Attachment 1 - PWS.pdf

REQUIREMENTS SPECIFICATION

FOR LEASE OF HEMATOLOGY ANALYZER

1. DESCRIPTION: The Contractor shall provide all personnel, equipment transportation, materials, books, supervision and other items and sources necessary for the lease of a Clinical Laboratory Hematology Analyzer to Ellsworth AFB, SD beginning on or around 15 July 2025, followed by 4 option years. The lease shall also cover cost per reportable requirements and associated supplies for the Complete Blood Count (CBC) test and automated 6-part differential analyzer with FDA approved immature granulocyte enumeration.

The instrument should

- Have a continuous feed auto loader

- Execute auto-sampling

- Automatically rerun tests

- Sample from I3x75 mm K2 and K3 EDTA tubes and BD microtainer tubes.

- Sample in open and closed mode

- Have an approved Authority to Operate (ATO)

- Connect to an LIS via RS-232 port, and Ethernet

- Connect to the DoD Laboratory Information System platform (MHS Genesis).

- Extended linearity for WBC, platelet, and RBC

2. TASKS

2.1. INSTALLATION: The contractor shall provide the government a minimum of 14 calendar days advance notice prior to commencement of work. Contractor shall provide information to the laboratory officer, in writing, identifying the number of people who will be working the day of the installation and any subsequent days to complete the installation process. The contractor shall furnish an installation specialist and/or service engineer to perform system installation. The Clinical Application Specialist, furnished by the contractor, must perform system validation procedures to include calibration, precision, accuracy, linearity studies and data stream verification for LIS interface capabilities.

The activities performed must include:

1. Setting up interface.

2. Entering reference ranges.

3. Setting up QC files and entering QC limits.

4. Linearity verification utilizing commercial linearity material to validate all measured parameters. If commercial linearity material is not available for any parameter to validate linear range, appropriate patient samples may be used.

5.Carry-over studies on measured parameters using high patient samples or linearity material.

6. To obtain acceptable performance of the analyzer, all studies must be presented to the laboratory officer for acceptance prior to contractor departure.

The contractor shall pay all instrument freight charges incurred to have the instrument delivered for installation.

2.3. LIS INTERFACE: The contractor shall furnish interface assistance to ensure that the system is interfaced with the LIS prior to departure. If purchase of additional equipment is required to maintain the LIS system interface, an equipment credit must be allowed as a discount by the contractor.

2.4. MAINTENANCE AND REPAIR/ SERVICE: The contractor shall provide the customer with service required to maintain the instrument at its full capabilities for the term of this agreement as stated below. The instrument belongs to the Contractor and it is the contractor's responsibility to keep the instrument up and running. If the need for a replacement instrument arises at any time during the contract period, the contractor will provide a replacement at the contractor's expense.

Services Must Include:

1. Must provide at least Standard Service (Mon -Fri, 0700. - 1700.) throughout the contract period

2. On-site response within 24 hours

3. 2-hour phone response upon dispatch by Technical Assistance Center

4. Technical Assistance Center 24-hour technical telephone support

5. At least two preventive maintenance/instrument calibration visits per year or more, depending on manufacturer recommendations

6. All necessary replacement parts must be provided by the contractor

2.5. REAGENT SHIPPING AND HANDLING: The contractor shall provide all manufacturer brand reagents and controls necessary to meet the estimated workload of ~4100 Complete Blood Cell counts per year, assuming reasonably efficient utilization. These reagents and controls must be provided on a mutually agreed, pre-determined shipping schedule for the assigned monthly sample volume at no additional cost to the government. Adjustment to any monthly shipment of reagents and controls in order to maintain adequate inventory must be allowed. A schedule of routine shipments should be provided along with the shipping mode based on geographical location. The mode of shipment used should be appropriate for the product being shipped to arrive within all manufacturer specifications. The shipment of temperature-controlled products that are restricted from shipping over weekends and holidays should be sent to arrive during normal duty days.

2.6. TRAINING: Unlimited basic operator training provided virtually.

2.7. SAFETY DATA SHEETS: The contractor shall provide all Safety Data Sheets (SDSs) for all required supply items that are utilized on the system at no cost to the government.

2.8. QUALITY CONTROL: The contractor shall provide a quality control program for constant peer group comparison of instrument performance to be maintained at the highest performance levels at no additional cost to the government. The quality control data must be made available for review by laboratory management within two weeks of data submission.

3. CONTRACTOR FURNISHED EQUIPMENT

3.1 The analyzer and all its support components i.e., UPS, printer and printer cartridges remain the property of the contractor.

4. GENERAL INFORMATION:

4.1 The Clinical Laboratory is located at 2900 Doolittle Dr, Building 6000, Ellsworth AFB, SD 57706. Normal laboratory business hours are Monday- Friday 0730- 1700. The Point of Contacts (POC's) are Clinical Lab Flight Commander or Clinical Laboratory Scientist at (605) 385-3522.

4.2 CONTRACTOR and VEHICLE PASS/BASE AUTHORIZATION: For base access the contractor shall submit a written request on company letterhead to the laboratory for a letter to be generated for base access. The request should list the following: contract number, location of work site, start and stop dates, and names and date of birth of employees and subcontractor employees needing access to the base, license number, and registration number. The laboratory will provide to the Visitor's center a letter requesting base access for the contractor personnel.

When reporting to the Visitor's Center, the authorized contractor individual(s) should provide a valid driver's license, current vehicle registration, and valid vehicle insurance certificate.