PEPFAR Quality Control and Method Validation Activity 13: Part 2

Quality lype number o current quality training determine Current analytical staff and OC be created procedures System he be created created current (QI) the sutnmary, and pet -review current Staff and method's current 3) QC used +0 System QC used av+s 3) QC used q) The of periodic review q) periodic review Analytical training QC Checklist Item Yes Comment At'Ofithe Road to Laborakok9 'Analytical QC Checklist Item Yes NO No Comment Checklist Yes ) frequen Job Aid 2: Ste sfor Develo in a QC Strate QC IMPROVEMENT PROJECT ASSIGNMENT Checklist The of periodic review QC FOLLOW UP VISIT REPORT nalytical phase of ( Analytical staff Quality The of periodic review for The of periodic vevtew current Points Comment Quality In Points training q) The of penodlC review Points Goal Gold and testing Frequency testing periodic review Quality On the Road to Laboratory Improvement Have positive improvements plan from workshop implemented 5 from workshop Is the plan detailed and yste Have positive improvements oals Laboratory 5 P's System OC SLMTA Trained Person(s) Facility Name: Facilitator Name Title Goals Develop the QC protocols eva\aaVe Celt OC excellent improvements) Score S=PIan implantable in its current state) Score is implantable in its current state) Score = l) Fcequer created Laborator) been implemented, and if Goals been implemented, and if explicit SO that explicit so that and *rends Select a test. 2) Type aod 2) Type and You have six months to implement a complete QC program (Steps 2-13) for two quantitative analytical workstations at your site. Type and Facility Name: Title of periodic review defec+inj and *rends *oais so, what are they? Development of a defec+lnj and +cends so, what are they? understanding is clear? understand their project? understand thei project? current Quality Goals Results The of peviodic review Quality The of periodic review At the end of six months, your deliverables for this improvement project are: for improvement q) The of periodic review Laboratory Select appropriate control materials. Select appropriate control materuales. Goals and Results 3. Results System Communicate IP achons +QKen when resul+s achons ±Qhen when achons ±QKen when Quality Goals Continue to monitor Investigate low achons when Quality 1 Analytical chons ±ahen when Identify needed On the Road to Laboratory Improvement Restults Laboratory On the Road to Improvement Determine your TEA limits Determine Goals— Results Laborator Goals_ e achons {aben when resul+s Remember the 5 P's Remember the 5 Ps Quality Goals Laborator) Laboratory eval'ka evaluc eval„c defecfinj and *rends achons +Q6en when System Date defecåinj and +cends System system iystem Monthly Logo: Monthly SEC Logo: Laboratory Analytical l) Apply appropriate QC rules to alert when a medically significant change has occurred in the measurement procedure. Purposeful defec+inj and *rends Frequency . and +cends Frequency Frequency l) Frequency Select appropriate Monthly Log Monthly Monthly SEC Logo Monthly SEC Were improvements Monthly SEC Log from 0-5 effective S 0-5 S Were improvements End Date: End Date: Start Date: Goals LD a. Select the TEA for the test; note the resources used for the selection. exceed qccep+oåle Laborator Results Results System l) weed effective? Describe. ceed i,) Type number Quality The End Date: ed Start Date: 2) Use quality indicators (QIs) to monitor the analytical performance (accuracy and precision) of the workstations on a monthly ( accuracy and preci Laboratory effective? Describe. number number b) The achons ±Q6en when Laboratory b) The achons ±ahen when re b) The achons when Instrument been La to [Laboratory rate 5; have Department management instrument i Instrument Ianstrument Depasurtment Instrument An Is the whole laboratory b. Select the Target Value (Clinical Decision Concentration) for each control; note the resource used for the selection. Improvement Project: QC Program for 2 Workstations a. 2. 1. c. Results with evidence Of completion the with Of completion the Goals Purposeful Laboratory basis. team involved in the been informed of the defec\ 4. 1. Laboratory Results Goals Quality SD OC c. Calculate the TEA in units. c, Calculate the TEA in units, improvement project? Results 3) Document the, corrective action taken when alerted by QI or QC rule. 3) Document the corrective action taken when alerted by QI or QC rule. Quality Quality Quality quality yste Signature Date yste defec± orkshop Visit Date of Visit QC Workshop Visit QC Workshop Visit Date of Visit Date of Visit Facilitator Name Planning Preven+ Determine current method performance Taking a turn tow Taking a turn toe Taking a turn toe Taking a turn to: Laboratorv Laboratorw Laboratory* Taking a turn toe: Taking a turn Taking a turn toe, Taking a turn toe v Taking a turn Taking a turn tow Signature Laboratory [Laboratory (Laboratory turn turn to", a turn toe Goals *oais Goals *oals Yoais Purposeful Qui WHERE WE EXPECT m WHERE WE ARE QC workshop Visit #2 QC Workshop Visit WHERE WE WHER E AP Planning Prevents Planning r ro WHERE WE ARE Labor atom WHERE Results ua It Results Results ro BE WHERE WE ARE WHERE WE EXPECT ro BE. the yste WHERE WE EXPECT ro BE WHERE WE ARE WHERE WE EXPECT ro BE , Quality Purposeful System exceed a. Calculate the current method's mean from a stable system for each control. Tne ua i You will receive two supportive site visits from the SLMTA team to assist you with this project. You are expected to file project achons ach-tons achons • achons achons rv Syste TEa TEa% Poor Performance. Goals Results Results 4. E WHERE WE ARE Poor Performa Performance. Poor WHERE WE ARE WHERE WE EXPECT ro BE SEc 2.0) ua it standardized process to Goals 4. updates (in person, by phone, or via email) every week with your assigned mentor for the first two months and then every three WHERE WE A RE Control QC policies and :ontrol WHERE WE ARE current SEC target larget Frequency (in TE on on Units) Target c. QC rules and total Checklist QC Checklist Item Checklist Total Score out of 45 possible points Yes Comment Yes No Comment Results WHERE Total Score out of 45 possible points please rate (O=NO data S data rate data S data Has the SEC baseline data Value WHERE WE EXPECT ro BE WHERE WE ARE WERE WE EXPECr ro BE WHERE WE ARE weeks thereafter. Evidence of these updates will be reviewed when the assignment is validated by the SLMTA team. Control Date WHERE WE EXPECT ro BE QC Checklist Item Comment Checklist Quality ua i Points With = Control Points ua units) SD units) Units) SEc Rule units Value TEa% Units Value # TEa% units) TEa% units) Units) TE units) SD unit s) units) unit s) s) sec SEC QC Rule ua 1 Sample Sample Units Sample Onits Value value Mean SD St) QC f, Instrument Analyte Instrument Analyte instrument Analyte Analyte units) Units) TEa% Moan S. t instrument Instrument Units Instrument An Inastrument Department been collected & analysis yste t, WHERE WE EXPECT WHERE WE ARE WHERE WE Please rate provre"s (O: No meetinz, 3 2Meeting with no Please rate progress (O: No meetinz, 2Meeting with no Please rate progress (O: No meetine, 3 2Meeting with no Please rate progress (O: No meetinz, 3 2Meeting with no Please rate progress No meetinz, 3 2Meeting with no Please rate prove" No meetine, 2Meeting with no ua Cont"ol immediately, verify your four Key Numbers of Quality, and fix the problem(s) System WHERE WE EXPEC System WHERE WE ARE Oyste ont ua i completed? Syste Select 0/0 TEA Control y Ste WHERE WHERE Control Date Please rate progress No meetinz, 2Meetin8 with no & S & S with with 0.00 ; Taking a turn towards QC Please rate No meetinz, 2Meetin8 with no 000, ty•b normal that WHERE WE ARE laboratory staff has been laboratory staff has becenved Con QUALITY At the conclusion of six months and following the validation of the successful implementation of your IP, the SLMTA team will Date S with documentation) S documentation) SD Control Select appropriate control laboratory staff has becenved laboratory staff has been 0.00 0.00 i 0.00' 0.00; 00 informed of the project? Planning Prevents Control SEc CONTROL WHERE WE ARE SD QUAL Workshop Materials workshop with staff QC workshop Visit #2 Date of Visit Date Of Visit TESTING Facilitator Name review informed of the project? award you a Certificate of Completion. QC Workshop Visit #2 Date Of Visit Date of Visit Facilitator Name Syste Quality D. 00 0.00? yste System basis to determine Date Q. Choose the appropriate Sigma-metrics QC Selection Tool for the number of controls used for the test. Choose the appropriate Sigma-metrics QC Selection Tool for the number of controls used for the test. PROFICIENCY PATIENT QUALITY QUALITY mease ratepogress No rneeting, 3 'Meeting with no 0-5 (O' No rneeting, 3 'Meeting with no (O' No rneeting, 3 -Meeting with no mease No rneeting, 3 -Meeting with no (O' No rneeting, 3 •Meeting with no (O' No rneeting, 3 *Meeting with no Is there documentation that Date System WHERE WE- QUALITY 0.01b SD yste TESTING SAMPLE PROFICIENCY PR SD QUA documentation S with documentation 5 with with & 5 -Meeting with documentation) Score rate progress No rneetine, 3 •Meeting with no QUALITY 4. CONTROL CONTROL Is there documentation that PATIENT PATIENT PATIENT Locate the Sigma-metric value on the Sigma-scale (scale at the top of the X-axis). value on the Sigma-scale (scale at the top of the X-axis). co Messages upper management has with upper management. from 0-5 & S & S Has laboratory management CON documentation & 5 with with TESTING TESTING (PT) PROF" 000 0.00 000, Control (QC) upper management has management excellent improvements) Score • SS ages PROFICIENCY been informed of the control materials SAMPLE CONTROL QUALITY TESTING Control PROFICIENCY PATIENT Validate the Sigma-metric against the SEC scale (scale at the bottom of the X-axis). Locidate the Sigma-metric value on the Sigma-scale (scale at the bottop of the X-axis). Validate the; Sigma-metric against the SEC scale (scale at the bottom bf the X-axis). SAMPLE SAMPLE SAMPLE CONTROL SAMPLE SAMPLE 1. PATIENT been informed of the 000, 0.001 0 001 0001 TESTING (PT) number of control project? staff adherence Of the QC TESTING charts QC Checklist Item _ Yes NO Comment SAMPLE Checklist (QC) Department Depasurtment QC Checklist Item PROFICIENCY Ysages Yes NO No Comment Checklist procedures to Systep Step System Challenges/ Recommendations Recommendations SEC Spreadsheet :' WHERE WE ARE CONTROL pATIENT PATIENT project? when instrument PATIENT Draw a vertical line from the Sigma-metric value to the SEC value. -16b -15b -18b protocol for the •n Points The The on Tie Poor Performance. Mess s PROFICIENCY 0-5 (0• No updates, 3 •Updates with no (0• No updates, 3 •Updates with no •e documentation that Is there documentation that messages workstations? SAMPLE 'lessages messages Messages (QC) PATIENT TESTING (PT) Assess probability of error rejection where the Sigma line intersects with the QC rule power curve. NO 3 With NO 3 with SAMPLE de SBS-em S "fem :ssa es SO st No SO st .essages . sages •ssages ssages ges essages ssages z ssages PROFICIENCY & a basis) & a (0• No updates, 3 •Updates with no basis. with & S with • SLMTA training materials Recommendation: Ensure that documentation of project updates have been Communicate IP assignment Communicate IP assignmnent documentation & S with • Monthly SEC Log 'J SAMPLE es PROF essayes based on Messages tea based on limits Ort limits based on based based On laboratory staff has received g based on Target Target based on Target baaed on Target on target Tat get on baned on band on baud on baaed on & a & a basis) g on violations from daily, on On con on 4. and hospital project updates have been I. Identify candidate QC rules in which Ped is 0.90 (90%). forwarded to the mentor? PROFICIENCY from QC workshop with staff meeting minutes is available. PATIENT updates on the project? SAMPLE updates on the project? TESTING (P T) Please rate improvement from 0-5 (O•Not implemented & S Have positive improvements TESTING (PT) TESTING TESTING ( T) Laboratory peer forwarded to the mentor? peer peer comparison companion . • . - staff and hospital g. Assess false rejection Oates of candidate QC rules from the table 0.05 (5%)]. Assess false rejection rates of candidate QC rules from the table 0.05 (5%)]. , • been implemented, and if c. •a 2. TESTING (PT) SAMPLE essays management Date Please rate progress (OzCannot locate plan from workshop please rate (0=Cannot locate plan from workshop rate progress (OzCannot locate plan from workshop & rate progress (O:Cannot locate plan from workshop & Does the site have a written SAMPLE so, what are they? Select the appropriate QC rule and total number of control measurements (N) that provide the lowest cost and are easiest to implement. sac. " sac: sac.-- sac. - sac:- sac. sac. - sac.- sac. sac: - 0-5 NO 3 with NO 3 with sue. SQC. Is there documentation that has Since to has updated Since has updated to has updated returning to has updated Since to 3. • , variation • Please rate progress (OzCannot locate plan from workshop & Step updated to 2. Does the site have a written 0-5 NO 3 with NO 3 with Is there documentation that . • plan that indicates they ROL documentation & 5 •Meeting with documentation) Score • has updated Since Site) George Klee Select appropriate control Job Aid: Selecting Challenge: No QC materials or QC materials not Complete Columns A, B, Comp SAMPLE documentation & 5 •Meeting with documentation) Score • with upper management. 4. 4. other plan that indicates they Pi from upper management has with upper management. 2. d. 4, PI 3. o. PI Pt 4. othet 4. othe' 3. 4. 0th'" 4. othet' Other 4, understand their project? informed of the project? understanding is clear? 2. On-going monitoring of QC Appropriate Control suitable for laboratory needs-- begin advocacy C, and D materials received updates on the The Qfld Mean received updates on the measurements vecÅSlon (QC) b. oti•cr S. otiu•r S. other 6, other other oti•cr othe•r Other S. 2. oth•er 20 Sample Materials (606) with upper management. project? a. Create the QC chart. project? summary, and peer-review Please rate progress (OzCannot locate plan from workshop please rate (0=Cannot locate plan from workshop please rate (0=Cannat locate plan from workshop please rate (0=gress CO—Cannot locate plan from workshop Please rate progress (O:Cannot locate plan from workshop & procedures plan detailed and Is the plan detailed and (OzNOt effective 5 be created Were improvements is stable review is implantable in its State) • is implantable in State) • is implantable in its • please rate (0=Cannat locate plan from workshop Is the plan detailed and Recommendation: Ensure that you have sufficient effective 5 accucacy QCd e accr- y it so that explicit so that accuracy QCCu SAMPLE effective? Describe. b. Determine how often a supervisor will review the QC chart, depending on the SEC or Sigma-metric. is implantable in its State) • management explicit so that m b es descft b es performance stock of the same lot number of control materials m descftb es m descflbes standing is clear? Is there documentation that Please rate progress No updates, 3 •Updates with no Please rate 0-5 No updates. 3 —Updates with no Please rate progress No updates, 3 -Updates with no Please rate progress No updates, 3 'Updates with no understanding is clear? 23 to adequately monitor the measurement process. accuracy progress involvement & have & have Is the whole laboratory project updates have been testing months and months and months and periodically assigned with Of • with Of • Is the who'e laboratory forwarded to the mentor? d. Develop a standardized process to investigate QC rule violations from daily, summary, and peer-reviewed QC data. team involved in the mm forwarded to the mentor? 2. Select %TEA Recommendation: The easiest approach is to Complete Column G and • Job Aid: Using TEA (813) • Job Aid: Using (813) Job Aid: Using TEA (813) with some Of completion) • team involved in the begin with the guidelines from your PT provider; • Job Aid: Sample TEA Job Aid: Sample TEA e. Monitor the accuracy, precision, SEC, and Sigma at least on a monthly basis. (QC) improvement project? The accuracy and if you have no PT provider, then use the CLIA Calculations (814) WHERE WE ARE no WHERE Descriptions for Column I and f. Take corrective actions as needed; continue to target poorly-performing analytical systems. — and allowable error limits. "easegate progress (O•No baseline data 5 excellent data mease rate progress (O•No baseline data S excellent data measerate progress (O•No baseline data S excellent data Please rate progress (O•No baseline data S excellent data Has the SEC baseline data • Job Aid: Westgard Job Aid: Westgard are located below the b. Messages present with analysis done well) Score • Please rate progress OS (O•No baseline data S excellent data Has the SEC baseline data an "case rate progress locate from workshop & and from been collected & analysis a. Internet Site (1008) table Please rate progress (O•Cannot locate plan from workshop & Does the site have a written analy±ic present with analysis done well) Score present with analysis done Score Score been collected & analysis ERE we ARE we ARE has updated Since first recommendations has Since first and has updated Since first visit and completed? plan that indicates they Total Score plan that indicates they have been incorporated into the plan) Score completed? Educate the analytical staff. understand their project? . WE EXPECT ro understand their project? RE WE expecr ro ro I. —'WHERE WE EXPECT ro g ERE EXPECr ro sac. I. WHERE SAC. OF SQC.