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Point of Care Testing

Point of Care Testing. Wednesday October 29 th 2003. XI. Point-of-Care Testing. Testing that occurs within a facility, but outside the physical space of the laboratory Applies to all facilities with a laboratory licence where point-of-care testing is performed

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Point of Care Testing

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  1. Point of Care Testing Wednesday October 29th 2003

  2. XI. Point-of-Care Testing • Testing that occurs within a facility, but outside the physical space of the laboratory • Applies to all facilities with a laboratory licence where point-of-care testing is performed • Do not apply to legally qualified medical practitioners who perform laboratory examinations for the exclusive purpose of diagnosing or treating patients in their own offices • Patient self-testing outside of a health care facility is also excluded

  3. XI. Point-of-Care Testing • 87 essential requirements • 6 recommended requirements • 10 sub-headings

  4. XI. Point-of-Care Testing • Responsibilities • Personnel policies • Document control • Purchasing and inventory • Process improvement • Equipment • Pre-analytical process • Analytical process • Quality assurance • Post-analytical process (reporting)

  5. References used in POCT section • MOHLTC: Point of care testing policy for hospitals and other facilities, 1999 • CMLTO. POCT position paper, 1999 • NCCLS AST2-A. POCT; Approved Guideline, 1999 • ISO/WD 22870: Quality Management of POCT, 2001

  6. Responsibilities: Lab Director • Establish a quality management system for POCT • Evaluation and selection of test equipment and systems • Ensure personnel performing POCT have documented training • Ensure the policies, processes and procedures for performance and QC are documented • Appoint an advisory management group

  7. POCT Advisory Management Group • Assist in evaluating and selecting equipment and systems • Assess clinical appropriateness of each test • Assess technical, analytical and clinical utility of each test • Allocate responsibilities

  8. Accountability • Accountability to ensure maintenance, quality control and testing are appropriately performed and documented rests with the individual performing those functions • Individual is also accountable to his/her professional college for ensuring he/she is competent

  9. Training • Establish a training program for POCT that is managed by an MLT or other qualified health professional • The content of the training program shall be documented • Only personnel who have completed the training shall perform POCT • Records shall be kept of trainers, trainees • A resource person shall be named

  10. Quality Assurance • Lab director to assign responsibility for quality management of POCT to a lab technologist or other qualified health care professional • All protocols for POCT shall be documented • QC data shall be recorded every time a control is tested, unless electronically linked to an information system • Operator to sign and date the QC data or this information shall be captured electronically

  11. Quality Assurance • Protocols shall define the authority to withdraw equipment or discontinue a test • Quality manager of POCT shall monitor the program regularly • Performance of operators shall be monitored • Retain QC records two years

  12. Case Scenario #1 • You are a lab director. You are aware that some instruments being used in your institution for POCT are outdated and inappropriately controlled. You do not know if you have the authority to remove them • This is a deficiency. The board of directors must define the roles of authority for POCT

  13. Case Scenario #2 • Nurses routinely perform the POCT in our facility. They view this as their territory and do not want the laboratory to interfere. • This is a deficiency. The laboratory director/designate(s) has overall responsibility for POCT. • Training • Process improvement • Quality Assurance • Accountability rests with the individual

  14. Summary Program Requirements(January 2002): • 680 Universal Requirements • Intended for use in pilots to be conducted prior to March 31, 2003 and for the initial assessment process scheduled to begin after April 1, 2003

  15. What? • Whats to be tested? • Why? • Where? • By whom? • How to start? • Results?

  16. What? • Rationale • Patient care algorithm • Business case

  17. Where? • ER • OR • ICU • Renal unit • Outpatient clinic • Facility check

  18. By Whom? • Nursing • Lab. Techs • Pump techs • Dialysis techs • MDs • others

  19. Results? • Off the instrument? • Interfaced • Record keeping • Paper trail • Computer-based • QC programmes • reevaluation

  20. How to start? • Need • Case to POCT advisory committee • Support and approval • MAC/Administration • Funding • IT challenges • Implementation

  21. Home-based testing? • Glucose • PTs • AIDS • Pregnancy • ??????

  22. The future? • Repertoire increasing • Whole blood testing • Trans-dermal • Real-time read-outs • Remote reporting • Stats to the Palm • Drugs/alcohol

  23. The future? • Information technology • Barcodes • SNOMED-CT • Algorithmic patient care • Standards of practice • Evidence-based medicine • e.g. coagulation monitoring

  24. THE FUTURE? -UNDERSTANDING THE CODE D DEXTER MD Department of Pathology and Molecular Medicine 2003

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