total quality management -...
TRANSCRIPT
What is Quality Management?
Total Quality Management
• TQM –first introduced in business world in 1957, Armand Feigebaum
• Total = Quality involves everyone and all activities in the company. •Quality = Conformance to Requirements •Management = Quality can and must be managed. • TQM = A process for managing quality; process for
improvement
• TQM brings:• Quality into work processes (preventing mistakes rather than
detecting them)• Involves everyone (encourages teamwork)• Values staff training• Emphasizes service-user satisfaction
Definitions
•Accreditation• Procedure by which an authoritative body gives formal
recognition of competency to an organization
•Quality management (TQM)• coordinated activities to direct and control an organization
with regard to quality
•Quality assurance (QA)• total process whereby the quality of outputs can be
guaranteed
• Quality Control (QC)• Process of detecting defects in the finished product
•Audit • an essential part of the quality assurance program. Audit is a
means of assessing whether one is achieving one's stated objectives:
For NHLS…• Accreditation
• SANAS – the formal body• ISO15189 – internationally recognized standard for medical
laboratories
• Quality management (TQM)• Training of new and existing staff, staff development, laboratory
manuals, safety policies, equipment maintenance etc.
• Quality assurance (QA)• Guarantee the outputs - relevant, reliable, timely, and correctly
interpreted laboratory reports• Right Result, at the Right Time on the Right Specimen, from
the Right Patient, interpretation based on Correct Reference Data & at the Right Price
• Audit –• what should we do – detailed in our SOPs? • what do we do – by reviewing selected reports? • Are we doing what we should be doing – compare to SOP? • Can we improve what we do? • Have we improved – ongoing measurement of quality?
Why do Quality Management?
A senior doctor at a Gauteng academic hospital said
the number of errors in the results of National Health
Laboratory Service tests had "rocketed" and test
turnaround times were too long.
Provide quality services to all service-users
• Service-users: • patients, physicians and other health care workers
• Limited resources - Set priorities based on• financial and human resources
• disease pattern and current health concerns in population
• consider organizational/customer objectives
Cost of quality service
• Incorrect patient management• Morbidity
• Mortality
• Litigation
• Loss of confidence
• Financial implications:• Redo doubtful test results
• Damaged equipment
• Waste of supplies
How Do We Manage Quality?
Quality assurance
•Process whereby the quality of lab reports can be guaranteed• Pre-analytic stage
• Analytic stage
• Post analytic stage
Documentation: Workflow can be traced with date & person, what tests/procedures have been requested, performed & reported
Pre-analytic stage
• Specimen collections: • Container expiry dates. • Training on specimen collection
• Specimen transport: • standardised.
• Specimen reception: • SOPs include, for example, rejection criteria
• Specimen registration: • quality control e.g. 10% check
• Staff members:• Trained, competency documentedt
Analytic stage
• Check integrity prior to testing• Follow SOPs• Internal quality controls
• before or with specimens.
• Reagents and supplies • Storage• Expiry• Controlled
• Analysers and equipment • Maintenance and service
• Training and competency of personnel.• Proficiency Testing Schemes (PTS)/ External Quality Assessments (EQA).
• NHLS schemes prepared and implemented following ISO 17043.• International PT Schemes
Post-analytic stage
• Reporting of results• processes to check and minimize transcription errors
• Processes to check automated transfer of results
• Correctness & clarity• Senior staff review results
• Efficient distribution & delivery (turnaround time)
•Urgent reports! – phoned to clinician
• Confidential
•Advice
Service-
users
Costs
Support system for
supplies, equipment
and supervision of lab
work
Total
commitment &
support from top
management
Training &
CPD
Standardization
Communication
TQM
Total commitment and support from top management
• This implies:• adequate laboratory facilities
• trained personnel
• required equipment and supplies
Training, Environment of continuous learning
• Training and development of laboratory personnel is the most efficient and cost-effective way of quality improvement• Reinforce or learn new technical skills
• Acquire managerial and organisational skills
• Identify existing staff skills and use to train other staff
Remedy – develop a culture of cost-consciousness and better management of available resources:
•Material – bulk purchases, appropriate selection, inventory and stock level management, correct storage and consider shelf-life of items
•Methods – follow standard operating procedures, quality control procedures, safety procedures
•Machines – follow operating instructions, regular preventative maintenance
•Manpower – staff training and development
Control processes through standardisation
• SOPs are a major component of any quality system• Written instructions that include all aspects of work practices
• Reduce the chance of process variability
• Reviewed and updated on a regular basis• Who should do this?
• Effective only if used with training
•Quality Control
Internal Quality control (QC)
•Measuring parameters of day-to-day or batch-to-batch analytical performance • Temperature charts of equipment where critical for the
test/storage • Testing QC samples with known test results/values with
each batch / each day
•Early detection of errors before leading to incorrect results
•All materials, equipment and procedures should be controlled
Operational support system (OSS) for supplies, equipment and supervision
•OSS includes:• Equipment maintenance
• Replenishment of consumables
• Supervisory systems
• Communications systems (IT)
• On-the-job training e.g. how to operate new instruments
• Expansion of services
Improve communication and break down barriers
• Establish effective channels of communication • Within organization• With clients
•Newsletters (monthly/quarterly)• Staff at peripheral labs will feel less isolated• Highlight problems• Commend good performance• Enhance training efforts• Introduce new test methods
• Cross-functional/interdisciplinary meetings/ward rounds• Serve to inform other health professionals about new test methods
or service improvements, facilitate pt care
• Visits to peripheral labs by qualified staff• Training, support, updating re: procedural changes
How Do We Assess Quality Management?
Ongoing review and assessment
• EQA / Proficiency Testing
•Non-conformances
• Internal Audits
• External audits (assessments)
External quality assessment (EQA)/Proficiency testing schemes/External QC
• System to assess if a laboratory performs to a satisfactory standard
• Identify systematic errors which in long term can be corrected • No immediate impact on quality
• Ideally scheme/s should cover all processes in place in lab• What do we do if thereis no scheme?
• The samples should be processed the same way as clinical samples
• Results are marked and compared with results of other participating labs• Some labs are used as referee labs
• Monitoring and feedback is crucial
No. Scheme National score NHLS Target
1 Bacteriology 88 75
2 Blood Gas * 76 90
3 CD4 92 90
4 Chemistry 96 90
5 CRP 81 No target
6 Endocrine 85 75
7 ESR * 84 90
8 Morphology 93 75
9 Mycology Moulds 78 75
10 Mycology Yeasts 89 75
11 Parasitology Blood 81 75
12 Parasitology Stool 85 75
13 RPR * 80 90
14 TB Microscopy 93 90
15Therapeutic Drug
Monitoring88 75
16 TPHA 87 90[1] A substantial number of Blood Gas instruments are placed in health facilities and operated by health professionals in the facilities. TQM for these instruments relies heavily on co-operation
between the NHLS and health staff. The NHLS is addressing these challenges and corrective actions are being implemented.[2] Laboratories are penalised for non-returns. Due to ESR EQA only taking place twice a year, this impacts negatively on the national score. On an individual basis, the laboratory results exceed the
targets. Non-returns are addressed on an ongoing basis.[3] Laboratories are penalised for non-returns. Due to RPR EQA only taking place three times a year, this impacts negatively on the national score. On an individual basis, the laboratory results
exceed the targets. Non-returns are addressed on an ongoing basis.
Non-conformances
•Descriptions of processes / actions that are outside accepted practice (usually as defined by SOP)
•Usually “ad-hoc”
•Are NOT a “punishment”
•Must be accompanied by root cause analysis and corrective action
• Can be monitored to detect trends
Audits
HorizontalVer
tica
l
Internal vs external
Examination audit (witnessing)
• Direct observation of a process
• Does the process follow the SOP?
• Does the person understand what they are doing?
KEEP CALM
IS COMING