The Point of Care Quality Control Debate - Whitehat

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So I Have a Device With EQCFeatures. What Would CMS LikeMe to Do?Follow the manufacturer’s package insert.Evaluate the system’s capability to monitor allanalytical elements of the testing procedure• Operator, analysis, environment, sample addition,sample/reagent interactions, test completion time.Evaluate the system’s Equivalent QC by oneof three processesCMS: Equivalent Quality Control Procedures Brochure #4
EQC EvaluationEvaluation ProcessExternal QCchecksOption 1System monitors allanalytic componentsDaily testing withinternal monitoringsystems10 consecutivedays of passingexternal QCAt least onceper monthOption 2System monitors someanalytic componentsDaily testing withinternal monitoringsystems30 consecutivedays of passingexternal QCAt least onceper weekOption 3System monitors noanalytic componentsNA60 consecutivedays of passingexternal QCAt least onceper weekCMS: Equivalent Quality Control Procedures Brochure #4
Page 1 and 2: The Point of Care Quality Control D
Page 3 and 4: A Show of HandsEQCEP23IQCPs
Page 6 and 7: ARCHITECT ® ImmunoassayProcess Pat
Page 8 and 9: Alere Triage ® Assay ProcedureWhat
Page 11 and 12: Triage Device ControlsUp to two imm
Page 13: QC LockoutsUser ID - Only validuser
Page 17: 493.1256 - QC proceduresFor each te
Page 21 and 22: Normal Population Distributions±2
Page 23 and 24: The Pen is Mightier than QC
Page 25 and 26: The QC Regulations• Who accredits
Page 27 and 28: CLSI to the Rescue!!!EP23User Defin
Page 29 and 30: 3/9/12 CMS Official MemorandumKey c
Page 31 and 32: Where to Obtain Information• CMS/
Page 33 and 34: Do This!!!Life-Cycle Risk Managemen
Page 35 and 36: StatisticalDataExisting QCprocedure
Page 37 and 38: Risk Assessment ToolsArrival to /ED
Page 39 and 40: Testing Process Fishbone DiagramTra
Page 41 and 42: FMEA BasicsFunction FailureModesEff
Page 43 and 44: Function FailureModesEffectsofFailu
Page 45 and 46: Function FailureModesEffectsofFailu
Page 47 and 48: Unacceptable orAcceptablewith Risk
Page 49 and 50: Variables to ConsiderEnvironmentalc
Page 51 and 52: PackageInsertVendorOutputRegulatory
Page 53 and 54: Risk Acceptability MatrixSeverity o
Page 55 and 56: Process Occurrence EvaluationCriter
Page 57 and 58: Now….What Needs Fixing?• Identi
Page 59 and 60: Do This!!!Life-Cycle Risk Managemen
Page 61 and 62: EP22-Presentation of Manufacturer's
Page 63 and 64: This is the future for QC of POCTA
Page 65: Questions?Thank You!Today is the yo

The Point of Care Quality Control Debate - Whitehat

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