June 7, 2019

Planned Parenthood Contracted Lab Cooperates with Investigation

JEFFERSON CITY, Mo. -- As a result of Missouri Department of Health and Senior Services' (DHSS) annual health inspection on March 11-13, 2019, of Reproductive Health Services of Planned Parenthood of the St. Louis Region, state regulators identified serious concerns, one of those involving the handling of fetal tissue extracted from abortions.

DHSS immediately referred its findings to the Centers for Medicare & Medicaid Services (CMS), the proper federal investigative authority into Clinical Laboratory Improvement Amendments of 1988 (CLIA) laboratories. An immediate investigation ensued into the processes conducted by Planned Parenthood's contracted laboratory, Boyce and Bynum Professional Services, which handles fetal tissue.

The Planned Parenthood contracted lab cooperated with state and federal investigators who met with individual clinicians and doctors, which confirmed the serious concerns regarding the analysis and handling of fetal tissue provided by Planned Parenthood of St. Louis. As a result of these investigations, on May 7, 2019, the laboratory was found to not be in compliance with Condition-level CLIA requirements and provisionally lost its accreditation with the College of American Pathologists. Specifically, the investigation was undertaken to determine why women remained pregnant after the abortion provider and the laboratory confirmed the presence of fetal parts and tissue in the post-surgical abortion pathological examination. 

A failed surgical abortion--a very rare complication--in which a woman remains pregnant after a surgical procedure, can usually be detected by the examination of fetal tissue confirming the abortion was performed both by the physician performing the abortion and pathological examination by an accredited laboratory. State law and standard of care require the physician to grossly examine tissue at the time of the procedure.

Further inquiry as to why failed surgical abortions occurred without the patient knowing that she was still pregnant led to an investigation that at this point in time discovered deficiencies in the contracted laboratory's processes related to the examination of fetal tissue. The investigation into additional reasons for this is ongoing but has been limited by the refusal of Planned Parenthood providers who performed the abortions to be interviewed.

The Planned Parenthood contracted laboratory fully cooperated with all aspects of the investigation and was informed Thursday, June 6, by CMS that their accreditation was restored with the College of American Pathologists, which allows DHSS to release this important information publicly at this time.

"I appreciate the collaboration with our state and federal regulators diligently working to ensure we uphold our duty to protect and inform the public about any health and safety concerns regarding any one of more than 4,000 health facilities in Missouri," said Dr. Randall Williams, director of DHSS. "The findings at Planned Parenthood's contracted laboratory contributed to adverse patient outcomes. It's important to note that the Planned Parenthood contracted laboratory is able to regain accreditation based on their willingness to fully comply with the investigation. It's the contracted laboratory's responsibility to ensure they are at all times following the CLIA requirements and to implement the corrective action plan to improve patient safety."

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