POCT and Laboratory Medicine/Accreditation

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 arun.garg@fraserhealth.ca 604-520-4330

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. Economics Population/Expectation Knowledge Forces Changing Lab Medicine

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

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

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 http:/www.nacb.org/impg/poct. • 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 www.medical-devices.gov.UK. • Clinical biochem nearer the patient Ed.V Marks, KGMM Alberti Longman Group Ltd. 1985, Vol 1 and 2 ISBN 0443031592.

25. References • Principles & Practice of Point of Care Testing. Ed. Gerald J. Kost Lippincott Williams & Williams 2002. • www.fda.gov/cd_html(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 (jrpeters@utmb.edu). • Point of Care Testing: Ed J. H. Nichols; Marcel Dekker Inc 2003 ISBN 0-8247-0868.7. • 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 • 2006-7 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