Avoiding the Most Frequent Joint Commission Laboratory Survey Findings using Robust Process Improvement Tools (RPI) AVOIDING THE MOST

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Avoiding the Most Frequent Joint Commission Laboratory Survey Findings using Robust Process Improvement Tools (RPI) AVOIDING THE MOST FREQUENT JOINT COMMISSION LABORATORY SURVEY FINDINGS USING ROBUST PROCESS IMPROVEMENT TOOLS (RPI) Presented by: Aneita Paiano, MBA, MT(ASCP) Laboratory Surveyor The Joint Commission 1

Objectives To learn some Robust Process Improvement (RPI) tools to help avoid common Joint Commission Findings. To learn the most common Joint Commission Laboratory Findings Robust Process Improvement RPI Combines Lean Six Sigma and Facilitating Change Defines factors critical to quality Uses data to design improvement Enlists stakeholders and process owners Eliminates defects and waste 2

RPI Continued Drastically decreases failure rates Simplifies and expedites processes Partners with staff and leaders to seek, commit to, and accept change RPI 3

QSA 01.01.01 Proficiency Test The laboratory participates in a CMS approved proficiency test for all regulated analytes Checklist to determine all regulated and unregulated analytes for each CLIA number http://www.jointcommission.org/assets /1/18/Proficiency_Testing_Enrollment_ Worksheet.pdf 4

Copyright, The Joint Commission 3/16/2015 Checklist Client name/ Presentation Name/ 12pt - 9 RPI Methods to Investigate Proficiency Test Errors Active Listening, Brainstorm Fishbone Diagram (Clerical, Sample, Environment, Method, Staff) Five Whys WWW Action Plan (Who What When) 5

Brainstorm Cause and Effect Diagram SAMPLE ENVIRONMENT ERRORS METHOD STAFF CLERICAL 6

7

Copyright, The Joint Commission 3/16/2015 Client name/ Presentation Name/ 12pt - 16 8

Copyright, The Joint Commission 3/16/2015 Client name/ Presentation Name/ 12pt - 17 Methods to Avoid Proficiency Testing Errors Good Laboratory Practice Quality Control (set limits, monitor, compare with peer group) Maintenance, Calibrations Training and Competency FMEA (Failure Modes Effects Analysis) WWW (Who What When) 9

Quality Control (Run Chart) 10

Failure Modes Effects Analysis FMEA Steps Form a Team Diagram the Process Brainstorm Failure Modes Consider Effects Prioritize Failure Modes Identify Root Causes of Failures Reassess the Process Make necessary Changes Monitor the Process 11

Copyright, The Joint Commission 3/16/2015 PROCESS STEP POTENTIAL POTENTIAL SEV POTENTIAL OCC CURRENT DET RPN ACTION FAILURE MODE FAILURE CAUSES PROCESS EFFECT CONTROLS Client name/ Presentation Name/ 12pt - 24 12

Form a Team Handling Proficiency Tests PRE Read PT Provider s Handling Directions Store and Handle Samples Appropriately Analytical Process PT as you would a patient sample POST Enter Results, Sign Attestations Send Results to PT Test Provider 13

Prioritize Failure Modes and Risks Use a Scale 1 to 3, 1 to 5, or 1 to 10 Possibility of Occurrence Severity of the Consequences Detectability (the higher the detectability the lower the score) Priority Risk Number (PRN) Criticality Index RPN = Severity x Occurrence x Detectability Severity and Occurrence can also be evaluated without detectability. 14

Redesigning the Process Process Redesign Tips Focus on critical elements Research best practices Literature search Manufacturer s Recommendations Network with colleagues and professional organizations 15

Decide the Level of Redesign Reduce occurrence Increase detectability to prevent error Mitigate the effects of the error Methods to Redesign the Process Reducing Variability Standardizing the Process Simplifying the Process Using Technology to Automate Build in Fail Safe Devices Documentation 16

Methods to Redesign the Process continued Provide comprehensive education Establish a culture of teamwork WWW Action Plan WHO WHAT WHEN 17

Competency Assessment 18

Competency Assessment (Non-Waived) Competency assessment includes: Direct observations of routine patient test performance, including patient preparation, if applicable, and specimen collection, handling, processing, and testing and monitoring, recording, and reporting of test results Review of intermediate test results or worksheets, quality control, proficiency testing, and preventive maintenance performance Competency Assessment non-waived (continued) Direct observation of performance of instrument maintenance function checks and calibration Test performance as defined by laboratory policy (for example, testing previously analyzed specimens, internal blind testing samples, external proficiency, or testing samples) Problem-solving skills as appropriate to the job 19

Use WWW to Assess Competency WHO WHAT WHEN WHO Can Assess Competency An individual qualified by education, experience, and knowledge related to the skill being reviewed assesses staff competence. Qualifications for this individual are described in the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) under Subpart M: 'Personnel for Nonwaived Testing,' 493.1351-493.1495. A complete description of the requirement is located at http://www.cdc.gov/clia/regulatory 20

WHAT Tests to Assess CHECKLIST All Laboratory Tests (or Test Systems) Performed WHEN to Assess Competency (non-waived tests) At least Semiannually for new staff and Annually thereafter 21

Resistance Analysis 22

THANK YOU 23

These slides are current as of 03/05/2015. The Joint Commission reserves the right to change the content of the information, as appropriate. Failure Modes Effects Analysis in Healthcare, Proactive Risk Assessment, 3 rd edition, The Joint Commission 2010 Perspectives; The Joint Commission Best Practices Library; The Joint Commission Center for Transforming Healthcare; The Joint Commission Contact Information: The Joint Commission (630) 792-5000 or Joint Commission Customer Service at (630) 792-5800 apaiano@jointcommission.org 24