OKLAHOMA CITY (KFOR) – The results of a surprise federal complaint investigation back in August into the state’s public health lab found issues with missing documentation related to the lab’s newborn screening process.
Newborn screenings are conducted on approximately four-million babies each year in all 50 states, according to the National Institute of Health (NIH), and they help identify a range of rare or serious diseases to assist with opportunities for early identification and treatment; more than 50,000 infants are screened per year in the state of Oklahoma, according to the Oklahoma State Health Department (OSDH).
In March, the Senate approved legislation to bring Oklahoma in line with federal standards regarding infant screenings, which include a range of rare conditions that are undetectable at birth except through testing.
Currently, Oklahoma screens for 57 of the 61 federally-recommended conditions through blood spot testing, along with two point-of-care conditions.
Prior inconsistencies in state Public Health Lab testing led to a comprehensive review of the system in 2021.
George Monks, M.D., former President of the Oklahoma State Medical Association (OSMA) told KFOR he believes the state’s decision to move the lab from Oklahoma City to Stillwater and the subsequent issues that have followed have crippled the lab’s ability to perform its public health mission, including those newborn screenings.
“Right now we have the worst public health lab in the United States [and] what you’re continuing to see [is] negative fallout as a result of this failed move,” he said while noting that the state is unable to perform several vital screenings, including bioterrorism testing and TB testing, while sending many more tests out to other states.
“What’s concerning to me [about this issue] is [that] they never notified Oklahoma physicians that there was an issue, and they realized they had a problem with false positive rates and never notified families,” he added.
The “unannounced onsite complaint investigation” was conducted by the Department of Health and Human Services Center for Medicare & Medicaid Services (CMS) between August 2nd and August 4th of this year and subsequently substantiated with a standard level deficiency for an “Establishment and Verification of Performance”.
The CMS regulates all laboratory testing (except research) performed in the nation through the Clinical Laboratory Improvement Amendments (CLIA), which establishes standards for quality lab testing
According to the report, the lab is required to document all activities; however, based on review of laboratory records, manufacturer’s instruction, laboratory procedures, and interviews with facility personnel, the report noted that the lab “failed to document all activities for the establishment and verification of newborn screening normal reference intervals from April 2021 and for current normal reference intervals for 34 of 34 analytes.”
The Oklahoma State Department of Health confirmed the report but said the citation was for missing documentation, adding that the department evaluated its records to ensure there were no patients who were negatively affected by the findings.
The citation by CMS is for missing documentation, and is at a standard level; which allows the PHL to maintain focus on continuous quality improvement. Records were evaluated to ensure there were no patients who were negatively affected by the findings.
“Standard level findings also identify that the facility remains in compliance, and no systematic failures exist. However, this was an opportunity to evaluate policies and procedures, for the assurance of the highest level of operation. These surveys help us continually raise the bar to better serve Oklahomans.”Oklahoma State Health Department
A subsequent statement from the CMS noted that the standard-level deficiency is a laboratory non-compliance, it “does not represent a negative outcome or potential harm to patients”.
A standard-level deficiency is a laboratory non-compliance that does not represent a negative outcome or potential harm to patients, and that is not of such a serious nature that CMS would require a laboratory to cease patient testing.
“When standard-level deficiencies are found, Clinical Laboratory Improvement Amendments (CLIA) reviews the deficiencies to determine if there may be condition-level non-compliance. CLIA requires a Plan of Correction (POC) from the laboratory, which is acceptable in content and time frame. If the laboratory has not corrected the deficiencies in 12 months, CMS may take an enforcement action.”Centers for Medicare and Medicaid Services (CMS)
“The lab has come back with a false positive rate that’s 150 times what was expected,” Monks continued.
“When you have such a high false positive rate with newsborn testing, that hurts Oklahomans.”
That sentiment was echoed Thursday by one family who said they’ve been impacted by the effects of a false positive screening for Malonic Acidemia, a rare condition. It is so rare that only 20-30 cases are documented in the world.
“There’s not a night I don’t go to bed that I don’t wonder if another family received a false positive and are having to go through hell because of it,” said Janis Blevins, whose granddaughter’s newborn screenings initially came bacl flagged for the disease.
“Anyone in the lab or outside of the lab there looked at the statistics provided by the health department, could easily see there were problems [so] to issue a statement that no patients were negatively affected is reprehensible. Oklahomans deserve better, much better,” she added.
“We’re talking about a public health lab that cannot be trusted for accurate results. And no one seems to be real concerned about it,” Janis said.
“And then there’s the commissioner of health who knew of the issues but failed to urgently address them,” she said.
“How many more families are going to have to go through what we went through,” added her daughter Lori Zehnder, a first time mom who said the first few weeks of her daughter’s life were challenging enough without the additional appointments and screenings that were required to rule out Malonic Acidemia.
“Those first six weeks were rough without having to add on something that could have been easily avoided if someone had taken the necessary steps to make sure things were done correctly. We rely on them to get it right the first time,” she said.
“I should have spoken up sooner but at that point, I was just trying to live through it,” she added in an interview Thursday with KFOR.
In an interview with KFOR in July, Health Commissioner Keith Reed said abnormal test results are a reality of screening programs, but don’t necessarily reflect adverse medical conditions.
“We’re not happy about it. We don’t want parents to go through that. But in order to test 50,000 plus kids in the in the state, we are going to have some abnormal results from that testing that very fortunately are going to end up being nothing of concern,” he said.
“Families that are told their newborn may have a lifelong crippling disease that will result in early death?”
“You can’t tell me that – that doesn’t negatively impact Oklahomans,” said Dr. Monks.
Common lab deficiencies across the nation for 2021 included personnel, procedures and facility administration.