shall not serve for terms longer than five years. Advisory committee members shall be reimbursed for travel expenses as provided in RCW 43.03.050 and 43.03.060.

NEW SECTION. Sec. 6. Such fees and collection procedures for obtaining a license and other regulatory services of the department shall be established by the department by rule consistent with RCW 43.20A.055.

NEW SECTION. Sec. 7. The department shall be the disciplinary authority to take disciplinary action against a holder of a certificate or license issued under this chapter upon a finding of a violation of this chapter. The department has the following authority:

(1) To conduct inspections of a laboratory licensed under this chapter;

(2) To investigate all complaints or reports of unprofessional conduct as defined in this chapter and to hold hearings as provided in this chapter;

(3) To issue subpoenas and administer oaths in connection with any investigation or hearing held under this chapter;

(4) To take or cause to be taken depositions and use other discovery procedures as needed in any investigation or hearing held under this chapter;

(5) To compel attendance of witnesses at hearings;

(6) To take emergency action ordering summary suspension of a license, or restriction or limitation of a licensee's activities pending proceedings by the department;

(7) To use the office of administrative hearings as authorized in chapter 34.12 RCW to conduct hearings. However, the department shall make the final decision regarding disposition of the license;

(8) To use consultants to assist in the direction of investigations and issuance of statements of charges;

(9) To enter into contracts for professional services determined to be necessary for adequate enforcement of this chapter;

(10) To contract with a licensee or other persons or organizations to provide services necessary for monitoring and supervision of licensees who are placed on probation, whose activities are restricted, or who are for any authorized purpose subject to monitoring by the disciplining authority;

(11) To grant or deny license applications, and in the event of a finding of unprofessional conduct by a license holder, to impose any sanction against a license holder provided by this chapter;

(12) To enter into an assurance of discontinuance in lieu of issuing a statement of charges or conducting a hearing. The assurance shall consist of a statement of the law in question and an agreement to not violate the stated provision. The license holder shall not be required to admit any violation of the law, nor shall the assurance be construed as such an admission. Violation of an assurance under this subsection is grounds for disciplinary action; and

(13) To subpoena records of a license holder for the purpose of conducting an investigation.

NEW SECTION. Sec. 8. A person, including but not limited to consumers, licensees, corporations, organizations, health care facilities, and state and local governmental agencies, may submit a written complaint to the disciplining authority charging a license holder with unprofessional conduct and specifying the grounds of the charge. If the disciplining authority determines that the complaint merits investigation, or if the disciplining authority has reason to believe, without a formal complaint, that a license holder may have engaged in unprofessional conduct, the disciplining authority shall conduct an investigation to determine whether there has been unprofessional conduct. A person who files a complaint under this section in good faith is immune from suit in any civil action related to the filing or contents of the complaint.

NEW SECTION. Sec. 9. (1) If the disciplining authority determines, upon investigation, that there is reason to believe a violation of section 17 of this act has occurred, a statement of the charge or charges shall be prepared and served upon the license holder at the earliest practical time. The statement of the charge or charges shall be accompanied by a notice that the license holder may request a hearing to contest the charge or charges. The license holder must file a request for hearing with the disciplining authority within twenty days after being served the statement of charges. The failure to request a hearing constitutes a default, whereupon the disciplining authority may enter a decision on the basis of the facts available to the disciplinary authority.

(2) If a hearing is requested, the time of the hearing shall be fixed by the disciplining authority as soon as convenient, but the hearing shall not be held earlier than thirty days after service of the charges upon the license holder. A notice of hearing shall be issued at least twenty days prior to the hearing, specifying the time, date, and place of the hearing. The notice shall also notify the license holder that a record of the proceeding will be kept, that he or she will have (a) the opportunity to appear personally and to have counsel present, (b) the right to produce witnesses, who will be subject to cross-examination, and (c) the right to produce evidence in his or her own behalf, to cross-examine witnesses testifying against him or her, to examine such documentary evidence as may be produced against him or her, to conduct depositions, and to have subpoenas issued by the disciplining authority.

NEW SECTION. Sec. 10. The procedures governing contested cases before agencies under chapter 34.04 RCW, the administrative procedure act, govern all hearings before the disciplining authority. The disciplining authority has, in addition to the powers and duties set forth in this chapter, all of the powers and duties under chapter 34.04 RCW, which include, without limitation, all powers relating to the administration of oaths, the receipt of evidence, the issuance and enforcing of subpoenas, and the taking of depositions.

NEW SECTION. Sec. 11. (1) In the event of a finding of unprofessional conduct, the disciplining authority shall prepare and serve findings of fact and an order as provided in RCW 34.04.120. If the license holder is found to have not committed unprofessional conduct, the disciplining authority shall forthwith prepare and serve findings of fact and an order of dismissal of the charges, including public exoneration of the licensee. The findings of fact and order shall be retained by the disciplining authority as a permanent record.

(2) The disciplining authority shall report the issuance of statements of charges and final orders in cases processed by the disciplining authority to:

(a) The person or agency who brought to the disciplining authority's attention information which resulted in the initiation of the case;

(b) Appropriate organizations, public or private, which serve the professions;

(c) The public, and notification of the public shall include press releases to appropriate local news media and the major news wire services; and

(d) Counterpart licensing boards in other states, or associations of state licensing boards.

(3) This section shall not be construed to require the reporting of any information which is exempt from public disclosure under chapter 42.17 RCW.

NEW SECTION. Sec. 12. The department shall not issue any license to any laboratory whose license has been denied, revoked, or suspended by the disciplining authority except in conformity with the terms and conditions of the certificate or order of denial, revocation, or suspension, or in conformity with any order of reinstatement issued by the disciplining authority, or in accordance with the final judgment in any proceeding for review instituted under this chapter.

NEW SECTION. Sec. 13. An order entered pursuant to proceedings authorized by this chapter, after due notice and findings in accordance with this chapter and chapter 34.04 RCW, or an order of summary suspension entered under this chapter, shall take effect immediately upon its being served. The order, if appealed to the court, shall not be stayed pending the appeal unless the disciplining authority or court to which the appeal is taken enters an order staying the order of the disciplining authority, which stay shall provide for terms necessary to protect the public.

NEW SECTION. Sec. 14. A laboratory who has been disciplined or whose license has been denied by a disciplining authority may appeal the decision as provided in chapter 34.04 RCW.

NEW SECTION. Sec. 15. A laboratory whose license has been suspended or revoked under this chapter may petition the disciplining authority for reinstatement after an interval as determined by the disciplining authority in the order. The disciplining authority shall hold hearings on the petition and may deny the petition or may order reinstatement and impose terms and conditions as provided in section 16 of this act and issue an order of reinstatement.

NEW SECTION. Sec. 16. (1) Upon a finding that a license holder has committed unprofessional conduct, the disciplining authority may issue an order providing for one or any combination of the following:

(a) Revocation of the license;

(b) Suspension of the license for a fixed or indefinite term;

(d) Compliance with conditions of probation for a designated period of time;

(e) Payment of a fine for each violation of this chapter, not to exceed one thousand dollars per violation;

(f) Denial of the license request;

(g) Corrective action;

(h) Refund of fees billed to and collected from the consumer;

(i) Failure to conform to rules set by the department under this chapter.

(2) Any of the actions under this section may be totally or partly stayed by the disciplining authority. In determining what action is appropriate, the disciplining authority shall first consider what sanctions are necessary to protect or compensate the public. Only after such provisions have been made may the disciplining authority consider and include in the order requirements designed to rehabilitate the license holder. All costs associated with compliance with orders issued under this section are the obligation of the license holder.

NEW SECTION. Sec. 17. The following conduct, acts, or conditions constitute unprofessional conduct for any license holder under the jurisdiction of this chapter:

(1) Misrepresentation or concealment of a material fact in obtaining a license or in reinstatement thereof;

(2) All advertising which is false, fraudulent, or misleading;

(3) Incompetence, negligence, or use of any prenatal test procedure which results in injury to a patient or creates an unreasonable risk that a patient may be harmed;

(4) Failure to cooperate with the disciplining authority by:

(a) Not furnishing any papers or documents;

(b) Not furnishing in writing a full and complete explanation covering the matter contained in the complaint filed with the disciplining authority; or

(c) Not responding to subpoenas issued by the disciplining authority, whether or not the recipient of the subpoena is the accused in the proceeding;

(5) Failure to comply with an order issued by the disciplining authority or an assurance of discontinuance entered into with the disciplining authority;

(6) Violations of rules established by any health agency;

(7) Misrepresentation or fraud in any aspect of the conduct of the business;

(8) Failure to adequately supervise staff to the extent that the consumer's health or safety is at risk;

(9) Failure to conform to rules promulgated by the department and set forth in accordance with this chapter.

NEW SECTION. Sec. 18. A laboratory that attempts to obtain a license by wilful misrepresentation or fraudulent representation is guilty of a misdemeanor.

NEW SECTION. Sec. 19. If the disciplining authority determines or has cause to believe that a license holder has committed a crime, the disciplining authority, immediately subsequent to issuing findings of fact and a final order, shall notify the attorney general or the county prosecuting attorney in the county in which the act took place of the facts known to the disciplining authority.

NEW SECTION. Sec. 20. The secretary, members of the boards, or individuals acting on their behalf are immune from suit in any action, civil or criminal, based on any disciplinary proceedings or other official acts performed in the course of their duties.

NEW SECTION. Sec. 21. If an individual or business regulated by this chapter violates section 17 of this act, the attorney general, any prosecuting attorney, the director, the board, or any other person may maintain an action in the name of the state of Washington to enjoin the person from committing the violations. The injunction shall not relieve the offender from criminal prosecution, but the remedy by injunction shall be in addition to the liability of the offender to criminal prosecution and disciplinary action.

NEW SECTION. Sec. 22. A new section is added to chapter 70.54 RCW to read as follows:

All persons licensed or certified by the state of Washington to provide prenatal care or to practice medicine shall provide information regarding the use and availability of prenatal tests to all pregnant women in their care within the time limits prescribed by department rules and in accordance with standards established by those rules.

NEW SECTION. Sec. 23. Section 22 of this act shall take effect December 31, 1988.

NEW SECTION. Sec. 24. A new section is added to chapter 48.21 RCW to read as follows:

On and after January 1, 1989, every group disability contract that covers hospital, medical, or surgical expenses on a group basis, and which offers maternity coverage to such groups, shall also offer coverage for prenatal diagnosis of congenital disorders of the fetus by means of screening and diagnostic procedures during pregnancy. Every group disability contract shall communicate the availability of such coverage to all group disability contract holders and to all groups with whom they are negotiating.

NEW SECTION. Sec. 25. A new section is added to chapter 48.44 RCW to read as follows:

On and after January 1, 1989, every health care services contract that covers hospital, medical, or surgical expenses on a group basis, and which offers maternity coverage to such groups, shall also offer coverage for prenatal diagnosis of congenital disorders of the fetus by means of screening and diagnostic procedures during pregnancy. Every health care services contract shall communicate the availability of such coverage to all health care service contract holders and to all groups with whom they are negotiating.

NEW SECTION. Sec. 26. A new section is added to chapter 48.46 RCW to read as follows:

On and after January 1, 1989, every health maintenance agreement that covers hospital, medical, or surgical expenses and which offers maternity coverage to groups, shall also offer coverage for prenatal diagnosis of congenital disorders of the fetus by means of screening and diagnostic procedures during pregnancy. Every health maintenance agreement shall communicate the availability of such coverage to all groups with whom they are negotiating.

NEW SECTION. Sec. 27. The sum of forty thousand dollars or so much thereof as may be necessary is appropriated for the 1987-89 biennium from the general fund to the department of social and health services to begin implementation of sections 1 through 21 of this act.

NEW SECTION. Sec. 28. Sections 1 through 21 of this act shall constitute a new chapter in Title 70 RCW.

NEW SECTION. Sec. 29. Sections 1 through 21 of this act are necessary for the immediate preservation of the public peace, health, and safety, the support of the state government and its existing public institutions, and shall take effect June 30, 1987.