Washington · statute · Wash. Rev. Code ch. 70.42 · 27 active provisions
The legislature intends that medical test sites meet criteria known to promote accurate and reliable analysis, thus improving health care through uniform test site licensure and regulation including quality control, quality assurance, and proficiency testing. The legislature also intends to meet the requirements of fed…
Unless the context clearly requires otherwise, the definitions in this section apply throughout this chapter.(1) "Department" means the department of health.(2) "Designated test site supervisor" means the available individual who is responsible for the technical functions of the test site and who meets the department's…
After July 1, 1990, no person may advertise, operate, manage, own, conduct, open, or maintain a test site without first obtaining a license for the tests to be performed, except as provided in RCW 70.42.030.
(1) As a part of the application for licensure, a test site may request a waiver from licensure under this chapter if the test site performs only examinations which are determined to have insignificant risk of an erroneous result, including those which (a) are approved by the federal food and drug administration for ho…
Test sites accredited, certified, or licensed by an organization or agency approved by the department consistent with federal law and regulations shall receive a license under RCW 70.42.110.
A licensee that desires to perform tests for which it is not currently licensed shall notify the department. To the extent allowed by federal law and regulations, upon notification and pending the department's determination, the department shall grant the licensee temporary permission to perform the additional tests. T…
The department shall adopt standards established in rule governing test sites for quality control, quality assurance, recordkeeping, and personnel consistent with federal laws and regulations. "Recordkeeping" for purposes of this chapter means books, files, or records necessary to show compliance with the quality contr…
(1) Except where there is no reasonable proficiency test, each licensed test site must participate in a department-approved proficiency testing program appropriate to the test or tests which it performs. The department may approve proficiency testing programs offered by private or public organizations when the program…
A test site shall have a designated test site supervisor who shall meet the qualifications determined by the department in rule. The designated test site supervisor shall be responsible for the testing functions of the test site.
(1) The department shall establish a schedule of fees for license applications, renewals, amendments, and waivers. In fixing said fees, the department shall set the fees at a sufficient level to defray the cost of administering the licensure program. All such fees shall be fixed by rule adopted in accordance with the p…
An applicant for issuance or renewal of a medical test site license shall:(1) File a written application on a form provided by the department;(2) Demonstrate ability to comply with this chapter and the rules adopted under this chapter;(3) Cooperate with any on-site review which may be conducted by the department prior…
Upon receipt of an application for a license and the license fee, the department shall issue a license if the applicant meets the requirements established under this chapter. All persons operating test sites before July 1, 1990, shall submit applications by July 1, 1990. A license issued under this chapter shall not be…
Under this chapter, and chapter 34.05 RCW, the department may deny a license to any applicant who:(1) Refuses to comply with the requirements of this chapter or the standards or rules adopted under this chapter;(2) Was the holder of a license under this chapter which was revoked for cause and never reissued by the depa…
Under this chapter, and chapter 34.05 RCW, the department may place conditions on a license which limit or cancel a test site's authority to conduct any of the tests or groups of tests of any licensee who:(1) Fails or refuses to comply with the requirements of this chapter, the rules or standards adopted under this cha…
Under this chapter, and chapter 34.05 RCW, the department may suspend the license of any licensee who:(1) Fails or refuses to comply with the requirements of this chapter or the rules adopted under this chapter;(2) Has knowingly or with reason to know made a false statement of a material fact in the application for a l…
Under this chapter, and chapter 34.05 RCW, the department may revoke the license of any licensee who:(1) Fails or refuses to comply with the requirements of this chapter or the rules adopted under this chapter;(2) Has knowingly or with reason to know made a false statement of a material fact in the application for a li…
(1) The department may prohibit a specific category or categories of services within the medical test site as related to noncompliance with the requirements of this chapter or the standards or rules adopted under this chapter by imposing a limited stop service. This may only be done if the department finds that noncomp…
(1) The department may give written notice to cease and desist to any person whom the department has reason to believe is engaged in the unlicensed operation of a medical test site.(2)(a) Except as otherwise provided in this section, the requirement to cease and desist unlicensed operation is effective 20 days after th…
Under this chapter, and chapter 34.05 RCW, the department may assess monetary penalties of up to ten thousand dollars per violation in addition to or in lieu of conditioning, suspending, or revoking a license. A violation occurs when a licensee:(1) Fails or refuses to comply with the requirements of this chapter or the…
If the insurance commissioner reports to the department that he or she has cause to believe that a medical test site has engaged in a pattern of violations of RCW 48.49.020 or 48.49.030 or has violated RCW 48.43.732, and the report is substantiated after investigation, the department may levy a fine upon the medical te…
The department may at any time conduct an on-site review of a licensee or applicant in order to determine compliance with this chapter. When the department has reason to believe a waivered site is conducting tests requiring a license, the department may conduct an on-site review of the waivered site in order to determi…
(1) Notwithstanding the existence or use of any other remedy, the department may, in the manner provided by law and upon the advice of the attorney general, who shall represent the department in the proceedings, maintain an action in the name of the state for an injunction or other process against any person to restrai…
Any test site which has had a denial, condition, suspension, or revocation of its license, or a civil monetary penalty upheld after administrative review under chapter 34.05 RCW, may, within sixty days of the administrative determination, petition the superior court for review of the decision.
No person who has owned or operated a test site that has had its license revoked may own or operate a test site within two years of the final adjudication of a license revocation.
All information received by the department through filed reports, audits, or on-site reviews, as authorized under this chapter shall not be disclosed publicly in any manner that would identify persons who have specimens of material from their bodies at a test site, absent a written release from the person, or a court o…