Improving Breast Imaging Quality Standards (2005) / Chapter Skim
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3 MQSA Regulations, Inspections, and Enforcement
3 MQSA Regulations, Inspections, and Enforcement
Pages 82-116
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From page 82... ...
Accrediting bodies are also responsible for reviewing equipment evaluations and quality control tests performed by each facility and reviewing the qualifications of mammography personnel. All personnel at mammography facilities, including interpreting physicians, radiologic technologists, and medical physicists, must meet initial qualifications, demonstrate continued experience, and complete continuing education programs.
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From page 83... ...
Certification bodies must issue Mam mography Quality Standards Act (MQSA) certificates allowing accredited facili ties to operate lawfully, and must perform annual inspections of each certified facility.
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From page 84... ...
The NMQAAC advises FDA on appropriate quality standards, assists in the development of sanctions, designs a method to investigate con sumer complaints, reports on new developments in breast imaging, determines whether a shortage of health professionals exists, and measures the costs and benefits of MQSA compliance. SOURCE: Mammography Quality Standards Act, 42 U.S.C.
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From page 85... ...
mammography quality control manual suggests standards for viewbox luminance and illumination levels; however, compliance with these recommended standards varies. An estimate from facilities in North Carolina in 2002 suggests approximately 15 percent (40 out of 248 total)
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From page 86... ...
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From page 87... ...
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From page 88... ...
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From page 89... ...
cat veah consebyamyt ann ted MQSA ili ther quar the, eenwteb-inetady int U tified expire rtifi suspended toy fac and ard annual an choose month- Con.
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From page 90... ...
iii) education ationc ph ogicl edu radio TABLE Regulation 900.12(a)
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From page 91... ...
( tech experience ogicl ogicl radio radio TABLE Regulation 900.12(a)
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From page 92... ...
icists 3-1 iii) ys education phla dicem TABLE Regulation 900.12(a)
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From page 93... ...
icists 3-1 iii) ys experience phla dicem TABLE Regulation 900.12(a)
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From page 94... ...
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From page 95... ...
the .y onsis-c ange ch entc s ee tie er were reom and per minimize the thrr gni ili fac high this. Continued ations andy iciansy afte at 43.8 improved Requir ectl ph oni fory regul from mammograph ref alit better of gulationsereth tode categor tinge approvedy uggestss itatd fite qu m nalif cre ac ben ove perfor thee ality chang keam ADS BI-R3 interpreth eadrlas survey ha ssap ouldc communication.
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From page 96... ...
are per be placedear esttes to cas edt i)
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From page 97... ...
kVp" ngeart yb la ,y ,t sur- ed teste eren vieweder dicem relar highera retain on -moc test Modern. tighyel basis.
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From page 98... ...
control e 3-1 rancus medi-y dit ause quality asy outcom TABLE Regulation 900.12(e)
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From page 99... ...
(iii) Continued e 3-1 rancus medi-y dit ause asy outcom TABLE Regulation 900.12(f)
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From page 100... ...
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From page 101... ...
Finally, language describing the timeframe for completion of continuing education and experience should be based on calendar years, to improve clarity. Continuing experience for medical physicists includes surveys of at least two mammography facilities during the previous 24 months.
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From page 102... ...
Butler, Senior Director, Breast Imaging Accreditation Programs, American College of Radiology, October 15, 2004.
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From page 103... ...
The mammography medical outcomes audit currently requires data to be compiled for each radiologist practicing in each separate facility. Facilities with the same interpreting physicians should be allowed to merge the medical audit data for their interpreting physicians.
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From page 104... ...
This revision should be incorporated into the final regulations because it ensures that the appropriate notification is sent to patients undergoing mammography examinations given that assessment. In addition, each assessment category should also be updated to be consistent with the 2003 Breast Imaging Reporting and Data System (BI-RADS)
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From page 105... ...
The Committee urges FDA to promptly remove the exemption of all interventional mammography from MQSA regulations. Specifically, all stereotactic breast biopsy procedures and equipment should be accredited by the appropriate accreditation body.
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From page 106... ...
5 Personal communication, C Finder, M.D., Associate Director, Division of Mammography Quality and Radiation Programs, Office of Communication, Education, and Radiation Programs (formerly the Office of Health and Industry Programs)
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From page 107... ...
As part of the Mammography Quality Standards Reauthorization Act of 1997, Congress gave FDA the authority to organize an inspection demonstration program (IDP) to determine whether MQSA inspections could be conducted less frequently than annually (Mammography Quality Standards Reauthorization Act.
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From page 108... ...
Butler, Senior Director, Breast Imaging Accreditation Programs, American College of Radiology, November 15, 2004.
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From page 109... ...
(California was also approved to accredit facilities, but the state's accreditation program 7 Personal communication, C Finder, M.D., Associate Director, Division of Mammography Quality and Radiation Programs, Office of Communication, Education, and Radiation Programs (formerly the Office of Health and Industry Programs)
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From page 110... ...
Accreditation body reviewers reviewing the performance quality of mammography facilities should have considerably more experience than the minimum established for physicians interpreting mammograms. The ACR currently requires review physicians to have 5 years of post residency experience in diagnostic radiology, with at least 50 percent of each year's practice in breast imaging, and be actively practicing in the modality reviewed.
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From page 111... ...
in the legislation.11 Replacing part (m) with a reemption clause could help ensure that MQSA regulations are uniformly followed by facilities in all states, largely because these regulations would provide both minimum and maximum requirements for mammography facilities and personnel.
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From page 112... ...
Continuing education/experience 0.90 1.93 Recordkeeping 0.10 0.19 Patient notification 4.84 4.15 Medical audit 7.54 5.78 Quality control tests 0.65 0.57 Annual physicist survey 1.00 0.35 Accreditation 0.31 0.39 MQSA inspection 0.45 0.65 Total 15.79 14.01 NOTES: Compliance with MQSA regulations presents a significant financial burden on mammography facilities. Recently, the American College of Radiology (ACR)
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From page 113... ...
FDA could also commission another study on the economic impact of compliance with the new medical audit procedures, as they did in 1997. SUMMARY AND CONCLUSIONS The final FDA Mammography Quality Standards Act regulations, promulgated in 1999, understandably require revision given the development of mammography practice in recent years.
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From page 114... ...
2003. Reauthorization of the Mammography Quality Standards Act.
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From page 115... ...
2003. The Mammography Quality Standards Act Final Regulations, Modi fications and Additions to Policy Guidance Help System #7; Guidance for Industry and FDA.
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From page 116... ...
2003. The Mammography Quality Standards Act.
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