36C25623Q1098_2_JA Redacted.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 1 of 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:

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 16, located at 5075 Westheimer Rd., Ste. 750, Houston, TX 77056. Program Office: Michael E. DeBakey VA Medical Center (MEDVAMC) located at 2002 Holcombe Blvd; Houston, Texas 77030; purchase request #:

2. Nature and/or Description of the Action Being Processed: This procurement is for Brand Name upgrade of ClearSight Upgrade Kits (HEMCSMUPG) with ClearSight Pressure Controller Cover (PCCVR) of the MEDVAMC fourteen (14) current HemoSphere Advanced Monitoring Systems (HEMCARDIAQ), along with a purchase of six (6) additional new HemoSphere Advanced Monitoring Systems (HEMCARDIAQ) with the ClearSight Upgrade Kits (HEMCSMUPG) with ClearSight Pressure Controller Cover (PCCVR).

3. : This procurement is for

Brand Name purchase of six (6) additional new HemoSphere Advanced Monitoring Systems (HEMCARDIAQ) as well as ClearSight Upgrade Kits (HEMCSMUPG) with ClearSight Pressure Controller Cover (PCCVR) of the fourteen (14) currently on hand HemoSphere Advanced Monitoring Systems in MEDVAMC operational rooms. The six (6) additional HemoSphere Advanced Monitoring Systems (HEMCARDIAQ) as well as ClearSight Upgrade Kits (HEMCSMUPG) with ClearSight Pressure Controller Cover (PCCVR) will be introduced in Anesthetizing locations that currently do not have the physiologic monitors due to ongoing expansion of Care Line offerings to MEDVAMC. The upgrades will enable the currently active 14 HemoSpheres and the 6 new HemoSpheres to utilize Edwards ClearSight non-invasive continuous blood pressure monitoring module, as well as allow simultaneous use of FloTrac metrics such as SVR to be monitored while using Swan-Ganz Catheter.

The purchase of the 6 new machines and total of 20 upgrade kits comes with all associated cables, modules, and accessories necessary to have a fully functional system except for the disposable sensors, which are already approved by the facility CPRC and compatible with the connectivity and transmission of data to Draeger Innovian electronic health record application for documentation in the OR. The HemoSphere Advanced Monitoring Systems is a comprehensive all-in-one monitoring system that utilizes a single display unit to visualize continuously various biometric signals including (when utilized by the clinical team):

FloTrac invasive cardiac monitoring: uses a specialized Edwards branded disposable pressure transducer (communicating live data to the display monitor) that uses a clinically validated manufacturer proprietary algorithm to provide continuous cardiac output and systemic vascular resistance, useful for intraoperative diagnoses, treatment, and management of high-risk patients and those undergoing major surgery (i.e. Transplant, Cardiac, Thoracic, major abdominal, major Vascular, major ENT neck dissections).

ForeSight cerebral oximetry: uses a specialized Edwards branded tissue oximetry module with disposable sensors (communicating live data to the display monitor) that uses a clinically validated manufacturer proprietary algorithm to provide continuous oxygenation information (a surrogate of brain blood flow and oxygen tension) of the brain, for intraoperative diagnosis, treatment and management of patients undergoing brain surgery or major surgery who are at risk for hypoxemic brain injury.

Effective Date: 02/01/2022 Page 2 of 5

Swan-Ganz continuous cardiac output and mixed venous oxygen monitoring: uses a specialized Edwards branded Swan-Ganz module connected to a pulmonary artery catheter (communicating live data to the display monitor) that uses a clinically validated manufacturer proprietary algorithm to provide (1) continuous cardiac output and cardiac index information,

(2) continuous systemic mixed venous oxygenation, for intraoperative diagnosis, treatment and management of patients undergoing major non-cardiac and cardiac surgery who are at high-risk for volume shifts, blood loss, and hemodynamic instability and patients with pulmonary hypertension + cor pulmonale.

ClearSight non-invasive continuous blood pressure monitoring: uses a specialized set of Edwards branded module, cables and disposable sensors (communicating live data to the display monitor) that uses a clinically validated manufacturer proprietary algorithm to provide continuous blood pressure, cardiac output and systemic vascular resistance, useful for intraoperative diagnoses, treatment, and management of high-risk patients and those undergoing surgery requiring continuous blood pressure monitoring but short in duration or not necessitating invasive blood pressure monitoring.

The various biometric signals mentioned above are often critically important for patient monitoring, diagnosis, and treatment at MEDVAMC, one of the highest (by volume and complexity) anesthesia delivering VHA facilities in the nation. With a growing Heart failure (ECMO, Heart Assist devices, Cardiac Transplant) program, a solution that allows a single system to visualize and provide trending of biometric signals is essential and Edwards Hemosphere provides a satisfactory solution. With near-complete deployment of HemoSpheres at the MEDVAMC OR and NON-OR anesthetizing locations, as well as the SICU, introduction of a new system that allows the same capabilities would be challenging due to:

Substantial duplication of costs associated with purchase of new display monitors, stocking of associated disposables, purchase of warranties and/or biomedical engineering service.

certifications, and time for clinical training of staff with use of different graphical user interface

Inability to deploy continuous non-invasive blood pressure, hemodynamic (SVR and CCO) monitoring as alternatives to ClearSight technology are not available commercially to our knowledge.

Requirement for multiple monitors in the Anesthesia workspace (a real estate challenge due to limited space in the OR) to display the various biometric signals as most alternative options do not have a signal display monitor streaming all the signals captured from the patient.

Uncertainty with connectivity and transmission of data to Draeger Innovian electronic health record application for documentation in the OR.

Inability to continue trending and monitoring invasive and non-invasive biometric parameters in the SICU that is also employing HemoSphere technologies, allowing us to plug-and-play the critical monitoring in the immediate post-operative setting.

Loss of standardization across all anesthesia sites at MEDVAMC and associated risk exposure from failure to operate the equipment as intended due to variation in graphical user interface and/or need to look at more than one monitor.

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:

Effective Date: 02/01/2022 Page 3 of 5

(X) Only One Responsible Source (Brand Name) and No Other Supplies or Services Will Satisfy Agency Requirements

( ) 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. Demonstr the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The Care Line is requesting additional equipment, along with required software upgrades which will enable the current equipment to interfaces seamlessly, while providing standardization. Only the OEM, Edwards Lifesciences, LLC and their authorized SDVOSB distributor, 1st American Medical Distributors Inc.

can satisfy this requirement. The HemoSphere Advanced Monitoring Systems is currently owned and used at the MEDVAMC. An upgrade of the monitoring system software is required in order for the system to continue to be in compliance with the current with Draeger Innovian electronic health record system. Per GAO decision B-290414, B-411904, and B-416195 where, as here, a requirement relates to human safety concerns, the agency has the discretion to set its minimum needs to achieve not just reasonable results, but the highest possible reliability and effectiveness. Therefore, the brand name only approach is substantiated.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Additional efforts were made by the Anesthesia Care Line to identify and explore alternative systems that provide similar capabilities for biometric signal capturing and trending, including Masimo technologies. It was determined that none are able to meet our requirements with satisfaction due to need for multiple monitors, inability to provide non-invasive continuous blood pressure monitoring capability.

Furthermore, alternative solution would require purchase of additional monitors and accessories, not compatible with current HemoSpheres. There is also uncertainty with integration with Draeger Innovian electronic health record used at MEDVAMC for documenting anesthesia care. To purchase a different brand would cause the facility an additional requirement of creating a new Standard Operating Procedure (SOP) and time spent training on the new equipment. The delay caused by required training on new equipment would cause a delay in delivering patient care.

The Contract Specialist consider the items that are prioritized for use by the VAAR. Below contains a list of websites researched in regard to the FAR & VAAR Priorities for Use of Mandatory Government Supply Sources (FAR 8.002 and VAAR 808.002). In addition, the below took in consideration the specific requirements of the Veterans First Contracting Program which requires to apply the Rule of Two to all contracting determinations.

CS completing a search of: AbilityOne, General Services Administration (GSA) Federal Supply Schedule (FSS) eLibrary, GSA Advantage, VA NAC, Medical Electronic Catalog (ECAT), VA Supply Chain Master Catalog, System for Award Management (SAM), Federal Procurement Data System (FPDS), Interagency Contract Directory, and SBA Dynamic Small Business Search (DSBS) per the VHAPG Part 810.001 Market Research paragraph 5 with only the OEM: Edwards Lifesciences, LLC and their authorized distributor 1st American Medical Distributors Inc. with no existing contracts.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: It is anticipated that at least two responses from solicitation. Price fair and reasonableness will be determined through competition, similar historical pricing on 36C25622P1517 awarded to Edwards on 9/21/2022 in the amount of for new HemoSphere Monitoring Systems and 36C25621P0255 awarded to 1st American Medical on

Effective Date: 02/01/2022 Page 4 of 5

11/24/2020 in the amount of for new HemoSphere Monitoring System, and IGCE.

Additionally, upon request other than Cost or Pricing Data, if required, to make a separate determination of Price Reasonableness. Base on the comparison it is anticipated that pricing submitted in response to the solicitation will 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: In accordance with FAR Part 10 and VAAR 810, the Contract Specialist (CS) conducted market research using the following techniques. Previously knowledge base from combined market research from two previous acquisition requirement that were found to be for the same items required here. Therefore, procurement returned the two packets to Care Line for this new combined packet request and funding. The two previous packets posted Request for Information (RFI)s; 36C25623Q0433 posted to GPE on 02/22/2023, with a close date of 02/27/2023 with one response from OEM: Edwards Lifesciences, LLC and 36C25623Q0671 posted to both GPE and eBuy on 4/4/2023 with a close date of 4/11/2023 with no responses.

The CS reached out to the OEM to determine if they had any SDVOSB/VOSB or SBs that were authorized to distribute the requested products. The response was, they have one (1) SDVOSB, 1st American Medical Distributors Inc., who is authorized to distribute the requested products.

CS consider the items that are prioritized for use by the VAAR. Below contains a list of websites researched in regard to the FAR & VAAR Priorities for Use of Mandatory Government Supply Sources (FAR 8.002 and VAAR 808.002). In addition, the below took in consideration the specific requirements of the Veterans First Contracting Program which requires to apply the Rule of Two to all contracting determinations. CS completing a search of: AbilityOne, General Services Administration (GSA) Federal Supply Schedule (FSS) eLibrary, GSA Advantage, VA NAC, Medical Electronic Catalog (ECAT), VA Supply Chain Master Catalog, System for Award Management (SAM), Federal Procurement Data System (FPDS), Interagency Contract Directory, and SBA Dynamic Small Business Search (DSBS) per the VHAPG Part 810.001 Market Research paragraph 5 with only the OEM: Edwards Lifesciences, LLC and their authorized distributor 1st American Medical Distributors Inc. with no existing contracts.

Based on the market research conducted, there is one (1) LB and one (1) SDVOSB that have the capability to meet this requirement. As such, the Rule of Two has not been met. Therefore, it is recommended the Government proceed with an Unrestricted solicitation IAW FAR 13.5.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: The required equipment and system upgrades are proprietary in nature and so it has to be procured from the manufacturer or their authorized distributor. This software upgrade will allow existing hardware to be supported with the newest platform that is compatible with Draeger Innovian electronic health record used at MEDVAMC for documenting anesthesia care. Per GAO decision B-290414, B-411904, and B-416195 where, as here, a requirement relates to human safety concerns, the agency has the discretion to set its minimum needs to achieve not just reasonable results, but the highest possible reliability and effectiveness. Therefore, the brand name only approach is substantiated.

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

a. Edwards Lifesciences, LLC; the OEM and a Large Business

b. 1st American Medical Distributors, Inc.; the OEM authorized distributor and a SDVOSB