Inspections, Compliance, Enforcement, and Criminal Investigations
Healthcare Partners Medical Group 17-Oct-01
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
19900 MacArthur Blvd., Suite 300
Irvine, California 92612-2445
Telephone (714) 798-7600
Return Receipt Requested
October 17, 200
W/L Number: 08-02
Robert Margolis, M.D.
Chief Executive Officer Inspection
Healthcare Partners Medical Group
1025 West Olympic Avenue
Los Angeles, CA 90640-1329
Dear Dr. Margolis:
We are writing to you because on September 20, 2001, your facility located at 2601 Via Campo, Montebello, California 90640 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 1 finding at your facility:
- Level 1: Mammograms were processed in processor #1 (a [redacted] machine), which is located in the darkroom, when it was out of limits on at least 5 days during "February 2000. Patient mammograms were processed on those days even though the processor was out of limits.
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 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 (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.
In addition, your response should address the Level 2 findings that were listed on the inspection report provided to you at the close of the inspection. These Level 2 findings are:
- Level 2: Corrective action before further exams (for a failing image score, or a phantom background optical density, or density difference outside the allowable regulatory Limits) was not documented for unit ?#3 (a [redacted] machine, model [redacted] which is located in the mammography room.
- Level 2: Corrective actions for processor quality control failures were not documented at least once for processor #1 (a- machine) which is located in the darkroom.
- Level 2: The processing speed (using the S.T.E.P. procedure), for processor #1 (a [redacted] machine which is located in the darkroom), is at least 85, but less than 100 for extended processing.
It is necessary for you to act on this matter immediately. Please explain to this office, in writing, within fifteen(15) working days horn 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 find results, where appropriate; 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: 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 flee to contact Scott Goff (Compliance Officer) at telephone number 949-798-7644.Sincerely,
Alonza E. Cruse