SOW - VACT Spirometry Purchase - 7.21.2023.pdf

Attachment # 1 36C24123Q0927 7.21.2023

VACT Healthcare System

Spirometry Purchase

Statement of Work

Privacy Statement:

Contractor shall adhere to all VA Privacy & Security, and Privacy Act and HIPAA requirements if exposed to protected health information (PHI) or when obtaining or reviewing information. This includes all log files, error traps, screen capture images and database query results used to aid staff with product troubleshooting or product support activities.

Background/General Information:

VACT Healthcare System is seeking to purchase additional Spirometry equipment to complement its

CBOC center operations. The MGC Pulmonary systems are already installed at VACT. VACT also hosts a

VISN centric server to handle data flow. It is imperative that additional pulmonary/respiratory equipment integrates with the existing server to preserve current workflow practices. The need is for seven additional Spirometry systems. VACT currently has MGC Spirometry systems in use.

The vendor will provide all necessary labor, equipment, management, supplies, and other resources to provide the needed equipment and maintenance support for the replacement equipment as detailed in this statement of work.

Requirements:

Equipment and Supplies

Equipment provided must have the following characteristics to be considered acceptable:

1. Ease of use/ergonomic design.

2. Ability to move unit on wheels.

3. Ability to raise and lower.

4. Controls are easily accessible.

5. Diagnostic capabilities must meet the American Thoracic Society Standards in performing spirometer tests

6. Infection control concerns:

a. Ease of ability to replace consumable and/or clean items within the breath path to mitigate infection risks.

b. Provide a list of disposable items

c. Provide Reusable Medical Equipment (RME) cleaning requirements.

7. Interoperability concerns:

a. Ability to interface with the existing VA infrastructure and patient record (VistA/CPRS)

b. Ability to interface with the current Pulmonary MGC BreezeSuite software

c. Reports should adhere to ATS guidelines.

8. Provide technical specifications of the hardware and software proposed, including:

a. The operating system and application, with its capabilities as outlined above in the diagnostic capabilities.

b. The design of the system, identifying all hardware included, such as computers, servers

(virtual), middleware and licenses.

c. The peripherals provided with the system(s), such as printers, monitors, CPU, and computer specifications.

d. System encryption or ability to safeguard ePHI.

9. Warranty: the vendor will provide at least a 1‐year warranty on all equipment and services.

10. Provide a list of all user‐replaceable items (consumables) needed for the systems.

Systems required

(7) Full‐function spirometer with preVent flow sensor, onboard environmental sensors and

BreezeSuite cardiopulmonary diagnostic software. Includes: Installation manual, user manual and operator instruction video.

(7) 3 Liter Calibration Syringe for CPFSD

(7) Umbilical Clip assembly for CPFS/D USB Series

(7) Kit 1 – Includes prevent II Filter (oval with lip grip) & Nose Clip (Qty 100)

(7) preVent Flow Sensor Handle

(7) MultiUser Software Option for CPFSD

(7) preVent Flow Sensor (box of 24 Qty)

(7) 1 Hour Remote Professional Service Time

(7) Five‐Year UltraCare Preferred Support Agreement for CPFSD

Training sessions required

(7) 4 Hours Remote Training

(7) One Day Onsite Installation and Operator Training for up to 4 People

Contractor Responsibilities:

• Implementation Services shall include on‐site installation coordination of all equipment and accessories, a training plan, and schedule for Go‐Live.

• Materials provided shall be new equipment, parts, and accessories.

• The vendor shall deliver materials to the job site in original equipment manufacturers (OEM) original unopened containers, clearly labeled with the OEM's name, equipment model and serial identification numbers, delivery order number, and VA purchase order number.

• The vendor is responsible for inventorying materials prior to delivery to VA sites to check for accuracy in quantity and part number.

• All on‐site installation services shall be vendor‐provided by technical staff (not sales reps) fully trained to service and install products, parts, and accessories as specified.

• The vendor shall provide, maintain, and dispose all material waste and packaging associated with the products and/or waste generated during the installation services.

• Vendor will be responsible for moving waste materials from job site(s) to a vendor‐provided waste container, and then off site.

• The vendor shall provide the following documentation:

‐ Two copies of the operator’s manual for each system.

‐ Two copies of complete technical service manuals including troubleshooting guides, necessary diagnostic software and equipment, schematic diagrams, and parts lists.

‐ Electronic versions of both operator’s manual and technical service manuals.

‐ DVD or web‐based training for both operator’s manual and service if available.

‐ Vendor must also have or be willing to secure a BAA with the Federal Government.

Government Responsibilities:

• VACT is responsible for inventorying materials prior to acceptance of order

• VACT shall identify and provide limited daily storage of vendor parts/supplies at the time of delivery and reject items that do not conform to this requirement.

Training Requirements:

• Contractor will provide technical training to ensure clinical engineering and clinical staff at VACT to enable them to use and provide user‐level support for the systems procured. Contractor shall provide any special service tools and/or test equipment comparable with that provided to the

OEM’s service personnel