Quality Assessment

• Quality Assessment (QA)


  Overall process of guaranteeing patient care and is regulated throughout the total system
• Quality Management System (QMS)


  Refers to all the laboratory's policies, processes, procedures, and resources to achieve quality testing
• Quality Control (QC)


  Refers to the materials, procedures, and techniques that monitor the accuracy, precision, and reliability of a laboratory test
• Programs


  • Procedure manual
  • Internal QC
  • External QC
  • Standardization
  • Proficiency testing
  • Record keeping
  • Equipment maintenance
  • Safety programs, training
  • Education and competency assessment of personnel
  • Scheduled and documented review process
• CLIA '88


  Clinical Laboratory Improvement Amendments '88 - Regulation that stipulates all laboratories performing testing on human specimens must be licensed and obtain a certificate from the CLIA program
• Accreditation agencies


  • Joint Commission on the Accreditation of Healthcare Organizations (JCHAO)
  • College of American Pathologists (CAP)
  • American Association of Blood Banks (AABB)
  • American Osteopathic Association (AOA)
  • American Society of Histocompatibility and Immunogenetics (ASHI)
  • Commission on Laboratory Assessment (COLA)
• Preanalytical components


  Test requests, patient preparation, timing, specimen collection, handling, and storage
• Criteria for urine specimen rejection

  • Insufficient volume
  • Inappropriate specimen type or collection
  • Visibly contaminated
  • Incorrect preservative
  • Unlabeled or mislabeled
  • Request form incomplete
  • Delay between collection and receipt
• Policy for handling mislabeled specimens

  1. Do not assume information

  2. Do not relabel

  3. Do not discard

  4. Leave specimen as is

  5. Notify personnel

  6. Identify problem on requisition

  7. Make responsible person participate

  8. Report to supervisor
• Analytical factors


  • Reagents
  • Instrumentation and equipment
  • Testing procedure
  • Quality controls
  • Preventive maintenance
  • Access to procedure manuals
  • Competency of personnel
• Precision/Reproducibility


  Ability to obtain the same result on repeated measurements
• Accuracy


  Results close to the true value, achieved through standardized procedures and proficiency testing
• Proficiency Testing/EQC


  Prepared samples provided to the lab, results compared to other labs using similar methods
• Agencies conducting Proficiency Testing

  • American Association of Bioanalysts (AAB)
  • American Proficiency Institute (API)
  • American Academy of Family Physicians
  • Wisconsin State Laboratory of Hygiene
• Postanalytical factors


  • Reporting of results
  • Interpretation of results
• Critical values in urinalysis

  • Pathologic urine crystals
  • Strongly positive glucose and ketones
  • Reducing substance other than glucose or ascorbic acid in infants
• Quality management errors can occur in preanalytical, analytical, and postanalytical phases