LAB MAN

• Quality Management System


  • Coordinated activities to direct and control an organization with regard to quality (ISO, CLSI)
  • All aspects of the laboratory operation need to be addressed to assure quality; this constitutes a quality management system
  • Guide of the organizations (laboratory) towards quality
  • Two organizations that set standards for laboratory: ISO: International Organization for Standardization, CLSI: Clinical and Laboratory Standards Institute
• 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

  • Accurate, Reliable, Timely
• In general, laboratory errors

  Cost in time, personnel effort, patient outcomes
• Inaccurate results


  Wrong diagnosis of the Doctor → wrong treatment → complications → longer medication
• 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
• Why is the path of workflow essential to consider in health laboratories?
• Laboratory tests are influenced by
• 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

  • Group of people that share the same purpose
  • Quality Policy integrates the mission, vision, and core values of the company
  • Quality Policy is the statement of the organization about the commitment to quality, made or written by the top management
• Personnel


  • Human resources, Job qualifications, Job descriptions, Orientation, Training, Competency assessment, Professional development, Continuing education
  • The most important lab resource (assets) is competent and motivated = PRODUCTIVITY
• 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
• Factors affecting productivity

  • Competence
  • Motivation
• Equipment

  • Acquisition
  • Installation
  • Validation
  • Maintenance
  • Calibration
  • Troubleshooting
  • Service and repair
  • Records
• Equipment in the laboratory must

  Be useful for laboratory operations, function properly, and be maintained
• Equipment in the laboratory

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

  • Vendor
  • Qualifications
  • Supplies and reagents
  • Critical services
  • Contract review
  • Inventory management
• Inventory in the laboratory


  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 includes

  Collection and handling of specimens
• Sample management

  • Hemolyze specimen: RBCs are ruptured
  • Plasma color (hemolyze): Red
• 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 is accuracy and confidentiality of the lab results of the patient
• Documents and Records

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

  • SOP manual (Standard Operating Procedure)
• Occurrence management

  Deals with errors or events that cannot happen in the laboratory
• Occurrence management

  • 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


  Examining laboratory performance and comparing it to standard
• Internal assessment includes

  • Quality indicators
  • Audit program
  • Audit review
• External assessment includes

  • Proficiency testing (EQA)
  • Inspections
  • Accreditations
• Process improvement

  Focuses on opportunities for improvement, 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
• Sensitive Patients

  Established rapport