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RTRT’’s Commitment to Qualitys Commitment to QualityThe FundamentalsThe Fundamentals
Susan Blonshine RRT, RPFT, FAARC, AESusan Blonshine RRT, RPFT, FAARC, AE--CC
The Quality Management System The Quality Management System (QMS) provides a framework for (QMS) provides a framework for managing and monitoring activities managing and monitoring activities to address quality standards and to address quality standards and achieve organizational goals.achieve organizational goals.
CLSI Document HS4CLSI Document HS4--A2, 2004A2, 2004..
StageStage Activities PerformedActivities Performed
Total Quality Total Quality ManagementManagement
Management approach centered on Management approach centered on sustained high quality, by focusing on longsustained high quality, by focusing on long--term success through customer satisfaction.term success through customer satisfaction.
Quality Cost Quality Cost ManagementManagement
Includes the stages below and also the Includes the stages below and also the economic aspects of the economic aspects of the ““cost of quality.cost of quality.””
Quality Quality Management Management SystemSystem
Systematic processSystematic process--oriented approach to oriented approach to quality objectivesquality objectives..
Quality Quality AssuranceAssurance
Planned and systematic activities to provide Planned and systematic activities to provide confidence that an organization fulfills confidence that an organization fulfills requirements for quality.requirements for quality.
Quality ControlQuality Control Operational process control techniques to Operational process control techniques to fulfill requirements for quality and fulfill requirements for quality and governmental compliance.governmental compliance.
Why Quality Systems?Why Quality Systems?Consistent, high quality servicesConsistent, high quality services
Enhance employee potentialEnhance employee potential
Business advantageBusiness advantage–– Streamline processesStreamline processes–– Increase productivity and efficiencyIncrease productivity and efficiency–– CostCost--effectiveeffective
Why Quality Systems?Why Quality Systems?Reduce or eliminate medical errorsReduce or eliminate medical errors–– Patient safetyPatient safety
Meeting customer requirementsMeeting customer requirements
Potential for successful governmental Potential for successful governmental and accreditation assessments and accreditation assessments
Current Quality ModelsCurrent Quality ModelsCLSI HS1CLSI HS1--A2 Quality System Model for A2 Quality System Model for Healthcare (2004)Healthcare (2004)
ISO 9001 Quality System ModelISO 9001 Quality System Model
–– Healthcare Application 2001 and updateHealthcare Application 2001 and update–– 15189 Clinical Laboratory specific15189 Clinical Laboratory specific–– CLSI GP26CLSI GP26--A3 Application of a Quality System A3 Application of a Quality System
Model for Laboratory ServicesModel for Laboratory Services
Current Quality ModelsCurrent Quality Models
Malcolm Baldridge Award for Malcolm Baldridge Award for Healthcare, Education, BusinessHealthcare, Education, Business
CLSI HS4CLSI HS4--A2 Application of a Quality A2 Application of a Quality System Model to Respiratory ServicesSystem Model to Respiratory Services
QMS Guidance QMS Guidance -- A TimelineA Timeline
1994Publication of
ISO 9001:1994
2002Publication of
CLSI HS1-A and CLSI GP26-A2
1999Publication of CLSI GP26-A
2003Publication of
ISO 15189:2003
2004Publication of
CLSI HS1-A2 and CLSI GP26-A3
2000Publication of
ISO 9001:2000 and ISO 15189:2000
1999Publication of
ISO 17025:1999
QSEs and ISO9001QSEs and ISO9001
CLSICLSI ISOISOOrganizationOrganization 4.1 General requirements4.1 General requirements
5.1 Management commitment5.1 Management commitment5.3 Quality policy5.3 Quality policy5.4 Planning5.4 Planning5.5 Responsibility, authority, 5.5 Responsibility, authority,
communicationcommunication5.6 Management review5.6 Management review6.1 Provision of resources6.1 Provision of resources
PersonnelPersonnel 6.2 Human resources6.2 Human resources
EquipmentEquipment 7.6 Control of measuring7.6 Control of measuringand monitoring devicesand monitoring devices
Documents andDocuments andrecordsrecords
4.2 Documentation requirements4.2 Documentation requirements
Purchasing and inventoryPurchasing and inventory 7.4 Purchasing7.4 Purchasing
Customer serviceCustomer service 5.2 Customer focus5.2 Customer focus
Process improvementProcess improvement 8.5 Improvement8.5 Improvement
QSEs and ISO9001QSEs and ISO9001Process ControlProcess Control 7.1 Planning of product7.1 Planning of product
realization realization 7.2 Customer7.2 Customer--relatedrelated
processesprocesses7.3 Design and development 7.3 Design and development 7.5 Production and service7.5 Production and service
provisionprovision
Occurrence managementOccurrence management 8.3 Control of nonconforming 8.3 Control of nonconforming productproduct
AssessmentsAssessments——external and internalexternal and internal 8.1 General8.1 General8.2 Monitoring and measurement8.2 Monitoring and measurement8.4 Analysis of data8.4 Analysis of data
Information ManagementInformation Management Not addressedNot addressed
Facilities and safetyFacilities and safety 6.3 Infrastructure6.3 Infrastructure6.4 Work environment6.4 Work environment
Critical RequirementsCritical Requirements
Commitment to qualityCommitment to qualityfrom senior management from senior management
and throughout the organizationand throughout the organization
Model Structure For a Quality Model Structure For a Quality SystemSystem
Quality System EssentialsQuality System EssentialsOrganizationOrganizationPersonnelPersonnelEquipmentEquipmentPurchasing and InventoryPurchasing and InventoryProcess ControlProcess ControlDocuments/RecordsDocuments/RecordsOccurrence ManagementOccurrence ManagementAssessmentAssessment-- internal and externalinternal and externalProcess ImprovementProcess ImprovementCustomer Service and SatisfactionCustomer Service and SatisfactionInformation ManagementInformation ManagementFacilities and SafetyFacilities and Safety
Service's Path of Workflow
CLSI Document HS1-A2, 2004.
Laboratory Path of WorkflowLaboratory Path of Workflow
Preanalytic(Pre-examination)
Documents and RecordsOrganization
PersonnelEquipment
Purchasing and InventoryProcess Control
Information ManagementOccurrence Management
Assessment: External and InternalProcess Improvement
Customer Service and SatisfactionFacilities and Safety
Quality System Essentials (QSEs)
Analytic(Examination)
Postanalytic(Post-examination)
Quality system essentials apply to all operations in the path of workflow
Pulmonary Diagnostics Path of Workflow
Pretest Testing Session Post-test
Patient Assessment Patient Training Results ReportTest Request Test Performance InterpretationPatient Preparation Results Review/Selection Clinical ConsultationEquipment Preparation Patient Assessment for
Further Testing
CLSI Document HS4-A2, 2006.
PF Lab: Pretest PhasePF Lab: Pretest Phase
Patient AssessmentPatient Assessment–– clinical historyclinical history–– patient signs and symptomspatient signs and symptoms–– other indicators that guide the physicianother indicators that guide the physician
or practitioner to make recommendationsor practitioner to make recommendationsrelated torelated to appropriate testingappropriate testing
–– standardized ordering format may guidestandardized ordering format may guidethe processthe process
Pretest PhasePretest Phase
Test Request ProcessTest Request Process–– generating the ordergenerating the order–– patient instructionspatient instructions–– scheduling scheduling –– sequencing of test performance may sequencing of test performance may
impact test results impact test results
Pretest PhasePretest Phase
Patient PreparationPatient Preparation–– specific demographic and history specific demographic and history
information from the patient (e.g., information from the patient (e.g., questionnaires, height and weight)questionnaires, height and weight)
–– assessing patient compliance with pretest assessing patient compliance with pretest instructionsinstructions
–– verifying the clinical indication or verifying the clinical indication or contraindications for testingcontraindications for testing
–– consent forms when appropriateconsent forms when appropriate
Pretest PhasePretest Phase
Equipment PreparationEquipment Preparation
–– calibration and gathering equipment and calibration and gathering equipment and suppliessupplies
–– selection of reference valuesselection of reference values
Testing SessionTesting Session
Patient trainingPatient trainingTest performanceTest performanceResults review and selectionResults review and selectionPatient assessment for further testingPatient assessment for further testing
PostPost--test Phasetest Phase
Results reportResults reportInterpretationInterpretationClinical consultationClinical consultation
Operating Process: Spirometry Test Result Selection and Reporting
Perform spirometry, meeting acceptability and reproducibility requirements
Select largest FVC from acceptable maneuvers
Select instantaneous flows from the “best curve”
Report the highest peak flow
Print all acceptable curves
Document patient cooperation, effort, or standards not met
Verify accuracy of demographic, environmental, anthropometric data
Generate report
Verify accuracy of selected data
Enter interpretation into the operating process
DefinitionsDefinitions
PoliciesPoliciesWhat do we do?What do we do?
ProcessesProcessesHow does it happen in this organization?How does it happen in this organization?
ProceduresProceduresHow do I do this activity?How do I do this activity?
Forms and RecordsForms and RecordsDocuments/files to record data, information or Documents/files to record data, information or resultsresults
CLSI Document HS1-A2, 2004.
Quality System Essentials Quality System Essentials (QSEs)(QSEs)
12 fundamental components for building 12 fundamental components for building a quality management system. Each a quality management system. Each QSE encompasses QSE encompasses policiespolicies, , processesprocesses, and , and proceduresprocedures necessary necessary to manage and improve work practices to manage and improve work practices that will ultimately lead to better patient that will ultimately lead to better patient carecare
CLSI Quality System CLSI Quality System Essentials (QSEs)Essentials (QSEs)
Documents and Documents and RecordsRecordsOrganizationOrganizationPersonnelPersonnelEquipmentEquipmentPurchasing and Purchasing and InventoryInventoryProcess ControlProcess Control
Information Information Management Management Occurrence Occurrence ManagementManagementAssessments: Internal Assessments: Internal and Externaland ExternalProcess ImprovementProcess ImprovementCustomer SatisfactionCustomer SatisfactionFacilities and SafetyFacilities and Safety
Documenting the SystemDocumenting the SystemOrganizationOrganization’’s quality policys quality policy
The Quality ManualThe Quality ManualQSE: OrganizationQSE: Organization
Quality Management System Quality Management System QSE: Documents and RecordsQSE: Documents and Records
Document structureDocument structureQSE: Documents and RecordsQSE: Documents and Records
Quality System Quality System Documentation HierarchyDocumentation Hierarchy
CLSI Document HS2-A, 2004.
QSE: Documents & RecordsQSE: Documents & Records
Development of the system for Development of the system for controlling documents and recordscontrolling documents and records
Analysis and validation of processes, Analysis and validation of processes, development of SOPs and development of SOPs and implementation of process controlsimplementation of process controls
CLSI Document HS1-A2, 2004.
QSE: Documents and RecordsQSE: Documents and Records
System for controlling documentsSystem for controlling documents–– Creation, identification, revision, review, Creation, identification, revision, review,
distribution, and archivingdistribution, and archiving
System for controlling recordsSystem for controlling records–– Identification, collection, review, indexing, Identification, collection, review, indexing,
accessing, storage, retention, and disposalaccessing, storage, retention, and disposal
Master Index
Document Identification
Document Name Effective Date
Location(s)
Documents and RecordsDocuments and RecordsPolices, processes, and proceduresPolices, processes, and procedures
Retention ScheduleRetention Schedule
Master IndexMaster Index
QSE: OrganizationQSE: Organization
Establishment of management commitmentEstablishment of management commitment–– Quality planningQuality planning–– Quality officer/staffQuality officer/staff
Identification of the service's path of workflowIdentification of the service's path of workflow
Development of the quality manualDevelopment of the quality manual
CLSI Document HS1-A2, 2004.
XYZ Service Quality ManualSection 1…………………………………………………………………………………PurposeSection 2……………………………………………………………………………………ScopeSection 3……………………………………………………………Quality Policy StatementSection 4…………………………………………………………Quality Goals and ObjectivesSection 5……………………………………………..Policies for Quality System Essentials5.1……………………………………………………………………… Documents and Records5.2……………………………………………………………………………………Organization5.3………………………………………………………………………………………Personnel5.4.……………………………………………………………………………………..Equipment5.5…………………………………………………………………… Purchasing and Inventory5.6………………………………………………………………………………...Process Control5.6.1………………………………………………………………………………… Preservice5.6.2……………………………………………………………………………………..Service5.6.3…………………………………………………………………………………Postservice5.7…………………………………………………………………………Information Management5.8………………………………………………………………………Occurrence Management5.9………………………………………………………………Assessments: Internal and External5.9.1.………………………………………………………………Findings From Occurrences5.9.2……………………………………………Findings From Customer Satisfaction Surveys 5.9.3………………………………………………………………...Findings From Complaints 5.9.4………………………………………………...Findings From Internal Quality Indicators 5.9.5..…………………………………………………………...Findings From Internal Audits 5.9.6……………………………………………………..Findings From External Assessments5.10…………………………………………………………………………Process Improvement5.11………………………………………………………………………………..Customer Service5.12……………………………………………………………………………..Facilities and Safety
Document number/version Facility Name/LocationPage 1 of 1 Effective Date
QSE: PersonnelQSE: Personnel
Job descriptionsJob descriptionsOrientationOrientationTrainingTrainingCompetency assessmentCompetency assessmentContinuing education and professional Continuing education and professional developmentdevelopment
QSE : PersonnelQSE : Personnel
Job qualifications and descriptionsJob qualifications and descriptions–– ATSATS–– ERS ERS –– AARCAARC
Training and Competence Assessment Training and Competence Assessment ProgramsPrograms
CLSI Document HS4-A2, 2006.
Training and Competence Training and Competence Assessment ProgramsAssessment Programs
Orientation and TrainingOrientation and Training
Training GuidesTraining Guides
Competence AssessmentCompetence Assessment
Documentation of Training and Documentation of Training and Competence AssessmentCompetence Assessment
CLSI Document HS4-A2, 2005.
QSE: EquipmentQSE: Equipment
Acquisition, installation, and Acquisition, installation, and identificationidentificationValidationValidationCalibration, maintenance, and useCalibration, maintenance, and useTroubleshooting, service, and repairTroubleshooting, service, and repairEquipment recordsEquipment records
QSE : EquipmentQSE : Equipment
The Equipment Management PlanThe Equipment Management Plan
Equipment SelectionEquipment Selection
Equipment InstallationEquipment Installation
CLSI Document HS4-A2, 2005
Equipment SelectionEquipment Selection
Management PlanManagement Plan–– List of acceptable vendorsList of acceptable vendors–– Develop productDevelop product--evaluation matrixevaluation matrix–– Evaluate equipmentEvaluate equipment–– Determine acceptable limits of accuracy Determine acceptable limits of accuracy
and precisionand precision
CLSI Document HS4-A2 2005
Equipment SelectionEquipment Selection
Management PlanManagement Plan–– Consider database optionsConsider database options–– Consider quality control and calibration Consider quality control and calibration
routinesroutines–– Consider computer standardsConsider computer standards–– Identify warranty and service agreementsIdentify warranty and service agreements–– Perform onPerform on--site evaluationsite evaluation–– Correlate old and new equipmentCorrelate old and new equipment
CLSI Document HS4-A2, 2005
Equipment InstallationEquipment Installation
Develop installation manualDevelop installation manual
Validate equipment functionValidate equipment function
Perform biomedical checksPerform biomedical checks
Validate reference values selectedValidate reference values selectedCLSI Document HS4-A2, 2005
QSE: Purchasing and InventoryQSE: Purchasing and Inventory
PurchasingPurchasing–– Critical supplies and serviceCritical supplies and service–– Vendor qualification and evaluationVendor qualification and evaluation–– Contract reviewContract review
InventoryInventory
QSE : Process ControlQSE : Process Control
Develop flowcharts for processesDevelop flowcharts for processesProcess ValidationProcess ValidationIdentify and Write Standard Operating Identify and Write Standard Operating ProceduresProceduresProcess ControlProcess Control–– Quality ControlQuality Control–– Proficiency TestingProficiency Testing
CLSI Document HS1-A2, 2004
Process Flowchart ExamplesProcess Flowchart Examples
Data managementData management
Guideline/standards development Guideline/standards development
Meeting managementMeeting management
Project developmentProject development
Interpretation of dataInterpretation of data
Request For Proposal (RFP) processRequest For Proposal (RFP) process
QSE: Information ManagementQSE: Information Management
Commitment to quality in the flow of Commitment to quality in the flow of information between service unitsinformation between service units–– Ingoing and outgoing informationIngoing and outgoing information–– Computer access and securityComputer access and security–– Data integrityData integrity–– Information system Information system ““downtimedowntime””–– Information requests (external, internal)Information requests (external, internal)
CLSI Document HS1-A2, 2004.
QSE: Occurrence ManagementQSE: Occurrence Management
Capturing informationCapturing information–– Uniform formats and formsUniform formats and formsReport formsReport formsImmediate action and investigationImmediate action and investigationOccurrence analysisOccurrence analysisCorrective actionCorrective action
QSE: Occurrence ManagementQSE: Occurrence Management
Policy forPolicy for
Identification, documentation and Identification, documentation and investigation of nonforming eventsinvestigation of nonforming eventsClassification, analysis, and data Classification, analysis, and data trendingtrendingIdentification of need for root cause Identification of need for root cause analysisanalysis
Occurrence Log
OccurrenceNumber
Reported by
OccurrenceType
OperationsProcessInvolved
Occurrence Source
Corrective Action
CompletedDate
Corrective Action
Verified(Yes or No)
Finalized and Closed out
(date)
QSE: AssessmentsQSE: Assessments
External assessmentsExternal assessments–– Accreditation assessmentAccreditation assessment–– External quality assessmentExternal quality assessment–– BenchmarkingBenchmarking
Internal assessmentsInternal assessments–– Quality indicatorsQuality indicators–– Internal audit programInternal audit program
Periodic reportingPeriodic reporting
QSE: Process ImprovementQSE: Process Improvement
Identifying opportunities for Identifying opportunities for improvementimprovementPreventive and corrective actionPreventive and corrective actionProblem resolution processProblem resolution processQuality improvement toolsQuality improvement toolsPeriodic reportingPeriodic reporting
PDCA
Plan: a mission-consistent, customer-oriented action plan
• Identify opportunities for improvement from data sources.• Prioritize improvement activities.• Develop an action plan for the selected activity:
– initiating a new process, and– improving an existing process.
• Identify– customer needs,– participants,– time frames,– outcome measurements, and– success criteria.
Do: Put the plan into action.
• Implement the action plan:– pilot project first, and– broaden only after success.
• Collect performance data.
Check: Has the planned and implemented change created intended improvement?
• Analyze collected data.• Compare performance data to established success targets and original performance data to
determine if improvement was achieved.• Identify any unexpected peripheral benefits.• Identify unanticipated problems in other areas.
Act: Decide what to do next.
• Determine if customer needs were met.• Take action based on the results:– Success: • Revise the processes for further improvements (optional).
• Assess again to determine if improvement is maintained.• If a pilot project, standardize to the bigger group.
– Lack of success – revise the action plan and repeat.
QSE: Customer ServiceQSE: Customer Service
Identifying the customerIdentifying the customer
Identifying customer needsIdentifying customer needs
Customer feedbackCustomer feedback
Mechanisms to respond to inputMechanisms to respond to input
QSE : Service and SatisfactionQSE : Service and Satisfaction
Internal (Division or Agency)Internal (Division or Agency)–– PhysiciansPhysicians–– StaffStaff–– Other therapistsOther therapists–– NursesNurses–– Other caregiversOther caregivers–– Leadership teamLeadership team
CLSI Document HS4-A2, 2005.
QSE : Service and SatisfactionQSE : Service and SatisfactionExternalExternal–– PublicPublic–– PatientsPatients–– PhysiciansPhysicians–– ClinicsClinics–– Accrediting bodies (JCAHO, CAP)Accrediting bodies (JCAHO, CAP)–– Regulatory groups (CLIA)Regulatory groups (CLIA)–– Laboratories (state lab directors)Laboratories (state lab directors)–– Other agencies (CMS, FDA)Other agencies (CMS, FDA)
CLSI Document HS1-A2, 2004.
Customer Needs Assessment Process
Work Flow Responsible Party How It Happens
Customers are identified
Customers needs are determined
Processes, products, or services to be designed
and/or changed are identified
Collaborate with Marketing Department
* Internal Partners* External Customers* Employees
* Interviews* Focus groups* Inclusion on CI teams* Formal and informal surveys* Client representative feedback* Event management* Complaints
* Strategic analysis* Technology driven* Product driven* Service driven
QSE Process Control
QSE Process Improvement
Customer Satisfaction Survey Process
Work Flow Responsible Party How It Happens
Process, product, or service to be assessed
is identified
Assessment method is chosen
Assessment is conducted
Collaborate with Marketing Department
* Patient Safety/Care* Technology driven* Product driven* Service driven
* Contact Marketing Dept* Design your own assessment method* Use previous examples
Results are analyzed and reviewed
* Calling* Interviews* Written questionnaire
* Communicate results with appropriate staff and management
Does process,
product, orservice need
to bechanged?
END
No
Yes QSE Process Control
QSE Process Improvement
QSE: Facilities and SafetyQSE: Facilities and Safety
FacilitiesFacilities–– DesignDesign–– EnvironmentEnvironment
SafetySafety–– Safety requirements and programsSafety requirements and programs
Planning and Programming
Schematic Design
Design Development
Construction Documents
Bidding and Negotiation
Construction
Move in
Gather Information: tours, equipment,
staffing, site information
Generate Planning Information:program,
area,relationship,
blocks,cost
Sign off and OK to proceed to the next phase
Gather Information:internal workflow,
equipment and casework layout, people
movement
Generate:floor plans
Sign off and OK to proceed to the next phase
Gather Information:engineering information, casework information, equipment specifics,
finishes
Generate: more detailed floor plans, casework elevations, start specifications, color
schemes
Sign off and OK to proceed to the next phase
Generate: detailed plans and specifications for contractor to
understand Architects’ and Engineers’ intent
Send to contractor for bidding
Generate:cost estimates for construction
Contractor awarded bid and set date to start
Generate:moving plan and timelines
How to BeginHow to Begin
PlanningPlanning–– Gap analysisGap analysisInitial PhasesInitial Phases–– Documents and recordsDocuments and records–– Process controlsProcess controls–– Occurrence controlOccurrence controlContinuing implementationContinuing implementation
ResourcesResourcesATS Pulmonary Function Laboratory management ATS Pulmonary Function Laboratory management and procedure manualand procedure manualsecond editionsecond edition
ATS/ERS statementsATS/ERS statements
AARC CPGsAARC CPGs
CLSI documentsCLSI documents
ISO documentsISO documents
Staff BenefitsStaff BenefitsStaff are more process focused (think Staff are more process focused (think globally)globally)
Increased accountability (clear definitions)Increased accountability (clear definitions)
Improved training (customer/employee Improved training (customer/employee satisfaction)satisfaction)
Develops team attitude (removes Develops team attitude (removes departmental barriers)departmental barriers)
Keys to SuccessKeys to Success
AbilityAbility
AgilityAgility
Skating to where the puck is going to beSkating to where the puck is going to be
Wayne GretzkyWayne GretzkyHockey StarHockey StarNew York RangersNew York Rangers
CLSI DocumentsCLSI Documents
Clinical and Laboratory Standards Clinical and Laboratory Standards Institute:Institute:
940 West Valley Road940 West Valley RoadSuite 1400Suite 1400Wayne, PA 19087Wayne, PA 19087--18981898610610--688688--01000100
Thank You!Thank You!
Any Questions?Any Questions?