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VHAPM Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

VHAPM Part 813.106 Page 1 of 3 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID:_36C263-21-AP-0810_____________________

1. Contracting Activity: US Department of Veterans Affairs, Network Contracting Office (NCO) 23, 4801 Veterans Drive, St. Cloud, MN 56303-2099. Organizational Activity: US Department of Veterans Affairs, Minneapolis VA Healthcare System, One Veterans Drive, Minneapolis MN 55417.

2237 Number.: 618-21-1-106-0340

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: The Minneapolis VA Laboratory requires a one-time delivery of two hematology slide stainers which will be used to replace their current slide stainers. The current slide stainers from 2007 are rapidly declining in performance, malfunctioning, and negatively impacting stain quality. The current slide stainers are obsolete and replacement parts can no longer be obtained. The purpose and use of these slide stainers are to stain bone marrow, body fluids and peripheral blood specimens, which are used for morphologic identification and enumeration of specific leukocyte and erythrocyte populations. These slide stainers are essential to prepare diagnostic slides for pathology, as well as maintain hematology laboratory workflow and turn-around-times.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: There are three known sources of slide stainers for bone marrow, body fluids and peripheral blood specimens.

Millipore Midas Slide Stainer Aerospray 7152 Slide Stainer Siemens Hematek 3000 Benchtop Slide Stainer

The above slide stainers are capable of staining bone marrow, body fluids and peripheral blood specimens. However, it is extremely imperative that the Minneapolis VA laboratory produces high quality stained slides for pathology review, as these slides are used for diagnostic purposes.

The physical size of the slide stainers also needs to be considered as the space in the Hematology laboratory is very limited. Dimensions per manufacturer technical specifications:

The Hematek 3000 dimensions are: 22” (H) x 54” (W) x 46” (D).

The Aerospray 7152 dimensions are: 10” (H) x 22” (W) x 21” (D).

The Millipore Midas dimensions are: 15” (H) x 18” (W) x 21” (L))

Minneapolis has had the Aerospray since 2007. It has demonstrated exceptional slide quality and consistency over the last several years. The Minneapolis laboratory has also passed several CAP Laboratory Inspections and Proficiency Testing using this slide stainer. The Aerospray does

VHAPM Part 813.106 Page 2 of 3

Revision 02 Eff Date: 03/31/2020 not require direct plumping, requires limited maintenance, does not require a water source, does not use bleach for maintenance, and the staining components are sold individually which allows for easier and less expensive troubleshooting. The Minneapolis laboratory and space accommodate the Aerospray well, as it has a small footprint. Staff are knowledgeable on how to operate it. The ability to continue using the same reagents and stain protocols is paramount to retain stain consistency and quality for pathology diagnoses. Prior to 2007, Minneapolis used the Siemens Hematek. The Minneapolis laboratory moved away from it due to excessive precipitate on slides and clogging issues in the stain lines and on the platform itself. Also, the stain components for the Hematek are sold as a pack so it is more difficult and expensive to troubleshoot issues with individual components.

Minneapolis has performed an evaluation at a local laboratory which has the Millipore Midas slide stainer. Slides were sent for staining and returned for analysis. User feedback and slide examples showed decreased stain quality and increased stain variability compared to the Aerospray. A direct water source is needed, or an additional water bath attachment is required, which adds to the footprint. The Millipore Midas has an increased maintenance requirement, requiring cleaning baths with bleach which will lead to greater stain variability. The Minneapolis laboratory staff do not have experience using this slide stainer, and the expectation to develop new stain protocols, complete training, staff competency and validation of new methods while also completing patient testing is unrealistic.

Minneapolis has reached out to the national VA Supervisors group and Heme TEAMS group to see what other VA facilities are using. One facility uses the Millipore and is in the process of switching to the Aerospray due to the variability in stain quality and the required water supply.

Three facilities use the Siemens Hematek. This system does not require bleach during maintenance. The stain components are sold in a pack. One of these facilities only stains peripheral blood and the other two facilities stain both peripheral blood and bone marrow. One facility uses the Aerospray with high recommendations for dynamic staining compared to the Siemens Hematek. This facility indicated poor performance with their previous Siemens Hematek and stated they would rather perform a manual stain.

4. Description of market research conducted and results or statement why it was not conducted: As the Minneapolis VA laboratory was aware of three potential sources that could meet this requirement, they performed an evaluation at an outside/local laboratory using the Millipore Midas slide stainer and performance was found to be less than satisfactory. User feedback and slide examples showed decreased stain quality and increased stain variability compared to the Aerospray.

As these stainers are utilized to diagnose patient treatment, it is vital that they provide exceptional quality and consistency.

Minneapolis has reached out to the national VA Supervisors group and Heme TEAMS group to see what other VA facilities are using. One facility uses the Millipore and is in the process of switching to the Aerospray due to the variability in stain quality and the required water supply. Three facilities use the Siemens Hematek. This system does not require bleach during maintenance. The stain components are sold in a pack. One of these facilities only stains peripheral blood and the other two facilities stain both peripheral blood and bone marrow. One facility uses the Aerospray with high recommendation for dynamic staining compared to the Siemens Hematek. This facility

VHAPM Part 813.106 Page 3 of 3

Revision 02 Eff Date: 03/31/2020 indicated poor performance with their previous Siemens Hematek and stated they would rather perform a manual stain.

Minneapolis previously used the Siemens Hematek prior to 2007. They moved away from it due to excessive precipitate on slides and clogging issues in the stain lines and on the platform itself. Also, the stain comes as a pack on the Hematek so it is harder to troubleshoot issues with individual components.

The Contracting Officer completed a VIP search using NAICS 334516, which yielded 125 matches.

ELITechGroup Inc, a small business is the manufacturer of this equipment and has no authorized SDVOSB/VOSB distributors, therefore the Rule of Two has not been met. A notice of intent to sole source to ELITech Group Inc has been posted to beta.SAM,

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief