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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Women's Breast Care Clinic 02-Aug-06

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

Public Health Service
Food and Drug Administration

 

New Orleans District
Southeast Region
297 Plus Park Blvd
Nashville, TN 37217
Telephone: 615-781-5385
Facsimile: 615-781-5383



August 2, 2006

WARNING LETTER
2006-NOL-14

OVERNIGHT DELIVERY
FEDERAL EXPRESS



FACILITY ID# 147447

Mark McPhail, C.E.O.
Women's Breast Care Clinic
2124 14th Street
Meridian, MS 39301-4040

Dear Mr. McPhail:

On June 19, 2006, a representative of the U.S. Food & Drug Administration (FDA) conducted an inspection at your facility as a follow-up to an inspection conducted by a Senior Health Physicist with the State of Mississippi, Division of Radiological Health, on July 29, 2005. This inspection revealed serious problems 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 a facility can perform quality mammography procedures.

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" FDA Inspector Carl Huffman provided your facility on June 20, 2006, via facsimile.

The violations noted are identified below:

Level 1:

Processor Quality Control records in the month of April 2006 were missing for at least 30% of operating days, for processor 1 [redacted] Mammography room at Women's Breast Care Clinic [See Title 21, Code of Federal Regulations (CFR), Part 900.12(e)(1)].

Processor Quality Control records were missing at least 5 consectuive days for processor 1, [redacted] Mammography room at Women's Breast Care Clinic [See21 CFR 900.12(e)(1)].

Phantom Quality Control Records were missing for at least 4 weeks for unit 4, [redacted] MIV, MAMMO Room #1 [See 21 CFR 900.12(e)(2)].

Phantom Quality Control records were missing for at least 4 weeks for unit 5, [redacted], MIV, MAMMO Room #2 [See 21 CFR 900.12(e)(2)].

Phantom Quality Control records were missing for at least 4 weeks for unit 6, [redacted], MIV, MAMMO Room #3 [See 21 CFR 900.12(e)(2)].

Level 2

The facility has not specified adequate procedures to be followed for infection control or did not follow them when required at Women's Breast Care Clinic [See 21 CFR 900.12(e)(13)].

Corrective actions for processor Quality Control failures were not documented at least once for processor [redacted] Mammo at Women's Breast Care Clinic [See 21 CFR 900.12(d)(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 4, [redacted] MIV, MAMMO Room #1 [See 21 CFR 900.12(d)(2)].

Corrective action before further exams, for a failing image score, or a phantom background optical density, or dens it difference outside the allowable regulatory limits, was not documented for unit 5, [redacted] MAMMO Room #2 [See 21 CFR 900.12(d)(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 6, [redacted] MIV, MAMMO Room #3 [See 21 CFR 900.12(d)(2)].

A Medical audit and outcome analysis was not done for the facility as a whole at Women's Breast Care Clinic [See 21 CFR 900.12(f)(1)].

There is no designated audit (reviewing) interpreting physician for Women's Breast Care Clinic [See 21 CFR 900.12(f)(3)].

A medical audit and outcome analysis was not performed separately, for each individual radiologist, at Women's Breast Care Clinic [See 21 CFR 900.12(f)(1)].

A medical audit and outcome analysis was not performed annually at Women's Breast Care Clinic [See 21 CFR 900.12(f)(2)].

On July 11, 2006, we received your response to the MQSA Facility Inspection Report. Your response was inadequate as follows:

1. You failed to submit your revised infection control policy to document your correction of the Level 2 finding on the infection control mechanism used by your facility. Submit this policy with your response to this letter.

2. Your corrective action for the Level II finding for equipment which has failed a quality control test stated, "The process for identifying QC failures, obtaining service, and collecting documentation of service performed as well as appropriate approval to use equipment which has failed a QC test, will be well defined in the Quality Assurance Manual." This is inadequate as there is no "appropriate approval to use equipment which has failed a QC test". Mammograms shall not be performed on mammography equipment which has had no corrective action.

3. You did not include a copy of your new policy covering the method of performing medical audits at your site. This deviation was a repeat violation from your 2001 inspection. The policy should include a requirement for annual audits, and your response also should have included a copy of the audit for FDA review. Submit a copy of the policy and the current audit with your response to this letter.

We also would like to request a copy of the quality assurance manual mentioned in your response to the Level III findings in your inspection report. Your response stated the expected completion date of the manual is August 2006. We would like to have a copy of this manual for FDA review.

Because these noncompliances may be indicative of serious underlying problems which 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;

  • Requiring your facility to notify patients who received mammograms at your facility, and their referring physicians, of the deficiencies, the potential harm resulting from such deficiencies, appropriate remedial measures, and other relevant information;

  • Seeking civil money penalties up to $11,000 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; and,

  • Seeking a court injunction against your facility [See 42 USC 263b (h)-(j) and 21 CFR 900.12(j)].

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

You should respond in writing to FDA within fifteen (15) working days from the date you 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; and,

3. Sample records which demonstrate proper record keeping procedures.

Please submit your written response to the above issues to the attention of Cynthia R. Crocker, Compliance Officer, U.S. Food and Drug Administration, New Orleans District, 100 W. Capitol Street, Suite 340, Jackson, Mississippi 39269. Please submit a copy of your response to this letter to:

Jimmy Carson
State of Mississippi
Division of Radiological Health
P.O. Box 1700
Jackson, MS 39215-1700

Finally, you should understand there are many requirements pertaining to mammography operations. 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 & Drug Administration, P. O. Box 6057, Columbia, MD 21045-6057 (1-800- 838-7715) or through the Internet at: http://www.fda.gov/cdrh/mammography/index.html.

Should you have questions concerning the content of this letter, please direct your questions to Karen Smallwood, Radiation Specialist, telephone number 615-781-5380, extension 144.

Sincerely,

/S/

Carol S. Sanchez
Acting District Director
New Orleans District