36C26321Q0035 – Sources Sought – 6640–Sources Sought CPT/CPRR Urinalysis testing Lab

Oct 9, 2020 | Sources Sought

This is a REQUEST FOR INFORMATION (RFI) only. Market research is being conducted to determine the amount of qualified and capable businesses that can provide the items requested below. If you believe your firm is able to provide the items requested below, you are encouraged to respond by the due date with all of the required information indicated below in order to be considered. Due date for responses is close of business (4:30PM local time/CT) on Friday, October 16, 2020. Email responses to Melanie Stockman at melanie.stockman@va.gov. All questions must be submitted in writing to the Contracting Officer in writing via email. Because this is a request for information only, answers to questions will not be posted. Telephone inquiries will NOT be accepted/returned. Only authorized distributors will be considered in the procurement process.

When submitting a response to this RFI, offerors must include the following:
Indicate socio-economic status
Include picture of offered items and support literature, brochure etc
Indicate any existing Government contract where item(s) may be purchased (i.e. FSS/GSA contract etc)
Point of contact, DUNS number, complete mailing address, telephone number & email address
Proof of authorized distributor status for ALL items submitted for consideration
Demonstrate ability to provide installation/training

DISCLAIMER-This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201 (e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.

NAICS: 325413

Size Standard: 1250 employees

SPECIFICATIONS:
Cost per test Urinalysis Testing for MPLS and TP

Basic Requirement:
1.1.1 The Minneapolis Veteran Affairs Healthcare System, 1 Veterans Drive, Minneapolis, Minnesota, 55417, here in after referred to as the MVAHCS, and the Twin Ports outpatient Clinic, herein after referred to as TPCO, are in need of a Cost-Per-Test or Reagent Rental contract for a walk-away, fully automated Urinalysis testing for the Minneapolis and Twin Ports laboratories. They will both need a primary and a backup instrument. The need of the agreement is to be for one year (12 months) plus an additional four, twelve-month long, option year periods to be exercised at the discretion of the government.
1.1.2 The contractor shall propose the suggested/recommended equipment/ reagents that meet the requirements of the facility. The contractor may offer different instruments to each site to meet each sites individual needs. The Primary and back up method offered to MVAHCS must be identical and easily switched back and forth.

Required Features:
1. 2.1The instrument shall be approved by the Food and Drug Administration (FDA) for the use in urinalysis testing.
1.2.2The instrument shall have macroscopic and microscopic testing capabilities.
1.2.2.1 Instrument shall include hardware and software to perform microscopic testing visually electronically through a monitor rather than with a manual microscope.
1.2.2.2Macroscopic chemical analysis of urine is to include but not limit to: Color, Clarity, specific Gravity, PH, presence/absence of leukocytes, nitrates, total protein, glucose, ketone, ascorbic acid, blood, and bilirubin.
1.2.2.3 Microscopic analysis of the urine shall be able to detect at least: RBC/HPF, URINE WBC/HPF, WBC CLUMPS, BACTERIA, YEAST, SQUAMOUS EPITHELIAL, TRANSITIONAL EPITH. CELLS, RENAL EPITHELIAL CELLS, HYALINE CASTS, EPITHELIAL CASTS, WBC (White Blood Cell) CASTS, RBC (Red Blood Cell) CASTS, GRANULAR CASTS, FATTY CASTS, TRI PHOSPHATE CRYSTALS, CA++ OXALATE CRYSTALS, CA++ PHOSPHATE CRYSTAL, CA++ CARBONATE CRYSTAL, URIC ACID CRYSTALS, WAXY CASTS
1.2.2.4 The instrument shall be walk away-fully automated.
1.2.2.5 The instrument shall have a barcode scanner that scans MVAHCS and TPCO labels. Both sites utilize the standard 128 code.
1.2.2.6 Equipment must accept, at a minimum, 10 characters in specimen identifier that is alphanumeric.
1.2.2.7 The instrument shall contain software with evaluation rules that can be adjusted by MVAHCS and TPCO per clinical director instructions for specimen review at each site.
1.2.2.8 Contractor shall collaborate with each lab to write/develop protocols to establish customer configurable rules to enhance workflow management and productivity at no additional cost to the government.
1.2.2.9 Contractor shall assist customer with optimizing operation and utilization of the data management system to fully integrate desired testing instrumentation enhancing productivity and management of workflow at no additional cost to the government.
1.2.2.10 The primary and back up instruments instrument shall have auto-validation capabilities.
1.2.2.11 Contractor must offer a back-up testing instrument for the event the primary instrument is non-operational.
1.2.2.11.1 Back up testing instrument for MVAHCS must be fully automated.
1.2.2.12 The instrumentation shall have monitors/screens that clearly display information in all light conditions.
1.2.2.13 Contractor shall supply printer(s) (one per instrument supplied) that has the capability of printing a patient report with patient demographic information that includes minimally the patient s name and accession or unique identifier number (UID).
1.2.2.14 An uninterruptible power supply (UPS) with line conditioner for each instrument provided. (This includes UPS units for sites with automation lines, specimen management systems, data management systems, refrigerated storage, etc,) Each UPS must provide electrical power for a minimum of 15 minutes after electrical power fails and the system must allow for an automatic controlled shutdown to prevent damage to the instrument and data records.
1.2.2.15 Sufficient memory to store patient information and test records with downloading capability to an external medium for long term storage of patient records and other information.
1.2.2.16Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage.

Equipment Rental:
1.3.1 The Reagent Rental or Cost-Per-Test price shall include at no additional cost: all equipment, installation, reagents, calibrators, controls, standards, disposables and consumable supplies (i.e. cups, probes, etc.), control products, linearity testing material, printers, interface (including software and hardware) to the VA Lab package in VistA system through Data Innovations, training of end users, system preventative maintenance (including parts, labor, travel), all shipping costs, and term of agreement to support the instrument for the term of the contract.

1.3.2Equipment may be provided under a Reagent Rental/Cost-Per-Test agreement or on an equipment rental basis. If equipment is provided under a Reagent Rental/Cost-Per-Test agreement, then all equipment costs shall be figured into the price of the reagents.
1.3.2.2Equipment Ownership: Contractor shall retain ownership of the equipment.
1.3.2.3Equipment replacement: In the event any parts of the instrument or supplied items is no longer functional it shall be the contractor to replace those in a timely manner.
1.3.3 Removal of Equipment: Upon termination or completion, the MVAHCS Bio Medical department will remove the hard drive and terminate it according to VA policies and procedures. The actual equipment will be the contractor s responsibility to dismantle, decontaminate and remove the equipment from MVAHCS and TPCO premises. All costs for removal and return of equipment shall be borne by the contractor.

Site Preparation and Planning:
1.4.1The contractor will make recommendations regarding site preparation and planning. The Contractor will provide documentation and information characterizing the physical, electrical, technological, and environmental requirements of the equipment prior to installation.
1.4.2 A risk assessment will be completed before instrumentation can be placed on the MVAHCS and TPCO systems.
1.4.3 Remote access cannot be guaranteed to the contractor. Instrumentation shall be installed and able to be fully operational without remote access being granted to the contractor. No additional cost to the government shall incur if remote access is not granted, and instrument must be able to have full operational capabilities without the remote access.

Equipment Installation:
1.5.1 The Contractor shall bear the responsibility of delivering and installing all equipment to both sites at no additional cost to the government. The installation of all equipment will be coordinated with the both Laboratory Services. Installation will proceed at a mutually agreed time after confirmation has been given that all equipment has been delivered and the site is ready for installation.

Validation Studies:
1.6.1 The vendor shall assist with the performance of all validation Studies: precision, method comparison with the current instrumentation, accuracy, linearity, calibration verification, reference interval verification, determination of sensitivity and specificity. The vendor shall perform all the statistical analysis and report data in an organized, clearly comprehensible format. These validation results shall be approved by MVAHCS clinical director. Vendor shall assist with reference ranges to include handling data with appropriate software to establish or validate reference intervals.
1.7 Operator Training:
1.7.1 The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility s services for all laboratory staff to be fully efficient in operating all aspects associated with instrumentation, at no additional cost to the government.
1.7.1.1 Initial training shall include two operators per facility, and shall include training on the operation of the system, data manipulation/ advanced middleware rules writing, data analytics, report writing and customization, and instrument trouble shooting and repair.
1.7.1.2 Thereafter initial training, the Contractor shall provide training for minimally one operator per facility per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between MVAHCS and the Contractor.
1.7.1.3 A training program that involves off-site travel shall include the cost of airfare, room and board for each participant.
1.8 Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item required to establish instruments for operation for performance of acceptance testing. This applies to all equipment as well as additional or replacement equipment placed under the terms and conditions of this contract. The Contractor shall perform/assist, to the satisfaction of the Government, all validation studies.

1.9. Equipment Maintenance: Contractor agrees to maintain the equipment in good working condition and will repair or replace any defects in the equipment during the contract period at no additional expense to the government. (Maintenance shall include all upgrades).

1.9.1 Service Calls: A technical assistance center must be available by hotline M-F 7am-9pm CST with a maximum call back response time of 1 hour with on-site service provided, not to exceed 24 hours following determination that site service is required.
1.9.2 Preventive maintenance: Contractor shall provide scheduled preventive maintenance service calls as required by manufacturer s recommended PM schedule. This schedule shall be sent with response to solicitation.
1.9.3 Upgrades: The vendor must provide upgrades to instrument hardware and software in order to maintain the integrity of the system and state-of-the art technology at no additional charge to the government. This must be provided as they become commercially available and at the time as they are being provided to commercial customers. This requirement only applies to system upgrades that enhance the model of equipment being offered (i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer vendor supported, etc.).
1.9.4. Down Time: During the time of the contract, should the repair record of laboratory equipment reflect a downtime of 4% during a 3-month period, a determination will be made by the designated representative of the government to replace the malfunctioning equipment with new equipment. Replacement of equipment will be the responsibility of the contractor.
1.9.5. Government s Responsibility- The user will perform routine maintenance and cleaning as required in the manufacturer s operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph.

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