Inspections, Compliance, Enforcement, and Criminal Investigations
Sampson Regional Medical Center 25-Jun-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
Atlanta District Office
60 Eighth Street, N.E.
Atlanta, Georgia 30309
June 25, 2001
VIA FEDERAL EXPRESS
Inspection ID: 1349650007
Sampson Regional Medical Center
607 Seaman Street
Clinton, NC 28328
Dear Mr. Hesketh:
Your facility was inspected on 6/12/01 by a representative of the North Carolina Department of Environment & Natural Resources (DENR), Division of Radiation Protection, acting on behalf of the Food and Drug Administration (FDA) . This inspection revealed that your facility failed to comply with certain Quality Standards for Mammography as specified in Title 21, Code of Federal Regulations (CFR) , Part 900.12, as follows:
Repeat Level 2 Non-Compliance:
1. your facility has not specified adequate written procedures for collecting and resolving consumer complaints or did not follow them when required.
Level 2 Non-Compliance:
2. The phantom image score (using an FDA-approved mammography phantom) is at least 3 fibers but is less than 4 fibers for unit #2 [redacted] located in room #2.
3. The phantom QC is not adequate for unit #2, [redacted] because the image was not taken at a clinical setting.
The specific deficiencies noted above appeared on your MQSA Facility Inspection Report which was issued to your facility following the close of the inspection. Item #1 also cited in was the previous inspection of your facility.
Because the above deficiencies may be symptomatic of serious underlying problems that could compromise the quality of mammography at your facility, they represent serious violation of the law which may result in FDA taking further regulatory action without notice to you. If you fail to promptly correct these deficiencies, FDA may, without further action notice, initiate regulatory. under MQSA, FDA may:
- impose civil money penalties on a facility of up to $10,000 for each failure to substantially comply with, or each day of failure to substantially comply with, the Standards.
- suspend or revoke a facility?s FDA certificate for failure to comply with the Standards.
- seek an injunction in federal court to prohibit any mammography activity that constitutes a serious risk to human health.
It is your responsibility to ensure adherence to each requirement the Mammography Quality Standards Act of 1992 (MQSA) and FDA?s regulations. You are responsible for investigating and determining the causes of the deficiencies that the inspection identifies and promptly initiating permanent corrective actions.
Please note that FDA regulations do not preclude a State from enforcing its own State mammography laws and regulations. In some cases, these requirements may be more stringent than FDA?s. When you plan your corrective action(s), therefore, YOU should consider the more stringent State requirements, if any.
Within 15 working days after receiving this letter, you should notify the FDA in writing of:
- specific steps you have taken to correct all of the violations noted in this letter;
- each step your facility is taking to prevent the recurrence of similar violations;
- equipment settings (including technique factors), raw test data, and calculated final results, where appropriate; and
- sample records that demonstrate proper record-keeping procedures, if the non-compliances that were found relate to quality control or other records. (Note: Patient names or identification should be deleted from any copies submitted.)
If your facility is unable to complete the corrective action within 15 working days, you should state the reason for the delay and the time within which corrections will be completed. Please send the original copy of your response to:Serene A. Kimel, Compliance Officer
U.S. Food and Drug Administration
60 8th St., NE Atlanta, GA 30309
With a copy to:North Carolina DENR
Division of Radiation Protection
3825 Barrett Drive
Raleigh, NC 27609-7221
U.S. Food and Drug Administration
5701 Executive Center Drive, Suite 104
Charlotte, NC 28212
(NOTE : If phantom image is required for corrective action, please submit original to North Carolina DENR, Division of Radiation Protection. )
Finally, you should understand that there are many FDA requirements pertaining to mammography. This letter pertains only to findings of your inspection 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.
You may choose to address both FDA and state requirements in your response. If you have any questions regarding this letter or how to ensure you are meeting MQSA standards, please call Thomas Clarida at 704-344-6116.
Ballard H. Graham, Director