Fairbanks, Alaska
April 17, 2013
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Need
Cost
Specifications
QC
Training
Regulatory
IT Considerations
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POC testing has grown and will keep growing
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Urine dip sticks
Rapid strep
Rapid HIV
Bedside glucometers
Blood gas analyzers
Coagulation
Cardiac markers
Biomarkers
Etc, etc ad infinitum
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“2012, more than 120 companies came to Los
Angeles to showcase POC products at the
AACC Clinical Lab Expo, and the buzz about
POC spilled over into sessions at the AACC
Annual Meeting. Speakers covered many POC
topics, including the explosion of technology
and where future opportunities lie”
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Indentify need (I want vs. we need)
◦ Need
WILL POC test(s)?
Reduce TAT
Reduce LOS
Improve care management (think care protocols)
Improve patient convenience/satisfaction/disease
management
Improve care giver/physician satisfaction
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Consider the environment
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ED, OR, Cath Lab, ICU, NICU, OP Clinic,
Floors, Offsite
Will reduced TAT improve outcome?
Alternatively, are there ways to improve TAT
from core lab?
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Consider the environment
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Skill level of users: RNs, RTs, PCTs
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Potential test volume
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How many POC devices needed?
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Device type: Multi-sample cartridge, single use
cartridge/strip, near patient, bedside
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Infection control considerations
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Waived/non-waived
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Consider the environment
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Cost per test POC vs. core lab
Supplies, QC, expendables, maintenance, IT
Potential for higher error rate than central lab error
Training/competency considerations
◦ Ease of use, reliability
◦ Number of users, ability of users
Management time
◦ Software capabilities
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Importance of need, want (both)
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Turn around vs. cost
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Bottom Line
Does reduced TAT improve care?
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Does want ever trump need?
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Reduced TAT
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Quicker results for caregivers
◦ Caregiver and operator often the same person
◦ Quicker intervention
◦ Facilitates care protocols
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Tight glycemic control
Heparin protocols (Cath Lab, CVOR)
Ventilator/oxygen protocols (ABGs/Lytes)
Resuscitation ABGs/Lytes/Glucose/Lactate
Sepsis protocol (procalcitonin, biomarker panels?)
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Reduced morbidity/mortality
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Glycemic control protocols
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Reduces infection/faster resolution
Improves renal function
Reduces muscle wasting
Reduces severity and incidence of anemia
Protects endothelial cells (critical in sepsis care)
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Aggressive therapy can lead to life-threatening
hypoglycemia
Capillary samples potentially give misleading
results in critically ill
Venous line draws, preceded by 2x deadspace
waste draw (Critical Care Med 2003 Vol. 31, No. 6 pp 1654-1658)
Protocol policy for confirmatory results from lab
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Heparin protocols
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Reduced post operative/procedure complications
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Facilitates better resource utilization
◦ Less time in Cath Lab/CVOR/Recovery/ICU
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POC coag = reduced blood product utilization*
*Despotis GJ, et al. The effect of intraoperative treatment algorithm on
physician transfusion practice in cardiac surgery. Transfusion 1994;
34: 290-296.
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Ventilator/oxygen protocols
◦ Ventilator weaning protocols reduce ventilator and
ICU LOS
◦ Reduce recovery time and overall LOS
Oxygen protocols
◦ Oxygen > 40-60% is cytotoxic
◦ Longer exposures increase toxicity
◦ Protocols optimize supplemental oxygen use
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Resuscitation
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ABGs/lytes/glucose/lactate critical in
management of resuscitation
Lactate helps predict survival
◦ Lactate greater than 8 mM/L for 2hrs = 90%
mortality *
*Weil, WM, Affifi, AA. Experimental and Clinical Studies on Lactate and
Pyruvate as Indicators of the Severity of Shock. Circulation, 41: 9891000, 1970.
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Sepsis protocols
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Rapid identification (Sepsis vs. SIRS)
◦ Sepsis Biomarkers could save lives/reduce morbidity
 Procalcitonin (shows promise)
 Sepsis Biomarker Panels in development
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Early antibiotic administration important
◦ Early antibiotic administration with appropriate ongoing
management improves outcome (survival decreases by
7.6% for every hour antibiotic therapy is delayed)*
*Kumar A, Roberts D, Wood DO, et al.; Crit Care Med 2006;34: 1589-96
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Sepsis protocols
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Optimizing acid/base, fluid/electrolyte
management improve survival*
ABGs/lytes/glucose/lactate critical in sepsis
management
◦ Lactate > 4.0mm0l/L indentifying sepsis
◦ Lactate < 4.0mmol/L goal for managing
oxygenation/perfusion/BP/acid-base fluid-elect.
*Surviving Sepsis Campaign: International guidelines for
management of severe sepsis and septic shock: 2008. R. P.
Dellinger et al. Crit Care Med 2008; 36 296-327.
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Reduced error from transport and specimen
handling
Blood gases:
◦ Air bubbles can alter pO2
(error amplified with Pneumatic Tube transport)
◦ Icing reduces metabolic changes but can increase
pO2
◦ Icing has potential to increase K (hemolysis and
inhibition of Na/K pump)
0.5% hemolysis ≈ 0.5 mmol increase in K
5.0% hemolysis ≈ 2.0 mmol increase in K
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Reduced LOS = Reduced cost
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Reduced morbidity = Reduced cost
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Faster resulting does not necessarily translate
to better care
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User competency/QC is critical
Need clinically significant accuracy
Correct patient identification (think barcodes)
Care givers need to be able to act on results
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Generally higher cost/test
Regulatory compliance (devil in the details)
Increased operator training/competency
Potential analytic errors “I just want a number”
Patient identity errors “did I scan the wrong
barcode?”
Device tracking “we didn’t lose the glucometer”
Supply stream management
Are there other costs??????
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Will a POC test/device improve outcome and
ultimately save costs?
◦ Improve resource utilization
 Rapid triage, treatment or discharge (LOS)
◦ Potential to reduce unnecessary testing
◦ Reduce liability (atypical MI discharged from ED)
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Improve customer satisfaction? (patient, care
givers, physicians)
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Reduces hospital stay
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Improves treatment adherence
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Reduces complications
*Price CP, Point of Care Testing. BMJ May 2001; 322: 12851288.
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POC instrumentation has improved in ease of
use and analytic quality.
However, due to likely limited technical
background of testing staff, training and
quality control are critical for reliable results*
*England JM, Et. al. Guidelines for near-patient testing:
haemotology. Clin Lab Haem 1995; 17: 300-309
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Medical Error, including laboratory and POC
error has contributed significantly to cost and
lost confidence in medical care quality
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1999 study by Institute of Medicine
reported that medical errors may result in
as many as 98,000 patient deaths annually
in the United States at a cost of $17-29
billion.
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1 in 7 patients (13.5%) experienced serious
hospital error, resulting in harm:
 Prolonged hospital stay
 Permanent harm
 Required life sustaining interventions
 Contributed to death
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Medical Harm
 134,000 Medicare beneficiaries experience
harm from medical error each month
 1.6 million harmed each year
Mortality
 15,000 or 1.5% die from causes associated
medical error each month
 180,000 deaths each year (nearly 500/day)
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Training/competency assessment should
include evidence of knowledge/skills for
entire process to prevent error in
testing/reporting POC results:
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Pre-analytic (specimen handling)
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Analytic (includes interfering substances)
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Post-analytic (no such thing as right results on
wrong patient)
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*3 month study (University Hospital of Padua)
4 POC sites (Internal Med, Nephrology, Surgery, ICU)
40490 analyses
189 errors ( 0.47% frequency)
74% of errors did not effect outcome
◦ 49 tests (0.12%) did effect outcome
*Plebani M, Carraro P. Mistakes in stat laboratory: Types and
frequency. Clin Chem 1997;43:1348-51.
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40490 tests with 189 errors
Frequency distribution
 68.2% Pre-analytic
 13.3% Analytic
 18.5% Post-analytic
*Plebani M, Carraro P. Mistakes in stat laboratory: Types and
frequency. Clin Chem 1997;43:1348-51.
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How many users over how many shifts/sites?
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Is train the trainer appropriate?
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Knowledge and practical demonstration
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Competency fairs (remember QC material
costs)
Accrediting agency requirements
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Does POC/middleware vendor offer operator
management package?
Automated user notification of expiration, searchable
operator DB, operator lockout, user levels, etc.
Flexible testing: randomized questions, T/F, multiple
choice, skill check off, high level of automation
Tests by User Group
Intranet test access for testing
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Specifications (more than analytical quality)
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Quality expectations (accuracy at decision points)
Methodology
Ease of use
Reliability
Interfering substances
Manageability
 QC, user, devices, supplies, results, interface
◦ IT considerations
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Specifications Comparisons
Many resources are available, example:
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Coagulation analyzers-point of care, self-monitoring
CAP Today, May 2011; pps 28-36.
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7 manufacturers, 17 models, 40 comparisons
List price, cost per sample, specimen type,
available tests, QC methods, testing time, wireless
LIS/HIS linkage, training, methodology, error
detection, available interfaces, data management
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Physical size
Environmental requirements
Electrical requirements/UPS
Battery life/recharge cycle time
Cleaning/decontamination
Cartridge/test strip specs
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Single use/available tests
Cartridge/menu/sample capacity
Refrigerated/non-refrigerated
Shelf life
Inventory tracking
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Methodology
Sample type/size
Inaccuracy
Imprecision
Total allowable error (TEa)
Linearity
Reportable Range
Analytic Measurement Range
6 sigma (TEa – SD)/CV
◦ Sigma-metrics the new CLIA QC approach?(EP23A-IQCPs)
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World Class Quality is 3.4 DPM or 6 sigma
Airline safety (passenger fatalities)
◦ 0.43 DPM, better than 6 sigma process
Airline baggage handling
◦ 4000 DPM or 4.15 sigma process
Typical non-lab business process is 4 sigma
Minimum acceptable process is 3 sigma
Remember Ford SUVs with Firestone tires
production was 5 sigma
Firestone
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Pre-analytical Errors in Point-of-Care Testing:
Auditing Error of Patient Identification in the Use of
Blood Gas Analyzers, Natalie A Smith, David G
Housley, Danielle B. Freedman, Point of Care,
Volume 10: Number 4, December 2011.
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"A total of 1961 pre-analytic errors were identified out of
104,979, giving an overall error rate of 1.9%.“
Sigma table: a 1.9% error rate is equivalent to 3.6 Sigma
(rounding up). Or, about 17,864 defects per million
opportunities.
POC pre-analytic error alone nearly exceeds
acceptable error
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Limitations
Hemolysis (whole blood)
Room air contamination (blood gases)
Improper sample collection
Inappropriate anticoagulation
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Interferences (check manufacturer specs)
High pO2 (some glucose strips)
Thiopental (pCO2, iCa, K)
Benzalconium (iCa)
Salicylate (Cl)
Dopamine (glucose, lactate)
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Cost Benefit
◦ Purchase cost vs reagent rental
 Total cost over contract life
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Consumables/re-useables
Quality control/proficiency tests
Service /support
Repair/replacement/shipping
Software interface costs/license/maintenance
Training costs/recertification
User/management time (think automation)
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(Y/N)Level of automatic error detection
Outdated cartridge, strip, reagent, operator
Sensor/analyzer/reagent/cartridge errors
Interfering substance detection
Automated error detection/correction and documentation
The best systems have the shortest time for error
detection
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CLIA classification
Waived, moderate complexity (non-waived)
Instrument/method verification
Quality Control
Consider quality requirements/regulations
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External QC
Internal QC
EQC designation (option1 or 2)
CMS transitioning to EP23A (IQCP)
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Laboratory Regulation Evolution
CLIA
1988
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CLIA QC
1992
2003
EQC
2011
2012
IQCP
Risk Management
Right QC!
EQC phase out
Where to begin?
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2013-15?
IQCP
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CLIA Interpretative Guidelines 493.1256(d)
Option 1 Internal QC
Test Systems with Internal and/or Procedural Controls that
monitors the Entire Analytic Process
Laboratory Responsibility:
“ The laboratory must perform the test system’s internal
control procedure(s) in accordance with manufacturer’s
instructions and two level’s of external control material for
10 consecutive days of testing”
Will be phased out with IQCP
Slides 45-50 Iliuminations: Sharon Ehrmeyer
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http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/IQCPbenefits.pdf
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1. Collect FACTS (for
informed decisions)
2. Diagram testing process;
and identify/evaluate
potential risks
IQCP
3. Develop and
document the plan
4. Implement and monitor
the plan for
effectiveness (CQI)
*Adapted from: CLSI EP23-A :Laboratory QC Based on Risk Management. www.CLSI.org; JO Westgard. Six Sigma Risk
Analysis (2011). Westgard QC, Inc. Madison, WI; The Joint Commission Resources. Failure Mode and Effects Analysis in
Health Care: Proactive Risk Reduction (3rd ed.). TJC Resources. Oakbrook, IL.
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Applies to CMS-certified labs and non-waived
testing
◦ Accrediting organizations (i.e., CAP, TJC, COLA, etc.) have
not yet adopted the IQCP approach
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It is not mandatory
◦ Default QC is 2 external controls per test per day for most
tests
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It is for new analytes / test systems
◦ There will be no grandfathering
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After education and transition date, EQC, to solely
meet CLIA QC, will be phased out
CMS March 2012 Memo. http://cms.hhs.gov/Medicare/Provider-Enrollment-and-Certification/
SurveyCertificationGenInfo/ Downloads/SCLetter12_20-.pdf; CMS presentation at CLSI EP23-A Workshop, May
2012
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Manufacturer instructions always must be followed
No CLIA (subpart K) regulations will change
Key concepts for IQCP development will be in
revised Interpretive Guidelines (Appendix C, SOM)
◦ Replace current EQC requirements
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CMS survey process won’t change
◦ Will expect to see information, key steps and ongoing evaluations
CMS March 2012 Memo. http://cms.hhs.gov/Medicare/Provider-Enrollment-and-Certification/
SurveyCertificationGenInfo/ Downloads/SCLetter12_20-.pdf; CMS presentation at CLSI EP23-A Workshop,
May 2012
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Identifies how sites mitigate/eliminate harmful
risks in the entire testing process
Varies in detail depending on the device and
testing circumstances (testing requirements,
environment, etc.)
◦ Analytical phase includes testing device’s mitigation
features for ensuring quality test results
◦ Addition quality (QC/QA) activities are included, if needed
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Final plan is monitored for effectiveness and
modified as needed
CMS March 2012 Memo. http://cms.hhs.gov/Medicare/Provider-Enrollment-and-Certification/
SurveyCertificationGenInfo/ Downloads/SCLetter12_20-.pdf; CMS presentation at CLSI EP23-A Workshop,
May 2012
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CMS/CLIA Website:
http://www.cms.gov/Regulations-andGuidance/Legislation/CLIA/index.html?redirect=/clia/
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CMS CLIA Central Office:
410-786-3531
IQCP Link:
http://www.cms.gov/Regulations-and-Guidance/
Legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html
CMS presentation at CLSI EP23-A Workshop, May 2012
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AACC –
CLIA Updates, Hear What is in the Works
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June 27, 2012 available online
ILluminations Webinar: Jan 16, 2013: A
Practical Roadmap for EP23_A
Implementation in the Point of Care
Available online at www.ILww.com
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IT Considerations
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Docking units
Barcode capabilities
Serial/ethernet connection
Wired vs. wireless (both?)
Wired
 Static IP/DHCP (Dynamic Host Configuration Protocol)
◦ Wireless (APs, signal strength, encryption)
◦ Server
 Physical/virtual
◦ Back-up DB/configuration
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Patient and operator ID
◦ Patient identification/operator id barcodes can help
◦ Barcode
 39, 128, 2D or dimensional (many others)
 Can reader be programmed/recalibrated on site?
 Some ID software can limit patient ID to band specific ID
characters. Helps prevent scanning the wrong barcode.
◦ RFID systems in infancy for healthcare, might offer
the best hope
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Dimensional Barcode
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POC network a valuable tool in
managing
Patient results
Orders (entered, POC generated and ordered
tests or combination)
Interfaces
Users
User competency
Analyzers/devices/supplies
HIPAA audits
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Server: PC, Physical, Virtual
◦ Operating System (OS) Windows Server, Linux
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Network: Wired, wireless (both), docking
stations
◦ Wired: Serial/ethernet
◦ Wireless: Encryption
WEP (Wired Equivalent Policy) not recommended
WPA, WPA2 (WiFi Protected Access)
MAC (Media Accesss Control) filtering(00 C0 09 B1 79 0D)
Access points/ signal strength tests
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Languages/linkage
ASTM- American Society of Testing and Materials
Primarily results (now LIS1A or LIS 2A)
HL7-Health Level 7
Results, patient information, billing information
ADT/POCT
Order Generation and Order Down Load with
Demographic down load confirmation
POCT 01A (Connectivity Industry Consortium-2000)
Improves multi-vendor operability
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Bidirectional connectivity
Standard plug and play connection (good luck)
Use existing communication infrastructure and IP addresses
Means of meeting regulatory standards
Compatibility with LIS order process
Software that is compatible with commercial DB vendors
Security
Ease of use
Connectivity speeds that don’t impair patient care delivery
Point of Care, The Journal of Near-Patient Testing and
Technology. Vol 9 No 4, Dec 2010 p 194.
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HIS/LIS
EMR
Interface and drivers
Order entry/download/generation
ADT capabilities
Middleware
◦ Links instrument/analyzer/application to HIS/LIS
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Web based
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GEMWeb Plus 200 Infrastructure
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Can be a BIG challenge
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Can offer significant benefit
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Is here to stay and expanding
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EP-23 or IQCP is here (almost, but soon)
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