(a) A clinical laboratory license may be revoked, suspended, or limited by the Mayor on proof that the laboratory or one or more of its employees:
(1) Has made misrepresentations in obtaining the license or in the operation of the laboratory;
(2) Has engaged or attempted to engage or represented the laboratory as entitled to perform any laboratory procedure not authorized by the license;
(3) Has rendered a laboratory report actually performed in another laboratory without designating the fact that the examination or procedure was performed in another laboratory;
(4) Has failed to submit a plan for corrective action or failed to correct deficiencies as required in § 44-209; or
(5) Has failed to file a report required by the provisions of this chapter or the rules issued pursuant to this chapter.
(b)(1) If the Mayor determines, after investigation, that the conduct of a licensee presents an imminent danger to the health and safety of the residents of the District, the Mayor may summarily suspend or restrict, without a hearing, the license of the laboratory employee.
(2) The Mayor, at the time of the summary suspension or restriction of a license, shall provide the licensee with written notice stating the action that is being taken, the basis for the action, and the right of the licensee to request a hearing.
(3) A licensee shall have the right to request a hearing within 72 hours after service of notice of the summary suspension or restriction of license. The Mayor shall hold a hearing within 72 hours of receipt of a timely request, and shall issue a decision within 72 hours after the hearing.
(4) Every decision and order adverse to a licensee shall be in writing and shall be accompanied by findings of fact and conclusions of law. The findings shall be supported by, and in accordance with, reliable, probative, and substantial evidence. The Mayor shall provide a copy of the decision and order and accompanying findings of fact and conclusions of law to each party to a case or to each party’s attorney of record.
(c)(1) When the Mayor, after investigation, but prior to a hearing, has cause to believe that any clinical laboratory or laboratory employee is violating any provision of this chapter and the violation has caused or may cause immediate and irreparable harm to the public, the Mayor may issue an order requiring the alleged violator to cease and desist immediately from the violation. The order shall be served by certified mail or by personal service.
(2) The alleged violator may, within 15 days of the service of the order, submit a written request to the Mayor to hold a hearing on the alleged violation.
(3) Upon receipt of timely request, the Mayor shall conduct a hearing and render a decision.
(4)(A) The alleged violator may, within 10 days of the service of an order, submit a written request to the Mayor for an expedited hearing on the alleged violation, in which case the alleged violator shall waive his or her right to the 15-day notice.
(B) Upon receipt of a timely request for an expedited hearing, the Mayor shall conduct a hearing, pursuant to subchapter I of Chapter 5 of Title 2, within 10 days of the date of receiving the request and shall deliver to the alleged violator at his or her last known address a written notice of the hearing, at least 5 days before the hearing date.
(5) The Mayor shall issue a decision within 30 days after an expedited hearing. If a request for a hearing is not made, the order of the Mayor to cease and desist is final. If, after a hearing, the Mayor determines the alleged violator is not in violation of this chapter, the Mayor shall revoke the order to cease and desist. If any person fails to comply with a lawful order the Mayor issued pursuant to this section, the Mayor may petition the court to issue an order compelling compliance or take other action authorized by this chapter.
(d) Except as provided in this subsection, no license shall be revoked, suspended, or limited without a hearing pursuant to subchapter I of Chapter 5 of Title 2. If a license is revoked or limited for failure to demonstrate continuing satisfactory performance, reinstatement of the license shall require demonstration of proficiency over a testing period, not to exceed 6 months.
(e) Any laboratory director, laboratory owner, or designated supervisory physician who willfully and knowingly participates in the unlawful operation of a clinical laboratory in the District of Columbia, and any person who intentionally impedes a District of Columbia official or employee in the performance of his or her authorized duties under this chapter or any rules issued pursuant to this chapter, shall be guilty of a misdemeanor and, upon conviction, shall be subject to a fine not exceeding $1,000 per day until the violation ceases, imprisonment for not more than 90 days, or both. Prosecution shall be in the Superior Court of the District of Columbia upon information by the Attorney General for the District of Columbia or one of his or her assistants.
(f) A violation of this chapter shall be a civil infraction for purposes of the Department of Consumer and Regulatory Affairs Civil Infractions Act of 1985. Civil fines, penalties, and fees may be imposed as sanctions for any infraction of the provisions of this chapter, or the rules issued under authority of this chapter, pursuant to Chapter 18 of Title 2. Adjudication of any infractions shall be pursuant to Chapter 18 of Title 2.
(g) Notwithstanding the availability of any other remedy, the Attorney General for the District of Columbia or one of his or her assistants may maintain, in the name of the District of Columbia, an action in the Superior Court of the District of Columbia to enjoin any person, agency, corporation, or other entity from operating a clinical laboratory in violation of the terms of its license, the provisions of this chapter, or any rules issued pursuant to this chapter.
(Mar. 16, 1989, D.C. Law 7-182, § 13, 35 DCR 7718; Apr. 13, 2005, D.C. Law 15-354, § 63, 52 DCR 2638; Oct. 20, 2005, D.C. Law 16-33, § 5012(k), 52 DCR 7503; Mar. 2, 2007, D.C. Law 16-191, § 5(s)(2), 53 DCR 6794.)
1981 Ed., § 32-1512.
This section is referenced in § 44-209.
Effect of Amendments
D.C. Law 15-354 substituted “Attorney General for the District of Columbia” for “Corporation Counsel”.
D.C. Law 16-33 deleted “or physician office” following “clinical” throughout the section; in subsec. (c)(1), substituted “any clinical laboratory” for “any laboratory”.
D.C. Law 16-191, in subsec. (c)(1), validated a previously made technical correction.
For temporary (90 day) amendment of section, see § 5012(k) of Fiscal Year 2006 Budget Support Emergency Act of 2005 (D.C. Act 16-168, July 26, 2005, 52 DCR 7667).
References in Text
The “Department of Consumer and Regulatory Affairs Civil Infractions Act of 1985”, referred to in subsection (f), is D.C. Law 6-42.