Phleb trial

• Point-of-Care Testing (POCT)


  Laboratory testing near the site of patient care rather than in the clinical laboratory
• POCT


  • Includes testing at the bedside, outpatient sites, within or outside the hospital or clinics, or at home
  • POCT is a supplement to, NOT a replacement for central laboratory services
• Previous terms for POCT

  • Alternate site testing
  • Near patient testing
  • Decentralized testing
  • Bedside testing
  • Ancillary testing
  • Portable devices
  • Reagent test kits
• Advantages of POCT


  • Faster TAT of results
  • Decreased length of hospital stays
  • Immediate availability of results
  • Increased effectiveness of health-care provider-patient interaction
• Turn-Around Time (TAT)


  Time-period that occurs upon receiving of the patient samples up to the time when laboratory results are released
• STAT


  Short turn around time
• Therapeutic TAT


  The time from initiation of consultation to the time the appropriate treatment is given
• POCT Technology


  • Small handheld user-friendly instruments
  • Provide mobility
  • Low maintenance
  • Ease of use
  • Cost effective
  • Decreased sample volume
  • Decreased potential for error
  • Reliable test results
  • Compliance with CLIA regulations
• Benefits of POCT


  • Improved survival rate of critical patients
  • Rapid progress in the management of the patient
  • Earlier discharge from the hospital
  • Less hospital expenses and a more efficient use of hospital resources
• POCT Coordinator


  A senior member of the staff designated by the Department of Pathology to supervise POCT
• Locations of POCT


  • Critical Nursing Units – ICU, ER, Burn Unit, OR, Delivery Room, Recovery Room
  • General Nursing Units
  • Out patient clinics and other units where POCT would be useful
• Drawbacks of POCT


  • Regulatory problems
  • Accreditation
  • Billing mechanisms
  • Patient results documentation
  • Quality control
  • Inventory management
  • Dilution effect on operator competency
• Samples for POCT


  • Whole blood
  • Urine
  • Swabs
  • Saliva
  • Other body fluids
  • No sample/non-invasive
• POCT Instrumentation


  • Maintenance
  • Calibration
  • Quality control
  • Documentation
  • Understanding of quality assessment criteria
• POCT Operators


  • Laboratory personnel
  • Nonlaboratory personnel
  • Nurses
  • Physicians
  • Respiratory therapists
  • Radiographers
  • Medical or nursing assistants
  • Ambulance personnel
  • Patient care technicians
  • Patients
• Regulation of POCT


  • CLIA '88 regulation of laboratory testing
  • Center for Medicare and Medicaid Services (CMS)
  • Commission on Laboratory Assessment (COLA)
  • The Joint Commission (JC)
  • College of American Pathologists (CAP)
  • Food and Drug Administration (FDA)
  • Bureau of Health Facilities and Services (BHFS) in the Philippines
• Test Complexity Classification


  • Waived
  • Moderate complexity
  • High complexity
  • Provider performed microscopy (PPM)
• Waived Tests


  Tests cleared by the FDA for home use, employ simple methodologies, and pose no reasonable risk of harm to the patient if test will be performed incorrectly
• Waived Testing


  • Simple procedures approved by FDA for home use
  • Easy to perform
  • Likelihood of erroneous results is negligible
  • Poses no risk of harm to patient if test is performed incorrectly
  • Requires no special training
  • Requires minimum quality control
• Physician Office Laboratories (POL)

  A laboratory where the tests performed are limited to those done for the physician's own patients that are seeking medical consultation
• Moderate Complexity Testing


  • More difficult to perform
  • Requires documentation of training
  • Test principles
  • Instrument calibration
  • Quality control
  • Minimum of high school diploma
  • Proficiency testing
  • On-site inspections
  • Competency testing
• High Complexity Testing


  • Sophisticated instrumentation
  • High degree of interpretation by testing personnel
  • Formal education, with degree in laboratory science
  • Laboratory testing in microbiology, blood bank, and immunology
• Provider-Performed Microscopy Procedures (PPM)


  Clinical microscopy procedures only, performed by personnel such as physician's assistants, nurse practitioners, midwives, physicians, and dentists who meet moderate complexity requirements
• Quality Assessment (QA)


  Laboratories inspected every 2 years in the US, and every year in the Philippines through NEQAS by BHFS/NRL's
• Quality Control


  Part of a larger system referred to as QA, performed to ensure that acceptable standards are met, includes internal, external, electronic, proficiency testing, calibration, and maintenance
• Quality Control


  • Controls are manufactured specimens with known values, tested in the same manner as samples, and plotted in a Levey-Jennings Chart
• Shift


  Six sudden consecutive values on one of the mean, caused by instrument malfunction or new lot number of reagents
• Trend


  Gradual increase or decrease for six consecutive values, caused by gradual deterioration of reagents or deterioration of instrument performance
• There are multiple opportunities to make an error within the testing phases of POCT, and incorrect results can influence the way the patient is treated or not treated
• Sources of POCT Errors

  • Prevention of incorrect results
  • Patient identification
  • Proper sample collection
  • Storage of test materials
• There are multiple opportunities to make an error within the testing phases, and incorrect results influence the way the patient is treated or not treated
• Sources of POCT Errors

  • Patient identification
  • Proper sample collection
  • Storage of testing supplies
  • QC
  • Sample application and test performance
  • Result interpretation
  • Documentation of results
• POCT Blood Glucose


  Monitor glucose levels in diabetes mellitus patients (hypoglycemic or hyperglycemic), Glycosylated (HbA1c) hemoglobin monitors glucose present in hemoglobin for the past 3-4 months
• POCT Blood Glucose


  • Reagents strips: properly stored, protected from heat, not discolored
  • Ensure correct sample collection and type and amount of sample
  • Do not reapply blood
• Transcutaneous Bilirubin Testing


  Measures bilirubin levels (babies forehead), Hemolytic Disease of the Newborn (HDN), Detects and monitors hyperbilirubinemia, Non-invasive, Measures light intensity; converted to absorbance units, Confirm elevated results with dermal puncture
• POCT Hemoglobin (Hgb)


  Measures hemoglobin levels, Purposes: Provide a means to monitor anemia, Screening of hemoglobin levels for blood donation purposes
• POCT Hemoglobin (Hgb)


  Hgb is determined photometrically using a dry reagent system, The reagents in the microcuvette lyse the RBCs to release Hgb which is converted to azide methemoglobin by sodium nitrite and sodium azide to produce a color reaction
• Components of routine urinalysis

  • Physical (color, clarity)
  • Chemical (reagent strip)
  • Microscopic (not POCT)
• Urinalysis


  1. Physical Exam

  2. Chemical Exam

  3. Centrifugation (450 rcf, 0.5-1.0 ml sediment)

  4. Microscopic Exam
• Urine Chemical Analysis


  • Specific gravity
  • pH
  • Glucose
  • Bilirubin
  • Ketone
  • Blood
  • Protein
  • Urobilinogen
  • Nitrite
  • Leukocytes