TempTrak Environmental Monitoring Upgrade Brand Name Justification

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP
Attachment 2: Request for Sole Source Justification Format >SAT
OFOC SOP Revision 08
Original Date: 03/22/11 Revision 08 Date: 04/18/2018
Page 1 of 7
DEPARTMENT OF VETERANS AFFAIRS
Justification and Approval (J & A) For
Other Than Full and Open Competition (>SAT)
Acquisition Plan Action ID: 36C255-19-AP-0869
Contracting Activity: Department of Veterans Affairs,NCO 15, all VISN 15: VA Heartland Network facilities including:
VA Medical Centers (VAMC s):
Harry S. Truman Memorial (Columbia, MO) 589-19-2-5334-0367
John J. Pershing VA Medical Center (Poplar Bluff, MO) 657-19-2-3919-0074
Kansas City VA Medical Center (Kansas City, MO) 589-19-3-1794-0020
Marion VA Medical Center (Marion, IL) 657-19-2-2002-0055
Robert J. Dole VA Medical Center (Wichita, KS) 589-19-2-4741-0846
VA Eastern Kansas Health Care System - Colmery-O'Neil VA Medical Center (Topeka, KS) 589-19-3-7622-0020
VA Eastern Kansas Health Care System - Dwight D. Eisenhower VA Medical Center (Leavenworth, KS) 589-19-3-7622-0019
VA St. Louis Health Care System John Cochran and Jefferson Barracks Division (Saint Louis, MO) 657-19-2-1528-0070
CBOCS and outlying stations will be included under their respective 2237 for their area.
Nature and/or Description of the Action Being Processed: This action is a brand name acquisition for the Cooper-Atkins environmental management (EM) system (TempTrak) for eight (8) VISN 15 VA medical centers, the affiliated Community Based Outpatient Clinics (CBOCs) and outlying stations. The resulting contract will be a firm fixed priced contract. This procurement will be using simplified acquisition procedures and is for the commercial item TempTrak environmental management system upgrade. In accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.
The goal is to remedy gaps in current EM, improve Standardization, Efficiency, Effectiveness, Compliance with VA Directives, Compliance with Regulations. By achieving these objectives, VISN 15 will improve patient care and safety, reduce staff hours spent manually monitoring and recording environmental factors, and comply with national, local, and VA standards. Currently six of the eight VAMCs in VISN 15 use TempTrak EM solution from Cooper-Atkins Corporation. TempTrak environmental monitoring solution has been thoroughly integrated into clinical operations at these facilities.
Research was performed to develop levels for Environmental Monitoring (EM) so products and installations could be defined in stages(levels). Level 1 through Level 3 are required to achieve current industry best practices and to comply with VA regulations and directives. Level 1 through Level 3 are included in the VISN-Wide initiative.
Level 1 - This level meets long standing requirements from a variety of regulatory agencies including Joint Commission and CAP. This level of coverage has been the norm for decades. It focuses on Pharmacy and the Clinical Lab. This level includes:
Pharmacy and Lab Refrigeration
Pharmacy and Lab Refrigeration Heat and Humidity
Pharmacy Pressure Differential in the IV, Ant and Compounding Areas
System infrastructure and design for the areas listed above
Level 2 This level focuses on Surgery and Food & Nutrition. This level includes:
Surgery Heat and Humidity and Refrigeration
All Food & Nutrition storage for patient food
Level 2.5 Initially, data for CBOC s and Outpatient Clinics was not collected. When asked to include them they were designated Level 2.5. This level includes:
Pharmacy and Lab Refrigeration at CBOCs and Outpatient Clinics
System infrastructure and design at CBOCs and Outpatient Clinics
Level 3 This level meets the VHA Directives 1116 and 1761, and EM for critical infrastructure locations. This level includes:
Heat, Humidity and Pressure differentials for Logistics, Nursing Floors, Sterile Processing, and storage areas
Heat, Humidity in OIT and Biomedical Engineering critical infrastructure locations
Description of Supplies/Services Required to Meet the Agency s Needs: TempTrak is the Environmental Monitoring system currently installed in six of the eight VAMC s and their CBOCS. Due to completed construction and new VA directives regarding environmental monitoring, there are specific area within VISN 15 that do not meet the standards outlined by VA directives and best commercial practices. Topeka and Leavenworth VAMCs will be receiving a complete system under this upgrade, so they meet the applicable directives and be compatible throughout VISN 15.To meet these directives, VISN 15 must upgrade/add to the current TempTrak system. The EM solution shall be compatible with the predominate existing system, TempTrak to leverage past expenditures, installations, training, and experience. The system must:
Remedy Gaps in EM in VISN 15 Currently there are various gaps in EM coverage throughout VISN 15. These gaps are the result of numerous factors such as new VHA Directives 1761 and 1116, new regulatory requirements, changes in best practices, and out of date system implementations. VISN 15 requires enhancements to current EM systems to bring all facilities up to current standards.
Standardization - To establish uniformity in environmental monitoring automation standards by implementing a single technical solution to be utilized by all clinical services and integrated into standard operating procedures (SOPs) at all VISN 15 facilities.
Efficiency - reduce staff hours spent manually monitoring and recording environmental factors.
Effectiveness Automation will provide alerts, reports, trends, and various system automations that current paper systems cannot offer.
Compliance with Directives - To ensure appropriate temperature, relative humidity, air pressure relationship, and air exchanges in designated clinical areas throughout VAMCs and associated CBOCs are monitored and managed in accordance with Veterans Health Administration (VHA) directives.
Compliance with Regulations - To ensure all pharmaceutical, laboratory, and food products throughout VISN 15 VAMCs and CBOCs are stored and maintained in accordance with U.S. Pharmacopoeia (USP), Food and Drug Administration (FDA), College of American Pathologists (CAP), Joint Commission, American Association of Blood Banks (AABB) requirements and all other regulatory agencies.
Maintain EM Objectives - Current VISN 15 EM systems are inconsistently deployed and maintained. This upgrade to the existing system is to streamline the maintenance process to meet new requirements created by new construction, new directives, regulatory requirements and other factors.
The system will include but not be limited to the appropriate numbers of:
NIST Traceable 24V / 0.1 Streamlined Pressure Differential Unit (No Visual Display or On-Device Alarming)
Internal Temperature + Relative Humidity Transmitter
Installation
Base Station - Buffer and Receiver
Signal Repeater
Internal Temperature + Relative Humidity Transmitter
Base Station - Buffer and Receiver
NIST Traceable Solid Simulator Probe 30ft
NIST Traceable Internal / External Transmitter
NIST Traceable Internal Temperature + Humidity Transmitter
Open/Close Contact Transmitter
NIST Traceable 24V /0.1 High Resolution Pressure Differential Monitor
NIST Traceable Non-Armored - Ultra Low, Liquid Nitrogen Probe
NIST Traceable Solid 5ml Vial Simulator Probe
Dishwasher Temperature Transmitter Kit
Installation
TempTrak Enterprise Software License and Remote Installation
Base Station - Buffer and Receiver
900 MHz Signal Repeater
Solid Simulator Probe 6'
Internal/External Temperature Transmitter
NIST Traceable Solid Simulator
NSIT Traceable Internal/External Temperature Transmitter
Internal Temperature + Relative Humidity Transmitter
NIST Traceable Internal Temperature + Humidity Transmitter
NIST Traceable Non-Armored - Ultra Low, Liquid Nitrogen Probe
On-Site Departmental Configuration Assistance and Training
I-Care 24/7 Remote Support
Installation
The estimated award date is June 30, 2019 through April 30, 2020.
Statutory Authority Permitting Other than Full and Open Competition: FAR13.5 Simplified Procedures for Certain Commercial Items: 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); for purchases exceeding the simplified acquisition threshold. The requirements at 13.501(a) apply to sole-source (including brand-name) acquisitions of commercial items conducted pursuant to subpart 13.5.
Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): As detailed in Section 1 above, VISN 15 includes eight VAMC s. TempTrak infrastructure and devices are a major system that is already installed in the clear majority i.e. six of the eight VAMC s and many of their associated CBOC s. In addition to the infrastructure and devices, the system has been programmed to meet those facility s needs, and staff have been trained to manage the TempTrak system. This requirement is an expansion of an existing system. Devices such as temperature probes are proprietary to each manufacturer i.e. TempTrak is the only manufacturer that makes temperature probes that communicate with TempTrak infrastructure. The VHA would be forced to change out all the infrastructure, e.g. receivers, repeaters, servers, etc., that are already installed to change to a different manufacturer s temperature probe or other expansion hardware. The VHA would experience substantial increase of cost from the removal of the current system to a different manufacturer rather than adding to the current system as requested.
Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A sources sought was posted to FBO on March 4, 2019, the responses were due no later than 14 March 2019. The sources sought was issued as a brand name only and business size was unrestricted to determine the set-aside if any can be used. Brand name was specified due to TempTrak proprietary software and no other system is compatible with the existing TempTrak within the facilities. The sources sought included a brief description of the TempTrak capabilities and system overview. Trillamed was the only response to the sources sought besides communicating directly with Cooper-Atkins. Although Trillamed is an SDVOSB and is the only authorized distributor for the manufacturer, based on the market research results, the CO is not confident they will provide fair and reasonable pricing. Therefore, the Veterans First Contracting Program, Rule of Two cannot be met.
Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The price will be determined priced fair and reasonable based on past similar requirement contracts, commercially available catalogue price list through Cooper-Atkins. This solicitation will be full and open competition. Additionally, the government will be asking for additional discounts due to the quantity of products purchased.
Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition through a
sources sought, advising industry of the pending acquisition and soliciting inquiries from interested parties. A query of the VIP dateabase resulted in 6 vendors under the FSC code 6685. However, none listed were authorized distributors. A query on Federal Procurement Data System (FPDS) resulted in similar requirements were awarded to Cooper-Atkins solely prior to mid 2018. Trillamed began receiving awards in late 2018 as they became an authorized distributor. A Query on FBO returned the same results. I found through internet searches that there are a few other manufacturers that offer an environmental monitoring product like Cooper-Atkins. I contacted Cooper-Atkins, regarding authorized distributors, they identified Trillamed as their only authorized distributor. Additionally, Cooper-Atkins also informed me that no other system is compatible with TempTrak.
Based on an analysis of the market research, the contracting officer does not have a reasonable expectation that two or small business concerns owned and controlled by veterans will submit offers and that the award can be made at a fair and reasonable price that offers best value to the United States. Therefore, pursuant to 38 U.S.C 8127(d), the acquisition will not be set aside for veteran-owned small business concerns. Furthermore, market research did not identify two or more small businesses that could fulfill the requirement; therefore, the acquisition will be solicited as unrestricted using brand name.
Any Other Facts Supporting the Use of Other than Full and Open Competition: The current system already in place throughout most of VISN 15 utilizes 900mhz as their wireless platform instead of network WIFI. Surveying the market, network WIFI wireless features the common specifications with other manufacturers. As stated in section 3, TempTrak is already in place in six (6) of the eight
(8) main facilities and associated outlying stations. VISN 15 tried to use the WIFI enabled product and found that with network outages, the system failed. When the network was inoperable for days due to awaiting parts, the environmental system on WIFI was not providing the real time data to ensure patient and staff safety. The 900mhz platform, though old technology, has proved to be more reliable and has less down time. Due to the 900mhz platform and proprietary equipment, only two (2) interested parties have been identified to provide this requirement.
Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Cooper-Atkins and Trillamed LLC.
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: Due to the current TempTrak infrastructure in place and that this requirement is adding to and upgrading, the main barrier in place is the number of distributors for the TempTrak system. Competition is dependent on the number of authorized distributors that Cooper Atkins partners with in the future. The Government will continue to monitor the authorized distributors Cooper Atkins identifies.
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.
3/29/2019
______________________
Mark
Bollinger
VISN 15 Program Manager VISN 15
Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:
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.
Philip A. Bouffard Digitally signed by Philip A.
1674537
Bouffard 1674537
Date: 2019.03.29 07:23:51
-05'00'
Philip Bouffard 3/29/2019
Contracting Officer NCO 15 Contracting
One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.
Paul A. Hemenway
Digitally signed by Paul A. Hemenway 653155
653155
Date: 2019.03.29 08:50:43
-05'00'
Paul Hemenway 3/29/2019
NCO 15 Supply Team Branch Chief NCO 15 Contracting
Director of Contracting (Not required over SAT but exceeding $700K): I certify the justification meets requirements for other than full and open competition.
Loyd D JACKSON 346520
Digitally signed by Loyd D JACKSON 346520
Date: 2019.04.16 10:03:22 -05'00'
{Acting) 16 April 2019
Scott R. Fiscuss Date
Director of Contracting NCO 15 Contracting
VHA SAO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval (if over $68 million) or approve ($700K to $68 million) for other than full and open competition.
Randy L. Hays 534204
Digitally signed by Randy L. Hays 534204 Date: 2019.04.16 10:21:29 -07'00'
Randy L. Hays Date
Acting Executive Director
VHA Regional Procurement Office Central.