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VHAPG Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT Last Updated: 02/01/2022 Page 1 of 6 LIMITED SOURCES JUSTIFICATION ORDER >SAT FAR PART 8.405-6... VHAPG Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT Last Updated: 02/01/2022 Page 1 of 6 LIMITED SOURCES JUSTIFICATION ORDER >SAT FAR PART 8.405-6 Acquisition Plan Action ID: 36C259-22-AP-2386 J&A Tracking Number: 2022-08-08T03:59:34 Contracting Activity: Department of Veterans Affairs Network Contracting Office 19 6162 S. Willow Drive, Suite 300 Greenwood Village, CO 80111 Organizational Activity: Department of Veterans Affairs Cheyenne VA Medical Center 2360 East Pershing Blvd Cheyenne, WY 82001 Eastern Oklahoma VA Health Care System 1011 Honor Heights Drive Muskogee, OK 74401 Oklahoma City VA Health Care System 921 NE 13th Street Oklahoma City, OK 73104 Sheridan VA Medical Center 1898 Fort Road Sheridan, WY 82801 VA Eastern Colorado Health Care System 1700 N. Wheeling Street Aurora, CO 80045 VA Salt Lake City Health Care System 500 Foothill Boulevard Salt Lake City, UT 84148 VA Western Colorado Health Care System 2121 North Avenue Grand Junction, CO 81501 Cheyenne 2237: Funding memo Muskogee 2237: 623-23-1-022-0017 Oklahoma City 2237: Funding memo Sheridan 2237: 666-23-1-113-0011 Aurora 2237: 554-23-1-023-0006 Salt Lake City 2237: 660-23-1-071-0001 Grand Junction 2237: Funding memo Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). Order against: FSS Contract Number: _V797P-7322A Name of Proposed Contractor: Abbott Laboratories, Inc. Street Address: 200 Abbott Park Road City, State, Zip: Abbott Park, IL 60064 Phone: (800) 366-8020 Description of Supplies or Services: The estimated value of the proposed action is $ 2,739,980.00 This is a requirement for VISN 19 for cost-per-test (CPT) Point of Care testing, including contractor-owned analyzers, equipment, and all required reagents, cartridges, standards, controls, and any other required peripherals necessary to produce a combination of the following test results at the patients bedside: blood gas and blood gas with HCT (arterial, venous, mixed venous), chemistry testing (glucose, creatinine, Sodium, Potassium, chloride, BUN, ionized calcium, lactic acid), Hemoglobin/hematocrit, troponin, Kaolin and Celite Activated Clotting Time, fingerstick INR and other possible tests for the above listed locations. The incumbent Contractor, Abbott Laboratories, will continue to provide this product for which they are the sole manufacturer and distributor. The estimated value of the proposed action is $2,739,980.00 for base year of 12-months and four (4) 12-month option periods to follow. The estimated cost of each 12-month period of performance is $547,996.00. This sole source BPA will run from October 1, 2022 through September 30, 2023, followed by four (4) 12-month option periods to continue services without interruption and maintain critical patient care. The current Task Order expires on 9/30/2022, with no extensions available. This requirement is a sole source to Abbott Laboratories. Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor s unique qualifications to provide the required supply or service. FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays: FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; Abbott Laboratories provided a Proprietary letter stating that Abbott is the sole manufacturer and marketer of the i-STAT System and its associated tests. CPT service is only available through Abbott Laboratories. The accessibility of bedside Point of Care testing is critical to patient care. Abbott is the only vendor that can offer the entire test menu required for bedside testing on a single, portable analyzer. Bedside testing ensures real-time patient care, essential to surgery and critical need patients. FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures. FAR 8.405-6(b): Items peculiar to one manufacturer: A patent, copyright or proprietary data limits competition. The proprietary data is: These are direct replacements parts/components for existing equipment. The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination: GSA has determined that pricing on the Federal Supply Schedule (FSS) has been deemed fair and reasonable. Additionally, the VA will receive discounted pricing per test based on the high volume of this VISN contract from Abbott and has had satisfactory or better service performance from Abbott Laboratories on past and current contracts. Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. Market research was performed and included a Sources Sought listing, running searches on VetBiz, GSA eLibrary, and SBA, as well as verifying through responsibility checks their ability to receive an award. Contract Specialist (CS) conducted three searches on VetBiz on 7/27/2022 using NAICS code 334516 and keywords i-STAT, testing, and Abbott. No SDVOSB/VOSB concerns resulted. CS conducted search on GSA eLibrary on 5/2/2022 under Cost-Per-Test Clinical Analyzers 66III category. Four large businesses were listed, Abbott Laboratories, Biomerieux, Roche Diagnostics, and Siemens Healthcare Diagnostics. One small business concern, Sebia, was also listed. Biomerieux only offers microbiology testing instrumentation and reagents. Biomerieux does not offer Point of Care testing. Biomerieux cannot fulfill this requirement. Roche Diagnostics does offer some bedside Point of Care testing. The handheld Roche Accutrend analyzer can test for cholesterol and glucose, the handheld Roche Accu-Chek can test for glucose, and the handheld Roche CoaguChek can test for clotting time and fingerstick INR, however Roche does not offer cost-per-test pricing by Federal Supply Schedule (FSS). Roche does not offer bedside Point of Care testing for blood gas, blood gas with HCT (arterial, venous, mixed venous), blood creatinine, blood electrolytes (sodium, potassium, chloride), blood BUN, ionized calcium, lactic acid, hemoglobin/hematocrit, and troponin. Roche Diagnostics cannot completely fulfill this requirement. Siemens does offer bedside Point of Care testing. The handheld Siemens epoc Blood analyzer can test for blood gas, blood electrolytes (sodium, potassium chloride), blood BUN, lactic acid, and hematocrit and the Xprecia Stride Coagulation analyzer can test for clotting time and fingerstick INR. Siemens does not offer cost-per-test pricing by FSS. Siemens does not offer bedside testing of blood glucose, creatinine, ionized calcium, and troponin. Siemens cannot completely fulfill the requirement. Sebia does not offer bedside Point of Care testing. Sebia specializes in electrophoresis testing. Abbott Laboratories can fulfill this requirement completely. Abbott is the only vendor that offers FSS cost-per-test pricing which includes all required tests using the handheld Abbott i- STAT. The i-STAT is the only portable Point of Care analyzer that offers the entire menu of required tests on a single mobile platform. Abbott Laboratories is the only vendor that can provide all required test cartridges, as well as, all required reagents necessary to deliver reliable quality control and patient results for the i-STAT system. CS conducted search on SBA on 7/27/2022 using NAICS 334516 and keyword Abbott. One small business concern resulted, International Diagnostics Equipment. Inspection of the website revealed that this business only sells refurbished i-STAT analyzers. It does not offer a cost-per- test option, reagents, or consumables. CS posted a Sources Sought (36C25922Q0331) to GSA eBuy (RFQ1556121) on 5/4/2022. One response was received from Nova Biomedical (large business). This company could not provide handheld analyzers for bedside testing, nor the entire scope of testing required. A sole source letter was received from Abbott Laboratories. Any Other Facts Supporting the Justification: The Abbott i-STAT reagent cartridges (testing method) are only compatible with the Abbott i- STAT analyzer specifically manufactured for bedside Point of Care testing. Abbott Laboratories provided a Proprietary letter stating that Abbott is the sole manufacturer of the i-STAT analyzers and test cartridges. A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made: Contracting office will survey the market to access any new technology and changes in the industry. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. KASEY ZAKARE Digitally signed by KASEY ZAKARE Date: 2022.08.18 15:09:00 -06'00' Kasey Zakare, COR/Assistant LIM DATE Pathology & Laboratory Services Rocky Mountain Regional VA Medical Center Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: Contracting Officer s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. Digitally signed by RONNIE RONNIE JONES JONES Date: 2022.08.19 06:06:21 -06'00' Ronnie Jones, Branch Chief, Services 2 DATE One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition. DIONDRA COLEMAN Signed by DDOC Digitally signed by DIONDRA COLEMAN Date: 2022.08.19 08:38:43 -06'00' Albert Williams DATE Director of Contracting Network Contracting Office 19 HIGHER LEVEL APPROVAL (Required for orders over $750,000): VHA RPO HCA Review and Approval (over $750,000 to $75 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. CURTIS JORDAN JORDAN Digitally signed by CURTIS Date: 2022.08.22 14:53:45 -06'00' Curtis M. Jordan DATE Executive Director, Regional Procurement Office West VHA Head of Contracting Activity (HCA)