SOO Coagulation 2025.pdf

STATEMENT OF OBJECTIVES

The Keesler Medical Center at Keesler AFB, Mississippi requires two (2) identical and completely separate Coagulation analyzers. The successful offeror shall furnish all equipment, to include instrument installation, set-up, equipment validation (along with the associated supplies and labor), reagents, controls, and any necessary services (e.g., maintenance of furnished equipment) to Keesler Medical Center, Keesler AFB, MS for the purpose of Coagulation testing.

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 4,000 Prothrombin time (PT) assays, 3,000 Activated Partial Thrombin time (aPTT or PTT) assays, 600 d-dimer assays, and 150 fibrinogen assays per year. In addition, yearly lot to lot conversion performed by a company specialist shall be provided in pricing. All equipment and reagents shall be supplied and serviced through the Vendor to include all parts, equipment, supplies, and other services required to ensure Keesler Medical Center is able to meet its objectives as listed herein. Equipment and associated peripherals must be delivered in such a time that installation, set-up and validations are completed and approved by the Laboratory Director to begin patient testing by the start of the base year of the period of performance. In addition, the Contractor must have an approved authority to operate (ATO) prior to use and any subsequent billing. ATO approval must be maintained and valid through the life of the contract.

Period of Performance:

Base: 1 October 2025 – 30 September 2026 Option 1: 1 October 2026 – 30 September 2027 Option 2: 1 October 2027 – 30 September 2028 Option 3: 1 October 2028 – 30 September 2029 Option 4: 1 October 2029 – 30 September 2030

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

1.1. Analyzers must have a bi-directional interface that can connect to and be fully interoperable with the laboratory information system and have an approved ATO as listed on CSTAR (https://info.health.mil/apps/HIT/cstar/Pages/Systems.aspx) prior to award. ATO approval must be maintained and valid through the life of the contract.

1.2. Middleware must have an approved ATO prior to use and any subsequent billing, and approval must be maintained and valid through the life of the contract.

1.3. Each interface shall allow for recognition and interpretation of MHS Genesis generated bar-code labels on all sample tube types. Connectivity between the Vendor instrument systems and middleware to each LIS will be required at varying times during the contracted period of performance. Location: 81MDTS/SGQC Clinical Laboratory, Keesler Medical Center, Keesler Air Force Base, MS.

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

https://info.health.mil/apps/HIT/cstar/Pages/Systems.aspx

2.1. Instruments/Equipment shall meet the following minimum requirements:

2.1.1. Instruments must be Food and Drug Administration (FDA) approved for testing to PT and PTT, D-dimer, and Fibrinogen. D-dimer must also be FDA approved for exclusion of deep venous thrombosis (DVT) and pulmonary embolism (PE) when used in combination with a pretest probability (PTP) score, without further imaging studies.

2.1.3. Each analyzer must automatically calculate INR (international normalization ratio) and included with each PT result.

2.1.4. Each analyzer must be fully automated.

2.1.5. Each analyzer must have a reagent bar-code identification system containing the lot number, expiration date, and unique identification code.

2.1.6. Users must be able to program on board user defined decision rules according to laboratory needs. Any additional software required to meet these requirements must be included in the offer price.

2.1.7. Each analyzer must have a cap piercing needle.

2.1.8. Each analyzer must automatically perform on-board dilutions when needed.

2.1.9. Each instrument must be tabletop and no larger than 68” in width (this includes any operating systems that sit beside the analyzer), 36” in height, and 34” in depth.

2.1.10 Instruments must be able to interrupt routine processing for STAT sample processing with minimal delay from order to aspiration.

2.1.11. Must be able to submit monthly quality control (QC) for peer group comparison.

2.1.12. Instrument must have on-board QC program with the following characteristics: Levy- Jennings charts, individual data point accumulation and cumulative QC data information, such as, standard deviation, coefficient of variation and mean for each test.

2.1.13. Instruments must audibly and visually alert user when QC is out of range and must be able to halt testing and /or print an alert on patient reports when quality control (QC) has not been performed or is out of range.

2.1.14. Instruments must be capable of audibly notifying the end user when reagents need to be replaced, and errors are detected.

2.1.15. Each instrument must have its own on-board waste container. No drain available for waste.

2.1.16. Instruments must have onboard rules for auto-verification.

2.1.17. Instruments must have the ability to detect insufficient sample volumes.

2.1.17.1 Instruments must have the ability/technology to detect and eliminate interference from lipemia, icterus and hemolysis, preventing recollections and delays in care for emergent and critical care patients.

2.1.18 All instruments and testing must be set up and validated in compliance with Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and College of American Pathologist (CAP) standards.

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

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

2.1.21. Peripherals shall include at a minimum; Instrument stands (as needed), uninterruptable power sources (UPSs), electrical line conditioners, as required, instrument-specific computer terminals/CPUs, keyboards, computer mouse; Printers shall include at a minimum, initial toner for each as needed, and other equipment where required.

2.2. Reagents/Consumables.

2.2.1. The Vendor will include all reagents, controls and consumables in the contract. perform 4,000 Prothrombin time (PT) assays, 3,000 Activated Partial Thrombin time (aPTT or PTT) assays, 600 d-dimer assays, and 150 fibrinogen assays annually for 5 years (base plus 4 one-year options).

2.2.2. In determining reagent requirements, the Vendor 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. PT, PTT, D-dimer and Fibrinogen reagents must be pre-calibrated. If not, calibration must be included in TSS/CAS (Technical Support Specialist/Clinical Application Specialist) performed lot conversion and reagent lot numbers must be sequestered.

2.2.4. For applicable tests, (PT, PTT, and fibrinogen) the company must be able to provide a TSS/CSS (Technical Support Specialist/Clinical Application Specialist) to perform yearly lot conversions to include normal range verification studies and sequester reagents that require lot conversions for each contract year.

2.2.5. Sequestered lots of reagent and quality control (QC) must have a shelf life that is 18 months or more.

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

3.1. Preventative maintenance and 24/7 technical support 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 (local service personnel preferred) 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 Vendor service personnel in accordance with requirements as specified in the Vendor’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 Vendor shall adhere to all required reporting procedures for Keesler Air Force Base.

3.4. In all cases, the Vendor 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 Vendor.

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

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

3.7. Operator level daily maintenance must be minimal and take less than approximately 10 minutes daily.

4. Training (Subfactor 1D).

4.1. The Vendor 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, rental car), 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 (lodging (hotel), per diem, and travel (airfare, rental car) 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 the use of 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 Clinical Laboratory Rm 1E326 301 Fisher St Keesler AFB, MS 39534

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

5.2.1. The Project Manager will provide a timeline identifying critical points in the delivery/installation phase, wherein Day 0 = Notice of Award.

5.3. No less than 10 calendar days from the contract award, vendor shall coordinate and conduct a post-award site visit for the purpose of coordinating the schedule for equipment installation and validations.

5.3.1. Vendor must include Utility layout required and CAD drawing with detailed analyzer layout with proposal. (See current layout – attachment 1).

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

Instruments must be installed, validated and ready for patient testing by the start of the base year of the period of performance. The on-site installation process should begin no less than 90 days after award, but as soon as necessary to ensure equipment is fully operational on first day of the base year of the period of performance. This includes all correlation, precision, linearity, normal ranges, and any other required validation studies by a vendor provided Clinical Application Specialist. The Clinical Application Specialist should possess a thorough knowledge of method validation/verification and, where applicable, is familiar with the use of clinical laboratory statistical evaluation software (e.g. EP Evaluator®). The assigned Clinical Application Specialist will be responsible for the entire method validation. The completed validation studies and raw data must be provided to the Hematology 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 regulations and CAP standards.

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

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