Performance Work Statement 21 Nov 19.pdf

PERFORMANCE WORK STATEMENT (PWS)

FOR

AUTOMATED BLOOD BANK INSTRUMENTATION

AT

88TH MEDICAL GROUP (MDG)

WRIGHT-PATTERSON AIR FORCE BASE, OH

21 November 2019

PERFORMANCE-BASED WORK STATEMENT

TABLE OF CONTENTS

SECTION PAGE

I.GENERAL REQUIREMENTS 3

II.INSTRUMENT TRAINING AND SUPPORT 4

III.INSTRUMENT REPAIR AND MAINTENANCE 4

IV.MINIMUM REAGENT REQUIREMENTS 6

V.UPGRADE OF EQUIPMENT 7

VI.CONTRACT OR PERSONEL 7

VII.CONSERVATION OF UTILITIES 7

I. General Requirements:

A. 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.

B. 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.

C. The Government is seeking instrumentation, reagents, consumables, and support to perform, on a single platform, the following but not limited to blood bank tests:

i. ABO/RH Group

ii. Antibody Screen

iii. Antibody Identification

iv. Antigen Typing

v. Cell Panels

vi. Crossmatch (AHG)

vii. DAT (IgG and Polyspecific)

viii. Eluates

ix. RH Phenotype

x. Serial Dilutions for Titration Studies

D. The desired instrumentation shall meet the performance specifications:

i. System must use column agglutination technology

ii. Instrument must be capable of fully automated serial dilutions

iii. Testing system must not utilize proprietary system liquids

iv. Instrument must offer up to 24 hours walkaway time

v. When operational, the instrument must always be in a ready mode and at no time go into hibernation of ‘sleep’ state

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

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

viii. 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.

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

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

xi. Vendor must have a demonstrated ability to supply automated and nonautomated FDA licensed reagents for blood bank or transfusion service testing under their own brand

xii. Fully loaded waste containers shall each not weigh more than 11 lbs. and be accessible to waist height

xiii. Optical resolution of the on-board camera must be at least 5 megapixel resolution down to 32 x 32 microns, and store a digital image of both the front and back of each gel card to record test results

xiv. System must have capability to interface to the laboratory information system CHCS and MHS Genesis

II. INSTRUMENT TRAINING AND SUPPORT

A. The Contractor shall provide instrument transportation, delivery, and installation, to include calibration and test and system validation support, within 10 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.

III. 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.

IV: MINIMUM REAGENT REQUIREMENTS:

The Contractor will provide the following maintenance and repair services:

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.

V: 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.

VI: 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”.

VII: 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.

I. General Requirements: