H.R.4382 - Mammography Quality Standards Reauthorization Act of 1998105th Congress (1997-1998)
Summary: H.R.4382 — 105th Congress (1997-1998)
Passed House amended (09/15/1998)
Mammography Quality Standards Reauthorization Act of 1998 - Amends the Public Health Service Act to authorize appropriations to carry out provisions relating to the certification of mammography facilities.
Requires that appeals from certification denials follow procedures in effect at that time (currently, in effect on a specified date).
Requires that standards for accreditation bodies: (1) mandate review of clinical images by qualified review physicians (currently, by qualified practicing physicians); and (2) prohibit those conducting reviews from having any relationship (currently, any financial relationship) with the facility being reviewed that would constitute a conflict of interest.
Modifies mammogram record retention requirements.
Requires that a summary of the written report regarding a mammography be sent directly to the patient (regardless of whether there is a physician of the patient available) in terms easily understood by a lay person.
Allows inspection of facilities (currently, certified facilities) for compliance with certification requirements and mammography quality standards (currently, compliance with mammography quality standards). Authorizes a demonstration program under which inspections are conducted less often than the current minimum of annually. Allows inspections to be conducted by a local agency on behalf of the Secretary of Health and Human Services.
Empowers the Secretary to require a facility to notify patients who received mammograms if the Secretary determines the quality was so inconsistent with standards as to present a significant risk to the individual or public health. Authorizes civil money penalties for failure to comply.
Allows certificate suspension or revocation for a failure to comply with an accreditation body's requests for records or materials. Modifies requirements for certification suspension before holding a hearing.