3 POC: Sensible selection POC testing has grown and will keep growingUrine dip sticksRapid strepRapid HIVBedside glucometersBlood gas analyzersCoagulationCardiac markersBiomarkersEtc, 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)NeedWILL POC test(s)?Reduce TATReduce LOSImprove care management (think care protocols)Improve patient convenience/satisfaction/disease managementImprove care giver/physician satisfaction
6 POC: Need vs. Want Consider the environment ED, OR, Cath Lab, ICU, NICU, OP Clinic, Floors, OffsiteWill 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, PCTsPotential test volumeHow many POC devices needed?Device type: Multi-sample cartridge, single use cartridge/strip, near patient, bedsideInfection control considerationsWaived/non-waived
8 POC: Need vs. Want Consider the environment Cost per test POC vs. core labSupplies, QC, expendables, maintenance, ITPotential for higher error rate than central lab errorTraining/competency considerationsEase of use, reliabilityNumber of users, ability of usersManagement timeSoftware capabilities
9 POC: Need vs. want Importance of need, want (both) Bottom Line Turn around vs. costBottom LineDoes 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 personQuicker interventionFacilitates care protocolsTight glycemic controlHeparin protocols (Cath Lab, CVOR)Ventilator/oxygen protocols (ABGs/Lytes)Resuscitation ABGs/Lytes/Glucose/LactateSepsis protocol (procalcitonin, biomarker panels?)
11 POC: Obvious benefits Reduced morbidity/mortality Glycemic control protocolsReduces infection/faster resolutionImproves renal functionReduces muscle wastingReduces severity and incidence of anemiaProtects endothelial cells (critical in sepsis care)
12 Glycemic control precautions Aggressive therapy can lead to life-threatening hypoglycemiaCapillary samples potentially give misleading results in critically illVenous 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 complicationsFacilitates better resource utilizationLess time in Cath Lab/CVOR/Recovery/ICUPOC 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 LOSReduce recovery time and overall LOSOxygen protocolsOxygen > 40-60% is cytotoxicLonger exposures increase toxicityProtocols optimize supplemental oxygen use
15 POC: Obvious benefits Resuscitation ABGs/lytes/glucose/lactate critical in management of resuscitationLactate helps predict survivalLactate 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 morbidityProcalcitonin (shows promise)Sepsis Biomarker Panels in developmentEarly antibiotic administration importantEarly 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 managementLactate > 4.0mm0l/L indentifying sepsisLactate < 4.0mmol/L goal for managingoxygenation/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 benefitsReduced 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 pO2Icing 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
19 POC: Obvious benefits Reduced LOS = Reduced cost Reduced morbidity = Reduced costFaster resulting does not necessarily translate to better careUser competency/QC is criticalNeed clinically significant accuracyCorrect 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/competencyPotential 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 managementAre there other costs??????
21 POC: DecisionWill a POC test/device improve outcome and ultimately save costs?Improve resource utilizationRapid triage, treatment or discharge (LOS)Potential to reduce unnecessary testingReduce liability (atypical MI discharged from ED)Improve customer satisfaction? (patient, care givers, physicians)
22 POC : multiple studies indicate* Reduces hospital stayImproves treatment adherenceReduces 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 POCMedical Error, including laboratory and POC error has contributed significantly to cost and lost confidence in medical care quality1999 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 stayPermanent harmRequired life sustaining interventionsContributed to death
26 Medicare Study on Medical Error Medical Harm134,000 Medicare beneficiaries experience harm from medical error each month1.6 million harmed each yearMortality15,000 or 1.5% die from causes associated medical error each month180,000 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 analyses189 errors ( 0.47% frequency)74% of errors did not effect outcome49 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 errorsFrequency distribution68.2% Pre-analytic13.3% Analytic18.5% 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 demonstrationCompetency 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 automationTests by User GroupIntranet test access for testing
32 POC: sensible selection Specifications (more than analytical quality)Quality expectations (accuracy at decision points)MethodologyEase of useReliabilityInterfering substancesManageabilityQC, user, devices, supplies, results, interfaceIT considerations
33 POC: sensible selection Specifications ComparisonsMany resources are available, example:Coagulation analyzers-point of care, self-monitoringCAP Today, May 2011; pps7 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
35 Specifications Methodology Sample type/size Inaccuracy Imprecision Total allowable error (TEa)LinearityReportable RangeAnalytic Measurement Range6 sigma (TEa – SD)/CVSigma-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 processAirline baggage handling4000 DPM or 4.15 sigma processTypical non-lab business process is 4 sigmaMinimum acceptable process is 3 sigmaRemember Ford SUVs with Firestone tires Firestone production was 5 sigma
37 POC error ratePre-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
39 POC: sensible selection Cost BenefitPurchase cost vs reagent rentalTotal cost over contract lifeConsumables/re-useablesQuality control/proficiency testsService /supportRepair/replacement/shippingSoftware interface costs/license/maintenanceTraining costs/recertificationUser/management time (think automation)
40 Device Specifications (Y/N)Level of automatic error detectionOutdated cartridge, strip, reagent, operatorSensor/analyzer/reagent/cartridge errorsInterfering substance detectionAutomated error detection/correction and documentationThe best systems have the shortest time for error detection
41 Specifications CLIA classification Quality Control Waived, moderate complexity (non-waived)Instrument/method verificationQuality ControlConsider quality requirements/regulationsExternal QCInternal QCEQC designation (option1 or 2)CMS transitioning to EP23A (IQCP)
42 IQCP Risk Management Right QC! EQC phase out Where to begin? Laboratory Regulation EvolutionCLIA 1988CLIA QC 19922003EQC20112012?IQCPIQCPRisk ManagementRight QC!EQC phase outWhere to begin?Where to begin?
44 Equivalent Quality Control (EQC) (fading out of picture, EP23 or IQCP next) CLIA Interpretative Guidelines (d)Option 1 Internal QCTest Systems with Internal and/or Procedural Controls that monitors the Entire Analytic ProcessLaboratory 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 IQCPSlides 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, IQCPsAre customized for each test in its environmentOptimize the use of manufacturer integrated controlsOffers sites flexibility to meet CLIA QC compliance requirementsIs adaptable for new technologiesIncorporates other quality informationStrengthens partnerships with the device manufacturerFormalizes by incorporating risk management data used by the laboratoryProvides equivalent quality testing to meet the CLIA QC regulations
46 Steps for IQCP development* Diagram testing process; and identify/evaluate potential risksIQCPCollect FACTS (for informed decisions)Develop and document the planImplement 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 approachIt is not mandatoryDefault QC is 2 external controls per test per day for most testsIt is for new analytes / test systemsThere will be no grandfatheringAfter education and transition date, EQC, to solely meet CLIA QC, will be phased outWell 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 changeKey concepts for IQCP development will be in revised Interpretive Guidelines (Appendix C, SOM)Replace current EQC requirementsCMS survey process won’t changeWill expect to see information, key steps and ongoing evaluationsGo through the slide.CMS March 2012 Memo. SurveyCertificationGenInfo/ Downloads/SCLetter12_20-.pdf; CMS presentation at CLSI EP23-A Workshop, May 2012
49 IQCP SummaryIdentifies how sites mitigate/eliminate harmful risks in the entire testing processVaries 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 resultsAddition quality (QC/QA) activities are included, if neededFinal plan is monitored for effectiveness and modified as neededGo 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.htmlCMS 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 onlineILluminations Webinar: Jan 16, 2013: A Practical Roadmap for EP23_A Implementation in the Point of CareAvailable online at
52 POC: sensible selection IT ConsiderationsDocking unitsBarcode capabilitiesSerial/ethernet connectionWired vs. wireless (both?)WiredStatic IP/DHCP (Dynamic Host Configuration Protocol)Wireless (APs, signal strength, encryption)ServerPhysical/virtualBack-up DB/configuration
53 POC: result reliability Patient and operator IDPatient identification/operator id barcodes can helpBarcode39, 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
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)
61 POC Network Considerations Languages/linkageASTM- American Society of Testing and MaterialsPrimarily results (now LIS1A or LIS 2A)HL7-Health Level 7Results, patient information, billing informationADT/POCTOrder Generation and Order Down Load with Demographic down load confirmationPOCT 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 addressesMeans of meeting regulatory standardsCompatibility with LIS order processSoftware that is compatible with commercial DB vendorsSecurityEase of useConnectivity speeds that don’t impair patient care deliveryPoint of Care, The Journal of Near-Patient Testing and Technology. Vol 9 No 4, Dec 2010 p 194.
63 POC Network Considerations HIS/LISEMRInterface and driversOrder entry/download/generationADT capabilitiesMiddlewareLinks instrument/analyzer/application to HIS/LISWeb based