haemodialysis_quality_standards - Rotary International District 3310

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5.3.6 Record All the results shall be properly documented and made available for inspection. 5.4 Microbial Contaminant 5.4.1 Method of Testing Total Viable counts (Colony Forming Units) using spread plate Agar (TGEA) or equivalent. Calibrated loop technique shall not be used. The presence of pyrogen/endotoxin shall be determined using Limulus Amoebocyte Lysate (LAL) method. 5.4.2 Frequency of Testing Monthly for bacterial count and endotoxin test 5.4.3 Sites of Sampling Minimum sites of sampling for testing i. Post RO membrane ii. iii. iv. First point of the distribution loop End point of distribution loop (Last machine port) Reprocessing bay (for indirect feed) 5.4.4 Handling of water sample Assay within 30 minutes of collection If immediate assay is not possible, refrigerate immediately at 5 o C and assay within 24 hours of collection 26 Haemodialysis Quality and Standards
5.4.5 Limits and Action Level Maximum Allowed CFU level < 100 CFU/ml Endotoxin level < 0.25 EU/ml Action Level CFU level > 50 CFU/ml Endotoxin Level> 0.125EU/ml (Ref: AAMI/ISO 23500: 2011) If Action Levels are observed, disinfection and retesting shall be done immediately to restore the <strong>quality</strong> into acceptable level. 5.4.6 Laboratory All samples shall be sent to an accredited laboratory recognized by the Director General of Health. 5.4.7 Record All the results shall be properly documented and made available for inspection. Haemodialysis Quality and Standards 27
Page 1: MOH / P / PAK / 235.12 (GU)
Page 5 and 6: This document was developed by the
Page 7 and 8: LIST OF APPENDICES Appendix 1: Micr
Page 9 and 10: Foreword By The Deputy Director Gen
Page 11 and 12: Dr Loh Chek Loong Consultant Nephro
Page 13 and 14: National Kidney Foundation Dato’
Page 15 and 16: CHAPTER 2: PHYSICAL FACILITIES 2.1
Page 17 and 18: CHAPTER 3: EQUIPMENT 3.1 Haemodialy
Page 19 and 20: 3.3.2 Basic requirements in a water
Page 21 and 22: (g) Reverse Osmosis (RO) Module
Page 23 and 24: (j) Disinfection of Distribution Lo
Page 25 and 26: CHAPTER 4: DIALYSIS CONSUMABLES 4.1
Page 27: CHAPTER 5: WATER QUALITY 5.1 Dialys
Page 31 and 32: 6.3 Prescribing haemodialysis treat
Page 33 and 34: CHAPTER 8: INFECTION CONTROL MEASUR
Page 35 and 36: 8.4.5 In some situations such as re
Page 37 and 38: 8.7.2 Infection Control Precautions
Page 39 and 40: Appendix 1 Microbial requirements f
Page 41 and 42: Appendix 3 DAILY R.O WATER TREATMEN
Page 43 and 44: Appendix 5 200 hours training for P
Page 45 and 46: Appendix 7 Monitoring of intra-dial
Page 47 and 48: Appendix 9 Date Type of dialysers N
Page 49 and 50: Appendix 11 Method of measurement o
Page 51 and 52: If a common supply cart is used to
Page 53 and 54: Appendix 13 Recommended training on
Page 55 and 56: References 1 haemodialysis and rel
Page 57: UKM URR Urea Kinetic Modelling Urea

haemodialysis_quality_standards - Rotary International District 3310

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