NOTE: You must complete this course and successfully pass the post-test to fulfill the training requirement.
The purpose of this course is to provide you with the tools and techniques to plan and conduct a successful inspection of a biorepository. It provides inspection or auditing techniques, which will assist you in gathering the appropriate information to determine if your findings support compliance with the requirements. This course is appropriate for new as well as experienced team leaders and team members.
After completing this SAM eligible activity and post-test, you should be able to:
- Use the information included in the Inspector’s Inspection Packet to make decisions including determining team size and selecting appropriate team members.
- Recognize the Commission on Laboratory Accreditation (CLA) policies that relate to the conduct of on-site inspections.
- Understand the information included in the Team Member Packet and use that information to prepare in advance for the inspection.
- Use the appropriate inspection techniques (R-O-A-D).
- Be familiar with the purpose and use of checklists.
- Effectively apply time management strategies to facilitate the inspection process.
- Evaluate compliance with the requirements for the director’s role and responsibilities.
- Apply appropriate General Checklist requirements.
- Based on the information gathered during the inspection, cite deficiencies when the intent of the requirements is not met.
- Provide recommendations in compliant situations to promote process improvements.
- Ensure that recommendations are not provided in lieu of citing deficiencies in situations that are not compliant with accreditation requirements.
- Ensure consistent interpretation of common checklist items (eg, QM, PT, QC, patient safety, method specifications, personnel/competency, safety, computers, reports).
- Compare findings related to requirements common to all checklists of the biorepository to uncover systemic problems.
- Inform supervisors of potential deficiencies as the deficiencies are identified (prior to Summation).
- Apply the practice of corrected on-site versus removing deficiencies appropriately.
- Complete the pink ISR pages with sufficient detail to clearly describe the noncompliance.
- Recognize the purpose and importance of the Presummation and Summation Conferences.
- Complete ISR Part A (overall quality of the laboratory services) with sufficient detail to ensure that the comments support and supplement the deficiencies cited in Part B.
Accreditation: The College of American Pathologists (CAP) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
CME Category 1: The College of American Pathologists designates this internet enduring material educational activity for a
maximum of 3.5
AMA PRA Category 1 Creditâ„¢. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
CE (Continuing Education for non-physicians): The CAP designates this educational activity for a maximum of 3.5 credit(s) of continuing education. Participants should claim only the credit commensurate with the extent of their participation in the activity.
This activity meets the American Board of Pathology’s (ABP) Continuing Certification (CC) requirements for Self-Assessment Modules (SAMs)..
This activity is approved for continuing education credit in the states of California and Florida.
The American Society for Clinical Pathology (ASCP) Board of Certification (BOC) Certification Maintenance Program (CMP) accepts this activity to meet the continuing education requirements.
You have a total of three opportunities to take and pass the post-test. If you correctly answer 72% or more of the post-test items, you may claim credit. CME/SAM credit can be applied to the American Board of Pathology (ABP) Self-Assessment Module (SAM) requirements.You must pass the post-test to claim credit; therefore, if you do not pass, you cannot claim credit.
Pop-up blockers must be turned off.
CAP Learning has recognized that some Veteran’s Administration, US Government, and military participants may have difficulty accessing the online assessment portion of this activity. If you experience difficulty or have any questions, please contact a representative of the CAP Learning Division at 800-323-4040 option 1 or email@example.com.
This activity and evaluation is available February 28, 2019, and will expire on February 27, 2020, at 12:00 AM (ET). You MUST claim credit by this date and time.