POCT

• Learning Objectives


  • Define point-of-care testing (POCT) and state various locations where POCT is performed
  • Discuss the advantages and disadvantages of POCT
  • State the regulations required for POCT and the qualifications required for health-care personnel to perform testing
  • Explain the POCT quality control procedures for Clinical Laboratory Improvements Amendments (CLIA) compliance
  • Describe the tests and instrumentation commonly used in POCT
• Key Terms


  • Calibration
  • Control
  • Critical value
  • Point-of-care testing
  • Proficiency testing
  • Quality control
  • Reagent
  • Shift
  • Trend
  • Turnaround time
• Point-of-care testing (POCT)


  Performance of laboratory tests at the patient’s bedside or nearby rather than in a central laboratory
• Locations where POCT is performed

  • Critical care or intensive care units
  • Operating suites
  • Emergency department
  • Neonatal intensive care units
  • Satellite laboratories
  • Physician offices
  • Ambulatory clinics
  • Ambulances or helicopters
  • Long-term care facilities
  • Workplace screenings
  • Health fairs
  • Dialysis centers
  • Home settings
• Factors that have motivated the practice of POCT include the increased acuteness of inpatient illnesses that require a faster turnaround time (TAT) of results and the decreased length of hospital stays that require the increased performance of procedures and care on an outpatient basis
• Turnaround time (TAT)


  Defined as the time from when the health-care provider orders the test until the result is returned to the health-care provider
• In critical care units or surgical suites, the TAT of stat tests is of the utmost importance in providing the best possible patient care
• POCT is well suited for

  Decentralization of laboratory testing and cross-training of personnel to perform certain tests at the patient’s bedside
• The immediate availability of test results provides convenience to both the patient and the health-care provider by decreasing the time required for diagnosis and treatment, resulting in faster patient recovery
• Quick and accurate test results enable the patient to be treated immediately, thereby improving patient outcomes
• POCT technology benefits have been realized in many traditional laboratory settings
• POCT technology has several identified drawbacks
• Common sample types for POCTs

  • Whole blood
  • Plasma
  • Urine
  • Direct swabs from an infected area
  • Saliva
  • Other body fluids
• Operators performing POCT


  • Phlebotomists
  • Nurses
  • Physicians
  • Respiratory therapists
  • Radiographers
  • Medical and nursing assistants
  • Ambulance personnel
  • Patient-care technicians
  • Medical laboratory scientists
  • Patients
• Medical laboratory scientists perform the least number of POCTs, but the laboratory is often responsible for administering the POCTs program
• CLIA ‘88 regulates the qualifications for health-care personnel authorized to perform POCT
• CLIA ‘88 encompasses all laboratory testing and requires every testing site examining specimens derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of disease, or impairment of or assessment of health to be regulated
• All testing sites are subject to the federal law CLIA ‘88 that defines the standards and guidelines for performing laboratory testing and must be licensed based on the test complexity model regardless of the number of tests performed or whether there is a charge for the test
• The Center for Medicare and Medicaid Services (CMS) administers CLIA ‘88 and requires CLIA certification for reimbursement of laboratory tests
• CMS grants deemed status to accrediting organizations that have demonstrated equivalency with CLIA standards
• Compliance with CLIA and accrediting organizations’ regulatory standards is mandatory and is normally evaluated using a biannual inspection process
• Failure to comply with the regulatory standards can lead to federal sanctions and loss of accreditation and the ability to legally perform all laboratory testing
• Under CLIA, all clinical laboratories, regardless of location, size, or type, must meet standards based on the complexity of the tests that they perform
• Test complexity is determined by the testing characteristics such as stability of the reagent, preparation of the reagent, operational steps, calibration, and QC
• Complexity also depends on the degree of knowledge, training, experience, troubleshooting, and interpretation required in the testing process
• The complexity level of the highest complexity test performed determines the level of certification required
• The Food and Drug Administration (FDA) has the responsibility for categorizing tests and classifying testing devices and systems
• Laboratory testing is classified into four complexity categories: waived, moderate complexity
• Laboratory testing classification


  Waived, moderate complexity, high complexity, provider-performed microscopy procedures (PPM)
• Common Point-of-Care Testing Associated With Laboratory Departments

  • Hematology: Hemoglobin, hematocrit, erythrocyte sedimentation rate (ESR)
  • Chemistry: Glucose, arterial blood gases (ABGs), bilirubin, lipid panels, blood urea nitrogen (BUN), electrolytes, creatinine, comprehensive metabolic profile, cardiac markers, liver function, human chorionic gonadotropin, hemoglobin A1c
  • Serology: Human immunodeficiency virus, mononucleosis, Helicobactor pylori
  • Urinalysis and body fluids: Reagent strip urinalysis, occult blood, gastroccult, body fluid pH
  • Urine toxicology (drugs of abuse): Amphetamines, marijuana, cocaine, benzodiazepines, barbiturates, ethanol
  • Microbiology: Group A Streptococcus, influenza A/B, bacterial vaginosis, detection of biowarfare agents, respiratory synctial virus (RSV
  • Coagulation: Prothrombin time (PT)/international normalized ratio (INR), activated partial thromboplastin time (APTT), activated clotting time (ACT
• Laboratories performing moderate or high complexity (nonwaived) testing must meet requirements for proficiency testing, patient test management, QC, quality assessment, and personnel
• Major differences in regulatory requirements between moderate and high complexity testing

  Are in the QC and personnel standards
• POCTs may be waived, moderate, or even high complexity if performed under the oversight of a laboratory that is CLIA certified for nonwaived testing
• Waived tests are defined as simple procedures that are cleared by the FDA for home use, employ methodologies that are easy to perform, and pose no reasonable risk of harm to the patient if performed incorrectly
• Moderate complexity tests require documentation of training in testing principles, instrument calibration, and QC. Testing personnel must have a minimum of a high school diploma or equivalent
• High complexity tests require sophisticated instrumentation and a high degree of interpretation by the testing personnel. Personnel must have formal education with a degree in laboratory science
• Provider-Performed Microscopy Procedures (PPM) can be performed by physician’s assistants, nurse practitioners, midwives, physicians, and dentists during a patient’s examination
• Professionals allowed to perform tests within the new category

  • Physician’s assistants
  • Nurse practitioners
  • Midwives
  • Physicians
  • Dentists
• Laboratories performing tests


  Must meet moderate complexity requirements for proficiency testing, patient test management, QC, and QA as required by the accreditation agency
• CLIA PPM tests


  • Refer to Box 15-2