Attachment 2 - Chemistry Immunoassay System Essential Characteristics_Final.docx

Chemistry Immunoassay Analyzer System Essential Characteristics

Essential Characteristics:

The system shall consist of:

1. Four (4) chemistry/immunoassay analyzers shall be the same model and perform the same tests in order to work together and form a chemistry/immunoassay system.

2. Contracted chemistry/immunoassay analyzer system shall be capable of performing general chemistry, special chemistry, immunoassay, and screening for electrolytes, therapeutic drugs, drugs of abuse, toxicology, hepatitis, diabetes, hepatic diseases, thyroid diseases, cardiac diseases, anemia panels, and autoimmune diseases, as defined below.

3. The contractor shall provide Six Sigma Analysis for the chemistry and immunoassay testing methodologies of the proposed analyzers as part of the initial validation testing of the equipment to ensure accurate results.

4. The contractor shall include an additional 20% volume of all assays for initial validation testing. The contractor shall be capable of administering repairs on-site within 24 hours.

5. The contractor shall be available for telephone troubleshooting consultation 24 hours a day, 7 days a week, 365 days per year, except on Federal Government holidays, as listed on the Office of Personnel Management (OPM) website.

The chemistry/immunoassay analyzer system shall be capable of performing at least, but not be limited to, the tests and of performing each test at least at the minimum workload identified in the Minimum Estimated Required Workload – Tests document.

6. The chemistry/immunoassay analyzers and automation system track shall fit within the following maximum dimensions: less than 29’ long and less than 38’ wide in its longest/widest areas or less than 1,102 sq ft.

7. The system shall be capable of utilizing the following sample types without the need for pre-treatments: serum, plasma, urine, and cerebrospinal fluid (CSF).

8. The system shall include specimen hemolysis, icterus, and lipemia detection capabilities.

9. The system shall be capable of pre-calibrating and storing at least 2 lots (batches) of the same reagent onboard the unit.

10. The system shall have sufficient onboard storage to accommodate daily workload as outlined in Minimum Estimated Required Workload - Tests, and a testing throughput of 1,550 tests per hour. The system shall be capable of first pass linearity up to 1,500 for critical enzymes and tests such as ALT, Amylase, CK and bHCG.

11. The minimum following tube sizes shall be processed and tested on the platforms: 13x75 mm, 13x100 mm, 16x75 mm, and 16x100 mm.

12. The system shall be connected to the automated specimen processing system to distribute specimens to available analyzers.

13. The system shall include auto-validation and manual validation capabilities.

14. The system shall have a walk-away shut down and re-start capability.

15. The system shall complete STAT (urgent) requests in, at most, 60 minutes.

16. The system shall complete STAT testing results for cardiac enzymes, Troponin, parathyroid hormone, hCG, and nT-proBNP with a turnaround time of less than 30 minutes.

17. The system shall be capable of utilizing Code 39 sample tube bar codes for accurate sample identification.

18. The system shall include reagents with a 90-day shelf life when delivered.

19. The system shall include reagent packs that can be loaded without requiring the analyzer to be in stand-by mode or requiring the analyzer be taken offline.

20. The system shall have the ability to flag results as being suspicious to allow for optimal sample troubleshooting.

21. The system shall include an Immunoassay Module that has humidity and temperature controls.

22. The system shall include customizable, programmable panels of testing.

23. The system shall be capable of starting up without priming or washes.

24. If the analyzers use water, the vendor shall provide a Reagent Grade Water System and Total Organic Carbon (TOC) water quality testing annually. The Reagent Grade Water System must fit within the maximum dimensions noted above.

25. The system shall be capable of external data storage in compliance with Navy/Defense Health Agency (DHA)/Department of Defense (DoD) Information Assurance (IA) regulations.

26. The system shall be capable of operating at the following power: 220 VAC within +/- 10 percent of the nominal voltage, 50/60 Hz, single phase.

27. The vendor shall provide two (2) operational and two (2) service manuals for each system.

28. The contract shall include an automation and tracking system. The automation system shall interface with the chemistry/immunoassay system. The automation system shall be an open data automation solution that is able to connect to other laboratory analyzers. The automation system shall manage individual samples and use point in space instrument connectivity.

29. The automation system shall include the following modules: a front-end sample processor/in-put/out-put module, bulk input module, a cold storage and retrieval module, two (2) centrifuge modules, de-capping modules, a rack output module, a re-capping module, de-sealer, and re-sealing module. The vendor shall propose an adequate quantity of modules to reflect the workload. The automation system shall be capable of reading all tube types. The centrifuge modules shall have a total minimum capacity of 80 tubes. The cold storage module shall hold a minimum of 15,000 tubes and be capable of automatically disposing expired tubes.

30. The automation system shall include STAT loading and prioritization processing. The automation system shall include automatic dilution, rerun, reflex, and add-on testing. The automation system shall be capable of reading specimen Code 39 bar code labels. The automation system shall be a circular track design with radio frequency identification (RFID) sample tracking or barcode tracking. The automation system shall include front-end sample processing and sorting capabilities, as well as back-end sample manager and storage capabilities.

31. The automation system shall include data management, inventory management, automated repeat and reflex testing, auto-verification, and specimen rack position identification. The inventory management system shall include automated RFID or barcoded inventory management. The inventory management system shall include on-board monitoring of reagent inventory. The inventory management system shall be part of the system or part of the middleware.

32. The vendor shall provide validation upon installation of the analyzers, including normal range verification, demonstration of linearity, reportable range, replication studies, recovery studies, custom rule building and establishment of initial control ranges using control materials. The vendor shall provide Laboratory Information System (LIS) support and training for auto-verification of assays. Corrective system maintenance coverage shall include response times, as specified below.

33. Training shall be provided by the vendor, as specified below.

34. The system shall include an uninterruptible power supply (UPS) that is compatible with all system components, is capable of conditioning the power to the system, and allows the system a minimum of 30 minutes run time in case of a temporary power outage.

35. The system shall bi-directionally interface with MHS Genesis, HL7, and the DoD LIS.

The system shall be installed in compliance with Occupational Safety and Health Administration (OSHA) regulations.

Contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, distributor, or reseller for the proposed equipment/system such that 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 including quality management and universal benchmarking to ensure accurate results.

System Support

a. The vendor shall provide system installation, validation, and correlation.

b. The vendor shall provide validation of the equipment following installation, including Six Sigma Analysis of chemistry and immunoassay testing methodologies.

c. The analyzers and automation should be currently authorized to interface with Military Health System (MHS) Genesis.

Training

a. The contractor shall provide on-site operator training for Government personnel upon initial implementation for the base year and for each option year exercised. The training shall include: initial automation system user training for approximately twenty-three (23) staff members, initial clinical chemistry/immunoassay user training for approximately twenty-three (23) staff members, and user training for a minimum of two (2) staff members for each additional option year.

b. The contractor shall provide yearly off-site training for key operator staff excluding travel, lodging, meals, expenses, and incidentals.

c. On-site assistance during system validation shall be provided.

Reagent and Supply Delivery

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

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

c. The contractor shall provide deliveries to the delivery point identified below:

Naval Medical Center Portsmouth 620 John Paul Jones Circle Portsmouth, VA 23708

Maintenance

a. The Vendor Field Service Engineers shall be original equipment manufacturer (OEM) trained, experienced, and 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 (CM).

b. The Vendor shall provide telephonic communications to discuss technical matters relating to the performance of this contract. An English-speaking 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 OEM’s specifications and/or equipment certification.

Preventive Maintenance Services

a. Normal Business Hour Maintenance Coverage will be Monday through Friday, between 8:00 A.M. to 5:00 P.M. EST. Vendor shall provide full-service preventive maintenance.

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

c. Vendor shall perform preventive maintenance service checks at the OEM’s recommended intervals at a date and time mutually-agreed upon by the vendor and the Government throughout the life of the contract.

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 The Joint Commission (JC), OEM, the College of American Pathologist’s (CAP), and Food and Drug Administration (FDA), and National Institute for Standards and Technology (NIST) standards.

Corrective Maintenance

a. Vendor shall provide on-site corrective maintenance between the hours of 8:00 A.M. and 5:00 P.M. EST, Monday-Friday, to include unlimited service calls. Telephonic support shall be available 24 hours per day, 7 days per week, 365 days a year, excluding Federal Government holidays, which are identified online at the following site: https://www.opm.gov/policy-data-oversight/pay-leave/payadministration/fact-sheets/holidays-work-schedules-and-pay.

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. Equipment shall be operational within forty eight (48) hours of the initial trouble call.

c. Government request for corrective maintenance will be placed by NMC Portsmouth Biomedical Engineering Division (BIOMED) personnel, to the Vendor. Corrective maintenance shall be completed during the hours specified above.

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 1) shall provide instruction in determining operator error; 2) shall determine the most likely cause of the problem; 3) shall determine if resolution of the problem requires the dispatch of a Field Service Engineer (FSE); and 4) should identify replacement parts likely to be required to return the equipment to 100% operational condition as specified by the OEM.

e. Pricing shall be inclusive to include all parts, consumables, labor, travel, and shipping associated with performing corrective maintenance on the system as well as any other costs associated with performing corrective maintenance on equipment that utilizes water and or sewage, including the cost of water utilized by vendor during corrective maintenance and any drainage costs associated with that water.

f. The vendor FSE shall have his/her own service manuals, specifications, schematic diagrams, and parts lists to assist in the evaluation and repair of all equipment included in this contract.

Uptime

a. Equipment shall be returned to operational condition within 48 hours after telephone notification from BIOMED. The Contractor shall maintain an overall uptime rate of 95% or better for all equipment. Uptime is equal to equipment availability minus down time. Uptime and down time are values used to calculate the mean time between failures (MTBF).

b. Uptime Calculation: Uptime is calculated on a rolling 6 month basis. Until the Contractor has at least 6 months of performance experience at NMC Portsmouth, the uptime shall be calculated cumulatively for the entire duration of the contract. The downtime indicator in DMLSS or manual calculations may be used to compute these metrics.

c. Variables Definitions:

U= Possible Equipment Uptime (100%) H= Hours of Coverage per day H1= Begin Coverage Time during each day H2= End Coverage Time during each day A= # of covered days of the week W = Weeks of Coverage in a Year C= Uptime Commitment (95%)

d. Known (for this contract):

H1= 0800 hours H2= 1700 hours A= 5 days per week W= 52 weeks per year C = 95%

e. Calculations:

D= Hours of Calculated Downtime (Unknown) T= Total Actual Uptime Percentage (Unknown) Δ= % difference from Uptime Commitment (Unknown)

f. *Note* - Downtime hours shall fall within the Contractor’s hours of coverage. Downtime hours outside of the coverage timeframe. shall not be calculated as a metric of vendor performance. Downtime ends once the system is available for full clinical use.

Replacement Parts/Updates

a. The vendor 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 are required to be shipped, shipping shall be performed in the fastest reasonable means possible at no additional charge 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, non-refurbished, and certified as OEM replacement parts.

e. The vendor shall install software revisions and updates (field service changes) that are required by FDA- or manufacturer-announced safety hazards, alerts, or recalls, including the FDA Year 2000 (Y2K) Compliance Directive, as part of the contract at no additional charge to the Government. Updates and revisions shall be performed as soon as possible after release, no later than the first scheduled Preventative Maintenance inspection after release. For any updates that have been identified as critical or required for the proper operation of equipment by the OEM, the vendor shall provide installation within 30 days of release regardless of preventative maintenance schedules.

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

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 the 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’s personnel.

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 FSE as required for the completion of the services in accordance with this contract.

Vendor Report Requirements.

a. During normal duty hours, vendor FSE personnel shall check-in with the Biomedical Engineering Division 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 Duty BIOMED personnel.

b. The vendor shall provide a full-service report to BIOMED within two (2) days of 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: parts used, parts number/nomenclature, part new or reconditioned, part manufacturer, and problem/corrective action taken or recommended

ix. Problem resolution or pending action

x. Signatures:

1. Field Service Technician performing services

2. BMET verifying service rendered (Identify Medical Treatment Facility)

xi. 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 and contact information (i.e., telephone number)

Vendor Responsibility.

a. The vendor shall be responsible for the repair/replacement of damaged Government-owned equipment and property due to the negligence of the vendor or its representatives. All such replacement or repair shall be at the vendor's expense and shall be inspected to the satisfaction of the Contracting Officer or appointed BIOMED representative.

Removal of Government Property

a. No equipment shall be removed without the approval of the Materials Management Department of the Medical Treatment Facility (MTF). Property passes for equipment removal shall be obtained by the vendor via the Materials Management Department of the MTF. Any failure to obtain such passes which results in detainment or prosecution of vendor FSE personnel are the sole responsibility of the service vendor personnel.

b. The vendor shall provide a detailed description of removed items in writing on the vendor’s company letterhead. For associated items/accessories, the vendor will provide a detailed written description and quantities of items to be removed. This description will include, as a minimum, the manufacturer’s serial numbers and facility equipment control numbers (ECNs) of all equipment and/or items removed. In the event that items/sub-assemblies/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 custody.

d. In regard to patient information confidentiality and privacy, all vendors shall not remove equipment containing patient information from the Government site. The equipment hard drive(s) and/or solid-state drive(s) shall be removed at the MTF prior to removal. Furthermore, equipment removed from the MTF will be prorated from the date of removal for service maintenance fees. If hard drives are to be replaced, they shall be left at the MTF for disposal.

e. Hard Disk and Solid-State Drives (HDD & SSD): In regard to patient information confidentiality and privacy, all Contractors and/or service Contractors shall not remove equipment containing patient information from the NMC Portsmouth. HDD nor SSD shall ever be removed from the MTF, by the Contractor under this maintenance agreement. Removal of protected health information (PHI) and personally identifiable information (PII) from the equipment prior to removal from site must be properly coordinated with the COR and Command Equipment Manager.

Regulatory Requirements: The analyzer and all of the components, shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States.

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