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POC: Instrumentation, People, Parts, Places, Connectivity John J Ancy, MA, RRT

Fairbanks, AlaskaApril 17, 2013

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Need Cost Specifications QC Training Regulatory IT Considerations

POC: Key considerations

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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

POC: Sensible selection

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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”

POC Spotlight

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Indentify need (I want vs. we need)◦ NeedWILL POC test(s)?Reduce TAT Reduce LOS Improve care management (think care protocols)Improve patient convenience/satisfaction/disease

managementImprove care giver/physician satisfaction

POC: Sensible selection

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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?

POC: Need vs. Want

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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

POC: Need vs. Want

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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

POC: Need vs. Want

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Importance of need, want (both) Turn around vs. cost

Bottom LineDoes reduced TAT improve care?

Does want ever trump need?

POC: Need vs. want

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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?)

POC: Obvious benefits

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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)

POC: Obvious benefits

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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

Glycemic control precautions

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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: 290-296.

POC: Obvious benefits

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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

POC: Obvious benefits

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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: 989-1000, 1970.

POC: Obvious benefits

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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: 1589-96

POC: Obvious benefits

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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: 2008. R. P. Dellinger et al. Crit Care Med 2008; 36 296-327.

POC: Obvious benefits

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Reduced error from transport and specimen handlingBlood 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 K5.0% hemolysis ≈ 2.0 mmol increase in K

POC: Obvious benefits

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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

POC: Obvious benefits

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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??????

POC: Higher 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)

Improve customer satisfaction? (patient, care givers, physicians)

POC: Decision

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Reduces hospital stay

Improves treatment adherence

Reduces complications

*Price CP, Point of Care Testing. BMJ May 2001; 322: 1285-1288.

POC : multiple studies indicate*

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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

POC: sensible solution

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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 $17-29 billion.

Reducing Error at POC

Medicare Study on Medical MistakesOffice 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

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Medicare Study on Medical Error

Medical Harm 134,000 Medicare beneficiaries experience

harm from medical error each month 1.6 million harmed each yearMortality 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:

Pre-analytic (specimen handling)

Analytic (includes interfering substances)

Post-analytic (no such thing as right results on wrong patient)

User training/competency

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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.

Error distribution (Stat Lab Study)

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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.

Error distribution (Stat Lab Study)*

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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

User training/competency

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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

User training/competency

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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

POC: sensible selection

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Specifications ComparisonsMany resources are available, example:Coagulation analyzers-point of care, self-monitoringCAP Today, May 2011; pps 28-36.

7 manufacturers, 17 models, 40 comparisonsList price, cost per sample, specimen type, available tests, QC methods, testing time, wireless LIS/HIS linkage, training, methodology, error detection, available interfaces, data management

POC: sensible selection

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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

Specifications

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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)

Specifications

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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

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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.

"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

POC error rate

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Limitations Hemolysis (whole blood)Room air contamination (blood gases)Improper sample collectionInappropriate anticoagulation

Interferences (check manufacturer specs)

High pO2 (some glucose strips)

Thiopental (pCO2, iCa, K)

Benzalconium (iCa)Salicylate (Cl)Dopamine (glucose, lactate)

Specifications-limitations/interferences(Great topics for user training/competency)

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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)

POC: sensible selection

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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

Device Specifications

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CLIA classificationWaived, moderate complexity (non-waived)Instrument/method verification

Quality ControlConsider quality requirements/regulations

◦ External QC◦ Internal QC◦ EQC designation (option1 or 2)◦ CMS transitioning to EP23A (IQCP)

Specifications

IQCP Risk Management Right QC! EQC phase out

Where to begin?

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CLIA 1988

CLIA QC 1992

2003 EQC

2011 20122013-15?

IQCP

Laboratory Regulation Evolution

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How we really feel about regs

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Equivalent Quality Control (EQC)(fading out of picture, EP23 or IQCP next)

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

Steps for IQCP development*

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*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.

2. Diagram testing process; and identify/evaluate potential risks

IQCP

1. Collect FACTS (for informed decisions)

3. Develop and document the plan

4. Implement and monitor the plan for effectiveness (CQI)

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

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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

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

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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

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

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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

Additional resources CMS/CLIA Website:

http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia/

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 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

EP-23 IQCP Webinars

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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

POC: sensible selection

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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

POC: result reliability

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Barcodes

Dimensional Barcode

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POC network a valuable tool in managing

Patient resultsOrders (entered, POC generated and ordered

tests or combination)InterfacesUsersUser competencyAnalyzers/devices/suppliesHIPAA audits

POC Network Considerations

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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 recommendedWPA, WPA2 (WiFi Protected Access)MAC (Media Accesss Control) filtering(00 C0 09 B1 79 0D)

Access points/ signal strength tests

POC Network Considerations

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

Identifying wireless networks1.Right Click on Wireless Icon in tray (lower right next to time)2. Select Configure WIFI3. Signal quality and speed, broadcast, not broadcast4. Select Properties (next slide view)

BSSID (Basic Service Set ID)Wireless g or n

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Speedtest.net

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Languages/linkageASTM- American Society of Testing and Materials

Primarily results (now LIS1A or LIS 2A)HL7-Health Level 7

Results, patient information, billing informationADT/POCT Order Generation and Order Down Load with

Demographic down load confirmationPOCT 01A (Connectivity Industry Consortium-2000)

Improves multi-vendor operability

POC Network Considerations

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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.

POCT2-A: Requirements

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HIS/LIS EMR Interface and drivers Order entry/download/generation ADT capabilities Middleware

◦ Links instrument/analyzer/application to HIS/LIS Web based

POC Network Considerations

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GEMWeb Plus 200 Infrastructure

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Can be a BIG challenge

Can offer significant benefit

Is here to stay and expanding

EP-23 or IQCP is here (almost, but soon)

POC Testing