Inspections, Compliance, Enforcement, and Criminal Investigations
Valley General Hospital 19-Oct-01
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
October 19, 2001
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Reference: Warning Letter SEA 02-04
Inspection ID: 1450030007
Mr. Mike Watson, Radiology Manager
Valley General Hospital
Mammography Suite 700
14701 179th SE
Monroe, WA 98272
Dear Mr. Watson:
We are writing to you because on October 10, 2001, your facility was inspected by Mr. Bill Van Pelt with the State of Washington, acting on behalf of the U.S. Food and Drug Administration (FDA). This inspection revealed a serious regulatory problem involving the mammography at your facility.
Under a United States Federal law, the Mammography Quality Standards Act of 1992, 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 inspection revealed the following repeat level 2 and 3 findings at your facility:
1. 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 2, [redacted] Mammo Room (Repeat level 2).
2. Mammograms were processed in processor [redacted] at site Valley General Hospital, when it was out of limits on at least 2 but less than 5 days (level 2).
3. The fixer retention QC is not adequate for processor [redacted] because the fixer retention QC tests were not done at the required frequency (Repeat Level 3).
The specific problems noted above appeared on your MQSA Facility Inspection Report, which was issued to your facility at the close of the inspection. These problems are identified as Repeat Level 2 and 3 because they identify a failure to meet a significant MQSA requirement.
Because these conditions 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.
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:
- 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; and
- 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). *
*This note is not applicable for letters that also address patient notification.
Please submit your response to U.S. Food & Drug Administration, Attention Thomas S.
Piekarski, Compliance Officer, 22201 23rd Drive, SE, Bothell, Washington 98021-4421.
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, Maryland 21045-6057 (1-800-838-7715) or through the Internet at http://www.fda.gov.
Russell W. Gupp for