ORGANIZATION IN QMS

BIJAY KUMAR GUPTA

M.SC. BIOCHEMISTRY & MOLECULAR BIOLOGY
5TH SEMESTER
DHULIKHEL, KUSMS
WHAT DO YOU THINK ABOUT ORGANIZATION?
• Organization is the form of every human association for the attainment of a common
purpose.
-Mooney and Reiley
• An organization is a collection of people working together in a coordinated and
structured fashion to achieve one or more goals
• In general, organization is a process of identifying and grouping the work to be
performed, defining and delegating responsibility and authority, and establishing
relationships to enable people to work most effectively together in achieving
objectives.
• In a quality management model, the
organization refers to the management and
supporting structure of the lab.
• It is a foundational element, interconnected
with all other quality management components.
CHARACTERISTICS ESSENTIAL TO SUCCESS

• Managerial commitment is essential for a successful quality management

system.
• All management levels must actively support and participate in quality activities.
• Visible support from management helps staff understand the importance of the
system.
• Without management engagement, it is impossible to establish necessary policies
and resources
• Decision-making levels must also be involved to ensure proper implementation.
CONT..

• The organizational structure must support the laboratory's quality goals.

• The laboratory must be legally structured according to local laws.
• All necessary organizational elements for a quality management system must be
in place
 KEY ORGANIZATIONAL COMPONENTS

1. Leadership:
• Full commitment to quality management system
• Requires:
 Visionary thinking
 Team building and motivation
 Strong communication skills, Responsible resource use

2. Organizational structure:
• Clearly defined hierarchy
• Functional or organizational chart with:
 Roles and responsibilities
 Clear reporting lines.
3. Planning process:
• Requires effective planning skills
• Must include:
Defined time frames
Assigned responsibilities
Human and financial resource allocation
Workflow management
CONT..

4. Implementation:
• Effectively manage projects and routine operations
• Allocate resources strategically to meet objectives
• Adhere to timelines for planned activities
• Ensure successful achievement of goals and deliverables
CONT..

5. Monitoring:
• Essential for maintaining and improving quality:
Track and evaluate system performance continuously
Compare progress with benchmarks and standards
Identify gaps and initiate corrective actions
Drive continuous quality improvement, the core aim of the QMS
Laboratory Organization
Adapted from: Laboratory Quality Assurance and Quality Control (QA/QC) Al Salama hospital, Saudi
arabia
Fig1 : Federal Organogram of Nepal
Fig 2: At the federal level of the health care system
Source: MOHP
Fig 3: At the provincial level
Fig 4: At local government level
CONT..

PHC/ORCS: Primary health care/ outreach clinics

FCHVS: Female community health volunteers
EPI: Expanded program on immunization
 TYPES OF LABORATORIES IN NEPAL

1. Public health
laboratory
2. Hospital-based laboratory
Government-based lab Private hospital based Government & private
laboratory teaching hospital
based laboratory

Center hospital laboratory Basic hospital based Standalone laboratory

laboratory

Provincial hospital Specialized hospital Research laboratory

laboratory based laboratory

Primary health center Referral laboratory

laboratory

Health post-based Reference laboratory

laboratory
 TERMINOLOGY

• National public health laboratory refers to the central authority responsible for
regulating and managing public health laboratory services.
• Regional public health laboratory refers to the public health laboratories
established at the regional level.
• Teaching hospital refers to a hospital established for the purpose of teaching
medical science subjects, which provides health-related services and has been
granted approval by the concerned authority
• Hospital-based laboratory refers to a laboratory based within a hospital that
provides laboratory services after obtaining approval from the concerned authority.
CONT..
• Standalone laboratory refers to a laboratory that is not based in a hospital but is
established independently to provide only laboratory services and has received
approval to operate. It includes private laboratories, privately owned
clinics/polyclinics-based laboratories, and laboratories conducting examinations
for foreign employment-related medical tests
• Public health refers to medical science, medical practice, and public health.
Public health is the provision, diagnosis, treatment, and prevention of diseases
related to people’s health, medical treatment. It encompasses all activities related
to public health, including disease prevention, health promotion, and community
health assessments.
 RESEARCH LABORATORY:
• Research laboratories conduct research work related to public health based on
human samples in national-level laboratories related to public health, identifying
positive and negative diseases related to public health.
• According to sub-clause (1), research work on human samples is conducted in
national public health laboratories, which is mandatory or previously approved
by the concerned authority.
• Research laboratories that conduct research have the role of continuous
monitoring, cooperation, or coordination of national public health laboratories.
• According to this sub-clause, research work conducted in laboratories requires
necessary policy improvements for public health, including health policy groups
"b" and "a" level public health care
 REFERRAL LABORATORY:

• Referral laboratories are laboratories within the country or outside the country
that can conduct tests on samples that other laboratories cannot test.
• Laboratories within the country conduct supplementary testing or confirmatory
testing procedures on samples that can be collected from humans, and samples
that cannot be tested due to a lack of testing facilities can be sent to referral
laboratories with the permission of the concerned authority.
 Cont..
• According to sub-clause (1), laboratories that have facilities for testing samples
within the country can send samples to foreign referral laboratories with the
permission of national health laboratories when the condition is not available
within the country.
• Foreign referral laboratories receive recognition from national public health
laboratories.
• National public health laboratories can send samples outside the country for
testing, and a list of approved national technical consultant committees should be
prepared in consultation with the concerned technical advisory committee.
 REFERENCE LABORATORY:

• Reference laboratories conduct quality control testing and regulation of other

laboratories, perform calibration of equipment, conduct reference testing, and
edit and compile laboratory-related tasks.
• Reference laboratories receive recognition from the government.
• Reference laboratories approved by the Nepal government, besides other
laboratories, are allowed to use the word "reference" in their names.
CLASSIFICATION OF LABORATORY GROUPS

• Based on the standards mentioned in clauses 17 and 21, laboratories are

classified into five groups (namely "E", "D", "C", "B", and "A" levels).
• "E" group laboratories:
Laboratories falling under this group are laboratories based in government health
posts.
Private laboratories falling under this group must fulfill all the standards specified
for this group for government laboratories to designate them under the specified
standards mentioned in the clauses
CONT..
• Space: 150 sq. ft or more
• Equipment/consumables/reagents/kits: as required to perform designated tests.
Modern/advanced technology should be adopted.
• Human resource: minimum two
• Services (ranges of tests): to be provided by these laboratories include:
Hematology: TC, DC, hemoglobin, ESR, blood grouping for non-transfusion
purposes, BT, CT
Biochemistry: sugar, urea, bilirubin T & D, S. Uric acid, total protein, serum albumin
Microbiology: sputum AFB stain (Z-N stain)
Tests by RDTS: with simple interpretation
Miscellaneous: routine urine analysis, routine stool analysis, urine pregnancy test,
stool for reducing substances
 D" GROUP LABORATORIES

• Laboratories falling under this group are laboratories based in government

primary health centers.
• This laboratory conducts general nature tests.
• Private laboratories falling under this group must fulfill all the standards
specified for this group in order for government laboratories to designate them
under the specified standards mentioned in the clauses:-
CONT..

• Space: 250 sq. ft or more with designated areas for sample collection, sample
processing, and reporting
• Equipment/consumables/reagents/Kits: As required to perform designated tests.
Modern/advanced technology should be adopted.
• Human Resource: Minimum four, one of them should be a Lab Technologist or above
CONT..

• Services (range of tests): To be provided by these laboratories include all the

services/tests approved for "E" category (Basic) laboratories, plus the following:
 Hematology: RBC count, PT, APTT, Platelet count, Hematocrit, Red cell Indices
 Biochemistry: SGOT, SGPT, ALP, Lipid profile, creatinine, sodium, potassium
 Microbiology: Gram stain and KOH mount for fungi
 Serological tests: RPR, Widal test, ASO Titre, RA Factor, CRP
 Tests by RDTs: All
 Miscellaneous: Stool for occult blood, Urine ketone bodies, urobilinogen, bile
salt, bile pigment, Bence Jones protein
 "C" GROUP LABORATORIES

• Laboratories based in hospitals of 50 beds and above fall under this group.
• Private laboratories falling under this group must fulfill all the standards
specified for this group for government laboratories to designate them under the
specified standards mentioned in the clauses:-
• Space: 400 sq. ft or more with designated areas for sample collection, sample
processing, and reporting
• Equipment/consumables/reagents/Kits: As required to perform designated tests.
Modern/advanced technology should be adopted.
CONT..
• Human Resource: Minimum six with at least 50% technical manpower should
have having Bachelor’s Degree or above, with at least one having Master’s
Degree or above, depending upon the nature of the tests
• Services (range of tests): To be provided by these laboratories include all the
services/tests approved for “D” category (Intermediate) laboratories, plus the
following:
• Hematology: Absolute counts, Blood grouping for transfusion purpose, Cross
matching, and reticulocyte count, peripheral blood smear examination
• Biochemistry: Cardiac Enzymes, other enzymes, Thyroid Function Test ( T3,
T4, TSH)
CONT..

• Microbiology: All Routine bacteriology culture, ELISA for infectious disease,

e.g., HIV, HBsAg, HCV, etc.
• Histopathology/Cytopathology, Bone Marrow aspiration and biopsy service
• Miscellaneous: CSF and body fluid analysis, Semen analysis
 "B" CATEGORY LABORATORY STANDARDS

• 51 beds to 200 beds - General hospitals, all other hospitals, and sub-regional
hospitals should have laboratory services equivalent to this category.
• 50 beds and above - Special service hospitals and specialty hospitals should have
laboratory services and specialty services. At a minimum, B category services
should be available.
CONT..

• This category of laboratory should have the following minimum facilities:

Space: 1000 sq. ft or more with adequate rooms required for all specialized
services. 1000 sq. ft or more with adequate rooms required for all specialized
laboratory services (depending on the type of services).
General hospitals should have laboratory services with the main 4 divisions
(microbiology, Histocytology, hematology, and biochemistry). At a
minimum, 3 divisions services should be available. Specialty services should
be available based on the specialty hospital's requirements or the state's
needs.
CONT..
• There should be adequate space for sample collection,
information/reception/cash counter, reporting room, QC unit, library, meeting
hall, and office of the laboratory heads.
• Equipment/consumables/reagents/Kits: As required to perform designated tests.
Modern/advanced technology should be adopted.
• Human Resource: Twelve or four per discipline with 50% technical manpower
should have having Bachelor’s Degree or above, with at least three having a
Master’s Degree or above, depending upon the nature of the tests
CONT..

• Services (range of tests): To be provided by these laboratories include all the

services/tests approved for "C" category (Standard) laboratories.
• In addition, these specialized laboratories can provide all services, including
special Coagulation profile, hormone analysis, Immuno-histochemistry (IHC),
Tumor markers, Advanced C/S (anaerobic culture, fungus culture), hemolytic
profile, tests performed by ELISA/CLIA technique as per requirement
 A" CATEGORY LABORATORY STANDARDS

• This category should provide highly specialized laboratory services in addition

to all other laboratory services.
• This category includes government or private hospitals with 200 or more beds,
laboratory services based in medical colleges, research laboratories, central and
referral hospitals, and laboratories of hospitals with 50 or more beds that provide
monthly specialized services, as well as highly specialized standalone
laboratories.
CONT..

• This category of laboratory should have the following minimum facilities:

• Space: 2000 sq. ft or more (depending upon the number of specialized
services). There should be adequate space for sample collection,
Information/reception/cash counter, reporting room, QC unit, library, meeting
hall, and office.
• Equipment/consumables/reagents/Kits: As required to perform designated
tests and expected advanced technologies.
CONT..
• Human Resource: Minimum 24 or six per discipline (Hematology, Biochemistry,
Microbiology, Histocytopathology) with 50% technical manpower should have a
Bachelor’s Degree or above, with at least one per department having Masters
Degree or above, depending upon the nature of tests
• Services (range of tests): Laboratories will provide advanced level/sophisticated
technologies in all the services/tests approved for "B" category (Specialized)
laboratories, molecular tests, super specialized tests like flow cytometry, genetic
study. In addition to this, some special test services provided by "A" category
labs include super-specialized services in different disciplines. Microbiology,
Histocytology, hematology, and biochemistry)
 LABORATORY CATEGORIES BASED ON THE
TYPE OF HEALTH FACILITY OR SERVICE:
S.N. Type of facility/laboratory Minimum Remarks
required
category
1. Health post E If lab service is available
2. Primary health center D If lab service is available
3. General/ district hospital(up to 50 beds) C Government or private

4. General/ district/ sub-regional hospitals (51- B Government or private

200 beds)

5. General/regional/central hospitals(> 200 A Government or private

beds)
6. Specialized Hospitals (up to 50 beds) B

7. Specialized Hospitals (>50 beds) A

S.N Type of Facility/Laboratory Minimum
Required Remarks
Category
8. Outpatient/Foreign Employment Testing Labs C

9. Stand-alone Laboratories E to A Based on scope and

capacity

10. Private Clinic-based Laboratories D If lab service is

available

11. Research Laboratories B

12. Specialized or Super-specialized Laboratories B

13. Blood Transfusion Laboratories B

14. Reference Laboratories A

15. Medical College/Teaching Hospital Laboratories As per NMC Determined by Nepal
(Govt./Private) Medical Council
CHALLENGES IN LABORATORY ORGANIZATION

• Unequal resource distribution(urban vs rural)

• Lack of trained human resources in remote areas
• Poor infrastructure and power supply
• Inadequate quality control in small private labs
• Limited research funding
 SUMMARY

• Organization is foundational in QMS.

• Strong leadership, clear structure, and continuous monitoring are essential.
• Nepal’s labs are classified by capability and function, ensuring appropriate
quality standards at every level.
REFERENCES

• Ministry of Health and Population (MOHP) reports, 2077 B.S.

• National public health laboratory (NPHL) publications, 2073 B.S.
 CASE STUDY 1: REFERENCE LABORATORY -
NATIONAL PUBLIC HEALTH LABORATORY, TEKU

• Background:
The National Public Health Laboratory (NPHL), Teku, acts as Nepal’s reference
laboratory, responsible for advanced diagnostics, external quality assurance
(EQA), and setting standards for other labs.
 ACTIONS TAKEN:

• Organizational Structure: Established specialized units (Molecular, Serology,

Microbiology, QA).
• Legal Compliance: Operated under Ministry of Health & Population guidelines.
• Leadership: Appointed a dedicated QA manager and technical leads for each unit.
• Continuous Monitoring: Conducted regular EQA programs for district and provincial
labs.
• Capacity Building: Organized training workshops for lab staff across Nepal.
 RESULTS

• Improved reliability and comparability of test results nationwide.

• Enhanced capacity for outbreak investigation (e.g., COVID-19, dengue).
• NPHL recognized as a regional reference lab by WHO.