Combined Synopsis/Solicitation for Urgent Point of Care Influenza Testing CPT Page 7 of 8 General Information Document Type: Combined Solicitation/Synopsis Solicitation Number: 36C25918Q9736 Posted Date: July 30, 2018 Current Response Date: August 30, 2018 Product or Service Code: 6550 In vitro Diagnostic Substances, Reagents, Test Kits Set Aside: No set-aside NAICS Code: 334516 Analytical Laboratory Instrument Manufacturing Contracting Office Address SAO West, Network Contracting Office 19 (NCO 19) Rocky Mountain Acquisition Center Department of Veterans Affairs 6162 South Willow Drive, Suite 300 Greenwood Village, CO 80111 Places of Performance Oklahoma City VA Medical Center 921 N.E. 13th Street Oklahoma City, OK 73104 Ardmore VA Clinic 2002 12th Ave NW, Suite E Ardmore, OK 73401 Lawton/Ft. Sill VA Clinic 4303 Pittman and Thomas, Building 4303 Ft Sill, OK 73503 North May VA Clinic 2915 Pine Ridge Road Oklahoma City, OK 73120 South Oklahoma City VA Clinic 7919 Mid America Blvd. Oklahoma City, OK 73135 Stillwater VA Clinic 320 N. Perkins Avenue Stillwater, OK 74074 Wichita Falls VA Clinic 149 Hart Street Sheppard Air Force Base, TX 76311 Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued. This solicitation is a request for quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2005-99 7/16/2018. The associated North American Industrial Classification System (NAICS) code for this procurement is 334516- Analytical Laboratory Instrument Manufacturing, with a small business size standard of 1,000 Employees. The Network Contracting Office 19 (NCO 19) is seeking to purchase Urgent Point of Care Influenza Cost Per Test (CPT) utilizing a Blanket Purchase Agreement (BPA). The purpose of this acquisition is to provide Oklahoma City VA Medical Center with the services listed in the Statement of Work. The BPA holder shall provide written notice to the VHA Contracting Officer, of any changes that impact the BPA and services provided, specifically to any items on this resultant BPA. Changes include, but are not limited to, price decreases, product or service deletions, CPT code changes, and/or exchange in vendor company information, including contract administrator, company name, address and phone number. 1. PERIOD OF AGREEMENT: This BPA will be established for a five-year (60 months) ordering period. 2. EXTENT OF OBLIGATION: The Government is obligated only to the extent of authorized purchases made under the resultant Call Orders. This BPA does not obligate any funds, nor is the Government obligated to make any purchases under this BPA. The Government does not guarantee any volume of purchases through a BPA. The terms and conditions included in this BPA apply to all purchases made pursuant to it. In the event of an inconsistency between the provisions of this BPA and the BPA Holder s invoice, the provisions of this BPA will take precedence. 3. INDIVIDUALS AUTHORIZED TO PURCHASE UNDER THE BPA: Any individual who has contracting authority, on behalf of VHA, may place orders against this BPA. 4. ORDERING/INVOICING: Orders will be placed against this BPA via Electronic Data Interchange (EDI), via facsimile, in writing, or by phone. Each individual BPA Call Order will describe the tasks, services and deliverables required. Each new Call Order placed under this BPA will be the result of a streamlined ordering process which includes a request for quotation (RFQ). Unless otherwise agreed to, all deliveries under this BPA must be accompanied by delivery tickets or sales slips that must contain the following information at a minimum: a. Name of Contractor b. BPA Number c. Call Order Number d. Purchase Order Number e. CPT Number/Description etc. f. Date of Order g. Quantity, Unit Price, and extension of each item (unit prices and extensions need not be shown when incompatible with the use of automated system if the invoice is itemized to show the information); and h. Date of Shipment BPA ordering will be decentralized. Orders will be placed by field offices directly under the BPA. Invoicing, acceptance, and payment shall be in accordance with the instructions provided in each individual Call Order. All Orders shall be placed on a Firm Fixed Price basis. Ordering Procedures are in accordance with FAR 13.303. All requirements under the BPA will be issued on competitive basis. Any individual order not exceeding $10,000.00, any VHA VISN 19 Government Purchase Card holder may place the order and use their credit card as a form of payment. 5. DELIVERY: Authorized personnel from the Oklahoma City VA Medical Center may request delivery on placed orders. Each BPA Call Order will list the station Point of Contact (POC) authorized to schedule deliveries. The POC will be responsible for technical monitoring of the contractor s cost per test reporting and will interpret specifications or technical portions of the work. The POC is not authorized to perform, formally or informally, any of the following actions: (1) Promise, award, agree to award, or execute any contract, contract modification, or notice of intent that changes or may change this contract; (2) Waive or agree to modification of the delivery schedule; (3) Make any final decision on any contract matter subject to the Disputes Clause; (4) Terminate, for any reason, the contractor's right to proceed; (5) Obligate in any way, the payment of money by the Government. Only a warranted Contracting Officer is authorized to obligate funds on this or any other contract action. The contractor shall immediately notify the Contracting Officer in writing if the POC has taken an action (or fails to take action) or issues directions (written or oral) that the contractor considers to exceed the above limitations. The contractor shall provide the Contracting Officer information copies of all correspondence to the POC. 6. REPORTS: Not Required 7. CANCELLATION: This BPA may be canceled if the BPA holder fails to perform in accordance with the terms and conditions of this BPA, any order established under this BPA, or if deemed as in the best interests of the Government. 8. ORDER OF PRECEDENCE: Where delivery terms, FOB terms, or ordering requirements have been modified by this BPA, those modified terms will apply to all purchases made pursuant to it and take precedence. 9. AUTHORIZED LIMITS: The Government estimates, but does not guarantee, that individual BPA Orders placed against this Agreement may reach $150,000.00/per Order. This Order Limit may be increased by mutual agreement of the parties as necessary, in whole or part. The authorized Ceiling Limit of the Agreement is set at $550,000.00 over the period covered by the Agreement; this ceiling is also not a guarantee. The Ceiling Limit may also be raised in association with Order Limit increases or other conditions which, by mutual agreement of the parties, maybe considered necessary. Authorization for individual orders above the stated order and/or Ceiling Limits must be coordinated through the Contracting Officer before larger valued orders can be issued and prior to commencement of work. All unauthorized work, regardless of amount, will be processed through the ratification process. All interested companies shall provide quotation for the following: CLIN Table Item # Description Qty EA Price Amount 1 Cost per Test requirement for FDA-approved, CLIA-waived, rapid, molecular based, point of care analyzers and assay detecting Influenza A and/or Influenza B viruses when present in nasal or nasopharyngeal (NP) swab specimens. Analyzers will be installed and utilized in the medical center Emergency Department and Fast Track clinics as well as five remote Community Based Outpatient Clinics (CBOCs). Estimate about 2,000 tests per year. POP Begin: 10-01-2018 POP End: 09-30-2023 10,000 TOTAL STATEMENT OF WORK General Requirement: This requirement is for a Cost per Test requirement for FDA-approved, CLIA-waived, rapid, molecular based, interfaced, point of care analyzers and assay detecting Influenza A and/or Influenza B viruses when present in nasal or nasopharyngeal (NP) swab specimens. Cost per Test: The cost per test cost is inclusive of all aspects of performance which are built-in to the price for the point of care test kits. This includes provision of the following at no additional cost: Point of Care analyzers including all hardware and software required for testing and result transmission to network software that can download the patient result into his/her VA electronic patient record. All reagents, standards, controls, supplies, parts, accessories and any other item required for the proper operation of the contractor s equipment. All quality control (provide control material or credit to purchase controls from other vendor), calibration and correlation study testing that is prescribed by Clinical and Laboratory Standards Institute (CLSI). All necessary maintenance to keep the equipment in good operation condition (this element includes both preventive maintenance and emergency repairs). Connectivity hardware, software, license fees, upgrades and maintenance for the connectivity system. Training for all personnel operating the equipment at each of the installation sites Delivery, installation, verification, and removal of equipment. Provide all upgrades to the equipment hardware and operating system software within 60 days of issuance. Connectivity Solution: Provide a middleware solution for point of care (POC) testing connectivity that can be used to post patient test results into the hospital s laboratory information system, VistA/CPRS. Middleware may be vendor owned or third-party owned and compatible with vendor owned analyzers. The cost for installation, initial and annual license fees, upgrades, hardware and software needed will be built into the CPT price for the point of care test kits. Maintenance and Repairs: Exchange program for malfunctioning units and guarantee for a replacement unit to be sent within 24 hours of notification. Provide technical support service to assist in troubleshooting 24-hours per day, seven days per week including Federal holidays. Installation and Training: Provide installation and verification/validation of analyzer and assay at each testing site. Provide on-site operator training for all personnel operating the analyzers at each testing site. Specific Requirements: Analyzer and Assay: FDA cleared/approved Considered waived complexity by Clinical Laboratory Improvement Act (CLIA) approved for point of care testing Capable of producing rapid (< 30 minutes), accurate and reproducible results Influenza A/B testing by established molecular in vitro diagnostic methods. Assay updated routinely for inclusivity of all known circulating viral sub- and sero-types to ensure maximum detection of Influenza infection. Have minimal sample manipulation and user hands-on requirements Test Quantity: Test quantities are solely dependent upon severity and timing of annual Flu Season. Yearly quantities provided are estimates based upon prior history of actual volumes and are not a guaranteed minimum. Equipment shall be provided, regardless of the test use ratio per testing unit used by an individual site. No test minimum or maximum requirements shall be applied. Locations Provide analyzers and supplies for each of the following locations: Location Address # Analyzers Required Oklahoma City VA Medical Center 921 N.E. 13th Street Oklahoma City, OK 73104 2 Ardmore VA Clinic 2002 12th Ave NW, Suite E Ardmore, OK 73401 1 Lawton/Ft. Sill VA Clinic 4303 Pittman and Thomas, Building 4303 Ft Sill, OK 73503 1 North May VA Clinic 2915 Pine Ridge Road Oklahoma City, OK 73120 1 South Oklahoma City VA Clinic 7919 Mid America Blvd. Oklahoma City, OK 73135 1 Stillwater VA Clinic 320 N. Perkins Avenue Stillwater, OK 74074 1 Wichita Falls VA Clinic 149 Hart Street Sheppard Air Force Base, TX 76311 1 Point of Contact: Trenda Brown, MT(ASCP) trenda.brown@va.gov (405) 456-5243 Transition Period: All equipment and peripherals delivered and installed and personnel trained at each participating facility within 30 days of award. Invoicing: Payments shall be made in arrears upon receipt of a proper invoice. Award shall be made to the offeror whose quotation offers the best value to the government, considering price and non-price factors. The government will evaluate in accordance with FAR 13 and FAR 52.212-2; Technical Capability, Past Performance, and Price. (1) Technical Capability- a. Submit literature of Point of Care analyzers, including all hardware and software required for testing and result transmission to network software. B. Submit statement that they can meet all requirements in the Statement of Work. (2) Past Performance- Submit most recent and relevant contracts for the same or similar items and other references (including contract numbers, points of contact with telephone numbers and other relevant information). (3) Price- Complete CLIN Table. The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. The following solicitation provisions apply to this acquisition: FAR 52.209-5, Representation by Corporations Regarding an Unpaid Tax Liability or a Felony Conviction under Any Federal Law (Mar 2012) (Deviation). FAR 52.212-1, Instructions to Offerors Commercial Items (Jan 2017) FAR 52.212-3, Offerors Representations and Certifications Commercial Items (Jan 2017) VAAR 852.215-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors (Jul 2016) (Deviation) Offerors must complete annual representations and certifications on-line at http://orca.bpn.gov in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required. The following contract clauses apply to this acquisition: FAR 52.204-9, Personal Identity Verification of Contractor Personnel (Jan 2011) FAR 52.212-4, Contract Terms and Conditions Commercial Items (Jan 2017) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders (Jan 2017) The following subparagraphs of FAR 52.212-5 are applicable: Subparagraph (b)(1), (b)(2), (b)(4), (b)(6), (b)(7), (b)(8), (b)(9), (b)(25), (b)(27), (b)(28), (b)(29), (b)(30),(b)(31), (b)(32), (b)(33), (b)(34), (b)(35), (b)(42), (b)(48), (b)(54), (b)(57), (c)(1), (c)(2), (c)(4), (c)(8). FAR 52.222-54, Employment Eligibility Verification (Oct 2015) FAR 52.224-1, Privacy Act Notification (Apr 1984) FAR 52.224-2, Privacy Act (Apr 1984) FAR 52.228-5, Insurance Work on a Government Installation (Jan 1997) FAR 52.232-19, Availability of Funds for the Next Fiscal Year (Apr 1984) FAR 52.237-3, Continuity of Services (Jan 1991) VAAR 852.203-70, Commercial Advertising (Jan 2008) VAAR 852.215-71, Evaluation Factor Commitments (Dec 2009) VAAR 852.203-70, Commercial Advertising (Jan 2008) VAAR 852.237-7, Indemnification and Medical Liability Insurance (Jan 2008) VAAR 852.237-70, Contactor Responsibilities (Apr 1984) VAAR 852.271-70, Nondiscrimination in Services Provided to Beneficiaries (Jan 2008) All quoters shall submit the following: [insert number of copies and information to be submitted]. All quotations hall be sent via email to bai.perney@va.gov. This is an open-market combined synopsis/solicitation for products as defined herein. The government intends to award a Blanket Purchase Agreement as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" Quoters shall list exception(s) and rationale for the exception(s). Submission shall be received not later than August 30, 2018 at 2:00 PM MST bai.perney@va.gov. All submission shall be 5MB or less. If the email is going to be more than 5MB, then please submit in multiple emails labeling 1 of XX, 2 of XX, etc. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Contracting Officer, Bai Perney, bai.perney@va.gov by August 16, 2018 at 2:00 PM MST. Point of Contact Bai Perney, Contracting Officer, bai.perney@va.gov or 303-712-5815
