Inspections, Compliance, Enforcement, and Criminal Investigations
Roosevelt General Hospital 02-Aug-02
7920 Elmbrook Drive
Dallas, TX 75247-4982
August 2, 2002
RETURN RECEIPT REQUESTED 02-SWR-WL-51/8
Roosevelt General Hospital
14121 US Hwy. 70
P.O. Box 868
Portales, NM 88130
Dear Mr. D?Agostino:
Re: Inspection ID - 2265540001
We are writing to you because on June 5, 2002, a representative of the Food and Drug Administration, (FDA) inspected your facility. This Inspection revealed serious regulatory problems involving the mammography at your facility. Under the Mammography Quality Standards Act of 1992 (MQSA or the ACT), 42 U.S.C. 263b, and its implementing regulations set forth in Title 21, Code of Federal Regulations (CFR), Part 900, your facility must meet specific requirements for mammography. These requirements help protect the health of women by assuring that facility can perform quality mammography. The inspection revealed the following violation at your facility.
- The system to communicate results is not adequate because there is no system in place to provide timely lay summaries. (see 21 CFR 900.12(c)(2)
- Your facility failed to produce documents verifying that the interpreting physician [redacted] met the continuing experience requirement of having interpreted or multi-read 960 mammograms in 24 months. (See 21 CFR 900.12. (a)(1)(ii)
The specific problem noted above appeared on your MQSA Facility Inspection Report, which was issued to your facility at the close of the inspection.
These conditions represent a violation of the law that may result in FDA?s instituting regulatory action against your facility. Possible actions include, but are not limited to placing your facility under a Directed Plan of Correction and/or charging your facility for the cost of on-site monitoring. Failure to correct these violations promptly could also cause FDA to seek civil money penalties up to $10, 000 for each failure to substantially comply with or each day failure to substantially comply with the MQSA standards, seek suspension or revocation of your facility?s FDA certificate, or seek a court injunction against further mammography (see sections 363b(h) through (1) of the Act).
It is necessary for you to act on this matter immediately. Please explain to this office in writing within fifteen (15) working days from the date you received this letter:
1. the specific steps you have taken to correct all of the violations noted in this letter:
2. each step your facility is taking to prevent the recurrence of similar violations;
3. equipment settings (including technique factors), raw test data, and calculated final results, where appropriate; and
4. sample records that demonstrate proper record keeping procedures, if the findings 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 submit your response to:
Deborah M. McGee, Radiation Specialist
Food and Drug Administration
7920 Elmbrook Drive, Suite 102
Dallas. TX 75247-4982
Finally, you should understand that there are many FDA requirements pertaining to mammography. This letter pertains only to certain findings of your inspection and does not necessarily address other obligations you have under the law including, but not limited to, correcting the other violations cited on your MQSA Facility Inspection Report. 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 607. Columbia, MD 21045-6057 (1-800-838-7715) or through the Internet at http://www.fda.gov/cdrh/mammography/lndex.html.
If you have more specific questions about mammography facility requirements, or about the content of this letter, please feel free to contact Deborah M. McGee at (214) 655-8100, ext. 138.
Gary L. Pierce
Regional Food and Drug Director