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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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C.H.S. Radiology of Marion 30-Jul-03

Department of Health and Human Services' logo

Public Health Service
Food and Drug Administration

  Detroit District
300 River Place
Suite 6900
Detrolt, MI 48207
Telephone: 313-393-9100
FAX: 313-393-8139


WARNING LETTER
2003-DT-18

July 29, 2003

Ms. Julie Dalrymple
Center Administrator
C.H.S. Radiology of Marion
1391 North Baldwin Ave.
Marion, IN 46940

Dear Ms. Oairymple:

We are writing you because on July 2, 2003, your facility was inspscted by a representative of the State of Indiana acting on behalf of the Food and Drug Administration (FDA). The inspection revealed a serious dt#iciency 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 1 finding:

1. During the month of June, 2003, processor quality control (QC) records were missing for at least 30% of the days when mammograms were processed including 5 consecutive days with missing processor QC records. This is in violation of Title 21Code of Federal Regulations (C.F.R), Section 900.12 (d)(2):see 21 C.F.R. 900.12 (e)(1).

The specific violation noted above appeared on your MQSA Facility lnspgction Report (copy enclosed), which your facility received qt the olose of the Inspection. This problem is identified as a Level 1 because it identifies a failure to meet a significant MQSA requirement. This condition may be symptomatic of serious underlying problems that could compromise the quality of mammography at your facility, and it represents a violation of the law that 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, suspension or revocation of your facility's FDA certincate, or obtaining a court injunction agrainst performing further mammography.

In addition, you should also address the following Level 2 finding that was listed on the inspection report provided to you at the cloee of the inspection.

1. During the month of June, 2003, phantom QC records were missing for at least 2 of the 4 weeks. This is in violation1 of Title 21 C,F.R. 800.12 (d)(2): 988 21 C.F.R. 800.12 (e)(2).

It is necessary for you to act on this matter immediately. Please provide to this off ice in writing within feeen (15) working day8 from the date you receive this letter:

  • the specific steps you have taken to corract the Level 1 and 2 violations noted in this letter;
  • each step your facility is taking to prevent the recurrence of similar violations;
  • the sample records that demonstrate proper record keeping procedures, if the findings relate to quality control or other reoords. (Note: Patient names or identification should be deleted from airy copies Submitted).

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 case6, these requiremsnts may be more sWng6nt than FDA’s, When flu 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 offics 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 hrrve 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 Druga Administration, P.O. Box 6057, Columbia, MD 21045-6057 (1-800-638-7715) or through the Internet at http://www.fda.gov/cdrh/mammography.

tf you have any questions regarding this letter or how to ensure that you are meeting MQSA standards, phase call Mr. Dennis E. Swartz, Radiological Health Specialist, at 313-383-0156.

Sincerely, yours,

/s/

Joann M. Givens

District Director

Detroit District Office