CLSI Solutions to the Top 10 Deficiencies
Are you struggling with deficiencies from your latest inspection?
CLSI has the resources you need. We've identified the top 10 most commonly cited deficiencies by major accreditation organizations, and created document lists to address each area. Each document list is designed to provide you with the tools to help you prepare for accreditation inspection, improve areas of concern, and resolve deficiencies.
Plus, it's never too late to join CLSI as a member. Our members receive a 50% discount on documents, solution packages, and programs. Learn more about membership.
Create a custom solution package for your lab today.
Custom 5-Document Package | Select Any 5 Documents
Nonmembers: $800
Custom 10-Document Package | Select Any 10 Documents
Nonmembers: $1,530
Simply fill out our online form for a custom quote request, or contact Customer Service directly at either customerservice@clsi.org or +1.610.688.0100 to order your custom document package today. Member rates apply.
Request a Custom Package Quote
View Our Solution Packages by Deficiency Category
Adverse and Nonconforming Events
Do you proactively manage and resolve deviation from policies, processes, and procedures? These documents provide guidance for managing adverse events, preventing repeat occurrences, and ensuring better quality.
- QMS12 | Development and Use of Quality Indicators for Process Improvement and Monitoring of Laboratory Quality, 2nd Edition
- M29 | Protection of Laboratory Workers From Occupationally Acquired Infections, 4th Edition
- QMS06 | Quality Management System: Continual Improvement, 3rd Edition
- QMS11 | Nonconforming Event Management, 2nd Edition
Controls: Mean and Standard Deviation
Do you need help identifying the source of error in controls or results? These documents cover a variety of quality control topics including implementation, maintenance, and troubleshooting equipment—accuracy depends on managing sources of error.
- EP18 | Risk Management Techniques to Identify and Control Laboratory Error Sources, 2nd Edition
- EP27 | How to Construct and Interpret an Error Grid for Quantitative Diagnostic Assays, 1st Edition
- QMS13 | Quality Management System: Equipment, 1st Edition
- C24 | Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions, 4th Edition
Lab Director Responsibilities
Have you taken on new supervisory, management, administrator, or director-level responsibilities? These documents will get you up to speed on implementing or running a quality management system, managing documents, and fulfilling leadership and management responsibilities.
- QMS05 | Quality Management System: Qualifying, Selecting, and Evaluating a Referral Laboratory, 2nd Edition
- QMS25 | Handbook for Developing a Laboratory Quality Manual, 1st Edition
- QMS02 | Quality Management System: Development and Management of Laboratory Documents, 6th Edition
- QMS14 | Quality Management System: Leadership and Management Roles and Responsibilities, 1st Edition
- QMS01 | Quality Management System: A Model for Laboratory Services, 5th Edition
Method Correlation
Are you confident in the consistency and reliability of testing platform results within your organization? Quality results need consistency to be truly reliable. These documents will ensure the quality of test results.
- EP31 | Verification of Comparability of Patient Results Within One Health Care System, Interim Revision
- EP21 | Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures, 2nd Edition
- EP14 | Evaluation of Commutability of Processed Samples, 3rd Edition
- EP32 | Metrological Traceability and Its Implementation, A Report
- EP29 | Expression of Measurement Uncertainty in Laboratory Medicine, 1st Edition
- EP26 | User Evaluation of Between-Reagent Lot Variation, 1st Edition
- EP09c | Measurement Procedure Comparison and Bias Estimation Using Patient Samples, 3rd Edition
Method Validation and Verification
Would your laboratory benefit from a toolkit for method validation and calibration verification? These documents focus on interference, linearity, reference intervals, trueness, and precision, including related troubleshooting.
- EP10 | Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures, 3rd Edition
- EP06 | Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach, 1st Edition
- EP05 | Evaluation of Precision of Quantitative Measurement Procedures, 3rd Edition
- EP15 | User Verification of Precision and Estimation of Bias, 3rd Edition
- EP19 | A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures, 2nd Edition
- EP07 | Interference Testing in Clinical Chemistry, 3rd Edition
- EP28 | Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory, 3rd Edition
Patient and Specimen Identification
Are there problems in your process, such as collection, transportation, processing, testing, and disposition? These documents will help you ensure test result accuracy by ensuring positive patient and specimen identification from collection to disposition.
Personnel Records, Responsibilities, and Competence
Does maintaining an efficient competence assessment program seem like a mystery? This comprehensive source of solutions will make you a personnel management pro.
- POCT13c | Glucose Monitoring in Settings Without Laboratory Support, 3rd Edition
- QMS03 | Training and Competence Assessment, 4th Edition
- POCT12 | Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities, 3rd Edition
- QMS15 | Assessments: Laboratory Internal Audit Program, 1st Edition
- QMS16 | Laboratory Personnel Management, 1st Edition
Proficiency Testing
If you get cited on this complex program, you’re not alone! CLSI has you covered with these documents, from continual improvement in your quality management system to detailed guidance on a solid proficiency testing program.
- MM14 | Design of Molecular Proficiency Testing/External Quality Assessment, 2nd Edition
- QMS24 | Using Proficiency Testing and Alternative Assessment to Improve Medical Laboratory Quality, 3rd Edition
- C24 | Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions, 4th Edition
Specimen and Reagent Storage
Do you experience challenges with specimen storage, handling, waste streams, or environmental safety? These documents will help you solve facilities issues, design new processes, or solve existing problems.
- GP17 | Clinical Laboratory Safety, 3rd Edition
- EP25 | Evaluation of Stability of In Vitro Diagnostic Reagents, 1st Edition
- QMS04 | Laboratory Design, 3rd Edition
- GP44 | Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests, 4th Edition
- GP05 | Clinical Laboratory Waste Management, 3rd Edition
Waived and Quantitative QC
Are you experiencing problems at the point of care? These documents are your solution for waived and point-of-care testing.
- EP25 | Evaluation of Stability of In Vitro Diagnostic Reagents, 1st Edition
- EP12 | User Protocol for Evaluation of Qualitative Test Performance, 2nd Edition
- POCT08 Quick Guide | Quality Control Log Sheet Quick Guide
- EP10 | Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures, 3rd Edition
- EP18 | Risk Management Techniques to Identify and Control Laboratory Error Sources, 2nd Edition
- POCT08 Flow Chart | Quality Control Troubleshooting Flow Chart
- POCT08 | Quality Practices in Noninstrumented Point-of-Care Testing: An Instructional Manual and Resources for Health Care Workers, 1st