DRAFT SOO UA Equipment_Attachment 1.pdf

STATEMENT OF OBJECTIVES

The Keesler Medical Center at Keesler AFB, Mississippi requires one (1) Urinalysis (UA) system with two (2) functioning analyzers, one primary and one backup. The successful offeror shall furnish all equipment, reagents, controls, and any necessary services (e.g., maintenance of furnished equipment) to Keesler Medical Center, Keesler AFB, MS for the purpose of Urinalysis testing under an equipment lease agreement. This requirement will be met via equipment rental/lease or on a Cost Per Reportable Result (CPRR) basis. The requirement must include reagents to perform 900 UA chemistry test monthly and 700 UA microscopic exams monthly for 5 years (12-month base plus four 12-month options). All equipment and reagents shall be supplied and serviced through the Contractor to include all parts, equipment, supplies, and other services required to ensure Keesler Medical Center is able to meet its objectives as listed herein.

Period of Performance:

Base: 1 October 2024 – 30 September 2025 Option 1: 1 October 2025 – 30 September 2026 Option 2: 1 October 2026 – 30 September 2027 Option 3: 1 October 2027 – 30 September 2028 Option 4: 1 October 2028 – 30 September 2029

1. Authorization to Operate (ATO) (Subfactor 1A)

1.1 Primary and back up analyzer must have a bi-directional interface that can connect with laboratory information system (LIS), as listed on https://info.health.mil/apps/HIT/cstar/Pages/Systems.aspx. Newly installed instruments will require an approved authorization to operate (ATO) on the DHA network in order to interface with the LIS. An approved ATO is required prior to use and any subsequent billing.

2. Instruments/Equipment and Reagents/Consumables (Subfactor 1B).

2.1. Instruments/Equipment.

2.1.1. Instruments must be Food and Drug Administration (FDA) approved for testing.

2.1.2. The primary analyzer must be able to perform a complete urinalysis exam to include 12 part macroscopic chemistry (glucose, protein, bilirubin, urobilinogen, pH, blood, ketone, nitrite, leukocyte esterase, clarity, specific gravity and color) and microscopic exam.

2.1.3. The analyzers must meet all necessary power requirements as dictated by the current laboratory workspace. Workspace power is as follows: Power supply must be 120VAC.

2.1.4. Both analyzers and any additional attachments ideally fit in a 30” (depth) x 60 (length) x 50” (height) space limitation. Analyzers must fit within this space to keep from interfering with the specimen window operation. Outlets are approximately 4’ from workbench. The offeror shall provide a diagram or other graphical representation demonstrating how its proposed equipment fits within the prescribed dimensions with its quote.

2.1.5. Each analyzer must be able to perform positive identification of patient samples.

2.1.6. The entire system must be independent of remote connections (internet, cloud, etc.) to be functional and serviceable.

2.1.7. Medical Technicians shall have the ability to walk away without any negative impact during the operational running of cycle.

2.1.8. Must test for 10 urine chemistries (including specific gravity) and color and clarity.

2.2. Reagents/Consumables.

2.2.1. The contractor will include all calibrators, controls and reagents and supplies in the contract.

2.2.2. In determining reagent requirements, the Contractor shall consider requirements for routine quality control runs, routine calibration, periodic calibration/calibration verification in accordance with departmental policy and troubleshooting of out-of-control assays when calculating the yearly requirements.

2.2.3. Reagents/supplies must be shipped on a regular schedule.

3. Service and Maintenance (Subfactor 1C). The Contractor shall meet the following service and maintenance requirements.

3.1. Preventative maintenance and 24/7 technical support (with local service personnel preferred) included with service contract along with all replacement parts, supplies and labor.

Response to service needs provided not later than 24 hours and resolution not later than 48 hours from report of service need or receipt of replacement parts within standard business hours (5 days, 8 hours). If both analyzers are down, service personnel must be on-site within 4 hours of initial notification.

3.2. Service contract shall provide all personnel, equipment, tools, materials, supervision, parts, transportation, and other items and services necessary to perform all required repairs and scheduled preventive maintenance/safety inspections and calibrations of equipment. The performance of scheduled periodic preventive maintenance, safety checks, and calibrations that are not normally performed at the operator level shall be performed by Contractor service personnel in accordance with requirements as specified in the Contractor’s instrument maintenance manual. Completion of analyzer installation will establish time-zero for determining the time frame for performance of periodic services.

3.3. Any service technician provided by the Contractor shall adhere to all required reporting procedures for Keesler Air Force Base.

3.4. In all cases, the Contractor shall provide all reagents, calibrators, controls, and any other materials necessary to troubleshoot instrument failure. Replacement parts used, as necessary, claimed from local operator-level maintenance kits as well as any reagents that may have been used shall be replaced at no cost by the Contractor.

3.5. If an analyzer move is deemed necessary, the contractor shall relocate/revalidate any instrument if requested by the Government at no additional cost.

3.6. Contractor shall provide product service and support to include updates to operational software throughout the life cycle of the equipment.

3.7. Must have minimal daily (equal or less than 20 minute hands-on), weekly (equal or less than 30 minutes hands-on) and monthly (equal or less than 2 hour hands-on) maintenances.

4. Training (Subfactor 1D).

4.1. The Contractor shall provide the following training at no additional cost to the Government:

4.1.1. Initial training (upon award) for two (2) key operators including lodging (hotel), per diem, and travel (airfare) expenses to/from Keesler AFB, hotel, and training location (offsite location). Additional training, upon request, for one operator per year per instrument (if offsite, lodging (hotel), per diem, and travel (airfare) expenses included to/from Keesler AFB, hotel, and training location). Alternative training delivery (i.e., distance training), if determined by the Government customer to be of equivalent quality, may be entertained in lieu of offsite, in-person training for non-initial training.

4.1.2. All training shall include basic analyzer operation, troubleshooting procedures, performance of operator level periodic preventive maintenance procedures, and use any data management/quality control software.

5. Delivery and Installation (Subfactor 1E).

5.1. All systems shall be delivered to the appropriate location indicated below.

Keesler Medical Center 81MDTS/SGQC Laboratory 1E326 301 Fisher St Keesler AFB, MS 39534

5.2. The Contractor shall assign a Program Manager to oversee all operations required for successful implementation and execution of the requirement.

5.3. Within 10 working days after contract award, Contractor shall coordinate and conduct a post award site visit for the purpose of coordinating the schedule for equipment installation.

5.4. Contract must include instrument installation, set-up, validation, supplies and labor.

Instruments must be installed, validated and ready for patient testing within 60 days of award.

This includes all correlation, precision, normal range and any other required validation studies by a contractor provided technical service representative (TSR). The TSR should possess a thorough knowledge of method validation/verification. The assigned TSR will be responsible for the entire method validation to the standards of the acting medical director. The completed validation studies and raw data must be provided to the management staff electronically and in a binder at least 3 weeks prior to analyzer functionality.

5.5. Method validation/verification will be conducted in accordance with CLIA and/or the College of American Pathologists (CAP) and to the ultimate satisfaction of the medical director.

5.6. The method validation/verification will be completed and approved by the Laboratory Director prior to reporting of patient results. Payment for services will not begin until the analyzer system has been approved for reporting of patient results.

5.7. All instrument reagents, calibrators, and other required reagents/materials used in the method validation/verification study will be provided by the Contractor at no additional cost to the Government. Assay lots will be quality checked upon delivery. Contractor’s customer samples may also be used. These materials will not be used in the analysis of specimens for patient care.