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Point of Care Patient Testing (POCT)

Point of Care Patient Testing (POCT)

Student Name: POCT Student Number:

EXCECUTIVE SUMMARY:
This report aims to examine PoCT devices for testing glucose and Hba 1c in diabetics for the
purpose of providing recommendations for Hba 1c and glucose devices. The report critically
evaluates testing devices and considerations for pre and post PoCT testing.
HBA1c:
Waddingham (1) reiterates that glycosylated hemoglobin (A1C) is a type of Hb that is usually
used in the identification of the average concentration of plasma glucose for a preceding 2-3
months period. In every 120 days this test is usually repeated for the purpose of producing
results and some of the devices used to test Hba1c include Biorad in2it, Quo lab HbA1c
analyzer, and Orient Gene (1).
Blood glucose testing:
Testing of the blood glucose is mainly done for the purpose of determining the body’s level of
glucose. There are various devices that are used in testing level of glucose in the body. Some of
the devices used for testing the body glucose concentrations or levels are Accu-Check Performa,
FreeStyleOptium, OneTouch®, and StatStrip Glucose (1).
Advantages and disadvantages of assays for glucose and HbA1c:
This table shows clear comparison between Glucose meter and HbA1c (2).
Glucose Meter HbA1c

Results processing Fast result (within seconds) Rapid and reliable
Transport and size Portable, easy to carry Versatile and adaptable to
different locations

Cost Low High
Measurement Widely available Not reality available

Student Name: POCT Student Number:
worldwide

Patient preparation prior to
collection of blood

Stringent requirements None

Accuracy Low accuracy High accuracy

o Pre-analytical considerations

 Instructions for patient preparation

This should begin with introduction and identification of the patient/client subsequent to
obtaining consent after the procedure has been explained to the patient/client. The PoCT washes
hands and prepares equipment such as cotton wool gauze/balls, alcohol swab, gloves, automated
skin device, bio-hazard sharps container, and Bandaid as well as micro-collection tube (1).

 Blood Collection Technique:

Many instruments that are utilised in PoCT use direct blood application onto a test strip or
heparinised whole blood (WB) (3). This implies that capillary blood can be often used in
performing testing instead of venepuncture (4). Different types of tubes can be used to collect the
blood including plasma/plasma-Gel (Lithium Heparin) and glucose determination (fluoride) (5).
o Patient safety and risk management
Despite the fact that glucose meters are used to monitor glucose levels by most clinics, nursing
homes, physician offices, diabetics, and nursing units, the role of laboratory in diabetes diagnosis
remains very vital (3). The function of laboratory remains essential in diagnosing, monitoring, as
well as management of diabetes by checking severe metabolic imbalances that threaten the lives
of diabetic patients such as hyperosmolar nonketotic coma, diabetic ketoacidosis, and
hypoglycemia (4).

Student Name: POCT Student Number:
o Operator training and on-going competency assessment

 Training of POCT staff

Theoretical and practical aspects of conducting PoCT should be covered as a minimum
requirement (6). This includes training on pathophysiology and disease process, significance and
clinical utility of the test, sample collection requirements (such as correct anticoagulant or
preservative), patient preparation, reagent preparation and storage, device calibration, how to
perform the test, as well interpretation and reporting of PoCT results (7). Moreover, practical
training should include a complete demonstration of how the devices are used in performing the
PoCT tests (8, 9).

 PoCT Competency

Both written and practical assessments are used to establish competency of PoCT staff after
completing formal training (3). This is done to ensure the trainees are competent after which they
are issued with a competency certificate. However, post-training competency surveillance is
implemented to ensure testing quality is not compromised over time (6, 10, and 11).

o Analytical considerations of devices
 The type of quality control (QC) of devices.

In any PoCT program it is always a mandatory component to ensure quality control testing is
conducted regularly. However, the checking of quality should include should be ‘external quality
assurance’ and ‘internal quality control’ testing. Quality control of devices used in PoCT is
conducted using QC kits that are provided by the reagents and/or devices manufacturers (6, 10).

Student Name: POCT Student Number:

 Frequency of QC Testing:

With every delivery of new reagents testing of a quality control sample must be done. Also as a
minimum requirement every month one quality control sample must be tested while part of the
process of PoCT testing can be checked through electronic QC (6).

o Recording of QC, action limits and procedures to be followed with QC
failure

Even though most devices used in PoCT electronically store the QC results, it is good to record
the QC results manually on a result sheet and check them against limits or assigned values for
each QC. If the results are outside the limits the device is not suitable for PoCT use before
calibration is done (6).
o External quality assessment (EQA) procedures
EQA or Proficiency Testing is used to objectively assess obtained results’ quality through
comparison of different testing sites and different methods’ performance (6). This is done
through cooperation between different health centres which analyse an identical specimen that is
unknown on their PoCT device and sending the results to the provider of EQA who sends back a
report detailing the performance of a participating health centre (6, 11).

o Maintenance and performance records and evaluation of PoCT devices
For PoCT instruments and devices to perform accurately and reliably maintenance and servicing
must be done according to manufacturer’s instructions. The records of details of maintenance,
service as well as faults and corrective actions of a PoCT instrument/device are kept in the
maintenance and service log book (6).

Student Name: POCT Student Number:

o Post-analytical
 Instructions for the recording / reporting of results

The patient’s report either hardcopy or electronic must have two unique identifiers of the patient,
for example, patient name and date of birth, patient name and ID, time and date of test, the
results, the operator’s identity (12).

 Post implementation follow-up and confirmation of performance
requirements

Depending on the results recorded by the PoCT staff, the patient is referred back to the necessary
health professional for appropriate treatment or management and follow-up tests are done for
monitoring (12).

Student Name: POCT Student Number:

References

  1. Waddingham S. Making Sense of HbA 1c . The British Journal of Primary Care Nursing,
    2008; 5(3): 125-127.
  2. World Health Organization. Use of Glycated Haemoglobin (HbA1c) in the Diagnosis
    of Diabetes Mellitus, Report of a WHO Consultation; WHO/NMH/CHP/CPM/11.1,
    2011: 1-25.
  3. Laboratory Media Incorporated. The Laboratory’s Role in Diagnosis and Monitoring of
    Diabetes, 2014:
  4. Nathan DM, Kuenen J, Borg R et al. Translating the A1C assay into estimated average
    glucose values. Diabetes Care, 2008, 31:1473-1478.
  5. Massi-Benedetti M. Changing targets in the treatment of type 2 diabetes. Curr Med Res
    Opin, 2006, 22(2):S5-13.
  6. Australasian Association of Clinical Biochemists. Point of Care Testing:
    Implementation Guideline. Western Australia, Mount Lawley: 2009.
  7. Nathan DM, Turgeon H, Regan S. Relationship between glycated haemoglobin levels
    and mean glucose levels over time. Diabetologia, 2007, 50:2239-2244.
  8. McCance DR, Hanson RL, Charles MA et al. Comparison of tests for glycated
    haemoglobin and fasting and two hour plasma glucose concentrations as diagnostic
    methods for diabetes. BMJ, 1994, 3 08:1323-1328.
  9. Engelgau MM, Thompson TJ, Herman WH et al. Comparison of fasting and 2-hour
    glucose and HbA1c levels for diagnosing diabetes. Diagnostic criteria and performance
    revisited. Diabetes Care, 1997, 20:785-791.
  10. Gallagher EJ, Bloomgarden ZT, Le Roith D. Review of hemoglobin A 1c in the
    management of diabetes. Journal of Diabetes, 2009, 1:9-17.
  11. Roberts WL, De BK, Brown D et al. Effects of hemoglobin C and S traits on eight
    glycohemoglobin methods. Clin Chem, 2002, 48:383-385.
  12. Othman YH, Remsh EA, Al-Katani A, Al-Johani A. How to Manage Successful Point
    of Care Testing Program, Lippincott Williams & Wilkins, 2008; 7(4): 239-242
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