Source: https://development.code.dccouncil.us/dc/council/code/titles/44/chapters/2/
Timestamp: 2019-04-23 16:28:41+00:00

Document:
D.C. Law Library - Chapter 2. Clinical Laboratories.
↪ Chapter 2. Clinical Laboratories.
§ 44–202. License requirements for clinical laboratories.
§ 44–204. Qualifications of technical personnel.
§ 44–206. Mayor’s authority to establish Laboratory Advisory Board.
§ 44–209. Proficiency testing programs.
§ 44–211. Confidentiality of test results.
§ 44–212. Penalties and enforcement.
(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, biophysical, cytological, pathological or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. Such examination also includes one or more procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the human body. The term “clinical laboratory” shall include all independent, hospital, physician-operated, health-care, and District of Columbia government laboratories.
(5) “Cytotechnologist” means a person who meets qualifications for a cytotechnologist under 42 CFR § 493.1483.
(7) “Laboratory director” means the person responsible for administration of the technical and scientific operation of a clinical laboratory, including supervision of procedures and reporting findings of tests.
(8) “Laboratory reference system” means a system of periodic testing of methods, procedures, and materials of laboratories, including the distribution of manuals of approved methods, inspection of facilities, and cooperative research.
(8A) “Moderately complex test” means a laboratory test that requires a series of steps, reagents, additions, or instrumentation, the result of which is determined by a visual signal.
(10) “Proficiency testing program” means an external program approved by the Mayor to monitor proficiency in the performance of medical laboratory tests.
(12) “Specimen” means materials derived from the human body.
(13) “Testing event” means a specific evaluation or set of evaluations offered or performed by a laboratory to test accuracy as part of required proficiency testing.
(14) “Testing personnel” means an individual employed or otherwise engaged by a clinical laboratory to perform clinical laboratory tests or examinations.
(15) “Waived test” means a test that is non-instrumental in nature, the result of which is determined by a visual signal.
D.C. Law 16-33, repealed pars. (1), (4), (6), (9) and (11); added pars. (6A), (8A), (13), (14) and (15); and rewrote pars. (3), (5) and (7).
For temporary (90 day) amendment of section, see § 5012(a) of Fiscal Year 2006 Budget Support Emergency Act of 2005 (D.C. Act 16-168, July 26, 2005, 52 DCR 7667).
Short title of subtitle B of title V of Law 16-33: Section 5011 of D.C. Law 16-33 provided that subtitle B of title V of the act may be cited as the Clinical Laboratory Amendment Act of 2005.
The reference to “ 42 C.F.R. § 405.1315(c) (1987)”, appearing in (5), does not appear in the 1990 edition of CFR.
(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.
(2) Performing or offering to perform clinical laboratory tests or examinations on specimens acquired in the District of Columbia, regardless of the location of the clinical laboratory at which the tests or examinations are performed.
(c) Clinical laboratories that, prior to March 16, 1989, were not or would not have been subject to licensure in the District of Columbia may operate without a license until one year after the issuance of rules pursuant to § 44-213.
(d) An application for a clinical laboratory license shall be made by the owner of the clinical laboratory on forms provided by the Mayor. The application shall contain the name of the owner, the name of the laboratory director, the categories of laboratory tests for which the clinical laboratory license is sought, an approved proficiency testing program in which the clinical laboratory plans to participate, the location and physical description of the facility at which tests are to be performed, and other information as the Mayor may require.
(e) A license shall be valid only for the premises stated on the application.
(f) A license shall automatically become void 30 days following a change in the laboratory director, or 30 days following a change in ownership or location of the clinical laboratory. A new application for a license may be made prior to a change in the laboratory director, ownership, or location of the clinical laboratory, or prior to the expiration of the 30-day period, in order to permit the uninterrupted operation of the clinical laboratory.
(g) Unless already terminated or renewed, a clinical laboratory license shall expire 2 years from the date of initial issuance or the date of last renewal. An application for a license shall be accompanied by a license fee determined by the Mayor that is commensurate to the cost of inspection.
(h) A clinical laboratory license shall specify on its face the names of the owner and the director of the laboratory, the categories of laboratory tests authorized, and the location at which the tests may be performed. Each clinical laboratory licensed under this chapter shall post its license in a conspicuous place on the premises, and have its license readily available for inspection by the public.
(4) The clinical laboratory is operated in the manner required by this chapter and rules issued pursuant to this chapter.
(j) Any license issued pursuant to this section shall be issued as a Public Health: Laboratory endorsement to a basic business license under the basic business license system as set forth in subchapter I-A of Chapter 28 of Title 47.
D.C. Law 15-38, in subsec. (j), substituted “Public Health: Laboratory endorsement to a basic business license under the basic” for “Class A Public Health: Laboratory endorsement to a master business license under the master”.
D.C. Law 16-33 deleted the last sentence in subsec. (a); added subsec. (a-1); repealed subsec. (b)(4); in subsec. (c), substituted “one year” for “6 months”; in subsec. (g), substituted “2 years” for “one year”.
For temporary (90 day) amendment of section, see § 3(dd)(1) of Streamlining Regulation Emergency Act of 2003 (D.C. Act 15-145, August 11, 2003, 50 DCR 6896).
For temporary (90 day) amendment of section, see § 5012(b) of Fiscal Year 2006 Budget Support Emergency Act of 2005 (D.C. Act 16-168, July 26, 2005, 52 DCR 7667).
Delegation of authority pursuant to D.C. Law 7-182, see Mayor’s Order 89-211, September 15, 1989.
(a) A clinical laboratory shall be under the direct and personal supervision of a laboratory director.
(B) Be certified by the American Board of Pathologists, the American Board of Osteopathic Pathology, the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or other accrediting board acceptable to the Mayor in one of the laboratory specialties.
(c) The laboratory director shall be responsible for the proper performance of all tests in a clinical laboratory. The laboratory director shall direct and supervise the testing of specimens and be responsible for the continuous application of quality control procedures to the clinical laboratory work in accordance with the rules issued pursuant to this chapter. The laboratory director shall be responsible for the work of subordinates. Clinical laboratory records of all work performed shall indicate the name of the laboratory director and be signed by or otherwise indicate the person who actually performed the test.
(d) The laboratory director shall be accessible to the laboratory to provide onsite, telephone, or electronic consultation, as needed. If the laboratory director cannot be accessible on a short-term basis for a period of time to be determined by the Mayor, the laboratory director shall designate, in writing, a substitute laboratory director who is qualified to be director in accordance with rules issued pursuant to § 44-213.
(e) No person may serve as a director of more than 5 clinical laboratories.
D.C. Law 16-191 validated a previously made technical correction in (b).
For temporary (90 day) amendment of section, see § 5012(c) of Fiscal Year 2006 Budget Support Emergency Act of 2005 (D.C. Act 16-168, July 26, 2005, 52 DCR 7667).
(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 consultant, a clinical consultant, and testing personnel. A person may function in more than one of these capacities if he or she meets the qualifications specified in this chapter and in rules issued pursuant to § 44-213.
(2) The laboratory director, technical consultant, clinical consultant, and testing personnel shall meet the qualifications as specified in rules issued pursuant to § 44-213.
(c)(1) A clinical laboratory performing highly complex tests shall employ a laboratory director, a general supervisor, a technical supervisor, a clinical consultant, and testing personnel. A person may function in more than one of these capacities if he or she meets the qualifications specified in this chapter and in rules issued pursuant to § 44-213.
(2) The laboratory director, general supervisor, technical supervisor, clinical consultant, and testing personnel shall meet qualifications as specified in rules issued pursuant to § 44-213.
(3) In addition to the requirements set forth in paragraph (1) of this subsection, a clinical laboratory that performs highly complex tests in the subspecialty of cytology shall employ a cytology general supervisor, a cytology technical supervisor, and a cytotechnologist. A person may function in more than one of these capacities if he or she meets the qualifications specified in this chapter and in rules issued pursuant to § 44-213.
D.C. Law 16-33 rewrote the section.
For temporary (90 day) amendment of section, see § 5012(d) of Fiscal Year 2006 Budget Support Emergency Act of 2005 (D.C. Act 16-168, July 26, 2005, 52 DCR 7667).
For temporary (90 day) amendment of section, see § 3(dd)(2) of Streamlining Regulation Emergency Act of 2003 (D.C. Act 15-145, August 11, 2003, 50 DCR 6896).
For temporary (90 day) repeal of section, see § 5012(e) of Fiscal Year 2006 Budget Support Emergency Act of 2005 (D.C. Act 16-168, July 26, 2005, 52 DCR 7667).
(4) Developing rules and procedures for inspections of laboratories.
(b) The Mayor shall appoint the members of the Board within 60 days of March 16, 1989.
(c) The Board shall transmit its written recommendations to the Mayor within 180 days of the date of the appointment of all members and shall then cease to exist.
(d) The Mayor may appoint a temporary board, at the Mayor’s discretion, for whatever periods of the time the Mayor deems necessary because of advancements in technology or other purposes consistent with carrying out the provisions of this chapter.
This section is referenced in § 44-201.
D.C. Law 16-33 rewrote subsecs. (a)(1) and (a)(2).
For temporary (90 day) amendment of section, see § 5012(f) of Fiscal Year 2006 Budget Support Emergency Act of 2005 (D.C. Act 16-168, July 26, 2005, 52 DCR 7667).
(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 perform only waived tests.
(b) To ensure that each clinical laboratory is in compliance with the provisions of this chapter, and the rules issued pursuant to this chapter, the Mayor shall conduct an on-site inspection prior to the laboratory’s initial licensure and before each license renewal. Temporary licenses or renewals may be granted for a period not to exceed 60 days to afford the Mayor sufficient time to conduct the on-site inspection. The Mayor may issue a provisional license for less than one year to a new clinical laboratory, pending satisfactory completion of additional follow-up inspections.
For temporary (90 day) amendment of section, see § 5012(g) of Fiscal Year 2006 Budget Support Emergency Act of 2005 (D.C. Act 16-168, July 26, 2005, 52 DCR 7667).
(a) The Mayor shall operate a laboratory reference system and shall prescribe standards for the examination of specimens.
(2) Limit the number of hours that laboratory personnel may work.
(c) The Mayor shall set standards for proficiency testing programs to determine a satisfactory result, a satisfactory level of overall performance, and a substandard level of overall performance.
(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 least 5 samples. Proficiency testing shall be conducted for each category of tests for which the clinical laboratory has obtained a license. If there is no sample available for evaluation during a testing event for a particular category of laboratory tests, the clinical laboratory must devise a system for self-evaluation of this category of tests. The system for self-evaluation shall be approved by the Mayor and performed at least twice per year.
(2) A determination of a substandard level of overall performance on 1 quarterly proficiency test, followed by completion of an approved course of education in proper laboratory techniques and procedures, and a satisfactory level of overall performance on the next quarterly proficiency test.
(d) Proficiency testing programs shall report the results of each proficiency test to the Mayor. Upon receipt of a determination of a substandard level of overall performance, the Mayor shall, within 30 days, inspect the clinical laboratory at any time during normal operating ours. For the purpose of this section, a substandard level of overall performance shall include intentional nonperformance.
(e) Upon completion of the inspection, the Mayor shall determine if any deficiencies exist. Upon an affirmative determination of any deficiency, the Mayor shall notify the laboratory director or the designated supervisory physician in writing of the deficiencies. The clinical laboratory shall submit a written plan to correct the deficiencies and an appropriate course of remedial education and dates by which the corrections shall be made to the Mayor within 30 days of the receipt of the notice of the deficiencies.
(f) If the clinical laboratory does not submit a plan for corrective action that is approved by the Mayor, or if a clinical laboratory is determined by the Mayor after a subsequent inspection not to have corrected the deficiencies as specified in the plan by the expiration dates in the plan, the Mayor may take action to revoke, suspend, or limit the laboratory license pursuant to § 44-212.
(g) The analyses and reports of a proficiency testing program may be considered by the Mayor in proceedings under § 44-213.
This section is referenced in § 44-202 and § 44-212.
For temporary (90 day) amendment of section, see § 5012(h) of Fiscal Year 2006 Budget Support Emergency Act of 2005 (D.C. Act 16-168, July 26, 2005, 52 DCR 7667).
(7) Require all smear specimen reports to be retained for at least 10 years.
For temporary (90 day) amendment of section, see § 5012(i) of Fiscal Year 2006 Budget Support Emergency Act of 2005 (D.C. Act 16-168, July 26, 2005, 52 DCR 7667).
(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.
(B) The court has issued a subpoena for the results of the patient’s laboratory tests, and except in a law enforcement investigation, the person seeking access has given the patient notice and an opportunity to contest the subpoena.
(c) All clinical laboratory results shall be reported to the requesting physician. When there is no requesting physician, the clinical laboratory shall report the test results to the patient and shall recommend that the patient forward the laboratory results to the patient’s personal physician as soon as possible.
D.C. Law 16-33, in subsec. (b)(1), deleted “or physician office” following “clinical” in two places.
For temporary (90 day) amendment of section, see § 5012(j) of Fiscal Year 2006 Budget Support Emergency Act of 2005 (D.C. Act 16-168, July 26, 2005, 52 DCR 7667).
(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.
This section is referenced in § 44-209.
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”.
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).
The “Department of Consumer and Regulatory Affairs Civil Infractions Act of 1985”, referred to in subsection (f), is D.C. Law 6-42.
(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 consistent with subchapter I of Chapter 5 of Title 2.
This section is referenced in § 44-202, § 44-203, § 44-204, § 44-208, § 44-209, and § 44-210.

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