A Maryland lab that was closed by the state for processing coronavirus tests without proper certification began the testing without the knowledge of its own director, according to Maryland health officials who said the situation posed a threat that justified emergency action.
The lab, Advanced Pain Medicine Institute (APMI) in Greenbelt, was testing samples gathered at three pop-up clinics held at churches in Baltimore City, Howard and Anne Arundel counties in June.
In a letter to APMI President and Medical Director Reza Ghorbani, the state said it had investigated the clinic after receiving a complaint and found the testing was being “performed without the approval or supervision” of the lab’s director.
The lab director, Sarwat Siddiqui, told state investigators last week that she didn’t approve of the institute’s testing validation and that the testing was started “without her knowledge or approval.” Siddiqui also said she considered the lab space at the Greenbelt office to be “inappropriate” for the kind of novel coronavirus test Ghorbani was using.
Siddiqui’s lack of involvement in the project made “the testing invalid and the results questionable,” according to the letter, a copy of which was obtained by The Washington Post.
“The Office of Health Care Quality has determined that the lack of inclusion of the laboratory director in charge of testing, poses a threat to public health and safety which imperatively requires emergency action,” the Maryland health officials wrote in the letter dated Saturday.
Siddiqui did not respond to an email or phone calls seeking comment.
State rules say that a lab 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 letter continued: “The absence of laboratory director participation to perform these crucial functions places the health and safety of the public at an unacceptable risk of harm that could result from inaccurate laboratory results and communications of test results to health care providers and patients.”
Maryland Health Secretary Robert Neall issued an order Saturday directing the lab to immediately stop coronavirus testing. The state also suspended APMI’s license to operate a medical lab and perform any lab testing.
The lab is on the sixth floor of an office building in Greenbelt. On Monday afternoon, the door to the lab was unlocked but no one appeared to be inside. The clinic has offices on the same floor. Ghorbani was there but said that his lawyers had told him not to comment and that they were working with the state.
Ghorbani said in an interview on Sunday that he was still trying to understand what led the state to shut down his operation, even though the reasons are made clear in the letter. He said he wanted to use his lab to help expand the state’s testing capacity for the virus, despite his medical specialization being in the treatment of pain, seeing an opportunity to “give back to the community.” He said he billed patients’ insurance if they had it, and absorbed the costs if not.
The virus has sickened a confirmed 67,254 people in Maryland and caused 3,175 deaths, according to The Post’s tally. Ghorbani’s testing operation was relatively small — the state had recorded more than 640,000 tests.
Ghorbani partnered with a Korean community group to gather samples at churches serving immigrants and minorities in Anne Arundel, Howard and Baltimore on three dates in June. In all, Ghorbani and the state say he had conducted about 1,000 tests. The group was about to begin a fourth clinic when the shutdown order was issued Saturday.
The state’s investigation was triggered by a patient complaint that they had failed to receive their test results.
Julian Min, a spokesman for the Korean group, said he was unaware of the internal issues at the lab and thought it had the proper certification to conduct the testing. Min said he was exploring options for keeping the program going.
“I’m not an expert,” he said. “I’m just the organizer bringing the community together.”
On Saturday, the Howard County Health Department agreed to give Min’s group 250 test kits for its pop-up clinic after the state halted Ghorbani’s operation. Those tests will be processed by LabCorp, the county said.
Ghorbani’s lab had an approval under a federal laboratory law, records show. But different tests require labs to follow different standards based on their complexity, and it wasn’t clear on Monday whether Ghorbani’s lab met the standard for the kind of coronavirus test he was using.
Ghorbani did not say Sunday exactly where he got the tests he was using, only that he used contacts he had to acquire them.
“Nothing is easy,” he said. “It’s very complicated. With covid-19 being fairly new, there are not a lot of resources out there.”
The Centers for Medicaid and Medicare Services, which regulates labs, did not respond on Monday to a request for comment about APMI’s lab approval status.
Ghorbani attended medical school at Tufts University and trained at Brigham and Women’s Hospital in Boston, according to state records. He has been based in the Washington region since 2007, according to APMI’s website.
Maryland officials have ordered Ghorbani to contact everyone whose test the lab processed to inform them that the results might be faulty. In a statement, the health department told people that they should consider getting retested and should seek medical care if they had symptoms of covid-19, the disease caused by the virus.
In its letter, the Maryland Department of Health told Ghorbani that he could only resume testing after submitting documentation to the department’s Office of Healthcare Quality that patients had been contacted and that he had appointed a lab director whose qualifications the state office had approved in writing.