POCT and Laboratory Medicine/Accreditation

Diagnostic Accreditation Program

May 12, 2008

POCT and Lab Medicine

Arun K. Garg PhD, MD, FRCPC

Medical Director, Lab Medicine/Pathology Fraser Health/RCH 330 E. Columbia StreetNew Westminster, BC V3L 3W7arun.garg@fraserhealth.ca604-520-4330

Point of Care Testing Accreditation

Colin Semple ART

Accreditation & Research Development OfficerDiagnostic Accreditation Program of BC

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.

Econ

omic

s

Population/Expectation

Knowledge

Forces Changing Lab Medicine

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.

Intitutional Testing

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

Point of Care Testing

Point of Care Testing

Others

Home testing – Patient Self Remote Testing – Robotics Home Care Testing – Physician Office Testing

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

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:

Cos

t

Therapeutic Turnaround TimeMedical Quality/Outcome

Forces of POCT

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

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

Acute 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.

Chronic Care and POCT

Fastest growing area of lab medicine Merger of molecular biology, information

technology, biomedical engineering Research and development cost

Technology and POCT

Economic sustainability Relevance of Technology and Medical

Outcome Integration of results in information system

and EMR

Challenges of POCT

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.

POCT and Non Lab Personnel

1. Medical Outcome/Quality.

2. Scientific, Technical Standards, Accreditation Requirements.

3. Administration.

4. Economics/Financial.

General Principles

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

Medical Outcome/Quality

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

Scientific/Technical (Pre-Analytical – Post)

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.

Administrative

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

Economics / Financial

Diabetes Clinics Home Care Oxygen Therapy Program Newborn Baby Bilirubin Program ER – Bedside Pregnancy Testing Program Cardio Thoracic Surgery Program Critical Care Program

Fraser Health and POCT

1. NAC:Lab Med. Practice Guidelines http:/www.nacb.org/impg/poct.

2. Guidelines for glucose monitoring using glucose meters in hospitals: An official statement of Can. Assoc. Path 1986.

3. Guidelines for Point of Care Testing Accreditation Guidelines, DAP 2001.

4. Management and Use of IVD Point of Care Test Devices. MDA. DB 2002(03) Bulletin www.medical-devices.gov.UK.

5. Clinical biochem nearer the patient Ed.V Marks, KGMM Alberti Longman Group Ltd. 1985, Vol 1 and 2 ISBN 0443031592.

References

6. Principles & Practice of Point of Care Testing. Ed. Gerald J. Kost Lippincott Williams & Williams 2002.

7. www.fda.gov/cd_html (FDA test of OTC self testing).8. Association of TCBili Testing in Hospital with decreased

readmission rate. Clin. Chem. 51(3) 540 (2005) John R. Petersen (jrpeters@utmb.edu).

9. Point of Care Testing: Ed J. H. Nichols; Marcel Dekker Inc 2003 ISBN 0-8247-0868.7.

10. Clinics in Lab Medicine Alternate Site Lab Testing vol 14 (3) September 1994 Ed Charles R. Hendof.

11. Point of Care Testing, 2nd Ed. Ed by CP Prince, A St John, JM Hicks. Washington, DC: AACC Press, 2004.

12. Proceedings of 21 International Symposium Refining Point of Care Testing Strategies for Critical and Emergency Care, 2006 AACC.

References

References

13. What’s New in Point of Care Testing

14. Stacy EF Melanson. Point of Care

15. March 2008, Vol.7(1), p.38

14. Eficiency of Self Monitoring of Blood Glucose in Patients with newly Diagnosed Type 2 Diabetes. (ESMON study) Randomized controlled Trial. BMJ

17 April 2008

•

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...

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

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

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

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

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

On-site survey protocols (Medical)

Selection and validation of methods/equipment e.g. Drugs of Abuse screening in ER

Roles and responsibilitieswho can order, perform, monitor? where?

POCT QC: selection, review

Laboratory medical leader’s role in POCT

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

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

Roles and Responsibilities

If not:

Just do whatever the **** you want, in whatever way you want.

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

“Rogue” POCT issues

Method and instrument selection, evaluation and validation

Roles and responsibilitiesTraining and competence testingDocumentationQuality Control and Proficiency TestingInstrument maintenance and monitoringReagents, chemicals and suppliesResults, records and reporting processes

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

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

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

Quality Control

QC policies and procedures are documented and maintained

Appropriate* controls are run with appropriate* frequency

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

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)

Proficiency Testing

Mandated analytes:

Glucose Lipids

INR Drugs of Abuse

Cardiac markers Blood gases

Electrolytes total Bilirubin

HbA1c hCG

BUN Creatinine

Hemoglobin Hematocrit

Urinalysis

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

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.

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.

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.

AACC Annual Meeting

Washington DC

July 27-31, 2008

International POCT Symposium

Critical and Point of Care Testing: Managing Technology for the Benefit of all Populations

September 18-20, 2008

Barcelona, Spain