Transcript POCT and Laboratory Medicine/Accreditation Diagnostic Accreditation Program May 12, 2008 POCT and Lab Medicine Arun K.

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 Street
New Westminster, BC V3L 3W7
[email protected]
604-520-4330
Point of Care Testing
Accreditation
Colin Semple ART
Accreditation & Research Development Officer
Diagnostic Accreditation Program of BC
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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.
Forces Changing Lab
Medicine
Knowledge
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.
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.
Point of Care Testing
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Others
Home testing – Patient Self
Remote Testing – Robotics
Home Care Testing –
Physician Office Testing
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Institutional Acute Care
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Traditional Lab Services – ER, ICU, OR,
Wards, Ambulance
Physician office
Ambulatory clinics
Community clinics
Pharmacies
Long-term/Extended Care
Home Care
Ambulance
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Some examples:
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Glucose meters
Urinalysis
Blood gases/electrolytes
Coagulation studies
Rapid Bacterial Strips
Glycalated HbA1c
Cardiac BioMarkers
Hormones, Pregnancy testing
Non blood skin reflectance - bilirubin
Forces of POCT
Medical Quality/Outcome
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Diagnosis of disease in acute care
Management of disease in chronic care
Acute Care and POCT
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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
Chronic Care and POCT
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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.
Technology and POCT
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Fastest growing area of lab medicine
Merger of molecular biology, information
technology, biomedical engineering
Research and development cost
Challenges of POCT
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Economic sustainability
Relevance of Technology and Medical
Outcome
Integration of results in information system
and EMR
POCT and Non Lab Personnel
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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.
General Principles
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Medical Outcome/Quality.
Scientific, Technical Standards,
Accreditation Requirements.
Administration.
Economics/Financial.
Medical Outcome/Quality
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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
Scientific/Technical
(Pre-Analytical – Post)
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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
Administrative
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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.
Economics / Financial
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Micro/Macro economic issues
Business Costs (capital, fixed, variable)
Billing issues (O/P, MSP)
Utilization Costs
Total Cost/Savings to the System
Fraser Health and POCT
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Diabetes Clinics
Home Care Oxygen Therapy Program
Newborn Baby Bilirubin Program
ER – Bedside Pregnancy Testing Program
Cardio Thoracic Surgery Program
Critical Care Program
References
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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.
References
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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 ([email protected]).
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.
References
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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
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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
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Advisory Committees for: Hematology,
Chemistry, Transfusion Medicine,
Microbiology, Anatomic Pathology,
Informatics, Point of Care
POCT Advisory Committee:
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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 responsibilities
who can order, perform, monitor? where?
POCT QC: selection, review
Laboratory medical leader’s role in POCT
Method/Instrument Selection/Validation
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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
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If not:
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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 responsibilities
Training and competence testing
Documentation
Quality Control and Proficiency Testing
Instrument maintenance and monitoring
Reagents, chemicals and supplies
Results, 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
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“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
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patient ID prior to POCT is often absent
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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
INR
Cardiac markers
Electrolytes
HbA1c
BUN
Hemoglobin
Urinalysis
Lipids
Drugs of Abuse
Blood gases
total Bilirubin
hCG
Creatinine
Hematocrit
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