Compliance Audit and Risk Management

Get Your IVF Lab Operations Up to Date with Ovation’s IVF Laboratory Compliance Audit and Risk Management Reviews

Ovation Off-Site Laboratory Director Diane Wright, PhD, HCLD/CC and Director of Risk Management Cassie Miller can conduct a thorough compliance and risk management audit of your IVF laboratory facilities and operations. By identifying laboratory successes as well as areas to target for improvement, this on-site laboratory compliance audit will help your lab achieve and maintain regulatory compliance and provide a safe and efficient environment for your team members and patients.

Your audit will be customized to your lab’s operations, and can include andrology, embryology, chemistry and clinical services. Typically completed in two days, this audit touches on every critical area of your lab services, with a 360-degree approach including people, facilities and processes.

  • Staff observation and interviews
  • Facilities and systems evaluation, focused on quality and safety
  • Assessment of patient and lab quality records

Once your IVF laboratory compliance audit is complete, Ovation will deliver a comprehensive report summarizing areas where service is appropriate, areas of concern, and a comparison of your clinical outcomes to local competition and national experiences. 

What’s included in an IVF laboratory compliance audit

Ovation’s single, flat audit fee covers multiple aspects of your laboratory operations, providing great insight into how your lab is currently performing and how you can raise the bar to improve the quality of services you provide.

Ovation’s highly skilled auditors will:

  • Determine your lab’s overall compliance with all national, federal, state, and local regulatory requirements (HIPAA, OSHA, FDA, CLIA, DOL)
  • Evaluate your lab’s working spaces and equipment during real-time operations
    • Organization and maintenance of physical space
    • Safe work practices, including good tissue practices
    • Equipment maintenance records, working status and quality
  • Review safety for staff and patients
    • Patient identification steps, chain of custody in all critical steps of care, labeling
    • Collection and handling procedures
    • Specimen labeling, documentation, storage and cryostorage inventory and records
    • Patient chart review
    • Alarm installation and monitoring
    • Emergency preparedness plan, including backup power and equipment
  • Investigate current and recent complaints, poor external inspections, and/or non­conforming events
  • Ensure staff qualifications, competencies and adequacy for services rendered
    • Interview of all staff member, as applicable
    • Personnel records for all team members
    • Review of laboratory director oversight as defined by regulation (CLIA, CAP, COLA, SART, state)
  • Document that policies and procedures are in place for all services audited
    • Availability of procedures to all team members, updated by review and current practice
  • Verify quality management program implementation and reporting
    • Evaluation of clinical outcome reporting, quality control records and proficiency testing records 
  • Review records of previous inspections, for history (CLIA, CAP, JCAHO, COLA, FDA, SART, CDC/NASS, state)

If you’re interested in learning more about how an Ovation IVF laboratory compliance audit could help to improve quality and safety in your lab, contact us to discuss your needs with our off-site lab director team.