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Radiologicals/mammography.


The clinics listed in this section have received warning letters for violations of the Mammography Quality Standards Act Mammography Quality Standards Act Imaging A regulation requiring mammography clinics to mail Pts–in addition to those sent to the Pt's physician–clear, easily understood, written reports of mammography within 30 days of the examination or sooner if  of 1993. The violations and inspecting entity are indexed as indicated below.

Biop--No examples/attempts of outside biopsy results

Cat--Mammography reports lacking assessment categories

CC--Lack of systems to handle consumer complaints.

CME/CEU--Personnel lacking continuing education continuing education: see adult education.
continuing education
 or adult education

Any form of learning provided for adults. In the U.S. the University of Wisconsin was the first academic institution to offer such programs (1904).
 credits

Corr--Failure to perform/document corrective action

MedAud--Failure to conduct medical audit/ outcome analysis for individuals or facility

OOL--Out of limits processor QC

Ph-QC--Missing phantom QC records

Pr-QC--Missing processor QC records

QC/QS--Quality assurance and/or QC deficiencies

Sys--Lack of a system to provide timely medical reports and/or lay summaries

Surv--Failure to conduct or adequately perform a physicist's survey annually.

Tr-Ex--Personnel lacking required training/ experience in mammography mammography, diagnostic procedure that uses low-dose X rays to detect abnormalities in the breasts. The early diagnosis of breast cancer made possible by the routine use of mammography for screening women increases a woman's treatment alternatives and improves her  interpretation

Inspecting agency tags:

F--Inspection conducted by FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
.

S--Inspection conducted by a state agency

L--Inspection conducted by a local agency

12139W

AP Diagnostic Imaging, Inc., Edison, NJ, Oct. 30 (New Jersey). Cat, CME/CEU, CC, Corr, IC, Ph-QC, Pr-QC, Surv, S

12140W

Diagnostic Imaging, Inc., Clifton Park, NY, Nov. 1 (New York New York, state, United States
New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of
). The letter stated the firm's diagnostic x-ray systems do not comply with the following items of the Performance Standard: "We measured the entrance exposure rate in the manual mode of the fluoroscopic Fluoroscopic (fluoroscopy)
An x-ray procedure that produces immediate images and motion on a screen. The images look like those seen at airport baggage security stations.

Mentioned in: Hypotonic Duodenography
 system to be 27 roentgens per minute at the point where the center of the useful beam enters the patient. This condition is a serious radiation health hazard health hazard Occupational safety Any agent or activity posing a potential hazard to health. Cf Physical hazard.  and warrants your immediate attention. We measured the entrance exposure rate in the Automatic mode of the fluoroscopic system to be 18.3 roentgens per minute at the point where the center of the useful beam enters the patient." An inspector from the State of New York audited the firm on behalf of FDA Sept. 23. S

12141W

Heimann Systems Corp., Alcoa, TN, Oct. 30 (CDRH-OC). An unnamed investigator inspected the x-ray system managed by the firm and located in the lobby of an FDA office building in Rockville, MD, Aug. 9. The inspector observed that it is possible for part of the human body to be easily inserted into the primary x-ray beam x-ray beam,
n the spatial distribution of radiation emerging from a radiograph generator or source. The colloquial term for radiographic beam. See radiographic beam.
 when FDA rules require that "the insertion of any part of the human body through any port into the primary beam shall not be possible." The inspection also uncovered that the machine was capable of generating x-rays when no operator was present.

12142W

Kaiser Permanente Hayward Medical Center, Hayward, CA, Nov. 6 (San Francisco). CME/CEU, Corr, Pr-QC, S

12143W

St. Joseph Medical Center St. Joseph Medical Center may refer to:

In the United States:
  • St. Joseph Medical Center — Burbank, California
  • OSF St. Joseph Medical Center — Bloomington, Illinois
  • St. Joseph Medical Center — Towson, Maryland
  • St.
, Tacoma, WA, Oct. 24 (Seattle) CME/CEU, Sys, S
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Publication:Warning Letter Bulletin
Date:Dec 2, 2002
Words:421
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