Inspections, Compliance, Enforcement, and Criminal Investigations

Regional Radiology 7/11/16

  

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

Public Health Service
Food and Drug Administration
 New Jersey District Office
Waterview Corporate Center
10 Waterview Blvd. 3rd Floor
Parsippany, New Jersey 07054
Telephone: (973) 331-4900
FAX: (973) 331-4969

 

WARNING LETTER
 
 
 
July 11, 2016
 
 
VIA UNITED PARCEL SERVICE
RETURN RECEIPT REQUESTED

16-NWJ-10
 
 
Re:       MQSA Inspection ID #2229050012
FEI# 3003095373
 
Ralph Dauito, M.D.
Lead Interpreting Physician
AIMS Diagnostics
2800 Rte. 130N., Ste. 202
Cinnaminson, NJ 08077
 
Dear Ralph Dauito, M.D.:
 
On 03/31/2016, a representative of the State of New Jersey, acting on behalf 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 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 mailed to you on 4/6/16. Additionally, the report was faxed to (b)(6), Chief Technologist, on 5/20/16. The violations are again identified below:
 
Level 1: Phantom QC records were missing for at least 4 weeks for unit (b)(4), room Mammo. {See 21 CFR Part 900.12(e)(2) & (d)(2)}
 
Level 2: Review workstation (monitor) QC testing is not adequate because: - QC testing was not done at the required frequency. {See 21 CFR Part 900.12(e)(6) & (d)(2)}
 
Level 2: Contrast-to-noise ratio QC testing is not adequate for unit (b)(4), room Mammo because: - QC testing was not done at the required frequency. {See 21 CFR Part 900.12(e)(6) & (d)(2)}
 
Level 2: Signal-to-noise ratio QC testing is not adequate for unit (b)(4), room Mammo because: - QC testing was not done at the required frequency. {See 21 CFR Part 900.12(e)(6) & (d)(2)}
 
Level 2: A medical physicist's survey has not been conducted for x-ray unit (b)(4), room Mammo within the last 14 months. {See 21 CFR Part 900.12(e)(9)(i) & (d)(2)}
 
Level 3: The repeat analysis QC is not adequate for site AIMS Diagnostics because: - Corrective action within 30 days was not documented. {See 21 CFR Part 900.12(e)(6) & (d)(2)}
 
On 5/23/16, the NJ Department of Environmental Protection (NJDEP) received your response to the MQSA Facility Inspection Report. We received your response from the NJDEP on 5/31/16. Your response was inadequate in that the physicist began his survey of the (b)(4) unit but was unable to complete the survey because the unit was failing various tests, including phantom, AOP, SNR, and CNR. He informed the facility that service needed to be called and he would return to complete the survey after the unit was repaired. The inspector noted that the repairs were never completed and yet your facility continued to image patients. As a result, the Division of Mammography Quality Standards (DMQS) has decided to perform a full Additional Mammography Review (AMR) ((b)(4) cases) for the time period of January 2015 to present.
 
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 $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
•  seeking a court injunction against your facility
 
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.
 
Please submit your response to this letter to:
 
Jon Dimaano
MQSA/Radiological Health Specialist
U.S. Food and Drug Administration
281 0 N. Parham Road, Ste. 160
Richmond, VA 23294
 
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/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 Jon Dimaano at (804)747-0124 x110.
 
Sincerely yours,
/S/
Craig Swanson
Acting District Director
New Jersey District
 
cc:
Ramona Chambus, Supervisor
Bureau of X-Ray Compliance
NJDEP
P.O. Box 420, Mail Code 25-01
Trenton, NJ 08625-0415
 
Priscilla F. Butler, M.S., FAAPM
Director, Breast Imaging Accreditation Programs
American College of Radiology
1891 Preston White Drive
Reston, VA 22091
 
 

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