SOW Vitros XT 3400 (FY 2027).pdf

Statement of Work

GENERAL INFORMATION

1.0 SCOPE OF WORK.

Navy Medicine Readiness & Training Command (NMRTC) Corpus Christi and Navy Medicine Readiness & Training Unit (NMRTU) Fort Worth require a Cost-Per-Test (CPT) contract for two (2) floor-model, low-volume, automated clinical chemistry analyzers, including reagents, quality control, maintenance, consumables, and associated lease. Both units shall be of the same make and model to ensure methodology standardization and reagent compatibility.

Workload quantities listed below represent actual tests/slides, not reportable results.

1.2 Minimum Annual Workload Requirements.

Navy Medicine Readiness & Training Command Corpus Christi Analyte Tests per year

Albumin 2,790 Alkaline Phosphate 2,700 Alanine aminotransferase (ALTV) 2,700 Aspartate aminotransferase (AST) 2,700 Bilirubin, Direct 540 Bilirubin, Total 2,700 Blood Urea Nitrogen 3,000 Carbon Dioxide 3,000 Calcium 3,000 Cholesterol 2,400 Chloride 3,000 Creatinine 3,000 Glucose 3,900 High Density Lipoprotein 2,340 Potassium 3,000 Sodium 3,000 Protein, Total 2,750 Triglyceride 2,340 Total Slide Volume 48,860

Navy Medicine Readiness & Training Unit Fort Worth

Albumin 990 Alkaline Phosphate 1,800 Alanine aminotransferase (ALTV) 1,800 Aspartate aminotransferase (AST) 1,800 Bilirubin, Total 1,800 Blood Urea Nitrogen 1,800 Carbon Dioxide 1,200 Calcium 1,200

Cholesterol 1,800 Chloride 1,500 Creatinine 1,800 Glucose 3,300 High Density Lipoprotein 990 Potassium 1,500 Sodium 2,000 Protein, Total 1,000 Triglyceride 990 Total Slide Volume 27,270

2.0 BACKGROUND.

The manufacturer shall provide all material, parts, labor, transportation, shipping, preventive maintenance, calibration, and unscheduled repairs for leased equipment.

2.1 Equipment Requirements.

Equipment Quantity Product Code Description Rental Type

2 6844458 VITROS XT 3400 System Cost-Per-Test 2 No Product Code VITROS XT3400 Warranty (M-F 8-5 PM) Warranty 2 No Product Code VITROS XT3400 (M-F 8-5 PM) Service 2 6801358 UPS -Uninterruptable Power Source - North America Accessory 2 1457225 CL - Startup Reagent Allowance Accessory

2.2 Analyzer Capabilities.

Analyzers shall support continuous, random, STAT, and batch modes; process adult and pediatric tubes;

maintain long on-board reagent stability; require infrequent calibration; and require no external water source or drainage.

2.3 Facility Constraints (Applies to Both MTFs)

These constraints represent the strictest limitations across both NMRTC Corpus Christi and NMRTU Fort Worth and apply equally to both sites:

• No facility modifications permitted

• Maximum footprint: 40 inches deep x 70 inches wide

• No plumbing or drainage available.

• Operating temperature: 18-24° Celsius

• Power available: 110-115V AC, dedicated 15A line

• Vendor must provide external UPS backup

3.0 CONTRACTOR REQUIREMENTS

3.1 Technical Requirements.

Contractor must be an OEM-authorized dealer/distributor/reseller. OEM warranty, service, and licensing must be maintained.

Contractor shall uncrate, transport, install, validate, and remove all packaging.

Contractor shall perform all initial operational and performance validations.

3.2 Reagent & Supply Delivery.

a. All supplied items and reagents shall be certified for use with the vendor equipment provided.

b. All supplied items and reagents shall be delivered IAW manufacturer’s shelf-life recommendations. Deliveries will be based on volume of testing performed at each location and coordinated with the Lab Supervisor.

c. All supplied items and reagents that require special handling (e.g. refrigeration, time sensitive, immediate open, etc.) will be marked in a clear manner with a label that is easily read, understandable, and a minimum of 3” x 3” (9 sq. inches). The label will be placed in three (3) or more locations on the container (top & two sides). Supplies/items that require refrigeration will have both the required Celsius and Fahrenheit temperature identified.

d. The contractor shall provide deliveries to the delivery points identified below:

Navy Medicine Readiness & Training Command Attention: Laboratory Department 10651 E. Street, BLDG H-100 Corpus Christi, TX 78419-5130

Navy Medicine Readiness & Training Unit Fort Worth Attention: Laboratory Department

1711 little Ave, NAS JRB Fort Worth Fort Worth, TX 76127

3.3 Maintenance.

a. Vendor shall provide OEM-trained personnel, experienced, English-speaking personnel.

b. Vendor shall provide all labor, tools, diagnostic equipment, software, materials, supplies, transportation, and parts necessary for PM, calibration, safety testing, and corrective maintenance.

c. Vendor shall provide telephonic technical support.

d. Equipment shall be maintained to OEM specifications.

e. Maintenance coverage: 0730-1630, Monday-Friday, excluding Federal holidays.

3.4 Preventive Maintenance (PM).

a. PM shall follow OEM recommendations and be performed during normal business hours 0730- 1630, Monday-Friday.

b. PM shall occur during the base period and each option year.

c. All test equipment used shall compliance with Joint Commission (JC), OEM, the College of American Pathologists (CAP), Food and Drug Administration (FDA), and National Institute of Standards and Technology (NIST) standards.

3.5 Corrective Maintenance.

a. Vendor shall provide on-site corrective maintenance from 0730-1630 CST, Monday-Friday, to include unlimited service calls. Customer and Technical support shall be available by phone during this time frame.

b. A vendor service technician shall respond via telephone within 2 hours after receipt of trouble call and provide on-site service within 24 hours after receipt of trouble call. Equipment shall be repaired and deemed operational within 48 hours.

c. The Government’s request for corrective maintenance will be placed by Biomedical Engineering Division (BIOMED) personnel, directly to the vendor or its representatives. Corrective maintenance shall be completed during the hours specified in the contract.

d. The vendor’s response to requests for service may include telephone consultation with the equipment user/operator and a vendor Field Service Engineer (FSE). Telephone consultation shall: 1) provide instruction in determining operator error; 2) determine the most likely cause of the problem; 3) determine if resolution of the problem requires the dispatch of an FSE; and 4) identify replacement parts likely to be required in order to return the equipment to 100% operational condition as specified by the OEM.

e. The vendor’s quoted annual pricing shall be inclusive of all costs including parts, consumables, labor, travel, and shipping.

f. The Vendor shall provide its representatives with its own service manuals, specifications, schematic diagrams, and parts lists to assist in the evaluation and/or repair of all equipment included in this contract.

3.6 Replacement Parts & Upgrades.

a. The vendor and its representatives shall have ready access to unique and/or high mortality replacement parts. All parts supplied shall be compatible with the existing system. In the event that replacement parts require shipment, shipping shall be performed in the fastest reasonable means possible at no additional cost to the Government.

b. The vendor shall replace all worn or defective parts necessary to restore the equipment to 100% operational condition as specified by the OEM.

c. Freight, postage, and storage charges associated with shipment and receipt of replacement parts and the return of parts shall be the responsibility of the vendor.

d. All replacement parts shall be new and certified as OEM replacement parts.

e. The vendor shall provide software revisions, updates, and upgrades (field service changes) required by FDA-announced or manufacturer-announced hazards, alerts, or recalls, including those falling under the FDA Year 2000 Compliance Directive, as part of the contract at no additional cost to the Government. Upgrades shall be performed as soon as possible after release, but no later than during the first scheduled PM inspection after release. For any updates that have been identified as critical, or required for the proper operation of equipment, the vendor shall provide installation within 30 days of release regardless of PM schedules.

f. With approval from the Government, the vendor may perform hardware/software upgrades as they become available.

3.7 Training.

a. The vendor shall provide initial on-site/web-based training to all technicians assigned to these sites prior to the initial use of the equipment.

b. The vendor shall provide a minimum of two (2) operator training at the vendor’s training facility prior to the delivery and installation of the equipment, two (2) each for Navy Medicine Readiness & Training Command Corpus Christi and Navy Medicine Readiness & Training Unit Fort Worth.

c. The vendor shall coordinate travel, lodging, and other training logistics (tuition and class materials, hotel, most meals and transportation is included in the leasing agreement of the analyzer, for each completed year of customer contract (each period of performance) at no cost to Government.

4.0 LABORATORY INTERFACE SYSTEM REQUIREMENTS.

4.1 MHS Genesis/HL7 Connectivity.

The system shall be capable of bi-directional interface with MHS Genesis (Cerner Millennium) using HL7 communication protocol.

4.2 HL7 Messaging Requirements.

The system shall receive HL7 order messages (ORM) and transmit HL7 results messages (ORU).

4.3 Interface Documentation.

The vendor shall provide all HL7 specifications, connectivity requirements, and interface documentation necessary for DHA approval.

4.4 Authority to Operate (ATO).

The Vitros XT 3400 already holds an approved DHA ATO. Vendor shall provide the existing ATO package, including:

• RMF artifacts

• System architecture diagrams

• Software versioning and patching documentation

• Security control documentation

Each MTF must complete its own site-specific ATO acceptance, but no new ATO is required for this model.

ATO acceptance must be completed prior to final system acceptance.

5.0 GOVERNMENT FURNISHED PROPERTY, MATERIALS, AND SERVICES

5.1 Government Furnished Property, Materials, and Services.

a. The Government will be responsible for maintaining the proper environment, including utilities and site requirements, necessary for the system to function properly as specified by the OEM.

b. The Government will operate the system in accordance with the instruction manual provided by the OEM.

c. The Government will not be responsible for damage or loss due to fire, theft, accident, or other disaster of vendor supplies, materials, or for the personal belongings brought onto Government property by vendor personnel.

5.2 Vendor Furnished Property and Material.

a. The vendor shall provide all service literature, reference publications, laptop computers and diagnostic software to be used by the Vendor service technicians and as required for the completion of the services in accordance with this contract.

5.3 Vendor Report Requirements.

a. During normal duty hours, vendor FSE personnel shall check-in with the Biomedical Engineering Division (BIOMED) upon arrival at the Government site and again prior to departure. The vendor FSEs shall personally notify BIOMED personnel of problems that result in the equipment being left disabled upon their departure. If equipment is left disabled, a method of physical use prevention of the disabled equipment shall be implemented, and the disabled equipment shall be locked out with a letter of intent in compliance with OSHA regulation to prevent any patient hazards. After normal duty hours, vendor FSEs shall notify the Officer of the Day Desk and the systems’ operator designated by BIOMED personnel.

b. The vendor shall provide BIOMED personnel with a full-service report within two (2) days after completion of all services performed. Each service report shall at a minimum document the following data legibly, in complete detail, and in English:

• Name of Vendor

• Contract Number

• Name of field service technician performing service.

• Vendor log/control number

• Date, time (beginning and ending), and hours on-site for service call.

• Description of problem reported by user

• Equipment identification factors to include manufacturer, make, model, serial number and Facility Equipment Control Number (ECN)

• Itemized description of service performed to include labor and travel costs, parts used, parts cost, parts number/nomenclature, part new or reconditioned, part manufacturer, and problem/corrective action taken or recommended

• Problem resolution or pending action

• Total billing cost

• Signatures

6.0 VENDOR RESPONSIBILITY

The vendor shall be responsible for the repair and/or replacement of damaged Government-owned equipment and property, resulting from the negligence of the vendor or its representatives. All such replacement or repair shall be completed at the vendor's expense and shall be inspected to the satisfaction of the Contracting Officer (KO) or his/her appointed representative.

7.0 REMOVAL OF GOVERNMENT PROPERTY

a. No equipment shall be removed without the approval of the Contracting Officer’s Representative and Materials Management Department (MMD) of the Medical Treatment Facility (MTF).

Property passes for equipment removal shall be obtained by the vendor via the MMD of the MTF. Any failure to obtain such passes, which results in detainment or prosecution of service vendor personnel, is the sole responsibility of the service vendor and their personnel.

b. The vendor shall provide a detailed description of removed items on the vendor’s company letterhead. For associated items/accessories, the vendor shall provide a detailed written description and quantities of items to be removed. Descriptions shall include, at a minimum, the manufacturer’s serial numbers and facility equipment control numbers (ECNs) of all equipment/items removed. If items/subassemblies/accessories are “repaired by replacement”, a detailed description of replaced items is to be included upon return of repaired components.

c. No additional charge shall be allowed for work performed off-site, or any additional time required. All charges resulting from a vendor’s determined requirement to transport Government-owned property, covered by this contract, to and from an alternate repair location shall be the responsibility of the vendor. The vendor shall provide insurance coverage for damage to or loss of equipment while in vendor or service vendor’s custody.

d. Regarding patient information confidentiality and privacy, all vendors and service vendors shall not remove equipment containing personally identifiable information or patient health information from the Government site. The equipment hard drive (HDD) shall be removed by MTF personnel prior to equipment removal from the site. Furthermore, equipment removed from the MTF will be prorated from the date of removal for service maintenance fees. If HDD are to be replaced, the HDD in disrepair shall be left at the MTF for disposal.

8.0 SERVICE BEYOND THE SCOPE OF THE CONTRACT

a. The vendor shall immediately, but not later than 24 consecutive hours after\discovery, notify BIOMED in writing of the existence of or the development of any defects in the scheduled equipment, for which the Vendor considers they are not responsible for repairing under the terms of this contract.

b. At the same time of this notification, the vendor shall furnish BIOMED with a written estimate of the cost to make the necessary repairs. Repairs considered by the Contracting Officer to be outside the scope of this contract shall not be covered under this contract but shall be ordered under a separate purchase order.

9.0 DELIVERABLES/SCHEDULE

The vendor shall ensure no break in service. Supplies shall be delivered every six (6) months.

10.0 PERIOD OF PERFORMANCE

The contract shall have an initial Base year with four (4) subsequent option years.

• Base year: 01 October 2026 – 30 September 2027

• Option year 1: 01 October 2027 to 30 September 2028

• Option year 2: 01 October 2028 to 30 September 2029

• Option year 3: 01 October 2029 to 30 September 2030

• Option year 4: 01 October 2030 to 30 September 2031

Customer Signature Date: 2SEP26