Breast Cancer Detection Center of Alaska 20-Dec-01

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Seattle District

Pacific Region

22201 23^rd Drive SE

Bothell, WA 98021-4421

Telephone: 425-486-8788

FAX: 425-483-4996

December 20, 2001

VIA CERTIFIED MAIL

RETURN RECEIPT REQUESTED

Reference: Warning Letter SEA 02-23

Inspection ID: 1668500007

WARNING LETTER

Robert A. Coghill, Executive Director

Breast Cancer Detection Center of Alaska

1905 Cowles Street

Fairbanks, AK 99701

Dear Mr. Coghill:

We are writing to you because on December 11, 2001, your facility was inspected by Clyde E. Pearce, a representative of the State of Alaska, 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 Limited 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 finding at your facility:

Your procedures are not adequate to communicate, as soon as possible, assessments of

"suspicious" or "highly suggestive of malignancy".

The specific problems 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 1, 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:

Medical audit and outcome analysis were not done for the facility as a whole.

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).*

PLEASE NOTE: Your response dated December 14, 2001, was received via certified mail on December 18, 2001. The letter addressed an inspection of your facility on September 24, 2001. Our records show the most recent inspection was December 11, 2001. In addition, the reply addressed performance of the phantom image on a daily basis; however, none of the findings of the recent inspection were related in any manner to phantom imaging.

Please submit your response to U.S. Food & Drug Administration, Attention Thomas S.

Piekarski, Compliance Officer, 22201 23^rd 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

District Director