FBO_SOW.pdf

STATEMENT OF WORK

for

CHEMISTRY/IMMUNO-CHEMISTRY INSTRUMENTS

The government has a requirement to lease new equipment (primary automated walkway

Chemistry/Immuno-chemistry instrument and duplicate back-up instrument, with on-board water system and back-up water system, additional bench-top Immuno-chemistry instrument if required in order to meet test menu criteria, workstations, computers with Windows 7 software or newer, any future software upgrades, keyboards/mouse, printers, Data Management System, auto-verification via Composite Health Care System - CHCS), with the capacity to perform

788,100 patient tests annually, required reagents, consumables, materials, start-up reagents, technical support, transportation, training, service, preventive maintenance, one service/operator’s manual, personnel for onsite installation/initial validation and other items and services necessary for the installation of the chemistry instruments (including chemistry/immuno-chemistry workstations) for the Clinical Laboratory located at 99th Medical

Group, Mike O’Callaghan Federal Medical Center (MOFMC), Nellis AFB, NV. In addition, the amount of reagents and consumables provided shall include an additional 35% of reagents and consumables to cover the running of Calibrations, Quality Control (QC), College of American

Pathologist (CAP) proficiency testing, and other periodic validation studies to cover a total of

1,064,000 tests per year. Contractor will comply with current National Electrical Code (NEC), National Fire Protection Association (NFPA) standards, and all Environment and Safety codes, laws and regulations. The contractor shall be responsible for all parts required to maintain a serviceable instrument.

Estimated Period of Performances is below:

Base Year: TBD

Option Year I: TBD

Option Year II: TBD

Option Year III: TBD

Option Year IV: TBD

1.1. The specifications of the Chemistry/Immuno-chemistry analyzers must be as follows:

a. The space allocated within the laboratory for the 2 chemistry analyzers is 285 inches wide or 23.75 feet. The work benches are fixed items in the laboratory and cannot be moved. Due to significant space limitations and the requirement to strategically place instruments, refrigerators and freezers for maximum ergonomic and workflow efficiency there is no alternative location within the laboratory to place the instruments.

b. The specifications of the system shall be able to perform patient testing serum/plasma/urine/CSF/other body fluids to perform the following fully automated tests: Acetaminophen, Albumin, ALP, ALT, NH3 Ammonia, Amylase, AST, Direct Bilirubin, Total Bilirubin, BUN, C3 Complement, C4 Complement, Calcium, Carbamazepine, Carbon Dioxide, Chloride, Cholesterol, CK, CK-MB, Cortisol, Creatinine, CRP, hsCRP, Digoxin, Estradiol, Ethanol-

Alcohol, Ferritin, Folate, FSH, Gentamicin, GGT, Glucose, Glycolated Hgb A1c, hCG, HDL, Fe-Iron, Lactic Acid, LDH, LDL, LH, Lipase, Lithium, Magnesium, Microalbumin (Urine), Myoglobin, Phenobarbital, Phenytoin, Phosphorus, Potassium, proBNP or BNP compatible to proBNP, Progesterone, Prolactin, PSA, PTH, Salicylate, Sodium, T3 (Free), T4 (Free), Testosterone, Theophylline, Tobramycin, Total Protein, Total Protein (CSF/Urine), Transferrin, Triglycerides, Troponin I, TSH, Uric Acid, TIBC/UIBC, Valproic Acid, Vancomycin, Vitamin B-12, and Urine Drugs (Amphetamines, Barbiturates, Benzodiazepines, Cannabinoids, Cocaine Metabolites, Methadone, Opiates, Phencyclidine).

c. Maximum time from start of analysis to result for specific STAT tests required for critical patient care:

Troponin I: 16 min; Myoglobin: 16 min; Mass CK-MB: 16 min.

d. The system shall have automatic/sensor capabilities to detect/quantify hemolysis, icterus, lipemic samples, and detect clotted/short samples.

e. The operator will have the ability to program frequency of calibration and QC, and the analyzer will automatically perform such functions by accessing onboard calibration and QC material. Once placed on the analyzer, the calibrator and QC material will be stored onboard until it is entirely consumed or reached expiration.

f. All reagents must be stored at room-temperature or refrigerated, not frozen. At least 95% of reagents must require no preparation or wait time before being loaded on the analyzer.

g. The analyzer shall have the capability of automatically creating an aliquot from the primary tube and retaining the said aliquot onboard the analyzer for up to two hours, making it available for the automatic processing of add-on, repeat and reflex testing. It shall have an automatic rerun capability to extended times or higher/lower dilutions, and auto-reflex to an alternate test assay as required.

h. The analyzer shall have an integrated sample and reagent barcode reader to allow hands free processing. It will have traditional QC with target values assigned to QC materials. It shall have numeric or pass/fail QC. It must terminate patient testing if QC fails or expires. It must provide critical result s and instrument error flags for the operator. It must be able to accept patient ID and/or accession number, and be able to accept canned or free text user comments. The reagent bar-coding tracking should include material name, lot number, expiration date, vial size and onboard volume.

i. It must be able to automatically perform linearity and Analytical Measuring Range verification procedures using onboard standards.

j. Any water source required for the instrument will be supplied by the vendor at no additional cost. It must include a separate FDA-approved back-up water source that will flow into the analyzer to be pressurized and purified in the event of a water outage.

k. Less than 15 minutes for tech hands-on routine daily, weekly, and monthly maintenance. The analyzer preventive maintenance down time shall not exceed 45 minutes.

l. Accept sample tubes: 15-16 mm outer diameter, 100-104 mm length, and have a throughput: up to 80 tests per hour. The instruments must have the flexibility for routine and STAT testing. The analyzer must be able to load samples, reagents, consumables and empty waste while the analyzer is running.

m. The manufacturer must be the same for all reagents, consumables, equipment, and service.

n. The system must be able to enter and run patient samples manually, with or without barcodes, during Lab Information System (LIS)/CHCS computer down time.

o. Must be able to print patient reports and QC data while running patient samples.

p. The system must be able to run new and old lot numbers of QC concurrently for parallel testing.

q. The system must include standard upgrades with no cost to the Government, for example, changes made to software, hardware, procedures, and consumables.

r. All IPUs and hardware must operate on Windows 7 or newer. The system must have bi-directional interface with our LIS, CHCS.

1.2. DATA MANAGEMENT SYSTEM

a. The configuration enables users to manage test results and quality control data from all analyzers via a single centralized workstation.

b. Enables at least 10 users to be logged into the system at one time from different workstations and allows software access levels to be customized per individual.

c. Auto-verification compatible with CHCS that verifies test results from analyzers using auto-verification rules. It applies customized rules automatically against reference ranges, QC, delta checks, and instrument flags to ensure that potentially inaccurate results are not auto-verified.

d. Data management system must transmit QC data to BioRad Unity software. The system manages QC from all interfaced analyzers.

e. It utilizes Westgard rules and Levey-Jennings charts, and provides a graphical view of patient moving averages enabling the user to easily see when patient results are drifting.

f. It must be capable of storing data from multiple QC lot numbers.

g. It provides customizable review highlighting for delta checks, critical results, QC violations, and instrument flags.

h. Search/Query tests by: Sample ID, Physician name or ID, Location, Date/Time, and user-defined queries.

i. Provides user-friendly reports for daily workload volume, Turn-around-times, and percent of results auto-verified.

j. It can export all data to commonly used file formats such as Microsoft Excel.

k. Shall have data storage capacity to store at least 2 years of quality control records in accordance with

College of American Pathologists guidelines.

2. OPERATIONAL REQUIREMENTS AND SPECIFIC TASKS:

2.1. The contractor shall provide the government a minimum of (14) calendar days advance notice for commencement of work. Contractor shall identify in writing to the Chemistry

Technical Supervisor or laboratory officer the names and the number of individuals that will be working during the installation.

2.2. The contractor shall provide a manufacturer’s certified installation specialist to install the analyzer. A Clinical Application Specialist must perform system validation procedures to include calibrations, accuracy & precision studies, analytical measurement range, quality control and parallel testing/comparison/correlation studies. The specialist will provide validation data and overall assessment to the lab manager for review. The requirements must include:

a. Setting up QC files and entering QC limits.

b. Performing correlation studies with current method.

c. Linearity verification utilizing commercial linearity material to validate all measured parameters. If commercial linearity material is not available for any parameter to validate linear range, appropriate patient samples may be used.

d. All studies must be presented to the laboratory officer for acceptance and approval prior to the contractor's manufacturer's (installation specialist, clinical application specialist and/or service engineer) departure.

e. The instrument must be on site at least 30 days prior to the old analyzer being removed to ensure all system/method validation studies are completed to provide continuous patient care services.

2.3. LIS INTERFACE: The contractor shall furnish interface assistance during installation. If interface cannot be completed prior to installation teams departure, the contractor agrees to provide telephone support to allow for interfacing of system.

2.4. MAINTENANCE AND REPAIR/SERVICE: The contractor shall provide the customer a

Field Service Engineer that resides within the local Las Vegas metropolis area. The contractor shall provide the customer with service required to maintain the instrument, contractor provided computer, printer and software, at full capability for the term of this agreement at the business hours agreement stated below. If a replacement system is needed before the end of the term, the contractor will provide a replacement at no cost to the government. The system replacement will take place after the manufacturer has exhausted troubleshooting options through their service escalation processes. All contractor employees must check in with the 99th Medical Group’s

Biomedical Equipment Technician (BMET) Repair Office and Medical Logistics prior to performing any repairs, service, or maintenance. When all necessary repairs or maintenance are completed, the contractor’s representative will supply the laboratory and the BMET office with a written, detailed service report explaining the repairs/maintenance performed prior to departing the facility. The Chemistry/Immuno-chemistry analyzers shall also include a maintenance and service agreement to include:

a. Years 1-5: Shall provide at least on-site (MOFMC), routine service IAW manufacturer's standards (7 days a week from 0900-2000), or most compatible to these hours.

b. Response for on-site repair based on vendor service escalation process, within 24 hrs.

c. Technical phone support 24 hours a day/7 days a week (including holidays)

d. Receive two (2) preventative maintenance visits each year with at least 48 hour notice prior to arrival.

e. The contractor shall be responsible for all parts required to maintain a serviceable instrument.

2.4. SHIPPING AND HANDLING:

a. The contractor will provide all instrument freight charges incurred for instrument delivery to the installation.

b. The contractor shall provide all manufacturer brand repair parts/materials at no additional cost to the government.

c. Reagents will be provided on a mutually-agreed, pre-determined shipping schedule for the assigned monthly sample volume at no additional cost to the government. Adjustment to any monthly shipment of reagent and controls in order to allow for adequate inventory must be allowed.

d. A schedule of standing order shipments shall be provided. The mode of shipment used shall be appropriate for the product being shipped to arrive within manufacturer’s specifications.

e. Temperature controlled products that are restricted from shipping over weekends and holidays shall be sent to arrive during normal duty hours (Monday thru Friday, 7:00am to 4:00pm).

2.5. TRAINING: Prior to installation, the contractor shall provide 2 off-site training slots per instrument with room, board, airfare, and 1off-site training slot per instrument for every option year that is renewed which also includes room, board, and airfare. When requested, on-site training shall be provided for all other testing personnel upon completion of installation. Training will be no cost to the Government.

2.6 The contractor shall provide Safety Data Sheets (SDS) for all required supply items that are utilized on the system at no cost to the government.

3. HOURS OF OPERATION: The laboratory operates on a 24 hour basis. Normal work hours are from 7:00 am to 4:00 pm, Monday thru Friday, excluding holidays. Request for work other than normal work hours must be coordinated and approved by the Contracting Office and

Laboratory Management.

No preventative maintenance or consumable deliveries shall be made outside of normal duty hours or Federal Holidays.

Federal Holidays are follows:

New Year’s Day – 1 January

Martin Luther King’s Day – Third Monday of the month in January

President’s Day – Third Monday of month in February

Memorial Day – Last Monday in May

Independence Day

Labor Day

Columbus Day

Veteran’s Day

Thanksgiving Day

Christmas Day

4. The laboratory POC shall be the Chemistry TSV, Non-Commissioned Officer in Charge or laboratory officer: 702-653-2828, 702-653-2825.

5. ENVIRONMENTAL COMPLIANCE: The contractor shall be responsible for the removal and disposal of any hazardous waste products generated by the contractor. The contractor shall prepare all disposal manifests for hazardous wastes or chemicals. Contractor shall obtain signatures from the Base Environmental office of any hazardous waste disposal prior to removal of items off the base.

5.1. HAZMAT PHARMACY REGISTRATION: The contractor shall register with HAZMAT

Pharmacy for any chemicals, etc., that are brought onto Nellis AFB. Contractor shall comply with all Hazmat Pharmacy requirements and procedures.

6. GENERAL INFORMATION: When the contractor’s representative is working in a potentially infectious area of the laboratory, they must wear a lab coat and gloves which will be provided.

6.1. CLEAN- UP. The contractor shall maintain the work area in a clean condition. Contractor shall dispose of all waste at an off-base permitted disposal site.

6.2 APPEARANCE: Contractor’s personnel shall present a neat appearance and be easily recognized. This may be accomplished by wearing distinctive clothing bearing the name of the company or by wearing appropriate badges, which contain the company and employee’s name.

The wear of open-toed shoes, eating or drinking in the lab is prohibited to comply with infection control requirements.

(End of Requirements Description.)