W91YTZ19Q0284_AMENDMENT_0001.pdf

W91YTZ19Q0284

W40M RHCO-ATLANTIC USAHCA

NORTHERN REG CONTR OFC NRCO

POC: HEIDI N. HOLLEY

6000 MACARTHUR BLVD, BASEMENT, RM B058

BETHESDA MD 20815-5003

SEE SCHEDULE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

1. The purpose of this amendment is to make changes to the Statement of Work (paragraph 8.10) and to provide responses to questions from industry.

2. See Summary of Changes for details.

3. All other terms and conditions remain the same.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 30

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 09-Jul-2019

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X W91YTZ19Q0284

X 9B. DATED (SEE ITEM 11)

25-Jun-2019

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer is extended, X is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

09-Jul-2019

CODE

W40M RHCO-ATLANTIC USAHCA

NORTHERN REG CONTR OFC NRCO

6021 5TH ST BLDG 1467

FORT BELVOIR VA 22060-5580

W91YTZ 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W91YTZ

FACILITY CODECODE

EMAIL:TEL:

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

The following have been added by full text:

RESPONSES TO INDUSTRY QUESTION

Question 1:

Section 8: Maintenance, Service and Repair

8.10 Maintenance Requirements:

Daily Maintenance should not require more than 5 minutes of hands on to complete Weekly Maintenance should not require more than 20 minutes of hands on to complete Monthly Maintenance should not require more than 20 minutes of hands on to complete.

There is no single contractor that can support this requirement. We are therefore requesting that this requirement be removed or updated to reflect realistic maintenance times.

Response:

Government agrees to change verbiage to say:

Daily Maintenance should not require more than 30 minutes to complete Weekly Maintenance should not require more than 30 minutes to complete Monthly Maintenance should not require more than 30 minutes to complete

Question 2:

Section 4: Analyzers

4.1 The Vendor shall provide a fully automated, discrete random access chemistry/immunoassay analyzer system capable of performing all of the required assays listed in Appendix 1. The system shall provide redundancy to ensure continuous operations, training, supplies, reagents, unscheduled maintenance, and preventive maintenance for the equipment.

We are requesting that any assay listed in Appendix 1 estimated at less than 2 tests per day, should be recategorized as preferred.

Response: The tests in Appendix 1 that are at lower volumes will remain required tests because they are required to meet in-house turnaround times and critical toxicity levels of therapeutic drugs which would not be tolerable to send out for testing.

Question 3:

4.6 Each analyzer will 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.

Is this a requirement for cap piercing or de-capping capability?

Response: No

Question 4:

Scope of Work: 1.2 For the purposes of this SOW, the automation system to be provided by the contractor includes at a minimum:

* Any and all analyzers to perform the required test menu

* Peripherals (e.g. Uninterruptable Power Sources (UPS), instrument specific computers, Computer Processing Units (CPU), printers, barcode scanners, terminals, monitors, etc.)

* Automation system will include two integrated analytical systems, and middleware shall be delivered and installed at the primary location: Laboratory, BACH, Ft. Campbell, KY.

Question: The term “automation system” typically denotes a track system with preanalytical and/or postanalytical processing. Is the government requiring laboratory track system automation including preanalytical and postanalytical processing?

Response: There is no requirement for preanalytical or postanalytical processing. The verbiage of “automation system” was used to infer that the system be automated from the point of sample entry to result availability.

Question 5:

4.6 Each analyzer will be a random access, discrete analyzer system with STAT interrupt capability and a primary tube sampling system capable of handling 100mmx 16mm,100mmx 13mm,75mmx 12mm,and 64mm x10.25test tubes with standard or Hemaguard caps.

Question: Is the government requiring an automated tube decapper? If so, is it required as part of a track automation system (preanalytical) or as a stand-alone machine that simply decaps tubes prior to being loaded onto the analyzer?

Response: No

Question 6:

6.2 2 Lease of this equipment shall include delivery, installation, all calibrators/standards, reagents/reagent packs, consumables, expendables, 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

Question: Does the government require the vendor to include third-party quality controls material (ie: Bio-Rad) or do you maintain a separate contract for quality control material as is typical in DoD facilities? If the Government requires the vendor to include third party QC material, please provide the annual budget so that all vendors use the same allowance in their quotes.

Response: No, we will provide a separate contract for quality control material. However, vendor will be required to provide manufacturer controls and calibrators when needed for troubleshooting.

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Question 7:

Does Blanchfield Army currently have a BioRad Unity Real time subscription and are you requesting that we provide the connectivity to the program through our middleware solution? Or, do you not currently use BioRad Unity Real time and want the vendor to provide both the connectivity to it and the actual software license for the product for the term of the agreement?

Response: We do not currently use BioRad Unity Real Time.

The following have been modified:

STATEMENT OF WORK

CHEMISTRY TESTING

Blanchfield Army Community Hospital (BACH)

FORT CAMPBELL, KY, 42223

The Laboratory at Blanchfield Army Community Hospital, Ft Campbell, KY is requesting a contract for two Chemistry and Immunoassay Systems and reagents. This contract request is for a period to include one 12 month base period and four 12 month option periods beginning October 01, 2019. This contract will be based on cost per reportable results of tests included in attached testing menu and be updated to include any additional tests brought on at a later date.

Any changes to the layout of the laboratory, environmental control, or to utilities as currently in existence to accommodate placement of their proposed analyzers must be identified in the Contractor’s proposal (i.e., must identify all site preparation requirements necessary for potential placement of their analyzers in the laboratory).

Contractor vehicles may be searched at the Fort Campbell entrance.

1. SCOPE OF WORK

1.1. The vendor shall provide all required systems, automation, accessories, peripherals, reagents, consumables, expendables, quality controls, calibrators, validation materials required for release of patient results. In addition the vendor is required to provide 24 hour 7 technical support and perform all maintenance; scheduled, unscheduled and emergency as required by the manufacturer for the entirety of the contract at no additional cost to the government.

Vendor is responsible for non-personal services to include, but not limited to, all personnel, equipment, transportation, tools, materials, training to include middleware rule writing, and other items and services necessary to provide chemistry/immunoassay automation systems and reagents. The contract pricing must be an all-inclusive price within the Cost Per Reportable (CPR). The vendor selected is responsible for equipment and services at the main facility at BACH, Fort Campbell, KY. The vendor shall perform to the standards of this Statement of Work

(SOW)

1.2. For the purposes of this SOW, the automation system to be provided by the contractor includes at a minimum:

Any and all analyzers to perform the required test menu Peripherals (e.g. Uninterruptable Power Sources (UPS), instrument specific computers, Computer

Processing Units (CPU), printers, barcode scanners, terminals, monitors, etc.)

Automation system will include two integrated analytical systems, and middleware shall be delivered and installed at the primary location: Laboratory, BACH, Ft. Campbell, KY.

Validation 01 August 2019 through 30 September 2019 Base Period 01 October 2019 through 30 September 2020

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First Option Year 01 October 2020 through 30 September 2021 Second Option Year 01 October 2021 through 30 September 2022 Third Option Year 01 October 2022 through 30 September 2023 Fourth Option Year 01 October 2023 through 30 September 2024

2. TESTING SYSTEM

2.1. The testing system must be manufactured, sold, installed and supported by one Contractor with no sub-contracting. 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 must be capable of interfacing with the military hospital computer system, i.e., the Composite Health Care System (CHCS). The Contractor must have an established driver compatible for interfacing the analyzer with the CHCS. The interface between CHCS and the analyzer must be bi-directional.

2.2. The testing system must 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 products required for testing, equipment displays and supporting literature must 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 direct loading and unloading capabilities for samples and include barcode reading for all reagents and samples.

2.5. All analyzers and associated parts and accessories will be new. Used, refurbished, or like-new equipment will NOT be provided in support of this contract at any time.

2.6. The testing system must 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. Contractor shall provide updates and upgrades of testing system upon availability at no charge. The Contractor and Contracting Officer’s Representative (COR) shall agree upon a date of installation of updates and upgrades.

2.8 All system components shall perform satisfactorily at any laboratory temperature between 68 and 80 degrees Fahrenheit and at any laboratory relative humidity between 40 and 80%.

2.9 Chemistry and Immunoassay platforms must be fully functional and provide patient results on the first day of this contracts performance period.

2.10 Billing by the vendor will be based on number to reportable tests run per month and submitted through Wide Area Work Flow not more than 10 days after the end of each month and will include a copy of the invoice as an attachment.

2.11 Must provide the ability to test hemolysis, icterus and lipemia indices and have the ability to determine testing interference by the result produced.

2.12 Must provide Troponin test results in no more than 18 minutes.

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3. INFORMATION MANAGEMENT

3.1 Contractor Information Systems (IS)/Network that are involved in the operation of systems in support of BACH shall operate in accordance with controlling laws, regulations, DoD, and local policy. The Contractor will comply with DoD guidance regarding allowable ports, protocols and risk mitigation strategies.

3.2 All Vendor systems that will communicate with Department of Defense (DoD) systems will interconnect through the established Military Healthcare System (MHS) Business to Business (B2B) gateway. For all Web applications, Vendors will connect to a Defense Information Systems Agency (DISA)-established Web Demilitarize Zone (DMZ).

3.3 In accordance with contract requirements, the Vendor will connect to the B2B gateway via a Vendor procured Internet Service Provider (ISP) connection. The Vendor will assume all responsibility for establishing and maintaining their connectivity to the B2B gateway. This will 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 Vendor will comply with DoD guidance regarding allowable ports, protocols and risk mitigation strategies.

3.5 The Vendor will provide all required information to support and initiate the requirements of the Army Cybersecurity/Risk Management Framework (RMF) requirements. These requirements may be found in appendix 3 of this document.

3.6 The Vendor shall establish appropriate administrative, technical, and physical safeguards to protect any and 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 will provide information for the Risk Assessment Analysis to the Government for all networking IT applicability.

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

3.9 The automation system must 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.

3.10 The data management system shall provide integrated central processing unit with sufficient data storage and printing capability to accommodate and provide immediate access to more than 2,000 patient records per day. The Vendor shall provide back up to network data management handling.

3.11 The Vendor will provide no less than three software licenses proving access to middleware solutions to no less than three users simultaneously.

3.12 Vendor will provide a single dedicated work station capable of accessing middleware program. This will be accomplished via communication connections between the automation, analyzers, and hospital Laboratory Information System (LIS). This dedicated workstation should include software and hardware but not limited to CPU, monitors, barcode scanners, printer etc.

3.13 Middleware must be capable of:

viewing system status to include reagent onboard stability and tests remaining provide dynamic/real time review and management of the quality control program management and verification of patient results writing rules for specimen auto verification/validation

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3.14 Middleware rules will be written by the vendor in conjunction with chemistry supervisor and validated prior to vendor leaving after installation at no additional cost to the government and must be dry validated prior to the first day of the period of performance. Rules will include auto-verification of normal patient results and middleware will also provide an avenue to turn off auto-verification if/when needed by all laboratory technicians.

3.15 Remote diagnostics and troubleshooting will be available using a uni-directional maintenance application that allows technical and service specialists at the Vendor’s technical support center or a field representative to remotely receive instrument information to diagnose a problem. The software will provide proactive monitoring of key instrument parameters to allow for predictive diagnostics.

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

3.17 The Data Management system will 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 will validate QC results by checking them against user-selected rules and automatically alert the operator when a rule violation has occurred.

3.18 The Government utilizes Bio-Rad quality control materials. The software program will provide a capability to upload (at a minimum) monthly data to Bio-Rad’s on-line/on-board QC analysis package, Unity™ Interlaboratory Program and Unity QC Data Management Solutions.

3.19 The QC software will 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 will provide the capability to write user defined Westgard QC Rules. In addition it will 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 must include the ability to apply Westgard quality control result decision rules in real-time, with the ability of the user to individually select the rules to be applied.

3.20 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 must be able to transmit to the host along with the appropriate comment.

Ability to lock out or suppress test analytes if QC performance is unacceptable.

3.21 If BACH changes laboratory information systems or moves to an electronic heath record during the period of performance, the vendor will be onsite before and after a transition to validate all chemistry and immunoassay analyzers to be sure a seamless transition at “go-live”.

3.22 Middleware should have the ability to write user defined rules for external reminders (example: daily reminder to take temperatures at 1300).

4. ANALYZERS

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4.1 The Vendor shall provide a fully automated, discrete random access chemistry/immunoassay analyzer system capable of performing all of the required assays listed in Appendix 1. The system shall provide redundancy to ensure continuous operations, training, supplies, reagents, unscheduled maintenance, and preventive maintenance for the equipment.

4.2 The analyzer systems and all reagents shall be Food & Drug Administration (FDA) approved. All analyzers and associated parts and accessories will be new.

4.3 The analyzer must have the on-board ability to maintain reagents at the proper storage temperatures for the assays listed in Appendix 1. The analyzer must be capable of maintaining calibration curves for all of the assays listed in Appendix 1 simultaneously.

4.4 There must be a single point of specimen entry for the routine analysis of all required chemistry and immunoassay tests. There must be an optional separate specimen point of entry for Stat specimens. This applies to each line of analyzers.

4.5 System must accept multiple specimen types on a single carrier simultaneously.

4.6 Each analyzer will 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.

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

4.8 If system requires additional water treatment, vendor will supply system and all components, accessories and maintenance items/supplies to maintain in good operating condition at no cost to the government.

Vendor will supply an annual water testing report to ensure compliance with manufacturers specifications of water quality.

5. FOOTPRINT

5.1 The physical limitations of the facility prevent major renovations to the existing structures. The provided area in which all required equipment must be able to physically fit is a 19ft x 9ft area with a centrally located waste disposal line.

6. REAGENTS

6.1. The Contractor shall provide all of the tests listed in exhibits, to include reagents, consumables, expendables, quality controls, validation materials and calibrators. For reagents with hazardous constituents, Contractor must 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 and Chemistry Supervisor.

6.2 Lease of this equipment shall include delivery, installation, all calibrators/standards, reagents/reagent packs, consumables, expendables, 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

6.3 The Contractor will also estimate the volume of user-replaceable maintenance items that will be required to support the analyzer, and any analyzer specific tools/supplies necessary to perform operator-level periodic maintenance tasks at the level of volume specified in Appendix 1. The contractor shall provide the operator level

10 | P a g e maintenance tool/spare parts kits and replenish all expended items. Replenishment will be made as needed or on a periodic basis not to exceed the normal preventive maintenance cycle.

6.4 Delivery of the reagents will be on an as needed basis and at no additional cost to the government. Individual orders will be placed by the COR or other designated authorized government personnel. Name and point of contact of authorized personnel will be provided to the Contractor.

6.5 The workload listed in the exhibits is an estimate based on projected annual volume. Orders of required items will 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 Eastern Standard Time (EST) will be delivered within 24 hours after the order is placed.

6.6 All reagents/reagent packs will 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.

6.7 The vendor shall assure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce a quality product. The reagent quality must be acceptable to satisfy proficiency testing standards of the College of American Pathologists (CAP) and the Joint Commission (JC). The Proficiency Test Program standards are used as Minimum Acceptable Standards (MAS) for assay performance. Reagent performance shall meet the MAS listed in the Appendix 2.

6.8 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 24 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.

6.9 Safety Data Sheets (SDS). For all products the contractor must 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.

6.10 The vendor shall pay for the delivery charges for shipping and handling of all items covered under this contract at no additional cost to the government.

6.11 Contractor must sequester appropriate quantity of materials required to perform testing volumes estimated in Appendix 1 to ensure that not more than three lot changes are required per period of performance. Shipments must be of not more than one lot number of like products.

6.12 Must have ability to load and unload reagent packs and consumables without taking instrument off-line.

6.13 Reagent prep must not exceed 60 minutes to meet testing criteria.

6.14 Patient samples must not require offboard pre-treatment prior to testing.

7. INSTALLATION AND INITIAL SET UP

7.1. Prior to performing maintenance and repair work, the contractor or contractor's representative shall report to the installation Visitor Center to and obtain clearance to enter the installation. The contractor will then obtain a visitor badge from the front desk of the facility. The contractor will be escorted by laboratory or maintenance personnel and sign into the maintenance log located in the Medical Maintenance Department. Individuals must sign out of the log when complete and the badge must be returned prior to departing the facility. The contractor is required to provide a copy of all service records to the Chemistry Supervisor and the COR not more than 48 hours after completion of services.

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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 will 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 will affect optimum performance once installation is completed. The Contractor will 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 Vendor will provide a dedicated team of project management professionals who are experienced in delivering on time installations. The Vendor shall not employ persons for work on this contract if such employee is identified to the Vendor 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.

7.3 The Vendor will provide an Information Technology Project Manager (IT PM) for implementation of the instrument interface and middleware. The IT PM will have demonstrated working knowledge of Information Security Requirements specific to DoD installations as detailed in Section 5 of this SOW. The IT PM will have a demonstrated working knowledge and competency in the uses of and configuration options for instrument middleware. The IT PM will work with Department of Defense (DoD) subject matter experts (SMEs) to configure and test the instrument interface with CHCS. The IT PM will be actively engaged in all aspects of this SOW. The IT PM will also actively collaborate with Laboratory SMEs to configure the system’s middleware to optimally meet medical treatment facility (MTF) requirements.

7.4. During the initial implementation, a technical representative must 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.

7.5. Upon completion of installation and on-site training, method validation studies, and analytical measurement range/linearity verification must be performed by vendor no less than seven days prior to the first day of the first period of performance to ensure that equipment is fully operational as negotiated and studies approved by department staff.

7.6 Method Validation will 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 will 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 will be provided by the Contractor at no cost to the Government. These materials will not be used in the analysis of specimens for patient care.

7.7. 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. Contractor 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 and abnormal control material. This should consist of a within run precision study of 10 normal and 10 abnormal controls or patient samples.

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Carryover studies must 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 must be representative of the patient population being tested. Reference range assessment must 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 must provide specific information defining how the suggested range was determined. A minimum of 20 reference individuals must 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 must be established. Establishing a reference must follow CLSI-28A guidelines. This requires a minimum of 100 reference individuals be used to establish a reference range.

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

7.8 The Contractor will 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 will provide method validation study results and reports electronically, on a CD or DVD. The Contractor will provide instrument settings and other configurations on a paper as well as electronically on a CD or DVD.

7.9 In the event that progress of the installation is interrupted through no fault of the vendor, the continuous installation referenced in the preceding paragraphs may be terminated until such time as the cause of delay has been eliminated, and then shall be resumed within 24 hours after the vendor has been notified that work may again proceed.

8. MAINTENANCE, SERVICE AND REPAIR

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 front desk of the facility. The contractor will be escorted by laboratory or maintenance personnel and sign into the maintenance log located in the Medical Maintenance Department.

Individuals must sign out of the log when complete and the badge must be returned prior to departing the facility.

The contractor is required to provide a copy of all service records to the Chemistry Supervisor and the COR not more than 48 hours after completion of services.

8.2. The Contractor shall provide 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. This also includes scheduled, unscheduled and on-call emergency repair service support.

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, scheduled preventive maintenance/safety inspections and calibrations of equipment as well as unscheduled/emergency services and repairs.

8.4 The vendor shall perform routine maintenance on the back up batteries provided for all equipment and replace the battery packs before they expire or in the event they become non-functional.

8.5. The performance of scheduled periodic preventive maintenance, safety checks, and calibrations that are not normally performed at the operator level will be performed by the vendor in accordance with requirements as

13 | P a g e specified in the 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 will establish time zero for determination of time frames for performance of the above periodic services.

8.6. 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 Contractor shall be on-site within 24 hours to provide unlimited emergency service. The equipment shall be repaired and operational within a minimum of 48 hours after initial response by the Contractor.

8.7. 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 will be made by the COR to replace the initial laboratory equipment with new equipment.

8.8 Should both instruments at BACH become inoperable, the Vendor’s technical specialist must be on-site within three hours of initial notification of emergency repair. The repair of at least one analyzer must 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 will arrange for the pickup and delivery of all critical specimens to a clinical laboratory of the Government’s choice for testing. During the period when both analyzers are inoperable, each patient report must include the testing laboratory’s reference range for the test being performed. The Contractor will 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 will be provided within 72 hours at no additional cost to the government.

8.9 All maintenance reports and literature shall be in English and a copy should be given to the BACH chemistry supervisor and COR. The report shall contain, at 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.

8.10 Maintenance Requirements

Daily Maintenance should not require more than 30 minutes to complete Weekly Maintenance should not require more than 30 minutes to complete Monthly Maintenance should not require more than 30 minutes to complete

9. TRAINING

9.1 Contractor will provide three training initial training slots covering instrumentation, software and middleware at the Contractor’s training site which will include all costs of off-site training, i.e., transportation (air and ground), room and board.

9.2 The Contractor will provide initial on-site operator training covering instrumentation, software and middleware for all technicians assigned to the Department of Pathology that work with the equipment across all shifts. The Contractor will provide two training slots per contract year, at the Contractor’s training site covering instrumentation, software and middleware at no additional cost to the Government. Operator training at the

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Contractor’s training site shall include all costs of off-site training, i.e., transportation (air and ground), room and board.

9.3 Upgraded Software/ Equipment: The Contractor shall provide all upgrades to the equipment hardware and operating system software without additional cost to the Government. These enhancements to the Contractor's equipment shall be delivered to the Government site and installed by the vendor within 60 days of their issuance or date of first commercial availability.

9.4 Upgrades or Replacement: Request for instrumentation upgrades or replacement, due to workload increase, menu changes, excessive reagent recalls, technological upgrades, excessive instrumentation failures/malfunctions, breakdowns, or service calls will be evaluated as needed with communication to the vendor for modification of the contract. A high incidence of problems with any equipment/analyzer supplied may indicate probable non-compliance with the terms of this contract and will entitle the Government to its replacement with another 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 vendor shall be performed within 60 days after request at no additional cost to the Government.

10. SPECIAL TASKS

10.1. The Contractor will provide one paper and one CD copy of the Operator and Maintenance manuals and a statement of the warranty terms. 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 will provide one paper and one CD copy of Standard Operating Procedures (SOPs) for each and every methodology included under the Proposal. The SOPs will 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 In addition to performing linearity studies initially, the vendor shall perform the linearity studies on all of the analytes performed on all of the analyzers provided by the vendor every six months thereafter at each location.

The vendor shall provide the technical representative to perform the study and the linearity materials needed for the study at each location at no additional cost to the Government. The representative will analyze the linearity study data and provide the statistical reports to the technical supervisor for review. The vendor shall perform the linearity studies in accordance with the term listed above every six months for the duration of the entire contract period, including option year/s and extension period/s.

10.4 New Test Method/s or Generation change of current test reagent/s: The vendor shall perform all validation studies including: installation/set-up, linearity, precision, accuracy, and correlation studies when new test is added to the current test menu or new generation of reagent/s are placed in use at no additional cost to the Government. The vendor must provide reagents and materials needed for the validation studies at no additional cost to the Government. The validation studies must be completed and statistical reports must be presented for evaluation before placing new test/reagents in use.

10.5 Upgraded Software/ Equipment: The Contractor shall provide all upgrades to the equipment hardware and operating system software without additional cost to the Government. These enhancements to the Contractor's equipment shall be delivered to the Government site and installed by the vendor within 60 days of their issuance or date of first commercial availability.

10.6 Upgrades or Replacement: Request for instrumentation upgrades or replacement, due to workload increase, menu changes, excessive reagent recalls, technological upgrades, excessive instrumentation failures/malfunctions, breakdowns, or service calls will be evaluated as needed with communication to the vendor for modification of the contract. A high incidence of problems with any equipment/analyzer supplied may indicate probable non-compliance with the terms of this contract and will entitle the Government to its replacement with another analyzer(s) that can produce the required criteria of this contract satisfactorily to the user at no additional cost to the

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Government. Removal of instrument by the vendor shall be performed within 60 days after request at no additional cost to the Government.

10.7 This standard language is for contractor employees with an area of performance within an Army controlled installation, facility or area. All contractor employees, to include subcontractor employees, requiring access Army installations, 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

10.8 For contractors that do not require CAC, but require access to a DoD facility or installation. Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 190-13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.

10.9 For contracts that require OPSEC Training. Per AR 530-1 Operations Security, the contractor employees must complete Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter. OPSEC Awareness for Military Members, DoD Employees and Contractors is available at the following website: http://cdsetrain.dtic.mil/opsec/index.htm

10.10 For Cyber Awareness (Information assurance (IA)/information technology (IT)) training. All contractor employees and associated sub-contractor employees must complete the DoD Cyber awareness training before issuance of network access and annually thereafter. All contractor employees working IA/IT functions must comply with DoD and Army training requirements in DoDD 8570.01, DoD 8570.01-M and AR 25-2 within six months of appointment to IA/IT functions. DoD Cyber Awareness Challenge Training is available at the following website:

https://ia.signal.army.mil/DoDIAA/

11. EQUIPMENT REMOVAL

At the end of the contract term, the contractor shall…