Quality improvement presentation Labs Diagnostics.pptx

qip for labs

1. QUALITY IMPROVEMENT PROGRAM – 2024 HEALTHCARE- DEPARTMENT OF LABORATORY SCIENCES

2. Members of QIP Team DR Amrita Singh: Head Lab Operation Dr Bhati : MS Dr Kalpana Jain: Sr Consultant Pathologist Dr. Vidya Menon: Consultant Pathologist Mr.Deepakk Kumar: Quality Manager Mr Prakash Chand: Supervisor All Technical staff

3. Aim for the current year-2024 1. To Record and Reduce All Pre analytical rejections. 2. CV of all the parameters to be improved

4. PREANALYTIC MONITORS

5. AVERAGE SAMPLE LOAD COMPARISON - 2024 Quarter 2023 2024 1 st Qtr (Jan-Mar) 1 03727 68991(Jan- Feb) 2 nd Qtr (Apl-Jun) 105224  - 3 rd Qtr (Jul-Sept) 107221  - 4 th Qtr (Oct-Dec) 101291  -

6. Comparison of Sample Load Quarter-wise for 2023

7. TOTAL NO. OF REJECTION QUARTER-WISE COMPARISON 2023-2024 QUATERLY SAMPLE LOAD-2023 SAMPLE REJECTION % SAMPLE LOAD-2023 SAMPLE REJECTION % 1 st Qtr (Jan-Mar) 1 03727 205 .2 68991(Jan-Feb) 124 .18 2 nd Qtr (Apl-Jun) 1 05224 1 90 0.18 -  - - 3 rd Qtr (Jul-Sept) 1 07221 1 98 0.18  - - - 4 th Qtr (Oct-Dec) 1 01291 1 89 0.19  - - -

8. 1. Pre-analytical Phase 2. Analytical Phase 3.Post –analytical Phase 1.Pre-analytical Errors Hemolysis QNS Clotted Inapp. Container Leakage Causes of Repeats : Where and What ?

9. CAUSES OF REPEATS PRE – ANALYTICAL CAUSES 1.Hemolysis 2.QNS/Repeat Sample 3.Clotted 4.Overfille/Underfilled 5.Wrong Container 6.Lipemic

10. Corrective Actions….. Two days Training session of Sample Collection Procedures organized for all Nursing Staffs & Phlebotomist by Becton Dickinson (BD) on 6-7 th Feb 2024 Do & Dont’s are circulated frequently.

11. ANALYTIC MONITORS

12. Instruments service Log Vitros 5600 (HALF YEARLY SCHEDULE) DONE ON DUE ON 26/11/2023 25/05/2024 Vitros 250 (HALF YEARLY SCHEDULE) DONE ON Done on 29/12/2023 28/06/2024 ACLTOP- Unit 1 (HALF YEARLY SCHEDULE) DONE ON DUE ON 22/12/2023 21/06/2024 NOTE : ALL WITHIN BUFFER PERIOD OF ONE MONTH

13. Instruments service Log ACLTOP- Unit 2 (HALF YEARLY SCHEDULE) DONE ON DUE ON 22/12/2023 21/06/2024 SYSMEX XN-1000 (YEARLY SCHEDULE) DONE ON Done on 13/04/2023 12/04/2024 ERBA H560 (YEARLY SCHEDULE) DONE ON DUE ON 09/12/2023 08/12/2024 NOTE : ALL WITHIN BUFFER PERIOD OF ONE MONTH

14. Instruments service Log VESMATIC (YEARLY SCHEDULE) DONE ON DUE ON 06/07/2023 05/07/2024 ABOTT Ci4100 (YEARLY SCHEDULE) DONE ON Done on UNDER VALIDATION NOTE : ALL WITHIN BUFFER PERIOD OF ONE MONTH

15. 1 ST QTR (Jan-March) 2 ND QTR (April-June) 3 RD QTR (July-Sept) 4 TH QTR Oct-Dec) No. OF BREAKDOWNS NA 1 1 NA CAUSE NA Lamp Changed Software Issue NA EQUIPMENT BREAKDOWN (VITROS 5600 RECORD (2023)

16. EQUIPMENT BREAKDOWN (VITROS-250) RECORD (2023) 1 ST QTR (Jan-March) 2 ND QTR (April-June) 3 RD QTR (July-Sept) 4 TH QTR (Oct-Dec) No. OF BREAKDOWNS NA NA NA NA CAUSE NA NA NA NA

17. EQUIPMENT BREAKDOWN (ACLTOP UNIT-1) RECORD (2023) 1 ST QTR (Jan-March) 2 ND QTR (April-June) 3 RD QTR (July-Sept) 4 TH QTR (Oct-Dec) No. OF BREAKDOWNS NA NA NA NA CAUSE NA NA NA NA

18. EQUIPMENT BREAKDOWN (ACLTOP UNIT-2) RECORD (2023) 1 ST QRTR (Jan-March) 2 ND QRTR (April-June) 3 RD QRTR (July-Sept) 4 TH QRTR (Oct-Dec) No. OF BREAKDOWNS NA NA NA NA CAUSE NA NA NA NA

19. EQUIPMENT BREAKDOWN (SYSMEX XN1000) RECORD (2023) 1 ST QRTR (Jan-March) 2 ND QRTR (April-June) 3 RD QRTR (July-Sept) 4 TH QRTR (Oct-Dec) No. OF BREAKDOWNS 1 (1 st Mar-2023) NA 1 NA CAUSE WBC CHAMBER BLOCKED NA BACKGROUND FAIL NA

20. EQUIPMENT BREAKDOWN (ERBA H560) RECORD (2023) 1 ST QRTR (Jan-March) 2 ND QRTR (April-June) 3 RD QRTR (July-Sept) 4 TH QRTR (Oct-Dec) No. OF BREAKDOWNS NA NA NA NA CAUSE NA NA NA NA

21. EQUIPMENT BREAKDOWN (VESMATIC) RECORD (2023) 1 ST QRTR (Jan-March) 2 ND QRTR (April-June) 3 RD QRTR (July-Sept) 4 TH QRTR (Oct-Dec) No. OF BREAKDOWNS NA NA NA NA CAUSE NA NA NA NA

22. EQUIPMENT BREAKDOWN ABBOTT Ci4100 RECORD 2024 1 ST QRTR (Jan-March) 2 ND QRTR (April-June) 3 RD QRTR (July-Sept) 4 TH QRTR (Oct-Dec) No. OF BREAKDOWNS UNDER VALIDATION CAUSE

23.     JAN FEB MAR APR MAY JUN JULY AUG SEPT OCT NOV DEC S.No Parameter L1 L2 L1 L2 L1 L2 L1 L2 L1 L2 L1 L2 L1 L2 L1 L2 L1 L2 L1 L2 L1 L2 L1 L2 1 Albumin-Serum 2.2 3.08 2.45 2.12 2.57 2.06 2.99 3.78 3.16 4.51 4.18 5.09 2.59 4.54 5.11 4.79 1.64 3.03 3.97 5.07 3.34 4.1 2.58 4.44 2 Alkaline Phosphatase (ALP)-Serum 3.72 3.68 3.21 2.88 2.53 2.15 1.23 1.51 5.38 4.61 6 4.56 4.45 3.85 4.39 5.65 3.4 4.8 3.06 3.23 2.76 4.37 1.89 0.99 3 ALT 3.69 7.96 6.34 9.18 6.53 5.15 2.95 2.52 7.81 6.82 7.08 6.92 7.44 4.55 6.33 5.86 6.89 5.24 9.49 6.36 5.93 3.1 2.49 1.49 4 Amylase-Serum 1.95 5.21 2.83 3.32 1.59 2.98 1.65 1.13 5.01 5.82 6.01 4.42 5.46 2.8 9.92 5.89 2.28 2.13 1.17 2.2  2.03 4.98 1.97 1.45 5 AST 1.76 6.78 2.1 4.14 5.87 3.88 3.86 1.36 9.18 6.01 6.46 6.63 8.5 5.49 7.52 5.78 4.22 4.6 4.53 5.44 3.65 2.58 2.97 1.43 6 Bilirubin Total-Serum 6.2 4.35 2.74 7.1 4.72 2.77 4.48 6.18 6.74 4.84 9.13 3.86 5.38 3.12 7.27 4.74 7.2 3.62 8.56 5.44 5.16 3.51 3.27 1.62 7 Cholesterol-Total-Serum 5.72 5.5 3.46 2.8 3.48 2.43 2.25 1.25 5.05 4.53 5.28 5.02 3.58 4.27 7.6 3.02 2.03 3.35 1.1 2.59 2.33 2.08 2.21 1.71 8 Creatinine 3.32 3.83 4.1 2.5 2.37 1.68 2.17 2.27 4.23 2.57 6.87 7.83 7.03 6.74 7.97 5.38 3.53 2.57 4.95 5.57 5.5 3.43 2.53 3.13 9 Cholesterol-HDL-Serum 2.96 4.31 2.85 1.26 3.63 1.46 2.31 1.21 5.59 6 5.19 6.5 4.88 4.2 8.32 5.68 2.14 5.07 1.6 3.35 0.7 2.97 0.98 2.14 10 Glucose 4.67 4.66 2.35 1.54 3.58 1.67 1.59 2.23 4.98 4.64 5.85 5.07 4.94 4.13 3.77 5.87 1.42 1.11 0.91 1.5 1.15 1.51 1.06 1.61 11 Total Protein 5.1 4.91 1.04 1.56 3.06 2.19 1.85 2.88 6.73 5.6 3.36 5.47 2.68 3.79 3.51 4.73 1.75 0.92 0.92 1.71 1.87 2.3 1.38 2.78 12 Triglycerides-Serum 4.4 3.62 1.54 2.72 3.9 1.6 1.68 1.57 4.76 4.47 4.3 5.27 3.63 4.87 3.7 6.66 5.53 5.54 4.26 2.57 2.72 2.17 2.21 1.84 13 Urea-Serum 8.14 8.45 2.11 3.99 1.51 2.74 1.75 1.49 5.5 4.68 3.74 6.25 3.76 4.54 3.89 6.57 1.39 0.89 2.22 2.83 2.98 2.79 1.97 1.7 14 Uric Acid-Serum 2.91 5.07 4.44 3.93 1.48 1.68 1.96 1.38 3.31 3.02 3.42 2.96 2.48 2.59 2.72 5.06 4.46 4.14 3.56 3.29 3.14 3.7 2.28 1.47 15 Direct Bilurubin 3.74 9.75 1.94 7.1 9.05 6.09 7.62 4.81 8.96 6.83 8.49 7.47 7.45 5.88 6.66 7.39 7.35 2.75 7.17 2.75 5.89 3.48 5.38 2.22 16 Calcium 2.73 5.27 1.93 0.87 1.31 4.07 1.65 2.43 3.49 2.97 2.64 2.37 2.57 1.38 4.72 4.21 2.18 1.82 1.24 1.82 2.77 2.59 2.54 1.69 17 Chloride 3.73 5.17 4.23 3.28 3.13 4.28 3.95 2.13 2.74 2.79 2.84 3.05 1.5 3.13 4.57 2.62 1.04  1.9 2.13 1.77 1.53 1.84 0.91 1.33 18 GGT 7.4 6.08 1.66 2.98 2.71 1.76 1.79 2.65 4.81 5.01 5.55 5.26 5.19 3.75 3.82 4.89 3.11 1.75 1.77 1.75 1.83 2.27 2.57 1.39 19 Iron 5.95 6.75 3.94 2.94 1.74 1.3 1.78 1.57 4.98 4.42 4.36 5.89 2.66 4.76 4.92 5.6 2.48 2.75 1.63 2.75 1.55 2.62 2.95 3.04 20 LDH 7.46 6.06 1.3 4.17 7.31 4.82 8.52 2.3 5.55 3.54 5.69 3.63 2.63 2.95 6.39 4.21 4.5 1.93 6.33 1.93 5.94 3.66 1.97 2.2 21 Lipase 8.94 5.39 7.66 8.16 9.11 2.07 3.68 6.6 6.05 5.82 6.82 7.12 5.95 7.12 7.28 6.21 2.03  2.0 1.51 2.4  2.14 2.76 3.39 2.19 22 Phosphorous 1.85 9.28 3.4 1.11 2.63 1.98 2.54 1.79 5.34 2.86 4.2 2.57 3 2.57 3.33 5.2 1.53 1.5  2.25  2.4 4.51 2.13 1.98 1.73 23 K+ 3.65 4.61 3.4 2.64 2.51 5.7 1.81 2 2.61 2.27 3.22 1.85 3.55 1.85 4.35 3.45 1.38     1.49 2.0 1.81 1.68 3.23 24 Sodium 2.79 2.64 2.4 1.84 2.5 4.45 1.51 5.33 2.07 2.5 1.57 3.41 2.11 2.39 2.41 2.03 1.37   7.53 6.56 1.73 1.48 0.7 0.87 25 UIBC 5.53 5.01 4.87 2.65 6.64 5.52 1.81 5.9 7.02 7 6.18   5.62   6.58   6.29   7.32   4.7   2.68   MONTHLY CV OF BIOCHEMISTRY-2023

24. MONTHLY CV OF BIOCHEMISTRY-2024   JAN FEB Parameter L1 L2 L1 L2 Albumin-Serum 2.11 2.14 2.52 2.25 Alkaline Phosphatase (ALP)-Serum 2.13 1.43 2.15 2.39 ALT 5.96 3.02 4.54 5.34 Amylase-Serum 1.95 2.57 4.96 3.38 AST 2.19 1.3 3.77 5.66 Bilirubin Total-Serum 4.84 4.61 7.09 4.21 Cholesterol-Total-Serum 1.09 1.57 0.92 3.76 Creatinine 3.83 3.67 5.0 2.91 Cholesterol-HDL-Serum 0.79 3.84 2.09 5.25 Glucose 1.36 1.12 2.96 2.06 Total Protein 1.07 0.99 2.1 3.42 Triglycerides-Serum 1.59 1.19 2.73 2.74 Urea-Serum 1.59 1.37 2.71 2.86 Uric Acid-Serum 3.62 3.48 2.35 3.2 Direct Bilurubin 4.66 2.59 9.05 5.22 Calcium 2.69 1.74 2.26 3.36 Chloride         GGT 1.79 1.03 3.09 2.42 Iron 2.18 1.73 2.89 2.79 LDH 5.31 5.39 4.68 5.1 Lipase 1.75 1.66  3.0 2.92 Phosphorous 2.5 1.75  2.1 1.86

25. Month JAN FEB MAR APR MAY JUN JULY AUG SEPT OCT NOV DEC Parameter L1 L2 L3 L1 L2 L3 L1 L2 L3 L1 L2 L3 L1 L2 L3 L1 L2 L3 L1 L2 L3 L1 L2 L3 L1 L2 L3 L1 L2 L3 L1 L2 L3 L1 L2 L3 25-Hydroxy Vitamin D-Serum 2.42 2.6 6.4 2.11 4.95 6.18 1.62 4.41 9.67 8.61 3.83 8.68 6.96 5.15 6.96 6.25 3.64 8.49 6.2 2.91 7.06 2.9 6.21 4.5 6.09 6.85 5.11 7.34 9.34 4.08 5.54 3.58 4.68 3.9 4.11 3.73 ParaThyroid Hormone (PTH) 2.18 2.56 7.33 3.5 2.71 1.33 2.18 2.7 1.36 2.03 1.67 2.33 1.91 2.64 4.67 4.08 4.63 7.89 2.87 2.86 6.41 4.35 6.71 5.37 4.35 3.15 4.22 1.33 4.6 4.58 2.6 4.45 1.93 0.69 1.66   HIV 10.37 3.54 4.66 7.49 4.6 6.7 6.9 5.19 2.22 4.22 6.9 6.6 8.05 3.75 5.5 4.47 6.2 7.07 4.22 4.94 5.15 6.5 6.3 3.08 5.31 5.8 6.64 8.72 6.4 7.2 6.54 7.4 6.5 5.4 6.5 6 .7 HCV 4.15 4.41 2.47 3.35 3.9 2.81 2.52 5.45 3.14 4.56 4.35 6.19 5.06 5.51 4.6 5.14 7.09 1.36 8.36 5.5 5.4 3.45 5.5 5.1   HBsAg 6.03 5.98 6.45 8.44 6.25 7.61 4.31 7.46 7.86 6.02 7.44 8.82 6.23 8.32 7.23 4.38 4.73 5.3 6.27 5.46 5.1 5.84 6.0 6.23   Prostate Specific Antigen (Total PSA)-Serum 10.02 5.17 8.83 2.67 4.64 7.41 2.63 2.77 7.3 7.05 6.32 9.56 8.08 3.15 2.83 6.89 8.46 5.53 6.92 8.21 5.36 4.83 4.42 4.27 5.72 3.43 2.85 6.67 9.47 1.23 5.24 3.39 2.77 4.84 3.05   Thyroid Stimulating Hormone (TSH)-Serum 6.81 5.89 6.08 3.51 7.39 4.23 4.36 7.67 4.17 4.87 9.58 7.09 8.93 5.47 6.04 7.89 7.43 5.71 6.5 7.16 4.39 2.66 3.4 3.82 4.64 1.65 1.61 6.12 6.11 1.76 6.3 2.63 1.61 3.02 1.83   Thyroxine-Free (FT4)-Serum 4.86 7.33 6.84 2.51 7.43 3.4 2.66 3.8 5.83 4.65 6.88 8.51 5.78 7.6 6.14 9.79 8.16 8.04 6.73 7.92 3.22 5.03 2.74 7.35 3.41 5.91 1.83 2.28 3.3 3.9 5.43 6.84 2.92 4.95 5.6   Vitamin-B12 4.08 4.39 2.31 6.55 1.34 5.08 6.65 6.8 7.42 5.53 8.66 5.92 8.42 1.89 3.87 8.15 3.29 7.41 7.46 2.59 5.01 4.2 1.82 3.77 6.33 1.91 3.05 6.06 4.49 2.97 4.6 4.35 2.63 4.97 0.89   Tri-Iodothyronine Free (FT3)-Serum 5.07 1.84 3.36 6.36 1.77 3.08 1.57 7.49 5.66 6.37 7.22 6.56 4.19 4.32 1.46 4.95 5.82 7.06 4.11 4.01 5.78 7.14 5.48 3.99 2.44 1.93 4.63 3.54  4.2 4.5 5.35 5.14 1.97 4.37 3.61   Beta- Human Chorionic Gonodotropin Hormone 7.65 2.92 2.01 6.59 4.22 5.94 4.94 4.92 2.4 5.85 4.99 6.2 6.91 5.91 6.13 7.86 8.09 6.26 7.11 6.9 5.82 2.43 5.91 6,14 5.6 1.88 3.39 4.64 8.35 3.27 6.78 5.08 6.46 4.32 3.45   MONTHLY CV OF IMMUNOASSAY-2023

26. MONTHLY CV OF IMMUNOASSAY-2024 Month JAN FEB S.No Parameter L1 L2 L3 L1 L2 L3 1 25-Hydroxy Vitamin D-Serum 5.23 6.05 5.65 4.99 6.12 5.34 2 ParaThyroid Hormone (PTH) 4.42 0.99 3.02 3.05 3.29 2.98 3 HIV 1.65 1.42 3.31 2.77 1.56 3.27 4 HCV 3.92 3.29 3.91 4.91 3.42 2.25 5 HBsAg 5.64 5.17 5.52  5.6 8.53 5.9 6 Prostate Specific Antigen (Total PSA)-Serum 2.06 1.71 1.92 2.08 1.45 2.94 7 Thyroid Stimulating Hormone (TSH)-Serum 3.09 6.28 4.8 2.8 6.1 2.04 8 Thyroxine-Free (FT4)-Serum 2.83 1.34 3.25 2.0 1.87 2.66 9 Vitamin-B12 3.13 4.75 7.28   3.4 2.36 10 Tri-Iodothyronine Free (FT3)-Serum 3.48 2.58 1.88 4.68 2.68 5.78 11 Beta- Human Chorionic Gonodotropin Hormone 2.63 3.27 3.72 4.01 1.92 1.85

27.   JAN FEB MAR APR MAY JUN JULY AUG SEPT OCT NOV DEC Parameter L1 L2 L1 L2 L1 L2 L1 L2 L1 L2 L1 L2 L1 L2 L1 L2 L1 L2 L1 L2 L1 L2 L1 L2 HBA1C 5.2 39 2.6 3.21 2.8 5.21 2.01 3.6 3.95 3.51 4.82 5.93 3.59 2.79 1.69 2.34 1.59 1.95 2.89 2.98 2.83 3.94 2.78 2.14 MONTHLY CV OF HbA1c-2023

28. MONTHLY CV OF HbA1C-2024   JAN FEB S.No Parameter L1 L2 L1 L2 1 HBA1C 2.08 1.57 3.72 3.38

29. MONTHLY CV OF HAEMATOLOGY (XN1000)-2023   JULY AUG SEPT OCT NOV DEC S.No Parameter L1 L2 L3 L1 L2 L3 L1 L2 L3 L1 L2 L3 L1 L2 L3 L1 L2 L3 1 RBC 1.49 1.73 1.03 1.48 1.4 1.98 1.49 1.5 1.98 1.49 1.73 0.89 1.48 0.93 1.25 1.73 1.27 0.56 2 HGB 0.88 0.53 0.34 0.72 0.4 1.54 0.88 0.8 1.54 0.88 0.53 0.5 0.72 0.42 0.6 0.53 0.65 0.42 3 HCT 1.73 2.37 0.35 1.6 1.45 2.12 1.73 1.7 2.12 1.73 2.37 0.81 1.6 1.18 1.48 2.37 0.95 0.88 4 MCV 0.68 0.79 0.81 0.51 0.38 0.55 0.68 0.7 0.55 0.68 0.79 0.96 0.51 0.41 0.45 0.79 0.4 0.52 5 MCH 1.43 2.01 0.98 1.35 1.39 1.33 1.43 1.4 1.33 1.43 2.01 1.37 1.35 0.81 1.4 2.01 1.33 0.74 6 MCHC 1.54 2.4 1.92 1.34 1.41 1.59 1.54 1.5 1.59 1.54 2.4 1.05 1.34 1.15 1.57 2.4 1.35 0.84 7 RDW-CV 1.12 1.79 2.7 1.26 1.66 3.12 1.12 1.1 3.12 1.12 1.79 2.29 1.26 2.23 2.23 1.79 1.52 2.11 8 PLT 4.51 3.21 2.92 6.32 3.13 3.65 4.51 5 3.65 4.51 3.21 0.95 6.32 3.08 2.35 3.21 2.97 1.93 9 MPV 2.61 1.83 1.8 3.06 1.48 3.41 2.61 3.7 3.41 2.61 1.83 1.02 3.06 1.28 1.24 1.83 1.34 1.3 10 WBC 3.9 2.76 1.82 3.29 2.22 3.5 3.9 3.9 3.5 3.9 2.76 3.1 3.29 1.32 1.34 2.76 1.85 2.37 11 NEU% 4.08 2.18 0.65 4.29 3.3 3.43 4.08 4.1 3.43 4.08 2.18 1.39 4.29 2.18 0.84 2.18 1.85 1.01 12 LYM% 6.13 2.58 1.96 3.41 2.55 4.65 6.13 6.1 4.65 6.13 2.58 3.14 3.41 3.69 2.45 2.58 2.86 1.84 13 MON% 7.64 3.4 5.74 9.15 8.79 9.71 7.64 9.1 9.71 7.64 3.4 4.75 9.15 8.57 6.6 3.4 7.91 8.55 14 EOS% 4.7 14 11.64 10.64 9.47 10.46 4.7 4.7 10.46 4.7 14 4.89 10.64 9.71 11.68 14 14.1 9.06 15 BAS% 8.45 10.34 6.53 17.05 8.14 37.12 8.45 8.5 37.12 8.45 10.34 13.47 17.05 9.28 14.05 10.34 16.45 12.86 16 NEU# 4.35 3.27 1.94 5.16 5.19 2.31 4.35 4.3 2.31 4.35 3.27 2.31 5.16 2.68 3.54 3.27 3.21 1.82 17 LYM# 3.31 2.2 3.66 3.43 1.87 7.44 3.31 3.3 7.44 3.31 2.2 2.99 3.43 3.59 3.41 2.2 2.64 1.92 18 MON# 7.73 6.71 5.37 7.08 9.67 8.17 7.73 7.7 8.17 7.73 6.71 3.57 7.08 8.71 6.47 6.71 7.61 9.96 19 EOS# 7.01 17.41 12.83 12.28 8.06 7.12 7.01 7 7.12 7.01 17.41 7.79 12.28 14.51 12.21 17.41 12.79 9.38 20 BAS# 8.95 11.86 7.17 10.7 7.44 8.85 8.95 8.9 8.85 8.95 11.86 9.37 10.7 9.75 13.58 11.86 16.51 11.39

30. MONTHLY CV OF HAEMATOLOGY-2024   JAN FEB Instrument Name S YSMEX XN1000   S.No Parameter L1 L2 L3 L1 L2 L3 1 RBC 1.33 1.35 1.08 1.73 1.29 1.18 2 HGB 0.68 0.36 1.64 0.53 0.32 0.4 3 HCT 0.91 0.21 1.42 2.37 1.23 1.8 4 MCV 0.51 0.29 0.46 0.79 0.29 0.46 5 MCH 1.27 1.14 1.33 2.01 1.41 0.86 6 MCHC 1.22 0.91 1.53 2.4 1.38 1.84 7 RDW-CV 1.64 1.36 3.12 1.79 1.18 1.13 8 PLT 4.26 3.88 3.65 3.21 2.89 2.52 9 MPV 1.32 1.17 3.41 1.83 0.89 1.02 10 WBC 3.72 2.22 3.17 2.76 1.6 1.64 11 NEU% 4.16 3.3 3.43 2.18 1.66 0.35 12 LYM% 3.72 1.8 4.2 2.58 2.05 2.93 13 MON% 6.31 9.33 9.68 3.4 5.96 3.88 14 EOS% 6.73 6.15 2.2 14 9.04 9.69 15 BAS% 9.7 4.47 7.52 10.34 13.1 7.04 16 NEU# 4.82 5.19 2.31 3.27 2.82 2.34 17 LYM# 3.79 1.87 7.7 2.2 2.35 2.58 18 MON# 7.92 8.56 8.96 6.71 8.85 2.26 19 EOS# 8.66 9.95 3.33 17.41 9.37 6.4 20 BAS# 9.75 9.37 7.55 11.86 8.99 9.35

31. MONTHLY CV OF COAGULATION-2023   JULY AUG SEPT OCT NOV DEC S.No Parameter L1 L2   L1 L2   L1 L2   L1 L2   L1 L2 L3 L1 L2 L3 1 PT INR 9.65 4.56   4.5 7.95   4.88 5.35   5.13 4   7.97 9.03   9.11 9.28                                             APTT 9.93 9.31   8.52 9.89   8.52 9.89   7.74 8.29   9.71 9.87   9.11 9.93  

32. MONTHLY CV OF COAGULATION-2024   JAN FEB S.No Parameter L1 L2 L3 L1 L2 L3 1 PT INR 7.97 9.03   8 8.9                     APTT 9.71 9.87   9.1 9.3                  

33. 1. Controls were Re run. 2. Fresh controls were run. 3.Calibration was done and controls were run. 4.Recalibration with fresh reagent was done and controls were run. 5. Application Specialist from the company was called. When Internal Quality control( IQC) was out of control: 1.Procedure used are reviewed 2.Environmental conditions ( temp) was checked 3.Recent events : new reagent kit/lot. Instrument repair/AMC was checked . 4.Manufacturer’s trouble shooting guide was followed. Probable Cause Known General : Steps followed for Internal QC outlier …….

34. Bio-Chemistry Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Retained Testing (Once a Year) ● Carry Over Study (Biannually) ● ● AMR Study (Biannually/ Receipt of High Sample ) ● ● Precision (Once a Year) ● EQAS ● ● ● ● ● ● ● ● ● ● ● ● Hematology Jan Feb Mar Apr May Jun Jul Aug Sept Oct Nov Dec Retained Testing (Once a Year) ● AMR Study ● Precision (Once a Year) ● EQAS ● ● ● Q.C Studies Miscellaneous Studies : Schedule

35. RETAINED SAMPLE STUDY HEMATOLOGY (2024) ( once annually) Analyte Name Fresh Sample Retained Difference Acc Criteria Hb 14.2 14.4 1.4 % < 1.97 X scope CV RBC 4.43 4.48 1.12 % < 1.97 X scope CV WBC 8.39 8.36 0.35 % < 1.97 X scope CV Platelets 276 276 0 % < 1.97 X scope CV PCV 42.1 43.7 3.8 % < 1.97 X scope CV Q.C . STUDIES Difference of Parameters - SATISFACTORY

36. Department : Biochemistry Analyte Name Sample 22.2.24 Reading Retained 25.2.24 sample Reading % Difference Acc Criteria Urea 19 19 < 1.97 X NABL CV Creatinine 0.75 0.78 4 < 1.97 X NABL CV Uric Acid 5.5 5.6 1.8 < 1.97 X NABL CV Cholesterol 160 162 1.25 < 1.97 X NABL CV Triglycerides 118 121 2.54 < 1.97 X NABL CV Alkaline 109 112 2.75 < 1.97 X NABL CV Albumin 4.42 4.5 1.8 < 1.97 X NABL CV Protein 7.55 7.67 1.5 < 1.97 X NABL CV Cacium 9.45 9.81 3.8 < 1.97 X NABL CV Phosphours 3.33 3.43 3 < 1.97 X NABL CV HDL 37 38 2.7 < 1.97 X NABL CV LDL 99.4 99.8 0.4 < 1.97 X NABL CV Sodium 139 141 1.43 < 1.97 X NABL CV Potassium 4.31 4.45 3.24 < 1.97 X NABL CV Chloride 104 103 0.97 < 1.97 X NABL CV RETAINED SAMPLE TESTING 2024 ALL Parameters - SATISFACTORY

37. Department: Biochemistry Analyte Name Sample Reading 22.2.24 Retained sample Reading 25.2.24 % Difference Acc Criteria SGOT 23 24 4.3 < 1.97 X NABL CV SGPT 20 20 < 1.97 X NABL CV ALKALINE 109 112 2.75 < 1.97 X NABL CV T.BIL 0.81 0.77 4.9 < 1.97 X NABL CV D.BIL 0.15 0.15 < 1.97 X NABL CV T.PROT 7.55 7.67 1.5 < 1.97 X NABL CV GGT 20 20 < 1.97 X NABL CV CHOL 160 162 1.25 < 1.97 X NABL CV TGL 118 121 2.54 < 1.97 X NABL CV HDL 37 38 2.7 < 1.97 X NABL CV LDL 99.4 99.8 0.4 < 1.97 X NABL CV RETAINED SAMPLE TESTING 2024 ALL Parameters - SATISFACTORY

38. Carry over study VITROS 5600 Analyte Reading Low sample (L) High sample Reading (H) Carry over % Formula used Acc. Criteria Triglycerides 1 66 542 L1 – L3 / H2- L3 X 100 Allowable Bias% 2 65 542 3 65 541 0.2 %

39. Linearity of Vitros 5600 ) Serum SGPT ( AMR of 5.1-942 U/L ) AMR STUDY FOR BIOCHEMISTRY Sample -ID ASSIGNED VALUE VALUE OBTAINED % DIFFERENCE Sample 1 903.66 903.6 Sample 2 451.83 451.3 0.11 Sample 3 225.91 222.3 1.62 Sample 4 112.95 111.33 1.45 Sample 5 56.47 56.0 0.83 Sample 6 28.23 28.0 0.82 Sample 7 14.11 14.0 0.78

40. Amr study for hematology Linearity study for Hemoglobin (SYSMEX XN1000) Sample -ID ASSIGNED VALUE OBSERVED VALUE % DIFFERENCE Sample 1 21.1 21.1 Sample 2 10.55 10.53 0.18 Sample 3 5.27 5.23 0.76 Sample 4 2.63 2.63 Sample 5 1.31 1.3

41. ANALYTE No. of run Values Obtained with Runs MEAN SD CV Glucose 5 95 94 94 96 95 94 0.83 0.88 Urea 5 17 17 17 17 17 17 PRECISION VITROS 5600 : 20.02.2024 ACCEPTABLE CRITERIA : < 1.97 X CV SATISFACTORY

42. ANALYTE No. of Run Values Obtained with Runs MEAN SD CV Phosphorous 5 1. 3.97 2. 4.01 3. 4.04 4. 3.97 5. 3.97 3.99 0.03 0.8 Calcium 5 1. 9.3 2. 9.27 3. 9.41 4. 9.25 5. 9.24 9.29 0.06 0.74 PRECISION VITROS5600 : 2 0.2.2024 Criteria for Acceptability : < 1.97 X CV - SATISFACTORY

43. ANALYTE No. of runs. Values Obtained with Runs MEAN SD CV% ACCEPTABLE CV TLC 5 6.99 6.88 6.86 6.96 6.92 6.92 0.05 0.78 < 1.97 X scope CV Hb 5 12.6 12.5 12.6 12.5 12.5 12.54 0.05 0.44 < 1.97 X scope CV Platelets 5 256 262 255 265 262 260 4.3 1.65 < 1.97 X scope CV RBC 5 4.43 4.4 4.42 4.41 4.41 4.41 0.01 0.26 < 1.97 X scope CV HCT 5 38.0 37.7 38.3 38.2 38.2 38.08 0.23 0.63 < 1.97 X scope CV PRECISION CHECK for Hematology SYSMEX XN1000

44.         Old Reagent Lot Val. New Reagent Lot Val.       Lot No.   Patient Sample Patient Sample % Difference A ccept. Criteria Analyte Old New Date of Run Normal S1 Ab S2 Normal S1 Ab S2 Normal Abnormal % CHOL 2798 3578 01.12.22 128 241 131 239 2.29 0.82 1.97X scope cv ALT 3335 3491 5.1.23 12 67 13 62 0.13 3.35 1.97X scope cv UREA 3277 3723 20.2.23 13 50 13 52 1.04 1.97X scope cv T.PROT 3279 3809 25.2.23 5.97 8.1 6.3 8.12 0.009 0.02 1.97X scope cv VITROS 5600– Reagent lot check

45. Competence Details for Hematology S. No Name of Test Result-1 SriNiwas Result-2 Narender % Difference Results 1. HB 13.7 13.7 Satisfactory 2. PCV 41.2 41.4 Satisfactory 3. TLC 6.13 6.37 Satisfactory 4. RBC 4.88 4.91 Satisfactory 5. MCV 84.4 84.3 Satisfactory 6. MCH 28.1 27.9 Satisfactory 7. MCHC 33.3 33.1 Satisfactory 8. RDW 14.0 14.1 Satisfactory 9. PLT 262 261 Satisfactory 10. DLC(%) Neut (51.2) Lymph(39.6) Mono(6.4) Eo (2.8) Ba (0.0) Neut (50.4) Lymph(39.4) Mono(6.6) Eo (3.6) Ba (0.0) Satisfactory 11. DLC(absolute) Neut (3.14) Lymph(2.43) Mono(0.39) Eo (0.17) Ba (0.00) Neut (3.21) Lymph(2.51) Mono(0.42) Eo (0.23) Ba (0.00) Satisfactory ACCETABLE CRITERIA FOR COMPETENCE : < 1.97xscope cv%

46. Competence Details for BIOCHEMISTRY S.No Name of Test Result -1 Jitender Result-2 Antriksha %Difference Acceptable criteria 1.97X scope cv Results 1. Glucose fasting 103 102 0.3 1.97X scope cv Satisfactory 2. Cholesterol 195 197 1 1.97X scope cv Satisfactory 3. TG 174 175 1.6 1.97X scope cv Satisfactory 4. HDL 31 31 1.97X scope cv Satisfactory 5. LDL 129 131 1.5 1.97X scope cv Satisfactory 6. VLDL 34.8 35 0.4 1.97X scope cv Satisfactory 7. UREA 22 23 0.5 1.97X scope cv Satisfactory 8. CREAT 0.71 0.71 1.97X scope cv Satisfactory 9. UA 7.6 7.5 1.3 1.97X scope cv Satisfactory 10. SGOT 44 45 1.7 1.97X scope cv Satisfactory 11. SGPT 59 59 1.97X scope cv Satisfactory 12. GGTP 39 40 2.2 1.97X scope cv Satisfactory 13. ALP 111 111 1.97X scope cv Satisfactory 14. T.BIL 0.76 0.75 1 1.97X scope cv Satisfactory 15. D.BIL 0.16 0.16 1.97X scope cv Satisfactory 16. T.P 8.12 8.13 0.3 1.97X scope cv Satisfactory 17. ALB 4.72 4.68 0.5 1.97X scope cv Satisfactory 18. CA 9.6 9.53 0.8 1.97X scope cv Satisfactory 19. P4 3.55 3.47 1.1 1.97X scope cv Satisfactory 20. NA 137 138 0.9 1.97X scope cv Satisfactory 21. K 4.1 4.14 0.3 1.97X scope cv Satisfactory 22. CL 101 103 1.3 1.97X scope cv Satisfactory

47. Analyte Survey SEPT OCT NOV DEC JAN FEB ALB BIORAD 0.79 0.55 0.46 1.18 0.06 ALP BIORAD 0.49 1.18 0.72 0.73 - 0.66 0.51 ALT BIORAD 0.34 - 0.66 0.31 0.11 0.37 - 0.13 AST BIORAD 0.74 0.37 0.06 0.63 0.85 - 0.61 Bil-D BIORAD 0.42 0.85 0.51 0.57 0.67 0.86 Bil-T BIORAD - 0.12 0.67 - 0.13 0.02 0.94 - 1.08 CA BIORAD 1.37 0.94 - 0.61 1.08 1.33 - 0.67 CHO BIORAD 0.58 1.33 0.86 1.42 0.65 0.14 CREAT BIORAD - 0.9 0.65 - 1.08 -0.96 - 0.97 - 0.03 CL BIORAD - 0.08 - 0.97 - 0.67 - 0.14 0.76 0.89 GGTP BIORAD 0.94 0.76 0.14 1.55 0.89 - 0.76 HDL BIORAD 0.58 0.89 - 0.03 - 0.08 0.96 - 0.04 LDL BIORAD 1.36 0.96 0.89 0.69 - 0.37 - 0.35 K BIORAD -0.28 - 0.37 - 0.76 0.03 0.48 - 0.11 NA BIORAD -0.02 0.48 - 0.04 0.40 -0.06 - 0.07 PHOSP. BIORAD 0.3 -0.06 - 0.35 0.56 0.92 0.22 TP BIORAD 0.84 0.92 - 0.11 0.54 0.08 0.18 TG BIORAD 0.65 0.08 - 0.07 0.98 1.17 0.7 UA BIORAD 0.76 1.17 0.22 0.26 0.28 0.06 UREA BIORAD 0.54 0.28 0.18 0.85 0.49 0.51 GLUCOSE BIORAD 1.12 0.49 0.7 0.78 1.18 - 0.13 External PT Biochemistry

48. External Q.C : 2024(AIIMS) HORIBA H500 CYCLE FEB 2024 Z SCORE WBC RESULT AWAITED RBC HB HCT MCV MCH MCHC PLT.C P/S Criteria : Z score of all parameters < 2: Satisfactory

49. Post Analytical Monitors (2023) S. No 1 st QRTR 2 nd QRTR 3 rd QRTR 4 th QRTR 1. Panic Values (informed) 3099 2912 2987 2993 2. Panic Values (non informed) With Reason. NA NA NA NA 3. Delayed Reports NA NA NA NA 4. Clerical Errors NA NA 1 1

50. Complaints : Non Technical issues Operational : Staff related : Administrative : Safety : No Accidents. No Issues 2 . In terms of technical issues QC outliers : No issues.

51. FEEDBACK FROM STAFF…….. Feedback from supervisors or staff which could help us improve our processes.

52. INTERNAL QUALITY AUDIT Last Internal Audit was conducted on : July-2023 Total Non-Conformances Detected : 01 All NC’s Close within stipulated time

53. Customer Overall Experience 2023 EXCELLENT GOOD AVERAGE POOR Number 9 16 5 Percentage 30 % 53.84% 16.16 % % TOTAL NO. OF FEEDBACK : 30 CUSTOMER SATISFACTION

54. Customer Overall Experience 2023

55. DOCTOR SATISFACTION ASSESSMENT - 2023 EXCELLENT GOOD AVERAGE POOR 25 TOTAL NO. OF FEEDBACKS : 25 In terms of Satisfaction.....

56. TURNAROUND TIME….. Turnaround time is maintained, no outliers seen

57. AIM FOR 2024 To Record and Reduce All Pre analytical rejections CV of all the parameters to be improved

58. MANAGEMENT REVIEW PARTICIPANTS : DR Amrita Singh: Head Lab Operation Dr Bhati : MS Dr Kalpana Jain: Sr Consultant Pathologist Dr. Vidya Menon: Consultant Pathologist Mr.Deepakk Kumar: Quality Manager Mr Prakash Chand: Supervisor All Technical staff

59. Thank You