L1

• Aspects of the laboratory

  • 12 essentials
• Quality Management System


  • Coordinated activities to direct and control an organization with regard to quality (ISO, CLSI)
  • Guide of the organizations (laboratory) towards quality
  • Two organizations that set standards for laboratory: ISO and CLSI
• Achieving a 99% level of quality means accepting a 1% error rate
• Consequences of a 1% error rate in France

  • 14 minutes without water or electricity
  • 50,000 parcels lost by postal services
  • 22 newborns falling from midwives’ hands
  • 600,000 lunches contaminated by bacteria
  • 3 bad landings at Orly Paris airport
• Laboratory results must be accurate, reliable, and timely
• In general, laboratory errors cost

  Time, personnel effort, patient outcomes
• Inaccurate results lead to

  Wrong diagnosis by the Doctor → wrong treatment → complications → longer medication
• Complexity of laboratory system

  Pre-examination, Examination, Post-examination phases
• Path of workflow


  1. Intercept of operations that occurs in testing

  2. 3 Phases: Pre-examination, Examination, Post-examination

  3. Patient is always the start, and the end is result interpretation
• The entire process of managing a sample must be considered from sample collection to reporting and saving of results
• Factors influencing laboratory tests

  • Laboratory environment
  • Knowledgeable staff
  • Competent staff
  • Reagents and equipment
  • Quality control
  • Communications
  • Process management
  • Occurrence management
  • Record keeping
• Twelve Quality System Essentials

  • Set of coordinated activities that function as building blocks for quality management
  • Each essential must be addressed to achieve quality
• Organization examples


  • School, Hospital, Church, Laboratory
• Quality Policy


  • The mission, vision, and core values of the company are integrated
  • Statement of the organization about the commitment to quality
• Personnel requirements


  • Human resources
  • Job qualifications
  • Job descriptions
  • Orientation
  • Training
  • Competency assessment
  • Professional development
  • Continuing education
• The most important lab resource is competent and motivated for productivity
• Equipment requirements


  • Equipment
• Personnel


  • Human resources
  • Job qualifications
  • Job descriptions
  • Orientation
  • Training
  • Competency assessment
  • Professional development
  • Continuing education
• Equipment


  • Acquisition
  • Installation
  • Validation
  • Maintenance
  • Calibration
  • Troubleshooting
  • Service and repair
  • Records
• Equipment in the laboratory must be useful for laboratory operations, must function properly, and must be maintained
• Equipment in the laboratory

  • Refrigerator
  • Oven
  • Centrifuge
  • Microscope
• Purchasing and Inventory


  • Vendor
  • Qualifications
  • Supplies and reagents
  • Critical services
  • Contract review
  • Inventory management
• In the laboratory, inventory is the list of reagents and supplies
• Process Control


  1. Quality control

  2. Sample management

  3. Method validation

  4. Method verification
• Quality control


  • CBC: Complete Blood Count
• Sample management


  Collection and handling of specimens
• Method validation


  • Lab results form has 2-3 signatures
  • Signature of Pathologist for validation
• Method verification


  Signature of 2 Medical Technologies for verification
• The purpose of these factors is to ensure the quality of the laboratory testing processes
• Information Management


  • Purpose: accuracy and confidentiality of the lab results of the patient
  • Confidentiality
  • Requisitions
  • Logs and records
  • Reports
  • Computerized laboratory information systems (LIS)
• Backup records are necessary for LIS if the computer malfunctions
• Documents Records


  • Creation
  • Collection
  • Revision and review
  • Control and distribution
  • Storage, retention
• Documents Records


  • SOP manual (Standard Operating Procedure)
• Occurrence Management


  • Occurrence: errors or events that cannot happen in the laboratory
  • Complaints
  • Mistakes and problems
  • Documentation
  • Root cause analysis
  • Immediate actions
  • Corrective actions
  • Preventive actions
• Occurrence Management


  • Incident Report (IR): a guide to learn from your mistake
• Laboratory Assessment


  • Assessment: examining laboratory performance and comparing it to standard
  • Internal
  • External
• Process Improvement


  • Opportunities for improvement (OFIs)
  • Stakeholder feedback
  • Problem resolution
  • Risk assessment
  • Preventive actions
  • Corrective actions
• Customer Service


  • Customer group identification
  • Customer needs
  • Customer feedback
  • Sensitive Patients: Pregnant women and Babies
• Established rapport
• Sensitive Patients


  • Newborn Screening: Feather Lancer