Draft_ SOW Coagulation Reagents.docx

DRAFT STATEMENT OF WORK

FOR

COAGULATION REAGENTS

1. GENERAL REQUIREMENTS:

1.1. SCOPE OF WORK: The contractor shall provide Coagulation Reagents (including instruments, equipment, peripheral equipment, maintenance, training, tools, materials, and support at no extra cost to the Government) able to connect to the government owned Roche (8100) Total Laboratory Automation (TLA) in support of Madigan Army Medical Center, Joint Base Lewis McChord, WA. The Contractor shall be responsible for furnishing maintenance, services, repairs, and parts as required in order to maintain the systems in optimal operating condition. The Contractor shall perform to the standards of this PWS.

1.2 HOURS OF OPERATION:

1.2.1 Normal Hours of Operation. The contractor shall perform the services required under this contract during the following hours: Monday through Friday between the hours of 0700 - 1630.

1.2.2 The Contractor shall provide equipment maintenance service/direct customer service and support, 24 hours/7 days a week, to include hotline telephone service, and direct connect remote instrument diagnostic capability to assist operators in correcting equipment operation problems.

1.3 REMOVAL OF EQUIPMENT. The Contractor shall not remove any equipment from the Government work site without prior approval of the COR or his/her designated representative.

1.4 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 may become 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.

1.5 EQUIPMENT TROUBLESHOOTING. When the Government performs troubleshooting with the Contractor, the Contractor shall replace all reagents, calibrators, controls and any other materials used at no additional cost to the Government IAW Paragraphs 5.4.2.1 (below).

2. SPECIFIC TASKS:

2.1. DESCRIPTION: The contractor shall support two (2) compatible, fully automated random access coagulation analyzers, capable of performing clotting, chromogenic and immunological assays listed in Appendix 1, with a minimum throughput of 50 test per hour, all sample and calibrator dilutions must be performed automatically. The system shall provide redundancy (to ensure continuous operations). The contractor will provide all training, supplies, reagents, unscheduled maintenance, and preventive maintenance for the equipment. The system must be able to connect to the Roche (8100) Total Automation Line (TLA). The methods must have a minimum peer group of 20 laboratories in the College of American Pathology (CAP) Surveys. All equipment displays and supporting literature must be in the English language. All equipment modifications shall include delivery, installation, all calibrators/standards, reagents/reagent packs, and quality control materials necessary to perform the specified assays, initial Method Validations per CLIA/NCCLS/DPALS QM guidelines and analyzer removal at the termination of the contract. 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 in Appendix A. Costs shall be amortized over the total number of tests described in this SOW and factored into the cost per reportable or patient billable.

2.1.1. For the purposes of this PWS the analyzer system includes at a minimum:

· Any and all analyzers

· Peripherals (e.g. Uninterruptable Power Sources (UPS), instrument specific computer terminals and CPUs, etc)

· Any equipment needed to connect the analyzers to the Roche TLA.

2.1.2. The analyzer system will be located at:

Madigan Army Medical Center 9040A Fitzsimmons Drive Tacoma, WA 98431

2.1.3. Within 10 working days after contract modification for upgrade, the Contractor shall coordinate and conduct a site visit to the MAMC Department of Pathology for the purpose of coordinating a schedule for equipment installation

2.1.4. Method Validation will be conducted in accordance with method validation protocols established by the Department of Pathology’s Quality Management Program (these protocols are in concordance with applicable standards as described by the Clinical Laboratory Standards Institute (CLSI) and/or required by the College of American Pathologists (CAP)). Relevant guidelines listed in Appendix 1 (below) are the minimum guidelines that will be referenced when conducting method validation. Additional guidelines may be required, depending on regulatory requirements.

2.1.4.1. Method Validation will include but not be limited to, normal range verification, demonstration of linearity, reportable range, correlation with current methods (comparison of methods study), 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.

2.1.4.2. The Contractor shall provide a qualified Technical Service Representative, who possesses a thorough knowledge of method validation (a minimum of two (2) years extensive experience) 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.

2.1.4.3. All reagents, calibrators and linearity materials used in the Method Validation Study will be provided by the Contractor at no additional cost to the Government. These materials will not be used in the analysis of specimens for patient care.

2.1.4.4. The Government’s Technical Supervisor will obtain patient specimens for use in the Method Validation. In the event that 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.

2.1.4.5. The contractor shall be responsible for the collection and transportation of equipment upon expiration or termination of the contract.

3. ANALYZERS.

3.1.1. The two analyzers need not be identical, but each analyzer must have the same test menu capability and utilize the same reagents/reagent packs, ensuring that a test’s reagents/reagent packs can be moved between the two instruments interchangeably. Each analyzer must provide all required coagulation test menu capabilities on the same individual instrument platform Additionally, each analyzer system must 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 for the production of hard copy patient reports and other reports generated via the analyzer system’s data management system. The data management system’s quality control program 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.

3.1.2. The analyzer systems will provide users with rapid, reliable test results that are critical for patient care. These analyzer systems must be capable of performing in low, medium, and high volume work periods to produce results that are accurate and precise throughout the manufacturer’s stated linearity/analytic measurement range.

3.1.3. Clot based assays shall not be subject to interference from hemolysis, icterus, lipemia or other atypical colored plasmas.

3.1.4. Minimum actual through-put shall be 30 Prothrombin Time (PT), 20 Activated Partial Thromboplastin Time (aPTT), 10 Fibrinogen, and 10 D-Dimer per hour with both open mode (manual sampling) and closed mode sampling.

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

3.1.6. The analyzer systems must come equipped with an un-interruptible power supply capable of providing all necessary electrical power to each analyzer system, to include the data management system, for 15 to 20 minutes.

3.1.7. The analyzer systems and all reagents shall be FDA approved. All analyzers and associated parts and accessories will be new. No used, neither refurbished, nor like-new equipment will be provided in support of this contract at any time.

3.1.8. The electrical requirement for the analyzer systems must be 220V/50Hz.

3.2 REAGENTS.

3.2.1 The analyzer must be capable of maintaining calibration curves for all of the assays listed in Appendix A below simultaneously.

3.2.2 The Contractor will also 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, at the level of use specified in Appendix A.

3.2.3 Reagents must have a minimum shelf life of three months upon receipt by the Government, or, if this shelf life requirement cannot be met, the Contractor must identify the guaranteed shelf life after receipt that can be accommodated in their response to the Solicitation for Bid.

3.2.4 The manufacturer will sequester the required quality control materials and test reagents and ensure that no more than one lot change occurs per contract year.

4. NOT USED

5.0. MAINTENANCE AND SERVICE

5.0.1. MAINTENANCE. The contractor shall be responsible for furnishing maintenance, services, repairs, and parts as required in order to maintain the systems in optimal operating condition.

5.0.1.1. The contractor is required to maintain all equipment and peripherals installed under this contract except for repairs necessitated by willful damage or negligence on the part of the U.S. Government.

5.0.1.2. The contractor shall 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 will 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 determination of time frames for performance of the above periodic services.

5.0.1.3. The Contractor shall 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, at the level of use specified in Appendix 1. An operator level maintenance tool/spare parts kit will be provided and replenishment of all expended items will be made by the contractor, at no additional cost to the Government. Replenishment shall be made as needed or on a periodic basis not to exceed the normal preventive maintenance cycle.

5.0.1.4. The Contractor shall provide all reagents, calibrators, controls and any other materials necessary to troubleshoot the reasons for the analyzer failure at no additional cost.

5.0.1.5. 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.

5.0.1.6. 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 shall be required to correct the deficiency to a fully operational status in accordance with manufacturer specifications at no additional cost to the Government.

5.4.5. SERVICE:

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

5.4.5.2. The Contractor shall perform preventive maintenance services (PMS), safety tests, calibrations, and unscheduled repair services in accordance with procedures and practices prescribed by the manufacturer of the equipment.

5.4.5.3. The Contractor shall provide a full unscheduled, preventive maintenance or scheduled periodic maintenance service (as required by the Contractor’s instrument maintenance manuals) for the analyzers and any associated equipment provided by the Contractor as part of the analyzer system at no additional cost to the Government.

5.4.5.4. Upon analyzer failure, the Contractor’s qualified service technician shall be on-site to provide unlimited emergency service (service requiring immediate repair; an unscheduled maintenance/service requirement). The Contractor’s qualified service technician shall establish telephonic contact within 60 minutes of the Government notification to the Contractors 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 48 hours after initial response by the Contractor.

5.4.5.5. Should both analyzers at MAMC become inoperable, the Contractor’s technical repair specialist must be on- site within four (4) hours of initial notification

5.4.5.5.1. 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 arrange the pickup and delivery of critical specimens to a College of American Pathologists accredited clinical laboratory.

5.4.5.5.2. 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 laboratory, for as long as both analyzers remain inoperable.

5.4.5.8. The contractor shall provide routine calibration services for those calibration procedures that are outside the scope of user responsibility.

5.4.5.9. The Contractor shall provide all necessary 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, at no additional cost to the Government.

5.5. TRAINING:

5.5.1. The Contractor will provide initial on-site operator training to all technicians assigned to the Government site (i.e., MAMC Dept of Pathology Core Laboratory staff) prior to initiation of use of the analyzer for patient testing. In addition, the Contractor will provide training for one (1) primary operators, at the Contractor’s training site, prior to delivery and installation of the analyzer.

5.5.2. The Contractor shall provide a training slot per analyzer per contract year, at the Contractor’s training site, at no additional cost (including transportation airfare, rental car, per diem, etc.) to the Government. The Contractor may charge the Government only for training services exceeding the basic requirement for a given contract year.

5.5.3. The Contractor shall provide on-site training for 8 technicians annually at no cost to the Government or individual trainee.

5.5.3.1. 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 advanced troubleshooting.

5.6. INFORMATION MANAGEMENT.

5.6.1. The analyzer system shall (must) be capable of interfacing with the military hospital computer system, i.e., MHS Genesis. The Contractor shall (must) have an established driver compatible for interfacing the analyzer with the IM. The interface between IM and the analyzer shall (must) be bi-directional.

5.6.2. The analyzer system shall (must) 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 for the production of 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.

5.6.2.1. 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).

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

5.6.1 The Data Management system must use Microsoft Windows 10 that includes the most current version with all the security updates.

5.6.2 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.

5.6.3 The Contractor shall follow Army Regulation 25-1, “Army Knowledge Management and Information Technology, AR 25-2, “Information Assurance (IA)”, and DoD 6025.18-R, DoD Health Information Privacy Regulation.

5.6.4 In accordance with contract requirements, Contractors shall connect to the B2B gateway via a Contractor procured Internet Service Provider (ISP) connection. The Contractor shall assume all responsibility for establishing and maintaining their connectivity to the B2B gateway. This shall include acquiring and maintaining the circuit to the B2B gateway and acquiring a Virtual Private Network (VPN) device compatible with the MHS VPN device.

5.6.5 The Contractor shall comply with DoD guidance regarding allowable ports, protocols and risk mitigation strategies and will provide, maintain and configure VPN concentrator that complies with DoD security standards.

5.6.6 All costs for VPN hardware and software shall be incurred by the Contractor.

5.6.7 The Contractor shall initiate, maintain, and document personnel security investigations appropriate to the Business Associate Representative’s responsibilities and required access to MEDCOM Sensitive Information (SI) as determined by the site Chief Information Officer.

5.6.8 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.

5.7 DEFENSE HEALTH AGENCY (DHA) CYBER LOGISTICS (CYBERLOG) CYBERSECURITY/ RISK MANAGEMENT FRAMEWORK (RMF) REQUIREMENTS

5.7.1 The Contractor shall provide an up to date operating system that includes all software patches and updates for all programs installed on the operating system. The operating system and all the programs on the operating system must stay up to date with all software patches and updates throughout its lifecycle.

5.7.2 The Contractor shall include all costs to achieve the initial Authority to Operate (ATO) and maintain it during the lifecycle.

5.7.3 The Contractor shall pass pre-validation technical screening (vulnerability scans utilizing NESSUS, Security Content Automation Protocol (SCAP) scans, and Security Technical Implementation Guides (STIGs) checklists) within 6 months of the contract award

Appendix 1

Estimated Workload Volume/Year

**Note: Estimates based on three-year data analysis (CY20222 - CY2024)