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Inspection Reports Reveal Violations In Mammogram Centers

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ClickonDetroit.com
updated 2:00 p.m. ET April 25, 2008

In Michigan, mammogram Centers are inspected once a year. They are checked on everything from having qualified specialists on staff to maintaining and updating records and making sure the mammogram machines are meeting standards. Local 4's Karen Drew looked through a year of inspection records for the 330 mammogram clinics across the state. Six metro Detroit mammogram centers were cited for noncompliance of state standards. Four of the six centers in Local 4's investigation are in compliance with state standards. Two have not sent the state "notice of corrective action." Those two centers are Advanced Radiological Center in Southfield and Rochester Diagnostic and Speciality Center in Rochester.

The six centers that were cited are:

  • William Beaumont Mammography Center in Troy located at 44201 Dequindre in Troy

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    READ FULL INSPECTION REPORT:

    Troy Beaumont Investigation Report

    Conrad Nagle, corporate chief of imaging services for Beaumont Hospital, issued this statement:

    Patient care quality and safety was never compromised with the two machines that received state citations. Our mammography images are always examined for quality and accuracy before a patient leaves our facility to ensure high quality imaging. We perform multiple daily and weekly quality and safety checks on our mammography equipment in addition to the annual state testing.

    Beaumont Hospital also issued this information:

    Of the two machines that received citations: One was used for tissue specimen testing only. Tissue image quality evaluation was not compromised. The machine has been taken out of service because it is no longer needed. The other machine was used for call-back, diagnostic patient testing that is performed after a patient?s breast problem is detected through screening mammography. This machine did pass the testing performed by state inspectors using a federal ?phantom? on the same day. It has since been replaced with a new digital mammography machine as part of Beaumont, Troy?s conversion to a fully digital mammography service. There was no inappropriate radiation exposure with either machine. In patient mammography, we examine the image and will repeat the test, if needed, to ensure that we have a high quality image before a patient leaves our facility. Beaumont fully supports the state?s annual mammography inspection program. We also conduct our own ongoing equipment inspections with a full-time medical physicist who performs routine, regular testing. If there is any indication that a machine is not performing optimally, we stop using it.

  • St. John Macomb Breast Cancer Centerlocated at 28363 Hoover Road in Warren

    READ FULL INSPECTION REPORT:

    St. John Macomb Investigation Report

    St John Macomb Breast Center issued this statement:

    The St. John Macomb Breast Center provides patients with high quality breast imaging services. If these non-compliance issues, which were all promptly addressed, would have had any impact on the quality of images, the state would not have allowed mammograms to continue on these machines.

  • Advance Radiological Center located at 23077 Greenfield Road in Southfield

    READ FULL INSPECTION REPORT:

    Advance Radiological Center Investigation Report

    A spokesperson from the center issued this statement:

    In response to our FDA/MQSA Mammography inspection back in April of 2007,our facility was cited with a Level 1 non-compliance because of two things, of which were corrected immediately and there was no compromise of patient care. Our hand-held quality control unit (densitometer) was out for repair and we did not have access to another one that would have allowed us to do our daily film processor control or weekly Phantom test. Simply put, we have to test the chemicals in the film developing tank before we can process mammogram film. This particular unit allows us to do that. We continued to do mammogram's during this time but we did not develop the mammogram film. We were instructed by our physicist to store the film and then develop them once our unit came back from repair. This took almost 3 weeks. We then had to do a 10 day average on all the readings from our quality control to make sure our target numbers were in range. At four weeks out we developed the film. State laws require us to notify a patient of their results within 3 weeks after a mammogram. Under normal circumstances our patients are notified. We did not anticipate having our equipment out for repair so long. We usually have access to a loaner but one was not available from the repair company. If this same event had happened within a 3 week time span we would not have been cited. We did what we thought was the right thing to do by not developing film in chemicals that could have compromised quality. Time simply ran out on us. Our most recent inspection was March 25, 2008. There were no items of non-compliance. Our facility passed all requirements.

  • Rochester Diagnostic & Specialty Center located 543 North Main in Rochester

    READ FULL INSPECTION REPORT:

    Rochester Investigation Report

  • Associated Radiologists of Clarkston located at 7210 N. Main Street in Clarkston

    READ FULL INSPECTION REPORT:

    Associated Radiologists of Clarkston Inspection Report

  • St. Joseph Mercy- Woodland Health Center located at 7575 Grand River Avenue in Brighton

    READ FULL INSPECTION REPORT:

    Woodland Investigation Report

    Lauren Stokes, a spokesperson for St. Joseph issued this statement:

    Avant Imaging provides the imaging services at St. Joseph Mercy Woodland Health Center. On February 8, 2008, Avant Imaging was inspected by the State of Michigan and cited for a minor infraction - an infraction that does not impact patient care. Following the inspection, engineers were called and adjusted the mammography machine to meet the State's requirements. A service report was filed, the appropriate form was sent to the State and a certificate of compliance from the State of Michigan was issued on April 3, 2008. This was a routine inspection by the State. Had the inspector found something notably wrong, Avant Imaging would not have been permitted to continue offering mammography exams. Mammographies were, at all times, permitted to continue and high quality standards were always met. If high quality standards were not being met, imaging procedures.would have ceased until the issue was identified and resolved.

    If you would like to find out more about other mammogram centers in Michigan, this Web site has information you may need.

    TheWeb site only says if the facility was in compliance or not, it does not give specific details about non-compliances.

    Four of the six centers in Local 4's investigation are now in compliance with state standards. Two centers have not sent the state "notice of corrective action." Those two centers are Advanced Radiological Center in Southfield and Rochester Diagnostic and Speciality Center in Rochester.

    The Food and Drug Administration also lists certified mammography facilities on their Web site. There is no inspection information on this Web site.

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