This course is one of 8 online modules on Patient Safety offering 1.0 continuing education (CME/CMLE) credit per module that can be used to fulfill CC Part II and CMP requirements. 

Faculty/Authors
Alexandra Brown, MD, Chief Medical Officer, ASCP, Chicago, IL
Cody Carter, MD, Assistant Professor of Pathology, Loma Linda University School of Medicine, Loma Linda, CA 
Sachin Gupta, PhD, MBA, MLS(ASCPi)MB, LSSBB, CPHQ, Scientific Director, Center for Quality and Patient Safety (CQPS), ASCP, Chicago, IL
Matthew Rosenbaum, MD, Staff Pathologist, Director, Quality & Patient Safety, Beth Israel Deaconess Medical Center, Boston, MA
Dana Warfield, MPH, Director, Quality and Regulatory, Pathology and Clinical Laboratories, NYU Langone Health, NY, NY 

CME/CMLE Credit: 1.0
Estimated Completion Time: 1 hour
Format: Online Educational Activity

Physician Competencies: Patient Care, Medical Knowledge, Practice-Based Learning and Improvement, Professionalism, Systems-Based Practice 

Accreditation Statement: The American Society for Clinical Pathology (ASCP) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education (CME) for physicians. This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME).

Credit Designation Statement: The American Society for Clinical Pathology (ASCP) designates this enduring material for a maximum of 1 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Instructions

To claim CME/CMLE credit for the exercise, do the following:

1. Review the Technical Considerations.
2. Review the Faculty Disclosures.
3. Click Go to Course to view an overview of the modules in this course.
4. Click Access to begin the course.
5. Review the Educational Activity.
6. Submit the course Evaluation.
7. Enter the maximum number of credits offered and click Claim CME to register credit.

Faculty Disclosures
The faculty have no relevant financial relationships with commercial interests to disclose. 

Technical Considerations

Release Date: 9/18/2023  
Review Date:
Expiration Date: 12/31/2026  

• Explain the necessity of Root Cause Analysis.
• Describe how to perform a Root Cause Analysis.
• Distinguish the advantages and disadvantages of using a Failure Modes and Effects Analysis (FMEA) to an ISO risk assessment.
• Explain the performance of an FMEA.
• Define a Risk Assessment and its components.
• Explain the performance of a risk assessment.
• Define the legal obligations of healthcare facilities related to medical device incident reporting.
• Discuss the importance of reporting products problems to the manufacturer.
• Explain the benefits of voluntary reporting systems