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

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

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

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  1. POC: Instrumentation, People, Parts, Places, ConnectivityJohn 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) • 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 1654-1658) • 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: 290-296.

  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: 989-1000, 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: 1589-96

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

  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: 1285-1288.

  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: 300-309

  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 $17-29 billion.

  25. 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

  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. ClinChem 1997;43:1348-51.

  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. ClinChem 1997;43:1348-51.

  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 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

  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) • Limitations 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 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. Laboratory Regulation Evolution • IQCP • Risk Management • Right QC! • EQC phase out 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 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

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

  46. Diagram testing process; and identify/evaluate potential risks Steps for IQCP development* • Collect FACTS (for informed decisions) • Develop and document the plan • Implement and monitor the plan for effectiveness (CQI) IQCP *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.

  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 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

  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 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

  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 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

  50. 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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