operational guidelines for regional coordinators

PROGRAM FOR STRENGTHENING INTER-SECTORAL

ORDINATION FOR PREVENTION AND CONTROL OF

ZOONOTIC DISEASES

OPERATIONAL GUIDELINES FOR REGIONAL COORDINATORS

NATIONAL CENTRE FOR DISEASE CONTROL (Directorate General of Health Services) 22-SHAM NATH MARG, DELHI - 110 054 Ministry of Health and Family Welfare

Govt of India

Operational guidelines for Regional Coordinators

CONTENTS 1. Introduction ................................................................................................................................................... 3 2. Zoonoses Global Scenario .............................................................................................................................. 3 3 Program for Strengthening Intersectoral Coordination for Prevention and Control of Zoonotic Diseases ...... 6 4 Objectives ............................................................................................................................................................. 6 5 Institutional Mechanism ....................................................................................................................................... 6 6 Rationale for regional coordinator under ISC ....................................................................................................... 6 7 The role of the Nodal Agency – National Centre for Disease Control .................................................................. 7 8 Activities envisaged by Regional Coordinators ..................................................................................................... 7 9 Expected outcomes from Intersectoral Coordination (RC)................................................................................... 9 10 Financial Guidelines: ............................................................................................................................................. 9 11 Recording, Reporting and Monitoring: ............................................................................................................... 10 12 Performance Parameters- .................................................................................................................................. 11 13 Annexure -1 ........................................................................................................................................................ 12 14 Annexure - 2 ....................................................................................................................................................... 14 15 Annexure -3 ........................................................................................................................................................ 15 14 Utilisation Certificate format- Annexure -4 ........................................................................................................ 17

2 Program For Strengthening Inter-Sectoral Ordination For Prevention And Control Of Zoonotic Diseases


1. INTRODUCTION

Zoonosis occurs throughout the world transcending the natural boundaries. Their important effect on

global economy and health is well known, extending from the international movement of animals and

importation of diseases to bans on importation of all animal products and restrictions on other

international trade practices. So, zoonosis no longer is solely a national/local problem, they have a global

impact. Over 30 new pathogens of man have been discovered in the last three decades, 75% of these are

shared with lower animals and a number of other diseases previously thought to be limited to man have

now been found to be zoonosis. Recent outbreaks of Severe Acute Respiratory Syndrome (SARS), Avian

Influenza and Ebola have shown once again the potential of microorganism from animal reservoirs to

adapt to human hosts. During the past decade, many previously unknown human diseases have emerged

from animal reservoirs, from agents such as Nipah virus, West Nile virus and Hantan virus. More than 300

zoonosis of diverse aetiology are now recognized. Among these, particularly important are Anthrax,

Plague, Brucellosis, Bovine Tuberculosis, Leptospirosis, Salmonellosis, spotted fever caused by

Rickettsiae, rabies, several common arthropod borne viral infections (Arbo viral infection like Japanese

Encephalitis), and certain parasitic diseases, especially Cysticercosis, Hydatid Disease, Trypanosomias

and Toxoplasmosis. Several factors are known to favour emergence and spread of zoonotic diseases.

These include microbiological adaption, ecological changes environment, globalization of agriculture, food

production and trade and human behaviour factors.

2. ZOONOSES GLOBAL SCENARIO

Historically, zoonotic diseases had a tremendous impact on the evolution of man, especially those

cultures and societies that domesticated and bred animals for food and clothing. Zoonoses are among the

most frequent and dreaded risk to which mankind is exposed. Zoonoses occur throughout the world

transcending the natural boundaries. Zoonotic diseases have an influence over the global economy and

health, since international movement of live animals could cause importation of diseases to the country,

ban on importation of live animal and animal products therefore leading to restrictions on international

trade practices. So, a zoonotic disease is no longer solely a national problem. For effective prevention and

control of zoonotic disease surveillance at global level is pertinent. With recognition of inter-relationships between countries, the internationalization of control

efforts have become more relevant to technical, economic and social areas. Controlling zoonotic disease is

the top priority for international agencies and formulating control strategies as per the health and

economic problem specific to each region. Over the last two decades, there has been considerable change

in the occurrence of certain importance zoonotic diseases in different parts of the world, due to socio

ecological changes such as urbanization, industrialization and diminishing proportion of people working

in the so-called primary sector. In the future, the world could be confronted with new challenges due to constant interference

with the ecology. Many different determinants contribute to the emergence of new zoonotic agents, and it

is rare that these factors act singly. Among the forces that shape their emergence are human

demographics and behaviour; technology, industry, and agriculture; economic development and land use;

international travel, commerce, microbial adaptation and change and breakdown of public health

measures. Most of the infections in man that have been discovered in the last twenty years were shared

with animal population. Similarly numerous diseases previously thought to be limited to man have now

been identified as zoonotic. Reference could be made to various types of Encephalitis, Eosinophilic

Meningitis, Capillariasis, Anisakiasis, Lyme disease, Monkey pox Diseases in humans, Lassa Fever,

Marburg disease and Ebola for which an animals were linked to.



Emerging and Re-emerging Infections: 1996 – 2016

Given the obvious link between human health and pathogens that circulate in domestic animals

and wildlife, we must be alert to pathogen flow in any of these areas. The unique dynamic interaction between the humans, animals, and pathogens, sharing the same environment should be considered within the

“One Health” approach, which dates back to ancient times. Among zoonoses, certain zoonotic diseases are

recognized as particularly important and are prioritized. These diseases are Anthrax, Plague, Brucellosis,

Bovine Tuberculosis, Leptospirosis, Salmonellosis, Spotted Fever caused by Rickettsiae, Rabies, several

common arthropod borne viral infections (arboviral infection), and certain parasitic diseases, such as

Cysticercosis, Hydatid Disease, Trypanosomiasis and Toxoplasmosis.

2.2 India Scenario

Classical infectious diseases like rabies and plague are well known for centuries, are zoonotic in

nature and have not been eradicated despite major efforts. Some of the zoonotic diseases like plague have

re-emerged with three outbreaks in a span of ten years. India is experiencing rapid urbanisation,

industrialisation, increasing incomes and changing food preferences raising demands for animal source

proteins, leading to a larger section of the workforce being in close contact with livestock, making a wider

section of the population extremely susceptible to zoonotic diseases. The zoonotic diseases of major

public health importance in India are Leptospirosis, Plague, Rabies, Anthrax, Scrub Typhus, Brucellosis,

Kyasanur Forest Disease, spotted fever caused by Rickettsiae and parasitic diseases like Cysticercosis,

Hydatid disease, Trypanosomiasis and toxoplasmosis. Japanese encephalitis and Leptospirosis outbreaks

have been reported year after year in our country. Recently, new zoonotic entities such as Crimean Congo Heamorrhagic fever, Nipah virus infection

and Avian Influenza & H1N1 Influenza have stirred the public health machinery. In addition to existing

zoonoses, country faces potential threat of exotic zoonotic infection viz Yellow Fever, Hanta virus

infection, Rift Valley fever, Ebola & Marburg disease. The vector, susceptible host and conductive

environment are prevalent in our country. The IDSP data reveals that zoonosis is prevalent across all the states and frequent outbreak is

reported from time to time in the country. During 2014 to 2018 IDSP has reported 225 outbreaks due to

zoonotic pathogens with 4432 cases and 101 deaths.


Operational guidelines for Regional Coordinators Table -1 States who have reported Zoonotic outbreaks since 2014-17(Source IDSP) Data as on

Feb.2019

Sl. Disease 2014 2015 2016 2017 2018 Total

No.

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No

1 Anthrax 6 55 1 11 177 12 32 205 3 23 135 9 6 52 0 78 62 25

4

2 Brucellosis 1 15 0 0 0 0 2 49 0 2 25 0 0 0 0 5 89 0

3 CCHF 6 6 4 15 18 8 12 13 6 5 5 3 0 0 0 38 42 21

4 Influenza A 0 0 0 2

213 0 2 102 0 3

196 1 8 269 1 15 78 2

H1N1, 0

H3N2 and

Influenza B

5 KFD 4 101 0 4 326 9 4 219 0 1 20 1 2 10 2 15 67 12

6

6 Leptospiros 6 74 1 6 71 1 11 207 6 5 87 0 4 134 0 32 57 8

is 3

7 Nipah Viral 0 0 0 0 0 0 0 0 0 0 0 0 1 19 17 1 19 17

Encephaliti

s

8 Scrub 4 202 1 8

181 6 6 304 3 9

101 3 8 486 2 35 12 15

Typhus

74

9 Seasonal 0 0 0 0 0 0 0 0 0 0 0 0 1 75 0 1 75 0

Influenza

Total 27 453 7 46

986 36 69

1099 18 52

785 18 31

1109 22 225 4 10

4 1 3

2


3 PROGRAM FOR STRENGTHENING INTERSECTORAL COORDINATION FOR

PREVENTION AND CONTROL OF ZOONOTIC DISEASES

Zoonotic diseases cannot be eradicated and are difficult to control. Intersectoral coordinated

approach with “One Health Approach” is required for their effective prevention. Effective surveillance,

prevention and control of existing and newly evolving threats from animal reservoir require strong link

between the different sectors.

Department of Health & Family Welfare, Ministry of Health and Family Welfare, Govt. of India

initiated a new scheme “Strengthening of Intersectoral coordination for prevention and control of

zoonotic diseases” to be implemented in 12th Five year plan during 2012-13 to 2016-17. The program is

continued for another three years i.e 2017-18 till 2019-20 under umbrella scheme of NCDC. The budget

outlay for the program for three year i.e. 2017-18 till 2019-20 is Rs 8.68Crores as approved by SFC

(placed at Reference).

4 OBJECTIVES 1. Establish an inter-sectoral coordinating mechanism at National, State and District Level by utilizing

the existing surveillance system (IDSP) to detect early warning signals of impending outbreaks for

timely and effective public health actions. 2. Facilitate sharing of relevant information within stakeholders for taking appropriate actions. 3. Development of Laboratory capacity for diagnosis of Zoonotic diseases. 4. Capacity building and creating awareness among health and veterinary professionals about Zoonotic

Diseases of Public Health Importance (ZPHI). 5. Activities such as Information, Education and Communication for spreading awareness among target

population for all ZPHI.

Broadly the program is aimed to operationalize “One Health” Mechanisms through strengthening

Intersectoral Coordination among all stakeholders at the National, State, and District and below district

level.

5 INSTITUTIONAL MECHANISM

i. To meet the programme objective, it is envisaged to utilize the existing resources and

infrastructure for prevention and control of priority zoonosis in health, veterinary, wild life and

other sectors to establish the Intersectoral Coordination at National Level, Regional Level, State

Level, and District Level and even below the District Level. ii. At a National Level, National Centre for Disease control is the Nodal agency for implementation of

the programme.

iii. At a Regional Level, the Regional Coordinators, will be coordinating the programme activities and

will strengthen liaising with the other sector to operationalize the One Health mechanism. iv. At the State Level, State Health Department (DHS) and state IDSP will coordinate the programme

activities.

v. At district level, CDMO and District Surveillance Officer will coordinate the programme activities at

district and below district level.

6 RATIONALE FOR REGIONAL COORDINATOR UNDER ISC


Operational guidelines for Regional Coordinators The programme of Intersectoral Coordination for Prevention and Control of Zoonotic Diseases

involves coordination between various State stake holders such as Health Department/Veterinary Departments/Wild Life Department, Academics, Medical/Veterinary Colleges, and Medical/Veterinary

Institution etc. Therefore a need was identified to recognize one Designated Institute working in the field of zoonoses that can coordinate with all the stake holders and catalyse the joint activities to be

undertaken by various stakeholders for prevention and control of zoonosis. Accordingly regional Coordinators have been identified in consultation with experts from the Field of Zoonotic Diseases in

States who can work with 3 to 4 States Health Department, Veterinary Department, Wild Life Department and can undertake the activities envisaged under ISC Programme i.e. surveillance, training of manpower,

laboratory strengthening diagnosis of zoonosis. There is provision of recurring and nonrecurring Grant in Aid under the program for each

Regional Coordinator. The Grant in Aid is released after signing an MOU between Dean/ Director of

respective institute / organization and Director NCDC. The head/ Dean of identified institute as Regional

Coordinator will nominate a Nodal Officer preferably Head of Microbiology/ Community Medicine for

regular coordination with NCDC.

7 THE ROLE OF THE NODAL AGENCY – NATIONAL CENTRE FOR DISEASE CONTROL

i. Policy Decisions: Formulation of Guidelines on Diagnosis, case management, prevention of

control of zoonotic disease.

ii. Developing trained workforce to combat zoonotic Diseases: Training of Master Trainers for

capacity building of medical and Veterinary Professionals on zoonotic diseases in diagnosis

treatment and prevention and Control of Zoonotic Diseases. iii. Coordination with the identified Regional Coordinator for strengthening diagnostic in the region

for important zoonotic diseases.

iv. ACSM: Development of proto type IEC material and formulation of strategy for dissemination of

the same.

v. Coordination with the respective State Health Authorities to identify Nodal Officer/Regional

Coordinator (RC) for the programme. vi. Overall monitoring of the programme activities and zoonosis situation.

vii. Coordination with the other stake holders (ICMR, ICAR, IVRI, MoA, MOEF, DADF and wild life

institutes etc.)

viii. Financial Management.

8 ACTIVITIES ENVISAGED BY REGIONAL COORDINATORS Regional coordinator will be assigned 04-05 State to coordinate the programme activities in the

respective States. The transfer of grant-in-aid to the regional coordinator will be undertaken as per rules

after signing a MoU between the Head of the Institute and Director NCDC. Following programme activities

are envisaged to be undertaken through regional headquarters.

8.1 CAPACITY BUILDING ACTIVITIES:

8.1.1 ORGANIZATION OF JOINT ORIENTATION WORKSHOPS FOR MEDICAL AND VETERINARY

PROFESSIONAL: Each regional coordinator will organize joint orientation training workshop for state level/ district level

health and veterinary professional covering all zoonotic diseases of public health importance. The RC may

request faculty support from NCDC or any other institute / organization. The batch size for the joint

orientation work shop should be between 20-40 ( including health , veterinary , wild life professionals /

entomologists etc)



8.1.2 HANDS –ON TRAINING ON LAB DIAGNOSTICS FOR LABORATORY PROFESSIONALS Each regional coordinator will organize at least one hands-on –training of laboratory professional for

diagnostic capacity of State Medical/ Veterinary college/ District Public Health Laboratory/ Reference

Medical Laboratory under IDSP or any other health care institute of State or centre government according

to the need .

8.2 Strengthening of Surveillance and Outbreak Investigations:

Each regional coordinator will work to strengthen the surveillance of zoonotic diseases in their

region. The RC will facilitate the data sharing between health, veterinary sector and other stakeholders on

zoonotic diseases. The RC will function in collaboration with State Surveillance Officer and State

Veterinary officer to monitor the trend of the zoonotic diseases of public health importance in their

jurisdiction and will provide support to the States for outbreak investigation of the zoonotic diseases.

Each regional coordinator will also function as Sentinel Surveillance site for the zoonotic diseases and will

coordinate with other sentinel sites as per guidelines. Each health sector Regional coordinator will enter the data on available zoonotic diseases on the

IDSP and IHIP portal. The veterinary sector Regional Coordinator will also enter the minimum essential

data on zoonotic diseases among livestock population on IDSP/ IHIP portal and will share the periodic

analysis report with NCDC. The Regional Coordinator is expected to share the feedback analysis with concerned stakeholder

to facilitate the timely action required to respond the outbreak.

8.3 Referrals Diagnostic Services:

As the regional coordinator (RC), will work to strengthen diagnostic on zoonotic disease in the

institute for respective zoonotic disease prevalent in the state utilizing the GIA received under the

programme. The RC will provide the referral diagnostic services for other medical/ veterinary institutes for

zoonotic disease. It is envisaged that the RC will strengthen networking with the other laboratories such

as reference Medical College and District Public Health Laboratories of IDSP and State NCDC branch

wherever required. The non-recurring grant will be utilized for purchase of equipment’s as per need to strengthen the

diagnostics services. The minimum, standards to be followed by Regional Coordinator labs are placed at

Annexure –1.

8.4 Regional Coordinator Activities:

Each regional coordinator play a significant role in strengthening of intersectoral coordination among

stakeholders for efficiently responding to the zoonotic threats by following activities -

Regional Coordinator will coordinate with the respective state health and veterinary

Department to nominate/ identified a state focal point for the programme activities. It is

proposed from health site the state focal point to be the SSO, IDSP. Regional coordinator will facilitate the constitution of State and district level zoonosis committee

in the respective States under jurisdiction of the regional coordinator and also keep a track of

periodic meetings of these committees. It will establish coordination with veterinary medical colleges through Identified State focal point

(from veterinary sector from respective State) of the States for data on zoonotic disease of public

health importance in animals. Regional coordinator will work with the State government for preparation of action plan for

prevention of control of zoonotic outbreaks including training and IEC activities. Regional coordinator will facilitate and advocate for regular meeting of state and district level

zoonosis committee. (State- biannual meeting, district quarterly meetings)


Operational guidelines for Regional Coordinators 8.5 IEC activities- Funds are provided under Advertisement and Publicity which may be utilized for creation and

dissemination of IEC for generating community awareness on Zoonosis.

8.6 Inventory and mapping of lab facilities and Experts of Zoonotic Diseases: The Regional Coordinators are envisaged to maintain the inventory and mapping of lab facilities and

experts of Zoonotic Diseases in the region for all relevant sectors or stakeholders (health, entomologist,

wild life experts, Veterinary experts, ecologist and environment scientists and laboratory experts working

on zoonosis) according to zoonotic diseases prevalent in the region. The information so available may be

utilized by the states to access the experts on zoonotic diseases for technical support of experts and lab

facilities

8.7 OPERATIONAL RESEARCH: It is envisaged regional coordinator will conduct and participate in operational research on various

technical and programmatic intervention will also be conducted through regional coordinators.

9 EXPECTED OUTCOMES FROM INTERSECTORAL COORDINATION (RC)

A. Trained Manpower in the States:–It is expected that at the end of project, each regional

coordinator has developed trained professional in the states/districts from both medical and

veterinary sector for prevention and control of zoonosis disease including outbreak investigation

and rapid response. B. Laboratory Strengthening: - It is expected that at the end of the project, each RC has developed

capacity for diagnosis of zoonotic diseases prevalent in the identified states and will act as

regional referral center in the region. C. Strengthening the Surveillance: - It is expected that at the end of project, each RC has catalyzed

the surveillance of zoonotic disease in the identified states and joint review of zoonotic disease

data is undertaken by state zoonotic committee on regular basis.

D. Generating community awareness on Zoonosis: - It is expected that at the end of project, each

RC has developed IEC prototype for priority zoonosis in the state and disseminated through state

health and veterinary department. E. Strengthening the Inter-sectoral Coordination on Zoonosis: - It is expected that at the end of

the project each RC has catalysed the intersectoral coordination between

medical/veterinary/wild life sector for joint action on prevention and control of zoonosis in the

respective states.

10 FINANCIAL GUIDELINES:

1. Each Regional Coordinator shall be registered on PFMS as Grant in aid will be transferred to the

Intersectoral Coordination through PFMS. The instructions of Department of Expenditure,

Ministry of Finance regarding the use of PFMS Portal for Central Sector Schemes issued from time

to time shall be strictly followed by all Regional Coordinators.

2. Each regional coordinator shall maintain separate books of accountsfor the funds received as GIA

will furnish Statement of Expenditure duly audited by the Chartered Accountant and Utilization

Certificate in form GFR 12A as per General Financial Rules, 2017 within 3 months of closure of Financial Year i.e till 30th of each June .

3. Further release of grants would be subject to submission n of Utilization Certificate and activity/

performance report.



4. Budget Head wise activities to be conducted:

S/N Activities Budget Head Activities

1 Office Expenses &Travel Other Expenditure on organization of Meeting or trainings and expenses for administrative as per standard norms followed by institute. Travel attending or organizing expenses expenses included, expenses incurred for attending meeting , training and meetings/ trainings and supervisory visits workshops including conveyance & fixed travelling allowances but excluding leave travel concessions which would be part of salaries. This will included TA/DA to the nonofficial member on account of travel in India. (Training cost norms as per standard NHM norms)

2 Human Resources Professional Recruitment of Contractual Manpower Services 1. One Veterinary/ Public Health Consultant @ Rs 60000 pm 2. One Data Entry Operator @ 20000 pm. All recruitment to be done as per standard institute policy within the prescribed financial limit 3 IEC activities Advertisement and Creation , Translation, printing , dissemination of Publicity IEC Material 4 Laboratory Material & Supply Procurement of reagents, kits and consumables Strengthening (Recurring

)

5 Laboratory Material & Supply Procurement of equipment’s Strengthening

(Nonrecurring )

11 RECORDING, REPORTING AND MONITORING:

The RC will submit the periodic reports as per the prescribed formats given in annexures. The following

registers/ records should be maintained by Regional Coordinators:

1. Training Register with details of all training and capacity building activities undertaken under

the program

2. Standard SOPS for performing laboratory diagnosis of Zoonotic diseases 3. Stock Register for consumables and equipment maintenance registers 4. Record of Human Resources deployed under the program 5. Books of Accounts 6. Recording and reporting formats of the program


Operational guidelines for Regional Coordinators Periodic reports to be furnished by each Regional Coordinator to the NCDC are summarized as

under:

Report Contents Periodicity and date of Format submission

Monthly Report on Part A: Monthly, by 5th Day of Annexure -2, Laboratory Diagnosis Summary report of laboratory next Month

& Surveillance Diagnosis with line list of positive

cases

Part B:

Report of activities undertaken to

strengthen the surveillance

Quarterly Report on Capacity building , Trainings , Quarterly, by 7th Day Annexure -3, Programmatic hands on Workshops organized of first month every

Activities

Quarter

Report of IEC activities

undertaken

Report of Logistics

Inter-sect oral Coordination

activities

Expenditure Statement

Status of Human Resources

Fund utilisation Utilization Certificate Annually Annexure-4 Certificate by 30th of each May All the above reports will be submitted electronically by email & signed Hard Copy. The

designated email id for submission of reports is [email protected]

If state is implementing the Integrated Health Information Platform then, RC has to report their

entire laboratory test data in L form as per IHIP on real time basis.

12 PERFORMANCE PARAMETERS-

The regional Coordinator will be monitored based on below mentioned parameters

i) Capacity Building: Number of regional workshops/hands on training organized by concern regional

coordinator for training of 20-40 medical/veterinary professionals on diagnosis and

management of zoonosis.(Target: At least: 1) ii) Laboratory Strengthening:

Capacity developed in the RC for diagnosing priority zoonosis prevalent in the identified

states and will act as Regional Referral Center in the region .(Target: minimum 2 zoonotic

diseases). iii) Strengthening the Surveillance:

Monthly reporting format on zoonotic diseases shared by RC with state and NCDC

(target; 100%) Reporting of zoonotic diseases (outbreak/cases) improved through IDSP system.

(Target: real Time) Monthly Data on priority zoonosis shared by vet. Dept. with Health department

(target; 100%) iv) Generating community awareness on Zoonosis

IEC prototype (pamphlets /poster/audio spot or jingle/ video spot etc.) dissemination

(Target: min two activities)

v) Strengthening the Inter-sectoral Coordination on Zoonosis:

Facilitate & Advocate for biannual state zoonotic committee meetings.



13 ANNEXURE -1

Minimum Standards for Referral Diagnostic Services to be followed by Regional Coordinators

Intersectoral Coordinator are envisaged to play an important role in extending support to the States in

their jurisdiction for referral diagnostic services for a Zoonotic Diseases of Public Health Importance and

important NTDs . The diseases for which the regional coordinator are envisaged to build their capacity

and expertise are listed as under-

i. Rabies ii. Leptospirosis

iii. Anthrax iv. Scrub Typhus v. Brucellosis vi. KFD

vii. Toxoplasmosis viii. Avian Influenza ix. Cysticercosis x. Nipah

xi. Echinococcosis xii. Trypanosomiasis xiii. JE xiv. Swine Flu (H1N1)

xv. Plague xvi. CCHF

xvii. Any Ricketsial infections xviii. Bovine tuberculosis

Few of the above pathogen requires BSL-2, BSL -3 and BSL 4 facility and such organisms should be

handled accordingly as per its requirement.

As the institutes strengthened as Regional Coordinator are already having required infrastructure and

functional laboratories, GIA for nonrecurring and recurring grant is provided with intent for further

capacity building of these laboratories.

13.1 THE FOLLOWING STANDARD OPERATING PROCEDURE ARE EXPECTED WHILE

SUPPORTING REFERRAL DIAGNOSTIC SERVICES --

1. Record of Equipment Maintenance Maintain a stock register for all equipment received from the project. Update the register periodically whenever new equipment/s are received.

Keep a file containing instrument manuals and operating guidelines provided with the

instrument. New equipment should be calibrated and validated before routine use. Pipette, thermometer,

weighing balance and centrifuge should be calibrated by accredited calibration laboratory.

All the equipment other than above should be calibrated annually and centrifuges and

micropipettes should be calibrated every six months. Periodic performance check/calibration check for all equipment should be done and the

frequency of performance checks should be based on the day-to-day performance of the

equipment. Equipment Performances should be verified from Internal Quality Control and External

Quality Assessment results 2. Equipment history card must be maintained for every equipment and should

have: o Name of the equipment o Unique ID, model and the serial number

o Manufacturer’s name and address o Service person’s name, address and contact number o Date of installation 6. Calibration frequency, calibration certificates

o Repairs and service details 3. Quality Control measures should be undertaken, stock record maintenance for Stock

management of kits/reagents/media and stains.


Operational guidelines for Regional Coordinators 4. All laboratory personnel should have the necessary qualification, experience and competencies

for handling the equipment’s and reagents. Trainings should be conducted periodically to update

their skills. A QC guideline for each test procedure is a mandatory document at the testing

laboratory and all the personnel need to be strictly adhered to. 5. Laboratory Safety and Protection of Employee: All laboratories must have a written safety policy

and guidelines in-built into the SOP manual which must be followed

6. Proficiency Testing: All laboratories must participate in an external proficiency testing program

approved by DAC/NABL.

7. Report Generation and Records: Laboratory reports must have all the information on patient including type of specimen, date

and time of collection, receipt and reporting. All reports must be considered confidential and dispatched in a sealed envelope. A copy of the

report, laboratory worksheet and requisition forms are filed and placed in a locked cupboard 8. Occurrence Management:

Laboratory should have a system to monitor errors during testing, transcription and

communication through periodic checking of records and reports. A mechanisms for corrective

action (immediate) and preventive actions should also be in place.

9. Biomedical waste management: Appropriate disposal methods should be in place for management of biomedical waste.

10. Biosafety and Infection Control The laboratories would be handling infective organisms having high public health

significance; Safety in laboratories should be the priority and therefore includes protection of

both the staff and the environment from hazardous materials. Laboratory Safety Policies and procedures should be documented. All laboratory personnel

should be aware and follow the laboratory safety policies and procedures. The laboratories should have their own bio safety manual.

Policies should outline the use of sharps, disposal of bio-waste, reagents, sharps and other

wastes generated in the laboratory. Bio hazardous material should be handled in biological

safety cabinets (BSC) only within the laboratory. Under standard precautions, blood, body fluids and all body substances of patients are

considered as potentially infectious. 11. Storage of Pathogens and Records at Regional Reference Laboratories;

Laboratories should function as the repository for biological samples and records necessary

for reference and quality assurance programs. The repository should become a part of the

institution having the overall responsibility of the repository and the data. In general, long term storage facility should have elements of sufficient walk-in cold storage

facility or freezer space to accommodate the material being preserved and provide safe

movement of people and equipment. All freezers and computers should be also protected by

UPS (Uninterruptible Power Supply). The Apex and Regional Reference Laboratories should develop a record management system

for long term storage of specimens and its data. 12. Record Retention: All sample collection, storage, distribution and quality audit records should be

maintained for 5- 10 years (NABL). Guidelines for retention of records of specimens that no

longer exist in the storage facility also need to be developed.Specimen verification Specimen

Tracking system should be in place 13. Corrections and or changes: All Corrections and changes should be done by an authorized staff of

the institute. S/he should put a signature and date of correction on change in the record. The

correction should be made in such a that previous entries are also visible and not obliterated

completely.



14 ANNEXURE - 2


15 ANNEXUREOperational-3 guidelines for Regional Coordinators



14 UTILISATION CERTIFICATE FORMAT- ANNEXURE -4


operational guidelines for regional coordinators

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