Chemistry_PWS_v2.docx

STATEMENT OF WORK

FOR

Chemistry Analyzer

AIR FORCE MEDICAL

CLINICAL SUPPORT SERVICES

Non-Personal Services

DD MMM 2019

TABLE OF CONTENTS

Sections Title

1 Scope of Work

2 Operational/Service Requirements

3 Installation

4 Contractor Personnel

5 Additional Requirements

6 General Information

7 Performance Objectives

1. SCOPE OF WORK: Equipment Lease/Service program. The contactor shall provide all personnel, equipment, tools, materials, installation reagents, supervision, transportation, one service/operator’s manual and other ancillary components, equipment, items and services necessary for the installation and operation of the chemistry analyzer(s)* for ~175K annual (based off of the historical data of 173,811 tests in FY18, 184,587 tests in FY17, and 198,448 tests in FY16) Chemistry tests and at the Ehrling Bergquist Clinic, 2501 Capehart Rd, Bellevue Nebraska, 68113. Test menu:

Albumin, serum/plasma Alkaline phosphatase, serum/plasma ALT, serum/plasma Amylase, serum/plasma AST, serum/plasma Bilirubin, direct, serum/plasma Bilirubin, total, neonatal, serum/plasma Bilirubin, total, serum/plasma Calcium, serum/plasma Chloride, serum/plasma Cholesterol, serum/plasma CO2, serum/plasma Creatine kinase (CK), serum/plasma Creatinine, serum/plasma Creatinine, urine, quantitative GGT, serum/plasma Glucose, serum/plasma hCG, quantitative, serum HDL cholesterol, serum/plasma LD, serum/plasma LDL cholesterol, serum/plasma, measured Lipase, serum/plasma Magnesium, serum/plasma Microalbumin (urine albumin), quantitative Phosphorus, serum/plasma Potassium, serum/plasma Potassium, urine Protein, total, quantitative, urine Protein, total, serum/plasma Sodium, serum/plasma Sodium, urine Triglycerides, serum/plasma Urea, serum/plasma Uric acid, serum/plasma Alcohol/ETOH, serum/plasma C-reactive protein, high sensitivity Prostate specific antigen (PSA) T4, free TSH, serum/plasma Vitamin D, 25-hydroxy Hemoglobin A1c*

· 5,400 tests/yr

*Offering may include separate standalone analyzer to satisfy Hemoglobin A1c testing needs Specifications are as follows:

1.1. New (not previously owned) Food & Drug Administration (FDA)-approved analyzer(s) and components, with auto-loading feature.

1.2. Must be a discrete analyzer, capable of performing at least 150 patient tests/(hr)

1.3. Capable of processing adult and pediatric (micro-sample) specimen collection tubes.

1.4. For applicable tests, must meet performance requirements for federally regulated analytes.

1.5. Must include some “walk away” maintenance procedure capabilities, allowing for after-hours scheduling of maintenance tasks.

1.6. Must have on-board tracking of reagent, controls, calibrators, and ancillary reagents.

1.7. Included reagents/ancillaries are primarily ready-to-use, with minimal technician preparation required.

1.8. Provide reagents with stability through estimated usage (i.e., minimal reagent waste due to expiration).

1.9. Calibration material is provided for each assay.

1.10. Must have capabilities for user-defined test parameters.

1.11. Contractor shall only offer items which already have an Authorization to Operate (ATO), or items for which the contractor agrees to go through the DoD Information Assurance (IA) approval process and obtain a Risk Management Framework (RMF) ATO. A completed Joint Medical Device Risk Assessment Questionnaire (DRAQ), v1.1, for the offered system must be provided with proposal. All equipment and software supplied at initial and subsequent installations will accurately reflect responses provided on DRAQ.

1.12. The system must have barcode/data reading capabilities.

1.13. The system must have proven interface capabilities with Composite Health Care System (CHCS).

1.14. System must possess software capable of multitasking, i.e., allows technicians to perform data operations simultaneously with analyzer operations.

1.15. Must be capable of loading reagents while system is operational (stand-by not required to load).

1.16. If instrument-feed water is required for operation of the Chemistry system, must provide water purification system and applicable maintenance, supplies, and services.

2. OPERATIONAL/SERVICE REQUIREMENTS: Equipment and services must comply with Clinical Laboratory Improvement Act (CLIA), Occupational Safety and Health Administration (OSHA), Centers for Disease Control and Prevention (CDC), and FDA requirements. In addition to analyzer system, the contractor supplies the following at no additional expense to the government:

2.1. All materials, accessories, reagents, calibrators, and ancillary products necessary to operate the analyzer and report results via bi-directional interface.

2.2. All software and hardware necessary to operate the analyzer, manage integrated software, and print analyzer reports.

2.3. The contractor shall directly provide scheduled preventative maintenance inspections (PMIs), calibrations/calibration material, and on-site repair services for all provided equipment at the manufacturer- or regulatory agency-required intervals. Manufacturer-recommended parts, materials, updates, technical data, tools and test equipment shall be used, as applicable.

2.4. Maintenance Services: Once maintenance actions are initiated, shall be continued through completion unless otherwise coordinated with the laboratory. Services shall be performed during normal duty hours of 0730 to 1630, Monday thru Friday. The contractor shall provide a service report for any maintenance, inspection, or repair activities performed on site, prior to departing the clinic.

2.4.1. Scheduled Maintenance. The contractor shall coordinate required PMIs and system calibrations at least two weeks in advance, and will performance scheduled services with minimal disruptions to laboratory operations. These inspections shall include quality assurance checks for proper operation, detection and correction of incipient failures, actions pertaining to periodic technical inspections, lubrications, adjustments, calibrations, controls, cleaning, and replacement of worn parts at a biannual frequency.

2.4.2. Customer Support. The contractor shall provide telephone customer service for analytical equipment Monday through Friday, 0730-1630 CST, excluding federal holidays. Telephone assistance shall be toll-free to the government for troubleshooting and/or repair support for malfunctions. All tools, test equipment, parts, and supplies necessary to return the equipment to operating specifications will be provided at no additional government expense.

2.4.3. Unscheduled Maintenance. If the analyzer system is not operational, and telephone support fails to resolve the issue, the contractor’s representative is to arrive within one business day of the service request. All tools, test equipment, parts, and supplies necessary to return the equipment to operating specifications will be provided at no additional government expense. Unscheduled downtime for non-preventative maintenance/repairs shall not exceed 5% of the total operational time.

3. INSTALLATION

3.1. The contractor shall provide an Uninterrupted Power Supply (UPS) for the analyzer and supporting equipment. The contractor shall ensure that the UPS provides enough power during a commercial power outage to sustain analyzer system operations for the lesser of instrument shutdown cycle or 30 minutes. All contractors shall include with their quote the specific type of UPS (make, model) required for their equipment.

3.2. The contractor must provide Safety Data Sheets (SDSs) and instructions for use (IFUs) for all required supply items that are utilized on the system at no cost to the government prior to installation, and allow continued access to updated materials throughout contract period.

3.3. To obtain acceptable performance on the analyzer, all studies must be presented to the laboratory director or designee for acceptance and approval prior to the contractor representative’s departure.

3.4. Installation support personnel shall 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.

3.5. The contractor shall provide a dedicated representative to perform/oversee system installation, set up, and method verification studies. The contractor shall provide all reagent/materials needed to perform 2.4., and 3.5.1. through 3.5.4.

3.5.1. Establishing Quality Control (QC) files and entering QC limits.

3.5.2. Establishing user defined patient parameters, alerts, and reflexive testing.

3.5.3. Performing comparison studies with currently used test methods.

3.5.4. Performing linearity verifications to validate analytical measurement range for each assay.

3.5.5. Performing precision studies to verify manufacturer’s claims for each assay.

4. CONTRACTOR PERSONNEL

4.1. Point of Contact: The contractor shall provide dedicated point(s) of contact who shall be responsible for the performance of service and maintenance. The point of contact shall have full authority to act for the contractor on all matters relating to the execution of this contract. The contractor shall designate this individual in writing to the contracting officer representative (COR) upon contract award. The POC shall be available via telephone Monday-Friday, 7:30 AM-4:30 PM, excluding Federal Holidays.

4.2. Employee Training: The contractor shall provide on-site instrument operations training at time of equipment installation. Contractor shall provide advanced operator training on- or off-site for one government employee during the base year, and for one government employee at each option year thereafter. If off-site, this shall include transportation, food and lodging expenses. The contractor shall grant laboratory and biomedical equipment technician (BMET) staff access to available virtual training modules applicable to the analyzer system.

4.3. Physical Security: The BMET or Medical Laboratory will provide a representative to sign the contractor’s representative in at applicable security check points when performing service at the Erhling Bergquist Clinic. Representative(s) must possess a valid driver’s license, and comply with installation access provisions while performing services at the Ehrling Berquist Clinic. The contractor shall be responsible for safeguarding all government property, and shall check out with a government representative upon completion of work.

5. ADDITIONAL REQUIREMENTS

5.1. Reagents and consumables. The Contractor shall furnish all items needed to perform this contract according to all of its terms. The contractor shall provide all supplies necessary to perform correlation, precision, linearity and other studies related to installation and performance of the Chemistry testing.

5.2. Special Working Conditions: All equipment, parts, materials, and services supplied by the contractor shall conform to the applicable safety standards as indicated in the current code of Federal Regulations, Occupational Safety and Health Administration (OSHA) Standards.

6. GENERAL INFORMATION

5.1. Hours of Operation: The contractor shall perform preventive maintenance services and software upgrades required under this contract between normal business hours, 0730 to 1630, Central time, Monday through Friday excluding federal holidays.

5.2. Holidays: The contractor shall not be required to perform on-site services, repairs, and/or software updates during the following federal holidays: New Year’s Day, Martin Luther King’s Birthday, President’s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran’s Day, Thanksgiving Day and Christmas Day.

7. SERVICE SUMMARY OBJECTIVES