I.A.02__Sole-Source_JA_under_FAR_13.501.pdf

Control No: 19-RHCO-C-367

Version – February 2017

Sole-Source Justification and Approval Under FAR 13.501

1. Contracting Activity: Regional Health Contracting Office – Central Ft Carson Health Contracting Cell/WBAMC LNO 5005 Piedras St.

Ft Bliss, TX 79920

2. Description of Action:

Nature: New Requirement Follow-on Requirement

Contract Vehicle: Purchase Order Number _______________________________

Blanket Purchase Agreement (BPA) Number _______________

Order/BPA# _______ against FSS Contract #_____ _________

Order #___________ against Multiple Award IDIQ Contract Name or

Order #_______ against a single award IDC Contract

Modification # _______ to existing PO/TO/DO/Call Order

Pricing/Contract Type: Fixed Price Time & Materials/Labor Hours Cost-

Reimbursable Hybrid

Funds: Operations & Maintenance, Army (OMA) Other Funds: ________

FY: 2019

Name of Proposed Contractor and Address:

Stryker 5900 Optical Ct San Jose CA 95138

Brand Name Buy: Yes No

3. Description of Services or Supplies: This requirement is for specialty maintenance repair services on our Integrated Operating Room medical equipment manufactured by Stryker. The requirement is due to support our Surgical Department for patient surgical procedures. The equipment is both complex and costly. The maintenance agreement must include preventative maintenance for Stryker endoscopy equipment and communication equipment during normal business hours, parts coverage, including repairs, replacements, or loaners (as necessary), all travel, shipping, and labor charges included with the service agreement; software maintenance/upgrades (as necessary), and training for personnel on equipment usage. All maintenance services, parts, and equipment must be certified by Stryker, in accordance with the OEM standards.

Base: 1 Jun 19 to 31 May 20 Value: $258,724.26 Option1: 1 Jun 20 to 31 May 21 Value: $258,724.26 Option 2: 1 Jun 21 to 31 May 22 Value: $258,724.26 Option 3: 1 Jun 22 to 31 May 23 Value: $258,724.26

Total: $1,034,898.24

4. Authority: 41 USC 1901 as implemented in FAR 13.501(a) (1)(iii), sole-source (including brand name) under the authority of the simplified procedures for certain commercial items.

5. Reasons for Authority Cited:

a. A review of mandatory sources to include GSA/VA Schedules indicate that the maintenance services for Stryker may potentially be available, however, do not meet the agency requirement.

Additionally, Stryker will not indemnify its customers for liability or damages caused by products modified or repaired by third-party vendors.

b. Stryker is the only available source to provide preventative maintenance for Stryker endoscopy and communication equipment, parts coverage, including repairs, replacements, or loaners (as necessary), all travel, shipping, and labor charges included with the service agreement; software maintenance/upgrades (as necessary), and training for personnel on equipment usage.

c. Evans Army Community Hospital will not be able to maintain the high level of maintenance services on our Integrated Operating Rooms in order to support the Surgical Department. One-time service repairs would likely exceed the GPC threshold of 5K and without the contract maintenance repair services we would have to initiate a one-time contract prior to any one of our items being repaired. The contracting time frame can be up to several months before award and would not be conducive to our hospital’s needs. This undoubtedly would hinder our mission of patient care and cause procedures/surgeries to be routed outside Evans Army Community Hospital.

6. Efforts to Obtain Competition: Not applicable.

7. Actions to Increase Competition: Not applicable.

8. Market Research: A searched was completed on 15 January 2019. The searched showed 63 contractors using SIN 65 II A Medical Equipment and Supplies, category A-200, Equipment Maintenance and Repair. This list of 63 contractors was viewed for Stryker/Stryker Endoscopy/Stryker Corp, which is the tentative sole source provider. This vendor was not listed in GSA in this category. Further search showed Stryker equipment was listed in various categories. Three vendors were contacted from list of 63 to determine if the maintenance services for Stryker could be provided (See Table below).

Vendor Phone Time/Date

Contacted

Question 1: Do you provide maintenance services for

Stryker equipment?

Socio-economic

Category

Contract Number

Ben’s

Precision

Instruments, Inc. DBA:

BPI Medical

Inc.

253-883-5040

253-878-8719

15 Jan 2019

15:10

Yes. We repair several Stryker products.

Equipment must be sent in. No on-site support.

Provided email with example support coverage.

s V797D-50575

Caylor

Equipment

Services, LLC

804-833-5577 15 Jan 2019

15:30

Yes. We repair some on site, and others must be sent in.

Equipment covered can be trays, drills, lamps, etc.

Vendor will send an email.

s/dv 36F79718D0563

Isis Medical

Inc. (Support

Medical

Systems)

508-678-6100 15 Jan 2019

16:00

Left message. No

Stryker equipment listed in GSA s V797P-4244B

On 5 Mar 2019, a sources-sought was posted to FedBizOpps with a required response date of 8 Mar 2019, producing six interested vendors.

9. Interested Sources:

Vendor Business Type

General Medical Equipment

2230 W Chapman Ave Ste 155

Orange CA 92868-2316

SDB

BMT Consulting Inc

1337 Locust Rd NW

Washington DC 20012-1325

SDB, SDVOSB

Pacific Monarch Inc

34885 Doheny Pl

Capistrano Beach CA 92624-1715

Large

Skupien Solutions

2182 Hillsboro Valley Rd

Brentwood TN 37027-5413

SDB, WOB, WOSB

Advanced Surgical Services LLC

6714 Tree Knoll

Troy MI 48098

SB

RCG Medical Supply Company

404 Overlake Rd Ste A

Raeford NC 28376

SDVOSB

https://www.gsaelibrary.gsa.gov/ElibMain/contractorInfo.do?contractNumber=V797P-4244B&contractorName=ISIS+MEDICAL+INC.&executeQuery=NO

10. Other Facts: In addition to the above interested vendors, we also received a statement from the equipment manufacturer, Stryker, that they are the only company authorized to provide repair and maintenance service for their equipment; that Stryker does not sell or make otherwise available to any independent repair company new or remanufactured parts for servicing Stryker equipment; that all repairs pass an FDA-regulated, Stryker-certified quality assurance test and OEM specifications are guaranteed; that third-party repairs eliminate Stryker’s ability to test, warranty, or update a device; and that devices repaired by third-party companies could expose patients to significant risk and are no longer validated for biocompatibility, disinfection and sterilization, safety, or efficacy.

11. Technical/Requirements Certification: I certify 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.

Donna March COR, Medical Maintenance

12. Fair and Reasonable Price Determination: I hereby determine that the anticipated cost or price to the Government for this contract will be fair and reasonable. This determination will be made using the following: price analysis cost analysis IGCE audit:

other: Comparison to other like or similar services procured by the government

As a part of this basis, certified cost or pricing data is not required because the services being acquired are considered commercial.

Troy L. Davis

Contracting Officer

13. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Troy L. Davis

Contracting Officer

Approval

Based on the foregoing justification, I hereby approve the procurement of Endoscopic Equipment Maintenance services for Evans Army Community Hospital, Fort Carson, CO for $1,034,898.24, on an other than full and open competition basis conducted pursuant to the authority of 41 U.S.C. 1901 as implemented by FAR 13.501 and provided that the services herein have otherwise been authorized for acquisition.

Liza J. Esmond Special Advocate for Competition