Standard 2.1 Needs Assessment General: Donations 
Donations are made based on: an expressed need at the request of the recipient organization; after a thorough needs assessment confirms that the donation is appropriate for the setting; respect for the wishes and authority of the recipient organization; in conformity with the government policies and administrative arrangements of the recipient country; and the ability of the recipient organization to effectively handle and distribute donations.

PE 2.1.1 The organization collects and assesses information regarding the demographics and socioeconomic status of the population being served by the recipient organization.

PE 2.1.2 The organization collects and assesses information regarding the recipient organization’s role in the local healthcare infrastructure.

PE 2.1.3 The organization collects and assesses information specific to the donation regarding the recipient organization’s financial resources, facility conditions and services, and trained personnel resources.

PE 2.1.4 The organization confirms that the recipient organization provides clear specifications and quantities of the product needed and prioritizes requested items.

PE 2.1.5 The organization assesses the recipient organization’s policies and plans for taking into account the medical cultures, beliefs, and traditional health practices of the populations receiving donations.

PE 2.1.6 The organization confirms that the recipient organization has the proper storage for each product, including, as applicable, climate control, cold storage, security, shelving and storage capacity.

PE 2.1.7 The organization confirms that the recipient organization understands the packaging, labeling, maintenance and any applicable operating instructions.

PE 2.1.8 The organization assesses the following logistics capabilities of the in-country consignee and recipient organization, as applicable to the product and recipient country: 
a) their understanding of the recipient country's customs, rules and regulations; 
b) their knowledge of shipping and in-country transportation requirements; and, 
c) the storage capacity, climate control, and security available.

PE 2.1.9 The organization confirms that the recipient organization has a product disposal plan.

Standard 2.2 Needs Assessment: Consumables 
Donation of consumables to support a piece of equipment meet the manufacturer's specification for that piece of equipment.

PE 2.2.1 - The organization confirms that consumables donated to support a specific piece of equipment meet the manufacturer’s specification for that equipment.

PE 2.2.2 The organization confirms with the recipient organization that the appropriate product type and quantity, size, and material address the health needs of the target population.

PE 2.2.3 The organization confirms that the recipient organizations has access to the reagents or consumables required to operate the donated equipment.

Standard 2.3 Needs Assessment: Medical Equipment 
Donation of medical equipment occurs after it is tested and is determined to be appropriate for the recipient organization's operating environment.

PE 2.3.1 The organization uses individuals that are qualified or trained to evaluate and repair medical equipment, test and calibrate parts, identify parts for repair or replacement, and reject unusable equipment.

PE 2.3.2 The medical equipment needs assessment process considers the following factors: accessories; access to operating supplies; interoperability; energy consumption; maintenance; and, climate control requirements.

PE 2.3.3 The organization provides the recipient organization with a "responsible use guide" or other instructions that describe the requirements for appropriate use and maintenance of the medical equipment. When applicable, this includes: product information; installation; electrical, water, safety, sub-systems; maintenance; and, transportation requirements.

Standard 2.4 Needs Assessment: Pharmaceuticals 
Donation of pharmaceuticals occurs after a needs assessment is conducted to confirm the need, appropriateness, and capabilities of the recipient organization.

PE 2.4.1 Prior to donating pharmaceuticals, the organization considers the rules and regulations governing pharmaceuticals in the recipient country, including, but not limited: the pharmaceuticals approved for use in the country; pharmaceuticals on the recipient country’s WHO list of essential medicines; and any national standard treatment guidelines.

Standard 2.5 Needs Assessment: Medical Devices 
The organization is familiar with US Federal Drug Administration (FDA) medical device classifications and complies with their rules and regulations governing class I, II and III medical devices.

PE. 2.5.1 The organization complies with FDA rules and regulations governing class I, II and III medical devices.