St. Vincent Clay Hospital 10-Apr-02

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

Detroit District

1560 East Jefferson Avenue

Detroit, MI 48207-3179

Telephone: 313-226-6260

WARNING LETTER

2002-DT-25

April 10, 2002

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

Mr. Rich Johansen, CEO

St. Vincent Clay Hospital

1206 E. National Avenue

Brazil, IN 47894

Dear Mr. Johansen:

We are writing you because on March 26, 2002, your facility 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.

236b, 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:

1. There was no documentation to show that technologist [redacted] met the

minimum requirement of having taught or completed at least 15 CEU?s of

continuing education units in mammography in the previous 36 month period.

This is a violation of Title 21 Code of Federal Regulations section 900.12 (a)

(2)(iii).

The specific problem noted above appeared on your MQSA Facility Inspection

Report, which your facility received at the dose 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.

Since this condition may be symptomatic of a serious underlying problem that

could compromise the quality of mammography at your facility, it represents a

violation 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, assessing civil money penalties, suspension or revocation of

your facility?s FDA certificate, or obtaining 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 your staff at the close of the inspection.

Your facility does not have adequate written procedures for the collection and

resolution of consumer complaints including the resolution of serious complaints

and reporting or referral of serious complaints to the American College or

Radiology. This is in violation of Title 21 Code of Federal Regulations section

900.12 (h).

There is no designated audit (reviewing) interpreting physician to review the

medical audit outcome data at least once every 12 months. This is in violation of

Title 21 Code of Federal Regulations section 900.12 (f)(3).

Your facility has not established adequate procedures for the collection of biopsy

results when patients do not have a biopsy performed at your facility following a

positive mammogram performed and interpreted by your facility. The outcome

data also does not correlate the disposition of positive mammograms with

pathology results. This is in violation of Title 21 Code of Federal Regulations

section 900.12 (f)(l).

It is necessary for you to act on this matter immediately. 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 Repeat Level 2 and Level 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 records (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 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 (l-800-838-7715) or through the Internet

at http://www.fda.gov/cdrh/mammograhy.

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.

Sincerely yours,

Joann M. Givens

Detroit District Office