Attachment 2-HT940626SSN3825-RALS SOR.docx

Attachment 1 - SOR: Glucometers and Abbott i-STAT Analyzers RALS Data Management System

SOURCES SOUGHT NOTIFICATION (SSN) HT940626SSN3825

ATTACHMENT 1

STATEMENT OF REQUIREMENT

U.S. NMRTC SIGONELLA

GLUCOMETERS AND ABBOTT I-STAT ANALYZERS RALS

DATA MANAGEMENT SYSTEM

(Brand Name or Equal)

ORGANIZATION: U.S. Navy Medicine Readiness and Training Command Sigonella is responsible for providing the U.S. Navy, other military branches, and their military families with reliable quality health care. In addition, USNMRTC Sigonella is responsible for preparing for deployable support of operational forces and caring for their beneficiaries.

BACKGROUND AND OBJECTIVE: In order to provide the expected standard of care for patients who receive their healthcare services at NMRTC Sigonella, the hospital shall be capable of providing certain point of care waived laboratory tests that are performed on a routine or emergent basis. Point of care testing is vital in the detection and monitoring of cardiac arrest, diabetes, electrolytes, renal function, blood gas and various other analyses that are essential in the treatment of pathologic processes. Some of these tests are vital to the expeditious screening and timely treatment of acute disease such as myocardial infarction and organ failure, the ability to perform testing at the treatment facility is paramount.

Point of Care Testing devices require a software interface system that connects point-of-care test results and instruments to the MHS Genesis health record system and has been authorized by Defense Health Agency to operate on DoD networks. This authorization allows for the successful transfer of critical clinical information into patient electronic health records to allow for continued and safe patient care. The contractor shall perform installation, implementation, training and maintenance support for a data management system for Point of Care Testing.

GENERAL REQUIREMENTS: The effort required hereunder shall be performed in accordance with this Statement of Work and with all other terms and conditions set forth herein.

SCOPE: The contractor shall perform all tasks, including interface development, remotely through an already existing Virtual Private Network (VPN) connection between the current system and the Customer’s network. Services include managing the overall implementation, organizing the necessary resources to provide technical guidance, installation, testing, support for system configuration, on-site and/or virtual training and annual technology license for the system.

The contractor shall provide all training, services, materials and equipment necessary for the operation/repair/maintenance of the Rals Data Management System with the Glucose Module and the Abbott ISTAT Module located in the Laboratory at U.S. Navy Medicine Readiness and Training Command and the Souda Bay Clinic to ensure dependable and reliable equipment operation. The scope of work performed under these specifications includes the furnishing of all labor, and parts to perform all repairs on equipment listed, to ensure continued operation at their designed efficiency and capacity.

PERIOD OF PERFORMANCE:

The period of performance shall be for base plus 4 options years:

Base Year: TBD Option Year 1: TBD Option Year 2: TBD Option Year 3: TBD Option Year 4: TBD

SPECIFIC REQUIREMENTS:

Basic Services: Vendor shall provide software, software license, maintenance, and technical support on the data management system.

•Interface between Point of Care testing analyzers and MHS Genesis.

•Create and edit profiles in data management system to match Laboratory MHS Genesis test files.

•Allow operator ID and information to be listed in system’s database.

•Contractor shall provide all software maintenance releases as soon as possible after release but no later than 14 days after release.

•All supplied software shall be certified free of malicious codes/damaging properties such as viruses, Trojan horses, worms, spyware etc.

•All technical support personnel must be adequately trained and knowledgeable of supplied software.

Glucose Analyzers: For a total quantity of six instruments – contractor must provide the customer with the ability to manage all glucose analyzers device support to the data management system, provide the Customer with the ability to manage all the devices, patient results, operator certifications, and Quality Control testing from a single Point of Care data manager for US NMRTC Sigonella and the Souda Bay Clinic. The Glucometer results shall also be added to the current LIS (laboratory interface system), MHS Genesis.

Abbott i-STAT Analyzers: For a total quantity of five instruments – contractor must provide the customer with the ability to manage all i-STAT devices, patient results, operator certifications, and Quality Control testing from a single Point of Care data manager for US NMRTC Sigonella and the Souda Bay Clinic. The i-STAT results shall also be added to the current LIS (laboratory interface system), MHS Genesis.

CYBERSECURITY: Contractors shall be responsible for providing CYBERSECURITY maintenance support for as long as the contractor commercially supports the system/device. Contractor shall have a valid Authority to Operate (ATO) prior to installation.

AUTHORITY TO OPERATE: Contractor shall ensure that the contractor’s device or system maintains its ATO or operating system platform and patches/updates for as long as the contractor commercially supports the system/device.

PERFORMANCE REQUIREMENTS SUMMARY: The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

1. The contractor shall provide 24/7 uninterrupted software service with zero downtime. all patient results must successfully transmit to electronic health records (MHS Genesis) 100% of the time.

2. The contractor shall provide software updates as needed to ensure zero interruptions to patient care. - All patient results are successfully transmitted to electronic health records (MHS Genesis) 100% of the time.

PREVENTIVE MAINTENANCE:

Perform service repair/maintenance to industry standards.

Ensure that only FULLY QUALIFIED FIELD ENGINEERS and TECHNICIANS who have gone through original equipment manufacturer (OEM) or comparable third-party service schools for the above mentioned equipment, shall be employed in the performance of any and all work performed under this contract. Upon request, the contractor shall provide training certificates (or notarized copies) to the Medical Repair Branch for verification. The highest standard of professional capability and electrical/mechanica1 workmanship is to be maintained throughout the life of this contract.

Make repairs to the extent necessary (as determined by inspection tests or disassembly) to ensure a functional system that will efficiently serve its intended purpose.

CORRECTIVE MAINTENANCE: Correct inoperable condition in a timely manner. Immediately upon contract award, the contractor shall provide Medical Repair Branch an emergency telephone number. Contractor shall respond no later than eight (8) hours after telephone notification.

Provide only the work necessary to restore the equipment to a serviceable/operating condition by adjustments, replacement parts, or minor repairs when it is determined that extensive repairs and parts replacements are not necessary.

Equipment improvements/modifications shall be made only upon Medical Repair Branch written approval and direction.

Notify the Medical Repair Branch immediately upon receipt of OEM or replacement parts/equipment safety recalls notices.

Insure that original design and functional capabilities will not be changed, modified, or altered unless the Medical Repair Branch authorizes such changes.

Provide suitable OEM recommended repair equipment/tools required for the satisfactory execution of all repairs made.

Furnish manufacturer OEM approved lubricants and lubricate wear points within the equipment.

Extend to the Government all commercial warranties on replacement parts, consistent with standard industry practices.

Maintain an adequate spare parts inventory.

TITLE TO EQUIPMENT: The contractor shall not assume possession or control of any part of the equipment. The Government retains ownership to title thereof.

LIABILITY: The contractor shall not be liable for any loss, damage, or delay due to any cause beyond his reasonable control including but not limited to, acts of government, strikes, lockouts, fire, explosion, theft, floods, riot, civil commotion, war, malicious mischief or acts of God.

UTILITIES: The contractor may use Government utilities, (e.g., electrical power, compressed air, and water) that are available and required for any service performed under this contract. The building engineer, to ensure compatibility with the NMRTC Sigonella electrical wiring and equipment, must approve contractor electrical equipment.

GOVERNMENT PERSONNEL: U.S. NMRTC Sigonella employees will not perform maintenance, or attempt repairs to equipment while such equipment is under the purview of this contract unless agreed to in writing by the contractor.

SECURITY REQUIREMENTS: Contractor will be required to contact the U.S. NMRTC Sigonella laboratory department to be sponsored or request base access and wait at the main gate for an escort.

FIELD SERVICE REPORTS: Contractor must provide a written or electronic Field Service Report (FSR) and Certification in the English Language and to include the following:

· Contractor Name

· Identification of the equipment serviced: ECN (Equipment Code Number)

· Serial Number

· Type of service/tests performed

· Technician's Printed Name

· Telephone Number

· Signature and Date

· Time of Arrival Time Expended Repairing/Service

· Labor Hours, Rate and Materials

· Summary of Work Performed

· Accepted by End-User (Government Representative's Printed Name and Signature).

All Field Service Reports shall be submitted within 72 hours of completion of service.

PARTS AVAILABILITY: To ensure minimal equipment downtime, the contractor shall maintain replacement repair parts and materials necessary to perform each repair or supply said parts and materials within three (3) days.

COMPENSATION:

Labor: All compensation for labor is included in the contract price.

Parts and materials: All compensation for parts and materials is included in contract price.

Parts/Supplies Quality: Parts and Supplies provided under this contract shall be guaranteed to be equal in all respects, including performance, interchangeability, durability and quality to the OEM parts when new or as presently recommended by the manufacturer.

INVOICE AND PAYMENTS INSTRUCTION:

The Contractor is required to submit certified invoices conform to the contract line-item number structure of this contract and must include banking information (IBAN CODE) to:

U.S. NMRTC Sigonella, Italy SS 192 Km 76 95100 Catania Attn: Material Management Department Phone: 095-564930 Fax: 095-564583

Invoices shall be in the name of the Contractor and not any agent or a subcontractor. It will contain the following information: contract number, order number and item number as listed herein, identification of services, quantities, unit price and extended total price. The Contractor or his authorized representative will sign only the original of each invoice. If the invoices are signed or received in the name of a company or corporation the name of the person signing, as well as the capacity in which he signs, must appear.

Invoice must include your bank account info and the following statement in English and Italian:

"Transaction not subject to tax in accordance with Art. 72, comma 1, Lettera b) del D.P.R. 26 October 1972, No. 633" "Operazione non imponibile ai sensi dell'Art. 72, primo comma, Lettera b), DPR 26 Ottobre 1972, No. 633" Contractor shall maintain original paid invoices and other related records for the length of the contract plus one year and Contractor shall make historical invoicing data available to the government within ten (10) business days of a formal request. Archived information shall be provided in a mutually acceptable format.

Payment will be made in Euro by the Disbursing Officer, U.S. Naval Support Activity, Naples. Payment will be made as soon as possible after acceptance of the supplies or performance of the services. The Government will only pay for those supplies and services, or portions thereof, which have been accepted. Partial payments are authorized. Invoices not in compliance with these instructions are not considered to be proper invoices and may be rejected.

Upon receipt of accepted and certified invoices, payment will be made by Commercial Bill Pay Office (CBPO) Naples Tel. (TBD)

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