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A Costing Framework for QMS
Implementation
Wendy Kitson-Piggott Caribbean Med Labs Foundation
2nd CHART-CCAS-CMLF Joint Meeting 2013
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Why this study?
Context & Rationale
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Why this study?
• Considerations
– The global economic circumstance and impact on regional budgets
– Survival of medical and PH labs in the current economic environment
–Dilemma of decision-making for CMOs, PSs & Lab Managers – need informed advice
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Current Concerns
• Laboratory error
• Implementing the ISO 15189 standard
• Stepwise approach to QMS implementation
• Lack of dedicated budgets for many labs
• Lack of annual budgeting, planning & accountability
• Lack of data on the true costs of lab operations
• Lack of data to inform QMS projections and planning
• Lack of costing frameworks for QMS strengthening and/or accreditation
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Reminder that….
Laboratory tests trigger 85% of medical decisions
And undoubtedly a significant % of public health decision-making
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Reminder that…
• A new study of 120 clinical pathology labs, where blood, urine and other fluid tests are done, estimates that each year in the United States, more than 2.9 million of these errors occur, and more than 160,000 patients are harmed in some way as a result.
Ref: Gallin & Vetter 2006
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Reminder that we need a PRACTICAL approach ….
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Reminder that Change is inevitable
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A new priority – The Lab QMS
• Provides a framework for continuous improvement
• Maximises the outputs of the medical laboratory
• Underpins reliability, relevance and timeliness of lab information
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A new priority - Lab Budgeting
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Study: to collect evidence to…
• Guide new lab priorities: quality improvement, planning, costing & budgeting
• Develop a comprehensive framework that outlines major areas of lab quality expenditures
• Explore whether spending on specific quality elements result in greater impact on lab quality improvement
• To explore what other factors may significantly impact lab quality outcomes
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Study Methodology
• Data collected from 9 labs in 6 countries
• Data collection
– Self-administered QMS data collection tool
– Tool for collection of data on lab quality expenditures
– On-site validation of information
– Key informant interviews
– Document Reviews
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Profile of Study Participants
• English & non-English-speaking countries
• Island & non-island territories
• Populations: <100,000 to >9 million
• Private and public sector laboratories
• Status – 2 labs accredited (neither to ISO 15189)
– 1 lab certified to ISO 9001
– 5 labs initiated QMS implementation
– 1 lab QMS implementation not initiated
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1. Self-administered QMS tool
• Questionnaire patterned on the proposed tiered or stepwise approach to accreditation
• Based on ISO 15189 (3 Tiers)
• Collected information on QMS before & after the formal initiation of QMS implementation
• Disseminated to the 9 labs for completion
• Data validated in follow-up visits by CMLF research staff
• Data collated and analysed using ‘microsoft excel’
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2. QMS Data Collection Costing Tool
• Stratified by ISO 15189 requirements & by:
– Capital costs
– Materials & consumable costs
– Infrastructural costs
– Labour costs
– Administrative costs & fees
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3. Key informant Interview Tool
• Info sought included feedback on factors impeding or helping the quality improvement effort post formal initiation
• Specific lab staff identified for interviews – Laboratory Managers – Laboratory Directors – Quality Managers/Officers (current & recent past) – Senior Technologists
• 1-2hr interviews conducted face-to-face or by phone
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Document Reviews
• Laboratory documents were reviewed to collect data on quality performance before & after QMS implementation initiative: – Turnaround Time & Sample Rejection – QC Failures – HIV Repeat Testing & Reproducibility – Down Time (e.g stock outs, shortages- staff, reagents) – Proficiency Testing (PT) Performance – Litigation – Error Logs
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Major Limitation
• Lack of documentation and records in labs with respect to: – Quality indicators (TAT, PT, downtime, stockouts etc.) – Training events & associated funding sources – Cost of reagents, supplies, equipment, staffing, training
etc.
• Lack of documentation and records in the finance departments of MOH
• Thus costs are not absolute – dependent to some extent on recall and estimates
NB: Private lab financial records much better kept
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PRELIMINARY OUTCOMES
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Preliminary Outcomes
• Seven labs had an opportunity to initiate QMS implementation in 2003
• Progress of labs before & after formal initiation of QMS implementation: ISO 15189 Requirements
– Range of 0% to 46% overall progress in meeting the ISO requirements
• Accredited and certified labs had made the most progress and had the least # gaps across all Tiers
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1%
6%
12%
29%
18%
18%
16%
Analysis of Tier 1 PROGRESS - BEFORE & AFTER QMS IMPLEMENTATION
>50
>40
>30
>20
>10
0
Decline
Preliminary Outcomes
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Tier 1: from ‘No’ to ‘Yes’ n=80
# (%) Tier 1 Requirements % Labs moving from ‘no’ to ‘yes’
1 (1%) (quality coordinator) > 50 %
5 (6%) (e.g quality policy statement)
> 40 -50 %
10 (12%) (organogram & document ID) > 30-40 %
23 (29%) (EQA, IQC, audits)
> 20-30%
14 (18%) (SOPs, PM programme) > 10 -20%
14 (18%) (QMS plan, mgt review)
No change
13 (16%) (staffing, waste disposal) Decline
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Summary of Gaps in Tiers 1-3 in individual labs (n= 165)
TIER EXISTING GAPS BY LABORATORIES
Minimum Maximum Mean Median
Tier 1
17% 56% 39% 39%
Tier 2
13% 81% 40% 36%
Tier 3
2% 85% 46% 32%
Tiers 1, 2 & 3 Collectively
15% 67% 41% 40%
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Final Cost Categories
• Human Resources – salaries, training, meetings, retreats supporting lab quality
improvement
• Furniture, equipment & supplies – Computers, lab equipment, storage, refrigerators etc.
obtained to support improved quality
• Infrastructure – Plant renovations to support improved quality
• Quality control & safety • Administration
– application & licensing fees etc. to support improved quality
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Expenditure
• Ranged from >$US 300,000 to >$US 5 million
• Higher expenditures included significant upgrades to plant and infrastructure – (improved safety and testing facilities)
• There was seemingly no direct correlation between expenditure and QMS progress
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Observations
• Main expenditure categories
– HR; Equipment & supplies & Infrastructure
• Very varied expenditure patterns
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HUMAN RESOURCES FURNITURE, EQUIPMENT
AND SUPPLIES INFRASTRUCTURE
QUALITY CONTROL AND SAFETY
ADMINSTRATION
Costs 100,284 1,510,100 65,000 426,075 12,000
-
200,000
400,000
600,000
800,000
1,000,000
1,200,000
1,400,000
1,600,000
Co
sts
EXAMPLE OF INDIVIDUAL LAB EXPENDITURE
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HUMAN RESOURCES FURNITURE, EQUIPMENT AND
SUPPLIES INFRASTRUCTURE QUALITY CONTROL AND SAFETY ADMINSTRATION
Costs 225,612 260,866 5,240,499 8,200 153,000
-
500,000
1,000,000
1,500,000
2,000,000
2,500,000
3,000,000
3,500,000
4,000,000
4,500,000
5,000,000
5,500,000
Co
sts
EXAMPLE OF INDIVIDUAL LAB EXPENDITURE
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HUMAN RESOURCES FURNITURE, EQUIPMENT AND
SUPPLIES INFRASTRUCTURE QUALITY CONTROL AND SAFETY ADMINSTRATION
Costs 464,647 7,435 - 33,333 9,436
-
50,000
100,000
150,000
200,000
250,000
300,000
350,000
400,000
450,000
500,000
Co
sts
EXAMPLE OF INDIVIDUAL LAB EXPENDITURE
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Comparison of Expenditures by Cost Category
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QMS COSTING FRAMEWORK
• Organised according to the ISO 15189:2007 management and technical clauses
• Sub-components define the cost elements for each requirement
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Framework example
• Document Control
– Filing cabinets
– Office furniture
– Materials & supplies
– Maintenance
– Other capital costs
– Technologist time
– Clerical staff time
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Framework example
• Quality Management
– Quality Coordinator
– Consultant support
– Retreats
– Meetings
– Miscellaneous printing
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Framework example
• Facilities & Safety
– Plant & Infrastructure
– Driver
– Vehicle/transport
– Cleaners
– Storage
– Safety coordinator
– Shipping
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Other impacting Factors (variables)
Plus/Supports • Strong Leadership at the MOH, hospital and lab level –
seriousness of purpose • Supportive administrators • Staff enthusiasm, buy-in & teamwork • Really wanting to become accredited & get recognition • A dedicated quality manager/coordinator • Access to adequate resources • Sustained technical assistance • Sustained QMS training • Making certification mandatory
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Other impacting Factors (variables)
Minus/Hindrances • Lack of leadership or interest at MOH, hospital & lab level • Non-supportive political agendas • Failure to designate a dedicated focal point at the MOH and
in the lab • Staff changes within the MOH, hospital and lab • Turf protection & external jealousies • Demotivated staff • Underestimating the QMS effort • Lack of funding (austerity measures) • Lack of planning
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Benefits of QMS Costing Framework
• Provides guidance for administrative projections & budgeting
• Allows for detailed planning and a phased approach to implementation
• Ensures that all key stakeholders are on the same wavelength re QMS cost implications and minimum needs
• Limits the perception that lab is always asking for ‘something’ else
• Can be used to advocate for resources – linked to quality indicators & standard requirements
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Major Challenges to
QMS Implementation • Sustainability of effort
• Sustained leadership
• Holding gains & building on them
• Staff compliance and ownership
• Resourcing as funding gets tighter
• Proving value and avoiding cuts
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Next Steps
• Converting the QMS Costing framework into an electronic tool that would more easily summarise data
Thank-you
