Avoiding errors and risks in Avoiding errors and risks in aseptic workaseptic work

Mark Oldcorne

What errors can occur 1What errors can occur 11990: Johannesburg

◦ Death of 15 babiesContaminated IV feeds

2000: India2000: India ◦ Death of 3 young mothers and 3 newborn

babies Contaminated IV fluids

2001: USA 2001: USA ◦ FDA recall contaminated eye drops◦ containing

Pseudomonas mendocina Klebsiella pneumoniae

What errors can occur 2What errors can occur 22004: South Africa 2004: South Africa

◦ 6 premature babies died◦ Enterobacter cloacae

three containers one infusion set

A pharmacist's dirty hands the main reason2002: Brazil 2002: Brazil

◦ 36 n36 neonatal deaths in Brazil ◦ contaminated intravenous fluids.

Endotoxin contaminated IV medication

What errors can occur 3What errors can occur 3Evans Medical in Speke

(not connected with present trading company)

Tue 6th April 19715% Sterile Dextrose Solution Lot D1192

29th Feb – 2nd Mar 19715 deaths at Devonport Hospital

6th Mar 1972 - Investigation begins

12th Jul 1972 - Clothier Report issued by Department of Health &

Social SecurityReport 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 4What errors can occur 4

What errors can occur 5What errors can occur 5

What errors can occur 6What errors can occur 6

Error Incident RatesError Incident RatesBateman, R; 2003

◦Pilot n=198,000 items 357 errors reported 0.18% processes containing errors 7 left department; 1 administered

◦UK n=155,000 items 1697 errors reported 1.09% processes containing errors 31 left department; 3 administered

Taxis and Barber; 2003◦13% error rate for ward based preparation

Error Types Error Types Bateman, R; 2003Bateman, R; 2003

Error Types % Pilot

% UK

Labelling error 34 37Other 14 9Incorrect transcription 11 17Incorrect dose used 10 3Made up to incorrect final volume 10 3Incorrect expiry 8 8Calculation Errors 7 2Incorrect diluent or fluid 4 2Incorrect drug used 3 3Inadequate closure 1 0Particulates 0 13Incorrect container 0 3

Severity of ErrorsSeverity of Errors

Classification

Effect if undetected % Pilot

% UK

None No effect on patient 49 77

Minor Cause non-permanent harm

35 17

Moderate Cause semi-permanent harm

12 3.4

Major Cause major permanent harm

4 1.6

Catastrophic

Could cause death 0 1

Additional Error TypesAdditional Error TypesAseptic preparation units vs

Traditional Manufacturing Units

Microbiological Contamination operator transfer disinfection environment aseptic processing

Chemical◦right drug ◦correct amounts of drug◦right diluent◦right salt \ hydration states

Factors Contributing to Factors Contributing to errorserrors

Factors Influencing of Factors Influencing of ErrorsErrors Red – Clothier Report 1972!

People◦ 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◦ 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 Factors Influencing of ErrorsErrors

Records◦ transcription errors◦ actions not completed at time of action ◦ calculation errors◦ incorrect dose & strength◦ incorrect diluent◦ incorrect final volume

Instruments \ Equipment◦ inadequate equipment◦ lack of calibration◦ lack of maintenance activity and logs◦ functioning correctly◦ use for appropriate use◦ validation

Factors Influencing of Factors Influencing of ErrorsErrors

Procedures◦ lack of procedures◦ inadequate procedures (reflect practice –

contemporary) ◦ operators own interpretation of procedures◦ accessible◦ latest version

Ingredients◦ reconciliation checks◦ checks◦ selection errors – incorrect drug / diluent /

containerProduct

◦ inspection and batch review◦ incorrect expiry◦ lack or failure of final product testing

chemical, particulates, microbiology, endotoxins ◦ labelling errors

Sources of ErrorsSources of ErrorsHuman Errors

◦ never deliberate◦ usually careless◦ system shortfalls◦ overwork◦ ignorance

Mechanical Malfunction◦ software malfunction◦ hardware malfunction◦ lack of calibration◦ inappropriate use (e.g. re-use of single use

equipment)

Combinations - Swiss Cheese Scenario

Minimising ErrorsMinimising ErrorsPhil CrosbyZero 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 mistakesAim for perfection and miss it

RATHER THANAim for imperfection and hit it

Minimising ErrorsMinimising 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 RisksMinimising RisksAdoption of GxP systems

Rules and Guidance for Pharmaceutical Manufacturers and Distributors, 2007

Quality Assurance of Aseptic Preparation Services

Is that it? Unlimited ResourcesIntegration with

Risk managementRisk managementICH 9 Quality Risk Management

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

Apply to◦ development, manufacturing, release,

distribution, inspection, review processes◦ starting and final drug products

When◦ lifecycle of product

Risk AssessmentRisk Assessment1. Risk Identification

◦ What might go wrong?2. Risk Analysis

◦ What is the likelihood (probability) it will go wrong?

◦ What are the consequences (severity)?

3. Risk Evaluation◦ Compares identified risk and analysed

risk against given risk criteria◦ Risk score

Risk assessmentRisk assessmentObjective

◦Elimination to reduction to acceptable levels

Outcomes◦Patient safety◦Regulatory compliance◦Financial ◦Reputation

Risk ManagementRisk Management

Minimising ErrorsMinimising ErrorsRetrospectiveRetrospective

Deviation Management \ Change Control

Risk Management Tools

◦CAPA

◦RCA

Compare to Other Reporting Schemes

CAPACAPACorrective and Preventive ActionClosed loop process

1. Corrective Action ◦action taken to rectify the non-

conformance/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

RCARCARoot Cause Analysis

Structured and objective method - Asking◦What? How? Why?

Team approach – Facilitator

Analysing Errors - Human Error◦timelines etc.◦nominal group technique, brainstorming, brain-writing, fishbone, 5-whys, barrier analysis

Reporting SystemsReporting Systems

Local Reporting Scheme

◦Hospital or Trust based

National Reporting Schemes

◦Regional

◦National National Reporting and Learning System - NPSA

Pharmaceutical Aseptic Services Group / R.

Bateman

No Blame

Use of Quality IndicatorsUse of Quality Indicators

Trending environmental monitoring data

Deviation\Exception reports

Contamination rates

Trigger Tools

Safer Patient Initiative (SPI)

Minimising ErrorsMinimising ErrorsProspectiveProspective

Minimising errors by prospective

analysis

Process mapping

Risk Management Tools

◦FMEA

◦HACCP

FMEAFMEA Failure Mode Effects Analysis

◦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

HACCPHACCPHazard 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 points3. Establish critical limits4. Establish – system to monitor the CCP5. Establish corrective action when CCP not

controlled6. Establish system to prove HACCP system

working7. Establish record keeping system

Summary Summary Gauge your risks!Gauge your risks!

Prospective

Retrospective

Use Risk Management Tools

Remember they are only tools