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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Sally Jobe Breast Diagnostic & Counseling Center 13-Nov-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

SOUTHWEST REGION

Office of the Regional

Food and Drug Director

7920 Elmbrook Drive, Suite 102

Dallas, TX 75247-4982

TELEPHONE: 214-655-8100

FACSIMILE: 214-655-8130

November 13, 2001

WARNING LETTER

CERTIFIED MAIL

RECEIPT REQUESTED

02-SWR-WL-04/8

RE: Inspection ID -1041170009

Gladys Wortham

Quality Assurance Compliance Manager

Sally Jobe Breast Diagnostic & Counseling Center

8200 E. Bellview

Englewood, CO 80111

Dear Ms. Wortham,

On October 22, 2001, a representative of the State of Colorado acting in behalf of the Food and Drug Administration (FDA) inspected your facility. This inspection revealed a serious regulatory problem involving the mammography at your facility.

The Mammography Quality Standards Act of 1992 requires your facility to meet specific

standards. These requirements help protect the health of women by assuring that a facility can perform quality mammography. The inspection revealed the following repeated level 2 findings at your facility:

Level 2 repeat: Failed to produce documents verifying that the interpreting physician [redacted] met the continuing expedience requirement of having interpreted or multi-read 960 mammograms in 24 months.

Level 2 repeat: Failed to produce documents verifying that the interpreting physician [redacted] met the continuing experience requirement of having interpreted or multi-read 960 mammograms in 24 months.

The specific problems noted above appeared on your MQSA Facility Inspection Report, which was issued to your facility at the close of the inspection. [A finding is considered a repeat finding if the same type of violation was cited during the previous inspection, whether or not the finding is associated with the same piece of equipment (x-ray unit, processor, or darkroom) or the same personnel in a given category.]

Level 2 repeat findings maybe 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.

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. The inspection revealed the following level 2 findings:

Level 2: Failed to produce documents verifying that the interpreting physician [redacted] (OCME?Sin 36 months) met the continuing education requirement of having taught or

completed at least 15 category 1 continuing medical education units in mammography in 36 months.

Level 2: Failed to produce documents verifying that the interpreting physician [redacted] (11 CME?Sin 36 months) met the continuing education requirement of having

taught or completed at least 15 category 1 continuing medical education units in mammography in 36 months.

Level 2: Failed to produce documents verifying that the interpreting physician [redacted] (0 CME?Sin 36 months) met the continuing education requirement of having taught or completed at least 15 category 1 continuing medical education units in mammography in 36 months.

Level 2: Failed to produce documents verifying that the interpreting physician [redacted]

(7 CME?Sin 36 months) met the continuing education requirement of having taught or

completed at least 15 category 1 continuing medical education units in mammography in 36 months.

It is necessary for you to act on this matter immediately. You are required to respond to this office in writing within fifteen (15) working days from receipt of this letter. Please address the following:

- 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.

- 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:

Deborah M. McGee, Radiation Specialist

Food and Drug Administration

7920 Elmbrook Drive, Suite 102

Dallas, TX 75247-4982

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 (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 Deborah M. McGee at (214) 655-8100 ext. 138.

Sincerely yours,

Gary L. Pierce

Regional Food and Drug Director