Attachment 1 - Coagulation - SOW (20 May 24).pdf

STATEMENT OF WORK

FOR

David Grant Medical

Center

(DGMC)

Cost Per Reportable (CPR)

Automated Coagulation System

Revised date: 20 May 2024

TABLE OF CONTENTS

Section

1. Description of Services

2. General Information

3. Available Services

4. Technical Requirements

5. Definitions/Acronyms/Publications/HIPAA

6. Attachments/Technical Exhibit Listing

7. Facili ty Modifications

8. DHA Medical Device Equipment Cybersecurity/Risk Management Framework

Requirements

PART 1

1.0 DESCRIPTION OF SERVICES

1.1. Description of Services: David Grant Medical Center (DGMC) requires two analyzer platforms capable of performing Coagulation testing.

1.2 Scope: The contractor shall provide all management, tools, parts, materials (including all reagents, quality control materials, and consumable parts and accessories), equipment, travel, and labor necessary to provide the instrumentation described in Part 4 for the Clinical Lab located at David Grant Medical Center, Travis AFB. In addition, the contractor shall include all site preparation, construction, extended installation, incidental services, labor, shipping, supplies, materials. The contractor will be responsible to provide a fully operational turn-key system, meeting all minimum requirements and essential characteristics for each respective analyzer per the Statement of Work (SOW). Services include instrument use, preventive maintenance, troubleshooting guidance, 24/7 telephone service as well as response by a technical expert provided by the contractor 7 days per week from 0000 to 2359, including Federal Holidays and calibration services, not included in routine maintenance, at frequencies specified in the manufacturer’s service and operations manuals, and any required intervening repair service requirements for the entire contract period, including options if exercised. Expedited shipping options, to include overnight, should emergent supply needs arise. All patient and testing information must be accessible and accurate. All services provided shall be performed in accordance with all applicable laws, regulations, standards, local instructions, and commercial practices. All components outlined in this SOW, to include analyzers, associated peripherals, and data management systems will be serviced and supplied through a single contractor (to whom the contract is awarded), including any parts, equipment, or supplies not manufactured, provided, or serviced by the contractor.

1.3 Objectives:

1.3.1 Must provide two fully automated, discrete, random access coagulation analyzers. Each analyzer will be capable of performing all coagulation testing individually, allowing all testing to be performed using one single stand-alone analyzer while providing testing redundancy through a dual analyzer system.

1.3.2 Must be capable of performing all required coagulation testing assays outlined in Part 7, Attachment 2 of this SOW. All testing provided will be Food and Drug Administration (FDA) approved for use.

1.3.3 Must have a current Authorization to Operate (ATO) or be in the process of acquiring ATO for networked information technology to receive, process, store, display, or transmit Defense Health Agency (DHA) information. All aspects of the contractor’s system, to include both the analyzer itself and any associated components, software, and hardware, must have a current ATO authorization or be in the process of acquiring ATO. The vendor is required to maintain ATO authorization for all aspects of the provided system for the entire duration of the contract. Must be compatible with Military Health System and the Genesis Electronic Healthcare Record Platform.

1.3.4 Test performance and results will be 24/7 with no downtime.

1.3.5 All periodic preventive maintenance specified as not performed by end-user is upkept by the contractor and always performed within its recommended timeframe.

1.3.6 Performance of preventive maintenance, calibration, and quality will not render the department incapable of performing or resulting any testing.

1.3.7 Testing must be provided in a Cost Per Reportable (CPR) billing format.

1.4 Period of Performance (PoP): Base Year, four (4) (12 month) Option periods. With possible six (6) Month Extension

PART 2

2.0 GENERAL INFORMATION

2.1 Contractor Identification

2.1.1 Contractor personnel performing services in a contractor capacity in a Government facility are required to possess and wear an identification badge that displays his or her name and the name of their company.

2.1.2 Contractor personnel will be required to attend meetings or otherwise communicate with Government and/or other contract representatives to meet the requirements of this order. Contractor personnel shall make their contractor status known during introductions.

2.1.3 Contractor personnel, while performing in a contractor capacity, are prohibited from using their retired or reserve component military rank or title in any written or verbal communications associated with the contracts in which they provide services.

2.2 Place of Performance: The work shall be performed at David Grant Medical Center, Travis AFB.

2.3 Mission/Emergency Essential. The services outlined in this SOW are considered mission/ emergency essential. Inability to secure services on a timely manner can preclude use of medical equipment, cause compliance violations, and impair the provision of patient care.

2.4 Hours of Operation: Coagulation Services are available 24/7, 365 Days a year including Federal Holidays.

2.5 Recognized Federal Holidays:

New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Juneteenth Day Christmas Day Independence Day

2.6 Contractor Communication

2.6.1 Government’s Contracting Officer Representative (COR): The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: assure that the contractor performs the technical requirements of the contract; perform inspections necessary in connection with contract performance; maintain written and oral communications with the contractor concerning technical aspects of the contract; issue written interpretations of technical requirements, including Government drawings, designs, specifications; monitor contractor's performance and notifies both the Contracting Officer (CO) and contractor of any deficiencies; and provide site entry of contractor personnel. The COR is not authorized to change any of the terms and conditions of the resulting contract.

2.6.2 Post award conference/periodic progress meetings: The contractor agrees to attend any post award conference. At these meetings the CO will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues.

2.7 Safety: The contractor will ensure that its staff conduct operations in a matter that meets industry OSHA safety standards for the protection of Department of Defense (DoD) staff, patients, and public. The contractor is responsible for unsafe conditions associated with the actions of its personnel.

2.8 Quality:

2.8.1 Quality Control (QC): The contractor shall develop and maintain an effective QC program to ensure services are performed in accordance with this SOW. The contractor shall develop and implement procedures to identify, prevent, and ensure nonrecurrence of defective services. The contractor’s QC program is the means by which the work complies with stated requirements. The contractor’s QCP must be delivered to the CO within 30 days after contract is awarded. After acceptance of the Quality Control Plan (QCP) the contractor shall receive the CO’s acceptance in writing of any proposed change to his QC system. See Part 6, Attachment 3 - CDRL A001.

2.8.2 Quality assurance (QA): The government will evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan provides a systematic method for the Government to evaluate performance and to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

2.9 Delivery: Delivery instructions will be determined after award. Contractor at a minimum must be able to deliver within 30 days after award.

PART 3

3.0 AVAILABLE SERVICES

3.1 Services: The Government will provide the following services below:

3.1.1 Security Forces and Fire Protection: Phone numbers: Non-Emergency Fire Department: 424-3683;

Non-Emergency Security Police: 424-3293. Emergencies (call) 911.

3.1.2 Emergency Healthcare. The Military Treatment Facility (MTF) will provide emergency health care to save loss of life or limb and preserve undue suffering for contract personnel for injuries or illness occurring while on duty in the MTF. These services will be billed to the contractor at the current full reimbursement rate through TRICARE.

3.1.3 The space designated for the equipment and supplies will be provided at the Clinical Lab located at David Grant Medical Center, Travis AFB.

3.1.4 The government will furnish all required utilities such as water, telephone, electricity, etc. Long distance and Defense Switched Network (DSN) telephone services will be provided for official use only.

PART 4

4.0 TECHNICAL REQUIREMENTS

4.1 Instrumentation: Contractor shall provide two fully automated, discrete, random access coagulation analyzers that can meet the DGMC workload (while providing redundancy) and will meet all requirements below:

4.1.1 All tests must be FDA approved.

4.1.2 System will allow for testing of the following:

4.1.2.1 D-dimer, Prothrombin Time (PT), Partial Thromboplastin Time (PTT), Fibrinogen, and Heparin Anti-Xa.

4.1.3 Analyzer must be able to result at least 50 tests per hour. Analyzers will provide results for PT, PTT, Fibrinogen, D-Dimer, and Heparin Anti-Xa within 15 minutes of sample introduction to the system.

4.1.4. Must have the following additional features:

4.1.4.1 Built-in barcode scanner

4.1.4.2 Traditional QC with target values assigned to QC materials.

4.1.4.3 Numeric or pass/fail QC. Stops patient testing if QC fails or expires.

4.1.4.4 Abnormal, critical ranges, and instrument errors flag the operator.

4.1.4.5 Canned or free text user comments.

4.1.4.6 Accepts patient ID or accession number.

4.1.4.7 Automated Check for low sample level using built-in liquid-level sensing.

4.1.4.8 Prevents patient testing for reagent expiration.

4.1.4.9 User-defined automatic repeat, dilution, and reflex testing.

4.1.4.10 Specimen clot detection.

4.1.5 System will have cap-piercing sample probes. This will allow for the loading of capped specimens onto the analyzer for testing.

4.1.6 Vendor will provide two analyzers to ensure 100% uptime.

4.1.7 All coagulation analyzers will be placeable and operable on a benchtop or tabletop.

4.1.8 The vendor will offer a peer group data software for all performed assays and quality control.

4.1.9 QC peer group data must have real time, automatic electronic data upload capability to analyze quality control.

4.1.10 Must provide 24-hour, 7-days a week immediate access to QC peer review data (IQAP).

4.1.11 Must offer on board reagent monitoring.

4.1.12 System will have reagent management technology, such as Radio Frequency Identification (RFID), standard with reagent system.

4.1.13 The coagulation system will have the ability to provide quantifiable results for hemolyzed, lipemic, or icteric specimens for all performed testing assays.

4.1.14 The coagulation system will store all quality control results, calibration results, and patient results for a minimum of 2 years.

4.1.15 The coagulation system will not require more than 10 minutes for the performance of daily maintenance. The coagulation system will be able to identify and prioritize STAT and As Soon As Possible (ASAP) specimens over the performance of routine specimens.

4.1.16 The coagulation system will provide auto-verification capabilities. The system will not require operator intervention for specimens producing normal-defined results without errors; These results will be auto-verifiable by the system through user-defined rules.

4.1.17 The system will provide automatic performance of all quality control. At user-defined times, the system will automatically perform quality control using quality control material that is already on-board the system, without requiring user intervention. Each analyzer must include a comprehensive, fully integrated QC program that uses common statistical control rules (e.g, Westgard Rules). In addition, the QC program must be able to present data in a graphical format useful to detect shifts and/or trends in the QC system (e.g., Levy-Jennings charts).

4.1.18 Provides security capabilities. These include setting multiple standard and user-defined access levels, as well as defining menu options for each access level.

4.1.19 The system will come with a data management system, to include middleware, unless similar capability can be supported within the analyzer system.

4.1.20 Each system must have a maximum sample size less than 200 µL in all modes with a maximum dead volume of 250 µL.

4.1.21 Analyzer routine manual maintenance will be minimized; no manual maintenance is preferred.

4.1.22 The analyzer must have the on-board ability to maintain reagents at the proper storage temperatures for all assays that will be performed on the system.

4.1.23 The PTT reagent must be appropriately sensitive and responsive to Heparin.

4.1.24 The system must continually monitor the volume of all on-board reagents.

4.1.25 All analyzer/data management system displays and supporting literature will be in the English language.

4.1.26 Analyzer initial startup from the shutdown state must not exceed 30 minutes.

4.1.27 Each analyzer must come equipped with an un-interruptible power supply (UPS) capable of providing all necessary electrical power to each analyzer system, to include the data management system, for 15 to 20 minutes after loss of power. Furthermore, electrical line conditioners must be provided to support each analyzer if determined necessary upon evaluation of the local facilities.

4.1.28 All analyzers and associated parts and accessories shall be new. No used, refurbished, or like-new equipment shall be provided in support of this contract at any time.

4.1.29 The D-Dimer assay must be FDA approved for the exclusion of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).

4.1.30 All assays, reagents, and materials must be available directly through the Contractor. Reagents that are not manufactured by the contractor must be provided through alternative means by the contractor, to include any reagents, calibrators, controls, or other required reagents.

4.2 Data Management System (DMS): The contractor will provide a data management system that will meet all requirements below:

4.2.1 DMS must be compatible with MHS Genesis, with LIS interfacing capability. The contractor shall have a driver compatible for interfacing the analyzer with MHS Genesis. The interface between MHS Genesis and the analyzer shall be bi-directional.

4.2.2 The analyzer system shall include a DMS for control of the operation of the analyzer system, management of the quality control program, management of the on-instrument useful life of the reagents/reagent packs, and management of patient results. A printer to produce hard copy patient reports and other reports generated via the analyzer system’s DMS will be provided by the Contractor. The DMS shall have a comprehensive, fully integrated Quality Control (QC) software module that stores and evaluates quality control results. Results can be viewed in a variety of formats including Levy-Jennings charts, moving patient averages, and statistical summaries. The application shall validate QC results by checking them against user selected rules and automatically alert the operator when a rule violation has occurred.

4.2.3 The QC software shall have a large capacity to store graphics, results, cumulative patient reports, and quality control files with statistics – all available to the user.

4.2.4 The QC software shall provide the capability to write user defined Westgard QC Rules. In addition, it shall integrate with the result manager to allow viewing and maintaining of QC data cross multiple levels and lots for connected analyzers, provide a mechanism to maintain an action log of comments from QC review, provide real-time access to QC charts, graphs (Levy- Jennings) and provide the ability to add comments, and eliminate data points from statistics. The QC software shall include the ability to apply Westgard quality control result decision rules in real-time, with the ability of the user to individually select the rules to be applied.

4.2.5 The software shall provide a single operator interface for workload management, data management, and instrument operational status monitoring. The software controls the operations of the analyzer, monitors the lot number expiration date of on-board reagents and control materials. This shall be accomplished via communication connections between the automation, analyzers, and hospital Laboratory Information System (LIS).

4.2.6 The results management application shall manage patient data, sample, and QC results by offering archiving, status, calculation of results and long-term results storage.

4.2.7 The software shall provide proactive monitoring of key instrument parameters to allow for predictive diagnostics.

4.2.8 The contractor shall provide a data management system that allows for remote operational control of the analyzer system, management of the quality control program, on-instrument useful life of the reagents/reagent packs, and management of patient results.

4.2.9 The data management system shall provide a dynamic display sample status, allow for dynamic/real-time review and management of the quality control program, review of on- instrument useful life of the reagents/reagent packs, and management of patient results instrument. In addition, the status of automation components and communications shall be able to be monitored from a single remote interface.

4.2.10 The contractor will provide a middleware solution and full IT support as defined below at no additional cost to the Government throughout the life of the contract. Middleware capabilities shall include, at a minimum, the following features:

4.2.10.1 The capability to write user defined auto-verification/auto-result validation rules that can hold transmission of results for review by the user.

4.2.10.2 The capability to validate user defined auto-verification/result validation rules.

4.2.10.3 Support patient delta checks as part of the auto-verification process.

4.2.10.4 Establish Moving Averages (Average of Normals) protocols to identify trends that may affect patient results.

4.2.10.5 Store patient results for a minimum of 12-months to facilitate auto-verification/auto- result.

4.2.10.6 Provide patient result management system for statistical analysis to include metrics such as Time to Result; percent Auto-verification; percent of samples affected by Hemolysis, Lipemia, and Icterus with ability to drill down to level of blood collector.

4.3. Operator Training: Contractor shall provide initial and recurring training to technicians on instrument use, maintenance, and troubleshooting. Initial training will be provided to all technicians in person on-site. Recurring training shall include a web-based training program available on demand, and quarterly onsite training if necessary. The web-based training program must allow for an unlimited number of trainees to have personalized training plans that are accessed and tracked online. Web- based training shall include instructions for operation and maintenance of all included equipment. At least quarterly, the contractor will provide a representative to provide hands-on analyzer training to conduct onsite training for one day. Contractor shall provide comprehensive written operating instructions for all aspects of equipment functions (i.e. routine specimen analysis, calibrations, etc.) and training materials to DGMC equipment operators on the daily, weekly, monthly, and as required maintenance when required or requested by the laboratory staff. The service technician must be able to provide additional training in person as needed. In the case of quarterly onsite training, COR will be notified in the corresponding months’ COR Report that the training was accomplished (e.g. if quarterly training was completed in April, the April COR Report from the department will annotate that this training was done and on what day).

4.4 Instrument Installation and Validation: The contractor will install, validate, and correlate analyzers per College of American Pathologist guidelines at the company’s expense with results approved by Laboratory Medical Director and Hematology Technical Supervisor. Contractor shall set up and validate custom auto-verification rules in middleware based on DGMC laboratory specific requirements. Vendor also provides all validation reagent, calibrators, controls, and consumables needed to perform these tasks during the validation period.

4.5 Initial Inspection: All contractor owned equipment will be inspected and approved by the Biomedical Equipment Maintenance Section prior to use in the Medical Treatment Facility. Contact Program Manager to schedule inspection.

4.6 Shipping Options and Supplies:

4.6.1 The contractor will provide expedited shipping options should emergent needs arise for any supplies provided by the contractor. All supplies and materials necessary for operation of the instrument and performance of all patient testing will be always available to the DGMC lab. If order is placed within the overnight cutoff specified by the vendor, said supply item will arrive within 24 hours to the facility.

4.6.2 The contractor must provide an estimate of the yearly quantities of reagent/reagent packs, calibrators/standards, and quality control materials required to perform the volume of patient reportable tests for each assay as provided in Part 6 Attachment 2 of this SOW.

4.6.3 The contractor must consider requirements for routine quality control runs (as defined by the Laboratory Director), routine calibration, periodic calibration/calibration verification in accordance with departmental policy and/or the College of American Pathologists (CAP) and troubleshooting of out-of-control assays when calculating the requirements.

4.6.4 The contractor must estimate the volume of user-replaceable maintenance items that will be required to support the analyzer, and any analyzer specific tools/supplies necessary to perform operator-level periodic maintenance tasks. An operator level maintenance tool/spare parts kit will be provided, and replenishment of all expended items made by the contractor at no additional cost to the Government.

Replenishment shall be made as needed on a periodic basis not to exceed the normal preventive maintenance cycle.

4.6.5 Reagents must have a minimum unopened shelf life of twelve (12) months, and controls must have a minimum unopened shelf life of at least eight (8) months upon receipt by the Government.

4.6.6 The contractor shall sequester quality control materials and test reagents where possible to minimize the amount of lot variations sent to the laboratory.

4.6.7 All reagents provided shall be identical to those used in the FDA 510K approval application. All reagents/reagent packs shall be provided as follows:

4.6.7.1 Be provided by the manufacturer of the equipment.

4.6.7.2 Be marked with the required storage temperature.

4.7.7.3 Inclusive of an English language package inserts.

4.6.7.4 If bulk reagents are produced overseas, documentation of item equivalency must be provided.

4.6.7.5 Preservation and packing must be performed in accordance with the best commercial practice and in such a manner to afford adequate protection against damage during shipment from source to destination. All packaging and shipping information shall be clearly marked as to contents on both the shipping documents and the shipping container/box. All routine deliveries will be made Monday through Thursday, to exclude Federal Holidays.

4.6.7.6 Reagents/materials must be maintained at the proper storage temperature during transportation from the contractor's storage facility to the Government acceptance site and be delivered on time at the appropriate storage temperature.

4.6.7.7 The contractor will provide, upon shipment, an electronic tracking mechanism whereby the Government is able to identify the shipping status of any materials. Deliveries of required items must be in monthly drop shipments. Orders must arrive no later than one week from the requested date of delivery. Any supplies that are placed on back order shall be communicated electronically to the Government, clearly identified on the shipping documents, and delivered in a timely manner, not to exceed ten (10) working days. In the instance a backorder exceeds 10 working days, the contractor must provide testing services through local sub-contract at their cost.

4.6.7.8 An alternate quality control material must be provided by the contractor if a new lot of controls cannot be delivered one week prior to the expiration date of the lot currently in use.

4.7.7.9 Routine or scheduled orders will arrive no earlier than one week before or later than one week after the scheduled date of delivery. Emergency orders will be delivered within 24 hours after the order is placed, if done prior to Overnight cutoff.

4.6.7.10 The Contractor shall provide linearity materials for all testing that spans the vendor's published analytical measuring range (AMR) every six-months and as needed to verify repairs per the College of American Pathologist (CAP) inspection criteria.

4.6.7.11 All reagents must be stored at room-temperature, refrigerated, or frozen. At least 70% of reagents must require no preparation or wait time before being loaded on the analyzer. If the vendor cannot meet this preparation requirement; the vendor will disclose what percentage of reagents require preparation and/or wait time at time of Request for Proposal (RFP).

4.7 Accessibility and Accuracy: All patient and testing information must be accessible and accurate.

4.8 Regulatory Standards: All services provided shall be performed in accordance with all applicable laws, regulations, standards, local instructions, and commercial practices.

4.9 Service Reporting: Contractor shall furnish a legible service report to the Medical Equipment Repair Center (MERC) personnel, signed off by the department, including the date, time, company name and service representative, contract number, description of malfunction, description of any services performed, and any recommendations necessary to maintain equipment in the best operating condition.

4.10 Report Availability: In addition to furnishing the service reports, the contractor will store these reports and make them available to the Government at any point during the life of the contract.

4.11 Troubleshooting, Repair, and Maintenance: Troubleshooting guidance and 24/7 telephone service, including on-call emergency repair by a technical expert, will be provided by the contractor 7 days per week from 0000 to 2359, including Federal Holidays and calibration services, not included in routine maintenance, at frequencies specified in the manufacturer’s service and operations manuals, and any required intervening repair service requirements for the entire contract period, including options if exercised. The DGMC lab will be able to reach a live technical support representative within 30 minutes from initial dialing of technical support number. Timelines are listed in 4.11.6.

4.11.1 The Contractor will maintain all equipment installed under this contract except for repairs necessitated by willful damage or negligence on the part of the Government. This includes emergency repairs as well as Preventive Maintenance Services (PMS), safety tests, calibrations/calibration verifications, and unscheduled repair services in accordance with procedures and practices prescribed by the manufacturer of the equipment.

4.11.2 The Contractor must provide a full unscheduled and PMS throughout the contract. PMS must be inclusive of all costs for the performance of scheduled periodic maintenance (as required by the Contractor's instrument maintenance manuals), unscheduled maintenance and repair of the analyzers and any associated equipment provided by the Contractor as part of the analyzers, including replacement parts, replacement part shipment costs, and service technician travel costs for performance of maintenance services.

4.11.3 Scheduled routine PMS must be performed between 0730-1630 PST Monday-Friday, excluding Federal Holidays.

4.11.4 The Contractor must provide all personnel, equipment, tools, materials, supervision, parts, transportation, and other items and services necessary to perform all required repairs and scheduled preventive maintenance/safety inspections and calibrations of equipment. The performance of scheduled periodic preventive maintenance, safety checks, and calibrations that are not normally performed at the operator level must be performed by Contractor service personnel in accordance with requirements as specified in the Contractor's instrument maintenance manual. Completion of installation of the analyzers will establish time-zero for determining the time frame for performance of periodic services.

4.11.5 Upon notification of equipment failure, the contractor's qualified service technician must establish telephonic contact within 30 minutes of the Government's notification to the contractors Customer Service "Hotline."

4.11.6 For equipment supporting the Core Laboratory, the service technician must be on-site to provide unlimited service within twelve (12) hours of establishing telephonic contact. The equipment shall be repaired and operational within 48 hours after initial on-site response by the Contractor. Should both Coagulation analyzers become inoperable, the Contractor's service technician must be on-site within four

(4) hours of initial notification. The repair of at least one (1) analyzer must be completed within eight (8) hours of initial notification. If deemed necessary, after consultation with the COR, if at least one analyzer cannot be repaired within eight (8) hours of the initial notification, the contractor shall, where requested, arrange the pickup and delivery of critical specimens to a College of American Pathologists-accredited clinical laboratory, with priority testing service provided for STAT/ASAP specimens. The Contractor shall pay all costs associated with the provision of this alternative testing, including those for delivery of hard copy patient results by express courier, directly to the laboratory, for as long as all analyzers remain inoperable. The Contractor shall provide replacement parts used, as necessary, claimed from local operator level maintenance kits.

4.11.7 The contractor must provide all reagents, calibrators, controls, and any other materials necessary to troubleshoot analyzer failure.

4.11.8 The contractor must replace all reagents, calibrators, controls, and any other materials used by the Government to troubleshoot instrument failure prior to notification of the contractor.

4.11.9 The contractor's qualified service technician must ensure all repairs are completed and the analyzer is fully operational prior to departing the laboratory. If repairs cannot be completed the same day, the service technician must contact the COR to discuss the situation and provide an estimated date/time of completion. Once complete, the service technician or Customer Service "Hotline" will verify the repairs corrected the problem and the analyzer is operational in a follow-up call. This call will be made in a timely fashion (not to exceed 24 hours) after the service technician departs the lab.

4.11.10 The Government will make the equipment available to the contractor for servicing at such time and duration necessary to perform needed repairs.

4.11.11 All work shall be performed in a professional manner by an authorized service representative.

If any deficiencies are found due to negligence of the service representative, the Contractor is required to correct the deficiency to a fully operational status in accordance with manufacturer specifications at no additional cost to the Government.

4.11.12 All correspondence, service reports, and invoicing shall be in English.

4.11.13 Preventive maintenance services shall be performed in accordance with the manufacturer's standards/procedures. A preventive maintenance service shall include, but is not limited to, safety, calibration, or calibration verification (as appropriate), complete operational testing, lubrication, adjustments, and cleaning of equipment to which the operator does not have access. This also includes the installation of all non-operator parts required to ensure proper operation.

4.11.14 The contractor shall notify of the exact date and time for performance of a preventive maintenance service no later than ten (10) days prior to the scheduled preventive maintenance services.

4.11.15 Prior to performing Scheduled Maintenance and Unscheduled Repair Services work, the contractor's representative shall comply with current vendor reporting procedures at David Grant Medical Center.

4.11.16 Within one (1) working day after completion of a repair, the contractor's representative shall furnish the COR one (1) copy of a service report for all services performed with a copy to the Equipment Management Branch and the Laboratory Representative for the MTF. The report shall be in English and shall contain, as a minimum, the following information: Nomenclature and serial number, date, description of services performed, duration, location, list of parts or other actions taken to restore operability, and name of technician.

4.12 Charges for Service: The Contractor shall bill for services rendered in accordance with the Contract and Approved Price List.

4.13 Uptime: Systems must function with a 100% up-time and ability to perform patient testing 100% of the time. This pertains to having dual platforms. If there is a single platform, up-time and patient testing must be at 98%.

4.14 Standards of Performance: The analyzer must meet the characteristics of performance for precision and accuracy defined by 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

4.15 Standardized Offerings: Must provide standardized offerings (Standing orders for reagents and controls).

4.16 Alerts: The analyzer must have a method of audibly or visually alerting the operator for sudden out of range quality control.

4.17 Quality Control Fail-Safe: The analyzer must prevent results from entering the patient record in the event of failed quality control.

4.18 Dimensions: All analyzers together must fit on top of a 12 ft X 3 ft tabletop while allowing for multiple operator movement, reagent storage, and bench space Further, the analyzer must be able to navigate through doorways that are 42” wide by 83” tall. Tabletop that the analyzers will be on must be provided by contractor.

4.19 Calibrations: Contractor will have a representative perform all lot change calibrations on Coagulation analyzers on-site.

4.20 Removal of Equipment: Should the equipment or any component listed herein require repair at the contractor’s plant, contractor shall obtain a signed authorization from the COR authorizing removal of government equipment. Contractor shall not remove any equipment until loaner/replacement installed on-site. Contractor shall be responsible for damage or loss of equipment while in contractor’s possession.

4.21 Upgrade of Equipment: Subject to mutual agreement between the Government and the Contractor, instrumentation may be upgraded within the specifications of the contract as new technology becomes available. Additionally, the Government will add reagents through the life of this contract as a result of advances in technology or changes to clinical practice standards. Any such change to the reagents shall be mutually agreed upon by the contractor and the Government through a bilateral modification.

4.22 Testing Availability: The contractor will provide a minimum volume of the testing amounts described in Part 6, Attachment 2. The contractor will offer options to add more testing if more is needed beyond this estimated volume.

PART 5

5.0 DEFINITIONS/ACRONYMS/PUBLICATIONS/HIPAA

Definitions:

Contracting Officer (CO): A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

Contracting Officer’s Representative (COR): An individual, including a contracting officer’s technical representative (COTR), designated, and authorized in writing by the CO to perform specific technical or administrative functions. This individual does NOT have authority to change the terms and conditions of the contract.

Nonpersonal services contract: A contract under which the personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

Quality Assurance Surveillance Plan (QASP): An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance. The Government may either prepare the QASP or require the offerors to submit a proposed quality assurance surveillance plan for the Government’s consideration in development of the Government’s plan.

Acronyms:

AFB Air Force Base

ASAP

ATO Authorization To Operate CAP College of American Pathologists CLIA Clinical Laboratory Improvement Act

CLSI

Clinical and Laboratory Standards Institute

COR Contracting Officer Representative COR Contracting Officer CSI Construction Specifications Institute DGMC David Grant Medical Center DHA Defense Health Agency DMS Data Management System DoD Department of Defense DVT Deep Vein Thrombosis FDA Food and Drug Administration

IQAP

Interlaboratory Quality Assurance Program

IT Internet Technology LIS Laboratory Information System MERC medical Equipment Repair Center MTF Military Treatment Facility

OSHA

Occupational Safety and Health Administration

PE Pulmonary Embolism PMS Preventive Maintenance Services POP Period of Performance

PT

PTT

SOW

Statement of Work

QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Plan RFID Radio Frequency Identification RFP Request for Proposal

APPLICABLE PUBLICATIONS

The contractor must abide by all applicable regulations, publications, manuals, and local policies and procedures outlined in the SOW.

Applicable Publications

Applicable Publications (Current Editions): The contractor shall abide by all applicable regulations, publications, and manuals. Following is a list of basic publications applicable to the SOW. The most current version of the publication applies. Publications not on the internet or MTF policies and procedures can be obtained from the MTF. Current issues of publications and links to other service publications can be accessed at the following websites:

http://www.apd.army.mil/ http://www.defenselink.mil/pubs http://www.dtic.mil/whs/directives/ http://www.e-publishing.af.mil

Contractors are obligated to follow these codes as mandatory only to the extent that they apply to the contract.

Supplements, amendments, or changes to these mandatory publications may be issued during the life of the contract.

Advisory publications may be used for information and guidance but are not binding for compliance.

DEPARTMENT OF DEFENSE (DoD) REGULATIONS/MANUALS

INSTRUCTIONS/DIRECTIVES

PUB NO. TITLE

DoDD 5500.7 Standards of Conduct DoDI 5400.7-R Freedom of Information Act DoD 6025.18-R Health Information Privacy Regulation Jan 03 DoDD 8500.1 Information Assurance DoD 8580.02-R HIPAA Security Rule DODI 3020.37 Continuation of Essential DOD Contractor Services During Crises AFI 33-332 Air Force Privacy and Civil Liberties Program

DHA-IPM 18-013 Interim Procedures 18-013, Risk Management Framework AIR

FORCE INSTRUCTIONS/MANUALS

Publications Code:

AFI--Air Force Instruction AFMAN--Air Force Manual AFP--Air Force Pamphlet AF Form--Air Force Form DD Form--Department of Defense Form MDGI – Medical Group Instruction

Pre-Market Approval Section 510(k) of the Food, Drug and Cosmetic Act requires In Vitro device manufacturers to register with the FDA at least 90 days in advance of their intent to market a medical device. This is known as Premarket Notification - also called PMN or 510(k). Must be in compliance with Section 510(k) of the Federal Food, Drug, and Cosmetic Act for those medical device products intended to be delivered to the Government. Only devices that have received Premarket Notification Approval from the U.S. Food and Drug Administration shall be considered for award under this solicitation.

CYBERSECURITY

DHA CyberLOG MDE Cybersecurity/RMF Contracting Requirements

- Warranty and Post-Warranty Service Maintenance Agreement RMF/Cybersecurity Requirements/ Continuous Monitoring/ Risk Management

- General Defense Health Agency (DHA) Medical Device and Equipment (MDE) Cybersecurity/ Risk Management Framework (RMF) Contracting Requirements

- DHA Cybersecurity/RMF Acceptance / MDE Delivery Requirements

In addition to the above requirements (the digital documentation is available upon request), the vendor shall use and comply with the most recent published versions of the following references, as well as all regulations or guidance referenced within those publications:

(a) United States Law

(i) The Health Insurance Portability and Accountability Act of 1996

(HIPAA)

(ii) The Federal Information Security Management Act (FISMA)

(iii) The E-Government Act of 2002

(iv) H.R.2617—Consolidated Appropriations Act, 2023

(b) OMB

(i) Circular A-130

(ii) Guidance M-05-24, Implementation of Homeland Security Presidential

Directive (HSPD) 12—Policy for a Common Identification Standard for Federal Employees and Vendors

(iii) National Institute of Standards and Technology (NIST)NIST Special Publication (SP) 800-37 Rev. 2—Guide for Applying the RMF to Federal Information Systems

(iv) NIST SP 800-39—Managing Information Security Risk: Organization, Mission and Information System View

(v) NIST SP 800-53 Rev. 5—Security and Privacy Controls for Federal Information Systems and Organizations

(vi) NIST SP 800-60—Volume 1 Revision 1: Guide for Mapping Types of Information and Information Systems to Security Categories

(c) Federal Information Processing Standards (FIPS)

(i) FIPS Publication (FIPS PUB) 140-2, Security Requirements for Cryptographic Modules

(ii) FIPS PUB 199, Standards for Security Categorization of Federal Information and Information Systems

(iii) FIPS PUB 200, Minimum Security Requirements for Federal Information and Information Systems

(iv) FIPS PUB 201-3, Personal Identity Verification of Federal Employees and Vendors

(d) DoD

(i) DoD Instruction 5200.02, DoD Personnel Security Program (PSP)

(ii) DoD Instruction 8500.01, Cybersecurity

(iii) DoD Instruction 8520.02, Public Key Infrastructure (PKI) and Public Key

(PK) Enabling

(iv) DoD Instruction 8510.01, RMF

(v) DoD Instruction 8551.01, Ports, Protocols, and Services Management

(PPSM)

(vi) DoD Instruction 8580.02, Security of Individually Identifiable Health

Information in DoD Health Care Programs

(vii) DoD Instruction 6025.18, Privacy of Individually Identifiable Health

Information in DoD Health Care Programs

(viii) DoD Directive 5400.11, DoD Privacy Program

PART 6

6.0 ATTACHMENTS/TECHNICAL EXHIBIT LISTING

PART 6, ATTACHMENT 1 PERFORMANCE

REQUIREMENTS SUMMARY

The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

Performance Objective

Reference Performance Threshold

Method of Surveillance

Procedure

(PRS) # 1

The contractor shall provide a Coagulation system that functions with a 100% up-time and ability to perform patient testing 100% of the time.

Part 4, Section 4.13. 100% Uptime 100% Inspection 100% evaluation of any instrument downtime resulting in complete or partial loss of testing capability.

(PRS) # 2

Must have technical support available 24/7, 365 days per year.

Part 4, Section 4.11., 4.11.6, Part 2 Section 2.4.

100% Availability within 30 Mins always.

100% Inspection 100% investigations of any instance in which the DGMC Laboratory is unable to reach a live technical support representative within 30 minutes from initial dialing of technical support number.

(PRS) # 3

Analyzer meets characteristics of performance for precision and accuracy as defined by 1988 CLIA and

CLSI.

Part 4, Section 4.14. 100% Met 100% Inspection 100% inspection of any failure to meet precision and accuracy assessments.

(PRS) # 4

Maintain records of maintenance and instrument service.

Part 4, Section 4.10 100% Record Upkeep

100% Inspection 100% Inspection of all service reports following receipt of service from Contractor.

(PRS) # 5

All supplies and materials available for the laboratory

Part 4, Section 4.6 100% Availability

100% Inspection 100% inspection of any instance in which the DGMC laboratory loses any testing capability due to inaccessibility of supplies or materials.

(PRS) # 6

Maintain training requirements annually for each piece of equipment.

Part 4, Section 4.3 90%, Ensuring an alternative is given when normal means of training are not available

Periodic Inspection

Periodic surveillance of laboratory personnels’ competency with equipment.

(PRS) # 7

Preventive maintenance specified as not performed by end-user is upkept by the contractor and always performed within its recommended timeframe.

Part 1, Section 1.3.6. 100% Performed on Time

100% Inspection Periodic surveillance of preventative maintenance records, ensuring the timely performance of preventative maintenance within the manufacturers recommended timeframe.

PART 6, ATTACHMENT 2

ESTIMATED WORKLOAD DATA

ITEM TEST NAME ESTIMATED ANNUAL

QUANTITY

1 PT 5300

2 PTT 3927

3 Fibrinogen 156

4 D-dimer 783

5 Heparin Anti-Xa 61

PART 6, ATTACHMENT 3

DELIVERABLES SCHEDULE

Deliverable Frequency Medium/Format Submit To Applicable to:

Mission Essential Plan

Delivered within 30 days after award

60 CONS/CO &

DGMC COR

All

Implementation Plan and Schedule

Delivered within 30 days after award

60 CONS/CO &

DGMC COR

All

CDRL A001 –

Quality Control Plan

Within 30 days of Contract award

Contractor’s discretion

CDRL A001 to CO All

PART 7

7.0 FACILITY MODIFICATIONS/INSTALLATION

7.1 Prior to any such facility modifications, the contractor will present the final plans and cost estimates with a detailed statement of work to Facility Management (FM) office for review. These shall be presented in accordance with the Construction Specifications Institute (CSI) 50-division format with standardized divisions with all costs broken out. The final quotation shall include all site preparation, construction, extended installation, incidental services, labor, shipping, supplies, materials the Contractor will be responsible for to provide a fully operational turn-key system, meeting all minimum requirements and essential characteristics for each respective analyzer. Contractor will also provide visual representations (red-line drawings, drafts, diagrams, mock-ups, screenshots, etc.) to FM for review.

Contractor shall provide all licenses required to complete this project as outlined and all associated fees and payments. Upon review and concurrence, all plans and documentation and any associated billable costs will be sent to Contracting Officer for final approval.

7.2 During the site survey/visit, the contractor shall be responsible for determining all site-specific requirements necessary to ensure proper installation and operation of the system within required space per equipment specifications. It shall be the contractor's responsibility to determine any information necessary accomplish the installations.

7.3 Vendors are advised that there will be an opportunity, during solicitation, to visit the site and should bring all needed personnel to prepare their site preparation offer.

7.4 All work and material will follow the Whole Building Design Guide (WBDG.org), Unified Facilities Criteria 4-510-01, Change 3, Design: Military Medical Facilities, OSHA and the NFPA. Where there is any conflict in standards or codes the stricter of the two shall be followed. It is the responsibility of the contractor and any subcontractor to provide workmanship, parts, and materials in accordance with this scope of work. Associated with this shall be the workmanship of all work performed to adhere and conform to industry standards and common practices of the trades and professions.

7.5 Review of the facility modifications by the FM office in no way constitutes acceptance and/or approval. The Contracting office has the final authority.

PART 8

8.0 CYBERSECURITY/RISK MANAGEMENT FRAMEWORK

8.1 Contractor will ensure all Medical Device Equipment is in compliance with applicable requirements in DHA Cybersecurity and Risk Management Framework as referenced in “DHA Medical Device Equipment Cybersecurity – Service Maintenance Agreement Contracting Requirements” and “DHA Medical Device Equipment Cybersecurity – Risk Management Framework Contracting Requirements”.

Documents are attached for reference in Part 5 – Applicable Publications (Cybersecurity). Copies are available upon request.