P03 - Justification for Sole Source above SAT.pdf

Effective Date: 02/01/2022 Page 1 of 5

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C252-22-AP-0742

1. Contracting Activity:

Department of Veterans Affairs

VISN 12

Multiple VISN 12 Department of Veterans Affairs Medical Centers

695-23-1-133-0004 $244,682.00 (Base Year) $1,234,180.08 (Aggregated Total)

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

Sole Source procurement of Advanced Sterilization Products (ASP) maintenance services for Sterrad Sterilization Equipment located in multiple VISN 12 VAMCs:

Jesse Brown VA Medical Center Captain James A. Lovell Federal Health Care Center Edward Hines Jr. VA Hospital Oscar G. Johnson VA Medical Center William S. Middleton Memorial Veterans Hospital Clement J. Zablocki VA Medical Center Milo C Huempfner VA Outpatient Clinic

FAR 13.5 Simplified Procedures for Certain Commercial Items:

This procurement is for the maintenance of the Sterrad Sterilization Equipment for the VISN 12 VAMCs in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. This new purchase order will be awarded as Firm- Fixed Price with a base year and four (4) one-year option periods.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

The proposed new purchase order for the maintenance of the Sterrad Sterilization Equipment for the VISN 12 VAMCs will be a Firm-Fixed Price purchase order with a start date of 11/01/2022, which will include a base year and four (4) one-year option periods with an ultimate completion date of 10/31/2027. To properly maintain the equipment to the OEM specifications, a service agreement is required. The purchase order value for this procurement is estimated at $244,682.00 for the base year and $1,234,180.08 for the entire value of the purchase order.

Base Year: 11/01/2022-10/31/2023 $244,682.00 Option Year 1: 11/01/2023-10/31/2024 $248,630.00 Option Year 2: 11/01/2024-10/31/2025 $244,266.08 Option Year 3: 11/01/2025-10/31/2026 $244,306.00

Effective Date: 02/01/2022 Page 2 of 5

Option Year 4: 11/01/2026-10/31/2027 $252,296.00

Aggregated Total: $1,234,180.08

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

( X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Advanced Sterilization Products (ASP) does not provide proprietary OEM parts and software through distributors therefore ASP is the only Contractor that can provide maintenance and repairs to the Sterrad Sterilization equipment used at VISN 12 facilities.

An authorization letter provided by Miguel Hernandez, Director of U.S. Field Service and Worldwide Service Operations & Compliance of ASP on May 17, 2022 states: In order to ensure maximum performance of Advanced Sterilization Products (ASP) systems, we only authorize servicing by persons who have been trained and certified by ASP. ASP systems include STERRAD® Systems, EVOTECH® Endoscope Cleaner and Reprocessor, ASP AEROFLEXTM Automatic Endoscope Reprocessor. Training is product-specific and separate training is required for each product and model. Authorized service personnel include trained ASP service employees, OEM trained third-party service providers under contract with ASP to provide servicing on our behalf, and customers who have purchased and completed product-specific Biomed Training provided by ASP.

ASP currently does not endorse or have a formal business relationship with any small business, including Service-Disabled Veteran-Owned Small Business (SDVOSB), to provide servicing of ASP systems or to supply Original Equipment Manufacturer (OEM) parts. ASP has not trained the personnel of any SDVOSB on how to service ASP systems. Accordingly, as of the date of this letter, ASP is the only entity authorized to provide all scheduled preventive maintenance, corrective maintenance, repairs, OEM parts, calibrations, telephone support, and full access to ASP’s software for calibration and repairs for the Government.

Service attempted or performed by unauthorized persons will void ASP warranties and/or service agreements for the specific system in accordance with the provisions of ASP’s product warranty

Effective Date: 02/01/2022 Page 3 of 5 policy and service agreements. In addition, approved and proprietary parts are necessary to service all ASP systems. These parts are only available to ASP authorized personnel as detailed above.

Currently, VISN 12 has 18 Sterrad Sterilization units. These units still have on average 5-10 years of useful life. When comparing the replacement value of the units at an estimated cost of $56,778.62 per unit (a total of $1,022,015) plus the cost of required regular maintenance with the estimated cost of a service agreement, it is in the Government’s best interest to award a service purchase order to ensure scheduled maintenance is completed and to prevent the deterioration of the equipment to limit the replacement rate. In addition, installation of new equipment would create unnecessary downtime within the Sterile Processing Department, an essential department for the VAMC and ultimately affecting patient care.

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

A notice of intent to sole source was published on May 18, 2022, with a response date of May 23, 2022, in Contract Opportunities requesting capability statements from interested vendors.

No responses were received.

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

The CO has determined that the anticipated cost to the Government is fair and reasonable by comparison with the cost of maintenance services for similar sterilizer equipment. A recent RFQ issued for maintenance for Steris V-Pro (36C25222Q0680) received a quote of $15,113.58 per unit for the base year which is $1,520.14 (or 11%) more than the estimated price of $13,593.44 per unit for ASP’s maintenance service in the base year. The estimated cost for ASP’s maintenance service during the option years will increase by only 3% over the base year.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Market research in accordance with FAR Part 10 was conducted and an Intent to Sole Source was posted advising the industry of the pending acquisition and soliciting inquiries from interested parties. It has been determined that the requested maintenance is available from only one source, Advanced Sterilization Products Services, Inc.

VIP was searched on May 12, 2022, using NAICS 811219 and a combination of keywords (“Sterrad”, “Sterilizing Units Gaseous Plasma”, “Sterilization Units”, and “Gaseous Plasma”). Zero (0) vendors resulted. The rule of two was not met. When searching SBA with the same NAICS and keyword combinations, zero (0) vendors resulted. FPDS was searched on May 12, 2022, using keyword “Sterrad”, NAICS 811219, and limiting the search to only Department of Veteran Affairs. 637 actions resulted, with almost all actions awarded to either Ethicon (original vendor name) or Advanced Sterilization Products Services, Inc (current vendor name).

An Intent to Sole Source (36C25222Q0606) was posted on May 18, 2022, with a closing date of May 23, 2022. Zero (0) vendors responded.

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

Utilizing any non-authorized vendors would void any warranties and current service agreements.

Effective Date: 02/01/2022 Page 4 of 5

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

Advanced Sterilization Products Services, Inc (Original Equipment Manufacturer)

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:

At this time, only one source, Advanced Sterilization Products Services, Inc is qualified for the service on the Sterrad Sterilization Equipment and has shown to be reasonable and authorized. The Contract Specialist and Contracting Officer will continue to survey the marketplace during the purchase order period taking under consideration any new and innovative methods for the Sterrad Sterilization Equipment maintenance. Continual market research and purchase order administration will assist in determining the next purchase order’s procurement strategy.

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.

Meaghen Krebsbach Biomedical Engineer Clement J. Zablocki 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.

Ashley Johnson Contracting Officer NCO 12 – Great Lakes Acquisition Center

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Erika Cannaday Services Branch Chief

Meaghen A.

Krebsbach 733515

Digitally signed by Meaghen A. Krebsbach 733515 Date: 2022.08.26 11:54:03 -05'00'

Ashley A Johnson 319134

Digitally signed by Ashley A Johnson 319134 Date: 2022.08.29 15:46:37 -05'00'

ERIKA

CANNADAY

Digitally signed by ERIKA

CANNADAY

Date: 2022.08.30 15:22:36 -05'00'

Effective Date: 02/01/2022 Page 5 of 5

c. Division Manager Review: I certify the justification meets requirements for other than full and open competition.

Scott Ivy Division Chief

d. Director of Contracting Review: I certify the justification meets requirements for other than full and open competition.

Paul Lauro Director of Contracting

e. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

Terry L. Spitzmiller Executive Director Regional Procurement Office Central (VHA)

SCOTT IVY Digitally signed by SCOTT IVY Date: 2022.08.31 14:03:11 -05'00'

2 Sep 2022

Paul M. Lauro 1463508

Digitally signed by Paul M. Lauro 1463508 Date: 2022.09.02 14:37:34 -05'00'

TERRY

SPITZMILLER

Digitally signed by

TERRY SPITZMILLER

Date: 2022.09.06 12:35:24 -05'00'