SQA-V Gold Semiannual Validation/Proficiency/QC Recommendations

Transcription

1 MEDICAL ELECTRONIC SYSTEMS 5757 W. Century Blvd. Suite 805 Ls Angeles, CA Remember, it ALL Started with a Sperm! glbal.cm SQA-V Gld Semiannual Validatin/Prficiency/QC Recmmendatins OVERVIEW Prviding the best patient care requires labratry staff and pathlgists t strive fr the highest levels f perfrmance. In rder t meet these standards, maintain user prficiency, and cnfirm the crrect peratin f the SQA-V Gld Autmated Sperm Quality Analyzer, MES had develped a series f recmmendatins t be perfrmed n a semiannual basis. These recmmendatins include: 1. Semiannual System Mini-Validatin and Mtility/Mrphlgy QC It is highly recmmended that the facility cnfirm the precisin and lwer limit detectin ability f the SQA-V Gld by cmpleting an abbreviated validatin study n a semiannual basis. It is als suggested that 5 samples be cmpared t the backup methd n an annual r semi-annual basis (at the labratries discretin). In additin, rganizatins prviding semen analysis prficiency testing prgrams (CAP, NEQAS) require labratries t shw prficiency and quality cntrl acrss three main semen analysis parameters: Sperm cncentratin, mtility and mrphlgy. T date, the QC/prficiency testing samples prvided by these rganizatins d nt address mtility r mrphlgy due t natural limitatins assciated with shipping live samples. This recmmended Mini-Validatin in cnjunctin with the SQA-V s daily calibratin/self-test, and daily zer level MSC cnfirmatin can be used t demnstrate nging mtility and mrphlgy quality cntrl. Fr additinal mtility/mrphlgy QC infrmatin please cntact MES directly t request a technical bulletin (service@mes-llc.cm). 2. Semiannual Instrument Calibratin Cnfirmatin It is recmmended that twice per year, the SQA-V Gld calibratin is checked against the riginal factry calibratin parameters. Althugh there are acceptable calibratin ranges fr the SQA-V, the system parameters may be clse t the high r lw end f the range and practive maintenance will ensure cntinued uninterrupted use and ptimal clinical perfrmance frm the instrument. 3. Semiannual Cllege f American Pathlgists (CAP) Prficiency Challenge The SQA-V Gld is part f the CAP semen analysis prficiency challenge and as an autmated methd has a specific sample set that is peer reviewed against ther SQA-V Gld users. MES recmmends this survey as an unbiased appraisal f user prficiency and system perfrmance. Please cntact CAP directly fr mre infrmatin and fr rdering details: Manufacturers Validatin Kit (OPTIONAL) MES Manufacturers an ptinal Validatin Kit designed as a prficiency, training, and validatin tl fr the SQA-V Gld. It can be used t validate Cncentratin Accuracy, Precisin, Lwer Limit Detectin and Reprtable Range (Linearity) per CLIA Methd Validatin Regulatins. Prduct Cde: A-CA / File: SQA-V Gld Semiannual Validatin Instructins per CLIA Page 1 f 6

2 SYSTEM MINI-VALIDATION AND MOTILITY / MORPHOLOGY QC SETUP Turn the SQA-V Gld system and allw the instrument t cmplete its Stabilizatin and Self-Test. Print and save the system s Service Data Reprt. Check the Service Data Reprt t verify that the REF. 2 parameter is between 2,800 and 3,200 (ideal range). If this value is belw 2,800 mv r abve 3,200, perfrm a thrugh cleaning f the system per user guide instructins. Save all printuts prcessed during the validatin. Return yur data t MES via Fax r fr crunching ( / service@mes-llc.cm). PRECISION AND SENSITIVITY Running 5 replicate determinatins n at least tw levels f live human sperm is recmmended t estimate the imprecisin r randm errr f the methd. Fr the detectin limit experiment, a "blank" material is analyzed in 5 replicates. MES QwikCheck Beads negative cntrl is recmmended fr the lwer limit detectin prtin f the experiment. FOR LIVE HUMAN SAMPLES: NOTE: D nt lad a new capillary r discharge and refill the capillary between replicate tests; re-run the same aliqut in the same capillary fr all 5 replicates. Run each f the 5 replicate semen samples thrugh the Test New Patient ptin. Fr Patient ID use any sample number desired - N ther data entry is necessary n the first screen. Chse Fresh as the sample type. Select <= 1 M/ml fr the WBC Cnc. entry field. Yu may skip all ther fields by pressing enter t advance t the Aut-Calibratin screen (d nt tuch system during aut-calibratin). Mix yur sample (thrughly) by aspirating the sample in and ut 10 times with a transfer pipette. Lad the testing capillary per the instructins in the SQA-V Gld User Guide. Nte: Take great care t avid bubbles, under filling, r capillary tip wicking (during capillary drying). Insert capillary int the SQA-V Gld measurement cmpartment when prmpted t d s. After the test is cmpleted, imprt the result t V-Sperm and recrd Sperm Cncentratin, Mtility and Mrphlgy n the Mini-Validatin Data Entry Sheet. Select Retest Same Patient after each test t run the next replicate. Nte: Time is f the essence. Minimize the delay between tests as much as pssible. Enter all results int the SQA-V Validatin Study Data Entry Sheet and return t MES fr crunching. Repeat the steps abve fr all replicates acrss bth live human sperm samples. FOR NEGATIVE CONTROL ZERO LEVEL: File: SQA-V Gld Semiannual Validatin Instructins per CLIA Page 2 f 6

3 Set the SQA-V Cntrls via the V-Sperm (See SQA-V Gld User fr reference). Run 5 replicates f the negative cntrl frm the Run Cntrls sectin f the main menu. Chse the Negative Cntrl ptin frm the Run Cntrls menu (d nt run as level 1 r level 2 ). D nt discharge and refill the capillary between tests; re-run the same aliqut in the same capillary. The cntrl results are printed autmatically. Enter CONC. and MSC values in the Semiannual Validatin Study Results spreadsheet. Save all f the printuts and return them t Medical Electrnic Systems fr yur final Validatin Reprt. ACCURACY On an annual r semi-annual basis (at the users discretin) MES suggests cmparing 5 patient specimens analyzed n the SQA- V Gld t the backup methd t cnfirm user prficiency and crrect system peratin. MES suggests running 5 selected patient semen samples representing high, medium and lw sperm cncentratins. NOTE: Samples can be diluted and cmbined t achieve target qualities and increase the number f samples. T achieve an accurate cmparisn, please review these requirements and recmmendatins clsely befre beginning: The SQA-V analyzes semen samples strictly accrding t WHO Manual criteria and accurate validatin will be difficult if prcedures are nt fllwed clsely by manual analysis. Please cntact MES t request a cpy f this manual if yu dn t have ne. service@mes-llc.cm. MES currently recmmends WHO 5 th editin criteria fr manual analysis. Everything must be run at ROOM TEMPRATURE by bth methds. Samples shuld never be incubated. All samples shuld be run within 1 hur f cllectin n exceptins especially during validatin. Samples shuld be run n the SQA-V first as the testing cycle is much shrter. Manually, Mtility shuld be run first under the micrscpe t decrease any time variables. All samples need t be fully liquefied, and well mixed. Use QwikCheck Liquefactin material n stubbrn, viscus, and agglutinated r aggregated samples. This is a critical pint fr bth accurate cncentratin and mtility cmparisns. We recmmend visualizing all samples befre testing n the SQA-V. Extreme dd ball cases t watch ut fr include large amunts f uric acid crystals r cell debris. Als, cnfirm that sperm are present if yu bserve n r very few sperm, the sample shuld be run n pst vasectmy mde r simply reprted as zer acrss the bard. When cunting fields manually d nt ignre agglutinated r aggregated sperm. The system cunts all sperm, s if yu ignre the large clumps yu will affect the accuracy. This is a cmmn mistake with manual analysis there is a tendency t ignre fields that are clumped and agglutinated in search f easier fields t cunt. The SQA-V Gld analyzes Mrphlgy accrding t Kruger STRICT criteria under WHO 5 th editin reference ranges. It is critically imprtant that STRICT criteria be fllwed by manual bservatin. Fr clarificatin f these methds please cntact MES directly fr supprt: service@mes-llc.cm. It is cmmn t verestimate sperm mtility (manually), but this can ften be avided by reversing the rder f analysis (NP and IM first), using an eyepiece reticle, and being aware f, and aviding, t the extent pssible, ptential surces f bias. Make the preparatin immediately befre assessing. Read nly after any drifting has stpped t reduce bias in verall mtility. Select the field randmly and d nt deliberately select fields with high r lw numbers f mtile spermatza. One way t d this is t avid lking thrugh the culars until a field has been selected. D nt wait fr mtile spermatza t enter the field befre starting t cunt. Analyze quickly; analyze nly a small prtin f the grid at ne time, depending n sperm cncentratin. File: SQA-V Gld Semiannual Validatin Instructins per CLIA Page 3 f 6

4 Spend less time examining ne area f the grid, t avid cunting spermatza that swim int the area during analysis. Cunt prgressive, nn-prgressive and immtile spermatza in tw stages. If there are prblems with the technique, reverse the rder f analysis (Review Table 7.4 belw): SQA-V ACCURACY TESTING INSTRUCTIONS Run each f the 5 semen samples thrugh the Test New Patient mde. Enter yur relevant patient and sample data in the available fields Chse a sample type. Nte: Azspermic r extremely pr quality samples shuld be run n the Pst Vasectmy mde. Nte: Extremely decreased viscsity (watery) sample shuld be run n the system s Washed mde. Select <= 1 M/ml r > 1 M/ml fr WBC Cnc. based n results f QwikCheck Test Strips (see SQA-V Gld User Guide fr reference). Select > 1 M/ml fr samples with high amunts f debris r rund cells (50%+). Fr shrt samples, yu may chse a lw vlume ptin by selecting NO when asked if sample is greater than 0.5 ml. Mix yur sample (thrughly) by aspirating it in and ut 10 times using a transfer pipette. Lad the testing capillary per the instructins in the SQA-V Gld User Guide. File: SQA-V Gld Semiannual Validatin Instructins per CLIA Page 4 f 6

5 Visualize the sample t cnfirm the presence f sperm, and t check fr debris / rund cells. If n r few sperm are seen hit the Escape buttn twice and chse the Pst Vasectmy testing mde. If large amunts f debris r rund cells (50%+) are seen, hit Escape twice and chse the > 1 M/ml ptin. After the test is cmplete, imprt yur test int V-Sperm per nscreen instructins t archive the result. Perfrm manual testing per yu Labratries standard perating prcedure. Nte: Please fllw the recmmendatins frm sectin 1 clsely during manual analysis. Enter cncentratin, mtility and mrphlgy results frm bth methds int the SQA-V Validatin Study Data Entry Sheet and return t MES fr crunching. INSTRUMENT CALIBRATION CONFIRMATION CALIBRATION CONFIRMATION INSTRUCTIONS Twice per year, MES recmmends sending us the Service Data Reprt f yur SQA-V Gld fr a calibratin cnfirmatin. T print yur Service Data Reprt and return it t MES, please fllw these instructins: NOTE: The SQA-V internal printer will need t be laded with paper and printer ribbn. Please see user guide fr paper and ribbn lading instructins. Pwer yur SQA-V instrument ff, then n again s a fresh calibratin is perfrmed by the system. If the Self-Test data reprt des nt print ut autmatically, navigate t the Service menu and nce in the Service menu select Print Default Settings. Then select Print Self-Test Data. Tape this Self-Test reprt t a piece f blank white paper and fax the reprt t r scan and it t service@mes-llc.cm. Please include an address and yur cntact infrmatin with the Self-Test reprt. Yur SQA-V calibratin parameters will be cmpared t the initial calibratin parameters frm when the instrument was manufactured and presented back t yu in reprt frmat COLLEGE OF AMERICAN PATHOLOGISTS (CAP) PROFICIENCY CHALLENGE CAP SAMPLE PROCESSING INSTRUCTIONS NOTE: The CAP prficiency material is run as a CONTROL nt as a patient sample. Turn n bth the SQA-V and the PC laded with V-Sperm sftware. Frm the main menu f the SQA-V select: SERVICE > SERVICE DATA. Frm the V-Sperm cmputer, navigate t SET UP > SQA-V > SQA-V DEFAULTS and click CONTINUE. On the bttm half f the Setup screen, find CONTROLS. Select the STABILIZED SPERM ptin, and enter the fllwing fr Level 1 and Level 2: LOT NUMBER: Yur CAP reference number. TARGET VALUE: Enter 50 fr all levels. RANGE: Enter 50 - DATE: Tday s date. Click APPLY and wait a few mments fr the infrmatin t transfer t the SQA-V. Once the transfer is cmplete yu are ready t run the Prficiency Test n the SQA-V Gld. File: SQA-V Gld Semiannual Validatin Instructins per CLIA Page 5 f 6

6 Running Stabilized Sperm CAP Prficiency Material n the SQA-V: Frm the MAIN MENU f the SQA-V select: RUN CONTROLS > LEVEL 1 Lad the SQA-V testing capillary and insert it int the testing chamber per the nscreen instructins. If yu receive a result f 0.0, Re-Run the sample n the SQA-V s Test New Patient FRESH mde (see Nte belw). Repeat this prcess fr Level 2. Recrd yur actual TEST results and submit them t CAP. Please cntact MES with any questins at service@mes-llc.cm r Remember t re-set yur cntrl defaults back t Latex Beads after cmpleting the prficiency challenge! NOTE: Due t the nature f prepared Stabilized Sperm prficiency material, very lw cncentratin samples may reprt ZERO even thugh a few sperm a present. This ccurs because the ptical density f the Stabilized Sperm may be belw the dynamic range f the instrument. If yu receive a ZERO result n the QC mde described abve, it is recmmended that yu re-run the sample n the SQA-V s FRESH mde t achieve and reprt a result f < 2.0 M/mL. Fr clarificatin please cntact MES directly. File: SQA-V Gld Semiannual Validatin Instructins per CLIA Page 6 f 6