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Fairbanks, Alaska April 17, 2013 1. Need Cost Specifications QC Training Regulatory IT Considerations 2.

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Presentation on theme: "Fairbanks, Alaska April 17, 2013 1. Need Cost Specifications QC Training Regulatory IT Considerations 2."— Presentation transcript:

1 Fairbanks, Alaska April 17,

2 Need Cost Specifications QC Training Regulatory IT Considerations 2

3 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 3

4 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 4

5 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 5

6 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? 6

7 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 7

8 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 8

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

10 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?) 10

11 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) 11

12 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 12

13 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 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 14

15 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: ,

16 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 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 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 18

19 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 19

20 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 didnt lose the glucometer Supply stream management Are there other costs?????? 20

21 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) 21

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

23 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 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. 24

25 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 25

26 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) 26

27 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) 27

28 *3 month study (University Hospital of Padua) 4 POC sites (Internal Med, Nephrology, Surgery, ICU) 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 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 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 30

31 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 31

32 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 32

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

34 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 34

35 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) 35

36 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 Remember Ford SUVs with Firestone tires Firestone production was 5 sigma 36

37 Pre-analytical Errors in Point-of-Care Testing: Auditing Error of Patient Identification in the Use of Blood Gas AnalyzersPre-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 "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. Sigma table POC pre-analytic error alone nearly exceeds acceptable error 37

38 Limitations Hemolysis (whole blood) Room air contamination (blood gases) Improper sample collection Inappropriate anticoagulation Interferences (check manufacturer specs) High pO 2 (some glucose strips) Thiopental (pCO 2, iCa, K) Benzalconium (iCa) Salicylate (Cl) Dopamine (glucose, lactate) 38

39 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) 39

40 (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 40

41 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) 41

42 IQCP Risk Management Right QC! EQC phase out Where to begin? 42 CLIA 1988 CLIA QC EQC ? IQCP Laboratory Regulation Evolution

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44 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 systems internal control procedure(s) in accordance with manufacturers instructions and two levels of external control material for 10 consecutive days of testing Will be phased out with IQCP Slides Iliuminations: Sharon Ehrmeyer 44

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46 46 *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 (3 rd ed.). TJC Resources. Oakbrook,

47 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 47 CMS March 2012 Memo. SurveyCertificationGenInfo/ Downloads/SCLetter12_20-.pdf; CMS presentation at CLSI EP23-A Workshop, May 2012 SurveyCertificationGenInfo/ Downloads/SCLetter12_20-.pdf

48 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 wont change Will expect to see information, key steps and ongoing evaluations 48 CMS March 2012 Memo. SurveyCertificationGenInfo/ Downloads/SCLetter12_20-.pdf; CMS presentation at CLSI EP23-A Workshop, May 2012 SurveyCertificationGenInfo/ Downloads/SCLetter12_20-.pdf

49 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 devices 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 49 CMS March 2012 Memo. SurveyCertificationGenInfo/ Downloads/SCLetter12_20-.pdf; CMS presentation at CLSI EP23-A Workshop, May 2012 SurveyCertificationGenInfo/ Downloads/SCLetter12_20-.pdf

50 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

51 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 51

52 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 52

53 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 53

54 Dimensional Barcode 54

55 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 55

56 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 56

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61 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 61

62 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 dont impair patient care delivery Point of Care, The Journal of Near-Patient Testing and Technology. Vol 9 No 4, Dec 2010 p

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

64 GEMWeb Plus 200 Infrastructure 64

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

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