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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

All Care Medical Group, Inc. 19-Nov-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

WARNING LETTER
Certified Mail
Return Receipt Requested
November 19, 2001
W/L Number: 13-02
Inspection ID: 1798040007
CFN: 20-29,957
FEI: 1000519154

Craig Kaner
Chief Executive Officer
All Care Medical Group, Inc.
2675 East Slauson Avenue
Huntington Park CA 90255-2996

Dear Mr. Kaner:

We are writing to you because on October 18, 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 1: Phantom quality control (QC) records were missing for three (3) weeks in January, four (4) weeks in February, three (3) weeks in April, and one (1) week in May of the year 2001 for unit #l (a machine, model [redacted] serial number [redacted] which located in the mammography room.

- Level 1: Processor QC records in October 2000 were missing for seven (7) out of the twenty-two operating days (thirty-one percent [31%]) for processor #l (a [redacted] machine, model [redacted] which is located in the darkroom.

- Level 1: Processor QC records were missing at least five [5) consecutive days for processor #1 (a [redacted] machine, model [redacted] which is located in the darkroom.

- Level 1: Failed to produce documents verifying that the radio logic technologist, [redacted] met the initial requirement of holding either a valid state license or a valid certificate from an FDA-approved body.

- Level 1: Failed to produce documents verifying that the radiologic technologist, [redacted] met the initial requirement of holding either a valid state license or a valid certificate from an FDA-approved body.

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, 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: Not all positive mammograms were entered in the tracking system.

- Level 2: There is no designated audit (reviewing) interpreting physician.

- Level 2: Failed to produce documents verifying that the radiologic technologist, [redacted] met the continuing experience requirement of having performed two hundred (200) mammography examinations in twenty-four (24) months.

- Level 2: Failed to produce documents verifying that the radiologic technologist, [redacted] (zero [0] CEU?S in thirty-six [36] months) met the continuing education requirement of having taught or completed at least fifteen (15) continuing education units in mammography in thirty-six (36) months.

  • Level 2: Medical audit and outcome analysis was not performed annually.

- Level 2: Medical audit and outcome analysis was not done separately for each individual

- Level 2: Medical audit and outcome analysis was 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; 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 free to contact Scott Goff (the Compliance Officer assigned to this case) at telephone number 949-798-7644.

Sincerely yours,
Alonza E. Cruse
District Director