Sole Source Justification - Above Sat.docx

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification >SAT-$7.5M under FAR 13.5

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C250-25-AP-1172

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 10 located at 260 E. University Avenue, Cincinnati, OH 45219-2356, in support of VISN 10, Richard L. Roudebush (RLR) VA Medical Center (VAMC), 1481 West 10th Street, Indianapolis, IN 46202-2803. 2237 #: 583-25-3-095-2257.

2. Nature and/or Description of the Action Being Processed: This procurement is for the purchase of replacement brand name mattresses and accessories 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. A new firm fixed price contract will be awarded to the offeror providing the best value to the Government.

The Veterans Health Administration (VHA) Central Office issued a patient safety alert on 04/18/2024 relating to damaged mattresses posing potential safety risks to patients that include but are not limited to increased chances of hospital-associated infections (HAI) or tissue degradations, and patient deaths. During the audit of patient mattresses associated with the patient safety alert, it was discovered that mattresses at the RLR VAMC have not been replaced on a regular occurrence and that upkeep had not been appropriately managed. To address the issues that were found and reduce risk to the patients utilizing those mattresses; it was determined that a fleet wide replacement of all mattresses on Ward/ICU level beds and stretchers, is required. This new one-time firm fixed price purchase contract will serve as the vehicle to procure the associated mattresses directly linked to the patient safety alert and to correct the deficiencies discovered during the audit.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The following brand name supplies/products are required to meet the agency’s needs:

- Isolibrium w/ Dartex Cover – Manufacturer Part # 2972000000 – Quantity of 50 Units Each

- IsoFlex LAL 2860 – Manufacturer Part # 2860000000 – Quantity of 103 Units Each

- IsoFlex LAL Unit – 84” – Stocked w/ Dartex Option Cover – Manufacturer Part # 2860000019 - Quantity of 103 Units Each

Delivery is expected 30 days after receipt of order (ARO). FOB is Destination.

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 – Brand Name Equipment ( ) 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): Through market research it has been determined that only Stryker manufactured equipment will meet the needs of this requirement. The beds currently in use at the RLR VAMC are brand name Stryker Intouch and Stryker S3 Zoom beds. The only compatible mattresses that can fully integrate with the Stryker Intouch bed frames and inner sensors/controls are brand name Stryker Isolibrium support surfaces. The mattresses must have the proprietary mechanisms and programming codes to integrate fully with the Intouch bed frames. The controls and sensors associated with the frames are critical in determining the risk to the patient in regard to medication management, sore management, alarm management for the bed and nurse call system, and associated bed controls utilized with the mattresses.

Likewise, the brand name Stryker Isoflex LAL series mattresses are compatible with the brand name Stryker S3 Zoom beds. When researching the compatible mattresses to be utilized with the Stryker S3 Zoom ward level bed, it was discovered that in order to remain in compliance with our current patient bed service contract, only OEM parts may be utilized with the equipment as that is what the configuration on the system is set to.

Purchasing alternate mattresses and accessories would result in substantial duplication of cost to the Government that is not expected to be recovered through competition. Additionally, unacceptable delays would occur in fulfilling the agency’s requirements to correct deficiencies found during the audit of equipment conducted in response to the patient safety alert issued by (VHA) Central Office. Existing maintenance agreement(s) covering Stryker beds currently in the facility’s inventory could also be negatively impacted.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research was conducted in accordance with FAR Part 10 (See Section 8 below).

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The Contracting Officer will utilize the price analysis techniques in FAR 13.106-3(a) to determine the price to be fair and reasonable.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research initiated by the requesting service, Healthcare Technology Management (HTM), found that only one source can be utilized for manufacturing of the required mattresses and accessories. The HTM reached out to the OEM of the equipment to receive a list of authorized distributors. Those distributors were contacted and are identified in Section 10 below. Informal pricing quotes were received.

Additional market research queries were conducted by the Contracting Specialist using NAICS 339113, and keywords “Isoflex Mattresses.” Queries of VetCert, SBA DSBS, VA NAC, GSA Advantage, AbilityOne, SEWP databases and other sources found that the OEM is a large business with proprietary licenses for the technology used in manufacturing of the equipment. The OEM provided confirmation of (2) VetCert certified SDVOSB authorized resellers capable of meeting the agency’s needs. The product NAICS code is not found in the Non Manufacturer Rule (NMR) Class Waiver database. An exclusive SD/VOSB set aside is not allowed.

Due to the NMR findings, the VA and SBA Rules of Two were not obtainable. Based upon market research findings, it is determined that a fair and reasonable price for this acquisition can be obtained if competed as an unrestricted brand name solicitation.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None

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

- Stryker Sales, LLC (OEM – Large Business) / 21343 Network Place, Chicago, IL 60673-1213 / (513)479-7701 / Alex Stevens – alex.stevens@stryker.com

- TrillaMed (SDVOSB) / 30100 Telegraph Road, Suite 366, Bingham Farms, MI 48025-5800 / (248)203-9734 / Tejas Smart - tsmart@trillamed.com

- Beacon Point Associates, LLC (SDVOSB) / 1216 SW 4TH Street, Suite 4, Cape Coral, FL 33991-2129 / (239)984-3265 / Michael Summerour – michael.summerour@teambpa.com

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: The market will continue to be reviewed for availability of additional sources capable of meeting the agency’s need(s) for requested products/supplies.

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.

Effective Date: 11/15/24 Page 1 of 9

REVISION: 01

Acquisition ID#: 583-25-3-095-2257