The World Bank Third Additional Financing for Sri Lanka COVID-19 Emergency Response and Health System Preparedness Project (P177714) Additional Financing Appraisal Environmental and Social Review Summary Appraisal Stage (AF ESRS Appraisal Stage) Public Disclosure Date Prepared/Updated: 09/08/2021 | Report No: ESRSAFA243 Sep 10, 2021 Page 1 of 23 The World Bank Third Additional Financing for Sri Lanka COVID-19 Emergency Response and Health System Preparedness Project (P177714) BASIC INFORMATION A. Basic Project Data Country Region Borrower(s) Implementing Agency(ies) Sri Lanka SOUTH ASIA Democratic Socialist Ministry of Health, State Republic of Sri Lanka Ministry of Samurdhi, Household Economy, Micro Finance, Self-Employment, Business Development,, Ministry of Finance Project ID Project Name P177714 Third Additional Financing for Sri Lanka COVID-19 Emergency Response and Health System Preparedness Project Parent Project ID (if any) Parent Project Name P173867 Sri Lanka COVID-19 Emergency Response and Health Systems Preparedness Project Public Disclosure Practice Area (Lead) Financing Instrument Estimated Appraisal Date Estimated Board Date Health, Nutrition & Investment Project 9/20/2021 9/28/2021 Population Financing Proposed Development Objective To prevent, detect and respond to the threat posed by COVID-19 and strengthen national systems for public health preparedness in Sri Lanka Financing (in USD Million) Amount Current Financing 0.00 Proposed Additional Financing 0.00 Total Proposed Financing 0.00 B. Is the project being prepared in a Situation of Urgent Need of Assistance or Capacity Constraints, as per Bank IPF Policy, para. 12? Yes Sep 10, 2021 Page 2 of 23 The World Bank Third Additional Financing for Sri Lanka COVID-19 Emergency Response and Health System Preparedness Project (P177714) C. Summary Description of Proposed Project [including overview of Country, Sectoral & Institutional Contexts and Relationship to CPF] Component 1: Emergency COVID-19 Response: This component will focus on limiting local transmission of COVID-19 through containment strategies and strengthening systems to mitigate future risks. It will (a) support establishment of an Emergency Operation Center atthe Disaster Response and Management unit at the National level to improve coordination and timeliness of national level activities in emergencies of pandemic nature; (b) strengthen systems for contact tracing, case finding, confirmation, reporting and follow up; (c) strengthen the capacity of secondary and tertiary hospitals to respond to surge capacity through trained and well-equipped health workers and medical officers and equipped facilities; (d) set up isolation wards and intensive care units in select tertiary and secondary care hospitals; (e) implement a community engagement and risk communication strategy; (f) train social welfare workers, particularly those supporting elder care homes, centres with special needs people and orphanages to ensure proper isolation, treatment and transportation of suspected cases and avoid spread within homes; (g) support provision of psycho-social support and community-level outreach to women and children who are experiencing domestic violence when confined to their houses. Component 2: Strengthening National and Sub-national Institutions for Prevention and Preparedness: This component will support strengthening the capacity of national and sub-national institutions to respond to the ongoing COVID-19 pandemic and any public health emergencies that may occur in the future. In particular, it will (a) strengthen the National Institute of Infectious Diseases (NIID) by setting up a new isolation center within the premises of the NIID Public Disclosure and expand isolation units within the institute to build capacities for future responsiveness; (b) establish Regional Quarantine and Testing Centers (QTCs) equipped with testing facilities to augment the capacity of the NIIH; (c) establish Bio-Safety Level (BSL) 3 Laboratory Facilities at the National Medical Research Institute (MRI) to improve the capacity to run investigations for highly contagious diseases; and (d) strengthen laboratory facilities, infection control and waste management systems in secondary and tertiary hospitals. Component 3: Strengthening Multi-sectoral, National institutions and Platforms for One Health: This component will support investments in the one-health approach which will strengthen emergency response systems in the long term. This will entail a convergent approach that covers food safety, the control of zoonoses (diseases that can spread between animals and humans) and combatting antibiotic resistance. Specific focus will be placed on (i) conducting a needs assessment of national protocols for detection, surveillance, and response systems for animal and human health infections; (ii) establishing a mechanism for detection of priority existing and emerging zoonoses; and (iii) conducting awareness on anti-microbial resistance among human health, agricultural, and veterinary and enforcement of related legislations. Activities under this component would be implemented in collaboration with the related Ministries and stakeholders Component 4: Implementation Management and Monitoring and Evaluation: This component will support coordination and management of the project, including central and provincial arrangements for coordination of activities, financial management and procurement. This component would also support monitoring and evaluation of Sep 10, 2021 Page 3 of 23 The World Bank Third Additional Financing for Sri Lanka COVID-19 Emergency Response and Health System Preparedness Project (P177714) prevention and preparedness, building capacity for clinical and public health research, and joint-learning on pandemic preparedness across and within countries. Component 5: Contingent Emergency Response Component (CERC): In the event of an Eligible Crisis or Emergency, the project will contribute to providing immediate and effective response to said crisis or emergency. The allocation to this component is to minimize time spent on a reallocation of funds from programmed activities. The unused amount can be reallocated to other components if the CERC component is not triggered a year prior to project closing. D. Environmental and Social Overview D.1. Detailed project location(s) and salient physical characteristics relevant to the E&S assessment [geographic, environmental, social] This AF operation to the Sri Lanka COVID-19 Emergency Response and Health Systems Preparedness Project aims to provide a financial top up to scale up the on-going Sri Lanka’s national COVID 19 vaccination drive. It will support i) the direct bilateral purchase of approved vaccines; and (ii) freight and vaccine indemnification costs and other associated vaccination costs for a total of US$100 million. Vaccine associated costs will include costs relating to vaccine deployment and acquiring cold chain storage, based on need. All activities proposed under this AF remain well-aligned with the original PDO and the project design. Public Disclosure Sri Lanka’s national vaccination drive commenced in January 2021 and as of current records, 32% and 58% of population vaccinated with double and single doses, respectively. Given the critical role vaccination plays in Sri Lanka’s transition to a new normal, the GoSL targets to fully vacicnate 60% of its entire population by end of 2021. As such it has made agreements to obtain the balance required doses through discussions with several countries and international partners. The national vaccination drive has performed well to achieve high coverage in a short period of time, recording a maximum of 500,000 innoculations per day. This momentum was achieved with the involvement of the army medical team to supplement the national vaccination program in the interest of national priority to expedite vaccinations among priority groups. From there onward, the army medical team, under the overall supervision of the MOH, has been involved in the National COVID -19 vaccination program following the same processes & guidelines issued by the MOH for COVID vaccination. Vaccines are administered in all districts via district hospitals, field vaccination clinics and militay hospitals to achieve high efficiency. The country also has an establsihed and well- functioning system for vaccination requiring cold chain facility for 2-8 degrees. The GoSL is further strengtheing these faclities for the deployment of addiional doses using domestic resources. Funding from the first vaccine AF was not used for cold storage capacity strentheing while provision for same was included. Similalry, the second proposed AF will include provision for cold storage , should the Government require. In terms of physical characteristics, Sri Lanka is an island in the Indian Ocean with a land extent of 65,610 Km2. It has a widely varying topography characterized by three distinct zones (peneplains) distinguishable by elevation. South Central part of Sri Lanka, the highest peneplain, is the rugged central highlands, consisting of rolling hills with peaks rising to 2500 m above sea level, steep escarpments and gorges. The land descends from the central highlands to extensive internal plains which makes most of the island’s surface at 30 – 300 m above sea level elevations and the Sep 10, 2021 Page 4 of 23 The World Bank Third Additional Financing for Sri Lanka COVID-19 Emergency Response and Health System Preparedness Project (P177714) coastal belt that surrounds the island with a 1340 Km long coastline that consists of scenic sandy beaches indented by coastal lagoons, bays, heads and wetlands. Sri Lanka faces critical environmental challenges of which deforestation, land degradation, loss of soil fertility, soil erosion and landslides, water and soil pollution, solid waste management and human-wildlife conflict take significant proportions. Except for areas protected under the country’s conservation laws, most of the island is inhabited with fairly good road access and other basic infrastructure. Sri Lanka has a free and universal public health care system. Its health institutions are organized according to the level of service provided and are managed by central and provincial health administrations. The secondary, tertiary and specialized care health institutions are located in built-up urban and peri-urban areas whilst most of the primary care hospitals are typically located in rural areas with generally good accessibility. This AF will not entail construction of new facilities and hence E&S risks related to civil works will not arise. The key environmental risks of the proposed new AF would would be the same as the vaccnation AF before, that is health care waste management and occupational health and safety of health workers and community. The vaccination program that is targeted to achieve high coverage over a short period of time will continue to generate significant volumes of health care wastes such as used sharps, syringes, vaccine vials, cotton swabs and reagents as well as discarded PPEs that need to be properly disinfected and safely disposed. At present, Sri Lanka has limited capacity for the overall solid waste management, however, in the last decade or so, the country has made noteworthy progress in implementing the national framework for safe management of healthcare waste (HCW). A majority of the secondary and tertiary health institutions in the country have equipment such as autoclaves, Metamizers and incinerators for the disinfection and disposal of HCW. In addition, there are few Public Disclosure private sector service providers who are contracted by the Ministry of Health for the collection of HCW where it is incinerarted in environmentally licnesed private incineration facilities. In terms of social characteristics, Sri Lanka is a lower-middle-income country with a total population of 21.8 million. Sinhalese constitute the largest ethnic group in the country, with 74.8% of the total population. Sri Lankan Tamils are the second major ethnic group (11.2%), followed by Moors (9.2%.) and ‘Others’ including Muslims, Burghers and the forest dwellers (Veddahs) constituting the remaining (4.8%). Buddhism (70.2%) is the most prevalent religion followed by Hinduism (12.6%), Islam (9.7%), Christianity (7.4%) and Other religions (0.05%). Given the diverse nature of the Sri Lankan society, ethnically, linguistically, and religiously, it is essential that development interventions are designed following a fair, equitable, non-discriminatory and inclusive policy, so that no group is marginalized or discriminated against and equity in vaccine distribution and access is ensured. Sri Lanka also has a considerably large population of 60+ year old (i.e. 14 percent) who fall into the high-risk and priority group eligible to receive the COVID19 vaccination under the National Deployment and Vaccination Plan for COVID-19 (NDVP). As described in the NDVP, the MoH intends to vaccinate at least 60 percent of the Sri Lankan population in phases. Children under 18 years of age are still medically contraindicated for the vaccination, while vaccinating pregnant/lactating women has commenced in June 2021 (initially Sinopharm only; Moderna, Pfizer, AstraZeneca from August) as scientific evidence accumulated on their safety. The NDVP lays out these priority groups, based on the availability of vaccine supplies. Therefore, the project will ensure that socially and medically vulnerable and disadvantaged people will not be left out from receiving the vaccines and no person will be forced to receive vaccines against their will either. In addition to MoH, Military involved in the vaccination program will follow the established guidelines and code of conducts. The project will also ensure communications and adequate stakeholder Sep 10, 2021 Page 5 of 23 The World Bank Third Additional Financing for Sri Lanka COVID-19 Emergency Response and Health System Preparedness Project (P177714) engagement is done simultaneously addressing public misperceptions and vaccine hesitancy to improve the demand for the Covid19 vaccination. The parent project’s Environment and Social Management Framework (ESMF), disclosed in May 2020, clearly sets out the guidance on procedures on E&S assessment, preparation of site-specific Environmental and Social Management Plans (ESMPs) as well as Health Care Waste Management Plans taking into consideration national and international protocols for infectious disease control and health waste management (IC &HCWM) along with necessary guidance to mitigate the social risks. The ESMF was updated and disclosed in May 2021 to reflect additional risk management measures to cover COVID-19 vaccination in relation to the last AF to support the procurement and deployment of COVID-19 vaccination. As such, the ESMF adequatey covers the requirmenets of this AF and would only require minor edits to reflect the financial top up. D. 2. Borrower’s Institutional Capacity The Government of Sri Lanka (GoSL) has a number of environmental policies, regulations and standards on environmental protection. The National Environmental Act (NEA), administered by the Central Environmental Authority (CEA), is the overarching environmental regulation that provides the legal basis for environmental protection and pollution control in the country which it does through key regulatory instruments such as EIA, Environment Protection License (EPL), Schedule Waste License (hazardous waste including HCW) and environmental quality standards. The CEA is the mandated regulatory agency overseeing environmental management and to some Public Disclosure extent social management issues in the development sector. It has demonstrated technical capacity in assessing environmental and social risks of development activity and has benefited from many capacity-building initiatives in the past. While Sri Lanka has a strong EIA system, a number of weak areas that need improvement are observed, such as post EIA/EPL compliance monitoring and enforcement. Further, Sri Lanka requires EIA/EPL clearance only for development activities that fall within prescribed thresholds stipulated in its EIA regulations, and as such, development activities that are below the stipulated thresholds, are screened out of the process even when they potentially have serious impacts cumulatively. With regard to the health sector, the country has a draft national policy on health care waste management prepared in 2001, national guidelines on health care waste management, a code of hygiene which the Ministry of Health has been incrementally implementing over the last decade or so. The Ministry of Health (MoH), which is responsible for implementing the parent project and the AFs, has been implementing Bank-funded projects in the health sector for the last 15 years or so and has been trained on the implementation of safeguard policies. However, additional support will be required by the MoH to build capacity on World Bank's new Environment and Social Framework (ESF) and its additional requirements. Further, the MoH has a Directorate of Environmental and Occupational Health (DE&OH) headed by a Deputy Director-General with a separate budget line under the MoH. The DE&OH has a staff strength of 39 with capacity for occupational health and safety, food and drug safety, health care waste management, etc. Regarding HCWM, the DE&OH has facilitated 28 EPLs/SWLs for secondary and tertiary level hospitals in all nine provinces as of 2018 through the provision of equipment, training, evaluation and follow up support. Currently, two medical officers from the the DE&OH and the Health Promotion Bureau are designated to the PMU on a part-time basis to assist with E&S management requirements. Sep 10, 2021 Page 6 of 23 The World Bank Third Additional Financing for Sri Lanka COVID-19 Emergency Response and Health System Preparedness Project (P177714) In terms of national labor regulations, Sri Lanka lacks a single unified labor law/code; instead, a number of statutes govern employment and industrial relations in the country, which are fairly consistent with the requirements under ESS2. Likewise, Sri Lanka’s Right to Information (RTI) Act 2016 aims to promote open government, citizens’ active participation in governance, and accountability to the people of the country. However, the implementation of these legal provisions has been challenging due to their incomplete application and weak enforcement. The involvement of the Sri Lanka Army has contributed to strengthening the execution of the vaccination program of the MOH. The Sri Lanka Army Medical Corps has exactly the same cadre structure as that of its counterpart MOH and receives the same basic and post-graduate training the MOH professionals- medical specialists, medical officers, nursing staff, Public health inspectors, public health midwives – receive. Hence the army medical team supplements the national vaccination program under the overall supervision of the MOH who have been trained on the same processes and use the same guidelines issued by the MOH for COVID19 vaccination. The conduct of the military personnel, engaged with the public is governed by the Sri Lanka Army Act 1949. Further, a standing order containing, instructions, rules, regulations and procedures to be followed and adhered to by the military personnel deployed (Vaccination team) to carry out community vaccination, had been issued by Commander-in-Chief of the army infantry unit as well. Up until May 2021, the project was implemented by the PMU of the on-going Bank-funded Primary Sector Strengthening Project (PSSP) under the MoH. However, subsequent to the last vaccine AF, a separate PMU with a dedicated Project Director and other staff, which includes a full-time E&S specialist, has been appointed. As such, this AF will be implemented by the new PMU. In terms of parent project implementation, activities have largely been Public Disclosure focused on (i) the procurement of PCR test kits, and laboratory and biomedical equipment, (ii) the provision of essential works, goods, and services to around 70 COVID-19 treatment centers around the country, (iii) the establishment of isolation units in secondary and tertiary care hospitals around the country, (iv) increasing the ICU/HDU bed capacity in the country, and (v) the provision of mobility support to public health cadres for outreach and contact tracing through the procurement of 26 cabs and 805 motorbikes to be used by MoH/PHIs. Further, interventions under the AFs have supported about 2.5 million in social protection and for the deployment of vaccines and vaccination-related services. Advocacy and communication, including risk communication, under the project, will be carried out by the Health Promotion Bureau (HPB), together with relevant program stakeholders of the Epidemiology Unit, MoH, and other partners. HPB has decades of experience and learnings implementing communication activities for the ‘National Immunization Programme’ (NIP). The ‘Friends of the Facility’ committees formed by the World Bank-financed Primary Sector Strengthening Project (PSSP) which are attached to the Primary Health Care Centers will support community outreach activities of the Vaccination program. The already operationalized GRM under the parent project which functions as the National Grievance Management System for Health Services will be utilized for the vaccination program as well. In addition, the Family Health Bureau already has capacities supported by the parent project to take forward the relevant GBV prevention measures during vaccination deployment. The Directorate of EOHS has also commenced a program to implement OHS measures among health workers addressing some of the requirements of the LMP prepared for the parent project and under implementation. The overall implementation of environmental and social (E&S) risk management measures is rated Moderately Satisfactory. Progress made in terms of complying with actions noted in the ESCP for parent and the first vaccination Sep 10, 2021 Page 7 of 23 The World Bank Third Additional Financing for Sri Lanka COVID-19 Emergency Response and Health System Preparedness Project (P177714) AF is as follows. ESS1: Untill around May 2021, the primary challenge under the parent project has been the limited capacity of the PMU to implement the PSSP and the SL-COVID Emergency Project and its AFs. Due to the emergency nature of the operation, the PMU of the existing PSSP was used to deliver the parent project as a fast track measure. While strengthening the capacity of the PSSP PMU, as necessary, with additional staff and resources was part of the parent project implementation plan, filling of key staff positions suffered considerable delays including the E&S specialists. However, this has been resolved now with a new dedicated PMU being set up for the SL-COVID Emergency Project and its AFs and recruitment of a E&S specialist has been completed. The two specialists designated from the DE&OH and HPB as an interim measure will also continue under the new PMU structure who will support the full-time E&S specialist. Going forward, maintaining a dedicated E&S specialist is critical to ensuring th successful implementation of E&S actions as described in the ESMF, SEP, LMP and ESCP of the parent project and the AFs. Preparation of screening reports for two new proposed IDH facilities, conducting relevant stakeholder consultations and the subsequent preparation of ESMPs have been satisfactorily completed by the PMU; ESS2: Labor-management procedures and Codes of Conducts have been included ESMPs which should be including bidding documents/contracts. ESS3: HCWM plans are being discussed for the two new IDHs. A rapid survey to document HCWM in vaccination centers to address any gaps are being planned.; ESS4: Covid19 health & safety guidelines included into ESMPs. Project is also supporting SEA/SE prevention and response measures. The project has also completed a risk assessment of the vaccination program run by the Sri Lankan army to ensure necessary requirements are met; ESS7: Consultations have been conducted with the Indigenous Veddha community and measures incorporated into SEP. The vaccination program also ensured that locations of where Veddha community resided received vaccinations; ESS10: UNICEF has been contracted to implement risk communication activities. Ongoing consultations were conducted during E&S screening and during military risk assessment. Notable progress has been Public Disclosure made in terms of operationalizing the project Grievance Redress Mechanism (GRM. The project supported GRM functions as the National Grievance Management System for Health Services. Procurement is ongoing to install an IT system to automate the GRM. In regards to training, interim staff has received training on E&S screening, ESMP, HCWM plan preparation, carrying out consultations/engaging stakeholders, GRM operations, labor management procedures etc. In summary, compliance of the parent project and the AFs towards meeting the commitments of the respective ESCPs are moderately satisfactory, with documentation of HCWM and overall ESF compliance reporting are areas that need to be strengthened going forward. II. SUMMARY OF ENVIRONMENTAL AND SOCIAL (ES) RISKS AND IMPACTS A. Environmental and Social Risk Classification (ESRC) Substantial Environmental Risk Rating Substantial The environmental risks of the proposed AF for vaccines will remain the same as the one before. The proposed AF will have net positive environmental and social impacts, as it will help contain the disease by supporting the procurement and delivery of vaccines island wide to expedite the national vaccination drive. The AF will carry out immunization according to the NDVP, and will include the younger population of the country from 18 years and up giving high priority to higher risks groups such as multiple disadvantaged or other vulnerable groups, those with compromised immune systems due to pre-existing conditions etc. The environmental risks are considered Substantial. The key risks include: (i) potential environmental pollution and community health and safety issues from Sep 10, 2021 Page 8 of 23 The World Bank Third Additional Financing for Sri Lanka COVID-19 Emergency Response and Health System Preparedness Project (P177714) handling, transportation, and disposal of HCW. Wastes such as sharps, syringes, vials, swabs, reagents, medical equipment and PPEs, some of which would be contaminated with blood and bodily fluids, will be generated in significant quantities.HCW will require special handling and awareness as it may pose a huge risk to health care workers from occupational infections and to the communities if not disposed properly. (ii) OHS issues related to potential infection of health care workers as well as communities through handling of patients, supplies, vaccination and, if deemed required, the installation of cold chain facilities. The safety of these front line workers would need to be ensured via proper infection control procedures and provision of adequate PPEs. There will be no new civil works funded under the AF. The project may support strengthening the cold chain for vaccine storage and deployment, if needed, and if so the specifications for such equipment will ensure that these will not have significant environmental issues. Sri Lanka has experience in managing infectious waste. Infection prevention and control procedures in health institutions, especially higher-level facilities, are fairly well standardized. Waste separation at source is almost 100% and many of the secondary and tertiary health institutions have already installed treatment capacity such as sterilizers and incinerators. However, the system is not without gaps and shortcomings and the volume of waste generated via the vaccination program could stretch the existing system capacity. As COVID-19 is highly infectious, the project will need to exercise the highest level of due diligence in planning and implementing precautionary measures against the two risks mentioned above. The project has a very comprehensive ESMF which incorporates international and national guidelines published specifically for infection control and health care waste management from COVID diagnostic, isolation, treatment and vaccination centers. It also includes guidleines on managing fire risks relating to oxygen concentrators and plants. The ESMF has been updated in lline with the last vaccine AFapplying the latest international best practices specifically published on handling COVID-19 vaccination and the related waste generation. The ESMF already includes a comprehensive generic Health Care Waste Public Disclosure Management Plan (HCWMP) which will be used in developing site-specific HCWMPs for vaccination centers. As such the existing ESMF is consered adeqayre to cover the risks from this AF and will only require minor revsions to relfect the proposed financial top-up for the vaccine program. Social Risk Rating Substantial The social risks are considered ‘Substantial.’ The notable social risks include: i) risk of exclusion of priority groups, especially those who are socially and medically vulnerable and disadvantaged, including minority groups due to targeting errors and/or discriminatory practices preventing them from receiving timely access to vaccines including due elite capture of vaccines, ii) inadequate public engagement, spread of misinformation/rumors (about vaccine safety, based on previous vaccine experiences and religious and cultural norms) creating confusion, anxiety and affecting uptake of the COVID19 vaccination, which could even lead to possible social tensions incase of inequities and/or discriminatory practices, iii) people feeling pressured to receive vaccination against their will, iv) risks of SEA/SH for females including for healthcare workers & risk of use of excessive force by military, v) health & safety risks due to lack of facilities to manage Adverse Effects Following Immunization (AEFI), and vi) health risks due to improper disposal of medical waste on open waste dumps and discharge of contaminated water, causing injury to waste pickers and contaminating land and surface water. The National Deployment and Vaccination Plan for COVID- 19 (NDVP) lays out the rationale and criteria for prioritizing high-risk groups for vaccination and priority groups have been selected based on the WHO Fair Allocation Framework. This includes health workers and frontline staff, elderly people aged 60 years or more, and younger people with other co-morbidities. Vaccination centers need to ensure that everyone will be treated equally and in a dignified manner including paying attention to specific, culturally determined concerns of minority and vulnerable groups. In regards to mananging AEFI, Sri Lanka has a well- established, targeted, time tested AEFI surveillance system which will be utilized following WHO guidelines during Sep 10, 2021 Page 9 of 23 The World Bank Third Additional Financing for Sri Lanka COVID-19 Emergency Response and Health System Preparedness Project (P177714) COVID10 vaccine deployment. Communication campaigns and stakeholder engagement activities will need to utilize multiple forms of channels of raising awareness including mobilizing community groups to disseminate information especially among disadvantaged or vulnerable groups in hard to reach areas and will seek to dispel any public misperceptions to address issues of vaccine hesitancy. Informed written consent will be obtained from eligible individuals who receive vaccination, and consent forms will be developed adhering to a specific legal framework. Vaccination centers will have gender-sensitive facilities such as organize separate queues for and help pregnant mothers including mothers with infants, have segregated toilets and have at least one female staff or female military cardre in place etc. The project will promote the avoidance of SEA/SH by adopting the WHO Code of Ethics and Professional Conduct for all health workers, including community groups and military personnel. The vaccination program will be based on National Immunization Programme of the Ministry of Health and will be supervised and monitored by the Epidemiology Unit of the Ministry of Health, Provincial Directors of Health Services, Regional Directors of Health Services, Regional Epidemiologists, and the area Medical Officers of Health. As the military is involved in the vaccination program, the project conducted a risk assessment to ensure that adequate measures are in place to address the associated risks. Based on the findings from the risk assessment, the army medical team has received the necessary training on vaccination guidelines to follow, the Code of Conduct governed by the Sri Lanka Army Act 1949 (also inline with WHO Code of Ethics and Professional Conduct) and on human rights principles (in line with Humanitarian International law). In addition, complaint reporting hotlines and recording books are available at all vaccination centers operated by the army. B. Environment and Social Standards (ESSs) that Apply to the Activities Being Considered Public Disclosure B.1. General Assessment ESS1 Assessment and Management of Environmental and Social Risks and Impacts Overview of the relevance of the Standard for the Project: The AF project will have net positive environmental and social impacts as it will improve COVID-19 disease containment as well as strengthen emergency preparedness of the health system for similar future crisis. However, the project could also cause significant environmental, social, health and safety risks due to the highly infectious nature of the disease that can cause health care associated infections to both health workers and community (that could even lead to fatalities) as a result of exposure and inadequate adherence to OHS measures. It can also pose specific risks to multiple disadvantaged or other vulnerable groups who would be receiving treatment parallelly in the same facility as the vaccination center for other conditions, esepcially those with compromised immune systems due to pre-existing conditions. As such, effective administrative and infection containment controls will need be put in place to minimize these risks. In addition, the large number of health care facilities which will be carrying out vaccintion across the country simulatenously will generate relatively large volumes of hazardous and potentially COVID contaminated wastes, such as sharps, syringes, vials, reagents, swabs, PPEs and other essential medical equipment, within a relatively short period of time. Environmentally and socially sound vaccination center management will require adequate provisions for minimization of occupational health and safety risks, proper management of hazardous waste and sharps, use of appropriate disinfectants, appropriate chemical and infectious substance handling, transportation, and disposal procedures, etc. The experience so far shows that the vaccination centres has been hitherto well planned and managed and has been conducted largely in adherance to recommended COVID prevention and safety measures. Sep 10, 2021 Page 10 of 23 The World Bank Third Additional Financing for Sri Lanka COVID-19 Emergency Response and Health System Preparedness Project (P177714) Sri Lanka has a long history of successful immunization programme in the country guided by the National Immunization policy, last updated in 2015 and has a section specifically for introduction of new vaccines. However, this is by far, one of the largest vaccination programs to be deployed in the country and as such the risk of the sector’s current capacity to safely manage HCW could be stretched. Sri Lanka has invested much in bringing immunization systems and service delivery capacity to the level required to deliver the COVID-19 vaccines and it is working well. This includes cold storage management that is critically important maintain the potency of the vaccines. Sri Lanka has adopted a portfolio approach in procuring vaccines from the market. At the onset of the gloval COVID vaccination Sri Lanka undertook an assessment of its cold storage facilities to suit the range of vaccines in the market and has been increasing its cold storage capacity as required. However, Bank funds have not been used for the purpose, and the proposed AF may support same, only if the country requires so. To mitigate these environmental and social risks, the Ministry of Health (MoH) will apply the the Revised Environmental and Social Management Framework (ESMF), dated February 2021. The revised ESMF includes a comprehensive generic Infection Control & Health Care Waste Management Plan (IC & HCWMP) which includes specific guidance & protocols on developing site-specific IC & HCWMPs, taking into consideration: (i) existing treatment and disposal methods within the facility, (ii) current treatment capacity, (iii) rapid measures needed to augment capacity and/or, (iv) alternative disposal methodologies. The ESMF is in line with WHO recommendations and best practices in COVID-19 diagnostic testing and handling of the medical supplies, COVID-19 response, disposing of the generated waste, and road safety. The ESMF of the parent project was revised after the first vaccine AF with necessary guidance to cover additional risks. As the proposed AF is a finacial top up for vaccine procurement, the Public Disclosure current ESMF is adeqaute. Only minor edits to document the financial top up will be required. Likewise, the existing LMP adequately covers OHS measures to be followed by staff and military personnel working at vaccination clinics. Site specific IC & HCWMPs will be prepared and E&S measures will be incorporated into operational plans for vaccination clinics. Codes of Conducts will also be prepared and adopted by supply workers, healthcare & frontline workers, including military in the vaccination program. Sri Lanka has a well-established targeted time tested AEFI surveillance system including AEFI guidelines that is compliant with international requirements such as WHO Global Manual on Surveillance of Adverse Events Following Immunization (2014). The NDVP details out the plans in place for vaccine safety monitoring, surveillance and management from which relevant clauses will be extracted to be included. The social exclusion risks associated with the AF will be managed by ensuring that targeting and provision of access to vaccination services are carried out in a fair, equitable and inclusive manner. The National Deployment and Vaccination Plan for COVID-19 (NDVP), identifies prioritized groups who will be targeted for COVID-19 vaccines following the WHO concept for fair access and equitable allocation of COVID-19 health products. The priority identification of target groups will be based on the criteria specified at the time of the COVAX-AMC, COVAX application for COVID-19 vaccines and as per the NVDP prepared in early January 2021. However, based on availability and supply of COVID-19 vaccines and the demand, the priority population groups may have to be adjusted. Identification and referral of eligible target population for vaccination will be done as a collaborative effort between health and non-health agencies. Further, with regards to gender, there is a risk that vaccine deployment plans could leave women behind, considering the larger male mortality of COVID-19. The project will seek to ensure equitable targeting of vaccines among women, especially those also in the high-risks groups, during vaccine Sep 10, 2021 Page 11 of 23 The World Bank Third Additional Financing for Sri Lanka COVID-19 Emergency Response and Health System Preparedness Project (P177714) deployment by working with PH midwives and civil society organizations that work on women’s issues to ensure equal access to vaccines. The mobile vaccination program operated by the army will continue that prioritizes the vaccination of the elderly, sick, handicapped and feeble sections in society, a combined effort of the Sri Lanka Army Medical Corps (SLAMC), Directorate of Preventive Medicine and Mental Health MOH, Directorate of Supply and Transport, Sri Lanka Signal Corps, Sri Lanka Corps of Military Police. The SEP has also been revised to include details of project affected people, interested parties and vulnerable groups to be reached under the AF as well as key communication messages and channels to be utilized in reaching out to all key stakeholders. Requirements to conduct regular consultations, at different levels, with different partners, and in a culturally appropriate manner, is also described in the SEP. The project will use multiple outreach platforms for information sharing on the vaccination program, to dispel myths and improve vaccine uptake, including radio/TV, social media, information hotlines, community-based platforms, etc. The existing GRMs will also be made available for public to raise any complaints. GoSL does not have mandatory and forced vaccination policies. The NDVP details the procedures to ensure that voluntary consent will be obtained from all eligible individuals. Accordingly, policies and procedures are in place to ensure voluntary consent is obtained before vaccinating any individual and that there will not be any forced vaccination. Informed written consent will be obtained from eligible individuals who receive vaccination. A special COVID-19 vaccination card is also being developed. Monitoring and evaluation of the programme will be done to identify vaccine uptake, coverage for each dose, and to identify dropout rates. Public Disclosure In order to address risks associated with gender-based violence as well as equal access to information and services, the ESMF will also draw on COVID-19 Outbreak and Gender: Key Advocacy Points from Asia and the Pacific and other key internationally accepted guidlines. Operational guidelines for vaccination centers will ensure that everyone will be treated equally and in a dignified manner including paying attention concerns of minority and vulnerable group. In addition, vaccination centers will organize separate queues to help pregnant mothers including mothers with infants, have segregated toilets and have at least one female staff or female military cardre in place etc. By engaging female community health workers and female health workers and considering gender sensitive communication and information sharing approaches, the project will mitigate the risk of sexual exploitation, harassment and abuse as well as addressing social/cultural barriers to women’s access to information and to the vaccination program. The project has completed a risk assessment of the military run vaccination centers to ensure that measures are in place to address associated risks involved. The conduct of the military personnel, engaged with the public will be governed by the Sri Lanka Army Act 1949 and the standing order containing regulations and procedures to be followed by the military personnel deployed for vaccination, issued by the Commander-in-Chief of the army infantry unit. In addition, the ESMF describes detail measures that will be adopted when engaging military in the vaccination program. In doing so, the environmental and social assessment will be guided by the principles of proportionality and GIIP, and by applicable law, in relation to engaging security forces, rules of conduct, training, equipping, and monitoring of security forces. Sep 10, 2021 Page 12 of 23 The World Bank Third Additional Financing for Sri Lanka COVID-19 Emergency Response and Health System Preparedness Project (P177714) ESS10 Stakeholder Engagement and Information Disclosure The project has a structured approach to stakeholder engagement and public outreach that is based upon meaningful consultation and disclosure of appropriate information, considering the specific challenges associated with deployment of COVID19 vaccination. The SEP prepared for the parent project, has been updated in relation to the last AF on vaccines and it includes measures related to the provision of the COVID-19 vaccine. Among others, the updated SEP acknowledges the particular challenges with engaging marginalized and vulnerable social groups such as people with comorbidities, elderly, persons with disabilities, Veddha community, etc., and provides details on the communications, outreach and stakeholder engagement activities that will be carried out to ensure proper awareness raising, and timely and equitable information dissemination of the vaccination program. Stakeholder engagement strategies also point out ways to minimize close contact and follow the recommended good hygiene procedures as outlined in the US-based Centers for Disease Control (CDC) for patients with confirmed COVID-19 or persons under investigation for COVID-19 in health care settings. The current SEP, thus, will continue to apply to all implementing agencies to engage citizens (affected people, interested parties and vulnerable groups) as needed and for public information disclosure purposes. The community engagement (CE) approach, as described in the revised SEP, is based on the national COVID-19 vaccine deployment plan. The CE strategy, focuses on demand generation in communities, clarifying target groups and removing misconceptions related to vaccinations while ensuring a community feedback loop. Thus the objectives of the community engagement strategy includes: (i) disclosure of the criteria and justification for priority populations identified for vaccination programme, including clarification that people below 18 years of age will not be in the priority targeted group to receive the vaccines in the interim until the safety of vaccines for these groups has been Public Disclosure confirmed, (ii) building trust and awareness on COVID-19 vaccines, using data and evidence to dispel rumors and public misperceptions and to address vaccine hesitancy to improve demand generation, (iii) development and provision of context specific IEC/BCC materials targeted to priority groups, details on available services at the vaccination centers catering to needs of women and other high-risks groups and measures in place to manage Adverse Effects Following Immunization (AEFI), (iv) training of front line workers, including ‘Friends of Facility Committees’ about the COVID-19 vaccine, its importance and measures to promote safety and wellbeing of the public, (v) promoting the COVID-19 vaccine through use of different channels, including mass communication, social media and community & public outreach interventions, (vi) citizen engagement, feedback and grievance redressal mechanisms in place for the vaccine program, and (vii) dissemination of information on available services and helplines, and integrating SEA/SH mitigation measures in the SEP. WB supported the implementation of the national risk communication activities through the ERHSP. The campaign carried out in collaboration with the Health Promotion Bureau (HPB) tracks public perception of COVID-appropriate behavior, vaccine hesitancy, news and possible misinformation. In addition, a national media campaign was launched in May 2021 on national television and through social media to disseminate public information on infection prevention and control and safety protocols related to the resumption of daily activities. The campaign, which included short video clips, public service announcements, news segments, and animated advertisements, has reached approximately 15 million people through national television, and has recorded a reach of 5.3 million, with 1.6 million engagements on social media. Formative research and social listening tool to obtain real time, the sentiments and trends of key groups. This will enable the MOH to emend the communication campaign where necessary to address rumors, false believes on social media which need to be quickly addressed. These advocacy and Sep 10, 2021 Page 13 of 23 The World Bank Third Additional Financing for Sri Lanka COVID-19 Emergency Response and Health System Preparedness Project (P177714) communication activities, including risk communication, will be carried out by the Health Promotion Bureau (HPB), together with relevant programme stakeholders of the Epidemiology Unit, Ministry of Health, other health officers, and other partners. In addition, community groups such ‘Friends of Facilities Committees (FFCs)’ and Grama Niladari officers will also visit homes sharing information about the COVID19 vaccination program especially in hard to reach areas. The NDVP recognizes gender gaps in healthcare access, vaccine hesitancy and obstacles due to lack of female vaccinators. Experience under the COVID-19 vaccination drive indicates that vaccine hestiancy is not a major challenge. In order to ensure proper outreach and vaccination of women and younger groups, the AF will support targeted communication, as outlined in the NDVP, to disseminate information regarding the COVID-19 vaccination, particularly to dispel misconceptions about vaccines. Furthermore, the project will also mobilize ‘Friends of Facility Committees’ especially females, to play a critical role in communicating with women, providing them information about the vaccine and managing misinformation regrading COVID-19 vaccination during the roll-out and deployment. Awareness sessions will also target male family members who may prevent women from accessing the vaccine. To encourage women to get vaccinated, the vaccination centers will include female vaccinators who will also support outreach activities at the community level. The NDVP specifies that the vaccination team will include at least one female staff and out of four staff at the Vaccination centers. Vaccination sessions will be planned considering the privacy of clients. The vaccine program will utilize the existing GRM of the parent project which currently functions as the National Grievance Management System for Health Services. Notable progress has been made in terms of operationalizing Public Disclosure the project Grievance Redress Mechanism (GRM), which will have and will continue to play an important role in the vaccination program, too. The project supported GRM functions as the National Grievance Management System for Health Services. Grievance can be received through postal mail, e-mail (Suwasawana@health.gov.lk), short cord hotline (1907) and social media including WhatsApp & Viber. National call center is well resourced, can receive complaints in all local languages. GRM units have been established and awareness created in island wide in all hospitals. In addition to awareness done at hospitals, GRM details were published in the MoH website and through other ministry newsletters. Grievances are manually analyzed and forwarded to relevant departments in the MoH for responses. Procurement is ongoing to install an IT system to automate the GRM. The national call center has been adequately staffed and is able to receive complaints in English and in the two local languages. GRM units/committees have been established at in Hospitals nationwide. Since the establishment of the GRM, 1552 grievances have been received and 1314 have been resolved. As the project supports the entire health system, it is not possible to separately identify grievances related to project financed activities. However, the GRM at the moment analyzes the different types/categories of grievances received. From the grievances recived, 928 of the grievances were from people requesting Pfizer vaccine and others vaccine related enquiries such as requesting vaccines / vaccine certificates for foreign employees and individuals to be immigrated, requesting vaccines for elderly, people with special needs and pregnant mothers. Accordingly, the GRM guided the callers to information sources and also diverted the calls to MoH information hotline 1906 . Based on the types of grievances received, MoH strengthened its communication activities to address information gaps, e.g.: MoH encouraged public to not pick and choose vaccines, but to take the most accessible vaccine. At military run vaccination centers, complaint reporting hotlines and recording books are made available. Going forward, project will ensure the continued public disclosure of GRM details throughout the country through broadcast and print media. The grievance redress system will also be Sep 10, 2021 Page 14 of 23 The World Bank Third Additional Financing for Sri Lanka COVID-19 Emergency Response and Health System Preparedness Project (P177714) equipped to further to handle cases of SEA/SH with a survivor-centered approach and refer cases to key GBV service providers eg: MoH GBV Care centers (Mithuru Piyasas) , NGOs (e.g. Women In Need) etc. B.2. Specific Risks and Impacts A brief description of the potential environmental and social risks and impacts relevant to the Project. ESS2 Labor and Working Conditions Most activities supported by the AF project will be conducted by health staff and supportive non-health staff, i.e public servants and temporary workers employed by the MOH or provincial DOHs. Each vaccination centre will be staffed by a minimum seven health and supportive staff following the standard guideline for COVID 19 vaccination centres issues by the MoH. Activities under the vaccination program encompass delivery of vaccines, cold storage management, risk communication, mass communication for vaccine uptake, patient registration, vaccine administration, patient management and emergency treatment, handling and disposal of health care waste generated. At district level, the execution of the COVID 19 operations including vaccination happens under the guidance and supervision of the Governor of the province and the Provincial Director of Health Services, through a joint mechanism. The stakeholders of this joint mechanism are: the Governor, the District Secretary, Regional Director of Health Services, Deputy Inspector General of Police of the province, and the District Military Coordinator. The MOH and the District Secretary are responsible for the administrative planning of the vaccination process at district level – Public Disclosure dates and venue for vaccination and associated arrangements etc. and the Regional Epidemiologist requests the army medical team to supply a vaccination team to carry out vaccination at district locations based on the needs and thereafter the military undertakes to transport vaccines to the vaccination centers and administer the vaccines following the MOH COVID 19 vaccination guidelines The involvment of the Sri Lanka Army Medical Corps has contributed expedite the execution of the vaccination program of the MoH. The Sri Lanka Army Medical Corps has exactly same cadre structure as that of its counterpart MOH and receive the same basic and post graduate training the MOH professionals- medical specialists, medical officers, nursing staff, Public health inspectors, public health midwives – receive. Hence the army medical team supplements the national vaccination program under the overall supervision of the MOH who have been trained on the same processes and use the same guidelines issued by the MOH for COVID19 vaccination. The key risk for workers is exposure to COVID-19 (or other contagious illnesses as patients taken seriously ill with COVID-19 are likely to suffer from illnesses which compromise the immunes system, which can lead to illness and death of workers). The project will ensure the application of OHS measures as outlined in WHO guidelines which are captured in the updated ESMF and IC & HCWM plans. This encompasses procedures for entry into vaccination centers, including minimizing visitors and undergoing strict checks before entering; procedures for protection of workers in relation to infection control precautions; provision of immediate and ongoing training on the procedures to all categories of workers, and post signage in all public spaces mandating hand hygiene and PPE; ensuring adequate supplies of PPE (particularly facemask, gowns, gloves, handwashing soap and sanitizer); and overall ensuring adequate OHS protections in accordance with General Environmental and Health Safety Guidelines (EHSGs) and industry specific EHSGs and follow evolving international best practice in relation to protection from COVID-19. Sep 10, 2021 Page 15 of 23 The World Bank Third Additional Financing for Sri Lanka COVID-19 Emergency Response and Health System Preparedness Project (P177714) The experience so far inidcates that the main challenge at vaccination centres are the large numbers of people who que up to get the vaccine. However, this congestion is expected to reduce as the vaccination program continues with more and more people are fully vaccinated. However, all vaccination centres have been observed to be well managed in adherence with the basic health and safety protocols. Measures will also be put in place to provide additional psychosocial support and facilities for health workers to protect from burnout due to the increase in workload. To support female frontline workers the project will provide a stipend so they can arrange for childcare support for their children while participating in the roll out the vaccine. To encourage women to get vaccinated, the vaccination centers will include female vaccinators who will also support outreach activities at the community level. The NDVP specifies that the vaccination team will include at least one female staff and out of four staff at the Vaccination centers. The use of child labor will be forbidden in accordance with ESS2, i.e. due to the hazardous work situation, for any person under the age of 18. It will further be ensured that workers have access to necessary PPE and handwashing stations. Furthermore, there have not been any suspension or reductions in salaries and other benefits for healthcare or for other essential workers due to COVID-19 emergency measures and the project will continue to ensure that workers rights will be respected such as provision of overtime compensation, annual or sick leave, or severance etc. No large-scale labor influx is expected under the project. The project will adopt the WHO Code of Ethics and Professional Conduct for all health workers including community groups and military personnel. The conduct of the military personnel engaged with the public is also governed by the Sri Lanka Army Act 1949. Discussions have also been held with the newly recruited ESF Specialist (who will be the focal person to operate the labor GRM) to prepare Public Disclosure the necessary labor GRM guidelines, create necessary awareness and put systems in place to soon operationalize the GRM for project workers. The labor GRM will be made operational by the time of this AF becomes effective. The labor GRM will allow workers to quickly inform involved agencies of labor issues, such as a lack of PPE, unreasonable overtime, unsatisfactory work conditions etc. Accordingly, the project’s LMP will be updated with these additional measures. ESS3 Resource Efficiency and Pollution Prevention and Management The GoSL has conducted the vaccination program through district hospitals, field clinincs and lately though military hospitals which has shown to be quite efficient. This system is likley to continue until all eligible people in the country are fully vaccinated. Vaccination has been rolled out in a well organised manner recording a maximum of 500.000 innoculations a day. Hazardous waste produced by these clinics such as sharps, syringes, vials, packaging, PPEs and other medical equipment (all of which carry a high potenti risk of contamination with infections) has been collected safely in designated bins/boxes and taken to the nearest hospital with incineration facilities for final disposal or collected by provate sector service provides operating inconerators for clinical wastes. There is no evidence to indicate that the existing system has failed under the additional loads. Health care waste requires special handling and awareness as it could pose a huge risk to the environment from inadequate disinfection and unsafe disposal, which in turn can pose risks of occupational infections to health workers as well as communities nearby. The project will continue to pay close attention to this areas of HCWM. Sep 10, 2021 Page 16 of 23 The World Bank Third Additional Financing for Sri Lanka COVID-19 Emergency Response and Health System Preparedness Project (P177714) As stated before, Sri Lanka has made good progress in terms of HCWM with several secondary and tertiary care hospitals having obtained the Environment Protection License. These larger facilities have been continually upgraded with regard to their capacity to handle health care waste in a safe manner. However, gaps and shortcoming do exist, especially in the primary care sector where resources for safe HCWM and awareness among health workers are not yet up to standard. Each vaccination center or a cluster of centers within a given geographical areas, is required to prepare a site-specific IC & HCWMP following guidelines provided in the revised ESMF as of May 2021 (refer ESS1 above). These updates, which were done in response to the last vaccine AF, has incorpoarted guidance from the WHO COVID-19 vaccination guidance documents, the World Bank Group Environmental Health and Safety Guidelines for Waste Management Facilities and other best international practices in order to prevent or minimize accidental infections resulting from poor OHS and environmental contamination. The ESMF also includes guidance on the safe transportation and management of vaccines, samples and medical supplies or expired chemical products at distribution centers and health care facilities. No civil works are planned under the AF and in the event project funds are utilised for cold chain storage, priority will be given to procure energy efficient equipmet with with low GHG footprint . Given the highly expeditious and emergency nature of the vaccine drive, a rapid survey to document what has/not worked in safely handling HCW generated from the vaccination drive would need to be carried out. This would help identify a plan to procure basic facilities (such as sharp shredders, autoclaves, bins, incinerators of appropriate capacity) to strengthen disinfection, transport and disposal of HCW as the county continues to battle against COVID- 19. Public Disclosure ESS4 Community Health and Safety It is important for the project to ensure the safety of communities from potential COVID-19 as well as other infectious disease transmition due to project activities. As noted above, health care wastes generated at vaccination centers have high potential of transmitting pathogenic micro-organisms that can infect the community at large through accidental pricks and injuries from improperly disposed sharps in landfills and open dumps, contamination of land, water, air or through direct contact. There is a possibility for pathogens to be introduced into the environment if waste streams are not well contained/managed or due to accidents/emergencies. The IC&HCWMP in the ESMF describe: (i) how vaccination activities will be carried out out with all necessary biosafety measures with low incidences of accidents and incidents in line with Good International Industry Practice (WHO guidelines), (ii) measures in place to prevent or minimize the spread of COVID-19 and other infectious diseases, and (iii) emergency preparedness measures. Based on this, site-specific or cluster specific plans will need to be derived. All vaccination centers supported by the project will therefore have to follow respective procedures on proper handling, transport and disposal of HCW and stringent measures for infection control especially those workers cleaning before leaving the work place back into their communities. The observations of the vaccination clinics held so far are that they are well organised, with all health care and associated personal adhereing to personal protective measures and COVID safety guidelines, vaccination and patient data documentation is well carried out and that the waste is safely collected and disposed of. The vaccination clinics are supported by the Public Health Inspectors who Sep 10, 2021 Page 17 of 23 The World Bank Third Additional Financing for Sri Lanka COVID-19 Emergency Response and Health System Preparedness Project (P177714) help in ensuring adherance to COVID safety protocols and crowd management. The project has not received any grievances from communities on safety concerns, accidnetal injuries and infections so far. There is a very closely monitored cold chain system throughout the country with necessary precautionary measures built in to ensure potency of vaccines is maintained to minimize undue adverse events due to cold chain failures. Strict cold chain monitoring is done for all vaccine storing cold rooms through electronic systems. All the locations have their own power failure contingency plans such as backup power generators and thermo-stabilizers to ensure continued stable power supply for recommended temperature monitoring. As such, the borrower has adequate capacity to implement vaccine cold chain temperature monitoring in line with GIIP, during vaccine chain transport, storage and handling process. The NDVP has undertaken an assessment of cold storage available in the country for the plethora of COVID vaccines available in the market. Since SL’s successful immunization program usually stores vaccines in temp between 2 – 8 degrees, ultra-cold chain facilities are limited to the central level institutions. However, ultra-cold chain facilities from blood banks and universities will be deployed and the balance storage capacity will be procured in readiness to accept those vaccines that need -70 degree temperatures. So far, funds from the Bank funded project has not been utilised for cold strorage. The new AF may provide funding for cold storage, should the need arise and the Government requests assistance. A road safety plan for vaccine transportation has been included in the revised ESMF of May 2021. Measures to avoid/mitigate road accidents including transport disruptions due to unexpected floods/landslides/ storms etc. are covered in the road safety plan. Alternatives for transport disruptions will be identified and made available as backup for respective MOH offices. Vaccine distribution and transport is strictly monitored by the MOH and there has been Public Disclosure no recorded road accidents in relation to vaccine carrying vehicles. GoSL does not have mandatory and forced vaccination policies. The National Deployment and Vaccination Plan for COVID-19 (NDVP) details the procedures to ensure that informed written consent is obtained from eligible individuals who receive vaccination. Eligible participants will be duly informed on the benefits and possible adverse events of the vaccination and possible duration of protection before offering the vaccination. In the event of the vaccine receiver / eligible person is not mentally stable to provide the informed written consent, a responsible care giver will be identified to provide the consent. Another community health concern in the project include the potential for individuals to experience adverse events (including serious contraindications and illnesses) following vaccinations, although these events rarely occur. The country’s existing guidelines will be implemented for the Adverse Events Following Immunization (AEFI) detection, reporting and management of such events. Eligibility screening will be done by competent health staff capable of identifying contra indications for vaccination. Readiness for AEFI will be ensured by developing adequate competencies through trainings, and ensuring proper screening for AEFI before vaccination. Emergency readiness is assured through observation for minimum 20 minutes post vaccination, the availability of emergency trays with essential medicines together with oxygen facilities for proper management and specialized care arrangements at all vaccination centres. Accordingly, the MoH will closely monitor, track and respond to adverse events including provisions for compensation. This would be done with reference to the guidelines in the WHO Global Manual on Surveillance of Adverse Events Following Immunization (2014). Sep 10, 2021 Page 18 of 23 The World Bank Third Additional Financing for Sri Lanka COVID-19 Emergency Response and Health System Preparedness Project (P177714) Th project will assess Sexual Exploitation and Abuse/Sexual Harassment (SEA/SH) risks associated with project activities and take measures to mitigate the potential SEA/SH risks, by integrating SEA/SH components in trainings for healthcare workers, disseminating information on available services and helplines, and integrating SEA/SH mitigation measures in the SEP. By engaging female community health workers and female health workers and considering gender sensitive communication and information sharing approaches, the project will mitigate the risk of sexual exploitation, harassment and abuse as well as addressing social/cultural barriers to women’s access to information and access to vaccine. The project will ensure that all the vaccine centers have measures in place to promote gender friendly environment and enhance women and girls’ safety. The centers will organize separate queues for and help pregnant mothers including mothers with infants, have segregated toilets and have at least one female staff or female military cardre in place etc. Information and notices will be displayed on Code of Conduct, stating zero tolerance of SEA/SH with contact numbers to key GBV service providers eg: Mithuru Piyasas, WIN, and accessible and accessible GRMs to female beneficiaries. The project will promote the avoidance of SEA/SH by adopting the WHO Code of Ethics and Professional Conduct for all health workers, including community groups and military personnel. As the military is involved in the vaccination program, the project has conducted a risk assessment to ensure that adequate measures are in place to address the associated risks. Based on the findings from the risk assessment, the army medical team has received the necessary training on vaccination guidelines to follow, the Code of Conduct governed by the Sri Lanka Army Act 1949 (also inline with WHO Code of Ethics and Professional Conduct) and on principles of human rights (in line with Humanitarian International law). In addition complaint reporting hotlines and recording books are available at all vaccination centers operated by the army. Additional standing orders issued by Commander-in-Chief of the army infantry unit Public Disclosure stipulates, among other things, that every military person should conduct himself/herself with dignity, integrity and respect for the public, upholding the credibility of the army, and should : be unarmed, be vigilant of the persons entering the vaccination centers, manage the vaccine recipients in a public-friendly manner without causing any inconvenience to them, not vaccinate persons in army uniforms, organize separate queues for and help pregnant mothers, infirmed, elderly, mothers with infants, maintain cleanliness of the vaccination centers at all times etc. Both female and male military health cadres are deployed at these centers for ensuring gender respect, dignity among the patrons during the vaccination program. In the event of any violations of provisions as set out in the Army Act of Sri Lanka, inquiries will be held by the military police and if any person found guilty of offence will be punished and sanctioned under “punishments by courts martial in respect of civil offences” of the Army Act of Sri Lanka. Military police is responsible for monitoring and taking action. Presence of military police at community vaccination centers is also mandatory as army personnel involved in public activities have to be accompanied by the military police. Accordingly, the ESMF provides detail measures to be followed guided by the principles of proportionality, GIIP and applicable law. LMP also describes protocols & measures to prevent and respond to unlawful/abusive behavior, including sexual exploitation and abuse (SEA)/sexual harassment (SH) or excessive use of force, to ensure that such security/military personnel are adequately instructed and trained prior to deployment; and grievances mechanism to receive, monitor and resolve any complaints regarding the conduct of security/military personnel are also available. SEP also details the communication strategies to be implemented during military involvement. Sep 10, 2021 Page 19 of 23 The World Bank Third Additional Financing for Sri Lanka COVID-19 Emergency Response and Health System Preparedness Project (P177714) ESS5 Land Acquisition, Restrictions on Land Use and Involuntary Resettlement This standard is currently considered Not Relevant. The project is expected to deliver the vaccination program through existing facilities. As such, no land acquisition is envisaged or required. ESS6 Biodiversity Conservation and Sustainable Management of Living Natural Resources The vaccination program will take place within existing facilities. Any capacity enhancement HCWM will be done within existing systems given the fast track nature of the support. Hence, impacts of the project on natural resources and biodiversity are likely to be none or low, as such this standard is considered Not Relevant. ESS7 Indigenous Peoples/Sub-Saharan African Historically Underserved Traditional Local Communities Sri Lanka’s population includes Veddhas, primarily forest-dwellers, whose collective identity and presence is consistent with the characteristics that are specified in paragraphs 8 and 9 of ESS7. The population of Veddhas is estimated to be around 5000 - 10,000 and while they used to be concentrated in the south-central jungles of Sri Lanka, in the area known as Mahiyangana, they are becoming completely assimilated with most of them speaking Sinhala instead of their indigenous languages—the latter now nearing extinction. The proposed AF activities do not present adverse impacts on indigenous people. However, there is a potential for marginalizing indigenous and vulnerable people in accessing vaccines and vaccine related information. Vaccine Public Disclosure deployment and delivery when available, could counter local perceptions as well as cultural protocols and local medicinal practices of IP groups. Accordingly, ESS 7 is considered relevant for this project. Based on the experience of the first vaccine AF, vaccination of priority groups of vedhha community has been successfully carried out. The Vaccination of two dosages of Sinopharm vaccine has been completed for the age group above 60 years and the first dosage of the Sinopharm vaccine has been given for the age group above 30 years in MOH areas where highest population of “Vadda” community reside. These locations are: Dambana, Henanigala, Rathugala, Nilgala under the preview of MOH offices of Bibile, Ampara and Mahiyanganaya. Going forward, second AF for vaccines will also carryout vaccinations among the Veddas giving due respect for the rights, dignity, aspirations, identity, culture and livelihoods of IPs. Training and capacity building for health care workers under the project will emphasize the need to provide care for the priority and eligible population, regardless of ethnicity and social status, and with due considerations for the cultural protocols of IPs. The relevant aspects of ESS7 will be adopted to ensure full participation and consultation of IPs throughout the project implementation, and to create culturally-sensitive mechanisms by which IPs can raise concerns or seek redress for project-related grievances. Consultations and vaccination campaigns will be conducted through partnership with relevant IP organizations and traditional authorities. Lastly, stakeholder engagement and vaccinations will be conducted with extra precautions to minimize COVID-19 transmission risks, especially for Indigenous Peoples living in more remote areas or in voluntary self-isolation. This may require testing or vaccinating intermediaries conducting consultations who may travel in and out of communities. Based on the information available, the project activities (i) will not Sep 10, 2021 Page 20 of 23 The World Bank Third Additional Financing for Sri Lanka COVID-19 Emergency Response and Health System Preparedness Project (P177714) undertake forced vaccination; and is (ii) not expected to induce adverse impacts on land belonging to indigenous groups and are not expected to cause relocation of such groups or cause material changes to their ways of life. The principles and parameters to guide project activities among IP groups will be set out in the revised ESMF & SEP. ESS8 Cultural Heritage This standard is currently considered Not Relevant as the project is not expected to support any construction or rehabilitation activities that would involve the movement of earth (thereby potentially having an impact on tangible cultural heritage), or other activities that could have an impact on intangible cultural heritage. ESS9 Financial Intermediaries This standard is Not Relevant for the suggested project interventions, as no financial intermediaries will be used. B.3 Other Relevant Project Risks Sri Lanka has a long history of conducting successful immunization programs in the country guided by the National Public Disclosure Immunization policy, last updated in 2015, that has a section specifically for introduction of new vaccines. The implementation of the policy is guided by the National Advisory Committee on Communicable Disease (NACCD) and the National Immunization Technical Advisory Group (NITAG). The Epidemiology Unit within the MoH is the main responsible agency for the implementation, monitoring and evaluation of the National Immunization Policy. Immunization program is an integral part of the preventive care serves delivered through a well-structured network staffed by trained health care cadres with a strong information and risk management system. However, rolling out a mass vaccination operation at this scale can pose challenges that have not surfaced in the routine EPI program (as asmall error in logistic arrangement may disrupt the overall operation). There are uncertainties related to the COVID- 19 vaccine market, including trial, approval, availability and pricing, which require flexibility. Given the high demand for vaccines in the region and globally, considering a single type of vaccine will pose a risk of delays in provision given the limited production capacity of the manufacturers. Whilst the Project focuses on vaccines meeting the World Bank vaccine approval criteria, there is a risk that in some cases other vaccines procured by the Recipient under its national vaccination program (which might include vaccines not meeting the World Bank vaccine approval criteria) might end up being deployed through systems financed under the Project. These risks will be closely monitored by the World Bank during implementation. The project includes interventions to scale up and strengthen the implementation of effective NDVP. In addition, through robust monitoring, any risks related to improper storage of vaccines, delays in delivery and administration of vaccines caused by shortage of needed inputs/supplies will be identified and addressed. The World Bank will continue to engage with the GoSL and partners to secure vaccines and ensure its timely delivery. Developing plans for potential acquisition of other types of vaccines, when they become available and receive the necessary regulatory approvals, would spread the risk of delays in vaccine supplies due to production capacity. Sep 10, 2021 Page 21 of 23 The World Bank Third Additional Financing for Sri Lanka COVID-19 Emergency Response and Health System Preparedness Project (P177714) C. Legal Operational Policies that Apply OP 7.50 Projects on International Waterways OP 7.60 Projects in Disputed Areas B.3. Reliance on Borrower’s policy, legal and institutional framework, relevant to the Project risks and impacts Is this project being prepared for use of Borrower Framework? No Areas where “Use of Borrower Framework” is being considered: Not Applicable IV. CONTACT POINTS World Bank Contact: Deepika Eranjanie Attygalle Title: Senior Health Specialist Public Disclosure Telephone No: 5723+311 / 009-411-5561311 Email: dattygalle@worldbank.org Contact: Srinivas Varadan Title: Senior Social Protection Specialist Telephone No: 5785+79127 Email: svaradan@worldbank.org Borrower/Client/Recipient Borrower: Democratic Socialist Republic of Sri Lanka Implementing Agency(ies) Implementing Agency: Ministry of Health State Ministry of Samurdhi, Household Economy, Micro Finance, Self-Employment, Business Implementing Agency: Development, Implementing Agency: Ministry of Finance V. FOR MORE INFORMATION CONTACT Sep 10, 2021 Page 22 of 23 The World Bank Third Additional Financing for Sri Lanka COVID-19 Emergency Response and Health System Preparedness Project (P177714) The World Bank 1818 H Street, NW Washington, D.C. 20433 Telephone: (202) 473-1000 Web: http://www.worldbank.org/projects VI. APPROVAL Task Team Leader(s): Deepika Eranjanie Attygalle, Srinivas Varadan Practice Manager (ENR/Social) Maria Beatriz Orlando Cleared on 08-Sep-2021 at 14:38:2 GMT-04:00 Public Disclosure Sep 10, 2021 Page 23 of 23