DRAFT SOO_Hematology.pdf

STATEMENT OF OBJECTIVES

The Keesler Medical Center at Keesler AFB, Mississippi requires one (1) Hematology system with two (2) functioning analyzers, slide maker stainer, digital cell morphology system, with advanced red blood cell morphology software. 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 Hematology 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 31,000 Complete Blood Counts (CBC) results, as defined by the FDA, with at least a 6-part differential and 750 reticulocyte panels annually for 5 years (base plus 4 one-year 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. Analyzers must have a bi-directional interface that can connect with the 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 to interface with the LIS. An approved ATO is required prior to use and any subsequent billing.

1.2. Middleware must have an approved ATO prior to use and any subsequent billing.

Military Health System (MHS) Genesis FFP:

The analyzers must have an interface that is compatible to the current Government Laboratory Information System (LIS), Composite Health Care System (CHCS), and new Government LIS, Military Health System (MHS) Genesis. Each interface must allow for recognition and interpretation of CHCS and MHS Genesis generated bar-code labels on all sample tube types. Connectivity between the Contractors 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).

2.1. Instruments/Equipment.

2.1.1. Instruments must be Food and Drug Administration (FDA) approved for testing to include body fluids, including synovial fluid.

2.1.2. Each analyzer must be able to perform a complete blood count (CBC) with red blood cell indices and a 6-part differential to include Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature granulocytes. Included in the CBC are the following:

White Blood Cell Count (WBC) Red Blood Cell Count (RBC) Hemoglobin (Hgb) Hematocrit (Hct) Mean corpuscular volume (MCV) Mean corpuscular hemoglobin (MCH) Mean corpuscular hemoglobin concentration (MCHC) Red cell distribution width (RDW) Platelet (Plt) Mean platelet volume (MPV)

2.1.3. Each analyzer must be able to perform a reticulocyte panel.

2.1.4. Each analyzer must be able to perform an FDA approved immature platelet fraction (IPF) to allow monitoring of bone marrow activity in thrombocytopenic patients. Of the 31,000 CBC test, expect at least 25% (7,750) for IPF. (Specific request from Oncology).

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 the capability to perform automatic repeat of samples and reflex testing without technician intervention based on result criteria and defined decision rules and provide further action comments on patient printouts.

2.1.8. Each analyzer must retain a recent patient history for side-by-side comparison of past results.

2.1.9. The analyzers must meet all necessary power and waste requirements as dictated by the current laboratory workspace. Workspace power and waste requirements are as follows: Power supply must be 120VAC. Drain is plumbed at the back of analyzers. Access point to the drain is required in case of leaks. The drain is located at the rear in approximately the middle of the available space’s length.

2.1.10. Both analyzers and all additional attachments (computer, slide stainer, digital cell morphology system) fit in a 49.75” (depth) x 144” (length) x 80” (height) space limitation. The offeror shall provide a diagram or other graphical representation demonstrating how its proposed equipment fits within the dimensions below with its quote. (See Attachment 1)

2.1.11. Analyzers must be able to connect to and interface with slide maker stainer. Slides must have compatibility with a digital cell morphology system.

2.1.12. Instruments must be able to interrupt routine processing for STAT sample processing.

2.1.13. Contractor must have a Quality control program for peer group comparison and program shall meet or exceed all accreditation requirements (monthly statistics monitoring). User must be able to upload QC data to program using CD/DVD. Thumb drives and remote access are unauthorized.

2.1.14. Each analyzer must be able to perform positive identification of patient samples and sample cassettes shall have Positive sample identification.

2.1.15. Contract must include middleware if needed for auto-validation (instrument results flow directly to electronic health record based on user defined rules in middleware). If no approved ATO, middleware billing will be dormant until the ATO is approved for use and middleware is put into use.

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

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

2.1.18. 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 contractor will include all calibrators, controls and reagents in the contract. The requirement must include reagents to perform 31,000 Complete Blood Counts (CBC) results, as defined by the FDA, with at least a 6-part differential and 1,500 reticulocyte panels annually for 5 years (base plus 4 one-year options).

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 must be billed and shipped monthly.

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 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 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.

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 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 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, linearity, 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 and, where applicable, is familiar with the use of clinical laboratory statistical evaluation software (e.g. EP Evaluator®). 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 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 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, linearity materials 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.