Laboratory Services in Health Care

Laboratory

A laboratory is defined as

– “a facility

– for the examination of materials derived from humans

– for the purpose of providing information for the diagnosis, prevention

Laboratory in HealthCare

Overview

• Role of Laboratory in Health Care

• Laboratory Services
• Establishing a Laboratory
• Infrastructure
• Instrumentation
• Human Resources
• Quality & Safety

Role of Laboratory in HealthCare

• Diagnosis
• Treatment Efficacy
• Progress Monitoring
• Predictive/Prognostic
• Companion Diagnostics Individualized Medicine or Personalized Medicine

Companion Diagnostics
Scope of Services

What labs are required?

Depends upon the scope of clinical services offered

• Pathology /Clinical Pathology

• Biochemistry
• Microbiology
• Clinical Pharmacology etc

What tests to offer?

Depends upon the scope of clinical services offered

• In house vs Commercial kits/reagents

• Outsourcing - Accredited/standard labs; MOU
• Outreach (Costing/tariff/increase in N)

Planning Infrastructure

Based on present (current) and future (anticipated) needs

• Services Offered
• Work process & flow, instruments and personnel
• Budget
• Facility Design
• Location
• Area Required
• Access restricted
• Anti rodent measures

Facility Design

Clustered
Biosafety Levels

Instrumentation

• Basic Equipment
• Specific Equipment
• Safety Equipment

Human Resources

• Qualified Personnel
• Education & Skill
• Training
• Experience
• Expertise
Manuals & Training

“What you hear you forget”;

“What you see you remember”

“What you do you learn

Written Instructions (unambiguous)

Procedure Manual

Standard Operating Procedure Manual

Training

• Generic Training for all

o Work Place
o Quality & Safety Practices
• Specific training
o Work process
• Continued Training

Materials Management

Policies governing

• Procurement ( applicable licenses)

• Supply
• Storage
• Usage
• Disposal

Equipment Maintenance

• Preventive Maintenance Contract

• Calibrations
• Internal maintenance team/protocol/schedule
• Equipment Performance Monitoring

Testing & Reporting

• Specimen Collection Manual

• Services Offered, specimens required, collection and transport procedure – room temp/ cold
condition/ ice pack or take container from lab
• Specimen Transport & Acceptance/Rejection criteria
o Chute system (cost benefit) - multiple buildings
o Acceptance criteria: Labelled Specimen container with patient ID, Test request slip
 o Rejection criteria: Unlabelled Specimen- discarded and rejecting receipt- collect fresh
specimen
• Turn Around Time
• Reporting: (policies; documentation)
o Urgent Report
o Critical Report
• Reports/Records
o Documentation
o Access Control
o Confidentiality
o Communication (hard copy/soft copy)

Laboratory Information system

• Hard Copy/Soft Copy

• “A system to receive, process, and store information” associated with the testing services,
the laboratory processes and the outcome (report)
• To interface with the Hospital Information system
– CMC Hospital Information Processing
– Online records, requests, results etc including imaging ––“real time”

Laboratory - Clinician Interface

Present and Future

• Existing services
• Feedback
• Need for additional services
• Introducing newer services
– Validation
– Verification
• Clinical validation cut offs etc

Quality & Safety

Two vital components of structure and process

• Accreditation standards
• NABH (Institution & laboratories)
• NABL (laboratories)

Quality: A Degree of Excellence

Quality Control (Internal)

Quality Assessment (External)

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Quality Assurance
FACTORS INFLUENCING ANALYTICAL VARIABLES

PROFICIENCY OF PERSONNEL

Education, Training. Aptitude. Competence, Commitment, Adequate number, CME, Supervision,

Motivation

REAGENT STABILITY, INTEGRITY AND EFFICIENCY

Stable, Efficient, Desired quality, Continuously available, Validated

EQUIPMENT RELIABILITY

Meet technical needs, Compatible, User and Maintenance friendly, Cost effective, Validated

SPECIFICITY AND SENSITIVITY OF SELECTED TEST

Adequate ST, Sufficient SP, Cost effective, Compatible with available infrastructure and expertise,
Interpretable, Meets the needs/ objectives, validated

PROCEDURAL RELIABILITY USING SOP

DOCUMENTATION

All the written policies, plans, procedures, instructions and records, quality control procedures and
recorded test results involved in providing a service or the manufacture of a product

ASSESMENT

USE OF APPROPRIATE CONTROLS

Internal Labs: Calibrated against national

External: Supplied by manufacturer, National, Internation

Quality Assurance Program

• Quality Assurance Program

• Quality Manual (Systems & processes)
• Internal Quality Control (IQC) to detect (immediate errors) and minimize them
• External Quality Assessment (EQA) to monitor long term precision and accuracy of results

Quality Indicators

Key Performance Indicators

• Define
• Monitor
• Rectify defects
• Sustain standards
• Raise the bar
• e.g. turn around time, redos, reporting errors
• Benchmarks
CONTINUOUS IMPROVEMENT CYCLE

• ANALYSIS & UNDERSTANDING

• MODELING & PLANNING
• DECISIVE ACTION
• KEY METRICS & REPORTING

DEMING CYCLE FOR CONTINUOUS QUALITY IMPROVEMENT MODEL

PDCA CYCLE

Audits & C.A.P.A.

• Audits Periodic scheduled/unscheduled

• Compliance and Non conformance to expected standards
• Problems/Risks
• Root Cause Analysis
• C.A.P.A.
o Corrective action to prevent recurrence
o Preventive action to prevent occurrence
o Remedial action

Quality Errors

• Before Testing (Pre Analytical)

o Specimen Collection
o Specimen Transport
o Specimen receipt (acceptance/rejection)
• During Testing (Analytical)
o Equipment reagent process (IQC & Calibration)
• After Testing (Post Analytical)
o Transcriptional
o Communication

Safety

• Occupational Health & Safety

• Safety Signage (Colors & Meaning)
Laboratory Safety

Hazard Management

• HIRA (Hazard Identification and Risk Assessment)

• Hazard Control
Hazards

• Physical
o Slips, Trips & Falls
o Temperature
o Sound
o Humidity
o Electrical
o Mechanical
• Chemical
• Biological
• Radiation
• Fire
• Ergonomics Physical & Cognitive

What is Hazmat?

What is hazmat?

Any substance (solid, liquid or gas) capable of harming people , property or the environment .

Pose risk to Health, Property & Environment

Chemical Hazards

PHYSICAL HAZARDS

• Flammable
• Compressed gas
• Oxidising
• Corrosive
• Explosive

HEALTH HAZARDS

• Corrosive
• Skin irritant
• Toxic

ROUTES OF EXPOSURE

Inhalation

Ingestion

Skin absorption

• Physical, Health & Environmental Hazards

• Chemical Inventory Hazmat List
• Hazard Identification & Risk Assessment
• Safety Data Sheet (SDS) the backbone of chemical safety
• Appropriate Safety Measures for storage, usage and disposal
• Safety equipment
o Specific P.P.E.
o Emergency eye wash station/kit,
o Emergency shower
 • Spill Management Protocols

SAFETY DATA SHEET

Hazard Communication
Spill Cleanup Protocol

Mercury

Generic

Hazards - Biological

• Standard Precautions (Universal Precautions)

• Biosafety equipment (Biosafety Cabinet, Biosafe centrifuges etc )
• Appropriate P.P.E.
• Hand Hygiene
• Biomedical Waste Management

Standard Precautions (Universal Precautions)

• Where
• When
 • How

Biosafety Equipment

Training

Information Resources

SOP

Personal Protective Equipment

Commission and Omission

Hand Hygiene

Provisos of various types

BIOMEDICAL WASTE MANAGEMENT

SEGREGATION at SOURCE

DISINFECTION

Prevention

Vaccination

Hazards Radiation

• Radiation Hazards
• Laboratories and other areas such as imaging services and radiation therapy units
• A.E.R.B. guidelines
• Appropriate P.P.E. & safety equipment
• Monitoring Exposure

Hazards Fire

• Sources of Fire
• Areas of High Risk
• Firefighting Devices & Training
• Fire fighting Team
• Emergency evacuation protocols
• Mock Drills
Hazards - Ergonomic - Physical

Ergonomics is the science and practice of designing tasks and workplaces considering our capabilities
and limitations OR Fitting the work to the person - User, Equipment/Work Space & Tasks

Prevention of Work

Related Musculoskeletal Disorders (WMSD)

Reduced fatigue and discomfort; Increased productivity; Improved quality of work

Work Area

Work Practices

Work Processes

Pipetting (Repetitive motions); Microscope usage (neck & shoulder pain)

Biosafety Cabinet (constrained knee & leg postures)

Laboratory design, Task variability,

Hazards - Ergonomic – Cognitive

• Multitasking
• Increase in demand on multiple fronts
• Errors in prioritization
• Errors/failure in tasks
o Leads to
o work stress,
 o depression and
o poor productivity
• Interface with patient, instrument and clinician
o Errors in information, input output communication

Hazards Incident Management & Emergency Preparedness

• Hospital emergency codes: coded messages announced over a public address system of a hospital
to alert staff to various classes of on site emergencies

• Convey essential information quickly to staff, with minimal misunderstanding, while preventing
stress and panic among visitors to the hospital

Red Fire
Yellow In Facility Hazardous spill
Blue Cardiac Arrest
Violet Patient’s Violence
Pink Child abduction/ Missing person
White Mob violence situation
Brown External mass casualty
Black Bomb threat
Orange Internal casualty
Green All clear

Futuristic

• Satellite centers for specimen Collection

• Mobile collecting/testing facilities etc

Summary

• Role of Laboratory in Health Care

• Laboratory Services
• Establishing a Laboratory
• Infrastructure
• Instrumentation
• Human Resources
• Quality & Safety