LABORATORY QUALITY MANUAL
LABORATORY QUALITY MANUAL
Chato District Hospital Laboratory (CDHL)
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Title: Laboratory Quality Manual
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Manual number:
CDH-LAB-REC
02-vers 01
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Effective date:
01/11/2013
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Revision date:
01/11/2015
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Pages: 32
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Prepared and signed by:
Laboratory manager
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Authorized
and signed by:
Medical
Officer Incharge
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1.0
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Medical Officer Incharge
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01/11/2013
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TABLE OF CONTENTS
The Chato District Hospital Laboratory CDH wishes to extend
sincere gratitude to Ministry of Health (MOH) for initiating the process of
Accreditation in the Country.
Special thanks should go to the ICAP laboratory Mentors for moral
support and for their dedicated efforts in organizing, communicating, coaching
and pushing staff in the process of preparation of this Quality Manual
document.
Finally, we would like to acknowledge and congratulate the members
Document Development Team who have devoted their time, energy and acknowledge
to the development of this manual.
TO THEM WE
ARE GRATEFUL
Laboratory Manager
Kassulu
District Hospital
EQA-External Quality Assessment
MOH- Ministry of Health
CDC-Centres for Disease Control
CLSI-Clinical Laboratory Standards Institute
QMS-Quality Management system
QM-Quality Manual
MSD-Medical Stores Department
IPC-Infection Prevention Control
MSDS-Material safety data Sheets
CDHL-Chato District Hospital Laboratory
IQC- Internal Quality Control
QO- Quality Officer
SOP-
Standard Operating Procedure
TAT-
Turnaround Time
ICAP-
International Center AIDS Care and treatment Programs
All
quality definitions are as per ISO 9000:2000 and ISO 15189:2007
Calibration
The set of operations which
establish, under specified conditions, the relationship between values
indicated by a measuring instrument or measuring system or values represented
by a material measure, and the corresponding known values of a reference standard.
Corrective action
Action taken to eliminate
the cause of an identified nonconformity or other undesirable situation.
Documentation
All the written or
electronic instructions and records, quality procedures and recorded test
results involved in the manufacture of a product.
Non-Conformity
The non fulfillment of a
specified requirement.
Quality
The totality of features and
characteristics of a product, service or test method that bear on its ability
to satisfy stated or implied needs.
Quality Assurance
All those planned and
systematic actions necessary to provide adequate confidence that a product,
service, test method will satisfy given requirements for quality.
Quality audit
A systematic and independent
examination to determine whether activities and related results comply with
planned arrangements and whether these arrangements are implemented effectively
and are appropriate to achieve objectives.
Quality control
The operational techniques
and activities that are used to fulfill requirements for quality.
Quality management
Aspect of the overall
management function that determines and implements the quality policy.
Quality policy
Overall quality intentions
and direction of an organization as regards quality as formally expressed and
authorized by top management.
Quality system
The organizational
structure, responsibilities, procedures and resources for implementing quality
management.
Specification
Document that states the
requirements to which the product, service, or test method has to conform.
Traceability
Ability to trace the
history, application or location of an item, activity or result by means of
documented records.
Validation
The act of confirming a
product, service, or test method that it meets the requirements for which it
was intended.
Laboratory
Clinical laboratory for the
biological, microbiological, immunological, chemical, immune-haematological,
haematological, biophysical, cytological, pathological or other examination of
materials derived from human body for the purposes of providing information for
the diagnosis, prevention, prognosis, surveillance and treatment of disease in
assessment of the health of human beings, and which may provide a consultant
advisory service covering all aspects of laboratory investigation including the
interpretation of results and advice on further appropriate investigation.
Laboratory staff
All members of staff who
work at Chato District Hospital Laboratory
Technical staff
Laboratory members of staff
who performs laboratory testing and other related activities
Laboratory Management
Comprises of Laboratory
Manager, Quality Officers, Safety Officers and Heads of Sections
The quality manual has
been written to provide a guide to the strategies required for establishing and
maintaining a quality laboratory service in Chato District Hospital. The
quality manual provides a basis of delivering quality, clinical and laboratory
diagnostic service that are effective, efficient and safe.
This manual defines the
policies for the quality management system for the Chato District Hospital. The
manual is the ultimate document in terms of the quality system hierarchy. It
describes how all the competency requirements for both management and technical
requirements are to be met. The quality manual applies to all the sections of
the laboratory. All members of staff are to be trained in the use of this
manual and are required to apply these requirements whenever they perform their
work.
Chato District Hospital
Laboratory provides routine medical laboratory services in the following areas:
·
Microbiology:
·
Clinical Chemistry
·
Haematology
·
Parasitology
·
Serology
·
Blood Transfusion
Chato District Hospital (CDH) Laboratory
management is committed to the provision of diagnostic medical laboratory
testing services that are of high international standards in line with the
principles of good professional laboratory practice.
Management is also committed to the provision
of accurate, reliable, credible, relevant and timely laboratory results
obtained from tests that are always carried out in accordance with client
requirements and Quality Management System based on ISO 15189 requirements. The
management of Chato District Hospital Laboratory (CDH) is also committed to
providing an un-interrupted, efficient and cost effective service that will
stand as a hall mark in the overall management of patients in tits catchment
area
Management ensures that all laboratory
personnel are competent and qualified for the tasks they perform, and that all
personnel familiarize themselves with Quality Management System documentation
in order to implement the policies and procedures in their work. Management
undertakes to periodically review the performance of the Quality Management
System and quality objectives to ensure their effectiveness, continuing
relevance and suitability in ensuring production of reliable laboratory
results.
·
To achieve 5 stars of SLIPTA checklist
by August 2015.
·
To ensure all personnel are trained and
are competent to perform all the procedures in line with their work at any
given time.
·
To provide continued education classes
every week with attendance of more than 80% of laboratory workers.
·
To participate in accredited EQA schemes
and to achieve 85% or more in performance all the time.
·
To ensure that 90% of all patient
results are released within the established laboratory turnaround time at any
given time.
·
To maintain safe and healthy working
conditions to all employees and ensuring zero working accidents per month.
3. INTRODUCTION
Brief overview
The Department of Laboratory of CDH firmly believes that
Quality is the hallmark of our healthcare excellence and is the platform of all
functional elements of structure, process
and outcome. With this belief the department has prepared a quality manual
that describes the quality management system and refers reader(s) to the
appropriate processes and procedures for the services offered. The system
ensures that the laboratory services are efficient, effective and meet
professional and regulatory requirements in accordance with the health policy
by the Ministry of Health, Tanzania. The laboratory, in keeping with the
hospital goals & objectives, continually strives for excellence while
meeting and exceeding the needs of our patients and healthcare personnel.
About Chato District Hospital
(KDH)
CDH is a public health
institution. The hospital has _____beds capacity. It receives patients from District Hospital, Surrounding
Government and private health facilities. The hospital provides a range of
services including general surgical, obstetric and gynecology, medical,
pediatric, eye, dental, and other support services.
Department Of Laboratory
The Laboratory is a department within CDH
and functions as a part of the larger health system.
It provides specific diagnostic laboratory services that are vital to the
overall mission of providing patient care.
The department with about 11 technical staff has a
reputation for service quality, safety and continuous improvement. The department is
service oriented with special emphasis on accuracy, reliability and timely
reporting of laboratory test results. The department plays an important role
from its laboratory bench to patient bedside in supporting the hospital’s goal
of quality and compassionate patient care for all of its clinical programs.
4. 0 MANAGEMENT
REQUIREMENTS
4.1. Organization
and Management
KDH was established through
the Ministry of Health Tanzania, which authorizes it to provide public health
services to the population of the area. Chato
District Hospital laboratory follows the MOHSW reporting structures.
4.1.1 Management
Responsibilities
CDHL management is
responsible for design, implementation, maintenance and
improvement of the quality management system as described
below in this Quality Manual:
Authority
All members of staff are given authority by the Laboratory
Manager to conduct activities, examinations and use of equipment on behalf of BRRDH Laboratory in areas which they will have been deemed competent.
Authorizations are generally documented in their individual job descriptions
and followed by Staff Training and Competence Assessment Forms.
Resources
CDH provides aadequate human and financial resources to the laboratory department to
ensure they carry out their duties without disruptions and importantly meeting
the customer required turnaround times.
Confidentiality
Confidential information shall not be disclosed to any
third party without written authorization from the Medical Officer In charge or
his/her designee. On orientation all members of staff are trained and required
to sign a confidentiality to prevent them from disclosing confidential
information to outsiders.
Conflict of Interest
Responsibilities of all laboratory personnel of CDH Laboratory are defined in order to identify conflict of interest. CDHL is committed to identify and investigate any commercial, financial or
any other pressure provided by any person or a particular organization which
could influence its technical judgment or affect its competencies and trust.
All employees are to abide with Ethical Code of Conduct. All employees will
complete the Business Commercial Interest Disclosure form upon hire and update
the statement when need arises.
Internal and External Pressure
CDH Laboratory encourages all members of staff to disclose any internal and
external commercial, financial or other pressures and influences that may
affect the quality of their work. Members of staff are free to approach any
managerial staff in confidence and share their personnel pressures. It is the
responsibility of both the laboratory management and staff to generate and
report data objectively and therefore no
staff has authority to take any action or to require any action to be taken
which interferes with the laboratory in discharging this responsibility,
irrespective of the normal line of management.
Fraudulent Results
CDH Laboratory management is responsible for the
detection and prevention of fraudulent results misappropriations and other
irregularities. Each member of the management team will be familiar with the
type of improprieties that might occur within his or her area of responsibility,
and be alert for any indication or irregularity.
Any irregularity that is detected or suspected must
be reported immediately to the Laboratory Manager who coordinates all
investigations within the laboratory and other affected areas both internal and
external. All cases relating to fraud will be treated as having serious reputational
consequences. Anyone who will be found guilty after investigations, the Medical
Officer In charge/Laboratory Manager will take disciplinary actions
accordingly.
Activities that Diminish the Integrity of CDH Laboratory
Management ensures that
there is confidence in the laboratory operation by making sure all personnel
follow Ethical Code of Conduct as well as the procedure of activities that diminish CDH Laboratory operational integrity
and all other applicable policies and procedures.
Supporting Documents
·
Protection of confidential information Procedure
·
Activities
That Diminish NHL-QATC’s Operational Integrity
·
Ethical Code
of Conduct
·
Confidentiality and Conduct Undertaking
Form
·
Business
Commercial Interests Disclosure form
·
Disclosure of
Internal & External Pressures
4.1.2 Communication
Communication is vital for the effective performance
as well as continual improvement of a Quality Management System. It is in this
regard that CDH Laboratory management has put in place communication mechanisms that
will ensure that customer requirements (both internal and external) are met.
All communications (outgoing and incoming) are logged or filed whichever is
appropriate.
Internal Communication
To achieve collective ownership of the system by both
Management and staff, Laboratory management involves all staff in every aspect
of the development and implementation of the QMS. For effective communication
within the laboratory, management has put in place channels of communication,
which include but not limited to the following:
·
Memos, letters, notices
·
Meetings
§ Weekly Staff Meetings
§ Quarterly Quality Committee Meetings
·
Telephonic
·
Oral communication
·
Verbal or written instructions (e.g.
through Quality Manual, Lectures).
External
Communication
Communication
with external stakeholders is in the form of but not limited to electronic
mail, fax, telephonic and meetings. Laboratory management is authorized to
offer telephonic consultations on technical matters within the scope of their
responsibilities to external clients. Records of all communications shall be
kept thereof.
Supporting Documents
·
Records
of Minutes
·
Memoranda
·
4.1.3
KDH Laboratory Organisational Chart
Laboratory Manager
Responsible for:
- Coordinates the establishment of the quality management system
based on SLIPTA checklist and ISO standards 15189, supports its
implementation and coordinates activities pertaining to quality.
- Supervises and directs the work at sectional level.
- Coordinates and supervises staff induction, training and competence
assessment.
- Monitoring quality management system (QMS) implementation.
- Ensure the safety requirements of the laboratory are being
followed.
- Ensure that personnel have sound knowledge and recognize the
importance of participatory approach in policies and goals of the quality
management system as well as needs of customers, laws and regulations.
- Ensure the completeness of the quality management system (QMS) and
its continued maintenance and review.
- Providing and ensuring availability of resources.
- To
perform any other duties as assigned by the Medical Officer In charge from
time to time
Deputy Laboratory Manager
Responsible for:
- Assist the Lab Manager in Providing
advice to those requesting information about the choice of tests, the use
of the laboratory service and the interpretation of laboratory data
- Assist the Lab Manager in
supervising and oversee the technical functions of the CDH Laboratory
- Assist the Lab Manager in advising
the head of diagnostic services in technical matters pertaining to the CDH
Laboratory
- Serve as an active member of the
medical staff for those facilities served.
- Assist the Lab Manager in
monitoring all works performed in the laboratory to determine that
reliable data are being generated in the laboratory.
- Assist the Lab Manager in providing
effective and efficient administration of the medical laboratory service,
including budget planning and control with responsible financial
management, in accordance with institutional assignment of such
responsibilities.
- Assist the Lab Manager in providing
educational programs for the medical and laboratory staff and participate
in the educational programs of the institution
- Assist the Lab Manager in selecting
and monitoring all referral laboratories for the quality of service in
conjunction with the quality officers.
- Assist the Lab Manager in identification
and addressing of complaints, non-conformances and corrective actions.
- Assist the Lab Manager in advising on various developments and
review of policies and programs of the CDH Laboratory
- Assist the Lab Manager in planning,
issue orders or instructions, provide leadership, enforce discipline,
handling grievances, controlling outputs, and maintain work conditions and
preserving records.
- Assist the Lab Manager in
implementing a safe laboratory environment in compliance with good
practice and applicable regulations.
- Assist the Lab Manager in accountability
for the implementation of the quality management system.
- Assist the Lab Manager in
coordinating the planning and implementation of training workshops and
seminars.
- Assist the Lab Manager in scheduling
of organizing of management review meetings in consultation with the
quality officer.
- Assist the Lab Manager in compilation
and distribution of performance reports for Management review
- To perform any other duties as
assigned by the Medical Officer In charge/Laboratory Manager from time to
time.
Quality Officer
Responsible for:
- Development, implementation and revision of the Quality Management
System to ensure it is up to date at any given time.
- Organizing and facilitating internal staff QMS training.
- Planning and carrying out internal audits of the Quality Management
system
- Identification and addressing of complaints, non-conformances and
corrective actions
- To interact with the accreditation bodies on behalf of the
organization.
- Planning, conducting and facilitating quality assurance training
workshops and seminars.
- Scheduling of organizing management review meetings.
- Compilation and distribution performance reports for management
review
- To perform any other duties as assigned by the Medical Officer
Incharge/Laboratory
Manager services from time to time
Deputy
Quality Officer
Responsible for:
·
Assist the Quality officer in training
staff in medical laboratory QMS.
·
Implements and maintains a safe work
environment for laboratory staff
·
Monitor Quality Assessment events and
reports to management
·
Ensure quality procedures are maintained
with individual sections CDH Laboratory assists in the compilation of Quality
System reports for individual sections at CDH Laboratory
Safety Officer
Responsible for:
- Trains staff in safety.
- Implements and maintains a safe work environment for laboratory
staff.
- Monitor safety events and report to management
- Ensures safe and appropriate disposal of laboratory waste on a
daily basis.
- Compile a list of all hazardous materials, chemicals and reagents
used in CDH Laboratory followed by Material Safety and Data Sheets (MSDS)
for each hazardous substance.
Deputy
Safety Officer
Responsible for:
·
Assist the Safety officer in training
staff in medical laboratory safety.
·
Implements and maintains a safe work
environment for laboratory staff
·
Monitor safety events and reports to
management
·
Ensures safe and appropriate disposal of
laboratory waste on a daily basis.
·
Assists in the compilation of a list of
all hazardous materials, chemicals and reagents used in CDH Laboratory,
followed by Material Safety and Data Sheets (MSDS) for each hazardous
substance.
Section Heads
Responsible for:
- Supervision
of medical laboratory technologist/scientists within their respective
sections
- Identification
and addressing of complaints, non-conformances and corrective actions
relating to their sections
- Perform
routine and specialized laboratory tests.
- Review and approve all laboratory results before release
- Implementation
of the quality management system.
- Training
of junior members and orientation of
new members of staff within their sections
- To
conduct competency assessments of the medical technologists.
·
Comply with established quality
management system and safety procedures.
Medical laboratory Technologists and others
- The roles and responsibilities for all other members of staff are
defined in their respective Job descriptions available in their personnel
files.
NB: The job descriptions listed above only summarize the
functions of each role, for further details, check the respective job
descriptions.
Supporting Documents
·
Job
Descriptions
4.2 Quality Management System
The CDH Laboratory has a documented Quality Management
System which comprises of policies, procedures, forms, job descriptions,
external reference and regulatory documents and records. CDH Laboratory
management ensures that all members of staff have been trained on QMS and understood
it upon employment and as when necessary. Records of the training and
understanding of the QMS are documented in the reading and understanding form which
is found at the end of all Quality Manual and procedures. All relevant QMS
documents are made available at each work station for easy implementation.
Management has
instituted Internal Quality Controls (IQC) for all tests performed and ensures
that the laboratory participates in Proficiency Testing in each discipline of
the laboratory. CDH Laboratory management ensures that all instruments and
equipment are working properly and produced accurate results, through its
quality control and quality assurance policy, which also includes preventive
maintenance and calibration to ensure proper function of instruments, reagents
and analytical systems.
The following
diagram outlines the Quality Management System documentation structure
Quality System Documentation
|
The Quality Manual is the governing document that defines the quality system policies and
statements of intent by KDH Laboratory and is based on ISO 15189 requirements
Management and Technical Procedures describe who, what, when, where and how quality
management system and testing processes are performed.
Forms, Logs, Registers: either related to management or technical procedures
or not, are used for data collection.
Quality Records
are retained as objective evidence of compliance to the requirements of ISO
15189 and KDH Laboratory management and technical procedures per Quality
and Technical Record Control Procedure.
Supporting
Documents
·
Quality and Technical Records Control
Procedure
CDH laboratory
uses document control procedure to control all documents whether internally or
externally generated. A copy of each document in the QMS is archived for later
reference. All quality documents are
retained for a minimum period as defined in the Documents and Sample retention
guideline. One master copy of the quality documents is maintained as a soft
copy under the authority of the Quality Officer, and for daily use, a hard copy
of the Quality Manual and relevant procedures are available at each
workstation.
All
documents issued to personnel are reviewed by the Quality Officer and
Laboratory Manager and then approved by the Head of Laboratory Unit prior to
issue. The Quality Officer maintains the
Master Index which shows the current revision status of all documents and their
distribution. It is the responsibility of the Quality Officer and Deputy
Quality officer to ensure that only current authorized versions of appropriate
documents are available for use at each work station. All documents in the system are reviewed
every two years, revised when necessary, and approved by authorized personnel.
All obsolete documents are removed from the workstations by the Quality Officer
and Deputy Quality officer to prevent inadvertent use. All archived documents are written with the
words “OBSOLETE” with a red ink on all pages.
The laboratory management does not allow document corrections and
changes to be done by hand.
All
documents are uniquely identified with the following identifiers: Title;
Edition, Effective Date/Revision and Version Number; Number of Pages; Authority
for issue and Source identification
Supporting
Documents
·
Documents control procedure
·
Documents and Sample retention guideline
·
Master
Index
The CDHL
main function is to provide medical laboratory services to the KDH wards, out patients departments and
referred samples from nearby health facilities. Review of Contracts Procedure is
used for review of all contracts which can either be individual or large sample
sizes. Review of individual contracts is
done upon receipt of samples and request form, from the wards or request form
in case of out- patients department. It is a requirement that all samples and
request forms meet the acceptance criteria for them to be accepted by the
laboratory otherwise they will be rejected. Acceptance/Rejection criteria are
defined in the Sample collection Manual. Reviews are also done to check that
clients have not requested a test not done by the laboratory. For large sample sizes, the hospital
management shall notify the laboratory manager in writing who in turn shall review
whether the laboratory has the capacity to conduct the tests according to the
client’s requirements. The laboratory manager shall either accept the contract
if he/she deems that the laboratory has the necessary capacity to conduct the
work or deny the contract if the laboratory does not have the required
capacity. The laboratory manager can in some cases suggest having the testing
process staggered on different days depending on the availability of human
resources and reagents. In all cases
consideration is given to specimen collection, transportation, human resources,
equipment, reagents, time frame for testing and collecting results for the
laboratory to either accept or reject the contracts.
Supporting Documents
·
Review
of Contracts Procedure
The CDH
Laboratory uses Evaluation and Selection of Referral laboratories for
evaluating and selecting the services of referral laboratories for laboratory
tests not performed at CDH Laboratory or in cases where back-up services are
required. All referral laboratories are evaluated and selected on basis of the
following requirements, in their order of priority:
- Accreditation to
relevant ISO standard and equivalent standards
- Audit conducted by
CDH
Laboratory or a recognized body
- Satisfactory
performance in relevant proficiency testing.
- Acceptable results
for known samples.
The CDH
Laboratory maintains a list of all selected referral
laboratories with their contact details. Arrangements with the referral
laboratories shall be reviewed once in two years. All referred tests will be
recorded in Sample Referral Log which will be kept in the referring sections.
The CDH
Laboratory will be responsible for ensuring that
referral laboratories examination results and findings are provided to the
person making the request. The results from accredited referral laboratories
shall be sent to the requested clinicians as they are.
Supporting Documents
·
Evaluation and Selection of Referral
laboratories
·
Sample Referral Log
·
Evaluation Check List For Referral
Laboratory
The
CDH
Laboratory follows government procurement
regulations in purchasing equipment and supplies for the laboratory. All
required items are purchased by CDH
Laboratory through the CDH
Procurement Department. CDH
Laboratory collaborates with hospital procurement and
supply department to make sure that equipment and other supplies purchase are
of acceptable quality.
The
CDH
Laboratory performs inspection on all received items
before they can be put into inventory. Inventory control procedure is used to
monitor all the items placed into inventory. All items shall be subject to
quality control before they can be used for testing patient samples. The
reagents which pass quality control shall be accepted and put into use, and
those which fail the quality control tests shall be rejected and returned to
the supplier.
All
items are stored according to the manufacturer’s recommendations and all
storage facilities shall be monitored for temperature to ensure that
temperature will not affect the stored items.
Supporting
Documents
·
External Services and Supplies Procedure
·
Inventory Control Procedure
·
Receiving and Inspection checklist
·
Inventory Control form
Any qualified technical laboratory
personnel can provide advice on the choice of examination and the use of
services including repeat frequencies and the required type of sample. The laboratory has Sample Collection Manual that
is also used to provide information to clinicians for sample collections. The laboratory also provides advice to
clinicians in situations where laboratory results reveal that further analysis
is required.
The laboratory conducts quarterly meetings
with clinicians regarding the use of the laboratory services and for the
purpose of consultation on scientific matters. The minutes of these meetings
are maintained by the laboratory manager.
Supporting Documents
·
Sample
Collection Manual
·
Quality
Management Plan
·
Minutes
of Meeting with Clinicians
CDH Laboratory
uses Resolution of Complaints Procedure to receive record, investigate and
resolve complaints from the users of the laboratory. Complaints are received
through the suggestion box, phone calls from clinicians and other parties,
consultative meetings as well as verbal complaints and are recorded on the
Client Complaint Form. CDH Laboratory
investigates the genuineness of all complaints and takes the appropriate
corrective action, using the Corrective Action Procedure. CDH Laboratory also
conducts surveys once in 12 months using Customer Satisfaction Survey Form. Data
from customer satisfaction surveys is collected and analyzed and a report is
generated. All complaints and suggestions from customer satisfaction surveys
are forwarded for management reviews and are resolved following Corrective
action Procedure.
Supporting
documents
- Resolution
of Complaints Procedure
- Corrective
Action Procedure
- Client
Complaint Form
- Customer
Satisfaction Survey Form.
The CDH Laboratory members of staff
identify nonconformities in their examinations or management systems when they
are not in compliance with their procedures or policies as stated in the
Quality Management System. All non-conformances shall be addressed according to
Identification and Control of Nonconformities procedure. It is the
responsibility of sectional heads or designee to clear non-conformities in
their respective sections.
Medical significance is considered for
each nonconformity identified and the nonconformity is then classified as
either a major or a minor. If the nonconformity is classified as major, the
operations are halted by laboratory manager and in such instances the
requesting clinician is also informed. Corrective action is taken immediately
and the results of nonconforming examination released are identified and
recalled. It is the responsibility of the laboratory manager to authorize the
resumption of examinations after satisfactory implementation of the corrective
action.
Each episode of nonconformity is
documented and recorded on the Non conformance log, and Non-Conformance -
Corrective Action Form. The Quality assurance committee reviews all corrective
actions quarterly to detect trends and initiated corrective action. For all
nonconformities, a root cause analysis is conducted by the use of tools like
the ‘5 whys analysis”, cause analysis diagram and brain storming sessions.
Supporting Documents
- Identification and control of
nonconformities procedure
- Non conformance log
- Non-Conformance
- Corrective Action Form
The
laboratory uses corrective action procedure to make corrective actions for all
identified non-conformities. Before a
corrective action is taken, root-cause analysis is done by using appropriate
tools such as Cause analysis diagram, 5 Whys Analysis and Brainstorming
sessions. For all non conformities, corrective action is taken and preventive
measures are put in place and monitored to prevent recurrence. Corrective
actions are recorded and documented on the non conformance corrective action
form. The sectional heads or personnel designated implement any changes
resulting from corrective action investigations. Changes in the quality
management system arising from the corrective actions are put in place by the
quality officer following the document control procedure.
Supporting
Documents
·
Document
Control Procedure
·
Corrective
Action Procedure
·
Non-conformance
Corrective Action Form
CDH Laboratory uses the preventive action
procedure to identify potential sources of non-conformities in technical and/or
quality management system and prevent its occurrence. When a potential non-conformance is identified,
a preventive action plan is developed, implemented and monitored by the Quality
Assurance committee to reduce the likelihood of it turning into a
non-conformance and to take advantage of the opportunities for improvement. The
Quality Assurance committee reviews the results of preventive actions on a
quarterly basis and minutes of reviews are maintained.
Supporting
Documents
- Preventive action Procedure
- Preventive action Plan
CDH Laboratory continuously improves the
quality management system by the review of all its operational policies and
procedures once in two years by laboratory management. During these reviews,
potential sources of non-conformance or other opportunities for improvement in
the quality management system or technical practices are identified and action
plans for improvement are developed, documented, implemented and monitored.
Continual Improvement procedure is used to conduct continual improvement
activities.
Once
the action has been taken, the quality assurance committee reviews and
evaluates the effectiveness of the actions through auditing of the concerned
area. The outcome of such actions shall be submitted to the laboratory
management for review and implementation of any changes to the quality
management system.
The
laboratory implements quality indicators in every section of the laboratory for
systematic monitoring and evaluation of the laboratory’s contribution to
patient care, and if an opportunity for improvement is identified the
laboratory management shall address them accordingly. The quality indicators
are displayed monthly on notice boards for all members to see their performance
in each section.
The
laboratory management provides access to suitable educational and training
opportunities for laboratory personnel and relevant users of laboratory
services like clinicians so as to improve in areas with high incidences of
non-conformities.
Supporting
Documents
·
Continual Improvement Procedure
·
List of Quality Indicators
CDH Laboratory
uses Quality and Technical Records Control Procedure for identification,
collection, indexing, access, storage, maintenance and safe disposal of quality
and technical records. Management ensures that all records are clear and
understandable before they are stored and that they are readily retrievable
whenever they are required. CDH Laboratory
stores its records as hardcopy. All records are stored in wooden and lockable
metal cabinets, to prevent damage from fire and flooding, deterioration, losses
and unauthorized access. CDH Laboratory
uses Document and Records Retention Schedule to define the length of time for
keeping all documents and records.
Supporting Documents
·
Quality
and Technical Records control Procedure.
·
Document
and Records Retention Guideline
In
order to verify that operations continue to comply with the requirements of the
quality management system, internal audits of all elements of the quality
management system, both managerial and technical, are conducted twice in 12
months as defined in the Internal Audit Schedule. Audits shall be formally
planned and organized by quality officer. Internal audits shall be conducted by
personnel qualified to conduct internal audits. Personnel shall not audit their
own activities. The procedure for internal audit defines types of audit,
frequencies, methodologies and required documentation. Three types of internal
audits conducted which are horizontal, vertical as well as witnessing. When deficiencies or opportunities for
improvement are noted, CDH undertakes
corrective or preventive action according to the respective procedures. The
results of internal audits shall be submitted to laboratory management for
review.
Supporting
Documents
·
Internal
Auditing Procedure
·
Internal Audit
Schedule
In
accordance
with a Management Review procedure, CDH Laboratory management conducts a review of the
Quality Management System
and all the testing activities twice in 12 months, on dates advised by
the Laboratory Quality plan. The
frequency of the reviews shall be increased depending on recommendations by the
management review committee. The
management review committee includes and not limited to;
- The laboratory manager
- The Deputy Laboratory manager
- Hospital Management (One representative)
- Quality officers
- Sectional heads
- Safety
Officers.
It is up to the chair person discretion to invite relevant
stakeholders for the management review meetings. The agenda for the management review is
detailed in the management review procedure.
The ability of the QMS to meet the laboratory’s
objectives is evaluated and any changes or improvements that may be essential are implemented. The quality and
appropriateness of the laboratory’s contribution to public and patient care
shall, to the extent possible, be monitored and evaluated objectively. The
results of the review shall be captured and incorporated into a plan that includes
goals, objectives and action plans. Action plans shall be executed within an
appropriate and agreed upon timeframe. Results of the management review are
communicated to all members of staff at least 2 weeks after the management
review meeting.
Supporting
Documents
·
Management
Review Procedure
·
Minutes of
Management Review Template
·
Laboratory
Quality Plan
CDH Laboratory has approved job descriptions that
define the qualification and duties of all personnel in place. All new staff
members undergo a period of laboratory orientation for them to be fully
conversant with laboratory practices and personnel policies upon engagement
with CDH Laboratory. The laboratory uses the Ministry of health personnel policies (Ethical
Code of Conduct). New members of staff are issued with the above
mentioned documents for reading and understanding the requirements of the
Ministry of Health. This is done in accordance with Staff Orientation
Procedure.
The laboratory management maintains records of relevant
education and professional qualifications, training and experience, and competence, records of
immunisation, certificate of registration, practicing license, and incident and
accident s of all personnel in personnel files.
The laboratory is directed by the head
laboratory services whose responsibilities are described in the job
description. The laboratory management in conjunction with the Hospital
administration ensure that staff resources are adequate to undertake the work
and carrying out other functions of the quality management system.
All laboratory technical members are trained in
internal quality control to ensure that they understand the basics of the
quality management system and can implement it effectively.
The laboratory management ensures that all personnel
are competent through training and thereafter authorized to perform particular
tasks. The competence tests are done after an interval of 2 years. Personnel are authorized to perform
particular tasks after they have been deemed competent in those particular
tasks. The laboratory also provides continuing education and training for all
members of staff each week. The laboratory ensures that all members of staff
are trained to prevent or contain the
effects of adverse incidents such as fire and accidents. The laboratory also conducts internal
continual education once every week.
Supporting Documents
·
Ethical
Code of Conduct
·
Staff Orientation Procedure
·
Staff Training and Competence Procedure
The CDH Laboratory management ensures that there is adequate
space to perform its work efficiently to ensure quality of patient results,
proper quality control procedures, and safety of personnel. The hospital
management provides resources to support the activities of the laboratory and
that the laboratory is maintained in a functional and reliable state. In
situations where the laboratory uses other facilities outside the permanent
laboratory facility, laboratory management ensures that the environmental
conditions will not affect the quality of the examinations.
The laboratory uses the Safety Manual as a guide to
protect patients, employees and
visitors from recognized hazards. All laboratory analysers
are connected to Uninterruptable power supply (UPS) and the hospital uses a
generator as a backup source of electrical power.
The laboratory
cleans and monitors environmental conditions using the Monitoring of Environmental
Condition Procedure. Fridge, freezer, incubator and water bath temperatures are
monitored twice on a daily basis. Records of monitoring the environmental
conditions are kept by the section heads and it is the responsibility of the
section head to review all the records on a monthly basis. Access to the laboratory
facilities is limited to laboratory staff only or any other person authorised
by the Laboratory Management
The laboratory management
ensures that relevant storage space and conditions are provided for continuing
integrity of samples, slides, documents, files, manuals, equipment, reagents,
laboratory supplies, records and results. Reagents and samples are not stored
in the same fridges/freezers to avoid contamination of reagents.
All hazardous/biomedical
waste is discarded into appropriate biohazard waste containers that are handled
and disposed off in accordance with the Safety Practices Procedure, KDH Laboratory Safety Manual
and also comply with guidelines of Infection Prevention control followed by all
other hospital sections. All work surfaces are maintained in clean condition
and records of daily cleaning and swabbing shall be recorded on Daily Cleaning
Checklist.
Supporting Documents
·
Monitoring
and Cleaning of Environmental Condition Procedure.
·
Safety
Practices Procedure.
·
Daily Cleaning Checklist
5.3. Laboratory Equipment
The
CDH Laboratory management
ensures that the laboratory has adequate equipment to provide uninterrupted
referral laboratory services to the nation. All equipments are validated to
confirm its suitability for the intended use before it is put into service.
Management has established an equipment management procedure which is used to
ensure that all equipment is functioning well at all times. Among several
things the following shall be done:
- Only trained and authorised personnel
shall use the CDH Laboratory equipments.
- All
equipments shall be regularly calibrated and serviced following an
established program. Members of staff are instructed not to
use equipment which is not calibrated or which the calibration period is
expired.
- All temperature sensitive equipment is
monitored twice daily to ensure that it is operating correctly.
- An equipment inventory is maintained to
monitor the location and status of each piece of equipment.
- All equipment is maintained on a daily,
weekly and monthly basis following the manufacturer’s instructions.
- All laboratory equipment shall be
regularly serviced, calibrated and tested for safety and efficiency.
- All non-functioning equipment is
appropriately identified to prevent its usage.
- In preventing contamination or
deterioration, the equipment shall be handled, transported, stored and
used by using the Equipment Management Procedure
- All equipment is prevented from
unauthorised access and tampering with the manufacturers’ settings.
Supporting Documents
·
Equipment Management Procedure
·
Equipment Calibration/Service Schedule
·
Equipment Inventory Form
·
Equipment Decontamination Form
Samples shall
be accompanied by a detailed Laboratory Request-Report Form. The request form
consist of the following at a minimum; patient identification details, date and
time of sample collection, date and time of sample reception in the laboratory,
date and time examination completed, sample type and examination requested,
clinical data and requesting clinician name. A Sample Collection Manual
provides information to clinicians regarding sample collection and laboratory
services, and is distributed to all sample collection sites.
Samples are traceable to a laboratory request form
to identify a particular individual by means of a laboratory allocated number. Samples and request forms lacking proper identification are not accepted
or processed by the laboratory. However, where there is uncertainty in the
identification of the sample or instability of the analytes in the sample and
the sample is an irreplaceable or critical (cerebrospinal fluid, biopsy and bone marrow aspirate) the
laboratory may process the sample but do not release the results until the
requesting physician or person responsible for the sample collection takes
responsibility for identifying and accepting the sample, or for providing
proper information, or all these.
The quality assurance
committee monitors and reviews the transportation of samples to ensure that
they are; within time frame appropriate of the requested examination, within
temperature specified intervals and with designated preservative and transported
in a manner that is safe for carriers, the general public and the receiving
laboratory. All samples from within the hospital are transported
in cool boxes, and all samples from external facilities should be securely
packaged to ensure safety of carriers as well as the environment.
All samples upon receipt are recorded in the
laboratory register in which the date and time of sample reception and the name
of the receiving officer is indicated.
CDH Laboratory reviews the
sample volume requirements for phlebotomy (and other samples such as
cerebrospinal fluid) every after two years to ensure that neither insufficient
nor excessive amounts of sample are collected. CDH Laboratory has a documented Sample Management
Procedure that defines receipt, labelling, processing, storage and disposal of
samples. CDH Laboratory ensures that
samples are allocated laboratory and section numbers and the sample portions
maintain the same section numbers for traceability.
CDH Laboratory does not allow
any verbal request for any examination. All samples are stored according to
Document and Sample Retention Guidelines.
Supporting Documents
·
Sample Management Procedure
·
Document and Sample Retention Guidelines
·
Sample Collection Manual
·
Sample Reception Form
CDH Laboratory
uses examination procedures found in authoritative text books and journals or
procedures which meet the needs of the users of the laboratory services.
In cases where
the laboratory develops an in-house procedure, it shall be fully documented and
validated before being put to use.
Laboratory management ensures that all procedures are validated
according to Method Validation Procedure.
Validations are conducted under the following circumstances;
i.
New method being put to use.
ii.
When there is a significant change to the testing
system, equipment or software.
Validation
files are kept under the responsibility of the quality officer. The procedures
are reviewed once in two years during the document review period by sectional
heads. All changes made to the examination procedure follow Document Control
Procedure.
CDH Laboratory has
documented all examination procedures and has made them available to relevant
personnel at their respective workstations. The Laboratory Manager is
responsible for ensuring that the contents of the examination procedures are
complete, current and have been thoroughly reviewed before being authorized by
the Head of Laboratory Services.
The laboratory has a documented list of
current examination procedures available in the Sample Collection Manual In
cases where the laboratory intends to change an examination procedure such that results or their
interpretations could be significantly different, the implications are
explained to users of the laboratory services through memoranda prior to the
introduction of the change.`
Supporting
Documents
·
Document Control Procedure.
·
Method Validation Procedure
·
Sample
Collection Manual
Internal Quality Control
CDH Laboratory
conducts internal quality controls on all tests carried out in the laboratory,
as outlined in the test examination procedures. For qualitative tests, positive
and negative controls are used and for quantitative tests, three levels of
controls are used (low, normal and high). All quantitative results are plotted
on Levy-Jennings Chart and interpreted based on the Westgard Rules. Quality Control Results Review Procedure is
used for reviewing the QC results.
External Quality Assessment
CDH Laboratory participates in External Quality
Assessment (EQA) schemes like NICD and NHL-QATC. The laboratory management
monitors the results of the external quality assessment and implements the
corrective action when EQA criteria are not fulfilled. The frequency of
participation is dependent on the EQA provider. Results of performance in EQA
are communicated to all members of the laboratory section concerned. EQA
results are reviewed using review of EQA results procedure.
Uncertainty of Measurements
Each section
shall determine uncertainty of measurement of results where possible by using measurement
of Uncertainty procedure. CDH Laboratory
does not report uncertainty of measurement on patients unless requested for by
the clinician or the laboratory service users. The uncertainty of measurement
is reviewed after every 2 years. Uncertainty of measurement results are kept on
Uncertainty of Measurement Records.
Calibration of Measuring Systems
The laboratory
conducts calibration of measuring systems using manufacturers’ recommended
calibration material. The calibration period varies according to manufacturer’s
recommendation.
For those
examination performed using different procedure or equipment or at different
sites or all these, the laboratory shall compare the results for verifying the
comparability of results after every 12 months or as needed. The sectional head is responsible for
conducting the comparability studies.
Supporting
Documents
·
Quality Control Results Review Procedure
·
Measurement of Uncertainty Procedure
·
Review of EQA Results Procedure
·
Uncertainty of Measurement Records.
Examination
procedures are done by competent personnel, and review and authorization of
results is done by other technical personnel competent in that test examination
procedure as well. Technically competent personnel will systematically review
and evaluate the results of examination in conformity with the clinical
information available regarding the patient.
The storage
and safe disposal of samples after examination is done according to the Sample
Management procedure and hospital guidelines. Samples are stored for a period
of time as defined in Document and Sample Retention Period Schedule.
Supporting Documents
·
Sample
Management Procedure.
·
Document
and Sample Retention Period Schedule.
CDH
Laboratory has formatted result reports in form of softcopy and Paper for
communicating results to the laboratory service users. Format of laboratory are
reviewed after two years with the laboratory service users. The laboratory
management and the laboratory service users share the responsibility of
delivering within the established turnaround time and to the appropriate
individuals. The laboratory uses Management of Results Procedure for generating
and reporting results and the procedure also defines the action steps for
reporting of results within the critical/alert intervals. Critical/alert value
intervals have been established in consultation with the clinicians.
Patient’s results are released to
clinicians however for outpatient; results may be given to the patient bind
with staple pins. No results are issued on the phone except for urgent sample
and results falling within critical value intervals are only issued to the
authorized receivers. The hard copy laboratory shall also be issued later to
the requesting clinician. In such situation a record of Communication of urgent
or Critical Value is maintained by the laboratory.
Alteration of reports is permissible
however it has to be done in accordance with Results Management procedure.
The sectional heads are responsible for
ensuring that all results whether internally generated or from referral
laboratories are legible and are without transcription errors. Records of
patient results are retained in patient registers for a period of time defined
in Document and Record Retention Schedule. All reports shall be issued and
interpreted in full and are copyright of CDH
Laboratory.
Reports shall not be used for any other purpose other than for treatment or
disease prevention.
Supporting
Documents
·
Results
Management Procedure.
·
Document
and Record Retention Schedule.
·
Communication
of urgent or Critical Value Results.
CDH
Laboratory is committed to promote the upholding of highest safety standards
for its employees and users of its services. To achieve this, the laboratory
has developed a Safety Manual to ensure safe work practices and has a Safety
officer who is responsible for enforcing safe working practices within CDH Laboratory. In
addition to the above mentioned strategies, the following have also been
implemented.
- Management ensures
that all employees are well trained in laboratory safety which covers all
issues regarding bio-safety and bio-security in their work environment as
well as corrective actions in cases of unexpected events.
- The CDH Laboratory
management shall provide a safe work environment by compliance with the
universal safety precautions and provision of appropriate personal
protective equipment to all members of staff.
- Safety is the
responsibility of everyone, therefore every employee while working in the
laboratory, shall take reasonable care of his/her own safety and that of
persons who may be affected by his/her actions.
- All personnel who
work in the laboratory shall be offered immunization to prevent infections
such as Hepatitis B and Yellow fever associated with organisms to which
the personnel are likely to be exposed. Personnel working in tuberculosis
laboratory have to be immunized also against TB infection and also undergo
medical check-up once annually for TB.
- All occupational
illness, injuries, adverse incidents, accidents and consequential actions
shall be reported to the Head of Laboratory Services or Laboratory Manager
and documented in Work Related Injury Form. The records shall be kept in
the personnel files. Employees who have had an occupational exposure to
blood or other potentially infectious material shall follow the Post
Exposure Prophylaxis Procedure and work practices outlined in the safety
manual to mitigate the effects.
- All chemicals are
stored according to the Material Safety Data Sheets instructions. Access
to laboratories is only to the authorized personnel. Management does not
allow the use of mobile phones when working in the laboratory.
- Safety Officer is
responsible for ensuring that the members of staff adhere to safety
guidelines in all operations of the laboratory.
Supporting documents:
·
Safety manual
·
Post Exposure Prophylaxis Procedure
·
Work Related Injury
Form.
Signing
page
We,
staff members of …………………………………………..do hereby certify that we have read,
discussed (where applicable) and understood the content of this manual. We
commit ourselves to abide by its spirit and shall strive to comply and make it
complied with.
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that all the staff, as listed above, have read, discussed and understood the manual
as indicated herein.
Name and signature of the Laboratory Manager: Date:
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