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Department of Health and Human ServicesCertified Mail
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WARNING LETTER
FLA-10-10
January 22, 2010
Re: MQSA Inspection ID #216085
FEI #3002616416
Edelio Mirabolo
Cardiovascular Diagnostic Image, Inc.
10621 North Kendall Drive, Suite 101
Miami, Florida 33176
Dear Mr. Mirabolo:
On November 20-23, 2009, a representative of the State of Florida, acting on behalf of the Food and Drug Administration (FDA), and a representative of FDA inspected your facility. The 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 (42 U.S.C. 263b), 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 MQSA violations observed during the current inspection, some of which were also observed during previous inspections on October 9, 2007, and November 25, 2008, were noted on the MQSA Facility Inspection Report and the document "Important Information about Your MQSA Inspection" that Inspector James Stokes left with you on November 23, 2009. These violations (referenced below as deviations from the quality standards set forth in Title 21 Code of Federal Regulations Part 900 Section 12 [21 CFR 900.12]) are again identified below.
Noncompliance Level 2
• The manufacturer QC procedures for your full field digital mammography (FFDM) device identified as Digital Unit #3, (b)(4) Mammography Room (excluding monitor & printer), were not being followed. This is a repeat violation. [21 CFR 900.12(e)]
• The time period between the previous and current surveys for Digital Unit #3, (b)(4) Mammography Room, was in excess of fourteen (14) months. This is a repeat violation. [21 CFR 900.12(e)(9)]
• Failed to produce documents verifying that the interpreting physicians Modar Ashouri and Ralph Dauito met the continuing education requirement of having taught or completed at least fifteen (15) Category I continuing medical education (CME) units in mammography in thirty-six (36) months. Dr. Ashouri only had eight (8) CME units during this time period; Dr. Dauito had none (0). This is a repeat violation. [21 CFR 900.12(a)(1)(ii)(B)]
• Failed to produce documents verifying that the interpreting physicians Modar Ashouri and Ralph Dauito met the continuing experience requirement of having interpreted or multi-read nine hundred sixty (960) mammograms in twenty-four (24) months. This is a repeat violation. [21 CFR 900.12(a)(1)(ii)(A)]
• Failed to produce documents verifying that the interpreting physician Ralph Dauito met the continuing experience requirement of having eight (8) hours of training in the new mammographic modality. This is a repeat violation. [21 CFR 900.12(a)(1)(ii)(C)]
• Five (5) out of five (5) mammography reports randomly selected for review failed to contain an acceptable assessment category. This is a repeat violation. [21 CFR 900.12(c)]
• The manufacturer recommended QC procedures for the monitor for Digital Unit #3, (b)(4) Mammography Room, were not followed. [21 CFR 900.12(e)]
• Failed to produce documents verifying that the interpreting physician Ralph Dauito met the initial experience requirement of having interpreted or multi-read two hundred forty (240) mammograms within six (6) months. [21 CFR 900.12(a)(1)(i)(D)]
• Failed to produce documents verifying that the interpreting physician Ralph Dauito met the initial requirement of having sixty (60) hours of documented medical education in mammography prior to April 28, 1999. [21 CFR 900.12(a)(1)(i)(C)]
• Failed to produce documents verifying that the radiologic technologist (b)(6) met the continuing experience requirement of having completed two hundred (200) mammography examinations in twenty-four (24) months. [21 CFR 900.12(a)(2)(iv)]
• Failed to produce documents verifying that the radiologic technologists (b)(6) and (b)(6) met the initial requirement of having forty (40) contact hours of training specific to mammography. [21 CFR 900.12(a)(2)(ii)]
• Failed to produce documents verifying that the radiologic technologists (b)(6) and (b)(6) met the requirement of having eight (8) hours of training in each mammographic-modality. [21 CFR 900.12(a)(2)(ii)(C)]
• Failed to establish and maintain a mammography medical outcomes audit program and designate an interpreting physician to review the medical outcomes audit data at least once every twelve (12) months in order to ensure the reliability, clarity, and accuracy of the interpretation of mammograms. [21 CFR 900.12(f)]
Noncompliance Level 3
• The QA program for your facility is inadequate in that your procedures for personnel responsibilities and QC -testing were missing or incomplete. This is a repeat violation. [21 CFR 900.12(d)]
• The required personnel qualification documents were not available during the inspection. This is a repeat violation. [21 CFR 900.12(a)(4)]
Florida District acknowledges and appreciates your promises to correct the above violations which you made during the course of the inspection. In addition, we have received your written response to the MQSA Facility Inspection Report dated December 3, 2009. However, based on the numerous repeat MQSA violations observed during the current inspection, we find that your response is inadequate in that you failed to provide adequate documentation of corrections made and corrective actions you have taken to bring your firm into compliance.
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; and/or
• 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 receive this letter. Your response should address the findings listed above and include the specific steps you have taken, or will take, to correct all of the violations noted in this letter and prevent the recurrence of similar violations, including projected timeframes for implementing those steps.
Please submit your written response to this letter to the attention of Matthew B. Thomaston, Compliance Officer, at the address below.
FDA, Florida District Office
555 Winderley Place, Suite 200
Maitland, FL 32751
Also, please send a copy of your response to the State of Florida at the address below.
State of Florida, Division of Radiological Health
705 Wells Road, Suite 300
Orange Park, FL 33609
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 contact Michael P. Divine, M.S., CDRH, at 301-796-5913.
Sincerey,
/s/
Emma R Singleton
Director, Florida District
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