Case Study

Client Challenge:

This healthcare client pivoted from the company’s core artificial intelligence business to COVID 19 PCR testing shortly after the start of the pandemic. Executive and laboratory management had little to no expertise with diagnostic testing and clinical laboratory regulatory requirements. Testing was launched before the appropriate infrastructure was implemented to ensure quality and regulatory compliance. Experienced laboratory staff were overwhelmed by the testing volume and unable to put the required systems in place. Approximately six months into COVID testing, a newly hired executive immediately recognized that the laboratory was not in compliance and revocation of CLIA certification was at risk with an initial accreditation inspection coming up.

To meet the challenge, Carrot Clinical:

Performed a remote audit of the clinical laboratory by reviewing regulatory records and internal policies, procedures, and records, and interviewing personnel to assess the laboratory’s quality system and compliance to requirements.
Wrote an audit report describing the gaps identified, the corrective actions required, and the risks to the laboratory if gaps were not corrected. Presented the findings to the executive leadership.
Worked with the laboratory management team to prioritize and correct the gaps.
Reviewed and revised laboratory policies, procedures, and forms for clarity, completeness, and compliance to regulations.
Trained the laboratory staff on quality system and regulatory requirements, and inspection preparation activities.
Performed an onsite audit to assess the facility.
Performed a mock inspection with the laboratory staff and coached them on how respond to inspector questions.
Supported the laboratory management team during the COLA accreditation inspection

Business Benefits/Results:

The laboratory corrected the gaps identified during the remote and onsite audits, coming into compliance with regulatory requirements. The laboratory completed the COLA inspection with only two findings and successfully attained accreditation.