Improving Patient Safety
in Renal Units
Haemodialysis associated haemolysis
Dr. Paul Rylance
Dr. Henry Brown
CD Forum March 2010
National Patient Safety Agency
Patient incidents

10% of patients in acute hospitals suffer from
some kind of patient safety incident

Up to half of these are preventable
Patient incidents
NPSA

Estimated 850,000 incidents/year harm or
nearly harm inpatients in the UK

44,000 incidents are fatal

40 incidents contribute to patient death in every
single NHS organisation every year
NPSA
Safer care for the acutely ill patient
Recognising and responding to early signs of deterioration
NPSA 2007
Patient harm from renal incidents
Patient Harm
Estimated / 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
Renal Association and
National Patient Safety Agency
(NPSA) Project
Formulating and Sharing
Solutions to Clinical Incidents
and Risk-Prone Situations
Clinical incidents and risk prone situations




Project Lead (PBR)
Project commenced June 2007
Multi-professional process, involving renal
doctors, nurses, renal technologists
Most incidents involve haemodialysis techniques
and equipment
Methods

Identification of incidents and risk prone situations





NPSA from NRLS database
Other specialities via NPSA
Personal communication to project lead (PBR)
NRLS database screened for prevalence of incidents
Sharing of solutions





email to Clinical Directors (+ reminders)
email to renal unit lead nurses + ART website
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
Solutions re-circulated to renal units by email
Renal Association/NPSA Project
Results: June 07 – Feb 10
Circulation of
27 Clinical Incidents and Identified Risks
Dislodged venous fistula needle during
haemodialysis leading to significant blood loss

Outcome : Blood loss++,
Patient died
Feb 06-Feb 07 NRLS n=10

Risk Factors




Restless patient
Tape becomes detached
 Sweaty arms
Venous pressure detectors
don’t respond
Arm under blanket
No Harm
Low
Severe

3
5
2 (LOC)
Lesson – Many nurses and
doctors unaware of
limitations of venous alarms
Solutions


Expose arms
Needle taping technique
Blood detector devices
? Haemodialysis machines
developed with blood loss
detectors
Renal Association / Centre for Evidencebased Prescribing (CEP) Survey


email questionnaire to all UK Renal Clinical
Directors and Lead renal nurses
Estimated prevalence/incidence of
dislodgement
UK: ~ 100/year (range: 0-4 episodes/unit/year)
 ~ 1 : 100,000 haemodialysis sessions


Severity
1 death (0.6%)
 6.4% Moderate/Severe harm (e.g. hospitalisation)
 93.0% No/Mild Harm

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
10 Risk Prone Situations
1.
2.
3.
4.
5.
6.
7.
Dislodged venous needle
Delays permanent vascular access
HD catheter Infections
Practical procedures (HD and PD catheters, renal biopsy)
Prescribing errors in renal failure
Monitoring of immunosuppressive drugs + opportunist infections
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
Renal patient incidents
Estimated
incidents/year (E&W)
Total
Patient Harm
Death/Severe/Moderate
Catheter Infections
18
8
Lack of suitably trained
staff
260
10
Medication /
iv potassium
1300
80
Transfer of patients
150
15
Source: NPSA / NRLS database
Failure of HD techniques



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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
Failure to use dialysis equipment
correctly


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Setting excessive ultrafiltration on HD
Lack of mixing of bicarbonate haemofiltration
bags (ICU)
Gambro AK200 set-up failure (increased K)
Nikkiso conductivity setting (Na 170)
Fresenius dialysate line configuration
Learning from other specialities


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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
Urethral trauma from female urinary catheters
used in males
Dialysis equipment manufacturing faults



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PD catheter clamps sold as HD clamps
Failure of Kimal Safety HD needles
Cracking of luer-locks on HD catheters
Breakage of HD catheter clamps
Corrosion of dialysate Line couplings
Percutaneous haemodialysis catheters falling out

change in cuff manufacture
MHRA Medical Device Alerts


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Kimal safety needles
Blood leakage of Braun Haemodialysis lines
Aquarius haemofiltration machines
Haemolysis associated with hydrogen peroxide
water sterilisation
Renal toxicity

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Membranous nephropathy caused by mercurycontaining face creams
Risk of harm from oral bowel cleansing solutions
Low molecular weight heparin dosage
(in preparation)
Haemolysis associated with dialysis

Hydrogen Peroxide

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Chloramine

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Hospital
Satellite dialysis unit / Water company
Patient related factors
Unknown / Kinking of Dialysis lines

Northern Ireland
Haemolysis associated
with dialysis
Potential lessons from the Northern Ireland
cluster
Dr. Henry Brown
Background
Causes of Haemolysis
Dialysate problems eg hypotonicity
Water contamination
Faulty roller clamps
Kinking of Lines
Construction faults with lines
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
Actions taken
Internal Review
Meeting with Industry & NIAIC
Investigation
Measures to protect patient safety
Search for other cases
MHRA visit
1.5
August 08 1
August 08 2
August 08 3
August 08 4
September 08 1
September 08 2
September 08 3
September 08 4
October 08 1
October 08 2
October 08 3
October 08 4
November 08 1
November 08 2
November 08 3
November 08 4
December 08 1
December 08 2
December 08 3
December 08 4
January 09 1
January 09 2
January 09 3
January 09 4
February 09 1
February 09 2
February 09 3
February 09 4
March 09 1
March 09 2
March 09 3
March 09 4
April 09 1
April 09 2
April 09 3
April 09 4
May 09 1
May 09 2
May 09 3
2.5
August 2008 –May 2009
Trigger case
2
Index case
1
0.5
0
Distribution of Cases
3
4
6
3
Possible explanation
Contaminated water/dialysate
NO
Damaged/faulty lines
NO
Patient related factors
NO
Kink
Arterial
Port
Kidney
Venous
Port
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
Is there any consensus of
water sterilising technique
in the UK?
Chlorine Survey
Gerard Boyle,
Senior Renal Technologist,
St.Georges Hospital,
Tooting
How is the water supplied to the clinic?
Direct from Water Supply
company main feed
27%
Through Hospital Estates
pipe distribution system
Other
73%
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?
Yes
No
43%
57%
30 Responses
Nearly half
of renal units
don’t know
chemicals
•17 – what
Yes
•13 - No
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?
3%
13%
7%
47%
17%
13%
0-1 years
2-3 years
4-5 years
6-7 years
8-10 years
11 years or older
Don't know
Half Renal
Unit water
systems are
more than 10
years old
How frequently do you monitor the feed water to the
Dialysis Clinic water treatment system for chlorine?
3% 3%
14%
14%
17%
49%
It is not monitored
Before each dialysis session
Once each day
Once each week
Once each month
Less frequently
As required
No consistent
monitoring
procedure
Gold Standard
should be
testing before
each dialysis
session
By what technique is the monitoring performed?
8%
6%
14%
22%
8%
42%
No monitoring performed
Dip strips
Colorimeter using tablet/powder reagents
Colorimeter using liquid reagents
Electrode sensor (such as Chlorosense)
Sample sent to lab
Automatic on-line continuous sensor
No consensus
of water testing
method
Some methods
may not be
accurate
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.
Evaluation of the RA/NPSA project

Rapid response has been achieved



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Quicker with Renal Association badging only
Involvement of lead nurses and renal technologists is
invaluable
Initial Feedback : All positive (one exception)
Some email communications not identified from large
volume of NHS emails
25% response rate makes evaluation difficult

Other units indicated circulation has occurred within renal
unit
Application to other specialities?

Royal College of Physicians


Adopted by Medical Specialties Board to develop
liaisons with all other medical specialities via the
RCP Joint Specialities Committees.
Other Specialities?

Specialities with high usage of medical equipment
Patient Safety

Good clinical practice

Multi-professional
responsibility

Part of Clinical
Governance

Health Service priority
paul.rylance@rwh-tr.nhs.uk
paul.rylance@nhs.net (soon)