PEPFAR Quality Control and Method Validation Activity 13 Handout 2: Improvement Project Assignment

IMPROVEMENT PROJECT ASSIGNMENT You have six months to implement a complete QC program (Steps 2-13) for two quantitative analytical workstations at your site. At the end of six months, your deliverables for this improvement project are: 1) Apply appropriate QC rules to alert when a medically significant change has occurred in the measurement procedure. 2) Use quality indicators (QIs) to monitor the analytical performance (accuracy and precision) of the workstations on a monthly basis. 3) Document the corrective action taken when alerted by QI or QC rule. You will receive two supportive site visits from the SLMTA team to assist you with this project. You are expected to file project updates (in person, by phone, or via email) every week with your assigned mentor for the first two months and then every three weeks thereafter. Evidence of these updates will be reviewed when the assignment is validated by the SLMTA team. At the conclusion of six months and following the validation of the successful implementation of your IP, the SLMTA team will award you a Certificate of Completion. Step Workshop Materials Challenges/ Recommendations SEc Spreadsheet 1. Communicate IP assignment SLMTA training materials Recommendation: Ensure that documentation of from QC workshop with staff meeting minutes is available. staff and hospital management 2. Select appropriate control Job Aid: Selecting Challenge: No QC materials or QC materials not Complete Columns A, B, materials Appropriate Control suitable for laboratory needs-– begin advocacy C, and D Materials (606) with upper management. Recommendation: Ensure that you have sufficient stock of the same lot number of control materials to adequately monitor the measurement process. 3. Select %TEA  Job Aid: Using TEA (813) Recommendation: The easiest approach is to Complete Column G and  Job Aid: Sample TEA begin with the guidelines from your PT provider; I Calculations (814) if you have no PT provider, then use the CLIA Descriptions for Column I  Job Aid: Westgard allowable error limits. are located below the Internet Site (1008) table HILS1770 Effective Date: 12/06/2016 Step Workshop Materials Challenges/ Recommendations SEc Spreadsheet 4. Determine current SEc  Job Aid: Parallel Testing Recommendation: If the measurement procedure Complete Columns E, F, when instrument is stable (607) has been stable for a month, use the existing J, and K  Job Aid: How to Calculate data measurements to calculate the current TE (705) Descriptions for Column mean and SD. F are located below the Challenge: If no QC materials –- begin precision table studies using patient samples, if possible, and assume bias is zero until you obtain more information; continue advocating for QC materials. Challenge: If no EQA program – begin advocacy with upper management; use package insert data, especially if verification studies were never performed. 5. Select appropriate QC rules  Handout: Sigma Metrics Challenge: If a method cannot be controlled with Complete Columns M and total number of control QC Selection (1003) QC rules (SEc = 0) – immediately stop patient and O measurements  SLMTA training material testing, implement the improvement method using the PDCA cycle for the analyte. 6. Create QC charts Job Aid: Creating a L-J Chart Challenge: Analytical Staff does not understand (511) basic QC – begin informal QC training with staff. 7. Determine frequency of  Job Aid: Frequency of Recommendation: Ensure that documentation of supervisor chart review Chart Review (909) each review is performed that includes date and  SLMTA training material initials of review. If corrective action is warranted, ensure follow-up actions are also documented. 8. Investigate low SEcs (SEc ≤ SLMTA training material Recommendation: Implement the improvement Circle Rows to be 2.0) measurement method using the PDCA cycle for the analyte; investigated procedures your investigation into the problem of low SEc may serve as a guide with Steps 9 to 11.  9. Develop the QC protocols Job Aid: Defining QC Recommendation: Protocols (407) Begin with process mapping for the workstation and your current process and refine and standardize  standardized process to Job Aid: Daily QC as needed. Investigational Template investigate QC rule (910) violations from daily, summary, and peer-review QC data 10. Identify needed QC policies SLMTA training material Recommendation: Use process mapping to and procedures to be identify document gaps in the QC process. created HILS1770 Effective Date: 12/06/2016 Step Workshop Materials Challenges/ Recommendations SEc Spreadsheet 11. Development of a formal SLMTA training material Recommendation: Include a quantifiable QC training program for measurement to evaluate the effectiveness of current analytical staff and your training program. new-hires Recommendation: Review job descriptions for the analytical staff and competency assessment for the workstation. 12. Continue to monitor the Challenge: SEc changed significantly -– adjust SEc on a monthly basis to selected QC rules if needed to provide adequate determine the current error detection; investigate the poorer method’s performance performing methods using PDCA. 13. Utilize monthly SEc as a Recommendation: Use the QI to monitor quality indicator (QI) for analytical performance of your site., If any SEc the analytical phase of falls below the defined QI target threshold, then testing investigate the method for the root cause of the problem. Recommendation: Include SEc summary as part of your monthly management report to the hospital administration. After the 6-month IP is completed, take the lessons learned from Steps 1-13 and begin working on another analytical workstation until all quantitative analytical workstations are being monitored on a monthly basis. HILS1770 Effective Date: 12/06/2016