Statement of Work 27 Nov 19.pdf

27 NOV 19

STATEMENT OF WORK: IMMUNOHEMATOLOGY ANALYZER

1. Scope

Automated pre-transfusion testing of patient and donor specimens. Full range of immunohematology testing must include the following test menu:

• ABO/RH Group

• Antibody Screen

• Antibody Identification

• Antigen Typing

• Cell Panels

• Crossmatch (AHG)

• DAT (IgG and Polyspecific)

• Eluates

• RH Phentotype

• Serial Dilutions for Titration Studies

1.1 Background

The Wright-Patterson Air Force Base (WPAFB) 88th Medical Group Laboratory Flight, hereafter referred to as “the Government,” is seeking a fully automated, walk-away, fully integrated with current and future LIS (CHCS and MHS Genesis), continuous access blood bank instrumentation.

An automated blood bank analyzer is needed which performs the full range of immunohematology testing, including cross-matches, cell panels, antigen testing and serial dilutions for titration studies. The analyzer must automate blood bank test processes including liquid pipetting, reagent handling, incubation, centrifugation, reaction grading and interpretation.

2. General Requirements

Performance period for this contract will be no more than 10 days from the date of award, and will run continuously for 60 months with the provision for re-evaluation of the contract at every 12 month period.

2.1 Specific Requirements/Salient Characteristics

a. System must use column agglutination technology

b. Instrument must be capable of fully automated serial dilutions

c. Testing system must not utilize proprietary system liquids

d. Instrument must offer up to 24 hours walkaway time

e. When operational, the instrument must always be in a ready mode and at no time go into a hibernation or “sleep” state

f. Testing system must have capability for a minimum of three pre-diluted antibody identification panels FDA cleared for use in conjunction with the instrument

g. Instrument must be able to run selected antibody identification panels

h. Supplier’s pre-diluted reagent red blood cells must utilize United States based donors. Reagent red blood cells and column agglutination technology cards must use United States based manufacturing

i. Vendor must supply an analyzer capable of bench top installation

j. Instrument system must have a pipette conditioning (e.g. dead) volume <20 µl

k. System must have capability to interface to the laboratory information system

(LIS) CHCS, and MHS Genesis

3. Instrument Training and Support

a. The Contractor shall provide instrument transportation, delivery, and installation, to include calibration and test and system validation support, within 5 calendar days after the contract award.

b. The Contractor shall provide initial on-site operator training to 2 instrument key operators prior to initiation and use of the instrument for patient testing.

c. Tech support should be covered M-F during normal operation hours from 8am- 5pm. Field engineers must on-site support for all repairs as needed. If service is needed, it should be scheduled the next covered business day.

4. Instrument Repair and Maintenance

The Contractor will provide the following maintenance and repair services:

a. Must provide onsite maintenance in accordance with manufactures guidelines, to include preventive maintenance.

b. Must provide all required tools, parts and labor as necessary to keep the instrument operational.

c. Must provide over the phone, instrument technical support when needed.

d. In the event of an instrument failure, the Contractor will provide onsite emergency repair service within twenty-four (24) hours of the time of notification of the malfunction. The Contractor is responsible for all tools, parts, travel/lodging and labor that are necessary to bring the instrumentation back online.

e. Scheduled routine services shall be performed between 0800-1700 Monday- Friday, excluding federal holidays.

f. The Contractor shall be responsible for the collection and transportation of equipment upon termination of the agreement.

g. The Contractor shall provide all reagents, calibrators, controls and any other materials necessary to troubleshoot the reasons for instrument failure at no additional cost to the Government.

h. The Contractor shall replace all reagents, calibrators, controls, and any other materials used by the Government in the process of troubleshooting instrument failure prior to the time of notification of the malfunction to the Contractor.

i. The Contractor shall furnish a malfunction incident report to the Transfusion Services department program manager or section chief upon completion of each service call. The report shall include, date and time notified, date and time of arrival, serial number, type and model number of instrument, time spent for repair, description of malfunction and repair, and proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

5. Reagent Requirements

a. The Contractor shall provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables, and any other materials required to properly perform tests on the instrumentation such that instrument operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity, and tested to assure precision and accuracy. Expiration date(s) must be clearly marked on reagent, standards, and control containers. Unexpected changes in methodology/technology shall be at the expense of the Contractor.

Alert/notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts, should be forwarded to the Government.

b. All reagent kits must be FDA approved.

c. Upon request or when a mandatory reagent changeover is required by the

Contractor, a service technician and sufficient reagents shall be provided by the Contractor for in-house validation of new reagents that are added to the instrument during the term of this agreement.

d. Following the validation performed in Section IV, Par C, each reagent shall exhibit acceptable agreement with test reagents currently in use, or with outside laboratory where applicable, as in the case of a new test introduced on the instrument.

e. The vendor shall comply with all FDA regulations and the current edition of the College of American Pathologist (CAP) checklist.

f. All reagents, controls, standards, and hardware must come from the specific manufacturer that produces the instrument. The reagents will be instrument specific, and not outsourced from other companies.

6. Upgrade of Equipment

a. The instrumentation shall be new, not refurbished or reused, at the time of installation with the most current version of the instrument model.

b. Subject to mutual agreement between the Government and the Contractor, instrumentation may be upgraded within the specifications of the agreement as new technology may become available.

c. Additionally, the Government will add reagents through the life of this agreement 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.

7. Contractor Personnel

a. The Contractor shall not employ persons for work on this agreement if such employee is identified to the Contractor by the Contracting Officer as a potential threat to the health, safety, security, general well- being or operational mission of the installations and their population.

b. Contractor employees shall present a neat appearance. Contractor personnel shall either wear a distinguishable uniform or badge on the exterior of their clothing while performing any service at any Government facility.

c. The Contractor shall not employ any person who is an employee of the Department of Defense, either military or civilian, unless such person seeks and receives approval according to DOD 5500.7R, “Joint Ethics Regulation”.

8. Conservation of Utilities

a. Lights shall be used only in areas where work is actually being performed.

b. Employees shall not adjust mechanical equipment controls for heating, ventilation, and air conditioning systems.

c. Water faucets or valves shall be turned off when not in use.

d. Environmental and Hazardous Materials Handling. If the disposal of any waste or byproduct of the instrument cannot be safely dumped into the facility’s drain system, the Contractor must provide guidelines for safely disposing these wastes or byproducts in accordance with local and national guidelines.

STATEMENT OF WORK: IMMUNOHEMATOLOGY ANALYZER