Note: Please complete the report and submit it to SMILE and your PNL within 30 days. Site/Laboratory Name: New York EQA Provider and #: CAP

Transcription

1 SMLE GENERAL NVESTGATON CHECKLST/FORM SURVEY NFORMATON EXTERNAL QUALTY ASSURANCE (EQA) Note: Please complete the report and submit it to SMLE and your PNL within 30 days. Site/Laboratory Name: New York EQA Provider and #: CAP Survey Name: FH9-A 2012 Analyzer Name/Model: Sysmex XE Date Survey Received: 2 Feb 2012 Date Analysis Performed: 10 Feb 2012 Date Survey Results Submitted: 15 Feb 2012 Date Evaluations Available: 2 March 2012 Previous Survey Problems (f yes, explain): No nvestigation Performed By: Mark Date: 11 April 2012 Unacceptable EQA Panel: Date of Repeat testing: Specimen Number Analyte Reported Repeated Result Result ntended Result/Peer Group FH9-01 Monocyte % 8.2 No samples FH retained for FH testing FH FH ROOT CAUSE ANALYSS PRE-ANALYTCAL ERRORS: YES NO N/A 1. Were proficiency testing materials received in the laboratory without delay? Please describe any delivery issues. 2. Were specimens shipped and stored appropriately according to temperature requirements? 3. Did all EQA vials arrive intact (i.e. no missing, broken or leaking specimens) f not, did you contact the provider and SMLE? 4. Did you prepare/reconstitute/dilute EQA specimens as indicated by the kit instructions? 5. f there were special instructions provided in the kit, were they followed? (Can be indicated by this symbol ) 6. Were the correct tests performed on the correct specimen(s)? 7. Was routine maintenance of instruments/equipment performed as scheduled (daily, weekly, monthly, etc.)? 8. Did you check lot numbers and storage conditions of kits, reagents, and materials used to perform testing on samples? 9. Were expiration dates verified before sample testing (Controls, reagents, etc.)? ANALYTCAL ERRORS: YES NO N/A

2 11. Did you review the current and past EQA event for bias, shifts and trends? f present, were investigations performed and what were the outcomes? Negative bias on this survey. 2. Did you evaluate the instrument/method for any problems prior to or after the EQA event? Describe any problems identified. 3. Was the calibration at the time of the EQA event reviewed for acceptability? f not acceptable, comment: 4. How do you establish your Quality Control (QC) mean and ranges? Lab established Use manufacturer s 5. Were all QC levels for this analyte within acceptable range(s) on day the survey was run? 6. Are Westgard QC rules used? f so, which ones? 7. Were QC/Levy Jennings charts reviewed for any trends, shifts and/or bias? A negative bias was noted for monocytes% on QC but since all were within 2SD no action taken. 8. Does your laboratory track precision by monitoring Coefficient of Variation (CV) for this analyte? f yes, was your CV acceptable at the time of the survey? 9. f manual calculation was performed for this analyte was it checked for accuracy? (dilutions, formula) 10. Was instrument or reagent manufacturer contacted? Requested service on instrument on 6 April Are questionable results reviewed by supervisor/pathologist before reporting? Not applicable POST ANALYTCAL ERRORS: YES NO N/A 1. Were the results correctly transcribed from the instrument print-out/ worksheets to the EQA Result Form? 2. Did you verify that the electronic results submitted matched the EQA result form (i.e. was the provider website checked for accuracy of results submitted?) 3. Were the correct instrument/method/reagent reported on the EQA Result Form? 4. Were the correct units reported? 5. Were results reported with correct decimal place? 6. Were your results graded in the appropriate peer group? 7. Did you select the correct result code for photographic images and/or microscopic examinations? NVESTGATVE ACTONS AND ROOT CAUSE: Briefly discuss what actions were taken in this investigation and what you believe is the primary cause of this EQA problem. The monocyte% was showing a negative bias on all 3 levels of the QC, no immediate action was taken as results were still within range. Daily QC checks between manual and automated differential counts are done and this too was within acceptable range. However, as was noted from the results of the FH9- A survey, significant differences between the monocyte% of the Sysmex XE and XT analyzers were noted. The biomedical engineer was called in to run calibrator material on the XE and do a sensitivity adjustment on the monocytes. See attachments for LJ Charts of monocytes % after sensitivity adjustments on the 6 th April, comparison of monocyte% between XE and XT after sensitivity adjustment and job card referring to sensitivity adjustment as performed by Biomedical engineer. Was Personnel training/competency reviewed? Staff education or re-training conducted, as appropriate? Hematology staff was re-trained to note any biases, trends or shifts even if within acceptable limits. Corrective action log was added to QC log. Type of Error:

3 Methodological Survey evaluation problem x Technical Other (explain) Clerical Study mpact: Were study participant results assessed for adverse effects? f applicable, review participant results, amend results and notify the following---physicians, study staff and network representatives. Study participants that had results during this time period were reviewed. Repeat testing showed all results within normal range so no adverse effect on participants was noted. FUTURE PREVENTATVE MEASURES/ ACTONS: Briefly discuss how you will prevent this problem from occurring in the future. Calibrator material run on the Sysmex XE analyzer every 6 months with service. f it is found that parameters are within the specified target range of the calibrator, no adjustment is made. n the future we will access parameters for biases, trends or shifts on our QC charts to decide if adjustments are required. PREPARED BY: Name/Title Date Signature Mark 11 April 2012 FOR SMLE USE ONLY. SMLE Review: Acceptable and complete nvestigation. nvestigation is incomplete. See comments. Name/Title: Date: 14 April 2012 Cinderella FOR NETWORK USE ONLY. PNL Review: Acceptable and complete nvestigation. nvestigation is incomplete. See comments. Name/Title: Date: 15 April 2012 Prince Charming Table for supporting documents: Attachment# Description of attachments Service report, QC charts and post QC results

4 Service Report- Site/Caller Summary: Site Site Name: Address: Zip City: PO Box: PO Box Zip: l Country: Caller Salutation: Title: First Name: Phone: Last Name: Fax: Case Summary Case Case Title: Assay Performance Call Type: Service Report SA-Code: ServVisit Em'cy Severity: Normal Priority: Medium Date of Order: Date: nstrument Summary nstrument nstrument Family: Hematology nstrument Line: XE-2100 Serial Number: Part Description: Hemato Analyzer XE-2100, Contract: Part Number: nstrument Problem Description nstrument Error: Problem description: Customer requests optimisation of Monocyte populations. Research log: Cleaned SRV and piercer needle, ran scs1000 verfication checks, performed whole blood senstivity adjustments, unit checked and tested ok, customer monitored unit ok. Spare parts/reagents used ldent-no. Manufact. Description nvoice Type Quantity No. FSE: Customer Signature: Full Name: Page t /1

5 tem Patient 10: Sample No.: Rack: 4 Tube:3 11/04/ :16:12 Ward: Dr.: Name: Birth: Sex: lnst.ld: XE nst.ld:xt-1800i-1 Negative Positive DFF WBC HCT [].. MCV MCH 29.3 g] sse MCHC 33.9 [g/d ] PLT 333 [109/L] M NRBC RDW-SD [fl] u Vl... RDW-CV l%1 POW fl MPV [fl] P-LCR [%] PCT 0.28 [%] [109/L] /:'; NEUT 4.73 ;: f%1 LYMPH 1.20 [109/L]..::.. : %, MONO 0.22 [109/L] SFL 3.5 -[o&; c > EO 0.06 [109/L] 1.0 o] DC BASO 0.00 [109/L] 0.0 l<.bt PLT-0 NRBC [109/L] [1 u v G /L] ọ. HPC# RET RF LFR MFR 6.21 [109/L] HGB 3.9 [g/d] l RBC [1012/L].. [1 03/ul] [%] [%] [%] [%] HFR [%] RET-He [pg] PF [%] [f1b [%] [/1OOWBC] [%] [10 6/ul] RBC :Jt PLT ' BALO 01 SFL.< U\_ SFL,......; <.. rt ,.:). WBC P Message(s) RBC/RET P Message(s) PLTP Message(s)

6 tem Patient 10: Sample No.: Rack: 4 Tube:3 11/04/ :16:12 Ward: Dr.: Name: Birth: Sex: nst.ld:xt-1800i-1 Positive Count DFF WBC/BASO -' "- V -, WBC 6.25 [10"9/L] RBC [10"12/L] HGB [g/dl].. HCT [L/L] ;.._:l < " ",., ""' MCV 91.4 [fl] MCH 29.7 [pg] MCHC 32.5 [g/dl] PLT 369 [10"9/L] ROW-SO 43.8 [fl] P.,LCR 14.0 [%] PCT 0.31 [%] NEUT 4.71 [10"9/L] LYMPH 1.20 [10"9/L] MONO 0.26 [10"9/L] 4.2 EO 0.07 [10"9/L] 1.1 BASO 0.01 [10"9/L] 0.2 G 0.01 [10"9/L] 0.2 c. :... RDW-CV 13.9 [%] POW 9.0 [fl].' -. r: :;, MPV [fl] f %1 [%] [%fill [% [%] <;<;( u V "- PLT ()!' sse BALO WBC P Message(s) RBC P Message(s) PLT P Message(s) Anemia

7 tem Patient 10: Sample No.: Rack: 4 Tube: 1 11/04/ :14:42 Ward: Dr.: Birth: Name: lnst.d: Sex: nst.ld:xt-1800i-1 XE Positive Positive Morph. DFF u WRrfRA O a.. WBC 8.96 [109/L] RBC 3.18 [1012/L] HGB 9.1 [g/dl] HCT []. :.. MCV [fl 28.6 MCH g] sse MCHC 34.1 [g/dl] PLT 183 [1 09/L] M NRBC RDW-SD 52.5 [fl] RDW-CV (%1... PDW 10.1 fl u MPV 9.4 [fl] " P-LCR 20.1 [%] PCT 0.17 [%] r. ' NEUT 5.71 * [109/L] 63.7 * ;;.:,...: LYMPH 2.38 [109/L] % [109/L].fo/rf; EO 0.13 * [109/L] 1.5 o] oc BASO 0.04 [1 09/L] 0.4 [%].l{.c' l' PLT-0 NRBC [1 09/L] [/1OOWBC] u G [109/L] 0.7 [%] HPC# [103/uL] RET [%] [1 06/uL] RF [%] LFR [%] MFR [%] HFR [%] RET-He [pg] PF [%] - ".:; ;..''fj." lj Jl {'' :. BALO /\ 1.,.. ". :. '. ). : SFL Ṿ. Ị. SFL SFL.. WBC P Message(s) RBC/RET P Message(s) PLTP Message(s) Left Shift?

8 tem Patient 10: Sample No.: Rack: 4 Tube: 1 11/04/ :14:42 Ward: Dr.: Birth: Name: Sex: nst.ld:xt-1800i-1 Positive Morph. Count DFF WBC/BASO A: WBC 8.78 [10"9/L] RBC 3.06 [10"12/L] HGB 9.0 [g/dl] HCT [] MCV [fl] MCH 29.4 [pg] MCHC 34.4 [g/dl] PLT 194 [10"9/L] ROW-SO 50.9 [fl] ROW-CV [%] POW 10.4 [fl] MPV 9.8 [fl] P-LCR 22.2 [%] PCT 0.19 [%] NEUT 5.55 * [10"9/L] 63.2 * LYMPH 2.28 * [10"9/L] 26.0 * f%1 MONO 0.78 * [10"9/L] 8.9 * [%] EO 0.14 * [10"9/L] 1.6 * [% BASO 0.03 [10"9/L] 0.3 [% G 0.08 [10"9/L] 0.9 [%] BC l. : ,.,.. ;b' "". u V "- ; <;<;(.ạ... _. :.;.. PLT sse BALO WBC P Message(s) RBC P Message(s) PLTP Message(s) Anemia Left Shift? Atypical Lympho?

9 tem Patient 10: Sample No.: Rack: 4 Tube: 2 11/04/ :15:27 Ward: Dr.: Name: Birth: Sex: lnst.d:xt-1800i-1 Positive WBC [10 9/L],A A' RBC 2.80 [10 12/L] HGB 7.5 [g/dl] (. HCT []..... MCV [fl MCH 26.8 g] MCHC 33.6 [g/dl] PLT 125- [10 9/L] M NRBC RDW-SD 52.3 [fl] u RDW-CV "...'.... c.: F'ol PDW 11.5 fl MPV 9.6 [fl] P-LCR 22.6 [%] PCT [%] NEUT * [10 9/L] 70.6 * l%1 LYMPH 1.38 * [1 09/L] 8.9 * % MONO 3.14 * [10 9/L] 20.2 jofj; Sfl EO 0.02 * [109/L] 0.1 o] DC BASO 0.03 [10 9/L] 0.2 [%] Kb l PLT-0 NRBC [10 9/L] [/1OOWBC] u G 0.41 [10 9/L] 2.6 [%] "...'. HPC# [10 3/uL] RET [%] [10 6/uL] RF [%] LFR [%] MFR [%] HFR [%] RET-He Sfl [pg] PF [%] : \ R B : C. " PLT.':.;:.! sse SFL /!;'.:. f BALO..:..'!]{...-::-,:,' ' ).. :.q- WBC P Message(s) RBC/RET P Message(s) PLTP Message(s) Monocytosis G Present Left Shift? Atypical Lympho?

10 tem Patient 10: Sample No.: Rack: 4 Tube: 2 11/04/ :15:27 Ward: Dr.: Name: Birth: Sex: lnst.d:xt-1800i-1 Positive Diff. Morph. DFF WBC/BASO Count "Vī ; WBC [10"9/L] RBC 2.74 [10"12/L]. HGB [g/dl].. M' HCT []..:,.- MCV [fl] MCH 26.6 [pg] MCHC 32.6 [g/dl] ụ... "- PLT 142 [10"9/L] ROW-SO 51.5 [fl] -' J '-';.:.. <;«;( RDW-CV [%] :{,.- POW 11.2 [fl]. MPV 9.7 [fl] P-LCR 23.1 [%] PCT [%] NEUT * [10"9/L] 70.2 * LYMPH 1.42 [10"9/L] MONO [10"9/L] EO 0.04 * [10"9/L] 0.2 * BASO 0.06 [10"9/L] 0.4 G 0.46 [10"9/L] 2.9 (%) [%] [%1m [% c [%] ; PLT sse BALO WBC P Message(s) RBC P Message(s) PLTP Message(s) Neutrophilia Monocytosis Present Left Shift? G Anemia

11 Material:control Mode:closed XE-2100 Quality control!instrument D Level(Lot) Lot NEoxp. oay loate Froiil' Number Of Plots:19 rxe: Leve11(New)QC JLO 31/05/ /04/ /04/2012 Print Date:11/04/2012 Time:16:34:24... r-- -- = Targ.= = 46.3 SO= 33.1 Mean= 19.9 CV= - ===--====--==-== = = 20.6 SO= Mean= CV= SD= SO= 1.36 Mean= 1.09 CV= 1.37 SD= 0.98 Mean= /////////////////

12 XE-2100 Qualiy con rol ll ll= 23.4 CV= 3.8 Ul 15.8 SD= Ul= 9.9 Mean= 09 Targ.= 4.0 CV= 11.4 ll= ---- SD= 0.94 Mean= :--::- ll ḻl= 5.2 CV= SO= Mean= 67.9 c. Pri noa e:11/04/2012 Time:16:34: Targ.= 29.3 Ul = 35.2 SD"' J:":"14l Ul= 1 T, arg.= t : Targ.= _ = Mean= CV= S-D-= Mean= 11.6 s_.2 c_v_= !...:.!!..._ CV= Ul= 3.75 SO= ll Ul Mean= 3.25 = 2.28 SO= Targ.= 1.90 Mean= = 1.52 CV= Ul= 1.02 SD= ' 0.64 Mean= 0.59,, - : -- - _ _ _ Tar: !Tar: CV= SD= Mean= SD= ----o.lo91

13 ll CV= 9.71 Ll Targ.= 4.37 Mean= _ L _L_L= 3._28_ cv_=_ ll//ll//////l/111/

14 Material:control Mode:closed XE-2100 Quality Control nstrument D 1 Level(Lot) LOt NO. 1 Exp. Day Date From TO Number of Plots:20 XE Level 3(New) QC /05/ /04/2012 ll/04/2012 i , } !l Print Date:ll/04/2012 Time:16:35:20 = 31.2 SD= 0.74 Targ.= 26.0 Mean= 26.3 = 20.8 CV= \--.J-'-3'!-)- - n----- (;, = 14.6 SD= Targ.= 9.7 Mean= 9.2 = 4.8 CV= 12.0 = 17.0 SD= 0.87 Targ.= 11.3 Mean= 11.3 = 5.6 CV= 7.7 = 89.0 SD= 0.72 Targ.= 71.2 Mean= 71.5 = 53.4 CV= 1.0 = 15.0 SD= 0.64 Targ.= 12.0 Mean= 12.6 = 9.0 CV= 5.1 = SD= Targ.= 9.24 Mean= 9.26 = 7.85 CV= 4.1 = 5.45 SD= Targ.= 4.54 Mean= 4.58 = 3.63 CV= = 2.54 SD= Targ.= 1.69 Mean= 1.60 = 0.84 CV= 10.9 = 2.97 SO= Targ.= 1.98 Mean= 1.97 = 0.99 CV= 7.3 = SD= Targ.= Mean= = 9.32 CV= 2.8

15 SMLE nvestigation Form for Qualitative/Quantitative Testing l///11/ll/l/1/l///// QC Chart Error Ex.doc Page 16

16 SMLE nvestigation Form for Qualitative/Quantitative Testing 2-1 QC Chart Error Ex.doc Page 17