Inspections, Compliance, Enforcement, and Criminal Investigations
Medical Center at Lancaster 20-Dec-01
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
7920 Elmbrook Drive
Dallas, TX 75247-4982
December 20, 200l
RETURN RECEIPT REQUESTED
RE: Inspection ID ? 1255830007
Linda 0. Judge, M.D.
Medical Center at Lancaster
2600 W. Pleasant Run Road
Lancaster, TX 75 146
Dear Dr. Judge,
On 12/14/2001, a representative from the State of Texas , acting on behalf of the Food and Drug
Administration (FDA) inspected your facility. This inspection revealed a serious regulatory problem involving the mammography at your facility.
The Mammography Quality Standards Act of 1992 requires your facility to meet specific standards. These requirements help protect the health of women by assuring that a facility can perform quality mammography. The inspection revealed the following level 1 finding at your facility:
- Level 1: The s y stem to communicate results is not adequate for site Medical Center at Lancaster because:
- There is no s y stem in place to provide timely lay summaries
The specific problem noted above appeared on your MQSA Facility Inspection Report, which was issued to your facility at the close of the inspection.
Level 1 findings may be symptomatic of serious underlying problems that could compromise the quality of mammography at your facility. They represent a serious violation of the law which may result in FDA taking regulatory action without further notice to you. These actions include, but are not limited to:
- Placing your facility under a Directed Plan of Correction.
- 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 Standards.
- Suspension or revocation of your facility? s FDA certificate, or obtaining a court injunction against further mammography.
In addition, your response should address the Level 2 findings that were listed on the inspection report provided to you at the close of the inspection. These Level 2 findings are:
- Level 2: The mammography equipment evaluation (by a medical physicist) for unit 1, General Electric Co. (GE Medical Systems), DMR, room Mammography Room was not done
- Level 2: Corrective action before further exams, for a failing image score, or a phantom background optical density, or density difference outside the allowable regulatory limits, was not documented for unit 1, General Electric Co. (GE Medical Systems), DMR, room Mammography Room
- Level 2: Failed to produce documents verifying that the radiologic technologist [redacted]
(10 CEU? s in 36 months) met the continuing education requirement of having taught or completed at least 15 continuing education units in mammography in 36 months
It is necessary for you to act on this matter immediately. You are required to respond to this office in writing within fifteen (15) working days from receipt of this letter. Please address the following:
- The 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.
- 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).
Please submit your response to:
Angela T. Moak, Radiation Specialist
Food and Drug Administration
7920 Elmbrook Drive, Suite 102
Dallas, Texas 75247-4982
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 (l-800-838-7715) or through the Internet at http://www.fda.gov/cdrh/mammography/index.html.
If you have more specific questions about mammography facility requirements, or about the content of this letter, please feel free to contact Angela Moak at (214) 655-8100 ext. 135.
C. D. Evans for Gary L. Pierce
Regional Food and Drug Director