LSJ (20-00044)_Redacted.pdf

Log #20-00044

Form 02.4G.AA 18 Apr 2016

LIMITED SOURCE JUSTIFICATION

FOR FEDERAL SUPPLY SCHEDULE ORDER

1. Identification of agency and contracting activity, and specific identification of the document as a

“Limited Source Justification (LSJ).”

This is a limited source justification executed by the Naval Medical Logistics Command (NMLC), Fort Detrick, MD, on behalf of the Navy to meet the customer requirements of Naval Medical Center San Diego (NMCSD).

2. Nature and/or description of contract action being approved.

The proposed action is a limited source justification to award a new Federal Supply Schedule (FSS) order from an existing contract to the contractor identified in paragraph 3 below. The placement of a Firm, Fixed-Price order is anticipated.

3. Description of the supplies or services required to meet the agency's needs (including the estimated value).

The Joint Tele Critical Care Network (JTCCN) requires a Tele-Critical Care (TCC) monitoring solution-as-a-service and ongoing maintenance to view patient bio-physiological data. Data from patient-level medical devices (to include patient ventilators (both invasive and non-invasive), bedside patient monitor(s), hemodynamic monitoring devices (such as FloTrac-Vigileo system), infusion pumps, intra-aortic balloon pumps, patient bed, and other monitoring equipment that may be used in patient care) will be sent via a gateway solution. The scope of this requirement includes 246 total beds across 33 sites which will include 93 current beds and 153 new beds spread across both CONUS and OCONUS locations.

The solution as a service and ongoing maintenance mentioned above will allow clinicians access real-time patient medical device data, which is required to care for critically ill patients. The system will need to accept HL7 data from all equipment within the ICU environment, to include (but not limited to); mechanical ventilators, bedside monitors, infusion pumps, patient beds, and other electronics capable of transmitting HL7 patient data. This information will need to be assimilated, organized, and displayed in a bio-ergonomic fashion for viewing by the remote Tele-Critical physicians and nurses. Alarms will be configurable, as will the display of information.

Training in use of the equipment is included in this procurement. The device must be capable of transmitting biophysiologic in real time manner (FDA approved physiologic wave form data is presented to the surveillance monitoring system in 1-6 seconds of occurrence) data from product codes (Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)(MHX), System, Network And Communication, Physiological Monitors (MSX), Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)(MWI), Low Patient Acuity Monitoring System (PFY), and Medical Device Data Systems (MDDS) when applicable).

Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system, such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

The system, including claims made for the product, shall be compliant with Food and Drug Administration (FDA) regulations, with respect to marketing and delivering medical products for use in the United States of America.

These requirements shall apply even if delivery is requested outside of the United States of America. The system shall be installed in compliance with Occupational Safety and Health Administration (OSHA) requirements.

The proposed source is Mission First Solutions LLC of 18304 Cabin Road, Triangle, VA 22172. Defense Health Program Operation and Maintenance Fiscal Year 20 funds in the amount of will be used for the base year which includes software, hardware, services and an annual solution support. The estimated total value of the contract is which includes base plus four (4) one (1) year options for 12 months renewal software license/annual solution support.

4. The authority and supporting rational (see 8.405-6(a)(1)(i) and (b)(1)) and, if applicable, a demonstration of the proposed contractor's unique qualifications to provide the required supply or service.

http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/08.htm#P286_49080

The statutory authority which permits restricting consideration of schedule contractors to fewer than that required is FAR 8.405-1(a)(1)(i)(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..

The Bernoulli/Capsule gateway solution has already been established at 16 MTFs. BUMED and DHA require the same Bernoulli/Capsule gateway solution for Naval Medical Center San Diego and other Navy, Army, and Air Force MTFs to include CONUS and OCONUS locations. The Benoulli/Capsule gateway solution is required for the following reasons: (1) consistency with the 16 existing MTFs using the same solution; (2) Bernoulli/Capsule gateway solution is the only solution able to meet the needs of the requirement as is it is the only vendor neutral platform that is FDA cleared for medical device integration (MDI) remote surveillance for both high and low acuity data in real time; and (3) Capsule Tech is the only current MDI solution which possesses an approved ATO within DHA. Mission First Solutions LLC is the only authorized distributor of the Bernoulli/Capsule gateway solution, as evidenced by an exclusive distribution agreement provided to the Government on 21 April 2020. No other vendor can provide the Bernoulli/Capsule gateway solution which is currently being used at 16 medical treatment facilities (MTFs) to support 93 critical care beds. Mission First Solutions is the only vendor that meets the minimum requirements of the Government and is available on the Federal Supply Schedule.

5. A determination by the ordering activity contracting officer that the order represents the best value consistent with 8.404(d).

GSA has determined the prices of fixed-price services and the schedule contracts to be fair and reasonable for the purpose of establishing the schedule contract. Therefore, ordering activities are responsible to make a separate determination of fair and reasonable pricing for individual orders. By placing an order against a schedule contract using the procedures in 8.405, the ordering activity has concluded that the order represents the best value (as defined in FAR 2.101) and results in the lowest overall cost alternative (considering price, special features, administrative costs, etc.) to meet the Government's needs. The Naval Medical Logistics Command Contracting Officer will determine, using the procedures in FAR 13.106-3, the prices are fair and reasonable and will document such determination with a level of detail commensurate with the complexity and circumstances of each order.

6. A description of the market research conducted among schedule holders and the results or a statement of the reason market research was not conducted.

Market research was performed from FY 17 to FY 19 for the initial purchase of the Bernoulli/Capsule gateway solution for 93 critical care beds at 16 MTFs. NMCSD conducted an RFI for Tele-Critical Care systems, from which we chose several (5) vendors to provide presentations at NMCSD. The groups that participated in this vendor fair were able to show their current systems, explain planned future upgrades, and have direct access to the TCC program leadership. These groups included Phillips, Deloitte (partnering with Bernoulli, Intouch, and Decisio), DocBox, MedWeb, and VitalNET. CAPT Davis, RN Griffith, and RN Campbell also visited several civilian TCC hub sites to view their systems in operation. Market research was conducted and it was determined the requirement was within the scope of the NASA SEWP V GWAC. Therefore, the requirement was competed on NASA SEWP as a brand name requirement. GMC Tek was the only vendor to provide a quote and was awarded Contract # NNG15SC76B Order N0025919F0163.

Market research was again conducted in FY20, as BUMED and DHA require the same Bernoulli/Capsule* gateway solution for Naval Medical Center San Diego and other Navy, Army, and Air Force MTFs to include CONUS and OCONUS locations. *Bernoulli was purchased by Capsule Technologies in 2019. Additionally, the exclusive authorized distributor of the Bernoulli/Capsule gateway solution has changed to Mission First Solutions LLC.

Mission First Solutions LLC is the only authorized distributor of the Bernoulli/Capsule gateway solution and is available on the FSS. Capsule/Bernoulli is the only vendor neutral platform that is FDA cleared for medical device integration (MDI) remote surveillance for both high and low acuity data in real time. Capsules MDI connectivity driver library is the largest in the world and meets the DHA’s medical device inventory for rapid deployment with little to no development. Capsule’s MDI current and developmental capability cannot be matched by any other vendor in the world. The breadth and depth of Capsule’s MDI capability and flexibility is required for DHA’s extremely diverse medical devise age multiple vendor current state to allow the Tele Critical Care program to continue implementation.

Capsule Surveillance is the only platform that meets the DHA data speed and accuracy requirements, with the Food and Drug Administration (FDA) 510 certifications to transmit and provide remote surveillance support of critical http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/08.htm#P83_13798 care patient’s data and alarms in real time. Capsule is compatible with the current Electronic Medical Record (EMR) Essentris and the future EMR Cerner. Capsule provides the DHA with a vendor neutral platform to aggregate data in real time for multiple uses to feed multiple system. No other single vendor solution on the market today can meet the needs or requirements of the DHA today.

The only other system that meets a portion of the DHA requirements is Phillips eCare Manager (Phillips), but Phillips cannot fulfill the vendor neutral stance and cannot deliver real time data within the maximum 6 second delay, which is required to ensure real time management of critically ill patients. Phillips has a delay of 30-60 seconds in presenting medical data to the surveillance system which does not meet requirements.

Remote patient monitoring of multiple manufacture medical device types, regardless of age, is the primary requirement to deploy Tele Critical Care clinical remote surveillance. The TCC program is being ramped up and deployed DHA wide. Without FDA certification, vendor neutral platform, the TCC program would be compromised due to lack of confidence in the data available requiring multiple clinical operations breakdowns and drastically increased costs due to patient transport. Without the Capsule Surveillance platform, the TCC program would not be able to roll out as planned and patient care will be compromised.

The capabilities assessment to determine which systems met requirements was facilitated by viewing the DHA database which contains all systems which have an approved Authority to Operate (ATO) within DHA. Without this approval, the systems may not be used on any DHA network. Capsule Tech is the only current MDI solution which possesses an approved ATO within DHA. Additionally market research was done to reach out to any vendor which met a portion of the requirement (Phillips) to determine if they met the FDA real time data transmission standard and Phillips did not as per communication with the company.

7. Any other facts supporting the justification.

This procurement uses a GSA Schedule and will be solicited and awarded in accordance with FAR Subpart 8.4.

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.

All future requirements will be handled on a case-by-case basis.