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

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

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

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”

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

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?

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

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

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?

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?)

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)

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 1654-1658) Protocol policy for confirmatory results from lab

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: 290-296.

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

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: 989- 1000, 1970.

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: 1589-96

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

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

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

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??????

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)

POC : multiple studies indicate* Reduces hospital stay Improves treatment adherence Reduces complications *Price CP, Point of Care Testing. BMJ May 2001; 322: 1285- 1288.

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: 300-309

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 $17-29 billion.

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

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)

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)

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;43:1348-51.

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;43:1348-51.

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

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

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

POC: sensible selection Specifications Comparisons Many resources are available, example: Coagulation analyzers-point of care, self-monitoring CAP Today, May 2011; pps 28-36. 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

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

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)

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

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

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)

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)

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

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)

IQCP Risk Management Right QC! EQC phase out Where to begin? Laboratory Regulation Evolution CLIA 1988 CLIA QC 1992 2003 EQC 2011 2012 2013-15? IQCP IQCP Risk Management Right QC! EQC phase out Where to begin? Where to begin?

How we really feel about regs

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

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 http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/IQCPbenefits.pdf

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. 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.

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. 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 Go through the slide. 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 Go through the slide. 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

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 www.ILww.com

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

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

Barcodes Dimensional Barcode

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

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

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

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)

BSSID (Basic Service Set ID) Wireless g or n

Speedtest.net

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

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.

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

GEMWeb Plus 200 Infrastructure

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)