Summary
Histopathology
is the branch of medical science which focuses on the microscopic diagnosis of
tissues in diseased states. It also comes handy on assessment of the efficacy,
safety and effectiveness of new drugs such as tamoxifen/herceptin at the
molecular level, medical devices and biologicasl (such as cervical cancer
vaccine) prior to approval for public use.
Towards this end, quality data must be generated from the histopathology
laboratory. In many developing
countries, doubts often arise on the quality of the data generated from
laboratory facilities. One of the
adduced reasons for this poor showing is lack of quality management system,
lack of understanding of the concept, implementation and monitoring of
Laboratory Quality Management System (QMS).
A thorough
understanding of the essentials of quality management system is therefore a
necessity by all stakeholders working in the histopathology laboratory
especially the histology scientist so as to foster the generation of reliable,
valid, complete, timely, precise, accurate, fault-proof (integrity), and
confidential data. This will ultimately
yield enviable outcomes such as reduction in incidences of high disease burdens
especially those of malignant origins.
This article is aimed at explaining the various essential components of
the laboratory quality management system as it applies to histopathology
laboratory setting with a view to empowering medical laboratory professionals
in that field to generating quality histopathology laboratory data through the
implementation of the quality management system.
Introduction
The prime
place of the histopathology laboratory just like others is to produce valid,
accurate, complete, reliable, timely, fault-proof and confidential data which
meets desired purpose. The production of
high quality histopathology slides must be viewed in the context of
cost-effectiveness, cost-benefit and cost-utility due to the reality of scarce
resources available in a low resource setting.
The necessity of top quality histopathology laboratory services cannot
be overemphasized as it provides the evidence-based foundation for medical
diagnosis, treatment and monitoring. Histopathology laboratory data is very
vital in the provision of epidemiological evidence at local, national and
international levels and boost effort towards prevention of future outbreaks of
epidemics through autopsy.
Inclusively,
histopathology laboratory data provides strong support for training and
research and it is the basic demand by accreditation bodies for regulatory
purposes.
National and
international health bodies responsible for determination of standards have
recently generated keen awareness to stir up the implementation of quality
systems to improve laboratory services.
The ISO 15189 especially is well suited for the histopathology
laboratory and aims at customers’ satisfaction.
Quality
management system in the histopathology laboratory will promote human capital
development, job satisfaction, detect and eliminate errors in laboratory processes
and procedures, foster high ethical practice and ultimately contribute to
building a strong health system. With
quality management system, laboratory policy formulation and implementation
becomes a sine qua non.
What is
Quality Management System (QMS)?
According to the ISO, quality management system (QMS) is
defined as ‘coordinated activities (management system) to
direct and control an organization with regards to quality’.
A
system is built around the path of work flow through policy formulation,
processes, procedures, control, assessment and improvement which will enable
the laboratory organization to achieve its desired quality goals.
Routine
operation of quality management system ensure that work is properly documented
which results in the generation of reliable data, improvement of services and
high degree of customer’s satisfaction.
When
quality management system is fully implemented, the laboratory is positioned
for high level accreditation status and helps the laboratory to generate valid,
complete, timely, confidential and high integrity data. Staff motivation, job satisfaction,
continuous professional development, improved leadership and management skills
coupled with high credibility rating constitute other benefits of quality
management system.
Definition
of Terms
·
Quality Policy: A written
commitment on the laboratory organizations’ processes, structures, procedures
and protocols and other coordinated activities geared towards quality results
and customers’ satisfactions
·
Personnel Policy: A
written policy on recruitment, orientation, task assignment and development of
staff
·
Equipment Policy: A
written commitment on how equipment will be purchased, used and maintained
·
Supply/Inventory Policy:
A written commitment on how laboratory reagents and consumables will be
ordered, received, used and preserved
·
Process Control Policy: A
written statement on specimen handling, quality control and laboratory
protocols.
·
Assessment Policy: A
written statement on how to audit and assess coordinated activities in the
laboratory to aid good laboratory practice
·
Information management
Policy: A written declaration on how
data will be managed in the laboratory
·
Documents/Records Policy:
A Written commitment on documents used in the laboratory and how to use them
·
Process improvement
Policy: A written statement on procedures established to improve laboratory
activities
·
Customers’ service Policy:
A declaration of how customers will be served to meet their demands
·
Safety/Facility Policy: A
written commitment on safety measures to be carried out by the laboratory and
professionals working therein.
·
Quality Control: This is
the operational procedures and protocols put in place to ensure that data
generated in the laboratory are accurate, reliable, valid, complete, precise,
specific and confidential.
·
Quality Assessment: This
is the structure put in place to monitor and evaluate compliance with
established protocols in the system to ensure results are reliable and also to
promote process improvement.
·
Procedure: A specified
way of performing a laboratory task or activity. It is documented in form or
Standard Operating Procedures (SOP).
·
Processes: Following a
documented procedure to generate expected results.
Essentials
of Quality Management System
Organization: Quality management
system cannot be implemented without the support of management. The laboratory
management must draw up a quality policy to describe in detail the mission,
vision, organogram and responsibilities stating clearly what is to be done, who
to do it and how it will be done. The
organization will also allocate resources and provide motivation to carry out
step wise implementation of the quality management system.
Personnel
The right mix of
qualified, competent and licensed laboratory professionals must be recruited,
given orientation, given task and job specification with a view to achieving
quality management system objectives.
Personnel must be motivated and given the right condition of work to
give maximum performance. Opportunities
for training and continuous professional development must be provided on
regular basis for high degree human resource management. The threat of quackery confronting
laboratories in developing countries should be totally mitigated. Human resources
in the laboratory should have the right qualification, given the right job, in
the right condition, at the right time and the right place.
Equipment: The right equipment
with right specification must be acquired, installed and maintained to promote
excellent performance at all times. New
equipment must be calibrated before use.
A maintainance log must be made available to document processes of
scheduled maintainance and whenever fault is developed, appropriate authorities
should be contacted for repairs. The
best professional with wrong equipment will still generate unreliable results.
Process Control: A laboratory handbook should be made
available to detail how specimens will be received and handled in the
laboratory. The content of the handbook
Control
blocks should be sourced for in –house or procured and included in each
technique performed in the laboratory e.g. appendix/uterus for H&E,
positive fungal block for GMS etc.
When
necessary, job aids should be given to professionals on the bench to carry out
simple tasks.
Inventory Control
The right reagent and consumables
for use in the laboratory must be selected, quantified,
Rate of
consumption of consumables should be tracked either manually using registers or
electronically using a simple MS file or Excel worksheet.
Reagents
must be stored appropriately in the refrigerator at 40C or at room
temperature as recommended by manufacturers. The factor of expiry date must be
considered when ordering for reagents and consumables.
Documents And Records
Documents
include written policies and procedures upon which the organizational quality
Each
laboratory must determine the kind of registers to use in order to capture all
the activities surrounding specimen handling and processing. All processes from
reception to release of results must be well accounted for in the record books.
Suggested registers include:
·
Histology
Day Book
·
Cut
Up Register
·
Decalcification
Register
·
Processing
Register
·
Sectioning
Register
·
H&E
Slides Register
·
Special
Stains Register
·
Blocks
Archive Register
·
Slides
Archive Register etc.
In a digital
environment, a Microsoft Access program can be used to document the aforementioned
records.
Information Management:
Managing
information in the histopathology laboratory could be manual or electronic.
Manual handling of information is susceptible to inherent errors of
transcription and other damaging factors. Most developing countries’
laboratories still adopt this method as a result of scarce resources.
However,
electronic information management provides a convenient, coordinated and
error-minimized platform for managing information being generated in the
laboratory. Laboratory Information System (LIS) should be incorporated as a
long term objectives of laboratories in developing countries. Grants and assistance from global agencies
can bring necessary succor in this direction.
A laboratory information system stores information
in a relational database, such as Oracle, DB2 or MS SQL. A link is established between samples, storage
conditions, test dates, analyst certification, instrument calibration and
testing parameters. It is aimed at supporting automation in the laboratory,
reducing turn around time, improving service quality, and reducing errors.
Occurrence Management
Unusual
incidences do occur daily in the histopathology laboratory. It could originate from methods, techniques,
safety issues, equipments, specimen handling (fixation) and other similar
sources. A recent survey in a tertiary institution’s
histopathology laboratory indicates that power failure and equipment breakdown
constitutes the two leading causes of unusual incidences which interrupts
services.
Each
laboratory must have a way of documenting these occurrences for the purpose of
reference and system integrity. It will also form the basis of reporting to
higher authorities on reasons why results/work is delayed.
Audit/Assessment
Self
auditing creates a strong foundation for process improvement which rubs
positively on the quality of service and results. Data obtained from such documentation avail
practitioners’ information on adherence to established guidelines, processes
and procedures. It reveals areas of
strength and weaknesses, identifies skill gaps and prepares the organization
for external auditing and assessment cum accreditation.
Each
laboratory must have an audit checklist to monitor and evaluate all activities
in the histopathology laboratory.
Process Improvement
New
discoveries, techniques and methods can provide valid reasons for improving
processes and procedures in the laboratory to enhance compliance with the lean
concept which demands the use of cheap but efficient resources in the delivery
of quality and timely results.
Feedback
obtained from the audit process also provides useful information for process
improvement. For example if a skill gap
is identified and the staff trained to acquire the skill, right application of
the skill is bound to improve the process.
When errors
are detected, they should be corrected and ultimately eliminated. This will
instill confidence and promote the generation of quality results.
Customers’ Service
Histopathology
laboratories exist in the first instance because her services are being
demanded by clients who may be individuals or corporate entities. The mantra
‘customer is king’ must be imbibed by the laboratory organization to ensure a
paradigm shift in thinking and service delivery.
Customers must
be made comfortable in the laboratory service environment throughout their
stay. A superb system of result delivery
should also be instituted which must be convenient and fast. Electronic means of delivery of results and
social media exploration could ensure return patronage by impressed clients. A
satisfied client is guaranteed to be retained.
It will not
be out of place for histopathology laboratories to have a customers’
relationship unit. The use of customers’
complaint form is recommended to harvest what the client detests in the
laboratory as well as getting a feedback on services and what the customer
really want.
Facilities and Safety
The
laboratory environment must be safe for practitioners, clients and the
public. Guaranteed safety starts from a
well designed and customized laboratory which meets both national and
international requirements for level 2 biosafety.
Each worker
must be made to observe basic precautionary measures in the laboratory and fire
extinguishers placed at strategic places in the laboratory. A first aid box is required for treatment of
simple injuries and all laboratory staff must be immunized against common diseases
like hepatitis. .
The laboratory must be designed to have
enough space to accommodate all machines and tools, working benches, shelf for chemicals, retained slides and block
storage. It must also support efficient and smooth workflow. It should have enough
sink and the room should be well air conditioned.
There should be enough space to also
accommodate specialized tests e.g. cytology, immunohistochemistry,
histochemistry, archive room, tissue bank etc.
The room must be well ventilated with
electrical wiring to standard laboratory specification.
Where there is challenge on power supply,
alternative sources of emergency power supply must be made available for
constant power generation.
Conclusion
Documentation
is the soul of good laboratory practice!
Any work done in the laboratory without documentation is good as not
done at all. Therefore, in order to
achieve high quality histopathology results in a consistent and satisfactory
manner that meets the expectations of clients, quality auditors and regulatory
agencies, the implementation of quality management system is a necessity.
The
top management of every histopathology laboratory organization should
demonstrate keen commitment in adopting this principle to accomplish desired
end.
Staff
training and motivation coupled with a conducive work environment is equally
essential in achieving quality goals.
It
is mandatory that all activities in the histopathology laboratory be documented
along work flow as a basic requirement for implementing quality management
system.
National
and global regulatory agencies should sustain the current level of awareness
generation, training and support to developing countries in the effort towards
stepwise implementation of quality management system with a view to generating
accurate, reliable, complete, valid, timely and confidential laboratory data
especially in the histopathology laboratory which will improve services,
support the development of new drugs, efficient treatments and better medical
diagnostic governance.
References
·
Benard Solomon
and Olutunde O.A.: Histopathology Laboratory Practical training guide for
Medical Laboratory Students and Interns
·
http://histopathologyresearchresources.blogspot.com/2012/07/quality-control-in-histopathology.html
·
https://globalhealthlaboratories.tghn.org/articles/improving-clinical-research-data-understanding-and-implementation-laboratory-quality-management-system-lqms/
No comments:
Post a Comment