Inspections, Compliance, Enforcement, and Criminal Investigations

Saint Mary's Medical Group, Inc. 12/4/14

  

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

Public Health Service
Food and Drug Administration
 San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
Telephone: (510) 337-6700 

 

WARNING LETTER


VIA United Parcel Service                                                                          
WL: 444592
Return Receipt Requested                                                                          

Re: MQSA Inspection ID # 2420640001
       Saint Mary’s Medical Group, Inc.
 
December 4, 2014
              
Helen Lidholm, Chief Executive Officer
Saint Mary’s Regional Medical Center
235 W. 6th Street
Reno, Nevada 89503

Dear Ms. Lidholm:
 
On October 15, 2014, a representative 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 left with Gracie C. Zamora, RT at your facility at the close of the inspection on 10/15/2014. The violations are again identified below:

Level 1: The facility was performing mammography without a valid certificate. Certification – 21 CFR 900.11(a)

Level 2: 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. 21 CFR Part 900.12(a)(2)(iv)(A) & (a)(4)

Level 2: The manufacturer recommended Printer QC procedures for digital unit 1, (b)(4), room Room 1 were not followed. 21 CFR Part 900.12€(6)&(d)(2)

Level 2: Failed to produce documents verifying that the interpreting physician (b)(4) (13 CME's in 36 months) met the continuing education requirement of having taught or completed at least 15 category 1 continuing medical education units in mammography in 36 months. 21 CFR Part 900.12 (a)(1)(ii)(B)&(a)(4)

Level 2: 1 of 7 random reports reviewed did not contain an acceptable assessment category for site Saint Mary's Medical Group, Inc.. 21 CFR Part 900.12(c)(1)(iv)

Level 2: The facility has not specified adequate procedures to be followed for infection control or did not follow them when required at site Saint Mary's Medical Group, Inc..21 CFR Part 900.12€(13)&(d)(2)

Level 2: The manufacturer recommended QC procedures for the monitor for digital unit 1, (b)(4), room Room 1 were not followed. 21 CFR Part 900.12(e)(6)&(d)(2)

Level 3: The MQSA certificate is not displayed. Display of Certificate - 42 USC 263b(b)(1)(A)(iii)

Level 3: The required personnel qualification documents were not available during the inspection. 21 CFR Part 900.12900.12(a)(4)

Because the 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
  • requiring your facility to notify patients who received mammograms at your facility, and their referring physicians, of the deficiencies, the potential harm resulting from such deficiencies, appropriate remedial measures, and other relevant information
  • 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 Compliance Follow-up Inspection to determine that each problem at your facility has been corrected.

We acknowledge receipt of you written response, dated November 6, 2014. Your response appears to adequately address the violations cited in this letter; however additional compliance action may be taken by the FDA if the results of the Additional Mammography Review indicate problems with the clinical image quality at your facility. If you wish to provide further responses or supplement your response, your submission should 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; i.e. printer and monitor records 
  4. Please submit any responses to:
                               Lawton Lum, Director of Compliance
                               San Francisco District
                               U.S. Food and Drug Administration
                               1431 Harbor Bay Parkway
                               Alameda, CA 94502

Please send a copy of your responses to:
                              Jacque Bowling
                              Nevada Division of Public and Behavioral Health
                              Radiation Control Program
                              2080 E. Flamingo Rd, Suite 319
                              Las Vegas, Nevada 89119

Finally, you should understand that there are many requirements pertaining to mammography. This letter pertains only to violations related to the recent inspection(s) 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 Russell A. Campbell, Compliance Officer at 510-337-6861 or russella.campbell@fda.hhs.gov.                                                                           
 
Sincerely yours,
/S/                                                                                                           
Kathleen M. Lewis, J.D.
District Director
San Francisco District 
 
cc:
 
Stephen R. Sweet, RT
Director of Imaging Services
Saint Mary's Medical Group, Inc.
18653 Wedge Parkway
Reno, NV 89511
 
Ed Sweeten
Nevada Division of Public and Behavioral Health
Radiation Control Program
2080 E. Flamingo Rd, Suite 319
Las Vegas, Nevada 89119
 
Leonard Lucey, J.D., L.L.M.
Legal Counsel and Senior Director
Breast Imaging Accreditation Program
American College of Radiology
1891 Preston White Drive
Reston, VA 20191-4397

 

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