1. POCT and Laboratory Medicine/Accreditation
Diagnostic Accreditation Program
May 12, 2008

2. POCT and Lab Medicine Arun K. Garg PhD, MD, FRCPC
Medical Director, Lab Medicine/Pathology
Fraser Health/RCH
330 E. Columbia Street
New Westminster, BC V3L 3W7

3. Point of Care Testing Accreditation
Colin Semple ART
Accreditation & Research Development Officer
Diagnostic Accreditation Program of BC

4. Pathophysiology of disease has been foundation for diagnosis/management/ prognosis of disease and maintenance of health.
Patient physician relationship is based on bedside medicine.
“Lab” medicine has been integral to science of this relationship
Delivery of lab medicine is a continuum from bedside to ward to central lab to bedside.

5. Forces Changing Lab Medicine
Economics
Population/Expectation
Knowledge

6. POCT – A diagnostic test when the result is required within 5 – 10 minutes of specimen collection and appropriate immediate medical decision is required based on the result.

7. Point of Care Testing Intitutional Testing
In vivo Point of Care Testing, In vitro Point of Care Testing, Ancillary testing, Satellite testing, Bedside testing, Near patient testing.

8. Point of Care Testing Others Home testing – Patient Self
Remote Testing – Robotics
Home Care Testing –
Physician Office Testing

9. Institutional Acute Care
Traditional Lab Services – ER, ICU, OR, Wards, Ambulance
Physician office
Ambulatory clinics
Community clinics
Pharmacies
Long-term/Extended Care
Home Care
Ambulance

10. Some examples: Glucose meters Urinalysis Blood gases/electrolytes
Coagulation studies
Rapid Bacterial Strips
Glycalated HbA1c
Cardiac BioMarkers
Hormones, Pregnancy testing
Non blood skin reflectance - bilirubin

11. Forces of POCT Therapeutic Turnaround Time Cost
Medical Quality/Outcome

12. Diagnosis of disease in acute care
Management of disease in chronic care

13. Acute Care and POCT Flow and productivity in acute care and POCT
Impact in ER/ICU/Critical Care area.
Comparative cost of POCT v/s central testing.
Limited success in acute care due to cost, complexity of medical decision process; broad scope of testing.
Potential in bedside diagnosis of infectious diseases including infectious agents.
Diagnosis in rural and isolated setting.
Drugs of abuse

14. Chronic Care and POCT
Positive impact on management of diseases such as Diabetes; anticoagulation.
Potential in therapeutic drug monitoring.
Management of chronic diseases such as renal disease, other endocrine disorders.
Improved outcome and quality of care, but no decrease in “budget requirement”.
Patient self care and management.

15. Technology and POCT Fastest growing area of lab medicine
Merger of molecular biology, information technology, biomedical engineering
Research and development cost

16. Challenges of POCT Economic sustainability
Relevance of Technology and Medical Outcome
Integration of results in information system and EMR

17. POCT and Non Lab Personnel
Key issue ‘foundation’ guidelines for POCT utilization.
Not limited to ‘traditional’ lab personnel for operation of devices.
Knowledge based support for standards, monitoring, utilization, quality.

18. General Principles Medical Outcome/Quality.
Scientific, Technical Standards, Accreditation Requirements.
Administration.
Economics/Financial.

19. Medical Outcome/Quality
Establishment of need, advantage/disadvantage, evidence from non lab perspective
Utilization parameters (ongoing)
Clinical outcome
Institutional impact on care
Individual impact on care (outcome rapid diagnosis)
Education (at the time of introduction and on going)
Clinical Governance (Med. Adv., Risk/Delegation)
Diagnosis/Management
Interpretation of results
Designated personnel responsible

20. Scientific/Technical (Pre-Analytical – Post)
Analytical Evaluation (equipment, device, system)
Accreditation Requirement
Ongoing QA process, monitoring responsibility, internal/external, QC
Training/Maintenance/Record keeping
Disposable of supplies after use
Standard Operating Procedure (SOP)
Reporting, document of of results and workbooks
Integration - Information services
Integration - Therapeutics
Ongoing Lab Responsibility and Designated Personnel

21. Administrative Explicit documentation on budget and responsibility.
Material management, distribution.
Risk management.
Governance related to audit, utilization, material management, identification of all members involved, ongoing responsibility and authority.
Written standard operating procedure. (SOP)
Training/competence/certification.
Process structure.

22. Economics / Financial Micro/Macro economic issues
Business Costs (capital, fixed, variable)
Billing issues (O/P, MSP)
Utilization Costs
Total Cost/Savings to the System

23. Fraser Health and POCT Diabetes Clinics
Home Care Oxygen Therapy Program
Newborn Baby Bilirubin Program
ER – Bedside Pregnancy Testing Program
Cardio Thoracic Surgery Program
Critical Care Program

24. References
NAC:Lab Med. Practice Guidelines
Guidelines for glucose monitoring using glucose meters in hospitals: An official statement of Can. Assoc. Path 1986.
Guidelines for Point of Care Testing Accreditation Guidelines, DAP 2001.
Management and Use of IVD Point of Care Test Devices. MDA. DB 2002(03) Bulletin
Clinical biochem nearer the patient Ed.V Marks, KGMM Alberti Longman Group Ltd. 1985, Vol 1 and 2 ISBN

25. References
Principles & Practice of Point of Care Testing. Ed. Gerald J. Kost Lippincott Williams & Williams 2002.
(FDA test of OTC self testing).
Association of TCBili Testing in Hospital with decreased readmission rate. Clin. Chem. 51(3) 540 (2005) John R. Petersen
Point of Care Testing: Ed J. H. Nichols; Marcel Dekker Inc 2003 ISBN
Clinics in Lab Medicine Alternate Site Lab Testing vol 14 (3) September 1994 Ed Charles R. Hendof.
Point of Care Testing, 2nd Ed. Ed by CP Prince, A St John, JM Hicks. Washington, DC: AACC Press, 2004.
Proceedings of 21 International Symposium Refining Point of Care Testing Strategies for Critical and Emergency Care, 2006 AACC.

26. References What’s New in Point of Care Testing
Stacy EF Melanson. Point of Care
March 2008, Vol.7(1), p.38
Eficiency of Self Monitoring of Blood Glucose in Patients with newly Diagnosed Type 2 Diabetes. (ESMON study) Randomized controlled Trial. BMJ
17 April 2008

27. Point of Care Testing-Definition
For accreditation purposes:
Testing outside the confines of the traditional laboratory. Does not include satellite labs, or other dedicated space. Does not include physician’s office testing, long term care facilities, home care...

28. Accreditation Standards
Draft standards developed
08/2007 Standards released for testing
03/2008 Revisions to POCT Standards
05/2008 Advisory Committee Approval
05/2008 Board Approval

29. Advisory Committees
Advisory Committees for: Hematology, Chemistry, Transfusion Medicine, Microbiology, Anatomic Pathology, Informatics, Point of Care
POCT Advisory Committee:
2 medical biochemists
3 technologists
DAP staff
VCH, PHSA, VIHA, FHA

30. POCT Accreditation Standards
Method and instrument selection, evaluation and validation
Roles and responsibilities
Training and competence testing
Documentation
Quality Control and Proficiency Testing
Instrument maintenance and monitoring
Reagents, chemicals and supplies
Results, records and reporting processes

31. On-site survey protocols (technical)
Talk to the laboratory staff involved in POCT oversight: overview, QC, PT
Go the emergency department: What POCT is being performed? Assess storage, procedures, recording of results, instrument care and maintenance
Other suspects for POCT: ICU, OR, clinics, ambulances

32. On-site survey protocols (technical)
Go to nursing unit-observe a POCT glucose
look for procedures
look for protocols
Speak with a nurse educator:
orientation and training
competence assessment

33. On-site survey protocols (Medical)
Selection and validation of methods/equipment e.g. Drugs of Abuse screening in ER
Roles and responsibilities
who can order, perform, monitor? where?
POCT QC: selection, review
Laboratory medical leader’s role in POCT

34. Method/Instrument Selection/Validation
The medical need and rationale for POCT has been evaluated
Analysis of the service required, the service provided and alternate options
Cost benefit analysis
Methods are validated using documented policies, processes and procedures
Red + bolded = Mandatory

35. Roles and Responsibilities
Overall responsibility for POCT is assigned to the facility or regional laboratory leader or designate
The Laboratory Medical Leader defines the scope of POCT in consultation with the MAC, interdisciplinary practice groups or other appropriate groups.
The responsibilities and accountabilities for POCT are documented

36. Roles and Responsibilities
If not:
Just do whatever the **** you want, in whatever way you want.

37. Roles and Responsibilities
Accreditation surveys have noted:
“Rogue” POCT being performed
e.g. in the Emergency Room:
Urine dipsticks
Urine pregnancy testing
Fecal Occult Blood testing

38. “Rogue” POCT issues
Method and instrument selection, evaluation and validation
Roles and responsibilities
Training and competence testing
Documentation
Quality Control and Proficiency Testing
Instrument maintenance and monitoring
Reagents, chemicals and supplies
Results, records and reporting processes

39. Training/Orientation/Competence Testing
No mandatory items.
Survey information reveals that often POCT training and orientation is minimal and generally, no competence testing is performed

40. Documented Procedures
Documents are reviewed and approved prior to issue
Procedures are performed as written
There are processes to document that staff have been informed of changes to methodology

41. Documented Procedures
Survey Information
“laboratory” documents are missing or ignored including:
-hyperglycemic and hypoglycemic protocols
-procedures to be followed in the event that results beyond the linearity of the instrument
patient ID prior to POCT is often absent
gloves seldom worn

42. Quality Control
QC policies and procedures are documented and maintained
Appropriate* controls are run with appropriate* frequency

43. Quality Control Survey information:
By and large controls are performed in an appropriate manner
However, where there is a will, there is a way…despite lockout

44. Proficiency Testing
Advisory Committees (Chemistry and POCT) have input into what PT needs to be performed for POCT
POCT sites participate in PT as defined by the laboratory medical leader
(basically the same level of scrutiny applies to POCT as testing performed within the laboratory)

45. Proficiency Testing Mandated analytes: Glucose Lipids
INR Drugs of Abuse
Cardiac markers Blood gases
Electrolytes total Bilirubin
HbA1c hCG
BUN Creatinine
Hemoglobin Hematocrit
Urinalysis

46. Instruments and equipment
Documented maintenance schedules exist
Survey information:
Routine maintenance not always performed
Instrument or QC issues dealt with quickly-send to laboratory and get a replacement

47. Reagents and Supplies Receipt and service entry dates are recorded
Reagents etc. are transported/stored appropriately
Survey information:
Usually the laboratory has some role in this.
Most POCT supplies are stored at RT.

48. Recording of Results Standards needs some work here.
Survey information:
Usually POCT results are documented in the patient’s chart quickly.
Thermal printouts are a problem.

49. Summary
Approximately 85% of facilities with laboratories surveyed by the DAP use POCT.
Accreditation standards and survey processes will continue to evolve and identify further challenges associated with POCT.
POCT performed in physician’s offices, clinics and long term care facilities are not currently subjected to the same level of scrutiny.

50. AACC Annual Meeting
Washington DC
July 27-31, 2008

51. International POCT Symposium
Critical and Point of Care Testing: Managing Technology for the Benefit of all Populations
September 18-20, 2008
Barcelona, Spain