RT’s Commitment to Quality The Fundamentals Systems - NRRCC 2007.pdf · Equipment 7.6 Control of...

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


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


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


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


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


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


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


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


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


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


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


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


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)


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


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)


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


Gather Information:engineering information, casework information, equipment specifics,

finishes

Generate: more detailed floor plans, casework elevations, start specifications, color

schemes


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?

RT’s Commitment to Quality The Fundamentals Systems - NRRCC 2007.pdf · Equipment 7.6 Control of...

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