1. Fairbanks, Alaska April 17, 2013
POC: Instrumentation, People, Parts, Places, Connectivity John J Ancy, MA, RRT
Fairbanks, Alaska
April 17, 2013

2. POC: Key considerations
Need
Cost
Specifications QC
Training
Regulatory
IT Considerations

3. POC: Sensible selection
POC testing has grown and will keep growing
Urine dip sticks
Rapid strep
Rapid HIV
Bedside glucometers
Blood gas analyzers
Coagulation
Cardiac markers
Biomarkers
Etc, etc ad infinitum

4. POC Spotlight
“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”

5. POC: Sensible selection
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

6. POC: Need vs. Want Consider the environment
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?

7. POC: Need vs. Want Consider the environment
Skill level of users: RNs, RTs, PCTs
Potential test volume
How many POC devices needed?
Device type: Multi-sample cartridge, single use cartridge/strip, near patient, bedside
Infection control considerations
Waived/non-waived

8. POC: Need vs. Want Consider the environment
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

9. POC: Need vs. want Importance of need, want (both) Bottom Line
Turn around vs. cost
Bottom Line
Does reduced TAT improve care?
Does want ever trump need?

10. POC: Obvious benefits Reduced TAT Quicker results for caregivers
Caregiver and operator often the same person
Quicker intervention
Facilitates care protocols
Tight glycemic control
Heparin protocols (Cath Lab, CVOR)
Ventilator/oxygen protocols (ABGs/Lytes)
Resuscitation ABGs/Lytes/Glucose/Lactate
Sepsis protocol (procalcitonin, biomarker panels?)

11. POC: Obvious benefits Reduced morbidity/mortality
Glycemic control protocols
Reduces infection/faster resolution
Improves renal function
Reduces muscle wasting
Reduces severity and incidence of anemia
Protects endothelial cells (critical in sepsis care)

12. Glycemic control precautions
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 )
Protocol policy for confirmatory results from lab

13. POC: Obvious benefits Heparin protocols
Reduced post operative/procedure complications
Facilitates better resource utilization
Less time in Cath Lab/CVOR/Recovery/ICU
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:

14. POC: Obvious benefits 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

15. POC: Obvious benefits Resuscitation
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: , 1970.

16. POC: Obvious benefits Sepsis protocols
Rapid identification (Sepsis vs. SIRS)
Sepsis Biomarkers could save lives/reduce morbidity
Procalcitonin (shows promise)
Sepsis Biomarker Panels in development
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:

17. POC: Obvious benefits Sepsis protocols
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: R. P. Dellinger et al. Crit Care Med 2008;

18. POC: Obvious benefits
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

19. POC: Obvious benefits Reduced LOS = Reduced cost
Reduced morbidity = Reduced cost
Faster resulting does not necessarily translate to better care
User competency/QC is critical
Need clinically significant accuracy
Correct patient identification (think barcodes)
Care givers need to be able to act on results

20. POC: Higher costs 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??????

21. POC: Decision
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)
Improve customer satisfaction? (patient, care givers, physicians)

22. POC : multiple studies indicate*
Reduces hospital stay
Improves treatment adherence
Reduces complications
*Price CP, Point of Care Testing. BMJ May 2001; 322:

23. POC: sensible solution
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:

24. Reducing Error at POC
Medical Error, including laboratory and POC error has contributed significantly to cost and lost confidence in medical care quality
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 $ billion.

25. Medicare Study on Medical Mistakes Office of Inspector General- Dept
Medicare Study on Medical Mistakes Office of Inspector General- Dept. of Health and Human Services (released November 2010)
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

26. Medicare Study on Medical Error
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)

27. User training/competency
Training/competency assessment should include evidence of knowledge/skills for entire process to prevent error in testing/reporting POC results:
Pre-analytic (specimen handling)
Analytic (includes interfering substances)
Post-analytic (no such thing as right results on wrong patient)

28. Error distribution (Stat Lab Study)
*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:

29. Error distribution (Stat Lab Study)*
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:

30. User training/competency
How many users over how many shifts/sites?
Is train the trainer appropriate?
Knowledge and practical demonstration
Competency fairs (remember QC material costs)
Accrediting agency requirements

31. User training/competency
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

32. POC: sensible selection
Specifications (more than analytical quality)
Quality expectations (accuracy at decision points)
Methodology
Ease of use
Reliability
Interfering substances
Manageability
QC, user, devices, supplies, results, interface
IT considerations

33. POC: sensible selection
Specifications Comparisons
Many resources are available, example:
Coagulation analyzers-point of care, self-monitoring
CAP Today, May 2011; pps
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

34. Specifications Physical size Environmental requirements
Electrical requirements/UPS
Battery life/recharge cycle time
Cleaning/decontamination
Cartridge/test strip specs
Single use/available tests
Cartridge/menu/sample capacity
Refrigerated/non-refrigerated
Shelf life
Inventory tracking

35. Specifications 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)

36. Benchmarks for 6 sigma 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 Firestone production was 5 sigma

37. POC error rate
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.
"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

38. Specifications-limitations/interferences (Great topics for user training/competency)
Hemolysis (whole blood)
Room air contamination (blood gases)
Improper sample collection
Inappropriate anticoagulation
Interferences (check manufacturer specs)
High pO2 (some glucose strips)
Thiopental (pCO2, iCa, K)
Benzalconium (iCa)
Salicylate (Cl)
Dopamine (glucose, lactate)

39. POC: sensible selection
Cost Benefit
Purchase cost vs reagent rental
Total cost over contract life
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)

40. Device Specifications
(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

41. Specifications CLIA classification Quality Control
Waived, moderate complexity (non-waived)
Instrument/method verification
Quality Control
Consider quality requirements/regulations
External QC
Internal QC
EQC designation (option1 or 2)
CMS transitioning to EP23A (IQCP)

42. IQCP Risk Management Right QC! EQC phase out Where to begin?
Laboratory Regulation Evolution
CLIA 1988
CLIA QC 1992
2003
EQC
2011
2012 ?
IQCP
IQCP
Risk Management
Right QC!
EQC phase out
Where to begin?
Where to begin?

43. How we really feel about regs

44. Equivalent Quality Control (EQC) (fading out of picture, EP23 or IQCP next)
CLIA Interpretative Guidelines (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 Iliuminations: Sharon Ehrmeyer

45. Are customized for each test in its environment
So before starting the development process, let’s take a look at how CMS describes the role of IQCP. According to the government, IQCPs
Are customized for each test in its environment
Optimize the use of manufacturer integrated controls
Offers sites flexibility to meet CLIA QC compliance requirements
Is adaptable for new technologies
Incorporates other quality information
Strengthens partnerships with the device manufacturer
Formalizes by incorporating risk management data used by the laboratory
Provides equivalent quality testing to meet the CLIA QC regulations

46. Steps for IQCP development*
Diagram testing process; and identify/evaluate potential risks
IQCP
Collect FACTS (for informed decisions)
Develop and document the plan
Implement and monitor the plan for effectiveness (CQI)
If you decide that the individualized QC plan is the way to go, then these are the steps that most sources on risk management depict as part of the planning process.
The goal of the individualized QC plans is to ensure quality test results. The documented strategy identifies the various mechanisms the site implements in all phases of testing to prevent potentially harmful risks from entering the testing process.
Step one is to collect the facts so that informed decisions can be made. This really isn’t any different than what you already do as part of selecting a new instrument or method.
We all know that errors or risks can enter throughout the testing process – from pre-analytical to post-analytical. Step two is to diagram the complete testing process so that we are better alerted to potential problems from start to finish. Often diagrams or visuals can better assist us to identify and then ultimately evaluate potential risks.
Let’s look at each step in more detail.
Step three is the development and documentation of the plan based on the information collected.
Step four is the plan implementation. But like everything else we do in the laboratory, quality assessments and continuous quality improvement, when necessary, are essential.
*Adapted from: CLSI EP23-A :Laboratory QC Based on Risk Management. 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.

47. IQCP Summary Applies to CMS-certified labs and non-waived testing
Accrediting organizations (i.e., CAP, TJC, COLA, etc.) have not yet adopted the IQCP approach
It is not mandatory
Default QC is 2 external controls per test per day for most tests
It is for new analytes / test systems
There will be no grandfathering
After education and transition date, EQC, to solely meet CLIA QC, will be phased out
Well let me summarize. Remember that my intent was just to get you to start thinking about all of this.
Go through the slide.
CMS March 2012 Memo. SurveyCertificationGenInfo/ Downloads/SCLetter12_20-.pdf; CMS presentation at CLSI EP23-A Workshop, May 2012

48. IQCP Summary 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
CMS survey process won’t change
Will expect to see information, key steps and ongoing evaluations
Go through the slide.
CMS March 2012 Memo. SurveyCertificationGenInfo/ Downloads/SCLetter12_20-.pdf; CMS presentation at CLSI EP23-A Workshop, May 2012

49. IQCP Summary
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
Final plan is monitored for effectiveness and modified as needed
Go through the slide.
CMS March 2012 Memo. SurveyCertificationGenInfo/ Downloads/SCLetter12_20-.pdf; CMS presentation at CLSI EP23-A Workshop, May 2012

50. Additional resources CMS/CLIA Website:
Guidance/Legislation/CLIA/index.html?redirect=/clia/
CMS CLIA Central Office:
IQCP Link:
Legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html
CMS presentation at CLSI EP23-A Workshop, May 2012

51. EP-23 IQCP Webinars AACC – CLIA Updates, Hear What is in the Works
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

52. POC: sensible selection
IT Considerations
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

53. POC: result reliability
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

54. Barcodes
Dimensional Barcode

55. POC Network Considerations
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

56. POC Network Considerations
Server: PC, Physical, Virtual
Operating System (OS) Windows Server, Linux
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

57. http://www.ampedwireless.com/wifianalytics/ Free software

58. Identifying wireless networks 1
Identifying wireless networks 1.Right Click on Wireless Icon in tray (lower right next to time) 2. Select Configure WIFI 3. Signal quality and speed, broadcast, not broadcast 4. Select Properties (next slide view)

59. BSSID (Basic Service Set ID) Wireless g or n

60. Speedtest.net

61. POC Network Considerations
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

62. POCT2-A: Requirements 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.

63. POC Network Considerations
HIS/LIS
EMR
Interface and drivers
Order entry/download/generation
ADT capabilities
Middleware
Links instrument/analyzer/application to HIS/LIS
Web based

64. GEMWeb Plus 200 Infrastructure

65. POC Testing Can be a BIG challenge Can offer significant benefit
Is here to stay and expanding
EP-23 or IQCP is here (almost, but soon)