Inspections, Compliance, Enforcement, and Criminal Investigations

Westcoast Radiology, Ltd 5/23/18

 

  

Black HHS-Blue FDA Logo

 

 

 
Office of Medical Device and Radiological Health Operations (OMDRHO)
Division 2 Gentral
555 Winderley P l# 200
Maitland, FL32751
Telephone: (407) 475-4700 

 

WARNING LETTER
CMS # 554972
                                                                                               
UNITED PARCEL SERVICE
w/DELIVERY CONFIRMATION
 
May 23, 2018
 
Re: MQSA Inspection ID # 162487002
       FEI# 1000525950
 
Kim Ridley, COO
Westcoast Radiology
501 S Lincoln Ave
Clearwater, FL 33756
 
Dear Ms. Ridley:
 
On September 18, 2017, 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 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". The violations are again identified below:
 
Level 1: There is no system in place to provide timely medical reports. [See 21 CFR 900.12(c)(3)(i),(ii)].
 
Level 1: There is no system in place to provide timely lay summaries. [See 21 CFR 900.12(c)(2)(i),(ii)]
 
Level 1: There is no system in place to communicate serious or highly suggestive cases as soon as possible. [See 21 CFR 900.12(c)(3)(ii)]
 
You have failed to respond to the MQSA Facility Inspection Report as requested in the document "Important Information about your MQSA Inspection" emailed to you on October 25, 2017. 
 
Because the continued failure to resolve this (these) violation(s) 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. Note: Patient names or other information that would likely reveal the patient's identity can be deleted from any copies of records you submit.
 
Please submit your response to this letter to Compliance Officer, Andrea Norwood at oradevices2firmresponses@fda.hhs.gov
                       
Please send a copy of your response to:
                        Bureau of Radiation Control/Mammography Division
                        4052 Bald Cypress Way Bin C21
                        Tallahassee, FL 32399-1741
 
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.
 
Should you have questions concerning the content of this letter, please direct your questions to Karen Smallwood, Radiological Health Representative, telephone number 615-366-7823.
 
Sincerely,                                                                   
/S/ 
Blake Bevill, MS
Program Division Director
Office of Medical Device and Radiological Health
Division 2 – Central
 
 
Enclosures: West Coast Radiology (Clearwater) Post Inspection Report dated 9/18/2018
 
cc:
Nicholas Pospishil
Radiation Control
2044 All Childrens Way
Orlando, FL 32818

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