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Mammography Facility Adverse Event and Action Report – February 7, 2023: Advanced Women Imaging

Status of the Facility

Advanced Women Imaging is currently unaccredited and uncertified to perform mammography and cannot legally provide mammography services. The FDA recommends patients contact Advanced Women Imaging to get their medical records.

Facility

Advanced Women Imaging
6414 Bergenline Ave
West New York, NJ 07093

Facility ID Number

247764

Inspection/Reporting Entity

U.S. Food and Drug Administration (FDA)

Actions Taken by the FDA

Between 2020-2022, the FDA and the American College of Radiology (ACR) identified a pattern among the operations of four mammography facilities (see Table 1 below): when faced with potential corrective actions due to concerns that could impact the quality of mammography, a facility would inform the ACR that it had ceased operations, but then the owner/operator would subsequently submit a new accreditation application with differences in the facility name, personnel, and address that would make the application appear to be for a new facility.

Table 1. The FDA’s investigation, with collaboration from the ACR and State of New Jersey, has determined the following four facilities have sufficient similarity in name, personnel, equipment, and proximity to be considered constructively the same.

Facility Name Facility Address Start of Operation** End of Operation**
Advanced Women’s Imaging 560 60th Street, West New York, NJ 07093* March 10, 2015 March 10, 2020
Advanced Women’s Imaging 560A, 60th Street, Guttenberg, NJ 07093* March 11, 2020 May 10, 2021
Advanced Women Imaging/Bergenline 6414 Bergenline Ave, West New York, NJ 07093 December 21, 2021 July 28, 2022
Women’s Imaging Center 538 62nd Street, Guttenberg, NJ 07093 August 30, 2022 September 8, 2022

*The two addresses are effectively the same, as the ZIP code 07093 is recognized as both West New York, NJ and Guttenberg, NJ by the U.S. Postal Service.
**Based on dates within accreditation application, facility closure memos, and/or inspection

The FDA’s investigation concluded that information was being misrepresented to obtain a Mammography Quality Standards Act (MQSA) certificate. On January 4, 2023, the FDA revoked the MQSA Certificate for facility #247764 (the MQSA Certificate active at the time), as authorized by 42 U.S.C. § 263b(i)(1). Additionally, when the FDA revokes the certificate of a facility based on an act described in the MQSA (42 U.S.C. § 263b(i)(1)), then no person who owned or operated the facility at the time of the act may, within two years of the revocation of the certificate, own or operate a facility that requires a certificate under the MQSA (42 U.S.C. § 263b(i)(3); see 21 C.F.R. § 900.11(c)(4)). The FDA has identified two individuals at facility #247764 who qualify as owners and/or operators at the time of the violations: Saifulla K. Chaudhary and Zainab Shahid (also known as Zainab Chaudhary). These individuals may not own or operate a facility that requires a certificate under the MQSA for two years, starting January 4, 2023.

The FDA has advised patients to speak with their healthcare providers as soon as possible, and to read the updated safety communications for Advanced Women Imaging.

The following is a summary with additional details of the compliance violations at each of the locations identified in Table 1, above.

Advanced Women’s Imaging

Since its first attempt to obtain accreditation in 2015, Advanced Women’s Imaging (which will be referred to as “AWI-1”), located at 560 60th Street, West New York, NJ 07093, was, on multiple occasions, unable to obtain or maintain accreditation, partly due to image quality issues. In January 2020, the ACR informed AWI-1 that to re-instate its mammography unit, among other prerequisites, AWI-1 would need to implement an ACR-approved corrective action plan (CAP) and participate in a Scheduled On-Site Survey (SOSS) with the ACR. AWI-1 did not implement an ACR-approved CAP or participate in a SOSS. Instead, on March 10, 2020, AWI-1 sent the ACR a “Facility Closure Memorandum.”

Advanced Women Imaging

On March 11, 2020, the day after AWI-1’s reported closure without corrective action, an accreditation application was submitted by Advanced Women Imaging (which will be referred to as “AWI-2”) located at 560A 60th Street, Guttenberg, NJ 07093. The application contained slight differences in the facility name and address from AWI-1 (that is, Advanced Women Imaging rather than Advanced Women’s Imaging, and 560A 60th Street, Guttenberg, NJ 07093 rather than 560 60th Street, West New York, NJ 07093), and identified a different owner from AWI-1.

On August 25, 2020, AWI-2’s annual MQSA inspection revealed that AWI-2 was located at the same physical location as AWI-1. Additionally, required quality control tests were not performed from March 11, 2020, through August 25, 2020. As a result of the inspection findings, the FDA notified the facility that it was required to undergo an Additional Mammography Review (AMR) to determine if the overall quality of mammography performed at the facility was compromised due to the failure of the facility to operate in compliance with the MQSA and its implementing regulations, and whether there was a need to notify affected patients.

The ACR, at the request of the FDA, contacted the facility to request the clinical images and documentation needed to conduct the AMR of mammograms performed at AWI-2. The facility did not comply with the ACR’s request. On September 12, 2020, the facility’s accreditation expired, and on September 15, 2020, the FDA notified the facility that it was no longer certified and must cease performing mammography. On May 11, 2021, the ACR received a “Facility Closure Memorandum” from the facility stating that it ceased performing mammography as of May 10, 2021. The FDA posted a safety communication in response to the fact that AWI-2 did not submit images for evaluation under the FDA-requested AMR.

Advanced Women Imaging/Bergenline

On December 20, 2021, an accreditation application was submitted by Advanced Women Imaging located at 6414 Bergenline Avenue, West New York, NJ 07093. The facility located at 6414 Bergenline Avenue will be referred to as “Bergenline.”

On May 18, 2022, the ACR informed the FDA of discrepancies in quality control (QC) records submitted to the ACR by Bergenline as part of the mammography facility’s initial accreditation process. The FDA reviewed the information provided by the ACR, as well as the FDA’s compliance records, and noted similarities between the name, personnel, and proximity of Bergenline and AWI-1 and AWI-2 that both did not have current accreditation or certification and had outstanding compliance actions.

On June 15, 2022, the FDA, along with the State of New Jersey, Division of Climate, Clean Energy and Radiation Protection Bureau of X-Ray Compliance (“State of New Jersey”), conducted a For Cause inspection after receiving information that Bergenline may have been performing mammography exams at a location other than the 6414 Bergenline Avenue address listed in Bergenline’s accreditation application. The investigation revealed that Bergenline did not have a mammography unit located at, and did not perform any mammography, at the 6414 Bergenline Ave. location. Instead, the inspectors were directed to a mammography facility located at 560 60th Street, West New York, NJ 07093, which was not accredited and did not have an MQSA certificate. The results of the investigation supported that Bergenline misrepresented the location of the mammography unit on its accreditation application and supporting documentation to the ACR and was, in fact, operating at the same location at which mammography had been performed by AWI-1 and AWI-2, both of which did not have current accreditation or certification and had outstanding compliance actions. Further, the inspection revealed that the facility had not performed the weekly quality control tests recommended by the mammography unit’s manufacturer.

Based on the inspection findings, the State of New Jersey immediately embargoed the mammography unit, which prohibited the facility from using the unit to image any additional patients under State of New Jersey requirements.

On June 17, 2022, the ACR sent the facility a letter notifying Bergenline that the ACR intended to revoke the facility’s provisional accreditation because it discovered that the facility had misrepresented the location of its Fuji Cristalle mammography unit on its initial mammography facility application and associated documentation. The ACR stated that it had been informed that the mammography unit’s actual physical location was 560 60th Street, West New York, NJ, the same location as AWI-1, which was previously certified under the FDA’s facility #242249, and AWI-2, which was previously certified under the FDA’s facility #245768 with the address of 560A 60th Street, Guttenberg, NJ. On June 29, 2022, the ACR revoked Bergenline’s provisional accreditation.

Women’s Imaging Center

On August 11, 2022, AWI-2 submitted a “Machine Disposition Form” to the State of New Jersey to report that the mammography unit from the 60th Street facility had been “[s]old, traded, or donated to a person, company or facility.” The new location of the unit was identified as 538 62nd Street, West New York, NJ 07093. On September 7, 2022, ACR received an application for accreditation for a facility named “Women’s Imaging Center,” located at 538 62nd Street, Guttenberg, NJ 07093, with similarities between the name, personnel, and proximity of the AWI-1, AWI-2, and Bergenline facilities. On September 8, 2022, the State of New Jersey conducted an investigation into the disposition of the mammography unit and confirmed that the mammography unit had been moved from the 60th Street location to the 538 62nd Street location. The State of New Jersey investigation revealed that the facility at the 538 62nd Street location began performing mammography on August 30, 2022, without accreditation or certification. The State of New Jersey embargoed the mammography unit, which prohibited the facility from using the mammography unit to image any additional patients under State of New Jersey requirements.

Revocation

On September 14, 2022, the FDA issued a letter to Bergenline, notifying the facility that its MQSA certificate was no longer in effect and that it must cease performing mammography. Additionally, on September 14, 2022, the FDA sent Bergenline a Notice of Intent to Revoke Certificate, along with notice of opportunity for hearing, explaining the supporting facts and attaching the evidence supporting those facts. The letter further explained that pursuant to 42 U.S.C. § 263b(i)(3), if the FDA revokes the certificate of a facility based on an act described in 42 U.S.C. § 263b(i)(1), then no person who owned or operated the facility at the time of the act may, within two years of the revocation of the certificate, own or operate a facility that requires a certificate under the MQSA.

On January 4, 2023, the FDA revoked Bergenline’s MQSA certificate. Bergenline cannot legally provide mammography services during the two-year period from January 4, 2023, through January 4, 2025. Two individuals, Saifulla K. Chaudhary and Zainab Shahid (also known as Zainab Chaudhary) were identified by the FDA as owners or operators of the facility at the time of the violations and cannot own or operate a facility requiring an MQSA certificate until January 4, 2025.

The FDA has advised patients to speak with their healthcare providers as soon as possible, and to read the updated safety communications for Advanced Women Imaging.

Background - MQSA Program

The FDA compiles and makes available to physicians and the general public information that is useful in evaluating the performance of mammography facilities. As of October 2010, the FDA posts individual notices following completion of the adverse actions taken against facilities. This information is useful in evaluating the performance of mammography facilities nationwide and assists providers and patients in making informed decisions. For additional information, please see the Reports (MQSA) webpage.

Additional Resources

For more information, please refer to the MQSA Program (http://www.fda.gov/mammography). Annual and semi-annual reports issued prior to October 2010 can be found on the Document Archives (MQSA) webpage.

 
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