P03 OFOC STERIS LR signed.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT

OFOC SOP Revision 09 Page 1 of 5 Original Date: 03/22/11 Revision 09 Date: 04/17/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C242-20-AP-1538

1. Contracting Activity: Department of Veterans Affairs, VISN 2

Network Contracting Activity (NCO2) Buffalo VA Medical Center, 3495 Bailey Avenue, Buffalo NY 14215 VA2237 Purchase Requisition #528-21-1-4803-0001

2. Nature and/or Description of the Action Being Processed:

This is a request for other than full and open competition for the procurement for a service maintenance agreement for Steris sterilizers listed below located at the Buffalo VA Medical Center. The service maintenance agreement includes the following: On-site and telephone support to include labor and parts, preventative maintenance services, chamber cleanings and software support and updates. The proposed contract action shall be provided by Steris Corporation of 5960 Heisley Rd., Mentor OH 44060 for a base plus four option year from October 1, 2020 through September 30, 2025 with a firm fixed-price contact with a total cost estimated at $590,798.22.

Table 1:

Description SN Manufacturer Model loading carts (6) NSN American Sterilizer SPD3 steam sterilizer 011410720 Steris 146660-558 steam sterilizer 030210804 Steris 146660-558 steam sterilizer 012640401 Steris Century steam sterilizer 011719802 Steris Eagle Series surgical washer 3629507006 Steris Synergy

Steam Sterilizer 030111301 Steris

AMSCO

CENTURY

Washer 3627914032 Steris 500XLS Cart Washer 3614917015 Steris Basil 9500 Washer\Disinfector 3615414006 Steris Vision 1327

Sonic Irrigator 05131155804 Medisafe Sonic Irrigator

PCF

Washer\Disinfector 3622211013 Steris Reliance Synergy Ultrasonic Console 0511C1224 Steris Caviwave

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3. Description of Supplies/Services Required to Meet the Agency’s Needs: The requested service maintenance agreement consists of the following:

• Perform quarterly and semi-annual Preventive Maintenance (PM) to manufacturer specifications, including all parts, labor and battery replacement for the Transducers. The contractor shall coordinate with the Contracting Officer’s Representative (COR) at least one week in advance to schedule the services.

• Provide documentation of PM Service within 24 hours of service completion.

• Provide on-site service Monday-Friday 8:00am-5:00pm (except Federal Holidays) within

24 hours of service call placed. The on-site services shall include correcting any software issues as well as performing all required physical repairs and adjustments to return the sterilizers and accessories listed in table 1 to proper working order

• Provide all parts and labor for service calls including printers and accessory components as well as vacuum pump costs.

• Telephone response within 2 hours for service calls.

• Provide Maintenance & Repair of washer sterilizer 3 tier racks, various loading racks and equipment used with sterilizers.

• Calibrate, test and repair any soap\detergent\lubricant pumps used to distribute Steris products to our Steris equipment.

• Perform sterilizer Chamber Cleanings for all sterilizers listed in Table 1 twice a year

• Balston Steam Filters – Replace monthly

• Perform recall alert repairs within 48 hours of notification from client.

• Provide all software updates released to the public by Steris for all sterilizers listed in

Table 1.

• All work shall be performed by OEM trained technicians and only install new OEM parts

4. Statutory Authority Permitting Other than Full and Open Competition:

( X )(1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

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5. Demonstration that the Contractor’s Unique Qualifications or Nature of the

Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

A sole source verification memo from Steris was received stating they are the sole-factory-authorized supplier of both parts and service for the equipment they manufacture.

Steris Corporation has the only access to OEM parts and supplies. Failure to utilize OEM parts may result in the improper operation of the equipment. In addition, STERIS Corporation has over 950 factory trained field technicians who have access to proprietary software, as well as special diagnostic tools that are critical in maintaining this complex medical equipment. As a result, machine downtime and risk to surgical patient's safety is minimized.

Furthermore, using inexperienced, not certified and sanctioned technicians or parts to make alterations to the equipment or perform maintenance are constitute grounds for voiding OEM equipment warranty.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

An Intent to Sole Source Notice was posted to Beta.Sam.gov on June 16, 2020 to June 24, 2020. There were no responses that were received.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The anticipated price to the Government is $590,798.22 for a base with four (4) option years for software and maintenance support.

Pricing:

Base Year : $109,077.37

OY1: $113,440.46

OY2: $117,978.08

OY3: $122,697.21

OY4: $127,605.09

The Biomedical Department at the Buffalo VA Medical Center had provided an Independent Government Cost Estimate (IGCE) based on a quote dated 04/07/2020 which was originally for $686,477.50. The Contract Specialist sent an email to the vendor to discuss pricing inconsistencies. A review of the current contract (VA528-16-P-0358) identified significantly higher prices for the same services. The email requested the vendor to examine the discrepancy. The vendor agreed that there was indeed a pricing error and resent the quote with a $95,679.28 decrease, which now would equate to a 14% reduction from what the IGCE shows.

Based on a comparison of prices on contract VA528-16-P-0358, which is due to expire on 09/30/20, the initial quote represents an increase of approximately 7%. The revised pricing is about a 1.4% increase for the base and Option Years. The Medi-Safe equipment which is currently on Contract # VA242-17-P-3196 will be combined onto the new FY21 contract and the pricing provided in 2017 will remain the same with no annual increase to FY21.

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A search of FPDS showed the range for 2019-2020 to be $103,473.00 to $115,408.55 and the base year cost of $109.077.37 falls in the range. Utilizing the OEM’s service agreement is the best value for the government and the proposed pricing appears to be fair and reasonable based upon the Market Research conducted above.

8. Description of the Market Research Conducted and the Results, or a Statement of the

Reasons Market Research Was Not Conducted:

On 06/16/2020 a VIP search was conducted using the keywords, “Steris Sterilizer” and NAICS code 811219 and returned no results.

On 06/16/2020 a search was conducted on SBA’s website using NAICS code 811219 and keywords, “ Steris Sterilizer” which yielded zero responses.

A search conducted on GSA eBUY using the keywords, “ Steris Sterilizer” identified that Steris had 2 (two) FSS Contracts (V797D-60613 and GS-30F-022GA) both of these contracts were reviewed and neither had line items for service maintenance agreements. In fact under terms and conditions it was noted that Maintenance and Repairs were not covered, and Open Market Pricing was available upon request.

The current contracts (VA528-16-P-0358 and VA242-17-P-3196) which include these services were reviewed.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

The main barrier to competition is the necessity to go through the OEM to maintain all software and maintenance, IAW OEM specifications. Additionally, Steris holds the copy rights to their proprietary software and equipment which prevents other companies from servicing the Sterilizers currently being used by the Buffalo VA Medical Center.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

There was no other interest expressed.

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required:

In this situation, it is difficult to remove barriers to competition because the OEM is the qualified vendor to perform software updates and preventative maintenance of its own specialized equipment. This is especially true where proprietary software , and specialized electronics are used in IAW with OEM specifications.

OFOC SOP Revision 09 Page 5 of 5

Revision 09 Date: 04/17/2020

12. 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 and belief.

Lisa Rummings Date Program Support Assistant Buffalo VA Medical Center

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Joseph Cellino Date Contracting Officer Facility: RPO East NCO2

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

Cheryl Brimmer Date Branch Chief, Services Team

RPO East NC02

June 26, 2020 http://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx