POCT and Laboratory Medicine/Accreditation Diagnostic Accreditation Program May 12, 2008
Dec 23, 2015
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 [email protected]
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 ([email protected]).
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