JA-23-08-1419 Brand Name Only Redacted.pdf

CUI//SP-SSEL//FED ONLY

Control Number: JA-23-08-1419

Sole Source Justification and Approval (Including Brand Name)

Under FAR 13.501

1. Contracting Activity: U.S. Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD 21702-5014.

2. Description of Action: The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) requires a five (5) year Indefinite Delivery/Indefinite Quantity (IDIQ) contract. The resultant equipment delivery orders issued from the IDIQ will be Firm Fixed Price (FFP).

The source of funding for the autoclave delivery orders will be Defense Health Agency (DHA) and the Defense Threat Reduction Agency (DTRA).

The recommended Original Equipment Manufacturer (OEM) for this brand name requirement is: Getinge USA Sales, LLC; Cage Code 7Z1K6; 45 Barbour Pond Drive Wayne, NJ 07470; getinge.com.

USAMRAA anticipates a multiple-award Indefinite Delivery/Indefinite Quantity (IDIQ) equipment supply contract with TrillaMed LLC and Getinge USA Sales LLC competing on each equipment buy delivery order. The Government projects award of the IDIQ on or before 25 September 2023.

3. Description of Supplies/Services: The scope of work for the proposed IDIQ is:

1) procure new autoclave systems; and 2) procure new software operating systems.

As a material equipment-buy contract vehicle, autoclave repairs and preventive maintenance services will not be covered by the proposed IDIQ.

USAMRIID has fifty-three (53) Getinge autoclave systems, all of which have expired life cycles with expired warranties. Many autoclaves have software control systems that are obsolete: twenty-two (22) autoclaves are operating on MC11 controls which are obsolete and have not been supported by the OEM since 2001; eight (8) autoclaves are operating on PACS- 2000 controls; seventeen (17) are operating on PACS-3000 controls; and six (6) are operating on PACS-3500 controls.

All regulated medical waste from laboratories and biocontainment spaces (biosafety level 3 and 4) must be sterilized prior to disposition. Over the five-year period of performance for this proposed IDIQ, in the base year USAMRIID plans to replace five

(5) obsolete Getinge high-volume autoclave sterilizer systems. Fourteen (14) Getinge autoclave sterilizer systems are scheduled for proprietary Getinge software operating system upgrades. Thereafter, the nineteen (19) effected Getinge autoclave systems will be serviced and maintained under an extant Getinge preventive maintenance service contract W81XWH-21-C-0091. In addition to

Controlled by: Army Controlled by: USAMRAA CUI Category: Source Selection Distribution/Dissemination Control: FED ONLY POC: Jeff Flook, 240-313-8523 providing regularly scheduled preventive maintenance, this service contract is used for emergency unscheduled repairs as well as procurement of spare parts and cleaning consumables.

The estimated value of this effort is $7,200,000.00, inclusive of all options and extensions in accordance with Federal Acquisition Regulation (FAR) 52.217-8.

4. Authority Cited: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501 (a)(1)(ii) sole source (including brand name) under the authority of simplified procedures for certain commercial items.

5. Reason for Authority Cited: The proposed brand name manufacturer is Getinge USA LLC. Only one source of supply will satisfy agency requirements due to cost, milestone delays, and proprietary system limitations.

a. Cost:

1.) The inhouse inventory of fifty-three (53) Getinge autoclaves operate under the supervision of the Clinical Engineering Department of USAMRIID, which maintains the proprietary Getinge consolidated control system monitor which has online connectivity with all 53 Getinge autoclaves. The Getinge control system produces customized real time and hardcopy reportage relating to statistics, measurable effectiveness of steam sterilization cycles, data relating to holding periods and evenness of pressure, and logistical regression to identify autoclaves with ineffective sterilization cycles. Of the five autoclaves scheduled for replacement, the substitution of another brand name manufacturer would require the additional purchase cost of a consolidated control system monitor to be interconnected with the five new autoclaves. In effect, there would be two control panels monitoring the performance of two brands of autoclaves along with the associated additional procurement and maintenance cost.

2.) Fourteen (14) Getinge autoclaves are not scheduled to be replaced in the base year but will be scheduled for Getinge software operating system upgrades. The software operating systems are proprietary and only operate in conjunction with Getinge autoclave hardware. To introduce another brand name software operating system to operate on Getinge equipment is not feasible. For the purchase of alternative software operating systems to be practicable, it would require the replacement of fourteen (14) autoclaves to match the brand name software operating system upgrades, which would be cost prohibitive.

3.) Currently preventive maintenance and certification of Getinge autoclaves are performed by Getinge service contract W81XWH-21-C-0091. The replacement of the Getinge brand name by the introduction of another autoclave manufacturer would require an additional service contract to the Original Equipment Manufacturer (OEM) to provide onsite preventive maintenance. The cost of a second preventive maintenance service contract would be unaffordable.

b. Milestone Delays:

1.) For the five (5) Class S autoclaves scheduled for replacement in the base year, the lead time to custom build each autoclave is approximately twelve months. The introduction of autoclaves by another manufacturer would add an additional six months to the lead time for installation, operation, and performance qualification controls. Certification by a new manufacturer would require maintenance procedures and system functions tests. To comply with Army regulations, chemical integrator sterility tests and biological indicator sterility tests would be required for alternative equipment. Additional time would be required for the installation of a consolidated control system to monitor the quality performance of five alternative brand name autoclaves. Procurement time would need to be added to put a service contract in place with the manufacturer for preventive maintenance of alternative autoclaves.

Certification of new equipment and recommissioning of the laboratory protocols would reasonably result in six to eight months of downtime.

c. Proprietary Limitations:

1) Autoclave software operating systems are proprietary and not interchangeable.

Software control system upgrades by a non-Getinge manufacturer by necessity would require autoclave hardware replacement. Autoclaves are not standalone systems. Scientific protocols and mandatory regulations on compliance require autoclave systems to be connected to a control panel monitor to measure the quality of performance of each autoclave individually and collectively. Autoclaves by another manufacturer would require connectivity to a consolidated control monitor by the same manufacturer. Subsequently, a separate service contract for preventive maintenance to the alternative Original Equipment Manufacturer would be required.

In effect, software control proprietary limitations would result in two systems operating independently, with manual integration required for statistics, measurable effectiveness, data analysis, and quality control of sterilization processes reportage.

Getinge USA LLC is the recommended Original Equipment Manufacturer (OEM) in this Brand Name Justification. Getinge USA LLC is a distributor of their manufactured products and TrillaMed is the only licensed reseller of Getinge manufactured products.

In the subject Brand Name multiple-award IDIQ, Getinge and TrillaMed will compete for each equipment supply buy delivery order.

6. Efforts to Obtain Competition: In accordance with Federal Acquisition Regulation (FAR) 5.2 -- Synopses of Proposed Contract Actions, a Notice of Intent to award a Brand Name IDIQ will be published on the www.sam.gov website for 15 days concurrent with the posting of this redacted Brand Name Justification and solicitation HT9425-23-Q-0094.

7. Actions to Increase Competition: USAMRIID and USAMRAA will periodically conduct market research and analysis to determine if the Original Equipment Manufacturer has allowed additional licensed authorized resellers to distribute their products under this IDIQ.

As the commercial market for autoclave sterilization systems change with Artificial Intelligence (AI) applications concurrent with the progression of USAMRIID’s mission, consideration will be given to other manufacturers as the potential for more competition may materialize with the introduction of new systems and as new vendors enter the market. Additionally, future requirements will be synopsized in accordance with Federal Acquisition Regulation 5.203. If another potential source emerges, USAMRAA will assess whether competition for future requirements is feasible.

8. Market Research: In terms of minimizing expense and achieving cost savings, expediting equipment replacement and control upgrades to fulfill milestone objectives, and attaining a fully integrated autoclave hardware/software configuration, Getinge Brand Name is necessary for this requirement. USAMRIID has a current service contract with Getinge for preventive maintenance on Getinge autoclave sterilization systems. Some of the fifty-three (53) Getinge autoclaves inhouse have expired life cycles but can still be repaired and maintained with parts from Getinge as the manufacturer.

USAMRIID Clinical Engineering proposes to utilize the Biological Reliability Protection Program to execute and coordinate the autoclave equipment replacement and software control upgrades by utilizing on-site trained and Getinge certified employees through Getinge service contract W81XWH-21-C-0091. This maintenance contract serves as a preventive maintenance and emergency unscheduled repair service, with four full time equivalent service technicians on-site. The proposed Indefinite Delivery/Indefinite Quantity contract will be used to acquire replacement Getinge autoclave equipment and Getinge software operating system upgrades. The Getinge service contract will provide removal of existing equipment, decommissioning of the same, with installation, testing and start-up services for replacement equipment performed by Getinge certified employees.

Of the two vendors who will compete in the multiple-award IDIQ, TrillaMed has a socioeconomic classification as Service-Disabled Veteran-Owned Small Business (SDVOSB). Getinge is classified as other than small. Two or more small businesses do not exist that can compete in this brand name IDIQ.

Market research on the potential multiple-award IDIQ contractors:

Getinge USA Sales LLC: under cage code 7Z1K6, Getinge has System for Award Management (SAM) registration through 17 April 2024 with no exclusions.

Contractor Performance Assessment Reporting System (CPARS) exhibit Contractor Assessment Reports which total 403, ranging from Very Good to Exceptional. No derogatory information was derived from the Getinge Federal Awardee Performance and Integrity Information System (FAPIIS) Report.

TrillaMed LLC: under cage code 56FN2, TrillaMed has System for Award Management registration through 30 November 2023 with no exclusions. Contractor Performance Assessment Reporting System (CPARS) exhibit Contractor Assessment Reports which total 367, ranging from Satisfactory to Exceptional. No derogatory information was ascertained from the Federal Awardee Performance and Integrity Information System (FAPIIS) Report. In addition, TrillaMed offers Government Purchase Card procurement from their GSA Federal Supply Schedule for Getinge autoclave cleaning and maintenance supplies at the micro-purchase level.

9. Interested Sources: The notices required by Federal Acquisition Regulation 5.201 will be fulfilled by posting a Notice of Intent to award a Brand Name IDIQ on the

System for Award Management (SAM) www.sam.gov website for 15 days concurrent with the posting of this redacted Brand Name Justification and solicitation HT9425-23- Q-0094. Any responses received shall be examined for consideration.

10. Other Facts:

a. Procurement history.

(1) Equipment Supply Buy and Service Contracts:

Autoclave Equipment Supply Buy: W81XWH-22-P-0152 was awarded to TrillaMed on 9 September 2022 in the amount of $107,000.00 to remove two Getinge brand name autoclaves and replace with Getinge LSS275 Steam Sterilization systems for Jennifer Dankmeyer and Christopher Cote in the Bacteriology Division of USAMRIID.

Preventive Maintenance Service Contract: W81XWH-21-C-0091 was awarded to Getinge on 30 June 2021 in the amount of $9,814,226.04. It was competed unrestricted with no set-aside. This is a service contract for the Preventive Maintenance and Repair for sterilization and central vacuum equipment in Biosafety Labs (BSL) 1, 2, 3, and 4. Four full time equivalent employees, fully trained and certified as Getinge technicians with applicable BSL security clearances, provide preventive maintenance and troubleshooting for the Getinge manufactured autoclave installations at USAMRIID.

Preventive Maintenance Service Contract: W81XWH-16-P-0068 was awarded to Getinge on 30 December 2015 in the amount of $3,748,164.00. It was competed unrestricted with no set-aside. This was a service contract to provide two full time equivalent employees to perform preventive maintenance and emergency repairs on Getinge brand name equipment.

(2) Competitive Status of Prior Procurements:

Autoclave Equipment Supply Buy: W81XWH-22-P-0152, requirement was a direct award to TrillaMed as a Service-Disabled Veteran-Owned Small Business without competition under FAR 19.1406.

Preventive Maintenance Service contract: W81XWH-21-C-0091. The requirement was competed unrestricted. There were three offers in response to the solicitation.

Only one offer, Getinge USA, was evaluated as Technically Acceptable. Evaluation criteria was Best Value.

Preventive Maintenance Service contract: W81XWH-16-P-0068. The requirement was competed unrestricted. There was one offer in response to the solicitation. Getinge was evaluated as Technically Acceptable. Evaluation criteria was Best Value.

(3) Authority if less than Full and Open:

Autoclave Equipment Supply Buy: W81XWH-22-P-0152 - In accordance with FAR

19.1406 (none of the exclusions of 19.1404 were applicable), direct award was made to TrillaMed as a socioeconomic status of Service-Disabled Veteran-Owned Small

JONES.JASON.MATTHEW.100

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Digitally signed by

Jason M Jones Clinical Engineering Supervisor

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TTHEW.100720633 206336

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Jason M Jones Clinical Engineering Supervisor

Business (SDVOSB) in August of 2022.

Preventive Maintenance Service contract: W81XWH-21-C-0091 – not applicable, solicitation with full and open competition.

Preventive Maintenance Service contract: W81XWH-16-P-0068 – not applicable, solicitation with full and open competition.

(4) Paragraph 7 of Justification, if used:

Procurement of W81XWH-22-P-0152, W81XWH-21-C-0091 and W81XWH-16-P-0068 did not utilize a J&A.

(5) Changed circumstances from past procurement to now:

No discernable changes have occurred in the commercial market since fiscal year 2016.

(6) Unusual procurement patterns:

Not applicable.

(7) Justifications for previous awards – not applicable

b. Other facts. None.

11. Technical 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.

Signature: Date: Refer to Electronic Signature

Typed Name: Title:

12. 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.

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Tonya R. Kreps Contracting Officer

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Tonya R. Kreps Contracting Officer

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable. The basis for this determination will be price analysis of proposed pricing from Getinge and TrillaMed versus Independent Government Estimate. Certified Cost or Pricing Data is not required per FAR 15.403-1(b)(3).

14. Contracting Officer Certification:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Jeffrey S. Croley, Chief of Contracting Office Date

Rebecca L. Evans, Legal

John M. Niziolek, Contracts Group Chief

Tonya R. Kreps, Branch Chief Date

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KREPS.

TONYA.R.1247027978

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Digitally signed by

EVANS.REBECCA.L EVANS.REBECCA.LYNN.12440451

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CROLEY.JEFFERY.SCOTT.11443952

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CROLEY.JEFFERY.S

Tonya R. Kreps, Contracting Officer

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Digitally signed by

KREP

27978 Date: 2023.08.23 14:09:02 ‐04'00'

Reviews

I have reviewed this justification and find it adequate to support other than full and open competition.

Concurrence

Date

Digitally signed by

Christopher E. Sherman Command Advocate for

Competition

Signature: Date:

Typed

Approval

Based on the foregoing justification, I hereby approve the procurement of Getinge brand name only autoclaves IDIQ with a total dollar value $7,200,000.00 on another than full and open competition basis pursuant to the authority of 41 U.S.C. 1901 as implemented by FAR 13.501, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Name: Title:

SHERMAN.CH Digitally signed by

RISTOPHER.E.1 .E.1230688741

SHERMAN.CHRISTOPHER

230688741 Date: 2023.09.05 15:33:06 ‐04'00'