CHECKLIST FOR THE STEPWISE IMPROVEMENT PROCESS FOR .

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CHECKLIST FOR THE STEPWISE IMPROVEMENT PROCESS FOR STRENGTHENING LABORATORY QUALITY MANAGEMENT SYSTEMSINDICATING THE EQUIVALENCE WITH CLSI, QSE AND ISO 15189Index of CLSI QSE referred to in the checklistQSE 1QSE 2QSE 3QSE 4QSE 5QSE 6- Organization- Personnel- Equipment- Purchasing and Inventory- Process Control (Pre-Analytical, Analytical, Post-Analytical)- Documents and RecordsQSE 7QSE 8QSE 9QSE 10QSE 11QSE 12- Information Management- Occurrence Management- Assessment- Process Improvement- Customer Service and Satisfaction- Facilities and EnvironmentThe requirements given in the checklist are not the exact clauses given in the ISO 15189:2007, however the numbering used corresponds to the relevant sections of thestandard and the equivalent CLSI QSE (CLSI Guideline GP22-A2 - Continuous Quality Improvement - Integrating Five Key Quality System Components)MANAGEMENT REQUIREMENTS4.1 Organization and ManagementISO15189SectionRequirementWhat to look forCommentsTier 1Tier 2Tier 34.1.11Is the laboratory or the organization of whichthe laboratory is a part legally identifiable?Company registration, articles ofincorporation, license, other relevant legaldocumentationXXX4.1.21Is there a documented description of thelaboratory services that provides for patientcare and the needs of clinical personnel?Laboratory User Manual/GuideXXX4.1.3StatusQuality ImprovementCLSIQSERefer to 4.2.34.1.41Is there a written policy that addresses thedeclaration of conflicts of interest that couldinfluence the creditability of laboratoryactivities?Documented and approved policy onconflict of interestXXX4.1.5 (a)1Are lab personnel provided with theappropriate authority and resources to carryout their duties?Adequacy of staff, equipment andsupplies to perform the volume, scopeand quality of examinations requiredXXX4.1.5 (b)1Has laboratory management identified thepressures (both internal and external) that theirstaff may face and defined policies to helpremove or reduce the pressure?Documented and approved policies toprevent or reduce internal and externalpressures – e.g. conflict of interest,financial, commercialXXXYNN/A

CHECKLIST FOR THE STEPWISE IMPROVEMENT PROCESS FOR STRENGTHENING LABORATORY QUALITY MANAGEMENT SYSTEMSINDICATING THE EQUIVALENCE WITH CLSI, QSE AND ISO 15189CLSIQSE4.1.5 (c)1Have policies and procedures for ensuring theprotection of confidential information beendeveloped and implemented?4.1.5 (d)14.1.5 (e)RequirementWhat to look forCommentsTier 1Tier 2Tier 3Documented and approved policies andprocedures to ensure confidentiality ofinformationXXXAre there policies and procedures for avoidinginvolvement in any activities that woulddiminish confidence in the competence,impartiality, judgment or operational integrity ofthe laboratory?Policies and procedures to ensure themaintenance of integrity in conduct of theoperations of the laboratoryXXX1Has the organizational and managementstructure of the lab and its relationship to anyother associated organizations beendocumented?Documented management structure forthe laboratory – including its relationshipto other associated organizations (qualitymanual, organogram, serviceagreements)XXX4.1.5 (f)1Have the specified responsibilities, authoritiesand interrelationships of all personnel beendocumented?Documented organogram anddocumented job descriptions for allpersonnelXXX4.1.5 (g)1Is there adequate training of all staff andsupervision appropriate to their experienceand level of responsibility by competentpersons conversant with the purpose,procedures and assessment of results of therelevant examination procedures;Training and competency assessments forall staff and qualifications of supervisorystaffXXIs there technical management with overallresponsibility for technical operations andprovision of resources needed to ensurequality of laboratory procedures?Job descriptions and training records fortechnical management personnelXX4.1.5 (h)1StatusQuality ImprovementISO15189SectionREF 5.1.2REF 5.1.2XYNN/A

CHECKLIST FOR THE STEPWISE IMPROVEMENT PROCESS FOR STRENGTHENING LABORATORY QUALITY MANAGEMENT SYSTEMSINDICATING THE EQUIVALENCE WITH CLSI, QSE AND ISO 15189ISO15189Section4.1.5 (i)1StatusQuality ImprovementCLSIQSERequirementWhat to look forHas a quality manager been appointed anddelegated responsibility and authority forcompliance with the quality managementsystem?Individual with overall responsibility foroverseeing the quality managementsystem identifiedCommentsTier 1Tier 2Tier 3XXXXXXXYNN/AJob description and organogram4.1.5 (j)1Have deputies for all key functions beenappointed?Documented designation of who hasprimary and secondary responsibility forall key functions4.1.61Has laboratory management ensuredappropriate communication processes areestablished within the laboratory includingregarding the quality management system?Documentation of internal communicationprocesses including regarding the qualitymanagement system4.2 Quality Management ity ImprovementRequirementWhat to look forCommentsTier 1Have the documented policies, processes andprocedures been communicated to,understood and implemented by all relevantpersonnel? Documented policies, processes andproceduresDoes the quality management system includeinternal quality control and participation inorganized interlaboratory comparisons such asexternal quality assessment schemes? Internal quality control for all testsTier 2Tier 3X Evidence of communication of thisinformation to all staff and evidencethat laboratory management hasensured that all documents areunderstood and implemented EQA or interlaboratory comparisonprogrammes for all testsXXXXXYNN/A

CHECKLIST FOR THE STEPWISE IMPROVEMENT PROCESS FOR STRENGTHENING LABORATORY QUALITY MANAGEMENT SYSTEMSINDICATING THE EQUIVALENCE WITH CLSI, QSE AND ISO 15189ISO15189Section4.2.31StatusQuality ImprovementCLSIQSERequirementHave the policies and objectives of the qualitymanagement system been defined in a qualitypolicy statement and are they documented in aquality manual?Is the quality policy readily available toappropriate personnel?Does the quality policy include:a)the scope of service the laboratory intendsto provide;b)the laboratory management‘s statement ofthe laboratory‘s standard of servicec)the objectives of the quality managementsystemd)a requirement that all personnelconcerned with examination activitiesfamiliarize themselves with the qualitydocumentation and implement the policiesand procedures at all timese)the laboratory‘s commitment to goodprofessional practice, the quality of itsexaminations, and compliance with thequality management systemf)the laboratory management‘scommitment to compliance with thisInternational StandardsWhat to look for Quality policy statement documentedin a quality manual. Quality policy signed by appropriatepersonnel Quality ManualCommentsTier 1Tier 2Tier 3XXXYNN/A

CHECKLIST FOR THE STEPWISE IMPROVEMENT PROCESS FOR STRENGTHENING LABORATORY QUALITY MANAGEMENT SYSTEMSINDICATING THE EQUIVALENCE WITH CLSI, QSE AND ISO 15189ISO15189Section4.2.44.2.511StatusQuality ImprovementCLSIQSERequirementWhat to look for Does the quality manual describe thequality management system and structureof the documentation used, and include ormake reference to the supportingprocedures including technical procedures? Document hierarchy described in theQuality manual and supportingprocedures appropriately referenced Have the roles and responsibilities oftechnical management and the qualitymanager been defined in the qualitymanual? Roles and responsibilities ofmanagement and the quality managerreferenced in the Quality Manual Have all personnel been instructed on theuse and application of the quality manualand all referenced documents, and of therequirements for their implementation? Sign off sheet or information sessionrecords Is the quality manual up to date? Evidence of review and/or revision asrequired by document controlprocedureHas the laboratory established andimplemented programmes that regularlymonitor and demonstrate proper calibrationand function of Documented programme for preventivemaintenance and calibration available,which at minimum followsmanufacturer‘s recommendations- instruments? Calibration programme and records.- reagents? Preventive maintenance programmeand logs- analytical systems?CommentsTier 1Tier 2Tier 3XXXXXYNN/A

CHECKLIST FOR THE STEPWISE IMPROVEMENT PROCESS FOR STRENGTHENING LABORATORY QUALITY MANAGEMENT SYSTEMSINDICATING THE EQUIVALENCE WITH CLSI, QSE AND ISO 151894.3 Document ControlISO15189Section4.3.14.3.266StatusQuality ImprovementCLSIQSERequirementWhat to look forCommentsTier 1 Has the laboratory established andmaintained procedures to control alldocuments that form part of its qualitysystem? Documented procedures for thecontrol of all lab documents Are these controlled documents archivedfor a defined retention period? Archived copy of all controlleddocumentsAre procedures adopted to ensure that:a) documents issued to personnel reviewedand approved for use prior to issue?a) Laboratory‘s documents reviewed andapproved by authorized personnel priorto issueb) a master list or an equivalent documentcontrol procedure available to identify thecurrent revision status and distribution ofdocuments?b) Up-to-date document control log thatlists all the current valid revisions andlocation of documentsc) only current authorised versions ofappropriate documents are available at allrelevant locations?c) Current documents available at relevantlocationsd) documents are periodically reviewed,revised where necessary and approved byauthorised personnel?d) Records of periodic review, revisionand approval as necessary byauthorized personnele) invalid or obsolete documents are promptlyremoved from all points of use?e) Obsolete documents not onworkbenches and in manuals, dates ondocuments currentf) obsolete documents appropriately identifiedto prevent unintended use?f) Obsolete documents labelled as suchTier 2Tier 3XXXXYNN/A

CHECKLIST FOR THE STEPWISE IMPROVEMENT PROCESS FOR STRENGTHENING LABORATORY QUALITY MANAGEMENT SYSTEMSINDICATING THE EQUIVALENCE WITH CLSI, QSE AND ISO 15189ISO15189Section4.3.2CLSIQSE6Requirementg) If the laboratory‘s documentation controlsystem allows for the amendment ofdocuments by hand pending the re-issue ofthe documents:- Are the procedures and authorities for suchamendments defined?What to look forCommentsTier 1Tier 2Tier 3XXXg) Defined policies and procedures andauthorization for amending documentsby hand, if allowedAmendments clearly initialled and datedand a revised document re-issued in atimely manner- Are these amendments clearly marked,initialled, and dated?4.3.36StatusQuality Improvementh) Does the laboratory have procedures forhow changes in documents maintained incomputerised systems are made andcontrolled?h) Procedure for changes to computerizeddocumentsAre the quality system documents generatedby the laboratory uniquely identified with:Quality system documents uniquelyidentified in accordance with the statedcriteria- title, date of issue, revisionidentification/revision number, pagenumbering, the total number of pages or amark to signify the end of the document, theissuing authority(ies) and source identification?YNN/A

CHECKLIST FOR THE STEPWISE IMPROVEMENT PROCESS FOR STRENGTHENING LABORATORY QUALITY MANAGEMENT SYSTEMSINDICATING THE EQUIVALENCE WITH CLSI, QSE AND ISO 151894.4 Review of Requests and Service hat to look forWhere the laboratory enters into anagreement to provide medical laboratoryservices it shall have documentedprocedures for the establishment and reviewof such agreements.A policy and procedure established andmaintained for review of serviceagreements that includes a, b, c, d and eWhere the laboratory enters into anagreement to provide medical laboratoryservices the following shall take placea) The customers‘ and users‘ requirements,including the examination processes tobe used, shall be defined, documentedand understood.b) The laboratory shall have the capabilityand resources to meet the requirements.c) Laboratory personnel shall have the skillsand expertise necessary for theperformance of the intendedexaminations.d) Examination procedures selected shall beappropriate and able to meet therequirements and clinical needs.4CommentsTier 1Agreements to provide medical laboratoryservices shall take into account therequest—including any information neededby the laboratory to ensure appropriateexamination and result interpretation―theexamination, and the report.4.4.2StatusQuality ImprovementAre records of these service agreementreviews and any significant changesmaintained?Records of any service agreementreviews and changes agreedTier 2Tier 3XXYNN/A

CHECKLIST FOR THE STEPWISE IMPROVEMENT PROCESS FOR STRENGTHENING LABORATORY QUALITY MANAGEMENT SYSTEMSINDICATING THE EQUIVALENCE WITH CLSI, QSE AND ISO 15189ISO15189SectionCLSIQSEStatusQuality ImprovementRequirementWhat to look forCommentsTier 14.4.34Does the service agreement review cover anywork referred by the laboratory?Records of reviews conducted for workperformed by referral laboratories4.4.44Is the client (e.g. clinicians, health careproviders, health insurance companies)informed of any deviation from the serviceagreement that could impact clinicalindications or limitations of examinations?Laboratory communication with clients reany deviations from service agreements4.4.54If the service agreement needs to beamended after the work commences: Records of review for serviceagreements amended after workcommenced- is the same review process repeated?- are any amendments communicated to allaffected parties? Records of laboratory notification ofservice agreement amendments to allaffected partiesTier 2Tier 3XXYNN/A

CHECKLIST FOR THE STEPWISE IMPROVEMENT PROCESS FOR STRENGTHENING LABORATORY QUALITY MANAGEMENT SYSTEMSINDICATING THE EQUIVALENCE WITH CLSI, QSE AND ISO 151894.5 Review of Requests and Service re documented procedures available toevaluate and select- consultants who provide second opinions forhistopathology, cytology, and relateddisciplines?When referral laboratories or consultants areused, does laboratory management- have a procedure for monitoring the quality ofreferral laboratories and consultants?- ensure that the referral laboratory orconsultant is competent to perform therequested examinations?4What to look forCommentsTier 1- referral laboratories?4.5.2StatusQuality ImprovementAre arrangements with referral laboratoriesand consultants periodically reviewed toensure that:a) The requirements, including the preexamination and post-examinationprocedures are adequately defined,documented and understood?b) The referral laboratory‘s capability to meetthe requirements and that there are noconflicts of interest?c) Selection of examination procedures isappropriate for the intended use?d) The responsibilities for the interpretation ofexamination results are clearly defined?(Records of such reviews shall be maintainedin accordance with local, national or regionalrequirements) Procedures for evaluation andselection referral laboratories andconsultants who provide secondopinions for histology, cytology andrelated disciplinesTier 2Tier 3XXXX Procedures for monitoring the qualityand competence of referrallaboratories and consultants Competency assessment records forreferral laboratory (e.g. EQAperformance, accreditation status) andconsultantsRecords of reviews of referral laboratoriesand consultants that meet the listedcriteria a) to d)YNN/A

CHECKLIST FOR THE STEPWISE IMPROVEMENT PROCESS FOR STRENGTHENING LABORATORY QUALITY MANAGEMENT SYSTEMSINDICATING THE EQUIVALENCE WITH CLSI, QSE AND ISO 15189ISO15189Section4.5.3CLSIQSE4Requirement Does the laboratory maintainWhat to look for List of referral laboratoriesCommentsTier 1Tier 2Tier 3XXXXXX- a register of all referral laboratories?4.5.44StatusQuality Improvement- a register of all samples that have beenreferred to another laboratory? List of all samples referred to anotherlaboratory Are the names and address of the referrallaboratory given to the user? Copies of reports which includeinformation on name and address ofthe referral laboratory Is a duplicate laboratory report retained inboth the patient record and permanent fileof the laboratory? Copies of reports in both the patientrecord and the permanent file of thelaboratory Is the referring laboratory, and not thereferral laboratory, responsible to ensurethat examination results and findings areprovided to the person making the request? Procedure for return of results of testsdone by referral laboratory to therequesting provider Does the report have all the essentialelements of the results if it is reported by thereferral laboratory, without alterations thatcould affect any clinical interpretations? Copies of reports from referrallaboratory Copies of reports sent to requestingprovider by referring laboratorycontaining all essential elements of theresults reported by the referrallaboratory, without alterations thatcould affect clinical interpretationsYNN/A

CHECKLIST FOR THE STEPWISE IMPROVEMENT PROCESS FOR STRENGTHENING LABORATORY QUALITY MANAGEMENT SYSTEMSINDICATING THE EQUIVALENCE WITH CLSI, QSE AND ISO 151894.6 External Services and LSIStatusQuality ImprovementCLSIQSERequirementWhat to look forCommentsTier 1Tier 2Tier 3 Policies and procedures for theselection and purchase of key externalservices, equipment and suppliesX Do the purchased items consistently meetthe laboratory‘s quality requirements? Documented specifications foracceptance of purchased itemsX Procedures for inspection,acceptance/rejection and storage ofconsumable materials Does the laboratory havepolicies and procedure(s) for selection,purchasing of services, equipment, andconsumable supplies that affect the qualityof the tests and/or calibrations?Do procedures exist for theinspection, acceptance/rejection andstorage of consumable materials?Are purchased equipment/supplies/ reagents/consumable materials inspected forcompliance with standard specifications beforeuse?Records to verify that purchasedequipment, supplies and reagents areinspected for compliance withspecifications before use e.g. expirydates, shipping conditions, equipmentvalidation, etc. Is there an inventory control system for allsupplies? Records of inventory control systemthat include recording of lot numbers,date of receipt and date placed inservice Are records maintained for a specifiedperiod of time for external services,supplies and purchased products? Records maintained for periodspecified in quality manual Are these quality records reviewed duringthe management review? Records of review of inventory controlsystem during the management reviewe.g. management review minutesRequirementWhat to look forXXXXYNN/AXXXXQuality ImprovementStatusComments

CHECKLIST FOR THE STEPWISE IMPROVEMENT PROCESS FOR STRENGTHENING LABORATORY QUALITY MANAGEMENT SYSTEMSINDICATING THE EQUIVALENCE WITH CLSI, QSE AND ISO 15189Section4.6.4QSE4Tier 1 Does the laboratory evaluate suppliers ofcritical consumables and supplies andservices which affect the quality of testing? Records of evaluations ofsuppliers of critical consumables,supplies and services which affectquality of testing Does the lab maintain approved lists andrecords of evaluation? List of approved suppliersTier 2Tier 3YNN/AX4.7 Advisory ServicesISO15189Section4.74StatusQuality ImprovementCLSIQSERequirementTier 1Do appropriate laboratory professional staffprovide advice on choice of examination, useof services, repeat frequency, required type ofsample and interpretation of test results, whereappropriate?CommentsWhat to look for Documented evidence of meetingsand consultations between laboratorydirector and /or consultant/specialistswith clinical personnel Records of qualifications, training andcompetency assessment forlaboratory and associatedprofessional staffTier 2Tier 3YNN/AX4.8 Resolution of ComplaintsISO15189Section4.8CLSIQSE8StatusQuality ImprovementRequirementCommentsWhat to look forTier 1 Are policy and procedures available forresolution of complaints or other feedbackfrom laboratory users? Policy and procedure for theresolution of complaints or otherfeedback Are records of complaints, investigations andcorrective actions taken maintained by thelaboratory? Records of complaints, investigationsand corrective actionsTier 2Tier 3XXYNN/A

CHECKLIST FOR THE STEPWISE IMPROVEMENT PROCESS FOR STRENGTHENING LABORATORY QUALITY MANAGEMENT SYSTEMSINDICATING THE EQUIVALENCE WITH CLSI, QSE AND ISO 151894.9 Identification and Control of ementTier 1 Does the laboratory have a policy andprocedures to address situations when anyaspect of its examinations does not conformwith its own procedures or the agreed uponrequirements of its quality managementsystem or the requesting clinician.Tier 2Tier 3Policy and procedure for managing nonconformances that meet the criteriaoutlined in a) to h).XRecords of recurrent/potential recurrentnonconforming examinations and rootcause analysis and corrective actionsXa) Personnel responsible for corrective actionsare defined?b) Actions to be taken are defined?c) The medical significance of thenonconforming tests is considered andrequesting clinician informed whereappropriate?d) The examinations are halted and reportswithheld as necessary?e) Corrective actions and decisions are takenimmediately?f) Non-conforming test results andexaminations already released arerecalled?g) The responsibility for authorisation of theresumption of work is defined?h) Details of non-conformity events aredocumented and reviewed at regularspecified intervals to detect trends andinitiate preventive actions?8Is there evidence of prompt implementation ofprocedures to address a recurrent/potentialrecurrent nonconforming examination and toidentify, document and eliminate the rootcause(s)? (See 4.10)CommentsWhat to look for Do these ensure that :4.9.2StatusQuality ImprovementYNN/A

CHECKLIST FOR THE STEPWISE IMPROVEMENT PROCESS FOR STRENGTHENING LABORATORY QUALITY MANAGEMENT SYSTEMSINDICATING THE EQUIVALENCE WITH CLSI, QSE AND ISO 15189ISO15189Section4.9.38StatusQuality ImprovementCLSIQSERequirementTier 1Are procedures defined and implemented forthe release of results in the case ofnonconformities, including review of suchresults and are these recorded?CommentsWhat to look forTier 2Tier 3YNN/AX Procedures for release of results andfor notifying users of the service whena non-conformance is identified e.g.equipment malfunction Records of non-conformances andactions taken Record of review of results ofexaminations reported around the timeof the non-conformance4.10 Continual StatusQuality ImprovementCLSIQSERequirementTier 1 Do the procedures for corrective actionsinclude an investigation process todetermine underlying causes of theproblem? Do the findings, where appropriate, lead topreventive actions? Are corrective actions appropriate to themagnitude and the risk of the problem?CommentsWhat to look for Procedures for corrective actions thatinclude root cause analysisTier 2Tier 3XXXXXX Records of root cause analysis beingused to correct and prevent furthernon-conformancesDoes the management document andimplement any changes required to itsoperational procedures resulting fromcorrective action investigations? Documented changes in procedures asindicated by the corrective action androot cause analysis investigationsAre the results of corrective actions monitoredto ensure their effectiveness in overcoming theidentified problems?Records that assigned personnel arereviewing records of corrective actionsand monitoring the problem resolution Records of implementation of changesin proceduresYNN/A

CHECKLIST FOR THE STEPWISE IMPROVEMENT PROCESS FOR STRENGTHENING LABORATORY QUALITY MANAGEMENT SYSTEMSINDICATING THE EQUIVALENCE WITH CLSI, QSE AND ISO 15189ISO15189Section4.10.410StatusQuality ImprovementCLSIQSERequirementCommentsWhat to look forTier 1 Are the appropriate areas of activity auditedin accordance with 4.14 when there is adoubt(s) on the laboratory‘s compliance? Audit reports of laboratory areas wherenon-compliance with policies orprocedures is suspected Are the results for corrective actionssubmitted for laboratory managementreview? Records of review of corrective actionsduring management review e.g.meeting minutes, etc.Tier 2Tier 3XXYNN/A4.11 Corrective ActionISO15189Section4.11.1CLSIQSE10Requirement Are the needed improvements andpotential sources of non-conformancesidentified?10 Do procedures for preventive action includeinitiation of such actions? Are procedures for preventive actionseffective?CommentsWhat to look forTier 1 If preventive action is required, are actionplans developed, implemented andmonitored for effectiveness and to takeadvantage of the opportunities forimprovement?4.11.2StatusQuality Improvement Procedure by which staff actively lookfor potential sources of nonconformances and areas forimprovement Action plans for implementingpreventive action Records of monitoring of action planimplementationProcedures for preventive action includingresponsibility for initiation and monitoringof effectiveness of such actionsTier 2Tier 3YNN/A

CHECKLIST FOR THE STEPWISE IMPROVEMENT PROCESS FOR STRENGTHENING LABORATORY QUALITY MANAGEMENT SYSTEMSINDICATING THE EQUIVALENCE WITH CLSI, QSE AND ISO 151894.12 Preventive r 1 Are potential sources of non-conformancesor other opportunities for improvement inthe quality management system ortechnical practices identified through reviewat regular intervals, as defined by themanagement system? Documented systematic process andprocedure for reviewing the qualitymanagement system and operations toidentify opportunities for improvement If improvement is required, are action plansdeveloped, documented and implemented? Action plans to guide continuousimprovement as necessary4.12.210Is the effectiveness of the actions takenevaluated through a review or audit of the areaconcerned?Audit reports and/or records of review ofarea in which nonconformance has beenaddressed to determine if action takenhas been successful4.12.310Are the results of actions resulting from thereview submitted to management for reviewand implementation of any needed changes?Records of submission of reviews andimplementation of suggested actions4.12.410 Are quality indicators implemented tosystematically monitor and evaluate thelaboratory‘s contribution to patient care? List of quality indicators designatedand monitored for evaluating thelaboratory‘s contribution to patient caree.g. turnaround time, quality control,EQAS results, corrective actions,customer complaints When improvements are identified, arethese issues addressed regardless ofwhere they occur? Does laboratory management ensure thatthe laboratory participates in qualityimprovement activities that deal withrelevant areas and outcomes of patientcare?10Are suitable training opportunities for all labpersonnel and relevant users of the laboratoryprovided?CommentsWhat to look forTier 2Tier 3XXXX Records of implementation ofcontinuous improvement plans4.12.5StatusQuality Improvement Records of implementation ofimprovements identified Minutes of quality improvementmeetingsTraining plans and recordsYNN/A

CHECKLIST FOR THE STEPWISE IMPROVEMENT PROCESS FOR STRENGTHENING LABORATORY QUALITY MANAGEMENT SYSTEMSINDICATING THE EQUIVALENCE WITH CLSI, QSE AND ISO 151894.13 Quality and Technical RecordsISO15189SectionStatusQuality ImprovementCLSIQSERequirementCommentsWhat to look forTier 1Tier 2Tier 34.13.16Does the laboratory establish and maintainprocedures for identification, collection,indexing, access, filing, storage, maintenanceand safe disposal of quality and technicalrecords?Procedures for managing storage,retention and disposal of quality andtechnical recordsXX4.13.26Are all records legible and easily retrievable,stored to prevent damage or deterioration,loss, and unauthorized access?Laboratory records and storageXX4.13.36 Is retention time policy for all recordsestablished?XX Is the retention time for test results definedby the nature of test and some records inaccordance national, regional or localregulations?Document and record retention policy thatis consistent with any national, regional orlocal regulations.Records maintained may include but arenot limited to:a) request forms (including the patientchart or medical record only if used asthe request form),b) examination results and reports,c) instrument printouts,d) examination procedures,e) laboratory work-books or sheets,f)accession records,g) calibration functions and conversionfactors,h) quality control records,i)complaints and action taken,j)records of internal and external audits,k) external quality assessmentrecords/inter-laboratory comparisons,XYNN/A

CHECKLIST FOR THE STEPWISE IMPROVEMENT PROCESS FOR STRENGTHENING LABORATORY QUALITY MANAGEMENT SYSTEMSINDICATING THE EQUIVALENCE WITH CLSI, QSE AND ISO 15189ISO15189Section4.13.3CLSIQSEStatusQuality ImprovementRequirementTier 16CommentsWhat to look forl)Tier 2Tier 3YNN/Aquality improvement recordsinstrument maintenance records,including internal and externalcalibration recordsm) lot documentation, certificates ofsupplies, package insertsn) incident/accident records and actiontakeno)staff training and competency records4.14 Internal AuditsISO15189Section4.14.1CLSIQSE9StatusQuality ImprovementRequirement Does the laboratory conduct selfassessment/internal audits of its systemperiodically and in accordance with apredetermined schedule? Are all elements of the quality

INDICATING THE EQUIVALENCE WITH CLSI, QSE AND ISO 15189 ISO 15189 Section CLSI QSE Requirement What to look for Quality Improvement Status Comments Tier 1 Tier 2 Tier 3 Y N N/A 4.2.4 1 Does the quality manual describe the quality management system and structure of the documentat

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