PEPFAR Quality Control and Method Validation Activity 14 Worksheet: Reference Interval

194 Reference Interval Worksheet 14D03 Method being evaluated: 12345 Analyte: AST Transfer Measurement Procedure: AST performend on XYZ analyzer Units: U/L Proposed Reference Interval: Males < 38 U/L Females <32 U/L Partition 1: Male Partition 2: Female Run # Date Collect Analysis Initials Result Date Collect Analysis Initials Result Time Time Time Time 1 27-Nov 13 0800 0900 AM 28 27-Nov 13 0930 .000 AM 12 2 27-Nov 13 0910 1000 AM 27-Nov 13 1030 1100 AM 22 3 27-Nov 13 0930 1100 AM 37 28-Nov 13 0900 1000 LS 6 4 27-Nov 13 1000 1100 AM 32 28-Nov 13 0930 1000 LS 18 27-Nov 13 1015 1100 AM 27 28-Nov 13 1100 1200 IS 25 6 27-Nov 13 1030 1100 AM 39 28-Nov 13 1115 .200 LS 15 7 27-Nov 13 1045 1100 AM 19 29-Nov 13 0930 1000 TZ 21 8 28-Nov 13 0900 1000 LS 11 29-Nov 13 1000 1100 TZ 19 9 28-Nov 13 0915 1000 LS 37 29-Nov 13 1015 100 TZ 28 10 28-Nov 13 0930 1000 S 27 29-Nov 13 1030 1100 TZ 12 11 28-Nov 13 1015 1200 LS 32 29-Nov 13 1045 1100 TZ 22 12 28-Nov 13 1030 1200 LS 29-Nov 13 | 1200 1400 TZ 20 13 28-Nov 13 1100 1200 LS 16 29-Nov 13 1230 1400 TZ 25 14 29-Nov 13 1300 1400 T7 12 30-Nov 13 1300 1500 16 15 29-Nov 13 1315 1400 TZ 37 30-Nov 13 1315 .500 LS 21 16 29-Nov 13 1330 1400 TZ 15 30-Nov 13 | 1330 1500 LS 23 17 30-Nov 13 1000 1200 25 30-Nov 13 1400 1500 LS 28 n 18 30-Nov 13 1015 1200 LS 20 01-Dec 13 0800 0900 AM 23 19 30-Nov 13 1030 1200 36 01-Dec 13 0910 1000 AM 7 20 30-Nov 13 1045 1200 LS 22 01-Dec 13 0930 1100 AM 23 Reference interval is verified / needs to be re-evaluated. Reference interval is verified / needs to be re- evaluated. (circle one) (circle one) Analysis of transference performed by Date: Analyte Adult Reference Ranges Reference Range Cited % Verified (Expected 290%) Males < 38 U/L XYZ Manufacturer Range AST Females 532 U/L HILS1746 Effective Date: 12/6/2016