Acknowledgement

The training module on “Management Requirements for a Laboratory Quality

Management System” has been developed by the Labs for Life Project under the
Ministry of Health and Family Welfare, Government of India for highlighting the
importance and role of management in a quality management system in medical
laboratories in India. The module has been arranged as per the clause 4 of ISO15189.

Dr. Anu George and the entire Labs for Life Project team are duly acknowledged for
their continuing efforts in the development of training modules for the capacity building
of public health laboratories.

The efforts by Ms. Niharika Mishra, QMS Consultant is duly acknowledged for her
contribution towards the development of this module.

The valuable contributions by various technical experts from reputed institutions are
duly recognized.

The material in this training module has also utilized multiple open sources such as
Textbooks, Manuals, National and International Guidelines, Review Articles and related
Websites.

Sincere gratitude is expressed to the U.S. Centers for Disease Control and Prevention-
Division of Global HIV/TB (CDC/DGHT), India Office, its implementing partner Christian
Medical Association of India (CMAI) and Becton and Dickinson, collaborating partner for
Labs for Life project for providing technical assistance, guidance and support in
finalization of this module.
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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
List of Contributors

Dr. Naresh Goel : DDG,NACO & Project Coordinator L4L,MoHFW

Dr. Anu George : Technical Manager, Labs for Life

Dr. Sarika Mohan : Senior Scientific Advisor, CMAI

Ms. Niharika Mishra : Consultant

Dr. Sunita Upadhyaya : Lab Branch Chief, CDC/DGHT

Dr. Anju Kakkar : Pathologist & NABL Assessor

Dr. Puneet Nigam : Biochemist & Head of Quality Assurance,

Metropolis Healthcare Ltd.

Dr. Renu Dutta : Ex- HOD, Microbiology, Lady Harding

Dr. Saket Sinha : Quality Coordinator, Labs for Life Project

Dr. Pragyna Jena : Quality Coordinator, Labs for Life Project

Ms. Nupur Sinha : Technical Associate, Labs for Life Project

Ms. Chhavi Garg : Project Associate, Labs for Life

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Contents

List of Tables .......................................................................................................................................... 5

List of Figures ......................................................................................................................................... 5
Background ............................................................................................................................................. 6
How to use this module........................................................................................................................... 7
Chapter 1 – Quality Management System ............................................................................................ 10
Chapter 2: Organization and Management Responsibility (ISO 15189 Clause 4.1) & Quality
Management System (ISO 15189 Clause 4.2) ...................................................................................... 14
Chapter 3 - Examination by Referral Laboratories (ISO15189 Clause 4.5) ......................................... 30
Chapter 4 - External Services and Supplies (4.6) ................................................................................. 32
Chapter 5 - Advisory Services (4.7)...................................................................................................... 34
Chapter 6 - Resolution of Complaints (4.8) .......................................................................................... 36
Chapter 7 –Improvement Process (ISO 15189 4.9 – 4.12) ................................................................... 38
Chapter 8 - Evaluation and Audits (4.14) ............................................................................................. 50
Chapter 9 - Management Review (4.15) ............................................................................................... 59
Glossary ................................................................................................................................................ 62
List of Abbreviations ............................................................................................................................ 64
Annexure ............................................................................................................................................... 67
Annexure A: Confidentiality undertaking by the employee (to be submitted at the time of induction):
Sample67
Annexure B: Consent Form for FNAC: Sample ................................................................................... 68
Annexure C: Job description: Sample.................................................................................................. 69
Annexure D: Organogram of a Public health Laboratory: Sample ....................................................... 70
Annexure E1: Format for procedure for selection and evaluation of Referral laboratory: Sample ...... 71
Annexure E2 – Evaluation and Selection Criteria Format: Sample ...................................................... 74
Annexure F1: Format for Supplier Selection and Evaluation (Equipment): Sample ............................ 77
Annexure F2: Format for supplier selection and evaluation (Reagent): Sample .................................. 78
Annexure G: Format for Feedback and Complaint Resolution: Sample .............................................. 79
Annexure H: Format for NCE/Incident/ Occurrence/Accident reporting and immediate, corrective and
preventive action taken: Sample ........................................................................................................... 81
Annexure I Format for Records of Internal / External Audit: Sample .................................................. 82
Annexure JI: Format for assessing and managing risk: Sample ........................................................... 82
Annexure J2: CLSI EP23 Risk Assessment Matrix .............................................................................. 83
Annexure K:Format for recording Management Review Meeting reports: Sample ............................. 84

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
 List of Tables

Table 1: Management and Technical QMS Requirements ...................................................... 13

Table 2: Responsibilities of Lab Director(s) ............................................................................ 23
Table 3: Sample Training Calendar ......................................................................................... 29

List of Figures

Figure 1: Process Workflow in a Laboratory........................................................................... 10

Figure 2: Elements of a Laboratory Quality Management System.......................................... 15
Figure 3 Ethics ......................................................................................................................... 16
Figure 4: Principles in Laboratory Ethics ................................................................................ 17
Figure 5: No right way to do a wrong thing............................................................................. 17
Figure 6: Tiers of Indian Diagnostic Laboratories ................................................................... 21
Figure 7: Higher Management in a Laboratory ....................................................................... 21
Figure 8: Flow of Authority in a Laboratory ........................................................................... 22
Figure 9: Complaint Resolution Process Flowchart ................................................................ 37
Figure 10: Few Examples of Nonconformities ........................................................................ 39
Figure 11: Management of Non-conformities ......................................................................... 39
Figure 12: Root Cause ............................................................................................................. 42
Figure 13: Corrective Action Plan ........................................................................................... 43
Figure 14: Difference between Corrective Action and Preventive Action .............................. 44
Figure 15: Deming Cycle ......................................................................................................... 49
Figure 16: Making of a Checklist ............................................................................................ 52
Figure 17: Audit Cycle............................................................................................................. 54
Figure 18: Areas of Risk .......................................................................................................... 55
Figure 19: Identifying Potential Hazards for an Incorrect Test Result (ISO 15189:4.14.6) .... 56
Figure 20: Some Quality Indicators ......................................................................................... 58

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Background

In health systems, outcomes greatly depend on the accuracy, reliability and timeliness of
diagnostic services. Hitherto geared towards technical advances, the focus in medical
laboratories in the last two decades has shifted to establishing quality systems for achieving
these objectives.

The laboratory is a complex system, involving multiple operations, operators and locations of
operation, that need to be performed competently and in a synchronized manner. Thus quality
assurance in the laboratory requires both standardization and synchronization of various
factors such as safe sample collection and transportation ensuring the safety of the
operators& patients and integrity of the sample, optimum laboratory environment, adequate
quality control procedures, effective communications, record keeping, competent, committed
& skilled staff and adequate reagents and equipment that are fit for purpose and are stored
and maintained well. It entails ensuring access to required resources and making the available
resources functional through planning, training, rationalizing the workflow and error
reduction. Moreover, adapting to changing demands of the highly dynamic modern
diagnostic medicine requires continuous quality improvement which is possible only with
long term vision and monitoring & evaluation to direct the laboratory towards this vision.

All these cannot be accomplished by frontline employees alone. Management’s leadership

and commitment are essential to guarantee the best outcomes. Thus establishment of Quality
Management System (QMS) in the laboratories, to hold together the multiple components of
management and technical responsibilities, is essential for good laboratory practice. Quality
management helps in assuring conformance of the lab activities to the requirement of the
user, reduces waste and leads to improved productivity. This in turn, reduces costs and
provides a competitive advantage. QMS mandates that the upper level management support
the frontline employees and empower them to identify and solve problems in their work
processes.

There are International Standards that enable setting up laboratory Quality management
System. ISO 15189 Medical laboratories — Requirements for Quality and Competence is one
such standard that directs each activity to establish a Quality Management System. Other
guidelines such as, CLSI (Clinical Laboratory Standardization Institute) also provides
assistance in this regard. As compliance to the ISO standard begets accreditation in India, this
module explains each concept as mandated by the ISO standard, with regard to management
responsibilities in the establishment of Laboratory Quality Management System. The module
navigates the reader through each management clause and sub-clause of the ISO standard.
Effort has been made to align the flow of the concepts in accordance with the ISO clauses.

However, in some areas, rearrangements have been done to maintain flow. ISO clause
numbers are given alongside, wherever warranted. Additionally, it may be noted that some of
the ISO stipulated clauses have been discussed extensively as separate modules. In these
situations, the reader has been referred to the respective modules. Narration along CLSI

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
standards are resorted to in some areas to enable more clarity. Samples of many formats
required for the maintenance of the Quality Management System are included in the
annexure.

How to use this module

Chapter 1: describes the basic concepts about Laboratory Quality Management System in
conformance to ISO 15189. It outlines the clauses as stipulated by the standard.

Chapter 2: talks about the organization and management responsibilities (ISO 15189 clause
4.1 and some aspects of clause 4.2). This will help learners to understand about legal and
ethical issues in a medical laboratory, the importance of defining the organizational structure,
interrelationships, expectation and management responsibilities in the laboratory’s QMS.

Since clause 4.3, 4.4 and many aspects of clause 4.2 are addressed through other training
modules, these are not explained further. Lab for Life Project’s training module on
Documentation may be referred for clauses 4.2 & 4.3 and training module on Sample
Collection & Pre-analytical Best Practices may be referred for clause 4.4

Chapter 3: Ensuring that the referring labs are provided reports conforming to its Quality
Policy can be done only if the referral lab’s activities are understood fully. This chapter talks
about the details of these as per ISO clauses, the difference between referral and referring
laboratories and the requirements thereof. (ISO 15189: clause 4.5).

Chapter 4: External services and supplies refer to reagents, consumables, equipment; and
services sourced in. To ensure the quality of these, several steps have to be assured. As
details of these are addressed through other training modules, these are not explained further.
(ISO 15189 clause 4.6). Please refer to Equipment Management Module and Inventory
Management Module for details.

Chapter 5: It is the responsibility of the management that the potential users know and
understand the scope of the laboratory’s activities. It also is its responsibility to understand
the needs of the users and make additional services available. All these aspects are discussed
under the Advisory Services (ISO 15189 clause 4.7)

Chapter 6: Good laboratory practice warrants customer interactions. In such interactions lies
tremendous scope for improvement. In this regard, the ISO include resolution of complaints
(ISO 15189 clause 4.8) as an integral part of laboratory activities. Additionally, feedback is
suggested (4.14) as a powerful tool for improvement.

Chapter 7:This chapter explains a series of concepts towards continual improvement as

discussed in the standard under ISO 15189 clauses4.9 – 4.12.Nonconformities that can occur
in medical laboratories and the process for identification, handling and control of these,
importance of corrective action, process for corrective action whenever nonconformity is
detected, the concept the importance of continual improvement.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Since clause 4.13 is addressed through the training module on documentation this is not
explained further.

Chapter 8: Evaluation of a quality system is very important. This is a continuous process in

many respects but must include periodic, specific activities directed solely towards
evaluation. This chapter describes the evaluation and audits (ISO 15189 clause 4.14):
evaluation criteria for quality systems, definition, process and importance of audits, risk
assessment, reviews by external organizations are explained.

Chapter 9: Management review is a valuable component of the quality management systems

in accordance with ISO 15189. This chapter explains the methods and requirement of doing
the same

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Chapter 1 – Quality Management System

Learning Objectives: At the end of this chapter the reader will get an overview
overvie of -

o What is a Quality Management System

o What is ISO’s role in laboratory QMS
o How is management responsible
responsibl for running a lab effectively

What is a Quality Management System?

Syste

A quality management system can be defined as “coordinated activities to direct and control
an organization with regard to quality”.
quality”

To ensure the best patient care, quality and reliability in reports and confidence of users in the
laboratory services,, it is ideal to develop Quality Management Systems encompassing all
functions of the laboratories.. A medical laboratory comprises of a chain of various processes
performed by different personnel at different locations. The diagram below throws light on
this large concept in a simplified way.

PRE-PRE ANAYTIC PRE

PRE-ANALYTIC ANALYTIC POST
POST-ANALYTIC
PHASE PHASE PHASE PHASE

REAGENT
PURCHASE, PREPARATI REVIEWING AND
REGISTRATION REPORTING OF
TEST SELECTION ON, STORAGE AND USE
RESULTS WITH
ALGORITHMS, ADVIS INTERPRETATIONS
ORY, SENSITIZATION
EQUIPMENT
PATIENT
QUALIFICATION AND REPORT PRINTING AND
IDENTIFICATION
MAINTENANCE DISPATCH

INTERNAL & EXTERNAL ARCHIVAL OF SAMPLES

TEST PRESCRIPTION SAMPLE COLLECTION QUALITY ASSURANCE

STORAGE OF SAMPLES
SAMPLE SAMPLE PROCESSING
TANSPORTATION ARCHIVAL OF
DOCUMENTS &
PATIENT RECORDS
PREPARATION TEST ANALYSIS &
SAMPLE ACCESSIONING CALCULATIONS DISPOSAL OF SAMPLES

Figure 1: Process Workflow in a Laboratory

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Quality Management System integrates, standardizes and synchronises aspects of pre-pre
analytic, pre-analytic (pre-examination), analytic (examination) and post-analytic (post-
examination) phases of laboratory testing. Quality Management System (QMS) thus is an
important tool to achieve good outcomes in laboratory performance consistently (Figure 1).

How does a Lab Establish a Standardized QMS?

When a lab decides to set up a QMS in the lab, the question arises regarding how this can be
done. A lab requires guidance in all aspects regarding the standard protocols available. Such
standard protocols are available with prominent organisations viz. International
Standardization Organisation (ISO 15189), Clinical Laboratory Standardization Institution
(CLSI GP26). In India ISO 15189 is followed and National Accreditation Board for Testing
and Calibration Laboratories (NABL) gives accreditation for compliance with the ISO
standards.

In this module, the description of management requirements is from the ISO perspective. ISO
15189 draws its concepts from ISO 9001 and ISO 17025, with additional changes
incorporated for clinical laboratories. The current issue of ISO 15189 is released in year
2012. Conformance to this standard is awarded by accreditation by NABL and other
accreditation boards, in India.

How to Achieve Standardization of a Laboratory Using ISO 15189?

ISO 15189, “Medical laboratories — Requirements for quality and competence” fulfils
the requirement for both Quality and Competence, which are the essentials for reliability,
accuracy and continued improvement in performance of a clinical laboratory.

What is Quality?

As per ISO definition “quality is the degree to which a set of inherent characteristics
fulfils requirements”. This is demonstrated through documentation of the establishment,
implementation and maintenance of the QMS.

What is Competence?

As per ISO definition “competence demonstrated ability to apply knowledge and skills”.
The laboratory is also required to demonstrate its competence through assays of Quality
Control samples, repeat testing and split testing during the assessment process

How does ISO 15189 bring about standardization?

Laboratories are traditionally perceived as exclusively technical areas and technical expertise
is assumed to be sufficient to run laboratories well. However, laboratories are heavily
dependent on the management support for all kinds of resources. Laboratory management
allocates financial (operating and capital budget), physical (space, facilities, equipment and
supplies) and human (technical and support staff) resources to deliver adequate laboratory
services to the customers. The ISO 15189 facilitates interaction between management and
technical teams through a series of systematically stated clauses.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
The ISO 15189 Standard:: An Overview

Laboratory management is responsible to establish policies

in the laboratory to achieve the quality objectives and goals
towards delivering and enhancing the patient care. This is
achieved through a set of policy documents. Quality planning
and quality assurance are thus the responsibility of laboratory
management (Management Responsibilities).

The technical staff is required to implement and maintain the

QMS established by the management (Technical
Responsibilities).

ISO also mandates a Quality Manager to be the bridge

between the management and the technical staff.

ISO requires a stated Quality Policy by the management to pronounce its commitment to
quality. It also requires the management to state Quality Objectives towards its goal for
improvement. More about these
the are said in later sections. Management then should state its
policies in all areas of laboratory activities to achieve the set quality policy and quality
objectives. To ensure the sequence
equence and interaction of multiple processes, as work flows in a
laboratory, the ISO 15189 standard is divided into Management
Management and Technical requirements;
navigating the reader along the necessary activities.

The ISO 15189 standard incorporates

incorporate 4 major clauses; the first 3 of which deal with the
scope, references and glossary.
glossar Clauses 4 and 5 deal with the management and technical
requirements, respectively. Clause 4 deals with the establishment of a documented Quality
sub clauses pertaining to management requirements. Clause 5
Management System. It has 15 sub-clauses
stipulates technicall aspects for implementing and maintaining the QMS established by the
laboratory. It has 10 sub-clauses
clauses pertaining to technical requirements (Table 1). Each sub-
clause has further sub-clauses.
clauses.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
 Table 1: Management and Technical QMS Requirements

Clause 4 Management Requirements Clause 5 Technical Requirements

(Clause 4) (Clause 5)
4.1 Organization and 5.1 Personnel
Management
responsibility
4.2 Quality Management 5.2 Accommodation and
System environmental conditions
4.3 Document control 5.3 Laboratory equipment
reagents and consumables
4.4 Service agreements 5.4 Pre-examination processes
4.5 Examination by referral 5.5 Examination processes
laboratories
4.6 External services and 5.6 Ensuring the quality of
supplies examination results
4.7 Advisory services 5.7 Post examination processes
4.8 Resolution of complaints 5.8 Reporting of results
4.9 Identification and control 5.9 Release of results
of non-conformities
4.10 Corrective action 5.10 Laboratory information
management
4.11 Preventive action
4.12 Continual improvement
4.13 Control of records
4.14 Internal audit
4.15 Management review

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Chapter 2: Organization and Management Responsibility (ISO 15189
Clause 4.1) & Quality Management System (ISO 15189 Clause 4.2)

Learning Objectives: At the end of this chapter, the learners should be able to understand
the
o Concept of organizing the medical laboratory
o Legal and ethical issues in a medical laboratory
o Organizational structure -delineation of authority and responsibility, identification of
hierarchy
o Role of Laboratory Director(s) and Quality Manager
o Management’s role in the establishment, implementation and monitoring of QMS
o Importance of communication and training

In this chapter we will examine clause 4.1 and 4.2 with their sub clauses

2.1. Organization (4.1.1)

An ORGANIZATION is a team/unit of people, structured and

managed, to achieve a purpose or a goal taking into account
the client’s needs and purpose.

ISO 9001 introduces the concept of QMS by defining organizational activities/processes,

inter-relation between them and job descriptions of personnel responsible for each of them.
In developing a QMS;
• An overview of QMS requirements all along the sample path, described
earlier, has to come into focus.
• Involvement of all levels of staff is essential. The relevant staff at different
points must come into the planning, execution and maintenance of the QMS.

Thus the term “organization” indicates the management and the supporting organizational
structure of the laboratory. Organization is one of the essential elements of the quality system
which when coordinated with assigned responsibilities forms pillars of a quality management
system(Figure 2).

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
 Figure 2:: Elements of a Laboratory Quality Management System

Let us now examine how to organize a laboratory as per ISO ISO 15189 standard,
standard going by the
specific clauses. Each clause takes the reader into specific activities needed to ensure good
laboratory practices.

2.1.1. Legal Entity (ISO 15189: 4.1.1.2)

Legal entity is an association, corporation, partnership, proprietorship, trust,

or an individual, that has legal standing in the eyes of law

Need for legal entity

A medical
edical laboratory must produce relevant evidence of legal
legal identification which can be any
governmentt notification in support of establishment of institution / laboratory or any approval
from local or regulatory bodies

All district hospitalss are government concerns and may not require separate legal
identities.

Compliance requirements

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
 • Laboratory should comply with local / regional / national requirements, as applicable.
A few statutory compliances have been listed below:
o No objection certificate from the Competent Fire Authority
o Authorisation under Bio-medical Waste Management Rules, 2016
o Clearance from State Pollution Control Board

Please refer to IPHS standard, Annexure 8, p.102, ‘List of statutory compliances’

• International standards specifies that the laboratory should clearly identify itself to the
public, assuring that an identified person is in-charge and accessible.

Note: The laboratory or the hospital/organization of which the laboratory is a part should be
legally identifiable as per the existing law and authority. Every laboratory must at least make
public, the laboratory’s name and address, and the name of the director, including relevant
contact information.

2.1.2. Ethical Conduct (ISO 15189: 4.1.1.3)

WHAT IS ETHICS?

ETHICS IS

“A discipline dealing with what is good

and bad, with moral duty and obligation.”

“The set of moral principles by which

people conduct themselves personally,
socially or professionally.”

Figure 3 Ethics

The principles of doing “good” and not doing “harm” are the essence of every code of
medical ethics and the same is applicable in medical laboratories. Principles that form
fundamental in medical ethics are:

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Maintain Confidence in the Lab Competence, impartiality, integrity

Maintain Confidentiality All patient information to be confidential

Avoid Conflict of Interest Any competing interest must be declared

Statutory compliances Treat human samples as per statutory requirements,

comply with all regulations that apply

Autonomy Right of patients to take decisions for themselves

Beneficence Duty to act in the best interests of the patient

Non-maleficence Duty to avoid any harm to the patient

Justice Duty to remain fair and right

Figure 4: Principles in Laboratory Ethics

Responsibility:

Laboratory management holds the responsibility for supervision ethical conduct in the
laboratory while it is the duty of all the lab personnel to follow ethical conduct during all the
processes of the laboratory. Lab Director/Pathologist must ensure the same.

How is it implemented?

Figure 5: No right way to do a wrong thing

• Laboratory should also be aware of situations which could give rise to conflicts of
interest and take particular care and should have mechanisms to control these. Declare
the situations which may result in conflict of interests. The policy and process of third
party testing or other subcontract activities should be well defined and listed.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
• Ethics should become an important part of induction training
• Policies and processes should be made to safeguard the confidentiality of information
related to patient sample and test results. Undertaking of confidentiality must be taken
at the time of induction training. (Annexure A: Confidentiality Undertaking; Sample)
• Record of patient’s consent must be maintained.(Annexure B: Consent form; Sample)
• Ensure authorized access to results.
• Standardization of system and work processes to ensure impartial approach in all
activities
• Make adequate arrangements related to facility, workforce, finance or any other
resources to refrain lab personnel from any financial, commercial or any other
pressure which may affect the quality of the services provided by the laboratory.
• Handle patient samples (human samples, tissues or remains) as per specified legal
requirements.
• Work authorization should be given and documented to all the personnel in their
individual job descriptions. This should be a part of induction training.(Annexure C: Job
Description; Sample)

Note: Undefined or mixing of responsibilities for testing and quality creates internal conflicts
of interest that are detrimental to quality. So, laboratory should have predefined
responsibilities for all the lab personnel.

Examples of Breach of Confidentiality (What you should NOT do)

Accessing information that you do not need to know to do your job:

• Unauthorized reading of patient account information
• Unauthorized reading of a patient’s chart
Sharing, copying or changing information without proper authorization:
• Making unauthorized changes on a patient’s chart
• Making unauthorized changes to an employee file
• Discussing Confidential Information in a public area such as a waiting room,
elevator or cafeteria
• Posting a picture of a patient on social media.
• Emailing Confidential Information outside the institute/hospital by unsecure
methods (not encrypted)
Sharing your User ID and password: (for LIS equipped laboratories)
• Telling someone your password so that he or she can log in to your work
• Giving someone the access codes for employee files or patient accounts
• Being away from your computer while you are logged into an application

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 2.1.3. Organizational Structure

As per the ISO, some major factors must be ensured with regard to organisation; (a) defining
its structures with defined flow of authority,(b) stating each person’s job descriptions clearly,
(c) assigning lab director(s) and (d) a quality manager. We will look into each of these now.

a. Defining of organizational structure (ISO 15189 Clause 4.1.2.5)

The defining of organizational structure leads to efficient and effective laboratory operation
and meeting the quality goals.

The organizational structure in a medical laboratory is explained ideally in the form of an

organogram or an organizational chart depicting the designations, reporting relationship and
hierarchy.

Key Requirements:

• Clear designation of authority, inter-relationships and responsibility at each level

with an escalation matrix
• Accurate assessment of available personnel to perform different activities

What is an organizational chart?

An organizational chart depicts how jobs tasks are divided, grouped and coordinated. Jobs are
categorised into departments and departments are linked to frame an organizational structure.
It is a line diagram that outlines an organizational structure and supports an optimal path of
workflow. An organizational chart depends upon the goals, environment, technology and
size. In addition, the organizational chart must also describe how the laboratory is positioned
in the organization or its parent structures.

Organizational chart defines the working structure for the organization; organizes jobs
along lines of authority; defines reporting structure and span of control; defines authority
to make decisions and accountability for results; works together with job descriptions to
define the working structure of the organization. (Laboratory Quality Management
System Handbook, WHO

Why do we need an organizational chart?

o For establishing core authority and responsibility

o For clarifying different authorities and responsibilities for the Laboratory
Director/doctors, the Laboratory manager and the Technical supervisors and support
staff (e.g. IT, Administration, HR, etc.)
o For identifying hierarchies and relationships
o For clarifying reporting lines
o For clarifying expectations

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
 o For support the optimal path of workflow for the best possible quality outcome.
o For understanding the path of escalation of problem resolution

How to make an Organizational Chart?

• For the laboratory which is part of a hospital/organization two types of

Organizational Charts:
1. One reflecting the place of laboratory within the total organization i.e., the
relationship of the institution to the government structure.
2. One showing the organization of positions i.e., hierarchy in the medical
laboratory.
• List all the departments in the organization/laboratory and name of positions, as
applicable.
• Arrange each separately describing their relation to other in hierarchy.
• Each chart must be reviewed and authorized by the person assigned for the same.

Note:
• They are part of Quality Manual and must be accessible to all the lab personnel.
• Many errors can be prevented in the laboratory if the responsibilities of laboratory
personnel are clearly defined and all staff members of laboratory understand what
each is supposed to do and escalate to whom in case of some issue not getting
adequate, timely resolution

Healthcare System in India

Public Health System in India consists of state owned hospitals under state government and
few by the central government (Ministry of Health & Family Welfare). These facilities are
further categorized as Government Medical Colleges (Tertiary), District Hospitals, Sub-
district Hospitals, Community Health Centres (Secondary) and Primary Health Centres
(Figure 6).

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
 •Sub-Center (Rural areas)
•Primary Health Care Center
PRIMARY (Rural areas)
LEVEL •Community Health Centre
(Rural areas)
•Dispensaries (Urban areas)

•Sub-District Hospital (Urban

areas)
•Maternity and Child Hospital
SECONDARY (Urban areas)
LEVEL
•District Hospital (Urban areas)
•District Public Health Labs
(standalone)

•Tertiary Care Hospital, generally

has a minimum of 3 labs;
TERTIARY Pathology, Microbiology and
LEVEL Biochemistry. Also may be as part
of College Labs, Hospital
Labs, Emergency Labs

Figure 6: Tiers of Indian Diagnostic Laboratories

The organizational chart for higher management can be shown as below:

State District Medical

Authorities Authorities Superintendent

Figure 7: Higher Management in a Laboratory

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
The organizational chart (Figure
Figure 8)
8 for Functional Management
anagement can be shown as below:

Medical Superintendent

Lab
Lab-in-charge

Technicians, Stores, Bio-medical

Bio engineers

Support services, Housekeeping, Security

Figure 8: Flow of Authority in a Laboratory

Each of the above designations

ns may be held by one or more people. All these must be
depicted in the Organogram (Annexure D: Organogram; Sample)

b. Job Descriptions: A job description is a document that describes the general tasks,
or functions, and responsibilities of a position. It may specify the functionary to
whom the position reports, specifications such as the qualifications or skills needed
by the person in the job.
job All expectations from that functionary should be clearly
defined. Deputed work, emergency duties etc. should also be be incorporated. This
should be read and understood by the functionary and evidence towards this
documented. Such undertakings must be done during the induction training of staff.

c. Designating a Laboratory Director (ISO 15189: Clause 4.1.14)

A LABORATORY DIRECTOR RECTOR is person/persons who direct the laboratory with the
competence and skills and delegated responsibility for the services.
OR
A LABORATORY DIRECTOR is person/persons /persons responsible for all the activities and
administration in the laboratory.
laboratory

As the definition implies, the lab may be directed by more than one person. This is commonly
observed in government institutional labs as the defined responsibilities and authorities are
held by more than one person,
person, ideally one each from the management and technical
tech sides
The responsibilities assigned should be consistent with the
(designated co-directors).The
authorities given to the person.
person Howsoever the responsibilities are assigned; it should be
documented and evidenced.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Responsibilities of Lab Director:

Table 2: Responsibilities of Lab Director(s)

Nature of Activities Suggested co-

responsibility directors
Professional and • Clinical interpretation of the clinical laboratory HOD/Lab in-
Scientific: data. charge
• Communicate effectively in interpreting clinical
results to the referring physicians or care
provider or as applicable.
• Monitor all the processes performed in the
laboratory to ascertain on time patient care,
quality and reliability of services provided by
the laboratory.
• Preparation of Quality System Processes in
consultation with the Technical Managers.
Consultative/Ad • Provide consultation to physicians regarding the HOD/Lab in-
visory: medical significance and interpretation of charge
disparate laboratory findings.
• Recommend or advise additional test to
clinically ascertain the diagnosis of the disease.
Organizational: • Designing, approval, implementation and Dean/Principal/
maintaining of the quality management system. Medical
• Involvement in preparation of policy documents Superintendent/
along with the higher management. PMO/CMO
• Stating the quality policy.
• Ensure that the laboratory develops,
implements, and maintains a quality system
approach to laboratory testing to ensure
accurate and reliable patient test results.
• Ensure that the lab follow safe work
environment & meet State, Regulatory and
Accreditation requirements, whichever is
applicable.
Administrative: • Participation in all managerial decisions and Dean/Principal/
guides the daily operation of the laboratory, Medical
ranging from selection of staff, choice of Superintendent/
methods, purchase of equipment, quality PMO/CMO
assurance, quality control, safety in compliance
with good practice and scheduling of staff.
• Help in defining, implementing and monitoring

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
 the accepted standards of performance in
quality control, quality assurance, and cost-
effectiveness of the laboratory service.
• Assure that the laboratory participates
effectively in required quality management
programs.
• Personally demonstrate leadership for the staff
as they function as an integrated team.
Leadership is important to optimize services to
achieve the desired health outcomes for
patients.
Educational: • Ascertain that all the procedures and tests HOD/Lab in-
performed by the medical and technical staff charge
are within the scope of education, training, and
experience of the individual.
• Provide or arrange the trainings to the lab
personnel regarding procedures and tests
regularly.
• Develop opportunities for laboratory staff to
participate in continuing education programs.

In addition to the above stated responsibilities, the director(s) should also

• Have defined deputies to whom the selected duties/responsibilities may be delegated.
This person(s) also should possess the same competence as stated in the table. Such
deputations should be clearly defined in their job descriptions (5.1.3)

• Be able to relate and function effectively with applicable accreditation and regulatory
agencies, the medical community, and the patient population served.

Note: The duties and responsibilities of the Laboratory Director should be documented
under his/her Job Description.

d. Designating a Quality Manager (ISO15189: Clause 4.1.2.7)

The Quality Manager is the bridge between the management and the technical teams.
Therefore, he/she must be invested with the authority for the defined role and accessibility to
both sides. In a QMS, the Quality Manager holds a very key role and should be accorded due
importance. The robustness of the lab’s QMS is heavily dependent on the commitment of the
Quality Manager and the support he/she receives from both sides.

Therefore, lab management should appoint/designate a quality manager with delegated

responsibility and authority to oversee compliance with the requirements of the quality
management system and reporting directly to the level of laboratory management.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Quality Manager plays a key role in creation of QMS, spreading awareness amongst staff on
the quality policy and quality objectives, to make them familiar with the processes used to
achieve compliance with quality requirements.

Requirements for Quality Manager Quality Manager (as per NABL 112):
Designee shall be trained in 4-days Quality Management as per ISO 15189. She / He should
be a full time employee, and can be delegated with additional responsibilities

Responsibilities of Quality Manager (as per ISO 15189):

o Ensuring that processes needed for the quality management system are established,
implemented and maintained. e.g. ensuring that all levels of documentation are duly
completed and updated
o Reporting to laboratory management at the level at which decisions are made on
laboratory policy, objectives, and resources, on the performance of the quality
management system and any need for improvement. e.g. ensuring that all challenges
are identified, communicated to the management and followed up as quality
objectives towards improvement
o Ensuring the promotion of awareness of users’ needs and requirements throughout the
laboratory organization. e.g. opening channels of communication with the clinicians
and users
o Conducting management review. E.g. regular updating of all stakeholders with
documentation. It will be his/her responsibility to ensure that the meeting takes place,
to minute the meeting, identify the corrective action required, set timelines for these
and ensure compliance.
o Ensuring that all personnel are competent their assigned activities e.g. ensuring
correct observance of job descriptions

2.2. Need for Management Commitment (4.1.2.1)

Implementation of quality management system requires resources, facilities and review

processes for continuous improvement which is only possible through commitment
from management. Only with coordination between management and technical staff in the
organization can QMS be supported and implemented in the laboratory.

• Laboratory management should be committed to provide necessary qualified and

competent human and financial resource along with infrastructure facilities to
maintain laboratory quality management system as per ISO 15189.
• Management participation should be visible. This can happen through management
review meetings (MRM), interaction with staff, sharing customer expectations,
rewarding staff good performance, etc.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
• Management also designates/ recruits key personnel that ensure adherence to the
requirements and implementation of QMS like Quality Manager and Laboratory
Director.

Direct participation by the highest level

management in specific and critical
activities like facility
management, safety, quality, environment,
resources, etc. of an organization.
organization

MANAGEMENT COMMITMENT

“Management Commitment” is the primary and essential element for successful

establishment, implementation and monitoring of Quality Management System. The top or
senior management must accept the responsibility and involve themselves in the
establishment
ment and maintenance of quality system in the laboratory. Management must visibly
demonstrate and communicate this commitment.

Note: Quality manual, quality policy,

policy proceduress and records required by International
Standards and management reviews demonstrate management commitment to quality for
meeting QMS requirements.

2.2.1. Essential Components of QMS Establishment under the Purview of

Management:

Though we are essentially following

following the ISO, at this juncture, it will be good to look at the
CLSI guidelines about QMS.As per CLSI, there are 12 Quality System Elements (QSEs) that
come under the purview of the management. All these are applicable along the sample path.
path
These are organization,
nization, Customer Focus, Facilities and Safety, Personnel, Purchasing and
Inventory, Equipment Management, process Management, Documents and Records,
Information Management, Non-conforming
Non conforming event management, Assessments and Continual
Improvement.

A few of these concepts along with other requirements are explained below aligning them to
the ISO. The other points are explained in later chapters.

• Understanding and Meeting the needs of users:(ISO

users ISO 15189 Clause 4.1.2.2, Clause
4.7)

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
 o Laboratory management must ensure arrangements for best laboratory services
along with appropriate advisory and interpretive services for fulfilling the needs and
requirements of patients / users
o Ensure that the lab meets the requirements of regulation and accreditation.
o The same should be communicated effectively to the laboratory personnel for
better understanding of support and efforts being taken by the management.

• Expressing the Commitment towards Quality through Formulating and

Establishing Quality Policy: (ISO 15189 Clause 4.1.2.3)
Laboratory management is responsible for defining the quality policy of the laboratory.
The quality policy is the mission statement and expresses the intent of the management
to establish a QMS. This should:
o Be appropriate to the services provided by the laboratory.
o Include commitment to good professional practice, quality of examinations,
complies with the International Standard and continual improvement of the
quality of laboratory services.
o Provide a framework for establishing and reviewing quality objectives.
o Be communicated and understood within the organization.
o Be reviewed for continuing suitability.

• Ensuring Continual Improvement through Quality Objectives (ISO 15189 Clause

4.1.2.4)
o Laboratory management should identify the challenges in the working of the lab
and set measurable objectives
o These must be consistent with the quality policy.
o Quality indicators should be set for all objectives as per requirement to enable
measurement of progress.
o Quality objectives and indicators should be defined in consensus with all levels of
lab staff. Improvements or the lack thereof should be regularly communicated.

• Defining Responsibility, Authority and Interrelations:(ISO 15189 Clause 4.1.2.5)

As described previously, the laboratory management should define and document job
responsibilities, authorities and interrelationships of all the personnel for each laboratory
function. If required, deputies should be appointed for key managerial and technical
personnel.
Please refer to 2.1.3 of this module for details

• Communication:(ISO 15189 Clause 4.1.2.6)

Management should also ensure that:

o Laboratory should have intra and inter departmental (other laboratories and
clinical) meetings in a calendared manner. E.g. HICCs, Mortality Meets, CPC
meets, etc. Minutes of all these meetings should be kept.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
 o Laboratory should communicate with the management in a calendared and as and
when basis for better convergence.
o Lab management should establish means and processes for effective and timely
communication with others viz. patients, regulatory bodies (L forms to IDSP,
notifications of vector borne diseases to NVBDCP,HIV notifications to SACS,
BMW specifics as per 2016 rules to Pollution Control Boards) and Accreditation
& Certification bodies (NABL, SQAC of NHM).
o These communications should be in regard to the effectiveness of the laboratory’s
pre-examination, examination and post-examination processes and quality
management system.
o Communication can be through emails, circulars, notices or through meetings
(record of minutes of meeting).
o Records should be maintained of points discussed in communications and
meetings.

• Conducting Management Reviews: (ISO 15189 4.15)

Laboratory management must conduct periodic reviews at least once a year to examine the
suitability and effectiveness of the current established quality system in the laboratory. It
helps to anticipate potential process failures, compliance deficiencies, regulatory deviations
and areas of quality improvement. Any necessary changes in the policy, objectives and
quality system from the outcome of the reviews should be implemented and documented.
More about this is said in later sections.

• Training (ISO 15189 Clause 5.1.5)

Lab management, in coordination with the technical teams, should ensure adequate and
regular trainings of all personnel and ensuring that the person designated for the process
possess knowledge and competency to perform his or her duties. The training areas should
include at least the quality management system, assigned work processes and procedures, the
applicable laboratory information system, health and safety, including the prevention or
containment of the effects of adverse incidents, ethics and confidentiality of patient
information. A calendar for training has to be prepared and followed.
Personnel that are undergoing training must be supervised at all times and the effectiveness
periodically reviewed. A sample calendar is shown below

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
 Table 3: Sample Training Calendar

Training Calendar for Year 2017

No:
Responsibilit
Topic Propos Proposed Month/(s) Status
y
ed
Quality Jan/March/May/June/July/ Dr XYZ
8 3
management system Sept/ Nov/ Dec
Assigned work Feb/April/June/Aug/ Oct/ Dr ABC
6 2
processes Dec
Laboratory Jan/ July/ Sept/ Dec Mr DEF
4 2
information system
Health and safety 4 Feb/April/ July/ Dec Dr LMN 1
Ethics 1 March Dr PQR
Confidentiality 1 July Dr PQR

• Resource Allocation

Lab management should ensure adequate and appropriate resource allocation for the
proper conduct of pre-examination, examination and post-examination processes. These
must include:
o Appropriate accommodation and environment
o Adequate human resources at all levels of technical functioning including technical
supervisory staff, lab technicians, lab attendants, housekeeping and security
o Equipment availability and calibrations
o Regular supply of reagents and consumables
o Evaluating the resource utilization

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Chapter 3 - Examination by Referral Laboratories (ISO15189 Clause
4.5)

Learning Objectives: At the end of this chapter, the learners should be able to understand
the
o Difference between referral and referring laboratory
o Process for selection and evaluation of referral laboratories
o Reporting of referral laboratory results

Referral laboratory is an external laboratory to which a sample or sub-sample is

submitted for a supplementary or confirmatory examination and is considered to
have a similar or preferably better quality system.

Referring laboratory is a laboratory that submits samples or sub-samples for

supplementary or confirmatory test, or when routine examination could not be
carried out (e.g. due to equipment breakdown) and receives the report from the
referral laboratory

Test not performed routinely by the laboratory are outsourced. This does not come
under the ambit of Referral laboratory as per the ISO 15189 standard. However,
these tests must also be diligently monitored.

Referral system here implies sample referrals and not patient referrals. Currently,
in the public health system, patient referrals are the practice followed.

Under the following situations samples/consultation can be referred:

• Instrument breakdown or reagents not available
• Workload restrictions
• Client requested turnaround time cannot be met
• To seek a second opinion
• To seek opinion during absence of authorized signatory in the laboratory
• As part of the Proficiency Testing mechanisms
Referral laboratories and consultants shall be selected as per the criteria laid down by the
laboratory.

Some suggested criteria for referral laboratories:

• Accuracy and quality of results/consultations
• Meets facility and equipment requirements
• Uses verified testing and examination methods

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
 • Compliance to Safety requirements
• Employs qualified personnel
• Accredited under ISO15189
• Has documented QMS
• Follows QC practices
• Acceptable performance in proficiency testing
• Effective turnaround time
• Provides timely advisory services
• Passes on-site inspection
• No conflict of interests

Arrangements with referral laboratories and consultants must be reviewed and evaluated
periodically to ensure that the relevant parts of the International Standard are met. In cases,
where the correct interpretation and application of examination results needs collaboration
between clinicians and specialists from both referring and referral laboratories, this process
should not be hindered by commercial or financial considerations.

Documents required:
• The referring laboratory should have a documented procedure (QSP) for selecting and
evaluating referral laboratories and consultants who provide opinions as well as
interpretation for complex testing in any discipline.(Annexure E : Format for selection
and evaluation of referral laboratories; Sample)
• Record of approvals with signature on agreement/MoU should be preserved.
• A list of approved laboratories and approved consultants should be maintained.
• Record of reviews of arrangements and periodic evaluation with referral laboratories and
consultants should be maintained.
• Records of all the samples referred, date of referral, name of person referring and to
which referral laboratory/consultant should be maintained.
• Referring laboratory should standardize the procedure for reporting referral laboratory
results considering turnaround times, measurement of accuracy, transcription,
interpretative skill requirements.
• When the referring laboratory prepares the report, it replace include all essential
elements of the results reported by the referral laboratory or consultant, without
alterations that could affect clinical interpretation. The report replace indicate which
examinations were performed by a referral laboratory or consultant. The author of any
additional remarks replace be clearly identified in the report.
• Record or the photocopies of test reports are maintained.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Chapter 4 - External Services and Supplies (4.6)

Learning Objectives: At the end of this chapter, the learners should be able to understand
the

o Process for selection and evaluation of suppliers

o Documentation requirements

Any interruption in testing/services can affect patient care and management. Each laboratory
should maintain sufficient and uninterrupted supplies and services to fulfil the needs of the
clients and prevent wastage.

The supplies can be categorized as equipment, consumables, reagents and kits. The services
include warranty/guarantee, maintenance contracts, attending to breakdowns (remote or on
site) and calibrations.

The laboratory should select and approve suppliers based on their ability to supply external
services, equipment, reagents and consumable supplies in accordance with the laboratory’s
requirements; however, it may be necessary to collaborate with other organizational
departments or functions to fulfil this requirement.

Though this is a management requirement, technical inputs are critical to ensure quality
assurance in this aspect of lab operations. For details on equipment purchase, please refer
under Design Qualifications in the Equipment Management module.

As for reagents, the claimed Performance Characteristics as per manufacturer should be

checked and approved by the technical team before selections are made. Pre purchase
verifications for “fitness of purpose” are also possible before purchase if the manufacturer
supplies adequate Performance Characteristics like coefficient of variation (CV), sensitivity
and specificity, etc. Ideally, any financial bid should happen only after technical clearance.
For details on reagent purchase, please refer under Inventory Management Module

Both Management and Technical teams are equally accountable for the procurement of
External services and supplies

Documentation required for process of selection, evaluation and implementation of

external services and supplies:

• The laboratory should have a documented procedure for the selection and purchasing of
external services, equipment, reagents and consumable supplies that affect the quality of
its services. Purchasing information should describe the requirements for the product or
service to be purchased.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
• Criteria for selection of suppliers should be established and documented. Some of the
suggested criteria are –
o Equipment - warranty, AMC/CMC, Remote/onsite support service, downtime, etc.
o Reagent – maintenance of cold chain, long expiry, supply of steady lots, etc.
(Annexure F1 :Format for Equipment supplier selection and evaluation, Annexure
F2 : Format for Reagent supplier selection and evaluation; Samples)
• A current list of selected and approved of equipment, reagents and consumables should
be maintained.
• The laboratory should monitor the performance and evaluate the suppliers to ensure that
purchased services or items consistently meet the stated criteria. Laboratory should
maintain the records of the same.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Chapter 5 - Advisory Services (4.7)

Learning Objectives: At the end of this chapter, the learners should be able to understand
the

o Overview of advisory services in medical laboratory

o Documentation requirements

What is an advisory service in a medical laboratory?

An advisory service can be defined as a clinical

laboratory consulting service about the appropriate use
of clinical laboratory examinations (interval between
sample collections, indications of examination, obsolete
examinations, supplementary examinations, etc.), advice
on clinical cases, logistic issues and the clinical meaning
of examination results (interpretative comments).

Laboratory management should ensure that the following arrangements/processes are in place
and confirm their implementation by the technical team
• Advising clients on choice of examinations (mainly outpatients where there is no
doctor’s consultation) and use of the services, including required type of sample,
collection requirements, clinical indications, and limitations of examination procedures
and the frequency of requesting the examination.
• Advising on individual clinical cases and need for specific confirmatory/additional
testing
• Immediate communication of critical values
• Professional judgements on the interpretation of the results of examinations
• Promoting the effective utilization of laboratory services
• Consulting on scientific and logistic matters such as instances of failure of sample(s) to
meet acceptance criteria.
• Trainings/meetings between clinical staff and professional staff on the use of laboratory
services and clinical interpretations.
• Hospital-attached laboratory personnel are encouraged to participate in clinical rounds
and meetings.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Documentation required:
• Procedure for defining areas and implementation of advisory services.
• A list of critical (alert) values readily available to laboratory staff.
• Records containing notifications of critical (alert) values
• Records containing requests of advisory service (received and answered)
• An interpretive comment in every clinical laboratory report containing any laboratory
examination.
• Records of client feedback, suggestions and satisfaction surveys should be maintained.
• Records of clinical rounds undertaken by laboratory personnel.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Chapter 6 - Resolution of Complaints (4.8)

Learning Objectives: At the end of this chapter, the learners should be able to understand
the
o About the complaints in medical laboratory
o Process of resolution of complaints

What are complaints?

Complaints are objections, negative feedbacks, errors, or non-conformities involving work

quality, or failures to provide service or other requests of the users of the laboratory
services including timeliness.

The idea of quality, accurate and reliable laboratory services can be evaluated on the basis of
client satisfaction scores. Feedbacks from users of laboratory services covering key aspects
can be taken periodically and reviewed for improvements. Complaints are included as a
quality indicator in QMS of the laboratory for improvement of laboratory services, to avoid
errors in future and ensure client satisfaction. Complaints in the medical laboratory can be
received in writing, through emails, telephone, in person, on website or as feedback.

Laboratory management is responsible for ensuring the implementation of the complaint

procedure and facilitates process changes, if required. Laboratory supervisors are responsible
for recording complaints received on the complaint form and initiating corrective action in
consultation with Lab Director. The Quality Manager monitors the comments and complaints
received for trends, resolutions and corrective action. Every complaint should be taken to its
logical conclusion of ascertaining that the client who made the complaint is satisfied with the
remedial action taken; hence the title “resolution” of complaints.

Note: Feedback, on the other hand, are information about reactions to the performance and
services of the laboratory which can be used as a basis for improvement. Whereas complaints
are negative in nature, feedback can either be negative or positive.)
(Annexure G: Format for feedback & complaint resolution; Sample)

Resolution of complaints; some salient points:

• The laboratory must have a documented procedure for the management of complaints
or other feedback received from clinicians, patients, laboratory staff or other parties.
• The process of redressal should include receiving, reviewing, investigating the cause,
corrective action taken and closure.
• The laboratory should maintain a record of all the complaints received and their
investigation and action taken.
• The laboratory should have a complaint/feedback form to document each complaint and
its redressal.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
 Complaint Reporting
Complaint received by Form initiation
laboratory

Determining cause by Investigation

nature of Complaint

Decide on Appropriate
Corrective Action

QM maintains complaints, monitors

trends Take Corrective Action

The user is Completed CRF and CA Form

informed of the submitted to QM
remedial action

Figure 9: Complaint Resolution Process Flowchart

Note: The laboratory should follow the existing corrective action and preventive action
process in the laboratory during the resolution of complaints.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Chapter 7 –Improvement Process (ISO 15189 4.9 – 4.12)

Learning Objectives: At the end of this chapter, the learners should be able to understand
the meaning of the following

o Nonconformities in Medical Laboratory

o Process for Identification, Handling and Control of Nonconformities
o Importance of Corrective Action
o Process for Corrective Action Whenever Nonconformity is detected.
o Concept and Application of Preventive Action
o Process for Implementation of Preventive Action
o Concept and Importance of Continual Improvement
o Processes in Laboratory to Ensure Continual Improvement
o
This section deals with 4 clauses of ISO 15189; from 4.9 to 4.12

7.1 Identification and Control of Nonconformities (4.9)

Conformity: When the actual practices followed in the laboratory or the findings are in
concordance with the laboratory’s policies or the standard guidelines.

Non-conformity: Failure to fulfil the requirements of a specified process, structure or

service. May be categorized as major (complete) or minor (partial).

Any nonconformity in a medical laboratory raises a question on the effectiveness of lab

quality system or laboratory processes. Laboratory management must establish an effective
and continuous process to detect all the Non-Conforming Events (NCEs) or else they will
remain undetected.
Any nonconformity in performance implies that the policies and procedures set by the
laboratory require revision or are not being followed. Nonconformities may arise during
routine laboratory process, clinician complaints, internal and external audit, staff comments,
customer feedback, laboratory indicators, PT/EQAS failures or management review (Refer
Figure 10).

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
 Pre-Examination Examination Nonconformities Post-Examination
Examination
Nonconformities •Improper storage of reagents/kits Nonconformities
•Collection of incorrect sample •Inappopriate maintenance of •Non-validated
validated report
• Incorrect label on sample equipments •Reporting
Reporting of incorrect results
• Unlabelled sample • Errors in measurements or dilutions of due to Illegible and poor
• Incorrect storage of sample reagents handwriting
• Sample transported in • Testing patient sample after QC • Loss of report
improper conditions failure • Incorrect report to patient
• Improper packing of samples • Use of reagents after expiry date
• PT failure

Figure 10: Few Examples of Nonconformities

The laboratory nonconformities may lead to the risk of

o Inadequate or inappropriate
inappropria patient care
o Repetition of laboratory
aboratory results
o More invasive testing
o Inappropriate
ppropriate public health action
o Undetected communicable disease outbreaks (in some cases)
o Wastage of resources
o Increased cost to patients
pat and healthcare systems
o Even death of an individual.
Identification of nonconformities and appropriate corrective action aids in continual
improvement of laboratory services.

Figure 11: Management of Non-conformities

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Documentation requirements:
• The laboratory should have a documented procedure (QSP) to identify and manage
nonconformities (occurrences) in any aspect of quality system, including pre-
examination, examination and post-examination processes. This QSP may be extended to
include sub-clauses 4.10 (corrective action), 4.11 (preventive action) and 4.12 (continual
improvement) as well.
Responsibilities and definitions of responsibilities for handling NCEs are very important
in every lab and thus these should be clearly defined.
o The responsibilities and authorities for handling nonconformities should be
designated to appropriate personnel by the Quality Manager.(Though the
responsibility for monitoring for nonconformities belongs to everyone in the
laboratory)
o The cases when testing procedures and data reporting will be withheld due to
nonconformities should be well-defined and when, and under what conditions, the
examinations can be resumed should be specified.
o The steps that should be taken when the result of any nonconforming or potentially
nonconforming examinations already released are recalled or appropriately identified,
as necessary also should be defined.
o The responsibility for authorization of the resumption of examinations is defined.
o Each episode of nonconformity should be
• Documented, recorded
• Extent of non-conformity is determined
• Immediate action: contain damage
• Root Cause Analysis (RCA) is performed
• Corrective Action: prevent recurrence
• Results of the corrective action and its effectiveness is documented
• Preventive Action: prevent similar occurrence
• All supporting evidence for all the steps to be retained
• All the nonconformities should be logged and recorded and theses should be
reviewed at regular time intervals to detect trends and initiate corrective
action.

(Annexure H: Format for NCE/Incident/ Occurrence/Accident reporting and immediate,

corrective and preventive action taken; Sample)

Note:

o Corrective actions taken should be appropriate to the non-conformities encountered.

o Records of nonconformities must be communicated to the lab management and form a
subject of management review.
o Repeated non-conformities in the same area should be set as quality objective

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
7.2 Corrective Action (4.10)

Difference between remedial/immediate action and corrective action:

Immediate action is an action taken at the time of nonconformity, to mitigate its

immediate effects. For example, if an erroneous result has been reported, it is essential
to immediately notify all persons concerned about this error and withdraw the report.
Corrective action would be to provide the amended result.

Corrective action is an action taken to eliminate the detected nonconformity or other

undesirable situation (and the cause of it). As an example, a piece of equipment may
have been malfunctioning, and the corrective actions would be to recalibrate, repair or
otherwise address the equipment problem.

Benefits of Corrective Action:

• To prevent recurrence of the problem

• To initiate quality improvement

Laboratory management should develop a quality system wherein, the process for
identification of a nonconformity/occurrence/error, followed by a prompt investigation of the
same is established. Laboratory should initiate corrective actions for all the non-
conformances identified. Effective and compliant management of nonconformities involves
several steps. Each step should be documented.

Process steps for Corrective Action:

This is the reiteration and continuation of the above section on non-conformances (4.9).

1. Identification of the nonconformity/occurrence/error: Laboratory should define the

nonconformity/occurrence/error including source of the information, brief description
and supporting evidences for it. All the related information such as data, source
documents, PT reports or audit reports which confirms the presence of problem should
be included.
2. Assessment: The significance of the nonconformity should be critically evaluated. This
helps in diagnosing the impact and magnitude of the problem related to the
nonconformity. Appropriate staff should be involved to assess the medical significance
of the nonconformity.
3. Initiate immediate/remedial action if required: The appointed staff should
communicate appropriately about the nonconformity/occurrence to all those affected. If
required, testing should be paused and reports should be withheld. In case the results are
already released, reports should be recalled and the customers should be notified. If the
results are yet to be released, each should be reviewed before release. Testing should be
resumed only after signalled by the concerned authority.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
4. Root Cause Analysis (RCA):
(RCA)

Root Cause Analysis is a process for identifying the basic or causal factor(s) that
underlies variations in performance, including the occurrence or possible occurrence
of a nonconforming event.

Figure 12: Root Cause

It should be carried out by organizing a team consisting of laboratory staff familiar and
related to the problem. RCA includes majorly three processes-
• Identify
dentify what exactly happened,
• Why hy it happened and
• Determine forward actions to prevent
preve reoccurrence.

The root cause of the problem is identified by systematic and structured approach.
Create a list of all the causes with relevant data to determine the primary cause of it.
Consider the following and their role in the event/occurrence:
event/

• Man
• Method
• Materials
• Machine
• Measurement/Maintenance/Mother nature

Root cause analysis tools like 5 Whys,

W Fishbone Analysis, etc. can be used. Any hidden
causes should also be identified. It may be circumstances related to personnel,
equipment, reagents, training,
raining, etc.

For more details, refer to the training module on Quality Control Vol 1

5. Selection of corrective action: After the identification of cause(s), the corrective action
should be determined to resolve the problem. Laboratory should define the actions
acti that

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
 should be taken to eliminate the problem, person responsible and timelines for
implementation.
6. Implementation: Implement the suggested corrective action considering whether similar
problems exist in other areas of the laboratory. All the arrangements
nts related to resources,
finance, equipment, individual responsibilities and a schedule for implementation and
completion should be specified.
7. Communication: Laboratory staff should be involved in the improvement process.
Laboratory should have processes to communicate the quality issues, changes, outcomes
and trends to personnel responsible as well as staff.
8. Follow-upup and verification:A
verification: thorough follow up with monitoring, observation and
verification of the completion of all tasks should be performed to avoid any recurrence of
the same nonconformity. An An assessment of the appropriateness and effectiveness of the
corrective actions should be performed. The results of any nonconformity assessment
should be communicated to management forming a part of periodic
periodic management review.

Figure 13: Corrective Action Plan

It is imperative that the corrective action team/designated

team/designated individual have adequate
process knowledge, medical expertise
expert and authority to implement corrective action.

The responsibility for monitoring for occurrence belongs to everyone in the
laboratory.

Laboratory management should confirm the availability of necessary resources
required for the implementation of corrective action.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Documentation:

Laboratory should have a documented procedure for corrective action to be taken and its
documentation whenever non-conformity
non is identified. All the nonconformities should be
logged and documented properly. Laboratory should document each course of investigation,
plan and action for record. The records should be maintained for the period as defined by the
laboratory.

7.3 Preventive Action (4.11)

What is a Preventive Action?

Preventive action is the proactive action/s taken to eliminate the cause

caus of a potential
nonconformity or any other potentially undesirable situation or actions taken to improve
a process to prevent potential future occurrences of non-conformity.
non

Difference between Corrective Action and Preventive Action:

Both preventive and corrective actions are steps

steps taken to improve a process or to correct a
problem. Corrective action is taken to rectify the cause(s) of nonconformities to prevent
recurrence while preventive action is taken to prevent occurrence.. Corrective action is are
active process whereas preventive
ventive action is a proactive process.

Corrective action prevents recurrence and preventive action prevents occurrence.

Figure 14:: Difference between Corrective Action and Preventive Action

The term potential implies possibility. The lab is required to understand all possible problems
before it manifests.

Need for Preventive Action may be detected through

• External/internal
/internal audit findings

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
• Trends in process data
• Trends of root causes for nonconformities or complaints
• Quality reviews
• Quality risk analysis

These will be discussed in detail under ‘Evaluation and audit’ (4.14)

Preventive actions involve a planned and organized evaluation of processes and procedures to
identify potential error points, so action can be taken to prevent the errors from ever
occurring and aid quality improvement. It should be taken whenever an unacceptable trend is
detected in any process of a laboratory. Preventive actions require planning and team
participation.

The laboratory should establish and document a procedure (as indicated earlier, this can be
included in the common QSP for 4.9-4.12) for:

• Reviewing laboratory data and information to determine where potential nonconformities

exist
• Determining the root cause(s) of potential nonconformities
• Evaluating the need for preventive action to prevent the occurrence of nonconformities
• Determining and implementing preventive action needed. The preventive action taken
should be appropriate to the effects of the potential problems.
• Recording the results of preventive action taken
• Reviewing the effectiveness of the preventive action taken.

Note: Information regarding preventive actions should be subject to management review in

support of maintaining and improving the effectiveness of the Quality Management System.

7.4 Continual Improvement (4.12)

The continual improvement of the laboratory processes is a dynamic set of activities to

improve the effectiveness of quality management system. Continuous Quality Improvement
(CQI) should be applied to all procedures and processes that are a part of the path of
workflow in laboratory. Designing and implementing strategies to prevent or reduce errors or
to detect and correct them before the reporting of the test result, constitutes quality
improvement.

Effective continual improvement process warrants an understanding of all challenges as well

as opportunities for improvement. The Quality Manager is the key person who can bring
about this awareness usher in the improvement process. An effective Quality Management
System provides the ideal tools for continual improvement in laboratory

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
7.4.1. Quality Indicators (ISO: 15189 4.14.7):

Note: Technically, the following concepts are part of ISO: 15189 4.12 Continual
Improvement as well as ISO: 15189 4.14; Evaluation and Audits. The reader is required to
understand it also as part of ISO15189:4.14.

A Key Performance Indicator is a measurable value that demonstrates, at a glance, how well
any operation is performing in defined parameters. In a laboratory QMS, quality indicators
assume the role of KPIs. Thus a Quality Indicator (QI) is a measurement followed by analysis
to address how well the laboratory is meeting the user needs.
Laboratories should set quality objectives and goals to evaluate activities and obtain
necessary data to measure the performance of that objective.

The process of setting quality objectives and indicators is illustrated with an example from
the analytical phase of the Biochemistry dept. of a lab.

Assume that the following was the %CVs (Measure of imprecision) of a lab for a certain
month and the acceptable CV%

Monthly CV data of a laboratory for the month of June 2016

Analyte Observed CV% Acceptable CV%
Albumin 5.1 1.6
Glucose 4.8 2.3
Urea 5.5 6.1
Creatinine 3.1 3.0

Column 1 shows the name of the analyte, and columns 2 and 3 show the observed and
acceptable CV% (as per BV desirable database) for the analyte, respectively. What are the
Quality Objectives and Quality Indicators that may be set?

The Objective here, would be to bring down the CV% to acceptable levels. Action required
would involve stabilising the analytical system through proper preventive maintenance of the
equipment, monitoring reagent storage conditions, monitoring the lab environment, storage of
QC and calibrators, reviewing calibration frequencies.

The Indicators would be tracking the CV % of each analyte. To continue the illustration,
CV% of S. Albumin has been tracked over a period of 6 months and shows improvement and
meeting the quality objective of achieving acceptable levels of precision.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
 Albumin CV%
6 5.1 4.8
5 4.1
4
3.5
3 2.1 2.2 2
2
1
0
Jun-16 Jul-16 Aug-16 Sep-16 Oct-16 Nov-16 Dec-16

Once the quality objective has been achieved, as in the above case, the lab may move on to
other objectives, but it must continue to track the CVs as Quality Indicators, for the purpose
of continual improvement.

Dashboard: In information technology, a dashboard is a user interface that, somewhat

resembling an automobile's dashboard, organizes and presents information in a way that is
easy to read. In a lab, for quick evaluation of quality indicators, a Dashboard can be used. All
the Quality Indicators and other performance indicators can be displayed as a dashboard for
quick reference. An example of such a dashboard is given below. A few productivity
indicators and Quality Indicators in the pre-analytical, analytical and post analytical areas of
operation are plotted. A monthly pie chart (QI wise) and a continuous bar chart (area of
operation-wise) are plotted by this software. In saying this, it has to be reiterated that,
identification of the non-conformities is the most crucial step in the process of the
improvement process. The labs are well advised to enable a system towards these at each
point of operation.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
 Indicator Monthly data as pie graph
Six Monthly data as bar
graph
Snapshots from Labs for Life Project QI monitoring tool. The QI are captured here as
Percentage Defects. (% outside specified requirements; refer 3.19 of ISO:15189)

7.4.2. Management of nonconformities:

The Deming Plan-Do-Check-Act (PDCA) Cycle is the best way to confirm continual
improvement. It is a four step looping process:

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
 Plan — identify the problems and potential sources of any system weakness or error
by implementing a regular structured review of all operational procedures by
laboratory. Develop a plan from the collected
coll information.

Do— implement
mplement the plan and put it into action.

Check — thishis refers to the monitoring process. Also, assess the effectiveness of the
action using focused review and audit.
audit

Act — Implement the action plan and implement changes to the qualityquali system in
accordance with the review and audit results.
results Take any corrective action that is
required, and then re-check
check to ensure its effectiveness.
effectiveness

Note: The quality system should be reviewed for redundancies and inherent weaknesses
especially in areas that have frequent non-conformances
non conformances or complaints, closer scrutiny
should be applied.

As this diagram indicates, continual improvement is a process

process of incremental improvement of
planning-doing-checking-acting
acting with
wit the standard as the reference.

Figure 15: Deming Cycle

For Control of records (4.13), please refer to the Documentation Module

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Chapter 8 - Evaluation and Audits (4.14)

Learning Objectives: At the end of this chapter, the learners should be able to understand
the
o Evaluation criteria for Quality Systems
o Definition, process and importance of audits
o Definition, process and importance risk assessment
o Reviews by external organizations

8.1 General

Nonconformities to the ISO standards may arise from deviations from requirements which
can be pointed out by:

o Routine process audits, to be identify NCs in day to day to day work. Internal
policies and procedures of an organization of recording non-conforming events
(discussed earlier) must be in place for this
o Audits: Internal and external audits
o Risk Assessments
o Quality Indicators
o Staff suggestions
o Feedback from users

8.2 Audits

Audits are means of collecting factual, unbiased information about how well an
organization’s quality system is functioning. Assessment is an important tool to demonstrate
that the laboratory is meeting regulatory, accreditation, customer and organizational
requirements. The ISO definition for audit is a “systematic, independent and documented
process for obtaining evidence and evaluating it objectively to determine the extent to which
required criteria are fulfilled.”

The evaluation and internal audit processes are needed to:

• Demonstrate that pre-examination, examination and post-examination processes

meets the needs and requirements of the users;
• Ensure conformity to the quality management system;
• Continually improve effectiveness of the quality management system.

Actions required may include:

• Periodic review of collection processes. E.g. If the laboratory is using non-standard

techniques like reusable tubes, they may be amended.
• Periodic review of analytical processes. If an analytical process fails to meet
standards, this may be reviewed, and alternate methods looked into.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
 • Periodic review of post-analytical processes. Problems of transcription errors, or
meeting TAT, electronic options viz. LIS may be considered

Note: Accepted standards, whether national, international, local or standards from

accrediting organizations form the guide to be followed by the laboratory.

Different Types of Audits:

a. First party audit : The laboratory auditing itself on a regular basis for continual
improvement
b. Second Party Audit: It is an external audit performed by a customer or a contracted
organization (e.g. Insurance agencies) on behalf of a customer to ensure meeting of
requirements specified in the contract.
c. Third Party Audit: It is an external audit performed by an audit organization
independent of customer-client relationship or certification bodies or regulatory agencies
like ISO (International Organization for Standardization), NABL (National Accreditation
Board for Testing and Calibrating Laboratories), CAP (College of American
Pathologists), etc. for certification, accreditation or regulatory purposes.
d. Internal Audits: Internal quality audits are audits carried-out by the laboratory’s
personnel. It may be coordinated by the Quality Manager and is a strict requirement of
the ISO
e. External Audits: An assessment, by a body commercially and contractually independent
of the organization, i.e. suppliers, regulators and customers

Internal Audit: (ISO 15189: 4.14.5)

Internal audits examine the elements of the quality management system in the laboratory to
evaluate how well these elements comply with quality system requirements and assure
continual improvement in the quality system. They are also required by ISO 15189.

Purpose:

The laboratory should conduct internal audits to determine whether all activities the quality
management system, including pre-examination, examination and post-examination:

• Conform to the requirements of the ISO Standard

• Conform to the requirements established by the laboratory
• Are implemented, effective and maintained.

Note: The purpose of the internal audits is not to search for the guilty, or to find fault with
individuals' performance. The system is being audited - not the individuals.

Requirements:

Internal audits should be conducted as per criteria, scope, intervals and methods defined
and documented in quality management system.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
1. Scope
i. If the lab has three depts., audits must be undertaken in all these depts.
ii. Both management and technical areas must be audited
iii. Pre-analytical, analytical and post- analytical areas should be audited

2. Interval – As per NABL recommendations, IA should be done once a year, before the
MRM. But may be done more frequently if warranted.

3. Checklist - Any validated checklist may be used.

Checklists are generally made in the following manner –
o Areas needing standardization are identified
o Standards are defined
o Checkpoints are defined

Area of concern Set standard Set checkpoints

(identified by ISO) (defined by ISO)

Figure 16: Making of a Checklist

Checklist 1 & 2 of NABL 217 may be used. (This is a downloadable NABL document and
for use in the laboratory, the NABL footer may please be removed). NQAS checklist of
NHM, LQMS checklist of IDSP may also be used. It should be kept in mind that all elements
of ISO15189 are checked. Any checklist used should be validated by the auditor before use.
For NABL accreditation, checklist 217 is recommended.
A number of Excel based checklists have been developed under the Labs for Life project, which
may be used as comprehensive checklists for the entire ISO 15189:2012 standard or as system
wise checklists.
Checklist NABL 217 is statements of the standard and the checkpoints have to be understood
by the auditor. Alternatively the auditor may refer to the NQAS/SLIPTA/WHO Checklists
for this purpose.
4. Method
o Internal audits should be planned in advance and the audit programme or schedule should
be communicated to all the personnel in all depts. /areas in the laboratory. The detailed
schedule with date, time, and area to be audited should be communicated well in advance.
o The results of previous audits and closure of NCs may be made available to all
stakeholders
o It can be performed by an individual or a group of people trained to assess the
performance of managerial and technical processes of quality management system as per
ISO 15189 Standard.
o The auditors should be independent of the activity they are auditing to ensure objectivity
and impartiality. This means the laboratory personnel of one dept./area should not audit
their own activities.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
5. Process:

The auditing procedure consists of the following steps:

Audit preparation
The Quality Manager is responsible for the coordination of the audit and will choose the
auditor(s), dates and times of audit, and the checklist to be used and will also prepare the lab
towards the audit

The Auditor
• For purpose of NABL accreditation, the internal auditor should have done training on
Internal Audit by a NABET certified agency
• Should be familiar with the applicable local regulations and guidelines
• Should be familiar with the checklist
• Should read through the previous audit reports covering the same area

Auditing
The auditor should audit as follows:
• Starting with an opening meeting.
• Using standard auditing techniques and objective information concerning the subject
being audited should be collected.
• Documentary evidence of conformity or nonconformity should be collected. (NAF4 of
217 may be used to document NCs)
• Points where current procedures could be improved should be noted.

Writing the audit report

After the audit, the auditor should prepare an audit report which– classifies the findings of the
audit as follows:
• Acceptable: satisfies the requirements of ISO 15189 and the laboratory's own
standards, procedures, manual, etc.
• Major non-conformances :those which affect patient care directly e.g. any violation in
5.5, 5.6
• Minor non-conformances : those that may not satisfy the requirements of ISO 15189
fully, but may not affect the patients directly e.g. a missing sub-clause in an SOP
• Observation: an area of weakness that could be improved or a comment on something
done well e.g. an additional job aid that might help
The report should be signed off by all the participants (the auditor, auditees and observers)
stating location and date of the audit.

Following-up
• The laboratory should undertake appropriate corrective or preventive actions, which
should be documented and carried out within an agreed upon time. Follow-up and

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
 monitoring of the implementation and effectiveness of the corrective action,
action and if
required,
red, preventive action,
action should be done and documented (Figure 177).

Figure 17: Audit Cycle

6. Documentation:
• The laboratory should retain record of audits including audit programme, records of
meetings, audit report, corrective and preventive action taken, follow-up
follow report and
verification.
• The results of internal audits should
sh be submitted to laboratory management for review.

(Annexure I: Sample format of an audit record)

record

8.3 RISK MANAGEMENT (4.14.6)

Risk is a combination of probability of occurrence of harm and the severity

severity of this
damage.

Risk analysis is the systematic use of available information to identify hazards and to
estimate risk.

Risk assessment is identifying

identifying potential failure modes, determining severity of
consequences, identifying existing controls, determining probabilities of occurrence
and detection, and evaluating risks to identify essential control points.

Risk management is the identification, analysis

analysis and economic control of those risks
which can threaten the assets or earnings of an enterprise.

CLSI EP 23 referrersers to a process of depicting risk factors on a risk assessment matrix to

evolve strategies of intervention.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Risk has three components- the probability of occurrence of harm, the consequences of
that harm and detection rate. Based on the identified risk, a RPN (Risk Prioritization
Number) is calculated. Appropriate measures are implemented to mitigate each risk factor.
The laboratory has established risk management plan for the above mentioned phases of
testing.

Risk prioritization score (RPN) = Severity of harm x Likelihood of occurrence x Detection rate
Areas of risk in a medical laboratory:

Figure 18: Areas of Risk

In ISO: 15189, the risk assessment pertains to the risk of errors in patient reporting on
account of faulty work processes and ensuing failure on examination results. A risk is a
potential error waiting to happen putting the patient result and safety in danger.

Risk management includes steps, planning of risk, identifying the risk and its impact,
developing and establishing risk handling plans and monitoring for risk control. It helps in
preventing errors and clinical hazards.

This evaluation should include identifying the potential for error in five main areas:

• Specimen: The specimen may be at risk for error in the pre-analytic phase. Evaluate
critical steps in specimen collection, labelling, storage requirements, stability and
transport to the testing lab, processing, acceptability, and rejection criteria.
• Environment: The environmental conditions in the laboratory can affect the test
system’s performance, for example, temperature, airflow/ventilation, light intensity, noise
and vibration, humidity, altitude, dust, water quality, electrical failure/power supply
variance or surge, and adequate space.
• Reagent: The reagents, quality control materials, calibrators, and similar materials
required for test processing are susceptible to failure with shipping/receiving, storage
conditions, expiration date (unopened/opened state), and preparation.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
• Test System:: This risk assessment
assessment will primarily cover the analytic and post analytic
phase of testing and must consider function checks and maintenance as required by the
manufacturer. This may vary with the laboratory’s test volume and intended use of the
test results (i.e., screeningg or diagnostic). Factors in this category are quite variable: —
inadequate sampling, clot detection capabilities, capability for detection of interfering
substances (e.g., hemolysis, lipemia, icterus, turbidity) calibration-associated
associated issues —
optical, pipettes,
ttes, sample probes, barcode readers —built-in in procedural and electronic
controls, liquid quality controls, temperature monitors and controllers
• Testing Personnel: This potential risk relates to training and competency assessment.
The impact of inadequate training, ongoing competency, appropriate education and
experience qualifications of staff, and adequate staffing resources can be significant in
test systems that are highly complex.

Figure 19:: Identifying Potential Hazards for

for an Incorrect Test Result (ISO 15189:4.14.6)

A laboratory
aboratory should establish, document and maintain throughout the life-cycle,
life an ongoing
process, provisions for identifying hazards associated, estimating and evaluating the
associated risks, controlling these
these risks, and monitoring the effectiveness of the controls.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
(Annexure J2: Example of a Risk assessment and management record)

An example: Assume that the CV% of a parameter is unacceptably high. It immediately

points to a risk of imprecision. All factors described above must be checked and root cause
determined. Additionally, the laboratory is required to understand other aspects of quality
such as the bias through peer group data to assess the inaccuracies and from there the total
error. The laboratory should then compare it with available quality specifications and decide
whether the method is acceptable and fit for purpose. If not, the method should be changed.

For more details, refer to Quality Control module, Vol. 1

8.4 QUALITY INDICATORS(4.14.7)

This has already been discussed in Chapter 7, however some more details are provided
below.
Quality indicators are established measures used to determine how well an
organization meets needs and operational and performance expectations.

All laboratories should implement a process to monitor and evaluate laboratory performance
by using a set of indicators which cover at least one element or activity from pre-
examination, examination, and post-examination phases that needs improvement.

Points to consider while developing and setting quality indicators:

• Good Quality Indicators are measurable, achievable, interpretable, actionable, balanced,

engaging and timed.
• While deciding the quality indicators, the concept of path of workflow in the laboratory
should be considered. A minimum of 2 per area; pre-analytical, analytical and post
analytical may be considered.
• Too many quality indicators at a time become hard to be tracked.
• Quality indicators that will be most meaningful for the laboratory must be selected.
• The objectives, methodology and duration of measurement should be established.
• A quality indicator should be monitored (e.g. monthly, quarterly or six monthly) and as
long as it is useful.
• Improvement in a quality indicator is achieved by planning and involving all
stakeholders
• After it results in steady and acceptable performance, it should be replaced by a new one.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
 Some examples of quality indicators are listed below:

Pre-examination Examination Post-examination Others

Indicators Indicators Indicators • Number of laboratory
•Incomplete requisition •IQC failure • Turn-Around Times accidents
• Patient Identification • EQC failure • Percentage of • Documentation
accuracy ammended reports related errors
• Equipment failure
•Phlebotomy efficiency • Unavailability of • Customer complaints
• Inventory shortage
•Sample acceptability archived samples • Numbers and types of
• Technical problems
rates non-conformances
•Uncertainty of
•Accuracy of collected Measurement
samples • Invalid test results
• Inappropriate sample • Misinterpretations
transport or storage

Figure 20: Some Quality Indicators

8.5 Reviews By External Organizations: (4.14.8)

The reviews about the performance of the laboratory can be obtained through accreditation
organizations which includes accreditation assessments, regulatory agencies’ inspections, and
health and safety inspections. This process can also be termed as external audit. The assessors
will verify that laboratory policies, processes and procedures are documented and comply
with designated standards. Different standards can be used for the assessment processes.
Examples of audits using ISO 15189 standards are NABL, NQAS, LQMS (WHO). Other
kinds of audits include MCI, PCBs, etc.

After the review, the recommendations of the assessors are presented as nonconformities or
potential nonconformities to the laboratory management and staff, which are then followed
by a thorough written report. The laboratory should review the recommendations of the
assessors, take appropriate immediate action(s) and as appropriate corrective action(s) or
preventive action including timelines and who is responsible to ensure continuing compliance
with the International Standards.

All the actions taken including reviews, corrective action and preventive action taken should
be recorded and stored.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Chapter 9 - Management Review (4.15)

Learning Objectives: At the end of this chapter, the learners should be able to understand
the
o Various aspects of management review
o Process and importance of management review

Management review is evaluation of the overall performance of an organization's quality

management system and identification of improvement opportunities. These reviews are
carried out by the organization's top managers and are done on a regular basis.

Management review is a periodic meeting of management at which it reviews the status and
effectiveness of the quality management system of the laboratory. It acts as a mode of
evaluation and analysis of current practices for the purpose of quality improvement.

Management review is a valuable component of the quality management systems including

medical laboratory QMS in accordance with ISO 15189. It is the responsibility of the
Quality Manager to plan, schedule and coordinate the MRM. An MRM is generally
conducted after the Internal Audit. This will enable the management to understand the needs
of the laboratory and address them adequately. The frequency of management reviews
should not be more than 12 months. However, when a QMS is being established, shorter
intervals should be fixed. Quarterly reviews are recommended to keep both technical and
managerial functionaries in contact and engaged in the quality improvement process.

The report of the management review meeting (MRM) is mandatory for application for
accreditation. The three components of the MRM are –

• Review inputs
• Review activities
• Review outputs

Review Inputs

They imply the data/information submitted by the technical team to the management team for
deliberations.

The input to management review should include information from the results of evaluations
of at least the following:

• The periodic review of requests, and suitability of procedures and sample

requirements.
• Assessment of user feedback

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
 • Staff suggestions
• Internal audits
• Risk management
• Use of quality indicators
• Reviews by external organizations
• Trends in IQC programs
• Results of participation in inter-laboratory comparison programmes, PT/EQA
• Monitoring and resolution of complaints
• Performance of suppliers and inventory management
• Identification and control of nonconformities
• Results of continual improvement including current status of corrective actions and
preventive actions
• Follow-up actions from previous management reviews
• Changes in the volume and scope of work, personnel, and premises that could affect
the quality management system
• Recommendations for improvement, including technical requirements.

The lab may however choose to include any challenges like staff availability/attrition,
training and CME opportunities and other specific challenges.

Review Activities:

At the review, the management is required to analyse the input information and determine the
causes of nonconformities, trends and patterns that indicate process problems. The
management should also look at opportunities for improvement and the need for changes to
the quality management system. The quality policy and quality objectives may be reviewed
and amended. New objectives may be set and new indicators defined to enhance the
laboratory’s contribution to patient care.

Review Outputs:
The decisions at the MRM should be documented and minutes circulated and explained to all
lab members. The responsible persons should be oriented towards any new objectives and
indicators chosen at the MRM.

Reports of the management review should be retained for the time interval as stated in
guidelines. (Annexure L:Format of a Management Review meeting record, Sample)

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
REFERENCES:

1. ISO 15189:2012: International Standard: Medical Laboratories- Particular requirements

for quality and competence. Third edition.
2. Laboratory Quality Management System: Version 1.1, 2011, WHO.
3. NABL 112: Specific Criteria for Accreditation of Medical Laboratories.
4. NABL 161: Guide for Internal Audit and Management Review for Laboratories.
5. International vocabulary of metrology — basic and general concepts and associated
terms (VIM): JCGM 200:2008.
6. CLSI GP26-A4QMS: A Model for Laboratory Services
7. CLSI EP23-A, Laboratory Quality Control Based on Risk Management; Approved
Guidelines

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Glossary

Accreditation : Procedure by which an authoritative body gives formal

recognition that a body or person is competent to carry out
specific tasks. Reference: ISO 15189
Accuracy : The closeness of a measurement to its true value.
Audit : A documented activity performed to verify, by examination
and evaluation of objective evidence, that applicable
elements of the quality system are suitable and have been
developed, documented, and effectively implemented in
accordance with specified requirements

Compliance : An affirmative indication or judgement that the supplier of

a product or service has met the requirements of the
relevant specifications, contract or regulation; also the state
of meeting the requirements. Meets both the text and the
spirit of a requirement.
Incidence : An individual occurrence of brief duration or secondary
importance
ISO Standards : A set of international standards providing guidance for
quality in the manufacturing and service industries;
developed by the International. Organization for
Standardization (ISO) to help companies effectively
documents the quality system elements to be implemented
to maintain an efficient quality system. The standards,
initially published in 1947, are not specific to any particular
industry, product or service; they are broadly applicable to
many kinds of organizations.
NABL : National Accreditation Board for Testing and Calibration
Laboratories (NABL) is an autonomous body under the
aegis of Department of Science & Technology,
Government of India, and is registered under the Societies
Act.

Non Conformance : Non-fulfilment of a requirement

Indicators : Established measures used to determine how well an
organization is meeting its customers' needs as well as
other operational and financial performance expectations

Organogram/Organization : Defines the working structure for the organization;

Chart organizes jobs along lines of authority; defines reporting

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
 structure and span of control; defines authority to make
decisions and accountability for results; works together
with job descriptions to define the working structure of the
organization.
Process control : Concerns monitoring all operations of the laboratory.
QMS : A quality management system (QMS) is a collection of
business processes focused on achieving quality policy and
quality objectives to meet customer. It is expressed as the
organizational structure, policies, procedures, processes
and resources needed to implement quality management.
Early systems emphasized predictable outcomes of an
industrial product production line, using simple statistics
and random sampling

Quality Assurance : A planned and systematic set of quality activities focused

on providing confidence that quality requirements will be
fulfilled.
Quality Control : A set of activities or techniques whose purpose is to ensure
that all quality requirements are being met. Simply put, it is
examining “control” materials of known substances along
with patient samples to monitor the accuracy and precision
of the complete examination process.
Quality Policy : Overall intentions and direction of an organization related
to quality as formally expressed by top management.
Reference: ISO 9000:2005.
Risk Management : The identification, analysis and economic control of those
risks which can threaten the assets or earnings of an
enterprise.
Sensitivity : Sensitivity is the lowest concentration of an analyte that
can be measured. This is also LoD/LoQ
Specificity : Artefactual increase or decrease of quantity of analyte due
to the presence of any interfering substance(s).
TAT : Length of time that a sample’s final result may be issued to
the ordering physician.
Validation : Confirmation, through provision of objective evidence, that
the requirements for a specific intended use or application
have been fulfilled.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
List of Abbreviations

AMC : Annual Maintenance Contract

BMW : Bio-Medical Waste
CA : Corrective Action
CAP : College of American Pathologist
CAPA : Correction and Preventive Action
CLIA : Clinical Laboratory Improvement Amendments
CLSI : Clinical & Laboratory Standards Institute
CMC : Comprehensive Maintenance Contract
CME : Continuing Medical Education
CMO : Chief Medical Officer
CQI : Continuous Quality Improvement
CV : Coefficient of Variation
EQA : External Quality Assessment
HICC : Hospital Infection Control Committee
HOD : Head of Department
HR : Human Resource
IDSP : Integrated Disease Surveillance Programme
IPHS : Indian Public Health Standards
ISO : International Organization for Standardization
IT : Information Technology
LIS : Laboratory Information System
LQMS : Laboratory Quality Management System
MCI : Medical Council of India
MoU : Memorandum of Understanding
MRM : Management Review Meeting
NABET : National Accreditation Board for Education and Training
NABL : National Accreditation Board for Testing and Calibration
Laboratories
NC : Non conformance
NCE : Non-Conforming Event
NHM : National Health Mission
NQAS : National Quality Assurance Scheme
NVBDCP : National Vector Borne Disease Control Program
PCB : Pollution Control Board
PDCA : Plan Do Check Act
PMO : Primary Medical Officer
PT : Proficiency Testing

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
QC : Quality Control
QM : Quality Manager
QMS : Quality Management System
QSP : Quality System Protocols
RCA : Root Cause Analysis
RPN : Risk Prioritization Number
SACS : State AIDS Control Society
SLIPTA : Strengthening Laboratory Management Towards Accreditation
SOP : Standard Operating Procedure
SQAC : State Quality Assurance Committee
TAT : Turn Around Time
WHO : World Health Organization

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Annexure
Annexure A: Confidentiality undertaking by the employee (to be submitted at the time of
induction): Sample

I understand and acknowledge that:

1. I shall respect and maintain the confidentiality of all discussions, deliberations, patient care records
and any other information generated in connection with individual patient care, risk management
and/or peer review activities.

2. It is my legal and ethical responsibility to protect the privacy, confidentiality and security of all
information relating to the laboratory, including business, employment and medical information
relating to our patients, members, employees and health care providers.

3. I shall only access or disseminate patient care information in the performance of my assigned duties
and where required by or permitted by law, and in a manner which is consistent with officially
adopted policies of the institute/hospital, or where no officially adopted policy exists, only with the
express approval of my supervisor or designee. I shall make no voluntary disclosure of any
discussion, deliberations, patient care records or any other patient care, peer review or risk
management information, except to persons authorized to receive it in the conduct of lab affairs.

7. I understand that any and all references to HIV testing, such as any clinical test or laboratory test
used to identify HIV, a component of HIV, or antibodies or antigens to HIV, are specifically protected
under law and unauthorized release of confidential information may make me subject to legal and/or
disciplinary action.

8. I understand that the law specially protects psychiatric and drug abuse records, and that
unauthorized release of such information may make me subject to legal and/or disciplinary action.

9. My obligation to safeguard patient confidentiality continues after my termination of employment or

affiliation with the laboratory.

I hereby acknowledge that I have read and understand the foregoing information and that my
signature below signifies my agreement to comply with the above terms. In the event of a breach or
threatened breach of the Confidentiality Agreement, I acknowledge that institute may, as applicable
and as it deems appropriate, pursue disciplinary action as described in the bylaws.

I further understand that I may also be subject to civil or criminal legal penalties if I violate these
security policies.

Dated: _____________

Name &Signature: _________________________________________________________

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Annexure B: Consent Form for FNAC: Sample

FNA Consent Form

Patient Name_______________________________

Patient DOB:_____/_____/__________

The procedure of Fine Needle Aspiration (FNA) will consist of the following:

A needle will be inserted into the neck mass from 1 to 4 different angles; the samples will
then be sent out for cytopathology evaluation.

Complications may include:

Pain at the injection sites, infection, and air trapped under the skin, mild bleeding

I confirm that I do not have any bleeding disorders, and have abstained from blood thinners

or aspirin therapy for 5 days prior to the procedure.

I have read and consent to have a Fine Needle Aspiration performed by Dr. XYZ

Patient’s signature ___________________________ Date: _____/_____/__________

Post FNA Instructions

1. Do not take aspirin for 2 days following the procedure.

2. Take painkillers every 6 hours as needed for pain, unless you are allergic to it.
3. If you experience sudden neck swelling, or shortness of breath, go to the nearest
emergency medical service.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Annexure C: Job description: Sample

Job Title: Laboratory Technical Manager

Job Summary

A Laboratory Technical Manager is responsible for managing a medical laboratory, including

supervision of laboratory staff.

Nature of Work

This position reports to a Director of the laboratory. This position receives assignments in
terms of broad goals and is given considerable latitude for decision-making and establishing
priorities in managing the laboratory. The Laboratory technical manager is responsible for
supervising the various tests, results, software systems, quality control, and pricing for the
lab, as well as supervising staff, primarily Medical Technologists.

Duties

• To supervise and train staff in the performance of laboratory functions – both

administrative and technical operating procedures. To evaluate staff proficiency and
performance.
• To establish and implement written operating procedures and protocols for tests
performed in the laboratory
• To establish and maintain a routine documented schedule of quality control and
quality assurance, including external quality control.
• To develop and direct the statistical and record keeping software functions of the
laboratory.
• To perform laboratory testing – haematology, immunohematology, bacteriology,
mycology, urinalysis, immunology, chemistry, endocrinology, serology, and
parasitology. To obtain and process specimens; perform tests; interpret and report
results.
• To review test results, and follow-up on abnormal and critical values.
• To evaluate and establish costs/price for individual in-house tests with supervisor and
independently negotiate price for off campus testing.
• To stay abreast of new tests, new procedures, and new technology in the medical
technology field. To initiate discussion with medical and administrative personnel
regarding implementation of new methodology, tests, and procedures as appropriate.
• To manage laboratory inventory, establish preventative maintenance schedule for
equipment; oversee computerized records system.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Annexure D: Organogram of a Public health Laboratory: Sample

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Annexure E1: Format for procedure for selection and evaluation of Referral laboratory:
Sample

1. General Policy

It the policy of XYZ lab that any work that needs to be referred, in-house or to external
laboratories, for whatever reason, are in compliance with this Quality Management System
and requirements ISO/IEC 15189 International Standards and other regulatory agency
requirements.

Referral laboratories are evaluated, selected and monitored by the management of XYZ
lab.All method and instrument validations and comparisons are performed before work is
placed with a referral laboratory or with a backup instrument.

2. Purpose

The purpose is to ensure that the use of referral laboratories is done in a standard way that
does not compromise the Quality of XYZ service to its clients.

3. Scope

This procedure covers the entire test schedule of XYZ and refers to any occasion that may
require the use of a backup system or referral of test work.

4. Responsibilities

Quality Manager

• Evaluation and monitoring of referral laboratories.

• Method and instrument validation and comparison of referral laboratories instruments
and XYZ instruments.
• Performance comparison between primary and back-up instruments at XYZ.

Lab Manager

• Selection of the referral laboratories to use when the need arises.

• Approval of the use of referral laboratories as required.
• Identify all tests that require the use of referral laboratories.

All staff

• Ensure that they report all malfunctioning equipment to the Lab Manager by filling
out a corrective action and problem report form.

Referral Laboratories

• Ensure that they fulfill XYZ conditions of service and requirements for referred work.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
5. Procedures

Evaluation of Referral Laboratories

All referral laboratories shall be evaluated before they can be short listed for selection. In the
first phase of the evaluation process , evaluation form document number XYZ/001FR026
shall be used in the collection of information from potential referral laboratories. The second
phase of the evaluation process shall involve method and instrument performance comparison
between the referral lab and XYZ

Selection

Once a method and instrument performance comparison is accepted, then cost factor
evaluated and this is the responsibility of the Laboratory Manager. Reasons for selections
shall be fully documented.

Monitoring

Constant monitoring of the referring lab for continued compliance to requirements. This shall
include bi-annual instrument comparison studies and annual initial evaluation process, EQA
reports analysis, IQC reports analysis and Instrument performance checks.

Instrument Comparison

Instrument comparison studies should be done biannually to ensure results from referral
laboratory instruments and XYZ instruments agree. This should follow the procedures laid
down in the SOP on Method and Instrument Validation. The same should be done for XYZ
back-up systems. All maintenance checks should be performed to the back up system.

Using Back up Measures for Testing

• Fill in the CAPA form when the non-conformity has been identified.
• Send CAPA form to the Laboratory Manager for assessment of the problem. Lab
Manager approves the use of back up instrument or referral laboratory.
• Notify appropriate personnel, e.g. at referral lab that you will be sending samples, Lab
staff to prepare the backup instruments.
• Send samples for testing ensuring that specimen integrity is maintained through the
proper transport procedures.
• Evaluate results all result reports obtained from back up instruments or referral labs to
ensure they conform to requirements.
• When corrective actions have been implemented and evaluated to have been effective,
the original testing system can then be put back in place for normal operations to
resume.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
6. Results reporting

All final reports sent to clients shall state that backup system or referral laboratory was used
for testing the samples. This can be achieved via the use of memos or indicating on the
reports.

7.Quality Assurance and Quality Control

Thorough evaluation process, thorough monitoring of selected referral labs or system,

appropriate documentation and record keeping.

8. Records

• Method and Instrument Validation and Comparison Records.

• Back-up Plan list.
• Corrective action and problem report forms.
• Evaluation and Selection Criteria Reports.
• Conditions of Service for referred work.

9. Reference

• XYZ Quality Manual Current Version.

• ISO/IEC 17025 International Standard.

Appendix – Evaluation and Selection Criteria Form

Revision History:

Revision Revision Revised By Brief description of revision

Level Date

(Format)

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Annexure E2 – Evaluation and Selection Criteria Format: Sample

Evaluation done by: ...........................................................................................

Date: ...............................................

Please attach supporting documents as and when necessary

A. Laboratory’s Capabilities (maximum 25 points)

1. Background (1-5 points): --

a) Does the laboratory have a reputation for high quality and integrity? ……..
b) How long has the lab been in business (e.g. 5 years, 10, more)? ……..
c) What are clients' general observations regarding the lab's services? ……..

2. Experience and references (1-5 points): --

a) Has the laboratory provided a list of References? …….

b) How long have clients been served by the lab? ………..

3. Quality Management (1-5 points): --

a) Does the lab have a QMS? …………………

b) Does the Lab have a Quality Assurance Plan? …………….
c) Is the Laboratory accredited? Is the documentation available? ……..

4. Equipment (lab and data handling) (1-5 points): --

a) Is the testing equipment adequate for the scope and volume of services offered?
b) Is there adequate backup in the event of equipment failure? ……….
c) Does the automated data processing equipment capability appear to be adequate for the
scope of the work contract (e.g., direct transmissions, online result reporting)?

5. Accreditation and certifications (1-5 points): --

Total points for section A: …………………….

Document where the lab was lacking: ....................................................

B. Quality assurance (maximum 25 points; assign 1-5 points for each question)

a) Is a written, organized, comprehensive quality control (QC) program in place? --

b) Is there a process for remedial action when QC tolerance limits are exceeded? --
c) Is an ongoing monitoring program in place to review, detect, and correct system errors?
d) Is a copy of proficiency testing (PT) results available for at least the previous 24 months,
and for deficiencies noted, were appropriate and timely corrective actions documented?
Attach copies --

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
e) Does the laboratory have a written, clearly defined protocol for notifying clients of
critical values?

Total points for section B: ____________

Document where the lab was lacking: …………………………………………………………

C. Efficiency of referral services (maximum 25 points; assign 1-5 points for each question)

a) Does the lab offer a sufficient range of services to satisfy our needs? --
b) Does the lab provide a written TAT for each test performed, and does the TAT meet our
needs? --
c) Are data elements for each test complete? –
d) Methods used for testing/reporting results --
e) Specimen handling policies/procedures. Includes clearly defined, comprehensive
instructions for preparing specimens as well as criteria for rejecting unsatisfactory
specimens --
f) Equipment maintenance policies --
g) Information and data handling policies/procedures --
h) Printing of reports via computer or printer in participating lab (is printer provided?) --
i) Adequate specimen pick-up service?
j) Does the lab have a written protocol for reviewing test reports for possible errors? --
k) Is the test report format clear and can it be read easily? --
l) Does the lab provide client consultation services on a daily basis, including client
services, technical advice, and medical consultation concerning appropriate test ordering
and interpretation of results? --
Total points for section C: --

Document where the lab was lacking: .......................................................................... .......

D. Personnel (maximum 30 points; assign 0-5 points for each question)

a) Percentage of technologists to technicians: [is greater than] 75% (5 points); 50% (3

points); [is less than] 25% (0 points) --
b) Does the lab employ a qualified supervisor during all hours of operation? Yes (5 points);
No (0 points) –
c) Are specific staff members assigned to assist us at all times? Yes (5 points); No (0 points)
d) Are doctoral-level scientists or pathologists available for consultation? Yes (5 points); No
(0 points)
e) Does the technical staff have expertise in all areas required? Yes (5 points); No (0 points)
f) Does the technical staff receive continuing education on an ongoing basis and is this
education documented? Yes (5 points); No (0 points) --
Total points for section D: --

Document where the lab was lacking: .......................................................................................

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
E. Results for method and instrument comparison studies: Acceptable/Unacceptable

Evaluator’s comments: ................................................................................................................

Lab Manager Comments: ............................................................................................................

Lab Approved/Not Approved: ...................................................................................................

Signature: .................................................. Date: ........................................................................

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Annexure F1: Format for Supplier Selection and Evaluation (Equipment): Sample

Equipment Equipment Equipment Equipment Total Comments Evaluation

Assessment 1 2 3 Marks by
Equipment
Name/ID
Name Of Service
provider
1 Promptness of
service
(If downtime
monitoring is
available, pl
mention)
2 Remote
support
3 Onsite support

4 CMC
availability
5 Availability of
spare parts

6 Provision of
Staff Training

Change to the
approved
supplier(Yes/No)If
yes, evaluate the
new supplier
Total Marks
Grading
Sign by QM

Grades from 1 to 5: 1 for poor performance, 2 average, 3 good, 4 very good, 5 excellent

Maximum marks possible 25.The policy has to be defined by the lab for cut off. This is to be
defined in the QSP

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Annexure F2: Format for supplier selection and evaluation (Reagent): Sample

Evaluation point Supp Supp2 Supp3 Total Comments Evaluation

1 Marks by
Change to the approved
supplier (YES/NO)If
yes, evaluate the new
supplier
1 Level L1 :
10
L2 : 8
L3 : 6
2 Maintaining
Rate Contract
3 Maintaining
Cold chain
4 Condition of goods on
reception
5 Promptness of Delivery

6 Maintaining Steady
Lots
7 Providing Long Expiry

8 SOS supply
9 Replacing failed
“Acceptance testing”
goods
10 Change to the approved Y/N Y/N Y/N
supplier). If yes,
evaluate the new
supplier
Total
Grading
Sign by QM

Grades from 1 to 5. 1 for poor performance, 2 average, 3 good, 4 very good, 5 excellent.

Maximum marks 50. The policy has to be defined by the lab for cut off. This is to be defined
in the QSP

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Annexure G: Format for Feedback and Complaint Resolution: Sample
Front Side (Feedback)

Date
Time
Name (Not Mandatory)

Phone No
Adress
Age/Sex
Feedback Form
1- Information and guidance at reception/registration
Good Satisfactory Unsatisfactory Poor

2- Time taken for registration /Total waiting Time

Good Satisfactory Unsatisfactory Poor
Good Satisfactory Unsatisfactory Poor
4-How do you rate the staff behaviour?
Good Satisfactory Unsatisfactory Poor
5- Hygiene and cleanliness in the lab
Good Satisfactory Unsatisfactory Poor
6- Are you satisfied with the report?
Yes No If no, why
7-Was the report delivered on time?
Yes No
Note- We are working to improve accessibility at the Lab. Your feedback is important to
us, Please help us continue improve accessibility at the lab sothat we can better serve our
patients.

Signature of Patient

Signature of QM

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
 Back Side (Complaints)
Date
Time
Name (Not
Mandatory)
Phone No
Address
Age/Sex
Complaint

Immediate Action

RCA

Resolution of the Complaint

Time taken for resolution

Preventive Action

Signature of
QM

Note: Please translate into local language. Make available at all customer interfaces.

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Annexure H: Format for NCE/Incident/ Occurrence/Accident reporting and immediate,
corrective and preventive action taken: Sample

Date/Time
Non-Conforming Event /
Incident / Accident

Clause No (ISO 15189)

Department
Reported by
Immediate Action

Corrective Action

RCA (Root cause analysis)

Preventive Action

Time Taken for resolution

Sign QM
Sign of Lab Director

1. NCE - Any event not in conformance to the stated policies & procedures of the lab. e.g.
Non fasting sample accepted for a lipid profile test, lack of Preventive Maintenance
2. Incidents - small occurrences/ mishaps e.g. Needle stick injuries, Spills
3. Accidents - larger occurrences e.g. Fire
Note: These formats should be available at all points of Laboratory services from
Registration to sample disposal. In all the above occurrences, the full follow up (including
immediate response, CAPA) should be documented and filed

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Annexure I Format for Records of Internal / External Audit: Sample
Type of
Audit
Name of
Auditor
Checklist No
(By Which
conducted
the audit)
Date of Audit

S. NC. Typ Claus Departme NCE in Responsibilit Time for Correcti Attached
N No e e nt (Area) Detail y closing ve action document
o the NC

Annexure JI: Format for assessing and managing risk: Sample

examination/Examinat
ion/Post Examination)

Person Assessing the

Sign of Lab Director

Tool used (Maintain

taken - approval by
Signature Of QM

Review of action
Process involved

(Mild/Moderate/

Action Taken
Place/Section

Type of risk
Occurrence
evidence)

Severity

Severe)
(Pre –
S.No

Date

risk

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Annexure J2: CLSI EP23 Risk Assessment Matrix

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Annexure K:Format for recording Management Review Meeting reports: Sample
Sl. No
Subject QMS
improvement
Improvement
of services to
users
Resource
Needs
Responsibility

Action Plan

Date of completion

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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
Labs for Life Project
Checklist for Management Requirements as per ISO15189 Clause 4

A Organization and Management Responsibility Y/N/P Remarks

1 Does the management have general awareness about laboratory QMS?

2 Is there a copy of ISO 15189 with the management?
3 Is the management engaged in the activities of the lab as per ISO mandate?
4 Does the lab have legal identity apart from the hospital identity? Answer Y/N/NA
5 Are documentary evidence available for the legal entity? Lab? Hospital?
6 Are the following available?
a No objection certificate from the Competent Fire Authority
b Authorization under Bio-medical Waste Management Rules, 2016
c Clearance from State Pollution Control Board
7 Does the management uphold ethical values?
a Is there awareness of situations which could give rise to conflicts of interest?
b Is ethics part of induction training?
c Are there policies to safeguard confidentiality such as confidentiality undertaking from staff?
d Is patient consent taken for invasive lab procedures?
e Is access restricted to patient results?
f Are samples handled as per legal requirements?
g Are work authorizations available for all staff?
h Is the organizational structure clearly defined?
Are there organograms done lab functioning and the relationship of the lab to bodies it is affiliated
i
to?
Is clear designation of authority, inter-relationships and responsibility at each level with an
8
escalation matrix available?
9 Are accurate assessment of available personnel to perform different activities available?
10 Is there a designated Lab Director ?
11 Are the responsibilities of the lab director shared?
12 Are all the responsibilities as defined in the standard met through these assigned people?
Do the assigned people have the skill, competence and authority to impart the assigned
13
responsibilities? Please define
14 Is there a designated Quality Manager?
Does the assigned person have the skill, competence and authority to impart the assigned
15
responsibilities? Please define
16 Has the 4-days training Quality Management as per ISO 15189 provided to this person?
17 Is the person a fulltime employee?
18 Were signed JDs evidenced for all staff?
19 Are there provisions for in-service training? (Workplace training/ CMEs)
20 Does this happen in a calendared manner?
Are all components addressed through training?(Standard testing practices, Safety, Quality System
21
Essentials)
22 Was the training calendar evidenced?
23 Is there documentation of this?
24 Is there a provision for staff vaccination and health check-up?
25 Is there documentation of this?
26 Is there a provision to note staff suggestions, feedback and grievances?
27 Is there documentation of this?
28 Is staff competency assessment conducted for all staff by authorized personnel, periodically?
29 Is there documentation of this?

B Management Commitment Y/N/P Remarks

Does the management provide necessary qualified and competent human and financial resource
1 along with infrastructure facilities to maintain laboratory quality management system as per ISO
15189
2 Are management review meetings done regularly?
3 Is the management aware of the need of the users?
4 Has the management put forth a Quality Policy to stat its intent and commitment for the lab?
5 Has the management stated Quality Objectives for continual improvement?
6 Has the management established channels of communications?
a with the lab
b within labs
c between labs and other departments
d between labs and regulatory bodies
e with the patients and users
7 Does the management provide training to its laboratory technical supervisory staff?
8 Does the management provide training to its laboratory frontline staff?
Does the management involve the laboratory staff in the decision- making process like equipment
9
and reagent purchase?
10 Are specific budgetary lab heads available?
11 Does the management ensure appropriate resource allocation for the lab for the following:
a Appropriate accommodation and environment
b Adequate human resources at all levels of technical functioning including technical
c supervisory staff, lab technicians, lab attendants, housekeeping and security
d Equipment availability and calibrations
e Regular supply of reagents and consumables
12 Does the management evaluate the resource utilization by the lab?

C Document Control Y/N/P Remarks

Has the management established a documentation procedure for the lab? Is there a documented
1
procedure available?
2 Are the following control procedures addressed adequately?
a Document Hierarchy
b Indexing of all documents as per standard
c Change procedures
d Retention
e Master Log
f Distribution
g Review
3 Are electronic documents under document control?

D Service Agreements Y/N/P Remarks

1 Is there a documented procedure for service agreements?

Does the management ensure that the needs of the users are met by the inputs provided to the lab
2
with reference to skill, quality of reagents, equipment etc.?
3 Is the test menu displayed?
4 Is there an enquiry desk or similar facility where patients and users can clear their doubts?
5 Are the users notified if there is any deviation form the agreements?
6 Are these documented?

E Examination by Referral Laboratories Y/N/P Remarks

1 Does the lab refer samples to other labs?

a Is there a documented procedure for this?
2 Are the following ensured with reference to these labs?
a Accuracy and quality of results
b Meets facility and equipment requirements
c Uses verified testing and examination methods
d Compliance to Safety requirements
e Employs qualified personnel
f Accredited under ISO15189
g Has a documented QMS
h Follows QC practices
i Acceptable performance in proficiency testing
j Effective turnaround time
k Provides timely advisory services
 l Passes on-site inspection
m No conflict of interests

F External Services and Supplies Y/N/P Remarks

1 Is there a documented procedure for managing this?

2 Does the management select suppliers with inputs from the laboratory?
Does the management ensure that disruptions in services are avoided by adequately managing
3
services and supplies?
Does the management ensure that disruptions in services are avoided by adequately managing
4
service providers and suppliers?
5 Are supplier evaluations done periodically?
6 Is this done objectively?
7 Are these documented?
8 Are AMC/CMC made available for all equipment?
9 Is technical support made available whenever required?
a Does this tech support include engineering support?
b Does this tech support include applications support?
10 Is remote support made available for all major equipment?
11 Are all spare parts adequately made available whenever required?
12 Was spare parts inventory evidenced for all major equipment?
13 Is there any stock out on the day of audit?
14 Are there lists of service providers available for ready reference?

G Advisory Services Y/N/P Remarks

1 Are advisory Services made available by the management?

2 Do these include the following:
a Advising clients on choice of examinations
b Advising on individual clinical cases and need for specific confirmatory/additional testing
c Immediate communication of critical values
d Professional judgements on the interpretation of the results of examinations
e Promoting the effective utilization of laboratory services
f Trainings/meetings between clinical staff and lab staff
3 Are these documented?

H Resolution of Complaints Y/N/P Remarks

1 Is there a documented procedure for this?

2 Does the complaint redressal mechanism have the following:
a Format for receiving complaints
b Format for receiving feedback
c Reviewing
d Investigating the cause
e Corrective action
f Continual improvements

I Improvement Process Y/N/P Remarks

1 Is there a documented procedure for this?

2 Are quality indicators set for areas needing improvement?
3 Are dashboards for these available?
4 Are they monitored, reviewed, discussed with the staff?
5 Does the lab have a format to capture non-conforming events and incidents?
6 Are these available at all points of operation?
7 Are they adequately filled-in by the staff?
8 Is there a laid down protocol for addressing the reported NCEs/ Incidents?
9 Are all NCEs/ incidents addressed as per the defined protocol, by the relevant staff?
10 Are these reviewed by the management?
11 Are they analyzed periodically?
12 Is this reviewed at the MRM?
13 Have the corrective actions been found satisfactory?
14 Have the preventive actions been found satisfactory?
15 Have management tools like FMEA, RCA etc. used for improvements?
16 Is there documented evidence available for such?
17 Have the findings of such interventions discussed with all relevant staff?
18 Has this brought about continual improvement in the system?

J Control of records Y/N/P Remarks

1 Does the lab have a documented procedure maintaining records?

2 Are the following addressed and implemented adequately?
a Identification
b Collection
c Indexing
d Access
e Storage
f Maintenance
g Amendment
h Safe disposal
3 Are all the necessary records evidenced?

K Evaluation and Audits Y/N/P Remarks

1 Does the management have procedures for periodically evaluating the laboratory?
2 Do these include the following:
a Routine process audits through NCE tracking
b Internal audits
c External Audits
d Risk Assessments
e Quality Indicators
f Staff suggestions
g Feedback from users
3 Is there a documented procedure for internal audits?
4 Are Internal Audits done in the pre-analytical, analytical and post-analytical aspects?
5 Is a validated checklist used?
6 Are all departments notified adequately before the IA?
7 Are reports prepared by the auditors and submitted as planned?
8 Are adequate corrective actions on taken on gaps found?
9 Are the findings and status updated at the MRM?
10 Are risk assessments done in bottleneck areas of the lab?
11 Are the findings communicated to the workers concerned?

L Management Review Meetings Y/N/P Remarks

1 Does the management review the activities of the lab through formal MRM?
2 Is this done at least once a year?
3 Are all activities as suggested by the ISO standard reviewed?
4 Is the review output communicated to all concerned?
5 Are documents for these evidenced?

Name & Signature of the Assessor________________________________________