A.02_SOW 2024.pdf

Statement of Work Two (2) Immunoanalyzers for Allergy, Thyroid Antibody, and Thyroid Peroxidase Testing – Includes

Equipment, Consumables, Reagents, Training, and Maintenance

1. General Scope of Work.

1.1 The contractor shall provide Dwight David Eisenhower Army Medical Center (DDEAMC) with two (2) analyzers: one (1) Immunoanalyzer with a capacity of greater than or equal to at least (>/=) 50 results/hour, continual random access sample loading and an on board storage of greater than or equal to (>/=) at least 150 different allergens and components and one (1) Immunoanalyzer with a capacity of greater than or equal to (>/=) at least 225 results/hour, continual random access sample loading and an on board storage of greater than or equal to (>/=) at least 300 different allergens and components for the Department of Pathology Microbiology and Immunology Section. Both instruments should be able to network together to be operated by one computer for efficient handling. One, or both, Immunoanalyzers must allow for auto antibody testing for thyroglobulin and thyroid peroxidase. Both analyzers must be ELISA based with a preferred measurement by Fluorescence Enzyme Immunoassay (FEIA) and single channel technology. Must provide calibration curves related to specific epitopes and not be required for individual disease states, must have an onboard calibration stability of 28 days or more, must have the ability to use non-lot specific reagents and provide Levey Jennings charts. This acquisition includes equipment, services, periodic maintenance, consumables, and reagents necessary to perform testing. The vendor must have connectivity ability to the hospital's MHS Genesis Systems (and Laboratory Information System (LIS)). The equipment will be located in the Microbiology Laboratory, Department of Pathology at Dwight David Eisenhower Army Medical Center, Fort Eisenhower Georgia. Funding will be allocated annually subject to the availability of funds.

1.1.1 All reagent kits must be Federal Drug Administration (FDA) approved for use in clinical testing.

The reagents must be delivered in the amounts specified within a week of the supply schedule delivery dates, to cover the workload. The reagents must have expiration dates no less than 6 months from the delivery date. The reagents must function properly, passing all lot-to-lot tests. Calibrators and controls must function properly and test with the ranges set by the manufacturer. Contractor shall deliver replacement consumable supplies within twenty-four (24) hours of receipt of verbal order if contracted consumables are found to be defective and unsuitable for use. The analyzer must perform the quoted and contracted workflow (approximately 25,000 samples per year). The analyzer must also be able to interface with the hospital information system (LIS & MHS Genesis) to allow for transfer of results.

The analyzer will be highly utilized for performing high volume testing of serum for allergy testing.

The automated analyzers will allow for continuous feed of samples during the testing time and will increase efficiency and testing. Vendor must deliver the analyzers within two months of the government's delivery of the contract at the quoted cost and aid in the validation, calibration, and correlation testing of the analyzers. Vendor will also provide connectivity support ensuring the seamless transition to the LIS MHS Genesis.

1.1.2 Vendor shall deliver the analyzers within two months of the Government's delivery of the contract at the quoted cost and aid in the validation, calibration, and correlation testing of the analyzers.

Vendor shall provide all maintenance with the exception of regular user maintenance. Vendor shall be responsible for all equipment repairs and provide repairs on-site within 24 hours. Any equipment downtime that exceeds 3 workdays shall require the vendor to provide alternate testing equipment and perform machine validation if necessary.

1.2 Personnel

1.2.1 Hours of operation:

On-site instrument services shall be provided Monday through Friday, 0800 to 1800, including Observed holidays.

1.2.2 Normal Hours:

Eisenhower Army Medical Center, Department of Pathology Section hours of operation are 7 days a week, 24 hours a day.

1.2.3 Personnel:

Services under this contract shall be performed by individuals who have demonstrated knowledge and competence in the servicing and maintaining of the specific instrumentation under the contract. The contractor shall ensure repair technicians have been trained on the specific equipment under this contact.

1.2.4 Personal Appearance:

Contractor personnel working under this contract shall practice high standards of personal hygiene and maintain a clean, neat appearance while on duty.

1.2.5 Security Requirements: (Access, General Protection, and Security Policy and Procedures)

Contractor personnel or any representative of the contractor entering Fort Eisenhower shall abide by all security regulations and shall be subject to security checks. Contractor and all associated subcontractor employees shall comply with all applicable installation, facility, and area commander installation and/or facility access and local security policies and procedures (provided by government representative). The contractor shall also provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshall Office, Director of Emergencies Services, or Security Office. Contractor workforce must comply with all personal identity verification requirements as directed by DOD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

1.2.5.1 Access and General Protection /Security Policy and Procedures.

Installation Access: Information to access Fort Eisenhower can be found at the following link:

https://home.army.mil/eisenhower/about/visitor-information . Information regarding preregistration is located at https://home.army.mil/eisenhower/about/visitor-information/visitor-preregistration . For an annual gate pass for maintenance technician, please contact the Contracting Officer Representative (COR) and provide requested documentation.

Access to U.S. installations, buildings and controlled areas is limited to personnel who meet security criteria and are authorized access to the installation. Failure to submit required information/data and obtain required documentation or clearances will be grounds for denying access to U.S. installations, buildings, and controlled areas. The Contractor shall ensure that any subcontractors used in performance of this contract complies with these requirements and that all employees, of both the Contractor and any subcontractor utilized by the Contractor, are made aware of and comply with these requirements. The Contractor shall be aware of and comply with the requirements associated with Installation Access Control. The Government is not liable for any costs associated with performance delays due solely to a firm’s failure to comply with Installation Access Control System (IACS) processing requirements. Contractor personnel or any representative of the contractor entering Ft. Eisenhower shall abide by all security regulations and shall be subject to security checks. When entering post, contractor https://home.army.mil/eisenhower/about/visitor-information https://home.army.mil/eisenhower/about/visitor-information/visitor-preregistration personnel must have vehicle registration, driver’s license, and proof of insurance. The Contractor shall return installation passes to the issuing IACS office when the contract is completed or when a Contractor employee no longer requires access.

iWATCH Training: The Contractor and all associated subcontractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity ATO). This locally developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 30 days after the contract is awarded and within 30 days after new employees commence contract performance.

iWATCH Training Link:

https://training.reliaslearning.com/resources/SwankMigr/902-SWK-1961-233435/256609/iWatch%20Anti- Terrorism%20Awareness%20Month%20PSA.mp4

1.2.6 Quality Assurance:

Upon completion of work, an acceptance inspection will be conducted by the Government (Medical Maintenance personnel) and by the equipment user to ensure services are completed. The Government's Contracting Officer Representative (COR) will evaluate the contractor’s performance under this contract using the method surveillance specified in Quality Assurance Surveillance Plan (QASP) attached. All surveillance observations will be recorded by the Government. When an observation indicates defective performance, the COR in conjunction with medical maintenance will obtain the contractor's representative initials on the record of the observation. All Material Safety Data Sheets associated with the reagents must be provided to Eisenhower Army Medical Center Laboratory upon receipt of the reagents or products. If any FDA mandated or company-initiated recall is issued on any kit or kit component in use at DDEAMC, the vendor will notify the COR, or some member of the testing lab within 24 hours of the issuance of the recall.

1.2.7 Quality Control:

The contractor shall be responsible to ensure that the quality of service and materials provided under this contract meet or exceed the performance work statement.

1.2.8 Completion of Service:

As needed, upon completion of services, a written service report will be provided to the Biomedical Maintenance/ Clinical Engineer Manager. The service report shall be completely filled out within 24 hours from completion of service, provide detailed information regarding the cause of equipment malfunction and corrective action taken, to include the time required to complete the work, and a list of parts replaced with a price for each part. Contractor shall provide the balance of the required information in writing to the Chief, Medical Maintenance, not later than ten (10) days after services are completed.

1.2.9 Upon completion of contractor provided maintenance, the contractor shall sign off on or affix a DD form 2163 Calibration verification sticker in accordance with instruction provided in Technical Bulletin

(TB) 38-750-2.

1.2.10 Performance Measures:

The contractor shall perform unlimited emergency service calls Monday through Friday, 0800-1800, including observed holidays. Response time for repairs will be within 24 hours once determination of service need is made. Contractor shall be able to provide as emergency support within (2) hours of telephone request. Success of the Allergy testing mission hinges upon the laboratory ability to provide rapid and accurate results to the providers and patients of DDEAMC. In the event of prolonged equipment failure, there will be a substantial monetary loss to the government. In the event of equipment failure, the https://training.reliaslearning.com/resources/SwankMigr/902-SWK-1961-233435/256609/iWatch%20Anti-Terrorism%20Awareness%20Month%20PSA.mp4 https://training.reliaslearning.com/resources/SwankMigr/902-SWK-1961-233435/256609/iWatch%20Anti-Terrorism%20Awareness%20Month%20PSA.mp4 government will withhold paying the invoiced until the next invoice date or until the service is completed.

As the result of an equipment failure, downtime experienced by the lab will cause an unacceptable delay in patient treatment. If an equipment failure resulting in downtime exceeds 3 working days, the vendor shall provide replacement equipment either as a temporary stop-gap solution (to be re-exchanged for the original equipment once repairs are made), or as a permanent replacement for the failing existing equipment.

2. Definitions.

2.1 Preventive Maintenance Checks and Services (PMCS): maintaining equipment in a "like new" operating condition in accordance with the manufacturer's specifications. Accomplished by providing systematic inspection, Calibration, Certification, Verification, detection and correction of incipient failures, before they occur or before they develop into a major defect. Cleaning and lubrication will be included as needed on all internal parts as well as external cleaning after services are performed.

2.2 Response Time: The time frame within which the contractor must arrive on-site, measured form the time of verbal notification that service is required. Response time for this contract is 24 hours after service call is confirmed.

2.3 FDA: Food and Drug Administration

2.4 CAP: College of American Pathologists

2.5 CLSI: Clinical and Laboratory Standards Institute

2.6 TJC: The Joint Commission on Accreditation

2.6 Contracting Officer: Contracting Officer (KO): A person duly appointed with the authority to enter into and administer contracts on behalf of the U.S. Government.

2.7 Contracting Officer Representative (COR): An individual designated by the contracting officer to act as his representative to assist in administering a contract. The source and authority for a COR are contained in the written letter of designation.

2.8 Quality Assurance Surveillance Plan (QASP): An organized written document used for the quality assurance surveillance. The document contains specific methods to perform surveillance of the contractor.

2.9 Lot - to- Lot:

2.10 MHS Genesis: The instruments will be able to communicate with MHS Genesis with tests requests automatically transferred from MHS Genesis to the instrument. The instrument will be able to send test results automatically to MHS Genesis and autoverified. This includes results that have a less than (<) or greater than (>) result. The instrument must be capable of providing results to two (2) decimal points. The instrument must be able to recognize single allergens and panels. The instrument must be able to auto-reflex from a positive allergen to their corresponding components (peanut, egg, milk, hazelnut, venom and walnut).

The instrument will be able to provide a value of 0-1000 ku/L for total IgE (tIgE).

2.11 LIS: Laboratory Information System: same as 2.10 above.

2.12 PM: Preventive Maintenance

2.13 OEM: Original Equipment Manufacturer

3. APPLICABLE PUBLICATIONS AND FORMS

3.1 TB 38-750-2

3.2 DD Form 2163: Calibration Verification

4.0 Contractor Furnished items

4.1 The contractor shall furnish all materials, manufacturer recommended Preventive Maintenance (PM) visits, Original Equipment Manufacturer (OEM) parts, labor and supplies necessary to perform the services and repairs. Travel is included in the overall contract cost.

5. Specific Tasks:

5.1 The contractor shall provide Dwight David Eisenhower Army Medical Center (DDEAMC) with two

(2) analyzers: one (1) Immunoanalyzer with a capacity of greater than or equal to at least (>/=) 50 results/hour, continual random access sample loading and an on board storage of greater than or equal to (>/=) at least 150 different allergens and components and one (1) Immunoanalyzer with a capacity of greater than or equal to (>/=) at least 225 results/hour, continual random access sample loading and an on board storage of greater than or equal to (>/=) at least 300 different allergens and components for the Department of Pathology Microbiology and Immunology Section. Both instruments should be able to network together to be operated by one computer for efficient handling.

One, or both, Immunoanalyzers must allow for auto antibody testing for thyroglobulin and thyroid peroxidase. Both analyzers must be ELISA based with a preferred measurement by Fluorescence Enzyme Immunoassay (FEIA) and single channel technology. Must provide calibration curves related to specific epitopes and not be required for individual disease states, must have an onboard calibration stability of 28 days or more, must have the ability to use non-lot specific reagents and provide Levey Jennings charts. This acquisition includes equipment, services, periodic maintenance, consumables, and reagents necessary to perform testing. The vendor must have connectivity ability to the hospital's MHS Genesis Systems (and Laboratory Information System (LIS)). Incoming equipment will be inspected by DDEAMC Medical Maintenance Branch and added to DDEAMC property books prior to installation. The contractor shall be responsible for qualifying new instrument and reagents on the analyzers. All activities performed by the contractor shall be documented with appropriate checklists and forms. This documentation shall be given to the Microbiology and Immunology supervisor. The contractor shall develop a site specific implementation plan prior to the delivery of the instrument. The contractor shall provide instrument training of primary operations on-site, and will assist with workflow optimization to ensure a smooth transition from our current method to the contractor's platform. The contractor shall validate the new system, providing needed reagents to complete validation. The contractor shall provide the validation guidelines in electronic and hard copy format. These guidelines shall contain but not limited to test cases from which the facility can select or modify according to Department of Pathology requirements. The analyzers must be able to interface as a bi-directional system with the current MHS Genesis LIS system. The contractor shall provide all necessary communication equipment.

5.2 At a minimum, the Contractor will be able to supply the following allergens and autoantibodies for testing with the capacity to add more allergens as requested by the allergists:

Grass Pollens Weed Pollens Microorganisms Fruit/Veg Egg and Fowl Oat IgE Bahia grass IgE Cocklebur IgE A alternate IgE Apple IgE Chicken meat IgE Pea IgE Bermuda Grass IgE Common Pigweed IgE A fumigatus IgE Asparagus IgE Egg IgE Peanut IgE Orchard Grass IgE Common Ragweed IgE C albicans IgE Avocado IgE Egg white IgE Pecan nut IgE Johnson grass IgE Dandelion IgE Chaemtomium IgE Banana IgE Egg yolk IgE Pine nuts IgE Meadow Fescue IgE Firebrush IgE C herbarum IgE Beetroot IgE Turkey Meat IgE Pistachio IgE Kentucky blue IgE Giant ragweed IgE Curvularia lunata IgE Blackberry IgE Egg and Fowl Poppy seed IgE Redtop Bentgrass IgE Lamb’s Quarter IgE E purpurascens IgE Blueberry IgE Chicken meat IgE Red Kidney

Bean IgE

Rye Grass IgE Mugwort IgE F Proliferatum IgE broccoli IgE Egg IgE Rice IgE Sweet Vernal Grass IgE

Nettle IgE H halodes IgE cabbage IgE Egg white IgE Rye IgE

Timothy IgE Plantain English IgE M racemosus IgE Carrot IgE Egg yolk IgE Sesame seed IgE

Tree Pollens Rough marshelder IgE P chrysogenum IgE Celery IgE Turkey Meat IgE Soybean IgE American beech IgE Russian Thistle IgE Phoma betae IgE Cherry IgE Misc Foods Sweet Chestnut

IgE American Pine IgE Lenscale Ige P pullulans IgE Cucumber IgE Baker’s yeast IgE Walnut IgE Bayberry IgE Sheep sorrel IgE R Nigricans IgE Date IgE Cacao IgE Wheat IgE Box-elder IgE Western ragweed IgE S botrysoum IgE Fig IgE Coffee IgE White Bean IgE Com silver birch IgE Wormwood IgE Fish/Shellfish Garlic IgE Cranberry IgE Components Cottonwood IgE Yellow Dock IgE Anchovy IgE Grape IgE Honey IgE nGAL d1 ovomucoid Elm IgE Epi/Animal Proteins Blue Mussel IgE Grapefruit IgE Malt IgE nGAL d2 ovoalbumin Grey Alder IgE Cat Dander IgE Cat fish IgE Kiwi fruit IgE Mushroom IgE Alpha-

Lactalbumin Hackberry IgE Chicken feathers IgE Clam IgE Lemon IgE Papain IgE Beta-

Lactalbumin sycamore IgE Dog dander IgE Crab IgE Lettuce IgE Sunflow Seed IgE Casein Mesquite IgE duck feather IgE Crayfish IgE Mango IgE Tea IgE Cor a1 Mountain Cedar IgE Gerbil IgE Fish, Cod IgE Melon IgE Spices Cor a8 Mulberry IgE Goat Epi IgE Gulf Flounder IgE Onion IgE Basil IgE Cor a9 Oak IgE Goose Feathers IgE Hake IgE Orange IgE Black Pepper IgE Cor a14 Olive tree IgE Guinea Pig Epi IgE Halibut IgE Papaya IgE Caraway IgE Jug r1 Pecan hickory IgE Hamster Epi IgE Herring IgE Peach IgE Chilipepper IgE Jug r3 Sweet gum IgE Horse IgE Lobster IgE Pear IgE Cinnamon IgE Alpha galactosidase IgE

Walnut Tree IgE Mouse epi IgE Mackerel IgE Pineapple IgE Ginger IgE PRU P3 White ash IgE Mouse urine prot IgE Octopus IgE Potato IgE Green pepper IgE Soy PR-10 White Pine IgE Rabbit Epi IgE Oyster IgE Pumpkin IgE Mint IgE Tri A 19 willow IgE Rat IgE Red Snapper IgE Raspberry IgE Mustard IgE rSes i 1 Mites Rat Urine IgE Salmon IgE Spinach IgE Nutmeg IgE Ara h1 Acarus siro IgE Sheep Epi IgE Scallop IgE Strawberry IgE Oregano IgE Ara h2 D farinae IgE Venom Shrimp IgE Swt PotatoIgE Thyme IgE Ara h3 D pteronyssinus IgE Bumble bee IgE Snail IgE Tomato IgE Vanilla IgE Ara h8 PR-10 G domesticus IgE Honey bee IgE Squid IgE Watermelon IgE Seed/Legume/Nut Ara h9 LTP L destructor IgE Paper wasp IgE Swordfish IgE Other Almond IgE rApi m1 T prutresentiae IgE Whitefaced hornet IgE Tilapia IgE Cochineal Extract

IgE Barley IgE rAPI m2

Parasites Yellow hornet IgE Trout IgE Formaldehyde IgE Brazil Nut IgE rApi m3 Ascaris IgE Yellow Jacket IgE Tuna IgE Gelatin IgE Buckwheat IgE rAPI m5 Meat Milk Walleye pike IgE Latex IgE Cashew nut IgE rAPI m10 Beef IgE Cheese Cheddar IgE Insects Seminal Fluid IgE Coconut IgE rVes v1 Pork IgE Goat’s Milk IgE Fire Ant IgE Silk IgE Gluten IgE rVes v5 Rabbit IgE Milk IgE Cockroach IgE Green Bean IgE rPol d5 Total IgE Antibodies Mosquito IgE Hazel nut IgE IgeTotal Thyroglobulin Ab Lentil IgE Thyroid Peroxidase Ab Maize Corn IgE

5.3 Contractor's representative shall report to the Medical Maintenance Branch, building 300, DDEAMC, prior to commencing all on-site services and repairs during normal operating hours from 0800 to 1600 Monday through Friday. If repairs are required or completed after normal duty hours the staff on-site will make sure service receipts are provided to the Medical Maintenance Branch.

5.4 Upon completion of services, a written service report will be provided to Department of Pathology, Microbiology and Immunology Laboratory personnel and Medical Maintenance Branch Manager. The service report shall be completely filled out, provide detailed information regarding the cause of equipment malfunction and corrective action taken, to include the time required to complete the work, price of labor (hourly rate), and a list of parts replaced with. Contractor shall provide the balance of the required information in writing to the Chief, Medical Maintenance Management, not later than seven days after services are completed. Contractor shall ensure repairs technicians complete close out documentation within 24 hours and issue an interim report

5.5 Software coverage: Contractor shall update all software to the customer and must notify to the customer when updates are released. This is at no cost to the government. Hardware upgrades that are related to safety concerns or needed to maintain instrument performance specifications will be mandatory and shall be performed by the Field Service personnel at no cost to the customer. All software and hardware upgrades must be performed by trained personnel. The Field Service Engineer shall schedule with the section supervisor of the upgrade.

5.6 Training: Included with the analyzer acquisition is comprehensive training for the employees of the Microbiology and Immunology Laboratory. Vendor will provide two (2) funded training slots at vendor training site. Additional training needs will be conducted on-site by vendor implementation representatives.

Request a Diagnostics Systems Specialist be assigned to the section to facilitate the analyzer implementation. These personnel shall perform the initial instrument qualification testing and provide guidance to the Microbiology and Immunology Laboratory, Eisenhower Army Medical Center staff for tasks such as writing SOPs and performing parallel testing.

6. Payments:

6.1 Contractor shall invoice through Wide Area Work Flow (WAWF). Monthly invoices will be input into WAWF not later 30 days after shipment of supplies. Monthly invoices will incorporate reagent use from the first day of the month through the last day of said month.

6.2 Contractor shall re-use the same invoice number listed on the original invoice with a letter behind the original invoice number when resubmitting an invoice. A new invoice number will not be generated for a previous shipment.

7. Non-compliance:

7.1 In the event the contractor fails to accomplish services within the months specified or within the required repair time frame, the entire agreement will be extended 30 days at no charge to the government.

8.0 Quality Assurance

QUALITY ASSURANCE SURVEILLANCE PLAN (OASP)

Performance Objective PWS Reference Acceptance Performance Level Monitoring Method Contractor shall ensure reagents provided shall bear the same lot number within designated shipments and meet or exceed proficiency testing standards of CAP, TJC, CSLI, and be approved by the FDA.

Para 1.1.1 Zero defects Observation by COR/QA or representative.

Contractor will provide timely PM and other periodic maintenance, notifying the customer one week in advance of all PM needs, software or hardware updates.

Para 1.1.2 Zero defects Observation by COR/QA or representative.

Contractor shall deliver replacement consumable supplies within twenty-four.

(24) hours of receipt of verbal order if contracted consumables are found to be defective and unsuitable for use.

Para 1.1.1 Zero defects Observation by COR/QA or representative.

Contractor shall provide emergency maintenance support within twenty (24) four hours of request

Para 1.2.10 Zero defects Observation by COR/QA or representative.

Contractor shall furnish a malfunction incident report to the Contracting Officer Representative (COR) within 24 hours of the completion of any maintenance call or maintenance action.

Para 5.4 Zero defects Observation by both Medical Maintenance and COR/QA or

, representative.

Contractor shall ensure all invoices are posted to WAWF not later than thirty

(30) days after shipment of supplies.

Para 6.1 Zero defects Observation by COR/QA or representative.

Eisenhower Army Medical Center, Department of Pathology Section hours of operation are 7 days a week, 24 hours a day.