Statement_of_Work-Sources_Sought.pdf

Statement of Work (SOW)

HEMATOLOGY ANALYZER

92 Medical Group/SGSL BLDG 9000

701 HOSPITAL LOOP STE 125

Fairchild AFB, WA 99011

1. Description of Services. The contractor shall lease, lease/purchase, or sell to the government a Hematology Analyzer over a period of 1 base year + 4 option years, with a fixed cost-per-test (CPT) price, necessary to produce Complete Blood Counts (CBCs) and Automated Differential (DIFF) Reports for the 92 Medical Group Laboratory, Fairchild AFB (FAFB), WA 99011. The Hematology must be able to perform the tests listed in Appendix A – Salient Characteristics.

The elements of performance must include: 1) Equipment lease/purchase, 2) Supplies/Reagents,

3) 24/7 Technical/Specialist Support, 4) Equipment Maintenance, Repair, Refresh and 5) Warranty and Replacement; and 6) Provide Cost-Per-Test (CPT) pricing for CBCs and DIFFs performed in the facility (3,000 tests/annually). The foot print of the proposed unit shall not exceed: "55 (D) in x 40 (W) in x 60 (H) in x 300 lbs (Wt)" for analyzer, analyzer clearance, monitor, keyboard, CPU, printer and pneumatic supply.

All items and services shall be provided in accordance with all federal, state, local laws, and regulations, manufacturers recommended standards, commercial requirements, and this Statement of Work (SOW). The system must have a windows-based printer, read/write disk drive for data input and archiving result capabilities using CD-ROM or USB flash drive.

2. Scope of Work. The government shall perform a minimum of 30 cost-per tests per day 5 days a week, Monday - Friday, between the hours of 0700 – 1700 (or when dictated by mission requirements) and the contractor shall provide one (1) hematology analyzer that has a self-contained waste management and other equipment and materials needed in order to perform these tests. The contractor shall install, maintain, replace, repair, provide supplies, warranty and replacement as required, in order to ensure the equipment is fully operational and within manufacturer specifications (See Appendix A). Contractor shall comply with current Food & Drug Administration (FDA), The Joint Commission (TJC), National Electric Code (NEC), National Fire Protection Association (NFPA) standards, and all Environmental and Safety codes, laws and regulations.

2.1. Maintenance. Contractor personnel shall be fully capable to test equipment, tools, perform troubleshooting, repair, preventative maintenance, software upgrades, firmware upgrades, operational checks, and adjustments to on-site equipment in order to ensure the equipment is fully operational at all times.

2.2. Maintenance Scheduling and Documentation. The contractor shall perform at least two

(2) regularly scheduled preventative maintenance (PM) inspections per year, per the manufacturer’s recommendations, for the equipment listed in this SOW. The contractor shall provide a maintenance schedule, in writing to the assigned government representative for review.

2.3. Repairs. The contractor is responsible for all repair costs to include parts and labor for the Hematology Analyzer.

2.4. Service calls for Emergency Repairs. The contractor shall respond within twenty four (24) hours after notification of an emergency service call. This includes on-site emergency response from 0800-1700, seven (7) days a week, if dictated by mission requirements.

2.5. Help Line. Contractor shall provide toll-free remote telephone support 7 days a week, 24 hours a day for diagnosing problems, delivering technical assistance to resolve complex equipment and scientific issues, and scheduling/responding to emergency repairs.

2.6. Training. Prior to installation, the contractor shall provide two training slots for two individuals, off-site at their training facility; the training must be completed within the first 12 months. After the first year, the contractor shall provide one (1) training slot per year over the course of the agreement. Also, during the installation on-site, training must be performed for all other testing personnel by a certified system specialist.

3. Government Furnished Property and Services.

3.1.The government will provide access to the 92 Medical Group - Laboratory.

3.2. The government will provide utility (electricity, email contact, telephone, and fax) and any needed administrative support necessary for the contractor to perform maintenance and repairs.

4. General Information. When the contractor representative is working in a potential infectious area of the laboratory, they must wear a lab jacket/coat and gloves which will be provided.

4.1. Hours of Operation. The normal hour of operation for the Medical Group Laboratory is 7:30 A.M. thru 4:30 P.M., Pacific Time, Monday-Friday excluding federal holidays and pacing days.

The following federal holidays are observed:

January 1 New Year’s Day 3rd Monday in January Martin Luther King, Jr. Day 3rd Monday in February President’s Day Last Monday in May Memorial Day July 4 Independence Day 1st Monday in September Labor Day 2nd Monday in October Columbus Day November 11 Veteran’s Day 4th Thursday in November Thanksgiving Day December 25 Christmas

4.2. The contractor shall notify the government’s on-site representative of any problems incurred during the performance of this contract.

4.3. CONTINUATION OF MISSION ESSENTIAL FUNCTIONS. IAW DoDI 1100.22 (Policy and Procedures for Determining Workforce Mix), and any applicable Air Force implementation, unless otherwise directed by an authorized Government representative, it is determined that services and procedures identified in this PWS are not mission essential during a crisis.

Attachment(s):

Appendix A - Salient Characteristics – Hematology Analyzer Appendix B - Equipment Installation

APPENDIX A – SALIENT CHARACTERISTICS – HEMATOLOGY ANALYZER

A.1. Analyzer: The contractor shall provide one (1) analyzer that meets the requirements and the performance characteristics identified in this SOW for accuracy and precision as defined in the Clinical Laboratory Improvement Act of 1988 (CLIA'88) and the Clinical Laboratory Institute (CLSI formerly NCCLS).

A.2. The contractor shall provide one (1) hematology analyzer that has a self-contained waste management, does not require extensive plumbing or drains, mixing assemblies or floor vents that have additional maintenance and cost and carry the potential for contamination risk that impact test results. The contractor shall also supply the equipment and materials needed in order to perform Complete Blood Counts (CBCs) and Automated Differentials (DIFF) tests. The contractor shall maintain, replace, repair, provide supplies, warranty and replacement as required, in order to ensure the equipment is fully operational and within manufacturer specifications.

A.3. Instruments and assays shall be FDA approved (the contractor shall provide proof of approval), and had no FDA warning letters or no more than three (3) FDA recalls issued over the past 24 months.

A.4. The specifications of the system must be able to perform patient testing using whole blood to perform the following fully automated tests and provide surface plots or histograms: White Blood Cell count (WBC), Red Blood Cell count (RBC), Hematocrit (HCT), Hemoglobin (HGB), Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Hemoglobin Concentration (MCHC), Platelet count (PLT), Nucleated Red Blood Cell (NRBC) %, Red Cell Distribution Width (RDW-SD), Mean Platelet Volume (MPV), Neutrophil (NEUT) Absolute (#), percent (%); Lymphocyte (LYMPH) #, %; Monocyte (MONO) #, %; Eosinophil (EO) #, %; Basophil (BASO) #, %; Immature Granulocytes (IG) %, Reticulocyte (RET) %, Reticulocyte Absolute (RET #), Immature Reticulocyte Fraction (IRF). All RET parameters must be a one-step method and not require any additional on-board reagents prior to testing.

Must have automatic Triplicate Counting for each specimen. Must directly measure each leucocyte population and MCV and MPV (vs. calculated parameters) in order to provide more accurate results.

A.5. Must have zero hands-on routine daily maintenance.

A.6. Must have one Single Aspiration Pathway, regardless of presentation mode, from point of aspiration to result. The analyzer shall be able to aspirate the 5-7 mL sample tube and micro-volume whole blood sample tube, aspirating a volume of no greater than 165 ulu in any mode.

Must have the capability to use multiple sized tubes in a single cassette and automatically repeat or reflex samples, without manual intervention or additional hardware or middleware.

A.7. Must have the ability to set the levels and sensitivities of a variety of Flags and Messages to meet individual laboratory requirements. Must have lineage specific blast flagging.

A.8. The system must have 2D barcode capabilities and must be fully inter-faceable to the government’s electronic health record (EHR) and laboratory interface systems (LIS), i.e. Composite Health Care System (CHCS), CERNER Millennium. The analyzer must have an integrated sample and reagent barcode reader and the reagent bar-coding tracking that shall include material name, lot number, expiration date, vial size and onboard volume. Shall have positive sample tube identification (sample tube bar-code must be read before, during and after aspiration).

A.9. Shall have a maximum of five reagent packs to minimize inventory levels and reagent maintenance. All reagent containers must be 10L size or smaller in order to meet current spacing requirements, storage areas and match those of the majority of lab partners in the geographic area (for emergency resupply purposes).

APPENDIX B – INSTALLATION – LAB HEMATOLOGY ANALYZER

B.1. Installation: Placement and installation of a hematology analyzer and all equipment components inclusive, but not limited to, the entire laboratory associated mechanical, electromechanical parts and supplies. Installation shall conform to Industry Standards and shall meet or exceed with all applicable codes to include Local/State Regulations, NFPA, building codes, communications codes, and other codes for each Utility identified. The contractor shall provide the following services for staff which shall include the following tasks and those listed in detail in paragraphs B.2. Through B.5.

B.2. The contractor shall provide an Uninterrupted Power Supply (UPS) for each analyzer and must be installed in the same room, to be positioned on the analyzer’s side. The UPS overall measurement and rear clearance for connection is no more than and weigh no more than 70 kg., with a minimum clearance of 102 mm on all 4 sides for proper ventilation. This UPS is a self-operated unit that provides enough power, during a commercial power outage to the analyzer, to ensure that the analyzer system remains operational thus prevents mechanical noise of the system, therefore, producing accurate patient results. The bidding vendor/contractor shall provide the specific type of UPS required for their emergency use at the 92 MDG.

B.3. Complete daily clean-up and a final (upon installation completion) clean-up of the work area.

To include any need for cosmetic repairs on walls, floorings, ceiling, etc.

B.4. The contractor shall provide a project manager to perform/oversee system installation, correlation, validation. The contractor shall provide all validation reagent/materials needed to perform these tasks.

B.5. The contractor is responsible for the removal of the analyzers at the end of the contract period.