Statement Of Work Vitros XT3400.docx

Ortho Diagnostics – Vitros XT3400 Contract

STATEMENT OF WORK

Naval Health Clinic Quantico requires an analyzer that does not utilize plumbing, drains, stirring mechanisms, water baths, re-used & washed cuvettes, mixing assemblies, floor vents, and deionized water. The Vitros Systems offered can easily accommodate changes in layout or redesign. Vitros does not require reagent preparation without any reagent hydration. The unique design of the Vitros system eliminates microbial growth contamination that can be found with wet chemistry systems; tubing, water bath, probes, pumps, cuvettes, and required external water system.

Vitros Systems do not require water to operate. This eliminates the need to install a water system, ongoing costs of maintenance and quality control associated with a water system. Ortho’s unique no water Vitros Systems provide the laboratory with the freedom to implement a design that will maximize workflow and efficiencies, truly providing the opportunity for a lean design.

Vitros Systems do not use reusable probes, eliminating risk of carryover, cross- contamination, and the need for probe washing. All Vitros System waste is contained within the system with daily disposal by the operator. Ortho’s proprietary Vitros Microslide (dry slide) technology makes Ortho’s offering unique. The operational advantages to this technology include: no reagent preparation or waste, no water, plumbing, or drains, no pumps or tubing, minimal storage space, minimal operator interventions, maximum ease of use, and consistent results over time and across the world. The Vitros Microslide technology would benefit the lab by reducing common interferences allowing for more accurate diagnosis in complex patient situations and by reducing the need for repeat testing all of which leads to more confidence in test results and better patient care. Ortho's dry slide technology is robust from reagent degradation, minimizes HIL (hemolysis, icterus, lipemia) interference through its spread layer, and is capable of long calibration intervals up to 6 months.

The requirement is for a cost-per-test or cost-per-reportable contract for one (1) Analyzer, Laboratory, Chemistry, reagents, quality control, maintenance, and consumables for Naval Health Clinic, Quantico (NHCQ). The contracted unit shall be capable of performing general Chemistry testing for a minimum annual workload of 10,000 specimens. The analyzer shall be capable of preforming the tests listed below with the minimum workload indicated.

TEST VOLUME

The fully automated analyzers shall be capable of performing following test included in panel.

Comprehensive Metabolic Panel (Chem 14) Sodium, Potassium, Chloride, Glucose, BUN, Creatinine, Calcium, Anion, GFR, T.BIL, ALT, Alkaline Phosphatase, Albumin, AST

The automated analyzer shall be capable of performing tests using dry slide micro tip and microslide procedures to reduce testing time and liquid waste. The automated analyzer shall be capable of processing various sample types including neonatal sample, plasma, or serum.

The Chemistry analyzer shall be capable of operating in various modes including continuous, random STAT and batch specimen. The analyzers shall be capable of processing various adult and pediatric test tubes. The Chemistry analyzer shall not require an external water source or drainage for operation. The dimensions for the bench top analyzer shall not exceed 35x42.3x30.31 in (HxWxD). The electrical requirements are 110 VAC and 60 Hz. Chemistry analyzer must have an approved ATO (authority to operate) and be compatible with LIS systems.

The vendor shall provide installation, initial validation testing, onsite and offsite user training and preventive maintenance coverage. The vendor shall provide validation of the analyzers, including normal range verification, demonstration of linearity, reportable range, replication studies, recovery studies and establishment of initial control ranges using control materials.

Corrective system maintenance coverage shall include response times, as specified in the Statement of Work (SOW). Training shall be provided by the vendor, as specified in the SOW.

The system shall bi-directionally interface with the MHS Genesis and with the laboratory information system (LIS), as specified in the SOW. The vendor shall provide two (2) operational and two (2) service manuals, each in English.

The contract will have an initial base year with four (4) subsequent option years.

Base year: 01 May 2024 to 30 April 30 2025 Option year 1: 01 May 2025 to 30 April 2026 Option year 2: 01 May 2026 to 30 April 2027 Option year 3: 01 May 2027 to 30 April 2028 Option year 4: 01 May 2028 to 30 April 2029

The system, including claims made for the product, shall be compliant with Food and Drug Administration (FDA) regulations, with respect to marketing and delivering medical products for use in the United States of America. These requirements shall apply even if delivery is requested outside of the United States of America. The system shall be installed in compliance with OSHA requirements.

Contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

Upon delivery, the contractor shall be responsible for uncrating the unit/system, transporting it through the facility to the location of intended use for installation, and removing of all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage. The vendor is also responsible for the initial instrument operational and performance validations.

1. Reagent and 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 point identified below:

Naval Health Clinic Quantico Attention: Laboratory Department 3259 Catlin Avenue Quantico, VA 22134

2. Facility Constraints

a. Laboratory Footprint: The units shall be installed in a 180" L x 54" W space on floor.

b. Do not need the facility to provide plumbing such as water and drainage.

c. Yes, the facility has biohazard collection.

d. No operating environment, ventilation/exhaust requirements, or other constraints.

e. No extra Power requirements needed.

3. Maintenance.

a. The vendor shall provide OEM-trained, experienced, English-speaking personnel. The vendor shall provide all labor, tools, diagnostic equipment, software, material, supplies, transportation, parts, and equipment necessary to perform Preventive Maintenance (PM), Calibration (CAL), Safety Testing (ST), and corrective maintenance.

b. The vendor shall provide telephonic communications with the Government to discuss technical matters relating to the performance of this contract. A systems operator shall be made available to answer technical questions regarding system operations and applications.

c. Equipment listed in this contract will be maintained to meet and retain the original equipment manufacturers (OEM’s) specifications/equipment certification.

d. The vendor shall provide maintenance services Monday through Friday from 0700- 1700 local time, excluding Federal Government holidays as seen at the following site: https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/factsheets/ holidays-work-schedules-and-pay. This includes annually required performance maintenance. Customer and Technical support should be available by phone 24 hours, 7 days a week.

4. Preventive Maintenance Services.

a. Normal Business Hour Maintenance Coverage will be Monday through Friday, from 0700-1700 local time, excluding Federal Government holidays. Vendor shall provide full-service preventive maintenance.

b. Preventive maintenance shall be performed in accordance with OEM recommendations.

c. The vendor shall perform PM service checks during the base contract period at the OEM’s recommended intervals. Vendor will also perform PM service checks during each option year at a date and time mutually agreed upon by the vendor and the Government.

d. All test equipment used in the performance of this contract shall be calibrated, as required by the OEM, and shall be in compliance with Joint Commission (JC), OEM, the College of American Pathologist’s (CAP), Food and Drug Administration (FDA), and National Institute of Standards and Technology (NIST) standards.

5. Corrective Maintenance

a. Vendor shall provide on-site corrective maintenance from 0700-1700 Local Time, Monday-Friday, to include unlimited service calls. Telephonic technical support shall be available 24 hours per day, 7 days per week.

b. A vendor service technician shall respond via telephone within two (2) hours after receipt of trouble call and provide on-site service within twenty-four (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 laboratory 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 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 a 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 have and provide to its representatives 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.

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.

7. Training

a. The vendor shall provide initial on-site operator training to all technicians assigned to the NHCQ Laboratory service prior to the initial use of the equipment.

b. The vendor shall provide a minimum of one (1) operator training at the vendor’s training facility prior to the delivery and installation of the equipment.

8. System Interface Requirement

a. The system shall be capable of bi-directionally interfacing with the MHS Genesis.

b. The system shall have the ability to receive HL7 order messages (ORM) and information from the LIS and provide DICOM Modality Worklist to the modalities.

c. If the vendor is not already approved to connect to MHS Genesis bi-directionally, the vendor shall agree to complete any bi-directional interface integration at no additional cost to the Government. Interface integration must be completed prior to final acceptance of the system.

d. Middleware: Discuss commercial middleware (if applicable)

9. 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.

10. 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.

11. Vendor Report Requirements.

a. During normal duty hours, vendor FSE personnel shall check-in with the laboratory upon arrival at the Government site and again prior to departure. The vendor FSEs shall personally notify laboratory 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 laboratory personnel.

b. The vendor shall provide to laboratory personnel 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:

i. Name of Vendor.

ii. Contract Number.

iii. Name of field service technician performing service.

iv. Vendor log/control number.

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

vi. Description of problem reported by user.

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

viii. 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.

ix. Problem resolution or pending action.

x. Total billing cost.

xi. Signatures:

1. Field Service Technician performing services

2. Laboratory verifying service rendered

xii. In the event that agents/sub-vendors are used in the performance of repairs, said agent shall be identified on the service report by company name, point of contact, and contact information (i.e. telephone number and email).

12. Vendor Responsibility.

a. 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.

13. 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. In the event that 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 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. In regard to patient information confidentiality and privacy, all vendors and/or 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.

14. Service Beyond the Scope of the Contract

a. The vendor shall immediately, but not later than 24 consecutive hours after discovery, notify laboratory personnel 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 laboratory personnel 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.