Inspections, Compliance, Enforcement, and Criminal Investigations
Virginia Hospital Center Arlington Health System 30-May-02
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Public Health Service |
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Baltimore District Office |
Department
of Health and Human Services02-BLT- 17
CFN: 1124218
Facility ID:141739
Inspection ID #1417390667
May 30, 2002
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REOUESTED
Ms. Esther Wolfrey, Radiology Administrator
Virginia Hospital Center Arlington Health System
17 15 North George Mason Drive
Suite 403
Arlington, Virginia 22205
Dear Ms. Wolfrey:
A representative from the Commonwealth of Virginia under contract to the Food
and Drug Administration (FDA) inspected your facility on April 30, 2002. 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 violations of Section 354(f) of the Act at your facility identified
on your inspection report:
Your facility failed to document that corrective action was taken when nhantom
image testing
outside of pre-set limits for the following machines on the dates indicated:
[redacted] unit [redacted] located in room 4 on 9/19/2001 [redacted] unit located
in room 3 on 9/6 and 9/13/2001 [redacted] unit located in room 2 on 9/6/2002
[21 CFR 900.12(e)(8)(ii) and 21 CFR 900.12(e)(2)(i though iv)].
The [redacted] unit located in room 4 does not indicate the focal spot or
the target material after exposure when in automatic exposure control mode [21
CFR 900.12(b)(7)(i through iii].
The measured fog density in your mammography darkroom is redacted]. This exceeds the allowed limit of .05 optical density [21 CFR 900.12(e)(4)(i)].
The time period between the previous and current medical physicist surveys for the [redacted] unit [redacted] located in room 4 exceeded 14 months [21 CFR 900.12(e)(9)(i)]
Your facility failed to provide documentation which verified that Dr. [redacted] met the continuing experience requirement of having interpreted or multi-read 960 mammograms in 24 months [21 CFR 900.12(a)(1)(ii)(A)].
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 identify a failure to comply with a significant MQSA requirement.
Because these conditions may be symptomatic of serious underlying problems that could compromise the quality of mammography performed at your facility, they represent a violation of the law that may result in FDA taking regulatory action.
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 MQSA standards; suspension or revocation of your facility’s FDA certificate; or obtaining a court injunction against further mammography (see Sections 354(h) through (j) of the Act).
It is necessary for you to act on this matter immediately. Please explain to this office, in writing, withinfifteen (15) working days from the date you receive this letter:
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The specific steps you have taken to correct the violations noted in this letter.
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Each step your facility is taking to prevent the recurrence of similar violations.
Your response should be submitted to: Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 2 12 15, to the attention of Steven B. Barber, Compliance Officer. 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 may 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 technical questions about mammography facility requirements, or about the content of this letter, please feel free to contact Elizabeth A. Laudig at (410) 779-5441.
Sincerely,
/s/
Roberta Wagner for Lee Bowers
Director, Baltimore District
