PEPFAR Quality Control and Method Validation Activity 12: Part 3

'Analytical Frequency of Frequency o Frequency I-cequency or ) Frequency o t-cequency Frequency o o) System Performing Corrective Action System Syste=l System Analytical ) Frequency of AC of of o. Of System l'AnalyticaI 2 Type number of fesfed l) Frequency OF AC 2) Type and numbe Analytical J'Analytical Type and number of Fystem Analytica, •Analytical l) Frequenc Analyticaf J Analytical 'Analytical' 'Analytical System Inter /AnaIyticaf analy±ical, Analytical ) Frequency of QC ) Frequency OF QC ) Frequency Type number 'Analyticall System requc Analytical, 2) Type Investigation of Summary QC Problems Worksheet* 2) Type number ±es+ 2) Type aud number of Type and number of GC 2) Type and numbel of i Analytical aÄnaly+ica Analytical •Analytical 1Änalytical 2) Type number Type and number f System requen of Type number fesfed 4ÄnalyticaI System Activity: Who's Talking Now proc ) Analytical Investigation of Summary QC Problems Worksheet* ) frequency of (AC Type number of GC sompks System 2) Type and number of QC requ Type aod number of l) Frequency (F AC frequency OF (AC Frequency OF (AC reque re Information: System yste Frequency l) Fre and number of 3) QC used Type and number of C 2) Type and number d Type and number d Type number Type and number o Type number of GC l) Analyte Under Investi ation Calcium (ISE Parameters) Analyte Under Investigation CAJcium (ISE R.rametgo) Date yste Type avid number of System 2) Type number so QC used The l) Frequency of QC Quality Quality 21)) Frequency OF QC Laboratory Performance Overview Analyte Under Investigation Alkaline Phosphatase 3) Date used System/ 2) Type and number s l) Frequency +0 2) Type number 2) Type and num Type and number of QC Type and number of Type number of 2) Type and number of QC Current data meet quality specifications: Level 1 OC Type and numl The Laborator 106. QC Flags: SEc < q) ID The Laboratory 3) q) [10.1, 102, 10.3) Goals [10.1, 102, b) Lab 15Q Laboratorws 3) 3 Type and number of ( 12.9 Quality? s. Quality Quality System Type and number of G 16610 2) Type number of Type aud number of C q) The q) The pert Quality ev Controls Affected: Level 1 Laborator• Other Quality Goals we Results Analytical Laboratory Laborator limits LD The q) The 40 LD ID The target values are valid: Level I The target values are valid: Level 1 'Laboratory Level 2 Other Goals Level Go [D The Quality q) Goals Goals less What will you need? What will you do? What Will need? pa The of periodic review defechnj root evalu Purpose b) The Where Quality review q) The OF periodic review used Quality Results Laboratory Goals The of revtew System Quality Laborator Quality review Quality Performing Corrective Action The Goals Quality eval, Quality Data & Calculations Relatin Results What Will you need?) Laboratory UNITY Wider Laboratory Analytical Goals review Need Need for Data For: We Are La borator Laboratory .Laboratory La boratory The review Goals b) The ac Wider con q) The OF periodic 3) Results q) The pericdlC T Analytical Analysisal Laboratory Quality q) The The T Ea limits are valid: Level 1 Goals q) con Goals b) Effective OC b) The achons +aKen b) Pne achons b) The Laborator QC Laboratory and Results b) The achons Level b) The achons faKen Quality Trueness What Will you need? Laborator Laborator Laboratory Goals 109.8 We Are Analytical limits Goals defec+inj and Goals defechnj less Lot Exp: 12— b) The achons and +rends 314-2012 q) The of Goals Laborator Goals Results Laboratory Laborator Laboratory Goals derec+ny Precision Results Results The Fretaency of Performing Corrective Action [D The ev System System Goals Quality Quality The The peviod and *rends TEa defec+inj and *rends and b) The ac+vons Goals You will assist a site with investigating Working in groups of 4-5, you will: Laborator Results b) Pne ac+tons +Q6er Frequency ts Frequency ons when resal+s 12.9 b) The achons b) The achons ±hen b) Assign who performs the investigation and by when Results b) The achons Results q) The defec b) The achons fahen What Laboratory Printed: 05— 14-2013 ILaboratory The current actual mean and SDI indicate a positive or negative b) The achons ±hen b) The achons when bias compared to the target Goals The Fretuency Results exceed Mean if Quality System defec+inj and +re and dafa Laboratory Laborator Laboratoryx Results Goals Mean Meon Laboratory Mean Goals b) The achons ±ahen when Results -VT-intertlaboratory flays on their finn exceed Goals r; b) The achons ±Q6en when d*ec+inj and defec+inj and Results Laboratory avd Laboratory Laborator 9 The 109.8 defec+inj anc defechinj anc ua I Results defe Quality b) The ac anc ua it uaii b) b) inter-laboratory flags on their ion- inter-labor9tBry flags on their io - defec±inj and Goals defectiny and b) The achtons +Q6en b) The achons ±ahen wh 10 we exceed ua t b) The achons ±QHen ua i cumulative or peer mean, beginning this month _ or gradually since Oct/2012. (based on the last page of the handout) ua exceed Laboratory Results Use Tool 3 and Handout 3 to complete • Use Tool 3 and Handout 3 to complete ua It ua 1 ua I problem Quality b) The achons +a6en b) The achons ±QKen b) b) Tne achons +a6en defecHnj an exceed l, ua b) The ac+ions +QHer b) The achons +ahen b) The achons +aHen Control b) The achons +Qhen A uLaboratory Laboratory ALaboratory 'Laboratory ua 1 J Laboratory ua It ua it Controlv Quality? Determine the root cause and extent of the problem by examining — 'Laboratory 'Laborator • uLaboratory - 'Laboratory Laborator _ALaboratory : Laboratory ILaboratory j Laboratory Quality exceed exceed we Current actual 60 4.10 11950 119 5 ' iLaboratory ua 1 Z Goals C_ontrol Control- exceed exceed Controli Controlj we it ua i Goals v ' ntrol Control] Results b) The achons Goals ...Control selective electrode (ISE) electrode (ISE) selective Quality Quality Goals s we Quality Goals S Goals Y Control 11950 119.0 106.7 wr The current actual SD and C VI indicate increased impression compared to the assigned to chart we TO cumulative we YSte "Its Its System exceed we Control or on ro trol w. we Re we exceec _ _uLaboratory .uLaboratory •aboratory AlLaboratory Laboratory - &boratory & boratory - uLaboratory Laborator _ALaboratory Laboratory ALaboratory ILaboratory u Laboratory JLaboratory 'LCaboratory Worksheet 3. Workshee wHeRe peer Method WHERE yste Z Goals 'trol exceed Peer Grou Method 4576 91 106.7 106.6 Goals Goals exceed I exceed •rol Date (t 'trog Quality ua It ontrol 'Laboratory Control Date .ystem _LLaboratory —ALaboratory —'Laboratory ua It ual ,yste Syste we •Its SD, , beginning this month AIts documents and records and talking with personnel •Its Its 'Its -Its Method Control' ua I ua 1 Goals All. Method WHERE yste System 106.7 ua it Syster• System YSte peer 4.0 Calcium we when ua 1 methodologies. You will focus your e ;oddogies- You will focus your WHERE exceed Control •Its Its WHERE WE exceed I WC we ua i Control WHERE we ARE achons SD SD WHERE we ARE Ats wc WHERE WE WHERE WE ARE to hen wr we chart ua 1 ua t yste WHERE WE WHERE WHERE WE WHER e n we the re l: ua 1 WHERE WE ro WHERE WE ARE Jendrassik Grof ua Assi ed to chart WE WHERE WE WHERE Perform an investigation of calcium to ua it WHERE Patient results may be erroneously High ua it WHERE WHERE ARE WE WHERE we ARE QUALITY WE ARC 104.3 WE ua it SAMPLE we , Control we Use t Control te WHERe a sca 106.6 TESTING (PT) investigation solely on calcium to investigation solely to ua WHERE WE ARE we ARE ua It Value Value we Value investigation Value Value TE WE OFICIENCY Quality WHERE u; Date System; (04.3 [04.3 ua Control 100.} 104.3 VICIENCY (04.3 ua 1 ua It WHERE WE C 12. q WHERE we ARE m WHERE we ARE Log an occurrence report if erroneous results have been released. 12.9 WHERE we 12.8 PROFICIENCY 'ING (PT) ro 10}.3 [04.3 we 60 We QUALITY WHERE we WC wc TE -ICIENCY 3OFIClENCY ICY WE PROFICIE•• E'Ä'CIENCY CONTROL ROFICIENCY AOFICIENCY PATIENT WHERE WE WHERE WE Control AFICIENCY OFICIENCY WE ARE WHERE we ARE ENT 12. q PROF' Action: Date WHERE WHERE we ARE WHERE we WHERE AR WHERE We RE T 'ESTING (PT) OROFICIE WE QUALITY we determine the root cause of the ISE determine the root cause of the BSE cumulative Cumulative te *OFICIENCY 105 55.0 WE AR' Dedicated Reagent Dedicated Reagent tNCY 17.4 Con ystem - 4 12. ? Control SING (PT) PATIENT determine the root cause and rmine the root cause and———— 104.3 CONTROL 55.0 Control PATIENT 'ATIENT 17.4B 12.8 12.9 12.q TEST.. WE QUALITY 12. q PROFICIENCY PATIENT STING CPT) WHERE YSte PATIENT CONTROL 91 ENT (QC) TE (QC) QUALITY TE Control Calculation) 12.9, Peer Grou Method we ystegv SAMPLE we People TESTING QUALITY . TESTING (PT) STING (PT) 'STING (P' TING (PT) •ING (PT) TE 12.8 Syste>l eon TESTING (PT) CONTROL pmoVL mmoVL SAMPLE PATIENT we Investigation MUST include why daily QC processes failed to alert us Date h' AMPLE CONTROL Method (91) (QC) ev 12.9 System / TING (PT) Syste PROFICIENCY bres SA ean da4n (0+.3 SAMPLE QUALITY PATIENT IAMPLE (0}.3 problem. QUALITY (QC) propose corrective action for the ISE ean TEC on current data Current actual (QC) assigned o ose corrective action for the Verify validity of all statistics used to generate within-laboratory and peer data Date CONTROL a scan Mean i, AMPLE Meon (0}.3 (04.3 T E on current data data (PT) assiqneÅ (QC) eon ean Mean ea4n Less QUALITY propose So PROFICIEN PATIENT (QC) SAMPLE FICIENCY (QC) PROFICIENCY calculator) CVR: SAMPLE ean SE eon SEC on Current data -1.26 Less than O SEC On Current QUALITY (04.3 Fyste System PATIENT assigned assiqreÅ o assigreÅ assened +0 TE less ages less s glCIENCY TESTING (PT) TE Mean assigned + The eon e an ean 12.8 17.4 22 105 CONTROL eon PATIENT QUALITY (QC) 'SAMPLE SE CONTROL TESTING (PT) 12.9 rlENT CONTROL 12.9 assvgned o TEST ENCY •ROFICIENCY QUALITY assigned o, QUALITY when method performance no longer met quality specifications. when method performa ce no longer met quality assigned +0 assvgneÅ +0 TESTING (QC) 'OFICIENCY SAMPLE assigned o assigned o0 assigned PATIENT "ESTING eon CONTROL . SAMPLE ean assigred QUALITY CONT PROFICIENCY OFICIENCY CIE-NT CONTROL CONTROL The PROFICIENCY 12.9 Value CONTROL, 12. q Information: problem. 52.01 10 Messages SAMPLE PATIENT SAMPLE assigned o Information: PROFICIENCY QUALITY =.STING (PT) SAMPLE (QC) (04.3 CONTROL ESTING (PT) PATIENT IENT CONTROL CONTE CONTI Provide a post-it note to the facilitator if Provide a,ppgt-it note to the facilitator if QUALITY CONTROL QUALITY The accumcy and The and He TE a sc assigned o QUALITY accuracy and TE SAMPLE assigned 12.8 (QC) IENT assi LENT (QC) TESTING ea4n Current data meet quality specifications: Level I Level 2 LTIENT eon Value SAMPLE Current data meet quality specifications: Level I eun ANALYTICAL eun e an CONTROL essayes ean Current data meet quality specifications: I Value SAMPLE PROFICIENCY SAMPLE PROFICIE OROFICIENCY da4n Value OFICIENCY Mean QUALITY Mean Value TESTING (PT) N value PROFICIENCY ROFICIENCY TESTING SAMPLE SAMPLE Value ey (PT) (QC) The accuracy 118.0 119.0 OFICIENCY assigned o -E 104.3 CONTROL QUALITY (04.3 MPLE ENT Ä'ENT The target values are valid: Level I (00) PATIENT CONTROL QUALITY Meon SAMPLE loon SROFICIENCY '.E 2' (04.3 106.} 106.} 104.3 NT PATIENT The (00 ean Value SAMPLE (QC) SDI: (QC) The accuracy and eon —0.52 SAME m SAMPLE -0.204 assigned +0 The target values are valid: Level 1 What will you needo? What will you need? Sodium _ A. (PT) cot Propose and implement measures to address or alleviate the immediate PATIENT accurocy .3 57 accuracy and assigned 12.9 assi ned+o assigned o0 TESTING (PT) Re-assign mean on QC chart: Level 1 Value Level 2 12.9 SAMPLE you would like to interview a staff TESTING CONTROL assvgned Value The T Ea limits valid: Level I TESTING (PT) Lcvcl 2 assigned STING (PT) CONTROL SAMPLE t' assvgneÅ o TING (PT) TING (P PING (PT) assvqneÅ (00 (QC) ESTING (PT) PATIENT (00 (90 PROFICIENCY assi ned+o ean assigned (DO analytic sys T) 12.9 I (DO (PO The TEa limits are valid: Level I SAMPLE (QC) assigned c, (QC) andY+ic sys 'QC) c. SAMPLE assigned o (DO (QC) (PT) I (90 CONTROL Analysis (QC) CONT 119.0 118.0 119.0 119 5 The actual mean and SDI indicate a positive bias compared to the target What QC (DO QnalY+ic sys Less glue h AMPLE 'h AMPLE Ö.12D%' (PO 118.0 11950 • ING (P T) or negative essages What 457. (QC) essa S h+em 57 57 SAMPLE PATIENT Key Me Lessa essayes Q.nalY+ic The we on 119.0 messases 12.q Ö.12DH (PT) Analysisal SAMPLE SAMPLE e) 57 57 TESTING H ow many assvgneÅ o (DO The current actual mean and SDI indicate a positive or negative 455.3 119.0 119.0 Key messages messages messages Key messages assigned PROFICIENCY mean. beginning this month TESTING (PT) or gradually since / Value N Value t o to ANALYTICAL SAMPLE # Labs: 244 or peer 94 Re-assign SD on QC chart: Level 1 Level Level 3 SAMPLE problem. problem CONTROL Cumqlafive Less Key Messages ehon member. You only have time to interview ean QC VARIATION SA Value eun SAMPLE Cumulative Value 106.} messas€s (QC) • Handout 3: Calcium Report x. and Cumulafive Messages The current actual SD and CVI indicate increased imprecision compared to the assigned to chart cumulative (195 Value cumulafive 106.}? Cumulative messages 119.0 457.1 PATIENT essa 57 IIS —SAMPLE we Me 104.} ean cumulative essag€s to measure to IOC.} 106.} # Points: 4745 9699 5718 on ssages WC 119.0 SAMPLE Potassium q su(q I Cumulative cumulative SD, , beginning this month or gradually since / Value 457. ( The ssiqneÅ eon (90 455. 3 Tbe accuracy an accuracy Analytical Cumulafive Mean e an eon ean assigned Re-assign target values: Level 1 106.' 455.3 Level 2 ass'gned (q b IOC.(O I 457' (9b 106. C mean. beginning this month or gradually since / ass'gned 45K (9b Sty or peer 2 staff members. Patient results may be erroneously High 457' (9b 106.6 qsu(ql qsr. 3 The accuracy IOC.' 104.3 119.0 (90 SD The accuracy and The accuracy @€ecls (q b St) The accuracy and (DO QUALITY 119.0 57 qsu(q qsu(q I assigned o qsu(ql Value • Worksheet 3: Calcium Summary • Worksheet 4: Calcium Investigation Communicate changes and document (q I The accuracy 57 455.0 55.0 57 106.7 106.' Tbe accuracy The on 106.6 IOC.' 455.3 57 SAMPLE The accuracy and or ptecision 455.0 455.3 SAMPLE SQ SC Low Imprecise The accuracy ( assigned o When to 455.3 Action: aned Action: The accurac) Cumqlafive (q b The accucc 6- 6-8 Cumulafive 6-8 on Cumulative da4n cumulative da4Q da4n Value Value N Value IS the da4Q dafa 458.1 loon sc Re-assign T Ea limits: Level 1 Level 3 100.7 ICON 100. i SA Cumqla+"ve Cumulaf"ve da4 Cumulafive 1 DON ac 100.} toup Comparison Programs al 106.} sysfem de SD 100.7 458.1 Value Complete Worksheet 4 Shi-em es 106.} Value sac. St) evaluations • Worksheet 4: Calcium Investigation • Worksheet 3: Calcium Summary 457.1 — WHERE AR SC loon Alb WHERE Sys+em d IOC.' Calculate mean and SD on recent data population analy+ic toup sys+em d Propose and implement long-term strategy(ies) to prevent the problem 107.3 analy+ic Sys+e coup 106.' (0 106. ? 455.3 Cm analy+ic s Value 119.0 WHERE Analysis 457' qsu(q I •We WHERE ARE we ARE ARE — WHERE a Re WHERE 119.8 119.0 Calculate ean and SD on recent data population 't is ass 55.0 6-8 Re-assign mean on QC chart: Level I qsu(ql ass' 455.3 (PT) cumulative ass ned+e aess' 57 WHERE we ass' ned+o dafa 57 WHERE accuracy assi 496.0 WHERE ARE WHeRE a change +0 we 119.0 WHERE we ARE wyeRe aess• ass 6-8 Select a spokesperson • Select a spokesperson SD 57 119.0 • Envelope containing Tool 3: Calcium Abs assi ned+a 455.3 (90 57 ass' ned+o Re-assign mean on QC chart: Level I ean on QC chart: Level I Level 3 119.0 ass' ass' ned ass' Re-assign mean on QC chart: Level I Level 2 WHERE Re 118.0 Less umulafive (DO assigned dafu ass• WHERE Cumulative ass' 57 ass from reoccurring IS I CON ARC we Initiate corrective action to reduce bmpreciasion Initiate corrective action to reduce bimprecision propose corrective action for the ISE Initiate corrective action to reduce bias -s 104.3 IOO.? Cumulative 106.} 57 WHERE Less ass ned+v aess 10 to we ass Level 2 and Re-assign target values: Level 1 Re-assign target values: Level I 20 118.0 100.7 10 TO ass' (0 Change Cumulafive 70 60 119.0 SE mm.ol/l 10 .10 WHERE we ARE 119 5 1195 119 5 'tro 1(0. 106. IIS 119.0 oncen+ we Cumulative Investigation Records 119.0 11950 Sb 10 20 cumulative 10 qsu(ql 119.0 106. ve 6-8 to 10 10 457.1 10 100.} COnceD* Cumulative 1195 IIS Z 10 • The spokesperson will present his/her The spokesperson will present his/her Re-assign TEa limits: Level I concen+ WHERE we WHERE WHERE WE A, 11.0 Re-assign target values: Level I Concen+ Will .10 concen+ WE 1195 to 17.0% oncen concentr cumulative 11950 119.0 12.8 17.4 Peet assi ned q.O 104.3 106. CCnceD± used ass 11950 4.95 119.0 455.3 1195 has 457. ( 119 5 1195 10 cumulative 1195 cumulative (195 119.0 .D concen+ Concen± 104.3 Cumulative 1195 118.0 129.0 on concen mmol/L on Communicate changes and document 119 5 ass' ess 455.3 SQ 106. ? SO 10 ion Concent Select QC rules and strategy to maximize detection 457.1 Re-assign limits: Level I m mol/L concent I OC.(O Conceny Concen± 20 Concen+ :oncent jncen+ eon ass red +0 concen+ ass 55.3 .D concen± -sac. mmol/l_ assi Concen on 85 857'(9D Officer 11950 4.95 457' (9b) 95 sac. 119.10 assi 119.0 mmol/'l_ 457'(9D Abs ion Group 457.1 45.0 SQC. mmol/l ion concen • 2 post-it notes 17.4 Abs 457' (9b 9576 (91) 119.0 Ali ICK group's responses for Worksheet 4 to the nses for Worksheet 4 Concen All Initiate corrective action to reduce bias propose corrective action for the ISE on Initiate corrective action to reduce 91 10 129.0 Concen± 10 Initiate corrective action to reduce bias ass 10 Arrange instrument service from manufacturer concen+ 106.3 All 104.3 SQC. Abs Gou S(AC. All Method 10 Method Peer All *hen 55.0 Initiate corrective action to reduce bimprecision propose corrective action for the ISE concen 10 ass' ned+o Concen+ QC cm All Initiate corrective action to reduce bias 6-8 Alb (195 52.0 119.0 he am 455.3 457.1 cumulative 1195 519.0 119.0 119 5 52.0 Bas Revisit long-term strategy effectiveness (e.g. yearly QMS review meeting 857' (9b 100.4 Ali 119 5 c(qb 11950 17.4 d04a 457.1 Ali Concent to +0 10 3.10 Concen± 55.0 S. concent SDI: Cconcen+ :oncent • People to Interview folders —0.12 class during the debrief. class durihg the debrief. —0.12 119.0 Cumulafive bass 104.3 119 5 mmol/ 119.0 amly+ioal All 119 5 Initiate corrective action to reduce imprecision 55.0 cumulative 1195 we All Concen+ Temporarily discontinue reporting patient results 11950 55.0 mmol/l_ m mol/l_ SE TE Less O Ccnceny 57 55.0 455.0 455.6 455.0 10 550 119.0 WHERE Less 119 5 CVR: 0. 3.8 3.7 100. cumulative e Less 0 12.9 Gals c Less O C. Less O 4.95 concen-• Arrange instrument service from manufacturer he amly+ical ass ned+o 52.0 Less 0 Change the 55.0 lats Concen± Concen+ QC cm o. chanse chanse Ho loon c- Less O C. Cur Less O Concen+ with laboratory management, internal audit) aess conc change Al Less 95 Less Change e Les O 100.4 455.0 57 m mol/L ass' TE TE 5. e Less Less O 55.0 SE SE e Less O All c. Less O 4.0 Less z q) Less Les O aess 57 119.0 119 5 accepfok change fie Group • Calculation Device (e.g. phone, # Labs: er,als horded c Less 95 O. chanse red+o on mmol/l mmol/l_ to -52.0 52.20 -2.20 -15.0 he Less O SE c- Less O chanse fro fie change Concen* 55. - Investigation Records Investigation performed by ass' All C Less O 1.4 14 SYS+em SYS+-em has 4.0 Concent change fie analy+ical # Points: mmol/l 6183 All 519.0 Change 52.0 10 Investigation performed by Investigation Records 55.6 on 55, 0 22 23 20 has OCCutt 55.0 ConceD+ Sys+em has occuv calculator) Concen+ has oc concen has Less 3.10 ass 52.0 10 Concen+ Document this entire process 55.0 10 3.120% mmol/ 90 minutes Concen+ aess Concen Concen 55.0 Concen± Sys+em has sys+•em has mmol/l Less O 10 115 All 119.0