25Q0014 - SON Chemistry Immunology Analyzers -3 Jun 2025.pdf

Statement of Need (SON)

MacDill AFB Chemistry and Immunoassay Platforms

3 June 2025

1.0 PURPOSE

1.1. This SON will provide the MacDill AFB laboratory with one new mid-volume integrated Chemistry/ Immunology platform or one new mid-volume Chemistry platform and one new Immunoassay (special chemistry) platform. The analyzer must fit in the allocated space area. The analyzer must not exceed 11 feet long, 5 feet width, and 5 feet high. The company must have a current authorization to operate (ATO) certificate for the proposed equipment. The equipment use, equipment service, calibrators, and reagents are to be included in the cost and proposal. This contract will include scheduled preventative maintenance, telephonic technical support as well as in-house service as needed.

The systems must be compatible with the Medical Group’s laboratory information system (LIS) which is the MHS Genesis and must include all normal ranges, reference intervals and units of measurement for each assay. The vendor must provide a type-one reagent grade water system if applicable/required.

Service contract covering the term of the agreement is the requirement of the contractor, if required.

1.2. NON-PERSONAL SERVICES AND/OR INHERENTLY GOVERNMENTAL SERVICES.

The Government will neither supervise contractor employees nor control the method by which the contractor performs the required tasks. It shall be the responsibility of the contractor to manage its employees and to guard against any actions that are of the nature of personal services or give the perception of personal services. If the contractor feels that any actions constitute, or are perceived to constitute personal services, it shall be the contractor’s responsibility to notify the PCO immediately. These services shall not be used to perform work of a policy/decision making or management nature, (e.g., inherently governmental functions).

All decisions relative to programs supported by the contractor shall be the sole responsibility of the Government.

2.0 REQUIREMENT/DESCRIPTION OF SERVICES

2.1. Point Of Contact. A point of contact and liaison will be provided for the laboratory staff at the 6th Medical Group.

2.2. Orientation. Contractor shall provide all necessary training required to operate the instrument to all laboratory personnel at time of delivery. Training and associated expenses (room, board, and airfare) for 2 key operator(s) per instrument for the base year of the contract and 1 key operator per instrument is included.

2.3. Hours of Operation: The MacDill AFB laboratory operates a 5-workday schedule (Monday – Friday 7:30-4:30) except for federal holidays, family days which the laboratory is closed.

2.4. Contractor must provide six sigma data (peer group data) on chemistry testing which is verified by 3rd party source, using Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) guidelines.

2.5. The systems must use random access technologies that improve workflow and efficiency.

2.6. The Platforms, at a minimum, must be able to perform the following tests from primary collection tube:

Albumin (ALB) Alcohol/Ethanol

(ALC/ETOH)

Alkaline Phosphatase

(ALK/ALKP)

Alanine Aminotransferase (ALT) Aspartate Aminotransferase

(AST)

Direct Bilirubin (dBILI)

Total Bilirubin (TBILI) Blood Urea Nitrogen (BUN) Bicarbonate (ECO2)

Calcium (CA) Cholesterol (CHOL) Chloride (CL)

Creatinine (CREAT) Gamma-Glutamyl Transferase (GGT)

Glucose (GLUC)

Hemoglobin A1C (HBA1C) High Density Lipoprotein

(HDL)

High Sensitive C-Reactive Protein (HSCRP)

Potassium (K) Phosphate (PHOS) Magnesium (MG)

Sodium (NA) Triglyceride (TRIG) Total Protein (TP)

Total Prostate-Specific Antigen

(TPSA)

3rd generation Thyroid- Stimulating Hormone (TSH)

Free Thyroxine (FT4)

2.7. Contractor will provide any corresponding liquid reagent ready to use w/o temperature equilibration to perform each test.

2.8. Contractor will provide a copy of the number of product recalls for the requested tests above within the last 12 months and within 14 days from the date of initiating recall. All requested assays must be FDA approved.

2.9. The analyzer provided by the contractor must meet the following:

2.9.1. Perform more than 25 HbA1Cs per hour without pretreatment and aliquoting sample from original collection tube. The HbA1C test must be able to be run in a full HbA1C sample rack.

2.9.2. A type-one reagent grade water system if required adequate to support the analyzer(s) for operation, liquid ready to use reagents and no required temperature equilibration or reconstitution.

2.9.3. Reagent cartridge must be >200 tests capacity for Comprehensive Metabolic panels with no disposable cuvettes for regular chemistry testing platform.

2.9.4. Instruments must have load on the fly capabilities for reagents, samples, bulk solutions and consumables without having to stand-by the instrument or wait for temperature equilibration for these functions. Analyzers must be able to repeat and reflex test, auto-rerun and auto-dilute.

2.9.5. Analyzers must feature error-proof reagent and commodity design with built in safeguards to prevent reagent mix-ups, probe crashes.

2.9.6. Analyzers must prevent the user from performing tests on a reagent that has not been calibrated.

2.9.7. Analyzer will alert user if a reagent has exceeded on-board stability or has exceeded the lot expiration date.

2.9.8. Except for electrolytes and up to three additional analytes, the frequency of calibration of both regular chemistry and immunoassay (special chemistry) must occur no sooner than 7 days.

2.9.9. Audible alarm and/or visual alerts are available to prompt user to perform calibration.

2.9.10. Quality control frequency must not to exceed once per 8 hours and IAW CAP requirements.

2.9.11. Analyzer must have QC notification capability to alert the user when QC is not acceptable and/or not performed.

2.9.12. Total annual instrument and hands on technician time should not exceed 60 hours for Chemistry and 50 hours for Immunoassay.

2.9.13. Total combined daily maintenance should not exceed 15 minutes.

2.9.14. Total combined weekly maintenance should not exceed 25 minutes hands-on time.

2.9.15. Total combined monthly maintenance should not exceed 60 minutes hands-on time.

2.9.16. The instrument must have easy access (front and/or top of analyzer) for part replacement.

2.9.17. Vendor shall provide any routine and special items required to operate and maintain the equipment in optimal condition such as: linearity materials for initial integration, printers, type-one reagent grade water supply (if required), consumable equipment parts, and required replacement parts for maintenance or service.

2.9.18. The systems must be able to assess the level of common indices (hemoglobin, lipemia, icterus) for each sample. If additional materials are needed, the materials will be included in the cost.

2.9.19. Analyzer must be able to compatible and performed quality control using third party quality control material.

2.9.20. The Chemistry analyzer must be able to detect clots and have an auto-clearing mechanism.

2.9.21. The immunoassay analyzer must be capable of run STAT samples and auto reflex testing.

2.9.2.1.1. Throughput of up to 100 tests per hour Random access for running any combination of samples at any time. In addition, must have rapid kinetics for improved turnaround time.

2.10. Equipment Administrative Support.

2.10.1. Computer software must include integrated on-board operational manual support to include management of quality control data, training, maintenance, and troubleshoot tips.

2.10.2. The vendor must provide a written operational manual.

2.10.3. Type-one reagent grade Water source (if required) and waste must have the ability to be self-contained.

2.10.4. The vendor must provide the water system (if required), maintenance, and supplies.

2.10.5. The manufacturer will provide a UPS for each analyzer capable to complete testing in progress as well as protection against electrical fluctuations.

2.10.6. During the last six months of this contract, we will operate at full capacity while also operating in the transitionary functionality to a new contract and new equipment.

2.10.7.

3.0 Administrative Support.

3.1. The contractor must deliver and complete the initial validation/comparison studies for each analyzer in accordance with College of American Pathology regulations and any other state requirements, provide to the 6th Medical Group Laboratory a complete record of validation(s) within 30 days of contract award.

3.2. The contractor will administer all corrective action for failed performance during initial validation until rectified and IAW CAP requirements.

3.3. The contractor will pay for all validation samples (i.e. Maine Standards or other commercial standards).

3.4. The Contractor will customize the software to meet specific customer requirements at no additional cost.

3.5. The contractor will conduct scheduled preventive maintenance and cover the cost of items necessary to perform the scheduled preventive maintenance.

3.6. Any time the analyzer is not functioning IAW the SON, a 24-hour response time (excluding weekends/federal holidays) from an on-site field service engineer will be required to ensure continuous service to the medical providers.

3.7. All technical updates and software upgrades must be provided for the analyzers and the reagents as applicable/required with the shipment of the reagent(s) at all times.

4.0 Required Supplies.

4.1. All reagents and supplies will be delivered to the MacDill Laboratory on an evenly distributed quarterly drop shipment not to exceed the annual usage IAW Attachment 1: MacDill Air Force Base Chemistry/Immunoassay Quarterly Reagent Usage.

4.2. Vendor must replace any reagent and calibrator material at no cost if a recall or issues are encounter with the material (i.e. product recall).

4.3. All deliveries must be within a week from the ordering date, tracked by the contractor and provide the government notification if excess is delivered. Any delays or unavailability must be immediately communicated (within 24 hours) to the 6th Medical Group Laboratory. Additional compensation will not be provided to the vendor for additional quantities shipped in error.

5.0 MINIMUM REQUIREMENTS AND DELIVERABLES

The contractor shall provide the following:

NAME SON Reference Due Date

Instrument Manual 2.71 & 2.72 With Delivery of Machine

24-hour response time for instrument malfunction

2.8.6 On-going support

Deliver and set up A type-one reagent grade water system/maintenance & parts.

2.9.2/2.7.4 Within 30 days of contract award

All technical updates and software upgrades.

2.8.7 As Required

Provided a complete record of validation.

2.8.1 With Delivery of Machine

Liquid reagent ready to use (w/o temperature equilibration).

2.7 On-going support

Customize the software 2.8.4 As requested

Reagent cartridge must be >200 tests capacity for Comprehensive Metabolic panels with no disposable cuvettes for chemistry testing.

2.9.3 Delivered with machine and

on-going support

Analyzers must prevent the user from performing tests on a reagent that has not been calibrated.

2.9.6 Delivered with machine and

on-going support

Analyzer must have QC notification capability to alert the user when QC is not acceptable and/or not performed.

2.9.11 Delivered with machine and

on-going support

Peer Group Data Report 2.4 Monthly Basis

Analyzer must be able to perform quality control using third party quality control material.

2.9.19. Daily Basis

All deliveries must be within a week from the ordering date

5.0 As requested

6.0 SERVICES SUMMARY

Services Summary

Reference Performance Objective Performance

Threshold

SON

Para.

SS1 Perform more than 25 HbA1Cs No more than 1 time 2.9.1 per hr without any pretreatment or aliquoting specimen from original collection tube per month

SS2 Total combine daily maintenance should not exceed 15 minutes.

No more than 2 time per month

2.9.13

SS3 Total combine weekly maintenance should not exceed 25 minutes hands-on time.

No more than 2 time per month

2.9.14

SS4 Total combined monthly maintenance should not exceed 60 minutes hands-on time.

No more than 1 time per year

2.9.15

SS5 Total annual instrument and hands on technician time should not exceed 60 hrs for Chemistry and 50 hrs for Immunoassay.

100% 2.9.12

SS6 All technical updates and software upgrades must be provided for the analyzers and the reagents as applicable/required with the shipment of the reagent(s).

100% 3.7