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Pennsylvania Statutes Title 35 P.S. Health and Safety § 5653. Authorization by department

Current as of January 01, 2026 | Updated by Findlaw Staff

(a) General rule.--A person shall not use a radiation machine to perform mammography unless the radiation machine is specifically authorized by the department under this act for use for mammography.

(b) Standards.--No person shall maintain or operate a screening mammography service without first obtaining a license to operate such a service, except that a provider of screening mammography services approved by the department under section 4163 of the Omnibus Budget Reconciliation Act of 1990 (Public Law 101-508, 104 Stat. 1388) is exempt from the provisions of this act.  Such license shall be based on meeting the following requirements:

(1) The radiation machine meets the criteria established by regulations promulgated under section 4163 of the Omnibus Budget Reconciliation Act of 1990.  The Department of Health may contract with the Department of Environmental Resources to determine whether the radiation machine meets the required criteria.

(2) The radiation machine is specifically designed to perform mammography.

(3) The provider of screening mammography services does all of the following:

(i) Establishes a quality control program, including inspections by a qualified radiation physicist, that meets the criteria established by regulations promulgated under section 4163 of the Omnibus Budget Reconciliation Act of 1990.

(ii) Retains and makes available to patients original mammograms as required by regulations promulgated under section 4163 of the Omnibus Budget Reconciliation Act of 1990.

(4) A radiation technologist who meets the criteria established by regulations promulgated under section 4163 of the Omnibus Budget Reconciliation Act of 1990 operates the radiation machine.

(5) The interpreting physician meets the criteria established by regulations promulgated under section 4163 of the Omnibus Budget Reconciliation Act of 1990.

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Cite this article: FindLaw.com - Pennsylvania Statutes Title 35 P.S. Health and Safety § 5653. Authorization by department - last updated January 01, 2026 | https://codes.findlaw.com/pa/title-35-ps-health-and-safety/pa-st-sect-35-5653/

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