Section 3. Quality & Quantity
The quality requirements of a product in the donor country should be applied to the recipient organization's country so that there is no double standard.
Standard 3.1 Quality & Quantity: General
If the quality of an item is unacceptable in the donor country, it is also unacceptable as a donation. Donated products that do not meet stated quality standards or have been recalled are not to be distributed. Because donations should not be wasted or become an environmental problem, the donated quantity is based on the recipient organization's need and capacity to use the product."PE 3.1.1 Donated products are obtained from a reliable source, and meet applicable quality standards in the donor and recipient countries.
PE 3.1.2 If donated products are obtained or received from an unfamiliar source, the organization has a process to assess the authenticity, usability, and quality of the product.
PE 3.1.3 The organization has procedures in place to ensure that expired products, including pharmaceuticals, consumables, and medical devices are not donated.
PE 3.1.4 The organization's donations to the recipient organization do not exceed the requested quantity and documented need.
PE 3.1.5 The organization engages from the recipient organization the person responsible for managing the inventory in the assessment and ordering process.
PE 3.1.6 The organization involves in the ordering process the personnel identified by the recipient organization who will use the product.
Standard 3.2 Quality & Quantity: Pre-shipment Packaging and Storage
To safeguard their quality and integrity, donations received by the organization are properly sorted, labeled, packaged, inventoried and stored prior to being shipped to the recipient organization.
PE 3.2.1 The organization has sorting practices and procedures to ensure that unusable or expired products are not donated.
PE 3.2.2 The organization provides adequate storage capacity to accommodate the products to be donated.
Standard 3.3 Quality & Quantity: Consumables
The organization avoids creating an unnecessary burden for the recipient organization by simplifying the product selection process, following required expiration date guidelines, and not shipping products that are unusable or expired.
PE 3.3.1 The organization has a system to sort disposable supplies into boxes of the exact same items, noting size or size range, and brand information, to enable the recipient organization to make informed decisions during the product selection process.
PE 3.3.2 The organization labels boxes with expiration dates, using the earliest expiration in the box as the date identified to the recipient organization.
PE 3.3.3 The organization complies with applicable laws, rules, and regulations relating to expiration date guidelines for disposable consumables.
Standard 3.4 Quality & Quantity: Medical Equipment
The organization donates medical equipment that is operational and has the necessary supplies and accessories to a recipient organization that has full knowledge of the ongoing use and maintenance requirements for the donated medical equipment.
PE 3.4.1 The organization confirms the medical equipment to be donated is fully operational at the system and subsystem levels, and that all essential accessories and supplies are available.
PE 3.4.2 The organization ensures that all donated medical equipment meets the manufacturer’s safety and performance specifications.
PE 3.4.3 The organization confirms that the recipient organization is aware of the requirements for the following, as applicable:
a) all ancillary equipment
b) installation location
c) electrical power
g) maintenance manuals and documentation
h) transportation packaging and storage
j) on-site storage
PE 3.4.4 The organization confirms that the recipient organization has access to available trained medical professionals and/or technicians to operate and maintain the requested medical equipment.
PE 3.4.5 The organization confirms that the recipient organization will address any gaps in qualified personnel or training.
Standard 3.5 Quality & Quantity: Pharmaceuticals
Donated pharmaceuticals have specific operational and safety requirements.
PE 3.5.1 On all package and shipping documents, the organization displays the following:
a) the pharmaceutical’s generic name;
c) expiration date;
d) lot and control numbers; and
e) storage/temperature requirements.
PE 3.5.2 The organization confirms that the recipient organization involves either a Pharmacist or Medical Director, either directly or by advising others, in the arrangements for donations of pharmaceuticals.
PE 3.5.3 The organization has procedures to ensure excess or expired medicines are not shipped.
PE 3.5.4 The organization ships pharmaceuticals with at least 12 months remaining before their expiration date or with prior written acceptance and assurance that the product will be utilized before expiration [See related PE 6.2.1 for emergency situations.]
PE 3.5.5 The organization ensures that excess or expired donations are destroyed in accordance with the manufacturers/donor’s prescribed procedures and applicable government regulations/WHO guidelines.
PE 3.5.6 For pharmaceuticals that have been recalled, the organization both prevents further distribution of them and if they have already been donated, requests the return or destruction of them by the recipient organization.
Standard 3.6 Quality and Quantity: Medical Devices
PE 3.6.1 The organization complies with applicable laws of originating and receiving countries relating to expiration date guidelines for disposable medical devices.