Glendale Adventist Medical Center 06-Dec-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

19900 MacArthur Blvd., Ste 300

Irvine, California 92612-2445

Telephone (949) 798-7600

WARNING LETTER

Certified Mail

Return Receipt Requested

December 6, 2001

W/L Number: 18-02

Inspection ID: 1903480007

cfn: 20-30,125

FEI: 1000519281

Robert McKay, M.D.

Lead Interpreting Radiologist

Glendale Adventist Medical Center

Radiology Department

1509 East Wilson Terrace

Glendale, CA 91206-4098

Dear Dr. McKay:

We are writing to you because on October 30, 2001, your facility was inspected by a

representative of the State of California acting in 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

(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. The inspection revealed the following Level I findings at your

facility:

- Level k Phantom quality control (QC) records were missing for the weeks of February

5^th, April 16^th, June 18^th, September 17^th, and October 1^st of the year 2001 for unit #5 (a

machine, model [redacted] serial number [redacted] which is located in room number III and is referred to as "Mammo. I".

- Level 1: Phantom QC records were missing for the weeks of December 8, 2000 and

February 23^rd, March 2^nd, March 9^th, March 16^th, March 23^rd, April 16^th, June 18^th,

September 17^th, and October 1^st of the year 2001 for unit #6 (a [redacted] machine, model [redacted] , serial number [redacted] which is located in room number 112 and is referred to as "Mammo. 2".

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 Level 1 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 (DPC), 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, of each day of failure to substantially comply with, MQSA 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; and

- please provide 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 submit your response to:

Thomas L. Sawyer

Director, Compliance Branch

U. S. Food & Drug Administration

19900 MacArthur Blvd.; Suite #300

Irvine, CA 92612-2445

Phone: (949) 798-7600

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 (telephone number 1-800-838-7715) or through

the Internet at http://www.fda.gov.

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

the content of this letter, please feel free to contact Scott Goff (the Compliance Officer

assigned to this case) at telephone number 949-798-7644.

Sincerely,

Alonza E. Cruse

District Director