Point of Care Patient Testing (POCT)

ONPS 2425/6

Assignment 2

Introduction of POCT
In order to improve patient access and patient throughput, a management review of the requirements for a rural (outreach) diabetes treatment clinic has established the need to provide POCT for glucose and HbA1c.  You have been asked to supervise the introduction of appropriate POCT devices for these two tests.

Provide recommendations and justification for your choice of glucose and HbA1c devices. Summarise your recommendations on how this may be achieved and the on-going operational procedures required in order to provide quality results for patient testing.  Include in your answer recommendations with regard to:

•    Critical evaluation of testing devices which provide results appropriate to clinical requirements (i.e. is the chosen device fit for purpose ?)

•    Pre-analytical considerations
o    Instructions for patient preparation and sample collection
o    Patient safety and risk management
o    Operator training and on-going competency assessment

•    Analytical considerations
o    Frequency and type of quality control (QC)
o    Recording of QC, action limits and procedures to be followed with QC failure
o    External quality assessment (EQA) procedures
o    Device maintenance and performance records

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

•    Post implementation follow-up and confirmation of performance requirements

Resources to use:
•    Prescribed textbook – Point-of-care testing.  Needs, opportunity and innovation. Edited by CP Price, A St John and LJ Kricka.  AACC Press, 2010.
o    MJ Pearson.  Equipment procurement and implementation. Chapter 17.
o    JP Gill and L Watkinson.  Quality control and quality assurance in POCT.  Chapter 18.
•    AACB POCT Implementation Guidelines
•    RCPA QAP website
•    Westgard website
•    Company literature
•    Medicare website

Title page: Your executive summary must have a title page with the project title, your name and student number.
Recommendations = Written (executive) summary:  Provide a written summary justifying your recommendations.  Word limit = 1000 words.
Justification = Excel spread sheet:  Develop two spreadsheets (one for each analyte) to be presented in the one workbook.  Each of these spreadsheets should critically compare devices against your selection criteria.
Referencing: Vancouver style
Due date: see course guide document for due date
Submission: For this assignment, there are two separate submission links – one for the summary word document and the other for the excel document
File submission: Submitted files should be named with your surname, student number and Assign 2.
Marks: 10% of course (5% written summary and 5% for the spreadsheets)

•    Assignment 2 some suggested references
o      ACBI Guidelines for POCT in primary & community care 2009.pdf (1.011 MB)
o      AACB, POCT implementation guide 2008.pdf (365.586 KB)
o      Optimal analytical performance for POCT, CG Fraser Clin Chim Acta 2001 307 37.pdf (135.326 KB)
o      How to manage successful POCT program, YH Othman etal POC 2008 7 239.pdf (81.394 KB)
o      Analytical performance & quality specifications, CG Fraser Clin Chem 1999 45 321.pdf (136.575 KB)
o      Test result variation & quality of evidence-based guidelines, CG Fraser Clin Chim Acta 2004 346 19.pdf (95.238 KB)
o      Australian Standard AS 4633 – content of laboratory manuals.pdf (118.635 KB)
o      MHRA, Management and use of IVD POCT devices 2010.pdf (325.299 KB)
These references may be useful as background material to help construct your selection criteria in order to form your recommendation