Training Module On Managment Requirements PDF
Training Module On Managment Requirements PDF
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
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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
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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
List of Tables
List of Figures
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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.
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.
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.
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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.
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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 -
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.
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
STORAGE OF SAMPLES
SAMPLE SAMPLE PROCESSING
TANSPORTATION ARCHIVAL OF
DOCUMENTS &
PATIENT RECORDS
PREPARATION TEST ANALYSIS &
SAMPLE ACCESSIONING CALCULATIONS DISPOSAL OF SAMPLES
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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).
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.
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
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
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.
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Table 1: Management and Technical QMS Requirements
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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
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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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.
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
• 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.
WHAT IS ETHICS?
ETHICS IS
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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Maintain Confidence in the Lab Competence, impartiality, integrity
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?
• 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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• 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.
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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.
The defining of organizational structure leads to efficient and effective laboratory operation
and meeting the quality goals.
Key Requirements:
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
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o For support the optimal path of workflow for the best possible quality outcome.
o For understanding the path of escalation of problem resolution
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
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)
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The organizational chart (Figure
Figure 8)
8 for Functional Management
anagement can be shown as below:
Medical Superintendent
Lab
Lab-in-charge
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.
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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Responsibilities of Lab Director:
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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.
• 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.
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.
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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
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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.
MANAGEMENT COMMITMENT
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.
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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.
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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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.
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.
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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Table 3: Sample Training Calendar
• 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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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
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.
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• 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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Chapter 4 - External Services and Supplies (4.6)
Learning Objectives: At the end of this chapter, the learners should be able to understand
the
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.
Both Management and Technical teams are equally accountable for the procurement 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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• 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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Chapter 5 - Advisory Services (4.7)
Learning Objectives: At the end of this chapter, the learners should be able to understand
the
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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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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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
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.
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)
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Complaint Reporting
Complaint received by Form initiation
laboratory
Decide on Appropriate
Corrective Action
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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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
Conformity: When the actual practices followed in the laboratory or the findings are in
concordance with the laboratory’s policies or the standard guidelines.
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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
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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.
Note:
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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)
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.
This is the reiteration and continuation of the above section on non-conformances (4.9).
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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.
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
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.
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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.
The term potential implies possibility. The lab is required to understand all possible problems
before it manifests.
• 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
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:
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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%
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.
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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)
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.
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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.”
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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
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 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:
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.
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:
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.
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).
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.
Risk analysis is the systematic use of available information to identify hazards and to
estimate risk.
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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:
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.
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)
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.
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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:
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 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.
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:
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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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REFERENCES:
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Glossary
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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
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Labs for Life Project Training Module on Management Requirements for a Laboratory Quality Management System
List of Abbreviations
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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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Annexure
Annexure A: Confidentiality undertaking by the employee (to be submitted at the time of
induction): Sample
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.
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: _____________
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Annexure B: Consent Form for FNAC: Sample
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.
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
I have read and consent to have a Fine Needle Aspiration performed by Dr. XYZ
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Annexure C: Job description: Sample
Job Summary
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
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Annexure D: Organogram of a Public health Laboratory: Sample
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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
Lab Manager
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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5. Procedures
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.
• 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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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.
8. Records
9. Reference
Revision History:
(Format)
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Annexure E2 – Evaluation and Selection Criteria Format: Sample
Date: ...............................................
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? ……..
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)?
B. Quality assurance (maximum 25 points; assign 1-5 points for each question)
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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?
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: --
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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
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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
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
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
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
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
Corrective Action
Preventive Action
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
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
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?
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?
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?
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?