A New Era in Quality Control: Developing an IQCP for Your Laboratory
|
|
- Naomi Boyd
- 6 years ago
- Views:
Transcription
1 A New Era in Quality Control: Developing an IQCP for Your Laboratory Gerald A. Capraro, Ph.D., D(ABMM) Medical Director, Clinical Microbiology & Diagnostic Virology Laboratories LSU Health Sciences Center Shreveport September 17, 2015
2 I have no relevant disclosures.
3 Objectives: At the conclusion of this lecture, the attendee will be able to: 1. Compare and contrast the current Equivalent Quality Control (EQC) strategy and the new Individualized Quality Control Plan (IQCP) 2. Describe the three components of an IQCP 3. Design an IQCP implementation strategy for his/her own laboratory
4 New Individualized Quality Control Plan (IQCP) EQC Use if manufacturer QC less rigid than regulation IQCP Use if manufacturer QC less rigid than regulation Transitional Updated Solution (2016) Standardized Rigid Analytic Requires internal QC Decreases external QC Customizable Flexible Pre Post Analytic Does not require internal QC May/may not decrease QC Replaces current EQC language in CLIA regulations as of January 1, 2016
5 Mandatory or Voluntary? IQCP is voluntary for laboratories Current CLIA control default regulations continue to be in effect: Pos & Neg QC each test day for qualitative tests 2 levels of QC each test day for quantitative tests EQC (based on using internal controls; weekly QC; shipment/lot QC; etc.) will be discontinued and will no longer be an acceptable QC option under CLIA in January 2016 The laboratory must choose to: follow CLIA default QC regulations, OR develop an IQCP
6 3 Components of IQCP 1. Risk Assessment Collect Data identify potential sources of error/failures in pre-analytical, analytical, and post-analytical phases of laboratory testing Assess the frequency of occurrence of the error and the potential harm from the error 2. Quality Control Plan Defines the mechanisms in place for detecting, controlling, or preventing errors Defines the QC acceptability criteria 3. Quality Assessment Designed to monitor the effectiveness of the QCP
7 Risk Assessment Identify the sources of potential failures and errors associated with the test system Evaluate the frequency of failures/errors Evaluate the impact due to failures/errors
8 Risk Assessment CMS-defined Risk Assessment Components Specimen Patient preparation, collection, labeling, storage preservation, stability, transportation, processing, acceptability, referral Test System Inadequate sampling, clot detection, detecting interfering substances, calibration issues, mechanical/electronic failure, optics, pipettors, bar code readers, function checks, built-in controls, external controls, temperature monitors/controllers, software/hardware, transmission of data to LIS, result reporting Reagent Shipping/receiving, storage, expiration dates, preparation Environment Temperature, airflow/ventilation, light intensity, humidity, altitude, dust, water, utilities, space Testing Personnel Training, competency, education, experience, staffing
9 Risk Assessment The resulting Risk Assessment is then used to develop the Quality Control Plan (How you will control for these risks)
10 Quality Control Plan A document/process/plan that describes the practices, resources, and procedures used to control the quality of a test system. Control all phases of testing specimen collection performance result reporting Must monitor the accuracy and precision of test performance Include the number, type, and frequency of QC Define criteria for acceptability of QC
11 Quality Assessment The laboratory must establish a review system for the on-going monitoring of the effectiveness of their QCP. The monitoring should include all 5 Risk Assessment Components (part of our RA): specimens, test system, reagents, environment, testing personnel When the laboratory discovers a testing process failure or error it must: conduct and document an investigation to identify the cause of the failure/error, determine its impact or harm, and
12 Implementation of IQCP Until December 31, 2015: Laboratories may use CLIA QC regulations (QC each day of testing), EQC, or IQCP By January 1, 2016: Laboratories must follow CLIA QC regulations (QC each day of testing) or IQCP* (no more EQC) All new and existing test systems must be in compliance *NOTE: Your IQCP must include testing of QC at least as stringent as recommended by the manufacturer.
13 Example Clostridium difficile EIA assay I. Risk assessment (RA) of the System II. Quality Control Plan (QCP) for the System III. Quality Assessment (QA) for the System
14 Risk Assessment Collect Information Manufacturer instructions Look specifically at the Limitations section to identify possible risks. Note manufacturer recommended QC (IQCP may not include QC that is less than that recommended by the manufacturer). Include a copy of your manufacturer s instructions in your IQCP materials. Manufacturer performance data Look for any risks associated with this system that have been identified in the manufacturer s performance data. Include copy in your IQCP materials. Literature published on assay Look for any risks/concerns associated with this system that have been identified in the literature. Include copies of pertinent articles in your IQCP materials. Accreditation/Regulatory requirements Ensure that your IQCP will be in compliance with any accreditation or regulatory requirements. Include copies of these requirements in your IQCP materials. Individual laboratory data available Review your verification (initial and any subsequent studies) and historical QC data to help define your IQCP. Include these data in your IQCP materials, or identify where this data can be found in the laboratory.
15 Historical data - Summary Historical Quality Review: QC data for the past 32 months (1/1/13-8/31/15) was reviewed. Testing was performed as outlined in the Clostridium difficile Quik Chek Complete Rapid Membrane Enzyme Immunoassay procedure found in the Bacteriology Test Manual. Our data showed: 0 occurrence of random QC errors involving the internal built in procedural controls that are a part of each test device. The appearance of the blue control dots on each test device confirms that the sample and reagents were added correctly, that the reagents were active at the time of performing the assay, and that the sample migrated properly through the Membrane Device. 0 occurrence of potential system QC errors that required corrective action involving external quality control testing.
16 Risk Assessment Conduct RA Identify where along the testing process risk/errors might occur. Determine the frequency of the error and the potential impact if an error would occur. Must include pre-analytical, analytical, and post-analytical areas of laboratory testing. Must include the 5 Risk Assessment Components (CMS): 1. Specimen 2. Testing Personnel 3. Reagent 4. Environment 5. Test System
17
18 Risk Evaluation For Severity of harm to the patient: Negligible: Inconvenience or temporary discomfort Minor: Temporary injury; not requiring medical intervention Serious: Impairment/injury requiring medical intervention Critical: Permanent impairment or life-threatening injury Catastrophic: results in patient death For Frequency of occurrence: Frequent: once per week Probable: once per month Occasional: once per year Remote: once every few years Improbable: once in the life of the system All risks need to have control measures in place.
19 Risk Assessment Conduct RA Identify where along the testing process risk/errors might occur. Determine the frequency of the error and the potential impact if an error would occur. Must include pre-analytical, analytical, and post-analytical areas of laboratory testing. Must include the 5 Risk Assessment Components (CMS): 1. Specimen 2. Testing Personnel 3. Reagent 4. Environment 5. Test System
20
21
22 Example Clostridium difficile EIA assay I. Risk assessment (RA) of the System II. Quality Control Plan (QCP) for the System III. Quality Assessment (QA) for the System
23 Quality Control Plan (QCP) Identify Measures to Control/Reduce Risk Build tables to include all of the risks identified in your risk assessment. Determine the frequency and impact for each risk identified. Indicate the measures you have in place to reduce/control these risks/errors. Include where to find these measures in your procedures, reports, logs, etc. Must also include: QC Testing frequency, amount, type Criteria for QC acceptability At least as stringent as the manufacturer s instructions May also include electronic QC, procedural QC, training, competency assessment, etc.
24
25
26 1$$$Specimen$X$$$PreXAnalytical$ 1$ SPECIMEN FREQUENCY$OF$ OCCURRENCE$ SEVERITY$OF$$ HARM$ MEASURES$TO$$ CONTROL$/REDUCE$RISK$ RELEVANT$ SOP$ PreviousTesting Within7Days Frequent Negligible Repeattestingiscontraindicated; Thistestisnotatestof cure; Specimensarerejectedwith documentationrecordedafter physician/designeenotification. Followtestingprotocol andguidelinesinprocedure Clostridium+difficileEIA TestProcedure BacteriologyTestManua SpecimenRejectionLog ProblemLogBook Unacceptable/Suboptima SpecimenProcedure LabGeneralP&IManua Collection/ Container Frequent Negligible Minor Specimensimproperlycollectedin preservativeswillcause invalidtestresults. Specimensreceivedthatarein preservatives(formalinorpva)are rejectedwithdocumentationrecorded afterphysician/designeenotification. Followtestingprotocol andguidelinesinprocedureand AlerePackageInsert(PI) Clostridium+difficileEIA TestProcedure BacteriologyTestManual AlerePI C.+Diff+Quik ChekComplete BacteriologyPIBook Unacceptable/Suboptimal SpecimenProcedure LabGeneralP&IManual SpecimenRejectionLog Specimen Transport Frequent Negligible Minor Specimensreceivedthataretooold willcauseinvalidtestresults. Specimensreceivedthatareover24 hoursoldarerejectedwith documentationrecordedafter physician/designeenotification. Followtestingprotocol andguidelinesinprocedureandpi Clostridium+difficileEIATest Procedure BacteriologyTestManual AlerePI C.+Diff+Quik ChekComplete BacteriologyPIBook Unacceptable/Suboptimal SpecimenProcedure LabGeneralP&IManual SpecimenRejectionLog
27
28
29
30 2$$$Testing$Personnel$X$$$Analytical$ 2$$$TESTING$ PERSONNEL FREQUENCY$OF$ OCCURRENCE$ SEVERITY$OF$$ HARM$ MEASURES$TO$$ CONTROL$/REDUCE$RISK$ RELEVANT$ SOP$ Personnel Qualifications Remote Minor Serious Onlylicensedandcertifiedstaffare hiredforpatienttestingandallowed toperformmoderatetohigh complexitytestsperclia. UHJobDescriptions UHHumanResources NewEmployee Orientation StaffingPolicy LabGeneralP&IManua Training Remote Minor Serious Newoperatorsaretrainedand deemedcompetentbefore beingreleasedtoperform andreportpatienttesting. Annuallyalloperatorsmustcomplete acompetencyassessmenttocontinue totestandreportpatientspecimens. SOPandPIareavailable atalltimestostaff. Operatorstestproficiencytesting samplesonarotationalbasis. CompetencyAssessment AdministrativeandSafety ProceduresManual Clostridium+difficile EIATestProcedure BacteriologyTestManual AlerePI C.+Diff+Quik ChekComplete BacteriologyPIBook CAPProficiencyTesting MicroPTBook CompetencyAssessment Guidelines LabGeneralP&IManual ColorVisionRecords CompetencyBook
31 2$$$TESTING$ PERSONNEL FREQUENCY$OF$ OCCURRENCE$ SEVERITY$OF$$ HARM$ MEASURES$TO$$ CONTROL$/REDUCE$RISK$ RELEVANT$ SOP$ Personnel Errors Probable Minor Serious Allerrorsareproperlydocumented withphysician/designee notificationpersop. Allpersonnelerrorsare distributedweeklybythelis departmentandreviewed withstaffanddocumented. CorrectiveActionReport QualityAssessmentPlan AdministrativeandSafety ProceduresManual SeparateandDistribute CorrectedResultsLog LISClerical ProcedureManual PolicyforCorrectedor ErroneousResults LISPolicyand InformationManual CorrectedResultsLog Competency Probable Minor Serious Annuallyalloperatorsmustcomplete acompetencyassessmenttocontinue totestandreportpatientspecimens Operatorstestproficiencytesting samplesonarotationalbasis. CompetencyAssessment AdministrativeandSafety ProceduresManual CompetencyBook CAPProficiencyTesting MicroPTBook
32 2$$$TESTING$ FREQUENCY$OF$ PERSONNEL OCCURRENCE$ SEVERITY$OF$$ HARM$ QualityControl Remote Minor Serious Proficiency Testing Remote Negligible MEASURES$TO$$ CONTROL$/REDUCE$RISK$ Eachtestdevicehasabuiltin proceduralinternal controlthatis recordedwitheachtestrun. Notestresultsarereported outwithoutverifyingthat theinternalcontrolisvalid. InvalidinternalQCtestsarerepeated andasupervisorisnotified DocumentedinternalQCtest resultsandexternaltesting QCare monitoredweeklyandmonthly. Newlotsandshipmentsaretested withexternalcontrolstoverify accuracybeforebeingused toreportoutpatientresults. Operatorstestproficiencytesting samplesonarotationalbasis. Allstaffreadandsignoff onptsamplecritiques. RELEVANT$ SOP$ Clostridium+difficile EIATestProcedure BacteriologyTestManua AlerePI C.+Diff+Quik ChekComplete BacteriologyPIBook QualityControl Procedure QualityAssurance ProceduresManual C.+difficileQCBook MicroPTPolicy CAPProficiencyTesting MicroPTBook
33
34
35
36 3$$$REAGENT$ FREQUENCY$OF$ INTEGRITY OCCURRENCE$ 3$$$Reagent$ $Analytical$ SEVERITY$OF$$ HARM$ Storage Remote Serious ExpirationDate Remote Serious MEASURES$TO$$ CONTROL$/REDUCE$RISK$ Kitsarestoredatthespecified temperatureaccordingtothe manufacturer sprecautions inthepackageinsert. Stafftrainedtostoresuppliesatthe properstoragetemperature Refrigeratortemperaturemonitored anddocumentedondailylog. Expirationdatesofallsupplies receivedarerecordeduponreceipt inordertopreventanexpired kitbeingputintoinventory. Stafftrainedtocheckkitandreagent expirationdatebeforeuse. Theexpirationdateisdocumented witheachtestruninordertoprevent incorrectresultsbeingreported. Staffbiweeklychecks expirationdateofallsupplies. RELEVANT$ SOP$ Clostridium+difficile EIATestProcedure BacteriologyTestManua AlerePI C.+Diff+Quik ChekComplete BacteriologyPIBook QualityControl Procedure QualityAssurance ProceduresManual TemperatureLogBook Clostridium+difficile EIATestProcedure BacteriologyTestManual AlerePI C.+Diff+Quik ChekComplete BacteriologyPIBook Schedulefor QualityControl QualityControlProcedure QualityAssurance ProceduresManual BiweeklyInventoryBook CompetencyAssessment AdministrativeandSafety ProceduresManual CompetencyBook
37
38
39
40
41
42 5$$$$$$$$TEST$ SYSTEM FREQUENCY$OF$ OCCURRENCE$ SEVERITY$OF$$ HARM$ MEASURES$TO$$ CONTROL$/REDUCE$RISK$ RELEVANT$ SOP$ Internal procedural control Improbable Minor Serious Testdeviceshaveabuiltininternal controlthatconfirmsthatthesample andreagentswereaddedcorrectly, thatthereagentswereactiveatthe timeofperformingtheassay,andthat thesamplemigratedproperlythrough themembranedevice. Italso confirmsthereactivityoftheother reagentsassociatedwiththeassay. Builtincontrolareaandlinewill detectreagentdeterioration Weeklypos/negexternalQCcontrols checkforkitreagentreactivity Kitsarenotusedpasttheexpiration dateofthekitand/orreagents Lotandexpirationdatesarerecorded witheachtestrun. Stafftrainedtocheckkitandreagent expirationdatesbeforeuse. Clostridium+difficile EIATestProcedure BacteriologyTestManual AlerePI C.+Diff+Quik ChekComplete BacteriologyPIBook C.+difficileQCBook BiweeklyInventoryLog CompetencyAssessment AdministrativeandSafety ProceduresManual CompetencyBook
43
44 6$$$$$$$$TEST$ RESULT FREQUENCY$OF$ OCCURRENCE$ SEVERITY$OF$$ HARM$ MEASURES$TO$$ CONTROL$/REDUCE$RISK$ RELEVANT$ SOP$ DataEntryintoLIS Probable Minor Serious Staffaretrainedtorecordresultsinto thedirectexamlogbookas wellasinthelis. Resultsarerecordedinorderto reduceclericalerrorswhilemanually enteringresultsintothelis. Resultsareinterpretedperthe manufacturer s packageinsert andthetestprocedure. Dataentryerrorsarecorrectedper policywithphysician/designee notificationdocumented. Allpersonnelerrorsare distributedweeklybythelis departmentandreviewed withstaffanddocumented. Clostridium+difficile EIATestProcedure BacteriologyTestManua AlerePI C.+Diff+Quik ChekComplete BacteriologyPIBook CompetencyAssessment CorrectiveActionReport QualityAssessmentPlan AdministrativeandSafety ProceduresManual SeparateandDistribute CorrectedResultsLog LISClerical ProcedureManual PolicyforCorrectedor ErroneousResults LISPolicyand InformationManual DirectExamBook CompetencyBook CorrectedResultsLog
45 6$$$$$$$$TEST$ RESULT FREQUENCY$OF$ OCCURRENCE$ SEVERITY$OF$$ HARM$ MEASURES$TO$$ CONTROL$/REDUCE$RISK$ RELEVANT$ SOP$ CriticalValue Reporting Probable Minor Serious Staffaretrainedtonotifythe physician/designeeonall positivetestresults. Staffaretrainedtonotify InfectionControlonallinpatient positivetestresults. Allphonenotificationsarehighlighted toprintoutonthelab sdaily criticalvaluereport CompetencyAssessment Contactand NotificationGuides AdministrativeandSafety ProceduresManual SignificantFindingsBook Clinician Complaints Occasional Serious Allcliniciancomplaints/concernsare investigatedandfollowedupon regardingdelayedresults,testing errors,andtestingprotocols Newriskswillbeincorporatedinto QCPplanasappropriate QualityAssessmentPlan AdministrativeandSafety ProceduresManual ComplaintForm MicroFormsManual $ $
46 Based on our: Risk Assessment Quality Control Program Overall Laboratory Quality Assessment program The QCP for our C. difficile EIA System will consist of adhering to the instructions in the C. difficile EIA SOP and recording results in the C. difficile QC Log Book QC will consist of: Testing the internal procedural control on each run. Testing positive and negative external controls on each new lot or shipment (based on review of historical QC data). QC Acceptability Criteria is defined in SOP Quality Control Procedure located in the Quality Assurance Procedures Manual found online on the MCN Healthcare website lsuhsc.ellucid.com.
47 Example Clostridium difficile EIA assay I. Risk assessment (RA) of the System II. Quality Control Plan (QCP) for the System III. Quality Assessment (QA) for the System
48 Quality Assessment Develop a Post-Implementation Monitoring Process that will allow you to know when a process is in need of review/revision. These may include the periodic review and monitoring of the following (not limited to these): Specimen collection/transportation, etc. protocols Staff training Competency assessment Proficiency testing Quality Control/Instrument function results Unexpected Errors Laboratory error investigation/remediation Complaint investigation/remediation Pre-analytical Analytical Post-analytical
49
50
51 Clinical Microbiology Portal Engaging, enlightening, empowering our clinical community The only comprehensive online resource for clinical microbiologists.
Developing an Individualized Quality Control Plan (IQCP) For Cepheid s GeneXpert Diagnostic Systems
Developing an Individualized Quality Control Plan (IQCP) For BACKGROUND On January 1, 2014, the Center for Medicare and Medicaid Services (CMS) adopted an alternative Quality Control (QC) procedure that
More informationIQCP for Streamlined ID QC of Vitek 2
IQCP for Streamlined ID QC of Vitek 2 Facility: EXAMPLE Test System: Vitek 2 Commercial Identification System Test System Primary SOPs include: GENERAL PROCEDURES: Quality Control for AST Cards and Identification
More informationIQCP : Where Do I Start? Developing a Successful IQCP: Let s Keep it Simple. Objectives 7/4/2015
Developing a Successful IQCP: Let s Keep it Simple Elia Mears, MHA MT(ASCP)SM Field Surveyor The Joint Commission Stacy Olea, MBA, MT(ASCP), FACHE Executive Director Laboratory Accreditation The Joint
More informationIndividualized Quality Control Plan IQCP It s not a 4 letter word
Individualized Quality Control Plan IQCP It s not a 4 letter word Yvette S. McCarter, PhD, D(ABMM) Director, Clinical Microbiology Laboratory UF Health Jacksonville Professor of Pathology University of
More informationDeveloping QC Plans Part 3. Performing a Risk Assessment to Identify Hazards and Target Failure Modes
Webinar Series sponsored by Thermo Fisher Scientific Developing QC Plans Part 3. Performing a Risk Assessment to Identify Hazards and Target Failure Modes James O. Westgard Sten A. Westgard Westgard QC,
More informationIQCP for Commercial Antimicrobial Susceptibility Testing (AST) System XYZ
Please note that some references to protocol, publications, performance data etc. are fictitious in this EXAMPLE. Please use your own DATA for your IQCP. The following represents one example of how you
More information9/2/15 (replaces 5/31/15 version) Page 1
Please note that some references to protocol, publications, performance data etc. are fictitious in this EXAMPLE. Please use your own DATA for your IQCP. The following represents one example of how you
More informationAngelia Dooley, MT, BS CRI Educational Surveyor. Terri Wolek, MBA, MT(ASCP) Bio-Rad Laboratories Senior Sales Product Manager
Friday April 7, 2017 E46 IQCP in 2017: How s it Going? Angelia Dooley, MT, BS CRI Educational Surveyor Terri Wolek, MBA, MT(ASCP) Bio-Rad Laboratories Senior Sales Product Manager DESCRIPTION: Come to
More informationExample # 2. IQCP for Antimicrobial Susceptibility Testing (AST) Test System: Beckman Coulter Microscan Walkaway 96. Facility: Written by: Date:
IQCP for Antimicrobial Susceptibility Testing (AST) Test System: Beckman Coulter Microscan Walkaway 96 Facility: Written by: Date: Implementation Date: This risk assessment and IQCP plan has been approved
More informationQUALITY CONTROL FOR AST: IQCP? Romney Humphries UCLA
QUALITY CONTROL FOR AST: IQCP? Romney Humphries UCLA WHAT IS QUALITY CONTROL? Procedures used to detect errors that occur due to: test system failure adverse environmental conditions variance in operator
More informationIQCP for Commercially Prepared CLSI-Exempt Media
Please note that some references to protocol, publications, performance data etc. are fictitious in this EXAMPLE. Please use your own DATA for your IQCP. The following represents one example of how you
More informationMarcia L. Zucker, Ph.D. ZIVD LLC
Marcia L. Zucker, Ph.D. ZIVD LLC 1 Two levels of liquid QC available from manufacturers Haphazard implementation 1990 s - POCT awareness increased Increased implementation of QC programs Expense of POCT
More information2015 Focus on Compliance What You Really Need to Know About the Individualized Quality Control Plan (IQCP) and Ensuring Your Laboratory s Compliance
The Individualized Quality Control Plan (IQCP): what you need to know to ensure compliance Deborah Perry, M.D. Objectives Describe changes to the quality control regulations Explain how the CAP has implemented
More information9/8/2014. Answers to All Your IQCP Questions. The History Lesson. Some repeat/review. Let s talk IQCPs. Disclaimers
Disclaimers I work for Alere Answers to All Your IQCP Questions Thomas Koshy, Ph.D. Sr. Director, Scientific Affairs Alere produces testing devices for use at the POC so I have more data on the testing
More informationDevelopment of an Individualized Quality Control Plan (IQCP) for MGIT Pyrazinamide (PZA) Drug Susceptibility Testing (DST)
Development of an Individualized Quality Control Plan (IQCP) for MGIT Pyrazinamide (PZA) Drug Susceptibility Testing (DST) Denise Hartline, BS, MT (ASCP) June 9, 2015 National Center for HIV/AIDS, Viral
More informationIQCP for Disk Diffusion Antimicrobial Susceptibility Testing (AST)
IQCP for Disk Diffusion Antimicrobial Susceptibility Testing (AST) Test System: Disk Diffusion Antimicrobial Susceptibility Testing (Kirby Bauer) / Twelve Disk Diffusion Test using BBL Disks Facility:
More informationIQCP Inspector Training Scenarios
Scenario 1: You are reviewing the product insert for a non-waived point of care blood gas analyzer that uses a cartridge for each patient sample to provide ph, po2 and pco2 results. The manufacturer s
More informationThe ABCs of IQCP 3/20/2017. Williamsport. UPMC Susquehanna. Katheryn Inglis, MS, MT(ASCP) B102: 3/27/2017
The ABCs of IQCP Katheryn Inglis, MS, MT(ASCP) B02: 3/27/207 Williamsport UPMC Susquehanna Located in Williamsport, Pennsylvania Home of Little League World Series Located in central Pennsylvania, UPMC
More information'How-To' Implement an Effective Proactive Risk Management Strategy
'How-To' Implement an Effective Proactive Management Strategy Sedef YENICE Satellite Educational Workshop on Intelligent Clinical Laboratory Management: Impacts on Quality System Improvement Hilton Durban
More informationLaboratory Quality Control Based on Risk Management
Laboratory Quality Control Based on Risk Management James H. Nichols, Ph.D., DABCC, FACB Professor of Pathology Tufts University School of Medicine Medical Director, Clinical Chemistry Baystate Health
More informationUrinalysis and Body Fluids CRg. Laboratory Regulation. Laboratory Regulation for Quality Assessment. Unit 1 B. Quality Assessment
Urinalysis and Body Fluids CRg Unit 1 B Laboratory Regulation Federal Regulations / Regulatory Organizations Laboratory structure / operation Quality test performed by qualified personnel to obtain quality
More informationIQCP for the Akers Bio PIFA Heparin Platelet Factor 4 Rapid Assay
On December 31, 2015 the ability to use Equivalent Quality Control (EQC) policies will expire. Laboratories will be required to either follow the quality control regulations as outlined in CLIA 88 or develop
More informationCAP Regulatory Potpourri for Microbiologists. Christi Wojewoda, MD Director of Clinical Microbiology 2/2/19
CAP Regulatory Potpourri for Microbiologists Christi Wojewoda, MD Director of Clinical Microbiology 2/2/19 Disclosures Vice Chair of the CAP Microbiology Committee Immediate Past Vice Chair of the CAP
More informationRisk Management in IVD Producer Relation between manufacturer and user. S.M.Boutorabi DCLS, PhD
Risk Management in IVD Producer Relation between manufacturer and user S.M.Boutorabi DCLS, PhD IVD Manufacturer Requirements International Standard ISO 13485-2016 Medical Devices Quality Management Systems
More informationIQCP for the Akers Bio PIFA PlussPF4 Rapid Assay
On December 31, 2015 the ability to use Equivalent Quality Control (EQC) policies will expire. Laboratories will be required to either follow the quality control regulations as outlined in CLIA 88 or develop
More informationA2LA. R231 Specific Requirements: Threat Agent Testing Laboratory Accreditation Program. December 6, 2017
Laboratory Page 1 of 17 Laboratory December 6, 2017 2017 by A2LA All rights reserved. No part of this document may be reproduced in any form or by any means without the prior written permission of A2LA.
More informationIndividualized Quality Control Plan IQCP Examples
Individualized Quality Control Plan IQCP Examples Susan E. Sharp, Ph.D., ABMM, FAAM Director, Airport Way Regional Laboratory Director, Regional Microbiology and Molecular Infectious Diseases Laboratories
More informationEvolving Clinical Laboratory Management Through Implementation of a Risk Assessment Plan
1 Evolving Clinical Laboratory Management Through Implementation of a Risk Assessment Plan SEDEF YENICE Session: Laboratory Management analytica conference 2016 May 10-12, 2016, Munich 2 Objectives Review
More informationLaboratory Accreditation Test Validation: A Brave New World for Anatomic Pathology
Laboratory Accreditation Test Validation: A Brave New World for Anatomic Pathology Francis E. Sharkey, MD, FCAP University of Texas Health Science Center, San Antonio, TX Richard W. Brown, MD, FCAP Memorial
More informationPlease consult the Product Package Insert before running the test
Please consult the Product Package Insert before running the test Sample Collection, Preparation, Storage and Volume Q. What type of blood sample should be used with the PIFA Heparin/PF4 Rapid Assay? A.
More informationQUALITY CONTROL/QUALITY ASSURANCE IN THE MOLECULAR MICROBIOLOGY LABORATORY
QUALITY CONTROL/QUALITY ASSURANCE IN THE MOLECULAR MICROBIOLOGY LABORATORY Richard L. Hodinka, Ph.D. University of South Carolina School of Medicine Greenville Greenville Health System, Greenville, SC
More information1/23/ CLIA CMS 2004 brochure on how to complete the initial performance verification. p.2
Disclaimers I work for Alere and Alere produces testing devices for use at the POC so I have more data on the testing areas my company covers. The handouts. The Point of Care Quality Control Debate Thomas
More informationPlan Subject Index Number Section Subsection Category Contact Last Revised References Applicable To Detail PRINCIPLE:
Subject Quality Assurance for Laboratory Testing Index Number Lab-0135 Section Laboratory Subsection Laboratory - General Category Departmental Contact Nancy Ekern Last Revised 7/27/2017 References Required
More informationSusan D. Munro, CLS, MT(ASCP) CAPHLD Annual Institute 2016
Susan D. Munro, CLS, MT(ASCP) smclinmicro@gmail.com CAPHLD Annual Institute 2016 1 What is an IQCP? Individualized Quality Control Plan Why and when is an IQCP required? How to perform a risk assessment
More informationMinistry of Health. Republic of. Central/National Public Health Reference Laboratory. Section: General
Ministry of Health Commented [M1]: Logo above Republic of Central/National Public Health Reference Laboratory Commented [M2]: Example Section: General Procedure of creation, review and approval of standard
More informationDRAFT MEDICAL DEVICE GUIDANCE DOCUMENT
November 2015 DRAFT DRAFT MEDICAL DEVICE GUIDANCE DOCUMENT REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES Medical Device Authority MINISTRY OF HEALTH MALAYSIA Contents Page Preface... iii 1 Introduction.
More information"IQCP for POCT in the Analytic Stage: Decentralized Testing Specific Risk Management and Mitigation"
"IQCP for POCT in the Analytic Stage: Decentralized Testing Specific Risk Management and Mitigation" Prof. Maria Stevens Hardy, IMA (ASCP), AHI & CLC (AMT) President & CEO Medical, Laboratory & Technology
More informationQUALITY CONTROL & STANDARD OPERATING PROCEDURES EHI JAMES OCHEIKWU.
QUALITY CONTROL & STANDARD OPERATING PROCEDURES EHI JAMES OCHEIKWU. OUTLINE Introduction Quality Control - Meaning Types of Quality Control Monitoring of Quality Control Multi-rule Quality Control Quality
More informationDisclosures. Laboratory Stakeholders. IVD vs. LDT. FDA Regulation of Laboratory Developed Tests 10/2/2015. FDA Regulation of LDTs
Disclosures FDA Regulation of Laboratory Developed Tests Beaumont Health System, 24 th Annual Symposium on Molecular Pathology September 16, 2015 Roger D. Klein, MD JD Director, Molecular Pathology Clinical
More informationCommon Deficiencies
Question text Deficiency #12: Does the laboratory have a documented system to ensure consistency of morphologic observations among all personnel performing (U/A, Micro, Hem) (sample) Suggested methods
More informationProducts & Services. Catalog
Products & Services Catalog TLC Products & Services Laboratory Start-Up: Manual Templates and Teleconference Training Laboratory Start-Up: Customized Manuals and Onsite Training Laboratory Manual Templates
More informationIndividualized Quality Control Plan King Faisal Specialist Hospital Experience. Dr. Dr. Huda Hassan, PhD
Individualized Quality Control Plan King Faisal Specialist Hospital Experience Dr. Dr. Huda Hassan, PhD Associate Associate Clinical Clinical Scientist, Scientist, Toxicology Toxicology Department Department
More informationMEDICAL DEVICE GUIDANCE DOCUMENT REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES
November 2018 Third Edition MEDICAL DEVICE GUIDANCE DOCUMENT REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES Medical Device Authority MINISTRY OF HEALTH MALAYSIA Contents Page Preface.... iii 1 Introduction....
More informationLabGuide 13 How to Verify Performance Specifications
1 LG 13 Comments? Feedback? Questions? Email us at info@cola.org or call us at 800 981-9883 LabGuide 13 How to Verify Performance Specifications The verification of performance specifications confirms
More informationProficiency Testing Turning Pitfalls into Positive Outcomes
Proficiency Testing Turning Pitfalls into Positive Outcomes Presented by: Margaret Blaetz, CLC, MLT(AMT), CCCP(AAPOL) CEO/Technical Consultant East Coast Clinical Consultants, LLC National Manager of Laboratory
More informationCLIA Personnel & Competency Requirements
Friday April 7, 2017 D32 CLIA Personnel & Competency Requirements John T. Daly, MD, FCAP Chief Medical Officer, COLA DESCRIPTION: In addition to the laboratory director, the CLIA regulations specify personnel
More informationLucia M. Berte Laboratories Made Better! P.C. Broomfield, Colorado, USA
Raising the Bar on Lab Quality: Understanding the Lab Test Life Cycle, Its Role in Your Lab's Recurring Cost of Bad Quality, and Proven Steps to Boost Quality while Reducing Cost Lucia M. Berte Laboratories
More informationMolecular Diagnosis Challenges & Solutions. Using Molecular Kits or Laboratory Developed Tests (Home Brew), Emphasis on Validation
Using Molecular Kits or Laboratory Developed Tests (Home Brew), Emphasis on Validation Molecular Diagnosis Challenges & Solutions Behzad Poopak, DCLS PhD Tehran Medical Branch- Islamic Azad University
More informationHow to Choose the Right Equipment/Platforms for your Laboratory
How to Choose the Right Equipment/Platforms for your Laboratory (A Public Hospital Laboratory Perspective) Michelle J. Francis Overview Public Hospital Pressures / Challenges Commercial vs In-house assays
More informationScenario. Designing Test Menus for a Majority Population 8/13/2013. Your Faculty
Designing Test Menus for a Majority Population Your Faculty Ruth Cheng, MBA, MT(ASCP) Supervisor, Specimen Processing Area Department Of Pathology Penn State Hershey Medical Center, Hershey, PA Acknowledgements
More informationLeveraging ISO s Quality Management System to Achieve 24/7 Inspection Readiness. Randy Querry Accreditation Manager Clinical
Leveraging ISO 15189 s Quality Management System to Achieve 24/7 Inspection Readiness Randy Querry Accreditation Manager Clinical Goals Provide brief background on A2LA Differentiate between CLIA and ISO
More informationStrengthening Laboratory Management Toward Accreditation. Module 6: Quality Assurance
Strengthening Laboratory Management Toward Accreditation Module 6: Quality Assurance Key Message My lab assures accurate and reliable testing processes. Desired Outcome Consistently accurate and reliable
More informationEstablishing Quality Control Target Values and Standard Deviations for Hematology Instrumentation
Establishing Quality Control Target Values and Standard Deviations for Hematology Instrumentation For informational purposes only. WHO REQUIRES IT AND WHAT THEY REQUIRE Regulatory agencies require the
More informationThe Total Quality Management Program for HIV Clinical Trial Network Laboratories A Summary in Progress
Introduction The Total Quality Management Program for HIV Clinical Trial Network Laboratories A Summary in Progress The HIV Clinical Trials Network Laboratories (NL) continually improve the quality and
More informationUnassayed Heparin / PF4 Antibody Panel Frequently Asked Questions
Please Consult the Product Package Insert Prior to Use Intended Use Q. What is the Intended Use of the Unassayed Heparin/PF4 Antibody Panel? A. The Unassayed Heparin/PF4 Antibody Control Panels are intended
More informationCurrent Topics in NYS Clinical Laboratory Oversight
June 13, 2018 1 Current Topics in NYS Clinical Laboratory Oversight Derek Symula, Ph.D. and Stephanie Shulman, MPH, MS, MT (ASCP) June 13, 2018 2 (i) Clinical Laboratory Reference System (CLRS) to monitor,
More informationImplementation Guide. 3a. Skills Checklist. 3b. Competency Exam. 3c. Answer Key: Competency Exam. 3d. Competency Assessment Checklist
Implementation Guide TABLE OF CONTENTS SECTION 1 Introduction SECTION 2 Pre-Implementation Checklist SECTION 3 Introduction: Operator Training and Competency Certification 3a. Skills Checklist 3b. Competency
More informationLaboratory Quality Control Requirements Should be Based on Risk Management Principles
Received 7.11.05 Revisions Received 8.10.05 Accepted 8.11.05 Laboratory Quality Control Requirements Should be Based on Risk Management Principles Donald M. Powers, PhD (Powers Consulting Group, Pittsford,
More informationHeparin / PF4 Assayed Antibody Serum Panel Frequently Asked Questions
Please Consult the Product Package Insert Prior to Use Intended Use Q. What is the Intended Use of the Heparin/PF4 Antibody Panel? A. The Heparin/Platelet Factor 4 Antibody Serum Panel is an assayed control,
More informationConsultation: Competence Standards for Medical Laboratory Science Practitioners in New Zealand
Consultation: Competence Standards for Medical Laboratory Science Practitioners in New Zealand The Medical Sciences Council of New Zealand is responsible for setting the standards of competence for Medical
More informationMOLECULAR TESTING: VERIFYING/VALIDATING INSTRUMENTS, REAGENTS AND ASSAYS. Richard L. Hodinka, Ph.D.
MOLECULAR TESTING: VERIFYING/VALIDATING INSTRUMENTS, REAGENTS AND ASSAYS Richard L. Hodinka, Ph.D. University of South Carolina School of Medicine Greenville Greenville Health System, Greenville, SC hodinka@greenvillemed.sc.edu
More informationMedical Microbiology Laboratory. Quality Management for the. Roberta B. Carey, Ph.D., D(ABMM), CMQ/OE(ASQ)
Analysis. Answers. Action. www.aphl.org Quality Management for the Medical Microbiology Laboratory Roberta B. Carey, Ph.D., D(ABMM), CMQ/OE(ASQ) Director, Laboratory Quality Management Program Centers
More informationWHO post-market surveillance of in vitro diagnostics
WHO post-market surveillance of in vitro diagnostics Geneva, 27 November 2015 Anita Sands Prequalification Team World Health Organization About post-market surveillance of IVDs > Some quality, safety and
More informationSLMTA Management Framework Page 1
LABORATORY MANAGEMENT FRAMEWORK SLMTA Management Framework Page 1 JOB TASK LIST LEVEL I Distinguishing Characteristics: These people manage themselves at their sites, even though they may not have supervisor
More informationMedical Cannabis Laboratory Approval Program
Medical Cannabis Laboratory Approval Program APPLICATION PROCESS AND REQUIRED DOCUMENTATION The Medical Cannabis Laboratory Application consists of three-steps to thoroughly assess applying laboratories.
More informationby author POC Testing in Clinical Microbiology
POC Testing in Clinical Microbiology S. M. Poutanen MD MPH FRCPC Sinai Health System/University Health Network, University of Toronto, Toronto, Canada April 24, 2018 Advisory Board/Consultant Merck Research
More informationThe Illusion of Quality: A Discussion of Roadblocks to Laboratory Quality and Case Studies of How to Make Things Better
The Illusion of Quality: A Discussion of Roadblocks to Laboratory Quality and Case Studies of How to Make Things Better Frederick G. Strathmann, PhD 2015 IFL Quarterly Webinar Series ARUP Institute for
More informationNEW YORK STATE DEPARTMENT OF HEALTH CLINICAL LABORATORY EVALUATION PROGRAM. Crosswalk of Proposed Revision to General Systems Standards
Any General Systems Standards not addressed here remain in effect. (changes are underlined) CURRENT STANDARD CURRENT GUIDANCE PROPOSED STANDARD PROPOSED GUIDANCE Quality Management System Sustaining Standard
More informationQAM-Q-113 Responsibilities of the Laboratory Quality Assurance Officer
1.0 Applicability and Purpose This procedure applies to responsibilities of the Laboratory Quality Assurance Officer (LQAO) at the Texas Institute for Applied Environmental Research (TIAER), Tarleton State
More informationMeets Standards AFTER REVIEW ( 2.5 pts) Fail to meet the standard safety precautions, counseled one time
Morgan State University 2014 MDTC 411 CLINICAL CHEMISTRY AND URINALYSIS PRACTICUM SUGGESTED LABORATORY ROTATION SCORING RUBRIC Please attach the student s test record to this evaluation Clinical Chemistry
More informationVerification of Disk Diffusion Tests
Verification of Disk Diffusion Tests Objectives 1. Describe disk diffusion tests 2. Describe process of FDA clearance of susceptibility tests 3. Discuss CLIA requirements for laboratory verification of
More informationAnnex 13 WHO guidelines for preparing a laboratory information file
World Health Organization WHO Technical Report Series, No. 961, 2011 Annex 13 WHO guidelines for preparing a laboratory information file Background The WHO Expert Committee on Specifications for Pharmaceutical
More informationWhat is? An Overview of Operational Processes
Friday April 7, 2017 LD4 What is? An Overview of Operational Processes John T. Daly, MD, FCAP Chief Medical Officer, COLA DESCRIPTION: This session focuses on other important topics for the laboratory
More informationCLIA Update Judith Yost, M.A., M.T.(ASCP) Director Division of Laboratory Services CLIA
Update 2013 Judith Yost, M.A., M.T.(ASCP) Director Division of Laboratory Services Topics For Discussion CMS/ Laboratory Enrollment Data Enforcement Actions Summary Data Regulations Update PT Revisions
More informationIndividualized Quality Control Plan (IQCP) (Or How I Spent My Summer Vacation) Dave Warshauer, PhD., D(ABMM) Deputy Director, Communicable Diseases
Individualized Quality Control Plan (IQCP) (Or How I Spent My Summer Vacation) Dave Warshauer, PhD., D(ABMM) Deputy Director, Communicable Diseases A. I ve heard more than enough about IQCP. Let s go on
More informationBasic Good Laboratory Practice. Christopher Jerome, B.Vet.Med., Ph.D
Basic Good Laboratory Practice Christopher Jerome, B.Vet.Med., Ph.D Goals Outline the concept of Good Laboratory Practice (GLP) Provide some specific guidelines applicable to day to day work in the laboratory
More informationMEDICAL DEVICE GUIDANCE DOCUMENT REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES
January 2018 Second Edition MEDICAL DEVICE GUIDANCE DOCUMENT REQUIREMENTS FOR LABELLING OF MEDICAL DEVICES Medical Device Authority MINISTRY OF HEALTH MALAYSIA Contents Page Preface.... iii 1 Introduction....
More informationPrepared by Date Adopted Supersedes Procedure # Adapted from HPTN Policy. Review Date Revision Date Signature
APPENDIX IV: LABORATORY QUALITY CONTROL POLICY Prepared by Date Adopted Supersedes Procedure # Adapted from HPTN Policy N/A Review Date Revision Date Signature Distributed to # of Copies Distributed to
More informationReady, Set, Test! AACC Conference Mass Spectrometry in the Clinical Lab: Best Practice and Current Applications September 17-18, 2013 St.
Ready, Set, Test! Ross Molinaro, PhD, MLS(ASCP) CM, DABCC, FACB Medical Director, Clinical Laboratories Emory University Hospital Midtown Emory Clinical Translational Research Laboratory AACC Conference
More informationWAIT! Ready, Set, Test! Financial Disclosure. Research/Educational grants/consulting/salary support
Ready, Set, Test! Ross Molinaro, PhD, MLS(ASCP) CM, DABCC, FACB Medical Director, Clinical Laboratories Emory University Hospital Midtown Emory Clinical Translational Research Laboratory AACC Conference
More informationThe Joint Commission's Most Challenging Standards and What you Can Do to Maintain Compliance
The Joint Commission's Most Challenging Standards and What you Can Do to Maintain Compliance Stacy Olea, MT(ASCP), FACHE Executive Director, Laboratory Program September 6, 2016 Objectives Identify the
More informationS1725 Method Validation and Verification: Case Studies and Laboratory Challenges
S1725 Method Validation and Verification: Case Studies and Laboratory Challenges James H. Nichols, PhD, D(ABCC) Lauren N. Person, DO, MPH, FCAP Objectives Identify the difference between method validation
More informationQuality Assurance by Liz McChlery
Quality Assurance by Liz McChlery Define QA and Total Quality Management Describe Quality Control Define and distinguish Accuracy and Precision Define a Biological Reference Interval Describe ISO15189
More informationMeaningful Competency Assessment
Friday April 7, 2017 D33 Meaningful Competency Assessment Kathy Nucifora, MPH, MT(ASCP) COLA, Accreditation Division Director Irwin Rothenberg, MBA, MS, MLS(ASCP) Technical Writer and Quality Advisor COLA
More informationLaboratory Internal Audit Plan MAY 2017
Laboratory Internal Audit Plan MAY 2017 Acknowledgements The following APHL workgroup members contributed to this document: Charlene Thomas, BS, MT(ASCP), manager, microbiologist, Alabama Bureau of Clinical
More informationSoftware Recalls Issues and Challenges
ASQ: Meeting the Compliance Challenge Perspectives from Government, Industry and Quality Professionals: April 28, 2010 Software Recalls Issues and Challenges Jeme Wallace Director Regulatory Affairs GE
More informationOverview. Overview. 03:38 PM 11/17/2017 Page 1 of 5
Page 1 of 5 Overview Overview Inactive No Effective Date Date of Last Change 11/13/2017 04:44:01.822 PM Job Profile Name E22000 - Medical Technologist Job Code E22000 Include Job Code in Name No Job Profile
More informationIQCP ELIGIBILITY CROSSWALK TABLE
IQCP ELIGIBILITY CROSSWALK TABLE: The first column lists those CLIA regulations (general QC and specialty/subspecialty) that are eligible for IQCP based on federal requirements. The second column designates
More informationWhat is an LDT? The Do s s And Don ts of Validating Laboratory Developed Tests
The Do s s And Don ts of Validating Laboratory Developed Tests Deirdre Astin, MS, MT (ASCP) Lab Quality Confab 2011 November 2011 San Antonio Texas What is an LDT? Laboratory developed tests (LDTs) are
More informationMeasurement Uncertainty Guide. ISO Accreditation Program
Measurement Uncertainty Guide ISO 15189 Accreditation Program Background Why This is Necessary The ISO 15189:2012 standard contains enhanced expectations regarding measurement uncertainty (MU) in clause
More informationSAMPLE. Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline Second Edition
November 2009 Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline Second Edition This guideline describes risk management techniques that will aid in identifying,
More informationQuality Assurance / Quality Control (QA / QC)
Quality Assurance / Quality Control (QA / QC) DOCUMENTATION DOCUMENTATION Provides a complete history of any sample from initiation to project completion Includes all associated activities Documentation
More informationALIT. DevelopinganIQCP. AStep-by-StepGuide. U.S. Department of Health and Human Services
ALIT DevelopinganIQCP AStep-by-StepGuide U.S. Department of Health and Human Services INTRODUCTION OVERVIEW TheClinicalLaboratoryImprovementAmendments of 1988(CLIA) regulations require a laboratory to
More informationTechnical Guidance and Specifications
Technical Guidance and Specifications Deirde Healy and Robyn Meurant WHO PQ Team Diagnostics Assessment Joint UNICEF, UNFPA and WHO meeting with manufacturers and suppliers of in vitro diagnostics, vaccines,
More informationEffective Management and Operations of GXP Laboratories
Effective Management and Operations of GXP Laboratories Course Objective: Upon completion of this course, attendees involved in establishing and assuring that Good Laboratory / Good Manufacturing Practice
More informationBioresearch Monitoring Inspections in Vitro Diagnostics Devices
Seite 1 von 7 U.S. Food and Drug Administration Protecting and Promoting Your Health Bioresearch Monitoring Inspections in Vitro Diagnostics Devices TABLE OF CONTENTS Introduction Nature, Scope, & Purpose
More informationQuality Manual. Quality Manual. Vera Bioscience / Anu Life Sciences. April 2018
Quality Manual Vera Bioscience / Anu Life Sciences April 2018 Page 1 of 15 TABLE OF CONTENTS Quality Manual Page 1. Company Overview 3 2. References 3 3. Exemptions, Alternatives and Variances 3 4. General
More informationCommon Issues in Qualification and Validation of Analytical Procedures
Common Issues in Qualification and Validation of Analytical Procedures Alexey Khrenov, PhD OTAT/CBER/FDA CMC Strategy Forum January 29, 2018 - Washington, DC Disclaimer These comments are an informal communication
More information