Sources Sought Notice.docx

This is a Sources Sought Notice announcement; market survey for information only, to be used for preliminary planning purposes. No proposals are being requested or accepted with this synopsis. THIS IS NOT A SOLICITATION FOR PROPOSALS AND NO CONTRACT SHALL BE AWARDED FROM THIS NOTICE. Any requests for a solicitation in response to this notice will not be honored. The Region Health Contract Office-C, Fort Hood, TX, has an upcoming requirement to solicit for and award a contract to provide for the following: Integrated Immunochemistry and Immunoassay Analyzer and Reagents for Reynolds Army Community Hospital, Fort Sill, Oklahoma 73503. This request is anticipated to result in a Firm Fixed-Priced contract. The type of solicitation to issue will be based upon the responses to this synopsis. Contact with Government Personnel, other than the Contract Specialist identified at the bottom of this notice, by any potential offeror, or their employees’, regarding this requirement is strictly prohibited.

The purpose of this synopsis is to gain knowledge of interest, capabilities and qualifications of various members of the Small Business Community to include Section 8(a), Historically Underutilized Business Zones (HUB-Zone), Women-Owned Small Business, and Service-Disabled Veteran-Owned Small Business (SDVOSB), as well as the interest, capabilities and qualifications of various members of the Large Business community, to compete and perform a Firm Fixed Price Contract for these supplies. The type of solicitation to issue will depend upon the responses to this sources sought synopsis. The Government must ensure there is adequate competition among the potential pool of responsive contractors.

The North American Classification System (NAICS) code for this requirement is 325413– “In-Vitro Diagnostic Substance Manufacturing”

The Small Business Size Standard in millions of dollars is 1,250 number of employees size standard.

Responses to this Sources Sought Notice should demonstrate the firm’s ability, capability, and responsibility to provide and deliver the products listed below. In response to this notice, interested parties shall submit a written Statement of Capability limited up to 3 pages and shall include the following information:

•Offeror’s name, address, point of contact, phone number, and e-mail address.

•Offeror’s interest in providing a proposal/quote on the solicitation when it is issued.

•Offeror’s capability to provide the products being requested.

Any interested offeror should understand all of the items that are needed for the specific Government requirement.

OFFEROR MUST BE ABLE TO DELIVER THE ITEMS TO REYNOLDS ARMY COMMUNITY HOSPITAL, FORT SILL, OKLAHOMA 73503.

•For reference at a minimum the proposed offeror must be able to provide the following item(s):

The lease of two (2) Integrated Chemistry and Immunoassay Analyzers. The proposed offeror MUST be able to provide for the attached list of reagents. The analyzers MUST be able to perform the following and meet the following specific requirements.

1. Analyzer:

a. Must provide ability to run Infectious disease and general chemistry testing on same platform.

b. Minimal time to perform daily maintenance.

c. Calibration stability must have a stability up to 84 days on board analyzer.

d. Reagents must stability have up to 18 months shelf life from date of manufacture.

e. Sampling tips must eliminate cross contamination. Disposable tips utilized to eliminate the need for carryover studies.

f. Must be able to use a minimum sample volume of 2-17 uL.

g. Must provide a Bidirectional LIS interface.

h. Must provide On-demand STAT capacity.

i. Must provide capacity to run over 100 chemistry, immunoassay or infectious disease assays at one time.

j. Should provide a minimum of 150 reagent positions on board at one time.

k. Must not require any added expense for plumbing, or drainage. Preference is the self-contained, on-board water management eliminates special requirements for off-board plumbing. If a water system is required the vendor will provide a discount to compensate for the cost of the filtrated water system. If there is a water filtrated system supply issue RAHC Lab will not consider using analyzers that required the additional filtered water system.

l. On demand STAT capacity.

m. Have on-board dilution. Specifically, auto dilution, auto repeat and auto reflex capability.

n. Have HDL, LDL, TIBC, HBA1C assays which require no pretreatment.

o. Troponin assay that offers superior sensitivity and demonstrates excellent distinction between ranges of plasma troponin levels and clinically significant levels of plasma troponin.

p. The manufacturer shall furnish the laboratory analyzer(s), data management system, all other equipment, chemistry immunoassay reagents, supplies and consumables necessary to operate the manufacturer's equipment. The Contractor shall be responsible for furnishing equipment maintenance, preventive services, unscheduled repairs, and parts as required in order to maintain the systems in optimal operating condition as well as training for Government personnel necessary to fully perform testing in accordance with vendor specifications.

q. All equipment and software must have an Authorize to Operate (ATO) on the Government network, additionally analyzer must be able to interface with Cerner MHS-Genesis upon correlation and validation.

2. The cost per reportable results that shall include costs covering:

a. Equipment use.

b. Data management system.

c. Reagents, calibrators, controls, repeats, waste, consumables, accessories, standards, miscellaneous supplies, and the costs associated with normal shipment of those products.

d. Delivery and installation of equipment.

e. All necessary maintenance to keep the equipment operating; this element includes both preventative maintenance and unscheduled repair. Equipment Troubleshooting: When the Government performs troubleshooting with the Contractor, the Contractor shall replace all reagents, calibrators, controls and any other materials used at no additional cost to the Government

f. Training for equipment operators.

g. Additional supplies required for commencing operations and performing required correlation, precision, carry-over, validation, and population studies.

3. Reagents will be provided bearing the same lot number within the designated shipments. These items will be of the highest quality, sensitive, specific and tested to assure precision and accuracy. The manufacturer must provide stock that meets proficiency testing standards of the College of American Pathologist (CAP), the Joint Commission on Accreditation of Health Organizations (JCAHO), the National Committee for Clinical Laboratory Standards (NCCLS), DHA, and be approved by the Food and Drug Administration (FDA).

4. Testing System will have the following characteristics:

a. The testing system must be fully automated to allow for walk away operations.

b. The system must have a Data management system for storage of patient results, quality control and preventative maintenance data. System will have a bi-directional interface to the analyzer and additionally analyzer must be able to interface with Cerner MHS-Genesis.

c. The manufacturer is required to provide new or re-manufactured state of the art equipment. Discontinued models are not acceptable.

d. The manufacturer will provide all upgrades to the equipment hardware and operating system software without additional charge to the Government. These enhancements to the equipment shall be delivered to the Government site and be installed by the manufacturer within 60 days of their issuance date of first commercial availability. Subject to mutual agreement between the Government and the Contractor, instrumentation may be upgraded within the specifications of the contract as new technology may become available. Additionally, the Government will add reagents through the life of this contract as a result of advances in technology or changes to clinical practice standards. Any such change to the reagents shall be mutually agreed upon by the contractor and the Government through a bilateral modification.

e. All models shall perform satisfactorily at any laboratory temperature between 68 and 80 degrees Fahrenheit and at any laboratory relative humidity between 40 and 80%.

f. The analyzer(s) shall be fully operational on the first day of the contract's performance period.

g. In the event that the contract is terminated for any reason, the manufacturer must allow the analyzer(s) to remain in place for a period not to exceed 60 days beyond the contracted price, for the purpose of meeting regulatory requirements of performing correlation and validation studies.

h. Supplies necessary to operate the instrument will be shipped within 3 days of order placement.

i. The Contractor shall provide an on-board water system (e.g. filtered, deionized etc.), if required by the analyzer, that shall provide uninterrupted service for a period of time to be determined by the Laboratory Director.

j. The middleware should provide an integrated QC Package and have the ability to export results into QC format.

k. The middleware should be able to provide lab custom programming to communicate via our interface to our EHR/LIS.

l. The instrument manufacturer will provide the purchasing customer the following support and services to ensure a guaranteed uptime of at least 97%: 24/7 telephonic technical support.

m. Provide automated calibration with onboard storage of calibrators, and automated running of controls with onboard storage of control material, and automated calibration of electrolytes.

n. Provide automated assay linearity with no manual steps required to perform linearity studies.

o. Provide automated unloading of empty reagent containers; instrument must be able to hold sample aliquot on board for up to 2 hours for add-ons and test re-run.

p. Release of primary sample tube < 5 minutes for STAT and < 15 minutes for Routines for sample re-testing or add-on tests.

q. No Instrument Pause or stand-by required for loading reagent, calibrators, and controls.

r. Reagents must not require any manual preparation and be ready to load from the refrigerator.

s. Cardiac Reagents must include high sensitive Troponin approved by ACC/WHO for low end detection and adhere to a less than 20 minute TAT.

t. Daily maintenance should not exceed 45 minutes to include quality control and calibration.

u. The Contractor selected must have either started the process or have acceptance by the U.S. Army Medical Information Technology Center (USAMITC) for current or future remote diagnostic capabilities, i.e. a CON/DIACAP.

v. Emergency Repairs and service concerns/questions shall be responded to within 24-48 hours of notification which may include having a field service engineer on-site within this time period.

5. Special Handling for Emergency Orders of Supplies. In the event that the consumables are found to be defective and unsuitable for use with the manufacturer's equipment, or the manufacturer failed to comply with the requirements for routine supply delivery, the manufacturer is required to deliver the consumable supplies within 24 hours of receipt of verbal order(s) from the Government activity without additional charge to the Government. If either circumstance has occurred, the manufacturer will deliver to the Government, the necessary consumables in sufficient quantity as required allowing operation of the equipment for one week (under normal Government test load volume).

6. The manufacturer, without additional charge to the Government, shall provide basic and advanced training. During initial set up and installation of the analyzers, the manufacturer shall provide on-site training, at no cost, to all personnel who will operate the equipment. The manufacturer shall provide advanced training at the manufacturer’s training facility for two Government personnel during performance of the basic period, and training of two Government personnel during each option period, at no cost to the Government. The contractor agrees that their proposal specifically includes that they will be responsible for all costs regarding lodging, transportation, meals and incidentals of the Government travelers in accordance with the Department of Defense Joint Travel Regulation. It is agreed that the Government traveler will be reimbursed for all authorized expenses upon presentation of a valid receipt to the contractor and payment shall be made to the Government traveler within ten business days. It is agreed that the Government traveler shall be personally responsible for all costs above the limits or unauthorized expenses established in the Joint Travel Regulation. The manufacturer shall provide supplemental training to the above Government personnel, without charge to the Government, upon installation of upgrade(s) in equipment hardware or operating system software connected with the operation of an instrument already furnished.

7. The manufacturer will perform complete correlation, precision, carry-over, and validation studies at the time of installation and for all new tests added throughout the contract period on manufacturer supplied and 3rd party assays. Population Studies will consist of 200 samples for high volume tests and 50-100 samples for low volume tests.

All studies will meet recommended NCCLS guidelines.

8. Site Preparation:

a. The manufacturer as a part of the equipment proposal, for any equipment not already in place, shall furnish site preparation specifications in writing. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate and conform to the manufacturer's specifications.

b. The Government shall prepare the site at its own expense and in accordance with the specification(s) furnished by the manufacturer.

c. Any alteration or modifications in site preparation, which are attributable to incomplete or erroneous specifications provided by the manufacturer, which would involve additional expense to the Government, shall be made at the expense of the manufacturer.

9. Ownership of Equipment:

a. Title to equipment shall remain with the manufacturer. All accessories furnished by the manufacturer shall accompany the equipment when returned to the manufacturer.

b. The manufacturer, at termination and/or replacement of equipment, will remove the equipment at no cost to the Government. The manufacturer will disconnect the equipment and will be responsible for all packing and shipping required to remove the equipment within seven (7) calendar days.

10. Preventive Maintenance.

a. The manufacturer will provide preventive maintenance at their recommended intervals to assure the continued reliable operation of the equipment.

b. Any service, maintenance, and equipment service charges required for operation. All necessary maintenance to keep the equipment operating; this element includes both preventative maintenance and unscheduled repair. Equipment Troubleshooting: When the Government performs troubleshooting with the Contractor, the Contractor shall replace all reagents, calibrators, controls and any other materials used at no additional cost to the Government.

c. The Contractor shall be responsible for furnishing equipment maintenance, preventive services, unscheduled repairs, and parts as required in order to maintain the systems in optimal operating condition as well as training for Government personnel necessary to fully perform testing in accordance with vendor specifications.

11. Unscheduled Repair:

a. Unscheduled repairs shall be performed by the manufacturer after notification that equipment is inoperative. The manufacturer shall provide the Government with a designated point of contact and shall make arrangements to enable their maintenance representative to receive such notification and be on site within 24 hours. The Government may incur labor and/or travel expenses if the repair is required outside of normal business hours (published by the manufacturer). In the event that two similar components (i.e. chemistry or immunoassay) of both analyzers are unable to perform minimum testing requirements established by the Government, regardless of holidays, weekends, or hour, the manufacturer will provide immediate repair service at no cost to the Government.

12. Any additional costs associated with equipment or supplies not disclosed in the contract, by the manufacturer, needed for full operation of this equipment, will be paid by the manufacturer at no cost to the Government.

Offeror’s capability to perform a contract of this magnitude and complexity (include offeror’s capability to provide for the following Integrated Chemistry and Immunoassay Analyzer and Reagents for Reynolds Army Community Hospital, Fort Sill, Oklahoma 73503-provide at least three (3) examples. Documentation of appropriate products must be presented in sufficient detail for the Government to determine that your company possesses the necessary means to compete for this acquisition.

Offeror’s type of small business and Business Size (Whether 8(a), HUB Zone, Women-Owned Small Business, Service Disabled Veteran Owned Small Business, etc.), or Large Business Status, should be documented in the Statement of Capability.

Interested parties are responsible for marking information that is proprietary in nature. No reimbursement will be made for any costs associated with providing information in response to this notice or any follow up information requests. The Government is not obligated to, nor will it, pay for or reimburse any costs associated with responding to this sources sought notice. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. No subcontracting opportunity is anticipated. A determination by the Government to not compete this proposed contract action based on the responses to this notice is solely within the discretion of the Government.

Interested Offeror shall respond to this Sources Sought Notice no later than 31 January 2024 at 3:00 P.M Central Standard Time. All interested businesses must be registered in the System for Award Management (SAM) at https://sam.gov to be eligible for award of Government contracts. Email your response to Karan E. Quiles, Contract Specialist: karan.e.quiles.civ@health.mil. Telephonic inquiries will NOT be honored. EMAIL IS THE ONLY CURRENT METHOD FOR CONTACT.