36C24720Q0407-000.docx

Attachment 2: Combined Synopsis/Solicitation for Commercial Items Template Contract Opportunity Combined Synopsis/Solicitation Notice

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DAYS AFTER THE RESPONSE DATE

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SET-ASIDE

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CONTRACTING OFFICE

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ADDITIONAL INFORMATION

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* = Required Field Contract Opportunity Combined Synopsis/Solicitation Notice FT10 Electrosurgical Unit 30084 36C24720Q0407 04-13-2020 N

SDVOSBC

339112 Department of Veterans Affairs VISN 7 Network Contracting Office LaVista Business Park - Bldg A 2008 Weems Road Tucker GA 30084 Richard Bogle Department of Veterans Affairs LaVista Business Park – Bldg. A 2008 Weems Road Tucker, Georgia 30084 Department of Veterans Affairs Charlie Norwood VAMC 1 Freedom Way / 950 15th St.

Augusta, GA 30904 30904

USA

richard.bogle@va.gov richard.bogle@va.gov

COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS

General Information

Contracting Office Address NCO 7 / Atlanta Commodity Team U.S. Department of Veterans Affairs LaVista Business Park – Bldg. A 2008 Weems Road Tucker, Georgia 30084 Description This is an open-market combined synopsis/solicitation for FT10 Electrosurgical Units (ESUs) as defined herein prepared in accordance with Federal Acquisition Regulation (FAR) subpart 12.6, as supplemented with additional information included in this notice. The Department of Veterans Affairs, Veterans Network Contracting Office (NCO7) has a requirement to provide the Charlie Norwood VAMC OR/Cath Lab with ten (10) portable FT10 Electrosurgical Units (ESUs). This announcement constitutes the only solicitation for proposals, a written solicitation document will not be issued. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2020-04 and VAAR Update 2018-19 rev.

The associated North American Industrial Classification System (NAICS) code for this procurement is 339112, with a small business size standard of 1000.

Services Provide Charlie Norwood VAMC OR/Cath Lab with ten (10) portable Electrosurgical Units (ESUs). The contract will require the vendor site assembly and installation services necessary to facilitate assembly, install, configuration, and implementation of all new ESUs.

This procurement contract will include all preparation and planning, labor, travel, and parts required to install and implement all ESUs. This includes, but not limited to, installation of new hardware onto roll stands, installation of all necessary foot pedals (bipolar/monopolar), initial inspection and configuration of new ESUs, and installation of any required supportive equipment.

This procurement contract will include End-User training for Operating/Cath Lab Staff for how to use the newly provided ESUs. This procurement contract will provide Biomedical Equipment Support Specialists (BESS) with training on how the newly provided ESUs work and how to support them.

The ESU systems shall be able to meet any technical and clinical elements, specific tasks, and terms and conditions included in the SOW for this procurement. Prospective Contractors shall be able to meet any clinical elements, specific tasks, or terms and conditions included in the SOW for this procurement.

Contract Type: The award will be firm fixed price.

This action is being executed as a 100% set-aside for Service-Disabled Veteran Owned Small Business (SDVOSB) concern. Per VAAR clause VAAR 852.219-11(b)(1) VA Notice of Total Veteran-Owned Small Business Set-Aside, and in accordance with 38 USC 8127(d) Veterans First Contracting Program and VAAR 852.215-70 Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors. Offerors must be listed on the VETBIZ website as an SDVOSB or VOSB and System for Award Management System (SAM) and completion of Reps and Certs in the SAM system prior to award at www.sam.gov for consideration.

Bases of Award

The bases of award shall be made utilizing lowest price technically acceptable (LPTA). Offer’s not deemed technically acceptable will be removed from further consideration of the contract award. See Attachment B.

Instructions to Offerors–Commercial Items / Evaluation Criteria

All interested companies shall provide a separate Technical Proposal and Pricing Schedule.

The government intends to award a contract as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. To facilitate the award process, all proposals must include a statement regarding the terms and conditions herein as follows:

"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

offeror shall list exception(s) and rationale for the exception(s).

Proposals shall remain valid for 60 days unless otherwise expressly stated on the proposal. Submitted proposals shall list two points of contacts including name, phone number, and email address.

The government will consider technical capability, past performance, and price. The government will evaluate information based on the following evaluation criteria: (1) technical capability factor "meeting or exceeding the requirement, (2) past performance, and (3) price. FAR 52.212-2, “Evaluation–Commercial Items,” explain the specific evaluation criteria to be included in paragraph (a) of that provision.

All contractual questions must be in writing (e-mail) regarding this solicitation and should be forwarded by 04/06/2020 at 3:00 PM EST via e-mail to the Contracting Officer Richard Bogle, at richard.bogle@va.gov.

Submission shall be received not later than 04/13/2020 at 1:00 PM EST. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). E-mailed offers will be accepted.

Attachments

Attachment A: For the Statement of Work (SOW).

Attachment B: For Technical Eval Factors and Bases of Award.

Attachment C: For Salient Characteristics

Attachment D: For the FAR provisions and clauses or they may be accessed electronically at http://acquisition.gov/comp/far/index.html.

Point of Contact Richard M. Bogle Contracting Officer richard.bogle@va.gov

STATEMENT OF WORK (SOW)

Charlie Norwood VA Medical Center (CNVAMC) as of February 9, 2020

1. Contracting Officer’s Representative (COR):

2. Contract Title: Procurement of replacement Electrosurgical Units (ESUs) for CNVAMC OR/Cath Lab.

3. Background: CNVAMC OR/Cath Lab Service currently has approximately nine (9) ESU systems for 9 operating rooms and one Cath lab. The current ESUs are Covidien/Medtronic, Inc. The ESU units are end of production and will be going end-of service life soon. The devices are currently seven years old, but since they are end of production and CNVAMC needs to prepare for replacement.

CNVAMC OR/Cath Lab Service is aiming to replace the existing ESUs with newer units that are more reliable and elegant in terms of hardware setup. OR/Cath Lab Service is looking to expand the number of beds with ESUs to ten (10).

Scope: This contract is to provide CNVAMC OR/Cath Lab with ten (10) portable ESUs. This contract will require any vendor site assembly and installation services necessary to facilitate assembly, install, configuration, and implementation of all new ESUs.

This procurement contract will include all preparation and planning, labor, travel, and parts required in order to install and implement all ESUs. This includes, but is not limited to, installation of new hardware onto roll stands, installation of all necessary foot pedals (bipolar/monopolar), initial inspection and configuration of new ESUs, and installation of any required supportive equipment.

This procurement contract will include End-User training for Operating/Cath Lab Staff for how to use the newly provided ESUs. This procurement contract will provide Biomedical Equipment Support Specialists (BESS) with training on how the newly provided ESUs work and how to support them.

The ESU systems shall be able to meet any technical and clinical elements, specific tasks, and terms and conditions included in the SOW for this procurement. Prospective Contractors shall be able to meet any clinical elements, specific tasks, or terms and conditions included in the SOW for this procurement.

4. Technical and Clinical Elements:

i. The proposed ESUs shall be 110 / 120 V (60 Hz) operating devices (no exceptions). Proposed ESUs shall have hospital grade NEMA 5-15 power cords.

ii. The proposed ESUs shall support the following operational modes:

a) Monopolar Cut (Pure and Blend)

b) Monopolar Coag (Soft, Fulgurate, and Spray)

c) Bipolar (with low, medium, and high effects)

d) LigaSure tissue fusion

e) Valleylab Mode

iii. The proposed ESUs shall have the follow capabilities and or meet the following technical specifications:

a) Proposed ESUs shall have two monopolar instrument receptacles. Shall have both a bipolar and a LigaSure bipolar receptacle. ESUs shall have two monopolar foot-pedal receptables as well as a bipolar and LigaSure bipolar receptacles.

b) Shall have a touchscreen display on the energy control platform / device.

c) Proposed ESUs shall have audio tones for each operation mode while activated (minimum 40 dBA, maximum 70 dBA).

d) Proposed ESUs shall have a receptacle to support ECG blanking and smoke-evacuation control.

e) Proposed ESUs shall have an auto bipolar feature that allows the device to start or stop bipolar RF energy based on detection of impedance between bipolar electrodes.

f) Proposed ESUs shall be able to automatically sense tissue resistance. ESUs, based on detected resistance, shall be able to adjust output voltage to maintain desired effect when passing across tissues with different resistance levels.

g) Proposed ESUs shall be compatible with Covidien monopolar, bipolar, and LigaSure instruments (no exceptions).

h) Shall be able to work with LigaSure advanced energy devices (no exceptions).

i) Proposed ESUs shall have 8 GB storage capacity.

j) Proposed ESUs shall be able to meet the following Output powers:

i. Monopolar Pure: 300 W

ii. Monopolar Blend: 200 W

iii. Monopolar Valley Lab Mode: 200 W

iv. Monopolar Coag Fulgurate: 120 W

v. Monopolar Coag Spray: 120 W

vi. Bipolar Low: 15 W

vii. Bipolar Medium: 40 W

viii. Bipolar High: 95 W

ix. LigaSure: 20 W

iv. CNVAMC shall not require the purchase of any new disposables / consumables in order to utilize the proposed ESUs (shall be able to utilize any currently stocked disposables / consumables).

v. Proposed ESUs shall have / be delivered with the following:

· Energy Output Platform

· Portable Cart

· Monopolar footswitch

· Bipolar footswitch

· Monopolar adapter.

vi. Offering Contractors shall accept trade-in (and provide trade-in credit) for nine (9) existing Force Triad ESUs.

vii. Biomedical training shall be provided for three Biomedical Equipment Support Specialists.

5. Specific Tasks:

i. The Contractor shall be responsible for installing all provided ESU systems. Contractor shall coordinate with OR, Cath Lab, and Biomedical Engineering staff regarding installation schedule.

ii. Contractor shall provide training to end-users for how to use and setup the newly provided ESUs.

iii. Contactor shall provide training to Biomedical Technicians for how the newly provide ESUs work and how to service / maintain them.

iv. Contractor is responsible for testing all provided ESU systems to ensure they are functioning properly prior to acceptance of work and equipment by VA.

v. A one-year warranty that includes all parts and labor is required. Vendor telephone support shall be free of charge.

vi. Contractor is responsible for configuring all ESUs so they are customized to meet the needs of CNVAMC end-users.

vii. The Contractor shall provide the new ESU systems as required in the PO within 45 days after receipt of order and ship to CNVAMC.

viii. Offering vendor shall provide documentation regarding cleaning requirements for the proposed ESU devices. A list of approved cleaners shall be provided.

6. Terms and Conditions:

i. The Contractor shall only invoice for the total amount agreed to on this procurement contract. The Contractor shall not conduct any work not included within this SOW / provided by the original pricing of this contract, including but not limited to labor, travel, parts provision, and shipping. If any additional services or equipment is necessary, the Contractor shall contact the Contracting Officer (CO) and Contracting Officer Representative (COR) immediately. The Contractor shall be liable for any work conducted (or equipment provided) outside the scope of this SOW (original order) without approval from the CO.

ii. The offering vendor shall provide details of the proposed ESUs clinical and technical alarms.

iii. Switches and controls of the proposed ESUs should be protected against accidental setting changes (e.g., due to someone brushing against the panel / screen). Device design should prevent misinterpretation of displays and control settings. The controls (i.e., switches, knobs, etc.) should be visible and clearly identified, and their functions should be self-evident.

iv. The offering vendor certifies that the proposed ESUs shall withstand normal hospital power interruptions, including generator testing, without manual intervention and that normal device operation will be restored automatically, without loss of data, once power is restored. The offering vendor shall specify and provide power conditioning if required.

v. The offering vendor shall confirm that the performance of the proposed ESUs shall not be affected by EMI radiated or conducted through the power lines from another device.

vi. The offering vendor shall provide a listing of all Recalls, Safety Alerts, and Field Engineering Change notices pertaining to the proposed ESUs over the past 12 months.

vii. Cleaning and disinfecting protocols for the proposed ESUs shall be provided and demonstrated to staff by the offering vendor. A list of acceptable cleaning and disinfecting chemistries shall be included with the purchase of the proposed ESUs.

viii. The offering vendor shall provide two copies of all service literature, including any necessary service and maintenance software, keys, and or passwords (in accordance with: 21-CFR 820.170(a), NFPA99 (2012 edition) Chapter 10.5.3, VAAR 852.211-70, and the VA NAC AS3000 clause).

ix. All work shall be performed in a professional manner by an authorized service representative. If any deficiencies are found due to negligence of the service representative, the contractor shall be required to correct the deficiency to a fully operational status in accordance with manufacturer specifications at no additional cost to the Veteran Affairs (VA).

x. The contractor shall be able to read, write, speak and understand English. All contractor representatives shall be sufficiently fluent in the English language to effectively communicate with Charlie Norwood VA Medical Center’s representatives.

xi. The contractor shall present a neat appearance commensurate with that required of a professional. Contractor personnel shall comply with medical treatment facility policies regarding personal appearance and conduct.

xii. The contractor is required to report to Biomedical Engineering Section office, Bldg. 801, Room 1B162, and sign in, and obtain an ID badge for repairs or services required during/after normal working hours. If unable to check in with Biomedical Engineering Section office, Bldg. 801, Room 1B162, then the contractor needs to check in with VA Police Office.

xiii. Repairs that cannot be performed at the VA site may be performed at the contractor’s site provided the POC approves removal of the equipment. In accordance with VA Handbook 6500.1, Electronic Media Sanitization, equipment that has removable media (i.e. Hard Disk Drives; USB devices; etc.) shall be removed prior to equipment leaving VA premises for repair. The contractor’s representative shall sign a receipt for the equipment. The repaired equipment shall be returned to the original premises within two (2) working days or the contractor shall provide a temporary replacement at no additional cost to the VA.

xiv. Safety shall be performed in accordance with NFPA 99, Chapter 7. This regulation can be reviewed in full text at the Biomedical Engineering Section. When required, the contractor’s service representative shall comply with the Occupational Safety and Health Administration lockout/tagout standards while performing maintenance on equipment. The VA and the contractor’s service representative shall exchange hazard communication information before the commencement of any repair.

xv. All correspondence, service reports and invoicing shall be in English and clearly legible.

xvi. The use of cellular phones and 2-way radios is expressly forbidden in certain areas of Medical Treatment Facilities and Health Clinics. The contractor shall not use cellular phones or radios in these areas. (i.e. Direct patient care areas, etc.).

xvii. Smoking Policy Enforcement: Smoking is prohibited within Charlie Norwood VA Medical Center and its clinics and within 15 meters of any building.

7. Performance Monitoring:

i. Contact with the vendor will continue after the equipment is purchased and setup to ensure systems are working correctly. Biomedical Engineering and representatives from OR/ Cath Lab will ensure that the ESU systems are setup correctly and working properly as part of the acceptance process.

ii. Impaired Contractor personnel: At any time during the performance of this contract, the Contracting Officer, Contracting Officer Representative (COR) or Director of the medical treatment facility may direct the contractor to immediately remove any contractor employee whose actions or impaired state raises reasonable suspicion that clear and present danger of physical harm exists to a patient, medical treatment facility personnel and equipment or to the impaired individual. This provision shall be used in emergency situations only and not for the purpose of bringing performance issues or other non-urgent concerns to the attention of the contractor.

8. Security Requirements:

No ePHI or ePII is involved in this contract. Vendor shall follow all rules set forth by CNVAMC regarding on-site installation and setup.

9. Invoicing

i. Invoices shall be submitted electronically in arrears to the address indicated VA FSC P.O. Box 149971 Austin Texas 78714. Please reference the Purchase Order Number (i.e. 509-A0000 or 509-C75…)

ii. Payment will be made upon receipt of a properly prepared, itemized invoice, validated by the COR, and submitted electronically.

iii. A proper invoice will contain:

· Contractor’s Name and Address

· Accurate Purchase Order Number

· Dates of performed services

· Total Amount Due

· Location of Service Performed

10. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).

N/A

11. Other Pertinent Information or Special Considerations:

a. Identification of Possible Follow-on Work.

N/A

b. Identification of Potential Conflicts of Interest (COI).

No potential conflicts of interests have been identified.

c. Identification of Non-Disclosure Requirements:

N/A

d. Packaging, Packing and Shipping Instructions.

N/A

e. Inspection and Acceptance Criteria.

Biomedical Engineering will ensure all hardware and software is setup correctly and working properly as part of the acceptance process. Biomedical Engineering will consult with OR / Cath Lab about any potential issues before completing the acceptance process.

12. Risk Control:

N/A

13. Place of Performance:

The work will be performed at Charlie Norwood VA Medical Center Downtown, located at 950 15th Street, Augusta, GA 30901.

Services to be acknowledged by, service reports to be sent to and invoices to be acknowledged by:

14. Period of Performance:

N/A

15. Delivery Schedule:

N/A

BASIS OF AWARD

CNVAMC Electrosurgical Unit (ESU) Procurement / Replacement

OFFEROR’S QUALIFICATIONS:

Award will be made to the Best Value offer. Offers shall meet technical acceptability evaluation criteria below:

**ALL factors must be rated ACCEPTABLE to be considered for award.

Technical Factors:

a) ESU System Operation Modes: Provided ESU systems shall be able to support the following operational Modes:

f) Monopolar Cut (Pure and Blend)

g) Monopolar Coag (Soft, Fulgurate, and Spray)

h) Bipolar (with low, medium, and high effects)

i) LigaSure tissue fusion

j) Valleylab Mode

b) ESU Features and Capabilities: Provided ESUs shall have all following features and capabilities as detailed in SOW part 5, section iii.

i. Shall have touchscreen display.

ii. Shall be able to work with LigaSure advanced energy devices (no exceptions).

iii. Shall have audio tones for each operation mode while activated (minimum 40 dBA, maximum 70 dBA).

iv. Shall have a receptacle to support ECG blanking and smoke-evacuation control. Shall have two monopolar instrument receptacles, one bipolar instrument receptacle, one LigaSure receptacle.

v. Shall have foot-pedal receptacles to support two monopolar instruments, one bipolar instrument, and one LigaSure instrument.

vi. Shall have auto bipolar feature that can start or stop device based on detection of impedance between bipolar electrodes.

vii. Shall have ability to automatically detect tissue resistance and adjust output voltage accordingly to help keep desired effect consistent across tissues that have different resistance levels.

viii. Shall be compatible with Covidien monopolar, bipolar, and LigaSure instruments.

ix. Shall be compatible with any existing consumables and or disposables currently used and stocked by CNVAMC.

x. Shall have 8 GB storage capacity.

c) Specific Hardware and Accessory Requirements (ESUs need to be provided with the following):

· Energy Output Platforms

· Portable Carts

· Monopolar footswitches

· Bipolar footswitches

· Monopolar adapters.

d) Contractor Capability / Installation Services:

i. Contractor shall be responsible for installing, configuring, testing, and implementing all provided ESU systems.

e) Education: Contractor shall be able to provide training to end-users for how to use and setup the newly provided ESUs.

f) Warranty: Contractor shall be able to provide 1-year parts and labor warranty for all hardware and software components provided. OEM telephone support shall be included in the warranty.

Acceptable ALL of the minimum acceptable criteria are clearly met by the proposal. The offerors proposal meets the technical capability requirements defined in the SOW.

NOTE: Once the proposals have been determined to be "technically acceptable," award will based on cost/price only.

Unacceptable

Not all of the minimum acceptable criteria are met by the proposal. An unacceptable proposal contains one or more deficiencies. Proposal fails to meet specified minimum technical capability requirements defined in the SOW.

The following table will be used for each proposal received to score each Best Value factor as to whether it is Acceptable or Unacceptable.

Technical Factors Offeror Technically Acceptable

A. ESU System Operation Modes

B. ESU Features and Capabilities:

C. Specific Hardware and Accessory Requirements:

D. Contractor Capability / Installation Services:

E. Education:

F. Warranty

Relevant Experience/Past Performance: The Relevant Experience/Past Performance evaluation will assess the relative risks associated with offeror’s likelihood of success in performing the requirement as indicated by that offeror’s record of Relevant Experience/Past Performance.

Offeror must provide at least two (2) customer of reference which shall demonstrate relevant past performance. These references shall contain name, address of facility, contact name, phone number, dates of service, and contract number, if applicable. The experience shall be of similar size and scope.

*** One Customer Reference shall be a VA Medical Center

Specifications and Salient Characteristics for The FT10 Electrosurgical Unit (ESU) Energy Platform Characteristics:

· Touch Screen Display

· Dimensions: 7”” x14.5” x 18.2”

· Weight: 22.3 lb.

Environment Operating Parameters:

· Operational Temp Range: 50 – 104 F

· Transport / Storage Temp Range: 14 – 104 F

· Relative Humidity for Operation: 20% to 75%

· Power: 100-120 VAC Storage Capacity: 8 GB Operational Modes:

k) Monopolar Cut (Pure and Blend)

l) Monopolar Coag (Soft, Fulgurate, and Spray)

m) Bipolar (with low, medium, and high effects)

n) LigaSure tissue fusion

o) Valleylab Mode Technical Characteristics and Functional Capabilities:

· Support / Integration with Smoke Evacuator devices.

· Audio tones for all operational modes while activated.

· Auto-bipolar feature

· Ability to automatically adjust output voltage based on detected tissue resistance values.

· Compatibility with Covidien monopolar, bipolar, and LigaSure instruments.

Basic Hardware per System:

· Energy Output Platform

· Portable Cart

· Monopolar footswitch

· Bipolar footswitch

· Monopolar adapter.

Set-Up: Offering vendor needs to provide all installation.

Warranty: 1-year warranty

CONTRACT CLAUSES

52.204-7 System for award Management

52.209-6 Protecting the Government’s Interest when Subcontracting with contractors Debarred, Suspended, or Proposed for Debarment (OCT 2015)

52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (OCT 2018)

52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (DEC 2019)

52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

52.225-25 Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran – Representation and Certifications 52.232-33 Payment by Electronic funds Transfer-System for Award Management (OCT 2018) 52.232-39 Unenforceability of Unauthorized Obligations 52.232-40 Providing Accelerated Payments to Small Business Subcontractors 52.233-4 Applicable Law for Breach of Contract Claim 52.247-34 F.O.B Destination

52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2020) VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED SMALL BUSINESS EVALUATION FACTORS (OCT 2019)

VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019)

VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE (JUL 2018)

VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

VHAPM Part 813.106-1/2 SAP: Soliciting Competition & Evaluation of Quotations/Offers Page 19 of 19 Original Date: 10/12/17 Revision 01 Date: 01/08/18