Middlesboro Appalachian Regional Hospital 9/27/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	CINCINNATI DISTRICT OFFICE 6751 Steger Drive Cincinnati, OH 45237-3097 513-679-2700; FAX 513-679-2772

September 27, 2011

WARNING LETTER CIN-11-224035-27

MAILED VIA UPS

Michael Slusher
Chief Executive Officer
Middlesboro Appalachian Regional Hospital
3600 W. Cumberland Ave.
Middlesboro, KY 40965

Dear Mr. Slusher:

RE: Inspection ID 2022180017

On August 18,2011, a representative of the Commonwealth of Kentucky, acting on behalf of the Food and Drug Administration (FDA) inspected your facility. This inspection revealed a serious problem 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 that a facility can perform quality mammography.

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" that the inspector mailed to Ms. Kathy Miracle, Director of Radiology of your facility on August 19, 2011. The violations are again identified below.

1. Level 2 (Repeat): Failed to produce documents verifying that two (2) of the radiologic technologists met the continuing experience requirement of having performed 200 mammography examinations in 24 months. ((b)(4) and (b)(4)) See 21 CFR 900.12(a)(2)(iv)

2. Level 2: The mammography equipment evaluation (by a medical physicist) for laser printer (b)(4) in the mammography room) was not done. See 21 CFR 900.12(e)(10)

On August 31, 2011, we received your facility response to the MQSA Facility Inspection Report. Your facility's response was inadequate in that Ms. Miracle responded with no plan of action of permanent correction for assurances that these non compliance issues do not recur.

Also, during the following previous annual MQSA inspections, your facility was cited for the same noncompliance issue as mentioned in above item #1:

1. August 26, 2010, along with one other Level 2 citation: "Failed to produce documents verifying that the radiological technologist (b)(4) met the continuing experience requirements of having performed 200 mammography examinations in 24 months. See 21 CFR 900.12(a)(2)(iv)

2. September 18, 2008, "Failed to produce documents verifying that the radiological technologist (b)(4) met the continuing experience requirements of having performed 200 mammography examinations in 24 months. See 21 CFR 900.12(a)(2)(iv)

3. November 13, 2007, along with one of three Level 2 citations: "Failed to produce documents verifying that the radiological technologist (b)(4) met the continuing experience requirements of having performed 200 mammography examinations in 24 months. See CFR 900.12(a)(2)(iv)

4. September 24, 2003, "Failed to produce documents verifying that the radiologic technologist (b)(4) met the continuing experience requirement of having performed 200 mammography examinations in 24 months. See 21 CFR 900.12(a)(2)(iv)

5. September 11, 2001, along with one of three Level 2 citations: "Failed to produce documents verifying that the radiological technologist (b)(4) met the continuing experience requirements of having performed 200 mammography examinations in 24 months. See 21 CFR 900.12(a)(2)(iv)

Because the continued failure to resolve these violations may be indicative of serious underlying problems that 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

seeking civil money penalties up to $10,000 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

see 42 USC 263b(h)-(j) and 21 CFR 900.12(j).

FDA may need to perform a fee based Compliance Follow-up Inspection to determine that 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;

3. sample records that demonstrate proper record keeping procedures;

Please submit your response to this letter to:

Mr. R. Terry Bolen
MQSA Compliance Officer
Food and Drug Administration
36 East Sixth Street, Suite 1910
Cincinnati, OH 45202
513-246-4134
FAX: 513-381-0219

Please send a copy of your response to:

Robert Gresham
Supervisor
Commonwealth of Kentucky
Cabinet for Health and Family Services
Radiation Producing Machine Program
275 East Main St.
Frankfort, KY 40621-0001

Finally, you should understand that there are many requirements pertaining to mammography. This letter pertains only to violations related to the recent inspections 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 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/index.html.

If you have additional or more specific questions about mammography facility requirements, or about the content of this letter, please feel free to contact R. Terry Bolen at 513-246-4134.
 

Sincerely yours,
/S/

Cheryl A. Bigham

Acting District Director

 

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