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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Central Peninsula General Hospital - Kenai Clinic 4/23/09

   

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996

 

April 23, 2009

 

VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Warning Letter SEA 09-16

Re: MQSA Inspection ID No: 2262540008

Ryan K. Smith, President and CEO
Central Peninsula General Hospital, Inc .
250 Hospital Place
Soldotna, Alaska 99669-7559

WARNING LETTER

Dear Mr. Smith:

On March 18-19, 2009, a representative of the Food and Drug Administration (FDA) inspected your facility located at 630 Barnacle Way, Suite B, Kenai, Alaska 99611. 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 (U.S.C.), 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.

This inspection revealed a violation of the MQSA at your facility. This violation was noted on the MQSA Facility Inspection Report and the document "Important Information about Your MQSA Inspection" that the inspector left with you at your facility at the close of the inspection. The violation is again identified below.

Level 2 (REPEAT): The Full Field Digital Mammography (FFDM) manufacturer recommended Quality Control procedures were not followed for Digital Unit (b)(4) Mammo Room No (b)(4) [see 21 CFR 900.12(e)(6)].

On April 6, 2009, we received your response to the MQSA Facility Inspection Report. Your response was inadequate in that your response, which did include training on Quality Control (QC), was not specific on how technicians were instructed in "trouble shooting." It was not indicated if these steps have been incorporated into a written Standard Operating Procedure. Although it was stated that knowledge transfer would be evaluated quarterly, the response did not address how management will oversee QC testing in the future to assure all procedures are followed in a timely manner and to prevent further violations in this area.

Your facility was cited for this same violation of the MQSA in September 2008. Because the continued failure to resolve this violation 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 $11,000 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 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. and sample records that demonstrate proper record keeping procedures, for example, recent Phantom Image Testing. 

Please submit your response to this letter to:

Lisa M. Althar, Compliance Officer
Food and Drug Administration
Seattle District Office
22201 23rd Drive SE
Bothell, Washington, 98021-4421

Please send a copy of your response to:

Clyde E. Pearce, Chief
Radiological Health Program
State of Alaska/DH&SS
Section of Labs, Radiological Health
4500 Boniface Parkway
Anchorage, Alaska 99507-1270

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 Lisa Althar, Compliance Officer, at 425-483-4940.

Sincerely,

 

/S/

 

Charles M. Breen
District Director

cc: Priscilla F. Butler, M.S., FAAPM
Director, Breast Imaging Accreditation Programs
American College of Radiology
1891 Preston White Drive
Reston, Virginia 22091

Clyde E. Pearce, Chief
Radiological Health Program
State of Alaska/DH&SS
Section of Labs, Radiological Health
4500 Boniface Parkway
Anchorage, Alaska 99507-1270