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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Holy Cross Hospital 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
RETURN RECEIPT REQUESTED 02-SWR-WL-05/8
RE: Inspection ID ?1740780007

Warren K. Spellman
Chief Executive Officer
Holy Cross Hospital
1397 Weimer Road
Taos, NM 87571

Dear Mr. Spellman,

On October 24, 2001, a representative 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 b y assuring that a facility can perform quality mammography. The inspection revealed the following level 1 repeated level 2 findings at your facility:

Level 1: Mammograms were processed in processor 1, Fuji, when it was out of limits on 35 days.

Level 2 repeat: 2 of 5 random reports reviewed did not contain an assessment category.

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 1 and repeated level 2 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: 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 2, Lorad Medical Systems Inc., MIV.

Level 2: The time period between the previous and current surveys for x-ray unit 2, Lorad Medical Systems Inc., MIV exceeds 14 months.

Level 2: The interpreting physician did not meet the continuing education requirement of having completed a minimum of 15 CME credits in mammography in a 36 month period: [redacted] (0 CME?S in 36 months).

Level 2: The interpreting physician did not meet the continuing experience requirement of having read or interpreted 960 patient examinations in a 24 month period: [redacted]

Level 2: The interpreting physician did not meet the continuing experience requirement of having read or interpreted 960 patient examinations in a 24 month period: [redacted]

Level 2: The interpreting physician did not meet the continuing experience requirement of having read or interpreted 960 patient examinations in a 24 month period: [redacted]

Level 2: The medical physicist did not meet the continuing experience requirement of having surveyed a minimum of 2 facilities and 6 units in a 24 month period: [redacted]

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