Inspections, Compliance, Enforcement, and Criminal Investigations
St. Anthony Hospital 09-Nov-01
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4424
November 9, 2001
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Reference: Warning Letter SEA 02-08
Inspection ID: 1378510008
Jeffrey Drop, Administrator
St. Anthony Hospital
1601 SE Court Place
Pendleton, OR 97801
Dear Mr. Drop:
We are writing to you because on October 15, 2001, your facility was inspected by J. Robert Rapcinski, a representative of the State of Oregon, acting on behalf of the 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. Level 2: Five often mammography reports reviewed at random did not contain an acceptable assessment category.
2. Level 3: The required initial qualification and/or continuing education and experience documents were not available during the inspection for: [redacted]. As of the date of this letter, the required documentation has been furnished to Mr. Rapcinski.
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 that 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.Sincerely,
Charles M. Breen