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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Santa Monica - UCLA Women's Imaging Center 30-Jan-02

Department of Health and Human Services' logoDepartment of Health and 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

January 30, 2002

Sharon Reyes-Siebuhr
Operations Manager Inspection
Santa Monica - UCLA Women's Imaging Center
1245 16th Street; Suite #110
Santa Monica, CA 90404-1240

W/L Number 2602
Inspection ID: 2226630003
CFN: 20-32,169
FEI: 3003146925

Dear Ms Reyes-Siebuhr:

We are writing to you because on December 28, 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 REPEAT Level 2 finding at your facility:

-Level 2: 2 of 6 random reports reviewed did not contain an acceptable assessment category. This is a REPEAT violation.

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 repeat Level 2 because it identifies a failure to meet a significant MQSA requirement in Title 21 Code of Federal Regulations section 900.12(c)(1)(iv) and (v).

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 (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, or 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 the violation 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).

We are concerned with your facility's problem of straying from MQSA compliance. On December 13, 2000, your facility was inspected (Inspection ID number: 2226630002) with a partial finding of "***2 of 6 random reports reviewed did not contain an assessment category. ***". On February 14, 2001, Dr. Tom Oshiro (medical physicist at your facility) wrote us and simply stated "This problem has been addressed by our radiologists and has been corrected." Based upon Dr. Oshiro's willingness to correct this problem, we wrote to Ms Nancy Kelly (operations manager) on April 5, 2002 that your voluntary corrective action was adequate, but subject to evaluation during your next regularly scheduled MQSA inspection. Now, for your 2001 MQSA inspection, the same problem has been detected again.

Your response should also include specifically why your proposed corrective action was not implemented in February 2001. Who (by name and title) had the authority,capability, and responsibility to carryout that corrective action and why that individual did not. Finally, please submit not only your applicable revised quality assurance section(s) in reference to correcting this problem, but additionally your validation process to verify that the change procedure is, in fact, being carried out.

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

Sincerely,

/S/

Alonza E. Cruse
District Director

cc:
Ms Priscilla F. Butler
Director, Breast Imaging Accreditation Programs
Standards & Accreditation Dept.
American College of Radiology
1891 Preston White Drive
Reston, VA 20191-4397

State of California
Dept. of Health Services
Radiological Management Health Unit
3530 Wilshire Blvd.; 9th Floor
Los Angeles, CA 90010-2310