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Page 10 of 13            Padilla et al. Rare Dis Orphan Drugs J 2023;2:27  https://dx.doi.org/10.20517/rdodj.2023.38

               Assurance exercise. The DOH also requires external review assessment as part of its NSC licensure
               requirement, and a review team of international experts (Dr. Bradford Therrell from the USA and Dr.
               Veronica Wiley from Australia), a local pathologist, and representatives from the DOH and NSRC provide
               periodic expert reviews as part of this process.


               Oversight issues
               Despite the overall success of the program, there are continuing national challenges yet to be fully addressed
               by the NSRC [Table 2]. Policies must be developed to address the timeliness of specimen submission and
               recall of screen-positive patients, which pose a particular challenge for patients from remote communities in
               the mountains or on remote islands. For screen-positive patients already presenting with symptoms upon
               recall, coordination with the needed subspecialist must be done to initiate acute care management. When a
               remote patient is confirmed, arrangements for follow-up and delivery of metabolic food (for metabolic
               patients) and drugs pose a logistical issue. In some instances, collaboration with the military has been
               necessary as the only viable alternative to accomplish this task. The presence of these geographically isolated
               and disadvantaged areas (GIDA) also presents a challenge in delivering continuing education to NBS
               frontliners. Telecommunications technology is currently being used to keep the program implementers
               updated. A locally developed ENBS mobile app now provides a one-stop communications hub for NBS
               information. The app streamlines messages to all healthcare workers about program activities and monitors
               compliance of newborn screening facilities.


               Table 2. Summary of challenges and possible solutions
                Challenges                    Possible solutions
                Quality of specimen submission during NBS   Re-training screeners at the NSFs
                initial test
                Efficiency of recall of screened positive   Collaborations with LGUs and DOH-CHDs for reaching patients living in difficult-to-reach
                newborns                      places, i.e., islands and mountains
                                              Training healthcare workers in communities to perform heel prick and to help in the recall of
                                              patients
                Prompt treatment of diagnosed patients  Early coordination with the needed subspecialist to initiate management of patients who
                                              already present symptoms on recall
                Presence of geographically isolated and   Collaborations with LGUs in education and implementation of the program
                disadvantaged areas           Use of telecommunications technology to keep the program implementers updated
                Maintain quality testing in the NBS laboratories Initiate and ensure compliance with standards among the NSCs through ISO 15189 certification
                Expansion of the treatment network  Coordination with DOH regional offices and provincial offices in identifying new sites for the
                                              continuity and satellite clinics

               DOH-CHD: Department of Health-Centers for Health Development; ISO: International Organization for Standardization; ISO 15189: international
               standard specifying requirements for medical laboratory competency; LGU: local government unit; NBS: newborn screening; NSC: newborn
               screening center (screening laboratory and follow-up); NSF: newborn screening facility (hospital or birthing facility).


               CONCLUSION
               The challenges to implementing sustainable national newborn screening in developing health systems have
                                    [38]
               been previously outlined . The implementation of NBS in the Philippines has been successful because of
               attention to overcoming these challenges that we have discussed in this paper. The success of the PNBSP has
               been attributed to a mix of actions and activities, including national policies, local health ordinances,
               dedicated program partners, health professionals, policymakers, and civil organizations (professional health
               societies, NGOs, parent support groups, etc.). The inclusion of a funding mechanism in the law was a

















               environment.
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