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Title XII PUBLIC HEALTH AND WELFARE

Chapter 192

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  192.766.  Machine not registered shall not be used for mammography — department to authorize machines, when — nonrenewable temporary authorizations — application form, information required — annual inspections — withdrawal of authorization, emergency order authorized — administrative penalty — injunctive relief. — 1.  Beginning sixty days after August 28, 1992, a person shall not use a radiation machine to perform mammography unless the radiation machine is registered with the department of health and senior services under department rules for registration of radiation machines and is specifically authorized under this section for use for mammography.

  2.  The department of health and senior services shall authorize a radiation machine for use for mammography if the radiation machine meets all of the following standards:

  (1)  The radiation machine meets the criteria for the American College of Radiology mammography accreditation program as adopted in June 1987, and amended in September 1988, and published by the American College of Radiology, which criteria are incorporated by reference.  The department of health and senior services shall make copies of those criteria available to the public and may by rule adopt modified criteria.  The department may accept an accreditation certificate issued by the American College of Radiology as evidence that a radiation machine meets those criteria.  If at any time the department determines that it will not accept any accreditation certificates issued by the American College of Radiology as evidence that a radiation machine meets those criteria, the department shall promptly notify each person who has registered a radiation machine under sections 192.760 to 192.766* and the rules promulgated under sections 192.760 to 192.766*;

  (2)  The radiation machine, the film or other image receptor used in the radiation machine, and the facility where the radiation machine is used meet the requirements set forth in department of health and senior services rules for radiation machines;

  (3)  The radiation machine is specifically designed to perform mammography;

  (4)  The radiation machine is used exclusively to perform mammography;

  (5)  The radiation machine is used in a facility that does all of the following:

  (a)  At least annually has a radiation physicist provide on-site consultation to the facility, including, but not limited to, a complete evaluation of the entire mammography system to ensure compliance with sections 192.760 to 192.766* and the rules promulgated under sections 192.760 to 192.766*;

  (b)  Maintains for at least sixty months, records of the consultation required in paragraph (a) and the findings of the consultation;

  (6)  The radiation machine is used according to department of health and senior services rules on patient radiation exposure and radiation dose levels;

  (7)  The radiation machine is operated only by an individual who can demonstrate to the department that he is specifically trained in mammography.  Beginning sixty days after the rules required under subsection 3 of section 192.762** are promulgated, the radiation machine is operated only by an individual who can demonstrate to the department that he meets the standards required by those rules.  If the department promulgates emergency rules covering the subject matter described in subsection 3 of section 192.762**, then for a period beginning sixty days after those emergency rules are promulgated and ending on the day that those emergency rules cease to be in effect, the radiation machine is operated only by an individual who can demonstrate to the department that he meets the standards required by those emergency rules.

  3.  The department may issue a nonrenewable temporary authorization for a radiation machine for use for mammography if additional time is needed to allow submission of evidence satisfactory to the department that the radiation machine meets the standards set forth in subsection 2 of this section for approval for mammography.  A temporary authorization granted under this subsection during the first eighteen months after August 28, 1992, shall be effective for no more than twelve months.  A temporary authorization granted under this subsection after eighteen months after August 28, 1992, shall be effective for no more than six months.  The department may withdraw a temporary authorization prior to its expiration if the radiation machine does not meet one or more of the standards set forth in subsection 2 of this section.

  4.  To obtain authorization from the department of health and senior services to use a radiation machine for mammography, the person who owns or leases the radiation machine, or an authorized agent of the person, shall apply to the department for mammography authorization on an application form provided by the department and shall provide all of the information required by the department as specified on the application form.  A person who owns or leases more than one radiation machine used for mammography shall obtain authorization for each radiation machine.  The department shall process and respond to an application within thirty days after the date of receipt of the application.  Upon determining to grant mammography authorization for a radiation machine, the department shall issue a certificate of registration specifying mammography authorization for each authorized radiation machine.  A mammography authorization is effective for three years.

  5.  The department shall annually inspect the radiation machine and may inspect the radiation machine more frequently.  The department shall make reasonable efforts to coordinate the inspections under this section with the department's other inspections of the facility in which the radiation machine is located.

  6.  After each satisfactory inspection by the department, the department shall issue a certificate of radiation machine inspection or a similar document identifying the facility and radiation machine inspected and providing a record of the date the radiation machine was inspected.  The facility shall post the certificate issued by the American College of Radiology or the department of health and senior services near the inspected radiation machine.

  7.  The department may withdraw the mammography authorization for a radiation machine if it does not meet one or more of the standards set forth in subsection 2 of this section.

  8.  The department shall provide an opportunity for a hearing in connection with a denial or withdrawal of mammography authorization.

  9.  Upon a finding that a deficiency in a radiation machine used for mammography or a violation of sections 192.760 to 192.766* or the rules promulgated under sections 192.760 to 192.766* seriously affects the health, safety, and welfare of individuals upon whom the radiation machine is used for mammography, the department may issue an emergency order summarily withdrawing the mammography authorization of the radiation machine.  The department shall incorporate its findings in the order and shall provide an opportunity for a hearing within five working days after issuance of the order.  The order shall be effective during the proceedings.

  10.  If the department withdraws the mammography authorization of a radiation machine, the radiation machine shall not be used for mammography.  An application for reinstatement of a mammography authorization shall be filed and processed in the same manner as an application for mammography authorization under subsection 4 of this section, except that the department shall not issue a reinstated certificate of mammography registration until the department receives the reinspection fee required under subsection 2 of section 192.764***, inspects the radiation machine, and determines that it meets the standards set forth in subsection 2 of this section.  The department shall conduct an inspection required under this subsection no later than sixty days after receiving a proper application for reinstatement of a mammography authorization.

  11.  In addition to the reinspection fee required under subsection 2 of section 192.764***, if a person violates subsection 1 of this section, the department of health and senior services may impose an administrative penalty against the owner of the radiation machine or, if a lessee of the radiation machine has effective control of the radiation machine, the lessee, of not more than five hundred dollars for each calendar week in which a mammography is performed in violation of subsection 1 of this section.  If a person continues to violate subsection 1 of this section for a period of two weeks after a fine is imposed under this subsection, the department shall post a conspicuous notice on the unauthorized radiation machine and at the entry to the facility where the radiation machine is located warning the public that the facility is performing mammography using a radiation machine that is not in compliance with state regulations and may pose a potential hazard to the public health.

  12.  The attorney general, on request of the department of health and senior services, shall bring an action for injunctive relief to prevent the violation of the provisions of sections 192.760 to 192.766* or rules or regulations promulgated under sections 192.760 to 192.766*.

  13.  Rules and regulations promulgated by the department of health and senior services pursuant to sections 192.760 to 192.766* shall be fairly consistent with rules promulgated by the Health Care Financing Administration for the Medicare Program:  Medicare Coverage of Screening Mammography to implement mammography screening requirements contained in the Omnibus Reconciliation Act of 1990.

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(L. 1992 S.B. 721 § 8)

*Words "sections 3 to 6" (renumbered 208.175, 208.176, 192.760, 192.762) appear in original rolls, but sections 5 to 8 (renumbered 192.760 to 192.766) seem to be germane, a manifest clerical error.

**Words "section 4" (renumbered 208.176) appear in original rolls, but section 6 (renumbered 192.762) seems to be germane, a manifest clerical error.

***Words "section 5" (renumbered 192.760) appear in original rolls, but section 7 (renumbered 192.764) seems to be germane, a manifest clerical error.


---- end of effective   28 Aug 1992 ----

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