July Kumalawati_Safety in POCT

Safety in POCT

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Safety in Point of Care TestingSafety in Point of Care Testing

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Point of Care TestingPoint of Care Testing

any analytical test performed for a patient any analytical test performed for a patient by a by a healthcare professional healthcare professional outside of outside of the the

conventional conventional laboratory settinglaboratory setting

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POCT devicesPOCT devices

•• urinalysis test strips used with or without a reader, urinalysis test strips used with or without a reader, •• blood glucose blood glucose metersmeters, , gg ,,•• blood blood gas analysers, gas analysers, •• electrolyte electrolyte analysers, analysers, •• myocardial myocardial marker (marker (troponintroponin‐‐T,T, troponintroponin‐‐II) ) analysersanalysers, , •• coagulation coagulation meters, meters, •• pregnancy pregnancy test devices, test devices, •• HbA1c HbA1c meters, meters, ,,•• testtest•• strips for drugs of abuse in urine, strips for drugs of abuse in urine, •• alcohol alcohol (ethanol) detection (ethanol) detection devicesdevices•• etcetc

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Policy on PointPolicy on Point‐‐ofof‐‐Care TestingCare Testing

to ensure that pointto ensure that point‐‐ofof‐‐care testing of care testing of patient patient samples samples is performed to acceptable analytical is performed to acceptable analytical and clinical standards of quality in a and clinical standards of quality in a safesafe and and

appropriate mannerappropriate manner

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Quality Error Rates in PointQuality Error Rates in Point‐‐ofof‐‐Care TestingCare Testing

O’Kane MJ, McManus P, McGowan N, Mark Lynch PL. Quality error rates in point‐of‐care testing. Clinical Chemistry 2011; 57 (9): 1267–1271

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Meier FA, Jones BA. Point‐of‐Care Testing Error. Sources and amplifiers, taxonomy, prevention strategies, and detection monitors. Arch Pathol Lab Med. 2005;129:1262–1267July Kumalawati

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SSources of POCT errorources of POCT error

•• operator incompetenceoperator incompetence

•• nonadherence to test proceduresnonadherence to test procedures•• nonadherence to test proceduresnonadherence to test procedures

•• use of uncontrolled reagents and equipmentuse of uncontrolled reagents and equipment

•• amplified byamplified by::–– incoherent regulationincoherent regulation

–– their likelihood of affecting patient care is amplified their likelihood of affecting patient care is amplified by the rapid availability of POCT results and by the rapid availability of POCT results and

–– the the results’ immediate therapeutic implicationsresults’ immediate therapeutic implications


Principles of POCT ImplementationPrinciples of POCT Implementation

•• POCT requests should be evaluated by the POCT requests should be evaluated by the POCT St i GPOCT St i GPOCT Steering Group POCT Steering Group

–– to ensure that clinical need and effectiveness are to ensure that clinical need and effectiveness are defined defined beforebefore a POCT service is introduced and a POCT service is introduced and that quality objectives are defined and that quality objectives are defined and subsequently evaluatedsubsequently evaluated

Guidelines for Safe and Effective Management and Use of Point of Care Testing. Academy of Medical Laboratory Science, Association of Clinical Biochemists in Ireland, Irish Medicines Board and RCPI Faculty of Pathology, November 28, 2007

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POCTPOCT h ld th ld t b id d h thb id d h th•• POCT POCT should not should not be considered when the be considered when the laboratorylaboratory can provide a result in can provide a result in a timely a timely mannermanner appropriate to the clinical conditionappropriate to the clinical condition


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•• Only IVDs that are Only IVDs that are approved by the POCT approved by the POCT Steering Group Steering Group should be used for POCTshould be used for POCT


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•• POCT Operational Team(s) POCT Operational Team(s) with relevant with relevant l h ld b i t d tl h ld b i t d tpersonnel should be appointed to personnel should be appointed to oversee oversee

the daythe day‐‐toto‐‐day operationday operation of POCT. of POCT.

•• Each Operational Team must be adequately Each Operational Team must be adequately resourced to enable them to implementresourced to enable them to implementresourced to enable them to implement, resourced to enable them to implement, monitor and audit the daymonitor and audit the day‐‐toto‐‐day POCT day POCT policypolicy Guidelines for Safe and Effective Management and Use of Point of Care Testing. Academy of

Medical Laboratory Science, Association of Clinical Biochemists in Ireland, Irish Medicines Board and RCPI Faculty of Pathology, November 28, 2007

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•• The The clinical laboratory clinical laboratory has an essential role in has an essential role in the the leadership and coleadership and co‐‐ordination ordination of POCTof POCT


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•• Standard operating procedures Standard operating procedures should be should be developed and implemented for POCT, in developed and implemented for POCT, in compliance with manufacturers’ instructions compliance with manufacturers’ instructions and relevant standardsand relevant standards


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•• Only Only trained fully competent trained fully competent staff may staff may yy y py p yyundertake POCTundertake POCT

•• POCT IVDs should be passwordPOCT IVDs should be password‐‐protected protected and only accessible by certified usersand only accessible by certified users


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•• Quality assuranceQuality assurance, both , both internalinternal and and externalexternal, is key to assuring the accuracy and , is key to assuring the accuracy and reliability of a POCT servicereliability of a POCT service


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•• ConnectivityConnectivity allows the central control and allows the central control and management of POCTmanagement of POCT analysersanalysers and facilitatesand facilitatesmanagement of POCT management of POCT analysersanalysers and facilitates and facilitates the exchange of information from a remote site the exchange of information from a remote site to the to the hospital information system and the hospital information system and the patient permanent recordpatient permanent record. .

•• Connectivity should be resourced to a levelConnectivity should be resourced to a levelConnectivity should be resourced to a level Connectivity should be resourced to a level which avails of the latest technology including which avails of the latest technology including electronic healthcare record electronic healthcare record and and unique patient unique patient IDID..


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•• All adverse incidents All adverse incidents that occur with POCT that occur with POCT IVDs IVDs should be reported should be reported to the designated to the designated hospital committee and the manufacturer, hospital committee and the manufacturer, as as appropriate.appropriate.


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Members of Members of PointPoint‐‐ofof‐‐Care Testing Care Testing Steering GroupSteering Group

•• A Laboratory ConsultantA Laboratory Consultant

•• A senior management representativeA senior management representative•• A senior management representativeA senior management representative

•• A senior scientist from participating laboratory disciplinesA senior scientist from participating laboratory disciplines

•• The Manager of each or all POCT Operational TeamsThe Manager of each or all POCT Operational Teams

•• Clinical Risk ManagerClinical Risk Manager

•• Senior Medical representatives from participating servicesSenior Medical representatives from participating services

•• Senior Nursing Representatives from participating servicesSenior Nursing Representatives from participating servicesg p p p gg p p p g

•• IT representativeIT representative

•• Risk ManagerRisk Manager


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Items evaluated by Items evaluated by POCT POCT Steering GroupSteering Group

(a) Clinical need;(a) Clinical need;(b) Suitability of proposed device for its intended purpose;(b) Suitability of proposed device for its intended purpose;( ) Cli i l ff i( ) Cli i l ff i(c) Clinical effectiveness;(c) Clinical effectiveness;(d) User training;(d) User training;(e) Quality assurance programme;(e) Quality assurance programme;(f) Maintenance programme;(f) Maintenance programme;(g) Compliance with safety and quality standards;(g) Compliance with safety and quality standards;(h) Compliance with data protection regulations;(h) Compliance with data protection regulations;((ii) Ad f d k i) Ad f d k i((ii) Adequacy of record keeping;) Adequacy of record keeping;(j) Evidence that what is proposed will be adequately funded (j) Evidence that what is proposed will be adequately funded

and supported;and supported;(k) Responsibility and accountability.(k) Responsibility and accountability.


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Training in a pointTraining in a point‐‐ofof‐‐care technique or devicecare technique or device

(a) The basic principles of the measurement;(a) The basic principles of the measurement;

(b) Demonstration of the proper use of the device in accordance (b) Demonstration of the proper use of the device in accordance with the with the manufacturer’s instructions;manufacturer’s instructions;;;

(c) Demonstration of the consequences of improper use;(c) Demonstration of the consequences of improper use;

(d) Instruction on sample collection including health and safety (d) Instruction on sample collection including health and safety aspects;aspects;

(e) Training in calibration and appropriate quality control (e) Training in calibration and appropriate quality control techniques;techniques;

(f) i h l d i f ll d(f) i h l d i f ll d(f) Instruction on the complete documentation of all data (f) Instruction on the complete documentation of all data produced;produced;

(g) Practical experience of the procedure, including the (g) Practical experience of the procedure, including the performance of a number of analyses that satisfy the performance of a number of analyses that satisfy the instructor of the trainee’s competence.instructor of the trainee’s competence.


July Kumalawati

Quality Assurance in PointQuality Assurance in Point‐‐ofof‐‐Care TestingCare Testing

(a) Correctly identifying the patient;(a) Correctly identifying the patient;

(b) Selecting the appropriate test;(b) Selecting the appropriate test;

(c) Obtaining a satisfactory sample;(c) Obtaining a satisfactory sample;

(d) Performing the test satisfactorily and (d) Performing the test satisfactorily and recording it correctly;recording it correctly;

(e) Interpreting the result correctly;(e) Interpreting the result correctly;

(f) Taking appropriate action.(f) Taking appropriate action.


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ConclusionConclusion

•• POCT needs similar management as core POCT needs similar management as core l b tl b tlaboratorylaboratory

•• The core laboratory has a very important role The core laboratory has a very important role in POCT managementin POCT management

•• Proper training and monitoring for personnel Proper training and monitoring for personnel involved in POCT is also importantinvolved in POCT is also important

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Documents

July Kumalawati_Safety in POCT