Tunisia SAHA QA - 20200601.docx

June 1, 2020 Tunisia Supporting Anti-Corruption in Healthcare Administration (SAHA) NOFO – SFOP0006619 Questions and Answers

1. In reference to funding opportunity # SFOP0006619, entitled “Tunisia Supporting Anti-Corruption in Healthcare Administration” (SAHA), we would like to confirm our organizational eligibility to apply before we proceed with the proposal preparation. The NOFO states on page 2 that “Applications will be accepted only from organizations that have previously operated in the Middle East & North Africa (MENA) region or have personnel who have previously worked in Tunisia and can demonstrate the ability to work with the MoH”. Our organization has no previous work experience in Tunisia. However we do have current programming in select Middle Eastern countries that is being implement by local partners on the ground. In preparing the application for this NOFO, we will 1) have local and international partner organizations with direct relevant experience in Tunisia; and 2) have key personnel who is working or have worked in Tunisia. Will the two conditions described above meet the eligibility requirement for this NOFO?

Answer: Confirming eligibility.

2. Can you share the “Integrated Country Strategy (ICS) sub objective 2.1.2” with us? (ref p6) Answer: An unclassified version of the ICS for public consumption can be found here.

3. What are the key findings of the WHO Mar 2019 debate on health sector challenges- corruption etc.? (ref p6) Answer: NEA cannot provide this information at this time.

4. Is there any report available or healthcare vision paper for the future?

Answer: Applicants are responsible for conducting their own research.

5. Will responders be provided with a current overview of existing regulatory framework and governance- and which departments are included?

Answer: Applicants are responsible for conducting their own research.

6. Are current regulatory process & procedures documented and maintained electronically or paper based?

Answer: Electronically.

7. What is the current Governance model, can this be shared?

Answer: NEA is unable to answer this question.

8. Is there a reference/aspirational framework they are working towards- US/UK/France/etc..?

Answer: NEA is unable to answer this question, but aims to support the MoH to achieve the best framework for the Tunisian context.

9. Will there be a country specific legal advisory support pertaining to local legal matters available?

Answer: The selected applicant is expected to abide by all applicable Tunisian laws without the direct support of the Embassy.

10. What is the delivery expectation- any guidance on phasing of workstreams i.e. expected timeframes for initial engagements, track and trace implementation, training etc.

Answer: Applicants should propose the timeline they deem best to achieve successful implementation.

11. Has there been any audit/gap analysis already carried out to assess current state and potential areas for improvement? If so, can this be shared.

Answer: There were multiple sources that informed project design for this opportunity, but nothing that can be shared at this time.

12. What is the volume of individual units of pharmaceuticals used annually in Tunisia?

Answer: Applicants should conduct the research necessary to put together their proposal.

13. What does the supply chain look like now? Number of pharmaceutical companies external? Internal? Number of distributors? Number of hospitals?

Answer: Applicants should conduct the research necessary to put together their proposal.

14. What is the current system/methodology in place for medicinal tracking? How are products tracked today?

Answer: Applicants should conduct the research necessary to put together their proposal.

15. What, if any, other systems are in place where potential integration will be required (e.g., “…better linking the MoH with the central pharmacy”.)?

Answer: Applicants should conduct the research necessary to put together their proposal.

16. Will there be a technical discovery opportunity session prior to response submission to gain a better understanding of potential areas of integration?

Answer: At this time, there are no such sessions planned.

17. Section VI A.1. - As we understand it, the grant is up to $5 million for the first 3 years, and a possible additional $1.5 for two more years – so a possible total of 5 years and $6.5 million. However, the language in this section says, “…the option year period of up to two years (for up to a total four-year project period)…” Please confirm timeframes and year totals?

Answer: There was a mistake in NOFO. NEA intends to award a 3 year project with option years that would bring the award to a potential 5-year total period of performance.

18. Section VI A.1. – Are the three pages allotted for the Option Years Project Narrative in addition to the Project Narrative’s 15 page maximum, or meant to be part of the 15 pages? (So: 15 pages together, or 15 + 3 pp?)

Answer: The option year page maximum (3 pages) is in addition to the Project narrative page maximum (15 pages).

19. Part IV states that NEA/AC and AmEmb Tunis will be substantially involved in selecting targeted laws and regulations to be updated. What does this mean for MoH consultations? Will State or the Embassy seek to direct MoH consultation approach, give feedback on priorities identified, or some other involvement? Will the Embassy or State be open to new reform priorities, if they arise?

Answer: NEA and the Embassy will facilitate engagement between MoH and the selected applicant as well as offer guidance on reform priorities. We certainly also welcome suggestions from applicants on high value-add areas of reform.

20. Page 2, Section “Funding Opportunity Synopsis” - Is there a requirement for a comprehensive “Track and Trace” solution for medicinal products or is the requirement for a simpler inventory and order management system?

Answer: Yes, there is a requirement for a comprehensive track and trace solution.

21. Page 6, Section “I. Funding Opportunity Description”, subsection “A. Problem Statement” - Is the requirement for tracking of supplies only or does it also include tracking of procurement and related processes?

Answer: The requirement is for tracking all products in the medicinal supply chain.

22. Page 7, Section “I. Funding Opportunity Description”, subsection “C. Project Design”, Subsection “Priority Area 1” - “As part of this platform, there should be a component that allows select hospitals to track the delivery of pharmaceuticals to patients” – How many hospitals are expected to be part of this pilot project?

Answer: The number of hospitals is yet to be determined but the applicant must address how they will track this type of delivery in their proposal.

23. Page 8, Section “I. Funding Opportunity Description”, subsection “C. Project Design”, Subsection “Priority Area 1” - “Capacity building sessions for MoH staff” Will the bidder be responsible for the logistical costs (travel, accommodation, meals, local conveyance etc.) for the staff for these training sessions? If yes, what is the proposed number of staff who would attend the sessions? How many such sessions are proposed?

Answer: The applicant should propose the number of sessions they deem necessary to address the priority area and will be responsible for the logistical costs, which should be reflected in the proposed budget.

24. Page 8, Section “I. Funding Opportunity Description”, subsection “C. Project Design”, Subsection “Priority Area 2” - “Provide expertise and lead a consultative process to empower the MoH to identify, update, and draft key regulations related to good governance” Who would be the participants for the consultative process? Will the bidder be responsible for the logistical costs (travel, accommodation, meals, local conveyance etc.) for the attendees for this consultative process?

Answer: Please see response to question 23 with regards to costs. Applicants should propose the consultative process they deem best to address the priority areas.

25. Page 8, Section “I. Funding Opportunity Description”, subsection “C. Project Design”, Subsection “Priority Area 2” - Who would be responsible for fees/ charges for “Establish an e-learning platform and video-conference infrastructure” – would it be the bidder or the sponsor? - “Put in place mandatory certification and re-certification systems for health professionals” Will the bidder be responsible for conducting the certifications? If yes, how many participants are expected to undergo a certification each year?

Answer: Applicants should propose all costs anticipated in accordance with the project being proposed. The selected applicant would be responsible for the certifications, although NEA cannot advise on the expected number of certifications.

26. Page 9, Section “I. Funding Opportunity Description”, subsection “C. Project Design”, Subsection “Key Deliverables” - “A 20% reduction in illegal diversion of pharmaceuticals within the MoH” What would be the modality of performing this assessment i.e. how would the quantum of change be assessed? What would be the baseline and endline for measurement? Would the assessment by volume of products or value of products? Who would be responsible for performing this assessment? What may be the consequences of not achieving this deliverable i.e. assessment reveals a less than 20% reduction in illegal diversion of pharmaceuticals?

Answer: Applicants should outline in their proposal how they will measure success against the key deliverables in the NOFO. The Embassy will support the selected applicant to identify the proper baseline.

27. For Priority Area 3, bullet b., the RFP mentions that staff must be "properly trained to execute good governance procedures, so the task is to "Upgrade the training materials in the seventeen (17) MoH training schools around the country". a. Please clarify if each of the 17 training schools use the same curriculum and training materials? If not, how many curricula are there that will need to be upgraded? b. Please clarify what topics the current curriculum covers in governance and accountability. c. Please confirm that the focus of governance and accountability will be on supply chain management skills and practices.

Answer: NEA cannot confirm whether each training school uses the same curriculum/materials nor how many curricula need to be upgraded. In terms of the current themes of governance in existing curricula, NEA is unable to provide this information. The focus of governance issues in the upgraded curriculum should not only focus on supply chain management; applicants should propose solutions they deem best to upgrade the existing training materials of the targeted schools.

28. For Priority Area 3, bullet b., it mentions the certification and recertification systems for health professionals (in coordination with Priority Area 2). a. Is there a certification system currently in place? If so, what health professionals does it cover, how often must one be recertified, and what topics or subjects does it cover? b. Will the certification/recertification system be related only to new laws, decrees, and procedures that fill regulatory gaps as developed under Priority Area 2 to managing or will it have to cover other areas in the RFP, e.g., the electronic medical tracking platform?

Answer: There is a certification system in place but applicants should propose solutions to upgrade this system and are encouraged to conduct the necessary research.

29. Under Priority Area 1, the RFP mentions that this is a pilot project. Please clarify how many hospitals will participate in the pilot project? To how many additional hospitals, offices, other health facilities might the electronic system be expanded to in the future?

Answer: At this point, the Embassy anticipates targeting around 5 hospitals, with expansion to be determined by the outcomes of this project.

30. The NOFO states “The MoH requires an updated regulatory framework and streamlined procedures in order to address inefficiencies that restrict their ability to deliver essential services to citizens and create opportunities for corrupt practices within the public health sector.” Are there any ongoing regulatory reform activities in the health sector? Can the mission provide any indication on how long it typically takes for a new legislation to be put in place?

Answer: Regulatory reform is a priority for the MoH but there has been little progress recently. The pace of new legislation is dependent on multiple factors that vary by legislation.

31. What tools and enforcement mechanisms are currently in place, legal or administrative, to address diversion and other illegal activities in the medicinal supply chain, and what are the main reasons why these have not been effective? (JSI) Answer: NEA is unable to provide an answer but encourages applicants to conduct the research necessary to submit their best proposal.

32. While the NOFO emphasizes the need for regulatory reform in the supply chain area, the regulatory framework priority area is not exclusive to supply chain. Regulatory reform in the entire health sector is an onerous task. Please clarify the intended scope of regulatory reform, the current status of regulatory reform efforts, and any ongoing reform efforts in this area.

Answer: Applicants should conduct research and propose their best strategy for regulatory reform that will address the priority area. Upon award, the Embassy will work with the selected applicant and MoH to identify reform priorities. Please see answer to question 30 above as well.

33. From which stage do you expect the "Tracking system for the medicinal supply chain" to start tracking? From "Tendering" to manage a competitive bidding process or from the point when a purchase order is issued for importation.

Answer: Tracking should start from purchase order and importation, but applicants are encouraged to assess corruption issues throughout the procurement process as part of the overall project.

34. Should the tracking system focus on imported medicine procurement only, or should it cover local procurement as well?

Answer: Tracking should cover all procurement.

35. Can you provide more detail on the warehousing and distribution network as it currently exists? For example, are there central medical store and regional stores that house and distribute to hospitals or is the import/delivery made directly to hospitals?

Answer: Applicants should conduct the research necessary to propose the best solutions to address the priority areas.

36. Can you provide the number of warehousing stores, number of hospitals, and estimated number of users the supply chain tracking system is supposed to accommodate? This estimated number of sites and estimated number of users information will be required in order to properly size and price a solution package.

Answer: Applicants should conduct the research necessary to propose the best solutions to address the priority areas. Please see answer to question 29 as well.

37. Para b, page 8: "...should include an additional component as well that tracks the delivery to patients when necessary);". Do you expect the supply chain system to have a patient management system module that will include patient registration, patient visit, diagnosis, and prescription filling or just the inventory part of fulfilling a prescription order to a named customer?

Answer: Applicants should propose the solutions they deem best to achieve the priorities laid out in the NOFO.

38. How many hospitals are expected to use the supply chain tracking system? Are there any phased adoptions such as piloting with a limited number of hospitals, fine-tune/improve, and then roll-out to the rest of the hospitals?

Answer: This is a pilot project with the potential for expansion. Please see answer to question 29 as well.

39. Are there any focus areas for the supply chain system such as by programs (e.g., essential medicines, TB, Malaria), by sourcing (e.g., imported medicines only), or by other categories?

Answer: No.

40. Who will host the supply chain tracking application and the online e-learning platform? For example, who will supply the vendors for initial hosting and eventual migration to the ministry of health, cloud based software as a service (SaaS) offering or some other mechanism?

Answer: The MoH will host the platform.

41. You mentioned 3 years as the initial project period. Do you expect technical and maintenance support in the option years?

Answer: Yes.

42. Can you provide information on any existing information systems with which the new supply chain tracking system needs to inter-operate for data sharing?

Answer: Applicants should conduct the research necessary to propose the best solutions to address the priority areas.

43. The NOFO calls for a 20% reduction in illegal diversion of pharmaceuticals within the MoH. Is this over the life of the project and is there a current estimate of the level of the illegal diversion in the system? Is it possible to share how this percentage was determined, i.e., what data was used, and how the indicator is expected to be measured?

Answer: This target is applicable to the life of the project. Please see answer to question 26 as well.

44. Has there been an analysis of the policy/regulatory gaps in the existing framework that can be shared at this time, or will the project conduct such an analysis. Can the NEA/AC provide an indication of how long typical regulatory reforms take to be adopted in Tunisia?

Answer: Please see answers to questions 19 and 30.

45. On page 10, Section III: Award Information, the Estimated Initial Award Project Funding is shown as $5,000,000 and the Estimated Length of Initial Project Period is 36 months. Then the Maximum Length with Option Year(s) is 5 years, and Estimated Award Ceiling for Option Year(s) $1.500,000. Later on page 14, under Option Years Project Narrative, it states: "The Option Years Narrative describes the efforts the applicant would propose to undertake during the option year period(s) of up to two years (for up to a total four-year project period). May you please clarify the initial project period, number of possible extension years, total project duration, and estimated budgets associated with each.

Answer: Please see answer to question 17.

46. Does NEA/AC envision any large scale hardware procurement by applicants in support of this project? Specifically, Priority Area 1.b, and Priority Area 3.a could require significant hardware investment, depending on the current facilities in place. If so, should bidders include these costs in their budgets?

Answer: All proposed activities should have associated costs reflected in the budget. Applicants should propose the solutions they deem necessary to achieve the priorities outlined in the NOFO.

47. Does NEA/AC have a preferred format for the options years notional budget?

Answer: Please use budget template in Appendix 1of the NOFO for guidance.

48. Other than the budget, budget narrative, and SF forms mentioned, are any other documents required for the cost proposal submission, especially related to any subcontractors?

Answer: Please see Section VI, A.1 of the NOFO for all required documents.

49. How many hospitals and warehouses will be connected to the platform?

Answer: Please see answers to questions 29 and 36.

50. How many ambulances will be connected to the platform? If so, the platform shall use both wireless radio internet (4G) and LAN cable internet.?

Answer: Applicants should propose the solutions they deem best to address priority area 1.

51. How many computers would be used in hospitals, MoH, and the Government?

Answer: Applicants should conduct the research necessary to propose the best solutions to address the priority areas.

52. Within emergency case interventions (accident scene or home emergency interventions) the platform shall work on mobile devices?

Answer: Applicants should conduct the research necessary to propose the best solutions to address the priority areas.

53. Shall the “Assembly of the Representatives of the People of Tunisia” be connected to the platform?

Answer: No.

54. Who is eligible to benefit from public health services? Every eligible patient must have a Social Security Number: SSN.

Answer: This question is not applicable to the NOFO.

55. Shall we consider devices connected to the platform at a hospital patient bed?

Answer: Applicants should conduct the research necessary to propose the best solutions to address the priority areas.

56. The number of medical, paramedical, and administrative staff eligible to be trained to the access and use of the platform?

Answer: Applicants should conduct the research necessary to propose the best solutions to address the priority areas.

57. Are we required to give a solution on how to store medicinal drugs in warehouses, hospital pharmacies, and an ambulance level?

Answer: Yes.

58. Are we required to give solutions related to the infrastructure of all facilities included in the tracking system for the medicinal supply chain?

Answer: Applicants should conduct the research necessary to propose the best solutions to address the priority areas.

59. Is the platform requested in the NOFO intended to manage inventory of the medicines or is it intended solely to manage the flow throughout the acquisition and distribution to hospitals? In other words is the emphasis on tracking & tracing or on optimizing the supply chain?

Answer: The platform will aim to manage the flow of pharmaceutical products with a focus on track and trace, but should also include inventory. Please also see answer to Question 20 above.

60. Can you please clarify the following sentence in page 8: the platform should include an additional component as well that tracks the delivery to patients when necessary. Is this when the medicine is delivered from hospitals local pharmacies to the patient, and what do you mean by “when necessary”?

Answer: This component refers to delivery directly to the patient from local pharmacies. Instances of “when necessary” will be determined by MoH and the Embassy after implementation has started, but applicants should demonstrate how they will deliver on that component in their proposal.

61. Do the e-learning platform and video conferencing equipment intended for the 17 schools and the health care practitioners in these schools?

Answer: The e-learning platform and video conferencing equipment is intended for health care workers, the 17 schools, and the MoH in general. Applicants should propose the solutions they deem best to address the issues outlined in the NOFO.