Inspections, Compliance, Enforcement, and Criminal Investigations
St. Vicent-Williamsport Hospital 01-Apr-02
Department of Health and Human Services
Public Health Service
April 1, 2002
RETURN RECEIPT REQUESTED
Ms. Jane Craigin, CEO
St. Vincent- Williamsport Hospital
412 N. Monroe Street
Williamsport, IN 47993
Dear Ms. Craigin:
We are writing you because on March 14, 2002, your facility was inspected by a representative of the State of Indiana acting on behalf of the Food & Drug Administration (FDA). The inspection revealed a serious compromise in the quality of the mammography services offered by your facility.
Under the Mammography Quality Standards Act of 1992 (MQSA), 42 U.S.C. § 263b, 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 finding:
1. Processor QC records were missing for at least 30% of the days in December 2001 when mammography films were processed. Specifically, the records show that mammograms were processed on 4 days in December and there was no evidence to show that any processor QC tests were performed on those days. This is in violation of Title 21 Code of Federal Regulations section 900.12(e)(1).
The specific problem noted above appeared on your MQSA Facility Inspection Report (copy enclosed), which was issued at the close of the inspection. This problem is identified as Level 1 because it identifies a failure to meet a significant MQSA requirement.
Since this condition may be symptomatic of serious underlying problems that could compromise the quality of mammography at your facility, it represents a 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, suspension or revocation of your facility's FDA certificate, or obtaining a court injunction against performing further mammography.
In addition, you should also address the following Level 2 finding that was listed on the inspection report provided to you at the close of the inspection:
2. Phantom QC records were missing for at least two (2) weeks, but less than four (4) weeks during the time that mammogram exams were being conducted. Specifically, phantom images were not taken during two (2) weeks in December 2001 and one (1) week in January 2002 when patients were receiving mammography exams. This is in violation of Title 21 Code of Federal Regulations section 900.12(e)(2).
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 receive this letter:
• the specific steps you have taken to correct the Level 1 and 2 violations noted in this letter;
• each step your facility is taking to prevent the recurrence of similar violations;
• the 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:
Mr. David M. Kaszubski
Director Compliance Branch
U.S. Food & Drug Administration
1560 East Jefferson Ave.
Detroit, MI 48207-3179
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 actions, you should consider the more stringent State requirements, if any. You should also send a copy of your response to the State of Indiana radiation control office that conducted the inspection referenced in this letter. You may choose to address both the FDA and any additional State requirements in your response.
There are many FDA requirements pertaining to mammography. This letter only concerns the findings of your recent 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.
If you have any questions regarding this letter or how to ensure that you are meeting MQSA standards, please call Mr. Dennis E. Swartz, Radiological Health Expert, at 313-226-6260 Ext. 155.
Joann M. Givens
Detroit District Office
Enclosure (MQSA Facility Inspection Report)