SOUTHLAKE -- A federal agency has banned a Southlake clinic from performing laboratory tests after another clinic operated by the same doctor produced inaccurate test results that could have led to improper medical treatment, according to a state survey conducted for the federal government.
Though no violations or problems were found at the Southlake Emergency Care Center, operated by Dr. Charles O'Hearn, federal law imposes the same sanctions on all clinics operated by the same doctor, said Bob Moos, public affairs specialist for the federal Centers for Medicare & Medicaid Services. The care center can continue to receive and treat patients, but under the sanctions, all lab work must be sent elsewhere until Jan. 9, 2013.
The inaccurate test results were at O'Hearn's Coppell Minor Emergency Center, federal documents show. They were noted by state inspectors who completed a survey there in February 2010 on behalf of the federal agency.
The inspectors for the Department of State Health Services also questioned why the Coppell lab lacked documents showing that some staff members met the minimal educational requirements for performing tests, according to federal documents. The Coppell clinic has since closed for financial reasons, O'Hearn's attorney said.
O'Hearn wrote in an e-mail that federal officials are misstating the facts and indicated that he may sue. "CMS inspected and reissued our lab license ... the certificate speaks for itself," he wrote in an e-mail. "CMS like many government [bureaucracies] is too arrogant to admit their mistake ... so we will see how much damages we are awarded at trial."
O'Hearn's attorney, Jeffrey Hall of Frisco, said his client is challenging the sanctions.
But Moos stood by the sanctions . CMS announced that it was revoking the Southlake clinic's lab license, officially called a Clinical Laboratory Improvement Amendments certificate.
Moos said that no license was reissued. A Feb. 3 enforcement letter to O'Hearn explains that the CLIA certificate must be returned to the Centers for Medicare & Medicaid Services.
"Your laboratory is required to cease all operations," reads the letter from Diane Murphy, branch manager for the agency's Dallas regional office. "If your laboratory continues testing after the sanctions are imposed ... any individual intentionally violating any CLIA requirement may be imprisoned or fined," she wrote.
Moos said he is not aware of any pending legal action by O'Hearn against the agency.
The Centers for Medicare & Medicaid Services made no determination whether anyone was injured because of the Coppell clinic's federal violations.
"When a lab gets a failing score on a proficiency testing sample, it's supposed to find out what went wrong and to make sure no harm was done to patients," Moos wrote in an e-mail. "But surveyors found no such documentation showing that this lab did that. So, CMS can't know whether patients were harmed or negatively affected."
But there were risks, officials said.
"Inaccurate test results may result in inaccurate diagnosis or inappropriate treatment," said Christine Mann, assistant press officer for the Department of State Health Services.
O'Hearn's lawyer said that there have been no accusations of misdiagnosis or malpractice against O'Hearn. "All Coppell Emergency Care Center laboratory test results were reviewed by both a nurse and physician, and no misdiagnoses occurred," he said.
Both clinics offered emergency medical care and are an alternative to emergency rooms.
The Southlake Emergency Care Center can continue to treat patients and offer clinical services but lab tests must be contracted out, Moos said. "There are no specific quality-of-care concerns with the laboratory at the Southlake Emergency Care Center," Moos said.
But federal investigators reported finding significant problems with the Coppell clinic. Most of the tests were blood counts used to diagnose infections and medical conditions like congestive heart failure, Moos said.
Under federal law, medical clinics must send some testing samples to a designated third-party clinic so both can test the same materials to ensure accuracy.
The facility under review "retests the samples and is supposed to arrive at the same or similar results," Mann said. "If the lab values do not match or come close, then the facility is said to have failed its proficiency testing."
A lab is required to pass three consecutive proficiency tests to meet federal guidelines, Mann said. In several tests, hematology for example, the lab had failing scores, some as low as 0, from 2007 through 2009, according to the federal survey report. The federal government requires a passing rate of 80 percent.
Employees identified in the report by two letters and a number did not have proof "from an accredited institution showing ... at minimum a high school diploma or equivalency," the report states. "There were copies of nursing licenses, but not college diplomas or transcripts found.
"TP5 stated she would obtain her education document from home and forward it to the surveyor by fax the next day. The education documents and training record were not received by the surveyor as promised."
The survey also showed a lack of documentation showing that proper procedures were being followed for the lab equipment.
The Coppell lab had "done tests that weren't accurate, and after the lab was informed of that, it failed to correct the problem through better training and better procedures," Moos said.
Hall said his client submitted a plan of correction but never received a response from authorities.
Nicholas Sakelaris, 817-431-2231