28 chapters · 499 sections in this title.
D.C. Code § 44-201 Definitions
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For the purposes of this chapter, the term: (1) Repealed. (2) “Board” means the Laboratory Advisory Board established by § 44-206. (3) “Clinical laboratory” means a facility for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysica…
D.C. Code § 44-202 License requirements for clinical laboratories
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(a) Except as provided in subsection (b) of this section, it shall be unlawful to operate a clinical laboratory in the District of Columbia, whether public or private, for profit or not-for-profit, unless licensed by the Mayor. (a-1) Except as provided in subsection (c) of this s…
D.C. Code § 44-203 Laboratory director
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(a) A clinical laboratory shall be under the direct and personal supervision of a laboratory director. (b) To qualify as a laboratory director, a person shall meet the applicable qualifications as specified in rules issued pursuant to § 44-213 and shall: (1) Hold a doctor of scie…
D.C. Code § 44-204 Qualifications of technical personnel
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(a) A clinical laboratory performing only waived tests shall employ testing personnel who meet the qualifications set out in rules issued pursuant to § 44-213. (b)(1) A clinical laboratory performing moderately complex tests shall employ a laboratory director, a technical consult…
D.C. Code § 44-205 License requirements for physician office laboratories
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Repealed Repealed.
D.C. Code § 44-206 Mayor’s authority to establish Laboratory Advisory Board
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(a) The Mayor shall appoint a Laboratory Advisory Board, which will advise the Mayor on: (1) Classifying laboratory tests as waived, moderately complex, or highly complex for the purposes of this chapter; (2) Developing additional requirements or limitations for clinical laborato…
D.C. Code § 44-207 Inspections
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(a) The Mayor shall conduct inspections of clinical laboratories licensed to perform moderately complex and highly complex tests, including inspections of their methods, procedures, materials, staff, and equipment and may conduct inspections of clinical laboratories licensed to p…
D.C. Code § 44-208 Quality assurance
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(a) The Mayor shall operate a laboratory reference system and shall prescribe standards for the examination of specimens. (b) The Mayor shall adopt rules pursuant to § 44-213 that: (1) Prohibit payment to laboratory personnel based upon the number of tests performed; and (2) Limi…
D.C. Code § 44-209 Proficiency testing programs
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(a) Each clinical laboratory shall participate in a proficiency testing program approved by the Mayor. (b) A proficiency testing program shall include at least 3 proficiency testing events per year, performed at approximately equal intervals. Each testing event shall include at l…
D.C. Code § 44-210 Cytology screening
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The Mayor shall adopt rules pursuant to § 44-213 that: (1) Limit the number of slides a cytotechnologist may examine to no more than 100 in a 24-hour period, irrespective of the site or clinical laboratory; (2) Prohibit cytotechnologists from examining slides at any building not …
D.C. Code § 44-211 Confidentiality of test results
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(a) A patient may request, in writing, access to or copies of the results of the patient’s own laboratory tests. (b)(1) All requests for clinical laboratory services, the results of all clinical laboratory tests, and the contents of patient specimens shall be confidential. (2) Pe…
D.C. Code § 44-212 Penalties and enforcement
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(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 engag…
D.C. Code § 44-213 Rules
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(a) The Mayor shall, pursuant to subchapter I of Chapter 5 of Title 2, issue proposed rules, including a schedule of civil fines, to implement the provisions of this chapter. (b) The Mayor may issue emergency rules, which shall be effective no more than 90 days and which shall be…