National Quality Assurance

Standards
for Integrated Public Health
Laboratories
2024

Ministry of Health and Family Welfare,

Govt. of India
© 2024, National Health Mission, Ministry of Health & Family Welfare, Government of India.

Reproduction of any excerpts from this document does not require permission from the publisher so long as
it is verbatim, is meant for free distribution and the source is acknowledged.

ISBN: 978-93-82655-37-4

Ministry of Health & Family Welfare

Government of India
Nirman Bhawan, New Delhi, India

Designed by: Royal Press

Printed by: Kamal Printers
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List of Abbreviations
1 AFB Acid Fast Bacilli
2 AIDS Acquired Immune Deficiency Syndrome
3 AMC Annual Maintenance Contract
4 AMR Antimicrobial Resistance
5 AoC Area of Concern
6 AST Aspartate Aminotransferase
7 BG Blood Group
8 BLS Basic Life support
9 BMW Biomedical Waste Management
10 BPHL Block Public Health Laboratory
11 BPHU Block Public Health Unit
12 BRI Biological Reference Interval
13 BSL-II Bio Safety Level-2
14 BT Bleeding Time
15 CB- NAAT Cartridge Based Nucleic Acid Amplification Test
16 CBC Complete Blood Count
17 CD 4/8 Count Cluster of Differentiation 4/8
18 CHC Community Health Centre
19 CHP Chemical Hygiene Plan
20 CLIA Chemiluminescence Immunoassay
21 CMC Comprehensive Maintenance Contract
22 COVID-19 Coronavirus Disease- 2019
23 CPCB Central Pollution Control Board
24 CQSC Central Quality Supervisory Committee
25 CRP C Reactive Protein
26 CSF Cerebrospinal Fluid
27 CT Clotting Time
28 DC Differential Count
29 DCIP Dichlorophenolindophenol
30 DEO Data Entry Operator
31 DH District Hospital
32 DQAC District Quality Assurance Committee
33 DQAU District Quality Assurance Unit
34 ELISA Enzyme Linked Immunoassay
35 EQAS External Quality Assurance System
36 ESR Erythrocyte Sedimentation Rate
xvi National Quality Assurance Standards for Integrated Public Health Laboratories

37 ESS Employee Satisfaction Survey

38 ETP Effluent Treatment Plant
39 FBS Fasting Blood Sugar
40 FEFO First Expiry First Out
41 FNAC Fine Needle Aspiration Cytology
42 FRU First Referral Unit
43 FSSAI Food Safety and Standards Authority of India
44 G6PD Enzyme Glucose-6-Phosphate Dehydrogenase
45 GTT Glucose Tolerance Test
46 H2S test Hydrogen Sulphide Test
47 Hb Haemoglobin
48 HbA1C Glycosylated Haemoglobin
49 HBV Hepatitis B Virus
50 HCFs Health Care Facilities
51 HCV Hepatitis C Virus
52 HDL High Density Lipoprotein
53 HIS Hospital Information System
54 HIV Human Immunodeficiency Virus
55 HPLC High- Performance Liquid Chromatography
56 HR Human Resource
57 HWC Health and Wellness Centre
58 ICC Infection Control Committee
59 ICU Intensive Care Unit
60 IDSP Integrated Disease Surveillance Program
61 IgM Immunoglobulin M
62 IHIP Integrated Health Information Platform
63 IPD In Patient Department
64 IPHL Integrated Public Health Laboratory
65 IPHS Indian Public Health Standards
66 IQAS Internal Quality Assurance System
67 IQC Internal Quality Control
68 ISQua International Society for Quality in Healthcare
69 IT Information Technology
70 JSSK Janani Shishu Suraksha Karyakram
71 KOH Potassium Hydroxide
72 LASA Look Alike Sound Alike
73 LDL Low Density Lipoprotein
74 LED Light Emitting Diode
 National Quality Assurance Standards for Integrated Public Health Laboratories xvii

75 LIMS Laboratory Information Management System

76 LJ Chart Levey Jennings Chart
77 LQMS Laboratory Quality Management System
78 LT Laboratory Technician
79 ME Measurable Element
80 MLC Medico Legal Case
81 MoHFW Ministry of Health and Family Welfare
82 MSDS Material Safety Data Sheet
83 NACO National AIDS Control Organisation
84 NACP National AIDS Control Program
85 NCD Non- Communicable Diseases
86 NGO Non-governmental organization
87 NHM National Health Mission
88 NHSRC National Health System Resource Centre
89 NQAP National Quality Assurance Program
90 NQAS National Quality Assurance Standards
91 NS1 Non-Structural Protein 1
92 NSF National Sanitation Foundation
93 NTEP National Tuberculosis Elimination Program
94 NVBDCP National Vector Borne Disease Control Program
95 NVHCP National Viral Hepatitis Control Program
96 OB Observation
97 OPD Out Patient Department
98 OT Operation Theatre
99 PAP Smear Papanicolaou Smear
100 PCR Polymerase Chain Reaction
101 PDCA Plan- Do- Check- Act
102 PHC Primary Health Centre
103 PHED Public Health Engineering Department
104 PI Patient Interview
105 PM-ABHIM Pradhan Mantri – Ayushman Bharat Health Infrastructure Mission
106 POCT Point of care tests
107 PPBS Post Prandial Blood Sugar
108 PPE Personal Protective Equipment
109 PSA Prostate Specific Antigen
110 PSS Patient Satisfaction Survey
111 PT Prothrombin Time
112 QA Quality Assurance
xviii National Quality Assurance Standards for Integrated Public Health Laboratories

113 QC Quality Control

114 QI Quality Improvement
115 QMS Quality Management System
116 QPS Quality and Patient Safety
117 RBC Red Blood cell Count
118 RBS Random Blood Sugar
119 RDT Rapid Diagnostic Test
120 Rh type Rhesus type
121 RO Reverse Osmosis
122 RPR Rapid Plasma Reagin
123 RR Record Review
124 RT- PCR Real Time reverse transcriptase – polymerase Chain Reaction
125 RTI Respiratory Tract Infection
126 SARS Severe Acute Respiratory Syndrome
127 SD Standard Deviation
128 SGOT Serum Glutamic-Oxaloacetic Transaminase
129 SGPT Serum Glutamate-Pyruvate Transaminase
130 SI Staff Interview
131 SMS Short Message Service
132 SOP Standard Operating Procedure
133 SQAC State Quality Assurance Committee
134 SQAU State Quality Assurance Unit
135 STD Sexually Transmitted Diseases
136 TAT Turn Around Time
137 TB Tuberculosis
138 TLC Total Leucocyte Count
139 TRF Test Requisition Form
140 UID Unique Identification Number
141 UPHC Urban Primary Health Centre
142 UPS Uninterruptible Power Supply
143 UPT Urine Pregnancy Test
144 UTI Urinary Tract Infection
145 VDRL Venereal Disease Research Laboratory
146 VIS Variance Index Score
147 VLDL Very Low-Density Lipoprotein
148 WHO World Health Organization
 National Quality Assurance Standards for Integrated Public Health Laboratories xix

Table of Contents
1. Introduction, Objectives and Scope 01

2. Background 03

3. NQAS for the Assessment of IPHL 07

4. Measurement System under National Quality Assurance Standards 19

5. Assessment Protocols and Scoring System 21

6. Certification Process 25

7. NQAS Checklist for Integrated Public Health Laboratories 29

8. List of Contributors 125

9. Bibliography 127
 National Quality Assurance Standards for Integrated Public Health Laboratories 1

Introduction

Medical laboratory services are an integral part of modern medicine and are considered pivotal for the
clinical decision-making. Healthcare Diagnostic techniques have evolved tremendously over the years; in
earlier days, patient diagnoses were more dependent on signs and symptoms gleaned by physicians. Medical
laboratories have revolutionised the whole scenario, becoming indispensable to clinical practices. The
importance of laboratory services was highlighted during the global coronavirus pandemic, and the crisis
has further fostered the market size of laboratory services.

Medical laboratories or clinical laboratories offer a vast array of lab-based procedures, and it helps physicians
to confirm their diagnosis, check the progress of treatment, and manage patients more efficiently. Laboratory
services in public health institutes involve a wide range of parameter and different types of laboratory
tests. In public healthcare facilities, the tests performed by the hospital laboratories vary depending on
their services. Most commonly, Rapid Diagnostic Kit (RDK), basic haematology, including microscopy and
Biochemistry, are provided at the primary care level. While more advanced services, including microbiology
and histopathology, are provided in secondary and tertiary care institutions.

To cater burden of emerging infectious diseases, increased prevalence of non-communicable diseases (NCD),
and current healthcare industry needs, it is crucial to strengthen the laboratory systems in the public health
sector. It necessitates catering to the patient's needs without much hassle and providing rapid, reliable,
and accurate test results cost-effectively. To ensure the accessibility, efficiency, effectiveness, and quality
of laboratory services Ministry of Health and Welfare, GoI supported establishing Integrated Public Health
Laboratories (IPHL) under PM-Ayushman Bharat Health Infrastructure Mission (PM-ABHIM). Indian Public
Health Laboratories (IPHL) are envisaged in 730 districts of States/UTs in a phased manner. It includes
establishing a network of integrated public health laboratories (IPHL) at the various levels (especially
regional, state, district, and block levels). IPHL provides hospital-specific, disease-specific laboratory
diagnosis and strengthens healthcare surveillance with quality-assured laboratory data. It also ensures the
integration of the district public health lab, human resource (HR), equipment, and infrastructure to avoid
duplication and disconnect.

To improve and sustain quality in public healthcare facilities and various programs, National Quality
Assurance Standards (NQAS) were launched by the Ministry of Health and family welfare, GoI, in 2013. In
the beginning, these standards were for district Hospitals, subsequently including, Community health centre
(both rural & urban), primary health centres (both rural and urban), Health and wellness centre – health
Sub-centre, Comprehensive lactation management centre, Adverse events following immunisation, etc.
NQAS aims to instil a culture of quality and safety in health systems by developing quality standards and
tools that are pro-public health, flexible, evidence-based, and current as per professional knowledge. The
NQAS standards are aligned with the national and international benchmarks defined by the Indian Public
health standards, World Health Organization (WHO) respectively. National Quality Assurance Standards are
accredited by the International Society for Quality in Healthcare (ISQua), Certification of Integrated Public
Health Laboratory against and quality standards for Laboratory services are an integral part of the NQAS
framework.
 2 National Quality Assurance Standards for Integrated Public Health Laboratories

National Quality Assurance Standards aims to provide quality services to its users (patient and healthcare
providers), stimulate district and block-level public health laboratories to demonstrate competency, and
continually maintain and improve quality standards.

Objectives:
National Quality Assurance Standards for Integrated Public Health Laboratories aim to:

• Ensure the availability of comprehensive, accurate, rapid and quality diagnostics services.

• Reduce errors in laboratory processes and improve the efficiency of the treatment.

• Establish and improve quality management systems, leading to high service standards.

• Ensure excellence in relation to the current knowledge and technical development in laboratory
functions.

Scope
The National Quality Assurance Standards (NQAS) for IPHL would be applicable to standalone IPHL in a
district or co-located with the District Hospital.

As per NQAS for District Hospital 2020 version, Laboratory standards and assessment checklist are part
of the Assessor’s Guidebook for a District Hospital. It includes quality improvement in sample collection,
transportation, testing, reporting and clinical decision-making for all the tests mandated in District Hospital.

NQAS-DH-2020 standards and assessor’s guidebook would continue to be applicable to such labs. which are
not converted into IPHL. While NQAS certification for IPHL will be mandatory for all the laboratories set up
providing diagnostic services as per IPHL guidelines.
 National Quality Assurance Standards for Integrated Public Health Laboratories 3

Background

Integrated Public Health Laboratories:

Delivery of accessible, equitable and quality care without any financial exclusion remains one of the stated
objectives of the Ministry of Health & family welfare. India’s population is facing the double burden of
communicable and non-communicable diseases leading to high mortality and morbidity, significantly
impacting human life and economic growth. The country needs to devise effective healthcare solutions
that not only boost control of the existing burden of diseases like HIV, TB, and Malaria but also prepare to
effectively detect, prevent, control, and manage emerging infectious diseases and their health threats. This
calls for identifying cost-effective and efficient healthcare diagnosis and delivery mechanisms.

Laboratory services are essential and fundamental part of the health systems. It plays a vital role before,
during and after treatment. Lack of access to high-quality diagnostic tests may deprive the patient from
accessing life-saving treatments and reduce the opportunities to prevent onward transmission and spread
of diseases. Without effective public health laboratory systems, public health responses will be delayed, and
global health security will be threatened. Non-availability/sub-standard laboratory services in public health
facilities, forces the users to use private health facilities, which results into out-of-pocket expenditure and
financial hardships. Therefore, access to appropriate, high-quality laboratory support is vital in healthcare
service provision, including surveillance, disease prevention, and control programs.

To bolster laboratories' infrastructure and disease surveillance capabilities in India, integrated public health
laboratories (IPHL) are envisaged to be set up at district and block levels under Pradhan Mantri Ayushman
Bharat Infrastructure Mission (PM- ABHIM). IPHL aims to provide comprehensive laboratory support for
communicable and non-communicable diseases along with Haematology, Biochemistry, Clinical Pathology,
Cytopathology, Histopathology, Microbiology, and outbreak investigation support. The epicentre of IPHL will
be a district with defined upward (Medical college) and downward (block public health laboratories and
other peripheral laboratories) linkages. IPHLs mandate establishing networks at various levels of health
care for providing diagnostics for disease-specific programmes and integrating healthcare surveillance
supported by quality-assured laboratory data.

“Integrated Public Health Laboratory (IPHL)’ extends to a laboratory providing comprehensive services,
including infectious diseases diagnostics along with testing of haematology, chemical biochemistry,
microbiology, and pathology parameters with bio-safety level-2, all combined under one umbrella. IPHL
involves physical, functional and data integration of different sections of the district hospital laboratories.

• The physical integration includes establishing a central sample collection facility in a patient-friendly
location.

• The functional integration includes the operation of various vertical program sections as the coordinated
limbs of a single body, i.e., the district public health laboratory, in the process sharing space, human
resources and equipment, thus avoiding duplication and disconnect.

• The data integration will be through an integrated Laboratory Information Management System (LIMS)
to monitor the data flow under various programs, facilities, and departments to feed into the IHIP
platform for coordinated public health action.
 4 National Quality Assurance Standards for Integrated Public Health Laboratories

National Quality Assurance Standards

Advent of the National Health Mission and, subsequently, National Health Policy ensure the availability
of accessible, affordable, and quality healthcare. With the influx of enormous resources, the country has
developed state-of-the-art facilities equipped with requisite modern equipment and instruments, manned
by the highly skilled workforce, and ensuring the availability of free drugs and diagnostics. Despite all such
efforts, poor quality of care has been the biggest obstacle in satisfying the patient’s needs.

Various models of Quality of care have been implemented in the country to overcome these challenges.
However, none could cater for the particular requirements of public healthcare institutions in terms of
service delivery, viz., healthcare facility’s quality and standard compliance as per National disease control
programme, immunisation, outreach services etc. To meet the specific requirements, there was a need for a
Quality system which is pro-public health, and to fulfil the void, National Quality Assurance Program (NQAP)
was launched in 2013.

Under the ambit of the National Quality Assurance Program, Standards of Care for various levels of health
facilities, viz. District Hospitals, Community Health Centres (FRU), Primary Health Centres (24*7), Urban
Primary Health Centres, and Health and wellness standards-Sub Centre have need framed. The uniqueness
of the National Quality Assurance standards is its measurement system which has been uniformly built upon
Areas of Concern, Standards, Measurable Elements and Checkpoints. Standards under each level of healthcare
institution (DH/CHC/PHC/HWC) have been arranged under Eight (8) broad themes, namely, Area of Concern
viz. Service Provision, Patient Rights, Inputs, Support Services, Clinical Services, Infection Control, Quality
Management and Outcomes in the system. Depending upon the services provided in available hospital
departments, the quality of care using the NQAS departmental checklist is measured and improved. E.g., In
district Hospitals, a gamut of 21 departmental checklists is available, viz—emergency, OPD, IPD, Laboratory,
OT, ICU, and Labour room.

NQAS for Integrated Public Health Laboratories (IPHL)

To ensure the provision of Quality in IPHL, standards of quality under 8 Areas of concern have been framed.
Area of concern wise list & intent standards of care has been explained in subsequent pages (15 onward) of
this guidebook.

The standards of Quality of Care apply to fully functional IPHLs, located within the district Hospital or
as standalone. The existing laboratory checklists under NQAS DH will remain applicable to laboratories
providing district Hospital services only and has yet to upgrade to IPHL. Once the laboratory in the district
hospital increases its scope as per IPHL, it can apply separately or along with DH NQAS for IPHL certification.

Institutional Arrangement for Improving Quality in IPHL

Implementing the National Quality Assurance Program is well supported by a sturdy institutional framework
ranging from the National to the facility level. Details of institutional arrangement under quality may be
referred from “Operational Guidelines for Improving Quality in Public Healthcare facilities”1.

1 https://qps.nhsrcindia.org/quality-assurance-framework/operational-guidelines
 National Quality Assurance Standards for Integrated Public Health Laboratories 5

Level Quality Structure Quality Drivers

Central Quality Supervisory

National NHSRC Secretariat CQSC
Committee (CQSC)

State Quality Assurance State Quality Assurance Unit

State
Committee (SQAC) (SQAU) & QA Assessors

District Quality Assurance District Quality Assurance

District
Committee (DQAC) Committee (DQAU)

Facility Quality Team Quality Circles

Figure1: Represent the institutional arrangement under National Quality Assurance Program

It is envisaged that the district quality assurance unit and district Hospital level quality team will support the
IPHL quality circles to implement quality standards, find gaps, undertake prioritisation, and take up rapid
improvement activities (PDCA) for their resolution.

The District QA committee and the nodal officer responsible for operationalisation and monitoring of
IPHL will supervise the IPHL quality activities and will be responsible for setting targets, monitoring Key
performance indicators, and orienting staff for quality standards and its implementation activities.

Quality Certification of IPHL under NQAS

Under National Quality Assurance Program, there is an arrangement for two categories of certifications;
State Certification, wherein the state team conducts the assessment and once the facility is state-certified, it
would be eligible for National Certification. The second category is National Certification, where the team of
national external assessors conducts the assessment. Upon external assessment from the national level, if the
facility meets all criteria laid down by Central Quality Supervisory Committee, the facility shall be awarded
a National Certificate which is valid for three years, subject to clearance of annual surveillance assessments.
However, if a facility does not meet all laid criteria, in that case facility is quality certified with conditionality.
A similar, certification mechanism will be followed for NQAS in IPHL. The step-by-step procedure may be
referred Operational Guidelines Improving the quality in Public Health facilities 2021.
 National Quality Assurance Standards for Integrated Public Health Laboratories 7

NQAS for the Assessment of IPHL

NQAS for IPHL is broadly divided into 8 Areas of concern: Service provision, Patient Rights, Inputs, Support
Services, Clinical Services, Infection Control, Quality Management Systems and Outcome. 8 Area Concerns
has fifty (50) Standards and one hundred seventy (170) Measurable elements. The intent of each Area of
concern and the list of standards are enumerated below:

Service Provision
IPHL is pivotal in ensuring comprehensive laboratory services to the population in its catchment area. The
scope of IPHL is to provide routine district hospital laboratory services, diagnostic facilities for various
communicable and non-communicable diseases, including national programmes TB, for HIV, malaria, viral
hepatitis etc., and collecting and testing clinical specimens of human origin as well as samples of water, food
and air during outbreaks and reporting of that information in real-time as part of public health surveillance
systems.

The area of concern – services provision measures the availability of functional integrated diagnostic
laboratory services. “Availability” of functional services means; services are functional and are being utilised
by the end-users because the mere availability of infrastructure or human resources does not always ensure
the availability of the functional services. For example, as per staff, the facility may have functional NCD
services, but if there are hardly any diagnostic tests undertaken, it may be assumed that the services are
unavailable or non-accessible to users. Compliance with these standards and measurable elements should be
checked, preferably by observing the delivery mechanism of the services, reviewing the relevant records, and
checking outcomes after service delivery There are following two (2) standards and measurable elements in
this area of concern:

Reference No. Standards & Measurable Element

Area of Concern - A Service Provision

Standard A1 Facility provides Integrated Diagnostic Laboratory Services as per mandate
ME A1.1 Facility provides comprehensive set of Laboratory services
ME A1.2 The facility provides Laboratory services for communicable diseases
ME A1.3 The facility provides Laboratory services for non-communicable diseases
ME A1.4 Facility provides services to support public health functions
ME A1.5 Facility provides laboratory based surveillance services for Infectious & Non-
infectious diseases
ME A1.6 Services are available for the time period as mandated
Standard A2 Facility provides support services to linked spokes
ME A 2.1 Facility provides technical support services to Block Public Health Labs & other
peripheral labs
ME A 2.2 Facility provides information management support
 8 National Quality Assurance Standards for Integrated Public Health Laboratories

Patient Rights
Mere availability of services does not necessarily meet the need of the community, unless the available
services are accessible to the users, and are provided with dignity and confidentiality. Access includes
physical access as well as financial access. Evidence suggests that patients' experience and outcomes improve
when they are involved in the care. So, the availability of information is critical for access and enhancing
patients’ satisfaction. Area of concern Patients’ rights include parameters such as service availability without
a physical barrier, consent having, maintenance of privacy & confidentiality of patients and their records,
ensuring availability of mandated free services and provisioning of financial protection. There are three (3)
standards in Patient Rights area of concern.

Area of Concern - B Patient Rights

Standard B1 The services provided at the facility are accessible and affordable
ME B1.1 The facility has user friendly and uniform signage system
ME B1.2 The facility displays its services, entitlements and relevant information
ME B1.3 Access to facility is provided without any physical barrier & friendly to specially-abled
people
ME B1.4 There is an established procedure for having consent before conducting any procedure
ME B1.5 The facility has defined and established grievance redressal system in place
ME B1.6 The facility provides cashless services as per prevalent government norms/schemes
Standard B2 The service provided at facility are acceptable
ME B2.1 Adequate visual privacy is provided at every point of care
ME B2.2 Services are provided in manner that are sensitive to gender
ME B2.3 Confidentiality of patients records and clinical information is maintained for every
patient, especially of those having social stigma
ME B2.4 The facility ensures the behaviours of staff is dignified and respectful, while delivering
the services
Standard B3 The facility has defined framework for ethical management including dilemmas
confronted during delivery of services at public health facilities.
ME B3.1 Ethical norms and code of conduct for medical and paramedical staff have been
established
ME B3.2 There is an established procedure for sharing of laboratory/patient data with
individuals and external agencies including non-governmental organization.
ME B3.3 There is an established procedure for obtaining informed consent from the patients in
case facility is participating in any clinical or public health research
ME B3.4 There is an established procedure to ensure laboratory services during strikes or any
other mass protest leading to dysfunctional laboratory services.
ME B3.5 Facility has established a framework for identifying, receiving, and resolving ethical
dilemmas’ in a time-bound manner through ethical committee/ locally applicable rules
 National Quality Assurance Standards for Integrated Public Health Laboratories 9

Inputs
To provide required services in IPHL, it becomes pertinent to ensure the availability of requisite infrastructure,
equipment, instrument, human resource, consumables etc. So, area of concern: Inputs predominantly cover
the facility's structural part. Standards have been framed in concurrence with operational Guidelines for
Integrated Public Health Laboratories (IPHL) and Indian Public Health Standards (IPHS). While assessing
the infrastructure component, one may encounter the term –viz. ‘adequate’ and ‘as per load ‘has been given
in the requirements for many standards & measurable elements, as it would be hard to assess the stringent
infrastructural norms for the facility as that should be commensurate with the patient load. There are seven
(7) standards in this area of concern.

Area of Concern - C Inputs

Standard C1 The facility has infrastructure for delivery of assured services, and available
infrastructure meets the prevalent norms

ME C1.1 Facility has adequate space as per work load

ME C1.2 Patient amenities are provided at sample collection area as per patient load

ME C1.3 Facility has layout and demarcated areas as per functions

ME C1.4 The facility has infrastructure for intramural and extramural communication

ME C1.5 The facility and departments are planned to ensure structure follows the function/
processes (Structure commensurate with the function of the hospital)

Standard C 2 The facility ensures the physical safety of the infrastructure

ME C2.1 The facility ensures the seismic safety of the infrastructure

ME C2.2 The facility ensures infrastructure in place for safe sample transportation

ME C2.3 The facility ensures safety of electrical establishment

ME C2.4 Physical condition of buildings are safe for providing mandated lab services

Standard C3 The facility has established Programme for fire safety and other disaster

ME C3.1 The facility has plan for prevention of fire

ME C3.2 The facility has adequate firefighting Equipment

ME C3.3 The facility has a system of periodic training of staff and conducts mock drills regularly
for fire and other disaster situation

Standard C4 The facility has adequate qualified and trained staff, required for providing the
assured services to the current case load

ME C4.1 The facility has adequate specialist/qualified personnel as per service provision

ME C4.2 The facility has adequate technicians/paramedics as per requirement

10 National Quality Assurance Standards for Integrated Public Health Laboratories

ME C4.3 The facility has adequate support / general staff

Standard C 5 Facility ensures reagents and consumables required for assured list of services

ME C5.1 The facility has adequate reagents and controls at point of use

ME C5.2 The facility has adequate consumables at point of use

ME C5.3 Emergency drug trays are maintained at every point of care, where ever it may be needed

Standard C 6 The facility has equipment & instruments required for assured list of services.

ME C 6.1 Availability of equipment & instruments for diagnostic procedures being undertaken in
the facility

ME C 6.2 Availability of functional equipment and instruments for support services

ME C 6.3 Departments have patient furniture and fixtures as per load and service provision

Standard C7 Facility has a defined and established procedure for effective utilization,
evaluation and augmentation of competence and performance of staff

ME C7.1 Criteria for Competence assessment and performance appraisal are defined for all
clinical and Para clinical staff

ME C7.2 Competence assessment and performance appraisal of Clinical and Para clinical staff is
done on predefined criteria at least once in a year

ME C7.3 The Staff is provided training as per defined core competencies and training plan

ME C7.4 Training needs are identified based on competence assessment and performance
evaluation and facility prepares the training plan

ME C7.5 There is established procedure for utilization of skills gained thought trainings by on
-job supportive supervision
 National Quality Assurance Standards for Integrated Public Health Laboratories 11

Support Services
The support services are the backbone of IPHL, and desired clinical outcomes cannot be envisaged in
the absence of support services. Area of concern- Support services include maintenance and upkeep of
infrastructure & equipment; storage & dispensing of reagents and consumables, safety and security of
patients, visitors and staff and availability of water and power back for smooth lab functioning.

It also emphasizes, ensuring all requisite support to the linked BPHU and peripheral laboratories in terms
of capacity building, hand holding and monitoring, along with ensuring lab. fulfil all prevalent statutory and
regulatory requirements. Support services have total ten (10) standards.

Area of Concern - D Support Services

Standard D1 The facility has established Programme for inspection, testing and maintenance
and calibration of Lab Equipment

ME D 1.1 The facility has established system for maintenance of critical Equipment

ME D1.2 The facility has established procedure for internal and external calibration of
measuring Equipment

ME D1.3 Operating and maintenance instructions are available with the users of equipment

Standard D2 The facility has defined procedures for storage, inventory management and
dispensing of consumables and reagents

ME D2.1 There is established procedure for forecasting and indenting consumables, reagents
and controls

ME D2.2 The facility ensures proper use and storage of consumables and reagents

ME D2.3 The facility ensures management of expiry and near expiry reagents

ME D2.4 The facility has established procedure for inventory management techniques

Standard D3 The facility provides safe, secure, and comfortable environment to staff, patients,
and visitors.

ME D3.1 The facility provides adequate illumination level at workstation

ME D3.2 The facility has provision of restriction of visitors in IPHL

ME D3.3 The facility ensures safe and comfortable environment for service providers

Standard D4 The facility has established Programme for maintenance and upkeep of the
facility

ME D4.1 Exterior of the facility building is maintained appropriately

ME D4.2 The facility is clean and hygienic

ME D4.3 Facility's infrastructure is adequately maintained

ME D4.4 The facility has policy of removal of condemned junk material

ME D4.5 The facility has established procedures for pest, rodent and animal control
12 National Quality Assurance Standards for Integrated Public Health Laboratories

Standard D5 The facility ensures 24X7 water and power backup as per requirement of service
delivery, and support services norms

ME D5.1 The facility has adequate arrangement storage and supply for potable water in all
functional areas

ME D5.2 The facility ensures adequate power backup in all patient care areas as per load

Standard D6 The facility ensures support to all linked labs as per service mandate

ME D6.1 The facility has established procedure for providing technical support to linked labs

ME D6.2 The facility has established procedure for providing capacity building support to linked
labs

ME D6.3 The facility has established procedure for providing information management support
using digital technology to linked labs and administrative authorities

Standard D7 Facility has defined and established procedures for Financial Management

ME D7.1 The facility ensures the proper utilization of fund provided to it

ME D7.2 The facility ensures proper planning and requisition of resources based on its need

Standard D8 Facility is compliant with all statutory and regulatory requirement imposed by
local, state or central government

ME D8.1 The facility has requisite licences and certificates for operation of facility and different
activities

ME D8.2 Updated copies of relevant laws, regulations and government orders are available at
the facility

Standard D9 Roles & Responsibilities of administrative and clinical staff are determined as
per govt. regulations and standards operating procedures.

ME D9.1 The facility has established job description as per govt guidelines

ME D9.2 The facility has an established procedure for duty roster and deputation

ME D9.3 The facility ensures the adherence to dress code as mandated by its administration /
the health department

Standard D10 Facility has established procedure for monitoring the quality of outsourced
services and adheres to contractual obligations

ME D10.1 There is established system for contract management for out sourced services

ME D10.2 There is a system of monitoring of quality of outsourced services

 National Quality Assurance Standards for Integrated Public Health Laboratories 13

Clinical and Diagnostic Services

Clinical services are the most important area of Concern as the ultimate purpose of the existence of an
integrated public health laboratory is to provide accurate, precise, reproducible, and reliable results for
clinical decision-making. It is the area of concern that ensure and assess quality in the key laboratory
processes, viz., registration of patient, pretesting, testing and post-testing, activities including internal and
external verification and validation of laboratory processes. In each set of standards, internal and external
validation of key processes, i.e., QA of control materials used in the laboratory, use of control charts to ensure
processes are stable, running levels of QC depending upon the number of tests performed by the laboratory,
use of the external quality assurance methods inter-laboratory comparison etc. is an integral part of clinical
services.

The area of concern also ensures the services not available in IPHL are provided through referral labs.
in medical college or other linked laboratories, maintaining and updating the records using IT-based
management systems. Linkage of all the processes, from the collection of the sample to the delivery of reports
using IT platforms, ensures a reduction in common errors, and increase effectiveness and efficiency in the
laboratory functioning. There are a total of nine (9) standards that measures the quality of clinical services.

Area of Concern - E Clinical and Diagnostic Services

Standard E1 The laboratory has defined procedures for registration of patients at the
laboratory
ME E1.1 The facility has established procedure for registration of patients visiting lab or sample
collection area
ME E1.2 The facility has established procedure for registration of the patient's sample received
from spokes/peripheral labs
Standard E2 Facility has established mechanism for referral linkages to maintain continuity
of services
ME E2.1 Facility has defined and established procedures for continuity of services
ME E2.2 The facility has defined and established procedures for intersectoral coordination
Standard E3 The facility has established and defined procedure for pre-testing activities
ME E3.1 The facility has established procedure for patient preparation
ME E3.2 The facility has established procedure for sample collection from patient care areas
ME E3.3 The facility has established procedure for sample labelling and documentation
ME E3.4 The facility has a standardised Test Requisition form for the tests
ME E3.5 The facility has established procedure for packaging and transportation of samples
ME E3.6 The facility has defined criteria for sample acceptance or rejection
Standard E4 The facility has established and defined procedure for testing activities
ME E4.1 Facility performs tests as per established procedure
ME E4.2 Test procedures are verified through routine quality control methods
ME E4.3 Facility has established procedure for Biological reference intervals & critical alert
values
14 National Quality Assurance Standards for Integrated Public Health Laboratories

Standard E5 Laboratory has defined and established procedure for the post testing processes
ME E5.1 The facility has established procedure for reporting of result
ME E5.2 The laboratory has defined procedure for revision/amendment of the reports when
required
ME E5.3 The facility has established procedure for sample storage and its disposal
Standard E6 The facility has established mechanism for internal and external validation of
testing procedures
ME E6.1 The facility has established mechanism of internal quality control using quantitative
methods
ME E6.2 The facility has established mechanism of internal quality control using semi
quantitative/qualitative methods
ME E6.3 The facility has established mechanism of external quality assurance
Standard E7 Facility has defined and established procedures for maintaining, updating of
patients’ clinical records and their storage
ME E7.1 Adequate form and formats are available at point of use
ME E7.2 Register/records are maintained as per lab policy
ME E7.3 The facility has established computerised information system to support lab functions
ME E7.4 The facility ensures safe and adequate storage and retrieval of medical records
Standard E8 The facility has defined and established procedures for Emergency Services and
Disaster Management
ME E8.1 The facility has disaster management plan in place
ME E8.2 There is procedure for handling legal cases
Standard E9 Facility provides National health program as per operational/Clinical Guidelines
ME E9.1 The facility has established procedure for services under various communicable
disease programmes
ME E9.2 The facility has established procedure for services under various non-communicable
disease programmes
ME E9.3 Facility provides service for Integrated disease surveillance program/Integrated Health
Information Platform (IHIP)
 National Quality Assurance Standards for Integrated Public Health Laboratories 15

Infection Control
The area of concern ensures laying down the infection prevention practices and their conformance. The
infection control pertains to monitoring basic infection control practices, ensuring compliance with hand
hygiene practices, and using Personal Protective Equipment (PPE), etc. It also covers standard practices for
maintenance of hygiene, sterilisation, and disinfectant as well as management of Biomedical waste, including
liquid waste management. Infection Control areas of concern have six (6) standards.

Area of Concern - F Infection Control

Standard F1 Facility has infection prevention control program and procedures in place
ME F1.1 Facility has functional infection control committee and has a defined procedure to
review the infection prevention and control practices
ME F1.2 Facility has established procedures for regular monitoring of infection control practices
ME F1.3 There is Provision of Periodic Medical Check-ups and immunization of staff
Standard F2 Facility has defined and Implemented procedures for ensuring hand hygiene
practices and antisepsis
ME F2.1 Hand washing facilities are provided at point of use
ME F2.2 Staff is trained and adhere to standard hand washing practices
ME F2.3 Facility ensures standard practices and materials for antisepsis
Standard F3 Facility ensures standard practices and materials for Personal protection
ME F3.1 Facility ensures adequate personal protection equipment's as per requirements
ME F3.2 Staff adhere to standard personal protection practices
Standard F4 Facility has standard Procedures for processing of equipment and instruments
ME F4.1 Facility ensures standard practices and materials for decontamination and cleaning of
instruments and procedures areas
ME F4.2 Facility ensures standard practices and materials for disinfection and sterilization of
instruments and equipment's
Standard F5 Physical layout and environmental control of the laboratory ensures infection
prevention
ME F5.1 Layout of the lab is conducive for the infection prevention and control practices
ME F5.2 Facility ensures availability of standard materials for cleaning and disinfection
ME F5.3 Facility ensures standard practices followed for cleaning and disinfection
ME F5.4 Facility ensures air quality of high risk area
Standard F6 Facility has defined and established procedures for segregation, collection,
treatment, and disposal of Bio Medical and hazardous Waste
ME F6.1 Facility ensures segregation of Bio Medical Waste as per guidelines
ME F6.2 Facility ensures management of sharps as per guidelines
ME F6.3 Facility ensures transportation and disposal of waste as per prevalent guidelines
ME F6.4 Facility ensures management of liquid waste as per prevalent guidelines
16 National Quality Assurance Standards for Integrated Public Health Laboratories

Quality Management System

Quality management requires a set of interrelated activities that assure the quality of services according
to set standards and strive to improve upon it through systematic planning, implementation, monitoring,
assessment, identification of non-compliances and acting upon them. The standards in this area of concern
are the opportunities for improvement to enhance the quality of services and patient satisfaction.

Area of concern-Quality management system covers aspects like the establishment of organisational
framework for quality improvement, measurement, assessment, and usage of patient satisfaction;
compliance to display and usage of work instructions; regular assessment using NQAS, and other monitoring
checklists for the improvement and sustenance of Quality system. There are nine (9) standards in the quality
management system.

Area of Concern - G Quality Management

Standard G1 The facility has defined mission, vision, values, quality policy and objectives, and
prepares a strategic plan to achieve them
ME G1.1 Facility has defined mission & vision statement
ME G1.2 Facility has defined core values of the organization
ME G1.3 Facility has defined Quality policy, which is in congruency with the mission & vision of
facility
ME G1.4 Facility has defined quality objectives to achieve mission, vision and quality policy
ME G1.5 Mission, Vision, Values, Quality policy and Objectives are effectively communicated to
staff and users of services
ME G1.6 Facility prepares strategic plan to achieve mission, vision, quality policy and objectives
ME G1.7 Facility periodically reviews the progress of strategic plan towards mission, vision,
policy and objectives
Standard G2 The facility has established organizational framework for quality improvement
ME G2.1 The facility has a quality team in place
ME G2.2 The facility reviews quality of its services at periodic intervals
Standard G3 The facility has documented, implemented, and updated Standard Operating
Procedures for all key processes and support services
ME G3.1 Laboratory standard operating procedures are available
ME G3.2 Standard Operating Procedures adequately describes process and procedures
ME G3.3 The staff is trained and aware of the standard procedures written in the SOPs
ME G3.4 The facility ensures documented policies and procedures are appropriately approved
and controlled
Standard G4 The facility has established internal & external quality assurance programmes
for laboratory functions
ME G4.1 The facility has established internal quality assurance programs for lab
ME G4.2 The facility has established external quality assurance programs for lab
ME G4.3 Actions are planned to address gaps observed during quality assurance process
 National Quality Assurance Standards for Integrated Public Health Laboratories 17

ME G4.4 Planned actions are implemented through Quality Improvement Cycles (PDCA)
Standard G 5 The facility seeks continual improvement by practising Quality method and tools
ME G5.1 The facility uses method for quality improvement in services
ME G5.2 The facility uses tools for quality improvement in services
Standard G6 The facility maps its key processes and seeks to make them more efficient by
reducing nonvalue adding activities and wastages
ME G6.1 The facility maps its critical processes
ME G6.2 The facility identifies non value adding activities / waste / redundant activities
ME G6.3 Facility takes corrective action to improve the processes
Standard G7 The facility has defined, approved and communicated Risk Management
framework for existing and potential risks
ME G7.1 Risk Management framework has been defined including context, scope, objectives and
criteria
ME G7.2 Risk Management framework defines the responsibilities for identifying and managing
risk at each level of functions
ME G7.3 Risk Management Framework includes process of reporting incidents and potential
risk to all stakeholders
ME G7.4 A comprehensive list of current and potential risk including potential strategic,
regulatory, operational, financial, environmental risks has been prepared
ME G7.5 Modality for staff training on risk management is defined
ME G7.6 Risk Management Framework is reviewed periodically
Standard G8 The facility has established procedures for assessing, reporting, evaluating and
managing risk as per Risk Management Plan
ME G8.1 The facility has defined and communicated Risk Management framework for existing
and potential risks
ME G8.2 Periodic assessment for Physical and Electrical risks is done as per defined criteria
ME G8.3 Periodic assessment for Chemical and Biological hazard is done as per defined criteria
ME G8.4 Periodic assessment for potential disasters including fire is done as per defined criteria
ME G8.5 Risks identified are analysed evaluated and rated for severity
ME G8.6 Identified risks are treated based on severity and resources available
ME G8.7 A risk register is maintained and updated regularly to record identified risks, their
severity and actions to be taken
Standards G9 The facility has established system for patient and employee satisfaction
ME G9.1 Patient and Employee Satisfaction surveys are conducted at periodic intervals
ME G9.2 The facility analyses the patient feedback and do root cause analysis
ME G9.3 The facility prepares the action plans for the areas of low satisfaction
18 National Quality Assurance Standards for Integrated Public Health Laboratories

Outcome
Measurement of the quality is critical for improvement of processes and outcomes. For the desirous
functioning of a facility, it becomes imperative to measure its indicators which can help in knowing the
productivity, efficiency, and utilization of the facility as a unit. These indicators not only show the “outcomes”
of the service delivery but also support the team to carry out improvement by implementing change ideas
as per the requirement. Indicators may be reported through a portal/ dedicated IT platform. Other than just
measuring indicators it is important to analyse the data for overall improvement using quality tools and
methods. Outcome areas of concern have total of four (4) standards.

Area of Concern - H Outcome

Standard H1 The facility measures Productivity Indicators and ensures compliance with
State/National benchmarks

ME H1.1 Facility measures productivity Indicators on monthly basis

ME H1.2 The facility endeavours to improve its productivity indicators to meet the benchmark

Standard H2 The facility measures Efficiency Indicators and ensure compliance with State/
National benchmarks

ME H2.1 Facility measures efficiency Indicators on monthly basis

ME H2.2 The facility endeavours to improve its efficiency indicators to meet the benchmark

Standard H3 The facility measures Clinical Care & Safety Indicators and ensure compliance
with State/National benchmarks

ME H3.1 Facility measures Clinical Care & Safety Indicators on monthly basis

ME H3.2 The facility endeavours to improve its clinical care & safety indicators to meet the
benchmark

Standard H4 The facility measures Service Quality Indicators and ensure compliance with
State/National benchmarks

ME H4.1 Facility measures Service Quality Indicators on monthly basis

ME H4.2 The facility endeavours to improve its service quality indicators to meet the benchmark
 National Quality Assurance Standards for Integrated Public Health Laboratories 19

Measurement System under National Quality Assurance Standards

A robust quality management system, confidence in providing accurate and reliable lab results, better
operational control, and enhanced customer satisfaction are the principles of high-quality laboratory
services. There are numerous ways/standards defined to measure the quality in laboratories. Measurement
is the essence of any standards as it involves efforts to reduce subjectivity and ensure that all the critical to-
quality components have been addressed holistically.

Further, the endeavour to measure the Quality in public health laboratories is much more difficult, due to
the involvement of a wide range of vertical Programmes and implementation support available from states
and districts. It is realised that there would always be some kind of ‘trade-off’ when measuring the quality.
One may have small and simple tools, but that may not be able to capture all micro details. Alternatively, one
may devise all-inclusive detailed tools, encompassing the micro-details, but the system may become highly
complex and difficult to apply across Public Health Facilities.

Since the inception of NQAP, the country has realised the importance of measurement of quality standards.
Therefore, the Quality Framework and Standards are linked to the measurement system under NQAP. The
proposed system has incorporated best practices from the contemporary systems and contextualised as per
the needs of the Integrated Public Health laboratories and Indian Public Health standards.

Quality Standards for IPHL

Quality Standards for IPHL are arranged under 8 Areas of Concern. There are 50 Standards. Each Standard
has specific Measurable Elements (i.e., 170 ME). These standards and Measurable Elements are assessed
through an IPHL checklist.

IPHL
Checklist

Checkpoint
Mesurable
Elements
Checkpoint
Standard Score
card
Area of Measurable Checkpoint
Concern Elements

Standard
Checkpoint

Figure 2: Representing the Arrangement of AoC, Standard, Measurable element, and Checkpoints

The filled checklist would generate Scorecard, which will include an overall score for the IPHL. A scorecard
can also be generated with Areas of Concern wise and Standard wise scores.
20 National Quality Assurance Standards for Integrated Public Health Laboratories

IPHL Score Card

Area of Concern wise Score IPHL Score
A Service Provision 50%
B Patient Rights 50%
C Inputs 50%
D
E
F
Support Services
Clinical Services
Infection Control
50%
50%
50%
50%
G Quality Management 50%
H Outcome 50%
Figure 3: Schematic representation of Area of Concern wise and Overall IPHL score card

Reference No. Standards & Measurable Element IPHL Score

Area of Concern - A Service Provision

Standard A1 Facility Provides Integrated Diagnostic Laboratory Services as per

50%
mandate

Standard A2 Facility provides support services to linked spokes 50%

Area of Concern - B Patient Rights

Standard B1 The service provided at facility are accessible and affordable 50%

Standard B2 The service provided at facility are acceptable 50%

Standard B3 The facility has defined framework for ethical management including
dilemmas confronted during delivery of services at public health 50%
facilities.

Area of Concern - C Inputs

Standard C1 The facility has infrastructure for delivery of assured services, and
50%
available infrastructure meets the prevalent norms

Standard C2 The facility ensures the physical safety of the infrastructure. 50%

Standard C3 The facility has established Programme for fire safety and other
50%
disaster
Figure 4: Schematic representation of Standard wise scorecard
 National Quality Assurance Standards for Integrated Public Health Laboratories 21

Assessment Protocols & Scoring System

Checklists are the main tools for the assessment. Before undertaking any assessment, assessors should
familiarise themselves with the checklists beforehand. The layout of the checklist is given below:

National Quality Assurance Standards

Checklist for Integrated Public Health Laboratory (IPHL) a
Reference Measurable Checkpoint Compliance Assessment Means of Verification Remarks
No. Element Method
Area of Concern - A Service Provision b
Standard
Facility provides Integrated Diagnostic Laboratory Services as per mandate
A1
ME A1.1 Facility Availability of SI/RR Hb%, TC, DLC, Platelet,
c
provides Haematology Red Cell Indices,
d comprehensive services ESR, BG & Rh typing,
set of Blood cross matching,
Laboratory Peripheral blood film,
services Reticulocyte count, h
e AEC, Prothrombin time
(PT) & International

f
Normalised Ratio
(INR), Activated partial
i
thromboplastin time
Availability of SI/RR Fibrinogen
Biochemistry Degradation Product
services (FDP) test, D-Dimer,
Coombs test direct
& indirect with titre, j
Sickling test for
g screening of sickle
cell anaemia, rapid
sickle cell test, DCIP
test for screening HbE
hemoglobinopathy,
G6PD enzyme
deficiency

Figure 5: Represent Anatomy of the Checklist

(a) Title of the checklist denotes the name of Integrate Public Health lab for which the checklist is intended.

(b) The horizontal bar in grey colour contains the name of the Area of concern to which the underlying
standards belong.

(c) Yellow horizontal bar contains the statement of the standard being measured.

(d) Extreme left column of the checklist in blue colour contains the reference number of Standard and
Measurable Elements. The Reference number helps in the identification and traceability of a standard.

(e) Second column contains the text of the measurable element for the respective standard.

(f) The column next to measurable elements on the right side has checkpoints for measuring compliance to
the respective measurable element and the standard.

(g) Next right to the checkpoints, a blank column is available where the finding of assessment in terms of
Compliance (2 marks), Partial Compliance (1 mark) and Non-Compliance (0 marks) should be written.
 22 National Quality Assurance Standards for Integrated Public Health Laboratories

(h) Next right to the blank column is the assessment method column. This denotes the ‘HOW’ to gather the
information. Generally, there are four primary methods for assessment - SI means staff interview, OB
means observation, RR means record review & PI, Patient Interview.

(i) Column next to the assessment method contains means of verification. It denotes what to see in a
particular Checkpoint. It may be a list of equipment or procedures to be observed, example questions
which may be asked to the interviewee or some benchmark, which could be used for comparison, or
reference to some other guideline or legal document. It may be left blank as checkpoints may be self-
explanatory.

(j) Next right to the means of verification, a remark section is given. It needs to be filled by the assessor
whenever partial or non-compliance is given.

Assessment Methods
Assessor should read measurable elements and checkpoints; and try to gather information and evidence
to assess the compliance to the requirement of measurable element and checkpoint. Information can be
gathered by four methods that is Observation (OB), Record review (RR), Patient interview (PI) and Staff
Interview (SI)

• Observations (OB) – Compliance with many measurable elements can be assessed by directly observing
the articles, process, and surrounding environment. E.g. Enumeration of articles like equipment,
reagents, consumables etc. Displays like signage, work instructions, and important information. Patient
amenities, chair, drinking water, complaint box etc. An environment like seepage, overcrowding, and
cleanliness. Procedures like measuring collection of samples, counselling, segregation of biomedical
waste etc.

• Staff Interview (SI) - Interaction with the staff help in assessing the knowledge and skill level, required
for performing job functions. Examples -Competency testing - Asking staff how to perform certain
diagnostic procedures. Demonstration – Asking staff to demonstrate activities like hand washing
techniques or newborn resuscitation. Awareness -Asking staff about awareness of quality policy and
quality objectives and Feedback about the adequacy of supplies, work safety issues etc.

• Record Review (RR) - – All processes, especially certain tests not performed regularly, cannot be
observed. A review of records may generate more objective evidence and triangulate the finding of the
observation. For example, on the day of assessment, regents, controls etc., may be available in adequate
quantity, but reviewing the expenditure register would reveal the consumption pattern of consumables.
Examples of record reviews are -Review of laboratory records for critical alerts, a culture report for
microbial surveillance, minutes of the quality circle meeting, safety audit checklists, risk assessment
and mitigation plan, reports of the mock drill, control charts- correction factor etc.

• Patient Interview (PI) -Interaction with patients & relatives may be useful in getting information about
the quality of services and their experience at the facility. It should include Feedback on the quality
of services, turnaround time, staff behaviour, waiting times, out-of-pocket expenditure, satisfaction of
clients/individuals etc.
 National Quality Assurance Standards for Integrated Public Health Laboratories 23
Scoring System
After assessing
Scoring System all the measurable elements, checkpoints and marking compliance, the
department/
After assessing allfacility scores elements,
the measurable can be calculated.
checkpoints and marking compliance, the department/ facility
scores can be calculated.
Rules of Scoring
Rules of Scoring
2 marks for each compliance
2 marks for each compliance
1 mark for each partial compliance
1 mark for each partial compliance
0 Marks for every Non-Compliance
0 Marks for every Non-Compliance

Full Compliance Partial Compliance Non-Compliance

• If the information • For providing partial • Non-compliance is

gathered gives the compliance, at least assigned to when
impression that all 50% or more facility fails to meet
the requirements of requirements should at least 50 percent of
the Checkpoint and be met. For partial the requirements
means of compliance a score of given in a checkpoint
verifications are 1 mark is given and its
being met, full corresponding
compliance (marks – means of verification.
2) should be In this case, ‘0’ score
provided for that is given.
checkpoint

Figure 6: Representing the Scoring rules
Figure 6: Representing the Scoring rules
All checkpoints have equal weightage to keep scoring simple. Once scores have been assigned to each
checkpoint, the Standard wise score can be calculated standard-wise by adding the individual scores for each
checkpoint. The final have
All checkpoints score should
equalbeweightage
given in percentage
to keepto compare
scoringit simple.
with otherOnce
publicscores
health laboratories.
have been
assigned
The to each
calculation of thecheckpoint,
percentage isthe Standard
as follows: wise score can be calculated standard-wise
by adding the individual scores for each checkpoint. The final score should be given in
The score obtained X 100/ No of checkpoints in checklist X 2
percentage to compare it with other public health laboratories.
Scores can be calculated manually, or scores can be entered into excel sheet given.
The calculation of the percentage is as follows:
The score obtained X 100/ No of checkpoints in checklist X 2
Scores can be calculated manually, or scores can be entered into excel sheet given.

Certi�ication Process
The NQAS for IPHL will be used as an assessment and certi�ication tool. Once the
laboratory substantially improves during internal assessment and achieves at least 70%
or more in NQAS assessment tools, it may become eligible for State & National
certi�ication. The criteria and process of certi�ication are explained below.

33
 National Quality Assurance Standards for Integrated Public Health Laboratories 25

Certification Process

The NQAS for IPHL will be used as an assessment and certification tool. Once the laboratory substantially
improves during internal assessment and achieves at least 70% or more in NQAS assessment tools, it may
become eligible for State & National certification. The criteria and process of certification are explained
below.

Steps of the State-level Certification Process:

a. District Quality Assurance unit/ facility level quality team will inform the State Quality Assurance unit
(SQAU) about its readiness for state assessments. The SQAU would verify the score and supporting
documents and initiate the process of state-level certification.

b. State certification may be conducted with the help of a team constituted of national assessors & internal
assessors available in the state. If the number of national assessors in the state is less, the Internal
assessor, along with a representative of IPHL (from another district- Pathologist/ microbiologist etc)
and a district/state consultant, can conduct the assessment.

c. On meeting all the criteria for state certification, the facility would be declared as ‘State level Certified’
by SQAC.

Steps of the National Level Certification Process

a. Once the IPHL is State Certified, the SQAC would send the application in the format given in Operational
Guidelines for Improving Quality in Public Health Facilities 2021, along with the requisite documents
to Director NHM, MoHFW, requesting the external assessment. NHSRC would check the application and
supporting documents before a team of assessors is deputed as per assessment norms.

b. The Certification Unit, NHSRC, shall coordinate the assessment process. The national assessor would
submit their findings, and a report is prepared, and submitted to MoHFW with recommendations for
certification.

c. NQAS certification of IPHL will remain valid for three years. After completing the first and second years
of the national certification, the state would organise a surveillance assessment. Its compliance report
will be submitted to the certification unit of the Quality & Patient Safety Division, NHSRC.

d. In the third year, Laboratories would be reassessed by a team of National assessors. In addition, National
Health System Resource Centre (NHSRC) and MoHFW may also undertake surprise assessments to
ascertain the sustenance of improvement activities.
 26 National Quality Assurance Standards for Integrated Public Health Laboratories

Figure 7 : National Certification Process

Certification criteria:
NQAS for IPHL applies to the laboratories where the facility for testing routine and public health-related
diagnostic facilities is in one place.

The certification criteria applicable to National & State levels is mentioned below:

National Level Certification: The national certificate is awarded by MoHFW, per the norms defined by the
CQSC. Detailed criteria for National certification are as follows:

Criteria 01- An aggregate score of IPHL is >70%

Criteria 02- An aggregate score of each AoC>70%

Criteria 03- A score of core standards (A1, E3, E4, E5 and E6) >70% (An increment of 5% on every
Surveillance audit & Re-certification)

Criteria 04- Individual standard-wise score is >50%

Criteria 05- Patient satisfaction score of 70% in the preceding Quarter or more or Score of 3.5 on Likert
Scale.
 National Quality Assurance Standards for Integrated Public Health Laboratories 27

For state-level certification score of above-criteria may be reduced by 5%

Award of Certification

(a) Certification: If the IPHL meets all of the above-mentioned five criteria.

(b) Certification with conditionality: If an IPHL aggregate score is 70% or more (Criterion I), and also meets
at least three criteria out of the remaining four (Criterion II, III, IV & V)

(c) Deferred: The certification may be deferred until follow-up assessments if IPHL’s overall score is 70% in
external assessment but does not meet the criteria for conditional certification.

Surveillance Assessment:

The State Quality Assurance Unit shall conduct annual surveillance for two years after attaining National
certification. State Quality Assurance Committee reserves the right to conduct more frequent surveillance in
case of complaints/concerns against the facility.

The facility has to submit a gap analysis report and a time-bound action plan to close the gaps found during
the National assessment & surveillance audit to the QPS team of NHSRC.

Re-certification:

To develop a culture of quality sustenance, the facility is expected to undergo recertification as defined in
Operational Guidelines for Improving Quality in Public Health Facilities 2021.
 National Quality Assurance Standards for Integrated Public Health Laboratories 29

NQAS Checklist
for
Assessment of IPHL
30 National Quality Assurance Standards for Integrated Public Health Laboratories

NQAS Checklist for Assessment of IPHL

National Quality Assurance Standards
Checklist for Integrated Public Health Laboratory (IPHL)

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Area of Concern - A Service Provision

Standard
Facility provides Integrated Diagnostic Laboratory Services as per mandate
A1

Facility provides Availability of Basic SI/RR Hb%, TC, DLC, Plate-

comprehensive set of Haematology ser- let, Red Cell Indices,
Laboratory services vices ESR, BG & Rh typing,
Blood cross matching,
Peripheral blood film,
ME A1.1 Reticulocyte count,
AEC, Prothrombin time
(PT) & Internation-
al Normalised Ratio
(INR), Activated partial
thromboplastin time
Availability of spe- SI/RR Fibrinogen Degrada-
cialised Haematolo- tion Product (FDP)
gy services test, D-Dimer, Coombs
test direct & indirect
with titre, Sickling test
for screening of sickle
cell anaemia, rapid
sickle cell test, DCIP
test for screening HbE
hemoglobinopathy,
G6PD enzyme deficien-
cy
Availability of ad- SI/RR Mixing study for Factor
vanced Haematolo- Deficiency & inhibitors
gy services in Haemophilia, Hae-
moglobin electropho-
resis, Hb-HPLC, Serum
Electrophoresis & free
light chain assay, Plas-
ma fibrinogen & Serum
protein electrophoresis
immunofixation, Flow
cytometry immuno-
phenotyping/Special
stains like MPO stain/
NSE stain/ leukocyte
alkaine phosphatase
(LAP) score
 National Quality Assurance Standards for Integrated Public Health Laboratories 31

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Availability of basic SI/RR GTT, S.Bilirubin (To-
Biochemistry ser- tal, Direct & Indirect),
vices S.Creatinine, Blood
urea, SGOT, SGPT, S.Al-
kaline Phosphatase,
S.Total protein, S.Albu-
min & AG ratio, S.Glob-
ulin, S.Total choles-
terol, S.Triglycerides,
VLDL, HDL, LDL,
GGT, Uric acid, S.LDH,
HbA1C, CRP, S.Electro-
lytes, Thyroid profile
Availability of spe- SI/RR S.Amylase, S.Iron, S.To-
cialised Biochemis- tal Iron binding capac-
try services ity, S.Ionised Calcium,
Arterial blood gas test,
Urinary protein, Urine
for microalbumin,
creatinine & protein,
Ferritin, Troponin-I/
Troponin-T, S.PSA, CSF
& body fluid analysis
Availability of Mi- SI/RR 1. Microscopy- Wet
crobiology services mount & gram stain for
RTI/STD, KOH mount
for fungal microscopy,
Slit skin smear, Gram
staining for clinical
specimen
2. Culture- Throat swab
for Diphtheria, Stool
hanging drop for Vibrio
Cholera, Blood/body
fluid culture, Urine/
other cultures, Diph-
theria culture, Culture
of stool, Bacterial
identification & AST,
Culture for coliforms,
Microbiological analy-
sis of Water (H2S test
for screening)
Availability of Cy- SI/RR FNAC, Pap smear, CSF
tology services & body fluid counts
cytology, Cell block
32 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Availability of SI/RR Histopathology, Tissue
Histopathology biopsy
services Give full compliance,
if processing of his-
topathology tests are
outsourced
Availability of SI/RR UPT, Urine test for pH,
Clinical Pathology specific gravity, leuco-
services cyte esterase, glucose,
albumin, bilirubin,
urobilinogen, ketone,
protein, nitrite, Urine
microscopy, Stool
for ova, cyst & occult
blood, Semen analysis,
Porphobilinogen
Availability of Se- SI/RR 1. RPR/VDRL, HIV 1 &
rology services 2, Widal, Leptospiro-
sis, Typhus, Measles,
Leishmaniasis, ASLO,
Rheumatoid Factor
(RA), Weilfelix
Availability of SI/RR PCR for influenza,
Molecular Biology/ COVID-19 & emerging
Virology services infectious diseases (as
and when required)
The facility provides Availability of lab SI/RR rk39 for Kala Azar,
Laboratory services services for vector ELISA for JE & IgG for
for communicable borne disease Chikungunya, NS1 &
diseases IgM for dengue, Malar-
ME A1.2 ia, Filaria, Dengue NS1
& IgM
As per the endemicity
in the geographical
area
Availability of lab SI/RR Microscopy for AFB
services for Tuber- CB-NAAT
culosis

Availability of lab SI/RR CD4/CD8 count, HIV 1

services for HIV &2
Give full compliance,
if the facility has
established linkages
with medical colleges
for availability of lab
services for CD4/CD8
count
 National Quality Assurance Standards for Integrated Public Health Laboratories 33

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Availability of lab SI/RR Slit skin smear
services for Leprosy

Availability of lab SI/RR Hepatitis B surface

services for viral antigen, Viral load for
hepatitis HBV & HCV, HCV anti-
body, Hep-A & E,

The facility provides Availability of ser- SI/RR FBS, PPBS, RBS, HbA1c
Laboratory services vices for DM
ME A1.3
for non-communica-
ble diseases

Availability of ser- SI/RR Liver function test,

vices for NAFLD/ Lipid profile, kidney
Stroke/ Chronic function test, PT-INR
kidney disease

Availability of ser- SI/RR C-Reactive protein,

vices for STEMI Troponin-I/ Tropo-
nin-T, D-Dimer

Availability of ser- SI/RR Histopathology, Tissue

vices for Cancer biopsy, PAP smear,
FNAC, Immuno histo-
chemistry

Facility provides ser- The clinical, Pub- SI/RR/OB Existing functional

vices to support pub- lic health or any labs like NACP, NTEP,
lic health functions other lab services NVBDCP, NVHCP, IDSP,
are mapped and NIDDCP, NPPCF, etc are
ME A1.4
restructured to pro- converged/integrated
vides comprehen- with IPHL
sive services under
IPHL

Provides referral SI/RR/OB For NACP, NTEP, NVB-

laboratory services DCP, NVHCP, IDSP etc.
for public health from lower down to
programmes IPHL and from IPHL to
higher facilities

Support block and SI/RR/OB Upload th data in IHIP

district surveillance to detect and respond
units to public health threats
34 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Facility provides Availability of SI/RR/OB 1. Mechanism/System
laboratory based sur- services for surveil- at place for surveil-
veillance services for lance of infectious lance & monitoring of
Infectious & Non-in- and non-infectious epidemic & endemic
fectious diseases diseases diseases
2. Check system is in
place to detect out-
ME A1.5
breaks by routine lab
investigations
3. Appropriate and suf-
ficient number of clin-
ical samples reached
to IPHL and etiological
diagnosis is made

Availability of ser- SI/RR/OB Active surveillance

vices for Microbio- for Hospital Acquired
logical surveillance Infections-
of facilities 1. AMR surveillance
2. Formulation of Anti-
biogram

Availability of ser- SI/RR/OB 1. Tracing of the source

vices for outbreak infection like pyrexia of
surveillance unknown origin
2. Detection of inappar-
ent infections/carriers
3. Early detection of
outbreak
4. Retrospective diag-
nosis like Rheumatic
heart disease
5. Detection of new dis-
ease agents like SARS,
COVID, emerging/
remerging bacterial &
viral diseases

Services are available 24x7 all lab ser- SI/RR/OB Check for:
for the time period as vices are available 1. Laboratory services
mandated are available at night
2. Look for number of
ME A1.6
lab tests performed at
night
3. Critical alerts are
informed at night
 National Quality Assurance Standards for Integrated Public Health Laboratories 35

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Standard
Facility provides support services to linked spokes
A2
Facility provides tech- Availability of SI/OB 1. Sample collection,
nical support services technical support testing and referral
ME A 2.1 to Block Public Health services to BPHL 2. Functional linkage
Labs & other periph- and other peripher- with spokes
eral labs al labs

IPHL provides sup- SI/OB/RR 1. Implementation of

port for monitoring, Quality Management
capacity building of System
BPHL & peripheral 2. Capacity building
laboratory staff support

Facility provides Availability of SI/OB Use of LIMS/HIS/

information manage- Information man- any other IT platform
ment support agement system in for tracking samples,
linked spokes or reporting of the test re-
peripheral health sults, storage, analysis
facilities & retrieval of lab data
OR
If IT system is not
ME A 2.2
available, paper based
record may be kept.
Partial compliance may
be given after verifying
the data & information
sharing and receiv-
ing process followed
(manual)

Area of Concern - B Patient Rights

Standard
The services provided at the facility are accessible and affordable
B1

The facility has user Availability of OB 1. Name of the IPHL is

friendly and uniform adequate and clear displayed prominently
signage system signages for IPHL at the entrance
2. Directional signages
from the entrance of
ME B1.1 the hospital/IPHL is
displayed
3. Internal sectional
signages are displayed
in processing and re-
porting area of IPHL
36 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Availability of OB 1. Directional signages
adequate and clear for sample collection
signages for sample area is displayed from
collection area the different part of the
hospital
-Give full compliance if
collection area is a part
of main IPHL
Signages are user OB 1. Signages and ser-
friendly & uniform vice information is
in colour displayed in bilingual
language including the
local language
2. Signages are visible
clearly
Restricted area sig- OB Access to authorized
nage are displayed personnel only

IPHL layout is OB Central Sample collec-

displayed at the tion area and reporting
entrance area is the part of hos-
pital layout if located in
hospital
The facility displays List of services OB Verify with scope of
its services, available are IPHL
ME B1.2
entitlements and displayed at the
relevant information entrance
Timing for collec- OB 1. Lab is functional
tion of samples are around the clock espe-
displayed cially for haematology
& biochemistry (can be
functional in 3 shifts
2. Timing for OPD sam-
ple collection starts
from 8AM
Timing for deliv- OB Turnaround time for
ery of reports are report collection is
displayed displayed
Relevant informa- OB Name, Scope of ser-
tion pertaining to vices, Patient's rights
IPHL is displayed & responsibilities, rel-
evant contact details,
user charges, if any, etc.
 National Quality Assurance Standards for Integrated Public Health Laboratories 37

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Patients & visitors OB/PI 1. Test specific instruc-
are sensitised and tions are displayed
educated for testing 2. Patient/relatives
requirements are informed about
pre-testing require-
ments (If applicable)
3. Good lab practice to
have bilingual infor-
mation sheets/flyers
available for specific
test like urine culture
and lipid profile, F, PP,
GTT etc.

Access to facility is IPHL provides bar- OB 1. Approach road to

provided without any rier free services to IPHL/hospital is acces-
physical barrier & patient sible without conges-
friendly to specially- tion
ME B1.3
abled people 2. Internal pathway
& corridors of IPHL/
hospital are accessible
without obstruction

Availability of Ramp OB Give full compliance if

with rails/lift in lab sample collection area
building & sample and testing area are at
collection area ground floor

There is no discrim- OB/PI Check Laboratory has

ination on basis of defined policy for en-
social & economic suring non-discrimina-
status of patients tion on basis of social
and economic status of
the patient

There is an Check procedure OB/PI/ 1. Informed Consent

established procedure for having consent RR & counselling is taken
for having consent and counselling of before HIV testing,
before conducting any the patient wherev- 2. Written consent is
procedure er required taken by treating phy-
sician on standardised
format in case of histo-
ME B1.4 pathological/ cytology
procedures (Check
TRF clearly mentioned
whether consent is
taken)
3. Written consent is
taken for invasive pro-
cedures
38 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
The facility has de- Availability of com- OB/RR 1.Complain box is
fined and established plaint box available in proximity
grievance redressal to IPHL/sample col-
system in place lection area/reporting
receiving area (may
be shared with main
hospital)
2. Process to complete
resolution of the com-
plaint is defined and
ME B1.5 displayed bilingual
3. Staff is aware about
complaints pertaining
to the lab & mechanism
of the complaint re-ad-
dressal
4. Lab ensures that
actions are taken
against the complaints
within the defined time
interval
Information about OB 104/state specific
complaint re-ad- number/ CM Portal
dressal is displayed
The facility provides IPHL provides free OB/PI As per the mandate of
cashless services as diagnostic services free diagnostic services
ME B1.6
per prevalent govern- as per guidelines/
ment norms/schemes state mandate
Check patient has OB/PI Ask patient randomly
not incurred any (At least 5)
expenditure on
diagnostics
Cashless investiga- OB/PI JSSK, Ayushman
tions for patients/ Bharat, applicable na-
beneficiaries tional & state specific
govt. schemes
Standard
The service provided at facility are acceptable
B2
Adequate visual Availability of OB Privacy is maintained
privacy is provided at screen/ partition at at OPD areas
ME B2.1
every point of care sample collection
area
Adequate privacy is OB IPD, Emergency & Crit-
maintained during ical areas
sample collection
 National Quality Assurance Standards for Integrated Public Health Laboratories 39

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Services are provided Separate queue for OB 1. IPHL and sample col-
in manner that are female and special- lection areas / report
sensitive to gender ly abled patients receiving areas
ME B2.2
2. Give the full compli-
ance, if token system is
followed
Laboratory has OB
defined policy for
non-discrimination
on basis of gender
Confidentiality of Laboratory has sys- OB/RR 1. Lab staff do not
patients records and tem to ensure the discuss the lab result
clinical information is confidentiality of outside
ME B2.3 maintained for every the reports gener- 2. Special precautions
patient, especially of ated are taken for the test
those having social results of having social
stigma stigma like HIV, etc.
Laboratory Records OB General staff/visitors
are kept at secure do not have access to
place the lab reports

HIV positive reports OB/SI As per NACO guide-

are communicated lines/state guidelines

The facility ensures Behaviour of staff OB/PI

the behaviours of is empathetic and
ME B2.4 staff is dignified and courteous
respectful, while de-
livering the services
Check there is no OB Patients are called one
overcrowding at by one/First come
OPD sample collec- first serve basis/call-
tion area ing system in sample
collection area (Except
for emergencies)
Standard The facility has defined framework for ethical management including dilemmas con-
B3 fronted during delivery of services at public health facilities

Ethical norms and Check code of con- OB/RR 1. Check for any circu-
code of conduct for duct is defined lar, policy, notice, gov-
medical and para- ernment order issued
medical staff have that explains the code
been established of conduct for staff
ME B3.1 such as specialists,
technicians and other
support staff
2. Check that updated
copy for code of con-
duct is available
40 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Check if staff is SI Check doctors and lab
aware of code of technicians are aware
conduct of code of conduct

There is an estab- Check IPHL has RR/SI Check list of agencies

lished procedure for defined protocols are available with
sharing of laboratory/ for data sharing IPHL wit which data is
patient data with indi- shared
viduals and external For any other agency
agencies including a formal permission
ME B3.2
non-governmental is sought from com-
organization. petent authorities
before sharing the data
including international
agencies, press and
NGOs

There is an estab- Check hospital en- RR/SI Check for policy or

lished procedure for sures that written practice, consent
obtaining informed informed consent is form is available in
consent from the pa- taken from patient the language which is
ME B3.3
tients in case facility participating in any understandable by the
is participating in clinical or public patient
any clinical or public Health research
health research

There is an estab- Laboratory has RR/SI 1. Check laboratory

lished procedure defined strategy to has made buffer stock
to ensure laborato- resume the basic and alternate source of
ry services during emergency and pa- supplies for reagents
ME B3.4 strikes or any other tient care services and consumables
mass protest leading during strikes 2. Strategy and coor-
to dysfunctional labo- dination with local
ratory services. disruption to maintain
laboratory functions

Facility has estab- Check ethical (a) Check the adequacy

lished a framework issues manage- of the framework &
for identifying, re- ment framework is it address the ethical
ceiving, and resolving defined issues and decision
ME B3.5 ethical dilemmas’ in making in declaring
a time-bound man- results
ner through ethical (b) Check facility’s
committee/ locally ethical management
applicable rules framework address is
 National Quality Assurance Standards for Integrated Public Health Laboratories 41

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
RR sues like sample collec-
tion, transfer, testing,
resulting, disclosure
of information or any
professional conflict
which may not be in
patient's best interest

- May be as per guid-

ance of the main
hospital

Check the list of RR/SI Check when the list

ethical issues is was last updated. En-
available and regu- gage with the available
larly updated medical professionals
to check what type
of ethical dilemmas
they are facing while
performing their job &
how they are dealing
with dilemma's.

Check regular RR/SI 1. Check the facility

review of identi- has defined mecha-
fied and reported nism identification and
ethical issue is done reporting of the ethical
and decisions are issues/ dilemmas con-
communicated to fronted during services
concerned staff delivery
2. Check the time-
ly resolution of the
identified and reported
ethical issues is done
3. Check information
regarding ethical di-
lemmas & its handling
is also given to new
joiner's

Area of Concern - C Inputs

Standard The facility has infrastructure for delivery of assured services, and available
C1 infrastructure meets the prevalent norms

Facility has adequate Adequate space is OB Adequate area for

space as per work available in central waiting, registration
ME C1.1 load sample collection and sample collection,
area report dissemination
(if done from sample
42 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
collection area) is
available in the central
Sample collection area

Laboratory space OB
is adequate for 1. Adequate area is
carrying out available for per-
activities forming tests, sample
storage, keeping equip-
ment, washing, steril-
ization, waste storage
before disposal, report
dissemination and
storage of reagents and
records etc. is available
2. Check testing areas
have adequate space
for sample processing
and there is no clutter-
ing of equipment at the
work stations

Adequate space OB 1. Adequate space/

is available for office for four special-
keeping staff ists, staff room, change
amenities room, and restrooms
are available
2. Toilet of staff are
with eye wash and
body wash facility

Patient amenities are Services counters OB 1. Availability of ade-

provided at sample are available as per quate no. of registra-
collection area as per patient load tion, sample collection
patient load and report collecting
counters as per patient
load.
2. Sample collection
ME C1.2 counters are adequate
as per patient load
(3-4)
- separate counter for
Female and elderly
patients
3. No overcrowding in
sample collection area
 National Quality Assurance Standards for Integrated Public Health Laboratories 43

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Availability of sit- OB Check adequate sitting
ting arrangement in arrangement as per pa-
the waiting area tient load is available
in waiting area

Availability of func- OB Availability of separate

tional toilets male and female toilets
in proximity to cen-
tral sample collection
area (for urine sample
collection)
May be shared with
main OPD/Hospital
building

Availability of OB In proximity to central

drinking water sample collection area
May be shared with
main OPD/Hospital
building

Facility has layout and Dedicated central OB 1. Dedicated area of

demarcated areas as sample collection sample collection with
per functions area the provision of recep-
tion, registration and
waiting area
2. Check negative
pressure is maintained
in microbiology sample
collection area
ME C1.3
3. Demarcated room/
area for FNAC, - with
provision of bed
Check adequate pri-
vacy is maintained in
each sample collection
point
4. Demarcated area for
sputum collection
44 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method

Demarcated sample OB/RR 1. Check that samples

receiving area received from spokes
are collected in a sys-
tematic way
2. Check that samples
received from the
central sample collec-
tion lab or IPDs or sent
through dumb waiter
are collected in a sys-
tematic way
3. Check the records
of quarterly audit of
preanalytical in spokes
and wards

Demarcated area OB (1) routine testing and

for sample process- public health-related
ing diagnostic facility is
located at one place.
(2) Demarcated ar-
eas for Haematology,
Biochemistry, Clinical
pathology, cytology,
microbiology, myco-
bacteriology, serology,
media preparation,
histopathology, etc.
- Effective separation
with adjacent labora-
tory sections in which
there are incompatible
activities (dirty/clean
areas, separate micro-
biology, and common
testing area)
- designated room for
specialized testing (e.g.
TB testing and PCR)

Demarcated report- OB 1. Designated report

ing area writing area (in main
lab)
2. Designated report
collecting area (In the
central sample collec-
tion area / in main lab)
 National Quality Assurance Standards for Integrated Public Health Laboratories 45

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Designated washing OB 1. In the central sample
and waste disposal collection area
area 2. In sample processing
areas

Designated eye- OB Standalone facility or

wash station attached to sink for
eyewash in case of
chemical splash in eye/
body

Availability of auxil- OB Small store room,

iary/accessory area server and electrical
room etc
(electrical room - may
be shared with main
hospital building)
The facility has Availability of func- OB Check availability of
infrastructure tional telephone landline/intercom/mo-
for intramural and Intercom Ser- bile/WhatsApp, etc. for
ME C1.4
and extramural vices intramural and extra-
communication mural communication
is available
Availability of func- OB Check hardware and
tional modules for software is available
Hospital or labo- for HIS/LIMS
ratory information
management
The facility and Unidirectional flow OB 1. Sample collection-
departments are of services Sample receiving-Sam-
planned to ensure ple processing at
structure follows respective area- An-
the function/ alytical area- report
ME C1.5 processes (Structure generation, review &
commensurate with authorization-Report
the function of the delivery.
hospital) 2. Ensure logical flow
of specimens from
receipt to disposal
Standard
The facility ensures the physical safety of the infrastructure
C2
The facility ensures Non-structural OB Check for fixtures and
the seismic safety of components are furniture like cup-
the infrastructure properly secured boards, cabinets, and
ME C2.1 heavy equipment's ,
hanging objects are
properly fastened and
secured
46 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
The facility ensures Dumb waiters are OB Give full compliance if
infrastructure in installed to trans- sample is transported
ME C2.2 place for safe sample port the samples manually ensuring all
transportation from collection area the sample transporta-
to testing area tion protocols

Alarm system is OB 1. Specially from criti-

used to indicate the cal areas like emergen-
sample drop cy IPD, ICU and emer-
gency
2. Provision of special
colour coding or elec-
tronic flag in LIMS for
critical samples

Process is defined OB/RR 1. Regular cleaning, op-

and followed for Pe- erations, maintenance
riodic Maintenance and trouble shooting in
of dumb waiters case of malfunctioning
2. Specimens are trans-
ported in clean sample
carriers if manually
transported

- Give full compliance

if dumb waiter is not
required/not installed
and alternate effective
system is in place for
sample transportation

Functional lift is OB (1) May be shared

available for easy with the main hospital
access to IPHL building.
Give full compliance
if the building is on
ground /first floor/
ramp facility
(2) Check for lift li-
cence if lift available in
lab (3) Periodic main-
tenance of lift
The facility ensures Check there is no OB In Lab and sample
safety of electrical loose hanging wires collection areas
ME C2.3 establishment and temporary
connection
 National Quality Assurance Standards for Integrated Public Health Laboratories 47

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Adequate electrical OB (1) For safe and
socket is available smooth operation of
lab equipment.
(2) Check extensions
are not used to run
heavy equipment
Power Audit and OB/RR Check six monthly once
Earthing is done at least
regularly
Constant out put OB Automatic voltage reg-
voltage is provided ulators are installed
to the equipment
Facility has mecha- OB/RR by competent electrical
nism for periodical Engineer
check / test of all
electrical installa-
tion
Physical condition of Work benches are OB Check bench tops are
buildings are safe for chemical resistant impervious to water
providing mandated and resistant to mod-
ME C2.4
lab services erate heat, organic
solvents, acids, alkalis,
chemicals.
Floors of the Lab- OB
oratory are non
slippery and even
surfaces and acid
resistant
Standard
The facility has established Programme for fire safety and other disaster
C3
The facility has plan Fire exits with sig- OB The department has
for prevention of fire nage are defined to sufficient no. of fire
ME C3.1 permit safe escape exits with fire exit
to its occupant at signage
the time of fire
Check that the fire OB (1) Check that fire exit/
exits are visible evacuation plans are
and routes to reach displayed
the exit are clearly (2) Fir exits are clut-
marked. ter-free
Laboratory has plan SI/RR Check Material safety
for safe storage and data sheet is available
handling of poten-
tially flammable
materials.
48 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Fire Safety audit is RR/SI May be along with
done by competent main Hospital build-
authorities ing/separately

The facility has Check fire OB 1. Class A , Class B, C

adequate firefighting Extinguishers type or ABC type in
Equipment are installed in sample collection, pro-
IPHL and sample cessing and reporting
ME C3.2 collection area area
2. Check dry CO2 type
extinguisher/s in the
testing areas for elec-
trical fires

No fire extinguisher OB Check the expiry date

is expired in lab, for fire extinguishers
circulation area, are displayed on each
waiting, area, extinguisher along
Corridors with due date for the
next refilling is clearly
mentioned.

The facility has a Check for staff SI (1) Check staff is aware
system of periodic competencies of
training of staff and for operating fire PASS- Pull the pin, A-
conducts mock drills extinguisher Aim at the base of fire,
regularly for fire S- Squeeze the lever, S
ME C3.3
and other disaster -Sweep side to side
situation (2) Staff is aware of
RACE
R- Rescue, A- Alarm, C-
Confine, E- Extinguish

Check periodic SI/RR May be part of hospi-

mock drills is tal's regular mock drill.
conducted

Standard The facility has adequate qualified and trained staff, required for providing
C4 the assured services to the current case load

The facility has ade- The organogram or OB/RR (1) Check organogram
quate specialist/qual- hierarchical struc- is displayed
ME C4.1 ified personnel as per ture of the laborato- (2) Clearly showing the
service provision ry is defined interrelationship of the
staff
 National Quality Assurance Standards for Integrated Public Health Laboratories 49

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Availability of Spe- OB 1-Pathologist
cialist 1-Microbiologist
1-Biochemist
Give full compliance if
at least two specialists
are available

The facility has ad- Availability of Med- OB/RR 11 lab technicians/ as

equate technicians/ ical Lab Technolo- per case load
ME C4.2
paramedics as per gist/ Lab Techni-
requirement cian

The facility has Availability of Data OB/RR As per case load

ME C4.3 adequate support / Entry Operator/
general staff Data analyst

Availability of Sani- OB/RR As per case load

tation staff/ House-
keeping staff

Availability of Secu- OB/RR As per case load

rity Guard
Standard
Facility ensures reagents and consumables required for assured list of services
C5
The facility has ade- Availability of OB/ RR Reagents for auto anal-
quate reagents and reagents, chemicals ysers, ELISA Readers
controls at point of and rapid diagnos- reagents, culture me-
ME C5.1 use tic kits dia, Acetone, Alcohol,
distilled water, Mi-
croscope gel, RDK for
malaria, dengue, etc.

Availability of con- OB/RR Quantitative / Qualita-

trol tive
Lyophilized / ready to
use
Assayed/unassayed etc
Check the availability
of controls for basic
haematology and
biochemistry tests if a
facility is appearing for
quality certification for
the first time and for
all tests subsequently
50 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Availability of OB/ RR Iodine Solution, Hae-
stains matoxylin-eosin, Gram
Romanowsky, StainZie-
hl- Nielsen, Acridine
orange, Albert stain,
India ink, calcofluor
white, KOH

The facility has ade- Availability of Labo- OB/ RR Blood collection tubes,
quate consumables at ratory consumables Swabs, needles, Syring-
ME C5.2 point of use es, Glass slides, Glass
marker/paper stickers,
Lancets etc.

Emergency drug trays Emergency Drug OB/ RR Must aware of basic

are maintained at Tray is maintained lifesaving skills, foot
every point of care, end elevation, IV line
where ever it may be set up, etc.
ME C5.3 needed OR
If standalone, emer-
gency drug tray is
maintained and staff is
trained to use it

Standard
The facility has equipment & instruments required for assured list of services.
C6

Availability of equip- Availability of func- OB Stethoscope, BP appa-

ment & instruments tional equipment & ratus, Povidone iodine,
for diagnostic proce- instruments in sam- Syringe, Vacutainers,
dures being undertak- ple collection area Vaccum needles and
ME C 6.1
en in the facility needle holder, Torni-
quets, Spirit/antisep-
sis, cotton swabs at
sample collection area

Availability of OB 1. Binocular Micro-

equipment for clini- scope, Urine analyser,
cal pathology Centrifuge, Bunsen
burner with gas supply,
etc.
2. Check the availabili-
ty of equipment as per
load
3. Check back-up of
the critical equipment
is available in case of
malfunction
 National Quality Assurance Standards for Integrated Public Health Laboratories 51

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Availability of OB 1. Binocular Micro-
equipment for hae- scope, Automated Cell
matology Counter (3 part/5 part)
with nucleated RBC
flag, Automated Coag-
ulometer, Automated
ESR analyser, Haemo-
globin HPLC machine
(variant analyser),
Serum electrophoresis
and Hb electrophoresis
2. Check the availabili-
ty of equipment as per
load
3. Check back-up of
the critical equipment
is available in case of
malfunction
Availability of OB 1. Binocular Micro-
equipment for scope, Centrifuge
cytology 2. Check the availabili-
ty of equipment as per
load
3. Check back-up of
the critical equipment
is available in case of
malfunction
Availability of OB 1. Automated Bio-
equipment for bio- chemistry analyser,
chemistry ISE based Electrolyte
analyser, Automated
Hormone Immuno-
assay analyser (CLIA
Based)
2. Check the availabili-
ty of equipment as per
load
3. Check back-up of
the critical equipment
is available in case of
malfunction
Availability of OB Electronic balance
equipment for Hot plate
media preparation Autoclave
room Ph meter
Bunsen burner with
gas supply
52 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Availability of OB 1. Binocular Micro-
equipment for bac- scope, Incubator, Auto-
teriology mated blood culture
Automated bacterial
ID/AST system, Bio-
safety Cabinet Class II
A2 (model conforming
to NSF standards),
Bunsen burner with
gas supply, Computer
with scanner, printer,
UPS, Hot air oven, inoc-
ulating loop, lamp
2. Check the availabili-
ty of equipment as per
load
3. Check back-up of
the critical equipment
is available in case of
malfunction
Availability of OB Binocular Microscope
equipment for my- (LED)
cobacteriology Fluorescent Micro-
scope
Biosafety Cabinet Class
II A2 with thimble
ducting (model con-
forming to NSF
standards)
NAAT machine
Tissue homogenizer
Bunsen burner with
gas supply
Availability of OB Centrifuge
equipment for se- ELISA reader and
rology and molecu- washer
lar biology/virology VDRL rotator/shaker
Real Time PCR ma-
chine
Biosafety Cabinet Class
II A2 (model
conforming to NSF
standards)
PCR Workstation,
ELISA reader and ELI-
SA washer
Microcentrifuge
PCR hood/PCR work-
station
 National Quality Assurance Standards for Integrated Public Health Laboratories 53

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Availability of func- OB Autoclave (Vertical &
tional equipment Horizontal), Biosafety
under NVBDCP cabinet, Hot air oven,
Incubators Binocular,
Microscopes, ELISA
reader & washer, Mi-
cropipette water bath,
Centrifuge, Mixer/
Rotator
Availability of func- OB Pipettes, Centrifuge,
tional equipment HIV test kits, test tubes
under NACP
Availability of func- OB Autoclave, Analytical
tional equipment & Precision balance,
under NTEP Bottle washer, Bio-
logical Safety Cabinet
class 2A with thimble
ducting, Electric micro
incinerator, Hot plate,
Incubator, Microscope
Binocular, Microliter
Pipette, Centrifuge, PH
meter, Hot air oven
Availability of func- OB Biosafety Cabinet Class
tional equipment ll A2 with thimble
& instrument for ducting, Cell counter,
testing samples Hormone, Electrolyte
and Urine analyser,
ESR tubes, Micropi-
pettes, Electrophoresis
unit, PCR machine,
Blood gas analyser,
NAAT machine, Glass-
ware and RDKs
Availability of func- Availability of OB Buckets for mopping,
tional equipment equipment for mops, duster, waste
ME C 6.2
and instruments for cleaning trolley, deck brush
support services
Availability of OB/RR Autoclave - Horizontal
equipment for & Vertical
sterilization and
disinfection
Availability of OB Computer, Printer, UPS,
equipment for Data bar code scanner/read-
Management er, etc.
54 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Departments have Availability of OB Refrigerator, Deep
patient furniture and equipment for stor- freezer, Test tube racks
ME C 6.3
fixtures as per load age of sample and
and service provision reagents

Availability of fix- OB Illumination at work

tures at lab station, Electrical fix-
tures, Air Conditioners
etc.

Availability of fur- OB (1) Lab stools, Work

niture bench's, rack and
cupboard for storage of
reagent, , Chair, tables
in Lab.
(2) Patient stool,
Chairs, tables in sam-
ple collection area

Standard Facility has a defined and established procedure for effective utilization, evaluation
C7 and augmentation of competence and performance of staff

Criteria for Compe- Check parameters SI/RR Check objective check-

tence assessment and for assessing skills list has been prepared
performance apprais- and proficiency of for assessing the
al are defined for clinical staff has competence of spe-
ME C7.1 all clinical and Para been defined cialists, Lab technician
clinical staff and paramedical staff
based on job descrip-
tion defined for each
cadre of staff.

Check performance SI/RR Check if performance

criteria for clinical appraisal critical
staff & non clinical clinical staff has been
has been defined defines as per state
service rules/ NHM
Guidelines and job
description of staff

Competence assess- Check for compe- RR (1) Check for records

ment and perfor- tence assessment of of competence assess-
mance appraisal of clinical & paraclin- ment including filled
Clinical and Para clini- ical is done at least checklist, scoring and
ME C7.2
cal staff is done on once in a year grading .
predefined criteria at (2) Verify with staff
least once in a year for actual competence
assessment done
 National Quality Assurance Standards for Integrated Public Health Laboratories 55

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
(3) Check on job
assessment for test
performance, record-
ing and reporting of
results, review of in-
termediate test results,
worksheets, QC results
etc., observe for instru-
ment handling, main-
tenance, and function
check. Competence
assessment for test
performance through
re-testing of previously
analysed samples, etc.
(4) Check feedback is
given to all staff after
competence assess-
ment

Check if annual per- RR/SI (1) Verify with records

formance appraisal that performance ap-
for clinical staff is praisal has been done
practiced at least once a year for
all specialists, Lab tech-
nicians and paramedic
staff.
(2) Check that pre-
defined criteria have
been used for the
appraisal only.
(3) Check feedback is
given to all staff after
performance assess-
ment

The Staff is provided Check operator is SI/RR Training on auto-

training as per de- trained for using mated Diagnostic
ME C7.3
fined core competen- automated diagnos- Equipment's like auto
cies and training plan tic equipment analyser
56 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Check lab techni- SI/RR Check training record
cian are trained for 1. Lab technicians is
sample collection trained on venous
blood collection, col-
lection of microbiology
samples like throat
swab, nasopharyngeal
swab, pus samples, slit
skin etc.
2. Staff nurses or desig-
nated person for sam-
ple collection in wards
are trained for Arterial
blood collection and
capillary blood collec-
tion (in case lab techni-
cian are not collecting
the blood from wards)

Check staff is SI/RR Check training records

trained for sample
transportation

Check that staff is SI/RR Check records of train-

trained on Labora- ing on biosafety (use
tory safety & Infec- and donning, doffing of
tion prevention and PPE; use of biosafety
control cabinets etc), biomedi-
cal waste management,
hand hygiene, disinfec-
tion and sterilization,
bio safety cabinet
certification etc.

Check staff is SI/RR Check records of

trained for Internal training on Internal
and External Quali- and External Quality
ty Assurance Assurance

Check that staff is SI/RR Specimen handling

trained for docu- manual, acceptance/
mentation prepa- rejection criteria, crit-
ration ical alerts, inventory
management, result
reporting format, IQC
records, SOP etc
 National Quality Assurance Standards for Integrated Public Health Laboratories 57

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Check staff is SI/RR Data entry, specimen
trained to use LIMS tracking ,reporting,
and IHIP analysis of data etc

Check that clini- SI/RR Check records of

cians are trained for training on syndromic
Laboratory-based diagnostic approach,
surveillance of in- preparation of line list
fectious diseases and generation of early
warning signals

Training needs are Check lab. has a SI/RR (1) Check that Lab
identified based on system for identi- head/ designated in
competence assess- fying the training charge has listed the
ment and perfor- needs and plan to gaps found during the
mance evaluation and address them. competence assess-
facility prepares the ment and performance
training plan appraisal exercise . (2)
ME C7.4 These gaps in perfor-
mance and competence
are factored in while
developing training
plan for staff.
(3) Check the records
of training need assess-
ment

Check annual SI/RR (1) Check induction

training calendar is and refresher training
prepared & updated is provided to all staff
(2) Training calendar
is prepared according
to the result of compe-
tency and performance
assessment & training
need assessments

There is established Staff is skilled to SI/RR (1) Check supervisors

procedure for utiliza- run automated make periodic rounds
tion of skills gained equipment's of department, and
thought trainings by monitor that staff is
on -job supportive working according to
ME C7.5
supervision the training imparted.
(2) Also staff is pro-
vided on job training
wherever there are
skill gaps
58 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Staff is skilled SI/RR (1) Check supervisors
for maintaining make periodic rounds
Laboratory records of department and
monitor that staff is
working according to
the training imparted.
(2) Also staff is pro-
vided on job training
wherever there is still
gaps

Area of Concern - D Support Services

Standard The facility has established Programme for inspection, testing and maintenance
D1 and calibration of Lab Equipment's.

The facility has All equipment's SI/RR 1. Check with AMC/

established system are covered CMC records
for maintenance of under AMC/ Warranty documents
critical Equipment CMC including 2. Staff is aware of the
preventive list of equipment cov-
maintenance ered under AMC.
3. Check all lab equip-
ME D 1.1 ment's are covered
under BMMP (check
the linkage with BMMP
programme as appli-
cable)
4. Preventive Mainte-
nance activities and
schedule is available
There is system of SI/RR 1. Equipment Log
timely corrective Books are maintained
break down 2. Breakdown records
maintenance of the are maintained
equipment's 3. Staff is aware of
contact details of the
agency/person in case
of breakdown.
4. Check all lab equip-
ment's are covered
under BMMP
 National Quality Assurance Standards for Integrated Public Health Laboratories 59

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Staff is skilled for SI Interview few of the
trouble shooting staff randomly
in case equipment
malfunction
Periodic cleaning, OB/RR 1. Done by the operator
inspection and 2. Check asset list of
maintenance of the equipment is main-
equipment's is done tained
Staff is aware of the SI Check for the Bench
Bench Aids for use Aids for routine use of
of equipment equipment
There is a system OB Defective/Out of order
to label Defective/ equipment are stored
Out of order equip- appropriately until it
ment's has been repaired
All equipment are SI/RR/OB 1. Checking is done by
checked for the a qualified person
safety of the users 2. Earthing is checked
six monthly for all ap-
plicable equipment's
3. Safety instructions is
available readily
4. There is a system of
reporting of equipment
related adverse event
Equipment accep- RR 1. Acceptance testing
tance testing is details should be part
done upon in- of installation report
stallation or after 2. Post preventive/
preventive mainte- breakdown main-
nance tenance acceptance
testing should be
documented in service
reports.
3. Post preventive/
breakdown mainte-
nance appropriate QC /
calibrators must be run
and outputs reviewed
as a part of acceptance
testing
60 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
IT equipment are RR/SI There is system of
covered under cor- timely corrective break
rective and preven- down maintenance of
tive maintenance the for computers and
program other IT equipment

The facility has estab- All the measur- OB/ RR Recalibration done
lished procedure for ing equipment's/ at least every six
ME D1.2 internal and external instrument are months or as per OEM
calibration of measur- calibrated specifications.
ing Equipment

There is system OB/ RR Check for the bar code

to label/ code or any record of cali-
the equipment to bration status
indicate status of
calibration/ verifi-
cation when recali-
bration is due

Calibrators are SI/RR 1. Haematology anal-

available and used ysers, Coagulation
for the automated analysers, Microbiolo-
analysers gy analysers, etc.
2. Calibrators are avail-
able as per the manu-
facturer instructions
2. Check when last cal-
ibration was done for
the analyser

In house calibration RR/OB/SI 1.List of equipment

is done by using that are internal cali-
reference material brated
or comparative 2. Reference material
techniques used for internal cal-
ibration demonstrate
traceability to SI Units
or appropriate mea-
surement standards

Laboratory has SI/RR Check the records

system to update
correction factor
after calibration
wherever required
 National Quality Assurance Standards for Integrated Public Health Laboratories 61

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Staff is aware of SI/RR Check for:
when and how to 1. A change of reagent
recalibrate the lot
equipment's 2. If QC results are out-
side of the acceptable
limits
3. After major mainte-
nance or service
4. When recommended
by the manufacturer

Records pertaining RR/OB Check for

to the calibration is Internal Calibration
maintained for each Records
equipment External Calibration
Certificate
Raw data generated
during the calibration
Certificate of Measure-
ment Traceability

Operating and main- Staff is aware of RR/SI Laboratory has main-

tenance instructions equipment Instal- tained the records
are available with the lation Qualification related to Installation
users of equipment (IQ), Operational Qualification (IQ), Op-
ME D1.3 Qualification (OQ) erational Qualification
and Performance (OQ) and Performance
Qualification (PQ) Qualification (PQ) for
all the testing equip-
ment's

Up to date instruc- RR/SI Check staff is aware of

tions for operation the instructions
and maintenance
of equipment's are
readily available
with staff

Standard The facility has defined procedures for storage, inventory management and dispensing
D2 of consumables and reagents

There is established There is established SI/RR Stock level are daily

procedure for fore- system of timely updated
ME D2.1 casting and indenting indenting of con- Requisition are timely
consumables, sumables, reagents placed
reagents and controls and controls
62 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
The facility ensures Reagents, control OB/RR Check reagents are
proper use and stor- and other consum- kept away from water
age of consumables ables are stored and sources of heat,
and reagents appropriately direct sunlight
All reagents, consum-
ME D2.2
ables, stains, media,
kits, and antimicrobials
should be stored as
recommended by the
manufacturer.

There is process for OB/RR Check for:

storage of reagents, 1. Temperature of
kits and material refrigerators are kept
requiring con- as per storage require-
trolled temperature ment
2. Temperature chart
records are maintained
and updated periodi-
cally
3. Regular defrosting is
done, as applicable
4. Reagents are not
stored on door shelves
of the refrigerator

Standard operat- RR/SI Check for availability of

ing procedures are SOPs
referred to prepare Working solutions are
the working solu- labelled having details:
tions and all the 1.Name of the solution
prepared solutions 2.Date and Time of
are labelled preparation
3.Content of the solu-
tion
4.Strength or concen-
tration
5.Storage conditions
6.Expiration date (in
case controls and cal-
ibrators are provided
by the manufacturers)
7.Prepared by (name)
 National Quality Assurance Standards for Integrated Public Health Laboratories 63

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Reagents, controls OB/RR Details relevant to
and other consum- usage like sensitivity,
ables are accompa- specificity, measuring
nied with relevant range, shelf life, SDS,
SOP storage and disposal
Reagents and OB/RR Reagents label con-
control are labelled tain name, strength or
appropriately concentration, date of
preparation/opening,
date of expiry, storage
conditions, warning
and opened by - initial/
sign
Laboratory has RR/SI 1. New lot of reagents
established proce- is verified for perfor-
dure for acceptance mance before use in
testing of all the the tests
reagents before 2. Records of lot Verifi-
putting into the use cation of reagents
The facility ensures No expired consum- OB/RR Check randomly for
management of ex- ables found expiry of the reagents,
ME D2.3
piry and near expiry controls and other
reagents consumables
Expiry and near RR Check the records
expiry reagent
are identified and
stored separately
The facility has estab- Hospital imple- OB/RR Based on First Expiry
lished procedure for ments scientific First Out (FEFO)
inventory manage- inventory man-
ME D2.4
ment techniques agement system
according to their
needs
There is practice SI/RR 1. Based on the con-
of calculating and sumption
maintaining buffer 2. Stock and expen-
stock of reagents diture registers are
and controls maintained
There is procedure SI/RR There is no stock out of
for periodically re- reagents
plenishing reagents,
control and other
consumables
64 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Description of RR Check for the invento-
reagents, kits and ry log having details
materials are main- of reagents , kits and
tained in the inven- material name,
tory log/register. batch/Lot/Cat. no.,
date of receipt, date of
expiry , date of enter-
ing into service etc

Standard The facility provides safe, secure and comfortable environment to staff, patients and
D3 visitors.

The facility provides Adequate illumina- OB Look for the presence

ME D3.1 adequate illumination tion at work station of undesirable reflec-
level at workstation tions and glare

Adequate illumi- OB Look for the presence

nation at sample of undesirable reflec-
collection area tions and glare

Adequate illumina- OB Check the illumination

tion at circulation adequacy at the stairs
area and corridors

The facility has provi- The access to lab- OB Look of restricted en-
sion of restriction of oratory's testing try signage outside the
visitors in IPHL area is restricted to testing areas
ME D3.2
the laboratory staff Biohazard warning
only sign is placed at labora-
tory doors

Mycobacteriology OB Biohazard warning

and virology sec- sign is placed at labora-
tions have con- tory doors
trolled access entry

The facility ensures Temperature con- SI/RR Fans/ Air condition-

safe and trol and ventilation ing/Heating/Exhaust/
ME D3.3 comfortable environ- in sample collection Ventilation as per envi-
ment for area ronment condition and
service providers requirement

Temperature con- SI/RR Fans/ Air condition-

trol and ventilation ing/Heating/Exhaust/
testing area Ventilation as per envi-
ronment condition and
requirement
 National Quality Assurance Standards for Integrated Public Health Laboratories 65

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Availability of sepa- OB 1. For histopathology
rate room for tissue sections
processing 2. Fume hoods are
available in tissue pro-
cessing area
3. Separate ventilation
for Biosafety cabinets
in microbiology

The facility has SI 1. Ask female staff

established mea- weather they feel se-
sure for safety and cure at work place
security of female 2. No female staff is
staff posted alone in the
night
3. CASH committee
is available (may be
shared with the main
hospital)

The facility has Ma- RR MSDS sheets must

terial Safety Data contain:
Sheets (MSDSs) for 1. Name of the chem-
chemicals ical;
2. Manufacturer’s in-
formation;
3. Hazardous ingredi-
ents/identity informa-
tion;
4. Physical/chemical
characteristics;
5. Fire and explosion
hazard data;
6. Reactivity data;
7. Health hazard data;
8. Precautions for safe
handling and use; and
9. Control measures.
10. Neutralisation /
Deactivation and dis-
posal
OR
as provided by the
manufacturer
66 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Standard
The facility has established Programme for maintenance and upkeep of the facility
D4
Exterior of the facil- Exterior of the OB 1.Whitewashed in uni-
ity building is main- building is plas- form colour
ME D4.1
tained appropriately tered and painted 2. No outdated poster
are pasted on the walls
Interior of the OB 1.Whitewashed in uni-
building is plas- form colour
tered & painted 2. No outdated poster/
information/instruc-
tion are pasted on the
walls
The facility is clean All areas are clean OB Floors, walls, roof, roof
and hygienic and without dirt, tops, sinks, waiting,
ME D4.2 grease, littering and sample collection area
cobwebs and testing areas are
neat and clean
Cleaning schedule RR 1. May be shared with
is maintained the main building
2. Regular inspection
of cleaning work by
designated person
Surface of furniture OB Check there is no dirt
and fixtures are or grease on furniture
clean
The facility has OB/RR/SI Check for:
standard proce- 1. Curtains/Blind &
dures for cleaning shades are cleaned
of curtains/blind & regularly
shades

Toilets are clean OB Check for:

with functional 1. Toilets in proximity
flush and running to the sample collec-
water tion area
2. Toilet in the staff
area
3. Check toilets are
clean and there is no
foul smell in the toilets
Facility's infrastruc- Check for there is OB
ME D4.3 ture is adequately no seepage , Cracks,
maintained chipping of plaster
Window panes, OB
doors and other
fixtures are intact
 National Quality Assurance Standards for Integrated Public Health Laboratories 67

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Periodic mainte- RR/OB Annual maintenance
nance of the infra- plan is available
structure is defined
at the regular
interval
There is no RR
clogged/over flow-
ing drain in facility

The facility has policy No condemned/ OB 1. Sample collection

of removal of con- Junk material is area
ME D4.4 demned junk material kept in the lab 2. Processing area
3. Report collection
area
Condemnation poli- RR Condemnation policy
cy is at place is available and staff is
aware of it.
May be shared with
main hospital
There is an estab- SI/OB Decommissioning and
lished procedure disposal is carried out
for decommission, as per the manufacture
disposal and con- instructions and as per
demnation of the the standard operating
equipment if no procedures
longer in use
The facility has es- No stray animal/ro- OB 1. Pest control mea-
tablished procedures dent/birds in lab sures are taken at regu-
ME D4.5 for pest, rodent and lar interval
animal control 2. Anti-termite mea-
sures are taken
Standard The facility ensures 24X7 water and power backup as per requirement of service
D5 delivery, and support services norms
The facility has ade- Availability of 24x7 OB/SI RO/filter water is
quate arrangement running and pota- available for drinking
ME D5.1 storage and supply ble water in sample collection
for potable water in and/or report collec-
all functional areas tion area
Facility has ade- OB/RR/SI 1. Provision to store
quate water stor- at least three days of
age facility as per water requirement
requirements 2. Water tanks are
cleaned at an interval
of maximum three
months
68 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Facility periodically RR
tests the quality
of water from the
source (municipal
supply, bore well
etc) for bacterial
and chemical con-
tent
Distilled/deionised OB/RR Testing must be done
water is used for every three months
testing
Water used for ana- OB/RR Parameters used for
lytical purpose is of water testing must be
reagent grade as per test require-
ments and manufac-
turer instruction in
cases of automated and
semiautomated anal-
ysers
The facility ensures Availability of OB/SI Check that UPS con-
adequate power power back up in nection with critical
ME D5.2
backup in all patient laboratory and equipment is provided
care areas as per load related areas
Availability of noise OB May be shared with the
less generator for main hospital building
the power backup

Standard
The facility ensures support to all linked labs as per service mandate
D6
The facility has estab- All spoke units are RR/SI Check the list of linked
lished procedure for identified & down- Block Public Health
ME D6.1 providing technical ward linkage is Laboratories and other
support to linked labs established for tests peripheral laboratories
is available
Regional/state/ RR/SI Facilities are identified
medical college are for upward linkages
identified & upward and staff is aware of it
linkage is estab-
lished for tests not
conducted at IPHL
Check routine RR/SI 1. Restructuring of rou-
testing and public tine and public health
health related test- diagnostics is done and
ing is integrated its functional
2. Check there is no du-
plication of diagnostic
services
 National Quality Assurance Standards for Integrated Public Health Laboratories 69

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
There is established RR/SI Check for established
system of integra- linkage between IPHL
tion between health and other laboratories
and other depart- under various depart-
ments ments like Central Pol-
lution Control Board
(CPCB), FSSAI, PHED,
veterinary, forensic
department, etc.
The facility has estab- The facility pro- RR/OB Check for
lished procedure for vides 1. Conduct training for
providing capacity capacity building hub and peripheral
ME D6.2 building support to support to the laboratory staff
linked labs linked labs 2. Check the records
for type and number of
trainings
The facility has estab- The facility has RR/SI 1. Information regard-
lished procedure for functional Labora- ing samples received
providing information tory Information in IPHL or sent to
management support Management Sys- regional/state lab are
using digital tech- tem (LIMS) to pro- recorded & updated for
ME D6.3
nology to linked labs vides information all samples including
and administrative regarding samples in-house samples
authorities 2. Randomly, select at
least 5 samples and
check for details
The facility has es- RR/PI 1. Reports are sent via
tablished system to Hospital Information
report test results System, email, SMS, etc.
to the patient
2. Randomly, select at
least 5 samples and
check for details
The facility has RR/SI LIMS support all the
functional Labora- information manage-
tory Information ment functions like
Management Sys- data collection, storage,
tem (LIMS) for data archiving for analysis,
management research, information,
and policy decisions to
detect, prevent and re-
spond to public health
threats in real time
70 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
There is an estab- RR/SI Check for functional
lished linkage with linkage between IPHL
Integrated Health with IHIP to support
Information Plat- surveillance and man-
form (IHIP) aging outbreaks
Standard
Facility has defined and established procedures for Financial Management
D7
The facility ensures There is system to RR/SI As given under PM-
the proper utilization track and ensure ABHIM, XV-Finance
ME D7.1
of fund provided to it that funds are re- Commission, etc.
ceived on time
Funds/Grants pro- RR As given under PM-
vided are utilized in ABHIM, XV-Finance
specific time limit Commission, etc.

Salary and compen- SI

sation of contractu-
al staff is given on
time
The facility ensures Facility prioritize RR/SI Requirement for funds
proper planning and the resource avail- are sent to state on
ME D7.2 requisition of re- able time
sources based on its
need
Utilisation certifi- RR/SI
cate is submitted on
time

Standard Facility is compliant with all statutory and regulatory requirement imposed by local,
D8 state or central government
The facility has req- Availability of RR Give full compliance if
uisite licences and valid No objection the facility shares fire
ME D8.1 certificates for oper- Certificate from fire NoC with main hospital
ation of facility and safety authority building
different activities
Availability of RR Give full compliance
Biomedical Waste if the facility shares
Management Au- BMW authorisation
thorisation for gen- with main hospital
erating BMW as per building
prevalent norms/
regulations
Availability of cer- RR
tificate of inspec-
tion of electrical
installation
 National Quality Assurance Standards for Integrated Public Health Laboratories 71

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
The facility ensure RR Any positive report of
relevant processes notifiable disease is in-
are in compliance timated to designated
with statutory re- authorities
quirement
Updated copies of Availability of copy RR Updated copy is avail-
relevant laws, regula- of Bio medical able, may be shared
tions and government waste management with the main hospital
ME D8.2
orders are available at rules 2016 and it's
the facility subsequent amend-
ments
Code of Medical RR Updated copy is avail-
ethics 2002 able, may be shared
with the main hospital
Person with disabil- RR Updated copy is avail-
ity Act 1995 able, may be shared
with the main hospital
Right to informa- RR Updated copy is avail-
tion act 2005 able, may be shared
with the main hospital
Indian Tobacco RR Updated copy is avail-
control Act 2003 able, may be shared
with the main hospital
HIV/AIDS preven- RR With mandatory provi-
tion and control Act sion of pre and post-
test counselling)
Epidemic diseases RR Updated copy is avail-
(Amendment) Ordi- able, may be shared
nance 2020 with the main hospital
Standard Roles & Responsibilities of administrative and clinical staff are determined as per
D9 govt. regulations and standards operating procedures.
The facility has estab- Staff is aware of SI Check lab staff is aware
lished job description their role and re- of their roles and re-
ME D9.1
as per govt guidelines sponsibilities sponsibilities

Job description of SI/RR Both regular and con-

staff is defined and tractual staff
communicated

The facility has a Duty roster of RR/SI Check for system for
established procedure specialist is pre- recording time of
for duty roster and pared, updated and reporting and relieving
ME D9.2
deputation communicated (Attendance register/
Biometrics etc) and
handover register
72 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Duty roster of lab RR/SI Check for system for
technician is pre- recording time of
pared, updated and reporting and relieving
communicated (Attendance register/
Biometrics etc)
Duty roster of other RR/SI 1. Housekeeping staff,
staff is prepared, security staff, data
updated and com- entry operator, etc.
municated may be shared with the
main hospital building
2. Check for system
for recording time of
reporting and relieving
(Attendance register/
Biometrics etc)
There is designated SI
in charge for IPHL

The facility ensures Specialist, techni- OB As per the state's

the adherence to cian and support norms
dress code as man- staff adhere to their
ME D9.3
dated by its admin- respective dress
istration /the health code
department

The facility has SI/RR Check for:

established proce- 1. Minimum profes-
dures for creden- sional qualification for
tialing of staff all cadre of staff has
been defined in accor-
dance with NMC norms
and respective profes-
sional councils
2. Professional qualifi-
cations and experience
of the doctors have
been verified before
inducting them into the
service
3. Formal screening of
health professionals for
skills and core compe-
tency have been done
and documented
 National Quality Assurance Standards for Integrated Public Health Laboratories 73

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Standard Facility has established procedure for monitoring the quality of outsourced services
D10 and adheres to contractual obligations

There is established There is procedure SI/RR Verification of out-

system for contract to monitor the qual- sourced services
management for out ity and (cleaning/Laundry/
sourced services adequacy of out- Security/Maintenance)
ME D10.1 sourced provided are done by
support services on designated in-house
regular basis staff

There is procedure SI/RR Check for:

to monitor the 1. Check if any of the
quality and adequa- lab test/service is out-
cy of outsourced sourced
laboratory tests/ 2. NABL / NQAS certi-
services on regular fication of outsourced
basis partner entity
3. Participation of
outsourced partner in
Proficiency Testing /
Inter Laboratory Com-
parison Program and
its results
4. Formal MOU /
Service Level Agree-
ment covering scope
of services, TAT, Crit-
ical Value Reporting,
Quality Management
parameters etc

OR
If lab test/services
are in-house, give full
compliance
Selection of out- RR 1. May be shared with
sourced agencies is the main hospital
done through com- 2. Review the contract
petitive tendering document
process
74 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
There is a system Facility has defined RR Check:
of monitoring of criteria for assess- 1. Regular monitoring
quality of out sourced ment of quality of and evaluation of staff
services outsourced services is done against defined
ME D10.2 criteria
2. Actions are taken
against non-compli-
ance/deviation from
contractual obligations
Records of black- RR May be shared with the
listed vendors are main hospital building
available
Area of Concern - E Clinical and Diagnostic Services
Standard
The laboratory has defined procedures for registration of Patients at the laboratory
E1
The facility has es- IPHL has defined RR 1. Area like OPD, IPD,
tablished procedure procedure for regis- Emergency and other
for registration of tration of patient critical areas of the
patients visiting lab hospital
ME E1.1 or sample collection 2. Through HIS or Man-
area ual, if process is manu-
al, details will be filled
in LIMS by Data Entry
Operator (DEO)
Test requisition is RR/OB Electronic or on paper
generated by quali-
fied Physician

Patient demograph- OB/RR Check for:

ic details & unique 1. Patient demograph-
identification no. ics like Name, age,
are recorded in Test Sex, Address, etc. are
Requestion form recorded
2. Time of sample col-
lection is recorded
3. Name and signature
of the sample collector
is recorded
4. Details of sample
received is mentioned
(in-house lab or pe-
ripheral health facili-
ties)
5. UID of all patients
(IPD/OPD) assigned by
hospital is mentioned
on TRF
6. History of the
patient is recorded, if
required
 National Quality Assurance Standards for Integrated Public Health Laboratories 75

Annexures Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Sample ID no is OB/RR (1) Sample ID for each
assigned to patient sample is generated
samples for track- manually/BAR Code
ing the sample form/ LIMS ID / HIS ID.
through lab (2) Check if sample ID
is alpha and/or numer-
ical identifier
The facility has es- Each sample RR/OB 1. From linked periph-
tablished procedure received at the eral health facilities
for registration of the laboratory is reg- (HIS/Manual), if pro-
ME E1.2 patient's sample re- istered manually cess is manual, details
ceived from spokes/ or through LIMS or will be filled in LIMS
peripheral labs HIS by Data Entry Operator
(DEO)
Patient demo- RR/OB 1. Unique ID for each
graphic details and sample is generated
Unique laboratory manually/BAR Code
identification num- form/ LIMS ID / HIS ID
ber are recorded 2.Tests requested and
referring lab/ clinician
details are recorded at
time of registration
Standard Facility has established mechanism for referral linkages to maintain
E2 continuity of services
Facility has defined Laboratory has RR/SI For all routine diagnos-
and established pro- established refer- tic tests and tests man-
cedures for continuity ral linkage for the dated under National
ME E2.1 of services sample transferred Health Programmes
from the BPHL/pe- like IDSP, NACP, NTEP,
ripheral facilities NVBDCP, NVHCP etc.

Laboratory has RR/SI 1. Laboratory has

functional upward assured linkage with
referral linkage for State PHL/ Medical
tests not available college lab for the tests
at the facility not being performed in
the lab
2. Check the relevant
government order for
assured linkages
The facility has de- The facility coor- RR/SI Like Central Pollution
fined and established dinates with other Control Board, FSSAI,
ME E2.2 procedures for inter- allied departments PHED, Veterinary, Fo-
sectoral coordination for intersectoral rensic department, etc.
convergence
76 National Quality Assurance Standards for Integrated Public Health Laboratories

Bibliography Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Standard
The facility has established and defined procedure for pre-testing activities
E3
The facility has estab- Procedure for the OB/SI Haematology, Bio-
lished procedure for patient preparation chemistry, Histopathol-
ME E3.1
patient preparation is defined ogy, Clinical Pathology,
Microbiology, etc.
The patient is pre- RR/OB/SI Check that the pa-
pared before col- tients are educated for
lecting the primary necessary instructions
sample before sample collec-
tion specially where
changes may take place
due to physiological
barriers.
Check with patients OB/PI Fasting blood sugar,
if instructions are cessation of drugs be-
give to them before fore sample collection
sample collection like hormones, special
timing of sample col-
lection, etc.
OR
Advised patient to sit
down till sweat subside
- for electrolyte or S.
protein
OR
Patient is advised to
take balanced diet a
night before- Urea and
urates, etc.
The facility has es- Procedure for the OB/SI Haematology, Bio-
tablished procedure sample collection is chemistry, Histopathol-
ME E3.2 for sample collection defined ogy, Clinical Pathology,
from patient care Microbiology, etc.
areas
IPHL has defined OB/SI It includes:
mechanism for 1. Sample collected
sample collection from OPD
within the facility 2. Samples from IPD of
or from the periph- the district hospital
eral health facilities 3. Samples collected
from spokes/peripher-
al facilities
 National Quality Assurance Standards for Integrated Public Health Laboratories 77

List of Abbreviations Assess-

Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Temperature is OB/SI 1. Temperature of
maintained for the collected sample is
samples collected maintained as defined
from the peripheral by the refree lab
health facilities 2. Check availability
and use off data log-
gers
Check steps to OB/SI 1. Assembly of re-
collect the sample quired material
are defined and 2. Pre collection verifi-
followed by Phle- cation of patient
botomist 3. Wear PPE
4. Determine site for
venepuncture: Ante
cubital area - most
commonly
5. Labelling of the
tubes
6. Venepuncture
7. Needle removal
8. Deliver blood in
respective tubes
9. Disposal of sharp
10. Verification of sam-
ple & logging of any
incident
The procedure for OB/SI 1. Labelling of tubes
venepuncture is de- 2. Patient is comfort-
fined and followed able and seated on
chair
3. Proper positioning
of patient's arm
4. Apply torniquet with
3-inch clearance above
the planned puncture
site
5. Clean the venepunc-
ture site with 70%
isopropyl swab
6. Allow it to dry
7. Alert the patient
before the venepunc-
ture, ask the patient to
clinch the fist and tell
them to relax, make
sure patient arm is in
downward position
78 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
8. Smoothly insert the
needle with bevel at
15-30 degree of angle
9. Remove the torni-
quet as soon as the
blood begin to flow
10. In case of multiple
punctures, record is
maintained

Sample collec- OB/SI 1. Minimum two blood

tion for the blood culture sets are collect-
culture is done as ed within 24hrs based
per the standard on
guidelines - Clinical condition
- Adequate volume
- number of sets
- Timing
2. Samples are collect-
ed before use of anti-
microbials
3. Vacutainer holder or
butterfly needles avail-
able to ensure proper
collection volume.
4. Staff is aware of
blood culture collec-
tion guidelines

Sample collection SI/PI Urine, Sputum, Stool,

other than blood is etc.
done as per proto-
col

Order of draw, mix- OB/SI As per the facility's

ing and inversion instruction
are defined and Samples containing
followed additives are mixed by
inverting, ensure no
shaking of the tubes
 National Quality Assurance Standards for Integrated Public Health Laboratories 79

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Instructions for RR/SI Check that the staff is
collection and aware of sample collec-
handling of primary tion instructions like
sample are com- order of draw, volume
municated to those of sample for different
responsible for type of tests, sample
collection collection instructions
for different age group
and sample collection
from patients admitted
in critical care unit, etc.

Laboratory has RR/SI Check the records for

system to record the details of person
the identity of per- collecting the sample:
son collecting the 1. at sample collection
primary sample area
2. for IPDs and other
departments

Check closed or OB/SI Check closed system-

evacuated system needle, holder and
of blood sample col- evacuated tubes are
lection is used used for sample collec-
tion

Check Phleboto- OB/SI Neonates, paediatric,

mist is aware of the elderly and patients
choice of needle with small veins
gauge, site selec-
tion in vulnerable
patients.

Staff is trained for RR/SI 1. Staff is trained on

handling the emer- BLS protocols and
gency in case of any management of hypo-
complication raised volemic shock
during sample col- 2. Availability of emer-
lection gency drug tray/crash
cart
3. Immediate trans-
port of the patient to
emergency or linkage
with the ambulance
for patient's referral, if
required
80 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
The facility has estab- IPHL has defined a RR/OB 1. The facility is using
lished procedure for procedure for label- the bar code as identi-
sample labelling and ling of the samples fier, if labelling is done
documentation manually, give partial
compliance
ME E3.3 2. If bar code is main-
tained, check randomly
how bar codes are
placed (volume of the
sample is visible from
outside)
Samples are la- RR/OB 1. Identifiers may in-
belled with at least clude (but not limited
two unique identi- to):
fiers Patient's name, Age,
Gender, Patient unique
id, Name of the test re-
quested, time and date
of sample collection or
bar codes
Laboratory has RR/OB/SI Check that Patient's
system to trace the name/unique id of the
primary sample sample is verified at
from requisition each working station
form
The facility has a Requisition of all RR/OB/SI 1. Requisition form
standardised Test laboratory test contain information:
Requisition form for is given in stan- Name and identifica-
the tests dardised requisi- tion number of patient,
tion form name of authorized
requester,
type of primary sam-
ple,
investigation request-
ed,
ME E3.4
date and time of prima-
ry sample collection,
signature of the prima-
ry sample collector and
time of receipt of sam-
ple by laboratory
2. Check randomly in
10 requisition forms
for uniform data col-
lection
 National Quality Assurance Standards for Integrated Public Health Laboratories 81

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
The facility has estab- Procedures are de- OB/SI Haematology, Bio-
lished procedure for fined for packaging chemistry, Histopathol-
ME E3.5
packaging and trans- and transportation ogy, Clinical Pathology,
portation of samples of samples Microbiology, etc.
Collected samples OB 1. Samples are collect-
are packed as per ed in vacutainers as
the standard guide- per the guidelines
lines 2. Samples are packed
in triple layered con-
tainer packing (partic-
ularly virology)
3. Check 10 samples
received from the
periphery and sample
collection area
Laboratory has RR/OB/SI Transportation of
system in place to sample includes: Tem-
monitor the trans- perature requirement,
portation of the preservation (if any),
sample within the time frame, special
facility and the pe- packaging require-
ripheral facilities ment to avoid leakage,
safety of the personnel
handling the sample,
tracking system for
samples, etc.

For infectious sample,

samples are transport-
ed in transport media,
in case of delay, or
categories are defined
based on the risk in-
volved
82 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Samples are trans- OB/RR Check for:
ported timely at the 1. Samples are picked
IPHL on the same day
2. Cumulative sample
transportation
time from all the
spokes/peripheral
health facilities to the
primary receiving hub
laboratory should not
exceed 2
hours (starting from
the point of pick-up)
3. Samples should be
picked up once a day
from PHCs, and twice a
day from CHCs/FRUs,
depending on the pa-
tient load
4. Verify with the req-
uisition slip
5. Data loggers are
used for monitoring
in terms of time and
temperature

There is a defined OB/SI 1. Pick-up of emer-

protocol for pick- gency samples (as per
up of emergency the clinical judgement
samples of Medical Officer) is
done
within 1 hour from
CHCs.
2. The reason for emer-
gency sample pick up
is documented by the
medical officer in test
requisition form

The sample dis- OB/RR Check real time data

patch time is entry in the LIMS
recorded electroni-
cally in the LIMS
 National Quality Assurance Standards for Integrated Public Health Laboratories 83

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
The facility has Check criteria is RR/OB/SI Checks staff is aware
defined criteria for defined for sample of sample acceptance
sample acceptance or acceptance and criteria which include
rejection followed appropriate container,
quantity/volume (in
case of blood/urine
sample), temperature
on receipt, quality
of sample (in case of
ME E3.6 tissue samples), any
leakage, etc.

As defined by the IPHL

in the standard oper-
ating procedures for
Haematology, Bio-
chemistry, Histopathol-
ogy, Clinical Pathology,
Microbiology, etc.

There is defined OB/SI 1. Accompanied by

procedure for sam- TRF,
ple acceptance of 2. Unequivocal trace-
in-house samples ability by request and
labelling, patient UID
and sample ID,
3. recording of the date
and time of the receipt
of the sample,
4. technician or autho-
rised person evaluate
the sample against the
acceptance criteria

The facility may use

department-wise
checklist for sample
acceptance, if any
84 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
There is defined OB/SI 1. Accompanied by
procedure of sam- TRF,
ple acceptance for 2. Unpack the patient
samples received sample and match it
from the spokes/ with TRF, if there is any
peripheral health inconsistency in sam-
facilities ple label and request
form then procedure
is defined to deal with
the discrepancies
3. Recording of the
date and time of the
receipt of the sample,
4. Sample colour ap-
pearance and volume
are noted in TRF
5. Record sample ID no
and patient informa-
tion in register/LIMS
for further monitoring
Sample prepara- OB/SI Check the staff is aware
tion as per defined of processing protocols
protocols
Check criteria is RR/OB/SI 1. Checks staff is aware
defined for sam- of sample rejection
ple rejection and criteria which include
followed Unlabelled sample,
incomplete or misla-
belled sample, incor-
rect container or pre-
servative, insufficient
sample, excessive delay
in receiving the sam-
ple, leaking container,
sub-optimal sample/
haemolysed sample,
specimen contami-
nated with biohazard
material, Prolonged
transport time
2. Check record is
maintained for rejected
samples along with the
reasoning
 National Quality Assurance Standards for Integrated Public Health Laboratories 85

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
3. Check IPHL inform
peripheral lab about
the rejected sample-re-
cord is maintained that
who has informed and
at what time
4. In case of emergency,
testing is performed
and result is given
stating that sample is
compromised so may
be co-related clinically

As per standard guide-

lines of Haematology,
Biochemistry, Histopa-
thology, Clinical Pathol-
ogy, Microbiology, etc.

There is a defined RR/OB/SI Check that:

set of activities post 1. Primary sample col-
sample rejection lector is informed
2. Request for another
sample is placed
3. Records of rejected
samples are main-
tained

Standard
The facility has established and defined procedure for testing activities
E4

Facility performs tests The facility per- RR/SI Laboratory has kept
as per established forms tests as the list of procedure
procedure per established for conducting each
procedure/test test.
kit instructions/ Test procedure in-
programme specific cludes:
ME E4.1
guidelines Name, Scope, Purpose
of examination, Method
of Procedure, Reagents,
equipment, glassware
required, Procedural
Steps, etc.
86 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Test procedures are Quality control RR/SI 1. Haematology, Bio-
verified through rou- mechanisms are chemistry, Histopathol-
tine quality control defined for all test ogy, Clinical Pathology,
methods procedures Microbiology, Cytology,
ME E4.2 etc.
2. Check IPHL runs
quality control at
defined interval as per
standard procedures
All test procedures RR/SI 1. Check for records for
are verified before verification in terms
routine use of performance char-
acteristics of quality
control method like:
Precision, Accuracy,
Range / Analytical
Measurement Range
(AMR), Clinical Report-
able Range (CRR) –
when sample is diluted
to report higher values
not covered by AMR,
Analytical Sensitivity,
Analytical Specificity,
carry over
2. For Rapid Diagnostic
Tests as per manufac-
turer's guidelines
Facility has estab- Critical values are RR/SI Check that:
lished procedure for defined for each 1. Staff is aware of criti-
Biological reference specialization cal values
intervals & critical 2. Critical Values are
alert values displayed / filed for
ME E4.3 ready reference in the
laboratory, check the
documents
3. Read-back in case
of telephonic or verbal
communication
There is an estab- RR/SI Critical result report-
lished procedure of ing register including
reporting the criti- register having details
cal alert values of :
Date, time, test details,
result details, respon-
sible laboratory staff
and person notified are
maintained at labora-
tory
 National Quality Assurance Standards for Integrated Public Health Laboratories 87

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Laboratory has RR/SI 1. BRI is documented
defined and updat- 2. BRI is updated annu-
ed its Biological ally and communicated
Reference Interval to the staff whenever
(BRI) and has a pro- there is change pro-
cedure to review cedure/ method of
the BRI testing
3. Check for BRI or clin-
ical normative range is
written in the reports

Standard
Laboratory has defined and established procedure for the post testing processes
E5

The facility has estab- The facility has a RR/OB Reports of the results
lished procedure for standardised for- include:
reporting of result mat for reporting of Name and Unique
result Patient Identification
Number, Date and Time
of Specimen Collection,
Date and Time of Test
done and result report-
ed, Name and address
of the Laboratory,
Name/Source of sam-
ple (e.g. – whole blood,
urine etc.), Name of
ME E5.1 doctor and referee fa-
cility, Interpretation of
results, method, mea-
surement units (SI)
and biological refer-
ence interval or clinical
decision limit or cut-off
values (as applicable),
Duly signed by autho-
rised signatory, identi-
fication of the person
releasing the report,
page number of total
number of the pages

All the results are RR/OB By technically compe-

reviewed by autho- tent and experienced
rised person designated person
88 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Interim results are RR Any preliminary report
followed by the generated for urgent
final reports sampling, critical result
intimation is followed
by the final report
signed by authorised
signatory
Reports are validat- RR Microbiologist/Pathol-
ed by authorised ogist/Biochemist
person
The Laboratory RR/SI TAT for each test is
defines the Turn defined and is commu-
Around Time (TAT) nicated to the patient
for each test both in form of display or
for the routine and information material
emergency cases
IPHL has defined OB/SI Through LIMS/SMS/e-
protocol for re- mail/hard copy
lease of the results
including referred/
outsourced tests
Staff is designated OB/SI In IPDs and other areas
to disseminate the of the hospital
reports
Staff is aware of OB/SI Like inadequate,
post analytical ambiguous report,
error improper data entry
and manual transcrip-
tion error (if LIMS is
not functional), failure
or delay in reporting
critical values, inad-
equate or incorrect
interpretation, valida-
tion of errors in data,
improper retention of
the sample, etc.
Reports are SI/RR/OB Tele equipment print
checked for tran- out, workbook, data-
scription errors sheet with the report
 National Quality Assurance Standards for Integrated Public Health Laboratories 89

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Check notification OB/SI/RR Through LIMS/SMS/e-
is sent by lab in mail
case of any delay in
the reporting
The laboratory has The laboratory RR/SI 1. Laboratory has
defined procedure for has procedure to clearly defined the re-
revision/amendment ensure revision of sponsibility of amend-
of the reports when results and correct ing the test results
required interpretation be- 2. Revision/ Amend-
fore release of the ments in the reports
results due to re-test/ re-sam-
pling/ QC failure etc.
are highlighted in the
ME E5.2
report.
3. Reason of amend-
ments are documented
along with the date of
amendment
4. All the amended
reports are stored by
the laboratory in soft
or hard copies
Laboratory has RR/ SI Check for the records
process of taking of amendment in
corrective actions reports, recall of the re-
for any discrepancy ports whenever there
in the test result is a issue related to the
accuracy of the results
during the review
The facility has estab- Samples are re- RR/SI Check for sample
lished procedure for tained and stored retention protocols,
sample storage and for re sampling and storage conditions as
its disposal additional examina- mandated, record of
ME E5.3
tion as per facility's storage is maintained,
policy & procedure samples are labelled
with time of prepara-
tion
90 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Separate refrigera- OB 1.It is clearly men-
tor is available for tioned on the refriger-
sample storage ator, "for samples only"
or "for kits only"
2. Temperature is
maintained for the re-
tained samples as per
the guidelines
3. System to identify
the date of sample
collection
4. If domestic refriger-
ator is used, calibrated
thermometer is placed
inside the refrigerator

Check kits are not

stored along with the
samples
Indexing is done OB/SI Check the methodology
for all the retained for indexing is defined
samples and followed
Standard The facility has established mechanism for internal and external quality assurance of
E6 testing procedures
The facility has estab- The facility has de- RR/SI 1. Quantitative/Quali-
lished mechanism of fined performance tative
internal quality con- evaluation mech- 2. Lyophilised/ready
trol using quantitative anism for control to use
ME E6.1 methods material 3. Assay/unassay
4. First party/second
party/third party
5. In-house/Commer-
cial
Internal Quality RR/SI Irrespective of size, lab
Control is done on should analyse IQC at
daily basis two levels,
- Two level of QCs once
in the peak hour daily
- One level every 8hrs
(3 times a day)
 National Quality Assurance Standards for Integrated Public Health Laboratories 91

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Staff is aware of RR/SI 1. When one level QC
defined protocol for is used
rejection of test run - Value is outside 3 SD
- 2 consecutive values
are outside 2 SD on the
same side, but within
3 SD
- 10 consecutive values
or above or below the
mean, but within 2 SD
2. When two level QC
is used
- Either QC value is
outside 3 SD
- Both QC values
are outside 2 SD, but
within 3SD/ difference
between QC values is
>4 SD
- 10 consecutive values
of the same level QC
are above or below the
mean, but within 2 SD
- 5 consecutive values
of one level & 5 consec-
utive values of the oth-
er level QC are above
or below the mean, but
within 2 SD
The facility has RR/SI Check the mechanism
mechanism of inter- for:
nal quality control 1. Retesting of any
in place when con- randomly chosen spec-
trol material is not imen/s
available 2. Replicate test of
sample by different
method, different
machine and different
person, whichever
applicable
3. Correlation of test
results with other pa-
rameters
92 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
The facility plot RR/SI 1. Staff knows how to
Levy Jennings’s (LJ) plot and interpret LJ
chart daily for Qual- chart using inbuilt soft-
ity Control values ware in the analysers
or using excel sheet
2. Outliers are identi-
fied
3. Corrective action is
taken and documented
on the identified out-
liers according to the
Westgard rule
The facility has es- Quality assurance RR/SI Bacteriology, Para-
tablished mechanism mechanisms are sitology, Mycology,
of internal quality defined for all steps Serology, Molecular
ME E6.2
control using semi of microbiology Diagnostics
quantitative/qualita-
tive methods
Quality assurance RR/SI To identify and manage
mechanisms are the potential errors
defined for all steps
of histopathology
and cytology
IQC (Qualitative) RR/SI Smears, ESR, Urine
are defined for all Analysis, Semen Analy-
steps of Haema- sis, Boddy fluid analy-
tology and Clinical sis like CSF
Pathology
Internal Quality RR/SI As defined in pro-
Control processes gramme guidelines
are followed for (like TB, Malaria, etc.)
national health
programmes
The facility has es- External Quality RR/SI Haematology, Microbi-
tablished mechanism Assurance methods ology, Cytology, Bio-
of external quality are defined for test chemistry, Histopathol-
ME E6.3
assurance performed in IPHL ogy, Clinical Pathology,
etc. or as per the scope
of services
IPHL has defined RR/SI EQAS or Peer group
the ways to conduct comparison or ex-
external quality change of sample or
assurance split testing
External Quality RR/SI For monitoring, accura-
Assurance is done cy and calculating bias
on regular basis
 National Quality Assurance Standards for Integrated Public Health Laboratories 93

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
providers are iden- RR/SI Process for receiving
tified for Proficien- the sample, analysis,
cy Testing/EQAS sharing the result, eval-
uation of the result and
notification of result is
defined
EQAs reports are RR/SI 1. Staff is aware of
analysed and eval- EQAS reporting system,
uated how to evaluate, inter-
pret, and compare like
Z score/VIS score, etc.
2. Staff is aware about
the acceptable perfor-
mance criteria for the
analytes
3. Corrective actions
are taken on abnormal
values/ Outliers
Staff is aware of RR/SI 1. Incorrect units
common errors that 2. Incorrect sample
may occur under tested
EQAS 3. Incorrect classifica-
tion of testing methods
4. Improper reconsti-
tution
5. Transcription errors
External quality RR/SI 1. Onsite evaluation
assurance program done monthly
implemented as per 2. Random Blinded re-
NTEP program checking (RBRC) done
monthly
External quality RR/SI
assurance program
implemented for
NVBDCP
External quality RR/SI
assurance under
NACP

Standard Facility has defined and established procedures for maintaining, updating of patients’
E7 clinical records and their storage

Adequate form and Standard Formats RR/OB Printed formats for

formats are available available requisition, consent
ME E7.1
at point of use and reporting are
available
94 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Register/records are All records are la- RR All the Laboratory
maintained as per lab belled and indexed records have unique Id
policy number as per docu-
ment control policy of
ME E7.2
the facility. The records
can be maintained as
physical copies or elec-
tronically (LIMS)

Records and regis- RR 1. Test registers, IQAS/

ters are maintained EQAS Registers, Ex-
for laboratory as penditure registers,
per the retention Accession list etc.
criteria 2. Look for state and
NMC guidelines for
records

Facility maintains RR The records can be

the records of the maintained as physical
samples being copies or electronically
sent/received to/ (LIMS)
from the referral
laboratory

The facility has estab- The facility has OB/RR Look for the availabil-
lished computerised established Lab- ity of following infor-
information system to oratory Informa- mation through func-
support lab functions tion Management tional LIMS/HIS:
System (LIMS) to 1. Samples tracking
support lab func- from collection to
tions reporting
2. Reporting of test
result
3. Collection, storage,
archiving and analys-
ing laboratory data for
decision making
ME E7.3 4. Reporting of anal-
ysed data to district
and state administra-
tion, Ministry of Health
& Family Welfare
5. Inventory manage-
ment (kits and re-
agents etc.)

If IPHL maintains
paper based records,
check work flow, qual-
ity and audit trail for
the sample processed
 National Quality Assurance Standards for Integrated Public Health Laboratories 95

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Facility has defined OB/SI/RR As per state policy
policy for retrieval
and archiving of
digital records

The facility ensures Laboratory has OB Check the mechanism

safe and adequate adequate facility for of storage (physical
ME E7.4
storage and retrieval storage of records copies/electronic
of medical records copies)

Safe keeping of OB Check that:

patient records 1. System clearly define
who all are authorized
to access the patient's
physical/electronic
information
2. Access is limited
to authorised person
only both for physical
records or Password/
finger print protected
computer system
3. Check records are
easy to retrieve
4. Any restriction/
firewall to protect the
individual’s informa-
tion from mis-use in
case of LIMS

The facility has SI/RR As per state policy

policy for retention
period for differ-
ent information &
records

Facility has defined SI/RR Check the policy for

policy for records both manual and elec-
retrieval tronic records as per
state policy

Standard The facility has defined and established procedures for Emergency Services and
E8 Disaster Management

The facility has disas- Staff is aware of SI/RR Check disaster man-
ter management plan disaster plan or agement committee is
ME E8.1 in place contingency plan at place and IPHL takes
part in regular mock
drills
96 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Role and respon- SI/RR Check staff is aware of
sibilities of staff is their role during di-
defined saster/mass causality
situation

Emergency proto- SI/RR Check the availability

cols are defined and and awareness for
implemented managing the func-
tionality of lab during
emergencies such as
fire, spill, etc.

There is procedure Samples of legal SI/RR 1. Requisition and re-

for handling legal cases are identified ports are marked with
cases MLC
2. Reports are handed
ME E8.2
over to authorized
personnel only
3. Records are kept
confidential

Standard Facility provides diagnostic services under National health program as

E9 per operational/Clinical Guidelines

The facility has estab- There are estab- RR/SI As per programmatic
lished procedure for lished procedures guidelines
services under var- for laboratory diag-
ME E9.1
ious communicable nosis of Tuberculo-
disease programmes sis as per prevalent
guidelines

There are estab- RR/SI including opportunistic

lished procedures infections
for laboratory
diagnosis of AIDS
as per prevalent
guidelines

There are estab- RR/SI As per programmatic

lished procedures guidelines
for laboratory
diagnosis of Lepro-
sy as per prevalent
guidelines
 National Quality Assurance Standards for Integrated Public Health Laboratories 97

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
There are estab- RR/SI As per programmatic
lished procedures guidelines
for laboratory di-
agnosis of viral hep-
atitis as per preva-
lent guidelines

There are estab- RR/SI As per programmatic

lished procedures guidelines
for laboratory
diagnosis of Malaria
as per
prevalent guide-
lines

There are estab- RR/SI Filaria, Kala-azar, Den-

lished procedures gue, Chikungunya, Zika
for laboratory diag- and Japanese Enceph-
nosis of integrated alitis
vector-borne dis-
eases as per preva-
lent guidelines

The facility has es- There are estab- RR/SI As per programmatic
tablished procedure lished procedures guidelines
for services under for laboratory diag-
various non-com- nosis of non-com-
ME E9.2 municable disease municable diseases
programmes (hypertension,
diabetes) as per
prevalent guide-
lines

Facility provides Weekly reporting SI/RR 1. Data is submitted

service for Integrated of Confirmed cases manually or through
disease surveillance on form "L" from IHIP (integrated health
program/Integrated laboratory information platform)
ME E9.3
Health Information 2. Collected data is
Platform (IHIP) analysed from BPHU or
other peripheral health
facilities
98 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Systematic collec- SI/RR For surveillance and
tion, analysis and outbreak monitoring
interpretation of
disease specific
data

IPHL provides SI/RR Support specific

support for sur- sampling for air, water,
veillance to other soil/faeces, food, sam-
departments during ples from animals, etc.
outbreak

Area of Concern - F Infection Control

Standard
Facility has infection prevention control program and procedures in place
F1

Facility has function- Infection control RR 1. May be shared with

al infection control committee is con- the main hospital (as
committee and has a stitute at the facility per the MoHFW guide-
ME F1.1 defined procedure to line)
review the infection 2. ICC is approved by
prevention and con- appropriate authority
trol practices

Roles and responsi- RR/SI IPHL staff is aware of

bilities are defined their roles and respon-
and communicated sibility
to its members

ICC meet at period- SI/RR 1. Meetings are con-

ic time interval ducted Monthly, and
minutes maintained
2. Records of Infection
control activities are
maintained
3. Check analysis of
Infection Control
activities is presented
in meeting and actions
are taken

Facility has estab- Regular monitoring RR/OB Like Hand Hygiene

lished procedures for of Standard precau- Audit, BMW practices,
ME F1.2 regular monitoring tions for infection adherence with stan-
of infection control control dard practices of PPE,
practices etc.
 National Quality Assurance Standards for Integrated Public Health Laboratories 99

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
IPHL supports Dis- RR 1. Defined format for
trict hospital and requisition and report-
peripheral facilities ing of HAIs ( CLABSI,
in HAI surveillance CAUTI, SSI, VAP)
2. Report of the sur-
veillance are collated,
analysed and shared
with concerned health
facility

IPHL has defined RR Like SSI, CAUTI, CLAB-

process for collec- SI, VAP
tion of samples for
active HAI surveil-
lance

Feedback is given RR/SI 1. Action plan is shared

to the respective and discussed with
health facility concerned health
facility
2. HAI data is report-
ed to national / state
level data bases as per
guidelines

There is Provision There is procedure RR/SI Hepatitis B, Td, etc.

of Periodic Medical for immunization
ME F1.3
Check-ups and immu- of the staff as per
nization of staff schedule
Periodic medical RR/SI 1. Pre-employment
check-ups of the health check-up is per-
staff formed
2. At least once in a
year
Standard Facility has defined and Implemented procedures for ensuring hand hygiene
F2 practices and antisepsis
Hand washing facil- Availability of hand OB 1. Check for availability
ities are provided at washing Facility at of wash basin near the
point of use Point of Use point of use, ensure
ME F2.1
sink is functional
2. Elbow-operated taps
are available
Facility ensures OB/SI 1. Check for availabil-
availability of anti- ity/ Ask staff if the
septic soap/liquid supply is adequate and
at point of use uninterrupted
100 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Availability and use OB 1. Preferred method,
of alcohol hand rub except when hands
are visibly soiled or
after contact with
patients, contact with
samples, removal of
gloves etc.
2. Contact time, at east
20-30 sec
Display of Hand OB Prominently displayed
washing Instruction above the hand wash-
at Point of Use ing facility , preferably
in Local language
Hand washing sink OB To prevent splashing
is wide and deep and retention of water
enough
Staff is trained and Adherence to steps OB/SI Ask for demonstration
adhere to standard of Hand washing
ME F2.2
hand washing prac-
tices
Staff aware of when OB/SI Ask for 5 moments of
to hand wash hand washing

Facility ensures stan- Facility ensures OB/RR Check for regular

dard practices and uninterrupted and supply
ME F2.3
materials for antisep- adequate supply of
sis antiseptics
Proper cleaning OB 1. Cleaning protocols
of testing area or and appropriate use
surfaces as per of antiseptics use for
procedure cleaning are displayed
in testing areas
2. Various cleaning
/ antiseptic agents
used are reviewed and
approved by infection
control committee
Standard
Facility ensures standard practices and materials for Personal protection
F3
Facility ensures ade- Availability of OB/SI Gloves, Mask, Head
quate personal pro- personal protective caps, Shoe cover,
ME F3.1 tection equipment's equipment at point Apron, N-95 respira-
as per requirements of use tors, Gum boots, Eye
covers, etc.
 National Quality Assurance Standards for Integrated Public Health Laboratories 101

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Facility ensures ad- OB/SI Ask the staff about reg-
equate and regular ular availability of PPE
supply of personal
protective equip-
ment
Staff adhere to stan- No reuse of dis- OB/SI Ask the staff that PPE
dard personal protec- posable gloves and is not reused like cap,
ME F3.2
tion practices Masks Mask, Gloves, Apron,
N-95 respirators etc.
Compliance to SI/OB 1. Check adherence
correct method of with Donning & Doff-
wearing and re- ing practice
moving the PPE 2. Staff do pre-and
post-inspection activity
for PPE usage
Staff is aware about SI/OB like size, fit and prop-
appropriate selec- er selection based
tion of PPE on nature of patient
interaction and po-
tential exposure to
hazard with respect to
area of working, e.g.
face shield or chemical
splash goggles in case
of chemicals
Staff is aware about SI/OB Check whether soiled
appropriate dispos- PPEs are disposed in
al of PPE after use appropriate bins

Standard
Facility has standard Procedures for processing of equipment's and instruments
F4
Facility ensures stan- Decontamination OB/SI/RR Applicable to all equip-
dard practices and and cleaning of ment
materials for decon- equipment is done
ME F4.1
tamination and clean- as per guidelines
ing of instruments
and procedures areas

Cleaning of reus- OB/SI Test tubes, Petri dishes,

able items is done Micropipettes, Glass
as per guidelines slides, racks, etc.
102 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Decontamination of OB/SI Ask staff about how
operating & Proce- they decontaminate
dure surfaces work benches
(Wiping with 0.5%
Chlorine solution)
Facility ensures stan- Disinfection and OB/SI Disinfection by hot air
dard practices and sterilization as oven at 160 degree Cel-
materials for disinfec- appropriate for re- sius for 1 hour or other
ME F4.2
tion and sterilization usable items approved methods as
of instruments and per laboratory proce-
equipment's dure
Autoclave is used OB/SI
for culture media
and other infected
material
Standard Physical layout and environmental control of the laboratory ensures
F5 infection prevention
Layout of the lab is Facility layout OB 1. Separate area for TB
conducive for the ensures separation sample collection
infection prevention of infectious patient 2. Patient with acute
ME F5.1
and control practices at sample collection febrile respiratory
area symptoms are placed
at least 1m away
Respiratory hygiene OB Collection area and
and cough eti- report receiving area
quettes posters are
displayed
Facility layout en- OB Microbiology, Myco-
sures separation of bacteriology (TB) and
each operating area Molecular diagnostic
lab are separated from
rest of the laboratories
through an access con-
trolled entry
Floors and wall OB Look for non-slippery
surfaces are easily floor (or epoxy grout in
cleanable tiles), surfaces should
be smooth & washable,
seamless and imper-
vious with sealed or
welded joints
 National Quality Assurance Standards for Integrated Public Health Laboratories 103

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
No fabrics or OB
carpeting is in the
laboratory
Facility ensures avail- Availability of RR/SI Sodium Hypochlorite,
ability of standard disinfectant as per 70% Isopropyl alcohol,
ME F5.2
materials for cleaning requirement Phenolic compound
and disinfection
Availability of RR/SI Hospital grade phenyl,
cleaning agent as disinfectant detergent
per requirement solution

Staff know how to SI 1. Cleaning material

use cleaning solu- is prepared and used
tion as per manufacturer
guidelines
2. Staff is aware of
validity of prepared
cleaning solution like
hypochlorite
Facility ensures Staff is aware of SI/RR 1. Depend upon the
standard practices blood spill manage- size of the spill, man-
followed for cleaning ment age as per the guide-
and disinfection lines
ME F5.3
2. All the blood spills
are reported, check
the incident reporting
format
Staff is aware of mi- SI/RR As per the guidelines
crobiological spill
management
Three bucket OB Damp mop with deter-
system is used for gent and water fol-
cleaning of lab lowed by disinfection
with 0.5% chlorine
Standard practice of OB Unidirectional mop-
mopping and scrub- ping from inside out
bing are followed
Ensure used mops OB/SI Soak in 0.5% chloring
should be clean solution for 30 min fol-
appropriately lowed by washing with
detergent
104 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Cleaning equip- OB Any cleaning equip-
ment's like broom ment leading to disper-
are not used in lab- sion of dust particles in
oratory air should be avoided
Facility ensures air Negative Pressure OB/RR 1. Check at Highly
quality of high risk in lab infectious area like
area Mycobacteriology &
Virology maintained
negative pressure
-2.5Pa (Particularly for
TB containment lab
-12.5Pa)
2. HEPA filter H13-
ME F5.4
14/99.7% efficiency
with air flow speed
25-35 FPM
3. Humidity 45-65%
4. Check for daily mon-
itoring record of HVAC
parameters and annual
validation report from
third party

Adequate air ex- OB/RR 1. Check separate duct-

changes are main- less AHU is present at
tained Mycobacteriology &
Virology lab
2. Required number of
Air exchange is 12-15
and out of these, six
should be fresh air
exchanges per hour

HVAC system is in OB Other than mycobacte-

place riology and virology

Standard Facility has defined and established procedures for segregation, collection, treatment
F6 and disposal of Bio Medical and hazardous Waste.

Facility ensures Availability of co- OB Check the availability

segregation of Bio lour coded bins and at pre-testing, testing
Medical Waste as per liners at point of and post-testing areas
guidelines waste generation in terms of:
ME F6.1 *Adequate number
*Covered
*Foot operated
* Liners are non-chlo-
rinated
 National Quality Assurance Standards for Integrated Public Health Laboratories 105

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Segregation of An- OB/SI Human Anatomical
atomical and soiled waste, Items contami-
waste in Yellow Bin nated with blood, body
fluids, dressings, cotton
swabs, lab culture,
specimen of microor-
ganism, dishes used for
culture, routine mask
and gowns

Segregation of in- OB/SI Items such as tubing,

fected plastic waste bottles, intravenous
in red bin tubes and sets, syring-
es (without needles
and fixed needle sy-
ringes) and vacutainers
with their needles cut)
and gloves, plastic cul-
ture plates/petric
plates

Display of work OB Pictorial and in local

instructions for language
segregation and
handling of Bio-
medical waste

There is no mixing OB Sample Collection area,

of infectious and testing area
general waste

Check bins are not OB Bins/liners are filled

overfilled up to 2/3rd of its ca-
pacity in sample collec-
tion and testing area

Facility ensures man- Availability of OB At point of use

ME F6.2 agement of sharps as functional needle
per guidelines cutters

Segregation of OB/SI Needles, blades, dis-

sharps waste carded or contaminat-
including Metals in ed metal sharp
white (translucent)
Puncture proof,
Leak proof, tamper
proof containers
106 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Used slides are OB/SI NTEP-slides are
disinfected before disinfected with 5%
disposal phenol/40% phenolic
compound/phenolic
compound

Availability of post SI/OB/RR * Hepatitis B vaccina-

exposure prophy- tion to all staff with oc-
laxis cupational exposure to
blood and body fluids
* Sero-protection is
verified after comple-
tion of the three dose
vaccination series i.e.
antibodies to HBsAg at
least 10mlu/ml
* Fourth dose is offered
if antibody titre below
10mlu/ml
* For HIV, as per NACO
guidelines

There is a mecha- RR/SI All the injuries (nee-

nism to report the dle-stick injury, chem-
injuries or unusual ical or blood splash,
incidences etc.) or unusual inci-
dences are reported to
the supervisor

Staff knows what to SI/RR As per NACO guidelines

do in condition of
needle stick injury
Contaminated and OB/SI Slides, glass culture
broken Glass are plates / petri dishes,
disposed in punc- etc.
ture proof and leak
proof box/ contain-
er with Blue colour
marking
Facility ensures Discarded samples OB/SI Pre-treat to sterilize
transportation and are pre-treated with non-chlorinated
disposal of waste as before disposal chemicals onsite , as
per prevalent guide- per WHO guidelines
ME F6.3
lines on safe management
of waste from HCFs,
thereafter sent for
incineration
 National Quality Assurance Standards for Integrated Public Health Laboratories 107

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Disposal of biomed- OB/SI As per latest BMW
ical waste as per rules
guidelines

Transportation of OB/SI Check biohazard signs

bio medical waste are displayed on bins
is done in close con- as well as trolley used
tainer/trolley for waste transporta-
tion

Storage & Trans- OB/SI Check storage and

portation e-waste transportation of
e-waste to recyclers
done as per CPCB
guidelines

Facility ensures Disinfection of OB/SI as per the standards of

management of liquid liquid waste before liquid waste-current
ME F6.4 waste as per preva- disposal BMW guidelines
lent
guidelines

Availability of OB/SI check lab is well con-

functional effluent nected to ETP
treatment plant

Area of Concern - G Quality Management

Standard The facility has defined mission, vision, values, quality policy and objectives,
G1 and prepares a strategic plan to achieve them

Facility has defined Vision and mission RR/SI As per state and na-
mission & vision statement have tional health policy
ME G1.1 statement been defined ade-
quately May be shared with the
main hospital

Facility has defined Core values of the RR/SI Check if core values of
core values of the lab are defined organization such as
organization non-discrimination,
transparency, ethical
clinical practices, com-
ME G1.2
petence etc have been
defined.

May be shared with the

main hospital
108 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Facility has defined Quality Policy is de- RR/SI Check quality policy
Quality policy, which fined and approved of the facility has been
is in congruency with defined in consultation
the mission & vision with hospital staff and
of facility duly approved by the
head of the facility. Also
ME G1.3 check Quality Policy
enables achievement of
mission of the facility
and health department

May be shared with the

main hospital

Facility has defined SMART Quality RR/SI Check short term valid
quality objectives Objectives have quality objectivities
to achieve mission, framed have been framed
vision and quality addressing key quality
policy issues in each depart-
ME G1.4 ment and cores ser-
vices. Check if these
objectives are Specific,
Measurable, Attainable,
Relevant and Time
Bound.

Mission, Vision, Check of staff is RR/SI/OB Interview with staff for

Values, Quality policy aware of Mission , their awareness. Check
and Objectives are Values, Quality Poli- if Mission Statement,
ME G1.5 effectively commu- cy and objectives Core Values and Qual-
nicated to staff and ity Policy is displayed
users of services prominently in local
language at Key Points

Facility prepares stra- Check if plan for im- RR/SI Verify with records
tegic plan to achieve plementing quality that a time bound
mission, vision, policy and objec- action plan has been
quality policy and tives have prepared prepared to achieve
objectives quality policy and ob-
ME G1.6
jectives in consultation
with hospital staff .
Check if the plan has
been approved by the
hospital management
 National Quality Assurance Standards for Integrated Public Health Laboratories 109

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Facility periodically Check time bound RR/SI Review the records
reviews the progress action plan is being that action plan on
of strategic plan to- reviewed at regular quality objectives
wards mission, vision, time interval being reviewed at least
policy and objectives once in month by de-
partmental in charges
ME G1.7
and during the quality
team meeting.
The progress on quali-
ty objectives have been
recorded in Action Plan
tracking sheet
Standard
The facility has established organizational framework for quality improvement
G2
The facility has a Quality circle has RR/SI Check if quality circle is
ME G2.1 quality team in place been formed in the formed and its func-
Laboratory tional

There is a desig- RR/SI

nated nodal person
for coordinating
quality activities
Team members are RR/SI Check staff is aware of
aware of their roles roles and responsibili-
and responsibilities ties in terms of quality
activity in the facility

The facility reviews Quality circle meets RR/SI Check the records
quality of its services monthly and review
ME G2.2
at periodic intervals the quality activi-
ties

Minutes of meeting RR/SI 1. Results for internal

are recorded /External assessment
are discussed in the
meeting
2. Facility Quality indi-
cators are reviewed in
meeting
3. Action taken report
is reviewed
4. Follow up actions
from previous meet-
ings are reviewed
110 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Standard The facility has documented, implemented and updated Standard Operating
G3 Procedures for all key processes and support services
Laboratory standard The facility has doc- RR/SI
operating procedures umented Quality
ME G3.1
are available system manual

The facility has doc- RR/SI

umented lab safety
manual

Standard operating RR/SI

procedure for the
lab has been pre-
pared and approved

Current version of RR/SI

SOP are available
with process owner

Standard Operating Laboratory has RR/SI Haematology, Microbi-

Procedures adequate- documented pro- ology, Cytology, Bio-
ly describes process cess for Collection/ chemistry, Histopathol-
ME G3.2
and procedures receiving, handling ogy, Clinical Pathology,
and transportation etc.
of primary sample

Laboratory has doc- RR/SI Haematology, Microbi-

umented process ology, Cytology, Bio-
on acceptance and chemistry, Histopathol-
rejection of primary ogy, Clinical Pathology,
samples etc.

Laboratory has doc- RR/SI Haematology, Microbi-

umented procedure ology, Cytology, Bio-
on receipt, label- chemistry, Histopathol-
ling, processing and ogy, Clinical Pathology,
reporting of prima- etc.
ry sample

Laboratory has RR/SI Haematology, Microbi-

documented pro- ology, Cytology, Bio-
cedure on receipt, chemistry, Histopathol-
labelling, process- ogy, Clinical Pathology,
ing and reporting of etc.
primary sample for
emergency cases
 National Quality Assurance Standards for Integrated Public Health Laboratories 111

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Laboratory has doc- RR/SI Haematology, Microbi-
umented system for ology, Cytology, Bio-
storage of examined chemistry, Histopathol-
samples ogy, Clinical Pathology,
etc.

Laboratory has doc- RR/SI Haematology, Microbi-

umented system for ology, Cytology, Bio-
testing and valida- chemistry, Histopathol-
tion of samples ogy, Clinical Pathology,
etc.

Laboratory has doc- RR/SI Quantitative and Qual-

umented system for itative
repeat tests due to
analytical failure

Laboratory has doc- RR/SI Quantitative

umented biological
reference intervals

Laboratory has RR/SI Haematology, Microbi-

documented critical ology, Cytology, Bio-
reference values chemistry, Histopathol-
and procedure for ogy, Clinical Pathology,
immediate report- etc.
ing of results

Laboratory has RR/SI Haematology, Microbi-

documented proce- ology, Cytology, Bio-
dure for release of chemistry, Histopathol-
reports including ogy, Clinical Pathology,
details of who may etc.
release result and
to whom

Laboratory has RR/SI Haematology, Microbi-

documented inter- ology, Cytology, Bio-
nal quality control chemistry, Histopathol-
system to verify the ogy, Clinical Pathology,
quality of results etc.

Laboratory has doc- RR/SI Haematology, Microbi-

umented External ology, Cytology, Bio-
Quality assurance chemistry, Histopathol-
program ogy, Clinical Pathology,
etc.
112 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Laboratory has doc- RR/SI Haematology, Microbi-
umented procedure ology, Cytology, Bio-
for maintenance chemistry, Histopathol-
and calibration of ogy, Clinical Pathology,
equipment etc.
Laboratory has RR/SI Haematology, Microbi-
documented the ology, Cytology, Bio-
Standard Operat- chemistry, Histopathol-
ing Procedure for ogy, Clinical Pathology,
maintaining the etc.
confidentiality of
reports
Work instruction/ RR/OB
clinical protocols
are displayed
Laboratory has doc- RR/SI Haematology, Microbi-
umented procedure ology, Cytology, Bio-
for validation of chemistry, Histopathol-
results of reagents, ogy, Clinical Pathology,
stains, media and etc.
kits etc. wherever
required
Laboratory has RR/SI Haematology, Microbi-
documented system ology, Cytology, Bio-
for storage, retain- chemistry, Histopathol-
ing and retrieval of ogy, Clinical Pathology,
laboratory records, etc.
primary sample,
Examination sam-
ple and reports of
results
Laboratory has doc- RR/SI Haematology, Microbi-
umented system of ology, Cytology, Bio-
resolution of com- chemistry, Histopathol-
plaints and other ogy, Clinical Pathology,
feedback received etc.
from stakeholders
Laboratory has doc- RR/SI Haematology, Microbi-
umented procedure ology, Cytology, Bio-
for internal audits chemistry, Histopathol-
ogy, Clinical Pathology,
etc.
 National Quality Assurance Standards for Integrated Public Health Laboratories 113

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Laboratory has RR/SI Haematology, Microbi-
documented proce- ology, Cytology, Bio-
dure for purchase chemistry, Histopathol-
of External services ogy, Clinical Pathology,
and supplies etc.

The staff is trained Check staff is a RR/SI Haematology, Mi-

and aware of the aware of relevant crobiology, Cytology,
standard procedures part of SOPs Biochemistry, Histopa-
ME G3.3 written in the SOPs thology, Clinical Pa-
thology, etc. in terms of
pre-testing, testing and
post-testing activities

The facility ensures Hospital has estab- RR/SI (a) Check availability
documented policies lished procedure of requisition forms &
and procedures are for drafting, re- formats for developing
appropriately ap- viewing, approving the required docu-
proved and controlled the Quality Man- ments. A system in
agement systems place to draft, review
documents the QMS documents
ME G3.4 and approval to use the
documents is given by
appropriate authority.
(b) Check the de-
tailed procedure is
mentioned in Quality
Improvement manual
and followed

Hospital has estab- RR/SI (a) Check all the QMS

lished procedure documents and re-
for controlling & cords (both internal
updating the QMS & external origin) are
documents controlled.
(b) Check the docu-
ments are updated as
and when required
114 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method

Hospitals has RR/SI (a) Check system in

established system place to retention and
to provides identi- retrieval the all QMS
fication number to documents
the QMS documents (b) Check all docu-
and records ments have title, ef-
fective date, reference
number etc and signed
by competent authority
(C) Check the system is
meticulously followed
in all departments

Master list of the RR/SI (a) Check master list of

documents and re- documents and records
cords is available is maintained.
(b) Check the list is
updated.

Standard The facility has established internal & external quality assurance programmes
G4 for laboratory functions

The facility has estab- Routine monitoring RR/SI 1. check the daily
lished internal quality of lab and related rounds are taken using
assurance programs areas is done by daily round checklist
ME G4.1
for lab designated person 2. Corrections and
corrective actions are
taken immediately

Internal audit plan RR/SI 1. Check for annual au-

and schedule is pre- dit plan as per defined
pared to conduct intervals
internal assessment 2. Check internal audit
of the lab schedule of last inter-
nal assessment
3. Check process is at
place to communicate
about conduct of in-
ternal assessment and
their results
 National Quality Assurance Standards for Integrated Public Health Laboratories 115

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Person is identified RR/SI 1. Person is trained to
to conduct internal coordinate the internal
and external assess- and external assess-
ment ments' activities
2. Person is aware of
their roles and respon-
sibilities before, during
and after the internal
and external assess-
ments
Internal assessors RR/SI 1. Internal assessors
are identified are trained to use the
NQAS checklist
Internal assessment RR/SI 1. Internal assessment
is done using NQAS is done at periodic
checklist interval
2. Records of internal
assessment are main-
tained
Non-compliances RR/SI Check the non-compli-
are enumerated ances are presented &
and recorded discussed during quali-
ty team meetings
The facility has estab- State assessment is RR/SI 1. Records of state
lished external quality done using NQAS assessment are main-
ME G4.2
assurance programs checklist tained
for lab
Non-compliances RR/SI Check the non-compli-
are enumerated ances are presented &
and recorded discussed during quali-
ty team meetings
Actions are planned Check action plans RR/SI Randomly check the
to address gaps ob- are prepared and details of action, re-
served during quality implemented as per sponsibility, time line
ME G4.3 assurance process internal/state/na- and feedback mecha-
tional/surveillance nism
assessment record
findings
Planned actions are Check PDCA or RR/SI Check actions have
implemented through relevant quality been taken to close the
Quality Improvement method is used to gap. It can be in form of
ME G4.4
Cycles (PDCA) take corrective and action taken report or
preventive action Quality Improvement
(PDCA) project report
116 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Standard
The facility seeks continual improvement by practising Quality method and tools
G5
The facility uses Basic quality im- RR/SI PDCA & 5S
method for quality provement method
ME G5.1
improvement in ser-
vices
Advance quality im- RR/SI Six sigma, lean
provement method

The facility uses tools 7 basic tools of RR/SI Minimum 2 applicable

for quality improve- Quality tools are used (Histo-
ment in services gram, Control Chart,
ME G5.2
Stratification, Pareto
Chart, Scatter Diagram,
Fish bone, Check sheet)
The facility maps its key processes and seeks to make them more efficient by reducing
Standard
non
G6
value adding activities and wastages
The facility maps its Process mapping of RR/SI like delayed reports,
critical processes critical processes critical alerts, work
ME G6.1
done flow of the technical
areas
The facility identifies Non value adding RR/SI Non value adding ac-
non value adding activities are iden- tivities (MUDAS), time
ME G6.2
activities / waste / tified spent in non-value
redundant activities added activities
Facility takes correc- Processes are RR/SI
ME G6.3 tive action to improve rearranged as per
the processes requirement
Standard The facility has defined, approved and communicated Risk Management
G7 framework for existing and potential risks
Risk Management Check for availabil- RR/SI 1. CHP includes SOP
framework has been ity of Laboratory on control measures
defined including Safety Chemical to reduce the risk of
context, scope, objec- Hygiene Plan (CHP) exposure to hazardous
tives and criteria to protect the staff material e.g. women of
childbearing age
ME G7.1 2. Protocols for precau-
tions to be followed in
case of any accident/
emergency is available
and displayed appro-
priately
 National Quality Assurance Standards for Integrated Public Health Laboratories 117

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
3. Frequency of peri-
odic medical check-up
for occupationally
acquired diseases
4. Provision for ad-
ditional personnel
protection for workers
dealing with reagents
& material with carcin-
ogens, toxins, chemi-
cals, etc.
5. Specific measures
taken to ensure proper
and adequate perfor-
mance of protective
equipment, such as
fume hoods.
Risk Management Check if responsi- RR/SI Review risk man-
framework defines bilities for identify- agement framework
the responsibilities ing and managing delineation of respon-
for identifying and risk has been de- sibilities amongst staff
managing risk at each fined and commu- for identifying the risk
ME G7.2 level of functions nicated in their work area and
their management.
Verify with the staff
members if they are
aware of their respon-
sibilities
Risk Management Check if process of RR/SI Review risk manage-
Framework includes reporting risks and ment framework for
process of reporting hazards have been process of reporting
ME G7.3
incidents and poten- defined incidents including
tial risk to all stake- near miss and potential
holders risks
A comprehensive list Check if list of RR/SI 1. Review risk man-
of current and po- existing and poten- agement framework in-
tential risk including tial risk have been cludes list of identified
potential strategic, prepared current and potential
regulatory, operation- risks. These may
al, financial, environ- include hazard safety,
mental risks has been strategic, financial,
ME G7.4
prepared statutory, operational
and environmental
risks.
2. The laboratory
prioritize and act on
identified risks.
3. Actions taken to
118 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
address risks is based
on potential impact on
laboratory examina-
tion results, as well as
patient and personnel
safety

Modality for staff Check training on RR/SI Verify with the training
training on risk man- risk management records. Training and
agement is defined has been providesd information impart-
ME G7.5 to key staff mem- ed to the staff on the
bers hazards of chemicals
in their work areas and
related information.

Risk Management Check risk manage- RR/SI Check with the records
Framework is re- ment framework is that quality team/ risk
viewed periodically reviewed at least management commit-
ME G7.6
once in a year tee reviews the frame-
work at least once in a
year

Standard The facility has established procedures for assessing, reporting, evaluating
G8 and managing risk as per Risk Management Plan

The facility has Risk management RR/SI Check if a valid risk

defined and commu- plan has been pre- management plan is
nicated Risk Manage- pared and approved available at the facility
ment framework for by the designat-
ME G8.1
existing and potential ed authority and
risks there is a system of
updating it at least
once a year

Risk Management RR/SI Check if risk manage-

Plan has been ment plan has been
effectively commu- communicated to all
nicated to all the stake holders
staff, and as well as
relevant external
stakeholders

Risk assessment RR/SI Check if risk assess-

criteria and check- ment checklist is avail-
list for assessment able with stakeholders
have been defined
and communicated
to relevant stake-
holders
 National Quality Assurance Standards for Integrated Public Health Laboratories 119

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Periodic assessment Check if periodic RR/SI Verify with the assess-
for Physical and Elec- assessment of Phys- ment records. Compre-
trical risks is done as ical and electrical hensive of physical and
ME G8.2
per defined criteria safety risk is done electrical safety should
using the risk as- be done at least once in
sessment checklist three month
Periodic assessment Check periodic as- RR/SI 1. Identify the risk
for Chemical and Bio- sessment of chem- group category
logical hazard is done ical Hazard is done 2. Check comprehen-
as per defined criteria periodically sive assessment of both
ME G8.3
manmade and natural
chemical hazardous
event is done at least
once in year
Check periodic as- RR/SI 1. Identify the risk
sessment of Biolog- group category
ical Hazard is done 2. Check comprehen-
periodically sive assessment of bi-
ological hazard is done
at least once in year
Periodic assessment Check periodic as- RR/SI Check comprehensive
for potential disasters sessment of poten- assessment of both
including fire is done tial disaster is done manmade and natural
ME G8.4
as per defined criteria periodically potential disaster is
done at least once in
year
Check periodic as- RR/SI Verify with the records.
sessment of testing A comprehensive risk
area and staff safety assessment of all test-
risk is done using ing processes should
defined checklist be done using pre-de-
periodically fined criteria at least
once in three month.
Risks identified are Check if various RR/SI Risk identified should
analysed evaluated risks identified be listed and evaluated
and rated for severity during the risk as- for their security and
sessment proceeds frequency for occur-
are formally evalu- rence. A risk severity
ME G8.5
ated score / grade should be
given to each risk iden-
tified and according
gaps should be rated.
Verify with the records
120 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Identified risks are Check if risk have RR/SI Check risks are pri-
treated based on se- high severe are oritized base on their
ME G8.6
verity and resources prioritised. severity rating. Verify
available with the records
A risk register is Check if a risk regis- RR/SI Check hospital admin-
maintained and up- ter is maintained istration/ responsible
dated regularly to re- committee maintains a
cord identified risks, risk register which risk
their severity and identified, their sever-
ME G8.7 actions to be taken ity, action to be taken
to mitigate risk and
follow up action
Check for risk regis-
ter has been updated
timely
Stan-
The facility has established system for patient and employee satisfaction
dards G9
Patient and Employee There is a designat- RR/SI
Satisfaction surveys ed person to co-or-
ME G9.1
are conducted at peri- dinate satisfaction
odic intervals survey
Patient feedback RR/SI/PI 1. Form is available in
is taken at regular local language
intervals 2. Sample is adequate

May be shared with the

main hospital
There is procedure RR/SI At least once in a year
to conduct em-
ployee satisfaction
survey at periodic
intervals
A mechanism is RR/SI To correlate the ac-
in place to take curacy of results with
feedback from the clinical findings at least
clinicians once in 6 months
The facility analyses There is procedure RR/SI 1. Patient feedback is
the patient feed back for compilation of analysed on monthly
ME G9.2
and do root cause patient feedback basis
analysis forms
Root cause analysis RR/SI
is done for low per-
forming attributes
 National Quality Assurance Standards for Integrated Public Health Laboratories 121

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
Results of Patient RR/SI
satisfaction survey
are recorded and
disseminated to
concerned staff
There is procedure RR/SI Root cause analysis is
for analysis of Em- done
ployee satisfaction
survey
There is procedure RR/SI Root cause analysis is
for analysis of clini- done and action plan is
cian's feedback prepared
The facility prepares There is proce- RR/SI
the action plans for dure for preparing
ME G9.3 the areas of low satis- Action plan for
faction improving patient
satisfaction
There is procedure RR/SI
to take corrective
and preventive
action
There is procedure RR/SI
for preparing action
plan for improving
employee satisfac-
tion
Area of Concern - H Outcome
Standard The facility measures Productivity Indicators and ensures compliance
H1 with State/National benchmarks
Facility measures pro- No. of Haematology RR Within the hospital and
ME H1.1 ductivity Indicators test done per 1000 from peripheral health
on monthly basis population facilities
No. of Biochemistry RR Within the hospital and
test done per 1000 from peripheral health
population facilities
No. of Serology RR Within the hospital and
test done per 1000 from peripheral health
population facilities
No. of Clinical RR Within the hospital and
Pathology test done from peripheral health
per 1000 popula- facilities
tion
122 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
No. of histopathol- RR Within the hospital and
ogy & cytology from peripheral health
test done per 1000 facilities
population

No. of microbiology RR Within the hospital and

test done per 1000 from peripheral health
population facilities

Percentage of lab RR The time period for

test done at night night time may be in-
cluded as 8PM to 8 AM

The facility endeav- Trends analysis RR

ours to improve its of Indicators is
ME H1.2 productivity indi- done at Periodic
cators to meet the Intervals
benchmark

Standard The facility measures Efficiency Indicators and ensure compliance with State/National
H2 benchmarks

Facility measures VIS/Z scores or RR Biochemistry & Hae-

ME H2.1 efficiency Indicators equivalent of lab matology
on monthly basis

Percentage of test RR
failed in EQAS/PT/
any other

No of IQC failures RR

Turnaround time RR
for emergency lab
investigations

Turnaround time RR
for routine lab
investigations

Turnaround time RR
for receiving the
samples from pe-
ripheral labs in case
of emergency

Lab test done per RR

technician

Downtime of RR
critical equipment
breakdown
 National Quality Assurance Standards for Integrated Public Health Laboratories 123

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
The facility endeav- Trends analysis RR
ours to improve its of Indicators is
ME H2.2 efficiency indicators done at Periodic
to meet the bench- Intervals
mark

Standard The facility measures Clinical Care & Safety Indicators and ensure compliance with
H3 State/National benchmarks

Facility measures % of critical values RR Within the hospital and

Clinical Care & Safety reported within one from peripheral health
ME H3.1
Indicators on monthly hour facilities
basis

No of missed criti- RR
cal alerts

No of adverse RR Especially haematoma,

events per thou- syncope, infection,
sand patients nerve damage, etc.

Number of sharp RR
exposure or other
occupational inju-
ries reported

Test demography RR Proportion of Haema-

tology, biochemistry,
serology, Microbiol-
ogy, cytology, clinical
pathology

Report correlation RR Proportion of lab

rate report co related with
clinical examination

Proportion of false RR For Rapid diagnostic

positive /false neg- Kit test, as per the ap-
ative plicability

Percentage of RR
P-forms going into
L-forms

Percentage of RR
Outbreaks detected
by routine labora-
tory-based surveil-
lance
124 National Quality Assurance Standards for Integrated Public Health Laboratories

Assess-
Refer- Compli-
Measurable Element Checkpoint ment Means of Verification
ence No. ance
Method
The facility endeav- Trends analysis RR
ours to improve its of Indicators is
ME H3.2 clinical care & safety done at Periodic
indicators to meet the Intervals
benchmark
Standard The facility measures Service Quality Indicators and ensure compliance with
H4 State/National benchmarks
Facility measures Ser- Waiting time at RR Time motion study/
ME H4.1 vice Quality Indica- sample collection turnaround time
tors on monthly basis area
Waiting time at re- RR
port receiving area

Percentage of re- RR Haemolysis, specimen

jected samples with illegible missing
paperwork or labels,
inadequate sample vol-
ume, improper trans-
portation
percentage of RR
contaminated blood
cultures
Patient Satisfaction RR
Score
Number of stock RR
out incidences of
reagents & consum-
ables
No of rapid diag- RR
nostic kits discard-
ed due to unsatis-
factory reasons
The facility endeav- Trends analysis RR
ours to improve of Indicators is
ME H4.2 its service quality done at Periodic
indicators to meet the Intervals
benchmark
 National Quality Assurance Standards for Integrated Public Health Laboratories 125

List of Contributors
Sl. No. Name Designation
1. Shri Apurva Chandra Secretary, Health & FW, MoHFW
2. Ms Aradhana Patnaik Additional Secretary & Mission Director (NHM), MoHFW
3. Maj Gen (Prof) Atul Kotwal Executive Director, NHSRC
4. Dr. Neha Garg Director, NHM-II, MoHFW
5. Dr. J N Srivastava Advisor, QPS, NHSRC
6. Dr. Ashoke Roy Ex Director, RRC-NE
7. Dr. Raj Prabha Moktan Director, RRC-NE
8. Dr. Kaustubh S. Giri Deputy Secretary - NHM
9. Dr. Tamanna Sharma Lead Consultant, MoHFW
10. Dr. Anil Kumar Gupta Lead Consultant, MoHFW
11. Ms Stella Grace Consultant, MoHFW
Expert Group Members
1. Dr (Col) Jyoti Kotwal Prof & HoD, Dept. of Haematology and Clinical Pathology, Sir
Gangaram Hospital, New Delhi
2. Dr. Naresh Goel DDG (LS & IEC), NACO(Ret.)
3. Wg Cdr Smita Rani HOD, Pathology, AFCME
4. Dr. Purva Mathur Prof. Laboratory Medicine, JPN Apex Trauma Centre, AIIMS,
New Delhi
5. Dr. Sanjay Mishra Regional Director Health Services, Jabalpur Division, MP
6. Dr. Renu Gupta Assistant Professor, Microbiology, IHBAS Hospital, Delhi
7. Dr. Abhyuday Shakti Tiwari Nodal Officer HAMAR Lab, OSD-NHM, Chhattisgarh
8. Dr. Kailash Chand Jat Laboratory Head, DH Sikar, Rajasthan
9. Dr. Juhee Chandra HoD, Dept. of Clinical Pathology, Jeevan Anmol Hospital, New
Delhi
10. Dr. Mayank Dwivedi Public Health Specialist, Laboratory Advisor, CDC
11. Dr. Indranil Roy Public Health Specialist, Laboratory Advisor, CDC
12. Dr. Ranjan Kumar Chaudhary Advisor, HCT
13. Ms. Mona Gupta Advisor, HRH-HPIP
14. Dr. K Madan Gopal Advisor, PHA
15. Dr. Deepika Sharma Lead Consultant, QPS, NHSRC
16. Dr. Arpita Agrawal Sr Consultant, QPS, NHSRC
17. Dr. Naveen Kumar Consultant, QPS, NHSRC
18. Dr. Annapoorna K N Consultant, QPS, NHSRC
National Health Systems Resource Centre (NHSRC) and RRC-NE team
1. Mr. Anjaney Shahi Lead Consultant, HCT
2. Ms. Vinny Arora Lead Consultant, Certification Unit
126 National Quality Assurance Standards for Integrated Public Health Laboratories

3. Dr. Chinmayee Swain Sr Consultant, QPS

4. Dr. Anup Basistha Ex Sr Consultant, QPS, RRC-NE
5. Dr. Neeraj Gautam Sr. Consultant, Certification Unit
6. Dr. Surbhi Sethi Sr. Consultant, ED Secretariat
7. Dr. Abhay Dahiya Consultant, QPS
8. Dr. Vineeta Dhankhar Consultant, QPS
9. Mr. Anand Yadav Consultant, QPS
10. Dr. Siddhi Dhond Consultant, QPS
11. Dr. Ratan Shekhawat Consultant, QPS
12. Dr. Deepika Gaur Consultant, Certification Unit
13. Ms. Rachna Kumari Consultant, Certification Unit
14. Dr. Amrita Rastogi Consultant, Certification Unit
15. Ms. Sonia Verma Consultant, Certification Unit
16. Ms. Nasrain Nikhat Khan Consultant, Drugs & Logistics
17. Mr. Gulam Rafey Consultant, Drugs & Logistics
18. Dr. Ajay Kumar Arya Consultant, QPS, RRC-NE
19. Dr. Ravikar Singh Consultant, QPS, RRC-NE
20. Mr. Ranjith R Menon Health Service QA Specialist, ADB
21. Dr. Priyanka Kumari Consultant, HRH-HPIP
22. Dr. Harioum Sharma Consultant, PHA
23. Dr. Syeda Tahseen Kulsum Consultant, CDC
24. Dr. Aman Sharma Junior Consultant, QPS
25. Ms. Sowjanya Jarugula Junior Consultant, Certification Unit
26. Dr. Pavitra Sangwan Short Term Jr Consultant, Certification Unit
27. Dr Richa Verma Ext. Consultant, QPS
28. Ms. SL Chochoi Ext. Consultant, QPS, RRC-NE
29. Dr. Tanya Garg Fellow, QPS
30. Dr. Neha Ninawe Fellow, QPS
31. Ms. Sherin Fellow, Certification Unit
32. Ms Tripti Gupta Fellow, Certification Unit
33. Mr. Brajaraj Tripathy Fellow, Drugs & Logistics
34. Ms. Indu Suryawanshi Secretarial Assistant, QPS
 National Quality Assurance Standards for Integrated Public Health Laboratories 127

Bibliography
1. Operational Guidelines for Improving Quality in Public Healthcare Facilities, 2021

2. Operational Guidelines for Pradhan Mantri Ayushman Bharat Health Infrastructure Mission, October 2

3. Assessor’s Guidebook for Quality Assurance in District Hospital,2020

4. Free Diagnostics Service Initiative (FDSI),2015 & 2019 Ministry of Health and Family Welfare,
Government of India

5. Guidelines on Integrated Public Health Laboratories, 2022, Ministry of Health and Family Welfare,
Government of India

6. ICMR Guidelines for Good Clinical Practices (GCLP) 2021

7. WHO Handbook Good Laboratory Practices (GLP), Quality practices for regulated non -clinical research
and development.

8. Indian Public Health Standards, 2022, Ministry of Health and Family Welfare, Government of India

9. ISO 15189: 2022 Medical laboratories - Requirements for quality and competence

10. LIFE (Laboratory Improvement for Excellence) National initiative for District Hospital Laboratory
Quality Improvement.

11. Manual for Laboratory Diagnosis of common epidemic prone disease for District Public Health is a
Laboratories, IDSP, NCDC

12. Manual of Laboratory Techniques for District Public Health Laboratories, NICD, DGHS, GoI

13. NABL 112 document June 2019-Specific Criteria for Accreditation of Medical Laboratories

14. WHO guidelines on drawing blood: best practices in phlebotomy

15. National guidelines for infection prevention and control in healthcare facilities, National Centre for
Disease Control, 2020

16. Laboratory Safety Guidance by Occupational Safety and Health Administration U.S. Department of
Labor 2011

17. Implementation Guidelines for E-Waste (Management) Rules, 2016

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130 National Quality Assurance Standards for Integrated Public Health Laboratories