FA481422TF066 - Attachment 1 - SON.pdf

Statement of Need (SON) FOR

MacDill AFB Urinalysis 27 April, 2022

1.0 PURPOSE

1.1. The contractor shall provide the MacDill AFB and Sabal Clinic laboratories with two table top fully automated urine chemistry with a microscopy analyzers with streamline flow. Each automated solution must include a chemistry module, workcell bridge, microscopy module CPU, monitor, and uninterrupted power supply (ups). The analyzers must have load-and-go walkaway capability and Edit-Free Release technology to minimizes interruptions and technician intervention. The analyzer must fit in the allocated space area, therefore should not exceed 87 inches. The analyzers must have Digital Flow Morphology technology with Auto Particle Recognition (APR) Software to standardized results. Must be able to recognize and auto-classifies 12 urine particles based on the size, shape, contrast and texture. The company must have a current authorization to operate (ATO) certificate for the propose 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 Composite Healthcare System (CHCS)/Genesis and must include all normal ranges, reference intervals and units of measurement for each assay.

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 for each option year is included.

2.3. Hours of Operation: The MacDill AFB and Sabal Clinic laboratories operates a 5 workday schedule (Monday – Friday) with the exception of federal holidays, family days which the laboratory is closed.

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

2.4.1. The systems must use random access technologies that improve workflow and efficiency and provides onboard validation and result verification into a single step without the need for additional middleware.

2.4.2. The analyzer must have sample identification capability by using auto ID-barcode and keyboard entry ID and be capable to process up to 50 urines per hour.

2.4.3. The analyzer should operate with Windows 10 and communicate bidirectional with host query.

2.4.4. The Urinalysis test capability must include:

Chemsitry:

Glucose, Protein, Bilirubin, Urobilinogen, pH, Specific Gravity, Blood, Ketones, Nitrite, Leukocyte, Color, Clarity, Color Compensation Pad

Microscopy:

Urine particles: RBC, WBC, WBC Clumps, Squamous Epithelial Cells, Non-Squamous Epithelial Cells, Hyaline Casts, Unclassified Casts, Crystals, Bacteria, Yeast, Sperm, Mucus

Additional categories for subclassification:

Unclassified casts: Granular, Cellular, Waxy, Broad, RBC, WBC, Epithelial Cell, Fatty Casts

Crystals: Calcium Phosphate, Uric Acid, Calcium Carbonate, Leucine, Cystine, Tyrosine, Amorphous Calcium Oxalate, Triple Phosphate Non-squamous epithelial cells: Renal Epithelial, Transitional Epithelial

Yeast: Budding Yeast, Yeast with Pseudohyphae

Other: RBC Clumps, Fat, Oval Fat Bodies, Trichomonas, Dysmorphic RBCs .

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

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

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

2.4.8. Quality control frequency must not to exceed once per 8 hours.

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

2.4.10. 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.

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

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 for each site.

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

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 45 days of contract award on both sites.

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

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) if applicable. Electronic delivery of upgrades may not be an option, coordinate with 6 MDG for method required.

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. The vendor should provide enough supplies to enable the process of 5.1K urine samples per year at MacDill AFB and 1.7K urine samples per year at Sabal Clinic.

4.2. Vendor must replace any reagent and calibrator material at no cost if a recall or issues are encounter with the material (e.i. 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 (w/I 24 hrs) to the 6th Medical Group Laboratory. Additional compensation will not be provided 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 2.10.2. With Delivery of Machine

24-hour response time for instrument malfunction

3.6. On-going support

All technical updates and software upgrades.

3.7. As Required

Provided a complete record of validation.

3.1. With Delivery of Machine

Customize the software 3.4. As requested

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

2.4.6. 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.

2.4.9. Delivered with machine

and on-going support

6.0 CONTRACTOR MANPOWER REPORTING

In accordance with Section 8108 of the National Defense Appropriations, Act of Fiscal Year 2011 the contractor shall report, annually, the number of contractor employees performing services on Department of Defense installations in support of this contract. The contractor shall also report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract via a secure data collection site. The contractor shall completely fill in all required data fields in the eCRMA (electronic Contractor Manpower Reporting Application) located at http://www.ecmra.mil. Reporting inputs shall be for the labor executed during the period of performance for each Government fiscal year (FY), which runs 1 October through 30 September. While inputs may be reported any time during the FY, all data shall be reported no later than 31 October* of each calendar year. Contractors may direct questions to the CMRA help desk.

*Reporting Period: Contractors are required to input data by 31 October of each year. Uses and Safeguarding of Information: Information from the secure web site is considered to be Proprietary in nature when the contract number and contractor identity are associated with the direct labor hours and direct labor dollars. At no time will any data be released to the public with the contractor name and contract number associated with the data.