PEPFAR Quality Control and Method Validation Activity 13: Part 1

lype and number number Type and number of Type and number Type number of ype and number sampks number sampks (k sampks +0 ase-d +0 samp s PRINCIPLES OF ASSURANCE 3) QC used QC used QC used +0 to beg used +0 Process Map a Complete QC Program for Two Workstations Mp a Complete QC Program tor workstations eva\uave eva\uaVe evaluaVe evaluave evaluaVe evalua+e evaluave evalua+e QC Quality 3) QC used +0 Worksheet 1: Ma in Your IP Activity: Process Mapping Your IP IDe of periodic review Apply appropriate Improvement Project q) The of peviodlC review for q) The OF periodic review for q) The of periodic revtew for q) The of peqiodlC review for q) The of review q) The of revtew for q) The periodic review q) The of periodic revtew of pevtodlC revtew Quality luality Quality. q)e of periodic review The of periodic Tevtew q) The of periodic review for [D The of periodic review The of pevtodjc review The of periodic review for The of pevtodjc Tevtew The of petiodic review for LD The of periodic Tevtew The of review The of periodic review Quality The of periodic review LD The of periodic review for The of pevtodlC Tevtew q) The of periodic review of periodic vevtew The of revtew q) The of periodic Teview for The of review OF periodic review for Quality The Frequency of periodic review The of peviodlC review The OF periodic review for q) The OF periodic review The of periodic review Laboratory N Goals Quality The of petiodic review 1.4 Are policies and standard 7.4 Are budgetary projections based on 7.4 Are budgetary projections based Are potiCies•nd standard Quality Workshop Objectives evalua+e LD The of periodic review OUTCOME Goals INPUT PROCESS / 8.10 Are OC results monitored and reviewed q) The of periodic veview for 8.10 Are QC results monitored and reviewed 11.10 Are QC results monitored and reviewed OUTPUT q) The OF Teview Laborator Laboratorv of Laboratory. Laborator QC rules to alert no and *rends Laboratory Laboratory Laborator Laboratory, Quality Goals Goals The 09 periodic review The of Tevtew Laboratory. Laboratorv Go s Goals persaqnei. facility and The OF review The 09 Tevtew personnel, test, facility and operatingorocedures (SOPs) for on personnel, test, facility and operating procedures (SOPs) for and fids Quality and Goats Goals def Results The of revtew The of periodic Tevtew defecflnj and +cends defec+lnj *rends defecflnq and +cends defeciin and +cends defecåinq defec+inq and *rends defec+lnj and *rends defecfinq_ and *rends defec+inj and *rends .aboratory defecåinj and +rends defec+lnj and +cends defecHnj and *rends -aboratory and *rends defec±ånj defec±inj and +cends defecåinj and *rends defec+inj and +cends defec+inj and +rends s and +cends and *rends Ys and +cends defe s and *rends defec\inj and +rends defec+lA3 and +rends defec\inj and +t-ends and The of periodic review q) The of periodic review and *rends de and +cends (biases, shifts, trends, and Levy-Jennings (biases, shifts, trends. and Levy-Jennilgs The of review and +cends and +rends o and *rends and *rends and *fend s INPUT PROCESS and +rends INTPUTS OUTPUTS Process M3p Complete QC Program workstations Process Map Complete QC Program M.p a Complete QC Program tor Worustat•ons a Complete QC Program 'or worustat•ons and +rends Activity: Process Mapping Your IP Activity Process Mapping Your IP equipment needs, and quality laboratory fupctions current, functions cur.-enl. Laborator laboratory functions current, when Your Laboratory Laboratorv Results Goals Goals ecfinj and *rends s and +cends Goals Process Map Complete QC Program for Two Worsstat•ons Results Process Map Complete QC Program for Two Workstations Map a Complete QC Program tor Two Workstations b) The achons Results defec*inj Activity: Process Mapptng Your I Activity. Process Mapprng Your IP Activity- Process Mapp•ng Your IP Process Mapping Your IP "itv: Process Mapping Your IP u charts)? Is there documentation of corrective Key Message ... Assignment analytical the analytical ±ahen when charts)? Is there documentation of charts)? Is there documentation of corrective charts)? Is there documentation of CO)rective Goals Labs are vital. S ±Qhen when resul+s S +Q6en when resul+s ' and +cends appropr.ate appropniate ur ac b) The achons +Q16en when b) The achons when resul+s defecfinj and +cends defec+in def b) The when resuH-s b) The achor- b) The b) The achons ±Q6en when b) The achons fQ6en when resul+s Results Laboratorw. defecåinj an b) b) b) INPUT PROCESS PROCESS b) and +cends s. and *rends fid +rends d +cends when b) b) The achons when b) The achons ±Q6en when I Knowledge Analytical and +rends 1) Communicate IP assignment from QC workshop with staff and as€„urance procedures and assu rance procedures and assurance procedures and and @vaifabfeand approved by availabe available and approved by ons ±ahen when when a medically The ±QKen when resul+s b) The achons ±Qhen when The achons ±Qhen when resul+s action taken when alerte y ±Qhen when resul+s chons ±QKen when thons +Q6en when resul+s -Hons ±Qhen when .hons ±Qhen when resul+s ±Q16en when resul+s Goals The achons +Qhen when The achons ±Qhen when achons when achons ±Qhen when achons +Q6en when achons ±Q6en when resul+s -The achons +ahen when e achons ±ahen when resul+s achons +Qhen when achons ±QKen when acton ±aken when alerte+s chons +a6en when +Q6en when resul+s ions ±QHen when resul+s en when resul+s chons when e achons +Qhen when Providers-gain— nchons ±ahen when CA-tons when resul+s Hons +Qhen when resul+s e achons when taken when alerted OUTPUT OUTCOME Yen when resul+s hen resul+s when resul+s n when resul+s when resul-ks QC to QC rules to when Results b) The and *rends S when resul+s Ken when resul+s System Labs are vital. Labs are vita[ FYs and +rends and {rends s and *rends and *rends and +rends - action when qualitygoniro\ye$uåsexceeci the corrective action when quality control results action when quality control results exceed the quality control results exceed the b) The achon Frequency c; l) Frequency • Apply appropriate QC 1. Apply appropriate QC rules to gained from Frequency VOu dog ahen s€hen resal+s Focus on the needs of the users b) The ad-ions maleria's? materials? hospital management authorized personnel? What will you do? vou dog dog do? Purpose What ions when resul+s Puroose purpose wahen CA-ions +Qhen when resul+s chons +Q6en when Hons ±Qhen when A-ions +Qhen when fa6en when resul+s when exceed Purpose Puruose when when resul+s b) when resul+s acceptable range in a timely manner? nce in a exceed the acceptable range in a timely Type mdnurr,ber Y number nu.mber QC workshop rules to alert when a accep+Q61e achcns 4) 2) exceed -d QQQep+Q61e -d QCQep+061e exceed exceed accep+oåle exce exceed QQCep+QåIe d accep+ohule QCQep+061e en when resul+s -ed qccep+061e 3) hen when resul+s QQCep+Q61e 6en when resul+s qccep+Qhule OQQep+061e n resul+s significant change Handouts, manner? medically significant confidence with the occurred To understand and apply Statistical QC (SQC) Working in one of 3 groups, you will: qccep+oåle OCCep+061e exceed QCcep+Q61e — exceed exceed qccep+al QQCep%hoIe PEPFAR QC Workshop Mapping a process is an Handouts, change has occurred ex Quality Worksheets, WHERE WE ro WHERE WHERE WHERE WE WHERE job aids, and Laboratory. Labor atom Laboratorn Laboratorw_ Laboratory Laboratorw LaboratorV_ Laborator Laboratorv Laboratory, Laboratorv. in the measurement LaboratorW Goals S ro BE Goals Goats Performing the riphl; QC Perforrnirng the right rid Support from Hospital Management Labo atory Goa'S Goals . has occurred excellent managerial tool Participate in the discussion led by your What VOu need? What VOu need* What need? What Will need? at VOu need? need? Improving tb Improving tv Focus on processes to increase What improving Results You have six months to implement a Quality worksheets WHERE WE EXPECT ro BE procedure. WHERE WHERE WE EXPEC/, WHERE WE WHERE WE EXPECT What will vou need? What Will vou need? WHERE WE EXPECT ro BE WHERE WE ARE WHERE WE EXPEcr ro. WHERE WE EXPEcr r WHERE WE EXPEcr r, WHERE WE EXPECT ro BE WHERE WE EXPEcr ro B., RE Outcome Pencils WHERE WEARE WHERE WE AXPEr WHERE WE EXPECT ro WHERE WE ARE ARE E WHERE WE ARE WE E-APEcr ro B WHERE WE E WE ARE WHERE WE EXPEC E EXPECT BE WHERE WE ARE WHERE WE EAPEcr T BE WHERE WE ARE WE ARE WHERE WE ARWE WHERE WE ARE WHERE WE ARE WHERE WE ARE O BE WHERE WEARE ro BE WHERE WE ARE WHERE WE ARPEr WHERE WE AHERE WHERE we ARE E WE EXPECT WHERE WE ARE WHERE WE that WHERE ARE WHERE WHE ARE E EXPECT ro BE WHERE Tne achons Tne achons fa6en Type EXPEcr ro BE WE EXPECT ro BE WHERE ARe Tne laboratory results to EXPECT ro BE WHERE WE EXPECT TO BE , WHERE. cr ro BE WHERE EXPECT BE WHERE WE EXPECT ro BE., WHERE WE ro BE , RE EXPECT ro BE WHERE WE ro BE WHERE WE EXPECT ro BE, WHERE WE EXPECT Eo BE , WHERE WE EXPEcr ro BE, - W'E EXPECT ro BE, EARE —WHERE WE EXPECT ro BE , WHERE WE EXPECT TO BE INTPUT OUTPUT —WHERE WE EXPECT ro BE WHERE WE EXPECT ro EE The faKen WHERE WE EAPEcr T WE EXPECT ro BE WHERE WE EXPECT ro BE , .R, WHERE WE EXPECT ro BE , quality of pat INTPUT l/ fahen WHERE WE EXPECT ro EE , WHERE WE EXPECT ro BE WHERE WE EXPECT ro achons fahen achons ±ahen ac+ons achons faKen WE ARE ARE WHERE WE EXPECT ac+'ons achons achions WHERE WE ro EE 'WHERE WE EXPECT ro BE , PROCESS ROCES ROCESS WHERE WE ro BE WHERE WE EXPECT ro BE , WHERE WHERE WE , ro WHERE WE EXPECT ro BE WHERE WE EXPECT ro EE. WHERE WHERE WEARE WHERE WE ro BE • WHERE WE EXPECT WHERE ARE WHERE WE ARE from QC • Use quality indicators 2 Use quality indicators (QIs) to WHERE WE EXPECT ro EE , WHERE WE EXPECr ro BE , WHERE WE EXPECT ro BE , to begin the planning stage HERE ro ro WHERE. WHERE WE EXPEcr ro BE 3) WHERE WE W WE ARE Quality WHERE WE EXPECT ro BE -—eamieader. team leader. WHERE WE ro BE WHERE WE ARE care deliverec• care deliverec i WHERE WEAR WHERE WE EXPECT WHERE ARE WHERE WE ARE WHERE WE WHERE WE ARPE WHERE Control WHERE WHERE WE ARE WHERE WE ARE E ARE ARE , WHERE WE ARE ro BE Control WHERE WE EXPEcr ro BE WHERE WEARE WHERE WE ARE Control WE ARE WHERE WE EXPECT ro BE we,' WHERE WE EXPECT ro B RE WE A RE i WHERE ARE i WHERE WE worksheets workshop ARE ERE WHERE WE -RE WE ARE (QIs) to monitor the Improvement E WE ARE WHERE we EXPECr ro , RE EXPECT ro BE WHERE WE EXPECT ro BE , WHERE WE EXPECT ro BE BE WHERE WE ARE WHERE WE ARE* WHERE WHERE ARE WHERE WE ARE J WE ARE ARE ( WHERE WE ARE ) WHERE WE A RE w ARE It WHERE ARE care dehverec WHERE WE WHERE WEARE WHERE WE BE WHERE WE ARE WHERE WE ro BE WHERE WHERE WE ARE WHERE WE EXPEC iystegp,r care WHERE ; WHERE WHERE WE EXPECr WHERE WHERE WE ARE Laboratoryv WHERE WHERE WE Laboratorv. WHERE WE EAPEcr T ARE WHERE WE ARE WHERE WHERE WE ARE ua i of a project. ua analytical WHERE WHERE WE ARE Knowledge Quality Control i WHERE WE WHERE WE A RE WHERE WE Control Il WHERE ARE treat their patients 1. Apply appropriate QC rules to WHERE , WHERE WE ARE Markers cand the productivity of work WHERE WE ARE WHERE WE AXPEr WHERE 3) Use the information gained from the last Contrnuouslv Syste YSte yste Fys»te Fyste Fystem Fystem System SLMTA performance System ystem Fystem Syste_ Systenv Document Control Contrnuously alert when a medically gained from System achions ystem Use QIs to monitor alert when a medically significant Continuously complete QC program Training (accuracy and Improvement Project Assignment corrective action • Tape Tape Tape Systed QC (QC) (QC significant change has significant change significant change hæ TESTING Q. QC (QC) QUALITY five workshop days to identify the steps. change has occurred in the hange has occurred in the Ychange has occurred in the precision) of the action taken when alerte y taien when Alerted when • Monitor and evaluate quality control in your diagnostically instead Complete QC Complete occurred in the measurement occurred in the meæsorementÅ o k ho o ho k ho ho Wor o Complete eneasurement procedure. ineasurement procedure. QUALITY easurement procedure. QI QC rule or QC rule or QC rule. workstations on a Qi or QC Qi or QC rule What will you need? What will you needo? What Will need? you need? CONTROL analytical the analytical Analytical PATIENT Implement a Total QC Stra eg Implement a Total QC Strateg improving the Improving tb PATIENT CONTROL Messayes i procedure. Messages messages procedure. PROFICIENCY 'l 2. Use quality indicators (QIs) to Using Worksheet 1 map the process steps monthly basis. QUALITY TESTING (PT) TESTING Use data to improve services Desired Outcome QUALITY QUALITY (QC) QUALITY SAMPLE O' SAMPLE (QC) TESTING 2. Use quality indicazars LA's) to QC se quality indicators (QIs) to 2 Use quality indicators (QIs) to 2. Use quality indicators (QIs) to 2se quality indicators (QIs) to 2. to SAMPLE QUALITY • Document the Program monitor the analytical performance SAMPLE SQC. QC PROFICIENCY • PROFICIENCY* SAMPLE OFICIENCY PROFICIENCY PROFICIENCY of just empirically. for ana;ytic QUALITY Handouts -Z Handouts, for two quantitative analytical CONTE —A analytical CONTROL CONTROL.. CONTROL CONTROL • Handout 1 QUALITY I PATIENT performance performance on a PATIENT. PATIENT CON CONTRO.- CONT F PATIENT •hat are needed be performed at a site. that are needed to be performed at a site. CONT' onitor the analytical the analytical onitor the anal ]tical corrective action (#ccuracy and precision) of the (accuracy and precision) of the 'ROFICIENCY PROFICIENCY (accuracy and n) of the The fie Tie CONTROL CONTRC— W0E'kshe Worksheets, Workshoets Worksheets workshopts STING (PT) •ESTING (PT) TESTING (PT) TESTING TESTING (PT) TESTING (PT) t TESTING TESTING (PT) ING (PT) (PT) Key Messages Messages messages -y messages Messayes •he sages taken when alerted by action taken when alerte y SAMPLE lessages (QC) performance (accuracy and ENCY CONTROL (QC) -E SAMPLE (QC) . tessages 'S workstations on a monthly basis. orkstations on a monthly basis. s an nthly basis. SAMPLE ass ages i Issayes ssayes PATIENT +ssayes rESTlNG (PT) PATIENT (C Program Worksheets • Worksheet 1 worksheets, worksheets Worksheets, Work Job Aids s ayes ages essayes ess ages sages ages ey gessages e j essayes essaqes ey essays ess ayes essayes messages OSS ages ossages sages (QC) (QC) QI or QC rule. ey essayes Messages Improvement Project Assignment Write the group's responses on the SAMPLE precision) of the workstation SAMPLE - SAMPLE monthly basis D si n n effecti e QC ro am in your 3. Document the corrective action . Document the corrective action Use teams to improve quality b) SAMPLE SAMPLE (QC) SAMP SAMPLE SAD SA SAF on a monthly basis. (QC) (QC) taken when alerted by QI or QC rul . when )jyQI or Q workstations at your site. SAN • Pencils Q. a. essayes messayes ess s provided blank paper; one step per paper. essayes Key Messages 3. Document the corrective 3. Document the corrective action Educate Analytical Staff sac: SCC. — sac. SAMPLE Laboratory. laboratory. SAMPLE veCSton eclSton an treatment results in a an Laboratory laboratory. the laboratory an taken when alerted action taken when alerte y acton ±aken when alerte+s taken SLMTA vs Ston an • Blank paper 10) and an ion accuracy and y and d an The accuracy and acy and an and@qec'ßon eclslon Ston SLMTA Training Tape the papers in the correct order in the the papers in order in the 'Slon Abs QI or QC rule. Training Key Message Key message Key Messages ey essayes • Improve communication f' Messages 1.6 n descöl b es descfl b es descflbes descft b es • Markers Markers Key hesso designated wall space for your group (5 designated wall space for your group Sys+em descftbes sysYem describ es b es bes Sys+em describ es y*em descfl b es scft b es •yah-em b es escri b es Sys+em b es Sys+em descftb es m descftb es SPFem describes sysfem es ys+em descfl b es '-em b es • Transfer basic QC knowledge to your analytical 12) Fem descfl b es b es em descftbes em descftb es em descflb es •m descftb es m b es descfl b es b es ore cost-effective describes descflb es Document the Sys+em descfl b es Sys+em descflb es Document WHERE es fie specificåiens on an fie minutes). • Tape defines fie ARE WHERE WE ARE Key Messages WHERE WE ARE RE WE ARE ERE ARE , WHERE WE ARE WHERE WE ARE WEARE WHERE WE Eo WE 3.6 Is there a system for competency assessment of EARE WE ARE RE Messages E WE ARE and — and staff in your laboratory. corrective action and efficient descft b es OF m b es b es escfl b es specific beins +0 make specific bein9 to maKe personnel (both new hires and existing staff) and does it personnel (both w hires and existing staff) and does it personnel (both new hires and existing staff) and amlyfe beins +0 make nd Be prepared to defend your responses and and and and and na and WHERE WE ERE WE ARE WHERE WE E WE ARE WHERE WE include planning and documentation of retraining and does it include planning and documentation of IS WE WE ARE 13) Utilize monthly SEC as a quality indicator (QI) for the analytical defines fie defines —WHERE we EXPECT ro B ARE amly+ioal cliniQ/ty fie WH taken when alerted acton ±aken when alerte+s Resul+s Results - specificat during the debrief. durin the debrief. retraining and reassessment, when indicated? s the reassessment, when indicated? when is IS Is hase of testin —WHERE We exprcr r and WHERE WE EXPECT ro BE , IS the Q. Il IS RE EXPECT ro BE IS IS IS fie —"WHERE WE EXPECT ro QC cm reqec+ —'WHERE IS fie QC cm eßechely feqec+ —th#ERE IS defines —WHERE WE EXPECT ro *WHERE IS •r ro BF IS WHERE WE ro DE WHERE WE EXPEC NHERE WE EXPE WHERE WE ro WHERE WE EXPECr EXPECT ro ERE WE EXPECT ro WHERE WE expecr ro —WHERE WE EXPECT ro B WE EXPECT ro 8E ERE WE EXPECr ro +0 fro F WHERE Expecr WHERE WE ro F WHERE EXPECr ro WHERE -WHERE EXPECr ro +e ro WE EXPECr ro •r ro ro VE ro +e beins ro B WE EXPECT ro WE EXPECT ro ro beins SAC. sac.- S(ACL sac. SAC. sac. sac. S(AC. SQC. and SAC. OF SQCI SAC: PAT. SQCJ by QI or QC rule S OF SAC. SAC. sac: sac. +0 Abs specific +0 specific WHERE limi+s specific specific +0 change IS Anamly+icql Anamly+ical amly+ioal +0 +0 Anamly+icql amly±icql cliniQlly Analytical analytical +0 WHERE defines fie fie Activity 10: Improvement Project Assignment 95 minutes WHERE Is no-k WHERE WE aruly±i0Ql Introduction Is amly\-icql amly±-ical c fie WHERE WE WHERE WHERE WE VHERE WE HERE WHERE WHERE WE RE WE WE we