Columbia-St. Mary Hospital 22-Feb-02

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

Minneapolis District

240 Hennepin Avenue

Minneapolis, MN 55401-1999

Telephone. 612-3344100

February 22, 2002

WARNING LETTER

CERTIFIED MAIL

RETURN RECEIPT REQUESTED Refer to MIN 02 - 25

Leo P. Brideau

Chief Executive Officer

Columbia-St. Mary Hospital

2025 East Newport Avenue

Milwaukee, Wisconsin 53211

Dear Mr. Brideau:

A representative of the State of Wisconsin, acting on behalf of the Food and Drug

Administration (FDA), inspected your mammography facility, Glendale Clinic-

Green Bay Road, at 9233 No. Green Bay Road, Milwaukee, WI 53209 (MQSA

facility ID = 114033). The inspection date was February 20, 2002. This inspection

revealed serious regulatory problems involving the mammography at your facility.

Under a United States Federal law, the Mammography Quality Standards Act of

1992 (MQSA), 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. Based on the documentation your site

presented at the time of the inspection, the following Level 1 and Level 2 findings

were documented at your facility.

Level 1 Non-Compliance

1. The system to communicate results is not adequate for your Glendale

Clinic-Green Bay Road site because there is no system in place to provide

timely medical reports and there is no system in place to provide timely lay

summaries.

Level 2 Non-Compliance

2. Two of eight random reports reviewed did not contain an acceptable

assessment category for the Glendale Clinic-Green Bay Road site.

The specific problems noted above appeared on the MQSA Facility Inspection

Report which was issued to your facility following the close of the inspection.

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 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.

Please submit your response to Thomas W. Garvin, Radiological Health Specialist,

Food and Drug Administration, 2675 No. Mayfair Road, Suite 200, Milwaukee, WI

53226- 1305.

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, MD 21045-6057 (l-800-838-7715) or

through the Internet at http://www.fda.gov/cdrh/mammography/index.html.

If you have specific questions about mammography facility requirements, or about

the content of this letter, please feel free to phone Mr. Garvin at (414) 771-7167

ext. 12.

Sincerely,

David R. Yost

Acting Director

Minneapolis District