Site selection
The classification of health facilities by volume and the tiered health system: Patient volume is one of the major criteria for site selection for the implementation of Pima POC testing for initiation of ART and/or ART monitoring. The health institutions are, therefore, classified into three categories according to the number of patients they serve for testing.
Low level testing sites (1-5 patients per day)
In these sites, the number of patients requiring testing is estimated to be 1-5 patients per day. These sites are currently using the referral linkage system and the results are obtained in a minimum of one week. A total of 5-25 patients require testing in these health institutions per week. Since the number of patients is small, a weekly referral system should continue to be used for testing. For those sites that are very far from the reference labs and have poor sample transportation systems, placing a Pima® device to serve a group of low-volume sites may be considered. The site receiving a device will serve as a referral lab for other low volume sites around it that can send samples or refer patients. This will be a cost effective solution until simpler, inexpensive POC CD4 technologies are available.
Medium level testing sites (6-20 patients per day)
In these sites, the number of patients requiring testing is estimated to be 6-20 patients per day. Approximately, 30 to 100 patients require testing per week and currently a referral linkage system is used. Taking the throughput and the cost effectiveness into consideration, the Pima® device is the most adapted method of CD4 testing for this level of site as the turnaround-time to results will decrease and maximal patient impact will be attained as compared to conventional CD4 testing through sample referral.
High level testing sites (21-50 patients per day)
In this group of health facilities, the number of patients requiring CD4 testing is estimated to be 21-50 patients per day and 105-250 per week. In these health institutions, the number of patients to be monitored and initiated on ART is high; therefore, there is a need for on-site testing. The choice of a POC technology should however be balanced, depending on the availability of a high throughput technology, equipment cost, cost per test, and infrastructure requirements. Placing two Pima® devices or one high throughput POC CD4 technology, if and when available, will be considered. For facilities that have high patient volumes beyond the capacity of Pima® devices and fulfill the necessary infrastructure requirements, conventional CD4 machines will be considered. If facilities receive a POC CD4 technology that cannot handle the volume of patient testing required, a referral system should be maintained to complement the POC testing.
Based on the above criteria, Pima® devices will be prioritized for placement in medium-level CD4 testing sites or, where applicable, networks of low-level CD4 test sites in hard-to-reach areas.
Basic requirements for site selection
Sites not meeting the basic requirements will not receive a Pima® device. These basic requirements are:
Infrastructure: The facility should have at least intermittent electricity to charge the device;
Treatment: At this time, only facilities providing ART services on-site will be eligible to receive a Pima® device;
Staffing: A facility should have at least one full-time trained laboratory personnel or other healthcare worker to oversee operation of the device.
Due to infrastructure considerations, health posts are not eligible to receive a Pima® device.