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 requests quotations for laboratory testing services. RFQ Number: RFQ 10-840-2017-1004 Date Issued: August 2, 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 August 8, 2017 at 1700 Hours Eastern Time (Washington DC) August 8, 2017 at 1700 Hours Eastern Time (Washington DC) August 11, 2017 at 1700 Hours Eastern Time (Washington DC) August 18, 2017 at 1000 Hours Eastern Time (Washington DC) 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 History... 2 New Program Design... 2 FHI 360... 3 DESCRIPTION OF THE RFQ...5 INSTRUCTIONS TO OFFERORS...5 Quotation format and submission Procedure... 5 Technical Quotation... 6 Cost Proposal Requirements... 7 TERMS AND REQUIREMENTS...7 Terms... 7 Requirements... 8 AWARD CRITERIA...8 APPENDIX A: SAMPLE TERMS AND CONDITIONS... 10 GEneral Terms and Conditions... 10 Special Terms and Conditions... 10
ACRONYMS AIDAR ARVs BP FAR FHI 360 GHI IQCs ISO IUDs OI OOS PEPFAR QA Ph. Int. RDTs RFQ RTKs SCMS USAID USAID GHSC-QA USG WHO USAID Acquisition Regulation Antiretroviral Drugs British Pharmacopoeia Federal Acquisition Regulation Family Health International Global Health Initiative 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 International Pharmacopoeia Rapid Diagnostic Tests Request for Quotation Rapid Test Kits Supply Chain Management System Program U.S. Agency for International Development USAID Global Health Supply Chain-Quality Assurance Program U.S. Government World Health Organization QA Laboratory Testing 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 HISTORY The Bureau for Global Health previously had two single-award indefinite quantity contracts (IQCs) responsible for the procurement and delivery of essential health commodities and supply chain assistance. The USAID DELIVER PROJECT focused its support largely on the President's Malaria Initiative (PMI) and programs in family planning/reproductive health, maternal and child health, emerging pandemic threats, and other areas. The Supply Chain Management System for HIV/AIDS (SCMS) IQC supported the President's Emergency Plan for AIDS Relief (PEPFAR). In 2014, USAID restructured its portfolio of projects related to health commodity procurement and QA. NEW PROGRAM DESIGN USAID consolidated the procurement and assistance elements of the USAID DELIVER PROJECT and SCMS IQCs into a single award to ensure an uninterrupted supply of essential USAID-donated health commodities, align USAID's health commodity requirements across the priority health elements, reduce costs to the USG, improve management and accountability, and ensure implementation flexibilities to respond to unpredictable global demands for USAID essential health commodities and assistance. In addition to this single award, the Bureau for Global Health issued a comprehensive QA award, the QA Program, which will promote the effectiveness and efficiency of USAID QA services by combining and coordinating QA activities across health elements. This contract will provide independent, essential, comprehensive QA and quality control services covering the different health elements in the Bureau. FHI 360 was awarded a contract for the QA Program in January 2015, and under the new contract FHI 360 is charged with establishing an international network of cost-effective laboratory testing facilities with proven capabilities to produce reliable, accurate, and precise testing results. FHI 360 this RFQ to solicit quotations from such facilities and ultimately to assure best value for ongoing QA testing services provided to the USG. QA Laboratory Testing 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. QA Laboratory Testing 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. QA Laboratory Testing RFQ 4
DESCRIPTION OF THE RFQ The USAID GHSC-QA Program requests responsive quotations to provide laboratory QA services for the following health commodities: Reproductive Health Products (Pharmaceuticals and Medical Devices); Ready to Use Therapeutic/Supplementary Foods (RUTFs); Kits for Voluntary Male Medical Circumcision (VMMCs); Other Laboratory Products (Point-of-Care Products); Essential Medicines, and; Pharmaceutical products used to treat HIV and Opportunistic Infections (OIs), including antiretroviral drugs (ARVs). Quotations must be provided in accordance with the Instructions to Offerors. 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 RFQ 10-840-2017-1004 for GHSC-QA - Name of Offeror. Offerors are not required to provide quotations for all testing services detailed in the Cost Quotation template; however, offerors are encouraged to quote as many testing services as possible to demonstrate capacity. Offerors should only quote the testing services for which the organization is accredited. 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 quotation 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. QA Laboratory Testing RFQ 5
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 12 sections listed below (in order). Each section must be numbered to match the corresponding requirement. Technical Quotations deviating from the specified format may be disqualified, and unsolicited brochures and marketing materials will not be reviewed. FHI 360 reserves the right to waive any administrative requirement. Section Technical Quotation Requirement 1 Brief (one page or less) introduction to the Offeror s organization and areas of expertise 2 Evidence of ISO 17025 accreditation, WHO Pre-Qualification, or other relevant international credentials. Include all essential information such as the scope of accreditation and expiration date(s). 3 Total number of staff dedicated to QA testing, management, and filing documentation 4 Description of QA testing equipment and instrumentation (type, manufacturer, quantity) 5 Historical QA testing data for the Offeror s organization, including: Number of lots of all products tested over the past 3 years, itemized by product type (essential medicine, ARV, medical device, etc.), active ingredient, strength, and form (injection, tablets, capsules, etc.), as applicable Itemize for each formulation type with laboratory testing method Indicate the turn-around time for testing upon receipt of the samples Provide detailed information on QA laboratory testing (assay, content uniformity, dissolution, etc.) 6 Copies of Standard Operating Procedures: For investigations and management of Out-of-Specifications (OOS) results For the services quoted in the Offeror s response 7 Detailed past performance references (maximum of 3) on major QA laboratory testing contracts with details of the client, donor, end-user/program, and contact information including name, phone number, and e-mail for each reference 8 Summary of procedures required for customs clearance of samples for receipt to your laboratory. Indicate the level of experience of staff within your facility in interacting and managing the communication with all appropriate parties (courier/government agency) for customs clearance. Upon shipment of a sample to your facility, please provide any QA Laboratory Testing RFQ 6
Section Technical Quotation Requirement information available that indicates the typical time frame required to proceed through the clearance process. 9 Year-end financial statements for the last two years 10 Legal certificate of registration of your company 11 Required Organizational Information Vendors must indicate whether they are a public or private organization. Certificate of incorporation and by-laws DUNS (if applicable) 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 Section 11 for each subcontractor. COST PROPOSAL REQUIREMENTS Cost proposals must be submitted in Microsoft Excel using the attached template provided by FHI 360 (FHI_360_RFQ_10-840-2017-1004-Cost_Quotation). Prices must be quoted in U.S. dollars ($). Offerors are not required to provide quotations for all testing services detailed in the Cost Quotation template; however, offerors are encouraged to quote as many testing services as possible to demonstrate capacity. Offerors should only quote the testing services for which the organization is accredited. TERMS AND REQUIREMENTS TERMS Validity Prices quoted shall remain valid for two years beyond the submission deadline for the RFQ. Award Type FHI 360 anticipates issuing fixed unit price purchase orders 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 GHSC- QA Program contract. Deliverables and work products produced by the vendor may be shared with QA Laboratory Testing RFQ 7
third parties as required to support the GHSC-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 International Certifications Prospective laboratories must provide evidence of certification to international standards, such as ISO 17025-accreditation or WHO Pre-Qualification. Offerors must submit proof of current certifications. Technical Specifications The QA testing services quoted and provided must fully comply with the prevailing ISO, WHO, or otherwise the most applicable/appropriate standards such as USP, BP, or Ph. Int. Source and Nationality Requirements The authorized USAID Geographic Code is 935 for this procurement. 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, and upon USAID s approval of any awardees. FHI 360 can only make an award if the quoted service fully complies with the technical specifications cited in this RFQ. With USAID s approval, FHI 360 may make an award to a single Offeror, should such an award be advantageous to the GHSC-QA Program. Alternatively, FHI 360 may make awards to different Offerors, should such multiple awards be more advantageous to the program. Quotations will be evaluated based on the following criteria: 1. Responsiveness to the RFQ in following instructions and providing all the required information 2. Demonstration of relevant international accreditations such as ISO 17025 or WHO Pre- Qualification 3. Qualifications and experience QA Laboratory Testing RFQ 8
4. Laboratory capabilities in terms of personnel and equipment 5. Turnaround times 6. Cost 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. QA Laboratory Testing RFQ 9
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. Attachment 1: Supplemental Terms and Conditions of the Purchase Order 1. All testing shall be conducted in accordance with the quoted standards and USAID GHSC-QA Standard Operating Procedures (SOPs). 2. Unit prices for testing shall be in accordance with vendor s quotations submitted in response to FHI 360 RFQ###. The quoted prices are included in the Excel worksheet provided by FHI 360 (Attachment 3). In cases where new testing services not included in Attachment 3 are required to meet program needs, the following protocol will be followed: FHI 360 will request a quote from the vendor. FHI 360 will evaluate the quote for reasonability by comparing the quoted amount to similar testing services provided under GHSC-QA. Any prices appearing to be unreasonable will be discussed and negotiated by FHI 360 and the vendor. Any prices deemed unreasonable will not be approved, and any such testing orders will be cancelled. In cases where the new product/test is similar to an existing product/test already included in the vendor s pricing schedule, reasonability will be based on the new quote being within 10% above or below the comparable item in the price schedule. Should the new quote exceed the 10% threshold, the vendor will provide any necessary documentation to justify the increased cost. Upon determination of reasonability, FHI 360 will provide the vendor with a notice to proceed by e-mail. Vendor will attach the email approval to the monthly invoice. 3. Vendor shall report all out of specification (OOS) results to FHI 360 within 24 hours of observation. Notification shall be made by e-mail to the following address: with a copy to. 4. Vendor is expected to complete testing orders within the following lead times: QA Laboratory Testing RFQ 10
TBD. Should any situation arise that may impact lead time, vendor shall notify FHI 360 by e-mail to the following address: with a copy to. 5. During each year of performance, vendor shall submit documentation of all relevant testing accreditations/certifications (ISO17025, WHO Prequalification, etc.) to FHI 360. Documentation shall be submitted by e-mail to the following address:. In addition, should accreditations or certifications change during the period of performance, vendor shall notify FHI 360 within 10 days. Accreditations must also be submitted for any approved subcontractors utilized. 6. Vendor agrees to notify FHI 360 by e-mail in the event of any requested changes regarding pricing, points of contact, technical capabilities, or other factors affecting the scope of work. Notification shall be made by e-mail to the following address:. 7. Monthly invoicing is required. Invoices must be provided in accordance with Attachments 2 and 4 and in a format acceptable to FHI 360 and USAID. Please refer to Attachment 2: Invoicing Instructions. Attachment 2: Invoicing Instructions for Testing Conducted under USAID GHSC QA Order/Invoicing Process: 1. FHI 360 or its designated subcontractor will notify vendor of the testing order by e-mail. 2. Vendor will conduct the testing in accordance with the purchase order. 3. At the end of each month, vendor will invoice FHI 360 for all testing completed using a format substantially similar to the Excel worksheet provided by FHI 360 (Attachment 4). 4. The purchase order 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 billing code. Costs for individual tests/techniques should be invoiced under the billing code associated with the product being tested. Invoices shall be submitted by e-mail to the following address:. 6. Upon review and approval of the invoice, FHI 360 will issue a single payment for all testing activities under the purchase order for each month. Attachment 4: Invoice Template Order No. Lot No. Product Type Description of Testing Price 1 Lot Price 2 or More Lots Standard Qty. Lots Tested Ext. Cost Product Type 1 -Description Billing Code Product 1a Product 1b QA RFQ 11
Product Type 2- Description Billing Code Product Type 2a Product Type 2b QA Laboratory Testing RFQ 12