Updated November 23, 2010

Each on-line audioconference consists of a pre-recorded audiofile of a live broadcast and handout materials. The sessions are available approximately three weeks following the live broadcast. Starting in 2009, files are provided in an MP3 format and are downloadable to portal devices.

As a participant in these audioconferences, you will:

• Enhance your knowledge of the inspection process
• Become familiar with changes in checklist requirements
• Understand the intent and interpretation of checklist requirements
• Expand your knowledge of what constitutes compliance

Target Audience:
Practicing pathologists, laboratory professionals, and pathology residents

Program Level:
Basic - Intermediate. Prior working knowledge of the CAP inspection process and Checklist content is recommended.

E-mail the education department if you need further technical assistance with this course.

The information contained in this resource is intended solely for education and communication purposes and is not intended to constitute medical advice. The CAP expressly disclaims any and all liability for any information included in this resource.

Audioconference Topics

Test Validation: A Brave New World for Anatomic Pathology
May 19, 2010
Richard W. Brown, MD, FCAP and Francis E. Sharkey, MD, FCAPP

Objectives:

After participating in this audioconference you will be able to:

• Discuss validation concepts and terminolog.y
• Explain positive and negative controls and predictive markers.
• Discuss automated imaging system.

Laboratory Developed Tests
April 21, 2010
William J. Castellani, MD, FCAP

Objectives:

After participating in this audioconference you will be able to:

• Compare and contrast new test validation requirements for CAP and CLIA for non-FDA approved tests.
• Describe approaches for analytical validation of non-FDA approved tests.
• Review test management expectations for non-FDA approved tests.

CAP Personnel Qualifications and Competency Requirements
March 17, 2010
Gregory A. Gagnon, MD, FCAP, Carolyn Gandy, MT(ASCP)SM, and Rodney Stewart, MBA, MT(ASCP)

Objectives:

As a result of participating in this session, you will be able to:

• Assess your personnel to ensure compliance with CLIA regulations.
• Differentiate training, competency assessment and performance evaluation.
• Develop and implement documentation that demonstrates compliance with CAP and CLIA personnel requirements.

Complying with the Team Leader Checklist
February 17, 2010
Paul Bachner, MD, FCAP

Objectives:

After participating in this audioconference, you will be able to:

• Enhance the effectiveness of the director in meeting the Standards of the Laboratory Accreditation Program.
• Improve communication with physicians and institutional administration.
• Evaluate critical documents that are required to implement an effective Quality Management Plan.

Accreditation Requirements for Waived vs. Non-waived Tests
January 20, 2010
Rawhi A. Omar, MD, PhD, FCAP

Objectives:

As a result of participating in this session, you will be able to:

• Define the two basic test categories of waived and non-waived tests
• Explain essential accreditation (testing) requirements that distinguish waived from non-waived
• Apply principles of quality assurance and continuous compliance in waived testing

Most Common POCT Deficiencies
November 18, 2009
Cynthia Foss Bowman, MD, FCAP

Objectives:

As a result of participating in this session, you will be able to:

• List the most common deficiencies related to the CAP POCT checklist
• Identify best practices to avoid POCT problems
• Identify strategies to demonstrate continuous compliance with POCT accreditation requirements

Laboratory Computer Systems
October 21, 2009
Bruce Beckwith, MD, FCAP

Objectives:

As a result of participating in this session, you will be able to:

• Describe the requirements for validating computer interfaces.
• Understand the principles for validating autoverification.
• Apply accreditation requirements regarding LIS in your own laboratory setting

Checklist Updates
September 16, 2009
Stephen J. Sarewitz, MD, FCAP

Objectives:

As a result of participating in this session, you will be able to:

• List important topics from the Lab General, Hematology and Microbiology checklists.
• Describe current and recent updates to the LAP inspection checklists including the rationale for the changes.
• Use the checklists to improve laboratory quality.

Blood Gas Analysis
July 15, 2009
D. Robert Dufour, MD, FCAP

Objectives:

As a result of participating in this session, you will be able to:

• Develop valid means for comparing different blood gas analyzers and for confirming analytical measurement range.
• Review QC results to detect important differences between instruments at an early time.
• Institute procedures to detect and prevent preanalytical variation in blood gas results.

The Rules, Tools and Jewels of the Cytopathology Laboratory Inspection
June 17, 2009
Dina Mody, MD, FCAP, and Michael Henry, MD, FCAP

Objectives:

As a result of participating in this session, you will be able to:

• Discuss CLIA 88 and compliance requirements unique to the Cytopathology laboratory.
• Explain the rationale behind the new/recent checklist requirements as they apply to areas in the cytology laboratory.
• Describe the deficiencies most frequently cited during inspections of cytology laboratories and strategies to avoid these.
• Apply strategies for preparation of unannounced inspections as currently required.

Accreditation Requirements in Molecular Pathology
May 20, 2009
Helen Fernandes, PhD

Objectives:

As a result of participating in this session, you will be able to:

• Describe the process of analytical and clinical validation for assays used in molecular diagnostics.
• Identify monitors for on-going quality control at the pre-analytical, analytical and post-analytical phases of molecular testing.
• Recognize the utility of analytical monitors for quality improvement in molecular pathology.

Unannounced Inspections: A Guide for Continual Readiness
April 15, 2009
Amy S. Gewirtz, MD, FCAP

Objectives:

As a result of participating in this session, you will be able to:

• Establish an approach to document control that will ease the retrieval of information during an unannounced inspection.
• Establish a step wise itemized protocol to more efficiently and effectively facilitate the entire unannounced inspection process.
• Develop your own laboratory’s action plan to better achieve continued readiness for the unannounced inspection.

How to Prepare and Comply with Your Quality Management Plan
February 18, 2009
Paul Bachner, MD, FCAP

Objectives:

As a result of participating in this session, you will be able to:

• Explain the reasons why the QM Plan is important
• List key compliance issues regarding quality management

Simple Tests, Tough Problems: Patient Care and Laboratory Inspection
in Coagulation
January 21, 2009
John D. Olson, MD, PhD, FCAP

Objectives:

After participating in this session, you will be able to describe patient care and accreditation issues regarding:

• ProTime/INR
• ISI, Sensitivity, Critical Values
• Calculation Verification
• Monitor Heparin Therapy
• aPTT and Reagent Sensitivity
• Heparin Assay
• D-Dimer Assay
• Type and Magnitude of Units
• Threshold for exclusion of VTE

Laboratory General Checklist: Safety for Laboratory Workers
November 19, 2008
Jerry L Harris, MD, FCAP

Objectives:

• Identify opportunities to make your lab a safer place for employees
• Apply safety requirements during inspections and inspection preparation

Laboratory General Checklist: Personnel Issues in the Clinical Laboratory
October 15, 2008
Richard M. Scanlan, MD, FCAP

Objectives:

• Explain the origins of regulations governing those who work in clinical labs
• Better assess the personnel policies and practices of your laboratory
• Help insure regulatory compliance for testing done outside the laboratory

Laboratory General Checklist: How to Validate a New Test
September 17, 2008
D. Robert Dufour, MD, FCAP, FACB

Objectives:

• Describe the necessary steps to validating new test performance
• Assure that all steps are performed for all new methods introduced in your laboratory

The Laboratory General Checklist
June 18, 2008
Francisco R. Velázquez, MD, SM, FCAP

Objectives:

• Effectively address all general and specific requirements
• Coordinate the general requirements applicable to any and all discipline
  specific checklists
• Identify opportunities to enhance your laboratory’s inspection readiness

Patient Safety and the Laboratory
May 21, 2008
Paul Valenstein, MD, FCAP

Objectives:

• List the CAP Patient Safety Goals
• Proactively address common risks
• Monitor laboratory performance
• Respond to incidents
• Document your patient safety program

Avoiding the Most Common Deficiencies
April 16, 2008
Paul Bachner, MD, FCAP

Objectives:

• Identify the most frequently cited deficiencies that are common to all checklists
• Develop strategies to efficiently and effectively demonstrate continuous compliance with these checklist requirements

Inspection Techniques
March 19, 2008
Erica J. Behnke, PhD, HCLD(ABB)

Objectives:

• Recognize the value of continuous preparation for an unannounced inspection
• Describe commonly used inspection techniques and approaches
• Explain the logistics of an unannounced inspection

AP for Histotechs
February 20, 2008
Francis E. Sharkey, MD, FCAP

Objectives:

• Recognize problems that may arise in the grossing room
• Identify critical technical parameters that affect the sensitivity, specificity and precision of immunohistochemical stains
• Develop procedures that improve the quality of Surgical Pathology reports

Checklist Updates
January 16, 2008
Stephen J. Sarewitz, MD, FCAP

Objectives:

• Describe revisions to the following checklists or topics: transfusion medicine, microbiology, water quality, proficiency testing, and technical consultant requirements
• Apply updated checklist requirements in the following areas to your own preparation efforts: method performance specifications, single use devices, built-in (internal) controls, CAP Patient Safety Goals, critical results, and document control

Performing Effective Self-Inspections
November 14, 2007
Renee R. Ellerbroek, MD, FCAP

Objectives:

• Explain the importance of the interim self-inspection
• Apply best practices and tips to your interim self-inspection
• Describe how maximizing the interim self-inspection will prepare you for an unannounced external inspection

Achieving Compliance with Limited Resources
October 17, 2007
Richard M. Scanlan, MD, FCAP

Objectives:

• Identify the major challenges a laboratory with limited resources faces
• Use the tools and strategies provided to meet CAP Laboratory Accreditation Program requirements efficiently

Document Control Management
September 19, 2007
William J. Castellani, MD, FCAP

Objectives:

• Describe the CAP LAP checklist requirements for document control
• List how policies, procedures, records and forms come under the document control requirements
• Discuss strategies and issues in implementing a rigorous document management system

Quality Management From the Top Down—Lab Managers and Supervisors
June 20 , 2007
Francisco R. Velazquez, MD, SM, FCAP

Objectives:

• Describe the role of the laboratory manager or supervisor in developing, implementing, and overseeing the program
• Define key elements of a quality management program (QMP)
• Identify criteria useful in evaluating the effectiveness of your own QMP

Quality Management From the Top Down—Lab Director’s Role
May 16, 2007
R. Bruce Williams, MD, FCAP

Objectives:

• Define key elements of a documented quality management program (QMP)
• Describe the role of the laboratory director in developing, implementing, and overseeing the program
• Identify criteria that evaluate your own QMP for effectiveness

Crucial Compliance Communications
April 18, 2007
Denise K. Driscoll, MS, MT(ASCP)SBB

Objectives:

• Describe the relationship between “getting ready for an inspection” and daily continuous compliance
• Identify communications (responses/notifications) required to maintain full accreditation
• Describe appropriate responses to facilitate accreditation process

Update on Unannounced Inspections
February 21, 2007
Francis E. Sharkey, MD, FCAP

Objectives:

• Explain the new reapplication and inspector assignment processes
• Identifiy changes to the on-site inspection process
• Describe how laboratories can prepare for unannounced inspections

Getting the Most Out of Your Proficiency Testing
January 24, 2007
Chantal R. Harrison, MD, FCAP

Objectives:

• Discuss the regulatory aspects and impact of proficiency testing (PT)
• Identify approaches to effectively manage and fully utilize PT in your laboratory
• List investigative techniques used to determine causes of poor PT performance and describe effective corrective actions
• Use PT summary discussions as continuing education opportunities