(a) Section §  3-1210.01 shall not apply to a cytotechnologist, histotechnologist, medical laboratory technologist, medical technologist, histologic technician, or phlebotomist who is:

(1) Licensed or registered in the District of Columbia under any other act and who engages in the practice for which he or she is licensed or registered;

(2) Employed by the United States government or any bureau, division, or agency thereof while in the discharge of the employee’s official duties;

(3) Engaged exclusively in education or research; provided, that the results of any examination performed are not used in the diagnosis, prevention, or treatment of a disease, or assessment of a medical condition;

(4) A student or trainee enrolled in a medical laboratory education program; provided, that the activities constitute a part of a planned course in the program, the person is designated by a title such as intern, trainee, or student, and the person works directly under a person licensed under § 3-1207.61;

(5) Exclusively performing laboratory tests, classified as waived pursuant to 42 CFR § 493, which are determined by the Secretary of the U.S. Department of Health and Human Services to have an insignificant risk of an erroneous result, including those which:

(A) Have been approved by the United Stated Food and Drug Administration;

(B) Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or

(C) The Secretary of the U.S. Department of Health and Human Services has determined pose no reasonable risk of harm to the patient if performed incorrectly;

(6) A pathologist or other licensed physician;

(7) A laboratory manager who does not perform or supervise laboratory tests; or

(8) Performing point-of-care testing; provided, that:

(A) A laboratory director, or other licensed individual to whom the laboratory director has delegated his or her duties as a laboratory director, provides oversight and is responsible for ensuring the development and implementation of:

(i) A protocol of implementation, including tests to be performed and staff who will perform the tests;

(ii) Criteria to be used in selecting the method of testing to be used for point-of-care testing;

(iii) Minimum training and education requirements for those who will perform point-of-care testing;

(iv) Documented in-service training, initial and ongoing competency validation of personnel performing point-of-care testing;

(v) An appropriate internal and external quality control protocol; and

(vi) Record keeping requirements; and

(B) Processes are in place and are acceptable to the Board that ensure and document the continued competency of point-of-care testing personnel.

(b) For the purposes of this section, the term

(1) “Laboratory director” means:

(A) A physician or dentist who is qualified and eligible to supervise and direct the technical and scientific operation of a medical laboratory by possessing the following:

(i) Certification in anatomic or clinical pathology, or both, by the American Board of Pathology, the American Osteopathic Board of Pathology, or qualifications that are equivalent to those required for certification;

(ii) Certification by the American Board of Pathology or the American Osteopathic Board of Pathology in at least one of the laboratory specialties;

(iii) Certification by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysts, or another national accrediting board in at least one of the laboratory specialties;

(iv) Certification by the American Society of Cytopathology to practice cytopathology or qualifications that are equivalent to those required for certification;

(v) Subsequent to graduation, 4 or more years of full-time general laboratory training or experience, of which at least 2 years were spent acquiring proficiency in one of the laboratory specialties in a licensed medical laboratory; or

(vi) Subsequent to graduation, other documented clinical laboratory training and experience as the Board determines by regulation is appropriate, taking into consideration the complexity and diversity of the laboratory tests to be performed; or

(B) A dentist, certified by the American Board of Oral Pathology for the specialty of oral pathology only, or qualifications which are equivalent to those required for certification.

(2) “Point-of-care testing” means analytical patient-testing activities that are performed under the supervision of the laboratory director within an institution, but are performed outside the physical facilities of the central medical laboratory and do not require permanent dedicated space, and include the use of analytical instruments that are temporarily brought to a patient care location.

(March 25, 1986, D.C. Law 6-99, § 763; as added May 2, 2015, D.C. Law 20-272, § 2(f), 62 DCR 1911.)