TOR/SOW to hire lab agency for Comprehensive National Nutrition Survey (CNNS)

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Definition of requirementThe selected lab agency will require collecting blood, urine and stool samples to provide comprehensive nutritional profiling of preschoolers (0-5 years), school-age children (6-14 years) and adolescents (15-19 years) in 30 states of India. List of the required indicators are given in annexure 1. The anthropometry and behavioural related data will be collected by other survey agencies. The selected lab agency will coordinate with the survey agencies during household data collection for collecting the blood, urine and stool samples from selected subjects across the 30 states of India and around 2500 locations (refer annexure 2) and provide the results.

ObjectiveTo estimate a nationally representative and comprehensive nutritional profiling of preschoolers (0-5 years), school-age children (6-14 years) and adolescents (15-19 years) in a robust manner to provide the true nutrition burden at national and states level among three age groups.

Background

India has one of the worlds highest child undernutrition rates. The 2006 National Family Health Survey shows that 48% of Indian children under five are stunted and 70% are anaemic. Importantly, micronutrient deficiencies are highly prevalent in India due to the poor quality of diet. A number of small-scale surveys have indicated a high prevalence of deficiencies of iron, vitamin A, folic acid, and other B-vitamins, which serves as the main underlying cause of anaemia. Even mild to moderate deficiencies of micronutrients lead to impaired cognitive development, poor physical growth, increased morbidity, and decreased work productivity in adulthood.

Increasing evidence shows that deficiencies of other micronutrients such as vitamin D and zinc are also very common in Indian children. Vitamin D status is strongly linked to the risk of developing osteoporosis and cancers of the breast, colon, prostate, and ovary later in life. Zinc deficiency leads to deficits in cognitive and motor function and contributes to an increased incidence and severity of diarrhea and pneumonia. Moreover, a large proportion of Indian children are affected by worm infestation, aggravating the incidence and prevalence of underweight and anaemia.

Importantly, however, no nationally representative data on the micronutrient status and worm infestation of preschool children exist in India. The most relevant information comes from the 2012 National Nutrition Monitoring Bureau (NNMB) Survey conducted in 10 states which assessed the population intake of micronutrients from food consumption data and clinical signs of micronutrient deficiencies. Clearly, micronutrient status and worm infestation measured by biochemical indicators have not been examined in any of the existing and planned national surveys. Recently, nutrition in school-age children and adolescents has been receiving growing attention in India. Available evidence indicates that more than one third of Indian school-age children and adolescents are thin and more than half the adolescent girls aged 15-19 years are anaemic. Micronutrient deficiencies and worm infestation are likely to be ubiquitous. Widespread undernutrition in these age groups poses a significant threat to their ability to fulfil their potential, impedes progress towards Education for All, and slows down economic and national development. Notably, India has been increasingly confronted with the double burden of malnutrition, characteristically defined by the coexistence of under- and over-nutrition. An increased prevalence of overweight and obesity is observed in children and adolescents, which has life-long consequences for non-communicable diseases (NCD) in adulthood. In addition, poor eating habits, lack of physical exercise, high glucose concentrations, and harmful lipid profiles during adolescence, which are all linked to NCDs in adulthood, are likely to be increasing.

Despite these devastating nutritional challenges, there is a dearth of information on the current nutritional status of school-age children and adolescents in India. School-age children and adolescents have often been excluded from health and nutrition surveys and surveillance. Although anthropometry and hemoglobin data will be collected in some of the planned national survey (NFHS-4), micronutrient status, worm infestation, and the nutritional risk factors for NCDs such as physical fitness, blood pressure, glucose concentration and lipid profiles have never been assessed among school-age children and adolescents in India.

RationaleIt is evident that contemporary and nationally representative data is virtually non-existent on several important facets to determine the true malnutrition burden, reorient policy according to needs of nutrition transition and serve as a baseline to evaluate progress of recently launched important initiatives such as the Rashtriya Kishor Swasthya Karyakram (RKSK), Rashtriya Bal Swasthya Karyakram (RBSK), and National Iron Plus Initiative (NIPI). There is an urgent need to dissect out the settings, burden and potential functional consequences of both undernutrition and overnutrition so that interventions initiated to remedy the former may not worsen the latter (for example, food supplementation). The noteworthy evidence gaps include anthropometric assessment of school children, biomarkers of important micronutrient deficiencies and cardio-metabolic risk, body composition, physical activity patterns, muscular strength, fitness, diet diversity and non-nutrient factors (sub-clinical inflammation, STH infection, education, and WASH practices). The proposed comprehensive nutritional survey is being designed to generate robust evidence on these aspects.

Intended user/sThe survey will provide the first-ever national data on the micronutrient status and worm infestation of children and adolescents in India. The information will help elucidate the major determinants of anaemia in children and adolescents, and evaluate the impact of the national micronutrient/deworming programmes. It will also be the first national efforts to document the extent and severity of over nutrition and nutritional risk factors for NCD among school-age children and adolescents at a national scale. These findings will serve as useful baseline data for important new initiatives such as the RKSK, RBSK, and NIPI and provide an unquestionable evidence base for advocacy, policy development, and programme design with the Government of India and State Governments.

Location/ duty Station of workSample collection from all 30 Indian states

Total duration of the assignmentTotal 15 months from start date

Travel requirementAround 2500 villages/wards in 30 states - refer annexure 2

Scope of Work Roles and Responsibilities: Identify/recruit team (for e.g. team leader, medical coordinators cum master trainers, quality assurance supervisors, health investigator for sample collection) Sending master trainers to attend centralized TOT organized by lead agency to understand operation Organize states level trainings for lab team by master trainers on standard operating procedure (SOP) and ethical issues under the supervision of quality control (QC) lab Collections of blood, urine and stool samples of preschoolers (0-5 years), school-age children (6-14 years) and adolescents (15-19 years) in the 30 states (around 60,000 subjects) under the monitoring and supervision of QC lab, lead agency and UNICEF Transportation of blood, urine and stool samples to designated laboratory centre within stipulated time Use best standard methods/technics to measure required indicators listed in annexure 1. Ensure quality of sample collection and coordinate with QC lab/lead agency Submit results of ongoing samples by unique ID in electronic medium to lead agency and QC lab

MethodologyAs stated before, there is a need to conduct blood, urine and stool tests using internationally recognised standard to provide comprehensive nutritional profiling of pre-schoolers, school-age children and adolescents to measure required indicators listed in annexure 1 through best standard methods/procedures. The anthropometry and behavioural data will be collected by other survey agencies and randomly selected subjects will be assigned to lab agency to collect the blood, urine and stool samples. The lab agency will coordinate with the survey agencies to get the subject name and address to collect the sample next day as soon as possible. There will be around 24 subjects in one location (village in rural area and ward in urban area) to collect the sample equally (eight) from the three age groups. The survey will cover around 2500 locations across the 30 sates (refer annexure 2).

Supervisor

Praween K. Agrawal

Reporting frequenciesWeekly updates on sample collection by states Monthly progress report of whole lab agency work

Performance/ Progress Reporting Requirements Yes, as stated above and listed in deliverables

References to standardsNo significant difference in the lab agency results from the QC lab (maximum 5 %)

DeliverablesDeliverables:1. An inception report on operational plan detailing recruitment and training of lab team, test type (for e.g. type of biomarkers), detailed analysis procedure, monitoring and supervision of sample collection, coordination mechanism with survey team, quality assurance plan and SOP with timeline within two months of contract signed2. A report on training attended by their medical coordinators cum master trainers with day wise attendance list within a week of TOT3. State-wise report on training organized for lab team (quality supervisors, sample collectors) by medical coordinators cum master trainers with day wise attendance list within a week of state training by survey agency 4. State-wise field movement plan as per household survey team (list and phone number of quality supervisors and sample collectors) one week before movement5. Fortnightly progress report on sample collection and quality assurance report along with photographs from field 6. Results of collected samples by unique ID (by village/ward) in electronic medium - within a week of collection7. State-wise fieldwork completion report- within a week of completion

Payment scheduleDeliverables:1. On receipt of inception report 15%2. On approval of inception report for TAC 15%3. A report on training with day wise attendance list 10%4. Completion report of 10 states 15%5. Completion report of other 10 states 15%6. Completion report of rest 10 states 15%7. Completion report from lead agency about all states data merged with household survey data 15%

Qualification requirements Team leader Mater in Pathology (preferably PhD) AND must have experience in handling blood products Medical coordinators cum master trainers - Mater in pathology AND must have experience in handling blood products Health investigators - Graduate in Medical lab technology/ B Pharma/ BUMS/BHMS/BAMS/ Degree in Nursing or Diploma in Medical lab technology AND must have experience in blood collecting/handling blood products

Technical evaluation criteria and weight allocated between technical and price proposal(please consult supply specialist before arriving at this section)

Weight assigned- (50% Technical and 50% Price)

Technical Proposal (50%) Agency background and experience of conducting similar work [25%] Proposing best standard methods/procedures to measure indicators listed in annexure 1 [25%] Quality assurance mechanism [25%] Team composition for viability of survey, implementation plan along with risk assessment and mitigation plan [25%]

Scope of work need to be completed by -Tick appropriateWith one and only one agencyWith one and more agenciesWith one individual

Annex for preparation of proposalsAnnexure 1. List of indicator to measure by lab in the three age groupsAnnexure 2: Approx. number of village/ward to cover for required sample size by states

Annex for reporting mechanismNA

This section is for internal use and must be part of all TOR/ MOUSuggestive format for assumptions to be identified with each task/ deliverables -S. No.ObjectivesActivitiesResources/ AssumptionsDeliverables with milestones Risks identifiedRisk mitigation planEffect of Risk on project

1To estimate a nationally representative and comprehensive nutritional profiling of preschoolers (0-5 years), school-age children (6-14 years) and adolescents (15-19 years) in a robust manner to provide the true nutrition burden at national and states level among three age groups Use best standard methods/technics to measure required indicators Identify/recruit lab team Centralized TOT /States level trainings for lab team on operation and SOP Collections of blood, urine and stool samples (around 60,000 subjects) Transportation of samples to designated laboratory centre within stipulated time Ensure quality of sample collection Submit results of ongoing samples by unique ID in electronic medium Available

Operational plan SOP submitted by 8th week of contract

Field work completed and lab results shared to lead agency to merge with unique ID of household survey in one year time

Delay in TAC/MHFW approval

High cost

Regular TAC meeting at every development

Make Government office take responsibility to own the whole project

Team work

Negotiation with all possible labs

Projected time may increase

Cost implication

Examples of reporting clear deliverable linking with activities#Activities/ TasksDurationDeliverablesMilestone

APreparatory phase: Develop operational plan (team composition, quality assurance, coordination mechanism to shared results with lead agency etc.) and SOP for the proposed assignment Hold discussions/meetings with UNICEF/TAC/lead agency Finalize the operational plan SOP and

8 weeks4 weeks

2 weeks2 weeksInception report Will lay out the detailed operational plan and readiness to launch the survey providing details about team composition, quality assurance, coordination mechanism to shared results with lead agency and SOP Operational plan and SOP submitted by 8th week of contract

BField work: Undertake training of lab teams Collect sample and provide the test results 3rd month4th to 15th months1. A report on training attended by their medical coordinators cum master trainers with day wise attendance list within a week of TOT2. State-wise report on training organized for lab team (quality supervisors, sample collectors) by medical coordinators cum master trainers with day wise attendance list within a week of state training by survey agency 3. State-wise field movement plan as per household survey team (list and phone number of quality supervisors and sample collectors) one week before movement4. Weekly sample collection progress report and data quality assurance report along with photographs from field - within a week 5. Results of collected samples by unique ID (by village/ward) in electronic medium - within a week of collection6. State-wise fieldwork completion report- within a week of completionField work completed and lab results shared to lead agency to merge with unique ID of household survey in one year

Annexure 1. List of indicator to measure by lab in the three age groupsNutritional Indicator GroupPreschool Children(0 - 5 years)School-age Children(6 - 14 years)Adolescents(15-19 years)

Body Composition Bioimpedance Bioimpedance Bioimpedance

Physical fitness Hand Grip Strength Hand Grip Strength

Anemia and hemoglobinopathies Hemoglobin Variant Hemoglobins Hemoglobin Variant Hemoglobins Hemoglobin Variant Hemoglobins

Inflammatory biomarkers C-reactive protein C-reactive protein C-reactive protein

Protein Serum protein and albumin Serum protein and albumin Serum protein and albumin

Micronutrients Iron: Ferritin, Serum transferrin receptor Vitamin A: Serum retinol Iodine: Urinary Iodine concentration, TSH Zinc: Serum zinc B-vitamins: erythrocyte folate, Serum B12, Methyl-malonic acid Vitamin D: Serum 25 (OH) D Iron: Ferritin, Serum transferrin receptor Vitamin A: Serum retinol Iodine: Urinary Iodine concentration, TSH Zinc: Serum zinc B-vitamins: erythrocyte folate, serum B-12, Methyl-malonic acid Vitamin D: Serum 25 (OH) D Iron: Ferritin, Serum transferrin receptor Vitamin A: Serum retinol Iodine: Urinary Iodine concentration, TSH Zinc: Serum zinc B-vitamins: erythrocyte folate, serum B-12, Methyl-malonic acid Vitamin D: Serum 25 (OH) D

Non communicable Diseases Blood Pressure Blood Glucose, HbA1C Lipid profile: Serum cholesterol, HDL/LDL, Triglycerides Renal function: Serum creatinine, urinary protein creatinine ratio Blood Pressure Blood Glucose, HbA1C Lipid profile: Serum cholesterol, HDL/LDL, Triglycerides Renal function: Serum creatinine, urinary protein creatinine ratio

Soil transmitted heminthiasis Stool samples Stool samples Stool samples

Annexure 2: Approx. number of village/ward to cover for required sample size by states and urban rural areaStatesUrbanRuralTotal

Arunachal Pradesh254873

Assam255378

Bihar2580105

Chhattisgarh254873

Goa382563

Gujarat286088

Haryana254065

Himachal Pradesh255580

Jammu & Kashmir257095

Jharkhand254873

Karnataka253863

Kerala303363

Madhya Pradesh257095

Maharashtra7860138

Manipur254368

Meghalaya255075

Mizoram333063

Nagaland254570

NCT of Delhi602585

Odisha255075

Punjab253863

Rajasthan257095

Sikkim254570

Simandhra 254065

Tamil Nadu8033113

Telangana7540115

Tripura254570

Uttarakhand 2598123

Uttar Pradesh254368

West Bengal7568143

INDIA102014852505