Office of Health Care Quality
Laboratories and Tissue Banks
7120 Samuel Morse Drive
Second Floor
Columbia, Maryland 21046
July 27, 2020

Dr Ron Elfenbein,
First Call Medical Care Gambrills
1071 MD 3 North
Gambrills, MD 21054
Maryland Laboratory Permit: 160173
CLIA: 21D2115778
RE: Departmental Action — Reporting Erroneous or Questionable Patient Test Results
Dear Dr. Elfenbein,
In order for a laboratory to perform testing under Maryland law, it must comply with all
Maryland regulations under the Code of Maryland Regulations (COMAR) Title 10, Subtitle 10.
Compliance with these regulations is a condition of licensure in the State of Maryland.
Based on information provided to OHCQ from a complaint survey conducted on July10,
2020 and outlined in the Statement of Deficiencies sent to you on July23, 2020, there is
sufficient evidence that the following violation has occurred and that the laboratory reported
erroneous or questionable patient test results that threatens the health or safety of the patients
tested:
D8100 Inspection Requirements CFR 493.1771 -Failed to Perform Sofia Covid Antigen
Testing in accordance with the manufacturer’s instructions
Per COMAR 10.10.08.05(A)(1), If the Department determines that a licensee has
reported an erroneous or questionable patient test result that threatens the health or safety of the
patient, the Secretary may order the licensee, within a specified period of time, to:
(1) Give prompt notice of the erroneous or questionable patient test result to the:
(a) Person who requested that the test be performed

 Dr. Ron Elfenbein and First Call Medical Care Gambrills must notify by the most
expeditious means and by mailing address, all patients tested for COVID-19 by Sofia method,
conducted by First Call Medical Care Gambrills informing the patients that their test results may
be questionable. Please provide the Office of Health Care Quality with a listing of all patients
notified and the date the patient was notified and a copy of the letter notifying the patients.
The Office of Health Care Quality has determined that the lack of oversight by the
laboratory director in charge of testing, posed a threat to public health and safety which
imperatively requires emergency action. Under COMAR 10.10.07.01 B(2)(a), a laboratory
director “shall participate in and actively oversee the planning, organization, direction, and
review of all laboratory operations to the extent necessary to ensure compliance with this
chapter.” The failure of the laboratory director to ensure that the laboratory was following
manufacturer’s instructions placed the health and safety of the public at an unacceptable risk of
harm that may have resulted in inaccurate laboratory results and communications of test results
to patients and health care providers.
If you have any questions about this letter, please contact Renee Webster at 410-402-8116
or 443-681-0278.

Sincerely,

Patricia Tomsko Nay, MD
Executive Director
cc:

Paul Celli, Administrator for Clinical and Forensic Laboratories
Paul Ballard, Assistant Attorney General

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