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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

LBJ Tropical Medical Center 12-Oct-06

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

San Francisco District
1431 Harbor Bay Parkway
Alameda. CA 94502-7070
Telephone: 510/337-6700




WARNING LETTER

October 12,2006

Certifcd Mail
Return Receipt Requested

Re: MQSA Inspection ID # 2238660006
FEW 3003418919

Toalala lafeta, Chief Technologist - Radiology
LBJ Tropical Medical Center
P.O. Box LBJ
Mammography Department
Pago Pago, AS 96799

Dear Mr Iafeta:

On June 23, 2006, a representative of the Food and Drug Administration (FDA) inspected your facility. This inspection revealed a serious problem involving the conduct of mammography at your facility. Under the Mammography Quality Standards Act of 1992 ("MQSA"), which is codified in Section 263b of Title 42 of the United States Code (USC), your facility must meet specific requirements to practice mammography. These requirements help protect the health of women by assuring that a facility can perform quality mammography.

The inspection revealed violations of the MQSA at your facility. These violations were noted on the MQSA Facility Inspection Report and the document "Important Information about Your MQSA Inspection " that the inspector left with you at your facility at the close of the inspection. An amended report was faxed and mailed to you on July 19, 2006. The violations are again identified below.

Level l (repeat): The system to communicate results is not adequate for site LBJ Tropical Medical Center because there is no system in place to provide timely medical reports and there is no system in place to provide timely lay summaries. [See 21 CFR 900.12(c)(2)(i) and (ii)]

Level 1: Failed to produce documents verifying that the interpreting physician met the initial requirement of being certified in the appropriate specialty by an FDA-approved board or having 2 months of initial training in the interpretation of mammograms prior to 4128199 and failed to produce documents verifying that the interpreting physician met the initial requirement of holding a valid state license to practice medicine: [redacted] [See 21 CFR 900.12(a)(1)(i)(A) and (B))

Level 2: Corrective actions for processor QC failures were not documented at least once ( Mid-density on October 7, 2005) for processor [redacted], room [redacted] at site LBJ Tropical Medical Center. [21 CFR 900.12(e)(1)(ii)]

Level 2: Corrective actions before further exams for a failing density difference outside the allowable regulatory limits, were not documented for unit [redacted] room [redacted] on November 14,21, and 28, 2005 and December 5 and 12, 2005. [21 CFR 900.12(e)(2)(iv)]

Level 2: Failed to produce documents verifying that the interpreting physician met the continuing experience requirement of having interpreted or multi-read [redacted] mammograms in 24 months: [redacted] [21 CFR 900.12(a)(1)(i)(D)(ii)(A)]

Level 2: Four (4) of nine (9) random reports reviewed did not contain an acceptable assessment category for~site LBJ Tropical Medical Center. [21 CFR 900.12(c)(1)(iv)]

We received your responses dated June 27, 2006 and June 30, 2006 to the MQSA Facility Inspection Report. Your responses were inadequate in that you failed to provide documentation demonstrating the correction of the violations. [n addition, your responses failed to include the specific steps you have taken to prevent the reoccurrence of the violations.

Because the continued failure to resolve these violations may be indicative of serious underlying problems that could compromise the quality of mammography at your facility, FDA may take additional actions, including, but not limited to, the following:

  • requiring your facility to undergo an Additional Mammography Review

  • placing your facility under a Directed Plan of Correction

  • charging your facility for the cost of on-site monitoring

  • seeking 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

  • seeking to suspend or revoke your facility's FDA certificate

See 42 USC 263b(h)-(j) and 21 CFR 900.12(j).

FDA may need to perform a Compliance Follow-up Inspection to determine that each problem at your facility has been corrected.

You should respond in writing to FDA within fifteen (15) working days from the date your received this letter. Your response should address the findings listed above and include:

1. the specific steps you have taken, or will take, to correct all of the violations noted in this letter, including projected timeframes for implementing those steps;

2. the specific steps you have taken, or will take, to prevent the recurrence of similar violations, including projected timeframes for implementing those steps;

3. sample records that demonstrate proper record keeping procedures;

Please submit your response to this letter to:

Russell A. Campbell, Compliance Officer
U.S. Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502
Tel. 510-337-6861
Fax 510-337-6703
russella.campbell@fda.hhs.gov

Finally, you should understand that there are many requirements pertaining to mammography. This letter pertains only to violations related to the recent inspection of your facility 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 2i045-6057 (1-800-838-7715) or through the Internet at http://www.fda.gov/cdrh/mammography/index.html.

If you have additional or more specific questions about mammography facility requirements, or about the content of this letter, please feel free to contact Russell A. Campbell at 510-337-6861.

Sincerely yours,

/S/

Barbara J. Cassens
District Director