Attachment 1 - SOW dated 8.16.24.pdf

Date: 16 Aug 2024

STATEMENT OF WORK

Cost-Per-Reportable-Results Reagents, Controls and Consumables for Coagulation Testing at Naval Medical Center San Diego

1.0 INTRODUCTION

1.1 Organization:

The Naval Medical Center San Diego (NMCSD) and its affiliated Branch Medical Clinics (BMCs) located in San Diego, California are responsible for providing the U.S. Navy, other military branches, and their military families with reliable quality health care. In addition to maintaining status as one of the nation’s premier care providers, NMCSD is responsible for preparing for deployable support of operational forces, as well as shaping the future of military medicine through education, training, and research.

1.2 Background and Objectives:

Department of Defense (DHA) has a requirement for a cost-per-reportable-results (CPPR) lease of two (2) analyzers to perform coagulation testing at the Laboratory Department in NMCSD. The contractor shall provide the analyzer and related services to the equipment as inclusive cost to the CPPR reagents, controls and consumables medical supplies. These medical supplies and analyzer provided by the contractor are used to test and screen the following for patients at NMCSD:

(1) assessment of congenital and acquired deficiencies of the extrinsic pathway (factors II, V, VII, X) and intrinsic pathway (factors XII, XI, IX, IX, VIII).

(2) to monitor warfarin and heparin therapy; and

(3) quantitative determination of fibrinogen level in plasma to diagnose for cases of diabetes, inflammatory syndromes, obesity, DIC (Disseminated intravascular coagulation), fibrinolysis, thrombolytic therapy, (i.e.

d-dimer test) and hereditary diseases.

Supplies from vendor shall be FDA approved and must be within FDA standards. All supply products shall meet Federal, State and Local regulatory requirements. All supply products shall be delivered timely, and shall be free of defects, shall be kept within 2-8 degree Celsius, have a clearly marked expiration date, lot number, and included package insert.

The contractor shall provide equipment, installation, validation, services, and consumables in accordance with the requirements as stated herein.

1.3. Quality Control (QC) and Quality Assurance (QA)

The contractor shall provide a Quality Controls, preferably having stability of 1 year or more. Quality Control (QC) Plan must include Quality Control Peer Group monitoring program. The contractor shall provide monthly QC Peer Group data report to the Government’s representative to ensure instruments are running in line with other medical facilities for the same type of analyzer.

1.4. Upgrade of Equipment.

The Government may add reagents through the life of this contract because 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.

2.0 REQUIREMENT

2.1 Task Description and Deliverables:

The contractor shall provide two (2) analyzers: one (1) for the Laboratory Automation Line and one (1) tabletop for back-up, capable of performing PT, APTT, Fibrinogen, Factor VIII and D-Dimer, as well as other equipment, service, consumables (including reagents, controls, and calibrators), and wearables (needles, tubes, lamps, etc.) necessary to perform the tests.

Equipment:

1. The analyzer system and required accessories will be from a single contractor. If equipment and/or reagents are not from a single source, the primary contractors shall be responsible for providing necessary assistance in order to maintain the laboratory testing until the end of the term mentioned in the contract.

2. The contractor shall provide unlimited service support with both telephone assist and 24/7 onsite field service engineers’ support. Travel and labor shall be included with minimum two preventive maintenance visits per year and as required.

3. The contractor shall provide minimal daily, weekly, and monthly maintenance requirements to reduce instrument non-availability.

4. Instrument will be capable of cap piercing, reducing the need for manual removal of sample caps and possible exposure of staff to contents.

5. Instrument testing turn-around times shall provide the clinician staff with timely results and enable them to quickly provide treatment to the patient.

6. The analyzers shall have onboard digital reagent management tracking of reagents for accurate determination of volume and expiration.

7. Reagents will be scanned into the instrument inventory for use via barcode scanner which will input all the reagent information such as reagent type, vial size, expiration date, lot #, on-board stability, and label values which will reduce possible errors from manual entry.

- Peripherals (e.g., Uninterruptable power sources (UPS), instrument specific computer terminals and CPUs, etc.)

- Floor standing model with reagent storage/tables/cart or a movable pedestal (floor stand) with shelf for supplies and computer peripherals (CPU, Printer, etc.).

8. Quality control material shall have a minimum on board instrument stability of 24 hours for PT, PTT, Fibrinogen, and 8 hours for D-Dimer.

9. The contractor shall be able to sequester a single lot of quality control for an entire year’s worth of testing and ship per the delivery schedule.

10. Quality control shall be easily shared as part of an Interlaboratory Quality Assurance Program to enable peer comparison with other laboratories as part of NMCSD’s lab quality assurance program requirements.

11. Method Validation shall include but not be limited to, normal range verification, demonstration of linearity, reportable range, correlation with current methods (comparison of methods study), validation of analytical measurement range (AMR), validation of precision (replication study) and accuracy (recovery study), and establishment of initial control ranges using control materials, to include third party controls, as designated by the Laboratory Director.

12. The contractor shall provide a qualified Technical Service Representative, who possesses a thorough knowledge of method validation and is familiar with the use of statistical evaluation software as determined by the Laboratory Director (e.g., EP Evaluator®), to provide technical assistance for the method validation studies. The assigned Technical Service Representative will be responsible for the entire Method Validation.

13. The contractor shall provide initial training for all technicians, supplies, reagents, unscheduled maintenance, and preventive maintenance for the system.

14. All equipment displays and supporting literature (to include Manuals/Guides, Safety Data Sheets (SDS), Reports, and all Communications) must be in the English language.

15. The contractor shall provide safety data sheets (SDS) for each item delivered under this contract that is considered HAZARDOUS MATERIAL by the United States or the Contractor’s representative Government. The SDS shall contain information on the hazards associated with each specific chemical or material and meet all regulatory agency (e.g., CAP, TJC, etc.) requirements. The SDS shall contain, as a minimum, identification of:

- The hazardous material

- The specific hazard

- The required practices for the safe use of the product

- First aid procedures

- What to do in the event of a spill or other mishap or accident.

16. The contractor shall include delivery, installation, setup, and all calibrators/standards, reagents/reagent packs, and quality control materials necessary to perform the specified assays, initial Method Validations per the Clinical Laboratory Standards Institute (CLSI) guidelines and the DPALS Quality Manual (QM).

17. All costs will be calculated on a cost per patient reportable or patient billable basis based on the number of patients listed for each Mandatory Test or Desired Test listed on Appendix 1. Costs shall be amortized over the total number of tests described in this Statement of Work (SOW) and factored into the cost per reportable or patient billable. Payment for services will not begin until the analyzer system has been approved for reporting patient results.

18. The contractor shall provide a water system (e.g., filtered, deionized etc.), if required by the analyzer, that shall provide uninterrupted service for a period to be determined by the Laboratory Director.

19. The contractor shall be responsible for the collection, removal, and transportation of equipment upon termination of the contract.

20. The contractor shall not remove any equipment from the Government work site without prior approval of the Government’s representative at NMCSD.

21. To ensure operator-to-operator standardization and best patient results without subjectivity and interpretation, the analyzers shall provide true walkaway results without operator re-classification and altering of given results.

22. The Government’s technical supervisors will obtain patient specimens for use in Method Validation. If specimen requirements for correlation studies cannot be met (e.g., insufficient number of patients to challenge the extremes of a curve), the Contractor shall assist in procuring additional specimens. These specimens may be obtained from other laboratories or from Contractor sources.

Analyzer Hardware/Software

1. The Analyzer system and all reagents shall be FDA approved and meet Federal, State and Local regulatory requirements. 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.

2. It must not have any adverse event(s) reported to FDA where instrument(s) had to be recalled.

3. Be compatible with and maintain bi-directional interface with HL7, the DOD Laboratory Information System, Military Health System (MHS) Genesis.

4. Be capable of reading specimen Code 39 barcode labels.

5. Fully automated system that provides specimen volume checks, integrity checks, perform root cause analysis and minimize repeat testing. It must provide ergonomic features such as touch screen to minimize use of other computer accessories.

6. Provide random access to the instrument in order to load STAT, routine samples, reagents and consumables.

7. Use standardized operational software to make training and operation of the analyzers efficient, simple, and as transparent as possible for the staff members. It must provide audit trail of maintenance, QC, and errors to comply with inspection readiness.

8. There shall be a single point of specimen entry for the routine analysis of all required tests. There shall be an optional separate specimen point of entry for STAT specimens.

9. Possess a touch screen/flat screen monitor for operator interface.

10. Possesses a single TCP/IP port to connect to the Laboratory Information System.

11. Comes equipped to perform continuous, random and statistical analysis; capable of real time or (online) Quality Control.

Reagents, Controls and Consumables

1. The analyzer shall have the on-board ability to maintain reagents at the proper storage temperatures for test assays listed above. All assays shall be FDA approved.

2. The workload listed in Appendix 1 is an estimate based on projected patient workload. Actual workload may vary. The workload numbers represent patient reportable results, and do not include calibrators, controls, or reruns due to troubleshooting.

3. Reagents shall have a shelf life not less than of 6 months upon receipt at the Receiving Activity (consignee), or as stated within the individual line item (i.e. Delivery Ticket, Invoice).

4. Controls shall have a shelf life of not less than 6 months.

5. An alternate quality control material must be provided by the contractor if the new lot of controls cannot be delivered two weeks prior to the expiration date of the lot currently in use.

6. All test kits shall be provided as follows:

(a) Be provided by the manufacturer of the equipment.

(b) Delivered on time (see Delivery of Equipment), at the appropriate storage temperature, and marked with any required temperature controls as necessary.

(c) Routine or scheduled orders shall arrive within one week before or after the scheduled date of delivery.

(d) Emergency orders shall be delivered within 24 hours after the order is placed.

(e) Be compatible with all reagent packs used with the Analyzers.

(f) Preservation and packing - preservation and packing shall be performed in accordance with the best, commercial practice and in such a manner to afford adequate protection against any damage during shipment from source to destination.

(h) All reagents provided shall be identical to those used in the FDA 510K approval application. If the bulk reagents are produced overseas, they shall be manufactured in conformance with ISO or CE standards AND must be equal to or better than the U.S. products in quality/manufacturing. If third party reagents/parts are used, primary vendor shall assist in resolving any issues with the test system. Documentation of item equivalency must be provided.

7. Note: The actual workload may fluctuate in the first year of the contract due to changes in the distribution of patient care and transition phase of the new analyzer. In addition, workload may expand in subsequent option periods due to fluctuations in patient volume, and with the inclusion of other locations within the Regional Medical Treatment Facility - Pacific. Appendix 1 provides the estimated workload for the base period of the contract as well as an estimated workload for each option period. All workload numbers represent total estimated patient reportable/billable results for the indicated year.

Information Management:

a. The analyzer system shall be capable of interfacing with the military hospital computer system, i.e., MHS Genesis. The contractor shall have an established driver compatible for interfacing the analyzer with the middleware. The interface between middleware and the analyzer shall be bi-directional.

b. The analyzer system shall include a data management system 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; and a printer to produce hard copy patient reports and other reports generated via the analyzer system’s data management system. The Data Management system 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. The QC software shall have a large capacity to store graphics and results, cumulative patient reports and quality control files with statistics - all available to user.

c. The QC software shall provide the capability to write user defined Westgard QC Rules. In addition, it shall integrate with the result manager for autoverification of results, allow viewing and maintaining of QC data across 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 point(s) from statistics. The QC software shall (must) 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.

d. Data Management system shall have a user friendly "Windows Based" interface that shall include a data management system for operational control of the analyzer system, management of the QC program, on- instrument useful life of the reagents/reagent packs, and management of patient results.

e. All software shall be the most current version, be fully supported by the software manufacturer and be current with all security updates. Software updates shall be provided at no additional cost to the Government throughout the term of the contract.

f. 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).

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

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

Middleware Functionality Capabilities

Middleware Key functionalities:

Comprehensive rule creation/edition/deletion capability for instrument flags, linearity, delta results and critical test results.

Auto-validation and manual validation features.

Online, real-time access to patient data for at least two years.

Provide technical support/consultation for the use of Middleware.

Interfacing: Middleware Architecture Support:

Seamless integration between LIS and middleware so that user does not need to switch between middleware and LIS. All work must be able to be performed in the middleware system.

Information Systems Security:

All Navy Medicine IT systems must maintain an appropriate level of confidentiality, integrity, authentication, non-repudiation, and availability.

a. All Contractor systems that communicate with Department of Defense (DoD) systems shall interconnect through established Virtual Private Network (VPN) Business to Business (B2B) gateway. The VPN B2B type required shall be determined only after an official VPN B2B request submission to appropriate approving agencies. The required VPN B2B type and procedure for establishing that type will be disclosed to the contractor upon discovery at a time after contract award. All software must be able to pass Government testing and review and be awarded an Authority To Operate (ATO) from DHA. Submission of the ATO request must be completed within six (6) months of contract award.

b. The Contractor shall validate that systems authenticate users through the use of the Common

Access Card (CAC) or CAC alternative as a part of a two-factor authentication mechanism on the business partner side of the VPN. The Contractor shall also identify the exact location from which remote operational control will take place from, the encryption that will be used, and how the vendor's technical users will maintain secure logon.

The Contractor’s responsibilities shall include the following:

Provides network information.

Procures Tier I or Tier II Internet Service Provider for connectivity.

Provides qualified on-site touch labor support technical support to help resolve telecommunications and support routine maintenance activities.

Obtains DOD Information Assurance Certification and Accreditation Pro cess (DIACAP) certification, DODI 8510.01.

Ensures personnel have appropriate security qualifications.

Ensures personnel complete annual Information Awareness Training.

Reports all problems to the MHS Help Desk.

Provides 24/7 on-call technical points of contact to assist with problem resolution.

Ancillary Maintenance and Services

The Contractor shall at no additional cost, be responsible for furnishing maintenance, services, repairs, and parts as required to maintain the systems in optimal operating condition.

Maintenance and Repair:

a. Upon notification of equipment failure, the contractor’s qualified technician shall establish telephonic contact within 60 minutes of the government notification to the contractor’s customer service “Hotline” and shall be on-site to provide unlimited emergency service (service requiring immediate repair) within four (4) hours of establishing telephonic contact. The equipment shall be repaired and operational within 8 hours after initial response by the contractor. Should both instruments become inoperable, the contractor’s technical specialist must be on-site within four (4) hours of initial notification. If the equipment cannot be repaired, a replacement instrument shall be provided within 72 hours. The contractor shall provide calibration of a temporary instrument at no cost. The contractor shall provide replacement parts as necessary for operator level maintenance.

b. If the analyzer cannot be fixed onsite and offsite repair is required, the contractor shall be responsible for arranging transport back and forth from the government site to the repair place at no cost to the government.

c. The contractor shall replace all reagents, calibrators, controls and any other materials used by the Government to trouble shoot the instrument failure prior to notification of the contractor.

d. The contractor shall notify the Government’s representative at NMCSD of the exact date and time for performance of a preventive maintenance service no less than 10 days prior to the scheduled preventive maintenance services.

e. The contractor shall provide one (1) copy of a service report for all services performed with a copy to the Biomedical Repair Department and the Laboratory Department’s Representative or Government’s representative at NMCSD. The report shall contain, as a minimum, the following information:

I. Nomenclature and serial number

II. Date III. Description of services performed (i.e., preventive maintenance service, or unscheduled repair service) IV. Location of services performed.

V. Duration of performance (hours)

VI. List of parts replaced, or other actions taken to restore operability of the instrument.

VII. Name of technician

Service:

a. The Contractor shall provide direct customer service and support, 24 hours/7 days a week, to include hotline telephone service (provided in English) and on-call emergency repair service support, to assist operators in correcting equipment operation problems.

b. The Contractor shall provide a list of unscheduled and routine preventive maintenance schedule (PMS).

PMS throughout the contract. PMS shall be at no additional cost to the Government 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 analyzer system, including replacement parts, replacement part shipment costs, and service technician travel costs for performance of maintenance services.

c. Scheduled routine services shall be performed between 0800-1700 Monday-Friday, excluding Federal

Holidays.

d. During any period when both analyzers are inoperable, the contractor shall pay all costs associated with the provision of alternative testing, including those for delivery of hardcopy patient results by express courier, directly to the testing laboratory, for as long as both analyzers remain inoperable.

e. The contractor shall notify the Medical Director, Department Head and the Government’s representative at NMCSD in writing as to the reason(s) (e.g., non-availability of parts, etc.) for non-compliance.

f. The Contractor shall provide all necessary user-replaceable maintenance items required to support the analyzer and any analyzer specific tools/supplies necessary to perform operator-level periodic maintenance tasks, at no additional cost to the Government.

Training:

a. The contractor shall provide initial on-site operator training to all technicians assigned to the Government site (i.e., NMCSD Core Laboratory staff) prior to initiation of use of the analyzer for patient testing. The Contractor shall also provide on-site training for 4 technicians annually at no additional cost to the Government or individual trainee.

b. The on-site operator training shall be provided by qualified Contractor trained personnel using contractor owned instrumentation in a mobile environment. The training shall encompass basic operation, maintenance and troubleshooting.

c. The contractor shall provide two training slots annually at no additional cost (including transportation airfare, rental car, per diem, etc.) to the Government. The contractor may request the Government additional charges through a bilateral contract modification issued by the contracting officer only for training services exceeding the basic requirement for a given contract year.

d. The contractor shall provide performance of operator level periodic preventive maintenance procedures, and use of the data management/quality control software.

e. Ongoing continuing education offered online must be offered with educational credits awarded for successful completion of courses.

Delivery of Equipment:

Equipment setup, on-site training, method validation studies, and analytical measurement range/linearity verification, shall be completed by contractor’s personnel.

During the initial implementation, a dedicated technical representative must be available on site throughout the entire implementation period. Substitutions must be coordinated with the Government’s representative at NMCSD.

Primary Location of Complete Systems:

Naval Medical Center San Diego

34800 Bob Wilson Dr.

San Diego, CA 92134

2.2 Task Personnel Requirements

2.2.1 U.S. Citizenship: U.S. citizenship is required.

2.2.2 Technical and Personal Skills:

All technical staff and service engineers employed by the contractor shall have backgrounds in engineering, science, or laboratory technologies. The contractor shall provide a rigorous training and credentialing program used to assess competency of and proficiency for those skills necessary to successfully trouble shoot and fix analyzers before being assigned to an account to provide such services.

3.0 Classification – Unclassified

Privacy Act Statement: “Pursuant to Title 5 United States Code 552a(m)(1), the contractor and all employees of the contractor working under this contract are required to comply with the requirements of 5 U.S.C. 552a (“The Privacy Act of 1974”).

4.0 Travel - No travel required.

5.0 Performance Period – 12-month base period and four (4) 12-month option periods.

6.0 Contractor’s Personnel:

Contractor employees performing related services on the leased analyzers under this contract shall be controlled, directed, and supervised at all times by management personnel of the contractor. Contractor management will ensure that employees properly comply with the performance work standards outlined in the statement of work. Contractor employees will perform their duties independent of, and without the supervision of, any Government official or other Defense Contractor. The tasks, duties, and responsibilities set forth in the contract may not be interpreted or implemented in any manner that results in any contractor employee creating or modifying Federal policy, obligating the appropriated funds of the United States Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee, or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulation (FAR). The Government will control access to the facility and will perform the inspection and acceptance of the completed work.

7.0 Invoice Schedule

Contractor may invoice monthly in arrears.

Invoices shall be submitted once a month at a minimum for supply orders – reagents, controls and consumables.

Related services such as the lease of the analyzers, training, quality control, maintenance/repairs, travel, etc. are all inclusive cost to the supply purchase order of this contract. The contractor can only bill the Government on supply orders and the Government can only accepts charges against the contractor’s accepted pricing list. Only one invoice may be submitted per month. Invoices must identify the invoicing period. If charges against more than one line item have occurred during the invoicing period, all charges must be combined into one invoice. Specific invoicing instruction will be provided in the contract award. The contractor’s failure to include the necessary information or a more frequent invoice submission than authorized will result in invoices being rejected.

Payment will be processed by Wide Area Workflow.

Appendix 1

Mandatory Tests Estimated Base#

Patients/yr.

Estimated Base#

Patients/mo.

Estimated Options 1-4# Patients/yr.

Estimated Options 1-4# Patients/mo.

PT 14,000 1167 14,000 1167

APTT 8,001 667 8,001 667

Fibrinogen 2,400 200 2,400 200

D-Dimer 3,800 317 3,800 317

Factor VIII 1000 83 1000 83