Statement of Objective dated 27JUN2024.pdf

STATEMENT OF OBJECTIVE

Chemistry and Immunoassay Reagent Testing Supplies in Support of Weed Army

Community Hospital at Fort Irwin, California Dated: 27 June 2024

1. GENERAL REQUIREMENTS:

1.1. SCOPE OF WORK: The Contractor shall provide Chemistry and Immunoassay Reagents

(including equipment, maintenance, and support at no extra cost to the government) in support of

Weed Army Community Hospital, Fort Irwin, CA 92310. The Contractor shall be responsible for furnishing maintenance, services, repairs, and parts as require in order to maintain the systems in optimal operating condition. The Contractor shall perform to the standards of this

Statement of Objective. It’s estimated that this will be a base year plus three renewable option years.

1.2. QUALITY CONTROL (QC) and QUALITY ASSURANCE (QA):

1.2. The Contractor shall provide a Quality Control (QC) Plan that contains, at a minimum, the items listed in 1.2.2 (below) to the Contracting Officer and the Government Point of Contact

(POC)/Contract Officers Representative (COR) for acceptance not later than 10 days AFTER the start of the contract. The Contracting Officer will notify the Contractor of acceptance or required modifications to the plan. The Contractor shall make appropriate modifications and obtain acceptance of the plan by the Contracting Officer.

1.2.1.1. The QC Plan shall include:

1.2.1.1.1. A description of the inspection system to cover all incidental support and maintenance services listed on the Performance Requirements Summary (PRS) (See para 9, this document).

Description shall include specifics as to the areas to be inspected on both a scheduled and unscheduled basis, frequency of inspections, and the title and organizational placement of the inspectors. Additionally, control procedures for any Government provided keys or lock combinations shall be included.

1.2.1.1.2. A description of the methods to be used for identifying and preventing equipment failure and/or defects.

1.2.1.1.3. A description of the records to be kept to document inspections and corrective or preventive actions taken. NOTE: The records of inspections shall be kept and made available to the Government throughout the contract performance period and for the period after contract completion until final settlement of any claims, if any, under this contract.

1.2.2. Quality Assurance (QA).

Government personnel will record surveillance observations, as needed, and provide to the

Contractor. The receipt of the observation does not necessarily constitute concurrence with the observation, only acknowledgment that the Contractor has been made aware of the unacceptable performance. Such surveillance will be done according to standard inspection procedures or other contract provisions. Any action taken by the Contracting Officer as a result of surveillance will be according to the terms of this contract.

1.2.3. 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 and 5.4.2.2 (below).

1.2.4. Performance Evaluation Meetings.

1.2.4.1. The Contracting Officer may require the Contractor to meet with the Contracting Officer and/or Government POC/COR, as deemed necessary.

1.2.4.2. The Contractor may request a meeting with the Contracting Officer, when the Contractor believes such a meeting is necessary. If required, written minutes of any such meetings shall be recorded in the contract and signed by the Contractor and the Contracting Officer. If the

Contractor does not concur with any portion of the minutes, such non concurrence shall be provided in writing to the Contracting Officer within 10 calendar days following receipt of the minutes.

1.3. HOURS OF OPERATION:

1.3.1. Normal Hours of Operation, Monday through Friday between the hours of 0630- 1530.

1.3.1.1. Holidays. Routine equipment servicing and reagent delivery will not be required on standard Federal Holidays. If an emergency arises, equipment servicing and reagent delivery will be provided in accordance with Section 5.4.3 of this SOO.

1.3.2. The Contractor shall provide equipment maintenance service/direct customer service and support, Monday thru Friday, to include hotline telephone service.

1.3.3. Legal Holidays. The following legal holidays will be observed by the Government:

New Year's Day 1 January

Martin Luther King's Birthday Third Monday in January

President's Day Third Monday in February

Memorial Day Last Monday in May

Juneteenth 19 June

Independence Day 4 July

Labor Day First Monday in September

Columbus Day Second Monday in October

Veteran's Day 11 November

Thanksgiving Day Fourth Thursday in November

Christmas Day 25 December

NOTE: Any of the above holidays falling on a Saturday will be observed on the preceding Friday;

holidays falling on a Sunday will be observed on the following Monday. Any holidays that are declared by Presidential Executive Order shall be observed in the same manner as the holidays listed above.

1.4. CONSERVATION OF UTILITIES. During maintenance, the Contractor shall make sure employees practice utilities conservation. The Contractor shall be responsible for operating under conditions that prevent the waste of utilities to include:

1.4.1. Lights shall be used only in areas where work is actually being performed.

1.4.2. Employees shall not adjust mechanical equipment controls for heating, ventilation, and air conditioning systems.

1.4.3. Water faucets or valves shall be turned off when not in use.

1.4.4. Environmental and Hazardous Materials Handling. If the disposal of any waste or byproduct of the analyzers cannot be safely dumped into each of the facility's drain system, the

Contractor must provide guidelines for safely disposing these wastes or byproducts in accordance with local and national guidelines.

1.5. RECORDS.

The Contractor shall maintain all records necessary to comply with regulatory requirements and

Food and Drug Administration (FDA) standards. The Contractor shall be responsible for creating and maintaining those Government required records that are specifically cited in this SOO or required by the provisions of a mandatory directive listed in section 5.4, Applicable Publications and Forms. If requested by the Government, the Contractor shall provide the original record or a reproducible copy of any such record within 5 working days of receipt of the request.

1.6. REMOVAL OF EQUIPMENT. The Contractor shall not remove any equipment from the

Government work site without prior approval of the Contracting Officer or his/her designated representative.

1.7. 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 or equipment shall be mutually agreed upon by the contractor and the Government through a bilateral modification.

1.8. SPECIAL WORKING CONDITIONS. All equipment, parts, materials, and incidental services supplied by the Contractor shall conform to the applicable Safety and Health Standards as indicated in the current code of federal Regulations, Title 29, Chapter XVII, paragraph 1910, Occupational Safety Health Act of 1970.

1.9. CONTRACTOR PERSONNEL.

1.9.1. Contractor Employees. The Contractor shall not employ persons for work on this contract if such employee is identified to the Contractor by the Contracting Officer as a potential threat to the health, safety, security, general well-being or operational mission of the installations and their population.

1.9.1.1. Contractor employees shall present a neat appearance and be easily recognized as

Contractor employees. Contractor personnel shall either wear a distinguishable uniform or badge on the exterior of their clothing while performing any service at any Government facility.

1.9.1.2. The Contractor shall not employ any person who is an employee of the US Government.

Additionally, the Contractor shall not employ any person who is an employee of the Department of Defense, either military or civilian, unless such person seeks and receives approval according to DOD 5500.7R, "Joint Ethics Regulation". The Contractor shall not employ any person who is an employee of the Department of Defense, if such employment would be contrary to local policies.

2. DEFINITIONS/ACRONYMS.

2.1. DEFINITIONS. Following is a list of basic definitions.

2.1.1. CONTRACTING OFFICER: The ONLY person with the authority to enter into, administer, change, and/or terminate contracts and make related determinations and findings.

2.1.2. GOVERNMENT POINT OF CONTACT (POC)/CONTRACTING OFFICER'S

REPRESENTATIVE (COR): A Government employee selected and designated in writing by the

Contracting Officer to act as his/her designated representative in administering a contract.

NOTE: The Government POC/COR is not authorized to make any changes to the terms and conditions of the contract.

2.1.3. QUALITY ASSESSMENT AND IMPROVEMENT. Those actions taken by the

Government to check services to determine if they meet the requirements of the CLIA/DoD

CLIP '88 & '03, CAP, JCAHO, U.S. Army Medical Command quality assurance and risk management programs, and ensure compliance with the terms and conditions of the contract.

2.1.4. QUALITY CONTROL. Those actions taken by a Contractor to control the performance of services to ensure that they meet the requirements of the contract.

2.1.5. SERVICES: Includes incidental maintenance services and support performed and materials furnished or utilized to maintain the equipment.

2.1.6. QUALITY IMPROVEMENT (QI): Those actions taken by the Government, in accordance with BJACH, Quality Plan, relevant CSLI standards for quality, AR 40-68, to assure services meet the requirements of the SOO.

2.2. ACRONYMS/ABBREVIATIONS. Following is a list of basic acronyms/abbreviations used in the contract.

AR Army Regulation

COR Contracting Officer's Representative

CAP College of American Pathologists

DA Department of the Army

DOD CLIP Department of Defense Clinical Laboratory Improvement Program

HIPAA Health Insurance Portability & Accountability Act of 1996

MAS Minimum Acceptable Standards

MEDCOM U.S. Army Medical Command

JC Joint Commission

OSHA Occupational Safety and Health Administration

PMS Preventive Maintenance Services

PRS Performance Requirements Summary

QA Quality Assurance

QA&I Quality Assessment & Improvement

QC Quality Control

SOO Statement of Objective

3. GOVERNMENT-FURNISHED FACILITIES, EQUIPMENT, MATERIAL, AND

SERVICES.

The Government will provide, without additional cost to the Contractor, the facilities, equipment, materials, and services listed below.

3.1. FACILITIES. The Government will furnish the facilities for set-up and operation of the

Contractor equipment analyzers required in support of the SOO. Contractor shall not alter the facility without prior approval from the contracting officer. The Contractor shall return the facilities to the Government in the same condition as received, fair wear and tear and approved modifications excepted. These facilities shall be used for performance of this contract only.

3.2. EQUIPMENT. No equipment will be provided.

3.3. MATERIALS. No materials will be provided.

3.4. SERVICES. The Government will provide the following services at no cost to the

Contractor:

3.4.1. The Government will provide the following utilities; electricity (110, 220), heating and air, solid refuse collection, and perhaps other utilities, excluding water. Appropriate water and septic may not be available.

3.4.2. Security: Police and Fire Protection, as is provided other personnel.

3.4.3. Emergency Healthcare for Contractor employees. The MTF will provide emergency health care for injuries or life threatening medical emergencies occurring while on duty. The Contractor shall reimburse the Government for such services as billed by the MTF, unless the Contractor employee is otherwise authorized to receive such services at no cost (e.g., is retired military or is a military dependent).

4. CONTRACTOR FURNISHED PROPERTY

4.1. General. Except for those Government-furnished items and services specified in section 3, the contractor shall furnish all items, equipment, and incidental support and maintenance services required under this contract.

4.2. Transportation. Transportation in support of any equipment and incidental support and maintenance services is the responsibility of the Contractor. The Government will not provide transportation.

4.3. Nametags. The Contractor shall furnish a nametag for each contract employee. The nametag will contain the name of the company and the employee.

4.4. If necessary, the vendor will provide a water purification system.

5. SPECIFIC TASK

5.1. DESCRIPTION

5.1.1. The Contractor shall provide two identical fully automated, discrete random access chemistry and immunology analyzer systems (or one system which can perform both functions) capable of performing all of the required chemistry assays listed in Appendix 1. The analyzer systems will be from a single Contractor and manufacturer. The Contract for the analyzer will be four (4) years beginning 01 October 2024 to 30 September 2028. The system shall provide redundancy (thus two, to ensure continuous operations), training, supplies, reagents, unscheduled maintenance, and preventive maintenance for the equipment. All equipment displays and supporting literature must be in the English language. Contractor shall include delivery, installation, all calibrators/standards, reagents/reagent packs, and controls (controls only for initial validation) necessary to perform the specified assays, initial Method Validations per CLSI

QM guidelines and analyzer removal at the termination of the contract. All costs will be calculated on a cost per test to include Calibrations and repeat testing basis based on the number of patients/tests 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 SOO and factored into the cost per reportable or test.

5.1.1.1. For the purposes of this SOO the analyzer system includes at a minimum:

- Any and all analyzers

- Peripherals (e.g., must include Uninterruptable Power Sources (UPS), instrument specific computer terminals and CPUs, printers, etc.)

5.1.1.2. The analyzer system will be located at:

Weed Army Community Hospital

Dept. of Pathology

Building 390, North Loop Road

Fort Irwin, CA 92310

5.1.2. Within 10 working days after contract award, Contractor shall coordinate and conduct a post award site visit for the purpose of coordinating schedule for equipment installation.

5.1.3. Method Validation will be conducted in accordance with method validation protocols established by the Laboratory'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).

5.1.3.1. Method Validation will include but not be limited to, normal range verification, demonstration of linearity with limit of quantitation verification (LOQ), limit of detection verification (LOD), reportable range, correlation with current methods (comparison of methods study), validation of analytical measurement range (AMR), validation of clinical reportable range (CRR), 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.

5.1.3.1.1. The Method Validation will be completed and approved by the Laboratory Director prior to reporting of patient results. Payment for services will not begin until the analyzer system has been approved for reporting of patient results estimated to be on 01 Oct 2024.

5.1.3.2. 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.

5.1.3.3. All reagents, controls, calibrators, performance verifiers, range verifiers, 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.

5.1.3.4. The Government's Technical Supervisor will provide patient specimens for use in the

Method Validation. Fort Irwin’s population tends to have very normal values. In the event that specimen requirements for high, low, or other 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.

5.1.3.5. Both the Contractor and Contractor personnel at each location shall abide by all Health

Insurance Portability & Accountability Act of 1996 (HIPAA) rules and regulations when conducting the Method Validation Study.

5.1.4. The Contractor shall provide one paper and two (2) CD copies of the Operator's and

Maintenance manuals and a statement of the warranty terms in the English language. The CD copies may be in the form of the manual built into the analyzer’s software. The level of detail required of appropriate instrument maintenance manuals extends only to routine maintenance procedures performed by the user. All instrumentation specified is non-Government owned leased equipment that is serviced and maintained by the Contractor.

5.1.5. The Contractor shall provide the reagents and shall coordinate exact quantities and shipment schedule with the Government POC/COR prior to shipment IAW Section 5.3.13, Deliveries (below).

5.1.6. The Contractor shall be responsible for the collection and transportation of equipment upon termination of the contract.

5.2. ANALYZERS:

5.2.1. Individual analyzer shall have fully automated, discrete random access capabilities for chemistry, immunometric, potentiometric, and colorometric assays within one integrated analyzer.

5.2.1.1. There shall (must) be a single point of specimen entry for the routine analysis of all required chemistry and immunoassay tests. There shall (must) be an optional separate specimen point of entry for STAT specimens, or STAT override capability.

5.2.2. The analyzer shall be a random access, discrete analyzer system with STAT interrupt capability and a primary tube sampling system capable of handling various size phlebotomy collection tubes to include 5 mL, 7 mL, 10 mL tubes; 1.5 mL sample cups; and 1.0 mL small sample containers. The analyzer will be capable of accommodating tubes manufactured by both

Becton-Dickinson and Greiner.

5.2.3. The analyzer systems shall provide users with rapid, reliable test results that are critical for patient care. These analyzer systems shall (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.

5.2.4. Minimum actual through-put shall be 50 tests per hour for immunometric assays, 300 tests per hour for enzymatic/rate and colorimetric/photometric assays and 100 tests per hour for ISE assays.

5.2.5. All analyzer/data management system displays and supporting literature shall be in the

English language.

5.2.6. Initial startup from the shutdown state shall (must) not exceed 20 minutes.

5.2.7. Electric provided will be 110/220. There is a single outlet available for each analyzer.

(Two outlets total). The Contractor is responsible for all connections. However, due to quality of power available and frequent outages/fluctuations in power, the system must come with an uninterrupted power source (UPS) capable providing continuous stable electricity due to electrical fluctuations, and capable of providing electricity for at least fifteen (15) minutes due to an electrical outage.

5.2.8 System must be waterless due to availability and quality of water, and disposal of liquids generated.

5.2.9. System must operate in an environment down to fifteen (15) percent humidity.

5.2.10. The analyzer systems and all reagents shall be approved by the Food & Drug

Administration (FDA). 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.

5.2.11 The Government will provide an existing space of 10.5 ft. by 4 ft. and height of 8 ft for each analyzer. The narrowest width of ingress/egress is 48 inches.

5.3. REAGENTS.

5.3.1. The analyzer shall (must) have the on-board ability to perform the tests shown in

Appendix 1. The analyzer must also maintain reagents at the proper storage temperatures for the assays listed in Appendix 1. All assays must be FDA approved.

5.3.1.1. The workload listed in Appendix 1 is an estimate of reagents needed and will be the quantities listed in the contract. These are based on projected patient workload. Actual workload will vary depending on health care needs. The workload numbers represent patient reportable results, and do not include calibrators, controls, or reruns due to troubleshooting or specimen dilutions.

5.3.1.1.1. The analyzers must be capable of holding and storing these reagents at temperatures required to store these reagents.

5.3.2. The assays listed in Appendix 1 shall (must) be approved by the FDA for plasma as well as serum samples, and were indicated also for urine, spinal fluids, and other designated body fluids. In addition, the Contractor shall clearly demonstrate an acceptable correlation, as defined in section 5.1.3 between plasma, serum, and other body fluid values during the initial set up and correlation studies.

5.3.3. All reagents (See Appendix 1) need not be maintained on an analyzer at the same time, but the analyzers provided shall (must) have the capability to add/change out reagents/reagent packs with only a minimal calibration/quality control requirement (i.e., shall (must) allow the user to calibrate any assay, remove the assay reagents/reagent packs for a period of undetermined time, and then reload the reagents/reagent packs to run the assay without the need for recalibration in most instances, thereby allowing the user to meet work test scheduling requirements specific to the location).

5.3.4. All Reagents shall (must) have the ability to be placed on the analyzer within an hour when removed from storage. (i.e., reagents shall be taken straight from refrigerator to the analyzer).

5.3.5. The assays listed in Appendix 1 must be capable of being run by each analyzer and must be capable of being on each analyzer at all times.

5.3.6. The Contractor shall optimize the specific arrangement of the reagents/reagent packs for assays that are routinely maintained on the analyzer during the initial installation of the analyzer and when a new assay is added to the test menu. The Contractor shall (must) ensure that all required reagents/reagents packs are accounted for in the loading plan for the assays that are routinely maintained on the analyzer (assays to be routinely maintained on the analyzers will be specified at the time of installation).

5.3.7. The Contractor shall provide an estimate of the yearly quantities of reagent/reagent packs, calibrators/standards, any controls, or verifiers used or recommended by the Contractor, required to perform the volume of patient reportable tests for each assay as provided in Appendix 1.

5.3.7.1. The Contractor shall ensure that requirements for routine quality control runs (as defined by the Laboratory Director and outlined in the Laboratory QA program), routine calibration, periodic calibration/calibration verification.

5.3.7.2. 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.

5.3.8. Reagents shall (must) have a minimum shelf life of three (3) months upon receipt by the

Government, or, if this shelf-life requirement cannot be met, the Contractor shall (must) identify the guaranteed shelf life after receipt that can be accommodated in their response to the Request for Proposal.

5.3.9. Assays shall (must) be stable enough to maintain a single control run per 24 hours of testing. Calibration frequency for all assays shall not be less than once every thirty (30) days under routine operations. This calibration frequency does not include calibrations required following instrument repair or servicing (e.g., field service type maintenance or service, major changed in instrument components that affect readout, QC troubleshooting, etc.) or other instances as described in the Laboratory QA Program or approved by the Laboratory Director.

5.3.10. All reagents, calibrators, range verifiers, and performance verifiers provided shall be identical to those used in the FDA 510K approval application. All reagents/reagent packs shall be provided as follows:

5.3.10.1. Be provided by the manufacturer of the equipment.

5.3.10.2. Be marked with the required storage temperature.

5.3.10.3. 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.

5.3.11. The government will provide its own controls and external quality control program.

However, the Contractor shall provide the reagents/reagents packs, calibrators/standards, quality control materials such as performance verifiers or range verifiers, user-replaceable maintenance items, and analyzer specific tools/supplies as needed. The Contractor will provide a toll-free telephone number at which these products may be ordered. The phone for orders must be manned Monday through Friday between the hours of 7:00 A.M. to 2:00 P.M. Pacific Standard

Time.

5.3.12. Deliveries. Deliveries of required items shall be per periodic orders and/or agreed upon shipment dates or emergent deliveries called in to the Contractor by the Contracting Officer as identified in the contract. Orders shall arrive within one week of requested date of delivery. Any supplies that are placed on back order shall be clearly identified on the shipping documents and shall be delivered in a timely manner, not to exceed ten (10) days. In the instance a back-order exceeds 10 working days, and reagent is not on hand to perform testing, the Contractor shall provide testing services through local sub-contract at their cost.

5.3.12.1. Emergency orders shall be delivered within 24 hours after the order is placed. NOTE:

Emergency orders will be rare and not exceed five (5) percent of the contract items.

5.3.13. 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. All packaging and shipping information shall be clearly marked as to contents on both the shipping documents and the shipping container/box. All deliveries will be made Monday through Friday, to exclude Federal Holidays.

Deliveries will be sent to:

Weed Army Community Hospital

ATTN: Laboratory

Building 390, North Loop Road

Fort Irwin, CA 92310

5.4. ANCILLARY MAINTENANCE AND SERVICE

5.4.1, ANCILLARY 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.

5.4.1.1. The Contractor shall maintain all equipment installed under this contract except for repairs necessitated by willful damage or negligence on the part of the Government.

5.4.1.2. 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 shall 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.

5.4.1.3. The Contractor shall provide a full unscheduled and preventive 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 in accordance with section 5.4.3.1 of this PWS.

5.4.2. REPAIR. The Contractor will provide a toll-free hotline where the Government may call in case of analyzer failure. That hotline will be manned twenty-four hours a day, seven days a week. Upon notification of equipment failure, the Contractor's qualified service technician shall attempt to talk the Government agent through repairs. If the government agent is not able to perform repairs, then a contractor service technician will be dispatched to make repairs. In the event that only one analyzer is down, the service technician will be on site within seventy-two

(72) hours. In the event both analyzers are down then the service technician will be on site within twelve hours (12) hours. In the event that spare parts are needed, and repairs cannot be performed immediately, all attempts will be made to have the repair parts here within the down times specified earlier in this paragraph. In the event both analyzers are down, repairs to at least one of the two analyzers will be completed within twelve hours, even if it involves cannibalizing parts from one analyzer to fix the other. The Contractor shall provide replacement parts as necessary for operator level maintenance.

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

5.4.2.2. The Contractor shall replace all reagents, calibrators, controls, and any other materials used by the Government to trouble shoot the instrument failure.

5.4.2.2.1. 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.

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

5.4.2.4. Preventive maintenance services shall be performed in accordance with the manufacturer's standards/procedures. A preventive maintenance service shall include, but is not limited to, safety, calibration, 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.

5.4.2.4.1. The Contractor shall notify the Government POC/COR or Chemistry Technical

Supervisor at least one day prior to arriving for performance of a preventive maintenance service.

5.4.2.5. Prior to performing Scheduled Maintenance and Unscheduled Repair Services work, the

Contractor's representative shall report to the laboratory at Weed Army Community Hospital and then be escorted to Security to get a visitors’ badge and then to Medical Maintenance to notify them what maintenance is being completed. The badge must be returned to security prior to departing the MTF.

5.4.2.6. Within one (1) working day after completion of a repair, the Contractor's representative shall furnish the chemistry supervisor, laboratory representative or Government POC/COR one

(1) copy of a service report for all services performed. 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 of services performed

• Duration of performance (hours)

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

• Name of technician

5.4.2.7. The Government and the Contractor shall exchange hazard communication information before the commencement of any repair.

5.4.2.8. When required, the Contractor shall comply with the Occupational Safety and Health

Administration lockout and tag out procedures while performing maintenance on electrical equipment.

5.4.2.9. Safety Inspections shall be performed at least annually in accordance with NFPA 99, Chapter 7. This regulation can be reviewed in full text online.

5.4.2.10. Preventive maintenance inspections and calibrations shall (must) be performed in accordance with Contractor's guidance as specified in the Contractor's instrument maintenance manual.

5.4.2.11. When appropriate, the Contractor's representative shall notify Medical Maintenance so a complete DD Form 2163 (sticker), entitled "Medical Equipment Verification/Certification" can be attached to the equipment upon completion of calibration services. If the DD Form 2163 is already attached to the equipment, Medical maintenance shall update the existing DD Form

2163. Procedures for updating the 2163 will be provided by medical maintenance.

5.4.3. SERVICE:

5.4.3.1. The Contractor shall provide direct customer service and support, Monday thru Friday, to include hotline telephone service (provided in English) and on-call emergency repair service support, to assist operators in correcting equipment operation problems.

5.4.3.2. 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.

5.4.3.3. The Contractor shall provide a full unscheduled and 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 analyzer 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.

5.4.3.4. Scheduled routine services shall be performed between 0700-1600 Monday-Friday, excluding Federal Holidays.

5.4.3.5. The Contractor's qualified service technician shall be on site to provide routine services;

service requiring immediate repair; and one (1), two (2) or four (4) scheduled services for preventive maintenance (as specified in the Contractor's instrument maintenance manual), safety and calibration as required by this statement of objective.

5.4.3.6. 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) as stated in paragraph 5.4.2.

5.4.3.6.1. 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.

5.4.3.6.2. 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.

5.4.3.6.3. The Contractor's qualified service technician shall ensure all repairs are completed and the analyzer is fully operational prior to departing the lab. In addition, the service technician or

Customer Service "Hotline" will verify the repairs corrected the problem and the analyzer is operational in a follow-up call. This call will be made in a timely fashion (not to exceed 48 hours) after the service technician departs the lab.

5.4.3.7. Should the analyzers become inoperable, the technical repair specialist shall be on-site as described in 5.4.2.

5.4.3.8.2. The repair of the analyzer must be completed as stated in paragraph 5.4.2. If deemed necessary after consultation with the Government POC/COR, if both analyzers are down through no fault of the government and cannot be repaired within twelve hours, even cannibalizing parts, the Government will ship all patient specimens to a College of American Pathologists accredited clinical laboratory and all associated costs will be reimbursed by the Contractor.

5.4.3.9. If the equipment is out of service for longer than three business days (from the time-of-service technician's arrival on site), the Contractor shall notify the Government POC/COR in writing as to the reason(s) (i.e., non-availability of parts, etc.) for non-compliance.

5.4.3.10. 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.

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

5.5. TRAINING:

5.5.1. The Contractor shall provide initial on-site operator training to all technicians assigned to the Government site (i.e., WACH Laboratory staff) prior to initiation of use of the analyzer for patient testing. In addition, the Contractor shall provide training for two (2) primary operators for the analyzer at the Contractor's training site, prior to delivery and installation of the analyzer at no cost to the Government.

5.5.1.1 The on-site operator training shall be provided by qualified Contractor trained personnel.

The training shall encompass basic operation, maintenance and troubleshooting.

5.5.2. The Contractor shall provide two additional training slots during the life of the contract after the base year, at the Contractor's training site, at no additional cost (including transportation airfare, rental car, per diem, etc.) to the Government.

5.5.3. All training manuals/guides, instructional literature, and any other related written/electronic material shall be in the English language. Training shall include basic operation of the analyzers, troubleshooting procedures, performance of operator-level periodic preventive maintenance procedures, and use of the data management/quality control software.

5.6. INFORMATION MANAGEMENT.

5.6.1. The analyzer system shall (must) be capable of interfacing with the military hospital computer system. That system is the MHS Genesis system currently owned or operated by the

Cerner and Oracle Corporations. The Contractor shall (must) have an established driver compatible for interfacing the analyzer with Genesis. The interface between Genesis and the analyzer shall (must) be bidirectional.

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 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.

5.6.2.2. The QC software shall provide the capability to write user defined Westgard QC Rules.

In addition, it should allow viewing and maintaining of QC data across multiple levels and lots for 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.

5.6.3. Data Management system shall (must) 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.

5.6.3.1. 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).

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

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

5.7. DELIVERY OF EQUIPMENT:

5.7.1. The Analyzers will be delivered to the location as indicated below within 30 calendar days after contract award. Equipment setup, on-site training, method validation studies, and analytical measurement range/linearity verification, shall (must) be completed by

Contractor personnel within a period of time to ensure that equipment is fully operational by 01 October 2024. 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 POC/COR.

5.7.2. PRIMARY LOCATIONS OF COMPLETE SYSTEMS:

5.7.2.1. The system shall be delivered to:

Weed Army Community Hospital

ATTN: Laboratory

Building 390, Outer Loop Road

Fort Irwin, CA 92310

The system shall be installed at the same location.

5.7.2.2. Exact installation locations at the primary location shall be coordinated by the Contractor with the point of contacts listed below:

Laboratory Supervisor, (Jay Still) TP# 760 383 5093

Tech on call after hours TP# 760 383 5083

5.8. SAFETY DATA SHEETS (SDS)

5.8.1. The Contractor shall provide safety data sheets (SDS) for each item delivered under this contract that is considered to be HAZARDOUS MA TERIAL. The SDS shall contain information on the hazards associated with each specific chemical or material. The SDS shall be printed in the English language and shall contain as a minimum the following information: identification of the specific hazard, the required practice for the safe use of the product, first aid procedures, and what to do in the event of a spill or other mishap or accident.

6. INFORMATION SECURITY

6.1. TELECOMMUNICATION

6.1.1. 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). All software must be able to pass MITC testing and review and be awarded a

Certificate of Networthiness (CoN) from NETCOM. Submission of the CoN must be completed within six (6) months of contract award. In the event any of these systems change, the

Contractor will do all possible to communicate through any replacement system.

6.1.2. 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.

6.1.3. 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.

6.1.4. 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.

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

6.2. DEPARTMENT OF DEFENSE INFORMATION ASSURANCE CERTIFICATION

AND ACCREDITATION PROCESS (DIACAP) IMPLEMENTATION PLAN

6.2.1. 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.

6.2.2. The Contractor shall provide information for the Risk Assessment Analysis to the

Government for all networking IT applicability.

6.5. ELECTRONIC SECURITY.

6.5.1. Contractor Information Systems (IS)/networks that are involved in the operation of systems in support of RWBAHC shall operate in accordance with controlling laws, regulations, DoD, and local policy.

6.5.2. Certification & Accreditation (C&A) requirements apply to all DoD and Contractor's

IS/networks that receive, process, display, store or transmit DoD information. The Contractor shall comply with the C&A process for safeguarding IS. Certification is the determination of the appropriate level of protection required for IS/networks. Certification also includes a comprehensive evaluation of the technical and non-technical security features and countermeasures required for each system/network.

6.5.3. Accreditation is the formal approval by the Government to operate the Contractor's

IS/networks in a particular security mode using a prescribed set of safeguards at an acceptable level of risk. In addition, accreditation allows IS/networks to operate within the given operational environment with stated interconnections; and with appropriate level of protection for the specified period.

6.5.4. The Contractor shall comply with C&A requirements, as specified by the Government that meet appropriate DoD Information Assurance requirements. The C&A requirements shall be met before the Contractor's system is authorized to access DoD data or interconnect with any DoD

IS/network that receives, processes, stores, displays or transmits DoD data. The Contractor shall ensure the proper Contractor support staff is available to participate in all phases of the C&A process. They include, but are not limited to:

• Attending and supporting C&A meetings with the Government

• Supporting/conducting the vulnerability mitigation process

• Supporting the C&A Team during system security testing

6.5.5. Contractors shall (must) confirm that their networks are locked down prior to initiating testing.

6.5.5.1. Conformation of system lock down shall be agreed upon during the definition of the

C&A boundary and be signed and documented as part of the System Security Authorization

Agreement (SSAA).

6.5.5.2. Locking down the system means that there shall be no changes made to the configuration of the system (within the C&A boundary) during the C&A process.

6.5.6. Any re-configuration or change in the system during the C&A testing process shall require a re-base lining of the system and documentation of system changes.

6.5.7. Information Assurance (IA) mitigation strategies include security updates, service packs, and changes to operating procedures as physical and cyber vulnerabilities are detected. Operating system, routers, servers, development platforms and the application being delivered to the

Government shall be in compliance with all known applicable Department of Defense Computer

Emergency Response Team (DoD-CERT) Alert, Bulletin, and Technical Advisory Notices published during the past 36 months.

6.5.8. Disposing of Electronic Media. Contractor shall follow the DoD standards, procedures, and use approved products to dispose of unclassified hard drives and other electronic media, as appropriate, in accordance with DoD Memorandum "Disposition of Unclassified Computer Hard

Drives," June 4, 2001. Contractor is required to…