Transcript Avoiding Errors and Risks in Aseptic Work

Avoiding errors and risks in
aseptic work
Mark Oldcorne
What errors can occur 1
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1990: Johannesburg
◦ Death of 15 babies
Contaminated IV feeds
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2000: India
◦ Death of 3 young mothers and 3 newborn babies
Contaminated IV fluids
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2001: USA
◦ FDA recall contaminated eye drops
◦ containing
Pseudomonas mendocina
Klebsiella pneumoniae
What errors can occur 2
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2004: South Africa
◦ 6 premature babies died
◦ Enterobacter cloacae
 three containers
 one infusion set
A pharmacist's dirty hands the main reason
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2002: Brazil
◦ 36 neonatal deaths in Brazil
◦ contaminated intravenous fluids.
Endotoxin contaminated IV medication
What errors can occur 3
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Evans Medical in Speke
(not connected with present trading company)
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Tue 6th April 1971
5% Sterile Dextrose Solution Lot D1192
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29th Feb – 2nd Mar 1971
5 deaths at Devonport Hospital
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6th Mar 1972 - Investigation begins
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12th Jul 1972 - Clothier Report issued
by Department of Health & Social Security
Report of the Committee appointed to inquire into the circumstances, including the
production, which led to the use of contaminated infusion fluids in the Devonport
section of Plymouth General Hospital. (London: HMSO, 1972)
What errors can occur 4
What errors can occur 5
What errors can occur 6
Error Incident Rates
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Bateman, R; 2003
◦ Pilot
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n=198,000 items
357 errors reported
0.18% processes containing errors
7 left department; 1 administered
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n=155,000 items
1697 errors reported
1.09% processes containing errors
31 left department; 3 administered
◦ UK
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Taxis and Barber; 2003
◦ 13% error rate for ward based preparation
Error Types Bateman, R; 2003
Error Types
Labelling error
Other
Incorrect transcription
Incorrect dose used
Made up to incorrect final volume
Incorrect expiry
Calculation Errors
Incorrect diluent or fluid
Incorrect drug used
Inadequate closure
Particulates
Incorrect container
% Pilot
34
14
11
10
10
8
7
4
3
1
0
0
% UK
37
9
17
3
3
8
2
2
3
0
13
3
Severity of Errors
Classification
Effect if undetected
%
Pilot
%
UK
None
Minor
Moderate
No effect on patient
Cause non-permanent harm
Cause semi-permanent harm
49
35
12
77
17
3.4
Major
Catastrophic
Cause major permanent harm
Could cause death
4
0
1.6
1
Additional Error Types
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Aseptic preparation units vs
Traditional Manufacturing Units
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Microbiological Contamination
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operator
transfer disinfection
environment
aseptic processing
Chemical
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right drug
correct amounts of drug
right diluent
right salt \ hydration states
Factors Contributing to errors
Organisational
/Strategic
Factors
Environmental
Factors
Human Error
Failure
Factors Influencing of Errors
Red – Clothier Report 1972!
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People
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poor staff training (or not at all!)
staff capability - technical and management
inappropriate staffing levels – excessive workloads
inappropriately supervised staff
not following procedures
individual staff concentration
seeing what you want to see
Environment
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air pressures – record but not acted on
poor transfer disinfection
cleanliness of work areas\equipment - inadequate cleaning
cleanliness of storage areas – high bioburdens
filtration
appropriate temperature and humidity
Factors Influencing of Errors
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Records
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transcription errors
actions not completed at time of action
calculation errors
incorrect dose & strength
incorrect diluent
incorrect final volume
Instruments \ Equipment
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inadequate equipment
lack of calibration
lack of maintenance activity and logs
functioning correctly
use for appropriate use
validation
Factors Influencing of Errors
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Procedures
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lack of procedures
inadequate procedures (reflect practice – contemporary)
operators own interpretation of procedures
accessible
latest version
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Ingredients
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Product
◦ reconciliation checks
◦ checks
◦ selection errors – incorrect drug / diluent / container
◦ inspection and batch review
◦ incorrect expiry
◦ lack or failure of final product testing
 chemical, particulates, microbiology, endotoxins
◦ labelling errors
Sources of Errors
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Human Errors
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never deliberate
usually careless
system shortfalls
overwork
ignorance
Mechanical Malfunction
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software malfunction
hardware malfunction
lack of calibration
inappropriate use (e.g. re-use of single use equipment)
Combinations
- Swiss Cheese Scenario
Minimising Errors
Phil Crosby
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Zero defects or Right First Time philosophy
◦ emphasis on prevention
◦ relies on measurement and data collection - eliminate
errors (and waste)
Zero defect does not mean that people NEVER
make mistakes
 Rather – they are not assumed or expected to make
mistakes
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Aim for perfection and miss it
RATHER THAN
Aim for imperfection and hit it
Minimising Errors
“To err is human”
“human error is caused by a lack of attention
rather than a lack of knowledge”
“lack of attention is created when we assume
that error is inevitable”
(or perhaps we think that the responsibility
lies elsewhere)
It means that accepting a 0.1% or even a
0.001% error rate is just not on, and that the
only level worth striving for is 0%
Minimising Risks
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Adoption of GxP systems
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Rules and Guidance for Pharmaceutical
Manufacturers and Distributors, 2007
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Quality Assurance of Aseptic Preparation
Services
Is that it? Unlimited Resources
Integration with
Risk management
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ICH 9 Quality Risk Management
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Principles of Quality Risk Management
◦ evaluation of risk to quality – based on scientific
knowledge and ultimately link to patient safety
◦ level of effort, formality and documentation of quality
risk management process – commensurate with level
of risk
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Apply to
◦ development, manufacturing, release, distribution,
inspection, review processes
◦ starting and final drug products
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When
◦ lifecycle of product
Risk Assessment
Risk Identification
1.
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What might go wrong?
Risk Analysis
2.
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What is the likelihood (probability) it will go
wrong?
What are the consequences (severity)?
Risk Evaluation
3.
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Compares identified risk and analysed risk
against given risk criteria
Risk score
Risk assessment
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Objective
◦ Elimination to reduction to acceptable levels
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Outcomes
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Patient safety
Regulatory compliance
Financial
Reputation
Risk Management
Prospective
RISK
Retrospective
Minimising Errors
Retrospective
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Deviation Management\Change Control
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Risk Management Tools
◦ CAPA
◦ RCA
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Compare to Other Reporting Schemes
CAPA
Corrective and Preventive Action
 Closed loop process
1. Corrective Action
◦ action taken to rectify the nonconformance/error
2. Preventive Action
◦ action taken to avoid repetition of the same
non-conformance. This could involve
modification or enforcement of procedures, or
implementation of further controls
3.
Change Control
RCA
Root Cause Analysis
 Structured
Asking
and objective method -
◦ What? How? Why?
 Team
approach – Facilitator
 Analysing
Errors - Human Error
◦ timelines etc.
◦ nominal group technique, brainstorming,
brain-writing, fishbone, 5-whys,
barrier analysis
Reporting Systems
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Local Reporting Scheme
◦ Hospital or Trust based
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National Reporting Schemes
◦ Regional
◦ National
 National Reporting and Learning System - NPSA
 Pharmaceutical Aseptic Services Group / R. Bateman
No Blame
Use of Quality Indicators
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Trending environmental monitoring data
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Deviation\Exception reports
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Contamination rates
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Trigger Tools
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Safer Patient Initiative (SPI)
Minimising Errors
Prospective
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Minimising errors by prospective analysis
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Process mapping
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Risk Management Tools
◦ FMEA
◦ HACCP
FMEA
Failure Mode Effects Analysis
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easy to use!!
evaluation of failure modes and likely outcomes
risk reduction
need in depth understanding of product and
processes
 methodically breaks analysis of complex processes into
manageable steps
◦ Used to
 prioritize risks
 monitor effectiveness of risk control activities
 prioritize validation activities
◦ Applied to equipment, facilities, products & processes
HACCP
Hazard Analysis and Critical Control Points
◦ Systematic, proactive and preventive tool
◦ Quality, Reliability and Safety aspects
◦ 7 steps
1. Conduct hazard analysis and ID preventive
measures – each step
2. Determine critical control points
3. Establish critical limits
4. Establish – system to monitor the CCP
5. Establish corrective action when CCP not
controlled
6. Establish system to prove HACCP system working
7. Establish record keeping system
Summary
Gauge your risks!
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Prospective
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Retrospective
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Use Risk Management Tools
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Remember they are only tools