STATEMENT_OF_WORK_CHEMISTRY_ANALYZER_22_NOV_19.pdf

STATEMENT OF WORK (SOW)

FOR

Chemistry/Immunoassay Analyzer

1.0 SCOPE OF WORK: The contactor shall provide all equipment, tools, materials, startup/future reagents, transportation/delivery, and any other items/services/ancillary equipment necessary for the installation/maintenance of the leased Chemistry/Immunoassay Analyzer in the Clinical Laboratory located at Holloman AFB, NM. Contractor’s equipment shall comply with current National Electric Code (NEC), National Fire Protection Association (NFPA) standards, and all Environmental and Safety codes, laws and regulations.

1.1 The specifications of the chemistry/immunoassay analyzer must be as follows:

1.1.1 Test blood, serum, plasma or urine on clinical chemistry assays for tests and estimated test volume listed in Appendix A. Capability to read barcodes and fully inter-faceable with the Composite Health Care System (CHCS) as well as the Military Health Care System Genesis computer system.

1.1.2 Utilize photometric, ion selective electrode and indirect measurement technologies and have an on-board test capacity of at least 42 reagent positions for multiple assays allowing for expansion of test menus as required. The required test menu is listed in Appendix A. All testing must be performed on the same platform.

1.1.3 Dimensions must not exceed a width of 120 inches, a depth of 60 inches; and a height of 70 inches.

1.1.4 Have the ability to store and easily retrieve patient results, quality control (QC) results and calibration curves with also the ability to view and print Levy-Jennings QC graph for each analyte.

1.1.5 Have continuous reagent loading and walkaway capability and be able to run multiple assays on the sample with the ability to accept current industry standardized sample tubes.

1.1.6 Have the flexibility for routine/ STAT testing with STAT test results available 15 minutes from the time the sample is loaded on the analyzer with STAT priority and must minimize sample and/or reagent carryover.

1.1.7 Have automatic on-board sample dilution, auto rerun and auto reflex capability.

1.1.8 Provide sample management with a clot detection system, liquid level sensing.

1.1.9 Have the ability to perform HBA1C with no sample pretreatment.

1.1.10 If the analyzer requires a water system, that system should be compatible with the chemistry analyzer and be included in the contract by the chemistry analyzer vendor.

1.1.11 The analyzer must have a corresponding survey from the College of American Pathologist

(CAP).

1.1.12 Analyzer must perform the tests and the estimated annual volumes listed in Appendix A.

2.0 DELIVERY/INSTALLATION OF CHEMISTRY ANALYZER

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 laboratory officer the names and the numbers 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 calibrations, accuracy, quality control and mode to mode studies. The installation requirements must include:

2.2.1 Setting up QC files and entering QC limits.

2.2.2 Performing correlation studies with current method.

2.2.3 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.

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

2.3 LABORATORY INFORMATION SYSTEM (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 is responsible to ensure the analyzer and all ancillary components such as computer, software, etc. is fully operational throughout the life of this contract.

2.4.1 Contractor shall respond within 24 hours of notification if the analyzer becomes less than fully operational.

2.4.2 Maintenance/service shall be conducted as follow:

2.4.2.1 Contractor must provide two preventive maintenance services annually and in accordance with the manufacturer’s standards with 48 hour notice prior to arrival. (Mon – Fri, 7:30 am to 4:30 pm)

2.4.2.2 If on-site repair is needed based on vendor service escalation process, contractor must notify the laboratory officer or designee within 24 hours.

2.4.2.3 The contractor is responsible for all parts required to maintain a serviceable system at no additional cost to the government.

2.4.2.4 Technical Phone Support 24 hours a day/ 7 days a week (including holidays)

2.4.3 If a replacement system is needed before the end of the contract, the contractor will provide a replacement at no cost to the government. The system replacement will take place after the manufacturer has exhausted its troubleshooting options through its service escalation process. All contractor employees must check in with the 49th Medical Group’s Biomedical Equipment Repair Office (BMET) prior to performing any repairs or maintenance.

2.4.4 Upon completion of any repairs or maintenance, the contractor’s representative will supply the laboratory with a written report explaining the repairs/maintenance performed prior to departing the facility. Additionally, the contractor’s representative must check out with the BMET office and provide a documentation of all work accomplished.

2.5 TRAINING: Prior to installation, the contractor shall schedule training for one key operator position, at an onsite or off site training facility, at the cost of the contractor.

Training shall be conducted prior to government acceptance of installation of the analyzer. The contractor shall provide two additional key operator training positions over the course of the 5-year contract.

2.5.1 In addition to above training requirements the contractor must provide routine operator training during the initial installation. Training must be performed for all other testing personnel by a certified system specialist.

3.0 SHIPPING AND HANDLING OF REAGENTS AND SUPPLIES: The contractor shall provide all manufacturer brand reagents and consumables necessary to meet the average monthly test volume as stated in the General Services Administration (GSA)/Federal Supply Schedule (FSS) Price List assuming reasonably efficient utilization. These reagents and consumables must be provided on a mutually-agreed, pre-determined shipping schedule for the assigned monthly sample volume 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. The shipment of temperature controlled products that are restricted from shipping over weekends and holidays shall be sent to arrive during normal duty hours.

3.1 The contractor must provide Material Safety Data Sheets (MSDS) or equivalent documentation for all required supply items that are utilized on the system at no cost to the government.

3.2 Delivery Requirements based on a "cost per kit" arrangement and the specifications contained in this Statement of Work (SOW). The Government “cost” is driven by the amount of reagent purchased to perform the number of estimated tests required per month by the 49th Medical Group.

3.3 Shall provide extended calibration stability with the same lot which would be 3 months for clinical chemistry assays.

4.0 HOURS OF OPERATION: Normal work hours are from 7:30 am to 4:30 pm, Monday through Friday. Request for work other than normal work hours must be coordinated and approved by Laboratory Management. No preventative maintenance or consumable deliveries shall be made on Saturday, Sunday or federal holidays as shown:

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 Christmas Day

5.0 ENVIRONMENTAL COMPLIANCE: The contractor shall be responsible for the removal and disposal of any hazardous waste products generated by the contractor during service visits.

5.1 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.

5.2 HAZMAT PHARMACY REGISTRATION: The contractor shall register with the base HAZMAT Pharmacy any chemicals, etc., that are brought onto the base.

Contractor shall comply with all Hazmat Pharmacy requirements and procedures.

6.0 GENERAL INFORMATION:

6.1 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.

6.2 The laboratory POC shall be the Officer in Charge, 575-572-3568.

6.3 Laboratory leadership will ensure a minimum of one (1) technician remains on-site during length of installation project to safeguard/secure laboratory supplies.

6.4 CLEAN-UP: The contractor shall maintain the work area in a clean condition by the end of the contract performance period. Contractor shall dispose of all waste at an off-base permitted disposal site.

6.5 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 is prohibited for infection control purposes.

Appendix A

Test Menu

Chemistry list of test test name estimated test per month estimated test per year with

QC

ALT 300 3,603

ALBUMIN 291 3,494

ALKALINE

PHOSPHATASE

297 3,569

AST 319 3,829

BICARBONATE 352 4,219

TOTAL BILIRUBIN 264 3,164

BUN 354 4,250

CALCIUM 352 4,224

CHORIDE 352 4,219

CHOLESTEROL 248 2,980

CREATININE (JAFFE) 355 4,254

GLUCOSE 365 4,375

GGT 78 934

HBA1C 48 572

HDL 248 2,970

LDH 51 614

LDL 62 740

PHOSPHOROUS 63 759

POTASSIUM 353 4,239

SODIUM 352 4,222

TOTAL PROTEIN 292 3,505

TRIGLYCERIDE 333 3,992

AMLYASE 52 618

MAGNESIUM 60 724

URIC ACID 66 786

DIRECT BILIRUBIN 81 969

CREATININE KINASE 54 653

LIPASE 54 646

FT4 108 1,293

TSH 232 2,785

Fe 88 1,050 Ferritin 88 1,050

TIBC 90 1,078

Folic Acid 98 1,175 Vitamin D 146 1,748

TOTAL CHEMISTRY 6942 83,302