Common use of Challenges Clause in Contracts

Challenges. Using the NMS costing study that is based on weight and volume estimate and not actual weight and volume figures has proven challenging to reevaluate the service fees. A costing study at JMS is underway using actual weight/volume figures. With our support, this year National Drug Authority (NDA) inspected 803 public and PNFP facilities for good pharmacy practice (GPP), and 58% of the facilities met the minimum GPP standards and were certified. This year’s inspection target of 2,000 facilities could not be achieved because NDA inspectors had to prioritize Good Distribution Practices (GDP) licensing inspections of wholesalers from January to April, 2017. Inspectors uploaded 1,618 GPP inspection reports to the electronic GPP (e-GPP) database. UHSC audited 100% of all GPP inspection reports for quality and to ensure the inspections actually occurred. This year, NDA regional head inspectors also supervised the lower level inspectors in compliance with our recommendation to NDA to assure the quality of facility inspections. As planned, we shifted the server and e-GPP database from UHSC to NDA; NDA will now take over responsible for maintaining the system and ensuring sustainability of electronic reporting. ▇▇▇▇ collaborated with NDA to distribute GPP posters and SAWA SAWA signage to all GPP- certified health facility pharmacies to be distributed together with the reward schemes. In December 2016, NDA issued licensure guidelines that required that pharmaceutical wholesalers and distributors must comply with the Phase 1 GDP standards by January 31, 2017 to receive operating licenses for the year or risk closure. The Phase 1 standards cover quality management systems, documentation, and standard operating procedures. In January 2017, UHSC and senior NDA inspectors trained 30 NDA inspectors to conduct the GDP inspections. In Q10, all of the wholesale and retail pharmacies and distributors that applied for NDA’s 2017 operating license were inspected to determine their compliance with GDP Phase 1 standards, and 497 wholesalers were licensed. In Q11, 54 wholesalers that did not meet the requirements were instructed by NDA to cease operations. The list of the unlicensed entities was published in the public domain. NDA will apply GDP Phase 2 standards—which cover infrastructure standards, complaints, and counterfeit handling and recall procedures—in 2018. Phase 3 standards, which will regulate transportation, will be implemented in 2019. The formation and operation of four regional wholesaler organizations is underway in the North, West Nile, Western, and South West regions. As appropriate, the wholesaler organizations will receive UHSC support next year on specific areas of GDP implementation. This year we held two meetings with the Pharmaceutical Society of Uganda to discuss their potential collaboration in training pharmacists on GDP. All distributors and wholesalers are supervised by technical directors who must be pharmacists, so improving their knowledge of GDP will strengthen implementation. We submitted a draft concept for the pharmacist GDP training as part of continuing professional development to the Pharmaceutical Society for their feedback.

Challenges. Using Non availability of VL reagents to PCR laboratory in Jalingo limited the NMS costing study that is based number of VL tests and analysis thus, affecting quality of care provided to the clients SIDHAS teams continued to support the Borno State Government to provide quality comprehensive HIV/AIDS services across seven supported facilities and 10 Internally Displaced Persons’ (IDP) camps. Comprehensive ART and PMTCT services were provided through the mobile ART teams. HTS were also provided to IDPs and identified positives were enrolled into care at the camps by the mobile teams; clients current on weight treatment on the other hand were provided with drug refills. Other packages of care provided to PLHIV in the camps included OI drugs refill, pharmaceutical care, and volume estimate and not actual weight and volume figures has proven challenging to reevaluate the service feesclinical pharmacovigilance. A costing study two-day onsite skills update session was conducted for two focal laboratory technicians at JMS is underway using actual weight/volume figures. With our support, this year National Drug Authority ▇▇ ▇▇▇▇▇ on sample preparation (NDA) inspected 803 public CD4 absolute and PNFP facilities for good pharmacy practice (GPPCD4 %), incubation, initializing, loading, count check beads QC testing, sample testing and 58% cleaning, decontamination, and machine shut down procedures. The session was integrated into one of the facilities met routine planned preventive maintenance (PPM) exercises carried out for the minimum GPP standards and were certifiedfacility. This year’s inspection target of 2,000 facilities could not be achieved because NDA inspectors had to prioritize Good Distribution Practices The SIDHAS team continued the North East (GDPNE) licensing inspections of wholesalers from January to April, 2017. Inspectors uploaded 1,618 GPP inspection reports to the electronic GPP (e-GPP) database. UHSC audited 100% TB emergency response initiative with TB screening of all GPP inspection reports clients in supported sites and initiation of eligible clients on IPT. A 2-day onsite multidisciplinary orientation was conducted for quality healthcare workers in ▇▇ ▇▇▇▇▇▇ (3F, 4M) and to ensure ▇▇ ▇▇▇▇▇ (1F, 4M) on IPT eligibility screening, initiation and refilling, counselling, documentation, and inventory management. The triaging strategy used under the inspections actually occurred. This yearNE TB emergency response initiative, NDA regional head inspectors also supervised and the lower level inspectors availability of INH stock in compliance with our recommendation to NDA to assure all supported facilities, resulted in increased IPT uptake in the quality of facility inspections. As planned, we shifted the server and e-GPP database from UHSC to NDA; NDA will now take over responsible for maintaining the system and ensuring sustainability of electronic reportingaffected facilities. ▇▇▇▇▇▇ collaborated with NDA to distribute GPP posters and SAWA SAWA signage to all GPP- certified health facility pharmacies to be distributed together also supported the state with the reward schemesinstallation of GeneXpert machines (supplied by NACA) at State Specialist Hospital, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Memorial Hospital, and General Hospital Biu. The team also provided technical assistance through a presentation on PMTCT at the WHO-organized training for newly recruited healthcare workers for hard-to-reach areas in the newly liberated LGAs in Borno. This quarter, ▇▇▇▇▇▇ provided technical assistance to the Borno State Agency for the Control of AIDS (BOSACA), SASCP and SMoH to commemorate the 2016 WAD on December 1, 2016 themed “Hands up for HIV Prevention”. As part of the WAD 2016 activities, the management of BOSACA, the State AIDS Program Coordinator (SAPC), and SIDHAS team, paid an advocacy visit to the management of Borno Radio and Television (BRTv). The team sensitized BRTv management on the HIV/AIDS situation in the state and solicited its support to create awareness about the epidemic. The BRTV General Manager, ▇▇▇▇ ▇▇▇▇, committed to use its radio and TV stations to sensitize and educate the people of Borno State on HIV/AIDS prevention, treatment, care and support. In December 2016, NDA issued licensure guidelines that required that pharmaceutical wholesalers and distributors must comply with the Phase 1 GDP standards by January 31, 2017 to receive operating licenses for the year or risk closure. The Phase 1 standards cover quality management systems, documentation, and standard operating procedures. In January 2017, UHSC and senior NDA inspectors trained 30 NDA inspectors to conduct the GDP inspections. In Q10, all of the wholesale and retail pharmacies and distributors that applied for NDA’s 2017 operating license were inspected to determine their compliance with GDP Phase 1 standards, and 497 wholesalers were licensed. In Q11, 54 wholesalers that did not meet the requirements were instructed by NDA to cease operations. The list of the unlicensed entities was published in the public domain. NDA will apply GDP Phase 2 standards—which cover infrastructure standards, complaints, and counterfeit handling and recall procedures—in 2018. Phase 3 standards, which will regulate transportation, will be implemented in 2019. The formation and operation of four regional wholesaler organizations is underway in the North, West Nile, Western, and South West regions. As appropriateaddition, the wholesaler organizations will receive UHSC support next year on specific areas of GDP implementation. This year we held two meetings team participated in a group discussion with the Pharmaceutical Society of Uganda to discuss their potential collaboration in training pharmacists on GDP. All distributors PLHIV organized by BOSACA and wholesalers are supervised by technical directors who must be pharmacists, so improving their knowledge of GDP will strengthen implementation. We submitted a draft concept for the pharmacist GDP training SASCP as part of continuing professional development the activities to commemorate the Pharmaceutical Society WAD2016 celebration in the state. National Emergency Management Agency (NEMA) also supported the celebration by providing household materials such as children clothing and milk supplements, plastic buckets, toilet soap, detergents and slippers to 103 PLHIV. ▇▇▇▇▇▇ also actively participated in various humanitarian coordination meetings such as the Protection Sector Working Group (PSWG), health sector working group, SGBV sub-sector working group, food security working group, and IPs/SEMA/NEMA coordination meetings. Participation of SIDHAS in these coordination meetings enhanced project visibility and strengthened collaboration with key stakeholders in the state for their feedbackmore effective programming.

Challenges. Using Inadequate supply of commodities during the NMS costing study that is last supply circle to some sites; Cotrimoxazole for CH Auchi and CD4 Cyflow reagent for UBTH, SCCH, SOH and FMH resulting in constant redistribution between sites. SIDHAS, in collaboration with the state government, continued the delivery of quality HIV/AIDS and TB services across eight ART and eight PMTCT supported sites in the state. HTS was provided to clients based on weight clinical symptomology or when requested by the client, identified HIV positives individual were placed on ART while positive pregnant women were placed on prophylaxis to reduce the risk of mother to child transmission of HIV. In order to sustain and volume estimate improve quality of care for clients currently on ART, clinical assessment of clients was conducted using WHO staging, CD4 count, and not actual weight VL assessment across supported facilities. Access to quality TB services for PLHIV was prioritized by screening for TB symptoms during clinical visit, and volume figures has proven challenging identified positives started on TB treatment. During the quarter, the team intensified efforts to reevaluate increase access to ART services for pediatrics through client tracking and follow up on DBS testing for EID. DBS samples were collected from HEIs from six supported sites comprising five ART and one PMTCT sites and sent for EID analysis at the Aminu Kano Teaching Hospital, Kano. During the quarter, the state team sensitized and mentored supported facilities on the revised LMIS reporting templates to enable them compile and produce quality bimonthly LMIS reports. The team facilitated commodity logistics during the quarter by redistributing ARVs and laboratory commodities from health facilities with excess commodities to sites with low stock. This was done to ensure uninterrupted service feesdelivery whilst also preventing expiries. To this end, 136 units of TDF/3TC/EFV 300/300/600mg were resupplied to GH Birnin-Kudu and 100 Rohren tubes transferred to GH Dutse to close stock gaps. SIDHAS carried out series of capacity building activities for healthcare workers this quarter. This was geared towards quality improvement in services provided to PLHIV in supported facilities. Healthcare workers from all eight SIDHAS supported ART sites were trained in three clusters on the VL platform from October 25 to December 30, 2016 in Birnin Kudu, Dutse and Ringim. A costing study total of 34 (5F; 29M) benefited from the training which covered the current PEPFAR policy direction for HIV/AIDS, as well as best practices and approach to handling VL test results among PLHIV. In addition, a one-day onsite orientation on Pharmacy Best Practice (PBP) was organized for pharmacy personnel at JMS is underway using actual weight/volume figuresFMC Birnin Kudu on October 26, 2016. With our supportThe orientation updated skills of the staff on pharmacy documentation, this year National Drug Authority (NDA) inspected 803 public client monitoring, drug counselling and PNFP facilities for good pharmacy practice (GPP)dispensing, service linkages, client retention, and 58% intervention on drug therapy problems. A total of 11 (9M; 2F) pharmacy personnel participated in the facilities met the minimum GPP standards and were certified. This year’s inspection target of 2,000 facilities could not be achieved because NDA inspectors had to prioritize Good Distribution Practices (GDP) licensing inspections of wholesalers from January to April, 2017. Inspectors uploaded 1,618 GPP inspection reports to the electronic GPP (e-GPP) database. UHSC audited 100% of all GPP inspection reports for quality and to ensure the inspections actually occurred. This year, NDA regional head inspectors also supervised the lower level inspectors in compliance with our recommendation to NDA to assure the quality of facility inspections. As planned, we shifted the server and e-GPP database from UHSC to NDA; NDA will now take over responsible for maintaining the system and ensuring sustainability of electronic reportingorientation. ▇▇▇▇▇▇ collaborated with NDA supported the installation of a GeneXpert machine provided by NACA and training of medical laboratory personnel on its operation and maintenance at the GHs Jahun and Kazaure during the quarter. The training had in attendance 16 laboratory technicians and scientist (▇▇ ▇▇▇▇▇ (5 M; 3F); GH Kazaure (7M; 1F)). Understanding of the laboratory staff was enhanced in the use of GeneXpert equipment for early detection of TB cases and quality treatment to distribute GPP posters clients. Following development and SAWA SAWA signage finalization of the state sustainability roadmap for HIV/AIDS in FY16, the Jigawa State Government signed the narrative document for both the State government and the Federal Medical Center Birnin Kudu. The document is expected to all GPP- certified health facility pharmacies serve as a guide to be distributed together the state government for future strategic direction towards coordinating and ensuring an effective HIV/AIDS state response. ▇▇▇▇▇▇ also supported the state government to convene its first post GBV care response committee meeting. The committee membership is drawn from law enforcement agencies, Ministry of Women Affairs, female lawyers’ association, medical women association and civil society organizations in the state. The committee is charged with the reward schemes. In December 2016responsibility of facilitating shared understanding of gender issues among all stakeholders, NDA issued licensure guidelines that required that pharmaceutical wholesalers as well as coordinating an effective response to gender issues at facility and distributors must comply with the Phase 1 GDP standards by January 31, 2017 to receive operating licenses for the year or risk closurecommunity levels. The Phase 1 standards cover quality management systems, documentation, and standard operating procedures. In January 2017, UHSC and senior NDA inspectors trained 30 NDA inspectors to conduct the GDP inspections. In Q10, all of the wholesale and retail pharmacies and distributors that applied for NDA’s 2017 operating license were inspected to determine their compliance with GDP Phase 1 standards, and 497 wholesalers were licensed. In Q11, 54 wholesalers that did not meet the requirements were instructed by NDA to cease operations. The list of the unlicensed entities was published inaugural meeting had in the public domain. NDA will apply GDP Phase 2 standards—which cover infrastructure standards, complaints, and counterfeit handling and recall procedures—in 2018. Phase 3 standards, which will regulate transportation, will be implemented in 2019. The formation and operation of four regional wholesaler organizations is underway in the North, West Nile, Western, and South West regions. As appropriate, the wholesaler organizations will receive UHSC support next year on specific areas of GDP implementation. This year we held two meetings with the Pharmaceutical Society of Uganda to discuss their potential collaboration in training pharmacists on GDP. All distributors and wholesalers are supervised by technical directors who must be pharmacists, so improving their knowledge of GDP will strengthen implementation. We submitted a draft concept for the pharmacist GDP training as part of continuing professional development to the Pharmaceutical Society for their feedbackattendance eight (4M; 4F) participants.

Challenges. Using Strike action embarked upon during the NMS costing study that quarter by staff of Federal Medical Centre Yenagoa which commenced since August 2016 and is based still ongoing, affected project implementation in the facility. SIDHAS team continued to leverage on weight volunteers and volume estimate and not actual weight and volume figures has proven challenging adhoc staff to reevaluate facilitate service provision pending when the strike action is called off. • Restricted movement to riverine areas due to insecurity limited access to facilities in those locations. The SIDHAS team will continue to be guided by security advisory from the Country Office security team In Edo State, SIDHAS prioritized capacity building of healthcare workers as a strategy towards improving quality HIV service feesprovision in supported facilities. A costing study at JMS is underway using actual weight/volume figures. With our supportAs part of this strategy, this year National Drug Authority the team conducted Joint Supportive Supervisory Visits (NDAJSSVs) inspected 803 public and PNFP to supported facilities for good pharmacy practice (GPP)GHs Iruekpen, Agenebode, Igarra, Usen, Iguobazuwa, CH Auchi, and 58% of PHCs Ikhueniro and Okugbo) during which the facilities met the minimum GPP standards and were certified. This year’s inspection target of 2,000 facilities could not be achieved because NDA inspectors had to prioritize Good Distribution Practices (GDP) licensing inspections of wholesalers from January to April, 2017. Inspectors uploaded 1,618 GPP inspection reports to the electronic GPP (e-GPP) database. UHSC audited 100% of all GPP inspection reports for quality and to ensure the inspections actually occurred. This year, NDA regional head inspectors also supervised the lower level inspectors in compliance with our recommendation to NDA to assure the quality of facility inspections. As planned, we shifted the server and e-GPP database from UHSC to NDA; NDA will now take over responsible for maintaining the system and ensuring sustainability of electronic reporting. ▇▇▇▇ collaborated checklist was applied as a quality assessment tool. Some of the identified gaps, such poor documentation, were immediately addressed; performance improvement plans were developed to address other areas requiring attention such as VL service uptake, client retention in care, improving PMTCT service delivery with NDA emphasis on the 18-month outcome, and closing EID/ART prophylaxis gaps. Folder audits were also conducted and various registers reviewed to distribute GPP posters address gaps such as incomplete documentation in the care cards, routine CD4 and SAWA SAWA signage VL monitoring, EID testing for babies, early update of inventory tools, and daily update of worksheets. The aim was to ascertain availability of complete and valid data across the thematic areas. Series of capacity building initiatives were conducted during the quarter in line with SIDHAS focus on improving skills and knowledge of healthcare workers in supported facilities. To this end, SIDHAS supported a 4-day Roche system analyst training on CAP/CTM (COBAS Ampliprep)/COBAS TaqMan PCR machine November 9 – 12, 2016 in University of Benin Teaching Hospital (UBTH) PCR suite. Four (2M; 2F) medical laboratory scientists were trained on operating, maintaining, and troubleshooting of the Roche COBAS TaqMan PCR machine. This has increased the pool of facility laboratory personnel trained on PCR technology from 5 to 9. Similarly, four (3M; 1F) UBTH PCR laboratory staff and the SIDHAS lab staff participated in a training on logistics management of HIV/AIDS (PCR) commodities for facility PCR laboratory staff. The training was conducted by USAID Global Health Supply Chain Program Procurement and Supply Management (GHSP-PSM) in Lagos from November 14 – 16, 2016. Four facilities (UBTH, Faith Mediplex (FMH), Central Hospitals (CHs) Auchi and Uromi) registered for NHLS CD4 EQA program and also participated in the Survey 4 Trial 40 and 41 (October and December 2016 surveys). In addition, reports of Trial 39 were received with all GPP- certified facilities scoring 100%; these were duly reviewed and filed at the facilities. Similarly, EQA PT samples for HIV serology and CD4 received from OASYS for the seven registered facilities (UBTH, Irrua Specialist Teaching Hospital (ISTH), FMH, Saint Camillus Catholic Hospital (SCCH), ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ Hospital (SOH), CHs Auchi and Uromi) were analysed, and results uploaded to the OASYS website by the sites’ personnel. The team, in collaboration with FMOH, HIV/AIDS Division and Nigerian Alliance for Health System Strengthening (NAHSS), conducted a 2-day training/learning meeting on national quality improvement project for SIDHAS supported health care facilities in the state. A total of 26 (23M; 3F) participants drawn from 19 NIGQual supported health facilities participated. The learning meeting focused on service quality improvement for HIV clients and documentation. The participants developed a quality improvement plan which the facility pharmacies CQI team will monitor over a 6-month period. The SIDHAS team facilitated a Micro Enterprise Fundamentals (MEF) step-down training for caregivers/support group members and older OVC (51M; 243F) across Benin, Oben, Auchi and Igarra. Participants had their capacities built on fundamentals of business development and income generating activities. This is expected to be distributed together provide an economic platform as a Launchpad to self-sustenance. As part of SIDHAS’ engagement with the reward schemesstate government, the team participated in a road walk to celebrate WAD 2016. In December 2016The walk, NDA issued licensure guidelines that required that pharmaceutical wholesalers led by the deputy speaker of House of Assembly, ▇▇▇ ▇▇▇▇▇▇, ended with a town hall meeting with stakeholders in the HIV/AIDS response in the state. The town hall meeting featured a stakeholders’ interactive session with panel members from the Network of Persons Living with HIV and distributors must comply with AIDS in Nigeria (NEPWHAN), and the Phase 1 GDP standards by January 31, 2017 to receive operating licenses Edo State Agency for the year or risk closureControl of AIDS (EDOSACA). The Phase 1 standards cover quality management systemsevent was graced by the Deputy Governor of the state, documentationEDOSACA, SMOH, Civil Society for HIV/AIDS in Nigeria (CiSHAN), Local Government and Chieftaincy Affairs (LGA), and standard operating proceduresIPs represented by Achieving Health Nigeria Initiative (AHNi). In January 2017, UHSC and senior NDA inspectors trained 30 NDA inspectors to conduct the GDP inspections. In Q10, all The discussion centred on challenges of the wholesale state HIV response and retail pharmacies and distributors that applied for NDA’s 2017 operating license were inspected to determine their compliance with GDP Phase 1 standards, and 497 wholesalers were licensed. In Q11, 54 wholesalers that did not meet the requirements were instructed by NDA to cease operations. The list of the unlicensed entities was published in the public domain. NDA will apply GDP Phase 2 standards—which cover infrastructure standards, complaints, and counterfeit handling and recall procedures—in 2018. Phase 3 standards, which will regulate transportation, will be implemented in 2019. The formation and operation of four regional wholesaler organizations is underway in the North, West Nile, Western, and South West regions. As appropriate, the wholesaler organizations will receive UHSC support next year on specific areas of GDP implementation. This year we held two meetings with the Pharmaceutical Society of Uganda to discuss their potential collaboration in training pharmacists on GDP. All distributors and wholesalers are supervised by technical directors who must be pharmacists, so improving their knowledge of GDP will strengthen implementation. We submitted a draft concept recommendations for the pharmacist GDP training as part of continuing professional development response going forward. A communique was drafted with resolutions reached for onward transmission to the Pharmaceutical Society Governor through his Deputy who was present at the event for their feedbacknecessary action.

Challenges. Using the NMS costing study that is  No progress was made on developing a web-based on weight TB ordering and volume estimate and not actual weight and volume figures has proven challenging to reevaluate the service fees. A costing study at JMS is underway using actual weight/volume figures. With our support, this year National Drug Authority (NDA) inspected 803 public and PNFP facilities for good pharmacy practice (GPP), and 58% reporting system because of the facilities met delays in obtaining the minimum GPP standards Global Fund money and recruitment of a qualified consultant by the Pharmacy Department; UHSC will therefore hire the consultant.  Delays in Global Drug Facility shipments of TB medicines and lengthy port clearing processes because the medicines were certified. This year’s inspection target of 2,000 facilities could not be achieved because registered at NDA inspectors had to prioritize Good Distribution Practices (GDP) licensing inspections of wholesalers from January to April, 2017. Inspectors uploaded 1,618 GPP inspection reports to the electronic GPP (ebadly affected MDR-GPP) database. UHSC audited 100% of all GPP inspection reports for quality and to ensure the inspections actually occurred. This year, NDA regional head inspectors also supervised the lower level inspectors in compliance with our recommendation to NDA to assure the quality of facility inspections. As planned, we shifted the server and e-GPP database from UHSC to NDA; NDA will now take over responsible for maintaining the system and ensuring sustainability of electronic reportingTB treatment services. ▇▇▇▇ collaborated recruited five technical personnel to support the Central Public Health Laboratory (CPHL) logistics management activities planned for Year 2 and beyond. The personnel, four of whom are based at CPHL, include a laboratory advisor, Lab SPARS technical officer, M&E officer, data manager, and programmer. Their work has been instrumental in the quick progress on Year 2’s priority of developing the Lab SPARS intervention. In collaboration with NDA CPHL staff, the Lab SPARS implementation approach was finalized. As with TB SPARS, Lab SPARS will be piloted in 20 districts. The districts, with over 310 facilities, were selected based on PEPFAR priorities and current UHSC support. The finalized Lab SPARS performance assessment tool has 27 indicators relating to distribute GPP posters five categories—stock management; storage management, ordering, receipt and SAWA SAWA signage reporting; laboratory equipment; and laboratory information system. A group of 14 laboratory specialists from CPHL and other stakeholders reviewed the materials for the two-week Lab SPARS supervisor training course . District laboratory focal persons, laboratory technologists/technicians, and regional laboratory focal persons (based at the regional referral hospitals) will be the key implementers of the Lab SPARS performance improvement approach. We also developed the framework for monitoring and evaluating the pilot of Lab SPARS; results will inform national rollout. Regular Lab SPARS reports will be available on facility and district performance. The web-based Lab SPARS reporting system, still under development, will enable Lab SPARS supervisors to all GPP- certified health facility pharmacies transmit data to be distributed together the web portal from any location. The UHSC laboratory team also helped update the lab test menu and techniques in line with the reward schemeschanges in the 2016 UCG and EMHSLU and helped CPHL identify the logistics information management data needs for the CPHL Equipment Logistics and Supplies department to monitor system performance and facilitate decision-making at all levels. In December 2016Three activities planned for Year 2 did not go forward   The bimonthly lab commodity ordering and reporting system was not developed. This activity depended on the recruitment of the senior programmer, NDA issued licensure guidelines that required that pharmaceutical wholesalers and distributors must comply which did not occur until Q7 because there are very few programmers with the Phase 1 GDP standards necessary skills available. UHSC and CPHL agreed instead to prioritize work on the Lab SPARS system.  The planned GIS mapping of laboratory equipment, requested by January 31CPHL, 2017 to receive operating licenses was not needed because the MoH Infrastructure Division was already conducting a similar assessment.  The unified product coding exercise (see JMS section for more details) will not include laboratory supplies as originally planned; the year or risk closurehuge number of different types and brands of reagents makes this exercise very complicated. The Phase 1 standards cover quality management systems, documentation, and standard operating procedures. In January 2017Through the QPPU, UHSC continued to support CPHL in forecasting and senior NDA inspectors trained 30 NDA inspectors to conduct the GDP inspections. In Q10, all of the wholesale supply planning for laboratory commodities and retail pharmacies and distributors that applied for NDA’s 2017 operating license were inspected to determine their compliance with GDP Phase 1 standards, and 497 wholesalers were licensed. In Q11, 54 wholesalers that did not meet the requirements were instructed by NDA to cease operations. The list of the unlicensed entities was published in monitoring stock status in the public domain. NDA will apply GDP Phase 2 standards—which cover infrastructure standards, complaints, and counterfeit handling and recall procedures—in 2018. Phase 3 standards, which will regulate transportation, will be implemented in 2019. The formation and operation of four regional wholesaler organizations is underway in the North, West Nile, Western, and South West regions. As appropriate, the wholesaler organizations will receive UHSC support next year on specific areas of GDP implementation. This year we held two meetings with the Pharmaceutical Society of Uganda to discuss their potential collaboration in training pharmacists on GDP. All distributors and wholesalers are supervised by technical directors who must be pharmacists, so improving their knowledge of GDP will strengthen implementation. We submitted a draft concept for the pharmacist GDP training as part of continuing professional development to the Pharmaceutical Society for their feedbackcentral warehouses.

Challenges. Using Shortages of test kits and CD4 reagents were experienced in Lagos State with resultant impact on service provision. However, the NMS costing study that is based impact was mitigated through redistribution of commodities to high volume facilities by the state team • Stock out of Dry Blood Samples (DBS) collection kits occurred in some supported facilities in Cross River State. This was redressed through the redistribution of DBS kits among facilities as a short-term measure. Stakeholders, developed a communiqué on weight health commodities security to strengthen distribution of commodities in the coming quarter • There was shortage of viral load reagents at the University of Calabar Teaching Hospital (UCTH) and volume estimate BMSH, Rivers State, as well as equipment breakdown at the DLHMH PCR. Samples were transferred and not actual weight analyzed at Anambra State University Teaching Hospital (ASUTH) as a stop gap measure • In Rivers State, security challenges continue to impede visits and volume figures has proven challenging supervision to reevaluate the service fees. A costing study at JMS is underway using actual weight/volume figures. With our support, this year National Drug Authority (NDA) inspected 803 public and PNFP facilities for good pharmacy practice (GPP), and 58% some of the facilities met and communities in Eleme, Ahoada and Onelga LGAs • Stock out of HIV test kits in some facilities in Rivers State due to delayed supply of laboratory reagents and RTK’s by Chemonics to supported sites • Erratic supply of drugs and laboratory consumables by GHSC-PSM to facilities in Akwa Ibom Highlights from Sustained Response States Access During the minimum GPP standards reporting quarter, activities aimed at maintaining quality of HIV/AIDS services across the continuum of care were sustained across the nine supported states of Adamawa, Anambra, Bayelsa, Bauchi, Borno, Edo, Jigawa, Kano, and Yobe. In line with the goal of increasing TB case detection and treatment, the states intensified efforts in respect of TB screening. In Jigawa sates, 832 clients were certifiedscreened for TB using the chronic care model by triage nurses. As a result, 20 HIV positive clients from two supported ART sites (▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ Specialist Hospital (RSSH): 7 and GH Dutse: 13) were sent for GeneXpert test. All the results returned negative for MDR-TB. In addition, 23 PLHIV were placed on IPT at RSSH and FMC Birnin Kudu. Similarly, a GeneXpert machine for Myco-bacterium Tuberculosis (MTB) detection was installed at General Hospital, Ekwulobia, Anambra State by the state government. This brings the number of supported sites with GeneXpert machines in Anambra state to six, resulting in increased TB case detection from 45% to 60% in the state. This year’s inspection target of 2,000 facilities could not be achieved because NDA inspectors had to prioritize Good Distribution Practices (GDP) licensing inspections of wholesalers from January to Aprilworld TB day was celebrated in conjunction with the respective state governments on March 24, 2017. Inspectors uploaded 1,618 GPP inspection reports The theme, “Unite to the electronic GPP (e-GPP) databaseEnd TB”, was marked with different events including rallies, press conferences, and active TB case finding across states. UHSC audited 100% of all GPP inspection reports for quality and to ensure the inspections actually occurred. This yearIn Adamawa state, NDA regional head inspectors also supervised the lower level inspectors in compliance with our recommendation to NDA to assure the quality of facility inspections. As planned, we shifted the server and e-GPP database from UHSC to NDA; NDA will now take over responsible for maintaining the system and ensuring sustainability of electronic reporting. ▇▇▇▇▇▇ collaborated with NDA the State Tuberculosis and Leprosy Coordinator (STBLC) to distribute GPP posters conduct a TB sensitization in the Internally Displaced Persons (IDP) camp in Fufore LGA of the state. The sensitization focused on TB identification, testing, and SAWA SAWA signage counselling of patients with presumptive and diagnosed TB. ART for PLHIV co-infected with TB also formed part of discussions with the IDPs. This activity resulted in the identification of 300 presumptive TB cases among the IDPs. Sputum samples were collected for TB diagnosis and linked for GeneXpert services. HIV tests were also carried out at the camp. At supported sites, 200 TB samples were also collected as part of World TB Day activities and linked to GeneXpert services. The state team successfully supported initiation of 210 new clients on Isoniazid Preventive Therapy (IPT) during the reporting period. Activities to commemorate the World TB Day in Anambra state spanned the course of March 20 – 24, 2017 across 13 selected facilities. Activities included outdoor campaigns, active case finding within facility outpatient departments (OPD) and clinics through screening by facility triage nurses, movement to TB/DOTs unit for sputum collection and transport to lab for AFB or GeneXpert, including documentation. Findings showed that of the 645 persons screened, 143 presumptive cases were identified, with 55 TB positive individuals diagnosed using the GeneXpert technology. This output surpassed the average number of clients per week screened and diagnosed. Efforts are ongoing by the state team to ensure all GPP- certified TB positive clients are started on DOTS. The SIDHAS team in collaboration with the Anambra state government also created a TB awareness video for public dissemination. The commissioner of health, ▇▇. ▇▇▇ ▇▇▇▇▇▇▇, expressed his appreciation to the USAID funded project for the support in ramping up TB awareness across health facility pharmacies institutions in the state. As part of quality improvement and treatment adherence efforts, the Kano State team audited 21 folders at the ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ Specialist Hospital (15) and Rijiyar Lemo Basic Health Centre (7). The objective was to be distributed generate a list of treatment defaulters for tracking and bridging the gap in seropositive pregnant mothers not currently on ARVs. A list of five clients was generated, one from Rijiyar Lemo BHC and 4 from MMSH. The three clients were successfully tracked and brought for ARVs. In Yobe State, ▇▇▇▇▇▇ conducted a Continuous Quality Improvement (CQI) assessment, using the Site Improvement Monitoring System (▇▇▇▇) tool, as part of efforts to set bench marks for quality improvement in supported sites. A major gap identified during the assessment was poor documentation. Capacity development plans were developed together with the reward schemesassessed facilities and are currently being implemented to guide the quality improvement activities. As a result of some of the implemented capacity development activities, Yobe state data quality has improved significantly as there were no data violations recorded against the supported sites in the state throughout the quarter. In a similar vein, a joint supportive supervisory visit was conducted by the FMOH/NAHSS/SIT/SIDHAS team to UBTH, ISTH, CH Uromi, UBTH, SOH, Faith Mediplex, SH Ossiomo and GH Ubiaja, in Edo State. The focus was to review implementation of the national quality improvement plan developed by the facilities during the NIGQUAL learning meeting held in December 2016, NDA issued licensure guidelines that required that pharmaceutical wholesalers and distributors must comply . A standard questionnaire was administered to assess quality of the improvement plan developed by the facilities. The visiting team was impressed with the Phase 1 GDP standards high level commitment demonstrated by January 31most facilities where the plan is being implemented. Routine supportive supervisory visits during the quarter focused on client folder audits to review viral load, 2017 TB screening and PMTCT. These exercises resulted in increased weekly identification, sample collection, and testing of eligible clients. In Anambra State, 329 eligible clients identified as a result of this exercise requested to receive operating licenses have their viral load tests done. Results are still being expected. Furthermore, backlog of viral load samples from Cross River and Jigawa states were received at the PCR laboratories located in ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ University Teaching Hospital (NAUTH), Nnewi and Anambra State University Teaching Hospital (ANSUTH). The samples were analyzed and results dispatched to the respective supported facilities. This effort is in line with routine viral load monitoring across board as well as attainment of the 3rd 90 in scale up LGAs. Similarly, viral load sample analyses were conducted in four treatment facilities in Bayelsa State namely GHs Brass and Nembe, and Cottage Hospitals Otuasega and Okpoama. Samples of 330 ART clients were transferred for analysis to the ▇▇▇▇▇▇▇▇▇▇▇ Memorial Specialist Hospital (BMSH) PCR Laboratory, Port-Harcourt, Rivers state, while 233 results were dispatched to the respective facilities for necessary action by service providers. The screening effort in the clinical management of 313 ART clients in IDP camps in Maiduguri, Borno State, resulted in the identification of 30 medication errors that were resolved along with 28 suspected cases of adverse drug reactions. Interventions were provided for the year or risk closure. The Phase 1 standards cover quality management systems, documentation, and standard operating proceduresindividual cases followed with the filling of 26 national pharmacovigilance forms for the ADR cases for delivery to NAFDAC. In January 2017Anambra, UHSC 67% of the HCC sites in the state documented and senior NDA inspectors trained 30 NDA inspectors submitted pharmaceutical care services reports that track ADRs and interventions on medication errors, an improvement over the 32% for the last quarter. SIDHAS continued to monitor integration of HIV/AIDS services through the conduct the GDP inspectionsof quarterly assessment of HIV service integration in pharmacies using pharmacy service integration checklists/trackers. In Q10Yobe State, all partitioning of the wholesale renovated dispensing area in GH Gashua to improve audiovisual privacy and retail pharmacies and distributors that applied for NDA’s 2017 operating license were inspected to determine their compliance with GDP Phase 1 standards, and 497 wholesalers were licensed. In Q11, 54 wholesalers that did not meet the requirements were instructed by NDA to cease operations. The list rotation of pharmacists at ART Pharmacy in FMC Nguru are some of the unlicensed entities was published in the public domain. NDA will apply GDP Phase 2 standards—which cover infrastructure standards, complaints, and counterfeit handling and recall procedures—in 2018. Phase 3 standards, which will regulate transportation, will be implemented in 2019. The formation and operation of four regional wholesaler organizations is underway in the North, West Nile, Western, and South West regions. As appropriate, the wholesaler organizations will receive UHSC support next year on specific areas of GDP implementation. This year we held two meetings with the Pharmaceutical Society of Uganda to discuss their potential collaboration in training pharmacists on GDP. All distributors and wholesalers are supervised by technical directors who must be pharmacists, so improving their knowledge of GDP will strengthen implementation. We submitted a draft concept for the pharmacist GDP training as part of continuing professional development recommendations made to the Pharmaceutical Society facility management for their feedbackprogrammatic integration and effective service delivery. It is expected that these would be achieved by the next quarter.

Challenges. Using Tenderers should detail fully the NMS costing study processes that is based on weight they would adopt to address the following challenges: identifying and volume estimate prioritising research of relevance to those who plan, provide or receive NHS and not actual weight other health and volume figures has proven challenging care services. accessing skilled researchers necessary to reevaluate meet DH, NHS and social care needs for research evidence, obtaining sufficient numbers of peer reviewers to assess proposals, balancing the service fees. A costing study at JMS is underway using actual weight/volume figures. With our supportneed to get work funded reasonably quickly whilst allowing the necessary assessment procedures and openness, this year National Drug Authority (NDA) inspected 803 ensuring efficiency of administration, ensuring compliance with good research governance by establishing quality assurance systems in line with DH’s research governance policy, establishing appropriate DH reporting systems, involving patients and the public and PNFP facilities for good pharmacy practice (GPP), and 58% in all aspects of the facilities met research process, handling policy sensitive research, managing potential conflict of interest that could arise in the minimum GPP standards research commissioning process. NETSCC is a critical component of the NIHR and were certified. This year’s inspection target provides support for the following Programmes of 2,000 facilities could not research: Efficacy and Mechanism Evaluation (EME) Programme; Health Services and Delivery Research (HS&DR) Programme; Health Technology Assessment (HTA) Programme; Public Health Research (PHR) Programme; Systematic Reviews (SR) Programme; NIHR Clinical Trials Unit (CTU) Support Funding – comprising a total programme spend of £138M a year (details can be achieved because NDA inspectors had to prioritize Good Distribution Practices (GDP) licensing inspections of wholesalers from January to April, 2017. Inspectors uploaded 1,618 GPP inspection reports to the electronic GPP (e-GPP) database. UHSC audited 100% of all GPP inspection reports for quality and to ensure the inspections actually occurred. This year, NDA regional head inspectors also supervised the lower level inspectors in compliance with our recommendation to NDA to assure the quality of facility inspections. As planned, we shifted the server and e-GPP database from UHSC to NDA; NDA will now take over responsible for maintaining the system and ensuring sustainability of electronic reporting. found at : ▇▇▇▇ collaborated with NDA to distribute GPP posters and SAWA SAWA signage to all GPP- certified health facility pharmacies to ▇://▇▇▇.▇▇▇▇.▇▇▇▇.▇▇.▇▇/). NETSCC will also be distributed together with the reward schemes. In December 2016, NDA issued licensure guidelines that required that pharmaceutical wholesalers and distributors must comply with the Phase 1 GDP standards by January 31, 2017 to receive operating licenses providing support for the year or risk closuredeveloping programmes supported through Official Development Assistance (ODA). NETSCC will provide identification, prioritisation, commissioning and management support services for the following: Efficacy and Mechanism Evaluation (EME) Programme Health Services and Delivery Research (HS&DR) Programme Health Technology Assessment (HTA) Programme Public Health Research (PHR) Programme Systematic Reviews (SR) Programme NIHR Clinical Trials Unit (CTU) Support Funding The key elements of each of the six NETSCC programmes are set out below in Section 1. Then follows three tables, with commentary - Section 2 - setting out key functions and processes that the successful bidder must demonstrate they are capable of delivering to a high standard. The Phase 1 standards cover quality management systems, documentation, and standard operating procedures. In January 2017, UHSC and senior NDA inspectors trained 30 NDA inspectors allocation of whole time equivalents (WTEs) to conduct the GDP inspections. In Q10, all elements of the wholesale and retail pharmacies and distributors that applied for NDA’s 2017 operating license were inspected to determine their compliance with GDP Phase 1 standards, and 497 wholesalers were licensed. In Q11, 54 wholesalers that did not meet the requirements were instructed by NDA to cease operations. The list work programme table 2 takes account of the unlicensed entities was published in the public domainresource currently required to manage specific programmes. NDA will apply GDP Phase 2 standards—which cover infrastructure standards, complaints, and counterfeit handling and recall procedures—in 2018. Phase 3 standards, which will regulate transportation, will It should be implemented in 2019. The formation and operation of four regional wholesaler organizations is underway in the North, West Nile, Western, and South West regions. As appropriate, the wholesaler organizations will receive UHSC support next year on specific areas of GDP implementation. This year we held two meetings with the Pharmaceutical Society of Uganda noted that some funding streams are more resource intensive to discuss their potential collaboration in training pharmacists on GDP. All distributors and wholesalers are supervised by technical directors who must be pharmacists, so improving their knowledge of GDP will strengthen implementation. We submitted a draft concept for the pharmacist GDP training as part of continuing professional development to the Pharmaceutical Society for their feedbackmanage than others.

Challenges. Using  Inadequate supply of CD4 test reagents and control by SCMS to some supported facilities  Stock out of PIMA control count beads at two facilities (▇▇▇▇ ▇▇ and Fagwalawa CHC)  Security challenges especially in the NMS costing study that southern part of Kano State  Inadequate manpower, staff attrition and transfer out of trained staff at facilities In the quarter under review, the SIDHAS team through the QMAP approach strengthened appointment scheduling systems, and the use of appointment diaries for tracking of mother-infant pairs at supported health facilities. These approaches have enabled supported facilities to generate defaulters lists for mother-baby pairs aimed at improved tracking and provision of referrals for DBS collection. As part of efforts to strengthen quality laboratory management systems in supported health facilities, technical assistance was provided to four ART sites on CD4 proficiency testing and external quality assurance. As a result, these sites (GH Hadejia, GH Kazaure, RSSH Dutse and FMC Birnin Kudu) were successfully registered online by One World Accuracy System for CD4 proficiency testing. In collaboration with the Jigawa State chapter of National Agency for Food, Drug Administration and Control (NAFDAC), the SIDHAS team conducted orientation on ADR for 35 (M:23, F:12) health workers from SIDHAS supported facilities. This orientation is based expected to increase the number of patients actively screened for ADRs and counseled on weight proper ADR management. Following this, NAFDAC Jigawa provided ADR reporting forms as well as Information Education and volume estimate and not actual weight and volume figures has proven challenging Communication (IEC) materials to reevaluate the service fees. A costing study at JMS is underway using actual weight/volume figures. With our support, this year National Drug Authority (NDA) inspected 803 public and PNFP facilities for good pharmacy practice reporting of ADR cases. During the quarter, the SIDHAS team conducted advocacy visits to the Honorable Commissioner for Health and the Executive Secretary Primary Health Care Development Agency (GPPPHCDA) on sites to be transitioned within the state. Following the site transitions, the state government expressed commitment to sustain service provision in these sites by concluding plans to procure and distribute Rapid Test Kits (RTKs). The team is working closely with the Director, Pharmaceutical Services to revamp and 58% facilitate the monthly pharmacists peer review meeting at the behest of the facilities met the minimum GPP standards and were certified. This year’s inspection target of 2,000 facilities could not be achieved because NDA inspectors had to prioritize Good Distribution Practices (GDP) licensing inspections of wholesalers from January to April, 2017. Inspectors uploaded 1,618 GPP inspection reports to the electronic GPP (e-GPP) database. UHSC audited 100% of all GPP inspection reports Honorable Commissioner for quality and to ensure the inspections actually occurred. This year, NDA regional head inspectors also supervised the lower level inspectors in compliance with our recommendation to NDA to assure the quality of facility inspectionsHealth. As plannedpart of stakeholder engagement activities in the state, we shifted the server team participated in the TB/HIV) TWG inaugural meeting convened by the State Tuberculosis and e-GPP database Leprosy Control Program (STBLCP). An outcome from UHSC the meeting was the TWG’s intention to NDAestablish and monitor adequate IPT services in health facilities. The team also continued its monthly engagements with the LMCU of the state during the quarter; NDA will now take over responsible for maintaining the system and ensuring sustainability this resulted in a progressive development of electronic reportingJigawa State aggregate logistics data template. ▇▇▇▇▇▇ collaborated with NDA to distribute GPP posters and SAWA SAWA signage to all GPP- certified health facility pharmacies to be distributed together with supported the reward schemes. In December 2016, NDA issued licensure guidelines that required that pharmaceutical wholesalers and distributors must comply with orientation of three LGAs where the Phase 1 GDP standards by January 31, 2017 to receive operating licenses for the year or risk closure. The Phase 1 standards cover quality management systems, documentation, and standard operating procedures. In January 2017, UHSC and senior NDA inspectors trained 30 NDA inspectors to conduct the GDP inspections. In Q10, all of the wholesale and retail pharmacies and distributors that applied for NDA’s 2017 operating license were inspected to determine their compliance with GDP Phase 1 standards, and 497 wholesalers were licensed. In Q11, 54 wholesalers that did not meet the requirements were instructed by NDA to cease operations. The list of the unlicensed entities was published in the public domain. NDA will apply GDP Phase 2 standards—which cover infrastructure standards, complaints, and counterfeit handling and recall procedures—in 2018. Phase 3 standards, which will regulate transportation, tool will be implemented in 2019. The formation and operation of four regional wholesaler organizations is underway in the North, West Nile, Western, and South West regions. As appropriate, the wholesaler organizations will receive UHSC support next year on specific areas of GDP implementation. This year we held two meetings with the Pharmaceutical Society of Uganda piloted prior to discuss their potential collaboration in training pharmacists on GDP. All distributors and wholesalers are supervised by technical directors who must be pharmacists, so improving their knowledge of GDP will strengthen implementation. We submitted a draft concept for the pharmacist GDP training as part of continuing professional development to the Pharmaceutical Society for their feedbackfull deployment.