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Improving Patient Safety in Renal Units Haemodialysis associated haemolysis Dr. Paul Rylance Dr. Henry Brown CD Forum March 2010.

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Presentation on theme: "Improving Patient Safety in Renal Units Haemodialysis associated haemolysis Dr. Paul Rylance Dr. Henry Brown CD Forum March 2010."— Presentation transcript:

1 Improving Patient Safety in Renal Units Haemodialysis associated haemolysis Dr. Paul Rylance Dr. Henry Brown CD Forum March 2010

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5 National Patient Safety Agency Patient incidents 10% of patients in acute hospitals suffer from some kind of patient safety incident 10% of patients in acute hospitals suffer from some kind of patient safety incident Up to half of these are preventable Up to half of these are preventable

6 Patient incidents NPSA Estimated 850,000 incidents/year harm or nearly harm inpatients in the UK Estimated 850,000 incidents/year harm or nearly harm inpatients in the UK 44,000 incidents are fatal 44,000 incidents are fatal 40 incidents contribute to patient death in every single NHS organisation every year 40 incidents contribute to patient death in every single NHS organisation every year

7 NPSA Safer care for the acutely ill patient Recognising and responding to early signs of deterioration NPSA 2007

8 Patient harm from renal incidents Patient HarmEstimated / year (England and Wales) Death or potential death~55 Severe~120 Moderate~550 Total~725 ~10 episodes (~1 death)/renal unit/year Literature: ?represents only a small proportion of incidents

9 Renal Association and National Patient Safety Agency (NPSA) Project Formulating and Sharing Solutions to Clinical Incidents and Risk-Prone Situations

10 Clinical incidents and risk prone situations Project Lead (PBR) Project Lead (PBR) Project commenced June 2007 Project commenced June 2007 Multi-professional process, involving renal doctors, nurses, renal technologists Multi-professional process, involving renal doctors, nurses, renal technologists Most incidents involve haemodialysis techniques and equipment Most incidents involve haemodialysis techniques and equipment

11 Methods Identification of incidents and risk prone situations Identification of incidents and risk prone situations NPSA from NRLS database NPSA from NRLS database Other specialities via NPSA Other specialities via NPSA Personal communication to project lead (PBR) Personal communication to project lead (PBR) NRLS database screened for prevalence of incidents NRLS database screened for prevalence of incidents Sharing of solutions Sharing of solutions email to Clinical Directors (+ reminders) email to Clinical Directors (+ reminders) email to renal unit lead nurses + ART website email to renal unit lead nurses + ART website A quarter to a third of CDs open emails in first 24 hours A quarter to a third of CDs open emails in first 24 hours Formulate solutions to incidents from replies from renal units and expert opinion Formulate solutions to incidents from replies from renal units and expert opinion Solutions re-circulated to renal units by email Solutions re-circulated to renal units by email

12 Renal Association/NPSA Project Results: June 07 – Feb 10 Circulation of 27 Clinical Incidents and Identified Risks

13 Dislodged venous fistula needle during haemodialysis leading to significant blood loss Feb 06-Feb 07NRLS n=10 No Harm3 Low5 Severe2 (LOC) Outcome : Blood loss++, Patient died Lesson – Many nurses and doctors unaware of limitations of venous alarms Risk Factors Risk Factors Restless patient Restless patient Tape becomes detached Tape becomes detached Sweaty arms Sweaty arms Venous pressure detectors don’t respond Venous pressure detectors don’t respond Arm under blanket Arm under blanket

14 Solutions Expose arms Expose arms Needle taping technique Needle taping technique Blood detector devices ? Haemodialysis machines developed with blood loss detectors

15 Renal Association / Centre for Evidence- based Prescribing (CEP) Survey email questionnaire to all UK Renal Clinical Directors and Lead renal nurses email questionnaire to all UK Renal Clinical Directors and Lead renal nurses Estimated prevalence/incidence of dislodgement Estimated prevalence/incidence of dislodgement UK: ~ 100/year (range: 0-4 episodes/unit/year) UK: ~ 100/year (range: 0-4 episodes/unit/year) ~ 1 : 100,000 haemodialysis sessions ~ 1 : 100,000 haemodialysis sessions Severity Severity 1 death (0.6%) 1 death (0.6%) 6.4% Moderate/Severe harm (e.g. hospitalisation) 6.4% Moderate/Severe harm (e.g. hospitalisation) 93.0% No/Mild Harm 93.0% No/Mild Harm

16 Centre for Evidence based Prescribing (CEP) report (Feb 2009) Universal use of Redsense monitor cannot be justified Risk of fatality is low Cost £8m Greatest value at increased risk Home HD Isolation rooms Restless patients

17 10 Risk Prone Situations 1. Dislodged venous needle 2. Delays permanent vascular access 3. HD catheter Infections 4. Practical procedures (HD and PD catheters, renal biopsy) 5. Prescribing errors in renal failure 6. Monitoring of immunosuppressive drugs + opportunist infections 7. Transfer of renal patients – ARF from outlying hospitals, satellite HD, ICU 8. Lack of experienced renal staff Doctors, nurses, “Hospital at Night” 9. Lack of haemodialysis facilities Planning, funding, trained staff 10. Sudden loss of dialysis facilities Loss/contaminated water supply, flooding, power loss

18 Renal patient incidents Estimated incidents/year (E&W) TotalPatient Harm Death/Severe/Moderate Catheter Infections188 Lack of suitably trained staff 26010 Medication / iv potassium 130080 Transfer of patients15015 Source: NPSA / NRLS database

19 Failure of HD techniques Venous needle dislodgement Venous needle dislodgement Fatal Pulmonary Embolus from an attempt to unblock an occluded arteriovenous fistula Fatal Pulmonary Embolus from an attempt to unblock an occluded arteriovenous fistula Air embolism from haemodialysis catheter disconnection Air embolism from haemodialysis catheter disconnection Bleeding from an infected fistula needling site Bleeding from an infected fistula needling site

20 Failure to use dialysis equipment correctly Setting excessive ultrafiltration on HD Setting excessive ultrafiltration on HD Lack of mixing of bicarbonate haemofiltration bags (ICU) Lack of mixing of bicarbonate haemofiltration bags (ICU) Gambro AK200 set-up failure (increased K) Gambro AK200 set-up failure (increased K) Nikkiso conductivity setting (Na 170) Nikkiso conductivity setting (Na 170) Fresenius dialysate line configuration Fresenius dialysate line configuration

21 Learning from other specialities Risk of intravenous injection of chlorhexidine during haemodialysis catheter insertion Risk of intravenous injection of chlorhexidine during haemodialysis catheter insertion Risk of injection of incorrect concentration of heparin flush solutions or other drugs mistaken for heparin Risk of injection of incorrect concentration of heparin flush solutions or other drugs mistaken for heparin Urethral trauma from female urinary catheters used in males Urethral trauma from female urinary catheters used in males

22 Dialysis equipment manufacturing faults PD catheter clamps sold as HD clamps PD catheter clamps sold as HD clamps Failure of Kimal Safety HD needles Failure of Kimal Safety HD needles Cracking of luer-locks on HD catheters Cracking of luer-locks on HD catheters Breakage of HD catheter clamps Breakage of HD catheter clamps Corrosion of dialysate Line couplings Corrosion of dialysate Line couplings Percutaneous haemodialysis catheters falling out Percutaneous haemodialysis catheters falling out change in cuff manufacture change in cuff manufacture

23 MHRA Medical Device Alerts Kimal safety needles Kimal safety needles Blood leakage of Braun Haemodialysis lines Blood leakage of Braun Haemodialysis lines Aquarius haemofiltration machines Aquarius haemofiltration machines Haemolysis associated with hydrogen peroxide water sterilisation Haemolysis associated with hydrogen peroxide water sterilisation

24 Renal toxicity Membranous nephropathy caused by mercury- containing face creams Membranous nephropathy caused by mercury- containing face creams Risk of harm from oral bowel cleansing solutions Low molecular weight heparin dosage (in preparation)

25 Haemolysis associated with dialysis Hydrogen Peroxide Hydrogen Peroxide Hospital Hospital Chloramine Chloramine Satellite dialysis unit / Water company Satellite dialysis unit / Water company Patient related factors Patient related factors Unknown / Kinking of Dialysis lines Unknown / Kinking of Dialysis lines Northern Ireland Northern Ireland

26 Haemolysis associated with dialysis Potential lessons from the Northern Ireland cluster Dr. Henry Brown

27 Background Causes of Haemolysis Dialysate problems eg hypotonicity Water contamination Faulty roller clamps Kinking of Lines Construction faults with lines

28 Index Case 44 year old female ESRD 2 o PCKD on haemodialysis for 42 months During routine HD session developed nausea, vomiting, abdominal pain, hypertension Haemolysis – red supernatant, raised LDH, fall in Hb of 3g/dl Inability of lab to report K + and other common variables Raised amylase, subsequent radiological evidence of acute pancreatitis Symptoms settled quickly

29 Actions taken Internal Review Meeting with Industry & NIAIC Investigation Measures to protect patient safety Search for other cases MHRA visit

30 August 2008 –May 2009 Trigger case

31 Distribution of Cases 4 6 3 3

32 Possible explanation Contaminated water/dialysate NO Damaged/faulty lines NO Patient related factors NO

33 Kidney Kink Arterial Port Venous Port

34 Learning points  Potential cause of significant morbidity / mortality  May go unrecognised  Haemolysed blood samples may be haemodialysis related, rather than from blood sampling  Aetiology may be difficult to identify  Importance of staff vigilance  Importance and benefit of clinical networks

35 Is there any consensus of water sterilising technique in the UK? Chlorine Survey Gerard Boyle, Senior Renal Technologist, St.Georges Hospital, Tooting

36 How is the water supplied to the clinic? Only a quarter of renal units have a direct feed from the water company mains

37 If the water is supplied through the Estates Department pipe system do you know what chemicals are added? 30 Responses 17 – Yes 13 - No Nearly half of renal units don’t know what chemicals are added Also - No consistent lines of communication between Estate departments and Renal Units

38 How old is the Water Treatment System that is used to supply water for your Dialysis Unit? Half Renal Unit water systems are more than 10 years old

39 How frequently do you monitor the feed water to the Dialysis Clinic water treatment system for chlorine? No consistent monitoring procedure Gold Standard should be testing before each dialysis session

40 By what technique is the monitoring performed? No consensus of water testing method Some methods may not be accurate

41 Clear guidelines / standards are needed for renal unit / hospital water supplies and sterilisation Communication and clearly defined lines of responsibility from the Water companies, through the estates departments to the dialysis clinic technical departments Re-examination of existing chlorine removal arrangements Plan B for when chlorine breakthrough occurs Adopt an appropriate testing frequency Use appropriate testing methods.

42 Evaluation of the RA/NPSA project Rapid response has been achieved Rapid response has been achieved Quicker with Renal Association badging only Quicker with Renal Association badging only Involvement of lead nurses and renal technologists is invaluable Involvement of lead nurses and renal technologists is invaluable Initial Feedback : All positive (one exception) Initial Feedback : All positive (one exception) Some email communications not identified from large volume of NHS emails Some email communications not identified from large volume of NHS emails 25% response rate makes evaluation difficult 25% response rate makes evaluation difficult Other units indicated circulation has occurred within renal unit Other units indicated circulation has occurred within renal unit

43 Application to other specialities? Royal College of Physicians Royal College of Physicians Adopted by Medical Specialties Board to develop liaisons with all other medical specialities via the RCP Joint Specialities Committees. Adopted by Medical Specialties Board to develop liaisons with all other medical specialities via the RCP Joint Specialities Committees. Other Specialities? Other Specialities? Specialities with high usage of medical equipment Specialities with high usage of medical equipment

44 Patient Safety Good clinical practice Good clinical practice Multi-professional responsibility Multi-professional responsibility Part of Clinical Governance Part of Clinical Governance Health Service priority Health Service priority

45 paul.rylance@rwh-tr.nhs.uk paul.rylance@nhs.net (soon) ul.rylance@rwh-tr.nhs.uk paul.rylance@nhs.netul.rylance@rwh-tr.nhs.uk paul.rylance@nhs.net


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