Effective - 28 Aug 1992
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.
Structure Missouri Revised Statutes
Title XII - Public Health and Welfare
Chapter 192 - Department of Health and Senior Services
Section 192.002 - Department of health and senior services established.
Section 192.006 - Health and senior services, department of, rulemaking authority, procedure.
Section 192.007 - Director, appointment — compensation — qualifications.
Section 192.014 - State board of health and senior services to advise department.
Section 192.015 - Fees for laboratory tests authorized — deposit in general revenue.
Section 192.016 - Putative father registry — fund created.
Section 192.025 - To accept and disburse federal funds for health purposes.
Section 192.031 - Hepatitis C programs established by department of health and senior services.
Section 192.033 - Strategies for raising public awareness on hepatitis C.
Section 192.040 - Department to issue reports — subjects.
Section 192.050 - Department to maintain certain bureaus — establishment of others.
Section 192.060 - Department to keep vital statistics.
Section 192.072 - Bureau of immunization to develop educational materials — contents, distribution.
Section 192.080 - Bureau of food and drug inspection.
Section 192.083 - Office of minority health, established — purpose, duties.
Section 192.090 - Inspection of hotels, inns and boardinghouses.
Section 192.100 - Inspection of beverages.
Section 192.110 - Department's duty as to diseases of animals.
Section 192.139 - Communicable disease reporting, guidelines for department.
Section 192.140 - Public health nurse provided — public and private places disinfected.
Section 192.150 - Interference a misdemeanor — duty of mayor and county commission.
Section 192.160 - Taxpayers may petition for the appointment of a nurse.
Section 192.170 - Money appropriated from current revenue.
Section 192.250 - Department to receive grants.
Section 192.260 - County health officer appointed by county commission.
Section 192.280 - Duties of county health officer — neglect, penalty — removal.
Section 192.290 - State regulations supersede local rules — additional local rules.
Section 192.310 - Cities of 75,000 or over excepted from sections 192.260 to 192.320.
Section 192.320 - Violation of law or quarantine — penalty.
Section 192.324 - Administrative and cost allocation fund created, use of moneys.
Section 192.326 - Disaster fund created, use of moneys during a state of emergency.
Section 192.390 - Cost of certain formulas to be provided — rulemaking authority.
Section 192.400 - Definitions.
Section 192.410 - Powers and duties of department.
Section 192.420 - Department to make rules — procedure.
Section 192.430 - Radiation sources to be kept safe.
Section 192.460 - Emergency orders — compliance required — hearing.
Section 192.470 - Judicial review.
Section 192.480 - Law not to limit medical use of radiation.
Section 192.490 - Violation of law or regulation, misdemeanor — injunctive relief.
Section 192.507 - Radiological laboratory to be established, purpose.
Section 192.650 - Cancer information reporting system established — purpose — rulemaking authority.
Section 192.653 - Reports required from certain health care providers, content — exemptions.
Section 192.665 - Definitions.
Section 192.700 - Arthritis program established — purpose.
Section 192.703 - Definitions.
Section 192.705 - Program coordinators, appointment, duties — compensation.
Section 192.712 - Expenses of board and committee members to be paid, subject to appropriations.
Section 192.714 - Regional arthritis centers to be established — purpose — regions designated.
Section 192.716 - Centers to establish programs for education and improved patient care.
Section 192.720 - Support for rheumatology trainees — amount — approval of candidates.
Section 192.723 - Research feasibility studies to be carried out by regional centers.
Section 192.725 - Arthritis information network to be established — staff.
Section 192.735 - Definitions.
Section 192.737 - Data analysis and needs assessment.
Section 192.739 - Confidentiality of reports — release of reports, requirements.
Section 192.740 - No liability for furnishing required information, exception.
Section 192.742 - Promulgation of rules, authority for, consultation with council.
Section 192.760 - Definitions.
Section 192.769 - Notice to patients upon completion of a mammogram — effective date.
Section 192.900 - Missouri public health services fund, established, purposes.
Section 192.947 - Hemp extract, use of, immunity from liability, when.
Section 192.965 - Office on women's health created, duties.
Section 192.968 - Committee to advise the office on women's health created, duties.
Section 192.2005 - Definitions.
Section 192.2010 - Shared care program established, goals — department duties.
Section 192.2100 - Alzheimer's disease and related disorders respite care program — definitions.
Section 192.2105 - Respite care program for Alzheimer's purposes.
Section 192.2110 - Rules and regulations for respite care program, procedure.
Section 192.2150 - Department to use services of certain organizations, when.
Section 192.2200 - Definitions.
Section 192.2215 - Revocation of license, when — notification of operator.
Section 192.2220 - Exceptions to licensure requirements for adult day care centers.
Section 192.2230 - Fee for license or renewal, limitation.
Section 192.2235 - Adult daycare program manual — regional training sessions.
Section 192.2245 - License denied — suspended — revoked — hearing procedure — appeals.
Section 192.2250 - Rulemaking authority.
Section 192.2255 - Rules, authority, procedure.
Section 192.2260 - Violations, penalties.
Section 192.2275 - Cost-based uniform rate for services, budget line item.
Section 192.2300 - Definitions.
Section 192.2400 - Definitions.
Section 192.2405 - Mandatory reporters--penalty for failure to report.
Section 192.2410 - Reports, contents — department to maintain telephone for reporting.
Section 192.2415 - Investigations of reports of eligible adults, department procedures.
Section 192.2425 - Investigation of elder abuse — report.
Section 192.2430 - Duty to report, immunity.
Section 192.2440 - Assistance to be given.
Section 192.2445 - Procedure when abuse, neglect, or physical harm may be involved — remedies.
Section 192.2450 - Interference with delivery of services, effect — remedy.
Section 192.2455 - Recipient unable to give consent, procedure, remedy.
Section 192.2460 - Director may proceed under other law, when — legal counsel may be retained, when.
Section 192.2470 - Discontinuance of services, when — exception.
Section 192.2505 - Confidentiality of records, records disclosed, when.