W81K0221Q0023-0001.pdf

W40M REGIONAL HEALTH CONTRACTING OF

US MEDCOM HCAA JBLM HCC

POC: SCOTT A. BARR

673 WOODLAND SQUARE LOOP SE, SUITE 101

LACEY WA 98503

0011554158

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

The purpose of this amendment is to extend the solicitation deadline to 9APR2021 at 2:00pm PST. Additionally changes w ere made to several of the requirements. See Amendment Summary text on page 2 of this Form SF30.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 13

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

16C. DATE SIGNED

BY 31-Mar-2021

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 W81K0221Q0023

X 9B. DATED (SEE ITEM 11)

18-Mar-2021

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 X is extended, 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 1 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

30-Mar-2021

CODE

W40M REGIONAL HEALTH CONTRACTING OF

REGIONAL HEALTH CONTR OFC PACIFIC

BLDG 339 CLARK ROAD

FT SHAFTER HI 96858-5098

W81K02 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W81K02

FACILITY CODECODE

EMAIL:TEL:

W81K0221Q0023

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:

AMENDMENT 0001 SUMMARY

This is a summary of changes made to the solicitation by Amendment 0001.

Closing date has been extended and offers are now due 9APR2016 by 2pm PST.

For clarification, pricing should be based upon Cost‐per‐Reportable‐Result not Cost‐per‐Test

Section 5.8 of the Statement of Work has been revised.

Exhibit B has been added which shows a layout of the space dedicated for the analyzers

Exhibit C has been added which provides more clear measurements

Exhibit D has been added which shows electrical

Exhibit E has been added which show communications

Section 5.18 has been removed

SECTION SF 1449 - CONTINUATION SHEET

SOLICITATION/CONTRACT FORM

The required response date/time has changed from 02-Apr-2021 02:00 PM to 09-Apr-2021 02:00 PM.

SUPPLIES OR SERVICES AND PRICES

Global Changes

CLIN 0001 -- CLIN 4001

The vendor part number COBAS 6000 has been deleted.

The following have been modified:

SALIENT CHARACTERISTICS

• Shall provide2 (two) mirrored, fully automated, discrete random access chemistry/immunoassay analyzers

• Shall include Uninterruptable Power Sources (UPS), instrument specific computers, Computer Processing Units (CPU), printers, barcode scanners, terminals, monitors for analyzer system

• Shall be manufactured, sold and supported by one Contractor

• Shall be capable of interfacing the analyzer with MHS Cerner Genesis Electronic Health Record

• Analyzers shall be bi-directional

• Shall be fully automated and process at least 30 samples per batch

• Shall be able to handle multiple tube sizes

• Shall include barcode reading for all reagents and samples.

• 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.

• The UPS shall be able to maintain system for at least 15 minutes

• 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

• Shall be able to process all tests as listed in Exhibit A

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

• Vendor’s system shall comply with Section 3 of the Statement of Work (SOW)

• Vendor’s system shall comply with the requirements of Section 5 of the SOW.

• Analyzers and reagents shall be FDA approved.

• For installation and calibration, the vendor shall comply with Section 7 of the SOW

• The Vendor shall provide direct customer hotline telephone service and support, 24 hours/7 days a week, and on-call emergency repair service support

• The Contractor shall provide initial on-site operator training of all technicians assigned to the Government.

As well as training at the vendor’s site as per Section 9 of the SOW.

• 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.

• Vendor shall review Section 8 of the SOW and the vendor shall include in their offer, response times if the vendor requires any different response times than those listed for this location due to the remoteness of Fort Wainwright.

STATEMENT OF WORK

STATEMENT OF WORK (SOW) CHEMISTRY TESTING

BASSETT ARMY COMMUNITY HOSPITAL

FORT WAINWRIGHT, ALASKA 99703

1. SCOPE OF WORK

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

1.2. For the purposes of this SOW, the system includes at a minimum:

- 2 mirrored analyzers

- Peripherals (e.g. Uninterruptable Power Sources (UPS), instrument specific computers, Computer Processing Units

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

Two integrated analytical systems and middleware shall be delivered and installed at the primary location:

Base Period* 01 May 2021 through 30 September 2021

First Option Year 01 October 2021 through 30 September 2022

Second Option Year 01 October 2022 through 30 September 2023

Third Option Year 01 October 2023 through 30 September 2024

Fourth Option Year 01 October 2024 through 30 September 2025

*actual start date is dependent upon when analyzers are delivered, installed, and calibrations are completed.

2. TESTING SYSTEM

2.1. The testing system must be manufactured, sold and supported by one Contractor. The testing system shall be serviced and supported by the awarded Contractor. This includes all on-site and off-site training, Information Technology (IT) management, IT implementation services, phone support, on-site and off-site services, as well as any future FDA approved testing that can be performed on contractor supplied testing system. The testing system must be capable of interfacing with the military hospital computer system, i.e., MHS Cerner Genesis Electronic Health Record. The Contractor must have an established driver compatible for interfacing the analyzer with MHS Cerner Genesis Electronic Health Record. The interface between MHS Cerner Genesis Electronic Health Record and the analyzer 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 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 the ability to process at least 30 samples per batch, overnight runs, continuous access for samples, a true walk-away system, and barcode reading for all reagents and samples.

2.5. All analyzers and associated parts and accessories will be new. Neither used, refurbished, or like-new equipment will 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. The Contractor and Contracting Officer’s

Representative (COR) shall agree upon installation of updates and upgrades.

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 Department of Defense Information Assurance Certification and Accreditation Process (DIACAP) Implementation Plan. This will include the required information for the System Identification profile.

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 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 at least 200 patient records per day. The Vendor shall provide back up to network data management handling.

3.11 The Vendor will provide a Thin Client-type data management system that allows for remote operational control of the analyzer system, dynamic/real-time review and management of the quality control program, review of on-instrument useful life of the reagents/reagent packs, and management of patient results.

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

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

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

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

3.16 The software will provide proactive monitoring of key instrument parameters to allow for predictive diagnostics.

3.17 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.

3.18 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. The Government utilizes Bio-Rad quality control materials. The software program will provide a link with 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.

4. PRE-ANALYTICS

4.1 The system shall receive specimens, record time from loading to final achieving or disposition. The information system component of this laboratory system must be able to communicate with laboratory information system for ordering information to be sent from Lab Information System to the System manager and shall include but not be limited to: order code, tube type, accession number, container identification, and receipt date and time.

4.2 Pre-analytic:

Must read all standard bar-codes

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

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

5. ANALYZERS

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

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

5.3 The analyzer system must be capable of interfacing with the military hospital computer system, i.e., MHS Cerner

Genesis Electronic Health Record. The Vendor must have an established driver compatible for interfacing the analyzer with MHS Cerner Genesis Electronic Health Record. The interface between MHS Cerner Genesis Electronic Health Record and the analyzer must be bi-directional.

5.4 Both analyzers will need to be identical. Each analyzer must have the same test menu capability and utilize the same reagents/reagent packs, ensuring that a test’s reagents/reagent packs can be moved between the two instruments interchangeably.

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

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

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

5.8 The instruments must meet the following size criteria:

• Refer to Exhibits B and C for room diagram and dimensions of floor area dedicated for the analyzers. Analyzers shall fit into the area specified.

• entry through door measurements - 80 inches height by 34 inches width

• must have both analyzers in layout plan with, power, water*, drain, data communications visual to room 1A-209 f 4076 Neely Road, Fort Wainwright, AK 99703 *if your system requires a water hook up, please indicate so in your quote. Drawings are not currently available for plumbing. The hospital will do its best to accommodate water supply.

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

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

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

5.12 All reagents used by the analyzer system must be liquid reagents which must are capped while onboard the analyzer.

5.13 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.

5.14 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.

5.15 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.

5.16 Each analyzer system must come equipped with an un-interruptible power supply capable of providing all necessary electrical power to each analyzer system, to include the data management system for at least 15 minutes.

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

5.18 (removed)

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

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

6. REAGENTS

6.1. The Contractor shall provide all of the tests listed in exhibits, to include reagents and calibrators (see Exhibit A).

These products must be manufactured by the Contractor and not by a third party. The testing system and all assays must be Food & Drug Administration (FDA) approved. All reagents provided will be identical to those used in the FDA 510K approval application. 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, Laboratory Manager and Lead Medical Technologist. All 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) / Clinical and Laboratory Standards Institute (CLSI) guidelines and analyzer removal at the termination of the contract

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

6.3. Delivery of the reagents will be on an as needed basis. 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.

6.4. 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 Alaska Standard Time will be delivered within 48 hours after the order is placed.

6.5. 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.

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

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

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

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

7. INSTALLATION AND INITIAL SET UP

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

7.2. The Contractor shall be responsible for installation, which consists of in-house delivery, positioning, and mounting of all equipment listed on the contract and connections of all equipment and interconnecting wiring and cabling if applicable in coordination with the facility biomedical engineer. Upon receipt of notice from the COR, an agreed date 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.

7.3. 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; there must be documentation of information "hand off" between the different Technical Representatives.

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

7.5. 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.

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

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

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

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

Carryover studies 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 30 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.

7.7 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.

8. MAINTENANCE AND SERVICES

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

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

8.3. The Contractor is required to maintain all equipment installed under this contract. The Contractor shall provide all personnel, equipment, tools, materials, supervision, parts, transportation, and other items and services necessary to perform all required repairs and scheduled preventive maintenance/safety inspections and calibrations of equipment.

8.4. The performance of scheduled periodic preventive maintenance, safety checks, and calibrations that are not normally performed at the operator level will be performed by Contractor personnel in accordance with requirements as specified in the Contractor’s instrument manual. A preventive maintenance service shall include, but is not limited to, safety, calibration, complete operational testing, lubrication, adjustments, and cleaning of equipment to which the operator does not have access. This also includes the installation of all non-operator parts required to ensure proper operation. Completion of installation of the analyzers will establish time zero for determination of time frames for performance of the above periodic services.

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

8.6. If any deficiencies are found due to negligence of the service representative, the Contractor shall be required to correct the deficiency to a fully operational status in accordance with manufacturer specifications at no additional cost to the Government. During the contract period, should the repair record of any laboratory equipment reflect a downtime of more than 72 hours in one calendar month, a determination will be made by the COR to replace the initial laboratory equipment with new equipment.

8.7. Repair:

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

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

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

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

Should both instruments at the BACH become inoperable, the Vendor’s technical specialist 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 College of American Pathologists accredited clinical laboratory of the Government’s choice for testing. During the period when both analyzers are inoperable, each patient report 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.

All work shall be performed in a professional manner by an authorized service representative. If any deficiencies are found due to negligence of the service representative, the Vendor shall be required to correct the deficiency to a fully operational status in accordance with manufacturer specifications at no additional cost to the Government.

During the contract period, should the repair record of any laboratory equipment reflect a downtime of 10% or more of the normal working days in one calendar month, a determination will be made by the representative of the Government to replace the initial laboratory equipment with new equipment.

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

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

Nomenclature and serial number.

Date.

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

Location and services performed.

Duration of performance (hours).

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

Name of Technician.

9. TRAINING

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

10. SPECIAL TASKS

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

10.2. The Contractor 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. Updates, upgrades or Replacement: Request for instrumentation updates, upgrades or replacement, due to workload increase, menu changes, technological upgrades, excessive instrumentation failures/malfunctions, breakdowns, or service calls will be evaluated as needed with communication to the contractor for resolution of the issue. A high incidence of problems with any equipment/analyzer supplied may indicate probable non-compliance with the terms of this contract and 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 contractor shall be performed within 60 days after request.

11. EQUIPMENT REMOVAL

At the end of the contract term, the contractor shall remove all equipment within 60 days after notification of the expiration of the terms of this contract but not until the completion of new contractor’s equipment installation inclusive of completed cross over studies. Contractor shall not remove hard drive from premises. All drives with patients’ information remains the property of the Government.

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

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

For Contractors requiring Common Access Card (CAC). Before CAC issuance, the Contractor employee requires, at a minimum, a favorably adjudicated National Agency Check with Inquiries (NACI) or an equivalent or higher investigation in accordance with Army Directive 2014-05. The Contractor employee will be issued a CAC only if duties involve one of the following: (1) Both physical access to a DoD facility and access, via logon, to DoD networks on-site or remotely; (2) Remote access, via logon, to a DoD network using DoD-approved remote access procedures; or (3) Physical access to multiple DoD facilities or multiple non-DoD federally controlled facilities on behalf of the DoD on a recurring basis for a period of 6 months or more. At the discretion of the sponsoring activity, an initial CAC may be issued based on a favorable review of the FBI fingerprint check and a successfully scheduled NACI at the Office of Personnel Management.

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.

Threat Awareness Reporting Program. For all Contractors with security clearances. Per AR 381-12 Threat Awareness and Reporting Program (TARP), Contractor employees must receive annual TARP training by a CI agent or other trainer as specified in 2-4b.

(End of Summary of Changes)