PEPFAR Quality Control and Method Validation Activity 13 Handout 3: QC Follow Up Visit Report

143 Handout 3: QC FOLLOW UP VISIT REPORT 1306 Facility Name: SLMTA Trained Person(s) Title Start Date: End Date: 1. Improvement Project: QC Program for 2 Workstations QC Workshop Visit #1 Date of Visit Facilitator Name QC Checklist Item Yes No Comment Checklist Points Is there documentation that Please rate progress 0-5 (0= No meeting, 3 =Meeting with no laboratory staff has been documentation & 5 =Meeting with documentation) Score = informed of the project? Is there documentation that Please rate progress 0-5 (0= No meeting, 3 =Meeting with no upper management has documentation & 5 =Meeting with documentation) Score = been informed of the project? Is there documentation that Please rate progress 0-5 (0= No updates, 3 =Updates with no project updates have been documentation & 5 =Updates performed on a weekly basis) Score = forwarded to the mentor? Does the site have a written Please rate progress 0-5 (0=Cannot locate plan from workshop & plan that indicates they 5=Plan has been updated since returning to site) Score = understand their project? Is the plan detailed and Please rate progress 0-5 (0=Cannot locate plan from workshop & explicit so that 5=Plan is implantable in its current state) Score = understanding is clear? Is the whole laboratory Please rate progress 0-5 (0=No involvement & 5= Tasks have been team involved in the assigned with some evidence of completion) Score = improvement project? Has the SEc baseline data Please rate progress 0-5 (0=No baseline data & 5 excellent data been collected & analysis present with analysis done well) Score = completed? HILS1746 Effective Date: 12/6/2016 144 QC Checklist Item Yes No Comment Checklist Points Have positive improvements Please rate improvement from 0-5 (0=Not implemented & 5 been implemented, and if excellent improvements) Score = so, what are they? Were improvements Please rate effectiveness from 0-5 (0=Not effective & 5 very effective? Describe. effective) Score = Total Score out of 45 possible points QC Workshop Visit #2 Date of Visit Facilitator Name QC Checklist Item Yes No Comment Checklist Points Is there documentation that Please rate progress 0-5 (0= No meeting, 3 =Meeting with no laboratory staff has received documentation & 5 =Meeting with documentation) Score = updates on the project? Is there documentation that Please rate progress 0-5 (0= No meeting, 3 =Meeting with no upper management has documentation & 5 =Meeting with documentation) Score = received updates on the project? Is there documentation that Please rate progress 0-5 (0= No updates, 3 =Updates with no project updates have been documentation & 5 =Updates performed on a weekly basis for the first two months and periodically thereafter) Score = forwarded to the mentor? Does the site have a written Please rate progress 0-5 (0=Cannot locate plan from workshop & plan that indicates they 5=Plan has been updated since first site visit and recommendations understand their project? have been incorporated into the plan) Score = HILS1746 Effective Date: 12/6/2016 145 QC Checklist Item Yes No Comment Checklist Points Is the plan detailed and Please rate progress 0-5 (0=Cannot locate plan from workshop & explicit so that 5=Plan is implantable in its current state) Score = understanding is clear? Is the whole laboratory Please rate progress 0-5 (0=No involvement & 5= Tasks have been team involved in the assigned with some evidence of completion since the last visit) Score 11 improvement project? Has the SEc baseline data Please rate progress 0-5 (0=No baseline data & 5 excellent data been collected & analysis present with analysis done well) Score = completed? Has laboratory management Please rate improvement from 0-5 (0=Not implemented & 5 designed and monitored excellent improvements) Score = staff adherence of the QC protocol for the workstations? Have positive improvements Please rate improvement from 0-5 (0=Not implemented & 5 been implemented, and if excellent improvements) Score = so, what are they? Were improvements Please rate effectiveness from 0-5 (0=Not effective & 5 very effective? Describe. effective) Score = Total Score_ out of 50 possible points HILS1746 Effective Date: 12/6/2016 146 Quality Indicators Are the following QI in place and being monitored Yes NO Comment SEc or Sigma EQA Sample Rejection rate Stock Outs Customer Complaints TAT What coaching was provided during this visit First Visit: Second Visit: Site visit Summary report First Visit: Second Visit: HILS1746 Effective Date: 12/6/2016 147 Follow up actions First Visit: Second Visit: HILS1746 Effective Date: 12/6/2016