P03 FAR 13.5 Sole Source Justification - Stryker Beds - VA San Diego.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Request for Sole Source Justification >SAT-$7.5M under FAR13.5

Effective Date: 11/15/24 Page 1 of 5

REVISION: 01

Acquisition ID#: 36C262-25-AP-1053

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C262-25-AP-1053

1. Contracting Activity: Department of Veterans Affairs, Regional Procurement Office West (RPOW), Activations Branch III. This acquisition will utilize purchase request, 2237: 664-25-1- 4001-0007.

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

This procurement is for brand-name Stryker patient beds and mattresses at the VA San Diego Spinal Cord Injury (SCI) and Community Living Center (CLC) 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.

The Stryker equipment line has been used at the VA San Diego Healthcare facility for several years.

The medical staff is experienced and well-trained on the equipment, which negates the downtime required for these highly skilled medical teams to retrain on unfamiliar products. The Stryker brand-name equipment is essential to the technical requirements to meet the needs of the SCI and CLC inpatient units. The Stryker brand-name beds and mattresses must be utilized, as the beds will connect to the Stryker Secure Connect System, which is already in use at this new facility. The Stryker beds and mattresses will also integrate with the existing Nurse Call and Vocera Communications system, currently deployed at the VA San Diego Medical Center.

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

Bed, Patient, Electric with Mattress – Stryker Procuity LE, Model LE 3009 (49 Each)

The Stryker brand-name beds and mattresses must be utilized, as the beds will connect to the

Stryker Secure Connect System, which is already in use at this new facility. The Stryker beds and mattresses will also integrate with the existing Nurse Call and Vocera Communications system, currently deployed at the VA San Diego Medical Center.

• Must have auxiliary power outlets built into the frame

• Must be able to expand bed length 12” through integrated bed extender for 96 inches of total surface length

• Must have the ability to support a single post trapeze

• Must have a three-sided electric brake and a manual brake

• Must have battery back-up

• Must have an integrated foley hook

• Must have integrated restraint hooks

• Must have an automatic under-bed light

• Must have an integrated foot end pump holder

• Must have a Smart Prompts

• Must have Motion Interrupt

Effective Date: 11/15/24 Page 2 of 5

Acquisition ID#: 36C262-25-AP-1053

• Must have wireless capability with FDA 510K Approval

• Must have a pendant port

• Must have advanced foot end controls that are located at the top of the footboard

• Must contain speakers that allow audio input from a patient’s television

• Must have 3-position side rails, capable of holding up to 350 pounds each to help with stand assist

• Must have a patient belongings holder

• Must have a USB port and dual phone holders

• Must have advanced siderail controls to include caregiver presets

• Must have CPR mode functionality

• Must provide one-touch/any position scale with weight history and add or remove equipment feature

• Must have a bed exit feature that can be enabled/disabled from the siderails or footboard

• Must have an Adaptive Bed Alarm to sense a patient’s weight and alert nurses if a patient is out of position or has left the bed

• Must have iBed Watch to visually alert user if side rails, height, or head of bed are not in compliance

• Must have a low height of 11.5 inches

• Must have turn assist to provide assistance up to 30 degrees

• Bed rails must move/stow to allow for easy bedside egress

• Must be able to accommodate mattress size of 35” x 84”

• Quantity: 49

Mattress -Stryker IsoTour

• Mattress surface must be composed primarily of gel structures that help redistribute pressure by buckling and absorbing the patient’s weight

• Mattress surface must be designed to help prevent all stages of pressure injuries by addressing key risk factors of skin breakdown: pressure, shear, and moisture

• Mattress must have a structure that promotes airflow up through the mattress directly beneath the patient

• Mattress must have HeelGelTM technology

• Mattress must be able to provide low air loss directly to a patient’s most vulnerable area for skin breakdown

• Mattress must have turn assist up to 30 degrees

• Mattress turn assist must be adjustable to any angle between 0 and 30 degrees based on patient tolerance and comfort

• Must include IsoTour pump

• Must have weight capacity of 500 lbs.

• Must include a minimum 10-year warranty

• Quantity: 49

Other medical requirements

Effective Date: 11/15/24 Page 3 of 5

Acquisition ID#: 36C262-25-AP-1053

• Must be able to integrate with the existing Nurse Call and Vocera Communications system already deployed at the San Diego VA Medical Center.

Estimated value: $1,247,990.31

Estimated delivery schedule: 120 days after receipt of order (ARO)

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

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

Stryker Corporation and its divisions is the manufacturer of the electronics and instrumentation that comprises the equipment required for this procurement. The Stryker Secure Connect System is a highly specialized system, which has already been installed at the VA San Diego SCI. Stryker Secure Connect is designed to help reduce errors and improve efficiency, providing reliability for crucial patient safety information, such as bed exit alarms that are transmitted to the facility's nurse call system. Accordingly, Stryker Corporation is the only firm capable of providing the supplies described in Section 3 above.

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

Per the Nonmanufacturer Rule, no Service Disabled Veteran-Owned Small Business (SDVOSB) concern or domestic Small Business concern manufacture this product, and it is not subject to an SBA waiver. Therefore, the Contracting Officer will create a Small Business set-aside as the SBA Rule of 2 can be met. Market research has shown that there are three (3) SDVOSB concerns who are authorized to distribute the items. The Contracting Officer has a reasonable expectation that 2 or more responsible small business concerns will provide an offer at a fair and reasonable price.

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

Based on market research, there are three (3) SDVOSB concerns who are authorized by Stryker, the Original Equipment Manufacturer (OEM) to distribute the required items. Based on competition, the Contracting Officer has a reasonable expectation that two or more responsible small business concerns will provide a quote at a fair and reasonable price. In an award for similar products procured by NCO 22 in FY 2023, two quotes were received from SDVOSB concerns. The awardee’s quote was for $3,986,619.89. The unsuccessful quote was priced at $3,996,753.26, a difference of only $10,133.36. This proves that these requirements are highly competitive, which will result in the Government receiving a fair and reasonable price.

Effective Date: 11/15/24 Page 4 of 5

Acquisition ID#: 36C262-25-AP-1053

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

Market research was conducted for this requirement. Due to the brand-name nature of this requirement, Stryker, the OEM was contacted directly to inquire about small businesses who are authorized to distribute these items. The representative from Stryker informed the Contract Specialist that there are only three (3) small business concerns who are authorized to distribute these items; Trillamed, LLC, Beacon Point Solutions, and Academy Medical, Inc. The Contracting Officer will create an open market small business set-aside, as the SBA Rule of 2 can be met. The Contracting Officer has a reasonable expectation that 2 or more responsible small business concerns will provide a quote at a fair and reasonable price.

The Buy American Act does apply to this requirement.

As described in Section 6 above, market research was conducted in accordance with FAR Part 10, by contacting Stryker, the OEM, and canvassing the manufacturer about small business concerns who are authorized to distribute these items. The Government was informed that only three (3) small business concerns are authorized to distribute these items; Trillamed LLC, Beacon Point Solutions, and Academy Medical Inc.

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

N/A

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

Trillamed, LLC Beacon Point Solutions Academy Medical Inc

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:

Due to the brand-name only nature of this requirement, future requirements of a similar nature will be solicited on an other than full and open competition basis.

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.

Krista G. Bunal RN/SPH Coordinator - VHA VA San Diego Healthcare System

Effective Date: 11/15/24 Page 5 of 5

Acquisition ID#: 36C262-25-AP-1053

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.

Timothy L. Garrity Contracting Officer RPOW Activations Branch III

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.

Gary W. Smith Branch Chief, Activations Branch III

Regional Procurement Office West

c. 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.

Curtis M. Jordan Executive Director, Regional Procurement Office West Head of Contracting Activity (HCA) https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx