PEPFAR Quality Control and Method Validation Activity 9: Part 3

QC Worksheet* QC W QC Investigation Worksheet* QC I W Applying Activity: QA Officer Needs Your Help! I Bias I TE in units TEA in units TEA in units in units SEC SEc Sigma QC Rules Based on the Sigma-metric units Analyte Under Investigation Instrument XYZ Chemistry Analyzer Date June rules AWEsome Numbers Inc. Patient-Focused Laboratory Quality OptimiZed Q.C. Processes - Sigma OptimiZed QC. Processes - Sigma [(TEA - IBiasl)/SD1 ((TEA - IBiasl)/SD1 SEC Monthly Review Log Controls Affected: Level I Level 3 Level 2 Level 1 Other: Other; Other Applying What did you observe on the QC Charts for the analyte control Puroose Purpose Analyte: Analyte I -True Valuel -True Value -True Value I Abs Bias + 1.65*SD (TEA Target value (TEA Target Value [(TEA - IBiasl)/SD1 - 1.65 [(TEA - IBiasl)/SD1 - 1 65 - IBiasl)/SD] - 1 65 Target - - 65 OR more None June during the month Of June 20XX? QC QC Platelet (Random or SEC + 1.65 SEc + 1.65 TEA (in TEA (in TE (in QC Target Ta 20XX Flags: class. Activity: QA Officer Needs Your Help' Activity: QA Officer Needs Your Helpl Activity: QA Officer Needs Your Help! What you do? What Vou do? Activity Activity: Calculating ASEc Purpose ontrol more rules Material Units units) Value Count (Systematic) Instrument Analyte Troubleshooting Out-of- Mean SD O timiZed .C. Process Puroose What What need? What VOu dog What Will VOU What dog What *Ill What *Ill VOU dog What do? What VOUd? What VOU do? What VOu do? What VOU What Will VOU do? What you dog What VOu What vou need? What vou need) What VOu doa What VOU dop What VOU doa Purpose purpose What VOU dog What will VOu do? What vou do? Applying more Applying R:4S (Random) Applying control control Sigma QC Rule Front Line Supervisor Chart Investigation investigation Sigma QC Sample rules more 271.8 14.6 26.35 Applying Control Runs 109/1) You are visiting a site and will Working individually, you will: more Frequency Chart Review Review and Quality From To TO Strategy Frequency of f control control Needs QA Needs your Hew' rules Applying QA Officer Needs Your Help! QA Otf.cer Needs Your Help! QA Officer Needs Your Help' Activity: QA Officer Needs Your Help! 1.65 *3 0+1.65 *3 Applying 49.8 31.1 26.39 726.3 30.4 0.51 39.2 more Needs Your Help! Reducing Lab Any QC such as 1:3.5s 20 6.7 5.00 6.90 5.0 more control rules control From sudden I y suddenly I y or gradually _ or gradually _ at on date assist the QA Officer with Ot • Review Handout 2 Review Handout 2 3.35 999.0 198.0 1-3.os Ix I X 4 Weeks Ix 4 Week Ix / 2Weeks 4x 4Weeks Ix 4Weeks 4 Weeks IxX 4 Weeks Ix / Weeks June control rules more = 5.0 =5.50 5.8 5.0 QA Needs Your Help' AST 47.50 9.8 274.8 6.01 15.7 control rules What VOU need? What VOU dop What need? Recent data are distributed: above below Recent data are distributed: Or evenly about or evenly about the mean. 4.00 5.51 5.50 6.91 6.01 3.35 3.00 1-2.0s 1-3.os 1-3.5s Ix 4 2Weeks Week Ix / 4 Weeks Ix 4 2Weeks 2x Week Ix / Weeks Ix / 2Weeks IxX 4 Weeks 4 Weeks IxX/ 4 Weeks I X 4 Weeks 4x 4Weeks Ix 4 Weeks Ix 2 Weeks / 4 Weeks June Applying What evidence did ou collect to su ort our observation? What rule has been violated? on more rules interpreting his statistics for control rotation of trol more 5.50 Routine I X I x 4 Weeks I X 4 Weeks / 4 Weeks rx Week None June more Record Name Information Obtained from Record • Participate in the plenary discussion Participate in the plenary discussion The % of data prior to the change within SD is: approximately 68% The % of data prior to the change within ± 1 SD is: approximately 68% The % of data prior to the change within +1 SD is: approximately 68% 68% 638.0 44.6 193.2 718.2 control rules more 4.50 4 Weeks 2x Week Ix Week Ix / Week IxX 4 Weeks Ix / 2Weeks Ix / 2Weeks I X 4 Weeks IxX 4 Weeks 4 Weeks Ix 2Weeks What 1-3.5s Routine I x What need) What you nee What you needj What you need2 What vou need) What you need@ What vou need? What wou need? What you need? What need? What *Ill vou need? What *Ill you need? What VOu d?g What *'Ill wou need? What Will vou need? What you dog What Hill vou need? None more cone staff at the control control workstation Applying A new lot number of cealibrator was started at run # on A new lot number of reagent was started at run # on more the month of June 20XX and more 5+ 1.65 *3 1.65 *3 IncrFre 1 2x / Week I X 4 Weeks Ix / 2Weeks 2x / Weeks 2Weeks rules Is it a systematic or random error? u mol/L sing the XYZ Analyzer ALT Bili-Total 4.01 31.35 71.1 31.1 Lab 20 1:3s If Margin for Error is Working in groups of 4-5, you will: workstation Applying A new boxtle Of controls was started at run # on A new bottle ofreagent was started at run on A new bottlumber of reagent was started at run # on A new lot number of reagenrator was started at run # on Week 5.51 4.501 3.1 2.51 1-3.5s 3.35 5.50 10.0 1-3.5s 1-3.05s 1-2.5s 1-3.51 1-2.0s 1-2.50s 1-3.50s IncrFre 2 IncrFre 1 inc:rFre 2 Fr 2 2x / Week Ix 4 Week / 4 Weeks Ix / 2Weeks 2x / Weeks I X 4 Weeks Week Ix / 2Weeks 2x / Week Ix / Week 4 Weeks Ix Wee Ix / Weeks rules rules From control Reducing rules rules lower/worse than peers Applying What control = 10.0 25.01 5.00 20.30 30.35 increasing the help him resolve any issues umol/L 1140.0 52.7 2574.0 541.8 Ix / Weeks 2x Week 31.1 3.35 6.01 5.50 0.65 3.350 Incr Fre 1 IncrFre 3 IncrFre 1 IncrFr 3 4 Weeks 2x / Week Ix 4Weeks 4x Weeks Ix / 2Weeks Ix Week Ix / Week Ix 2Weeks 2x / Week A new lot number of reagenrator was started at run #t on A new lot number of reagenrator was started at run # on A new bottle of contbratol was started at run #n # of control ntrol i of control Increasing Increasing the What is the potential cause of the 2.35 3.3 3.35 4.00 6.01 5.50 6.00 1-3.51 2x Week 4x Weeks 2x /Week Ix Week 2x / Week IxX 4 Weeks 2x Week 2x 2Weeks rx Week Yes! Make it better. 6.01 4.01 1-3.os 1-2.os 1-3.5s 1-2.0s Incr Fr 4 IncrFre 1 Incr Fre 1 IncrFre 4 IncrFre 3 Incr Fre 3 IncrFre 2 • Investigate each problem revealed during Investigate each problem revealed during rotation of more None Increasing the A w bottle Of calibrator was started at run # on ents XYZ Analyzer ALT Calcium umnol/L Calcium Calcium 71.33 31.01 0.505 10.44 20.35 20.39 251.60 3.60 reasing the Increasing the encountered. Assigning Stop! NO NOT report any results until acceptable quality is verified (Total Error < TEa) NO NOT report any results until acceptable quality is verified (Total Error < TEa) control Stop! stop! # of control easing the Applying control resolve A new box of controls was s at run # On A new box of controls was started at run # on A new boxtle of controls was started at run # On A new box of controls was started at run # On 1-2.0s 4.50 3.35 1-2.5s 3.501 6.00 3.35 2.00 6.501 25.50 5.00 2.50 1-2.50s 4.50 1-3.5s 3.50 5.51 5.50 on # of control Assigning experienced, æeasing the 0+ 1.65 *3 0+1.65 *5 Investi ate, take action and re Investi ate, take action and re eat rior patients as stated in Process # Q-111 Investigate, take action and repeat prior patients as stated in Process # Q-111 Investi ate, take action and re eat prior patients as stated in Process # Q-111 Investi ate, take action and repeat rior patients as stated in Process # Q-111 Investi ate, take action and repeat prior patients as stated in Process # Q-111 Investi ate, take action and re eat rior tients as stated in Process # Q-111 Investi ate, take action and re eat prior tients as stated in Process # Q-111 pose the plenary discussion using records rules 3.601 0.72 Lab Multirule such as staff at the rules rules rules error? measurements A new bottle Of control started at run A new boxtle Of contbratols was started at run # On # of control On competent b of control measurements measurements Increasing the increasing Assigning if control control more None measurements 'ncreasing the Increasing the = 8.3 10.5 5.501 2.00 3.35 of control • # of control Instrument maintenance occurred at run # Instrument occurred at run # on maintenance occurred at run on maintenance occurred at run # on ,ontrol look Applying XYZ Analyzer CKT CK Level I more 800.0 8000 110.0 271.0 727.3 44.3 20.20 27.4 30.3 5.51 -140.5 20 Ian. A rove or modi this before im lementin ! staff This is ONE ssible C strate Ian. A rove or modi this before im lementin ! C strate Ian. A rove or modi this before im lementin Ian. A rove or modi this before im lementin experienced, more more supplied with Tool 2. more Applied Assign Assigning As AS Signing Assigni control # of control workstation urements Assigning Assigning 1:3s/2 of A change in the analytical process occurred at run # on icreasing the None If more than one analyte is out-of- ieasurements more experienced, Step 4. measurements What will you need? What you need? What vou need? What will you needo? # of control rements 56359.0 5635.0 = 5.0 635.0 638.0 2574.60 200.20 =59.0 52.01 = 5.0 498.0 198.0 193.3 198.0 52.01 4.00 6.90 126.0 8.70 5659.0 7.50 surements of supervisor What is our assessment of the underl in cause of this issue? f control control control of control controls of control Applying 30 Lev1:Lev2 Combinations - 8 Tests in 6 Labs Other test(s) affected: rules experienced, experienced experienced. experienc Applying of control measurements more competent more more competent experienced, experienced, Assigning • Complete Worksheet 2 for each problem Complete Worksheet 2 for each problem more rules more # of control • Assigning measurements Com Competent competent competent The common staff Increasing the Creatinine 40.50 20.39 8.9 0.66 44.4 3.219 2.359 8.9 Increasing t'e increasing Instrument Wavelen h Wavelen th Rea Instrument C i brator Increasing tg the Applying rules staff control, do the analytes have any Increasing experienced, more Process to select Q.C. Strategy Staff staff denominator is: Assig n ing Instruments more Compare Sigma Lev 1 Lev 2 Assigning Di ser Test Princi I Shi Ot measurements the experienced Increasing • Worksheet 2: QC more asing Applying Applying # of control b of control competent ments competent umnol/L 1. Define the true value for each sample as per lab policy/hierarchy ...-.mpetent 565.0 559.0 198.8 419.2 8.9 814.6 3.219 3.44 investigated (40 minutes/problem) competent Increasing the Information: equency of staff frequency Of the AVC O mpetent experienced, qsslurn -4 Assigning more frequency of the 2+ 1.65 *5 2+1.65 *5 0+1.65 *3 Applying Assigning more more Increasing th 1.4 15 14 3.4 Lev 1 3.1 Lev2 6.9 Lev 2 6.9 Levi1 3.1 6.01 Increasing increasing Lab frequency of Applying Multirule such as 3.65 3.6 3.351 1.65 3.3 3.35 3.51 3.30 3.9 measurements competent staff experienced, control control 1. Define the true value for each sample as per lab policy/hierarchy 2. Setine the TEae limit for each sample as per lab policy/hierarchy 2. Set the TEa limit for each sample as per lab policy/hierarchy Competent Supervisor per lab staff staff common factors during testing? Investigation investigation experienced,—-- control # of control Lev 2 6.9 Lev2 6.9 31.9 supervisor xyz Analyzer more xyz Analyzer The QC chart SDan is assigned: The QC chart mean is assigned: Glucose Correctly Correctly_ 3.44 3.830 10.44 TOO high Too high high 31.19 Too Low 6.90 18.2 0.72 10.43 1.435 -140.05 1.25 9.83 high more None 14 12 1.4 15 10 more more more Increasing Increasing Increasing th Increasing the staff control 3. Gather recent mean & SD of all Q.C. Samples =10.3 -0.3 -10.3 1.95 2.35 1.92 1.23 5.00 3.35 2.350 -10.3 None measurements experienced, Increasing e *perience CALCIUM Applying the f control :ncreasing the T 00 Low Low LOW control EComplete Worksheet 3 for the case your Complete Worksheet 3 for the case your Complete Worksheet 2 for each problem the Reducing Re Staff From more rules experienced, rc•aiews staff I n creasing 20 signing # Of control # of control reasing Of con reviews more Assigning 4. Calculate Sigma for each sample 4. Ca•culate Sigma for each sample the experienced 257.60 20.20 2.25 rules 81.40 1.65 1.439 31.35 11.39 staff None frequency Frequency of Frequency frequency of more control Probable error type is: Systematic more Random_ Either Random or Systematic Random Either Random or Systematic control staff competent increasing • Worksheet 3: Case Scenario more ments rotation of rot- rotat rot rotati measurements more Step 6. more competent supervisor control to this site's A Officer? str None asing measureme experienced, meas the Assigning . competent staff 5. Select Q.C. Strategy for each sample based on Sigma Value 5. Select Q.C. Strategy for each sample based on Sigma value Patient results may be erroneously: High _ Low Imprecise Patient results may be erroneously: High Low Imprecise Low_ Imprecise rules expe rules Increasing of control rules control staff at the staff staff at t the group is assigned staf st equency of supervisor , Potassium experienced 2.59 Potassium ;reasing control the ments The change in method accuracy _ or precision The change in method accuracy _ Or precision experienced, frequency of Reducing rules control Increasing Frequency rules frequency Of staff increasing tncreasing experienced reviews experienced,;• Increasing the frequency tore more work works Investigation workstation staff Increasing increasing Increasing on • Handout 2: Monthly Review staff supervisor staff Coincides with a change Reagent Calibration _ Instrumentation Coincides With a change Reagent Calibration _ Instrumentation Coincides with a change in: Reagent Calibration Instrumentation Coincides with a change Reagent Calibration Instrumentation Coincides With a change Reagent Calibration_ Instrumentation controls Controls process supervisor more rules competent creasing I n creasing reviews Competent Why use separate strategies at each level? How can you implement separate strategies at each level? mm01/L mm 01/L um01/L umnol/L mmnol/L Level I recently? 0.015 0.218 0.81 48.00 4.01 0.316 0.104 0.164 0.104 44.04 Increasing the rotation of competent experienced, supervisor , of the rules Reducing competent Action: Frequency Frequency Select a spokesperson at the staff rules •petent rules reviews Change can Occur at One level and not the Other Change can occur at one level and not the Other Change can Occur at one level and not the Other supervisor experienced, Review # of control tation of reviews competent 5 1.65 5 + 1.65 petent igning Increasing the Increasing Frequency Staff otation of frequency of the O (TE> TEA) rotation of frequency of 20 5 1.65 5.05 1.6 -10.0 7.0 10.95 2.60 14.6 Repeat Controls Fresh Controls Sodium (and All patient samples No QC strategy is mm 01/1_ or Borderline patient samples_) with: or Borderline patient samples ) with: with: staff Frequency of experienced, 11.9 2. 11 • Envelope containing Tool 2: Incre incre more requency of ro•tation of Assigning Check the graph. Sigma of Lev 2 is seldom the same as Lev 1 oisor staff at the Once we resolved the problem, did Once we resolved the problem, d Step 1. None the Reducing Fresh Reagent New Lot of 10 Fresh Calibrator 1.4 New Lot of Fresh Controls Alternate Controls rules supervisor taff = 21.5 = 1.65 supervisor 2.351 frequency measurements # of control Reducing No single strategy works for a test where Lev 1 Sigma is 2.1 and Lev 2 is 6.9 is 2.1 and Lev 2 is 6.9 mmol/l_ staff at the Have the spokesperson present a 5-minute s aff at the 126.0 competent 20 20XX 71.8 0.183 Increasing Have the spokesperson orpqpnt a 5-minute frequency o' rrion of staff & -cm-at the Staff competent Rea ent Calibrator Investigation Records Investigation Recoreds workstation staff more supervisor Level 1 Level 3 supervisor rotation of more available; stop reporting staff at the How can you implement separate strategies at each level? How can you separate strategies at each 'eve'? How can experience d, experienced, Review frequency supe Reducing None g/L control g/L rotation Of XYZ Analyzer TP XYZ Analyzer ALT Tp Level I 471.0 workstation 0.70 XYZ Analyzer ALT 14 44.4 3.64 we document the problem and its Review Reviews Clean or maintain instrument Arrange instrument service from manufacturer It's not difficult. See details in FAQs at www.awesome-numbers.org workstation staff presentation for your assigned case to the the erform as rt Of their competent workstation reviews • Calculation Device (e.g. staff at the Increasing the Increasing Consult with supervisor, director, or technical specialist Temporarily discontinue reporting patient results patients and begin Review experienced, Level 1 Level 3 Lewel 3 274.8 31.1 44.4 3.44 3.519 3.85 1.23 Nsurements ing the rules Reviews Review Refer patient samples to another laboratory Assess current mean and SD against target and TEa class. staff at the Reducing • of control competent resolution? phone, calculator) staff # of control Reducing Increasing the Increasing 2. 3. 20 If change not corrected with action above and TE