Mammography Facility Adverse Event and Action Report - June 30, 2022: Capitol Radiology, LLC doing business as Laurel Radiology Services

Status of the Facility

The facility is currently unaccredited and uncertified to perform mammography and cannot legally provide mammography services. At this time, the FDA recommends that patients contact Capitol Radiology to obtain their medical records.

Facility

Capitol Radiology, LLC, dba Laurel Radiology Services
7350 Van Dusen Rd.
Suite B-10
Laurel, MD 20707

Facility ID Number

199653

Inspection/Reporting Entity

The U.S. Food and Drug Administration

Actions Taken by the FDA

The facility's annual Mammography Quality Standards Act (MQSA) inspection revealed that the facility failed to obtain accreditation of a Full Field Digital Mammography (FFDM) unit from the facility's accreditation body, the American College of Radiology (ACR), prior to using the unit to image patients. Additionally, the facility failed to perform the required weekly quality control tests of an imaging unit for at least twelve (12) consecutive weeks between June 16, 2020 and September 12, 2020. As a result, the U.S. Food and Drug Administration (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 whether there was a need to notify affected patients.

The ACR conducted the AMR of mammograms performed by Capitol Radiology, LLC dba Laurel Radiology Services ("Capitol Radiology" or "the facility"), and the review identified mammograms that did not meet the ACR's clinical image evaluation criteria, and noted that some of the observed deficiencies were severe. On March 24, 2021, the ACR revoked the facility's accreditation, and, on March 25, 2021, the FDA determined Capitol Radiology's MQSA certificate shall no longer be in effect (hereafter, "No Longer In Effect Determination").

On March 25, 2021, the FDA sent Capitol Radiology a letter directing the facility to send notification letters to all at-risk patients and their referring health care providers ("PPN letters" or "PPN order"). At-risk patients include those who had mammograms at the facility from June 26, 2018, until and including the date the facility ceased performing mammography. To date, the facility has not performed the ordered notifications.

On May 24, 2021, Capitol Radiology submitted a letter requesting internal agency supervisory review under 21 C.F.R. § 10.75 of the No Longer In Effect Determination and the PPN Order. On July 15, 2021, Dr. Robert Ochs, Deputy Office Director for the Office of In Vitro Diagnostics and Radiological Health, Office of Product Evaluation and Quality (OPEQ) in the FDA's Center for Devices and Radiological Health (CDRH), issued his decision regarding Capitol Radiology's request. Dr. Ochs upheld the No Longer In Effect Determination and PPN Order, as well as ACR's decision to revoke Capitol Radiology's accreditation. On September 14, 2021, CDRH received an email from Capitol Radiology with an attached letter dated September 13, 2021, requesting: (1) second-level internal agency supervisory review of the No Longer In Effect Determination and the PPN Order; (2) second-level internal agency supervisory review of ACR's underlying decision to revoke Capitol Radiology's accreditation; and (3) review of the Division of Mammography Quality Standards' (DMQS) November 10, 2020 decision to require the AMR and/or DMQS's December 4, 2020 denial of Capitol Radiology's request to be exempted from the AMR. On December 17, 2021, Dr. William Maisel, Director of OPEQ in the FDA's Center for Devices and Radiological Health, issued his decision on Capitol Radiology's request for supervisory review, upholding in full Dr. Ochs's July 15, 2021 decision.

On January 18, 2022, the FDA's Center for Devices and Radiological Health (CDRH) sent Capitol Radiology 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 Notice of Intent to Revoke Certificate identified Dr. Doriann Thomas and Larry McKenney as owners and operators at the facility at the time of the violations, and explained that, pursuant to 42 U.S.C. § 263b(i)(3), if 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. In accordance with 21 C.F.R. Part 16, CDRH gave Capitol Radiology ten business days to request an informal hearing regarding the proposed revocation. On January 27, 2022, Capitol Radiology provided notice by email that it was requesting an informal hearing regarding CDRH's proposed revocation of Capitol Radiology's MQSA facility certificate.

On May 6, 2022, Jacqueline A. O'Shaughnessy, the FDA's Acting Chief Scientist, made a finding that there is no genuine and substantial issue of fact as to whether: (1) Capitol Radiology has failed to comply with the standards of 21 C.F.R. § 900.12; (2) Capitol Radiology has violated or aided and abetted in the violation of any provision of or regulation promulgated pursuant to 42 U.S.C. § 263b; and (3) Capitol Radiology has failed to comply with prior sanctions imposed by the agency under 42 U.S.C. § 263b(h). As a result, Dr. O'Shaughnessy denied Capitol Radiology a hearing in accordance with 21 C.F.R. § 16.26, and revoked Capitol Radiology's certificate 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 Capitol Radiology that qualify as owners and/or operators at the time of the violations: Dr. Doriann Thomas and Larry McKenney. These individuals may not own or operate a facility that requires a certificate under the MQSA for two years, starting May 6, 2022.

Corrective Action

Capitol Radiology, LLC, doing business as Laurel Radiology Services failed to meet the quality standards of the Mammography Quality Standards Act (MQSA). The FDA has advised patients to speak with their healthcare providers as soon as possible, and to read the related safety communication. The facility's MQSA certificate is revoked and the facility cannot legally provide mammography services during the two-year period from May 6, 2022 to May 6, 2024. Two individuals, Mr. McKenney and Doriann Thomas, M.D., 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 for the two-year period from May 6, 2022 to May 6, 2024.

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 webpage. Annual and semi-annual reports issued prior to October 2010 can be found on the Document Archives (MQSA) webpage.