Inspections, Compliance, Enforcement, and Criminal Investigations
McPherson Hospital 31-Jul-02
1560 East Jefferson Avenue
Detroit, MI 48207-3179
RETURN RECEIPT REQUESTED
Mark K. Baumeier, D.O.
620 Byron Road
Dear Dr. Baumeier:
We are writing because, on June 19, 2002, your facility was inspected by a representative of the State of Michigan 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 Repeat Level 2 finding:
Corrective action before further exams, for a failing image score, or a phantom background optical density, or density difference outside of allowable regulatory limits, was not documented for unit 3, [redacted] DMR, room Rm 2 (42928). This is in violation of Title 21 Code of Federal Regulations 900.12(e)(8).
The specific problem noted above appeared on your MQSA Facility Inspection Report (copy enclosed), which your facility received at the close of the inspection. This problem is identified as a Repeat Level 2 because it identifies a failure to meet a significant MQSA requirement and indicates failure by your facility to implement permanent correction of the same problem found during your previous inspection.
Because these conditions may be symptomatic of serious underlying problems that could compromise the quality of mammography at your facility, they represent a violation of the law that may result in FDA initiating regulatory action without informal 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 up to $10,000 for each failure to substantially comply with, or each day of failure to substantially comply with, the MQSA standards, seeking suspension or revocation of your facility’s FDA certificate, or seeking a court injunction against performing further mammography. (See 42 U.S.C. 263b(h)-(j)).
It is necessary for you to act on this matter immediately. Please explain to this office in writing within fifteen working days from the date you received this letter:
- the specific steps you have taken or will take to correct all of the violations noted in this letter, any reason that corrective action has not been taken, and the time within which any steps not yet taken will be complete;
- each step your facility is taking to prevent the recurrence of similar violations;
- equipment settings (including technique factors), raw test data, and calculated final results, where appropriate; and
- documentation showing that correction is complete including, if the findings relate to quality control or other records, sample records that demonstrate proper record keeping procedures, (Note: Patient names or identification should be deleted from any copies submitted).
Please submit your response to:Mr. David M. Kaszubski
Director Compliance Branch
U. S. Food & Drug Administration
1560 East Jefferson Ave.
Detroit, MI 48207-3179
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 Michigan 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 http://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 313-226-6260 Ext. 155.
David M. Kazubski for Joann M. Givens
Detroit District Office