POINT OF CARE TESTING PMLS 2

Point-of-care testing(POCT)
• Referred to as __________________________________________________________________
• Performance of laboratory tests at the ____________________ rather than in a central laboratory.

POCT locations
• Satellite laboratories • Workplace screenings
• Physician offices • Health Fairs
• Ambulatory clinics • Dialysis centers
• Ambulances or helicopters • Home settings
• Long term care facilities

Advantages
1. Increased acuteness of inpatient illnesses which
require a faster turnaround time (TAT) of results
and the decreased length of hospital stays.
2. Provides convenience to both the patient and the
health care provider.
3. Provides effective health-care provider-patient
interaction.
4. Improving patient outcomes
5. Decreased chance of preexamination errors
6. Decreased sample volume, small analyzer size,
portability and ease of use.
Disadvantages
1. Problematic procedures:
2. Accreditation requirements
3. Charging and billing mechanisms
4. Documentation of patient results
5. Quality control testing and documentation
6. Inventory management
7. Fewer opportunities for the operators to maintain
their skill level

Common Point-of Care Testing

Operators- persons performing POCT

1. Phlebotomists 6. Medical and nursing assistants
2. Nurses 7. Ambulance personnel
3. Physicians 8. Patient-care technicians
4. Respiratory Therapists 9. Medical Laboratory Scientists
5. Radiographers

REGULATION OF POCT
• Under _______, all clinical laboratories, must meet standards based on the complexity of the tests they perform.
• Complexity level is based on:
▪ ___________________________
▪ Stability of reagent
▪ Preparation of reagent
▪ Operational steps
▪ Calibration and quality control
▪ ___________________________
▪ Degree of knowledge
▪ Training and experience
▪ Troubleshooting and interpretation

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POINT OF CARE TESTING PMLS 2
Four Classification of Laboratory Testing
1. ________________________________
• Simple procedures for home use
• Methodologies are easy to perform and to interpret
• Erroneous results is negligible
• Require no social training or educational background
• Require minimum quality control.

2. ________________________________
• More difficult to perform than waived tests
• Require documentation of training in testing principles, calibration and QC.
• Personnel have a minimum of high school diploma or equivalent.
• Facilities performing this are subject to proficiency testing and on site inspections

3. ________________________________
• Require sophisticated instrumentation and high degree of interpretation by testing personnel.
• Personnel have formal education with degree in laboratory
science

4. ________________________________
• Tests procedures that can be performed in conjunction with any
waived tests.
• Tests can be performed only with physician’s assistants, nurse
practitioners, midwives, physicians, and dentists during patient’s
examination.

QUALITY ASSESSMENT
• Laboratories performing moderate or high complexity tests must be inspected __________________

Patient Test Management

1. Patient preparation 5. Sample transportation
2. Proper sample collection 6. Sample processing
3. Sample identification 7. Accurate result reporting
4. Sample preservation

Quality Control Assessment

• QC must include:
▪ _________________________
▪ _________________________
▪ _________________________
▪ _________________________
▪ _________________________

Proficiency Testing Assessment

• All laboratories performing moderate or high complexity testing must enroll in an approved proficiency testing
program.
• Involved three events per year with five challenges per analyte in survey material.
• All survey specimens are tested in the same manner and no communications with other laboratories is permitted.

Personnel Assessment
• Education and training
• Continuing education

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POINT OF CARE TESTING PMLS 2
• Competency assessment
• Performance appraisals

Competency Assessment
• Required for all POCT personnel who performed moderate and high complexity testing at ___________________

Quality Assessment Records

• Laboratory must maintain patient test records for _________________
• Other records that must be kept:
▪ QC
▪ Reagent logs
▪ Proficiency testing
▪ Equipment maintenance
▪ Service calls
▪ Documentation of problems, complaints and communications
▪ Inspection files
▪ Certification of records

Quality Control
• QC of testing procedures is a part of a much larger system referred to as______________________________
• QC includes:
▪ ________________________
▪ ________________________
▪ ________________________
▪ ________________________

External Controls
• Tested in the same manner as a patient specimen and are used to verify test systems that use urine or blood
samples.
• Commercial controls are manufactured specimens with known values and available in several strengths

Internal Controls
• Controls contained within the test system
• Sometimes referred to as _____________________
• These are usually performed more frequently and are often performed with each test

Electronic Controls
• Electronic Quality Contol (EQC) uses mechanical or electrical specimen in place of liquid QC specimen.
• Can be internal to the POCT device or an external component inserted into the POCT device.
• This does not verify the functional integrity of the testing supplies
• Performed on timed schedule.

Documentation of QC
• Documentation of QC is required to confirm that the test system was able to produce valid tests results.
• Documentation includes:
▪ Dating and initialing the material when it is first opened
▪ Recording the manufacturer's lot number and expiration date each time a control is run
▪ Test results obtained
• Controls are plotted on a QC charts
• Results should fall within the _________________________- 95% of the time
• Values should be evenly distributed on either side of the mean, confirming ______________ and ____________
• Two consecutive values cannot fall outside of the ___________________
• No value should exceed ______________________
• Patient results must not be reported if QC is out of control

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POINT OF CARE TESTING PMLS 2
Common Errors of POCT

Prevention of common POCT errors

• Proper patient identification • Sample application and test performance
• Proper sample collection • Result interpretation
• Proper storage of testing supplies • Documentation of results
• Always perform and document Quality Control.

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POINT OF CARE TESTING PMLS 2
Procedures
• Laboratory testing is performed in three phases: PRE-EXAMINATION, EXAMINATION and POSTEXAMINATION
• Majority of all laboratory testing errors occur in the pre-examination and post examination phases of testing.
• Care must be taken at all stages of testing to ensure a quality result.

▪ Pre-examination Phase
• Patient identification is the primary concern prior to performing laboratory tests.
• Failure to identify the patient correctly in the POCT device can result to document a test result that was needed to
treat a patient.
• Factors such as correct collection and proper storage of equipment and supplies can affect patient outcomes.

b. Examination Phase
• The phase when the actual test is performed.
• Application of the sample to the test device and test timing are common errors.
• Test interpretation also is a part of the examination phase.
• POCT results can be qualitative, semiquantitative, or quantitative.

c. Post-examination Phase
• Post examination phase of testing is the documentation of results.
• This involves recording and reporting results, addressing critical values when indicated, following through the
confirmatory testing, and disposing of biohazard waste.

Procedure Manuals and Package Inserts

• CLIA requires that laboratories performing POCT follow manufacturer’s guidelines.
• Procedure Manuals and Package Inserts list all requirements for each stage of testing and includes:
▪ Sample collection and handling
▪ Safety precautions regarding different health hazards
▪ Instrument maintenance and calibration
▪ Reagent storage requirements
▪ Acceptable control ranges
▪ Specimen requirements
▪ Procedural steps
▪ Interpretation of results and normal values and sources of error
▪ Troubleshooting assistance.

Commonly performed POCT procedures

1. Blood glucose
• Performed as POCT to primarily monitor persons with diabetes mellitus.
• Definitive test used to measure the concentration of glucose in blood
• Must be performed on whole blood
• POCT glucose normal values are approximately 60 to 115mg/dL
• Procedure:
1. Whole blood obtained by dermal puncture some instruments can use blood samples collected in citrate,
heparin, or EDTA anticoagulant tubes.

2. The appropriate area of the reagent strip is covered with a drop of blood and inserted into the instrument.

3. The level of blood glucose is measured, and the results are displayed on screen.

• Glycosylated Hemoglobin (HBA1c)

▪ another tool for monitoring glucose levels.
▪ measured using waived POCT analyzer that provides an average plasma glucose level over 3-4 month
period.
▪ test measures the glucose within a red blood cell.

2. Transcutaneous Bilirubin Testing

• ideally suited to provide increased monitoring of infants who do not appear jaundiced but who may have risk

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POINT OF CARE TESTING PMLS 2
factors associated with hyperbilirubinemia.
• performed using _______________________
• The test is complete in less than 1 minute.
• The Bilicheck noninvasively directs white light into the skin of the newborn and measures the intensity of the
specific wavelength that is returned.
• The Bilicheck measures the intensity of more than 100 wavelengths of reflected light.
• Tcb testing is approved for use on newborns of ____________________________________________________

3. Hemoglobin
• The primary function of hemoglobin(Hgb) is to transport oxygen to all cells in the body.
• A decrease in the number of RBCs or the amount of Hgb in the cells(anemia) results in a decrease amount of
oxygen reaching the cells.
• Normal values for Hgb vary with age and gender.
*adult women ____________
*adult men ______________
• HemoCue Hemoglobin System – POCT analyzer that is designed to measure Hgb specially using arterial,
venous or capillary whole blood samples.
• Procedure:
1. A fresh capillary or anticoagulated whole blood sample is placed into a microcuvette and inserted into the
instrument.
2. The measurement is determined photometrically using a dry reagent system.
3. A dual wave-length photometer reads the absorbance of the reaction and corrects the hemoglobin value for
lipemia and leukocytosis.
4. Fill the cuvette with the blood in a continuous process without bubbles, making sure that the drop of blood is big
enough to fill the cuvete completely

4. Urinalysis
• Routine urinalysis consists of physical and chemical examination of urine and microscopic examination when
indicated.
• Urine should be tested within ___

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POINT OF CARE TESTING PMLS 2

• Routine chemical examination is performed using plastic strips containing reagent-impregnated test pads for
specific gravity, pH, glucose, bilirubin, ketones, blood, protein, urobilinogen, nitrite and leukocytes
• Correct handling and storage of reagent strips is critical for obtaining accurate results.
• Containers should be uncapped only long enough for a strip to be removed.

5. Occult Blood
• The purpose of occult (hidden) blood testing in stool (feces) is to detect _____________________________ that
is not visible to the naked eye.
• Detection is valuable aid in the early diagnosis of _____________________________________

• Hgb present in the stool sample reacts with hydrogen peroxide in the color developing reagent to release oxygen,
which then reacts with guaiac reagent to produce _______________________
• Patients should be instructed to avoid the following items ______________ before testing:
▪ red meat • horseradish ▪ other non-steroidal anti
▪ turnips • alcohol inflammatory drugs
• radishes • high doses of vitamin C
• melons • aspirin

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POINT OF CARE TESTING PMLS 2
6. Pregnancy Testing
• Bases on the detection of ____________________in urine or serum.
• HCG is produced by the cells of the placenta and depending on the sensitivity of the test kits, can be detected
approximately 10 days after conception.
• Most pregnancy test kits use monoclonal antibodies that react with different regions of the HCG molecule.
• Antibodies to HCG molecules are impregnated on a permeable membrane, and urine is added.
• If HCG is present in the urine, the antibodies will bind it on the membrane.
• The placement of the antibody on the membrane determines the shape of the color reaction (plus or minus sign,
line or circle)

7. Strep Tests
• Symptoms of a sore throat are an indication to test for _____________________________
• Rapid tests work well when a high number of bacteria are collected on the throat swab.
• It is a common policy to perform a throat culture on patients with negative results on rapid tests. Therefore it is
necessary to collect two throat swabs: one for rapid test and one for possible culture.
• Samples should be collected from the throat using a swab that does not have a wooden shaft.

8. Influenza A and B
• Influenza is a contagious viral infection of the respiratory tract caused by influenza viruses A and B.
• Waived POCT test kits provide a quick diagnosis within 10 minutes negative results may need to be confirmed by
cell culture.
• The influenza antigens may be detected directly from a ______________________________________________
• A test strip containing specific monoclonal antibodies is then placed into the extracted specimen.
• If influenza antigens are present in the extracted specimen, they will react with the monoclonal antibodies on the
test strip.

9. Whole Blood Immunoassays Kits

• Complete kits include reaction cassettes or cards, color developer, positive and negative controls, and detailed
instructions.
• All immunoassay kits use the same basic principle-that is the appearance of a color reaction when antigen and
antibody combine.
• Three frequently used immunoassays detect the antibodies present in Infectious mononucleosis (IM) and
gastrointestinal disorders caused by Helicobacter pylori and antigen troponin T present in a myocardial infarction(MI)

10. Blood coagulation Testing

• POCT instruments for coagulation testing are capable of providing a combination of PT(INR), APTT and ACT
results or only PT(INR) results.
• ProTime 3 Microcoagulation System is a system for PT testing consisting of Protime Intrument, a three channel
reagent cuvette with built-in QC and the terderlett Plus LV sample collection system
• The CoaguChek system performs a PT using a drop of fingerstick whole blood applied to a test strip containing
dried thromboplastin reagent and tiny iron particles.
• The HEMOCHRON Jr. signature whole blood Microcoagulation System is a POCT instrument that performs ACT,
APTT, and PT tests using a drop of whole blood per test.

11. Cholesterol
• Cholesterol is a lipid manufactured by the body for use in cell membranes and as a precursor to steroid
hormones.
• Normal values for cholesterol vary with age.
• Cholestech LDX analyzer measures total cholesterol, HDL cholesterol and triglycerides using a cassette
containing dry reagents capable of performing an enzymatic reaction when blood is added to the cassette.

12. Arterial Blood Gas and Chemistry Analyzers

• Arterial blood gases (ABGs), electrolyte testing, and cardiac markers are used for the stat analysis of a critical
patient population.
• POCT for electrolytes uses small instruments located in emergency departments, operating suites, and intensive
care and critical care units.

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POINT OF CARE TESTING PMLS 2
13. Chemistry Analyzers
• Various analyzers are available for waived POC chemistry testing.
• Instruments are portable, self-contained, and most include quality control and data management programs.
• The IRMA TruPoint Blood Analysis System- measures analytes using a single-use cartridge containing reagents
and electrodes for the determination of each analyte or group of analyte.
• A small sample of blood is injected into the system’s sensor cartridge and a test is performed in 2 minutes.
• Results are displayed on a screen and a hard copy can be printed.
• The hand-held i-Stat Portable Clinical Analyzer- uses test cartridges.
• Only a few drops of blood are inserted into the cartridge, which is placed into the analyzer and the result is
available within 2 minutes.
• The Piccolo Xpress point-of-care chemistry analyzer brings comprehensive CLIA waived diagnostics to physician
offices.
• Piccolo delivers laboratory-accurate chemistry results in minutes, using a unique menu of 14 single use reagent
panels.

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