North Carolina Administrative Code › Title 10A - HEALTH AND HUMAN SERVICES › Chapter 13 - NC MEDICAL CARE COMMISSION › Subchapter M - MAMMOGRAM AND PAP SMEAR CERTIFICATION › Section .0200 - MAMMOGRAPHY CERTIFICATION › Section 13M .0201 - STATE CERTIFICATION OF SCREENING MAMMOGRAPHY SERVICES

Current through Register Vol. 39, No. 2, July 15, 2024
(a)
				  All facilities performing screening mammograms shall be state certified by the
				  Division of Health Service Regulation, Department of Health and Human Services
				  in accordance with this Rule.
(b)
				  To be state certified, all equipment used in the performance of screening
				  mammography shall be dedicated to such use by manufacturer's design. Each piece
				  of mammography X-ray equipment, whether located in a fixed or mobile facility,
				  shall be maintained in a safe operating condition and shall be registered and
				  used in accordance with the Rules in
				  15A NCAC
				  11.
(c) To be state certified, all facilities
				  shall be certified by the Centers for Medicare and Medicaid Services or shall
				  be accredited by the American College of Radiology for the performance of
				  mammography screening.
(d) An
				  application for state certification shall be submitted to the Division of
				  Health Service Regulation listing the name and location of the facility
				  requesting certification, the name of the owner, and evidence that the facility
				  meets the requirements listed in Paragraphs (b) and (c) of this Rule.
				  Facilities shall be notified in writing within 45 days of the receipt of the
				  application that they have been certified or, if certification has been denied,
				  of the reasons for denial.
(e)
				  State certification must be renewed by a facility when certification or
				  accreditation renewal is required by the program that established state
				  certification eligibility pursuant to Paragraph (c) of this Rule.
(f) If a facility's certification or
				  accreditation for one of these programs is suspended or revoked, the facility
				  operator shall immediately notify the Division of Health Service Regulation and
				  the facility's state certification under this Rule shall be revoked. The
				  facility may apply for recertification when it can provide evidence that it
				  meets the requirements listed in Paragraphs (a) - (e) of this Rule.
(g) The North Carolina Medical Care
				  Commission delegates the authority to grant waivers of this Rule to the
				  Division of Health Service Regulation. The Commission, however, shall review
				  all waivers granted at its next regularly scheduled meeting and shall make any
				  revisions to waivers deemed necessary at that time.
(h) In order to be granted a waiver of this
				  Rule, a facility shall make a request for a waiver in writing to the Division
				  of Health Service Regulation providing the following:
(1) justification that the rule should not be
				  applied as written, because strict application would cause undue
				  hardship;
(2) justification that
				  adequate standards assuring early detection of breast cancer and affording
				  protection of health and safety exist and will be met in lieu of the exact
				  requirements;
(3) justification
				  that the purpose of this Rule is met through equivalent standards affording
				  equivalent protection of health and safety;
(4) information on the number of screening
				  mammograms performed monthly for the previous six months;
(5) information proving that there is no
				  state certified facility nearby by identifying the nearest state certified
				  facility and providing information regarding the accessibility of mobile units
				  in the area; and
(6) a plan for
				  meeting standards necessary for certification, including the time required to
				  meet standards.