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WARNING LETTER

East Jefferson General Hospital MARCS-CMS 595999 —


Delivery Method:
United Parcel Service
Product:
Medical Devices

Recipient:
Recipient Name
Lance Rouse
Recipient Title
Administrative Director
East Jefferson General Hospital

(b)(4)
United States

Issuing Office:
Center for Devices and Radiological Health

United States


WARNING LETTER
CMS# 595999

Re: MQSA Inspection ID# (b)(4)
FEI# 1000521307

Dear Mr. Rouse:

On January 08, 2019, a representative of the State/Commonwealth of Louisiana, 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 "Imp01tant Information about Your MQSA Inspection". The violations are again identified below:

Level 2: The x-ray unit 98, room Mammography 3 is not accredited per 21 CFR Part 900.4(a), (b) & (c)(4).

Level 2: The x-ray unit 12, room Mammography 3 is not accredited per 21 CFR Part 900.4(a), (b) & (c)(4).

You failed to respond to the MQSA Facility Inspection Report as requested in the document "Important Information about your MQSA Inspection" provided at the end of the inspection which necessitated issuance of a "No Response Letter" from this office dated March 20, 2019.

After prompting by a phone call on June 4, 2019 from thls office to your staff, we received a response by email on June 5, 2019. This response was inadequate in that it contained a corrective action plan for a previous identical citation from your December 8, 2016 MQSA inspection. During the 2016 inspection, your facility was cited for operation of unit 98 without accreditation. The Corrective action plan was titled "CORRECTIVE ACTION PLAN FOR ACR FAILURE REPORT 12/21/2016". Based on the fact the plan was created in 2016 and did not prevent the same violation in 2019, the preventive actions of your facility are inadequate.

An inadequate response letter was sent to your staff from this office on July 29, 2019 with detailed instructions on how to adequately respond to the citations and providing an additional 21 days to do so. To date, this office has not received any further communication from your staff pertaining to corrective or preventive actions.

Furthermore, 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
• 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 $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 ce1tificate

[See 42 USC 263b(h)-(j) and 21 CFR 900.12G)]

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. sample records that demonstrate proper record keeping procedures. Note: Patient names or other information that would likely reveal the patient's identity can be deleted from any copies of records you submit.

If you have questions regarding any issues in this letter, please contact Compliance Officer, Andrea H. Norwood at 407-475-4724 or at Andrea.Norwood@fda.hhs.gov. Or Karen Smallwood, Radiological Health Representative, at 615-366-7823 or at Karen.Smallwood@fda.hhs.gov. Please send your reply electronically to Compliance Officer Andrea Norwood oradevices2firmresponse@fda.hhs.gov. Refer to the Unique Identification Number (CMS Case #595999 when replying).

Please send a copy of your response to:

State of Louisiana
Department of Environmental Quality
P. O. Box 4312
Baton Rouge, LA 70821-4312

Finally, you should understand that there are many requirements pertaining to mammography. This letter pertains only to violations related to the recent inspection 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 on the FDA website at http://www.fda.gov/Mammography.

Sincerely,

/S/

Blake Bevill, M.S.
Program Division Director
Office of Medical Device and Radiological Health
Division 2 - Central

cc:
State of Louisiana
Department of Environmental Quality
P.O. Box 4312
Baton Rouge, LA 70821-4312

 
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