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Clinical laboratory services are a critical yet much neglected component of health systems in resource poor countries. They are crucial for public health, disease control and surveillance, and guide patient diagnosis and care, but their key role is often not recognized by governments or donors. Laboratory tests should be used to improve the outcome for individual patients or to provide public health information. However, if the quality of laboratory tests is poor, resources will be wasted on repeat tests or inappropriate management and the laboratory service will be inefficient. The primary goal of Laboratory Medicine is to provide information that is useful to assist medical decision-making, allowing optimal health care. This can only be obtained by generating reliable analytical results on patient samples. Meaningful measurements are indeed essential for the diagnosis, monitoring, treatment, and risk assessment of patients. Inadequate laboratory performance may have extensive consequences for practical medicine, healthcare system, and, in conclusion, for the patient. Poor quality results may actually lead to incorrect interpretation by the clinician, impairing the patient’s situation. Accreditation authorities have identified twelve quality system essentials that need to be in place for a laboratory to perform clinical tests adequately and in a quality assured manner. Along with each laboratory performing tests that are in its scope, it is essential that duplication and excess capacity is addressed by forging and operating a network of laboratories leading to consolidation and integration of clinical testing. A network would have collection centers at places convenient to the patients, supported by frequent transfer of samples in appropriate conditions to the laboratory. In the laboratory there is a need for increased automation and relevant training of personnel and the setting up of centralized accessioning, pneumontic chutes for transport of samples to the work bench and for bidirectional interphased equipment to transfer results to desk top of laboratory physicians and after validation of results for the results to be electronically transferred by SMS and/or PDF files via email and/or becoming available online for clients, supplemented by delivery of hard copies of the results. The challenge in the next decade for laboratory medicine is to accomplish these major changes in organization to meet fiscal restraint and shortage of adequately trained laboratory personnel. Collaborative networks, constructive use of point of care devices, and the development of rapport between laboratories and their clients leading to cost effective utilization of limited resources, are some of the strategies that will maximize patient benefit
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Laboratory reorganization in view of fiscal & human resource constrains
Dr. Ashok Rattan,Chief Executive,
Fortis Clinical research Ltd.,Adviser,
Religare SRL Diagnostics labs in Fortis / Escorts Hospitals, Delhi & NCR
ExternalAssessment
Optimal Laboratory SystemOptimal Laboratory System
Facilities
People
Equipment
Quality in Laboratory ServicesQuality in Laboratory Services
What is Quality ?What is Quality ?
• Quality is difficult to define,
Invisible when GOOD, impossible to ignore when BAD
• Doing the right thing, right (the first time)» Dr. James Hospedales, PAHO
• Meeting and exceeding expectations (STANDARDS)
International Standards OrganizationInternational Standards Organization
• Quality: – The totality of features & characteristics of an
entity that bears its ability to satisfy a stated or implied need
• Quality control: – Determines to what extent a product or service
complies with a set standard• Quality assurance:
– Is a more comprehensive approach to quality. Based on structure – process – outcome framework
• Total quality management: – an organization wide approach aiming at
continuously improving overall performance.
International standards for Diagnostic Labs:International standards for Diagnostic Labs:ISO 15189ISO 15189
• Importance of accreditation– Recognises competence– Facilitates exchange of services– Provides a valuable management tool– Ensures the needs & requirements of all
users
Principles of accreditationPrinciples of accreditation
• Adherence to high professional standards
– Timeliness of test results– Laboratory accuracy & precision– Clinical relevance– Qualification of laboratory professionals– Training of personnel– Prevention of error
Use of 12 QSE would ensureUse of 12 QSE would ensure
1. Reduction or elimination of medical error2. Likelihood to meet customer satisfaction3. Potential for successfully meet accreditation assessment4. Sustained attainment of quality objectives
We never make any mistakes in our Laboratory, Mr. Sharma
My name is
Sunil Verma
To err is human1999 (IOM report)
• 44,000 to 98,000 Americans die each year from medical error– >8th leading cause of death– >motor vehicle deaths, breast cancer or AIDS
• Laboratory tests errors: – 50 % : failure to use indicated tests– 32% : failure to act on results of test or findings– 55% : involved delay in diagnosis
Deaths in USA due to medical error areEquivalent to ONE Jumbo jet crashing every day of the year
Old Paradigm
Errors because of bad appleName, Blame and Shame
• Deficiencies in design, organization, maintenance, training and management create conditions in which persons are more likely to make mistakes.
• Deming Red beads experiment
Medical error is a failure of process
• The concept that errors result largely from the failure of systems, not from individual carelessness or inadequacy, is fundamental to the new efforts to address safety and runs counter to the traditional focus of medical training on individual performance
Blunt and Sharp end model
Swiss cheese model of error prevention
ExternalAssessment
Optimal Laboratory SystemOptimal Laboratory System
Facilities
People
Equipment
9+2
Establish NETWORKSet up Rapid response labsSupported by Reference Lab
Pre analyticalSample Collection & Transportation
SRL Clinical Reference Laboratory:SRL Clinical Reference Laboratory: The lab that never sleeps
Infrastructure & Trained ManpowerInfrastructure & Trained Manpower
AnalyticalAutomation
IT enabled bidirectional interphase
Post AnalyticalPost Analytical
Processes & AccreditationProcesses & Accreditation
Which tests are availableWhich can be ordered as STATHow to complete lab request form
Pt preparation & precollection assessmentCollection instruction
Transport, temperature, storage
Feedback on specimen quality
Tracking mechanism
Roles & ResponsibilitiesRoles & Responsibilities
Performing the tests as per SOPUse ICQParticipate in EQA
Verify validity of test results
Interpreting the findingsReconcile significant disparity
Preliminary reportsFinal reportReport TATCorrected reports
Specimen managementReport & material archiving
Data, data, data, My dear Watson, I can not do anything without data
Whatever gets measured, gets done• Why measure ?
– To take action to ensure success of reaching goals
• What ?– Key actionable process elements that will help
monitor the process• Where ?
– As close as possible to the variation• When ?
– As often as necessary• How ?
– As unobtrusively as possible
MonitoringMonitoring
Provide Regular Feedback Provide Regular Feedback & &
Monitor Corrective ActionMonitor Corrective Action
Effect on Workload in NCRTotal Accessioning
Labs Jan Feb Mar Apr May Jun Jul Aus Sep
GGN 26569 30818 42108 38933 44388 42634 44859 44281 46772
FHN 7875 8278 9667 9001 8589 8552 10405 11351 11783
FHVK 4949 5222 5569 4911 5083 4804 5350 6084 7148
PV 2736 3299 3887 3471 4232 4129 4883 5012 6902
FHJR 2287 1271 2926 2601 2843 2696 3269 3160 3719
SUN 2656 2951 3028 3321 3474 3471 3658 3938 5945
DLF 2843 2871 3459 3267 3264 3333 4485 6303 6294
ROT - - - 219 279 423 729 771 973
TOTAL 49,915 65,724 89,536
A decade back
Diagnosis known & tests available
Clinicians experienceIn test selection & interpretation
No difference
Situation now
Diagnosis known & tests available
Clinicians’ experience In test selection & interpretation
No expert adviceprovided unless asked
Potential solutions
• Use Reflex testing as much as possible to increase appropriateness of test selection
• Provide patient specific narrative interpretation of test results for complex evaluation of many areas of laboratory medicine (obtain relevant clinical information whenever necessary)
Potential solutions(Go the extra “mile”)
Results only
Canned comments with results (IR)
Patient specific interpretation of results (often requires detailed
clinical data)
Answer questions on lab Related issues
Necessary to getVisibility in patient care
Provide interpretative servicesFor complex tests
Necessary to gain indispensability in patient care
Secret of QualitySecret of Quality
• Juran: Reduce variation (Variation is evil)
ImpreciseImprecise PrecisePrecise Precise PreciseInaccurateInaccurate Inaccurate AccurateInaccurate Accurate
Even if we are on the right trackEven if we are on the right track
we risk being run over, if we just sit there
ACTACT
•Data and Lab Management•Safety•Customer Service
Patient/Client PrepSample Collection
Sample Receipt and Accessioning
Sample TransportQuality Control
Record Keeping
ReportingPersonnel CompetencyTest Evaluations
Testing
