Attachment 4 - Statement of Work.pdf

STATEMENT OF WORK

STATEMENT OF WORK (SOW) CHEMISTRY

TESTING BASSETT ARMY COMMUNITY HOSPITAL

FORT WAINWRIGHT, ALASKA 99703

1 SCOPE OF WORK

1.1. The vendor shall provide non-personal services, supplies and equipment to include, but not limited to, any personnel, equipment, transportation, tools, materials, supervision, training, and other items and services necessary to provide chemistry/immunoassay automation systems and reagents. The contract pricing shall be an all-inclusive price within the Cost Per- Reportable Result (CPRR). The vendor selected is responsible for equipment and services at Bassett Army Community Hospital (BACH), Fort Wainwright, AK. The vendor shall perform to the standards of this Statement of Work (SOW).

1.2 For the purposes of this SOW, the system shall include:

Two mirrored analyzers, peripherals (e.g. Uninterruptable Power Sources (UPS), instrument specific computers, Computer Processing Units (CPU), printers, barcode scanners, terminals, monitors, etc.

1.3 The instrument shall be compatible with the recently installed laboratory operations middleware (Navify or Infinity), or it must have its own middleware, that can route samples to the DoD's Cerner MHS Genesis system for peer review.

1.4 The analyzers shall process serum, plasma, urine, and spinal fluid simultaneously without the need for any operator sample pretreatment and shall operate at room temperature between 15 & 30 degrees Celsius.

1.5 The analyzers shall not exceed the following size criteria:

width <150 inches depth <45 inches height <70 inches

1.6 If a water system is required, one for each analyzer shall be supplied by the analyzer manufacturer, with installation and service included in the total cost outlined by the contract.

The hospital shall work with the contractor to establish drainage system.

1.7 Minimal maintenance required, and shall be: Daily <15min, weekly <30 min, and monthly <45min.

1.8 The expected contract timelines are below:

Base Period 01 October 2025 through 30 September 2026 First Option Year 01 October 2026 through 30 September 2027 Second Option Year 01 October 2027 through 30 September 2028

Third Option Year 01 October 2028 through 30 September 2029 Fourth Option Year 01 October 2029 through 30 September 2030

2 TESTING SYSTEM

2.1 The testing system shall be manufactured, sold and supported by one Contractor. The testing system shall be serviced and supported by the awarded Contractor. This includes all on-site and off-site training, Information Technology (IT) management, IT implementation services, phone support, on-site and off-site services, as well as any future FDA approved testing that can be performed on contractor supplied testing system. The testing system shall be capable of interfacing with the military hospital computer system, i.e., MHS Cerner Genesis Electronic Health Record. The Contractor shall have an established driver compatible for interfacing the analyzer with MHS Cerner Genesis Electronic Health Record. The interface between MHS Cerner Genesis Electronic Health Record and the analyzer shall be bi-directional.

2.2 The testing system shall include a data management system for control of the operation of the analyzers, 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 data management system.

2.3 All equipment displays and supporting literature shall be in the English language. Lease of this equipment shall include delivery, installation, all calibrators/standards, reagents/reagent packs, linearity material, and quality control materials necessary to perform the specified assays, initial Method Validations per Clinical Laboratory Improvement Act (CLIA)/College of American Pathology (CAP) guidelines and analyzer removal at the termination of the contract.

2.4 The analyzers shall be fully automated with the ability to process at least 30 samples per batch, overnight runs, continuous access for samples, a true walk-away system, and barcode reading for all reagents and samples.

2.5 All analyzers and associated parts and accessories shall be new. Neither used, refurbished, or like-new equipment shall be provided in support of this contract at any time.

2.6 The testing system shall come equipped with an un-interruptible power supply capable of providing all necessary electrical power to each analyzer system, to operate the data management and testing system for at least 15 minutes.

2.7 The instrument shall be able to connect to the manufacturer's server database for the purpose of QC evaluation with a peer comparison program. If this feature is unavailable, access to a server via website login where QC data may be uploaded and compared with peers shall suffice. Levy Jennings reports shall be accessible through analyzer software. It shall also offer automated linearity and precision programs to meet regulatory documentation requirements.

2.8 The analyzer shall support data entry with existing Bio Rad Unity Quality Control (QC) Peer Reporting Program for peer comparison to mitigate QC errors, meet compliance, and protect patient safety.

2.9 Contractor shall provide updates and upgrades of testing system. The Contractor and Contracting Officer’s Representative (COR) shall agree upon installation of updates and upgrades.

2.10 The system shall have immunoassay technology that allows for 10 minutes or less for cardiac markers and 30 minutes or less for all other immunoassays to minimize the use of other instruments for point of care. It shall also have a technology that allows for <8-minute Basic Metabolic Panel.

2.11 The analyzer shall have specimen volume sensing to detect clots and short samples, alleviating aspiration errors and preventing patient recollection. It shall also have the capability to alleviate cross-contamination and carryover of specimens.

2.12 The analyzer(s) shall have a reduced sample volume of 1.5 – 15 µL for chemistry and 5 – 30 µL for immunoassays.

2.13 The analyzer shall perform automatic reflex testing for different and same assays, perform automatic specimen dilutions when applicable, maintain assay rules, and display errors/actions for analyzer malfunctions.

2.14 Detection of hemolysis, lipemia, and icterus. Micro sampling shall be available to accommodate multiple-sized tubes.

2.15 The instrument shall have greater than three months of onboard stability for immunochemistry and clinical chemistry reagents. It shall also have extended shelf-life stability of reagents (>6 months for routine chemistry reagents).

2.16 The analyzers shall be able to automatically calibrate the next lot of reagents without any operator intervention needed. It shall not require any reagent preparation, mixing, or pre-opening before reagent testing, and the analyzer shall track calibration and shall be stable for no less than 30 days.

Test parameters shall include the following:

Acetaminophen Lipase Albumin Low-density lipoprotein Alkaline Phosphatase Luteinizing hormone Amylase Magnesium Aspartate Aminotransferase Microalbumin Alanine Transaminase Phosphate Calcium Potassium Carbon Dioxide Progesterone Chloride Prostate-specific antigen Cholesterol Salicylate C-Reactive Protein Sodium Creatine Kinase Testosterone

Creatinine-J Thyroid Stimulating Hormone (TSH) Direct Bilirubin Total Beta-Hcg Ethanol Total Bilirubin Folate Total Protein Follicle Stimulating Hormone Triglycerides Free T4 Troponin (TnT) Gamma-Glutamyl Transferase Urea Nitrogen Glucose Uric Acid Hemoglobin A1c Urine/CSF Protein High-density lipoprotein Vitamin B-12 Lactate Vitamin D Lactate Dehydrogenase Urine Creatinine NT-ProBNP MAG Urine

3 INFORMATION MANAGEMENT

3.1 All Contractor systems that communicate with Department of Defense (DoD) systems shall interconnect through the established Military Healthcare System (MHS) Virtual Private Network (VPN) Business to Business (B2B) gateway. For all Web applications, Contractors shall connect to a Defense Information Systems Agency (DISA)-established Web Demilitarize Zone (DMZ). An approved Certificate of Networthiness (CoN) shall be submitted to the contracting officer six (6) months of contract award.

3.2 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.

3.3 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.

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

3.5 The Vendor shall provide all required information to support and initiate the Department of Defense Information Assurance Certification and Accreditation Process (DIACAP) Implementation Plan. This shall include the required information for the System Identification profile.

3.6 The Vendor shall establish appropriate administrative, technical, and physical safeguards to protect all Government data, to ensure the confidentiality, integrity, and availability of Government data. As a minimum, this shall include provisions for personnel security, electronic security and physical security.

3.7 The Vendor shall provide information for the Risk Assessment Analysis to the Government for all networking IT applicability.

3.8 All costs for VPN hardware and software shall be incurred by the Vendor.

3.9 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.

3.10 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 shall take place from, the encryption that shall be used, and how the vendor's technical users shall maintain secure logon.

3.11 The system shall include a data management system for control of the operation of the analyzers, 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 data management system.

3.12 Department Of Defense Information Assurance Certification and Accreditation Process (DIACAP) Implementation Plan.

3.13 The Contractor shall provide all required information to support and initiate the DIACAP Implementation Plan. This shall include the required information for the System Identification profile.

3.14 The Contractor shall provide information for the Risk Assessment Analysis to the Government for all networking IT applicability.

3.15 The data management system shall provide integrated central processing unit with sufficient data storage and printing capability to accommodate and provide immediate access to at least 200 patient records per day. The Vendor shall provide back up to network data management handling.

3.16 The Vendor shall provide a Thin Client-type data management system that allows for remote operational control of the analyzer system, 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.

3.17 The Vendor shall provide minimum of 2 thin client middleware licenses as well as software and hardware to include but not limited to CPU, monitors, barcode scanners, printer etc. In addition, the status of automation components and communications, it shall be able to be monitored from a single remote interface.

3.18 All software and software licenses, interfaces, and hardware (e.g. servers, printers, monitors, UPS, CPU, barcode scanners, etc.) shall be included with cost of hardware required disclosed for removal if needed.

3.19 Remote diagnostics and troubleshooting shall be available using a maintenance application program that allows technical and service specialists at the Vendor’s technical support center or a field representative to remotely access the instruments to diagnose a problem.

3.20 The software shall provide a single operator interface for workload management, data management, and instrument operational status monitoring. This shall be accomplished via communication connections between the automation, analyzers, and hospital Laboratory Information System (LIS).

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

3.22 The results management application shall manage patient data, sample and quality control (QC) results by offering archiving, status, calculation of results and long-term results storage.

3.23 The Data Management system shall have a comprehensive, fully integrated QC software module that stores and evaluates quality control results. Results can be viewed in a variety of formats including Levy-Jennings charts 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 Government utilizes Bio-Rad quality control materials.

The software program shall provide a link with Bio-Rad’s on-line/on-board QC analysis package, Bio-Rad Unity™ Interlaboratory Program and Bio-Rad Unity QC Data Management Solutions.

3.24 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. The QC software shall provide the capability to write user defined Westgard QC Rules. In addition it shall integrate with the result manager for auto-verification 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 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.

3.25 The data management system shall offer software management features with rules capable of preparing data for auto validation prior to host transmission. The software shall have following capabilities:

• To write and validate user defined auto-verification/auto-result validation rules that can hold transmission of results for review by the user

• To write and validate user defined order /request rules

• To support patient delta checks as part of the auto-verification process

• To manage rules for optimal specimen handling with ability to send automated comments based on the rules to patient host record

• To support rules that recognize linearity limits, repeat for critical value tests, review for specimen integrity and delta checks on previous patient results etc.

• To support specimen Integrity based rules to cancel/edit tests based on the test performed and the interfering substance. Cancelled test shall be able to transmit to the host along with the appropriate comment

4 PRE-ANALYTICS

4.1 The system shall receive specimens, record time from loading to final achieving or disposition.

The information system component of this laboratory system shall be able to communicate with laboratory information system for ordering information to be sent from Lab Information System to the System manager and shall include but not be limited to order code, tube type, accession number, container identification, and receipt date and time.

4.2 The system shall integrate with Laboratory Informatics System (LIS) in order to log-in specimens, determine correct tube requirements, testing information, aliquot as needed, and specimen requirements.

4.3 Pre-analytic:

• Shall read all standard bar-codes

• Shall accept stats at any time and give them priority passage over routine samples

• Shall be able to handle varied (multiple) tube sizes running simultaneously

5 ANALYZERS

5.1 The Vendor shall provide a fully automated, discrete random-access chemistry/immunoassay analyzer system capable of performing all of the required assays listed in table 2.16. The system shall provide redundancy to ensure continuous operations, training, supplies, reagents, unscheduled maintenance, and preventive maintenance for the equipment.

5.2 The analyzer systems and all reagents shall be Food & Drug Administration (FDA) approved. All analyzers and associated parts and accessories shall be new. Neither used, refurbished, nor like-new equipment shall be provided in support of this contract at any time.

5.3 The analyzer system shall be capable of interfacing with the military hospital computer system, i.e., MHS Cerner Genesis Electronic Health Record. The Vendor shall have an established driver compatible for interfacing the analyzer with MHS Cerner Genesis Electronic Health Record. The interface between MHS Cerner Genesis Electronic Health Record and the analyzer shall be bi-directional.

5.4 Both analyzers shall need to be identical. Each analyzer shall 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.

5.5 System shall be able to process blood, serum, plasma, urine, and spinal fluid simultaneously, without the need for any operator sample pretreatment.

5.6 Waste stored on board, no liquid waste stream or waste does not react negatively in shared drain, e.g. ammonia and bleach. Waste documentation shall be provided by the manufacturer for all liquid waste that is acceptable for regular waste disposal in a sink drain that is shared by a urine analyzer e.g. iRICELL System. Documentation of compliance with all local, state, and federal regulation for discharge of liquid waste into domestics’ sewage systems shall also be provided.

5.7 Analyzer shall have no FDA Class I occurrences in the last 18 months. All analytes shall be FDA approved at the time of contract bid.

5.8 All assays tested by analyzer shall be available for proficiency testing from the College of American Pathologists (CAP) and have a peer group of greater than 10 participants over the last 18 months.

5.9 The analyzer shall have the on-board ability to maintain reagents at the proper storage temperatures for the assays listed in table 2.16. The analyzer shall be capable of maintaining calibration curves for all of the assays listed in table 2.16 also.

5.10 All reagents used by the analyzer system shall be liquid reagents which shall are capped while onboard the analyzer.

5.11 There shall be a single point of specimen entry for the routine analysis of all required chemistry and immunoassay tests. There shall be an optional separate specimen point of entry for Stat specimens.

5.12 Each analyzer shall be a random access, discrete analyzer system with STAT interrupt capability and a primary tube sampling system capable of handling 100mm x 16mm, 100mm x 13mm, 75mm x 12mm, and 64mm x 10.25 test tubes with standard or Hemaguard caps.

5.13 The analyzer systems shall provide users with rapid, reliable test results that are critical for patient care. These analyzer systems shall 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. Each analyzer system shall 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 at least 15 minutes.

5.14 Any item/part/supply excluded by the vendor but required for operation of the system at any time, shall be delineated in their technical proposal. The cost of any excluded items shall be disclosed in the cost proposal.

5.15 The analyzer system shall be able to determine hemolysis, icterus and turbidity levels without additional patient sample, reagents, consumables and no effect on throughput. It shall flag only assays affected by the interferent and the flag(s) and level shall be sent to the LIS or data management system.

5.16 The analyzer system shall have the ability to perform on-board dilution. Specifically, auto dilution, auto repeat and auto reflex capability. Manual dilutions of patient sample shall not be required in any form.

6 REAGENTS

6.1. The Contractor shall provide all of the tests listed in table 2.16, to include reagents and calibrators. These products shall be manufactured by the Contractor and not by a third party.

The testing system and all assays shall be Food & Drug Administration (FDA) approved. All reagents provided shall be identical to those used in the FDA 510K approval application. For reagents with hazardous constituents, Contractor shall provide a mechanism for the Laboratory to meet local discharge requirements. Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alerts and notifications of all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the COR, Laboratory Manager and Lead Medical Technologist. All equipment displays and supporting literature shall be in the English language. Lease of this equipment shall include delivery, installation, all calibrators/standards, reagents/reagent packs, linearity material, and quality control materials necessary to perform the specified assays, initial Method Validations per Clinical Laboratory Improvement Act (CLIA) / Clinical and Laboratory Standards Institute (CLSI) guidelines and analyzer removal at the termination of the contract

6.2. The Contractor shall also estimate the volume of user-replaceable maintenance items that shall be required to support the analyzer, and any analyzer specific tools/supplies necessary to perform operator-level periodic maintenance tasks. The contractor shall provide the operator level maintenance tool/spare parts kits and replenish all expended items. Replenishment shall be made as needed or on a periodic basis not to exceed the normal preventive maintenance cycle.

6.3. Delivery of the reagents shall be on an as needed basis. Individual orders shall be placed by the COR or other designated authorized government personnel. Name and point of contact of authorized personnel shall be provided to the Contractor.

6.4. The workload listed in table 2.16 is an estimate based on projected annual volume. Orders of required items shall be called or emailed to the Contractor. Deliveries shall arrive within five working days after the order is placed. No deliveries shall be accepted on weekends or federal holidays. Emergency orders placed before 2:00 PM Alaska Standard Time shall be delivered within 48 hours after the order is placed.

6.5 All reagents/reagent packs shall be provided as follows:

• Be provided by the manufacturer of the equipment.

• Be marked with the required storage temperature.

• 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.

6.6 In the event that the supplies are found to be defective and unsuitable for use with the Contractor's equipment or the contractor has failed to comply with the requirements, the Contractor shall replace the supplies within 48 hours of receipt of the order. The Contractor shall reimburse the government for any costs/supplies related to tests performed by another contractor or sent to a referral laboratory when reagents were not available due to product issues or instrumentation failure.

6.7 Safety Data Sheets (SDS). For all products the contractor shall provide a mechanism for the laboratory to meet local discharge requirement. The Contractor shall provide one set of paper copy and two electronic copies on Compact Disk (CD) of SDS of all reagents and consumables to be used on the system.

6.8 The vendor shall pay for the delivery charges for shipping and handling of the reagents. Any additional costs such as Industrial funding fees, special shipping and handling fees, or any other fee or charges shall be included in CPK.

6.9 Any item/part/supply/reagent excluded by the vendor but required for operation of the system at any time, shall be delineated in their technical proposal. The cost of any excluded items shall be disclosed in the cost proposal.

7 INSTALLATION AND INITIAL SET UP

7.1 Prior to reporting to the laboratory, the contractor or contractor’s representatives shall report to and obtain a visitor badge from the Equipment Maintenance Department of the facility. The badge shall be returned to the department prior to departing the facility.

7.2 The Contractor shall be responsible for installation, which consists of in-house delivery, positioning, and mounting of all equipment listed on the contract and connections of all equipment and interconnecting wiring and cabling if applicable in coordination with the facility biomedical engineer. Upon receipt of notice from the COR, an agreed date shall be established to proceed with installation. It shall be the Contractor's responsibility to inform the COR of any problems which may be anticipated in connection with installation, or which shall affect optimum performance once installation is completed. 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.

7.3 During the initial implementation, a technical representative shall be available on site throughout the entire implementation period, ensuring the installation and validations be completed within 30 days of equipment arrival. The same technical representative should be available throughout the entire implementation; there shall be documentation of information "hand off" between the different Technical Representatives.

7.4 Upon completion of installation, on-site training, method validation studies, and analytical measurement range/linearity verification shall be performed by Contractor personnel within a period of time to ensure that equipment is fully operational as negotiated.

7.5 Method Validation shall be conducted in accordance with method validation protocols established by the Clinical Laboratory Standards Institute (CLSI) and/or required by the College of American Pathologists (CAP). Method Validation shall include but not be limited to, correlation with current methods (comparison of methods study), validation of analytical measurement range (AMR), validation of precision (replication study) and establishment or verification of quality control ranges. All reagents, quality control materials, calibrators and linearity materials used in the Method Validation Study shall be provided by the Contractor at no cost to the Government. These materials shall not be used in the analysis of specimens for patient care.

• Contractor shall perform all validation studies at no cost to the government, to include manpower, linearity material and reagents, calibrators, controls and be consistent with current CLSI Standards and related documents, CAP Standards and Federal Regulations, for the following:

• Correlation studies should include a minimum of 20 samples, spanning the reportable range, shall be run by the present and the new method. Contactor shall analyze numbers and provide statistical data to accept the new method. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, and meet current standards defined by CLSI.

• Linearity analysis shall be performed on new contracted instrument for each analyte to determine reportable range using statistical tool in accordance with CLSI.

• Precision study shall be performed utilizing normal an abnormal control material. This should consist of a within run precision study of 10 normal and 10 abnormal controls or patient samples.

• Carryover studies shall be performed, as applicable, as part of the initial evaluation of the instrument. Contractor shall provide interpretation of raw data and validate no carryover exists within the testing system.

• Sensitivity: Sensitivity may be validated concurrently with the linearity verifications.

• Specificity studies: Adverse effects for increased bilirubin, hemolysis, lipemia, or other interrupting substances including blood and urine container are evaluated for interfering substances for each method performed.

• Reference Range: Determine a reference range for each test following CLSI guideline C-23A.

Samples used for the reference range study shall be representative of the patient population being tested. Reference range assessment shall be performed for each lab. A verification of the manufacturer's suggested reference range may be performed as long as the suggested range is based on a comparable population of test subjects. The manufacturer shall provide specific information defining how the suggested range was determined. A minimum of 30 reference individuals shall be used to verify the manufacturer's range. Any apparent outliers should be discarded, and new specimens obtained to provide a statistically valid verification.

• If the suggested manufacturer's range is not appropriate for the patient population, a reference range shall be established. Establishing a reference shall follow CLSI-28A guidelines.

This requires a minimum of 100 reference individuals be used to establish a reference range.

• Therapeutic range validation studies shall be performed by vendor for applicable analytes.

7.6 The Contractor shall provide statistical reports of method validation study and all result print outs, package inserts of materials used for method validation study in an organized fashion to the chemistry supervisor before using the analyzer systems for patient testing. In addition to the hard copy, the Contractor shall provide method validation study results and reports electronically, on a CD or DVD. The Contractor shall provide instrument settings and other configurations on a paper as well as electronically on a CD or DVD.

8 MAINTENANCE AND SERVICES

8.1 Prior to performing maintenance and repair work, the contractor or contractor's representative shall report to and obtain a visitor badge from the Equipment Maintenance Department of the facility. The badge shall be returned to the department prior to departing the facility.

8.2 The Contractor shall provide a list of maintenance agreement options. The Contractor shall provide a full preventative maintenance service for the lease period at no additional cost. Service shall include repair and replacement of defective parts, complete maintenance program (as required by the manufacturer’s maintenance manuals), and hotline telephone service, to assist operators in troubleshooting problems.

8.3 The Contractor is required to maintain all equipment installed under this contract. 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.

8.4 The performance of scheduled periodic preventive maintenance, safety checks, and calibrations that are not normally performed at the operator level shall be performed by Contractor personnel in accordance with requirements as specified in the Contractor’s instrument manual. A preventive maintenance service shall include, but is not limited to, safety, calibration, 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. Completion of installation of the analyzers shall establish time zero for determination of time frames for performance of the above periodic services.

8.5 The Contractor shall provide direct customer hotline telephone service and support, 24 hours/7 days a week, and on-call emergency repair service support, to assist operators in correcting equipment operation problems. The Contractor shall respond to telephonic requests for unscheduled repair within one working day.

8.6 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.

During the contract period, should the repair record of any laboratory equipment reflect a downtime of more than 72 hours in one calendar month, a determination shall be made by the COR to replace the initial laboratory equipment with new equipment.

8.7 Repair:

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

• The Vendor shall respond to telephonic requests for unscheduled repair within one working day for all sites.

• Upon the failure of any analyzer the Contractor’s qualified service technician shall be on-site to provide unlimited emergency service (service requiring immediate repair; an unscheduled maintenance/service requirement) within four hours. The equipment shall be repaired and operational within a minimum of 48 hours after initial response by the Contractor.

• Emergency Services and unscheduled services outside regular working hours, on weekends, and on Federal Holidays shall be listed as a separate line item. The Contractor’s qualified service technician shall be on-site to provide unlimited emergency service (service requiring immediate repair in the event of single instrument failure) within four hours. The equipment shall be repaired and operational within a minimum of 48 hours after initial response by the Contractor. Estimated emergency visits per year are six.

• Should both instruments at the BACH become inoperable, the Vendor’s technical specialist shall be on-site within three hours of initial notification of emergency repair. The repair of at least one analyzer shall be completed within 24 hours of initial notification. If at least one analyzer cannot be repaired within 24 hours of the initial notification, and if deemed necessary by the Government representative, the vendor shall arrange for the pickup and delivery of all critical specimens to a College of American Pathologists accredited clinical laboratory of the Government’s choice for testing. During the period when both analyzers are inoperable, each patient report shall include the testing laboratory’s reference range for the test being performed. The Contractor shall pay all costs associated with the provision of this service, including those for delivery of hardcopy patient results by express courier, for as long as both analyzers remain inoperable, at no additional cost to the Government.

• If the equipment cannot be repaired, a replacement instrument shall be provided within 72 hours.

• 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 Vendor shall be required to correct the deficiency to a fully operational status in accordance with manufacturer specifications at no additional cost to the Government. During the contract period, should the repair record of any laboratory equipment reflect a downtime of 10% or more of the normal working days in one calendar month, a determination shall be made by the representative of the Government to replace the initial laboratory equipment with new equipment.

• Within one working day after completion of work, the vendor shall furnish the copy of a service report for all services performed to the chemistry supervisor.

8.8 The report shall be in English and shall contain, as a minimum, the following information:

• Nomenclature and serial number.

• Date.

• Description of services performed (i.e., preventive maintenance service, or unscheduled repair service).

• Location and services performed.

• Duration of performance (hours).

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

• Name of Technician.

9 TRAINING

The Contractor shall provide initial on-site operator training of all technicians assigned to the Government. In addition, the Contractor shall provide training for two primary operators at the Contractor’s training site at no additional cost to the Government. The Contractor shall provide one training slot per contract year, at the Contractor’s training site at no additional cost to the Government. Operator training at the Contractor’s training site shall include all costs of off-site training, i.e., transportation (air and ground), room and board. The contractor shall also provide all software and middleware training as required for administrative use.

10 SPECIAL TASKS

10.1. The Contractor shall provide one paper and one CD copy of the Operator and Maintenance manuals and a statement of the warranty terms in the English language. The level of detail required of appropriate instrument maintenance manuals extends only to routine maintenance procedures performed by the user. All instrumentation specified as non- Government owned equipment are serviced and maintained by the Contractor.

10.2. The Contractor shall provide one paper and one CD copy of Standard Operating Procedures (SOPs) for each, and every methodology included under the Proposal. The SOPs shall include all relevant technical information regarding the methodology and shall be provided in Microsoft Word, capable of being customized/modified by the end user.

10.3. Updates, upgrades or Replacement: Request for instrumentation updates, upgrades or replacement, due to workload increase, menu changes, technological upgrades, excessive instrumentation failures/malfunctions, breakdowns, or service calls shall be evaluated as needed with communication to the contractor for resolution of the issue. A high incidence of problems with any equipment/analyzer supplied may indicate probable non-compliance with the terms of this contract and shall entitle the Government to its replacement with other analyzer(s) that can produce the required criteria of this contract satisfactorily to the user at no additional cost to the Government. Removal of instrument by the contractor shall be performed within 60 days after request.

11 EQUIPMENT REMOVAL

At the end of the contract term, the contractor shall remove all equipment within 60 days after notification of the expiration of the terms of this contract but not until the completion of new contractor’s equipment installation inclusive of completed cross over studies.

Contractor shall not remove hard drive from premises. All drives with patients’ information remains the property of the Government.

12 HOURS OF OPERATIONS

The laboratory is open 24 hours a day, 7 days a week, even though Bassett Army Community Hospital may be closed after 1600, Monday-Friday, for Walk-in, except for emergencies and inpatient care, and closes on weekends. Supply delivery through IMSA must be from Monday to Friday, 0730 – 1600. However, maintenance can be performed on any day, at any time.

The Point of Contacts (POCs) for laboratory services (analyzer maintenance) are:

CPT Nathan Webster and 1LT Kwasi Boakye (907-361-5011)

The POCs for supply delivery are:

Mr. Benjamin Cale and Mr. Kelly Arvin (907-361-9323)

The following Federal holidays are established by law (5 U.S.C. 6103):

New Year's Day (January 1). Lab-open/IMSA-close Birthday of Martin Luther King, Jr. (Third Monday in January). Lab-open/IMSA-close

Washington's Birthday (Third Monday in February). Lab-open/IMSA-close

Memorial Day (Last Monday in May). Lab-open/IMSA-close

Juneteenth National Independence Day (June 19). Lab-open/IMSA-close

Independence Day (July 4). Lab-open/IMSA-close

Labor Day (First Monday in September). Lab-open/IMSA-close

Columbus Day (Second Monday in October). Lab-open/IMSA-close

Veterans Day (November 11). Lab-open/IMSA-close

Thanksgiving Day (Fourth Thursday in November). Lab-open/IMSA-close

Christmas Day (December 25). Lab-open/IMSA-close

STATEMENT OF WORK – ADDENDUM FOR ANTI-TERRORISM/OPERATIONS SECURITY

AT Level I training. This standard language is for contractor employees with an area of performance within an DHA-controlled installation, facility, or area. All contractor employees, including subcontractor employees, requiring access to DHHQ, Direct Reporting Markets (MTFs), Small Markets and Stand Alone (SSO) facilities and controlled access areas, shall complete AT Level I awareness training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable and annually thereafter. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee, to the COR or to the contracting officer, if a COR is not assigned, within 05 calendar days after completion of training by all employees and subcontractor personnel. AT level I awareness training is available at the following website: http://jko.jten.mil.

Access and general protection/security policy and procedures. This standard language is for contractor employees with an area of performance within a DHA controlled installation, facility, or area. Contractor and all associated sub-contractors employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity http://jko.jten.mil/ verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DOD, DHHQ and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

iWATCH/Suspicious Activity Reporting Training. This standard language is for contractor employees with an area of performance within a DHA-controlled installation, facility, or area. The contractor and all associated subcontractors shall brief all employees on the local Suspicious Activity Training program (training standards provided by the requiring activity ATO). This locally developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the COR. This training shall be completed within 30 calendar days of contract award and within 05 calendar days of new employees commencing performance, with the results reported to the COR NLT 30 calendar days after contract award.

Service Training Certification Tracking System (STCTS) registration for contractor employees who require access to government information systems. All contractor employees with access to a government information systems must be registered in the STCTS at commencement of services, and must successfully complete the DOD Information Assurance Awareness prior to access to the IS and then annually thereafter.