Office of Procurement 359 Blackwell Street, Suite 200 Durham, NC 27701 USA Phone: (919) 544-7040 www.fhi360.org REQUEST FOR QUOTATIONS Description: The USAID Global Health Supply Chain-Quality Assurance Program (GHSC-QA) requests quotations for quality control (QC) product sampling services. RFQ Number: RFQ 10-840-2017-1008-QCPSS Date Issued: October 27, 2017 Key RFQ Dates: Action/Milestone Vendor Acknowledgement Forms Due Deadline for Questions FHI 360 Response to Questions Deadline for Receipt of Quotations Due Date November 6, 2017 10:00 AM Eastern Time November 6, 2017 10:00 AM Eastern Time November 9, 2017 10:00 AM Eastern Time November 17, 2017 10:00 AM Eastern Time Questions must be submitted via email to: PQCProcurement@fhi360.org. Questions received after the deadline will not be answered. Quotations must be submitted via email to: PQCProcurement@fhi360.org. Please refer to the Instructions to Offerors section beginning on page 5 for detailed instructions regarding the proposal format and submission requirements. This RFQ was issued by Family Health International (FHI 360) for the USAID Global Health Supply Chain Quality Assurance Program (AID-OAA-C-15-00001).
CONTENTS ACRONYMS...1 PROGRAM BACKGROUND...2 Overview... 2 Program Design... 2 FHI 360... 3 DESCRIPTION OF THE RFQ...5 Scope of Work... 5 Quote Specification... 5 Target Countries... 5 Listed Laboratories... 6 INSTRUCTIONS TO OFFERORS...6 Quotation format and submission Procedure... 6 Technical Quotation... 6 Cost Proposal Requirements... 8 TERMS AND REQUIREMENTS...9 Terms... 9 Requirements... 9 AWARD CRITERIA... 10 APPENDIX A: SAMPLE TERMS AND CONDITIONS... 11 General Terms and Conditions... 11 Special Terms and Conditions... 11
ACRONYMS AIDAR ARVs BP FAR FHI 360 GHI GHSC GHSC-QA IQCs ISO IUDs OI OOS PEPFAR QA QC Ph. Int. PMI RDTs RFQ RTKs RUTFs SCMS SOP USAID USG WHO USAID Acquisition Regulation Antiretroviral Drugs British Pharmacopoeia Federal Acquisition Regulation Family Health International Global Health Initiative Global Health Supply Chain Global Health Supply Chain-Quality Assurance Program Indefinite Quantity Contracts International Organization for Standardization Intrauterine Devices Opportunistic Infections Out-of-Specification U.S. President's Emergency Plan for AIDS Relief Quality Assurance Quality Control International Pharmacopoeia President s Malaria Initiative Rapid Diagnostic Tests Request for Quotation Rapid Test Kits Ready to Use Therapeutic/Supplementary Foods Supply Chain Management System Program Standard Operating Procedure U.S. Agency for International Development U.S. Government World Health Organization 2017 GHSC-QA Sampling RFQ 1
PROGRAM BACKGROUND OVERVIEW The U.S. Agency for International Development (USAID) is the U.S. Government (USG)'s principal implementing agency for international development assistance. Within USAID, the Bureau for Global Health has a broad portfolio that includes a wide array of programs and investments that represent the commitment and determination of the USG to prevent suffering, save lives, and create an environment that encourages development. Supply chain management, procurement of essential health commodities, and providing quality assurance (QA) for these commodities are essential components of the Agency's health portfolio and directly support the Agency's health contribution to the Global Health Initiative (GHI). PROGRAM DESIGN In 2015 the Bureau for Global Health issued a comprehensive QA award to FHI 360, the Global Health Supply Chain-Quality Assurance Program (GHSC-QA), which promotes the effectiveness and efficiency of USAID QA services by combining and coordinating QA activities.this contract will provide independent, essential, comprehensive QA and QC services covering the different health elements in the Bureau. FHI 360 is charged with designing and implementing a QC strategy that provides for appropriate monitoring of the quality of health commodities procured on behalf of USAID. As product sampling is an essential element of the QC strategy, FHI 360 is releasing this RFQ to solicit quotations from qualified sampling firms to identify implementation partner(s) offering best value for sampling services to the USG. 2017 GHSC-QA Sampling RFQ 2
FHI 360 FHI 360 is a human development organization dedicated to improving lives in lasting ways through research and projects in the areas of product QA, education, health, nutrition, economic development, environment, and civil society. Since 1971, FHI 360 has worked with approximately 1,400 partners in more than 125 countries, forging strong relationships with governments, diverse organizations, the private sector, and communities. By applying science to programs, FHI 360 is helping communities make measurable progress in the areas of health, education, disease prevention, poverty alleviation, and social inequity improving lives for millions. We have the unique ability to bring a 360-degree perspective to some of the world s most complex human development challenges. We translate this perspective into customized solutions that are making a real difference in people s lives around the world. FHI 360 envisions a world in which all individuals and communities have the opportunity to reach their highest potential. Together we are helping people find their own ways of connecting with one another, with knowledge, with essential services, and with the tools they need to reach that potential. FHI 360 vision FHI 360 envisions a world in which all individuals and communities have the opportunity to reach their highest potential. FHI 360 mission FHI 360 s mission is to improve lives in lasting ways by advancing integrated, locally driven solutions for human development. FHI 360 beliefs A 360-degree perspective is required to address complex human development needs. Sustainability comes from building the capacity of individuals, communities, and countries to address their needs. The key to improving lives is in generating, sharing, and applying knowledge. Partnering with governments, civil society organizations, the private sector, and communities leads to success. 2017 GHSC-QA Sampling RFQ 3
FHI 360 values Innovation to meet the evolving needs of our beneficiaries, funders, and partners. Mutual respect for diversity and cultural differences. Passion driven by a personal commitment to make a positive difference. Accountability for our work, measuring, reporting, and continually improving all that we do. Commitment to excellence assured by the highest ethical, quality, operational performance, and scientific standards. Teamwork across disciplines and geographies, within the organization and with our partners. 2017 GHSC-QA Sampling RFQ 4
DESCRIPTION OF THE RFQ GHSC-QA requests responsive quotations to provide product sampling services for health commodities such as: Reproductive Health Products (Pharmaceuticals and Devices); Essential Medicines including pharmaceutical products for HIV and Opportunistic Infections (OI); Rapid Diagnostic Test Kits (RDTs) and Rapid Test Kits (RTKs); Ready to Use Therapeutic/Supplementary Foods (RUTFs); Kits for Voluntary Male Medical Circumcision (VMMC); Other Laboratory Products (Point-of-Care Products), and; Narcotics. Quotations must be provided in accordance with the Instructions to Offerors. SCOPE OF WORK Services to be provided: Product sampling of all product categories listed above in accordance with prevailing standard operating procedures (SOPs) and international standards. The sampling agent will randomly select the specified number of items from each lot for sampling. Samples shall be forwarded via an international carrier to the testing laboratory specified by FHI 360. The sampling will include a report of the visual inspection and all other required activities for the specific product type being sampled. QUOTE SPECIFICATION Sampling will predominately be commodities at the manufacturing site before shipment to the final destination (pre-shipment sampling). However, sampling of commodities after arrival in country (post-shipment sampling) may be required from different locations (i.e., warehouses and central medical stores) throughout the GHSC program. Thus, quotations for both pre-shipment and post-shipment sampling are requested. The daily rates quoted shall not change during the period of performance, and expenses in excess of the quoted price will not be reimbursed. The cost quotation must be submitted using the Excel worksheet provided with the RFQ. Small businesses and consultants are invited to submit quotations. Offerors are not required to submit pricing for all locations listed in the cost template; however, Offerors are encouraged to quote as many locations as possible to demonstrate technical capacity. TARGET COUNTRIES Commodities purchased through the GHSC program may come from an extensive range of countries covering North and South America, Europe, Africa, and Asia. The exact locations are variable due to variances in procurement. Due to this complexity, multiple country scenarios across all commodity types are requested for quotation as listed in the cost quotation sheet (for both pre-shipment and post-shipment examples). The daily rates quoted will serve as proxies for evaluating reasonability of daily rates for similar sampling assignments during the period of performance. 2017 GHSC-QA Sampling RFQ 5
FHI 360 reserves the right to add or delete countries and/or additional agents from this list as needs dictate and the project progresses. LISTED LABORATORIES The laboratory to which the product samples will be sent will be determined by FHI 360 at the time of request. Approved laboratories may be located in a number of countries worldwide, including multiple labs in Africa, Asia, Europe, and North America. Due to this complexity, shipping costs of samples to the respective laboratories are to be excluded from the cost quotation sheet. INSTRUCTIONS TO OFFERORS QUOTATION FORMAT AND SUBMISSION PROCEDURE Technical and Cost Quotations must be submitted as separate files. Both files may be transmitted in the same e-mail; however, each file must be named and clearly labeled to identify the Offeror and quotation type (i.e., FHI 360-TECHNICAL, FHI 360-COST.). The subject line of the submission e-mail must read: Quotation 10-840-2017-1008-QCPSS for USAID GHSC-QA Program - Name of Offeror. The quotation, as well as all correspondence and documents relating to the quotation, must be in English. Intent to Participate/Not Participate Please advise FHI 360 of your receipt of the RFQ and your intent to submit or not submit a proposal by using the attached Acknowledgement Form and e-mailing it per instructions in the document. Bidders choosing to not participate must immediately erase any electronic versions of this RFQ. This RFQ in no way obligates FHI 360 to make an award, nor does it commit FHI 360 to pay any costs incurred by the Offeror in the preparation and submission of a proposal or amendments to a proposal. Quotations must be organized as shown below. TECHNICAL QUOTATION Obtaining consistent information from all bidders is essential if the evaluation criteria established by FHI 360 are to be consistently and systematically applied in the assessment of all responses. Bidders are therefore required to format their submissions in accordance with the requirements outlined in this section of the document. Failure to follow these requirements may result in the rejection of the response. Technical quotations must be provided in Microsoft Word or Adobe PDF format, and must include the 10 sections listed below (in order). Each section must be numbered to match the corresponding 2017 GHSC-QA Sampling RFQ 6
requirement. Technical Quotations deviating from the specified format may be disqualified, and unsolicited brochures and marketing materials will not be reviewed. Section Technical Quotation Requirement 1 Brief introduction to the Offeror s organization including: Summary of experience sampling all of the products quoted Locations from which product sampling is conducted List any countries where Offeror cannot or will not work. If no countries are indicated, it will be assumed that no limitations exist. List any countries where offerors utilize subcontract staff from a secondary organization for sampling, including the appropriate subcontract contacts and credentials. 2 Evidence of accreditations or other relevant international credentials 3 Total number of staff dedicated to product sampling with an itemization of the number of staff located in specific countries, accompanied with the geographical range in which these specific staff can work 4 Expected time frame for receipt of sampling report from time of sampling. 5 Description of any relevant sampling equipment and instrumentation that may be used (type, manufacturer, quantity) 6 Detailed past performance references (maximum of 3) for health product sampling contracts/engagements including the following details for each, as applicable: Client/donor, end-user/program, period of performance (MM/YYYY MM/YYYY), and contact information including name, phone number, and e-mail address for each reference 7 Copies of any available SOPs for sampling the product types quoted 8 in the past three years for each product type quoted; please use format provided below: Male Condoms Female Condoms Lubricants Injectable Contraceptives Oral Contraceptives 2017 GHSC-QA Sampling RFQ 7
Section Technical Quotation Requirement Implants Essential Medicines, including those for HIV and OIs RDTs/RTKs, excluding Malaria RDTs RUTFs Kits for VMMC Post-Shipment Testing 9 Year-end financial statements for the last three years 10 Legal certificate of registration 11 Required Organizational Information Vendors must indicate whether they are a public or private organization. Certificate of incorporation and by-laws DUNS (if applicable) Vendor Net Terms and Conditions Tax identification number (EIN or SSN for sole proprietors) (if applicable) List of officers and Board of Directors (if incorporated) 12 Identification of any Potential Subcontractors* *Identify any potential subcontractors and submit all required information listed in Sections 9 10 for each subcontractor. COST PROPOSAL REQUIREMENTS Cost proposals must be submitted in Microsoft Excel using the attached template provided by FHI 360. Prices must be quoted in U.S. dollars ($). Offerors are not required to provide quotations for sampling all products listed in the Cost Quotation template. Offerors should only quote those services for which the organization is qualified/accredited and has relevant experience 2017 GHSC-QA Sampling RFQ 8
Quotations provided to FHI 360 shall be all-inclusive (i.e. staff time, travel expenses, etc.) and stated as a daily rate per location. Shipping costs for sending samples to designated labs should be excluded. Expenses in excess of the quoted price will not be reimbursed. The daily rates shall remain the same throughout the contract period. The quotation must show a separate price for each manufacturing location. TERMS AND REQUIREMENTS TERMS Validity Prices quoted shall remain valid through January 1, 2020. Award Type FHI 360 anticipates issuing cost-reimbursable subcontract(s) based on the pricing submitted by Offerors. Work Products, Reports, and Deliverables All materials produced and delivered by the vendor and all work products will be considered work for hire and will become the property of FHI 360 and/or USAID in accordance with the QA Program contract. Deliverables and work products produced by the vendor may be shared with third parties as required to support the QA Program. Offerors must be prepared to warrant that all deliverables will be free of errors and that no copyrights have been violated. Invoicing Monthly invoicing is required. Invoices must be provided in a format that is acceptable to FHI 360 and USAID. The invoicing format will be determined prior to award. Purchasing Restrictions All purchasing associated with the QA Program must comply with ADS 312 (Eligibility of Restricted Products) and 22 CFR 228 (Rules on Source and Nationality for Products and Services). Sample Subcontract Terms and Conditions Refer to Appendix A for a sample set of subcontract terms and conditions. REQUIREMENTS Source and Nationality Requirements The authorized USAID Geographic Code is 935 for this procurement. 2017 GHSC-QA Sampling RFQ 9
AWARD CRITERIA FHI 360 is not obligated to make any award by virtue of having issued this solicitation. Award is predicated on FHI 360 receiving funding for this express purpose from USAID. FHI 360 can only make an award if the quoted service fully complies with the technical specifications cited in this RFQ. FHI 360 may make an award to a single Offeror, should such an award be advantageous to USAID GHSC-QA. Alternatively, FHI 360 may make awards to different Offerors, should such multiple awards be more advantageous to the Program. Quotations will be evaluated on the basis of the following criteria, in no particular order: 1. Responsiveness to the RFQ in following instructions and providing all of the required information 2. Qualifications and past performance 3. Delivery/turnaround time: Offeror provides the most advantageous delivery schedule for the base and option quantities 4. Price: Lowest evaluated price provided that Offeror s technical proposal is compliant with the specifications, delivery, other requirements and terms and conditions of the RFQ FHI 360 will recommend that award(s) be made to the responsible Offeror(s) whose quotation(s) represent the overall best value to the GHSC-QA Program. 2017 GHSC-QA Sampling RFQ 10
APPENDIX A: SAMPLE TERMS AND CONDITIONS GENERAL TERMS AND CONDITIONS FHI 360 s standard/general terms and conditions may be viewed at the link below: http://www.fhi360.org/sites/default/files/media/documents/purch-po-terms-conditions.pdf SPECIAL TERMS AND CONDITIONS Special terms and conditions similar to those below will be incorporated into the purchase order. Description Attachment 1: Indefinite Quantity Contract for Quality Control Sampling Services The Indefinite Quantity Contract (IQC) will be managed by FHI 360 to provide cost-effective quality control (QC) sampling services for various health commodities tested under USAID GHSC-QA. Cost-reimbursable blanket purchase orders (POs) will be issued to multiple QC sampling organizations who successfully responded to the request for quotations (RFQ). Each PO will have a ceiling amount to be invoiced against for work completed each month until the ceiling amount is reached. While it is anticipated that each sampling organization will be competitive in the IQC, FHI 360 cannot guarantee any amount of work or funding to any particular awardee. Pricing Sampling organizations working under the IQC are required to honor the pricing included in the cost quotations submitted in response to the RFQ. Quotations and invoices will be compared to the awardee s cost quotation for the RFQ to determine cost reasonability. It is understood that slight variances will occur over time and due to the details of each assignment. Work Orders Sampling orders will be issued on an as-needed basis by FHI 360. FHI 360 anticipates two common scenarios in awarding sampling orders: 1. Short-Notice / Time-Sensitive Orders: Urgent orders for which program staff has little notice to respond. In such cases, program staff will issue the sampling order to the sampling organization that represents the best value at the time. Best value will be determined on a case-by-case basis, but such decisions will generally be informed by: a. Expected cost based on the cost quotation; b. Local/regional presence in the country where the sampling is to occur; c. Response time; d. Experience sampling in the subject facility, and; e. Work load and performance to date of sampling organizations. 2. Competed Orders: Orders for which program staff has sufficient lead time to request quotes from awardees. When FHI 360 has advanced notice and sufficient information to request quotations from awardees, program staff will issue an RFQ for the sampling order. 2017 GHSC-QA Sampling RFQ 11
FHI 360 will provide a one-page form that awardees will use to issue quotations. Elaborate responses are not desired. Sampling organizations should complete the form and e-mail it to the designated point of contact by the deadline indicated. FHI 360 will generally allow five working days (Monday Friday) for quotations to be issued; however, in some instances fewer days may be allowed based on program needs. Should an awardee choose not to bid on a sampling order, the organization is required to notify FHI 360 that they will not be bidding by the stated deadline. Shipping/Courier Costs The DHL account number below must be used for all USAID GHSC-QA sampling orders unless directed otherwise in writing by FHI 360. On the DHL shipping form, the sampling agent must identify the product type being shipped (i.e., RTKs, IUDs, etc.). DHL Account: ######## In instances where DHL is not an option, FHI 360 will work with the sampling agent to make alternate arrangements. Reporting All required sampling reports must be emailed to GHSC-QA.Network@fhi360.org with a copy to the FHI 360 personnel who issued the order. Reporting must follow sample shipment by no more than three (3) work days. Should reporting for a given assignment be expected to lag beyond three work days, Crown Agents agrees to notify FHI 360 via e-mail in advance of the assignment or with as much notice as possible. All reporting shall be provided in accordance with GHSC-QA SOPs. Invoicing Awardees are required to adhere to the invoicing instructions and template included in Attachments 2 and 3, respectively. Any invoices deviating from the requirements specified will not be paid and require correction and resubmission. Attachment 2: Invoicing Instructions and Supplemental Terms and Conditions Order/Invoicing Process 1. FHI 360 or its designated subcontractor will notify vendor of the sampling order by e-mail. 2. Vendor will conduct the sampling in accordance with the purchase order (PO). 3. At the end of each month, vendor will invoice FHI 360 for all sampling completed using a format substantially similar to Table 1 in Attachment 3. 4. The PO number and release number must be included on all invoices. If they are omitted, the invoices may be returned to the vendor for correction and resubmission. 5. To ensure timely payment, it is critical that all data points are included and that all products are listed under the appropriate section. Invoices shall be submitted by e-mail to the following address: GHSC- QA.Network@fhi360.org. The following FHI 360 staff must also be copied: Jeffery Tremelling (jtremelling@fhi360.org), Laura Ellis (lellis@fhi360.org), and William Woodard (wwoodard@fhi360.org). 6. Upon review and approval of the invoice, FHI 360 will issue a single payment for all listed sampling activities under the purchase order for each month. 2017 GHSC-QA Sampling RFQ 12
Supplemental Terms and Conditions of the Purchase Order 1. All sampling and reporting shall be conducted in accordance with USAID GHSC-QA Standard Operating Procedures (SOPs). 2. The DHL account provided by FHI 360 must be used for all USAID GHSC-QA sampling orders. Table 1: Invoice Format Attachment 3: Invoice Template Date of Order Requested by Manufacturer/ Distributor Location Lot No. Male Condoms Date Sampled Date Report Submitted Daily Rate Days Cost Female Condoms Personal Lubricants Injectable Contraceptives Oral Contraceptives Implants Essential Medicines Rapid Test Kits (RTKs) Ready to Use Therapeutic Foods (RUTFs) Kits for Voluntary Medical Male Circumcision (VMMC) 2017 GHSC-QA Sampling RFQ 13