36C25720Q0690-001.pdf

Attachment 2: Combined Synopsis/Solicitation for Commercial Items Template

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

COMBINED SYNOPSIS/SOLICITATION FOR

COMMERCIAL ITEMS

General Information

Document Type: Combined Solicitation/Synopsis

Solicitation Number: 36C25720Q0690 15 May 2020 24 May 2020

SDVOSB

339112

Posted Date:

Original Response Date:

Product or Service Code:

Set Aside (SDVOSB/VOSB):

NAICS Code:

Contracting Office Address

Network Contracting Office 17, San Antonio, TX – Supply I

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation;

quotations are being requested, and a written solicitation document will not be issued.

This solicitation is a request for quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-101 10-26- 2018. This solicitation is being requested as Brand Name or Equal IAW

FAR 52.211-6.

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

The VA Olin E. Teague Veterans Medical Center Logistics office is seeking to purchase Portable MRI Ventilator.

All interested companies shall quotations for the following:

Original Date: 10/12/17

Schedule of Supplies

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

2.00 EA

HAMILTON-MR1 GOVERNMENT PACKAGE

LOCAL STOCK NUMBER: 161010

HAMILTON-MR1 Adult/Pediatric Configuration

LOCAL STOCK NUMBER: 161885

1.00 EA

HAMILTON-C3/C2/C1/T1/MR1 Battery Calibrator w/ Cord

LOCAL STOCK NUMBER: 3691040

HAMILTON MR1 Option Trends/Loops

LOCAL STOCK NUMBER: 161072

HAMILTON-MR1 Transport Kit

LOCAL STOCK NUMBER: 161140

HAMILTON MR1 Option DuoPAP/APRV

LOCAL STOCK NUMBER: 161071

HAMILTON MR1 Option NIV/NIV-ST

LOCAL STOCK NUMBER: 161073

HAMILTON-MR1 Dual E-Cylinder Tank Holder (WT Farley)

LOCAL STOCK NUMBER: MRI-PM2E-H

GRAND TOTAL

Delivery shall be provided 30 – 90 days ARO FOB Destination. The contractor shall deliver line all line items to the following address:

Original Date: 10/12/17

VA Olin E. Teague Veterans Medical Center 1901 Veterans Memorial Drive Attn: Warehouse Temple, TX 76504

Award shall be made to the offeror whose quotation is the lowest price technically acceptable. The government will evaluate information based on the following evaluation criteria: price, delivery, and technical acceptability.

Price – This the total amount of the offeror’s quotation to include all items listed on the schedule of supplies and any charges for shipping/handling (starting Page 1 of this RFQ).

Delivery – This is the offeror’s ability to deliver the equipment within 30 – 90 days ARO.

Technical acceptability – This is the offeror’s ability to provide equipment in accordance with the following salient characteristics:

STATEMENT OF WORK

MRI Ventilator A. Introduction/Background The Central Texas Veterans Health Care System (CTVHCS), has a requirement for procurement and maintenance of two (2) MR1-compatible Ventilators for the for the Respiratory Section of Medical Service located at 1901 S. Veterans Memorial Drive, Temple, Texas 76502. CTVHCS currently has one MR1-compatible ventilator. Once a year, scheduled maintenance is completed. Scheduled maintenance generally lasts about two months.

During maintenance periods, patients with ventilators are transferred to a private facility if they require MRI scans.

B. Objectives The CTVHCS aims to minimize patient transfers, to private facilities, by acquiring two (2) new ventilators. One for regular use, and one for use when primary ventilator is undergoing maintenance.

C. SCOPE OF WORK:

The vendor shall lightweight, portable ventilators that meet the fundamental needs of the facility and all requirements listed in the SOW and elsewhere herein. Pricing shall be all inclusive for this procurement, which shall include all equipment, training and installation.

Clinical Training: The vendor shall provide on-site training for clinical staff that covers weekday and weekend shifts 7:30 am-8 pm and 7:30 pm-8 am. The training should cover at least two weeks to include staff on annual leave. The Vendor shall provide availability of 24hr phone support.

Biomedical Training: The vendor shall provide an in-house training of service engineers and at a minimum of 2 Biomedical Engineering Support Specialists. This training shall be equal to the

Original Date: 10/12/17 training provided by the manufacturer to their service personnel (to include calibration, maintenance, and repair of the entire system purchased).

Warranty: One-year parts and labor with extended options available.

D. TECHNICAL REQUIREMENTS

• MR conditional up to 50ml,

• Telsa Spy Gaussmenter

• ≥ 9 hours of battery operating time

• Independent air supply

• Non-invasive ventilation and high oxygen flow

• ≥ 30 monitoring parameters

• Real time waveforms of paw, flow, and volume

• 100 to 240 V AC -15%/+10%, 50/60 Hz

• Store and display up to 1,000 events with date and time stamp follow up.

• Automatic response to leaks and configurable trigger sensitivity.

• Inspiratory leakage up to 85/min and expiratory leakage up to 40/min.

• Has stand and optional handle

• Include training for Bio-Medical staff,

• Technical manuals or keys for staff training

• Low/high minute volume for use in MRI suite, with high/low pressure, and low/high tidal volume, and low/high apnea time with low/high oxygen flow.

• Magnetic field sensors that measure static magnetic field, even when ventilator is turned off.

• Cylinder holder, auto-lock brake, universal mount hand and quick locking mounting plate that is aligned corrected on ventilator.

• Oxygen 280 to 600 kPa (41 to 87 psi), V´max 200 l/min with an integrated blower, peak flows 260 minute.

• Real-time visualization of the lungs with representations of tidal volume, lung compliance, resistance, and patient activity, visual representation of ventilator dependence, grouped into oxygenation, CO2 elimination, and patient activity, graphic display of target and current parameters for tidal volume, frequency, pressure, patient activity, and minute ventilation.

E. Security

C&A requirements do not apply, and a security Accreditation Package is not required.

F. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

The Certification requirements do not apply and a security accreditation package is not required.

Original Date: 10/12/17

G. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

A contractor/subcontractor shall request logical (technical) or physical access to VA information for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

H. VA INFORMATION CUSTODIAL LANGUAGE

1. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

2. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

3. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA.

Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

4. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

5. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve

Original Date: 10/12/17 electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

6. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

7. The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

I. SURRENDER OF HDD AND MEDIA SANITIZATION PROCEDURES

Contractor will be required to remove HDD for disposal by approved Central Texas Veterans Health Care System methods.

J. SECURITY INCIDENT INVESTIGATION

1. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

2. To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

K. LIQUIDATED DAMAGES FOR DATA BREACH

1. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. However, it is the policy of VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency.

2. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated

Original Date: 10/12/17 with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis.

Failure to cooperate may be deemed a material breach and grounds for contract termination.

3. Each risk analysis shall address all relevant information concerning the data breach, including the following:

(a) Nature of the event (loss, theft, unauthorized access);

(b) Description of the event, including:

(i) date of occurrence;

(ii) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

(c) Number of individuals affected or potentially affected;

(d) Names of individuals or groups affected or potentially affected;

(e) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;

(f) Amount of time the data has been out of VA control;

(g) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

(h) Known misuses of data containing sensitive personal information, if any;

Assessment of the potential harm to the affected individuals

(i) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

(k) Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(i) Notification;

(ii) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

(iii) Data breach analysis;

(iv) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

(v) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

(vi) Necessary legal expenses the subjects may incur to repair falsified or

Original Date: 10/12/17 damaged credit records, histories, or financial affairs.

The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

The following solicitation provisions apply to this acquisition:

1. FAR 52.212-1, “Instructions to Offerors–Commercial Items”

2. FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items”

Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items.” If paragraph (j) of the provision is applicable, a written submission is required.

The following contract clauses apply to this acquisition:

• FAR 52.212-4, “Contract Terms and Conditions–Commercial Items”

• FAR 52.212-5, “Contract Terms and Conditions Required to Implement Statutes or Executive

All questions related to this acquisition shall be submitted via email to matthew.lee5@va.gov. All questions are to be received no later than 1159PM CST 19 May 2020.

Quotes shall be submitted via email to matthew.lee5@va.gov. All quotes and additional required documentation are to be received no later than 1159PM CST 24 May 2020.

For information regarding this solicitation please contact:

Matt Lee Contract Specialist

(210) 694-6337 matthew.lee5@va.gov http://acquisition.gov/comp/far/index.html https://www.sam.gov/portal mailto:matthew.lee5@va.gov mailto:matthew.lee5@va.gov mailto:matthew.lee5@va.gov

Original Date: 10/12/17