Renal Association Patient Safety Project Paul Rylance Royal

Renal Association Patient Safety Project Paul Rylance Royal Wolverhampton Hospitals

BACKGROUND • 10% of patients in hospital experience suffer from some type of patient safety incident – Up to half are preventable. • 60% of incidents related to equipment are as a result of failure of usage • Patient Safety is an NHS priority – NHS Outcome Framework Domain 5

OBJECTIVES • Patient Safety project commenced June 2008 • Project lead (PBR) – Pilot project with NPSA – Established project via Renal Association • Renal Association working with – Renal units – National Patient Safety Agency (NPSA) – Medicines and Healthcare products Regulatory Agency (MHRA) – PBR appointed to Committee on Safety of Devices • Identify and learn from incidents and risks • Improve renal patient safety.

NPSA Incident Data Analysis • NPSA data • Estimated ~ 725 incidents/year occur in renal units in England Wales – Result in death or potential death – severe harm – or moderate harm • 10 or more / unit / year – ? Significant underreporting (n=55) (n=120) (n=550)

Incidents and risk-prone situations reported • 30 month period • 31 incidents and 5 risks identified • Circulated by email to renal unit clinical directors and lead nurses. • Source of information about incidents – Renal units – NPSA – MHRA (42%) - incl. nurses and technologists (28%) (30%) • 17 were circulated as NPSA or MHRA alerts.

Incidents and risk-prone situations reported • The largest number of incidents (36%) were due to failure of dialysis techniques or dialysis machine usage • Failure of dialysis machines (19%) • Failure of dialysis equipment or disposables (22%) • Medication (19%)

Failure of dialysis techniques • Venous needle dislodgement • Fatal Pulmonary Embolus from an attempt to unblock an occluded arteriovenous fistula • Air embolism from haemodialysis catheter disconnection • Bleeding from an infected fistula needling site • Bleeding from removal of femoral line

Failure of dialysis equipment usage • Setting excessive ultrafiltration on HD • Lack of mixing of bicarbonate haemofiltration bags (ICU) • Nikkiso conductivity setting (Na 170) • Fresenius dialysate line configuration

SURVEYS Venous needle dislodgements • Approximately 100 episodes of venous needle dislodgment/year in the UK – 1: 100, 000 dialyses – One death – 6. 4% resulting in moderate/severe harm • Report produced in conjunction with the Centre for Evidence-based Prescribing (CEP) concluded – Blood-loss detector can be indicated for high risk patients – Cannot be justified for universal use – Alternative alarm available (less expensive)

Electrical Safety of HD machines • HD machines not required to be earthed • Risk of electricution via dialysis catheter causing cardiac arrest • ? Could be a cause of some sudden deaths on HD Need to change electrical safety category of HD machines • MHRA reviewing this risk

Bleeding from dialyser to line connection • • Home HD patients Dialyser / HD machine behind patient Inadequate connection made Blood leak when plastic warms up No machine alarm ? Technique training / position of patient Plastic flexibility change

Manufacturing faults • • Non-safety needles PD clamps sold as HD catheter clamps HD catheter cuff glue Plastic changes – dialyser to line connection – ? Line kinking • Dialysate concentrate composition / labelling error

Haemolysis on Haemodialysis • Haemolysis on haemodialysis has been due to – Water sterilisation • Hydrogen peroxide in hospital (including 1 death) • Chloramine in community – Kinking of dialysis lines • Northern Ireland • Fresenius alert – Unknown causes.

Survey of water supplies and sterilisation techniques • Undertaken by a renal technologist – Gerry Boyle (St. George’s)

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

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

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

No consensus of water testing method or frequency

Working party to develop new standards for water supplies to renal units and water testing • Development of RA guidelines for water treatment • Water treatment equipment defined by technologists • Nephrologists and technologists involved at beginning of contract • Water treatment outside building and facilities PFI • Develop contact with NHS Estates

CONCLUSIONS • Renal Association Patient Safety project has facilitated – Rapid sharing of incidents and solutions. – Strong links with renal nurses and technologists – Renal units may have 10 or more life threatening incidents/year – Underreporting undoubtedly underestimates the incidence of incidents. – Failure of dialysis techniques and equipment usage is the greatest risk for patient safety • Emphasises the importance of training.

Future developments • Presentations – BRS/Renal Association oral presentation – Renal Nursing conferences (European/UK) – Dialysis 2011 course – Patient Safety 2011 – British Journal of Renal Medicine – ? RCP Medical Specialities Board

Future Developments • Use outcomes of the project to develop RA guidelines • Further develop links with other agencies and DH departments • Project overseen and responsible to RA Clinical Affairs Committee – Discussions with Graham Lipkin – Additional nephrologist involvement – Succession planning