Presentation on theme: "Going for Gold – The Bridge to Patient Care"— Presentation transcript:
1 Going for Gold – The Bridge to Patient Care use these colorsGoing for Gold – The Bridge to Patient CareStacy Olea, MBA, MT(ASCP), FACHEField Director
2 Objectives Learn about The Joint Commission Laboratory standards Explain the unique features of a Joint Commission Laboratory surveyUnderstand what to expect during your surveyLearn what happens after the survey has been completedReview how to use the available tools to assist you with continuous compliancePresent suggestions on how to resolve the top 10 findings
3 The Joint Commission’s Vision All people experience the safest, highest quality, best- value health care across all settings.The Joint Commission’s MissionTo continuously improve health care for the public, in collaboration with other stakeholders, by evaluating health care organizations and inspiring them to excel in providing safe and effective care of the highest quality and value.3
4 Reasons Organizations do not use The Joint Commission for Laboratory Accreditation Employed Surveyor CadreDid not know The Joint Commission offered a laboratory programThe Joint Commission does not have standards in Forensic Drug testingNo checklistThought the laboratory surveyors where physicians and nurses
5 Reasons Organization use The Joint Commission for Laboratory Accreditation Largest and oldest organization dedicated to survey process and risk evaluation for over 19,000 health care organizationsProfessional surveyor cadreTracer methodology and system evaluationLab Advantage combined services option (PT, CE, and accreditation)Organizational alignment for operational synergyCost is based on volumeMore than one way to meet the standardsAnnual procedure review can be done by signing one cover sheetAbility to detect risks that were unknown prior to the visitOnsite visit activities and findings added value to improving the quality of healthcareCollaborative approach
6 Accreditation Standards Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing (CAMLAB)Free print copyElectronic copy via E-ditionFocus on high quality, safe laboratory servicesExpectations for performance – reasonable, achievable, surveyableCMS recognizes Joint Commission accreditation as meeting CLIA requirements
7 Accreditation Standards Surveyors use standards for evaluationPatient tracer methodologyFollow samples from collection to result reportingOrganization-wide processesValuable component of a complex delivery systemNot an isolated department
8 Broad vs. Prescriptive Requirements Processes (means to an end)Many ways to accomplish goalsProcesses designed by OrganizationsRemains valid with changing sciencePrescriptiveSpecific requirements (specific outcome)The only wayEvidence-BasedReadjustments are required with changing science
9 Unique Issues with Laboratory Often uses prescriptive requirementsCLIA requirementsIndustry conventionAvoid prescriptive requirementsMultiple effective methods may existCould stifle emerging practicesTracers are a system review process (rather than task verification)Allows standards to be nimble
10 Standards Development Process Subject matter expert participationLaboratory PTAC reviewComprised of members from industry association stakeholdersNational Field Review6 week public comment periodBoard Committee (SSP) approves6-month notification to allow preparation
11 Standards Development Process New standards timeline (12-18 months)Research, revisionsPublic comment, pilot testingCAMLAB updated (6 months)Standards updatesFront matter/resource edits
12 Layout of CAMLAB Front Matter 13 Chapters Resources How to Use this Manual13 ChaptersShared ChaptersUnique ChaptersResourcesGlossaryStandards Applicability Grid
13 Standards Chapters Chapters Unique to CAMLAB DC - Document and Process Controlspecimen collection, test orders, test procedures, reporting, record retentionQSA – Quality System Assessment for Nonwaived Testingproficiency testing quality control, standards for specialties and subspecialties
14 Standards Chapters Chapters Shared with Other Programs EC – Environment of Carephysical environment, equipment, hazardous materials/waste, fire safety, utilitiesHR – Human Resourcesstaff qualifications, orientation, training, competence, performanceLD – Leadershipstructure, relationships, organizational culture, operationsNPSG – National Patient Safety Goalstwo patient identifiers, reporting critical results, hand hygiene
15 Anatomy of a Standard Standard Rationale/Introduction Identifies a goal (i.e., participation in proficiency testing)Rationale/IntroductionExplains why it is important to achieve the goalProvides background information for requirementElement of Performance (EP)Outlines the steps needed to achieve the goalExpectations for compliance
16 Standards Applicability Grid Not all requirements apply to all specialtiesBased on services provided by your laboratorySpecialties listed horizontally, standards vertically
17 Scoring Scoring Process Category A EPs: relate to structural requirementCategory C EPs: frequency based that are scored based on the number of times an organization is found not to be compliantPerformance expectationScore 2 = Satisfactory complianceScore 1 = Partial complianceScore 0 = Insufficient complianceTrack record achievements at the time of surveyScore 2 = 24 monthScore 1 = 6 to 23 monthsScore 0 = Fewer than 6 months
18 Accreditation Decision How accreditation decisions are madeCriticality modelThe more immediate the risk the shorter the period of time given to address noncomplianceAll partially compliant and insufficiently compliant EPs must be addressed
19 What is unique to our survey process? Employed surveyor cadrePriority Focus ProcessConcentration on the operational systems that directly affect the quality and safety of diagnostic servicesNational Patient Safety GoalsTracer Methodology
20 Employed Surveyor Cadre Effective evaluatorsProcess is thorough, fair, and objectiveProcess identifies most critical safety and quality issuesProcess is inclusive of mandatory (regulatory) and collaborative (inspirational) modesProcess is continuous, not event drivenProcess is guided by surveyor experience and expertise, informed by dataProcess looks at systems and integration, not a list of tasksAll have clinical laboratory management experienceA full time surveyor will evaluate approximately 60 laboratories a yearAnatomical pathologist surveyors are available upon requestSurveyor continual training and performance monitoring
21 Priority Focus Process Data driven tool that provides surveyors with pre-survey information that has been developed using a standardized methodologyHelps surveyors evaluate health care organizations’ performance more consistentlyHelps to focus the surveyors’ assessment on quality and safety issues specific to an individual laboratorySources used includes The Joint Commission, the laboratory and other public sourcesPFP reports are posted to your extranet site quarterly and as changes warrantThe top four-to-five priority focus areasThe clinical/service groups
22 Operational Systems Approach Our mission and vision drives us to look at how the laboratory is integrated into patient careWe will spend time outside of the laboratoryNonwaived ancillary Point of Care Testing sites (cardiac cath labs, ORs)A sampling of waived and PPMP Point of Care Testing sitesTransfusion administration and managementPerioperative Transfusion ServicesTissue storage and managementHospital Integration
23 NPSGUse at least two patient identifiers when providing laboratory services.EP1 - Use at least two patient identifiers when administering blood or blood components; when collecting blood samples and other specimens for clinical testing; and when providing other treatments or procedures. The patient’s room number or physical location is not used as an identifier.EP2 - Label containers used for blood and other specimens in the presence of the patient.
24 NPSGReport critical results of tests and diagnostic procedures on a timely basis.EP1 - Collaborate with organization leaders to develop written procedures for managing the critical results of tests and diagnostic procedures that address the following:The definition of critical results of tests and diagnostic proceduresBy whom and to whom critical results of tests and diagnostic procedures are reportedThe acceptable length of time between the availability and reporting of critical results of tests and diagnostic proceduresEP2 - Implement the procedures for managing the critical results of tests and diagnostic procedures.EP3 - Evaluate the timeliness of reporting the critical results of tests and diagnostic procedures.
25 NPSGComply with either the current Centers or Disease Control an Prevention (CDC) hand hygiene guidelines or the current World Health Organization (WHO) hand hygiene guidelines.EP1 - Implement a program that follows categories IA, IB, and IC of either the current CDC or WHO hand hygiene guidelines.EP2 - Set goals for improving compliance with hand hygiene guidelines.EP3 - Improve compliance with hand hygiene guidelines based on established goals.
26 Tracer MethodologyUses actual patients as the framework for assessing standards complianceIndividual tracers follow the experience of care through the entire health care process in the organizationSystem tracers evaluate the integration of related processesCoordination and communication among disciplines and departmentsIn-depth discussion and education regarding the use of data in performance improvementReference document available at
27 Tracer Methodology Common starting points for tracers Sample CollectionCritical resultsTransfusion MedicinePoint of Care TestingFrozen SectionsDocuments reviewed during tracersOrderInstrument maintenance records, calibration verification, quality controlPolicies and ProceduresEmployee competencyBlood Utilization ReviewProcess ImprovementPatient Medical RecordsStaff interviews and Direct Observations
28 Joint Commission Survey Options PathologistCorporate SurveysDedicated TeamOrientation to your OrganizationAnnual SummationSimultaneous SurveysOther ProgramsSister facilitiesConcurrent Surveys
29 On-Site Survey Activities Surveyor photo, bio and survey agenda are posted to the extranet site at 07:30 local time (mobile app)Depending on the complexity of the organization a survey may last more than one day and could involve a team of surveyorsOnce the surveyor arrives, the organization’s extranet must be checked for confirmation of the survey and identification of the surveyorPreliminary Planning SessionOpening ConferenceOrientation to the Organization
30 On-Site Survey Activities A Daily Briefing occurs every morning of a multiday survey, with the exception of the first dayCompetency AssessmentPersonnel education/qualification verificationRegulatory ReviewProficiency Testing Validation/Performance Improvement Data ReviewIndividual TracersPhysical EnvironmentSurvey Report PreparationCEO Exit Briefing and Organization Exit Conference
31 Required Documentation Documentation list for your surveyThe 24 month reference in the following items is not applicable to initial surveys, except for proficiency testing data.For initial surveys, a minimum of 4 months of data must be available for review.
32 Required Documentation As a laboratory, you should have the following information and documents available for the surveyor to review during the Surveyor Planning SessionName of key contact person who can assist in planning tracer selectionsCLIA Certificates, Specialties and Subspecialties, State Licenses, and personnel license or certification if required by the state or organization policyAn organizational chart and map of the facilityAbility to retrieve testing records for patients who have had laboratory tests or other services for the past 24 months (4 months if an initial survey)Performance improvement Data for the past 24 months (4 months if an initial survey)Proficiency data by CLIA number for the past 24 months
33 Required Documentation As a laboratory, you should have the following information and documents available for the surveyor to review during the Surveyor Planning SessionResults of periodic laboratory environment inspections from the safety committee or safety officerManifests for the disposal of hazardous waste for the past 24 months (4 months if an initial survey)A list of specialties and subspecialties performed by the labA list of tests performed (test menu) and instruments used including all ancillary and point of care sitesMeasures of Success (MOS) identified in the Plan of Action from the Periodic Performance ReviewEmployee personnel files will be reviewed, including employee education records, competency documentation, and employee health informationNote: Surveyors may need to see additional documents throughout the survey to further explore or validate observations or discussions with staff.
34 From Survey Report to Accreditation Decision A preliminary report is available on the extranet until midnight of the day the survey has been completed.The accreditation decision is not made until all of your organization’s post-survey activities are completedThe final summary of survey findings report will be posted on your extranet site.It will include which findings require an Evidence of Standards Compliance (ESC) submission within 45 days (direct impact standards) and/or 60 days (indirect impact standards)Upon approval of your organization’s last submitted ESC, your accreditation decision is posted to your extranet site and to Quality Check (
35 Standards Clarification Organizations have the opportunity to submit a clarifying ESC if they believe that their organization was in compliance with a standard at the time of the surveyThe clarification must be submitted within 10 business day following the posting of the organization’s report to the extranet.When submitting clarifying ESCs after a survey event, it is important to follow the directions in the submission tool. You need to address the EP as well as the actual surveyor observation.The submission of a clarification does not negate the requirement for submission of a corrective ESC within 45 or 60 days if the RFI continues, nor does it provide an organization with additional time to submit its ESC.
36 Corrective ESCAn acceptable corrective ESC report must detail the following:Action(s) that the organization took to bring itself into compliance with a standardThe title of the person(s) responsible for implementing the corrective actions or approving a revised policy, procedure, or processCompliance at the EP level and include a Measure of Success (MOS) if applicableThere may be times when an ESC will also be conducted on site by a surveyorProvides the opportunity to evaluate the organization’s success in correcting issuesAllows the surveyor to provide coaching and guidance to the organization supporting its efforts to achieve and maintain compliance
37 Measure of Success (MOS) A numerical or quantifiable measure, usually related to an audit to determine if action was effective and sustainedDue four months after notification of an acceptable ESCNot required for all ESCs
38 Help us improve the survey process Customer Value AssessmentBefore the survey happensAllows you to set expectationsAfter the survey is over to evaluation our performanceHCO EvaluationYour opportunity to provide us with feedback on the survey process and the surveyor(s)Exceed Expectations, Meets Expectations, Below Expectations, Not Observed14 questions with room for commentsAdditional line to enter your information if you want someone from The Joint Commission to contact you
40 Standards Interpretation Group (SIG) Phone:Option 6Online:FAQs:
41 Intracycle Monitoring Located on your Joint Commission extranet siteRequired on your off cycle year and can be accessed before your first surveyThree options availableOpportunity to ask questions and develop plans of action in a non-punitive manner
42 Leading Practice Library Opened to all of our accredited organizationsDatabase to formally identify and share leading practices (including case studies, white papers, tools, policies, etc.) which reflect excellent compliance with Joint Commission standards and National Patient Safety Goals.Sort by program
43 Center for Transforming Healthcare Formed in 2009 to find solutions to pressing health care issues identified by CEOsUses DMAIC principles to analyze and identify root causes which vary by institutionOne size does not fit all for persistent issues!Projects include:Hand hygieneHand off communicationsWrong Site surgerySurgical Site infections (with ACS)Safety CultureSolutions database available from Joint Commission to enter your own data and perform your own project to improve care
44 Lab Central New customer portal that improves accreditation: Allows organizations to organize files in one place to make surveys more efficientSurveyors can review data before the survey to get better snapshot of organizationData available for ICM discussion with SIGProvides a place for private document managementMandatory use starting January 1, 2013
49 From Accreditation to Continuous Compliance Concentrate on incorporating the frameworks and concepts of standards and EPs into day-to-day work rather than viewing the concepts as rules that must be followedRead Perspectives each month to identify new/updated standards, scoring, standards interpretationSign up for E-AlertsComplete your intracycle monitoringContact SIG to submit standard questionsEnter your information into Lab Central
50 Resources and Tools Resources and Tools available CAMLAB Perspectives monthly publicationJoint Commission Center for Transforming HealthcareAccount ExecutiveJoint Commission extranet siteLeading Practice LibraryBoosterPaksE-dition web-based manualLab CentralJoint Commission webpageCLSI crosswalkStandards’ Frequently Asked QuestionsTracer Methodology 101 articleSign up for E-AlertsLab FocusFree audio conferences
51 Resources on the Web Centers for Medicare & Medicaid Services (CMS) CLIA:COPs:Centers for Disease Control and Prevention (CDC)Food and Drug Administration CLIA Database SearchCLSI-Joint Commission CrosswalkCrosswalkWEB.pdf
53 Initial and Overall Top 10 DC The laboratory report is complete and is in the patient’s clinical record. EP2 - The laboratory report includes the name and address of the laboratory performing the test.QSA The laboratory performs calibration verification. EP3 – Calibration verification is performed every six months. See CAMLAB for additional Notes.QSA The laboratory performs correlations to evaluate the results of the same test performed with different methodologies or instruments or at different locations. EP2 – The laboratory performs correlations at least once every six months. The correlations are documented.
54 Initial and Overall Top 10 QSA The laboratory participates in Centers for Medicare & Medicaid Services (CMS) approved proficiency testing programs for all regulated analytes. EP5 – For each specialty, subspecialty, analyte, or test, the laboratory’s proficiency testing results meet satisfactory performance criteria in accordance with law and regulation. See CAMLAB for additional Notes.QSA The laboratory evaluates instrument-based testing with electronic or internal systems prior to using them for routine quality control. EP6 – The laboratory performs external quality controls at the following frequencies:As defined by the evaluation (either weekly or monthly)According to the manufacturer’s recommendationsWith each new lot number, shipment, or package of reagentsThe external quality control results are documented.
55 Initial and Overall Top 10 QSA The laboratory maintains records of its participation in a proficiency testing program. EP2 – For individual unacceptable proficiency testing results, the laboratory conducts an investigation of all potential causes, provides evidence of review, and performs corrective action sufficient to address and correct the issues identified in the investigation. These actions are documented. See CAMLAB for additional Notes.
56 Initial Top 10WT The organization maintains records for waived testing.EP3 – Quantitative test result reports in the patient’s clinical record for waived testing are accompanied by reference intervals (normal values) specific to the test method used and the population served. See CAMLAB for additional Notes.EP4 – Individual test results for waived testing are associated with quality control results and instrument records. See CAMLAB for additional Notes.NPSG Report critical results of tests and diagnostic procedures on a timely basis. EP3 – Evaluate the timeliness of reporting the critical results of tests and diagnostic procedures.
57 Initial Top 10DC The laboratory has procedures for each laboratory test. EP1 – Written laboratory procedures for each test meet the following requirements:They contain a complete description of the test.They include detailed instructions for performing the test.They adhere to manufacturers’ instructions (preanalytical, analytical, and postanalytical phases of testing).They include the date of implementation.They reflect the laboratory’s current practice.They are readily available to staff performing the testing.See CAMLAB for additional Notes.
58 Overall Top 10WT Polices and procedures for waived tests are established, current, approved, and readily available. EP3 – If manufacturers’ manuals or package inserts are used as the policies or procedures for each waived test, they are enhanced to include specific operational policies (that is, detailed quality control protocols and any other institution specific procedures regarding the test or instrument).QSA The laboratory participates in Centers for Medicare & Medicaid Services (CMS) approved proficiency testing programs for all regulated analytes. EP6 – The laboratory’s proficiency test performance is successful for each specialty, subspecialty, analyte, or test, as required by law and regulation. See CAMLAB for additional Notes.
59 Overall Top 10QSA The laboratory evaluates instrument-based testing with electronic or internal systems prior to using them for routine quality control. EP7 – The laboratory performs external quality controls at the number of levels specified by the specialty and subspecialty requirements (for example, blood gases require three levels of quality control). The external quality control results are documented.WT Staff and licensed independent practitioners performing waived tests are competent. EP5 – Competency for waived testing is assessed using at least two of the following methods per person per test:Performance of a test on a blind specimenPeriodic observation of routine work by the supervisor or qualified designeeMonitoring of each user’s quality control performanceUse of a written test specific to the test assessed
60 Objectives Learn about The Joint Commission Laboratory standards Explain the unique features of a Joint Commission Laboratory surveyUnderstand what to expect during your surveyLearn what happens after the survey has been completedReview how to use the available tools to assist you with continuous compliancePresent suggestions on how to resolve the top 10 findings
61 Demonstration of the Extranet and The Joint Commission Webpage