3. Quality & Quantity

3.1 Quality & Quantity – General

3.2 Quality & Quantity – Consumables

3.3  Quality & Quantity – Medical Equipment

3.3  Quality & Quantity – Pharmaceuticals


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    3.1 Quality & Quantity – General

    There should be no double standard in quality. If the quality of an item is unacceptable in the donor country, it is also unacceptable as a donation.
      3.1.1 – General – Sourcing Quality
      3.1.1.1 Donated products should be obtained from a reliable source. 3.1.1.2 Donated products should meet the applicable quality standards in both the donor and recipient countries.   3.1.1.3 Donated products that do not meet stated quality standards or have been recalled should not be distributed.

        Guidance: Prior to accepting a donation or donating a product the MSRO should determine that the product can meet the applicable quality requirements in both the donor and recipient country. In addition, all applicable sources should be checked to ensure the product is not currently under recall or any other advisories prior to being donated. Product quality measures also include, expiry date, appropriate packaging, appropriate storage environment, etc.  
        Resources  3.1.1 Donation Meets Quality Standards
        Recall Policy Resource Type: Example This resource, provided by Brother’s Brother is a good example of an MSRO recall policy. It is specific to pharmaceuticals and covers Class I, II, and III drugs.
        Source: Brother’s Brother Foundation. Signed Recall Policy. http://www.brothersbrother.org/.
        FDA List of Medical Device Recalls Resource Type: Website This website is run by the U. S. Food and Drug Administration (FDA) and lists all medical devices that have been recalled. Each recalled item provides a link to a separate page where details about the recall can be found.
        Citation: U.S. Food and Drug Administration. List of Device Recalls. Available at: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/
        FDA Medical Recalls Resource Type: Website This website lists all the U.S. Food and Drug Administration medical product recalls. The site lists recalls for the following categories: drugs, vaccines, medical devices, other biologics, blood and plasma products, and veterinary products.
        Citation: U.S. Food and Drug Administration. Recalls.gov. Medicine. Available at: http://www.recalls.gov/medicine.html. Accessed on: 9/5/13.
         
        Top 3.1.2 General – Logistics Quality It is important to understand and meet logistics quality requirements throughout the donation process to ensure that products arrive in working order and usable condition.
        3.1.2.1 Confirm adequate cold chain systems and/or temperature monitoring. 3.1.2.2 Confirm adequate storage & distribution. 3.1.2.4 Confirm adequate personnel.

          Guidance: Proper climate control, should be considered as well as shipment preparation and packaging, to maintain integrity of the product. These are especially important in the “last mile” where the product is transported in country to the final recipient.  
          Resources 3.1.2 Maintain Quality in the Donation Process
          Critical Learnings for Supply Chain Managers and Checklist Resource Type: Tool This resource is a supplement of the PQMD Mission Possible Training Program. It’s part of a larger set of resources and can be found in section 1.1. It contains information on procurement, use, reporting, as well as, stocking and disposal. It also contains a checklist on the critical skills a supply chair professional should have.
          Source: Partnership for Quality Medical Donations, Mission Possible. Available at: http://www.pqmd.org/assets/resource%20material%20-%20english.pdf. Accessed on 9/20/13.
          Handbook for Vaccine and Cold-Chain Handlers (PDF) Resource Type: Handbook UNICEF developed this handbook with a thorough framework and importance of the Cold Chair process. It includes information on cold chain systems, equipment, temperature monitoring, equipment maintenance, storage & distribution and responsibilities of personnel.
          Source: UNICEF, Available at: http://www.unicef.org/india/Cold_chain_book_Final_(Corrected19-04-10).pdf. Accessed on 9/20/13.

          Top 3.1.3 General – Packaging Quality Product should be packaged and shipped in a manner that safeguards its quality and integrity during transportation.  MSRO procedures should address all of the following.   See the attached guidance for more information.  
          3.1.3.1 Marking and Labeling Shipments. 3.1.3.2 Perishables and Thermal-Sensitive Products. 3.1.3.3 Corrugated Fiberboard Boxes. (avoid used boxes) 3.1.3.4 Cushioning. 3.1.3.5 Cargo Security. 3.1.3.6 Stretch Wrapping. 3.1.3.7 Palletizing Boxes. 3.1.3.8 Bagged Shipments. 3.1.3.9 Hazards of Shipment Testing.

            Guidance: Packaging should be specific to the product and designed to reduce damage during shipping. For example, syringes should be packaged accordingly and labeled as “fragile,” during each stage of the shipping process.
            Resources
            FedEx Packaging Guidelines for Shipping Freight Resource Type: Report
            This document was created by FedEx and outlines proper packaging procedures for shipping freight.
            Citation: FedEx. Packaging Guidelines for Shipping Freight. Available at:http://www.fedex.com/us/services/pdf/FreightPackagingGuidelines.pdf. Accessed on: 9/5/13.
            UPS Air Freight Packaging Pointers Resource Type: Report This document was prepared by UPS and provides pointers on packaging an air freight shipment. The chapters in the document include: Hazards of Distribution Pre-Shipment Testing; Marketing and Labeling Shipments; Perishables and Other Thermal-Sensitive Products; Corrugated Fiberboard Boxes; Wood Packages; Air Freight Pallets; Dunnage; Cushioning; Cargo Security; Stretch Wrapping; Drum and Pail Shipments; Spools and Reels; Palletizing Boxes; and Bagged Shipments.
            Citation: United Parcel Service. Air Freight Packaging. 2005. Available at: http://www.ups-scs.com/tools/packaging_pointers.pdf. Accessed on: 9/5/13.

            Top 3.1.4 General – Quantity It is also important that the quantities donated should fit the documented need in order to ensure that the donations is not wasted and does not become an environmental problem.  
            3.1.4.1 MSROs has a process to confirm the appropriate quantity to donate based on the recipients need and capacity to use the products.  

              Guidance: Donations determine the size of the facility being served. For example, if a hospital only has room for 5 beds, 15 beds should not be donated.  Recipients should be discouraged from sharing the donated products without the approval of the MSRO.
              Resources
              Facility Capacity Form Resource Type: Template This form allows the user to enter basic information about the capacity of the facility being served. It can be used to record information on facility type and capacity.
              Citation: Training4Good. Facility Capacity Form. Available at: https://docs.google.com/document/d/1wdI-h9bvcWm9wdpd55lJQcScSNlnpu9pMFRcZMPLMkw/pub
              CIA World Factbook Resource Type: Website This website provides basic demographic information on the various countries around the world. It can be used to find out basic information about large populations.
              Source: CIA. The World Factbook. Available at:https://www.cia.gov/library/publications/the-world-factbook/index.html. Accessed on: 9/16/13.
              WHO Procurement and Management of Supplies and Equipment Resource Type: Guidelines This document was created by the WHO and provides information on the proper procurement and management of supplies and equipment. The document provides practical guidelines for all stages of procuring and managing medical supplies and medical equipment. This is an excellent resource for any recipient that wants to learn more about the procurement process and management of medical supplies and equipment.
              Source: The World Health Organization. Procurement and Management of Supplies and Equipment. Available at: http://www.who.int/management/resources/procurement/MedicalSuppliesforPHC(2)Procurement&Management.pdf. Accessed on: 9/16/13.
              Medical Stores Management – Flow and Stock Information Resource Type: Guidelines This document was created by the Management Sciences for Health. It provides information regarding the proper management of inventory and stock flow. This is an excellent resource for a recipient wishing to learn more about proper inventory management and ordering.
              Source: Management Sciences for Health. Management Support Systems: Medical Stores Management. Available at: http://www.msh.org/sites/msh.org/files/mds3-ch44-medicalstores-mar2012.pdf. Accessed on: 9/16/13.

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              3.2 Quality & Quantity – Consumables

              3.2.1 Consumables –  Human Resources
                When donating consumables it is important to engage the person responsible for managing the inventory in the assessment and ordering process.
                3.2.1.1 MSRO will determine if the personnel that will use the product are involved in the ordering process. 3.2.1.2 MSRO will determine if the personnel responsible for inventory management are involved in the ordering process.

                  Guidance: When making a donation the MSRO should be aware of the individual at the recipient location who is responsible for maintaining inventory. Since this person most likely has the best idea what the facility actually needs, they should be involved in the donation process whenever possible.  In some locations this may be the same person.  
                  Resources
                  MSRO Facility Human Resources Questionnaire  Resource Type: Template This template is designed to list the human resources available at a partner facility. It can be used by an organization as is, or adapted to address their unique needs.
                  Citation. Training4Good. Available at: https://docs.google.com/document/d/1xu4muQhA0OKfiaxCXVdESKZt_pWM5_gmoINox2QQsug/pub
                  WHO Procurement and Management of Supplies and Equipment Resource Type: Guidelines This document was created by the WHO and provides information on the proper procurement and management of supplies and equipment. The document provides practical guidelines for all stages of procuring and managing medical supplies and medical equipment. This is an excellent resource for any recipient that wants to learn more about the procurement process and management of medical supplies and equipment.
                  Source: The World Health Organization. Procurement and Management of Supplies and Equipment. Available at: http://www.who.int/management/resources/procurement/MedicalSuppliesforPHC(2)Procurement&Management.pdf. Accessed on: 9/16/13.
                  Medical Stores Management – Flow and Stock Information Resource Type: Guidelines This document was created by the Management Sciences for Health. it provides information regarding the proper management of inventory and stock flow. This is an excellent resource for a recipient wishing to learn more about proper inventory management and ordering.
                  Source: Management Sciences for Health. Management Support Systems: Medical Stores Management. Available at: http://www.msh.org/sites/msh.org/files/mds3-ch44-medicalstores-mar2012.pdf. Accessed on: 9/16/13.

                  Top 3.2.2 Consumables – Sorting Practices   Organizations will have proper procedures in place to ensure that unusable or expired consumable products are not shipped, thus creating unnecessary burden for the recipient. 
                  3.2.2.1  MSROs will have a system of sorting disposable supplies into boxes of the exact same items (ex. Latex Exam Gloves size large). When applicable and necessary, organizations should note size or size range and brand information so the recipient can make informed decisions during the item selection process. 3.2.2.2 Label boxes with expiration dates, using the earliest expiration in the box as the date identified to the recipient, when applicable. 3.2.2.3 Follow all applicable laws/regulations in relation to expiration date guidelines for disposable medical devices. 3.2.2.4 Consumables are packed in boxes suitable for transportation.

                      Guidance:  Proper sorting helps MSROs ship only consumable products with at least 12 months remaining before their expiration date or with prior written acceptance and assurance that the product will be utilized before expiry and that the customs regulations in the recipient country will release shipments with short-dated products.
                      Resources – Code 3.2.2 Good Sorting Practices
                      Mission Possible: First Expiry First Out Resource Type: Video This resource provides an overview of the First Expiry First Out or FEFO procedure.
                      Source: Partnership for Quality Medical Donations, Mission Possible. Available at: http://www.pqmd.org/index.php?option=com_content&view=article&catid=26:what-we-do&id=48:mission-possible#firstexpiry. Accessed on 9/20/13.
                       
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                      3.3 Quality & Quantity – Medical Equipment

                      3.3.1 Medical Equipment – Supplies and Accessories
                      3.3.1.1 MSROs should confirm that donated health care equipment is fully operational at the system and sub-system levels, and that all essential accessories and supplies are available. 3.3.1.2 MSROs will confirm that the recipient is aware of all the ancillary equipment, ongoing supplies needed and utilities necessary to the support of the device or equipment being donated.

                        Guidance: A recipient’s medical equipment capacity should be analyzed during the needs assessment process. An organization should not donate the equipment without an expressed request from a recipient who has full knowledge of the ongoing use and maintenance requirements for the donated equipment.
                        Resources – 3.3.1 Ensure Equipment is Operation and has Necessary Supplies and Accessories
                         WHO Medical Device Regulations: Global Overview and Guiding Principles  Resource Type: Guidelines This report provides an overview of medical device regulation globally as well as a list of principles useful in considering the quality of a donation.
                        Citation: World Health Organization. WHO Medical Device Regulations: Global Overview and Guiding Principles. Available at: http://www.who.int/medical_devices/publications/en/MD_Regulations.pdf. Accessed on 8/6/13. 
                        Medical Equipment Ancillary Supply Checklist Resource Type: Template This template can be used to list the different ancillary equipment and supplies that accompany a piece of medical equipment being donated.
                        Source: Training4Good. Medical Equipment Ancillary Supply Checklist. Available at:  https://docs.google.com/document/d/1Bp2ByDNT5M7vYIM0FKpNDp_E4wOf_cgNcNyGkNMWo7o/pub.
                        Medical Device Donations: Considerations for the solicitation and provision. – WHO MEDICAL DEVICE TECHNICAL SERIES Resource Type: Guidelines This WHO resource was developed to help guide and inform medical equipment donation practices. It provides information for organizations both making and receiving medical donations.
                        Source: World Health Organization, © World Health Organization 2011.Available at: http://apps.who.int/iris/bitstream/10665/44568/1/9789241501408_eng.pdf Accessed on: 03-02-2016

                        Top 3.3.2 Medical Equipment – Manufacturer Standards The donated equipment should meet all of the manufacturer’s safety and performance specifications.  MSRO medical equipment should be checked for the following before approved for donation. 
                        3.3.2.1 Installation location requirements. 3.3.2.2 Electrical power requirements. 3.3.2.3 Water requirements. 3.3.2.4 Safety requirements. 3.3.2.5 Sub-systems requirements. 3.3.2.6 Maintenance manuals and documentation. 3.3.2.7 Transportation packaging and storage considerations. 3.3.2.8 Required supplies. 3.3.2.9 Onsite storage requirements.

                          Guidance: Prior to donation, equipment should be inspected by a trained technician to ensure it meets the manufacturer’s safety and performance specifications.
                          Resources
                          WHO Medical Device Regulations: Global Overview and Guiding Principles Resource Type: Guidelines This document was created by the World Health Organization. It has chapters on medical device safety, governmental regulation of medical devices, Global Harmonization Task Force (GHTF), standards, optimizing the use of regulatory resources, and priorities on the international agenda.
                          Source: The World Health organization. Medical Device Regulations: Global Overview and Guiding Principles. Available at: http://www.who.int/medical_devices/publications/en/MD_Regulations.pdf. Accessed on: 9/16/13.
                          Medical Equipment Responsible Use Guide Template Resource Type: TemplateThis template can be used by an MSRO when donating medical equipment and don’t have an existing Responsible Use Guide. It can record information including installation location requirements, electrical power considerations, water considerations, safety requirements, sub-systems, maintenance requirements, and transportation.
                          Source: Training4Good. Responsible Use Guide Template. Created on 9/18/13.

                          Top 3.3.3 Medical Equipment – Human Resources Properly trained physicians, nurses, and/or technicians who will operate and maintain the requested equipment. 
                          3.3.3.1 MSRO has a process to determine the number of qualified personnel with the skills to maintain the donated equipment.  3.3.3.2 MSRO has determined how the recipient will address any gaps in qualified personnel or training, if needed.

                            Guidance: An organization should assess the recipient’s human resource capacity during the needs assessment process. The recipient should be aware of how to properly maintain the equipment, and should have the proper tools to do so. If they do not possess the proper training and tools to maintain the equipment themselves, the recipient should provide documentation on their plan for meeting this requirement.
                            Resources
                            Facility Human Resources Questionnaire Resource Type: TemplateThis template allows the user to record important human resources information for the recipient facility. It can be used to record the number of doctors, nurses, midwives, pharmacists, lab technicians, and community health workers. It can also be modified to fit an individual organizations needs.
                            Citation: Training4Good. Facility Human Resources Questionnaire. Available at: https://docs.google.com/document/d/1xu4muQhA0OKfiaxCXVdESKZt_pWM5_gmoINox2QQsug/pub. Accessed on: 9/5/13.
                            Beyond Good Intentions: Lessons on Equipment Donation from an African Hospital Resource Type: Research Paper This research paper studies the effects of improper medical equipment donations from the perspective of an African hospital. The study cites lack of local expertise to maintain and repair the equipment as the major reason donations do not work.
                            Source: Howie SRC, Hill SE, Adegbola RA. Beyond good intentions: lessons on equipment donation from an Aftican hospital. Bull World Health Organ. 2008 January; 86(1): 52-56.
                            Best Practice Policies for Medical Equipment Donations: Lessons from India and Brazil Resource Type: Research Paper This research paper was written to investigate the question of how governments in developing countries can use best practice information for the donation of medical equipment, to develop effective health care policies. It provides great information and examples and is an excellent resource for organization’s wishing to learn more about the importance of quality.
                            Source: Lubert A, Pantoja M, Turrini G, Wang L. Best practice policies for medical equipment donations: lessons from India and Brazil. Sanford School for Public Policy. April 2012. Available at: http://research.sanford.duke.edu/students/Spring2012-8es.pdf. Accessed on: 9/17/13.

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                              3.4 Quality & Quantity – Pharmaceuticals

                            3.4.1 Pharmaceuticals – Documentation
                            3.4.1.1 The product’s generic name should appear on all package and shipping documents, along with other relevant information, e.g. quantity, expiration date, lot and control numbers, and storage/temperature requirements.

                              Guidance: The pharmaceutical should remain in its original shipping containers. If it is necessary to transfer the product into a new shipping container, the container must be properly labeled with all necessary information including quantity, expiration date, lot and control numbers, and storage and temperature requirements.  
                              Resources
                              WHO Model Certificate of Pharmaceutical Product Resource Type: Template This webpage provides a template for the WHO Certificate of Pharmaceutical Product. It is a great resource for any organization involved in the donation of pharmaceutical products.
                              Citation: The World Health Organization. Medicines: Model Certificate of a Pharmaceutical Product. Available at: http://www.who.int/medicines/areas/quality_safety/regulation_legislation/certification/modelcertificate/en/index.html. Accessed on: 9/5/13.
                              WHO Good Distribution Practices for Pharmaceutical Products Resource Type: Guidelines These guidelines were created by the World Health Organization in 2010. One section of the document addresses the proper repackaging and re-labeling of pharmaceutical products.
                              Source: The World health Organization. WHO Technical Report Series. Annex 5: WHO Good Distribution Practices for Pharmaceutical Products. 2010. Available at: http://www.who.int/medicines/areas/quality_safety/quality_assurance/GoodDistributionPracticesTRS957Annex5.pdf. Accessed on: 9/17/13.

                              Top 3.4.2 Pharmaceuticals – Human Resources
                              3.4.2.1 Pharmacists or Medical Director representing the recipient organization should be involved, either directly or by advising others, in the arrangements for donations of medicines.

                                Guidance: If working with staff other than the pharmacist or medical director, the organization should have expressed permission to work with specific staff from medical director/pharmacist.
                                Resources Code 3.4.1 Properly Qualified Human Resources for Pharmaceutical Donation Facilitation
                                Facility Human Resources Questionnaire Resource Type: Template This template allows the user to enter important human resources information for the recipient facility.
                                Citation: Training4Good. Facility Human Recourses Questionnaire. Available at: https://docs.google.com/document/d/1xu4muQhA0OKfiaxCXVdESKZt_pWM5_gmoINox2QQsug/pub. Accessed on: 9/5/13.
                                WHO Country Assessment Tool on the Uses and Sources on Human Resources for Health Product Type: Tool This diagnostic tool contains questions intended to gather information on the uses, type and quality of data on HRH at institutional level in countries. This step is critical to identify strengths and weaknesses of the current HRIS in countries. The resulting information can then be used to identify priorities and develop strategies to strengthen the HRIS at district, regional, or national level.
                                Source: World Health Organization. Health Workforce. Available at: http://www.who.int/hrh/statistics/survey_use_source/en/index.html. Accessed on 9/18/13

                                Top 3.4.3 Pharmaceuticals – Expired Medicines Organizations will ensure that they have proper procedures in place to ensure excess or expired medicines are not shipped, thus creating unnecessary burden for the recipient.
                                3.4.3.1 MSROs will ship only pharmaceutical products with at least 12 months remaining before their expiration date or with prior written acceptance and assurance that the product will be utilized before expiry and that the customs regulations in the recipient country will release shipments with short-dated products. 3.4.3.2 MSROs will has procedures in place to ensure excess or expired donations are destroyed in accordance with the manufacturers/donor’s prescribed procedures and applicable government regulations/WHO guidelines.

                                  Guidance: 
                                  Resources
                                  Guidelines for the Safe Disposal of Unwanted Pharmaceuticals in and after Emergencies Resource Type: GuidelinesThe WHO Guidelines for the Safe Disposal of Unwanted Pharmaceuticals in and after Emergencies provides general guidelines for healthcare clinics in developing countries to properly dispose of unwanted or expired medicine.
                                  Citation: The World Health Organization. Guidelines for safe disposal of unwanted pharmaceuticals in and after emergencies. 1999. Available at: http://www.who.int/water_sanitation_health/medicalwaste/unwantpharm.pdf. Accessed on: 9/5/13.
                                  Guidelines for Medicine Donation (PDF) Resource Type: Guidelines The WHO Guidelines for Medicine Donation provides general guidelines for donation medicine including considerations for expired medicine and disposal.
                                  Source: World Health Organization, Guidelines for Medicine Donations 2010. Available at: http://whqlibdoc.who.int/publications/2011/9789241501989_eng.pdf. Accessed on 9/20/13.
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