Inspections, Compliance, Enforcement, and Criminal Investigations

MRI Imaging Specialist 3/17/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Atlanta District Office
60 Eighth Street N.E.
Atlanta, GA 30309
Telephone: 404-253-1161
FAX: 404-253-1202 

 

WARNING LETTER
(16-ATL-08)

 
March 17, 2016

Via UPS Overnight Mail

Re:       MQSA Inspection ID # 2412720003
           FEI # 3010369387


Miguel Leon
Owner
MRI Imaging Specialist
6760 Jimmy Carter Blvd., Ste. 165
Norcross, GA 30071

Dear Miguel Leon:

On 02/17/2016, a representative of the Food and Drug Administration (FDA) inspected your facility. This fee-based follow up inspection of your facility was conducted as a result of your two previous non-compliant MQSA inspections on 07/01/14 and 6/17/2015. This inspection revealed continuing serious problems involving the conduct of mammography at your facility. Under the Mammography Quality Standards Act of 1992 ("MQSA"), which is codified in Section 263b of Title 42 of the United States Code (USC), your facility must meet specific requirements to practice mammography. These requirements help protect the health of women by assuring that a facility can perform quality mammography.

The inspection revealed continuing violations of the MQSA at your facility. These violations were noted on the MQSA Facility Inspection Report and the document "Important Information about Your MQSA Inspection" that was faxed to your facility on 02/19/2016. The violations are again identified below:

Level 1: The system to communicate results is not adequate for site MRI Imaging Specialist because: - There is no system in place to provide timely lay summaries. [See 21 CFR 900.12(c)(2)]

Level 2: Not all positive mammograms were entered in the tracking system for site MRI Imaging Specialist. [See 21 CFR 900.12(f)(1)]
 
Level 2: Contrast-to-noise ratio QC testing is not adequate for unit 1, room Mammography Room because: - QC testing was not done at the required frequency - Corrective actions (before further exams) for QC failures were not documented. [See 21 CFR 900.12(e)(6)]

Level 2: Medical audit and outcome analysis was not performed annually at site MRI Imaging Specialist. [See 21 CFR 900.12(f)(2)]

Level 2: Medical audit and outcome analysis was not done separately for each individual at site MRI Imaging Specialist. [See 21 CFR 900.12(f)(1)]

Level 2: Medical audit and outcome analysis was not done for the facility as a whole at site MRI Imaging Specialist. [See 21 CFR 900.12(f)(1)]

Level 2: Review workstation (monitor) QC testing is not adequate because: - QC testing was not done at the required frequency. [See 21 CFR 900.12(e)(6)]

Level 2: There is no designated audit (reviewing) interpreting physician for site MRI Imaging Specialist. [See 21 CFR 900.12(f)(3)]
 
You have failed to respond to the MQSA Facility Inspection Report as requested in the document “Important Information about your MQSA Inspection”.

Because the continued failure to resolve these violations may be indicative of serious underlying problems that could compromise the quality of mammography at your facility, FDA may take additional actions, including, but not limited to, the following:
  • requiring your facility to undergo an Additional Mammography Review
  • placing your facility under a Directed Plan of Correction
  • charging your facility for the cost of on-site monitoring
  • seeking civil money penalties up to $11,000 for each failure to substantially comply with, or each day of failure to substantially comply with, MQSA standards
  • seeking to suspend or revoke your facility's FDA certificate

See 42 USC 263b(h)-(j) and 21 CFR 900.12(j).

FDA may need to perform a Compliance Follow-up Inspection to determine that each problem at your facility has been corrected.

You should respond in writing to FDA within fifteen (15) working days from the date you received this letter. Your response should address the findings listed above and include:
  1. the specific steps you have taken, or will take, to correct all of the violations noted in this letter, including projected timeframes for implementing those steps;
  2. the specific steps you have taken, or will take, to prevent the recurrence of similar violations, including projected timeframes for implementing those steps;
  3. sample records that demonstrate proper record keeping procedures; Note: Patient names should be deleted from any copies of records you submit.
Please submit your response to this letter to:
                                  
Derek Price, Compliance Officer
U.S. Food and Drug Administration
60 Eighth St. NE
Atlanta, GA 30309

Please send a copy of your response to:
 
Jodie Mathews, ARRT
State of Georgia, Department of Community Health
Healthcare Facility Regulation Division
2 Peachtree St; Suite 31492
Atlanta, Ga 30303

Finally, you should understand that there are many requirements pertaining to mammography. This letter pertains only to violations related to the recent inspection(s) of your facility and does not necessarily address other obligations you have under the law. You may obtain general information about all of FDA's requirements for mammography facilities by contacting the Mammography Quality Assurance Program, Food and Drug Administration, P.O. Box 6057, Columbia, MD 21045-6057 (1-800-838-7715) or through the Internet at http://www.fda.gov/Mammography.

If you have additional or more specific questions about mammography facility requirements, or about the content of this letter, please feel free to contact Christopher Wilcox, CSO at 912-233-5519 x1104.
 
Sincerely yours,
/S/
Ingrid A. Zambrana
District Director
Atlanta District
 
cc:

Food and Drug Administration
Center for Devices and Radiological Health
Division of Mammography Quality Standards
White Oak Building 66, Room #4675
10903 New Hampshire Ave.
Silver Spring, MD 20903

Jodie Mathews, ARRT
State of Georgia, Department of Community Health
Healthcare Facility Regulation Division
2 Peachtree St; Suite 31492
Atlanta, Ga 30303

Page Last Updated: 03/17/2016
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