Urinalysis_Instrument_SOW_3_Jan_18.pdf

STATEMENT OF WORK (SOW)

FOR

AUTOMATED URINALYSIS INSTRUMENTATION

AT

92d MEDICAL GROUP (MDG)

FAIRCHILD AIR FORCE BASE, WA

As of 3 Jan 2018

PERFORMANCE-BASED WORK STATEMENT

TABLE OF CONTENTS

SECTION PAGE

I. GENERAL REQUIREMENTS 3

II.INSTRUMENT TRAINING AND SUPPORT 5

III. INSTRUMENT REPAIR AND MAINTENANCE 5

IV. MINIMUM REAGENT REQUIREMENTS 7

V. UPGRADE OF EQUIPMENT 8

VI. CONTRACTOR PERSONELL 9

VII. CONSERVATION OF UTILITIES 9

VIII. DEFICIENCIES IDENTIFIED 10

I. General Requirements:

A. The Fairchild Air Force Base (FAFB) 92d Medical Group Laboratory, hereafter referred to as “the Government,” is seeking one fully automated, walk-away, fully integrated, random access urinalysis instrument platform capable of 30 samples per hour for urine chemistry testing, and 20 samples per day for urine microscopic testing.

B. Performance period for this contract will be no more than 5 days from the date of award, and will run continuously for 12 months with the provision for a four time extension of this contract for an additional 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 urinalysis chemistry and microscopy tests:

i.Glucose ii.Protein iii.Bilirubin iv.Urobilinogen v.pH vi.Blood vii.Ketones viii.Nitrite ix.Leukocytes x.Clarity xi.Specific Gravity xii.Color xiii.Red Blood Cell (RBC) microscopy xiv.White Blood Cell (WBC) microscopy xv.Mucous microscopy xvi.Quantitative All Small Particles microscopy xvii.Bacteria xviii.Hyaline casts xix.Pathological casts xx.Crystals xxi.Squamous epithelial cells xxii.Non-squamous epithelial cells xxiii.Yeast xxiv.WBC Clumps xxv.Sperm

D. The desired instrumentation shall meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

E. The desired instrumentation shall require no more than a single workstation to accomplish the required testing as detailed above.

F. The desired instrumentation, without the use of additional middleware, shall indicate to the user when quality control (QC) values exceed the acceptable range set by the user, and must block the user from performing patient testing until such a time where QC is performed and values are within range.

G. The desired instrumentation, without the use of additional middleware, shall indicate to the user when QC has expired (it has been more than twenty-four (24) hours since the last acceptable QC value) and must block the user from performing patient testing until such a time where QC is performed and values are within range.

H. The desired instrumentation shall have a bidirectional computer interface that is compatible with MHS Genesis (Cerner Millenium).

I. The desired instrumentation shall include software to assist in screening negative samples by user defined criteria.

J. The desired instrumentation shall utilize on-screen verification of results.

K. The desired instrumentation shall be able to utilize automatically released results based on defined parameters set by the user in order to increase walk-away efficiency and decrease patient turnaround time.

L. The desired instrumentation shall be able to auto-classify predominant categories found in urine and body fluids as listed above, plus additional particle sub-classification categories to reduce manual reviews and repeat testing.

M. The desired instrumentation shall have FDA approval to test the following body fluid specimen types: Cerebral Spinal Fluid (CSF), Synovial, Pleural, Pericardial, and Peritoneal.

N. The desired instrumentation shall have FDA approval for urine preservative sample containers.

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 90 calendar days after the contract award.

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

C. The Contractor shall provide all expenses, including travel, lodging, meals, and any additional training specific expense, for 2 Government laboratory technicians to attend one off-site training event, which shall include at least one continuing-education accredited workshop, over the length of the first year of this agreement.

D. The Contractor shall provide all expenses, including travel, lodging, meals, and any additional training specific expense, for 1 Government laboratory technicians to attend one off-site training event, which shall include at least one continuing-education accredited workshop, for each of the exercised option years of this agreement.

E. The Contractor shall provide supplemental operating training to Government personnel, without additional charge to the Government, upon installation of any upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished under this agreement.

III. INSTRUMENT REPAIR AND MAINTENANCE:

At a minimum, the Contractor will provide the following maintenance and repair services:

A. Must provide onsite maintenance (monthly, quarterly, annually, etc.) 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 during all duty hours (24 hours a day, 7 days a week).

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. The Contractor shall provide onsite emergency repair within 8 hours of the time of notification of instrument malfunction. The Contractor is responsible for all tools, parts, travel/lodging and labor that are necessary to bring at the instrument back online within 24 hours of the time of notification of the malfunction.

F. Scheduled routine services shall be performed between 0730-1630 Monday-Friday, excluding federal holidays.

G. Emergency services, to include onsite emergency repair, shall be performed twenty-four

(24) hours a day, seven (7) days a week, to include Contractor and federal holidays.

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

I. 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.

J. 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.

K. The Contractor shall furnish a malfunction incident report to the Government upon completion of each service call. The report shall include, at a minimum, 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.

L. When required, the Contractor shall comply with the Occupational Safety and Health

Administration lockout and tag-out procedures while performing maintenance on electrical equipment.

M. The Contractor shall provide all material to verify analytical measurement range (AMR).

N. If the instrument requires a water source all repair of the water source will be covered by the Contractor IAW with the aforementioned repair timelines.

IV: MINIMUM 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. The minimum shelf life of the reagents will be three (3) months after the date of delivery.

C. All reagent kits must be FDA approved and will exhibit at least 95% sensitivity and 95% specificity.

D. Upon request or when a mandatory reagent changeover is required by the Contractor, a technical specialist 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.

E. Following the validation performed in Section IV, Par D, each reagent shall exhibit at least 95% 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.

F. The vendor shall comply with all FDA regulations and the most current College of

American Pathologist (CAP) accreditation requirements.

G. 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

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. 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.