Methodist Hospital Breast Center 08-Apr-03

Department of Health and Human Services            Public Health Service

Food and Drug Administration

Detroit District

300 River Place

Suite 5900

Detroit, MI 48207

Telephone: 313-393-8100

FAX: 313-393-8139

WARNING LETTER

2003-DT-13

April 8, 2003

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

Ms. Katrina B. Boyle, RT (R)(M)

Breast Imaging Coordinator

Methodist Hospital Breast Center

1801 North Senate Boulevard

Indianapolis, IN 46202

Dear Ms. Boyle:

We are writing you because on March 26, 2003, your facility at Methodist Outpatient Greenwood, 8830 S. Meridian Street, Indianapolis, IN 46217 was inspected by a representative of the State of Indiana acting on behalf of the Food & Drug Administration (FDA). The inspection revealed a serious compromise in the quality of the mammography services offered by your facility.

Under the Mammography Quality. Standards Act of 1992 (MQSA), 42 U.S.C. 263b, 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 recent inspection at your facility revealed the following Level I findings:

1. Your facility failed to reduce documentation to show that your interpreting physician, [redacted], met the initial requirement of being certified in an appropriate specialty area by an FDA approved board or having received 3 months of initial training in the interpretation of mammograms. This is in violation of Title 21 (C.F.R.) 900.12 (a)(4). See also 21 C.F.R. 900.12(a)(1)(I). (If [redacted] initially qualified as an interpreting physician before April 28, 1999, [redacted] would need to meet the interim regulation requirement of being certified approved board or having 2 months of initial training in the interpretation of mammograms. See 21 C.F.R. 900.12 (a)(l)(iii) and FDA?s interim regulation at 58 Federal Register 67565 (December 21, 1993).

2. Your facility failed to produce documentation to show that your interpreting physician, [redacted] met the initial requirement of being certified in a appropriate specialty area by an FDA approved board or having 3 months of initial training in the interpretation of mammograms. This is in violation of Title 21 C.F.R. 900.12 (a)(4). See also 21 C.F.R. 900.12(a)(l)(i). (If [redacted] initially qualified as an interpreting physician before April 28, 1999, [redacted] would need to meet the interim regulation requirement of being certified by an FDA approved board or having 2 months of initial training in the interpretation of mammograms. See 21 C.F.R. 900.12 (a)(1 )(iii) and FDA?s interim regulation at 58 Federal Register 67565 (December 21,1993).

The specific violations noted above appeared on your MQSA Facility Inspection Report (copy enclosed), which your facility received at the close of the inspection. These violations are identified as Level 1 because they identify a failure to meet significant MQSA requirements.

These conditions may be symptomatic of serious underlying problems that could compromise the quality of mammography at your facility and represents violations 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, seeking civil money penalties, seeking to suspend or revoke your facility?s FDA certificate, or seeking a court injunction against performing further mammography.

In addition, you should also address the following Level 2 findings that were listed on the inspection report provided to you at the close of the inspection:

1. Your facility failed to produce documentation to verify that your interpreting physician [redacted] met the initial experience requirement of having interpreted or multi-read a least 240 mammograms in a six (6) month period. This is in violation of Title 21 C.F.R. 900.12 (a)(4). See also 21 C.F.R. 900.12 (a) (1)(I)(D).

2. Your facility failed to produce documentation to verify that your interpreting physician, [redacted], met the initial experience requirement of having interpreted or multi-read at least 240 mammograms in a six (6) month period. This is in violation of Title 21 C.F.R. 900.12 (a)(4). See also 21 C.F.R. 900.12(a)(l)(i)(D).

3. Your facility failed to produce documentation to verify that your interpreting physician, [redacted] met the initial requirement of having at least 60 hours of medical education in mammography. This is in violation of C.F.R. 900.12 (a)(4). See also 21 C.F.R. 900.12 (a)(l)(i) (C). (If [redacted] initially qualified as an interpreting physician prior to April 28, 1999, would need to meet the interim regulation requirement of having at least 40 hours of medical education in mammography. See 21 C.F.R. 900.12 (a)(l)(iii) and FDA?s interim regulation at 58 Federal Register 67565 (December 21, 1993).

4. Your facility failed to produce documentation to verify that your interpreting physician, [redacted] met the initial requirement of having at least 60 hours of medical education in mammography. This is in violation of Title 21 C.F.R. 900.12 (a)(4). See also 21 C.F.R. 900.12 (a)(l)(i)(C). (If [redacted] initially qualified as an interpreting physician prior to April 28, 1999, [redacted] would need to meet the interim regulation requirement of having at least 40 hours of medical education in mammography. See 21 C.F.R. 900.12 (a)(l)(iii) and FDA?s interim regulation at 58 Federal Register 67565 (December 21, 1993).

Please explain to this office in writing within fifteen (15) working days from the date you receive this letter:

• the specific steps you have taken to correct the Level 1 and 2 violations noted in this letter;

• each step your facility is taking to prevent the recurrence of similar violations;

Please submit your response to: Mr. David M. Kaszubski

Director Compliance Branch

U. S. Food & Drug Administration

300 River Place, Suite 5900

Detroit, MI 48207

Please note that FDA regulations do not preclude a State from enforcing its own State mammography laws and regulations. In some cases, these requirements may be more stringent than FDA?s. When you plan your corrective actions, you should consider the more stringent State requirements, if any.

You should also send a copy of your response to the State of Indiana radiation control office that conducted the inspection referenced in this letter. You may choose to address both the FDA and any additional State requirements in your response.

There are many FDA requirements pertaining to mammography. This letter only concerns the findings of your recent 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 www.fda.gov/cdrh/mammography.

If you have any questions regarding this letter or how to ensure that you are meeting MQSA standards, please call Mr. Dennis E. Swartz, Radiological Health Expert, at 313-393-8156.

Sincerely yours,

/s/

Joann Givens

District Director

Detroit District Office