Code of Maryland Regulations (Last Updated: April 6, 2021) |
Title 10. Maryland Department of Health |
Part 2. |
Subtitle 09. MEDICAL CARE PROGRAMS |
Chapter 10.09.87. Free-Standing Independent Diagnostic Testing Facilities |
Sec. 10.09.87.03. Conditions for Participation
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A. General requirements for participation in the Program are that a provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03.
B. Requirements for participation in the Program as an IDTF provider/mobile IDTF provider require that the provider:
(1) Be approved by Medicare to furnish diagnostic services in an IDTF;
(2) Meets the licensure requirements in accordance with Regulation .02 of this chapter; and
(3) Meets performance standards in accordance with 42 CFR §410.33(g).
C. Specific Requirements for Participation in the Program as a Mobile IDTF Provider.
(1) The mobile IDTF shall have electronic technology that enables the same day exchange of patient records with the treating physicians office.
(2) An IDTF mobile unit shall:
(a) Maintain physicians order & diagnostic test records for each patient;
(b) Observe all patient rights;
(c) Obtain written, informed consent from a parent or legal guardian before providing services to a minor;
(d) Comply with all applicable federal, State, and local laws, regulations, and ordinances regulating:
(i) Equipment;
(ii) Flammability;
(iii) Construction;
(iv) Infection control;
(v) Sanitation procedures; and
(vi) Zoning;
(e) Comply with the statutes and regulations of the Maryland Department of the Environment for all radiographic and imaging equipment;
(f) Obtain all applicable county and city licenses or permits necessary to operate the mobile IDTF;
(g) Provide access to a ramp or a lift if services are provided to disabled individuals;
(h) Have ready access to an adequate supply of potable water, including hot water;
(i) Have immediate access to toilet facilities;
(j) Have an appropriately covered noncorrosive metal container for refuse and waste materials;
(k) Have a carbon monoxide detection device or system installed and in proper working condition;
(l) Have written procedures for medical emergencies; and
(m) Have appropriate equipment to treat medical emergencies.
(3) The owner or owners of a mobile unit shall submit a business plan to the Department for the mobile unit that includes:
(a) The mission of the mobile unit;
(b) Verification of ownership of the mobile unit;
(c) A list of the technical staff that will render services in the mobile unit; and
(d) The targeted population.