Inspections, Compliance, Enforcement, and Criminal Investigations

Centro Mas Salud Dr. Gualberto Rabell-Fernandez 12/21/17

 

  

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Office of Medical Device and Radiological Health Operations (OMDRHO)
Division 2 Central
555 Winderley Pl # 200
Maitland, FL 32751
Telephone: (407) 475-4700 

 
 

 

WARNING LETTER
CMS#537596
                                               
                                   
HAND DELIVERED
 
December 21, 2017
 
Re:      MQSA Inspection ID # 2281350015
            FEI: 3004179989
 
Ivan Andujar, Administrator
Centro Mas Salud
Calle Cerra Final Esquina Hoare 900
San Juan, PR 00907
 
Dear Mr. Andujar:
 
On July 14, 2017, a representative of the Departamento de Salud, on contract to the U.S. Food & Drug Administration (FDA), accompanied by two FDA inspectors, conducted an inspection at your facility. This inspection revealed serious problems 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 procedures.
 
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 your inspector provided your facility on July 31, 2017 via facsimile. 
 
The violations are again identified below:
 
Level 1: There is no system in place to provide timely medical reports. [See 21 CFR 900.12(c)(3)(i),(ii)]
 
Level 1: There is no system in place to provide timely lay summaries. [See 21 CFR 900.12(c)(2)(i),(ii)]
 
Level 1: There is no system in place to communicate serious or highly suggestive cases as soon as possible. [See 21CFR 900.12(c)(3)(ii)]
 
Level 1: Failed to produce documents verifying that the interpreting physician Gilberto Ramos Pesquera, MD met the initial requirement of being certified in the appropriate specialty by an FDA-approved board or having 2 months of initial training in the interpretation of mammograms prior to 04/28/1999. [See 21 CFR 900.12(a)(1)]
 
Your facility responded to the noncompliances noted on the report in a letter dated August 11, 2017.  The response is inadequate in that there are no assurances provided that medical reports for all patients have been or will be provided to the referring physicians and lay summary letters to the patients within 30 days of the date of the mammogram. No responsibility should be assigned to the patient to pick up a copy of the medical report or lay letter, or for delivery to the referring physician. Lay summary letters may be directly given to a patient at the time of the mammogram, as long as the mammogram has been interpreted by an MQSA qualified interpreting physician. Additionally, the procedure as described did not explicitly state that all mammograms will be read within 30 days of the mammographic image acquisition, and that mammograms with “Suspicious” or “ Highly suggestive of malignancy” assessments will be communicated as soon as possible.
 
Regarding the procedure your facility has implemented, MQSA allows facilities to develop or use a procedure and tracking system that works best for them. Facilities should monitor their systems to ensure that their policies and procedures are being followed. FDA supports the use of computer tracking and paper or patient log systems to assist in tracking timely issuance of medical reports and lay summaries. Some radiology computer reporting systems can track individual reports and generate summary reports indicating when a mammography report or lay summary has been issued or is overdue. By routinely checking these summary reports, facilities can ensure that all mammography results have been issued in a timely manner. FDA encourages facilities (1) to check with their computer support vendors to determine whether their software can generate these types of reports, and (2) to routinely assess their system(s) to ensure that these systems consistently document issuing mammography lay summaries and reports to all patients and their referring healthcare providers within the required timeframe.
 
Facilities that fax or email medical reports and/or lay summaries should have policies and procedures in place to ensure that, if any faxes or emails are reported as “delivery failure,” the reports and lay summaries are re-sent in a timely manner.
 
Additionally, your facility is responsible to maintain mammographic images and reports as described by the following regulation:
 
21 CFR 900.12(c)(4) - Recordkeeping. Each facility that performs mammograms:
 
(i) Shall (except as provided in paragraph (c)(4)(ii) of this section) maintain mammography films and reports in a permanent medical record of the patient for a period of not less than 5 years, or not less than 10 years if no additional mammograms of the patient are performed at the facility, or a longer period if mandated by State or local law.
 
Providing copies of images and/or medical records to patients and requiring that they sign a document making them responsible for the records does not meet the regulatory requirement of the above regulation, except as relates to the italicized exception in the above paragraph which reads as follows:
 
21 CFR 900.12(c)(4)(ii) -  Shall upon request by, or on behalf of, the patient, permanently or temporarily transfer the original mammograms and copies of the patient's reports to a medical institution, or to a physician or health care provider of the patient, or to the patient directly.
 
This regulation is meant to assure that all patients have ongoing access to records that your facility is required to maintain, short of a request by a patient, patient representative, or healthcare provider for transfer of those records to assure ongoing patient care, as described under 21 CFR 900.12 (c)(4)(i). Your facility cannot, by rote, assign this responsibility to the patient. Additionally, your facility should remove from its policies, procedures, and medical records releases documents, all statements indicating that the FDA requires patients to pick up their mammography records from your mammography facility. As described above, the responsibility for medical records retention under the MQSA rests with the facility; patients are not required to assume responsibility for their medical records. 
 
Regarding the documentation for Gilberto Ramos Pesquera, MD as provided, there were no records of the two months of training in mammography prior to reading or interpreting mammograms independently as required under the MQSA interim regulations (3 months for interpreting physicians who received their initial training after 4/28/1999.). We have reviewed our inspection records and have determined that Dr. Pesquera’s documentation of initial training was accepted during multiple prior MQSA inspections. We will continue to accept Dr. Pesquera’s residency letter from the University of Puerto Rico School of Medicine, dated July 12, 1994, and signed by Gladys Perez Kraft, M.D., even though it does not specifically mention the length of his mammography training. During future MQSA inspections Dr. Pesquera may present his July 12, 1994 residency letter and his November 20, 2009 signed attestation letter, to MQSA inspectors in support of his initial training under the MQSA.  This will be communicated to local inspectors and FDA.
 
Finally, Quality Control (QC) as recommended by the manufacturer must be performed at the required frequency the manufacturer recommends and the results determined to be compliant as outlined by the manufacturer and required by regulations. Your technologist indicated that she performs the phantom image quality control tests weekly, however, having a consultant come in to review and evaluate your quality control test results  on an average of every two weeks, is not sufficient to assure that your mammography program is complaint with the image receptor manufacturer’s QC program and the MQSA regulations. Facilities are required to take immediate corrective action, prior to imaging additional patients, when failing test results are noted for some quality control tests. Your quality control process may result in a delayed response to these types of failing QC test results.   Required QC testing, and the appropriate timing for corrective actions, are described in the QC manuals provided by your FFDM, printer, and Radiologist Review Workstations (RWS) manufacturers. During the inspection, records documenting QC appeared to have been done all at one time, as there were no variations in ink, QC edits or corrective actions which would be considered commonplace in monitoring and performance of recommended Quality Assurance activities. Additionally, the technologist reported that the consultant hired to perform expected QC charting after coming in about every two weeks and collecting associated QC tests, which may cause an issue in that any QC failure may not be identified immediately. 
 
Under the MQSA, facilities are required to produce clinical images that continuously comply with the standards for clinical image quality established by the facility’s accreditation body (See 21 CFR 900.12(i)). Each mammography facility must establish and maintain a quality assurance program that ensures the safety, reliability, clarity, and accuracy of mammography services performed at the facility (See 21 CFR 900.12(d)).
 
Because this continued noncompliance may be indicative of serious underlying problems which 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 (AMR)
·        placing your facility under a Directed Plan of Correction (DPC)
·        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 certificate
·        seeking a court injunction against your facility
 
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.   sample records that demonstrate proper record keeping procedures.
 
lf you have questions regarding any issues in this letter, please contact Compliance Officer, Andrea H. Norwood at 407-475-4724 or at Andrea.Noruvood@fda.hhs.gov. Please send your reply electronically to Blake Bevill, Director of Compliance Branch, oradevices2firmresponse@fda.hhs.gov.
 
Please submit a copy of your response to this letter to:
 
Raul Hernandez
Departmento de Salud
Call Box 70184
San Juan, PR 00936-8184
 
Finally, you should understand that there are many requirements pertaining to mammography operations. 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 & Drug Administration, P. O. Box 6057, Columbia, MD 21045-6057 (1-800-838-7715) or through the Internet at: http://www.fda.gov/cdrh/mammopraphy/index.html.
 
If you have additional or more specific questions about mammography facility requirments, or about the content of this letter, please fee free to contact Karen Smallwood, Radiological Health Representative, at 615-366-7823.
 
 
Sincerely,
/S/
Blake Bevill
Acting Program Division Director
Office of Medical Device and Radiological Health
Division 2 - Central

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