Clinical Laboratory Management 3031464192, 9783031464195

Table of contents :
Foreword
Preface
Acknowledgments
Contents
Editors and Contributors
About the Editors
Contributors
Abbreviations
Part I: Introduction to Laboratory Management
1: Role of Medical Laboratory Technology in Health Care
Background
Screening
Diagnosis
Disease Prognosis
Guidance for Treatment
Follow-Up
Evaluation of Substance Abuse
Investigation and Surveillance of an Epidemic
Teaching and Training
Suggested Reading
2: Overview of Laboratory Management
Background
Workforce
Machines/Equipment
Money
Finance
Accounts
Infrastructure
Physical Location
Layout and Design
Processes
Materials
Information System
Document Control and Record Keeping
Ethical and Legal Aspect
Laboratory Hazards
Supporting Services
Suggested Reading
3: General Principles of Management
An Organization and Its Need for Management
Principles of Management
Specialization/Division of Labor
Authority with Corresponding Responsibility
Discipline
Unity in Command
Unity of Direction
Subordination of Individual Interest to the General Interest
Remuneration of Staff
Centralization
Scalar Chain/Line of Authority
Order
Equity
Stability of Tenure
Initiative
Esprit de Corps
Management Skills
Technical Skills
Human Skill
Concept Skill
Design Skill
Suggested Reading
Part II: Human Resource Management
4: Strategic Human Resource Management
Human Resources as an Asset
Basic Human Resource Activities
Induction
Suggested Reading
5: Job Analysis and Job Evaluation
Definition and Terminology
Job Analysis and Job Evaluation—Are They the Same?
Job Analysis
Questionnaires
Interviews
Observations
Computer-Based System
Recent Advances in Job Analysis
Job Evaluation
Job Evaluation Process
Job Evaluation Methods
Factor Comparison or Key Job Method
Point Method
Ranking Method
Job Grading or Job Classification Method
Job Evaluation Committee
Suggested Reading
6: Recruitment and Selection
Background
Recruitment
Sources of Recruitment
Internal to the Organization
External to the Organization
Novel Approaches to Recruitment
Selection
Employment Interview
Unstructured Interview
Structured Interview
Staffing
Suggested Reading
7: Performance Management
Background
Process of Performance Management
Step 1: Goal Setting
Step 2: Establishment of Evaluation Criteria
Step 3: Source of Appraisal
Step 4: Methods of Performance Appraisal
Step 5: Communication of Appraisal
Tell and Sell Approach
Tell and Listen Approach
Mutual Problem-Solving
Methods of Performance Appraisal
Trait-Based Methods
Graphic Rating Scale
Forced Choice Method
Essay Method
Ranking Method
Forced Distribution Method
Behavior-Based Methods
Critical Incident Method
Checklist Method
Weighted Checklist Method
Behavior-Anchored Rating Scale (BARS)
Result-Based Methods
Productivity-Based Approach
Management by Objectives (MBO)
Competence Assessment
Issues and Problems in Performance Management
Suggested Reading
8: Staff Scheduling
Background
Scheduling Methods
Full-Time
Part-Time
Shift-Based
Seasonal
Rotating
On-Call
Pre-requisites of a Good Schedule
How to Prepare a Good Schedule?
Scheduling Approach
Heuristic Approach
First Come First Serve Approach
Linear Programming Approach
Legal Aspects of Staff Scheduling
Work Hours
Compensatory Leave
Women Safety at Workplace
Suggested Reading
9: Conflict Management and Industrial Relations
Background
Theoretical Perspectives of Industrial Relations
Other Approaches of Industrial Relations
Systems Approach
Social Action Theory
How to Manage Industrial Relations?
Industrial Disputes at the Workplace
Conflict Management
Stages of Conflict
Methods of Conflict Management
Consultation
Dialogue
Negotiation
Mediation
Suggested Reading
Part III: Accounting and Finance
10: Financial Decision-Making
Background
Financing Decision
Investment Decision
Operating (or Dividend) Decisions
Suggested Reading
11: General Accounting Principles
Background
Economic Entity Principle
Monetary Unit Principle
Going Concern Principle
Time Period Principle
Accrual Principle
Matching Principle
Revenue Recognition Principle
Dual Concept Principle
Cost Principle
Objectivity (Verifiable) Principle
Consistency Principle
Conservatism Principle
Full Disclosure Principle
Materiality Principle
Reliability Principle
Generally Accepted Accounting Principles
Suggested Reading
Part IV: Organization and Operations
12: Introduction to Hospital Organization and Operations
Introduction
Hospital Organization
Hospital Operations
Suggested Reading
13: Basics of Laboratory Organization and Operations
Laboratory Organization
Laboratory Operations
Advisory Services by a Clinical Laboratory
Suggested Reading
14: Location Decision, Facility Layout, and Facility Control
Location Decision
Statistical Methods for location Decision for a Standalone Laboratory
Cost–Volume–Profit Analysis
Factor Rating Method
Center of Gravity Method
Hospital Integrated Laboratory
Other Factors in Location Decision for a Standalone Laboratory
Laboratory Facility Layout Design
Laboratory Workflow
Facility Control
Suggested Reading
15: Designing a Safe Facility for Persons with Disabilities
Background
Guidelines for the Buildings to Provide Safe Access
Waiting Area
Accessible Examination Rooms
Accessible Route
Entry and Exit
Equipment
Floor Space
Toilet Facility
Staff Training
Accessibility for Staff Members with Disabilities
Suggested Reading
16: Equipment Management
Background
Equipment Life Cycle
Assessment of the Need for Equipment
Procurement of Equipment in a Laboratory
Usage and Maintenance of Equipment
Disposal After the End of Useful Life
Steps of Procurement of Equipment
General Information Regarding Handling of Equipment
Some Common Instruments Used in a Clinical Laboratory
Microbiology Incubators
Function Check
Door Gasket
Cleaning
AMC/CMC
Laboratory Refrigerators
Functional Check
Door Gasket
Cleaning
AMC/CMC
Laboratory Centrifuges
Function Check
Cleaning
Rotor Balance
Brushes and Bearings
Lubrication
Gaskets, Seals, Mounts
AMC/CMC
Micropipette
Calibration
Precautions
AMC/CMC
Cytocentrifuge
Function Check
Cleaning
Spill Management
AMC/CMC
Grossing Station
Maintenance
Cleaning
AMC/CMC
Tissue Processor
Cleaning
AMC/CMC
Tissue Embedding Station
Cleaning
Tissue Holding Tank
Work Stage
Paraffin Reservoir
Cold Plate
Microtome
Function Check
Cleaning
AMC/CMC
Hematology Analyzer
Function Check
Maintenance
Cleaning
AMC/CMC
Suggested Reading
17: Inventory Management
Background
Methods of Laboratory Inventory Management
Aggregate Inventory Management
Item Inventory Management
Inventory Classification
Anticipation Inventory
Fluctuation Inventory
Lot-Size Inventory
Hedge Inventory
Inventory Cost Calculations
Item Inventory Management
Inventory Ordering
Lot-for-Lot
Fixed Order Quantity
Fixed Time Method
Economic Order Quantity (EOQ) Model
Suggested Reading
18: Selection of Reference Laboratory Services
Background
In-House Testing Versus Outsourcing
Benefits of Outsourcing
Reference Laboratory Services
Suggested Reading
Untitled
19: Supply Chain Management
Background
Supply Chain Strategy
Demand-Driven Supply Chain Strategy
Agile Supply Chain Strategy
Collaborative Supply Chain Strategy
Collaborative Planning, Forecasting, and Replenishment Strategy (CPFR)
Vertically Integrated Supply Chain
Strategic Vendor Relationship and Cross-Docking
Decentralized Manufacturing and Distribution
Supply Chain Views
Cycle View
Pull–Push View
Role of Information System in the Supply Chain Management
Demand Management
Supply Chain Management in a Clinical Laboratory
Suggested Reading
20: Remote Sample Collection Facility and Sample Logistics
Background
Guidelines for SCF
Clinical Sample Logistics
Coagulation Tests
Tissue for Histopathology
Microbiological Samples
Samples for DNA/RNA-Based Analysis
Suggested Reading
21: Point-of-Care Testing
Background
Benefits of POCT
Mechanisms Used by POCT Devices
Qualitative Strip-Based POCT Methods
Unit-Use Analyzers
Bench-Top POCT Analyzers
Hemostaseological Coagulation Analyzers
Continuous Measurement POCT
Molecular Biology-Based POCT
Challenges in Implementation of POCT
Quality Control and Data Management
Analytical Errors
Suggested Reading
Part V: Quality Control
22: Quality Control: General Aspects
Background
Measurements
Standard Deviation
Co-efficient of Variance
Accuracy
Precision
Traceability
Measurement Uncertainty
Materials
Reference Material
Calibrator
Control Material
Methods
Reference Method
Standardized Method
Routine Working Method
Classification of Quality Control in a Laboratory
Alternatives of IQC
Alternative of EQA
Critical Result Handling
Suggested Reading
23: Quality Control in Hematology and Biochemistry Laboratories
Background
Internal Quality Control (IQC)
IQC Using Control Material
Westgard Rules
Types of Error
CUSUM (CUmulative SUM) Chart
IQC by Repeated Measurements on the Patients’ Samples
Average of Normals (AON)
Moving Averages Method (MA QC)
IQC in Hematology Laboratory
IQC in Coagulation Laboratory
IQC in Biochemistry Laboratory
External Quality Assessment (EQA)
Process of EQA
Computation of EQA Result
Statistical Measures of EQA
Deviation Index (DI)
U Score
Out-with Consensus Method
En Number
Bias Estimation
Youden Plot
Yundt Chart
Regression Line Analysis
Overall Laboratory Performance Measure
Laboratory Performance over Time
EQA for Qualitative Results
Suggested Reading
24: Quality Control in Histopathology
Background
Pre-Analytical Phase QC in Histopathology
Analytic Phase
Intra-Departmental Consultation
Frozen Section Review (FSR)
Surgical Pathology Random Case Review
Autopsy Pathology Random Case Review
Anatomical Pathology Clinical Indicator
Intradepartmental and Interdepartmental Conferences
Inter-Institutional Review (IIR)
Specimen Adequacy Report
Lost Specimen Record
Single Event Report
Histology Slide Delivery
Quality Control to Histology
Quality Control from Histology
Turn around Time (TAT)
External Quality Assessment in Histopathology
Suggested Reading
25: Quality Control Pertaining to Cytology
Background
Pre-Analytical Phase
Analytical Phase
Internal Quality Control in Cytopathology
Cyto-Histological Correlation
External Quality Assurance in Cytopathology
Suggested Reading
26: Quality Control in Clinical Pathology Laboratory
Background
Quality Control in Urine Analysis
Quality Indicators
Preanalytical Factors
Analytical Factors
Equipment
Reagents
Test Method
Microscopic Examination
Internal Quality Control in Urinalysis
External Quality Assessment and Proficiency Testing in Urinalysis
Quality Control in Semen Analysis
Quality Control Indicators
Pre-Analytic Factors
Analytic Factors
Internal Quality Control
IQC for Sperm Count
IQC for Percentage Values
Between Technician Variability
External Quality Assessment
Quality Control in Body Fluid Analysis
Suggested Reading
27: Quality Control in a Microbiology Laboratory
Background
Internal Quality Control
Pre-Analytical Phase QC
QC in Analytical Phase in a Microbiology Laboratory
Quality Control of Culture Media
Commercially Prepared Media
In-House Prepared Media
pH Testing
Checking the Sterility of the Culture Media
Performance Testing
Quality Control of Stains
Processing of Samples for Culture
QC of Bacteriological Techniques
QC for Antimicrobial Susceptibility Testing (AST)
QC in Serology
QC in sterilization and Disinfection
Maintenance of Reference QC Stocks
Bacteriology
Mycology
Mycobacteriology
Virology
Parasitology
QC in the Post-Analytical Phase in a Microbiology Laboratory
External Quality Assurance in a Microbiology Laboratory
Suggested Reading
Untitled
28: Quality Control in Molecular Diagnostics
Background
Quality Control in Diagnostic Molecular Laboratory
Molecular Assays—Steps Requiring QC
Selection of Molecular Assay
Primer Design
Use of Appropriate Enzyme Reagents
Validation of Assay
Selection of Samples for Validation
Parameters for Validation
Measure of Uncertainty of Molecular Assays
QC of Reagents in Molecular Laboratory
QC of Equipment
Controls Used in Molecular Lab
External Quality Assurance
Molecular Tests in HIV Testing
Retention of Records
Future of QC in Molecular Laboratories
Suggested Reading
29: Quality Control in Blood Transfusion Services
Background
Quality Control in Donor Selection and Donation Procedure
Quality Control for Reagents and Solutions in Blood Bank
Quality Control of Bovine Serum Albumin, Enzyme Reagents, Normal Saline
Quality Control of Reagent Red Cells
Preparation of Red Cell Reagents
Quality Control Measures
Quality Control of Blood and Blood Components
Factors Influencing the Quality of Blood Components
Parameters to Be Tested in QC of Blood Components
Equipment Calibration
Quality Control in TTI Testing
Document Control
Measures to Be Undertaken in an Event of transfusion Reaction
External Quality Assurance in Transfusion Services
Suggested Reading
30: Benchmarking and Key Performance Indicators
Benchmarking
Objectives of Benchmarking
Benchmarking Process
Classification, Advantages, and Disadvantages of Benchmarking
Key Performance Indicators (KPIs)
Classification of KPIs
Advantages and Limitations of KPIs
KPIs for Clinical Laboratory
Dashboard for KPIs
Suggested Reading
Part VI: Documentation and Information Systems
31: Document Control
Background
Document Control
Creation and Approval
Unique Identification
Periodic Review and Update
Revision and Amendment
Availability
Authorization
Removal of Obsolete Document
Standard Operating Procedures (SOPs)
Body of SOP
Types of SOPs
Test Procedure SOP
Equipment SOP
Sample Handling SOP
Reagent and Consumable SOP
Quality Control SOP
Personnel SOP
Facility SOP
SOP for Handling Complaints
Document Control SOP
Quality Manual
Suggested Reading
32: Statistical Methods in a Clinical Laboratory
Background
Screening Test
Diagnostic Test
Validity of a Test
Sensitivity
Specificity
Predictive Value of the Test Result
Positive Predictive Value (PPV)
Negative Predictive Value (NPV)
Receiver Operating Characteristic Curve (ROC) Analysis
Inter-Rate Agreement (Cohen’s Kappa Statistics)
Bland and Altman Plot
Suggested Reading
33: Role of Information Technology
Background
Need for Information Technology in Healthcare
Laboratory Information Systems (LIS)
Features of LIS
Test Ordering
Specimen Accessioning, and Processing
Analytic Phase
Result Entry and Validation
Notifications
Data Management
Data Security in LIS
Validation and Verification
Documentation
Protection
Safeguarding
Operation
Maintenance
Compliance
Authorities and Responsibilities
Minimizing Risks to and from Laboratory Information Systems
Risk Analysis
Risk Evaluation
Risk Control
Continuity Plan
Disaster Management Plan
Recovery Plan
Suggested Reading
34: Electronic Health Record Management
Background
Types of Electronic Health Record Systems
Transition from Physical Records to EHR
Stage I Preparation for the EHR Implementation
Step 1
Step 2
Step 3
Step 4
Stage II Implementation of EHR System
Step 5
Step 6
Stage III Post-Implementation Management
Step 7
Step 8
Standards for Electronic Health Records
Suggested Reading
Part VII: Laboratory Hazards and Safety
35: Laboratory Hazards
Background
Biological Hazards
Mechanical Hazards
Chemical Hazards
Fire Hazard
Class of Fire
Response to Fire Incident
Control of Fire
Electrical Hazard
Spill Management
Classification of Spill
Standard Cleaning Kit
Management of Chemical Spills
Management of Biological Spills
Small Spills of Biological Material
Large Blood Spills in a “Wet” Area
Large Blood Spills in a “Dry” Area
Biological Spill in a Biological Safety Cabinet
Biological Spill in Centrifuge
Radioactive Material Spills
Documentation
Suggested Reading
36: Biomedical Waste Management
Background
Biomedical Waste Management Procedures
Segregation
Classification of BMW and Specified Container for Segregation
Bio-Waste Bag
Sharps Container
Color-Coded Containers
Handling of BMW
BMW Storage
BMW Transport
General Waste Management at Laboratory
Suggested Reading
Part VIII: Legal and Ethical Aspects
37: Introduction to Ethical and Legal Aspects
Background
Principle of Medical Ethics
Informed Consent
Genetic Testing
Equity and Access to Laboratory Tests
Incidental Findings
Direct-to-Consumer Testing
Ethical Issues in Transfusion Medicine
Disclosure of Laboratory Errors
Collection of Information and Specimen
Special Procedures
Performance of Test and Reporting of Results
Retention of Medical Records and Specimen
Financial Arrangements
Research
Confidentiality
Legal Issues and Clinical Laboratory
Suggested Reading
38: Role of Consent in Laboratory Practice
Background
Implied Consent
Expressed Consent
Informed Consent
Written Consent
Informed Written Consent
Consent for Specific Procedures
Suggested Reading
39: Negligence and Malpractice
Background
Medical Negligence
Negligence in Laboratory Practice
Indemnity Insurance
Suggested Reading
Part IX: Planning, Accreditation and Licensing
40: Planning and Designing a Clinical Laboratory
Background
Location of a Laboratory
Laboratory Services Provided
Laboratory Design Considerations
Corridors and Doors
Other Facilities
Storage Space
Specimen Storage
Biomedical Waste
Space Requirements in a Laboratory
Patient Corridor
Administrative Area
Laboratory Area
Patient Area
Service Area
Record and Storage
Biosafety Levels in a Laboratory
Suggested Reading
41: Clinical Laboratory Accreditation
What Is Accreditation?
Accreditation Bodies
Laboratory Accreditation in India
Quality Management System Standards
ISO 15189 Standard for Medical Laboratories
Suggested Reading
42: Planning and Designing a Blood Bank
Background
Space for a Blood Bank
Functional Areas in a Blood Bank
Reception and Donor Waiting Area
Donor/Blood Collection
Blood Processing Area and Laboratory
Component Preparation Room
Records
Personnel and Competencies
Equipment and Reagents
Donor Room
For Hemoglobin Estimation
Emergency Equipment/Items
Laboratory Equipment
Reagents
Equipment for Blood Components
Suggested Reading
43: Licensing of a Blood Bank
Background
Blood Bank Licensing in India
Blood Bank Licensing in the United States of America
Blood Bank Licensing in United Kingdom
Suggested Reading
Part X: Other Management Activities
44: Market Basket Analysis
Background
Laboratory Market Basket
Suggested Reading
45: Brief of Promotional Activities
Background
Marketing Communication
Promotion Planning and Strategy
Situational Analysis
Establishing the Marketing Objectives
Budget Allocation
Specification and Management of Program Elements
Coordinate and Integrate the Efforts
Measurement of Effectiveness
Evaluation and Follow-Up
Health Check-Up Camps
Suggested Reading
46: Corporate Social Responsibility
Background
Theories of Corporate Social Responsibility
Components of Corporate Social Responsibility
Environmental Responsibility
Ethical Responsibility
Philanthropic Responsibility
Economic Responsibility
Why Should Organizations or Businesses Engage in CSR?
CSR Guidelines
United Nations Global Compact
Global Reporting Initiative
World Business Council for Sustainable Development
International Standards Organization
Suggested Reading
47: Customer Feedback Analysis and Customer Complaint Management
Background
Customer Feedback
Focus Group Meetings
Customer Complaint Management (CCM)
Ask the Right Questions from the Complaining Customer
Identify Customer Type
Respond Quickly
Suggest Solution
Maintain Complaint Logs
Customer Feedback Data Analysis
Customer Satisfaction Score (CSAT)
Net Promoter Score (NPS)
Suggested Reading
48: Risk Management
Background
Risk Management
Risk Identification and Analysis
Failure Mode Effect Analysis (FMEA)
Failure Reporting Analysis and Corrective Action System (FRACAS)
Suggested Reading
49: Internal Audit and Continual Improvement
Internal Audit
Advantages of Internal Audit
Internal Audit Process
Nonconformities
Continual Improvement
Types of Improvement
Sources of Insight for Continual Improvement
Steps for Continual Improvement
Suggested Reading
50: Management Review Meeting
Background
Objectives and Agenda of an MRM
Conduct of the MRM
Minutes of the Meeting (MoM) for MRM
Suggested Reading
Index

Citation preview

Clinical Laboratory Management Shakti Kumar Yadav Ruchika Gupta Sompal Singh Editors

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Clinical Laboratory Management

Shakti Kumar Yadav Ruchika Gupta  •  Sompal Singh Editors

Clinical Laboratory Management

Editors Shakti Kumar Yadav Department of Pathology and Lab Medicine All India Institute of Medical Sciences Bhopal, Madhya Pradesh, India

Ruchika Gupta Division of Cytopathology ICMR-National Institute of Cancer Prevention and Research Noida, India

Sompal Singh Department of Pathology North Delhi Municipal Corporation Medical College and Hindu Rao Hospital New Delhi, India

ISBN 978-3-031-46419-5    ISBN 978-3-031-46420-1 (eBook) https://doi.org/10.1007/978-3-031-46420-1 © The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 This work is subject to copyright. All rights are solely and exclusively licensed by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors, and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, expressed or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. This Springer imprint is published by the registered company Springer Nature Switzerland AG The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland Paper in this product is recyclable.

Dedicated to Our Parents and Teachers

Foreword

Clinical Laboratory plays a vital role in the modern healthcare by assisting physicians in screening, diagnosis, and prognosticating various diseases. This book Clinical Laboratory Management has been brought out at a very appropriate time. The book focuses on multidimensional aspects of laboratory management, tackling everything from resource management and quality control to the integration of technological advancements and a sneak peek into the marketing aspects of clinical laboratories. Recognizing the need for a systematic approach in clinical laboratory management, the authors have methodically curated the content of this book that will guide the beginners as well as the professionals in the field. This book offers readers an essential tool to navigate this evolving field. The authors delve into the important but hitherto neglected aspect of recruitment, selection, and performance management of laboratory personnel. Careful and due attention has been paid to the subject of quality control in a laboratory, both internal and external quality assurance. Laboratorians would find this book a useful guide for quality control in different types of laboratories— ranging from hematology and biochemistry to histopathology to molecular laboratories. Laboratory errors (pre-analytical, analytical, and post-analytical) and various hazards in a laboratory have also been discussed in adequate detail in this book. Since many laboratory managers, especially pathologists, also manage blood transfusion services, the organization and quality control of a blood bank have also been included in this book. The contemporary topics of ethical and legal issues, the vitality of consent, and the concept of negligence and malpractice in a laboratory have also been touched upon. Laboratorians managing their own laboratory practice would find the section focused on marketing activities useful to them. The exemplary work and dedication of the editorial team, Dr. Sompal Singh, Dr. Ruchika Gupta, and Dr. Shakti Kumar Yadav, along with their col-

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Foreword

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lective expertise, knowledge, and years of professional experience in the field, give this book an indispensable authority and relevance. Each of the editors and the distinguished authors have contributed their unique insights and deep understanding of pathology and laboratory management. Their diverse backgrounds and holistic approach has helped create a book that would serve as an exhaustive guide for anyone interested in Clinical Laboratory Management. I wish the entire team of this book great success!!! Hematopathology DRG-Unipath Lab, New Delhi, India Department of Pathology, Maulana Azad Medical College and associated hospitals, New Delhi, India

Tejindar Singh

Preface

Medical and paramedical personnel acquire considerable knowledge of “management” with experience over the period. However, for a young professional who is just starting their own clinical laboratory setup or is recruited in a managerial position in a clinical laboratory, there is a felt need for an understanding of the managerial aspects, especially in an institutional setting. Although this knowledge can be acquired from books on general management subjects, there is a paucity of books dedicated to clinical laboratory management. Hence, there is a need for a simple and concise text for management in clinical laboratory practice. This book has been written by experts from all the major fields of clinical laboratory, viz. pathology, biochemistry, and microbiology, as well as by professionals from the fields of community medicine and research. It has been designed keeping in mind the need for scientific management and total quality control in a laboratory practice. Hence, this book shall be useful for clinical laboratorians, students of medical laboratory technology, laboratory managers, and hospital managers. The book has been logically divided into ten parts with 50 chapters written in an easy-to-comprehend language, especially for those who have not been trained in the core management concepts. The first part “Introduction to Laboratory Management” makes the reader familiar with the general aspect of management. This is followed by “Human Resource Management” that describes the basic principles, and topics like job analysis and job evaluation, recruitment and selection, performance management, staff scheduling, and conflict management. This section will help readers to efficiently manage the workforce in their clinical laboratory setting. The next part on “Finance and Accounting” gives a brief overview of financial decision making and general accounting principles that should be known at least to individuals operating their own laboratories. The “Organization and Operations” part is dedicated to organizational structure from the hospital to individual laboratory level. This part also gives insights on important aspects of factors affecting the decision of location of a laboratory and its facility design, equipment and inventory management, supply chain management, selection of reference laboratory services, management of remote collection center and sample logistics, and point of care testing. Aspects of clinical laboratory design pertaining to persons with disabilities have been covered in a dedicated chapter.

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Preface

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An elaborate part on “Quality Control” explains internal quality control and external quality assessment in various sections of a clinical laboratory (not restricted to hematology and biochemistry laboratories) and blood transfusion services. The part on “Documentation and Information Systems” explains the importance of document control, SOP writing, role of information technology, and electronic health record management. The book also includes parts on “Laboratory Hazards and Safety” to describe hazards management and key aspects of biomedical waste management in a clinical laboratory setting, and “Legal and Ethical Aspects” including the concept of negligence and malpractice and the role of consent pertaining to a laboratory. The part on “Planning, Accreditation and Licensing” gives a detailed outline on how to plan a clinical laboratory and a blood bank, and explains the importance and the process of accreditation of a laboratory and obtaining a blood bank license. The last part covers management aspects like market basket analysis, promotional activities, corporate social responsibility, customer feedback, risk management, internal audit, and management review meeting pertaining to clinical laboratory management. We hope that this book will be useful for readers to understand the managerial aspects of a clinical laboratory and serve as a guide for more efficient clinical laboratory managers.   

Shakti Kumar Yadav Ruchika Gupta Sompal Singh

Acknowledgments

We gratefully acknowledge the guidance and encouragement provided by Prof. Tejindar Singh, the first teacher of pathology and laboratory management for Dr. Singh and Dr. Gupta and a guiding force behind this book, without whose inputs, this book would have been incomplete. Our sincere thanks are due to Prof. Ashok Kumar Mukhopadhyay who provided inspiration and motivation for writing this book. Through this book we take the opportunity to thank our seniors and colleagues for their constant support and help in every way in making the dream of this book a reality. We would also like to thank the students of B.Sc. (MLT) who motivated and encouraged us to write a simple yet comprehensive book on this subject. The strong support given by our families during the times we immersed ourselves in the writing and editing of this book helped us sail though such difficult times with ease. Last but not the least, thanks are due to our patients who always look forward to quality laboratory services; this book would not have been possible without their thoughts in our minds. Shakti Kumar Yadav Ruchika Gupta Sompal Singh

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Contents

Part I Introduction to Laboratory Management 1 Role  of Medical Laboratory Technology in Health Care ������������   3 Alekh Verma and Ruchika Gupta 2 Overview  of Laboratory Management������������������������������������������   7 Alekh Verma and Sompal Singh 3 General  Principles of Management������������������������������������������������  11 Alekh Verma and Sompal Singh Part II Human Resource Management 4 Strategic  Human Resource Management��������������������������������������  19 Alekh Verma and Sompal Singh 5 Job  Analysis and Job Evaluation����������������������������������������������������  23 Alekh Verma and Sompal Singh 6 Recruitment and Selection��������������������������������������������������������������  29 Ruchika Gupta and Sompal Singh 7 Performance Management��������������������������������������������������������������  33 Alekh Verma and Sompal Singh 8 Staff Scheduling ������������������������������������������������������������������������������  39 Ruchika Gupta and Sompal Singh 9 Conflict  Management and Industrial Relations����������������������������  45 Sompal Singh and Ruchika Gupta Part III Accounting and Finance 10 Financial Decision-Making ������������������������������������������������������������  53 Sompal Singh and Ruchika Gupta 11 General Accounting Principles ������������������������������������������������������  57 Sompal Singh and Ruchika Gupta

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Part IV Organization and Operations 12 Introduction  to Hospital Organization and Operations��������������  63 Alekh Verma and Sompal Singh 13 Basics  of Laboratory Organization and Operations��������������������  67 Alekh Verma and Shakti Kumar Yadav 14 Location  Decision, Facility Layout, and Facility Control������������  71 Sompal Singh and Ruchika Gupta 15 Designing  a Safe Facility for Persons with Disabilities����������������  75 Ruchi Rathore and Sompal Singh 16 Equipment Management ����������������������������������������������������������������  79 Alekh Verma and Shakti Kumar Yadav 17 Inventory Management ������������������������������������������������������������������  89 Sompal Singh and Ruchika Gupta 18 Selection  of Reference Laboratory Services����������������������������������  95 Ruchika Gupta and Shakti Kumar Yadav 19 Supply Chain Management������������������������������������������������������������  99 Sompal Singh and Ruchika Gupta 20 Remote  Sample Collection Facility and Sample Logistics ���������� 105 Ruchika Gupta and Shakti Kumar Yadav 21 Point-of-Care Testing ���������������������������������������������������������������������� 109 Shakti Kumar Yadav and Ruchika Gupta Part V Quality Control 22 Quality Control: General Aspects�������������������������������������������������� 115 Alekh Verma and Ruchika Gupta 23 Quality  Control in Hematology and Biochemistry Laboratories�������������������������������������������������������������� 121 Alekh Verma, Harsh Vardhan Singh, and Shakti Kumar Yadav 24 Quality  Control in Histopathology ������������������������������������������������ 133 Alekh Verma and Shakti Kumar Yadav 25 Quality  Control Pertaining to Cytology���������������������������������������� 139 Alekh Verma and Ruchika Gupta 26 Quality  Control in Clinical Pathology Laboratory���������������������� 143 Shikha Para and Shakti Kumar Yadav 27 Quality  Control in a Microbiology Laboratory���������������������������� 147 Sanjay Jain, Aarzoo Jahan, and Sompal Singh 28 Quality  Control in Molecular Diagnostics ������������������������������������ 155 Sanjay Gupta and Ruchika Gupta

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29 Quality  Control in Blood Transfusion Services���������������������������� 161 Laxmikanta Parida, Aarzoo Jahan, and Sompal Singh 30 Benchmarking  and Key Performance Indicators ������������������������ 169 Sompal Singh and Ruchika Gupta Part VI Documentation and Information Systems 31 Document Control���������������������������������������������������������������������������� 177 Shakti Kumar Yadav, Aarzoo Jahan, and Ruchika Gupta 32 Statistical  Methods in a Clinical Laboratory�������������������������������� 183 Neha Taneja, Alekh Verma, and Shakti Kumar Yadav 33 Role of Information Technology ���������������������������������������������������� 187 Namrata Sarin and Shakti Kumar Yadav 34 Electronic  Health Record Management���������������������������������������� 193 Ruchika Gupta and Shakti Kumar Yadav Part VII Laboratory Hazards and Safety 35 Laboratory Hazards������������������������������������������������������������������������ 199 Alekh Verma and Shakti Kumar Yadav 36 Biomedical Waste Management������������������������������������������������������ 211 Alekh Verma and Shakti Kumar Yadav Part VIII Legal and Ethical Aspects 37 Introduction  to Ethical and Legal Aspects������������������������������������ 219 Alekh Verma and Shakti Kumar Yadav 38 Role  of Consent in Laboratory Practice���������������������������������������� 227 Alekh Verma and Shakti Kumar Yadav 39 Negligence and Malpractice������������������������������������������������������������ 229 Alekh Verma and Sompal Singh Part IX Planning, Accreditation and Licensing 40 Planning  and Designing a Clinical Laboratory���������������������������� 235 Alekh Verma and Sompal Singh 41 Clinical Laboratory Accreditation ������������������������������������������������ 239 Sompal Singh, Harsh Vardhan Singh, and Ruchika Gupta 42 Planning  and Designing a Blood Bank������������������������������������������ 243 Sonam Kumar Pruthi and Sompal Singh 43 Licensing  of a Blood Bank�������������������������������������������������������������� 247 Ruchika Gupta and Sompal Singh

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Part X Other Management Activities 44 Market Basket Analysis ������������������������������������������������������������������ 253 Sompal Singh and Ruchika Gupta 45 Brief of Promotional Activities�������������������������������������������������������� 257 Sompal Singh and Ruchika Gupta 46 Corporate Social Responsibility ���������������������������������������������������� 263 Sompal Singh and Shakti Kumar Yadav 47 Customer  Feedback Analysis and Customer Complaint Management������������������������������������������������������������������ 269 Sompal Singh and Ruchika Gupta 48 Risk Management���������������������������������������������������������������������������� 273 Alekh Verma and Sompal Singh 49 Internal  Audit and Continual Improvement��������������������������������� 277 Sompal Singh and Shakti Kumar Yadav 50 Management Review Meeting�������������������������������������������������������� 281 Alekh Verma and Sompal Singh Index���������������������������������������������������������������������������������������������������������� 283

Contents

Editors and Contributors

About the Editors Shakti Kumar Yadav, MBBS, DCP, DNB,  is currently working as an Assistant Professor in the Department of Pathology and Lab Medicine at the All India Institute of Medical Sciences, Bhopal. He has a teaching and research experience of more than 13 years. Dr Yadav pursued his Diploma in Clinical Pathology from Gandhi Medical College, Bhopal, followed by DNB Pathology from Hindu Rao Hospital, New Delhi, and Senior Residency from the Department of Pathology in North Delhi Municipal Corporation Medical College and Hindu Rao Hospital, New Delhi. He has research interests in biomedical statistics, data science, artificial intelligence and its applications in pathology. He has more than 40 research publications and coauthored a book on biostatistics. Ruchika Gupta, MBBS, MD, MBA,  is working as Scientist E and Head of the Division of Cytopathology at ICMR-National Institute of Cancer Prevention and Research, Noida. She pursued her postgraduation in Pathology at Maulana Azad Medical College, Delhi, followed by senior residency at AIIMS, New Delhi. She has also trained in renal pathology at AIIMS, New Delhi. As an Assistant Professor and HOD in the Department of Pathology at Chacha Nehru Bal Chikitsalaya, Geeta Colony, she learned the nuances of laboratory management. She has more than 200 publications in various national and international peer-­reviewed journals to her credit. She also has coauthored two books for paramedical students and one book on biomedical statistics. At ICMR-NICPR, Dr Gupta has been actively involved in the organization and conduct of series of hands-on workshops and online certificate courses on cervical cancer screening for pathologists, and these courses have been attended by delegates from across the country and abroad. Sompal Singh, BSc, MBBS, MD, MBA,  is currently working as Senior Specialist in the Department of Pathology at Hindu Rao Hospital and North Delhi Municipal Corporation Medical College since 2005. He pursued his MD Pathology from Maulana Azad Medical College, New Delhi, followed by senior residency at the same institute. He conducted cell culture research during his senior research associateship from CSIR, New Delhi. He is a qualified statistician and a trained computer programmer. He holds 150 research publications in various national and international journals to his credit. He also has coauthored two books for paramedical students, one for medical undergraduate students, and one on biomedical statistics. He has a keen interest in teaching, medical education research, and breast pathology.

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Contributors Ruchika  Gupta Division of Cytopathology, ICMR-National Institute of Cancer Prevention and Research, Noida, India Sanjay  Gupta Division of Cytopathology, ICMR-National Institute of Cancer Prevention and Research, Noida, India Aarzoo Jahan  Department of Pathology, North Delhi Municipal Corporation Medical College and Hindu Rao Hospital, New Delhi, India Sanjay  Jain Department of Microbiology, North Delhi Municipal Corporation Medical College and Hindu Rao Hospital, New Delhi, India Shikha  Para  Department of Obstetrics and Gynecology, Gandhi Medical College, Bhopal, Madhya Pradesh, India Laxmikanta  Parida Regional Blood Transfusion Center, North Delhi Municipal Corporation Medical College and Hindu Rao Hospital, New Delhi, India Sonam  Kumar  Pruthi Department of Pathology, North Delhi Municipal Corporation Medical College and Hindu Rao Hospital, New Delhi, India Ruchi  Rathore Department of Pathology, All India Institute of Medical Sciences, New Delhi, India Namrata  Sarin Department of Pathology, North Delhi Municipal Corporation Medical College and Hindu Rao Hospital, New Delhi, India Harsh Vardhan Singh  Department of Biochemistry, North Delhi Municipal Corporation Medical College and Hindu Rao Hospital, New Delhi, India Sompal Singh  Department of Pathology, North Delhi Municipal Corporation Medical College and Hindu Rao Hospital, New Delhi, India Neha Taneja  Amity Institute, Noida, India Alekh Verma  Kailash Hospital, Noida, India Shakti  Kumar  Yadav Department of Pathology and Lab Medicine, All India Institute of Medical Sciences, Bhopal, Madhya Pradesh, India

Editors and Contributors

Abbreviations

AAB AABB ADASP AMC AON AST ATCC BARS BMW BSL CAP CCM CDC CDSCO CLIA CLSI CMC CPFR CSAT CSR CUSUM DGCI DI DICOM DTCT EAC ECCLS EHR EMR EOQ EQA FFP FMEA FNAC FRACAS FSR GAAP

American Association of Bioanalysts Association for the Advancement of Blood and Biotherapies Association of Directors of Anatomic and Surgical Pathology Annual maintenance contract Average of normals Antimicrobial susceptibility testing American Type Culture Collection Behavior-anchored rating scale Biomedical waste Biological safety level College of American Pathologists Customer Complaint Management Centre for Disease Control Central Drugs Standard Control Organization Clinical Laboratory Improvement Act Clinical and Laboratory Standards Institute Comprehensive maintenance contract Collaborative planning, forecasting, and replenishment Customer Satisfaction Score Corporate social responsibility CUmulative SUM Drugs Controller General (India) Deviation Index Digital Imaging and Communications in Medicine Direct-to-consumer testing European Accreditation Cooperation European Committee for Clinical Laboratory Standards Electronic health records Electronic medical records Economic order quantity External quality assurance Fresh frozen plasma Failure mode effect analysis Fine needle aspiration cytology Failure reporting, analysis, and corrective action system Frozen section review Generally Accepted Accounting Principles xix

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HIPAA HR HRM IAAC ICSH IFCC

Health Insurance Portability and Accountability Act Human resource Human resource management Inter-American Accreditation Cooperation International Committee for Standardization in Hematology International Federation of Clinical Chemistry and Laboratory Medicine IIR Inter Institutional Review ILAC International Laboratory Accreditation Cooperation ILO International Labor Organization IPC Indian Penal Code IQC Internal quality control ISO International Organization for Standardization IVD In vitro diagnostic KPI Key performance indicator LIMS Laboratory information management system LIS Laboratory information system MBO Management by objectives MLT Medical laboratory technology MoHFW Ministry of Health and Family Welfare, Government of India MRA Mutual recognition arrangements MRM Management review meeting NABL National Accreditation Board for Testing and Calibration Laboratories, India NACO National AIDS Control Organization NBTC National Blood Transfusion Council, India NIBSC National Institute of Biological Standard and Control NPS Net Promoter Score NPV Negative predictive value ONC-ATCB Office of the National Coordinator—Authorized Testing and Certification Bodies OSHA Occupational Safety and Health Administration P&L Profit and loss statement PAQ Position analysis questionnaire PC-PNDT Pre-conception and Pre-natal Diagnostic Techniques POCT Point of care testing POSH Protection of Women Against Sexual Harassment at Workplace Act PPV Positive predictive value PT Proficiency testing QA Quality assurance QC Quality control QMS Quality management system RCPAQAP Royal College of Pathologists of Australasia Quality Assurance Programs ROC Receiver operating characteristic ROI Return on investment

Abbreviations

Abbreviations

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SADCA SBTC SCF SCM SKU SMART SOP TAT US-FDA WBCSD WHA WHO

Southern African Development Community Cooperation in Accreditation State Blood Transfusion Council (India) Sample collection facility Supply chain management Stock keeping units Specific, measurable, achievable, realistic, and time-bound Standard operating procedure Turnaround time US Food and Drug Administration World Business Council for Sustainable Development World Health Assembly World Health Organization

Part I Introduction to Laboratory Management

1

Role of Medical Laboratory Technology in Health Care Alekh Verma and Ruchika Gupta

Background Health is defined by the World Health Organization as “a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity.” In today’s world, evidence-based medicine is the norm in healthcare. Medical laboratory technology (MLT) is a branch of science related to laboratory procedures performed in medical practice. The technical personnel in a medical laboratory not only assist the physicians in the diagnosis, monitoring, and appropriate management of diseases but also have a role in human and community health.

To understand the role of medical laboratory technology, we need to make ourselves aware of the various ramifications of laboratory techniques that have expanded in the last few decades. In the world of modern medicine, the medical laboratory has several specialized sections including microbiology, hematology, biochemistry, cytopathology, histopathology, immunology, blood banking, molecular biology, and cytotechnology. Through these specialties, medical laboratory technology plays a crucial role in many facets of healthcare such as screening, diagnosis, prognostication of various diseases, and so on and so forth (Fig.  1.1). We shall discuss these roles briefly in the ensuing sections.

A. Verma Kailash Hospital, Noida, India R. Gupta (*) Division of Cytopathology, ICMR-National Institute of Cancer Prevention and Research, Noida, India

© The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 S. K. Yadav et al. (eds.), Clinical Laboratory Management, https://doi.org/10.1007/978-3-031-46420-1_1

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Screening Teaching and Research

Infecous disease epidemiology

Diagnosis

Medical Laboratory

Invesgaon of substance abuse

Disease Prognosis

Guidance for treatment Follow-up

Fig. 1.1  Various roles of a medical laboratory

Screening

Diagnosis

Screening is the application of laboratory techniques to healthy (asymptomatic) individuals to detect diseases before it becomes clinically apparent. The best example of this role of MLT is cervical cancer screening where the staining and screening of cervical smears done by a cytotechnologist help in the early detection of cervical cancer. Similarly, hemoglobin electrophoresis or high-performance liquid chromatography (HPLC), genetic testing, or non-invasive prenatal testing performed by laboratory technical personnel help in the detection of hemoglobinopathies during the antenatal period, thereby preventing the birth of a thalassemia major child.

The diagnostic role of medical laboratory technology is far-reaching and well accepted that is exemplified by hematological techniques, biochemical tests, and microbiology tests, fine needle aspiration cytology, histopathological techniques to name a few.

Disease Prognosis Once a diagnosis of a disease is made, prognostication of the disease, especially malignant disorders, is an essential aspect where clinicians rely on laboratory results. Hormone receptors and

1  Role of Medical Laboratory Technology in Health Care

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c-erbB2/Her2neu expression in breast cancer or BRAF mutations in thyroid tumors have become the standard practice in cancer management today.

tests and protocol biopsies, sometimes with special stains in post-transplant patients for early detection of graft rejection or graft-versus-host disease.

Guidance for Treatment

Evaluation of Substance Abuse

Treatment of diseases, both malignant and chronic non-malignant has come a long way over the last century. “Targeted therapy” for various cancers such as the use of imatinib for treatment of tumors expressing c-kit protooncogene, trastuzumab for Her2neu-positive breast cancers, crizotinib for ALK-positive tumors are just a few examples. The institution of such targeted therapies mandates confirmation of the target oncogene expression or a signature genetic change in the cancer cells using various sophisticated laboratory techniques. Similarly, enzyme replacement therapy for diseases such as Gaucher’s disease, glycogen storage diseases, lysosomal storage disorders, hemophilia, and others require laboratory confirmation of the absence of the specific enzyme or the factor. Hence, the science of targeted therapy or enzyme replacement therapy requires close coordination and valuable inputs from the medical laboratory.

Nowadays, laboratory techniques are being increasingly used in the evaluation of substance abuse. Laboratory tests to detect the use of banned substances such as lysergic acid diethylamide (LSD), amphetamine, and erythropoietin are routinely performed on athletes during qualifying rounds for various competitions. Critical jobs like aircraft pilots, armed forces on the war front, and medical professionals in critical areas of the profession among others are evaluated for use of alcohol prior to critical placements. Identification of cotinine in urine helps to identify tobacco use in an individual. Confirmation of the use of banned substances is also required in medico-legal cases and some legal processes. In the era of the ever-enlarging arena of health insurance as well as term insurance, there may be a requirement for testing of blood and urine for substance abuse. For example, some insurance firms offer their term insurance products only to non-smokers.

Follow-Up

Investigation and Surveillance The use of effective therapy has helped in pro- of an Epidemic longing the life span of a lot of patients. In chronic diseases, including cancer, there is a requirement for regular follow-up with various laboratory tests to detect relapse of the disease early enough to allow for further control. There are numerous laboratory markers that fulfill this role of medical laboratories such as lipid profile, blood sugar, HbA1c, etc. for non-communicable diseases and tumor markers such as ­prostate-­specific antigen (PSA), carcinoembryonic antigen (CEA), CA 19-9 for tumors of the prostate, colon, and ovary, respectively. Another instance of this role is the renal or liver function

Investigation and surveillance of an epidemic also require intensive use of medical laboratory technology, both basic tests and advanced investigations for identification of the causative organism and guide about the methods of control. The most recent instance of this role has been the COVID-19 epidemic where laboratorians played a significant role in identifying the causative organism, defining its characteristics, providing guidance on control measures on an individual and organizational level, and developing a vaccine for prevention of severe infection.

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Teaching and Training One of the less recognized roles of medical laboratory technologists is their contribution to teaching and training future laboratory technologists and passing on the tricks of the trade. In addition, the involvement of laboratory technologists in medical research cannot be overemphasized. For instance, vaccine development, the introduction of new diagnostic procedures, molecular genetics, and others require the assistance of these personnel for the success of these procedures. The following sections of this book intend to equip you with techniques and methods of running and managing your laboratory effectively,

efficiently, and to a considerable extent error-free so as to provide the best possible care to the patient.

Suggested Reading Seyoum H. Introduction to medical laboratory technology. Haramaya University; 2006. https://www.cartercenter. org/resources/pdfs/health/ephti/library/lecture_notes/ med_lab_tech_students/medicallabtechnology.pdf. U.S.  Bureau of Labor Statistics. Clinical laboratory technologists and technicians: occupational outlook handbook. https://www.bls.gov/ooh/healthcare/ clinical-­l aboratory-­t echnologists-­a nd-­t echnicians. htm.

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Overview of Laboratory Management Alekh Verma and Sompal Singh

Background A clinical laboratory is an organization that requires multiple components for its function (Fig. 2.1). These include staff, machine, money,

infrastructure, processes, material, supporting services, and information systems. Let us learn a bit about these components to understand the laboratory as an organization.

Fig. 2.1 Theoretical components required to run a clinical laboratory

Workforce Human Resource Informaon Systems

Supporng Services

Machine / Equipment

Medical Laboratory

Materials

Money

Infrastructure

Processes

A. Verma Kailash Hospital, Noida, India S. Singh (*) Department of Pathology, North Delhi Municipal Corporation Medical College and Hindu Rao Hospital, New Delhi, India © The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 S. K. Yadav et al. (eds.), Clinical Laboratory Management, https://doi.org/10.1007/978-3-031-46420-1_2

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Workforce The manpower employed in/for the laboratory is an extremely valuable asset of a laboratory that includes the combined skills, knowledge, and abilities of the laboratory personnel. Hence, the management of this asset is imperative for the success of any laboratory. We shall discuss further this asset/resource in chapters on Human Resource Management (Part II).

alent industry guidelines and taxation laws. The Accounting Principles are briefly explained in Chap. 11 of this book.

Infrastructure Infrastructure for an organization, including a clinical laboratory, includes the physical location and layout of the same.

Machines/Equipment

Physical Location

For performing the required tests and providing service to the patients, a laboratory requires various equipment. The accuracy and precision of such tests depend in large measure on the condition of the equipment used. Hence, knowledge about their procurement, maintenance, and calibration is imperative and we shall discuss these further in the chapter on Equipment Management (Chap. 16).

There are two facets of the role of money in a clinical laboratory:

The location of a laboratory may vary from being standalone to within the premises of a small clinic or a big hospital. When located within a hospital, the clinical laboratory should be located at a suitable location with easy access from the outpatient department as well as the emergency unit and the wards. At the same time, the location of the laboratory should not hamper the movements of other patients (not requiring the services of a laboratory) in the hospital. For a standalone laboratory, the location may be determined using appropriate management tools (center of gravity method, cost–profit volume analysis, point rating method, transportation method of linear programming, and so on).

Finance

Layout and Design

Money is the basic requirement for starting and running any laboratory. The required capital for a laboratory can be acquired in the form of equity (self/private/public) or in the form of debt. There are various advantages and disadvantages of either of these sources. Readers will get a better understanding of these concepts in Chap. 10.

The layout of a clinical laboratory needs careful consideration to ensure optimum functionality as well as comfort for the patients and the laboratory personnel. The various sections of the laboratory should be aligned keeping in mind the frequency of interaction of patients during the delivery of service. For instance, a reception desk at the front of the laboratory is desirable for any business, with a phlebotomy section adjacent to this, so that the patient may not need to traverse the laboratory for submitting a blood sample. The cabin of the customer care manager should also be as near to reception as possible. Within each room in the laboratory, equipment and furniture must be so arranged that the movement of techni-

Money

Accounts Once a laboratory is started, all the monetary transactions related to it need to be recorded, classified, compiled, summarized, and published (publicly if required) as per the relevant and prev-

2  Overview of Laboratory Management

cal persons and materials/reagents/samples is not interfered with or hampered. These topics are dealt with in more detail in Chap. 14.

Processes Considering the clinical significance of laboratory reports, the importance of standardization and calibration of the equipment, materials as well as testing procedures cannot be overemphasized. The best approach to achieve this is to prepare and make available a published document or standard operating procedure (SOP) that is updated regularly and accessible at all the locations of its need. Of equal importance is a combination of internal quality control or external quality assessment to assess and maintain the quality of laboratory services. The readers are referred to Parts V and VI of this book for details.

Materials A clinical laboratory uses numerous reagents and chemicals. Hence, material management/inventory management is an essential aspect of laboratory practice. Apart from guiding the laboratory personnel on what reagents are required according to the tests being performed, inventory management also provides answers to questions such as when to order, how much to order and classify reagents depending on the need. Procedures such as ABC analysis can be utilized for this purpose. Details of inventory management are available in Chap. 17.

Information System With the increasing use of information technology and the requirement of close interaction with the clinician, laboratory information systems (LIS) have become an indispensable part of a clinical laboratory (Chap. 33). A typical LIS allows for integration of clinical information, ordering laboratory tests with their tracking and

9

receiving the results. Sometimes general office applications like email, word processor, power point presentations, spreadsheet application are required.

 ocument Control and Record D Keeping Document control and record keeping in a clinical laboratory should be as per the current guidelines of the relevant accreditation body such as College of American Pathologists in USA, National Accreditation Board for Testing and Calibration Laboratories (NABL) in India, or United Kingdom Accreditation Service in UK. Though such accreditation may not be mandatory for a clinical laboratory, having this accreditation provides credibility to the processes followed and the results provided by the said laboratory. Kindly refer to Chap. 31 for further details on this topic.

Ethical and Legal Aspect Ethics and legal aspects are two inter-related but different concepts. Ethics is a positive concept that is voluntary and includes perception of the “right” and “wrong” of an action. Conversely, legal aspects are enforced by law and issues arise due to non-adherence or noncompliance. Patient consent and confidentiality of information are usually ethical aspects, though sometimes law such as Health Insurance Portability and Accountability Act (HIPAA) appliable in USA also covers this aspect, whereas malpractice and negligence are mostly legal in nature. These aspects are discussed in detail in Part VIII.

Laboratory Hazards A clinical laboratory is a multifaceted and huge organizational system. Irrespective of the size of the laboratory, all kinds of hazards like physical (fire, radiation, sharps, moving parts), electrical, chemical, and biological are possible. Efforts

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have to be made to prevent these hazards from happening. Some of these hazards such as the biological and fire hazards are covered under various laws of the land (Biomedical Waste (Management and Handling) Rules, 1998, Building Safety Act and Fire Act) and are mandatory to be adhered to (Chap. 35).

Supporting Services All the services required to run a clinical laboratory or organization cannot be and sometimes should not be integral to that organization. Some of the supporting services are better outsourced for the organization to function at its best capacity. For instance, housekeeping services, accounting services, electric and water supply,

telecommunication services, sample transport, and security services may be outsourced by larger organizations.

Suggested Reading Clinical & Laboratory Standards Institute. QMS18Ed2 | process management. 2nd ed. https://clsi.org/ standards/products/quality-­m anagement-­s ystems/ documents/qms18/. Mekonnen E.  Health laboratory management and quality assurance. Gondar University College; 2004. https://www.cartercenter.org/resources/pdfs/health/ ephti/library/lecture_notes/med_lab_tech_students/ healthlabmanagement_qa.pdf. Nigam PK, Kumar V, editors. Good clinical laboratory practices guidelines. 2nd ed. Indian Council of Medical Research; 2021. https://main.icmr.nic.in/sites/default/ files/upload_documents/GCLP_Guidelines_2020_ Final.pdf.

3

General Principles of Management Alekh Verma and Sompal Singh

 n Organization and Its Need A for Management You might wonder that a clinical laboratory only needs to know about the tests to be conducted and everything that is related to these tests. Why should management principles be applied to a clinical laboratory? We need to remember that the laboratory is also an organization. An organization has various interacting sub-sections with common objectives and goals (Fig. 3.1). An organization can be likened to a living being due to its various interactions within itself and its environment. However, unlike all living beings, it is an immortal entity unless the owners decide to shut down the organization. The various sub-divisions of an organization interact with

each other and some of its divisions also interact with the outside environment. The environment with which an organization interacts not only provides resources and opportunities to the organization but also imposes certain sanctions on the functioning of the organization. Hence, every organization needs to be able to understand and deal with the dynamic environment around it. To do so, the activities of an organization have to be managed (by a manager) and its employees need to be led (by a leader). There is a very subtle but extremely vital difference between a manager and a leader, that all of us should understand right at the beginning. Let us look at the basic principles of management that are applicable to any organization, including a clinical laboratory.

A. Verma Kailash Hospital, Noida, India S. Singh (*) Department of Pathology, North Delhi Municipal Corporation Medical College and Hindu Rao Hospital, New Delhi, India © The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 S. K. Yadav et al. (eds.), Clinical Laboratory Management, https://doi.org/10.1007/978-3-031-46420-1_3

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Legal

Political

Production

Human Resource Management

Procurement

Social

Cultural

Organization (Goal & Structures) Technology for research and development

Finance and accounts

Marketing management

Technological

Economic Environment

Fig. 3.1  Organization and its environment

Principles of Management Henry Fayol laid down 14 principles of management that may guide any organization, including a clinical laboratory (Fig. 3.2).

Specialization/Division of Labor Working in specialized divisions of a laboratory, as required, helps to provide more focus and efficiency and also leads to progressive enhancement of skills of a worker in a particular division. Not everybody needs to know or become proficient in every technique used in the laboratory. For

instance, molecular testing requires a special skill set that may not be needed by staff employed in the clinical pathology section.

Authority with Corresponding Responsibility If a person is given a particular responsibility, the same should be combined with the appropriate authority to enable him/her to discharge that responsibility effectively. Responsibility without corresponding authority becomes a burden, while authority lacking responsibility may lead to arrogance and anarchy in an organization.

3  General Principles of Management

13

Specializaon / division of labor

Authority with corresponding responsibility

Discipline

Unity in command

Unity of direcon

Subordinaon of individual interest to the general interest

Remuneraon of staff

Centralizaon

Scalar/ line of authority

Order

Equity

Stability of tenure

Iniave

Espirit de Crops

Fig. 3.2  Fayol’s principles of management

Discipline Adherence to the rules and values helps to prevent chaotic conditions and hence is essential for an organization to achieve its goal. This discipline should percolate downwards from the highest management of an organization or laboratory. It may be worthwhile to remind here to “lead by example.” Be disciplined to expect the same from your colleagues and staff.

Unity in Command This principle implies that a subordinate is instructed by one superior only so that there is no confusion or conflict in the instructions handed down by more than one superior. However, this may not be possible in an organization functioning with a matrix structure. A similar structure arises during the implementation of a new project. In a matrix structure, every effort should be undertaken to ensure clarity of instructions for the successful discharge of an individual’s duties. In the event that two different superiors have the authority to give instructions to the same person, both need to make sure that their instructions do not contradict each other and do not confuse the

staff who is responsible for working on those instructions.

Unity of Direction Every organization should ensure that each person in the organization works toward a common goal that is made clear to the employees at the time of their joining as well as reinforced at regular intervals.

 ubordination of Individual Interest S to the General Interest An employee must accord his/her first priority to the interest of the organization rather than the personal interest. Employees should be clearly conveyed that the organization’s success would ultimately translate into their own career advancement, while the vice versa may not be true.

Remuneration of Staff Compensation of the staff should be just and fair as per the individual work profile and skill set.

A. Verma and S. Singh

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This is vital to ensure that frustration does not creep in among the staff and their morale stays high to achieve the goals of the organization.

Centralization Central governance is essential for an organization. This principle states that the prime issues should be controlled centrally by the top hierarchy, while the operational day-to-day decisions may be decentralized for optimum efficiency. Laboratory managers need to strike a delicate balance between centralization and decentralization.

Scalar Chain/Line of Authority This principle implies that the chain of command from top to bottom must be explicit and clear to all the members of the organization. Any change in the line of authority should be readily communicated to all the staff members.

Order All required resources should be placed in an orderly fashion to be available at the right time and at the right place.

Initiative It is defined as an additional or new work activity undertaken by an employee through self-­ direction. The top management should undertake measures to encourage workers’ initiative for the organization’s progress. The organization should also institute appropriate mechanisms to reward appropriately for such initiatives.

Esprit de Corps Various employees of the organization should be encouraged to work in team spirit with healthy interpersonal relationships to make an organization a “single body.” Managers at every level should strive to deal with and mitigate every instance of interpersonal conflicts amicably (refer Chap. 9 on conflict management).

Management Skills The difference between a manager and a “good” manager is that the latter possesses certain skills to effectively run an organization. There are four skills that are expected from a good manager:

Technical Skills

Each and every employee of the organization must be treated equally irrespective of race, creed, caste, religion, or gender.

This is the most important skill required and implies proficiency in the specialized field that the individual is going to manage/supervise. For a clinical laboratory, managers may possess technical skills in medical science, medical laboratory technology, accounting, finance, etc.

Stability of Tenure

Human Skill

The tenure of an employee should be sufficiently long to promote a sense of loyalty to the organization. This is especially important for top management positions as well as for specialized tasks since the latter might require extensive training of the manpower.

An organization is an integrated network of human beings; hence managers must possess the requisite human skills to maintain good interpersonal relationships and ensure the smooth functioning of the human resources of an organization.

Equity

3  General Principles of Management

15

Top Level Management

Mid Level Management

Supervisory Management Skills

Fig. 3.3  Required mix of management skills at various levels of management

Concept Skill This skill is related to the ability of abstract thinking. Managers with good conceptual skills can visualize the organization as a whole “system.” Such managers can also understand the surrounding environment of the organization and related industries. Without conceptual skills, SWOT (strength, weakness, opportunities, and threats) analysis is not possible.

Design Skill This is a problem-solving skill that is routinely required in any organization. The proportion of requirement of these four skills may vary with the managerial levels. An indicative (but not definitive) matrix of the four skills is depicted in Fig. 3.3. • Top management level • Middle level • Superior Level As can be seen from Fig. 3.3, managers in the top management positions of a laboratory (administrators or owners) require more of human and conceptual skills than technical skills

since they may not be directly involved in the daily running of equipment or conduct of tests. Conversely, middle-level managers (usually pathologists/medical scientists) would need more technical skills than top management and a similar level of human skills. The line managers (laboratory supervisors/senior technical officers) require higher technical skillsets because they are the managers who take care of the day-to-day running of the laboratory. The design or problem-­ solving skills are required at every managerial level, albeit in varying forms from day-to-day routine problems at the level of line managers to business-level financial or survival problems in a competitive environment at the top management level.

Suggested Reading Carpenter M, Bauer T, Erdogan B.  Management principles (v. 1.0). https://2012books.lardbucket.org/pdfs/ management-­principles-­v1.0.pdf. Kaur N, Khunteta R. Principles and practices of management. Jaipur: Think Tanks Biyani Group of Colleges; 2012. http://gurukpo.com/Content/MBA/Principles_ and_Practices_of_Management.pdf. University of Minnesota Libraries Publishing. Principles of management. 2010. http://open.lib.umn.edu/ principlesmanagement/.

Part II Human Resource Management

4

Strategic Human Resource Management Alekh Verma and Sompal Singh

Human Resources as an Asset Human resource (HR) is a resource that constitutes all the employees working for an organization, irrespective of their rank and designation in the organization. HR plays a central role in the organization’s pursuit of its competitive advantage. HR is an asset to an organization in the sense that this is owned by the organization and has an exchange value meaning that the organization pays a value in exchange of the employee’s skills. As discussed earlier, this asset is the sum total of all employees’ knowledge, skills, experience, and competencies. HR as an asset differs from other assets of an organization. Usually, assets can be duplicated by competitors or would depreciate over time. HR asset cannot be easily duplicated by competitors and its value grows with time as employees gain experience and improve their knowledge, skills, and competence. HR asset is dynamic in that an organization’s employees can move to other organizations and vice versa. Though the expenditure on hiring and training HR may become a little high for an organization, the expense should

A. Verma Kailash Hospital, Noida, India

be considered as an investment rather than merely a cost to the organization since trained human resource serves to advance the cause of the organization. Human resource management (HRM) was earlier known as personnel management with a very limited scope, including managing employee records and training programs and assisting them with their job-related problems. Nowadays, HRM has evolved in many ways and is considered a vital strategic activity (strategic management) for any organization to succeed. Hence, in today’s world, HRM is the management of activities related to employees of an organization, including but not limited to recruitment, selection, training, development, performance management, and compensation. Unlike the approaches adopted in the 1970s, strategic HRM in today’s world entails a convergence of human resource management and business strategy and is proactively concerned with an organization’s effectiveness and performance. Strategic HRM ensures that the organization’s business needs are met together with the individual and collective needs of the employees. Since any organization has a life cycle, the human resource strategy should be designed and developed as per the phase of the cycle (Fig. 4.1) and aligned with its own business strategy (Table 4.1).

S. Singh (*) Department of Pathology, North Delhi Municipal Corporation Medical College and Hindu Rao Hospital, New Delhi, India © The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 S. K. Yadav et al. (eds.), Clinical Laboratory Management, https://doi.org/10.1007/978-3-031-46420-1_4

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• Focus on staff recruitment & commitment

Start-up

Growth

Decline • Control the cost of labor

• Focus on staff training and development

Maturity

• Focus on ra
onaliza
on of workforce

Fig. 4.1  Human resource strategies corresponding to the business life cycle Table 4.1  Human resource strategies corresponding to business strategies Porter’s business strategy Cost leadership

Differentiation

Focus

Focus and niche

Goal of strategy Focuses on reducing the cost to lower than the average in the market and increases the efficiency of the laboratory The products or services provided by a laboratory are either perceived to be different or are made different from the competitors—providing patient-centric services Involves taking care of the needs of a particular segment of the market

Focuses on existing customers with aggressive cross-selling of new products

Human resource strategy Hierarchical pay with very few incentives and limited training. The career path of the staff is narrow Pay is fair with many incentives. Extensive training is provided to the staff. The career path is broad

Payment, incentives, training, and career path are similar to the differentiation strategy. Since it focuses on a target population, hiring from personnel trained in the target market is adopted Similar to the focus strategy

As can be seen in Fig.  4.1, a business or an organization experiences four stages in its life cycle:

a time, the organization needs to rationalize the workforce to ensure a higher return on investment in human resources.

• Start-up phase: In this phase, the organization needs to focus on recruitment of appropriate staff that is competent and committed to the organizational goals. • Growth phase: Once the competent and committed staff are available, their training and development would be required to ensure competitive advantage and growth of the business or organization. • Maturity: When an organization has achieved a significant part of its growth in its respective sector, the focus changes toward control of the cost of labor in order to maximize profits. • Decline: In the absence of innovation or change or adaptation to environmental factors, an organization faces a decline phase. At such

An indicative approach to aligning the organizational HRM strategy with the business strategy adopted by the respective organization is provided in Table 4.1. Of course, the HRM strategy would have to be flexible for adjustments with the changing business scenario. There is no “one size fits all” for the HRM strategy and every laboratory needs to recognize and devise its own best strategy, keeping in mind that the strategy may evolve over time.

Basic Human Resource Activities The basic human resource activities to be undertaken in any organization are illustrated in Fig. 4.2.

4  Strategic Human Resource Management

21 Human resource planning Job analysis Recruitment Selecon

Promoon

Succession planning

Rerement

Inducon training

Compensaon (Aer job evaluaon)

Training and Development

Competency tesng (performance management)

Fig. 4.2  Basic human resource activities in an organization

Induction Whenever a new staff joins the team, they need to be informed about the organizational goals, vision and mission, terms and conditions of their employment, details of the job and expectations, laboratory hazards and safety measures, occupational health, and other facilities available to the staff.

Suggested Reading Itika J.  Fundamentals of human resource management: emerging experiences from Africa. Leiden: African Studies Centre; 2011. https://openaccess.leidenuniv.

nl/bitstream/handle/1887/22381/ASC-­0 75287668-­ 3030-­01.pdf. Porter ME. Competitive advantage: creating and sustaining superior performance. New York: Free Press; 1985. Republished with a new introduction, 1998. https:// www.hbs.edu/faculty/Pages/item.aspx?num=193. The Association of Business Executives. Human resource management. London; 2018. http://www.waljob. net/download/hrbook/Human%20Resource%20 Management.pdf. The Open University of Hong Kong. Human resource management. https://www.opentextbooks.org.hk/ system/files/export/32/32088/pdf/Human_Resource_ Management_32088.pdf. University of Minnesota Libraries Publishing. Human resource management. 2016.

5

Job Analysis and Job Evaluation Alekh Verma and Sompal Singh

Definition and Terminology Let us make ourselves familiar with the terminology to be used in this chapter. Task: A distinct work activity Duty: A combination of related tasks Responsibility: Obligation to perform a duty Position: The combination of duties and responsibilities of a person Job: A group of related positions Job family: A group of two or more similar jobs Contents of job: Duties, responsibilities, and performance standards of the job Context of job: The physical and personnel environment of the job including the work schedule Job description: The content plus context of the job Job specifications: The knowledge, skills, and abilities required to perform the job For an employee or workforce to do justice to their jobs, the most important prerequisite is a clear description of the job along with the

required skills and training for adequate fulfillment of the job. This is where the HRM component of job analysis comes in.

J ob Analysis and Job Evaluation— Are They the Same? As mentioned in Chap. 4, strategic HRM requires an understanding of the strategic plans of the business or organization or laboratory. In addition, there has to be a clear understanding of the job descriptions and job specifications of its employees. The two terms “job analysis” and “job evaluation” are often used interchangeably. However, the two terms differ in their actual meaning. Job analysis provides the job description and job specifications of the various levels of the workforce, while job evaluation entails a comparison of the relative value of various jobs in the organization for the decision on compensation (Fig.  5.1). The process of job analysis is described in Fig. 5.2.

A. Verma Kailash Hospital, Noida, India S. Singh (*) Department of Pathology, North Delhi Municipal Corporation Medical College and Hindu Rao Hospital, New Delhi, India © The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 S. K. Yadav et al. (eds.), Clinical Laboratory Management, https://doi.org/10.1007/978-3-031-46420-1_5

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A. Verma and S. Singh

24 Fig. 5.1  Job analysis versus job evaluation

Fig. 5.2  Steps of the process of job analysis

Step 1

Describe the purpose of job analysis Step 2

Review the organization chart and select the job that requires analysis Step 3

Data collection and check for accuracy

Step 4

Write the results (job description + job specifications)

Job Analysis There are various methods for data collection for job analysis, as detailed below:

Questionnaires A questionnaire, with subjective and objective questions related to the job, is given to the employees to answer at their convenient time. Some examples are the position analysis questionnaire (PAQ) that analyzes the job in dimensions like information input, mental processes, work output, inter-personal relationships, job context, and job-related variables; function job analysis; and management position description questionnaire. This method is efficient for organizations with a large number of people ­ occupying the same job, especially when they are geographically dispersed. However, the results are dependent on the quality of the questionnaire

used and the recollection and communication abilities of the job holders.

Interviews During a personal interview, unlike the questionnaire method, the interviewer can explain the questions to the employee and enquire about the activities and the knowledge and skills required for this job. This method is appropriate if only a few employees occupy a given job or if a survey instrument is being developed for a larger segment of employees. However, there are chances of interviewer bias in such an analysis and this method is costly because of the staff-intensiveness.

Observations Routine and repetitive jobs can be easily analyzed by observing the job holders going through

5  Job Analysis and Job Evaluation

their work. However, this method is open to observer bias and is unsuitable for knowledge-­ based jobs as well as to assess the decision-­ making and thinking. An additional disadvantage is the time and cost involved in this method. Observations may be done through work sampling, critical incident observation, or employee logs. In the employee logs, the job holder fills up the diary as and when a task is performed. However, there are chances of job holder’s bias as he/she may not enter the task that seems unimportant to him/her.

Computer-Based System These systems offer a database of statements that may describe the various tasks depending on the responses. These methods reduce the time required for job analysis and facilitate the decentralization of the process. Job analysis, though appearing mundane, is an important task for an organization. Defining the job description and specification helps the organization in planning the type of workforce required, guiding the recruitment and selection procedure, alerting for the need for training and development, decisions on health, safety, security, and career and succession planning.

Recent Advances in Job Analysis Nowadays, in addition to the job description and specifications, job-related competencies are also identified. Competency is defined as an attribute the employee must possess in order to perform the related jobs. These competencies are observable and measurable behaviors. For competency-­ based job analysis, a behavioral event interview is conducted. In this method, a team of senior managers identifies the critical performance areas, and a panel of knowledgeable individuals obtains examples of the expected job behaviors and the actual occurrences. A description of the job competency is developed along with the knowledge, skills, and abilities needed and the

25

identification of standards for performance evaluation.

Job Evaluation Job evaluation is a process of systematically analyzing various jobs to ascertain their relative worth in an organization. Through job evaluation, the jobs are categorized in order of their importance to the organization. This process ensures a remuneration structure that is fair, equitable, and consistent with the importance of the job to the organization, thereby minimizing the discrimination based on age, gender, etc. Job analysis does not take into account the individual qualities of the job holder or employee, since the analysis is linked to the job and not to the employee. Two goals are balanced by job evaluation: (1) internal equity, and (2) external competitiveness or external equity. The process of job evaluation allows transparency and fairness of pay in an organization, thereby achieving internal equity. An adequately conducted job evaluation also ensures that the pay structure in the organization is externally competitive and the employees perceive their job as being similar in functions and pay structure to a job in a competitive organization. This, indirectly, would have a bearing on the potentiality of efflux of trained manpower from the organization. If the employees of an organization are satisfied with the fairness of the pay structure, they are unlikely to leave the organization to join a competitor. Hence, this process of job evaluation provides a vital competitive advantage to the organization.

Job Evaluation Process One of the key criteria for job evaluation is the value added by the job to the organization. Although job evaluation starts with laying down of its objectives, it should be preceded by job analysis (to get job description and job specificities). The process of job evaluation includes defining the objectives of this process, adopting

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Define objecves of job evaluaon

Job descripon & specificaon from job

Plan the Job evaluaon and select method

Conduct a wage survey

Classify the jobs as per importance

Fig. 5.3  Job evaluation process

the required method (that would be described in the following section), delineating the job structure, and conducting a wage survey (Fig. 5.3).

Job Evaluation Methods There are four methods for performing a job evaluation that can be categorized as analytical/quantitative and non-analytical/qualitative (Fig. 5.4). The qualitative methods are faster and more cost-effective, but the quantitative methods are more objective taking into account the skills and responsibilities of a job. We shall discuss these methods briefly.

Fig. 5.4  Methods of job evaluation

Point Method This is a widely used method of job evaluation involving a detailed analytical approach. An illustrative example of the point system of job evaluation is given below (Table 5.1). The method essentially uses the following steps:

1. Step 1: Selection of compensable and critical job factors (with sub-factors, if any) 2. Step 2: Assigning weights to each factor 3. Step 3: Construction of degrees for each This method starts with the recognition of some factor key jobs followed by selection of factors such as 4. Step 4: Assignment of points to each degree knowledge and skills, communication, decision-­ 5. Step 5: After this, the total points are calcumaking, impact, working environment, etc. for lated for each job. For example, job A 700 the jobs to be evaluated. Each of the factors of a points; job B 420 points; job C 250 points. job is then compared with the same factor of the 6. Step 6: After this market salary summary is key job followed by ranking of each factor. The done to find the pay of each job. For example, work of job is then obtained by adding together job A 1,20,000 INR, job B 80,000 INR, job C all the values for a particular job. This method is 40,000 INR. objective, systematic, and flexible compared to 7. Step 7: A regression analysis is done with other methods. Since only a few factors with reltotal points as independent variable and salary evance to the job performance are used, the as dependent (outcome) variable. chances of overlapping and overweighting of the 8. Step 8: Hence, to calculate salary of a new job factors are considerably reduced. However, this (job X) with total point of 630 salary is calcuis a time-consuming and expensive method. The lated as limited number of factors considered for the eval uation may sometimes lead to the evaluators Salary = Intercept + Slope × Total Points ( 630 ) ignoring some factors that may be vital for performance of a given job.

 actor Comparison or Key Job F Method

27

5  Job Analysis and Job Evaluation Table 5.1  Overview of point system Job factor

Weight 25

Degree of factor 1 2 10 15

Judgment and decision-making Independent judgment Education Responsibility Accountability Physical effort Working conditions

3 30

4 60

5 100

21 18 15 12 6 3

5 25 13 10 21 5

30 50 67 45 89 40

100 80

120

75

90

where Intercept and slopes are calculated from regression analysis. The point method of job evaluation is the most comprehensive and accurate method of job evaluation where prejudice and human judgment are minimized. However, this is time-consuming and expensive and may not be suitable for managerial jobs where the factors of a job cannot be measured quantitatively.

Ranking Method In this method, each job is compared with others in pairs and from each pair, the most impactful job is ranked. Through this method, the place of the job is determined (paired comparison method, Table  5.2). The process is performed twice or thrice to improve reliability. Ranking is the simplest and most easily understandable method consuming very less time. However, this approach can only be applied in organizations with fewer than 100 jobs. Since this is qualitative, personal bias of the evaluators may affect the process and the real difference between two jobs is not specified.

J ob Grading or Job Classification Method A job grade or class is a group of jobs with similar difficulty levels or skills required—an infor-

9 40 54 23 24 19

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Table 5.2  Overview of ranking system Job A Job B Job C

Job A – 1 2

Job B 4 – 2

Job C 4 1 –

Total 8 2 4

Rank 1 3 2

mation that is obtained from job analysis. The jobs in an organization are mapped to the most appropriate grade and wages are fixed for every grade of jobs. In this method, a detailed analysis of job factors is not done. This method is easy, simple, and economical for small organizations and government jobs. However, this method is not suitable for complex jobs that are unlikely to fit into one grade and is rarely used in the industry. This method is also influenced by the personal bias of the job evaluators. Apart from the factors considered in the quantitative methods of job evaluation, individual jobs may have certain factors that have a bearing on the wage and compensation. Such factors include: 1. Market comparison 2. Profit share 3. Company performance 4. Length of service 5. Job size 6. Individual performance 7. Internal relativity 8. Market positioning 9. Department performance 10. Pay heritage

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Job Evaluation Committee An organization is required to constitute a committee for the purpose of job evaluation. The chairman of such a committee should ideally be an individual who specializes in human resource management. The other members may include senior executive of the organization, head of the various departments, representatives of the employee union, and specialists from national and regional bodies. The committee should strive to evaluate the job positions in the organization in an impartial and objective manner while maintaining confidentiality of all matters pertaining to the process. The terms of reference of such a committee should be defined prior to the ­committee undertaking the job evaluation process. The committee should communicate only with the human resources department and not with the individual staff members of the organization.

In conclusion, job evaluation ensures transparency between the employee and the employer based on the organized framework for payment and grading. It gives a fairly good chance of equal value protection and allows comparison between two different jobs. For the employees, it provides a clear pathway for his/her further development. Sometimes, it enables to identify and tackle anomalies in case if there are any. Hence, job evaluation is a procedure that all managers should be prepared to perform in their organization.

Suggested Reading Herndon JS.  Job analysis and job evaluation method choice: user qualifications and implications for applications and research. Old Dominion University; 1986. . https://digitalcommons.odu.edu/psychology_ etds/279. https://doi.org/10.25777/xvfs-­8b13.

6

Recruitment and Selection Ruchika Gupta and Sompal Singh

Background

Recruitment

As we have learnt in Chap. 4, human resources or workforce is one of the vital assets of any organization, including a clinical laboratory. Hence, it is obvious that the process of recruiting staff in a laboratory has to be given due consideration. Let us first learn about some terms that are often used interchangeably and are closely related:

The process of searching for potential employees and encouraging them to apply for a given job in your organization is not an easy task. There are several steps involved in this process, as described below (Fig. 6.1).

• Staffing is the process of finding, attracting, and finally hiring new employees in an organization. • Recruitment is the name given to the process of discovering potential candidates for a given position and thus generating a pool of qualified applicants. • Selection involves gathering pertinent information about the applicants to a given job and appropriately using the information for making hiring decisions. Staffing includes both recruitment and selection processes. We shall now discuss both the processes in some detail. R. Gupta Division of Cytopathology, ICMR-National Institute of Cancer Prevention and Research, Noida, India S. Singh (*) Department of Pathology, North Delhi Municipal Corporation Medical College and Hindu Rao Hospital, New Delhi, India

Sources of Recruitment The sources for recruitment during the hiring process may be:

Internal to the Organization Potential employees may be found for promotion or demotion or transfer from one department or branch office to another. Sometimes, re-­ employment of retired or retrenched employees or the dependents of deceased employees may be undertaken, especially in public sector organizations. The methods that may be applied in this case include disseminating the information about the available job through the organizational databases, posting the job and allowing bidding for the same, informal methods of information spreading, and “inside moonlighting” meaning that current employees are allowed to take up additional job positions after the work hours of the current job in the same organization.

© The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 S. K. Yadav et al. (eds.), Clinical Laboratory Management, https://doi.org/10.1007/978-3-031-46420-1_6

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Analyze the job requirements Job Analysis

Human Resource Planning Number of staff, when they have to join, etc.

Define the sources of recruitment

Contact the sources

Fig. 6.1  Steps involved in the recruitment process

External to the Organization External sources may become essential when the organization looks to expand its current workforce or has to fill its entry-level positions for which the internal sources do not apply or require a skillset that is not available with the current employees or sometimes, to infuse new and fresh ideas in the organization. For recruitment from external sources, the methods available to the HR team include: • Direct applicants • Referrals and recommendations from the current employees • Sending information to professional bodies for prospective applicants • Advertising through employment agencies • Campus placements • Advertisements in print and electronic media

 ovel Approaches to Recruitment N • Employer branding: Branding message about the organization’s reputation as an employer, its mission, values, culture, and workplace experiences in order to attract new talent and retain the existing ones. • Special recruiting events such as job fairs • Competitive recruitment method • E-recruitment through social media, job placement websites, professional websites, etc. At the end of the recruitment process, the organization would have a pool of potential personnel to choose from. So, the next step is the “selection” process that we describe below.

Selection Once the recruitment process has generated a pool of candidates, the selection process goes ahead with choosing the most appropriate candidate for the given job. In this sense, selection is a predictive process where a prediction is made about the candidate who would be the most suitable for the job by gathering information about the various applicants. While recruitment is a “positive” process in that you add prospective candidates to the pool, selection is a “negative” process since there would be rejection of the unsuitable candidates. The selection process also includes various steps, as described below in Fig. 6.2.

Employment Interview Interviews conducted during the selection process may be unstructured or structured.

Unstructured Interview In the unstructured interview, the interviewee sets the pace and direction of the interview since the interviewer does not start the interview with a specific agenda. In this format, the questions are generally open-ended and can be tailored as per the skills and experience mentioned by the applicant in his/her application. However, the lack of structure and uniformity of the questions make it difficult to compare and rank the applicants.

6  Recruitment and Selection

Application by the candidate

31

Preliminary interview (eliminates unqualified candidates)

Check of references and recommendations

Employment test (Aptitude, Personality, Ability)

Medical examination

Work sampling (to identify and verify vital skills required for the job)

Final Selection Decision

Fig. 6.2  Steps involved in the selection process

The selection process may be approached in one of the following ways: •

•

•

•

Fig. 6.3  Types of questions in the selection process

Structured Interview Structured interviews have a defined set of questions that help to assess the applicants for the specific skills required for the given job. In this type of interview, the predetermined order of questions may or may not be adhered to. The interviews may be conducted in the following ways: Direct one-to-one interview: This is the most traditional method of selection interview that may be held in an unstructured or structured manner. Sequential interview: Sometimes, multiple interviews are conducted in a sequential manner with increasing hierarchy of the interviewer. Panel interview: In this method, the interview is conducted by a panel that generally includes four to five interviewers. One person in the panel usually serves as the leader. A properly conducted panel interview helps to unearth a better and more complete picture of the candidate’s knowledge, skills, and experience. For the interviews, the focus of the questions may be (Fig. 6.3): • Behavioral • Competency-based • Situational

• Multiple hurdle approach: Here, the steps in the selection process are carried out in sequential manner so that the potential candidates are supposed to cross these hurdles one by one. At every step, the unsuccessful candidates are eliminated from the process. • Compensatory approach: The steps of the selection process are conducted simultaneously, and one aspect or skill of the applicant may compensate for another. • Combined approach • Computer-aided selection approach • Decision-support system

Staffing Staffing is also known as personnel management, or personnel function. As mentioned earlier, staffing is the process that includes both recruitment (section “Recruitment”) and selection (section “Selection”). There are a number of factors that affect staffing in an organization (Fig. 6.4). Staffing may appear to be a relatively easy process to hire the appropriate people in your organization. Recruiters should be aware of the few challenges, some of which have remained the same and others evolve with the socio-politico-­ economic conditions of the region or the country that your organization operates in. 1. Employee turnover related to the changes in the economic contracts between the employer and the employee. The economic terms of hir-

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External factors • Labor market conditions • Socio-cultural • Government regulations and legal factors

Internal factors • Organizational size, policies, image, goodwill • Attractiveness of the job • Changes in employee roles

Fig. 6.4  Factors affecting staffing in an organization

ing are bound to change over time with changes in the political environment, especially for the jobs in the public sector. 2. Difficulties in retaining skilled employees: Personnel who acquire and hone their skills over time become a valued asset and sought after by other similar organizations. In such situations, it might be a little difficult to retain them unless the job in the present organization offers an advantage that others do not. 3. Slow process of hiring: If the organization spends more than 2–4 weeks completing the hiring process, there is a risk of losing the appropriate candidates to other similar hirers. Hence, the hiring process should be organized, fast-tracked, and transparent. 4. Purposefulness of the job: The new-age employees look for purpose in addition to the remuneration in their jobs. Hence, the recruiters should attempt to assign some meaning to the respective jobs to extend a feeling to the prospective candidates that they are not doing just menial jobs. When employees feel that

they are providing some meaning to the organization, they tend to stay. 5. Diversity and inclusivity: In recent times, the social and political environment and certain regulatory conditions stipulate that organizations have to ensure compliance with the diversity and inclusivity in their hiring process. A number of organizations are using alternative methods to create their workforce, such as: • Independent contractors or consultants • Staff leasing or outsourcing, for example housekeeping or security services are commonly outsourced to other agencies. • Hiring from non-traditional labor pool such as retired personnel, former defense personnel, etc. • Offering internships

Suggested Reading Gatewood RD, Feild HS, Barrick MR.  Human resource selection. Illustrated ed. Wessex: Incorporated; 2018. Goldstein HW, Pulakos ED, Semedo C, Passmore J, editors. The Wiley Blackwell handbook of the psychology of recruitment, selection and employee retention. Wiley-Blackwell handbooks in organizational psychology. Wiley; 2017. Nikolaou I, Oostrom JK, editors. Employee recruitment, selection, and assessment: contemporary issues for theory and practice. Illustrated ed. Current issues in work and organizational psychology. Psychology Press; 2015. Picardi CA.  Recruitment and selection: strategies for workforce planning & assessment. Sage; 2019. Roberts G.  Recruitment and selection: developing practice. Illustrated, reprint ed. CIPD Publishing; 1997.

7

Performance Management Alekh Verma and Sompal Singh

Background Performance appraisal is employed by all organizations as a human resource (HR)-driven approach for a systematic evaluation of the employees’ performance. An appraisal assesses an employee’s performance with respect to their past performance and its alignment with the organization’s goals and vision. The process of appraisal usually does not help the employee develop a strategy for future growth. In contrast to this, performance management is an integrated process that starts with goal setting, employee development, and appraisal of performance and concludes with feedback and rewards. In performance management, the managers work with their employees or subordinates to define the goals for the latter linked with the organization’s strategic goals, develop their capabilities through training, and then measure and review employee performance. Hence, performance management has two broad objectives: evaluation (for rewarding) and development (for feedback for training and development needs). To fulfill these two

A. Verma Kailash Hospital, Noida, India S. Singh (*) Department of Pathology, North Delhi Municipal Corporation Medical College and Hindu Rao Hospital, New Delhi, India

objectives, performance management is intended as a continuous process of planning, guiding, and reviewing an employee’s performance.

Process of Performance Management The steps involved in this process are depicted in Fig. 7.1 and discussed in detail in the following sections.

Step 1: Goal Setting Each employee’s goals should align with the organization’s strategic goals. For this step, the superiors work with the concerned employee to set his/her role in the organization and identify the employee’s development needs. A concept of “line of sight” objectives may be utilized for this purpose. For instance, if the laboratory’s goal is 10% revenue increase in the following year, each staff should be able to define their own objective which could range from developing a new test to enhancing testing capacity or visiting new avenues for customers or improving the efficiency of equipment in the laboratory. This step defines the performance standards which should be clearly communicated to the employee. These standards/ goals should be “SMART” (specific, measurable, achievable, realistic, and time-bound).

© The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 S. K. Yadav et al. (eds.), Clinical Laboratory Management, https://doi.org/10.1007/978-3-031-46420-1_7

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34 Fig. 7.1  Steps of performance management Setting the goal and expectations

Establish evaluation criteria

Define the source of appraisal

Method of performance evaluation

Communicate the evaluation

source approach (360° appraisal) to the appraisal is preferred since different people witness different facets of an employee’s performance.

Fig. 7.2  Various dimensions of job performance

 tep 2: Establishment of Evaluation S Criteria This step is also known as “dimensions of job performance.” These are the criteria on which the employee’s performance will be evaluated. These criteria may depend on whether there is a tangible output, or this is routine or knowledge-based or highly dependent on behavior and may be classified into: • Trait-based • Behavior-based • Result-based These evaluation criteria are explained in Fig. 7.2. It is imperative for the superior and the employee both to be clear regarding these criteria and there are no unsaid assumptions on either side.

Step 3: Source of Appraisal The source of appraisal refers to the manager who is authorized to conduct the performance appraisal. An employee’s appraisal may be performed by a superior/manager, by the employee himself/herself, by the subordinate (upward appraisal), by peers or the team, or by the customer. A multi-

 tep 4: Methods of Performance S Appraisal The method for performance appraisal may be selected depending on the evaluation criteria as identified in Step 2 of this procedure. The method may use trait-based, behavior-based, or result-­ based criteria. A few of the methods of performance appraisal are explained later in this chapter.

Step 5: Communication of Appraisal It is also known as an “appraisal interview.” This is the most important step of performance management and must be dealt with carefully. The feedback should be ongoing rather than onetime, and the communication should be done soon after the end of the appraisal period. Managers should ensure that the appraisal interview is focused on the performance problem and not on the employee, hence the individual’s selfesteem should not be attacked in any way. The discussion should be held in a location that offers privacy. The manager should make all attempts to speak in a non-threatening tone calmly in a non-­ judgmental manner and provide specific instances of undesirable behavior of the employee along with the impact of such behavior on the organization and the individual’s colleagues. If required, two separate interviews may be held—first one for the purpose of evaluation and the other to discuss the development/ improvement strategies.

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There may be three ways of communicating the appraisal:

 ell and Sell Approach T A one-way communication where the manager communicates the appraisal and the required actions for improvements. The employee does not have any say in the whole process. This usually leads to reduced motivation and eliciting of defensiveness on the part of the employee.  ell and Listen Approach T A two-way communication in which the employee is allowed to express his/her thoughts about the appraisal information as well as the suggested actions. However, the employee’s feelings do not change the appraisal or the change action plan. The opportunity to express their feelings leads to lower defensiveness in the employees. Mutual Problem-Solving The manager acts as a helper to encourage the employee in self-evaluation of performance and formulating an action plan for improvement. This technique of appraisal communication lowers the defensiveness and provides an avenue for improvement of employee–manager relationships. The method employed to communicate appraisals may depend on the maturity level of the employees and the human skills of the manager.

Methods of Performance Appraisal The methods of performance appraisal can be classified into three categories: trait-based, behavior-based, and result-based approaches (Fig. 7.3). Let us discuss some of these methods.

Trait-Based Methods  raphic Rating Scale G This is a traditional yet popular method of appraising the performance of employees. In this method, the desirable traits are listed, and rating

Fig. 7.3  Various methods of performance appraisal

is decided on a numbered scale that could be discrete (specific response such as “unlikely,” “hard to say,” “likely”) or continuous (two extreme values at either end). This method of appraisal is used by customer service helplines or similar services and every one of us must have provided an appraisal once in a while on such a scale. This method is easy to understand and execute. However, it is prone to subjectivity in the interpretation of the scale, personal bias, and does not allow for assessing the individual employees’ strengths and weaknesses.

 orced Choice Method F As the name suggests, the performance reviewer is required to make a choice out of dichotomous options for descriptive statements about the employee. Though this method attempts to avoid reviewers’ bias by getting some standardization, the forced choice does not allow the reviewer to expand on his/her opinion about the employee or discuss circumstantial evidence of certain situations. This method assumes that aspects of the employees’ performance are binary in nature, which they are not, and this is the reason that the forced choice method is not preferred in today’s world. Essay Method This is a “free form” method where the managers are required to answer open-ended questions on employees’ performance. This might appear to be a good method since it provides the manager with the opportunity to expand on his/her observations about the employees’ performance. However, this method makes it difficult for the HR department to compare the employees with each other. Since there are open-ended questions, the ability of the manager as a writer has a bearing on the appraisal.

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Ranking Method Here, all the employees are ranked in order of their performance. This method is commonly used in medium and small-sized organizations especially when employee awards or cost-cutting are under consideration. However, the relative nature of this method masks the low-performing employees under a manager. Also, there could be animosity among employees that would be unhealthy for the company.

A. Verma and S. Singh

nique appears to be better than the checklist method. However, there can be subjectivity in assigning the weights.

 ehavior-Anchored Rating Scale B (BARS) This method combines the rating scale and critical incident methods. In this method, critical incidents depicting effective and ineffective behavior are listed and edited into a common format with removal of redundancy. This is followed by rating of these incidents on a scale of Forced Distribution Method Employees in a workgroup are assessed on pre-­ one to nine and 6–7 such incidents are finally determined parameters and “distributing the used to create BARS. This method offers mulemployees on all points on the scale.” This tiple advantages such as clear standards, accumethod does not allow for performance outside rate analysis, consistent evaluation with the distribution scale. The “worst” performer is elimination of variance and reducing bias. punished even if the whole team may be an Hence, BARS is considered to be suitable for organizations of all sizes and can be used for exceptional performer. the entire workforce from entry level to top executives. However, this method is time-consuming and demanding for the managers, makBehavior-Based Methods ing it hard to make decisions about compensation and promotions. Critical Incident Method In this method, the manager maintains a record of “critical incidents” that may be favorable or unfavorable. These events are then recollected during Result-Based Methods the appraisal process. One limitation of this method is that regular work with constant output Productivity-Based Approach in the absence of critical incidents is not rewarded. This method is suitable for jobs where productivity is vital. In this approach, a minimum standard Hence, this method is rarely utilized now. is set, and the employee’s performance is evaluated against this standard. This method is suitable Checklist Method The managers are provided with a checklist hav- for long-term evaluation. However, the disadvaning questions with “yes” or “no” or “multiple tages of this method include no allowance for choice” type of answers. There could also be deviation of performance, and no rating for facsome statements that the managers have to assess tors such as team spirit or communication skills. and agree. Though this method is the least time-­ consuming, there is a lack of subjectivity and an Management by Objectives (MBO) inherent inability of the questionnaire to evaluate This approach, proposed in 1954 by Peter Drucker, involves the establishment of perforan employee’s tasks in a corporate setting. mance objectives by the employees themselves. This is a participative approach where the manWeighted Checklist Method This method is similar to the checklist method ager and the employee develop the objectives and with the addition that weights are given to the also review the progress together that allows for questions that could be equal or some questions modifications in the original objectives, if may receive more weight than others. This tech- required. For this approach to work effectively,

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the objectives that are set should be SMART. The objectives are designed in a cascading manner such that if the employees, managers, and ­departments achieve their respective objectives, the organization’s goal shall be met. As evident, this method has a lot of advantages such as self-­ motivation, better communication, clarity of the 2. goals and objectives with higher commitment, and alignment of individual objectives with the organization’s goals. As exciting as this sounds, MBO method suffers from certain demerits: overemphasis on goal setting rather than working out a plan to achieve them, ignoring the role of the environment or context when the goal was set, and comparison of the employee with the concept of an “ideal” employee. If this method is used improperly, unethical behavior by self-­ thinking employees to show achievement of targets falsely.

Competence Assessment The competence of the laboratory staff should be evaluated on a periodic basis. On the basis of this assessment, training and retraining may be scheduled to enhance the technical knowledge and skills required for the job.

I ssues and Problems in Performance Management Performance management, though a vital step in human resource management, can potentially be riddled with certain problems. 1. Ambivalence: There may be ambivalence on the part of the manager or the appraisee that hinders the process of performance management. The manager might not feel comfortable communicating negative feedback about an employee’s performance since he/she has to continue working with that individual in the future as well. This would hinder the manager’s participation in discussions about actions to improve an employee’s performance.

Conversely, the employee may exhibit ambivalence in the want for an objective view of performance but lack of acceptance of negative feedback leading to a defensive attitude and refusal to look for ways of self-improvement. Bias: Rater-based errors and biases such as variation of standards to assess different employees, recency effect (memory of a recent mistake by the appraisee), primacy effect (memory of an exceptional job done by the appraisee), central tendency error (rating all employees around the center of the bell curve), personal bias, halo effect (one criterion influences another criterion), contrast error (comparison with an exceptional appraisee), and some more sources of errors may creep in if the managers are not trained well enough in how to use the performance appraisal system.

Hence, to have an effective performance management system in an organization, the following points need to be kept in mind: 1. Try and conduct separate appraisals for evaluation and development of the employees. 2. Use job-related criteria for performance. Subjective criteria may be used only if they are clearly related to the job under evaluation. 3. Specify the performance standards to be applied uniformly to all employees in that workgroup or team and make sure that the same is understood by the employees. 4. Use appropriate data on performance with specific instances of negative or positive feedback. 5. Improve the supervisor–subordinate relationship for effective communication and avoid defensive nature of the employees during the appraisal process. 6. Provide ongoing feedback in a timely fashion with opportunities to the employee for improvement. 7. Multi-faceted appraisal may be better than a single-rater-based evaluation.

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8. Train the appraisers in the conduct of the appraisal and the criteria, standards, and benchmarks to be used. 9. Keep an appeal process in place to give an opportunity to the employees to discuss their disagreement with the appraisal provided to them. Refer to ISO 15189:2022 clause: 6.2.2, 6.2.4

Suggested Reading Cadwell CM. Performance management. AMACOM Div American Mgmt Assn; 2002. Smither JW, London M, editors. Performance management: putting research into action. J-B SIOP Professional Practice Series. Wiley; 2009.

8

Staff Scheduling Ruchika Gupta and Sompal Singh

Background

Scheduling Methods

So, you have performed job analysis, job evaluation, recruitment, and selection of the appropriate personnel in the laboratory. Now comes the time to schedule your staff’s workplan. In the usual sense, “scheduling” is a term from operations management and refers to the planning stage just prior to the production in manufacturing industries. The objectives of the stage of scheduling include:

For a clinical laboratory, the scheduling shall depend on the working hours which could vary from 8–10 h to 24 h. The majority of the laboratories function all 7 days of the week, and hence scheduling needs to be done keeping in mind that every member of staff would require some time off. The schedule may assume one or more of the following types:

• Ensuring that the due date of delivery of service/product is met. • Minimize the need for overtime by the staff. • Minimize the idle time of staff or equipment. • Minimize the cost of production or service, thereby maximizing profits. In this chapter, the focus shall be on staff scheduling that refers to the process of creating and managing a schedule of duty hours for the day or week among the various levels of staff so as to ensure completion of every task in the most optimal manner. R. Gupta Division of Cytopathology, ICMR-National Institute of Cancer Prevention and Research, Noida, India

Full-Time This schedule is for employees working on full-­ time or regular payroll, thus putting in about 35–40 h per week. For instance, consultants in a laboratory usually work on a regular payroll and work during routine office hours.

Part-Time This schedule is for employees who have been hired as part-time employees. Such employees usually work fixed hours during the week or as per their conditions of hiring.

S. Singh (*) Department of Pathology, North Delhi Municipal Corporation Medical College and Hindu Rao Hospital, New Delhi, India © The Author(s), under exclusive license to Springer Nature Switzerland AG 2023 S. K. Yadav et al. (eds.), Clinical Laboratory Management, https://doi.org/10.1007/978-3-031-46420-1_8

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Shift-Based This schedule is the best for laboratories that work 24  h a day, 7  days a week. Usually, the schedule consists of three shifts—morning, evening, and night. The timings of the shift may vary from country to country.

Seasonal This schedule may be followed in countries that witness extremes of weather conditions during the year, forcing the employers to modify the work timings accordingly. Such a schedule may follow full-time, part-time, or shift-based patterns.

Rotating This schedule pertains to shift-based work. This differs from shift-based schedule in a small fact—the rotating schedule follows a predefined pattern for the shifts of the employees.

On-Call Such a schedule involves that the employee be available and be able to reach the laboratory when needed.

Pre-requisites of a Good Schedule How would we know that the schedule prepared is good? In a laboratory, a schedule is considered good if both of the following conditions are met:

1. Each of the shifts in the laboratory must be staffed appropriately so that all the tests being performed in that particular shift can be conducted and are not carried over to the next shift. 2. The schedule should be free from errors. The common errors include scheduling the same staff in consecutive shifts or missing the duty-­off for staff on night duty or similar slipups. The aforementioned pre-requisites might appear very simple but the person or manager in-­charge of preparing the schedule in a laboratory is usually burdened with multiple documents that need to be consulted at the same time—such as timetables, availability calendars, employee requests for specific shifts or leave requests or time-off, etc. In view of the complexity of the task of scheduling, the person incharge may have to dedicate days or sometimes weeks to develop, edit, and finalize the schedule.

How to Prepare a Good Schedule? For a manager or the person in-charge, preparing a good schedule that fulfills the two criteria mentioned above requires the following steps to be followed: • • • •

Know your team well Understand their work preferences Prepare and publish the schedule in advance Be prepared for exigencies and have alternatives ready. These steps are depicted in detail in Fig. 8.1.

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Know your team

Work preferences

Prepare & publish

• List of names of staff with Contact information • Roles in the laboratory • Relevant skills & certifications • Status of employment and Overtime restrictions

• Allow employees to communicate their respective preferences • Prior information of leave, days off • Include one or two of the best employees in each shift, if possible

• Publish the schedule on time • Make the schedule easily accessible • Ask employees to suggest their substitutes for availing leave on the designated duty day

Be prepared for exigencies • Prepare a Plan B with availability chart of the other employees (should remain confidential) • May consider sharing an incomplete schedule for the employees to fill in

Fig. 8.1  Steps to prepare a staff schedule

Scheduling Approach

First Come First Serve Approach

The laboratory staff schedule may be prepared using the following approaches:

In this approach, employees who approach first with their specific requests regarding the schedule are given preference, provided that the conditions of a good schedule are being met.

Heuristic Approach This term literally means “rules of thumb” whereby practical experience guides the “quick fix.” In this approach, the schedule is prepared by a hit-and-miss method.

Linear Programming Approach This approach is a computer-assisted scheduling process. An example of the same is provided in Text Box 8.1.

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Text Box 8.1 Python Code for Linear Programming Based Approach for Scheduling

#n: Number of days for which the schedule has to be prepared #m: Number of employees #level[j]: The level of each employee #!pip install PuLP from pulp import * import numpy as np days = 31 employees = 5 min_resource_constrain = [1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1,1 ,1,1,1,1,1,1,1,1,1,1,1,1,1] # We need atleast 1 employee in each shift level = [1,1,1,1,1] # In this example we have five employees each of same level # Generate variables which represent each members attends or not. var_M = pulp.LpVariable.dicts('Morning', (range(days), range(employees)), 0, 1, 'Binary') var_E = pulp.LpVariable.dicts('Evening', (range(days), range(employees)), 0, 1, 'Binary') var_L = pulp.LpVariable.dicts('Leave', (range(days), range(employees)), 0, 1, 'Binary') obj = None for i in range(days): for j in range(employees): obj += (level[j] * var_M[i][j]) + (level[j] * var_E[i][j]) # + var_L[i][j] problem = pulp.LpProblem('shift', LpMaximize) problem += obj # Each employee should work at most one shift per day. for i in range(days): for j in range(employees): c = None c += var_M[i][j] + var_E[i][j] + var_L[i][j] problem += c == 1 #Minimum resource constraint for i in range(0, days): c = None d = None for j in range(employees): c += level[j] * var_M[i][j] d += level[j] * var_E[i][j] problem += c >= min_resource_constrain[i] problem += d >= min_resource_constrain[i] # Each employee should work same shift the next day. for j in range(employees):

8  Staff Scheduling

for i in range(days - 1): c = None c += var_M[i][j] + var_E[i+1][j] problem += c