Excellence in Medical Laboratory Quality Management

Quality Management Systems in Medical Laboratories Ensuring Excellence in Patient Care and Quality Performance in Cytopathology

Importance of quality in medical laboratories Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. Direct impact on patient care and safety Role in clinical decision-making Legal and ethical obligations KSA Vision 2030

Overview of quality management systems (QMS) Definition: Definition of QMS Historical context: evolution of laboratory quality management Systemic approach to quality

Regulatory Framework A. ISO 15189: Medical laboratories - Requirements for quality and competence ISO 15189 (Medical laboratories particular requirements for quality and competence) Europe - Key requirements and structure - Process-based approach - Focus on both management and technical competence

Regulatory Framework B. Clinical Laboratory Improvement Amendments (CLIA) - Scope and applicability - Requirements for laboratory certification - Quality control and proficiency testing mandates

Regulatory Framework C. Other relevant regulations and accreditation standards - College of American Pathologists (CAP) accreditation - Joint Commission standards - Regional and national regulatory bodies

Quality Control Quality Control is defined as a system for verifying and maintaining a desired level of quality in an individual test or process. Quality control activities Quality control activities span the testing process from the moment of specimen collection until the time the physician receives the report. Quality assurance Quality assurance A planned and systematic set of quality activities focused on providing confidence that quality requirements will be fulfilled. Quality assurance should include both internal quality control (IQC) and external quality assurance (EQA) (IQC) and external quality assurance (EQA) internal quality control

Key Components of a Laboratory QMS A. Organization and leadership - Defining quality policy and objectives - Management commitment and responsibility - Organizational structure and roles B. Customer focus - Identifying internal and external customers - Managing customer requirements and feedback - Measuring customer satisfaction C. Facilities and safety - Laboratory design and environmental controls - Safety protocols and hazard management - Waste management and disposal

Key Components of a Laboratory QMS D. Personnel management and competency - Recruitment and retention strategies - Training programs and competency assessments - Continuing education and professional development E. Equipment management - Selection and validation of equipment - Maintenance and calibration schedules - Troubleshooting and repair procedures F. Purchasing and inventory - Supplier evaluation and selection - Inventory control systems - Managing critical supplies and reagents

Key Components of a Laboratory QMS G. Process management - Mapping and standardizing laboratory processes - Implementing standard operating procedures (SOPs) - Process optimization and efficiency H. Information management - Laboratory Information Systems (LIS) - Data integrity and security - Reporting and communication of results I. Document control - Creating and maintaining quality manual - Document hierarchy and version control - Accessibility and distribution of documents

Key Components of a Laboratory QMS J. Occurrence management - Non-conformity identification and reporting - Root cause analysis techniques - Corrective and preventive action (CAPA) implementation K. Assessments: Internal and external - Internal audit programs - Management reviews - External quality assessments and accreditation audits L. Continual improvement - Quality improvement projects - Benchmarking against industry standards - Innovation and adaptation to new technologies

Clinical Laboratory Improvement Amendments of 1988 Bogdanich W: Lax laboratories: the Pap test misses much cervical cancer through labs errors. Wall Street Journal 1987;210(88):1,20 Clinical Laboratory Improvement Amendments of 1988: Final Rule. Fed Reg: United States Department of Health and Human Services, United States Government Printing Office 2003:3710-3711.

Clinical Laboratory Improvement Amendments of 1988 highlights: workload limits for cytotechnologists new quality control (QC) procedures 5-year retrospective rescreening cytologic-histologic correlation pathologist review of all abnormal Paps, and reactive and reparative changes , all non gynecologic specimens proficiency testing (PT)

Cytopathology QMS The Cytology Triangle represents the interdependence of the processes of 1) specimen collection and preparation. 2) microscopic screening practices. 3) the vigilance and proficiency of the cytotechnologist (the observer). Quality processes involving the three sides of the triangle yield quality outcomes. *Source: Mr. Mohammed H Elhoweris MSc, CT(IAC) , CTgyn(ASCPi ) Cytopathology Supervisor Dubai Healthcare City , Dubai, UAE

Key Components of Cytopathology QMS A. Specimen Collection and Handling - Proper labeling and patient identification - Appropriate collection techniques for different specimen types - Specimen preservation and transport protocols - Rejection criteria for inadequate specimens

Key Components of Cytopathology QMS B. Pre-analytical Phase - Accessioning procedures - Specimen adequacy assessment - Processing: LBC , Centrifugation , cell block preparation , staining , cover slipping). - Staining protocols and quality checks - Contamination control

Rejection examples

Contamination Control Hematoxylin, EA50, and OG6 should filtered daily using filter paper Alcohol, differentiation solutions, and xylene should be replaced daily. It is highly recommended that Gyn and Non Gyn samples be stained separately. Contamination control is essential step to avoid (Malignant floaters) that caused false positive results. Stains and reagents replaced according to lab SOP (number of slides).

Key Components of Cytopathology QMS C. Analytical Phase 1. Microscopic Examination - Standardized screening protocols - Workload limits for cytotechnologists - Inter observer correlation - Double screening policies for high-risk cases

Key Components of Cytopathology QMS 2. Cytopathologist Review - Criteria for pathologist review of all positive and suspicious cases - Consultation procedures for challenging cases - Cytotechnologist competency (10% rescreening) 3. Reporting - Use of standardized terminology (e.g., Bethesda System) - Clear and concise diagnostic reports - Timely reporting of critical results

Reports elements Patient s correct first and last name. Patient s correct date of birth. Patient medical record number. Cytology accession number. Name of physician ordered for the test. Address of the location where the test was performed. Specimen receiving Date Reporting date Specimen source Clinical data Macroscopic description (Cytology fluid volume, color, consistency, and if blood or tissue fragment seen. ) Specimen preparation and staining (Cytsopin , LBC , Type of stain). Microscopic description Interpretation (Diagnosis) Comment (recommendation , physician notification)

False-negative Pap interpretations False-negative Pap interpretations result from: sampling error sampling error -the collection device does not sample lesional cells, or there is inefficient transfer of lesional cells from the collection device to the glass slide laboratory error laboratory error - screening (i.e., abnormal cells are missed) - interpretation (i.e., abnormal cells are misinterpreted as benign)

Key Components of Cytopathology QMS D. Post-analytical Phase - Correlation with histology results - Clinician communication for result interpretation - Storage and retrieval of slides and reports

Key Components of Cytopathology QMS E. Quality Control Measures 1. Internal Quality Control - Random rescreening of negative cases (e.g., 10% rescreen) - Continuous monitoring of abnormal rates - Intra-laboratory comparisons of diagnostic rates

Key Components of Cytopathology QMS 2. External Quality Assurance - Participation in external proficiency testing programs - Inter-laboratory slide exchanges 3. Cytology-Histology Correlation - Regular review of cytology-histology discrepancies - Root cause analysis of significant discrepancies

Key Components of Cytopathology QMS F. Performance Metrics and Indicators - Abnormal Squamous Intraepithelial Lesion (ASIL) rates - Positive predictive value of HSIL (High-grade Squamous Intraepithelial Lesion) diagnosis - False negative rates for cervical cancer cases - Turnaround times for different specimen types

Key Components of Cytopathology QMS G. Continuous Quality Improvement - Regular cytology case conferences - Review of interesting and challenging cases - Implementation of new technologies (e.g., computer-assisted screening)

Quality Control and Quality Assurance

Quality Control and Quality Assurance A. Definitions and differences - Quality Control: real-time monitoring of testing processes - Quality Assurance: systematic activities to ensure quality requirements are met B. Quality control practices - Internal quality control (IQC) procedures - Statistical process control charts - Westgard rules and their application

Quality Control and Quality Assurance C. Quality assurance activities - Method validation and verification - Lot-to-lot verification of reagents - Reference interval studies D. Proficiency testing - Participation in external quality assessment schemes - Interlaboratory comparisons - Performance analysis and improvement strategies

Quality Control and Quality Assurance A. Internal quality control - Daily quality control of staining procedures - Rescreening protocols (e.g., 10% random rescreening, rapid prescreening) - Automated screening device quality control (if applicable) B. External quality assurance - Participation in proficiency testing programs - External slide review programs - Benchmarking against peer laboratories C. Continuous monitoring of key performance indicators - ASCUS:SIL ratio for gynecologic cytology - Unsatisfactory specimen rates - False-negative rates

Quality Control and Quality Assurance C. Quality assurance activities - Method validation and verification - Lot-to-lot verification of reagents - Reference interval studies D. Proficiency testing - Participation in external quality assessment schemes - Interlaboratory comparisons - Performance analysis and improvement strategies

Quality Control of Screening 1. Screening workload limits 2. prospective rescreening of 10% of negative Pap cases ( 10% rescreen ) 3. retrospective review of all negative Paps from women with a newly diagnosed high-grade squamous intraepithelial lesion (HSIL; 5-year lookback ) 4. review of discrepancies between Pap and biopsy results (Histology/cytology correlation) 5. ASCUS/HR-HPV Correlation

Quality measures in cytology Screening workload records: Screening workload records: The CLIA 88 regulations established, for the first time, workload limits for CTs in the United States. The maximum number of slides is 100 per 24-hour period. The minimum amount of time spent examining this maximum is 8 hours (average 12.5 slides per hour). (about 5 minutes for each slide). Prospective 10% rescreen: Prospective 10% rescreen: Retrospective rescreen ( 5 Retrospective rescreen ( 5- -year Lookback ) year Lookback ) ASCUS/HR ASCUS/HR- -HPV correlation. HPV correlation.

The CLIA 88 regulations require that cytology laboratories compile annual statistics 1- The number of cytology cases examined 2-the number of specimens by specimen type (e.g., urine, sputum, etc.). 3-the volume of cases by diagnosis (e.g., negative, atypical, suspicious, positive). 4- the number of unsatisfactory cases. 5- the number of Pap tests with discrepant histologic results. 6- the number of negative Pap tests that were reclassified as abnormal. 7- the number of Paps reported as HSIL, Adenocarcinoma, or other malignant neoplasm with no histologic follow-up.

Measures of Screening Performance Cervical cytology is limited (as are all screening tests) by both false positive (FP) and false negative (FN) results. A false positive is defined as a positive test result for a woman who does not have a cervical abnormality. A false negative is defined in this document as a negative cervical cytology test result in a woman with a cervical squamous or glandular intraepithelial lesion or cancer. Sensetivity, specifity, PPV

Measures of Screening Performance Specificity: The specificity of a test is defined as the rate of correctly identified persons without disease in relation to all persons without disease: true negatives/ (true negatives + false positives). Sensitivity: The sensitivity of the test is defined as the proportion of subjects with the disease correctly identified as positive out of all persons with disease: true positives/ (true positives + false negatives).

Risk Management in Medical Laboratories A. Identifying potential risks - Pre-analytical, analytical, and post-analytical phase risks - Equipment and process-related risks - Human factor risks B. Risk assessment techniques - Failure Mode and Effects Analysis (FMEA) - Hazard Analysis and Critical Control Points (HACCP) - Risk matrices and scoring systems

Risk Management in Medical Laboratories C. Implementing risk mitigation strategies - Developing risk control measures - Monitoring and reviewing risk management effectiveness - Integration of risk management into daily operations

Risk Management in Medical Laboratories IV. Risk Management in Cytopathology A. Identification of critical steps in the cytology process B. Implementation of error reduction strategies - Use of bar-coding systems for specimen tracking - Automated screening assistance tools C. Management of near-miss events and errors

Personnel Management and Competency A. Specific cytotechnology and cytopathology training requirements B. Ongoing competency assessments - Annual proficiency testing for individuals - Monitoring of individual performance metrics C. Continuing education and professional development

Continuous Improvement Methodologies A. Plan-Do-Check-Act (PDCA) cycle B. Six Sigma in the medical laboratory C. Lean principles for laboratory efficiency

Continuous Improvement Methodologies - ASCUS:SIL ratio for gynecologic cytology - Unsatisfactory specimen rates - False-negative rates

Technology and Quality Management . Technology Integration A. Digital cytology systems - Whole slide imaging for remote consultation and archiving - Artificial intelligence in screening assistance B. Laboratory Information Systems (LIS) tailored for cytopathology - Integration with electronic health records - Automated alert systems for critical results

Continuous Improvement in Cytopathology A. Regular review of QMS effectiveness - Annual management review of cytopathology quality indicators - Trend analysis of performance metrics - Solicitation of feedback from clinicians and patients

Continuous Improvement in Cytopathology B. Quality improvement projects - Identification of areas for improvement based on data analysis - Implementation of PDCA cycles for process improvements - Evaluation and reporting of improvement project outcomes C. Staying current with evolving standards and technologies - Regular review and update of SOPs based on current guidelines - Evaluation and implementation of new technologies - Participation in professional societies and standards-setting organizations

Challenges and Future Directions A. Impact of HPV testing on cervical cytology practices B. Integration of molecular testing in cytopathology C. Standardization of reporting for non-gynecologic cytology D. Quality assurance in the era of personalized medicine

Case Studies Successful QMS implementation examples. Lessons learned from quality-related incidents

Future Trends in Laboratory Quality Management

Conclusion