Medical accreditation organization investigates UH after fertility clinic malfunction

CLEVELAND - The agency that accredits University Hospitals' fertility clinic is investigating the hospital's compliance after the malfunction in their storage facility that left 2,000 eggs and embryos in question. 

The College of American Pathologists accredits more than 8,000 labs nationwide and internationally. University Hospitals reproductive lab is one them. 

"This is a very, very unusual event," said Dr. Paul Bachner, an Adviser with the College of American Pathologists Accreditation Committee.

According to Dr. Bachner, a federal statute requires most labs be accredited by an agency like CAP. But there is no federal requirement for reproductive labs.

University Hospitals' reproductive lab is one of 350 that elects accreditation. 

"They seek our accreditation voluntarily, they aren't required to be accredited by federal law," Dr. Bachner said. 

To maintain accreditation, it's mandatory that the hospital follows what the agency refers to as "scientifically rigorous" requirements. 

"They cover all activities of the lab," Dr. Bachner said.

CAP also conducts on-site inspection every two years. University Hospitals last inspection was April 26, 2016. 

The College of American Pathologists' investigation will come before the next scheduled inspection to make sure that the lab is still in compliance, following the liquid nitrogen storage facility's malfunction.

Dr. Bachner said the first step for this investigation is to send a letter sent to University Hospitals identifying data relevant to the malfunction. UH will have 30 days to respond. 

"They could still be in compliance even if there was a failure of a particular instrument, or for that matter, if there were human error involved," Dr. Bachner said.

Print this article Back to Top