Revised LSJ over SAT Anesthesia Machines CO BC 1_Redacted.pdf

Request for Limited Sources Justification Format >SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 9 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C24W-25-AP-0154

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C24W-25-AP-0154 JOFOC Log Number: FY25 – RPOW Activations - 1515

(1) Contracting Activity: Department of Veterans Affairs, Regional Procurement Office West Activations Branch 1, located at 5441 Babcock Rd, San Antonio, TX, 78240, in support of VISN 19 VA Health Care System at 1011 Honor Heights Drive, Muskogee OK 74401. 2237: 623-25-3-2455-0144

(2) Description of Action: This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). Eastern Oklahoma VA Health Care System has a new requirement to acquire new Anesthesia Delivery Systems. These are available on FSS 36F79720D0041, by SDVOSB, TrillaMed LLC.

Order against: FSS Contract Number: 36F79720D0041

Name of Proposed Contractor: TrillaMed LLC

Street Address: 30100 Telegraph Road, Suite 366

City, State, Zip: Bingham Farms, MI 48025

Phone: (248) 203-9734, tsmart@trillamed.com

UEI GW9FLBWB5625

Name of Proposed Contractor: GE Medical Systems Information Technologies

Street Address: 9900 West Innovation Drive

City, State, Zip: Wauwatosa, WI 53226

Phone: 847-420-9448, william.elliott@ge.com

(3) Description of Supplies or Services: The estimated value of the proposed action is Eastern Oklahoma VA Health Care System has a new requirement for a one-time purchase of five (5) new Aisys CS2 Anesthesia Delivery Systems for the activation of the new Tulsa VAMC. The Anesthesia Delivery Systems must be delivered to the new Tulsa VAMC between 09/15/2025 and no later than 09/30/2025.

The Aisys CS2 Anesthesia Delivery Systems are manufactured by GE Medical Systems Information Technologies (a GE Healthcare business) which is a large business. SDVOSB, TrillaMed LLC, is an

VHAPG Part 808.405-6 Limiting Sources Page 2 of 9 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C24W-25-AP-0154 authorized distributor of these systems. TrillaMed LLC provided a letter from GE demonstrating this and the systems also are available on FSS contract 36F79720D0041.

EOVAHCS requires five Aisys CS2, model # 1011-9050-000 with the following components, software, features and accessories:

1) Preset features to make starting the anesthetic cases quick and efficient.

2) Multiple ventilator modes which is helpful when you encounter more challenging patients.

3) The option to give a vital capacity breath on the which helps with lung recruitment.

4) Open architecture trolley with 4 drawers and vaporizer storage next to gas module bay.

Includes single width gas module bay

5) Manuals and Software

6) Tubing, connections and accessories needed for ventilation, monitoring, gasses and anesthesia

7) PCV, PCV-VG, SIMV PCV-VG, SIM PCV, SIMV VCV, PSVPro Ventilation Modes

8) Patient Monitor Mount

9) ecoFLOW Software Option

10) DISS Pipeline Fittings, ANSI Colors O2 Right, O2 Drive

11) N20 Pipeline DISS Fitting

12) Bag Support Arm

13) 100-120V NEMA 4 socket, individual circuit breakers

14) Active Adjustable Flow AGSS. High Vacuum, variable flow with bad indicator, includes scavenging bag

15) ACGO Mechanical switch for Jackson-Rees and negative leak test

16) O2 cylinder connection, pin indexed yoke, inboard

17) Air cylinder connection, pin indexed yoke, inboard

18) N20 cylinder connection, pin indexed yoke, outboard

19) O2 gas power outlet DISS

20) Folding Side Shelf

21) Suction regulator, 3 Mode, DISS Pipeline Fitting

22) Remote on/standby switch-AM to Aisys, DisVent extension cable

23) Sampel gas return for Spectrolite Config

24) Suction bottle mounting arm

25) Network Connectivity

26) Installation and connection to our record keeping software

(4) Identify the Authority and Supporting Rationale: see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

VHAPG Part 808.405-6 Limiting Sources Page 3 of 9 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C24W-25-AP-0154

FAR 8.405-6(b): Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is:

These are “direct replacements” parts/components for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing.

These systems must match existing systems in use at Jack C. Montgomery VAMC, Muskogee, OK.

Jack C. Montgomery VA Medical Center (EOVAHCS) currently uses Aisys CS2 Anesthesia Delivery Systems. Six machines were purchased in 2022 on delivery order 36C25922N0427, against FSS contract 36F79720D0041. The order also included 6 x CARESCAPE B850 MBC323 (ATO MODEL), 6 x VA PDM PATIENT DATA MOD, 4 x BIS MODULE, E-BIS-0, and 4 x NMT (TWITCH) MODULE, E-

NMT-0.

They will guarantee the safe and efficient provision of anesthesia services in the newly established operating rooms. These machines are vital for ensuring proper oxygenation, ventilation, and the administration of volatile anesthetics, thereby facilitating surgical procedures that would otherwise be excessively painful.

Maintaining this equipment in the new inpatient facility improves patient safety by minimizing operator confusion and errors. This consistency is vital due to surgeons working across facilities;

variations in equipment could delay responses or cause improper use during emergencies.

The closed-circuit anesthesia machine has emerged as a fundamental tool for delivering oxygen, facilitating ventilation, and administering volatile anesthetics, enabling the performance of procedures that would otherwise be intolerably painful in contemporary medicine. Anesthesia machines, along with the professionals who operate them, have become integral to the operating room, evolving to include a range of electronic monitoring devices and sophisticated ventilators, collectively referred to as the 'anesthesia workstation.' This review examines the critical components and functions of the anesthesia machine, emphasizing the necessity for the interprofessional team to comprehend its operation to avert negative outcomes.

Over the years, modern anesthesia machines have evolved into more sophisticated devices, featuring a variety of safety mechanisms, alarms, and informative displays that improve usability. However, despite these enhancements, the potential for user error remains, necessitating the vigilance and concentration of all personnel in the operating room to prevent critical situations such as failure to oxygenate or anesthesia awareness. While it is not essential for all operating room staff to fully comprehend the complex functions of the anesthesia machine, having a basic understanding of its components can contribute to a safer anesthetic experience for patients. The surgical and anesthesia teams are well-acquainted with these advanced machines, which are currently in operation at our facility.

These anesthesia machines are categorized as critical life-safety and emergency-use devices, highlighting the importance of choosing a system that is compatible with the existing

VHAPG Part 808.405-6 Limiting Sources Page 4 of 9 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C24W-25-AP-0154 infrastructure of the VA. Standardization is essential to mitigate risks such as anesthesia awareness, ventilation failure, and other serious complications. By investing in the Aisys CS2 Anesthesia Delivery Systems, the continuity of care is maintained, operational efficiency is improved, and the health and well-being of the veterans served by the Eastern Oklahoma VA Health Care System are ultimately protected.

(5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination: Supplies offered on the schedule are listed at fixed prices and have already determined the prices for these supplies to be fair and reasonable.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted:

A search of VETCERT was performed using NAICS 339112 and results showed a mix of 667 SDVOSBs and VOSBs.

A further search was performed on SBA DSBS using NAICS 339112 and keyword “anesthesia”, with results showing 14 vendors. One of the vendors is an SDVOSB.

American National Services LLC Expiration Date Mar 10, 2027

SAM UEI LDNAY53JNV24

DSBS Profile description reads: Our pharmaceuticals that we supply branch from in demand 503B medication to injectable anesthetics.

TrillaMed, LLC Expiration Date Sep 8, 2027

SAM UEI GW9FLBWB5625

MedSurg Catalog Search: Authorized distributor of Aisys products.

Sierra7, Inc.

Expiration Date: Dec 6, 2027

SAM UEI NP4TUKF8QCM5

MEDSURG Catalog Search: Authorized distributor of Anesthesia components, GE/Datex Ohmeda Avance/Aisys components.

Sources Sought Notice ID PKG072_CHIP-IN was posted on SAM.gov, 4/16/25 to 4/30/25. The following responses were received.

1) LESAVAGE LLC, UEI: ET3TUZH2T276

Only provided a corporate flyer with nothing about anesthesia systems and stated in their email:

“I am confident in our ability to manage this project for the Department of Veterans Affairs.”

2) BHPE LLC, Begini Howard Private Equity, UEI: UPDJHPJUYQ71

VHAPG Part 808.405-6 Limiting Sources Page 5 of 9 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C24W-25-AP-0154

Did not provide any useful information about anesthesia systems.

3) AFC INDUSTRIES provided a corporate flyer about carts.

4) Tracey Phillips, Associate Field Director for Draeger Inc. M835NJ4FS8T9, Ph: 215-262-0500, tracy.phillips@draeger.com. Draeger Inc. is a large business and uses SDVOSBs as authorized distributors of their products.

Provided a table list of Draeger’s Atlan 350XL anesthesia products showing comparisons to Aisys CS2 and how Atlan 350XL either meets or exceeds VA needs. In some cases, a third party is needed for a component.

5) Tejas Smart, VP, National Accounts, for SDVOSB, TrillaMed, LLC Direct: 248.410.2767, Email: tsmart@trillamed.com. UEI: GW9FLBWB5625, FSS: 36F79720D0041, provided authorized distributor letter from GE HealthCare and

GE anesthesia system:

Aisys CS2

Draeger anesthesia system:

Atlan 350XL

Manufactured USA Manufactured Germany

SDVOSB Distributor: TrillaMed LLC SDVOSB Distributors:

Janz and Sierra 7

FSS: 36F79720D0041 FSS: 36F79725D0031 with Sierra 7

MEDSURG catalog does not show that the entire Atlan 350XL system is available through FSS, but other services related to Atlan can be procured on FSS.

E-vent piston Draeger suggests Atlan as equivalent

TurboVent 2 Draeger suggests Perseus A500 as equivalent

Other: of the 14 small businesses found on DSBS only one profile described selling anesthesia machines.

BELL MEDICAL, INC., UEI: F9MGKUN27EB5

DSBS profile reads: Bell Medical has specialized in the sales and service of anesthesia machines and critical care monitors since 1975.

VHAPG Part 808.405-6 Limiting Sources Page 6 of 9 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C24W-25-AP-0154

The comparison of anesthesia systems below was performed by a Chief Certified Registered Nurse Anesthetist in VHA.

GE anesthesia system:

Aisys CS2

Draeger anesthesia system:

Atlan 350XL

The GE offers digital anesthesia gas vaporizers, allowing for exact delivery of anesthesia gas and actual level of anesthesia gas left in the vaporizer.

GE machines have digital gas and flow controls (oxygen, air, nitrous oxide, anesthesia gas), providing an exact setting.

The Draeger machines utilizes knobs to control the gas control which are not as accurate

GE Machines have the display on a moving arm, easily adjustable to have direct view during induction, emergence, and patient care.

The Draeger display is fixed into the center of the screen and not movable.

GE makes the risk of having a hypoxic mixture (not enough oxygen being delivered) impossible due to their electronic gas control.

Draeger has a mechanical delivery that could fail and provide hypoxia.

GE machines mix anesthesia and oxygen at the pipeline, allowing for changes to take effect immediately.

Draeger uses gas decupling, mixing anesthesia and oxygen in the breathing bag, increasing lag time for any change.

GE is based on electronics, most easily removable during a case.

Draeger is mostly mechanical, increasing wear and tear and replacement of costly parts.

GE has a gas module that snaps in and out of the connection.

Draeger has a gas module that is inside the machine and unable to be corrected during the case. The machine would be out of service until a technician can correct the issue. Currently, EOVAHCS has extra GE modules and would just swap the module for a new one.

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GE offers a universal interface with IT, currently compatible with our record keeping (Picis).

Draeger offers individual interfaces that will have to be included from the beginning.

With Et control, there is never a risk of not providing oxygen since the machine continuously measures oxygen deliver and controls it automatically.

Draeger does not have Et control.

GE offers digital gas delivery, or digital vaporizer.

Draeger's products do not provide digital vaporizer or digital gas delivery. Perseus does not offer a digital vaporizer; the Parseus has a dial setting.

FPDS was searched. Delivery order 36C24425F0253 was awarded on 3/27/25 to TrillaMed LLC, for the same products (5 machines) at Pittsburgh VAMC, totaling . The FPDS description reads:

“AISYS CS2 with and without End-Tidal Control”. The CO submitted a Procurement Request 2268. The 2268 was approved by their SB Specialist and HCA to support their award to TrillaMed LLC.

In reviewing an NIH article, this excerpt was noted: “Life-threatening perioperative anesthetic complications: major issues surrounding perioperative morbidity and mortality.”

“In 1978, Cooper et al published their study highlighting human errors as more common than pure equipment failure in preventable incidents, which was the first time such errors were reported systematically in the anesthesia literature.3 They found that 82% of incidents were inadvertent mistakes such as ‘syringe swaps’, accidental changes in fresh gas flow or unfamiliarity with clinical situations or equipment.” [SOURCE: Steadman J, Catalani B, Sharp C, Cooper L. Life-threatening perioperative anesthetic complications: major issues surrounding perioperative morbidity and mortality. Trauma Surg Acute Care Open. 2017 Aug 28;2(1):e000113. doi: 10.1136/tsaco-2017-000113. PMID: 29766107;

PMCID: PMC5887586.] WEB Address: https://pmc.ncbi.nlm.nih.gov/articles/PMC5887586/

Market Price ranges from for Aisys CS2 systems. The table provided by Draeger showed a price range of per Draeger’s machines, depending on clinician configuration. This would equate to for 5 systems. The Anesthesia Delivery Systems have never been procured before for new Tulsa VAMC. Historically, they have been purchased for surgery department at Jack C. Montgomery VAMC, EOVAHCS, on 36C25922N0427 (36F79720D0041), through Trillamed LLC. Refer to EER 170547 and VISTA PO 623-A20053.

Contract cost and covered 6 x AISYS CS2 ANESTHESIA MACHINES and associated equipment.

(7) Any Other Facts Supporting the Justification: These specialized devices provide anesthesia to patients undergoing surgery. They precisely mirror the equipment utilized at the Jack C. Montgomery VA Medical Center in Muskogee, Oklahoma, thereby ensuring that the VA staff remains familiar with the tools. Consistency in equipment is vital for instilling confidence in the surgical team and ensuring safety in emergency situations. Retraining on unfamiliar devices poses a risk of errors that are intolerable during such sensitive procedures. The safety of patients is of utmost importance.

VHAPG Part 808.405-6 Limiting Sources Page 8 of 9 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C24W-25-AP-0154

Lack of equipment familiarity contributes significantly to many preventable anesthesia errors. Excerpt from NIH article: “Life-threatening perioperative anesthetic complications: major issues surrounding perioperative morbidity and mortality.”

“In 1978, Cooper et al published their study highlighting human errors as more common than pure equipment failure in preventable incidents, which was the first time such errors were reported systematically in the anesthesia literature.3 They found that 82% of incidents were inadvertent mistakes such as ‘syringe swaps’, accidental changes in fresh gas flow or unfamiliarity with clinical situations or equipment.” [SOURCE: Steadman J, Catalani B, Sharp C, Cooper L. Life-threatening perioperative anesthetic complications: major issues surrounding perioperative morbidity and mortality. Trauma Surg Acute Care Open. 2017 Aug 28;2(1):e000113. doi: 10.1136/tsaco-2017-000113. PMID: 29766107;

PMCID: PMC5887586.] WEB Address: https://pmc.ncbi.nlm.nih.gov/articles/PMC5887586/

(8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made: There will be an opportunity to assess different makes and models of anesthesia systems when all anesthesia systems are close to end of life. This may increase competition.

(9) 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. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.