DRAFT SOO - Anesthesia Test Equipment_v20260213.pdf

STATEMENT OF OBJECTIVES (SOO)

Testing Equipment for Anesthesia Related Medical Equipment

Michael E. DeBakey VA Medical Center

1. Program Objective

1.1. Contractor shall furnish and deliver all required equipment, accessories, and related components necessary to provide brand name only IMT.Analytics Biomedical Test-sets of CITREX H5 Mobile and Ventilation & Anaesthesia” FlowAnalysier PF-300 Pro, along with all accessories identified in the Scope section, to the Michael E. DeBakey VA Medical Center (MEDVAMC) located at 2002 Holcombe Blvd., Houston, Texas 77030.

2. Scope

2.1. The contractor’s responsibilities shall include, but are not limited to:

2.1.1. Hardware and Software: Supply all devices, accessories, and associated software require for full functionality.

2.1.2. Licensing: Provide all necessary software license for operation and compliance.

2.1.3. Warranty: Include a minimum two (2) year warranty covering parts, labor, and service.

2.1.4. Software Updates: Provide lifetime software updates to ensure ongoing compatibility and performance.

2.1.5. User Training: Deliver initial and refresher training throughout the warranty period for clinical and technical staff to ensure proper use and maintenance of anesthesia equipment

2.1.6. Documentation: Provide all user manuals, technical documentation, and maintenance guides.

2.1.7. Support Services: Offer technical support and troubleshooting assistance throughout the warranty period.

2.2. All equipment and services must comply with applicable VA standards, regulatory requirements, and manufacturer specifications to ensure safe and effective testing of medical devices used in anesthesia.

2.3. Necessary equipment, accessory, and support configuration is as follows:

Equipment & Accessories Item # Description Qty UoM

1 IMT.Analytics Biomedical Test-Set, CITREX H5 Mobile 2 EA 2 IMT.Analytics Biomedical Test-Set “Ventilation & Anaesthesia” FlowAnalyser PF-300

Pro, with the below included accessories:

• MultiGas Analyzer OR-703

• SmartLung 2000

• FlowLab software (including activation code)

• Carrying case

• User Manual,

• USB Cable

• Power Supply

• Adapter set

• Protection Filter RT019

1 EA

Warranty & Support Item # Description

1 Two (2) Year Warranty on all equipment.

2 Updates to software for the life of the equipment.

3 Initial and refresher user training for clinical and technical staff throughout Warranty period.

DRAFT

2.4. Deliverables:

2.4.1. Delivery of Hardware & Accessories with updated Software to be coordinated by COR.

2.4.2. Software upgrades to be coordinated by COR

2.5. Delivery

2.5.1. Contractor shall have all equipment delivered to the Michael E. DeBakey VA Medical Center, 2002 Holcombe Blvd. Houston, TX 77030.

2.5.2. Deliver materials to job in manufacturer's original sealed containers with brand name marked thereon.

2.5.3. Package to prevent damage or deterioration during shipment, handling, storage, and installation.

Maintain protective covering in place and in good repair until removal is necessary.

2.5.4. Store products in dry condition inside enclosed facilities.

2.5.5. Any government requested delayed delivery up to 120 days after initial award delivery date, shall be at no additional cost to the Government.

2.5.6. Delivery will be coordinated through the COR.

3. Site Conditions

3.1. There shall be no smoking, eating, or drinking inside the hospital at any time unless done so in designated dining areas.

4. Period of Performance

4.1. The anticipated Period of Performance for overall project is delivery and acceptance of the testing equipment.

4.2. The anticipated Period of Performance for support services from the warranty is at a minimum 2 years from acceptance. Support services begin when the testing devices are accepted by the COR.

5. Inspection and Acceptance

5.1. The Contractor shall conduct a joint inspection with the COR once all equipment had been delivered. The COR shall inspect all equipment and provide a punch list of any and/or all missing or damaged products.

5.2. Contractor shall provide dates of completion of punch list items and replacement parts and/or short ship items from the manufacturer(s).

5.3. The COR shall ensure test equipment works satisfactorily prior to acceptance. Disputes shall be resolved by the Contracting Officer.

6. Deliverables

6.1. User and Service Manuals

6.1.1. The Contractor shall provide, at no charge, two (2) complete and unabridged printed copies and one

(1) electronic version (CD) of operator manuals, service manuals, electronic schematics, troubleshooting guides and parts lists for each model of equipment purchased to the Contracting Officer’s Representative (COR) with delivery of equipment. Additionally the Contractor free of charge shall provide any upgrades to these documents. These manuals will include all components and subassemblies, including those not manufactured by the Contractor. These manuals and documentation shall contain the diagnostic codes, commands, and passwords utilized in maintenance, repair and calibration of the equipment.

7. Protection of Property

7.1. Contractor shall protect all items from damage. The Contractor shall take precaution against damage to the building(s), grounds and furnishings. The Contractor shall repair or replace any items related to building(s) or grounds damaged accidentally or on purpose due to actions by the Contractor.

8. Security Requirements

8.1. Contractor is responsible for notifying COR for escorting duties prior to arriving at the facility. Contractor personnel shall check in with Biomedical Engineering (BA-200) upon arrival and departure each day. All contractor personnel must provide one form of valid picture identification at the time of check-in to receive a visitor’s badge. Badges must be worn above the waist and visible at all times while on the jobsite. All contractor personnel will be accompanied by a cleared member of the contractor (PIV cardholder) or MEDVAMC representative at all times while on the jobsite. All contractor personnel must turn-in their badges at the end of each day.

8.2. Contractor is responsible for notifying COR for vehicle parking prior to arriving at the facility. All contractor personnel must provide vehicle insurance, registration and valid driver’s license at the time of check-in to receive a vehicle-parking pass. Vehicle parking passes must be displayed on the front dashboard of the registered vehicle at all times while on MEDVAMC property. Contractor personnel will be allowed to register one (1) vehicle only. All contractor personal vehicles will be allowed to park in the designated vehicle parking spaces in the parking lot as advised by the VA Police upon registering the vehicle. All contractor personnel must turn-in their vehicle parking passes at the end of each day.

8.3. If the vendor requires a key, a $100 deposit will be required per key.

8.4. Information System Security/Privacy Language: See Below.

8.4.1. No data, on any type of storage device will be removed from this VA location.

8.4.2. Information technology security requirements: The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. The contractor shall comply with all Federal laws and regulations the VA has developed when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor. The information made available to the contractor by VA for the performance of this contract will be used only for the purposes of performance under this contract.

The certification and accreditation requirements do not apply to this requirement and a security accreditation package is not required.

8.4.3. SECURITY STATEMENT: Sensitive VA information is not contained within the systems covered by this contract.

8.4.4. Biomedical Engineering shall perform virus scans on all removable media prior to use on VA medical equipment. This includes all types of removable media, including media (e.g., USB devices, CDs, dongles, etc.) that has been issued by VA, media not issued by VA, and media brought in by vendors or independent service organizations. Within accordance of VA Directive 6500, Information Security Program, September 2007

8.4.5. The Vendor will not transfer any VA information to a location outside the VA and only to VA locations determined by the VA System Administrator. The information in these systems may be covered by the Privacy Act 1974 which contains criminal penalties of abuse of information.

8.4.6. During onsite service, the Vendor shall be chaperoned by VA Personnel. However, the vendor shall not be issued a UserID/Password.

8.4.7. Non-volatile memory devices, working or non-working, shall NOT be removed from the VA facility until the ISO has certified that the data has been destroyed. For magnetic devices and media, the data destruction will be by degaussing. Other forms of cleansing will be used for non-magnetic media.

8.4.8. The vendor will not have remote access to complete the repair(s) and preventive maintenance.

8.4.9. The vendor shall sign a Business Associate Agreement with the VA.

8.4.10. The COR or designee is responsible for the actions of the vendor during the repair.

9. Records Management Statement

9.1. All records (administrative and program specific) created during the period of the contract belong to

Michael E. Debakey VA Medical Center (MEDVAMC) and must be returned to MEDVAMC at the end of the contract or destroyed in accordance to the VHA Record Control Schedule (RCS)10-1.

9.2. Citations to pertinent laws, codes and regulations such as 44 U.S.C Chapter 21 , 29, 31 and 33; Freedom of

Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

9.3. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

9.4. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government ‘IT’ equipment and/or Government records.

9.5. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

9.6. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract or identified in the RCS 10-1.

9.7. The Government Agency owns the rights to all data/records produced as part of this contract.

9.8. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

9.9. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

9.10. No disposition of documents will be allowed without the prior written consent of the Contracting Officer.

The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

9.11. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under or relating to this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.