POCT and Laboratory Medicine/Accreditation

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POCT and Laboratory Medicine/Accreditation
Diagnostic Accreditation Program
May 12, 2008
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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_at_fraserhealth.ca
• 604-520-4330

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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.

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Forces Changing Lab Medicine
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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.
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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.
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Point of Care Testing

• Others
• Home testing Patient Self
• Remote Testing Robotics
• Home Care Testing
• Physician Office Testing

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• 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

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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

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Forces of POCT
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• Diagnosis of disease in acute care
• Management of disease in chronic care

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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

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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.

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Technology and POCT

• Fastest growing area of lab medicine
• Merger of molecular biology, information
  technology, biomedical engineering
• Research and development cost

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Challenges of POCT

• Economic sustainability
• Relevance of Technology and Medical Outcome
• Integration of results in information system and
  EMR

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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.

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General Principles

1. Medical Outcome/Quality.
2. Scientific, Technical Standards, Accreditation
   Requirements.
3. Administration.
4. Economics/Financial.

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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

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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

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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.

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Economics / Financial

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

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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

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References

1. NACLab 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.

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References

1. Principles Practice of Point of Care Testing.
   Ed. Gerald J. Kost Lippincott Williams Williams
   2002.
2. www.fda.gov/cd_html (FDA test of OTC self
   testing).
3. Association of TCBili Testing in Hospital with
   decreased readmission rate. Clin. Chem. 51(3) 540
   (2005) John R. Petersen (jrpeters_at_utmb.edu).
4. Point of Care Testing Ed J. H. Nichols Marcel
   Dekker Inc 2003 ISBN 0-8247-0868.7.
5. Clinics in Lab Medicine Alternate Site Lab
   Testing vol 14 (3) September 1994 Ed Charles R.
   Hendof.
6. Point of Care Testing, 2nd Ed. Ed by CP Prince, A
   St John, JM Hicks. Washington, DC AACC Press,
   2004.
7. Proceedings of 21 International Symposium
   Refining Point of Care Testing Strategies for
   Critical and Emergency Care, 2006 AACC.

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References

• Whats 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 physicians office testing,
long term care facilities, home care...
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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
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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

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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

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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

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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

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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 leaders role in POCT

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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

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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

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Roles and Responsibilities

• If not
• Just do whatever the you want, in whatever
  way you want.

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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

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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

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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

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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

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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

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Quality Control

• QC policies and procedures are documented and
  maintained
• Appropriate controls are run with appropriate
  frequency

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Quality Control

• Survey information
• By and large controls are performed in an
  appropriate manner
• However, where there is a will, there is a
  waydespite lockout

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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)

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Proficiency Testing

• Mandated analytes
• Glucose Lipids
• INR Drugs of Abuse
• Cardiac markers Blood gases
• Electrolytes total Bilirubin
• HbA1c hCG
• BUN Creatinine
• Hemoglobin Hematocrit
• Urinalysis

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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

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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.

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Recording of Results

• Standards needs some work here.
• Survey information
• Usually POCT results are documented in the
  patients chart quickly.
• Thermal printouts are a problem.

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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 physicians offices, clinics
  and long term care facilities are not currently
  subjected to the same level of scrutiny.

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AACC Annual Meeting

• Washington DC
• July 27-31, 2008

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International POCT Symposium

• Critical and Point of Care Testing Managing
  Technology for the Benefit of all Populations
• September 18-20, 2008
• Barcelona, Spain