-18343.pdf

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 2 of 9 Original Date: 08/30/17 Revision 01 Eff Date: 04/23/2018

Another major factor/consideration in choosing the right instrument, is an open system. The VA requires the most open system available in order to accommodate both clinical and research needs.

The more open an automated IHC instrument, the more flexibility of developing customized IHC protocols, including choosing primary and secondary antibodies, and application in different tissue samples. In addition, Boise VA research department wants to collaborate with clinical lab in using automated IHC instrument.

VHAPM Part 813.106 Page 6 of 9

The routine maintenance was minimal with not significant down time or adjustment of personnel:

• Daily maintenance was performed in less than 10 min.

• Weekly preventative maintenance was performed in less than 15 min.

• Monthly preventative maintenance didn’t required decontamination and it was performed in less than 30 min.

The following are some highlights of the unique features of Leica.

Unique Characteristics for Leica Bond-Max that no other automated stainer have:

• Leica BOND- MAX IHC stainer can produce 30 stained slides in 3.5 hours per run with continuous additional slide loading capability.

• Leica BOND-MAX can run 3 different detection systems simultaneously including ISH with capacity for 36 different reagents per run which increases the operational flexibility of the lab.

• Leica BOND-MAX utilizes patented Covertile technology which allows for minimal (150ul) reagent usage per slide, maintains individual slide humidity, and delivers unprecedented tissue retention on the patient slide resulting in fewer re-cuts and repeats.

s, g m ct d h

Leica Bond-Max dimensions (30 (W) x 30.5 (D) x 28 (H) in inches)

As a major contributing factor to the product required by the requesting station, the dimensions need to be equal to or less than the Leica Bond Max, or a construction project could likely be required to expand the available space within the laboratory to accommodate for only several inches of greater dimensions seen in other products. This potential cost is completely avoided by selecting the Leica Bond

VHAPM Part 813.106 Page 7 of 9

Max product. Additionally, the Leica Bond Max

Immunohistochemical stains/testing (IHC) are very important for anatomic pathology practice. The advantages of the IHC stainer are standardization of IHC testing, faster turnaround time and more accurate pathological diagnosis which results in better patient care. Because of this, patient life expectancy and quality of life after particular diagnosis can be expected to be extended and improved due to earlier treatment.

Technique(s) used to conduct market research:

• Scientific literature review

• Discussion with end users (Histopathology technician and Anatomic Pathology Supervisor from DOD and VAMC Anatomic Pathology Laboratories)

• Review of the IHC stainers manuals, catalog, brochures (Leica Biosystems Bond-Max and Ventana Medical System’s Benchmark XT)

• Tested a Leica Bond-Max demo in the laboratory

• Current histopathology technician in charge of the IHC project has previous work experience with Leica Bond-Max

Questions used in our market research:

• Can you tell me what are the top two things you like about the equipment and the least two things you do not like about the equipment?

• Overall, how do you find the IHC stainer to perform?

• What are the benefits of an open system vs a closed system?

• Can you please describe the customer service you have received?

• How much service time or down time have you experienced with the equipment?

• What is your average turn-around time for your IHC stains?

• What is your opinion on the ease of use?

• Are the pathologists satisfied with the quality of stains?

• What were your impressions of the training you received from the manufacturer?

• What other information would you like to share with us about the IHC stainer?

• Can you describe what maintenance needs to be performed on the equipment and how long it takes your techs to perform?

VHAPM Part 813.106 Page 8 of 9

Revision 01 Eff Date: 04/23/2018

Leica Biosystems, Biocare Medical, Celerus Diagnostics, Dako, Roche Ventana Medical System, and Thermo Scientific were identified during our literature review as the companies that offer an IHC automated stainer

Laboratory Projected workload and Maintenance goals:

Our current IHC workload is approximately 20-40 IHC stains per week, which is considered a small workload and therefore a smaller instrument will work best for our laboratory. A smaller instrument will be less expensive to purchase and maintain (service, reagents, and waste disposal). In addition, less maintenance relieves staff hours allowing greater focus on other areas of responsibility within the anatomic pathology laboratory, which in turn will result in an increase of workflow efficiency.

Open vs Closed systems:

Generally, there are two types of automated IHC open and closed system. The closed system or semi open systems limit the use of antibodies, reagents and detection system. The limitation of the closed system will not allow the use of the instrument for research or laboratory developed IHC test to further optimize IHC stains panels for which in turns will aid the pathologist in reaching an accurate diagnosis.

To have the flexibility to accommodate the needs of laboratory developed protocols for personalize medicine in the Anatomical Pathology Laboratory and the needs of the research department, we will need an open system that can accept any vendor’s reagents.

The Bond-Max fits perfect in our countertop available space, the instrument was easy to operate and had very minimal daily, weekly and monthly maintenance. Our current reference lab where we send out all our IHC tests use Ventana and the Pathologist were able to compare the slides from Bond-Max and they were satisfied with the quality of the Bond-Max IHC stainer.

Maintenance time and Cost:

For maintenance the instrument will not be operational during the maintenance of the equipment, therefore once per month the turn-around time of the IHC stains will be affected which will delay the patient treatment. Also, we currently only have two histopathology technician and every time the maintenance must be conducted a contract fee basis histopathology technician will have to come to cover the other duties of grossing and cytology processing while the fully staffed

VHAPM Part 813.106 Page 9 of 9

Revision 01 Eff Date: 04/23/2018 histopathology technician focusses on the maintenance of the equipment. Every time we have a fee basis histopathology technician the Bond-Max that only takes 30 min of hand on tech time which will cost the lab $10.90.

Hazardous waste Calculations and Cost:

Leica Bond-Max 190 slides were stained and the amount of hazardous waste generated was approximately 1 gallon in 1 month (20ml hazardous waste per slide).

hazardous waste per slide therefore if we stain 190 slides with this equipment it will generate approximately 8 gallons of hazardous waste in 1 month. According to GEMS coordinator (attached e-mail) 5 gallons of hazardous waste will cost (per 5 months of hazardous waste) and 15 gallons of hazardous waste will cost (per 1 3/4 month of hazardous waste). The GEMS coordinator indicated that they don’t have the facility to store the amount of waste generated by

Possible Revenue:

Bond-Max, which is an open system IHC stainer, will allow the Anatomic Pathology laboratory to provide IHC service to the research department with the potential to generate revenue that can offset some of the cost of the equipment and the reagents.

Patient Care Cost Reduction:

The importance of acquiring an IHC automated instruments is to run IHC test in house which will help pathologists give more definitive/accurate diagnosis, faster turn-around time and better patient care.

The pathologist will have the final diagnosis report available for the clinical team faster if the IHC is run in house vs send it out to a reference laboratory. The faster the clinical team have the pathology report the faster they can coordinate a treatment plan, which* will shorten the patient stay in the hospital and will potentially save the cost involved in an inpatient care.

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.

Michael J. Allred Date Branch Chief, Supply 2

NCO 20