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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
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