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. National Drug Authority Good pharmacy practice (GPP) certification 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. XXXX 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. Good distribution practice 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 No progress was made on developing a web-based TB ordering and reporting system because of the NMS costing study that is delays in obtaining the 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 not registered at NDA badly affected MDR-TB treatment services. Central Public Health Laboratory XXXX 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 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 weight PEPFAR priorities and volume estimate current UHSC support. The finalized Lab SPARS performance assessment tool has 27 indicators relating to five categories—stock management; storage management, ordering, receipt and not actual weight reporting; laboratory equipment; and volume figures has proven challenging to reevaluate the service feeslaboratory information system. A costing study at JMS is underway using actual weightgroup 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/volume figures. National Drug Authority Good pharmacy practice (GPP) certification With our support, this year National Drug Authority (NDA) inspected 803 public and PNFP facilities for good pharmacy practice (GPP)technicians, and 58% regional laboratory focal persons (based at the regional referral hospitals) will be the key implementers of the facilities met Lab SPARS performance improvement approach. We also developed the minimum GPP standards framework for monitoring and were certifiedevaluating 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 transmit data to the web portal from any location. The UHSC laboratory team also helped update the lab test menu and techniques in line with the changes 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. Three activities planned for Year 2 did not go forward   The bimonthly lab commodity ordering and reporting system was not developed. This year’s inspection target activity depended on the recruitment of 2,000 facilities could the senior programmer, which did not be achieved occur until Q7 because NDA inspectors had there are very few programmers with the necessary skills available. UHSC and CPHL agreed instead to prioritize Good Distribution Practices work on the Lab SPARS system.  The planned GIS mapping of laboratory equipment, requested by CPHL, was not needed because the MoH Infrastructure Division was already conducting a similar assessment.  The unified product coding exercise (GDPsee JMS section for more details) licensing inspections will not include laboratory supplies as originally planned; the huge number of wholesalers from January to April, 2017different types and brands of reagents makes this exercise very complicated. Inspectors uploaded 1,618 GPP inspection reports to Through 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. XXXX 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. Good distribution practice 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 2017QPPU, 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 Inadequate supply of CD4 test reagents and control by SCMS to some supported facilities  Stock out of PIMA control count beads at two facilities (Xxxx XX 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 Jigawa State 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. National Drug Authority Good pharmacy practice (GPP) certification 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 NDA; NDA will now take over responsible for maintaining the system establish and ensuring sustainability of electronic reportingmonitor adequate IPT services in health facilities. XXXX collaborated with NDA to distribute GPP posters and SAWA SAWA signage to all GPP- certified health facility pharmacies to be distributed together The team also continued its monthly engagements with the reward schemes. Good distribution practice 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 LMCU 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 licensedstate during the quarter; this resulted in a progressive development of Jigawa State aggregate logistics data template. In Q11, 54 wholesalers that did not meet XXXXXX supported the requirements were instructed by NDA to cease operations. The list orientation of three LGAs where 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.

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. National Drug Authority Good pharmacy practice (GPP) certification 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. XXXX 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. Good distribution practice 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 the The inability or unwillingness of 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. National Drug Authority Good pharmacy practice (GPP) certification With our supportroutinely share vital shipment data made it very difficult to accurately update supply plans for HIV, this year National Drug Authority (NDA) inspected 803 public and PNFP facilities for good pharmacy practice (GPP)TB, and 58% malaria commodities  Limited availability of and inaccurate logistics and health service data for forecasting and quantification AIDS Control Program In Year 2, 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 UHSC staff members seconded to the electronic GPP AIDS Control Program continued to strengthen the national web-based ARV ordering and reporting system (e-GPPWAOS) database. UHSC audited 100% of all GPP inspection reports for quality and to ensure the inspections actually occurredavailability of quality ART data on logistics and patients for program planning, monitoring and sharing. This Our ongoing work focused on maintaining the high WAOS facility reporting rate (currently >90%), disseminating bimonthly WAOS reports, and training of health workers and supervisors to improve the accuracy and completeness of ARV ordering and reporting. A highlight was that the UHSC team conducted the first assessment of WAOS data quality, including a desk review of six months of data and a field study carried out between June and October, 2015. The findings and recommendations led the MoH to undertake three important actions that will improve facility ARV management as well as the accuracy of WAOS reporting—  The ART facility accreditation guidelines and site assessment tool were updated to include, among other things, standards to assess a facility’s logistics management capacity. To date, 1,600 of the 2,000 active and inactive ART sites have been reassessed.  The MoH Resource Center has cleaned up the master ART site list (last updated in December 2014) by removing more than 170 inactive sites and adding 42 new sites that have been recently accredited. WAOS reporting indicators will now be more accurate.  Revisions were also made to the WAOS form and job aid to improve the accuracy of orders and patient information. During the year, NDA regional head inspectors also supervised our team worked closely with the lower level inspectors in compliance AIDS Control Program M&E team to produce the official national ART patient numbers by validating and triangulating WAOS patient data with our recommendation to NDA to assure the quality District Health Information System version 2 (DHIS2) patient numbers. These numbers are the basis for forecasting and quantifying national HIV commodity requirements and are key performance indicators for PEPFAR and the Global Fund. Toward the end of facility inspections. As plannedthe year, 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. XXXX 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. Good distribution practice 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 also participated in the public domain. NDA will apply GDP Phase 2 standards—which cover infrastructure standards, complaints, MoH stakeholder workshop for drafting the Consolidated Guidelines for Preventing and counterfeit handling and recall procedures—Treating HIV Infection 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 Uganda based on 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 implementation2015 WHO ART guidelines. We submitted a draft concept for ensured that supply chain considerations were appropriately factored into the pharmacist GDP training as part guidelines and that future implementation of continuing professional development to the Pharmaceutical Society for their feedbacknew formulations and other changes involve supply chain planning.