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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Mecklenburg Breast Screening Program MCHD 06-Sep-02

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

Public Health Service
Food and Drug Administration

 

Atlanta District Office
80 Eighth Street N.E.
Atlanta, GA 30309
Telephone: 404-253-1161
FAX: 404-253-1202


September 6, 2002

VIA FEDERAL EXPRESS

Fonda Oldham
Lead MQSA Technologist
Mecklenburg Breast Screening Program MCHD
2845 Beatties Ford Road
Mecklenburg County Health Dept.
Charlotte, NC 28216

Inspection ID: 2250300002

WARNING LETTER
(02-ATL-35)

Dear Ms. Oldham:

Your facility was inspected on August 14, 2002, by a representative of the North Carolina Department of Environment & Natural Resources (DENR), Division of Radiation Protection, acting on behalf of the United States Food and Drug Administration (FDA). This inspection revealed a serious regulatory problem involving the mammography services at your facility.

Under the Mammography Quality Standards Act of 1992 (MQSA), 42 U.S.C § 236b, your facility must meet specific requirements for mammography. These requirements help protect the health of women by assuring that a facility can perform quality mammography. The recent inspection at your facility revealed the following Level 1 violation:

. The system to communicate results is not adequate in that there is no system in place to provide timely medical reports; no system in place to provide timely lay summaries; and no system in place to communicate serious or highly suggestive cases as soon as possible. [21 CFRS 900.12(c)]

. The specific problem noted above appeared on your MQSA Facility Inspection Report, which was issued to your facility at the dose of the inspection. This problem is identified as Level 1, because it identifies a failure to meet a significant MQSA requirement, as described above.

Because this condition may be symptomatic of serious underlying problems that could compromise the quality of mammography at your facility, it represents a serious violation of the law which may result in FDA initiating regulatory action without further informal notice to you. These actions include, but are not limited to, placing your fac1ity under a Directed Plan of Correction(DPC), charging your facility for the cost of on-site monitoring, assessing civil money penalties up to $10,000 for each failure to substantially comply with, or each day of failure to substantially comply with the federal mammography standards, or suspending or revoking your facility's FDA certificate.

It is necessary for you to act on this matter immediately. Please explain to this office, in writing, within fifteen (15) working days after receiving this letter.

. The specific steps you have taken to correct the violation noted in this letter,
. Each step your facility is taking to prevent the recurrence of similar violations;
. Sample records that demonstrate proper recordkeeping procedures, if the noncompliance relates 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 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. You should also send a copy of your response to the North Carolina DENR, Division of Radiation protection, 3825 Barrett Drive, Raleigh, NC 27609-7221 and to Thomas Clarida, U.S. Food and Drug Administration, 5701 Executive Center Drive, Suite 104, Charlotte, NC 28212.

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 alt 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 any questions regarding this letter or how to ensure you are meeting MQSA standards, please call Thomas Clarida at 704-344-6116.

 

Sincerely yours,

Barbara A. Wood, Acting Director
Atlanta District