6640--Automated Slide Stainer

VHAPG Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT Last Updated: 02/01/2022 Page 1 of 4 LIMITED SOURCES JUSTIFICATION ORDER >SAT FAR PART 8.405-6 Acquisition Plan Action ID: 36C259-22-AP-3682 J&A Tracking Number: 2022-09-01T08:33:44 Contracting Activity: Department of Veterans Affairs Network Contracting Office 19 6162 S. Willow Drive, Suite 300 Greenwood Village, CO 80111 Organizational Activity: Oklahoma City VA Health Care System 921 NE 13th Street Oklahoma City, OK 73104 (2) 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: GS-07F-5934R Name of Proposed Contractor: Government Scientific Source, Inc. Street Address: 12351 Sunrise Valley Drive City, State, Zip: Reston, VA 20191 Phone: (800) 248-8030 (3) Description of Supplies or Services: The Department of Veteran Affairs, VA Oklahoma Health

Care System has a requirement for (2) two replacement Leica Bond Automated Slide Stainer s. Immunohistochemical staining is performed by these instruments and is the single most important ancillary test in surgical pathology (examination of tissue specimens) and cytopathology (examination of fluids and needle biopsy specimens). It allows the pathologist to better identify and classify cancers arising in different parts of the body, thereby ensuring that patients receive the most appropriate therapy. These instruments play a critical and essential role in the ability to accurately diagnose a patient's cancer. Only one of the two in the pathology department is currently functioning and it is unable to sustain the full daily workload. The manufacturer no longer carries parts to repair the models. The estimated value is estimated of the proposed action is $314,169.90. The estimated delivery date will be September 15, 2022. (4) 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; Government Scientific Source, Inc. (GSS) is the only small business source distributor for Leica Slide Stainer s. This requirement is a one-time purchase of two (2) replacement Leica Bond Automated Slide Stainer s. The Leica slide stainer s are compatible with the current equipment being used in the lab. Validation using the same instrument will be faster, and far less strenuous on the staff, which is currently critically manned for histopathology technician s, the lab is operating at 25% manning. Replacing the slide stainer s with a different brand will require more in depth and longer validation timeframes, which will adversely affect patient care and significantly delay turnaround time. In addition, replacing the slide stainer s with different instrumentation will involve additional tissue mailout to LabCorp and/or AmeriPath for validation comparison, this would create a need for more funding and increase delays in patient care. Changing to a new platform would require extensive assay re-optimization, re-validation, pathologist review/approval, additional training, and disruption to the pathology workflow and turnaround time for results. 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. (5) 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 the pricing on the Federal Supply Schedule (FSS) is fair and reasonable. Additionally, GSS has given the VA discounted pricing and has had satisfactory or better service performance on past and current contracts. (6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. Contract Specialist (CS) posted a Sources Sought notice to Contracting Opportunities on June 29, 2022, and it closed on July 11, 2022. The RFI number was 36C25922Q0469. There were no responses received. CS conducted a VIP search on July 1, 2022, with NAICS Code: 334516 and keywords Leica Bond Slide Stainer . The search provided one SDVOSB result for Cuna Supply, LLC. CS called Cuna Supply, LLC to verify they could provide the Leica Slide Stainer and the representative for Cuna Supply, LLC stated that they only provide lab cabinets. The CS conducted another VIP search on August 24, 2022, with the keywords Slide Stainer Histology ; the search results found 11 potential SDVOSB companies. When researching capabilities of these companies, it was found that seven of these companies are unable to provide any medical equipment at all. The CS called the four companies that do provide medical equipment and verified that none of these companies provide Lab equipment at this time. CS conducted a search on the Small Business Dynamic Search (SBDS) on July 1, 2022, with keywords Leica Slide Stainer ; The search provided zero results. CS conducted search on GSA eLibrary on July 29, 2022, with keywords Leica Bond Slide Stainer . The search provided zero results. The CS conducted another GSA eLibrary search on August 24, 2022, with the keywords Slide Stainer Histology ; the search provided zero results. (7) Any Other Facts Supporting the Justification: Leica BOND III produces the least amount of Hazardous waste of any IHC/ISH platform on the market. This reduces exposure to personnel and lessens the cost of waste disposal. Minimizing waste and utilizing a solution that offers volume formats to meet Lab needs (7 mL and 30 mL RTUs) enabling the use of the entire volume of the reagent before it expires. IHC and ISH can be performed using the same detection kit. Use of concentrated antibodies does not require purchase of a separate kit per antibody. Leica antibody containers can be directly filled in seconds. Leica BOND III is fully automated, simple to operate, and produces excellent quality slides with turnaround times of 10 slides in 2hrs or up to 30 slides in 2.5 hours Leica BOND III is the only IHC stainer that can produce 30 stained slides in 2.5 hours per run with continuous additional slide loading capability. It also works hand in hand with the recently purchased Leica HistoCore AutoCut Automated Microtomes. Routine maintenance of the BOND III is minimal. Daily maintenance can be performed in less than 10 min. Weekly preventative maintenance takes less than 15 min. Monthly preventative maintenance takes less than 30 min of downtime per instrument. In accordance with the market research results, GSS is the only company that can fulfill this requirement. The pricing for the Leica Bond III Processing Module (Slide Stainer s) is Federal Supply Schedule pricing and is considered fair and reasonable. The OEM (original equipment manufacturer), Leica, has one small business authorized distributor for this piece of equipment, Government Scientific Source (GSS). GSS indicated via email, and by proprietary letter that GSS is the sole distributor of test kits that are compatible with the Leica Bond Slide Stainer. This was backed up through additional market research. GSS is a small business, and it is in the best interest of the Government to award this requirement to GSS as a sole source. (8) 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: The Contracting office will survey the market to assess any new technology and changes in the industry. (9) 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. (This signature is the requestor s supervisor, fund control point official, chief of service or someone with responsibility and accountability.) Joseph Legault, Supervisory Medical Technologist VA OKC Health Care System DATE (10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: a. Contracting Officer s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. Ronnie Jones, Branch Chief, Services 2 DATE b. 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, DDoC, NCO19 DATE