P03 J_A.pdf

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

Effective Date: 02/01/2022 Page 1 of 6

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C262-23-AP-7752

1. Contracting Activity: Department of Veterans Affairs, VISN 22, VA Greater Los Angeles Healthcare

System for Purchase Request # 691-23-4-685-0617.

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

This procurement is to establish a new Firm-Fixed-Price contract to procure Equipment Sterilizer Cabinets for VA Greater Los Angeles Healthcare System (GLA) Sterilie Processing Serivce (SPS) in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items. The installation, training, and one (1) year maintenance service for this new equipment are also requested. New Equipment Sterilizer Cabinets purchase is essential for daily operation to obtain adequate sterile storage for Reusable Medical Devices (RMDs). Air Innovations, Inc, a small business, manufactures the Sterile Cabinets that are compatible with the VA Directive for Strage of RMDs and compliant with VA Directive for Temperature and Humidity Controlled units: VA Directive 1116(2); ANSI/AAMI ST79-2006; ANSI/ASHRAE/ASHE Standard 170-2017.

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

VA GLA SPS requires equipment sterilizer cabinets to sterilize, store, and protect Reusable Medical Devices (RMD). There are major temperature and humidity issues throughout the medical facility and CBOCs. Due to these concerning issues, surgical instruments and RMDs must be transferred back to SPS and be sterilized. New equipment sterilizer cabinets will provide proper temperature, humidity, and positive pressure required per VA Directives and AORN Standards. Also newly purchased sterilzer cabinets must be capable to interface with VA Network Environmental Monitoring System via an access port. Equipment Sterilizer Cabinet is essential to prevent delays in providing medical services in the facility with clean instruments being used on Veteran patients. VA GLA SPS also requires the proper installation of newly purchased equipment, training, and one (1) year maintenance service to ensure the using staffs’ safety. The anticipated period of performance will be for 13-17 weeks starting on the date of award. The estimated cost this requirement is $ and below is the breakdown:

CLIN Description Part# Unit Cost QTY UOM Ext. Cost

Air Innovations Sterile Storage including manufacturer part 99C0177-00 -DX (no UV light) and crate with pallet # 10C0081-

SSC4500DX $ 19 EA $

0002 Air Innovations Ceiling heat rejection package SSCHR24 $

6 EA $

0003 Air Innovations Ceiling heat rejection package SSCHR22 $ 13 EA $

0004 Installation/Training from Authorized Technician

SSC4000-

OSAI $ 1 JB $

Effective Date: 02/01/2022 Page 2 of 6

1-year Maintenance for Factory authorized Annual PM contract for 19 SSC cabinets to include all parts listed below, labor, transportation and lodging

SSCPM $ 1 EA $

Total $

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:

( ) Only One Responsible Source 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

(X) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Pursuant to 38 U.S.C 8127 (b), VA Greater Los Angeles Healthcare System’s Sterilizer Cabinet purchase requirement will be awarded to Aldevra, LLC – a certified Service-Disabled Veteran Owned Small Business (SDVOSB) in accordance with FAR 6.302-5 and VAAR 819.7008.

VA GLA SPS requires the new sterilizer cabinet to have following salient characteristics:

- Must provide Ceiling Exhaust Kit to allow venting though a ceiling tile and waste heat from the cabinet can be discharged to the large spaces above the ceiling.

- Must have UV-C light is located above the HEPA filter and floods the filter with intense UV-C rays, which will sterilize airborne viruses and bacteria on the HEPA filter.

- Must have Retransmit Kit to allow remote monitor the temperature, humidity, and pressure of the Sterile Storage Cabinet from another room.

- Must exceed requirements of VA Directive 1116(2); ANSI/AAMI ST79-2006; ANSI/ASHRAE/ASHE

Standard 170-2017. Conforms with UL60601-1.

- Must maintain 66°F to 72°F Temperature.

- Must integral pressure monitoring with alarm.

- Must maintain Humidity at 20% to 60% RH.

- Must have steam humidification utilizing standard demineralized water.

- Must maintain positive pressure +0.03”WC.

- Must meet IEC 60601-1 Medical Standard for Power Supplies.

- Must have 120V hospital grade plug-in-cord.

- Must have cleanable 304 stainless steel payload construction with cleanable white powder coated.

- Must have HEPA Filtration designed to exceed ISO 6 Cleanliness.

- Must have ducted heat exhaust.

- Must have 230 air changes per hour or better.

Effective Date: 02/01/2022 Page 3 of 6

- Must have UV-C light available.

- Must have integrated condensate control system.

- Must be capable to interface with VA network environmental monitoring system via an access port.

The small business named Air Innovations, Inc. manufactures Sterilizer Cabinets that meet all salient characteristics. The Air Innovaiton Sterile Storage Cabinet is manufactured using hospital grade 304 stainless steel for the interior payload. The cleanable white power coated storage cabinet is designed to control temperature, humidity, pressure, and cleanliness. Integrated cooling and steam humidifiers maintain temperature and humidity conditions within the chamber to meet desired set point conditions.

Aldevra, LLC is the only authorized distributor for the Air Innovations Sterile Storage Cabinets. The authorized dealer letter/agreement is uploaded on eCMS briefcase.

Aldevra, LLC is a ceritifed Service Disabled Veteran Owned Small Business (SDVOSB).

Vendor, Aldevra, LLC, is:

1. Determined to be a responsible source with respect to performance of such contract opportunity;

2. Considered to have a successful record of providing equipment/performing service to several VA medical centers at a fair and reasonable price; and

3. This requirement is valued under $5 Million.

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

SBA VetCert was utilized to survey SDVOSB and VOSB under the NAICS Code 339113 – Surgical Appliance and Supplies Manufacturing. SAM.gov and FPDS were utilized to study the similar past procurements and its procurement method. VA National Acquisition Center (NAC) MedSurg Catalog was reviewed to check if there are any mandatory contracts for the requested supplies/services.

Details of conducted market research findings are described under #8.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable:

Contracting has verified multiple contracts have been awarded to Aldevra, LLC through adequate competition in the past for Sterilzer Cabinets that are below SAT; verified through FPDS.

CS discovered the past procurement contract# 36C26122P1645 procured by NCO 21 for VA Pacific Islands Healthcare System along with the Intent to Sole Source notice# 36C26122Q0978 on SAM.gov. Per the intent to sole source notice, the identical Sterile Storage Cabinet Models including its accessories and services (installation, training, and 1-year maintenance) were procured at the total of $ for a total of five (5) cabinets, which makes an equivalent cost $ per unit. VA GLA’s anticipatd cost stands at $ for nineteen (19) cabinets; meaning $ per unit. Detailed line item costs comparison was not appropriate as FPDS record only indicate total contracted price. The current pricing per unit is actually cheaper than the previous purchase due to bulk discounts.

Effective Date: 02/01/2022 Page 4 of 6

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

SBA VetCert identified 850 potential SDVOSB and VOSB under NAICS code 339113 – Surgical Appliance and Supplies Manufacturing.

CS discovered the notice ID# 36C24123Q0920 on SAM.gov for Sterile Storage Cabinets for White River Junction Medical Center under VISN 01. This notice also included the Justification for Single Source Award over Micro-Purchase Threshold but below Simplified Acquisition Threshold stating that the Air Innovation Sterile Stroage is the compatible sterile storage with VHA Directives for RMDs. This single source justification stated that there were zero (o) firms expressed interest in satisfying the requirement.

FPDS was also utilized to find similar past procurements, and multiple awards were made to Aldevra, LLC in 2022 for Air Innovations Sterile Storage Cabinets, but identified past procurements’ contract value were under the SAT ($250K). The notice# 36C26122Q0978, an intent to sole source, was discovered on SAM.gov for Contract# 36C26122P1645, but CS concluded there were no other interested vendors as the final award was made to Aldevra, LLC and there was only 1 offer received per FPDS record. CS was able to compare the unit price based off the total awarded cost with the previous contract# 36C26122P1645 as described under #7. Identified past procurements through FPDS search have been uploaded to eCMS briefcase under meta-tag P02.

Sterile Storage Cabinets are considered medical equipment. Hence VA National Acquisition Center MedSurg Catalog was searched using the key-word ‘sterile storage cabinets’; however, there were no active items available.

VA Greater Los Angeles Healthcare System also contacted Aldevra, LLC to estimate the Independent Government Cost Estimate (IGCE). CS also contacted Aldevra, LLC to verify the initial quote. Aldevra, LLC also holds Multiple Award Schedule # GS-07F-175AA along with 36F79723D0090 under 65 II A – Medical Equipment and Supplies. However, Aldevra, LLC confirmed the requested Air Innovation Sterile Storage Cabinets, and its services are not currently under FSS/MAS contracts.

An Intent to Sole Source shall be posted on SAM.gov for at least 5 business days to survey if there are any other potential contractors that have capability to provide the supplies and services.

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

Aldevra, LLC is a certified Service Disabled Veteran Owned Small Business (SDVOSB) – verified through a SBA VetCert web-portal. Screenshots of this verification have been uploaded to eCMS briefcase meta-tagged S11.1 and S20.1. VAAR 819.7008 and VAAR 819.7009 allow sole source awards to verified Service-Disabled Veteran-Owned Small Businesses.

1. The anticipated award price of the contract is not exceeding $5 Million;

2. The requirement will be synoposied and the required Justification pursuant to FAR 6.302-

5(c)(2)(ii) will be posted in accordance with FAR Part 5 along with the Intent to Sole Source on SAM.gov for more than five (5) business days;

3. The SDVOSB has been determined to be a responsible contractor with respect to performance; and

4. In the estimation of the contracting officer contracted award can be made at a fair and reasonable price that offers best value to the Government.

Effective Date: 02/01/2022 Page 5 of 6

Therefore, it is recommended that Sterilizer Cabinets required by VA GLA SPS to be sole sourced to SDVOSB, Aldevra, LLC, per VAAR 813.106-70(c) which allows contracting officers to use other than competitive procedures to enter into a contract with a verified SDVOSB or VOSB for procurements above simplified acquisition thredshold, as authorized by FAR 6.302-5, VAAR 806.302-570(a) and (c).

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

Aldevra, LLC 3707 S Westnedge Avenue Kalamazoo, Michigan 49008-2979

UEI: WF95AG13LN37

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:

The Department of Veterans Affairs will continue to survey the marketplace for ‘equal to’ or better Sterile Storage Cabinets that will offer Veterans the most up to date care.

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.

Program Manager Sterile Processing Service VA Greater Los Angeles Healthcare System

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.

Contracting Officer Branch Chief, Supply Team 4

NCO 22

Effective Date: 02/01/2022 Page 6 of 6

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Division Chief

NCO 22