**1. Introduction**

Clefts of the lip and palate are among the most common congenital deformities, occurring in about 1 in 500 to 1 in 1000 births worldwide [1]. In many areas of the world, the number of patients with clefts far exceeds the capacity of the healthcare system to treat them. Consequently, only a fraction of the affected population receives treatment, resulting in a global backlog of over 600,000 untreated patients, with 72,000 in India alone [2]. Clefts of the lip and palate can have devastating consequences. Children with cleft palate have difficulty with speech and feeding, which can lead to malnourishment and developmental delay [3, 4]. Children with cleft lip face social stigma and often have lower levels of education and greater unemployment compared to their peers, despite having normal intellectual capacity [5–7].

The global response to this problem over the past several decades has been immense. Charitable organizations have provided more than 1 million free cleft repair surgeries and trained local surgeons to perform these procedures [8]. Historically, the success of these outreach efforts has been measured by the number of patients served, and little emphasis has been placed on the quality of care delivered. Research related to surgical missions is needed but seldom performed, often due to limited funding, manpower, and time [9, 10]. The logistical challenges of

locating former patients, varying degrees of patient compliance, and coordinating follow-up with local providers have also been noted as barriers [11, 12].

What little data that exists indicates that cleft mission work in low and middleincome countries (LMICs) has at times been associated with poor outcomes [8]. Complication rates following cleft palate repair in these settings often approach 30% and follow up rates are understandably much lower than at tertiary care centers in developed nations [13, 14]. In order to bridge this gap, thoughtfully designed quality improvement measures must be implemented, and outcomes must be tracked over time to prove the efficacy of these interventions. Recently, various groups have contributed to a growing body of literature related to such efforts, and some substantial improvements have been reported [13, 15, 16].

In this chapter, we discuss Operation Smile's quality improvement efforts in global cleft care during the past decade and review their impact on measured outcomes. Operation Smile (OS) is an international not-for-profit organization that has provided hundreds of thousands of free cleft lip and palate surgeries to patients in LMICs since 1982. The organization has placed an emphasis on optimizing patient care through research and maintains electronic medical records and photo documentation for all treated patients. By analyzing data collected from missions and cleft centers, OS has been able to implement standardized protocols and quality control mechanisms that have resulted in decreased complications and increased access to cleft care in LMICs.
