El Paso VAHCS iFOBT Analyzer Supplies

El Paso Veterans Affairs Health Care System (ELPVAHCS) Immunochemical Fecal Occult Blood Test Statement of Work (SOW) GENERAL El Paso Veterans Affairs Health Care System (EPVAHCS) facility. Require an FDA cleared automated iFOBT (Immunochemical Fecal Occult Blood) analyzer. The iFOBT is a rapid immunoassay for the qualitative detection of human hemoglobin in human fecal specimens as an aid in the diagnosis of gastrointestinal disorders.

DESCRIPTION OF WORK Contractor shall provide all accessories and consumables needed to maintain yearly operation of analyzer (collection devices, test bottles, cuvettes, wash solution, instrument cups, latex reagent, thermal paper, neg/pos controls, calibration kits) used for processing of patient results.

Fully automated instrument that is capable to run 280 samples per hour with a large sample memory with easy calibration and automatic serial dilutions as well as auto start, auto wash, and auto shutdown functions. Instrument needs to fit within a 48.8 w x 32 h x 32 d. Simple, minimal collection technique for patient and easy to use mailers which include sample bottle, tissue collection paper, and instructions.

The analyzer needs the capabilities of interfacing with VISTA/CPRS LIM systems to minimize transcription error, tech time and accurate record keeping. Testing samples should have minimum exposure to lab personnel. Yearly or as needed service maintenance Monday-Friday, 0800-1645 for troubleshooting/breakdown/preventative maintenance is required.

Prefer analyzer to be CDC and USPSTF recognized with best clinical evidence to support its use and have at least 97% specificity and 88% sensitivity used for detecting gastrointestinal bleeding associated with disorders such as colorectal cancer, polyps and diverticulitis.

PERFORMANCE REQUIREMENTS Maintenance: The vendor shall perform preventive maintenance at intervals specified by the manufacturer to ensure proper equipment performance. Maintenance includes the following:

Inventory and recording of system components. Monthly deliverables shall be received in full and on a scheduled time frame. Test all components for proper test performance. Equipment shall reproduce results according to manufacturer s specifications. After Preventative Maintenance (PM), the vendor shall submit a detailed work report to the COR for notice at no additional cost to the government. Delivery of PM parts or material; the vendor shall provide all preventive service materials at no additional cost to the government.

On-call Repairs: On-call repairs are emergency repairs beyond the scheduled maintenance. The vendor shall provide technical assistance not limited to test performance, or equipment malfunction Monday thru Friday 0800 -1600 hours. The vendor shall respond to a call for on-site repair and be at the job site within two hours (2) hours during regular working hours, Monday-Friday, 0800-1600 hours.

After repair, the vendor shall submit a detailed work report to include all required materials and is to be at no-charge to the facility. If the malfunction is reported to the vendor no later than 1600 hours, the failure elimination shall be started immediately on the same day. For delivery of repair parts or materials the vendor shall provide all parts and materials at no additional cost to the government.

Vendor shall remove all parts, equipment or materials replaced, or upgraded by the vendor due to and not limited to repairs, replacements, recall, and upgrades without any costs to the government. Safety Vendor Shall immediately notify the service of any changes in reagent kit composition, procedure modification, recall modification, recall notification or any changes that will affect the performance of the test or procedure according to FDA regulations.

Test Performance All test and procedures must comply and be approved by the FDA. All test, procedures, and equipment must perform at manufacturer s specifications, deviations from the performance specifications shall be corrected by the vendor. All test performance will be evaluated by and not limited for performance thru peer comparison, quality control and CAP peer evaluation according to CLIA.

DELIVERABLES/SUPPLIES The vendor shall provide on-site training for new personnel (as required) for testing and procedures. In addition, the vendor shall provide handouts and training materials in sufficient quantity for each participant. These are off-the-shelf courses. The vendor shall offer or conduct instructional course(s), provide lesson plans, course material and media (DVD s, CD s, videos, etc., if required) for each procedure at no additional cost.

The vendor shall deliver all equipment and UPS necessary for test performance at no government costs. The vendor shall deliver all and not limited to operational, maintenance, troubleshooting, small repairs, equipment specifications and test manuals. The vendor shall install the equipment and perform test verification according to manufacturer specification, CLIA, FDA and CAP requirements.

The vendor shall provide supplies (FOBT latex, FOBT Calibrator, FOBT controls, wash solution, buffer, cuvettes, calibrator cups and FOBT mailers). If requested supplies are on back-order, vendor is to inform COR as to the estimated time of availability. The vendor shall deliver all invoices for review according to the established contract at the end of each billing cycle. All items not contracted shall be specifically detailed on the invoice including description, quantity acquired, and government cost.

Remedies: Any changes in reagents or equipment modifications shall be immediately disclosed by the vendor electronically as well as by postal mail with supporting documentation of the change and detailed guidance against implementation within twenty-four hours of its application or according to FDA guidelines. Additional charges incurred by the government to provide the continuity of contracted tests to patients and not limited to outsourcing, transportation and or any other additional cost shall be covered by the vendor at no additional charge to the government.

WORK HOURS AND PERIOD OF PERFORMANCE:

Normal Work Hours: The service schedule shall be developed between the contractor and Contractor s Representative (COR) prior to any service being performed. The following is a list of U.S. Government holidays. If the holiday falls on a Saturday, the proceeding Friday is observed as the holiday; if the holiday falls on a Sunday, the following Monday is observed as the holiday and any other day specifically declared by the President of the United States to be a national holiday.

HOLIDAY DATE New Year s Day January 1 Martin Luther King s Birthday 3rd Monday in January President s Day 3rd Monday in February Memorial Day Last Monday in May Independence Day July 4 Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veterans Day November 11 Thanksgiving Day 4th Thursday in November Christmas Day December 25 PERIOD OF PERFORMANCE: Contract shall have a base year with four (4) option periods. Costs per Test Purchase Agreement will be in effect for 365-day period of a contract year. The period of performance shall reflect as follows:

Base Year 01 September 2024 30 August 2025 Option Year 1 01 September 2025 30 August 2026 Option Year 2 01 September 2026 30 August 2027 Option Year 3 01 September 2027 30 August 2028 Option Year 4 01 September 2028 30 August 2029 PERSONNEL: The contractor shall provide in writing the name and phone number of personnel within (10) ten calendar days of the award of the contract. The personnel shall be a qualified and experienced to perform the installation and maintenance services.

The contractor s personnel shall correspond with the COR on a regular basis to discuss any problems that the contractor or contractor s personnel may be experiencing during the performance of this contract. Unresolved problems shall be referred to the Contracting Officer for resolution. Contractor Service Personnel (CSP). All subcontractors performing work for primary contractor shall meet all specifications and standards that apply to CSP under this agreement.

CSP shall maintain clean and neat appearance and shall always wear an identification badge when performing services at the Government site. Identification badges shall be worn in a clearly visible area of the outer garment. BioMed shall furnish this badge. Due to conflict of interest, the contractor shall not employ a current DOD employee, military or civilian to provide services under this contract. Government point of contact (POC). The COR shall be the Government s POC.

If required, the COR shall be designated in writing to the Contractor and the scope of authority shall be set forth therein. Contractor shall respond only to calls from COR or a designated representative from the Medical Center.

SPECIFICATIONS: Contractor shall help with any user questions, or issues that are hardware support for physical equipment. This shall include repair and maintenance and shall require a qualified technician to be on site. The contractor shall provide all labor, equipment, supervision, and expertise, to provide maintenance services for the equipment list within the Statement of Work.

SECURITY STATEMENT: The Vendor shall not transfer any VA information to a location outside the VA and only to VA locations determined by the VA System Administrator. The information in these systems may be covered by the Privacy Act 1974 which contains criminal penalties of abuse of information. The vendor will NOT have remote Access to the system.

During onsite service, the Vendor shall be chaperoned by a VA System Administrator. The vendor shall NOT be issued a UserID/Password. The chaperon shall log the vendor onto the system and be accountable for the actions of the vendor. The Vendor shall not enter or shall immediately leave the computer room if the chaperon is not in the computer room.

Non-volatile memory devices, working or non-working, shall NOT be removed from the VA facility until the ISO has certified that the data has been destroyed.  For magnetic devices and media, the data destruction shall be by degaussing. Other forms of cleansing shall be used for non-magnetic media. The Vendor and all VA employees are required to immediately report any security violations to the Information Security Officer.  No other security statements are required.

ACRONYMS AND DEFINITIONS: Contracting Officer (CO). A person duly appointed with the authority to enter into and administer contracts on behalf of the U.S. Government. Contracting Officer s Representative (COR). An individual designated in writing by the Contracting Officer to act as an authorized representative of the Contracting Officer to perform specific contract administrative functions within the scope and limitations as defined by the Contracting Officer.

RECORDS: All records (administrative and program specific) created during the period of the contract belong to EL Paso Veterans Affairs Health Care System (ELPVAHCS) and must be returned to EL Paso Veterans Affairs Health Care System (ELPVAHCS) at the end of the contract or destroyed in accordance with the VHA Record Control Schedule (RCS)10-1.