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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

United Medical Center 5/4/12

  

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

Public Health Service
Food and Drug Administration
 
Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
Fax: (410) 779-5705

 

WARNING LETTER
CMS # 302259
 
May 4, 2012
 
OVERNIGHT MAIL
RETURN RECEIPT REQUESTED

 
 

Frank DeLisi, CEO
Not For Profit Hospital Corp. dba United Medical Center
1310 Southern Avenue SE
Washington, DC 20032  

Dear Mr. DeLisi:

On April 10, 2012, a representative of the Food and Drug Administration (FDA) inspected your facility. This inspection revealed a serious problem 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 a violation(s) 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 the inspector left with (b)(6), Director, Radiology/Cardiology Services at your facility at the close of the inspection on April 10, 2012. The violation(s) are again identified below:

Level 1 (REPEAT): The system to communicate results is not adequate for site Not For Profit Hospital Corp. dba United Medical Center because the system in place does not provide timely medical reports to all relevant health care providers within 30 days from the date of mammography examination. See 21 CFR 900.12(c)(3)(i)

Level 2: 1 of 10 random reports reviewed did not contain an acceptable assessment category for site Not For Profit Hospital Corp. dba United Medical Center because the use of the verbiage “Highly Suspicious for Malignancy” is not an acceptable overall final assessment category. See 21 CFR 900.12(c)(1)(iv)(E)

Level 3 (REPEAT): The required personnel qualification documents were not available during the inspection. See 21 CFR 900.12(a)(4)

Level 3: The measured fog density is equal to 0.07 for the darkroom at site Not For Profit Hospital Corp. dba United Medical Center. See 21 CFR Part 900.12(e)(4)(i)

On April 20, 2012 we received your response to the MQSA Facility Inspection Report. Your response was inadequate in that you have promised correction in the past to the repeat violations noted above. Following the May 24, 2011 inspection of your facility, you promised corrective actions via letter dated May 26, 2011 and telephone call dated July 25, 2011, from Mr. (b)(6).

The problem identified as repeat Level 1 indicates a failure to meet a significant MQSA requirement and indicates failure by your facility to implement permanent correction of this problem. 

 
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 $10,000 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 will need to perform a Compliance Follow-up Inspection to determine that each problem at your facility has been corrected. No additional response is needed from you at this time.

Finally, you should understand that there are many requirements pertaining to mammography. This letter pertains only to violations related to the recent inspections 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/cdrh/mammography/index.html.

If you have additional or more specific questions about mammography facility requirements, or about the content of this letter, please feel free to contact Rachel Evans, Regional Radiological Health Representative at (312) 596-6518.

Sincerely yours,
/S/
Evelyn Bonnin
District Director
 

cc:        Priscilla F. Butler, M.S., FAAPM
            Director, Breast Imaging Accreditation Programs,
            American College of Radiology
            1891 Preston White Drive
            Bureau of Radiation Control
            Reston, Virginia 22091