Machine not registered shall not be used for mammography--departmentto authorize machines, when--nonrenewable temporaryauthorizations--application form, information required--annualinspections--withdrawal of authorization, emergency orderauthorized--administrative penalty--injunctive relief.
192.766. 1. Beginning sixty days after August 28, 1992, a person shallnot use a radiation machine to perform mammography unless the radiationmachine is registered with the department of health and senior services underdepartment rules for registration of radiation machines and is specificallyauthorized under this section for use for mammography.
2. The department of health and senior services shall authorize aradiation machine for use for mammography if the radiation machine meets allof the following standards:
(1) The radiation machine meets the criteria for the American College ofRadiology mammography accreditation program as adopted in June 1987, andamended in September 1988, and published by the American College of Radiology,which criteria are incorporated by reference. The department of health andsenior services shall make copies of those criteria available to the publicand may by rule adopt modified criteria. The department may accept anaccreditation certificate issued by the American College of Radiology asevidence that a radiation machine meets those criteria. If at any time thedepartment determines that it will not accept any accreditation certificatesissued by the American College of Radiology as evidence that a radiationmachine meets those criteria, the department shall promptly notify each personwho has registered a radiation machine under sections 192.760 to 192.766* andthe rules promulgated under sections 192.760 to 192.766*;
(2) The radiation machine, the film or other image receptor used in theradiation machine, and the facility where the radiation machine is used meetthe requirements set forth in department of health and senior services rulesfor radiation machines;
(3) The radiation machine is specifically designed to performmammography;
(4) The radiation machine is used exclusively to perform mammography;
(5) The radiation machine is used in a facility that does all of thefollowing:
(a) At least annually has a radiation physicist provide on-siteconsultation to the facility, including, but not limited to, a completeevaluation of the entire mammography system to ensure compliance with sections192.760 to 192.766* and the rules promulgated under sections 192.760 to192.766*;
(b) Maintains for at least sixty months, records of the consultationrequired in paragraph (a) and the findings of the consultation;
(6) The radiation machine is used according to department of health andsenior services rules on patient radiation exposure and radiation dose levels;
(7) The radiation machine is operated only by an individual who candemonstrate to the department that he is specifically trained in mammography.Beginning sixty days after the rules required under subsection 3 of section192.762** are promulgated, the radiation machine is operated only by anindividual who can demonstrate to the department that he meets the standardsrequired by those rules. If the department promulgates emergency rulescovering the subject matter described in subsection 3 of section 192.762**,then for a period beginning sixty days after those emergency rules arepromulgated and ending on the day that those emergency rules cease to be ineffect, the radiation machine is operated only by an individual who candemonstrate to the department that he meets the standards required by thoseemergency rules.
3. The department may issue a nonrenewable temporary authorization for aradiation machine for use for mammography if additional time is needed toallow submission of evidence satisfactory to the department that the radiationmachine meets the standards set forth in subsection 2 of this section forapproval for mammography. A temporary authorization granted under thissubsection during the first eighteen months after August 28, 1992, shall beeffective for no more than twelve months. A temporary authorization grantedunder this subsection after eighteen months after August 28, 1992, shall beeffective for no more than six months. The department may withdraw atemporary authorization prior to its expiration if the radiation machine doesnot meet one or more of the standards set forth in subsection 2 of thissection.
4. To obtain authorization from the department of health and seniorservices to use a radiation machine for mammography, the person who owns orleases the radiation machine, or an authorized agent of the person, shallapply to the department for mammography authorization on an application formprovided by the department and shall provide all of the information requiredby the department as specified on the application form. A person who owns orleases more than one radiation machine used for mammography shall obtainauthorization for each radiation machine. The department shall process andrespond to an application within thirty days after the date of receipt of theapplication. Upon determining to grant mammography authorization for aradiation machine, the department shall issue a certificate of registrationspecifying mammography authorization for each authorized radiation machine. Amammography authorization is effective for three years.
5. The department shall annually inspect the radiation machine and mayinspect the radiation machine more frequently. The department shall makereasonable efforts to coordinate the inspections under this section with thedepartment's other inspections of the facility in which the radiation machineis located.
6. After each satisfactory inspection by the department, the departmentshall issue a certificate of radiation machine inspection or a similardocument identifying the facility and radiation machine inspected andproviding a record of the date the radiation machine was inspected. Thefacility shall post the certificate issued by the American College ofRadiology or the department of health and senior services near the inspectedradiation machine.
7. The department may withdraw the mammography authorization for aradiation machine if it does not meet one or more of the standards set forthin subsection 2 of this section.
8. The department shall provide an opportunity for a hearing inconnection with a denial or withdrawal of mammography authorization.
9. Upon a finding that a deficiency in a radiation machine used formammography or a violation of sections 192.760 to 192.766* or the rulespromulgated under sections 192.760 to 192.766* seriously affects the health,safety, and welfare of individuals upon whom the radiation machine is used formammography, the department may issue an emergency order summarily withdrawingthe mammography authorization of the radiation machine. The department shallincorporate its findings in the order and shall provide an opportunity for ahearing within five working days after issuance of the order. The order shallbe effective during the proceedings.
10. If the department withdraws the mammography authorization of aradiation machine, the radiation machine shall not be used for mammography.An application for reinstatement of a mammography authorization shall be filedand processed in the same manner as an application for mammographyauthorization under subsection 4 of this section, except that the departmentshall not issue a reinstated certificate of mammography registration until thedepartment receives the reinspection fee required under subsection 2 ofsection 192.764***, inspects the radiation machine, and determines that itmeets the standards set forth in subsection 2 of this section. The departmentshall conduct an inspection required under this subsection no later than sixtydays after receiving a proper application for reinstatement of a mammographyauthorization.
11. In addition to the reinspection fee required under subsection 2 ofsection 192.764***, if a person violates subsection 1 of this section, thedepartment of health and senior services may impose an administrative penaltyagainst the owner of the radiation machine or, if a lessee of the radiationmachine has effective control of the radiation machine, the lessee, of notmore than five hundred dollars for each calendar week in which a mammographyis performed in violation of subsection 1 of this section. If a personcontinues to violate subsection 1 of this section for a period of two weeksafter a fine is imposed under this subsection, the department shall post aconspicuous notice on the unauthorized radiation machine and at the entry tothe facility where the radiation machine is located warning the public thatthe facility is performing mammography using a radiation machine that is notin compliance with state regulations and may pose a potential hazard to thepublic health.
12. The attorney general, on request of the department of health andsenior services, shall bring an action for injunctive relief to prevent theviolation of the provisions of sections 192.760 to 192.766* or rules orregulations promulgated under sections 192.760 to 192.766*.
13. Rules and regulations promulgated by the department of health andsenior services pursuant to sections 192.760 to 192.766* shall be fairlyconsistent with rules promulgated by the Health Care Financing Administrationfor the Medicare Program: Medicare Coverage of Screening Mammography toimplement mammography screening requirements contained in the OmnibusReconciliation Act of 1990.
(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.
Machine not registered shall not be used for mammography--departmentto authorize machines, when--nonrenewable temporaryauthorizations--application form, information required--annualinspections--withdrawal of authorization, emergency orderauthorized--administrative penalty--injunctive relief.
192.766. 1. Beginning sixty days after August 28, 1992, a person shallnot use a radiation machine to perform mammography unless the radiationmachine is registered with the department of health and senior services underdepartment rules for registration of radiation machines and is specificallyauthorized under this section for use for mammography.
2. The department of health and senior services shall authorize aradiation machine for use for mammography if the radiation machine meets allof the following standards:
(1) The radiation machine meets the criteria for the American College ofRadiology mammography accreditation program as adopted in June 1987, andamended in September 1988, and published by the American College of Radiology,which criteria are incorporated by reference. The department of health andsenior services shall make copies of those criteria available to the publicand may by rule adopt modified criteria. The department may accept anaccreditation certificate issued by the American College of Radiology asevidence that a radiation machine meets those criteria. If at any time thedepartment determines that it will not accept any accreditation certificatesissued by the American College of Radiology as evidence that a radiationmachine meets those criteria, the department shall promptly notify each personwho has registered a radiation machine under sections 192.760 to 192.766* andthe rules promulgated under sections 192.760 to 192.766*;
(2) The radiation machine, the film or other image receptor used in theradiation machine, and the facility where the radiation machine is used meetthe requirements set forth in department of health and senior services rulesfor radiation machines;
(3) The radiation machine is specifically designed to performmammography;
(4) The radiation machine is used exclusively to perform mammography;
(5) The radiation machine is used in a facility that does all of thefollowing:
(a) At least annually has a radiation physicist provide on-siteconsultation to the facility, including, but not limited to, a completeevaluation of the entire mammography system to ensure compliance with sections192.760 to 192.766* and the rules promulgated under sections 192.760 to192.766*;
(b) Maintains for at least sixty months, records of the consultationrequired in paragraph (a) and the findings of the consultation;
(6) The radiation machine is used according to department of health andsenior services rules on patient radiation exposure and radiation dose levels;
(7) The radiation machine is operated only by an individual who candemonstrate to the department that he is specifically trained in mammography.Beginning sixty days after the rules required under subsection 3 of section192.762** are promulgated, the radiation machine is operated only by anindividual who can demonstrate to the department that he meets the standardsrequired by those rules. If the department promulgates emergency rulescovering the subject matter described in subsection 3 of section 192.762**,then for a period beginning sixty days after those emergency rules arepromulgated and ending on the day that those emergency rules cease to be ineffect, the radiation machine is operated only by an individual who candemonstrate to the department that he meets the standards required by thoseemergency rules.
3. The department may issue a nonrenewable temporary authorization for aradiation machine for use for mammography if additional time is needed toallow submission of evidence satisfactory to the department that the radiationmachine meets the standards set forth in subsection 2 of this section forapproval for mammography. A temporary authorization granted under thissubsection during the first eighteen months after August 28, 1992, shall beeffective for no more than twelve months. A temporary authorization grantedunder this subsection after eighteen months after August 28, 1992, shall beeffective for no more than six months. The department may withdraw atemporary authorization prior to its expiration if the radiation machine doesnot meet one or more of the standards set forth in subsection 2 of thissection.
4. To obtain authorization from the department of health and seniorservices to use a radiation machine for mammography, the person who owns orleases the radiation machine, or an authorized agent of the person, shallapply to the department for mammography authorization on an application formprovided by the department and shall provide all of the information requiredby the department as specified on the application form. A person who owns orleases more than one radiation machine used for mammography shall obtainauthorization for each radiation machine. The department shall process andrespond to an application within thirty days after the date of receipt of theapplication. Upon determining to grant mammography authorization for aradiation machine, the department shall issue a certificate of registrationspecifying mammography authorization for each authorized radiation machine. Amammography authorization is effective for three years.
5. The department shall annually inspect the radiation machine and mayinspect the radiation machine more frequently. The department shall makereasonable efforts to coordinate the inspections under this section with thedepartment's other inspections of the facility in which the radiation machineis located.
6. After each satisfactory inspection by the department, the departmentshall issue a certificate of radiation machine inspection or a similardocument identifying the facility and radiation machine inspected andproviding a record of the date the radiation machine was inspected. Thefacility shall post the certificate issued by the American College ofRadiology or the department of health and senior services near the inspectedradiation machine.
7. The department may withdraw the mammography authorization for aradiation machine if it does not meet one or more of the standards set forthin subsection 2 of this section.
8. The department shall provide an opportunity for a hearing inconnection with a denial or withdrawal of mammography authorization.
9. Upon a finding that a deficiency in a radiation machine used formammography or a violation of sections 192.760 to 192.766* or the rulespromulgated under sections 192.760 to 192.766* seriously affects the health,safety, and welfare of individuals upon whom the radiation machine is used formammography, the department may issue an emergency order summarily withdrawingthe mammography authorization of the radiation machine. The department shallincorporate its findings in the order and shall provide an opportunity for ahearing within five working days after issuance of the order. The order shallbe effective during the proceedings.
10. If the department withdraws the mammography authorization of aradiation machine, the radiation machine shall not be used for mammography.An application for reinstatement of a mammography authorization shall be filedand processed in the same manner as an application for mammographyauthorization under subsection 4 of this section, except that the departmentshall not issue a reinstated certificate of mammography registration until thedepartment receives the reinspection fee required under subsection 2 ofsection 192.764***, inspects the radiation machine, and determines that itmeets the standards set forth in subsection 2 of this section. The departmentshall conduct an inspection required under this subsection no later than sixtydays after receiving a proper application for reinstatement of a mammographyauthorization.
11. In addition to the reinspection fee required under subsection 2 ofsection 192.764***, if a person violates subsection 1 of this section, thedepartment of health and senior services may impose an administrative penaltyagainst the owner of the radiation machine or, if a lessee of the radiationmachine has effective control of the radiation machine, the lessee, of notmore than five hundred dollars for each calendar week in which a mammographyis performed in violation of subsection 1 of this section. If a personcontinues to violate subsection 1 of this section for a period of two weeksafter a fine is imposed under this subsection, the department shall post aconspicuous notice on the unauthorized radiation machine and at the entry tothe facility where the radiation machine is located warning the public thatthe facility is performing mammography using a radiation machine that is notin compliance with state regulations and may pose a potential hazard to thepublic health.
12. The attorney general, on request of the department of health andsenior services, shall bring an action for injunctive relief to prevent theviolation of the provisions of sections 192.760 to 192.766* or rules orregulations promulgated under sections 192.760 to 192.766*.
13. Rules and regulations promulgated by the department of health andsenior services pursuant to sections 192.760 to 192.766* shall be fairlyconsistent with rules promulgated by the Health Care Financing Administrationfor the Medicare Program: Medicare Coverage of Screening Mammography toimplement mammography screening requirements contained in the OmnibusReconciliation Act of 1990.
(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.
Machine not registered shall not be used for mammography--departmentto authorize machines, when--nonrenewable temporaryauthorizations--application form, information required--annualinspections--withdrawal of authorization, emergency orderauthorized--administrative penalty--injunctive relief.
192.766. 1. Beginning sixty days after August 28, 1992, a person shallnot use a radiation machine to perform mammography unless the radiationmachine is registered with the department of health and senior services underdepartment rules for registration of radiation machines and is specificallyauthorized under this section for use for mammography.
2. The department of health and senior services shall authorize aradiation machine for use for mammography if the radiation machine meets allof the following standards:
(1) The radiation machine meets the criteria for the American College ofRadiology mammography accreditation program as adopted in June 1987, andamended in September 1988, and published by the American College of Radiology,which criteria are incorporated by reference. The department of health andsenior services shall make copies of those criteria available to the publicand may by rule adopt modified criteria. The department may accept anaccreditation certificate issued by the American College of Radiology asevidence that a radiation machine meets those criteria. If at any time thedepartment determines that it will not accept any accreditation certificatesissued by the American College of Radiology as evidence that a radiationmachine meets those criteria, the department shall promptly notify each personwho has registered a radiation machine under sections 192.760 to 192.766* andthe rules promulgated under sections 192.760 to 192.766*;
(2) The radiation machine, the film or other image receptor used in theradiation machine, and the facility where the radiation machine is used meetthe requirements set forth in department of health and senior services rulesfor radiation machines;
(3) The radiation machine is specifically designed to performmammography;
(4) The radiation machine is used exclusively to perform mammography;
(5) The radiation machine is used in a facility that does all of thefollowing:
(a) At least annually has a radiation physicist provide on-siteconsultation to the facility, including, but not limited to, a completeevaluation of the entire mammography system to ensure compliance with sections192.760 to 192.766* and the rules promulgated under sections 192.760 to192.766*;
(b) Maintains for at least sixty months, records of the consultationrequired in paragraph (a) and the findings of the consultation;
(6) The radiation machine is used according to department of health andsenior services rules on patient radiation exposure and radiation dose levels;
(7) The radiation machine is operated only by an individual who candemonstrate to the department that he is specifically trained in mammography.Beginning sixty days after the rules required under subsection 3 of section192.762** are promulgated, the radiation machine is operated only by anindividual who can demonstrate to the department that he meets the standardsrequired by those rules. If the department promulgates emergency rulescovering the subject matter described in subsection 3 of section 192.762**,then for a period beginning sixty days after those emergency rules arepromulgated and ending on the day that those emergency rules cease to be ineffect, the radiation machine is operated only by an individual who candemonstrate to the department that he meets the standards required by thoseemergency rules.
3. The department may issue a nonrenewable temporary authorization for aradiation machine for use for mammography if additional time is needed toallow submission of evidence satisfactory to the department that the radiationmachine meets the standards set forth in subsection 2 of this section forapproval for mammography. A temporary authorization granted under thissubsection during the first eighteen months after August 28, 1992, shall beeffective for no more than twelve months. A temporary authorization grantedunder this subsection after eighteen months after August 28, 1992, shall beeffective for no more than six months. The department may withdraw atemporary authorization prior to its expiration if the radiation machine doesnot meet one or more of the standards set forth in subsection 2 of thissection.
4. To obtain authorization from the department of health and seniorservices to use a radiation machine for mammography, the person who owns orleases the radiation machine, or an authorized agent of the person, shallapply to the department for mammography authorization on an application formprovided by the department and shall provide all of the information requiredby the department as specified on the application form. A person who owns orleases more than one radiation machine used for mammography shall obtainauthorization for each radiation machine. The department shall process andrespond to an application within thirty days after the date of receipt of theapplication. Upon determining to grant mammography authorization for aradiation machine, the department shall issue a certificate of registrationspecifying mammography authorization for each authorized radiation machine. Amammography authorization is effective for three years.
5. The department shall annually inspect the radiation machine and mayinspect the radiation machine more frequently. The department shall makereasonable efforts to coordinate the inspections under this section with thedepartment's other inspections of the facility in which the radiation machineis located.
6. After each satisfactory inspection by the department, the departmentshall issue a certificate of radiation machine inspection or a similardocument identifying the facility and radiation machine inspected andproviding a record of the date the radiation machine was inspected. Thefacility shall post the certificate issued by the American College ofRadiology or the department of health and senior services near the inspectedradiation machine.
7. The department may withdraw the mammography authorization for aradiation machine if it does not meet one or more of the standards set forthin subsection 2 of this section.
8. The department shall provide an opportunity for a hearing inconnection with a denial or withdrawal of mammography authorization.
9. Upon a finding that a deficiency in a radiation machine used formammography or a violation of sections 192.760 to 192.766* or the rulespromulgated under sections 192.760 to 192.766* seriously affects the health,safety, and welfare of individuals upon whom the radiation machine is used formammography, the department may issue an emergency order summarily withdrawingthe mammography authorization of the radiation machine. The department shallincorporate its findings in the order and shall provide an opportunity for ahearing within five working days after issuance of the order. The order shallbe effective during the proceedings.
10. If the department withdraws the mammography authorization of aradiation machine, the radiation machine shall not be used for mammography.An application for reinstatement of a mammography authorization shall be filedand processed in the same manner as an application for mammographyauthorization under subsection 4 of this section, except that the departmentshall not issue a reinstated certificate of mammography registration until thedepartment receives the reinspection fee required under subsection 2 ofsection 192.764***, inspects the radiation machine, and determines that itmeets the standards set forth in subsection 2 of this section. The departmentshall conduct an inspection required under this subsection no later than sixtydays after receiving a proper application for reinstatement of a mammographyauthorization.
11. In addition to the reinspection fee required under subsection 2 ofsection 192.764***, if a person violates subsection 1 of this section, thedepartment of health and senior services may impose an administrative penaltyagainst the owner of the radiation machine or, if a lessee of the radiationmachine has effective control of the radiation machine, the lessee, of notmore than five hundred dollars for each calendar week in which a mammographyis performed in violation of subsection 1 of this section. If a personcontinues to violate subsection 1 of this section for a period of two weeksafter a fine is imposed under this subsection, the department shall post aconspicuous notice on the unauthorized radiation machine and at the entry tothe facility where the radiation machine is located warning the public thatthe facility is performing mammography using a radiation machine that is notin compliance with state regulations and may pose a potential hazard to thepublic health.
12. The attorney general, on request of the department of health andsenior services, shall bring an action for injunctive relief to prevent theviolation of the provisions of sections 192.760 to 192.766* or rules orregulations promulgated under sections 192.760 to 192.766*.
13. Rules and regulations promulgated by the department of health andsenior services pursuant to sections 192.760 to 192.766* shall be fairlyconsistent with rules promulgated by the Health Care Financing Administrationfor the Medicare Program: Medicare Coverage of Screening Mammography toimplement mammography screening requirements contained in the OmnibusReconciliation Act of 1990.
(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.
