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OSDH temporarily sends newborn screening to top national lab

Tuesday, March 16, 2021

Inconsistencies in state Public Health Lab testing lead to comprehensive review

OKLAHOMA CITY — As the Oklahoma State Department of Health works to transition newborn screening testing to the new state-of-the-art lab in Stillwater, inconsistencies found in how certain tests are being run and reported has led to a decision to send newborn screening to a top national lab until a thorough review of all testing is completed by the department. 

“As the new executive lab director, I am charged with building a best-in-class public health lab in the country,” said Dr. Michael Kayser, DO, FACMGG; a board-certified, clinical and laboratory geneticist and CLIA director for OSDH’s Public Health Lab. “In order to do that, we must ensure all testing is conducted according to scientific best practices with the highest level of rigor. Our new Stillwater laboratory has the latest equipment and testing standards putting Oklahoma on the cutting edge of science and innovation. It is critical we review all historical testing procedures before we transition testing to Stillwater, so we are working seamlessly and at the highest standard from day one.”

OSDH Deputy Commissioner Travis Kirkpatrick requested the Office of Accountability conduct thorough review prior to transitioning newborn screening to the new lab.  

“We can never compromise when it comes to the integrity of testing and reporting at the Public Health Lab,” said Kirkpatrick. “The extreme importance of the work we perform here mandates a comprehensive review of our processes and protocols.” 

Dr. Kayser has been reviewing test procedures since coming to the lab at the first of this year, and as part of that process discovered late last week that the Public Health Lab has not been adequately screening for a metabolic disorder called Tyrosinemia Type 1 (TT-1), one of 56 federal Recommended Uniform Screening Panel (RUSP) tests Oklahoma conducts on newborns.

The primary marker to identify TT-1 is the presence of succinylacetone. Oklahoma has never screened for succinylacetone. While we are one of three states not testing for succinylacetone,  moving forward we will test for TT-1in alignment with scientific best practices. 

“Reporting complete and accurate results is our top priority,” said Dr. Kayser, whose background includes caring for patients with genetic and metabolic conditions diagnosed by newborn screening.  Dr. Kayser was trained with the National Human Genome Research Institute at the National Institutes of Health in Washington, D.C., and is considered a leader in newborn screening.  One of his many accomplishments has been the launching of advanced genetic laboratories aimed at improving diagnostic and treatment capabilities for newborns at St. Francis Children’s Hospital in Tulsa.  He has been a pioneer in the expansion and use of newborn screening in the state. 

“Temporarily sending out our newborn screening as we relocate the lab ensures current tests will be conducted using the latest methodology and most advanced technology. Our decision underscores a desire to embrace the highest level of confidence and integrity in our research and testing methodologies moving forward in the new lab,” said Kayser. 

When completed, Oklahoma’s state-of-the-art Public Health Lab will be one of the preeminent labs in the nation with the best technology and trained staff capable of running tests in accordance with strict scientific standards. The relocation represents a new beginning for the lab with the latest equipment, training and protocols.

Sending Oklahoma’s newborn screening to a national lab will also immediately add four tests on the RUSP to the screening process, which will immediately serve all Oklahomans better. The new tests include: 

  • Adrenoleukodystrophy (ALD)
  • Spinal muscular atrophy (SMA)
  • Pompe
  • Mucopolysaccharidosis Type 1 (MPS1)

OSDH will be able to conduct these four additional tests at the new lab in Stillwater and will bring the total newborn tests the new lab can conduct to 61.

Starting today, Oklahoma will send its newborn screening to PerkinElmer Genomics in Pennsylvania, widely considered the top newborn screening lab in the country, until the OSDH review is complete.