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Table 1 A suggested FMEA Document for a schistosomiasis preventive treatment program for children aged below five in the uMkhanyakude District of KwaZulu-Natal

From: A prospective risk assessment of the implementation of a schistosomiasis preventive mass drug administration for children aged five years and below in the uMkhanyakude district of KwaZulu-Natal

Activity Potential Failure Mode Process Controls Detection Recommended Action(s)
Enrolment Parents not consenting Health education After community dialogue. Intensify health education. Evaluate the effect of the health education by 1. Registering children into the program shortly or soon after communicating with guardians.
2. Assessing the knowledge level of guardians relating to the program immediately after engagement.
  Child present but not treated Roll call Absence during treatment Register students prior to treatment. Use register to call up children for treatment. Trace absent children and treat. Use existing structures and mechanisms to call and trace present and absent children respectively e.g. guardians of children who could not make it to crèche or ECD can be contacted by Community Care Givers to take their child to the nearest clinic.
Weight measurements Inaccurate weight measurements Calibration of scales none Use measuring boards/ dosage poles.
Administration of drugs vomiting of medication watching child for 30 min following treatment By observation during the 1 h monitoring period Administer the drug carefully and in small amounts. Wrap tablet in bread for the older children
  drug stock outs Weekly stock check and monthly stock take. During the weekly stock check and monthly stock take. Communication between the monitoring and evaluation team and the District Pharmacist will result in the understanding of the demand of PZQ and the supply of adequate drug for the program. Advocating for generics and compulsory drug licensing can also help in the availability of affordable PZQ in consistently sufficient quantities.
Monitoring and evaluation Failure to trace patient Promptly audit the contact information before releasing the child to the guardian. When following up patients for monitoring and evaluation. Promptly audit the contact information before releasing the child to the guardian. Use electronic information storage such as tablets to collect the information. Tablets can be configured not to accept registrations with incomplete information.
Random sampling of children for disease surveillance can be done.
  Failure to provide sample to the laboratory Memo reminding clinics of the period when schistosomiasis cases are likely to be found and to provide laboratory samples for testing when schistosomiasis is suspected. When compiling information for monitoring and evaluation Localise the monitoring and evaluation activities by providing a resource for clinics to report on the laboratory outcomes for cases that were treated for schistosomiasis.
  Failure to provide sample to the laboratory Have an emergency number for the specimen collection driver to call in the event that the vehicle is not able to reach the clinics. When compiling information for monitoring and evaluation Have an alternative vehicle service on standby for emergencies.
  Sample provided to the laboratory but not suitable for testing Develop a sample evaluation report for all specimens sent to the lab by clinics. The quality of samples can be used for work appraisal. When specimens are being processed by the laboratory. The sample collectors need to ensure a quality check for appropriate storage on all specimens prior to collection.