-13277.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >$150K

OFOC SOP Revision 06 Page 1 of 8 Original Date: 03/22/11 Revision 06 Date: 08/30/2017

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>$150K)

Acquisition Plan Action ID:__VA-18-0030268 (Estimated Value: $296,274.00 Base +3)

1. Contracting Activity: Department of Veterans Affairs, VISN 08, James A Haley Medical

Center Planning UID: VA-18-0030268 2237#:

2. Nature and/or Description of the Action Being Processed:

This is a one-time request for other than full and open competition to purchase the GOJO SMARTLINK AMS Hand Hygiene (HH) Electronic Compliance Monitoring (ECM) system, that shall be used to monitor Inpatient HH Compliance Protocols. Acquisition is for a Base plus 3 Option Years. The system is “non-*RFID and non-**RTLS”, that uses the FedRAMP approved Microsoft Azure Cloud system to store data. The collected system numerical data is used for improving HH compliance and protocols, reporting to consumers at the National level, training staff personnel with GOJO clinical specialists using “Best Practices” strategies for improving compliance rates.

No end using facility staff (Medical, OI&T or BioMed) are required for monitoring, interacting or providing information to the Contractor/Vendor.

The intended use (end goal) of this solution is for improving healthcare for Veterans, reduction of hospital-associated/acquired infections (HAIs) and improving HH compliance rates and protocols, by monitoring the activities in Inpatient Units (13) and other areas where the system is functioning/set-up on a 24/7/365 basis. Reduction or elimination of HAI’s is a National Patient Safety Goal.

An ECM system is identified as a “Best Practice”, by The Joint Commission National Patient Safety Goal for enhancing the facilities ability to reduce HAIs. Each HAI event which can cost a hospital facility anywhere from $40,000 to $50,000 per patient per one weeks stay (H x P x W) and is not covered by medical insurance.

After several years of exhaustive review and research of various systems, the GOJO SMARTLINK AMS has proven that it meets and exceeds the various mandatory requirements specified by the Veterans Administration (VA), OI&T, Information Security Office (ISO) and BioMed.

*Radio Frequency Identifier – uses electromagnetic signal to identify object to which a tag(s) are attached

(Estimated Value: $296,274.00 Base +3)

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**Real Time Location System – are used to automatically identify and track the location of objects or people in real time, usually within a building or other structure.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

Purchase of the GOJO SMARTLINK AMS Hand Hygiene (HH) Electronic Compliance Monitoring (ECM) system, that shall be used to monitor Inpatient HH Compliance Protocols. The system is “non-*RFID and non-**RTLS”, that uses the FedRAMP approved Microsoft Azure Cloud system to store data. The collected system numerical data is used for improving HH compliance and protocols, reporting to consumers at the National level, training staff personnel with GOJO clinical specialists using “Best Practices” strategies for improving compliance rates.

In order to operate within the facility and adjoining or attached to VA OI&T and BioMed assets or infrastructure, the ECM must be approved, reviewed, vetted, evaluated and documented as being MOU, EPIC and VIPR certified by the VA OI&T and ISO at the National Level. This in turn allows for the product to be TRM approved.

Estimated value of the acquisition (Base + 3 Option Years) is as follows:

Base Year:

S-L HARDWARE Hardware/Installation Package Phase I

51 Ea

S-L-AMS Annual Software Program Agreement Phase I

51 Ea

MAINTENANCE

PLAN

AMS Maintenance Plan Phase I

51 Ea

CBS-AMS Optional Clinician- Based Support Phase I

64 Ea

S-L-SA PROGRAM Optional Service Alerts Annual Software Program Ag

153 Ea

S-L HARDWARE Hardware Installation Package Phase II

105 Ea

S-L-AMS Anual Software Program Agreement Phase II

105 Ea

MAINTENANCE

PLAN

AMS Maintenance Plan Phase II

105 Ea

CBS-AMS Optional Clinician- Based Support Phase

II

132 Ea

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S-L-SA PROGRAM Optional Service Alerts Annual Software Program Ag

315 Ea

S-L-AMS

Program A

SP-Enhanced

CBS-AMS

S-L-SA

Program

Option Year 1 Annual Software Program Agreement (Annual billing per room) Replacement Parts Supply Program, plus Remote System Monitoring (Annual billing per room) Clinician-Based Support (Hours billing based on approved statement of work) Service Alerts Annual Software Program Agreement (Annual billing per Dispenser)

Option Year 2 Annual Software Program Agreement (Annual billing per room) Replacement Parts Supply Program, plus Remote System Monitoring (Annual billing per room) Clinician-Based Support (Hours billing based on approved statement of work) Service Alerts Annual Software Program Agreement

Option Year 3 Annual Software Program Agreement (Annual billing per room) Replacement Parts Supply Program, plus Remote System Monitoring

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(Annual billing per room) Clinician-Based Support (Hours billing based on approved statement of work) Service Alerts Annual Software Program Agreement

Total Value:

Due to various delays (ex: RTLS Moratorium) and other events (ex: final lifting of the Moratorium over 2 years later, funding of acquisition), the desire is to have a period of performance (ASAP) of Base starting 28 February 2018 to 27 February 2019 and Option Year I from February 2019 to February 2020, Option Year II from February 2020 to February 2021 and Option Year III from February 2021 to February 2022. The GOJO SMARTLINK AMS capabilities to monitor, record and format numerical Hand Hygiene data, will be an integral part of this facilities strategy to decrease HAI with further reduction in costs, improve Veteran/Patient care by reducing the possibility of acquiring an HAI and improving Hand Hygiene Compliance rates, as recommended and identified by The Joint Commission.

4. Statutory Authority Permitting Other than Full and Open Competition:

(X) Simplified Procedures for Certain Commercial Items per FAR 13.5 The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2).

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the

Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

We have reviewed products and/or spoken to hand hygiene (HH) platform companies; to illustrate –

Hand Hygiene Compliance & Surveillance System –badge-based system ) – non-RFID/RTLS

: SMARTLINK Hand Hygiene Solutions – non- RFID/RTLS or can be RTLS depending on user needs (upgradable)

) – RFID badges

– Smartbands (similar to badges) and SmartTags on equipment

- RFID badge system ) – badge/”beacon” system; patented proprietary wireless network that retrieves data from the dispenser beacons, and bed beacons and transmits the data to a cloud based server for data analysis and reporting.

(an automated hand hygiene monitoring system from integrated with ) is the software. – RTLS

Badge/RFID system

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Any system not using badges, RTLS/RFID or beacons were evaluated – the VAH has had a moratorium on any RFID/RTLS-based. Only and were appropriate to review.

Comparison of the two remaining systems:

Company

Data transmission to cloud Uses RF (Radio Frequency) to communicate with counting modules. In addition, also capable of working with RTLS applications that utilize RF, LF, IR, and WiFi to record and report hand hygiene performance as an upgrade.

Technology is configured to operate on WiFi frequencies behind the VA Firewall that goes to a FedRAMP-approved Microsoft cloud storage. Easily adaptable into hospital’s existing PURELL Advanced Instant Hand Sanitizer and PROVON antimicrobial soap dispensers

Utilizes wireless communications technology built into their product dispensers to automatically track soap and sanitizer dispenser activations in patient-care areas (can work with other dispensers via external sensing devices). Uses unsecured cellular network and non-FedRAMP-approved cloud.

How does your system work? Sensor above the patient doorway tracks entry/exits as hand hygiene "opportunities" while the

Technology in the soap/sanitizer dispensers calculate the hand hygiene "events." All information is sent via an internet gateway to the software system.

The software calculates the hand hygiene events over opportunities into the "compliance rate."

Captures the number of times healthcare workers cleaned their hands by monitoring soap and hand sanitizer dispenser usage. Each time a dispenser is activated, it sends a cellular signal indicating a hand hygiene event has occurred on the unit. The actual number of hand hygiene events captured from the soap and sanitizer dispensers are divided by the expected number of hand hygiene events (using an algorithm derived from HOW2 study), resulting in a predicted compliance index.

Does your system also include product-usage monitoring in any way?

Does provide dispenser-specific usage data (number of dispenses), but this data is not translated automatically into product consumption (will indicate grossly when needs checking to refill)

Does not measure product usage as it relates to liquid volume.

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Hand Hygiene utilization (our VA uses CDC guidelines)

CDC Hand Hygiene in Healthcare Settings

World Health Organizations (WHO) Five Moments for Hand Hygiene

Support? After system installed and system operation validated, end-user training provided to facilitate effective site navigation and report generation. provides clinician-based support with all our operations. Provide an expert clinician who becomes part of our team. This clinician will guide on-site through set up and implementation and provide detailed improvement plans

Provides onsite training, ongoing customer support and an online toolkit with supporting tools such as staff meeting facilitation guides and visual reminders.

We require a system that follows CDC guidelines/recommendations (as a US Federal hospital system, we are to follow CDC, not WHO).

We require a system that provides results as a compliance rate, not a compliance index.

We (and OI&T) require a secure system that utilizes firewall protection and sends data to a FedRAMP-approved Government Microsoft AZURE cloud, not using a cellular-based system.

Of these two systems, GOJO provides the information in a format we require using CDC HH guidelines and operates within Federal OI&T secure internet cloud system.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

The following firms were researched and their potential product evaluated:

–badge-based system ) – non-RFID/RTLS

– non- RFID/RTLS or can be RTLS depending on user needs (upgradable)

) – RFID badges

- RFID badge system

– badge/”beacon” system; patented proprietary wireless network that retrieves data from the dispenser beacons, and bed beacons and transmits the data to a cloud based server for data analysis and reporting.

(HHS) is the software. – RTLS

: Badge/RFID system

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7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The GOJO Smartlink has also been procured by NCO-22 in Tuscon, AZ to support the NMVAHCS located in Albuerquerque, NM (36C25818C0032). The pricing charged for the GOJO S-L-AMS Smartlink is the same charge provided to the NCO-8 VA hospital of per room.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

The COR and the End Users had conducted exhaustive and long term reviews, research, inquiries on various products (Market Research). This was done by using the TRM, Internet, informal inquiries to vendors, research and contact current VHA End Users who are or may be using other products.

The intent was to find a solution that met or exceeded the requirements for the facility and government.

All but one did not meet the “non-RTLS or non-RFID”, FedRAMP Approved storage criteria, non-End User interaction with or reporting to product Vendor/Contractor on a daily basis and monitoring of Hand Hygiene Compliance and Protocol on a 24/7/365 basis with no End User involvement or interference.

Recently, a Request for Information (RFI) was posted on FBO to ascertain if there was any other firms in the market that could provide the requested service. Two (2) responses were received with each firm suggesting the same brand “ ”. One firm was the manufacturer and the other was an authorized distributor of the same product. The rationale explaining why does not meet the Government’s requirement as follows:

- The use of a cellular communication network will not utilize federally approved firewalls or FedRAMP approved products as well as not currently a TRM approved product thereby creating an IT security risk

- The VA do not use the WHO 5 Moments for hand hygiene monitoring as proposed by

; CDC guidelines are utilized

- Adding more than observations in and observations out increases the margin of error while confusing staff with extraneous information.

- Use of Census data and staffing ratios to obtain compliance rates is problematic. The VA requires data reported as events per hour which is less confusing and less likely to endanger confidence in the system.

- includes comprehensive clinical assessment and ongoing, on-site training which is not provided with .

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

As stated in item number 2, 3, 4, 5 and 6.

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

Genesis Government Solutions, Inc.

DebMed USA GOJO Industries, Inc

All but one did not meet the “non-RTLS or non-RFID”, FedRAMP Approved storage criteria, non-End User interaction with or reporting to product Vendor/Contractor on a daily basis and monitoring of Hand Hygiene Compliance and Protocol on a 24/7/365 basis with no End User involvement or interference.

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11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required:

12. 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 and belief.

_2/12/18__________________ Name: Date Title: Infection Control Coordinator Facility: James A Haley VA

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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

Name: Date Title: Contracting Officer Facility: NCO-8