SOW_SS.docx

STATEMENT of WORK for URINALYSIS INSTRUMENT

The government has a requirement to lease new equipment (primary automated walkway urinalysis workstations with back up/secondary urinalysis workstation, microscopic workstation, computer, mouse, keyboard, and printer) with the capacity to perform an average of 1,400~1,450 combined urinalysis, microbiology, and body fluid tests per month, 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 Urinalysis analyzers (chemistry and microscopic workstations) for the Clinical Laboratory located at 673th Medical Group, JBER Hospital, Joint Base Elmendorf-Richardson, AK. 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. The Urinalysis Instruments must be FDA approved.

Reference contract award for period of performance.

1.1. The specifications of the urinalysis instrument to perform chemical and microscopic analyses must be as follows:

a. The system (instruments, computer, monitor and appropriate clearances) must have a dimension of no more than 73” width, no more than 25” depth, and no more than 24” height due to limited space constraints in the designated testing area.

b. The manufacturer must be the same for all controls, consumables, equipment, and service.

c. The system must be able to process at least 40 samples per hour.

d. The system must be able to complete fully automated routine urinalysis profile, including urine test strip chemistry panel (bilirubin, urobilinogen, ketones, ascorbic acid, glucose, protein, blood, pH, nitrate, and leukocyte esterase), specific gravity, color, clarity, and microscopic analysis, providing quantitative or qualitative counts of formed elements.

e. The system must be able to perform ascorbic acid analysis identifying possible interferences of glucose, blood, leukocytes, and nitrite.

f. The system must be able to perform microscopic analysis to detect and classify red blood cells, white blood cells, white blood cell clumps, squamous epithelial cells, non-squamous epithelial cells, crystals, hyaline casts, unclassified casts, bacteria, sperm, mucus, and yeast.

g. The system must be able to enter and run patient samples manually, with or without barcodes, during LIS/CHCS computer down time.

h. The system must be able to perform testing/analysis of bodily fluids other than urine, (i.e., cerebrospinal fluid, synovial fluid, etc.).

i. The system must be able to print patient reports and quality control (QC) data while running patient samples.

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

k. The system must require minimal reagent and calibration preparation.

l. The system must have an onboard storage of up to 10,000 patient results for later retrieval.

m. The urinalysis test strips must contain a color compensation pad so that it performs testing despite color interference brought about by certain drugs or food.

n. The system must use a digital image capture for particle identification.

o. The system must be able to offer a urine culture panel that includes urine chemistry results (leukocyte esterase and nitrite) and urine microscopy results (white blood cell, bacteria, and other small particles).

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

q. The system must have bi-directional interface with the Lab Information System (LIS) called Composite Health Care System (CHCS).

r. For the duration of the contract the operating system must meet the cyber security requirements of the AF (i.e. Windows, etc.).

s. The system should only require minimal daily, weekly, and monthly maintenance which should be limited to less than 30 minutes each.

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 Urinalysis 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. A Clinical Application Specialist must perform system validation procedures to include quality control, calibrations, accuracy, and parallel testing/comparison/correlation studies.

The requirements must include:

a. Performing correlation studies with current method/assist with instrument validation.

b. To obtain acceptable performance on the analyzer, all studies must be presented in a binder to the Urinalysis supervisor or laboratory officer for acceptance and approval prior to the contractor’s/manufacturer’s (installation specialist, clinical application specialist and/or service engineer) departure.

c. The system shall be installed and operational no later than 60 days after award.

2.3. MAINTENANCE AND REPAIR/SERVICE: The contractor shall provide the customer with service required to maintain the instrument, 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 673th 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 Urinalysis analyzer shall also include a maintenance and service agreement to include:

Service must include:

a. Years 1-5: must provide at least on-site (JBER Hospital), routine service IAW manufacturer’s standards (Monday thru Friday, 7:00 AM to 4:00 PM).

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. Required preventative maintenance 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. The mode of shipment used shall be appropriate for the product being shipped to arrive within manufacturer’s specifications. Temperature controlled products that are restricted from shipping over weekends and holidays shall be sent to arrive during normal duty hours (Mon-Fri 7:00 AM to 4:00 PM).

2.5 TRAINING: Prior to installation, the contractor shall provide 2 training slots the first year and 1 training slot each year for the four remaining years. On-site training shall be provided for all other testing personnel upon completion of installation. On-site training will be no cost to the Government.

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

2.7 The contractor shall remove the equipment within 30 days of the end of the ordering period. The contractor shall provide at least 14 day notice of commencement of work to remove the equipment.

3. HOURS OF OPERATION: The laboratory operates on a 24 hour basis with normal business hours Monday through Friday 7:00 AM to 4:00 PM. 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 Urinalysis supervisor, Non-Commissioned Officer in Charge or laboratory officer: (907)580-6552.

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. The chemical manufacturer’s Safety Data Sheets will be used to properly dispose of chemicals or hazardous waste.

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.)