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