Inspections, Compliance, Enforcement, and Criminal Investigations
Inland Imaging, LLC at Medical Center 20-Mar-02
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
March 20, 2002
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Reference: Warning Letter SEA 02-36
Inspection ID: 1177700009
Kathleen Wilson, Chief Executive Officer
Inland Imaging, LLC, at Medical Center
820 S. McClellan, Suite 101
Spokane, Washington 99204
Dear Ms. Wilson:
We are writing to you because on March 6, 2002, your facility was inspected by Kelly Cameron, a representative of the State of Washington, 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 level 1 findings at your facility:
The Phantom QC records were missing for six months (from March 12, 200l through September 17, 2001) for unit number 4, identified as MIII, Lorad Medical Systems Inc.
The specific problem noted above appeared on your MQSA Facility Inspection Report, which was issued to your facility at the close of the inspection. This problem is identified as Level I, because it identifies a failure to meet a significant MQSA requirement. Because this condition may be symptomatic of serious underlying problems that could compromise the quality of mammography at your facility, it represents 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 finding that was listed on the inspection report provided to you at the close of the inspection. This Level 2 finding was:
The mammography processor equipment evaluation has not been performed for the Kodak, X- OMAT M35 or M35A-M processor which has been in service since December 2001. Because this processor is a major component of your mammography system, a medical physicist or a person under the direct supervision of the medical physicist shall perform the evaluation.
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 (l-800-838-7715) or through the Internet at http://www.fda.gov.
Charles M. Breen