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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Union Square Medical Imaging & Mammography 8/8/14

  

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

Public Health Service
Food and Drug Administration
 
New York District 
158-15 Liberty Avenue
Jamaica, NY 11433 

 

                                                                                                                                                                                     
 August 8, 2014
 
WARNING LETTER NYK-2014-55
 
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Zoya Maksumova, M.D.
Medical Director
Union Square Medical Imaging & Mammography, P.C.
200 Park Avenue South, Suite 1103
New York, NY 10003
 
Re: MQSA Facility ID 129825
        FEI 1000521638
 
Dear Dr. Maksumova:
 
On January 29, 2014 and February 11, 2014, a representative of the State/Commonwealth of New York City, acting on behalf of the Food and Drug Administration (FDA) inspected your facility. This inspection revealed 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 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 the inspector faxed to your facility on February 14, 2014. The violations are again identified below:
 
Level 1: Phantom QC records were missing greater than 4 weeks during a 12-week period for unit 3, room Mammo. [See 21 CFR 900.12(e)(2) and (d)(2)].

Level 2:
The FFDM manufacturer QC (excluding monitor & printer QC) procedures for digital unit 3, (b)(4) room Mammo were not followed. [See 21 CFR 900.12(e)(6)].
 
Level 2: The manufacturer recommended QC procedures for the monitor for digital unit 3, (b)(4), room Mammo were not followed. [See 21 CFR 900.12(e)(6)].
 
Level 2: Failed to produce documents verifying that the interpreting physician (b)(6) (0 CME's in 36 months) met the continuing education requirement of having taught or completed at least 15 category 1 continuing medical education units in mammography in 36 months. [See 21 CFR 900.12(a)(1)(ii)(B)].
 
Level 2: Failed to produce documents verifying that the radiologic technologist (b)(6) met the continuing experience requirement of having performed 200 mammography examinations in 24 months. [21 CFR 900.12(a)(2)(iv)(A)].
 
Level 2: Failed to produce documents verifying that the radiologic technologist (b)(6) met the requirement of having 8 hours of training in each mammographic modality. [See 21 CFR 900.12(a)(2)(ii)(C)].
 
Level 2: Failed to produce documents verifying that the radiologic technologist (b)(6) met the requirement of having 8 hours of training in each mammographic modality. [See 21 CFR 900.12(a)(2)(ii)(C)].
 
Level 2: Failed to produce documents verifying that the radiologic technologist (b)(6) met the requirement of having 8 hours of training in each mammographic modality. [See 21 CFR 900.12(a)(2)(ii)(C)].
 
Level 2: Failed to produce documents verifying that the radiologic technologist (b)(6) met the continuing experience requirement of having performed 200 mammography examinations in 24 months. [21 CFR 900.12(a)(2)(iv)(A)].
 
Level 2: Failed to produce documents verifying that the radiologic technologist (b)(6) met the requirement of having 8 hours of training in each mammographic modality. [21 CFR 900.12(a)(2)(iv)(A)].
 
On April 21, 2014, we received your facility letter dated March 21, 2014 (attached) submitted by Mr. Daniel Hamburger, Administrator of your facility, responding to the inspectional findings. The response failed to address the two most significant observations concerning the required QC testing. In addition, the response failed to provide documentation that (b)(6) and (b)(6) met the continuing experience requirements of having performed at least 200 exams in the last 24 months. Further, since (b)(6) failed to demonstrate meeting the MQSA requirements as a mammographer, the new modality training she provided is invalid. As such, any mammography exams performed by (b)(6) independently would be considered performed by an unqualified individual under 21 CFR 900.12(a)(2)(iv)(A). In addition, based on documentation provided for (b)(6), she may not lawfully perform mammography independently since she fails to meet the continuing experience requirements and new modality training required under 21 CFR 900.1(a)(2)(iii)(E). As such, any exams performed by (b)(6) independently would also be considered performed by an unqualified technologist. Mr. Hamburger was advised of these failures in our letter dated July 16, 2014 (attached).
 
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;
  • Requiring your facility to notify patients who received mammograms at your facility, and their referring physicians, of the deficiencies, the potential harm resulting from such deficiencies, appropriate remedial measures, and other relevant information;
  • 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; and
  • Seeking a court injunction against your facility.

See 42 USC 263b(h)-(j) and 21 CFR 900.12(j).
 
As relayed in our letter dated July 10, 2014 (attached) to Mr. Hamburger, we have asked the American College of Radiology (ACR) to conduct an Additional Mammography Review (AMR) of mammograms performed by your facility during the period of May 1, 2013 through November 30, 2013. The ACR will contact you regarding the selection of films for their review. You may be required to reimburse the ACR for the cost of this AMR. If this review shows that the clinical image quality of mammograms during this time has been compromised and may present a serious risk to human health, we may require that you notify patients and their referring physicians of this problem. We have enclosed a copy of the relevant FDA regulation at Title 21 C.F.R. 900.12(j) as a reference.

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; and
 
3.    Sample records that demonstrate proper record keeping procedures.

Please submit your response to this letter to:
                                               
Lillian C. Aveta                                                                                                                                  
Compliance Officer                                                                                                                           
U.S. Food and Drug Administration                                                                                                  
158-15 Liberty Avenue                                                                                                                                   
Jamaica, New York 11433                                                                                                                  
Tel: (718) 662-5576                                                                                                                          
FAX: (718) 662-5431                                                                                                                       
lillian.aveta@fda.hhs.gov
 
Please send a copy of your response to:
                                               
Mark Horberg
New York City Department of Health
and Mental Hygiene
125 Worth Street, Room 623
New York, NY 10013
 
Finally, you should understand that there are many requirements pertaining to mammography. This letter pertains only to violations related to the recent inspection 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 James R. Wormuth, CHP, MQSA Auditor 518-453-2314, ext. 1030
 
 
Sincerely yours,
/S/
Ronald M. Pace
District Director
New York District
 
cc:        Mark Horberg
            New York City Department of Health
            and Mental Hygiene
            125 Worth Street, Room 623
            New York, NY 10013
 
cc:        Wedlyne Guerrier
            New York City Department of Health
            and Mental Hygiene
            42-09 28th Street, 14th Floor
            Long Island City, NY 11101
 
cc:        Leonard L. Lucey, J.D., L.L.M.
            Legal Counsel and Senior Director
            Breast Imaging Accreditation Program
            American College of Radiology
            1891 Preston White Drive
            Reston, Virginia 20191-4397