B.08 Attachment 1-1 Solicitation Amendment W801K0425QA020.pdf

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

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

Offers 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 electronic communication 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 letter or electronic communication, provided each letter or electronic communication 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 NUMBER AS DESCRIBED IN ITEM 14.

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

NUMBER IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, 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.)

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

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

16C. DATE SIGNED

Previous edition unusable STANDARD FORM 30 (REV. 11/2016) Prescribed by GSA FAR (48 CFR) 53.243

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE PAGE OF PAGES

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

6. ISSUED BY CODE 7. ADMINISTERED BY (If other than Item 6) CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X) 9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

The purpose of this amendment is to:Block 14 (Description of Amendment/Modification):

-Provide responses to vendor questions received during the solicitation period;

-Issue corrections and revisions to the Statement of Work (SOW) to clarify requirements and specifications; and -Extend the solicitation closing date to allow vendors adequate time to review the updated requirements and modify their proposals accordingly.

All other terms and conditions of the original solicitation remain unchanged unless specifically modified herein. Vendors who have already submitted proposals are encouraged to review this amendment and submit revised proposals if necessary.

****All proposals must acknowledge receipt of this amendment. Failure to acknowledge receipt of this amendment may result in rejection of the proposal. Acknowledgment may be made by signing and returning a copy of this amendment, by including a signed copy with the proposal, or by letter or telegram which includes a reference to the solicitation number and amendment number.

Q1: Section 3.2, 3.7 - Confirm that Fort Bragg is asking each participating vendor to include a full middleware auto validation turnkey solution to MHS Genesis that is ATO/ASL approved A1: We do not require a middleware solution.

Q2: The requirement reads like Chemistry or Hematology requirement more than a Urinalysis requirement ~ please confirm if this indeed the intent.

A:2 - It is not intended to read like Hematology or Chemistry

Q3: There is priority language in the SOW. Is the intent to sole source?

A3: This information was erroneously pulled from the draft document of the SOW.

Below is a summary of all changes made to the SOW.

Section 3 - Information Management:

Deleted Section 3.2: Entire detailed paragraph about data management system software features, auto-verification rules, delta checks, specimen integrity rules, etc.

Deleted Section 3.7: "The software will provide proactive monitoring of key instrument parameters to allow for predictive diagnostics" Section 3.5 Data Management System:

Original: "Thin Client-type data management system that allows for remote operational control...dynamic /real-time review and management of the QC program" (erroneously pulled from draft document) Updated: Simplified to basic "data management system that allows for remote operational control" Section 3.10 QC Software:

Original: Detailed requirements including "Westgard QC Rules" (erroneously pulled from draft document) Updated: Simplified to "user defined QC rules" - removed all references to "Westgard QC Rules" Section 4.8 Testing System Capabilities:

Original: "ability to use fluorescent flow cytometry for urine particle counting to eliminate tech to tech variability. Perform urine particle counting and categorization" (erroneously pulled from draft document) Updated: Simplified to "ability to perform urine particle counting and categorization" Section 10 - Additional Requirements: (erroneously pulled from draft document) Deleted 10.1: Requirement for system to warm samples to dissipate interfering materials Deleted 10.2: Specific bacteria detection requirement of "<0.5um" Deleted 10.3: Minimal operator intervention requirement (moved to 10.2) Deleted 10.4: Chemistry strips onboard stability of 7 days requirement Deleted 10.5: Automatic color correction for dark urines requirement Updated Section 10.1:

Original: "ability to detect bacteria by a particle detection of <0.5um in improve patient care and reduce the need for tech verification procedures with varying size ranges" (erroneously pulled from draft

W81K0425QA0200001

document) Updated: Simplified to "ability to detect bacteria with varying size ranges"

Solicitation/Contract Form Continuation

The following changes have been made:

INFORMATION FROM TO

Response Due Time 10:00 AM 08:00 AM Response Due Date 04 Aug 2025 11 Aug 2025

Continuation of Description

Miscellaneous text in this section has been modified to:

1.0 INTRODUCTION:

1.1 Vendor shall provide four (4) identical, UA chemistry and UA microscopic systems to include wagon or stand, 2 systems for the Womack Army Medical Center (WAMC) 1 (one) system to locations listed in section 1.3. The resultant Cost-Per-Reportable-Result (CPRR) Indefinite Delivery Indefinite Quantity (IDIQ) Contract for the medical equipment, reagents, and consumables will have a five (5) year ordering period. All reagents must be Food and Drug Administration (FDA) approved for use in clinical testing with controls and/or calibrators that meet or exceed the College of American Pathologists (CAP) checklist criteria for clinical testing. The systems must perform the quoted and contracted workflow.

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

- 4 (four) identical, UA chemistry and UA microscopic systems to include wagon or stand.

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

1.3 One combined automated urine chemistry and microscopic system to include wagon or stand, and one identical automated urine chemistry and microscopic system to include wagon or stand as backup shall be delivered and installed at the primary location: Womack Army Medical Center, Fort Bragg, NC.

One combined automated Urine chemistry and microscopy system to include wagon or stand will be delivered and installed at secondary locations which are Outlying Clinics (OLC): One system shall be delivered and installed at Clark Health Clinic and one system shall be delivered and installed at Robinson Health Clinic.

SPACE AVAILABLE:

Womack Army Medical Center, Building 4-2817, Room BG0800, Rock Merritt Ave., Fort Bragg, NC 28310. Space available for the Hematology section and its operation is 12' by 3' at the main lab.

Clark Health Clinic, Building 5-4257, Bastogne Road, Fort Bragg, NC 28310. Space available for the Hematology section and its operation is 5' by 3' at Clark Clinic.

Robinson Health Clinic, Building C-1722 Tagaytay Street, Fort Bragg, NC 28310. Space available for the Hematology section and its operation is 5' by 3' at Robinson Clinic.

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 Food and Drug Administration (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 MHS Genesis. The Contractor must have an established driver compatible for interfacing the analyzer with the MHS Genesis. The interface between MHS Genesis 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 (QC) program, management of the on-instrument useful life of the reagents/reagent packs, and management of patient results; and a printer to produce hard copy of 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 QC 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 within 30 days after the termination of the contract.

2.4. The analyzers shall be fully automated with at least 100 tests per hour, continuous access for samples, a true walk-away system, and barcode reading for all samples.

2.5 The testing system shall include a wagon or cabinet system to hold the analyzers, accessories, and supplies in use.

2.6 System shall be able to integrate urine chemistry, and microscopic analysis analyzers on a single automated line.

2.7. 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.

2.8. The testing system must come equipped with UPS capable of providing all necessary electrical power to each analyzer system, to operate the data management and testing system for at least 15 minutes. The contractor should support the maintenance and replacement batteries to the UPS as needed.

2.9. 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.

3. INFORMATION MANAGEMENT

3.1 Contractor Information Systems (IS)/Network that are involved in the operation of systems in support of WAMC shall operate in accordance with controlling laws, regulations, Defense Health Agency (DHA) Cyber Logistics (CyberLOG) Cybersecurity/Risk Management Framework (RMF), and local policy.

DHA CyberLOG requirements are detailed in Appendix 2, titled Defense Health Agency (DHA) Cyber Logistics (CyberLOG) Cybersecurity/Risk Management Framework (RMF) Requirements, 5 January 2022.

3.2 The data management system shall provide basic instrument-level validation of normal results configured through the use of rules, flags, or other abnormalities that require tech review prior to upload into

3.3 All Contractor systems that wish to communicate with Department of Defense (DoD) systems and deployed vendor systems will need to initiate Business to Business (B2B) gateway approval through DHA, if not already approved. For all Web applications, Contractors will connect to a Defense Information Systems Agency (DISA)-established Web Demilitarize Zone (DMZ).

3.4 The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect all Government data and compliance with Health Insurance Portability and Accountability Act

(HIPAA) of 1996, to ensure the confidentiality, integrity, and availability of data. As a minimum, this shall include provisions for personnel security, electronic security and physical security.

3.5 The Contractor will provide a data management system that allows for remote operational control of the analyzer system, management of quality control, review of on-instrument useful life of the reagents /reagent packs, and management of patient results.

3.6 All software and software licenses, interfaces, and hardware (e.g., servers, printers, monitors, UPS, CPUs, barcode scanners, etc.) shall be included with cost of hardware required.

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

3.9 The Data Management system will have a comprehensive, fully integrated QC software module that stores and evaluates QC 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.

3.10 The QC software will have a large capacity to store graphics and results, cumulative patient reports and QC files with statistics - all available to user. The QC software will provide the capability to write user defined 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, and provide real-time access to QC charts and graphs.

4. ANALYZERS

4.1 The contractor shall provide complete Urinalysis system that has the ability to perform 9 Urine chemistries, specific gravity, color, clarity and microscopic analysis. The system shall provide redundancy to ensure continuous operations, training, supplies, reagents, unscheduled maintenance, and preventive maintenance for the equipment. This sub-paragraph pertains to the combined urine chemistry and microscopy analyzer.

4.2 The urine microscopy system shall have the ability identify and quantify the following parameters WBC, RBC, Cast, Epithelial cells, and bacteria and approved by FDA for auto validation to eliminate timely and unnecessary tech intervention and microscopic reviews.

4.3 The analyzer 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.

4.4 The analyzer shall be capable of interfacing with MHS Genesis. The Contractor shall have an established driver which is compatible for interfacing the analyzer with MHS Genesis. The interfacing between the hospital system and the analyzer shall be bi-directional.

4.5 The system shall have the on-board patient/Quality Control (QC) file storage for lookback of results during the review process.

4.6 The analyzer shall have ability to flag and alert the tech of abnormal finding such as yeast, sperm, crystals, and pathological cast to review either by digital images or microscopically.

4.7 The system shall have the capability to automatically run and reflex to identify urine particles without operator interventions, by the use of user defined decision rules and with or without the need for additional hardware or middleware.

4.8 The testing system shall have the ability to perform urine particle counting and categorization.

4.9 The testing system shall have true operator to operator standardization without subjectivity and interpretation, urinalysis solution must provide true walkaway final results without operator re-classification of urine particles.

4.10 The system shall have the ability to auto -release 'normal" sample results, based on user defined rules and to allow on screen easy viewing of urine chemistry and urine microscopy results.

4.11 The system shall have the ability to have on screen visual alerts in reference to correlation of urine chemistry and microscopy results as well as carryover alert.

4.12 The system shall have ability to load multiple samples at once for a minimum of 50 samples with continuous feed and have the ability to start the instrument and walk away during instrument analysis.

4.13 Patient sample racks must have a barcode that will allow the operator to track the rack and sample position number of each specimen through a display on the instrument screen.

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

4.15 The analyzer system shall have ability to store individual QC and ability to view, evaluate, and print quality control results while the instrument is analyzing patient samples. In addition, it shall have the ability to add/update quality control and calibrator material and values, as well as to track the changes.

4.16 The system shall stop analysis when there is QC and/or calibration failure.

4.17 The analyzer shall have user-friendly procedures for operators to perform daily, weekly or monthly Maintenance not to exceed 10 minutes.

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

5. REAGENTS.

5.1 The Contractor shall provide reagents for all assays listed in all Exhibits. For all of the tests listed in the Exhibits, reagents and calibrators shall be provided by the Contractor and not by a third party. All assays shall be FDA approved. The Contractor shall provide a continuously stocked inventory of reagents, calibrators, troubleshooting controls, required consumable supplies including all routinely replaced parts, disposables and any other materials required to properly perform tests on the equipment.

Name and point of contact of authorized personnel will be provided to the Contractor.

5.2 Quality of Reagents, Supplies and Disposables:

The Contractor 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 shall be acceptable to satisfy proficiency testing standards of the College of American Pathologists (CAP) and the Joint Commission on Accreditation of Health Care Organizations (JCAHO). The Proficiency Test Program standards are used as Minimum Acceptable Standards (MAS) for assay performance.

5.3. In the event that the supplies are found to be defective, short expiration, and unsuitable for use with the Contractor's equipment or the Contractor has failed to comply with the requirements herein, the Contractor shall deliver the replacement supplies within 24 hours of receipt of the verbal notification.

Contractor shall ship priority next day delivery to the Government activity. This shall be done at no cost to the Government, and in sufficient quantity required to allow operation of the Contractor's equipment for one week (under normal government test load volume).

5.4. The contractor shall pay all routine shipping fees for supplies and shall work with each facility to adjust reagent supply to match workload changes and to provide the option for each facility to establish a monthly or quarterly shipment table.

5.5. The workload listed in the exhibits is an estimate based on projected annual volume. Orders of required items will on standing order to meet the testing needs between shipments. 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.

5.6 All reagents/reagent packs will be provided as follows:

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.

Be provided by the manufacturer of the equipment.

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

5.8 The Contractor is required to provide a continuously stocked inventory of reagents, calibrators, troubleshooting controls, required consumable supplies including all routinely replaced parts, disposables and any other materials required to properly perform tests on the equipment. The Contractor shall notify the government of any unexpected changes in methodology/technology. Any additional reagents and supplies due to the unexpected changes in methodology/technology shall be at the expense of the Contractor. Alert/Notification of all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to Hematology Supervisor, Clinic Supervisor, or Lead Medical Technologist, WAMC.

5.9 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 the Exhibits. The contractor, at no additional cost to the government, 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.

5.10 All reagents shall be interchangeable between all sites analyzers to minimize supply issues or workload fluctuations.

5.11 Shipping Charges.

Any additional costs such as Industrial funding fees, special shipping and handling fees, or any other fee or charges shall be included in the Contractor's proposal.

5.12 For reagents with hazardous constituents, Contractor shall provide a mechanism for the Laboratory to meet disposal requirements.

5.13 Safety Data Sheets (SDS).

For reagents with hazardous constituents, Contractor shall provide a mechanism for the laboratory to meet disposal requirements. The Contractor shall provide SDS for each item delivered under this contract that is considered to be hazardous material. The SDS shall contain information on the hazards associated with each specific chemical or material. The SDS shall be printed in the English language and shall contain as a minimum the following information: identification of the specific hazard, the required practice for the safe use of the product, first aid procedures, and what to do in the event of a spill or other mishap or accident. The Contractor shall provide paper copies and/or electronic copies on CD of SDS of all reagents and consumables.

6. INSTALLATION AND INITIAL SET UP

6.1. Prior to reporting to the laboratory, the contractor or contractor's representatives shall report to and obtain a visitor badge from the HTMB of the facility. The badge must be returned to the department prior to departing the facility.

6.2. 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 those that 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(r)), to provide technical assistance for the method validation studies. The Contractor will provide a dedicated team of project management professionals who are experienced in delivering on time installations. The Contractor shall not employ persons for work on this contract if such employee is identified to the Contractor by the COR as a potential threat to the health, safety, security, general well-being or operational mission of the installations and their population.

6.4 The contractor shall specify any facility requirement such as capped drains, water supply, electrical voltage, and special power supply, required prior to equipment installation.

6.4. 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 90 days of equipment arrival. The same technical representative (or contractor designated replacement) should be available throughout the entire implementation; there must be documentation of information "hand off" between the different Technical Representatives.

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

6.6. Method Validation will be conducted in accordance with method validation protocols established by CLSI and/or required by 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 QC ranges. All reagents, QC 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.

6.7. 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 30 samples, spanning the reportable range, shall be run by the present and the new method. Contactor shall analyze numbers and provide statistical data to accept the new method. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, and meet current standards defined by CLSI.

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

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

Carryover studies shall be performed, as applicable, as part of the initial evaluation of the instrument.

Contractor shall provide interpretation of raw data and validate no carryover exists within the testing system.

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

Specificity studies: Adverse effects for increased bilirubin, hemolysis, lipemia, or other interrupting substances are evaluated 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 contractor for applicable analytes.

6.8. All reagents, quality control materials, calibrators and linearity materials used in the Method Validation Study will be provided by the Contractor. These materials will not be used in the analysis of specimens for patient care. The Technical Supervisor (WAMC and clinics) will obtain patient specimens for use in the Method Validation In the event that specimen requirements for correlation studies cannot be met (e.g. insufficient number of patients to challenge the extremes of a curve), the Contractor will assist in procuring additional specimens. These specimens may be obtained from other laboratories or from Contractor sources.

6.9. 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 Hematology 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. The Contractor will provide instrument settings and other configurations on a paper as well as electronically.

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

7. MAINTENANCE AND SERVICES

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

7.2. The Contractor shall provide a list of maintenance 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.

7.3. 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.

7.4 The contractor 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.

7.5. The performance of scheduled periodic preventive maintenance, safety checks, and calibrations that are not normally performed at the operator level will be performed by 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.

7.6. 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.

7.7. If any deficiencies are found due to negligence of the service representative, the Contractor shall 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 continuous hours in one calendar month, a determination will be made by the COR to replace the initial laboratory equipment with new equipment.

7.8 Repair:

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 problems.

The Contractor shall respond to telephonic requests for unscheduled repair within 2 hours of the initial phone call 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 contractor's regular working hours, on weekends, and on Federal Holidays will be identified in contractor's proposal. 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 WAMC become inoperable, the Contractor's technical specialist must be on-site within four 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 COR, the contractor will arrange for the pickup and delivery of all critical specimens to a CAP 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 hard copy 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 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 three or more working days in one calendar month, a determination will be made by COR to replace the initial laboratory equipment with new equipment.

Within one working day after completion of service, the contractor shall furnish the copy of a service report for all services performed to the hematology or clinic supervisor.

7.9 The report shall be in English, and a copy should be given to the Laboratory representative for the location where the work is performed. 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. TRAINING

The Contractor shall provide initial on-site operator training up to 25 government technicians. In addition, the Contractor will also provide 2 training slot per contract year.

9. SPECIAL TASKS

9.1. The Contractor will provide one paper and one electronic 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.

9.2. The Contractor will provide one paper and one electronic 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.

9.3 New Test Method/s or Generation change of current test reagent/s: The contractor shall perform all validation studies including installation/set-up, linearity, precision, accuracy, and correlation studies when new test(s) that are not listed in the exhibits are added to the current test menu or new generation of reagent/s are placed in use at no additional cost to the Government. The contractor must provide reagents and materials needed for the validation studies. The validation studies must be completed, and statistical reports must be presented for evaluation before placing new test/reagents in use.

9.4 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 contractor within 60 days of their issuance or date of first commercial availability.

9.5. Upgrades or Replacement: Request for instrumentation upgrades or replacement, due to workload increase, menu changes, technological upgrades, excessive instrumentation failures/malfunctions, breakdowns, etc., or service calls will be evaluated as needed with communication to the contractor 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 contractor shall be performed within 60 days after request at no additional cost to the Government.

10. ADDITIONAL REQUIREMENTS

10.1 The testing system shall have the ability to detect bacteria with varying size ranges.

10.2 The system shall require minimal operator intervention or review and classification of images.

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. . This includes the analyzer and all accessories provided by the contractor to be removed at the end of contract such as printers, peripherals, UPS, and computers. Contractor shall not remove hard drive from premises. All drives with patients' information remains the property of the Government.

Exhibit 1 - Test Menu and Workload (For maintenance purposes of the analyzers only, See CLIN line numbers for estimated reagent quantities)

WAMC Lab Test Menu Estimated Annual Usage 1 WAMC Urine Chemistry 55,000 2 WAMC Urine Microscopy 35,000 3 CLARK Health Clinic Urine Chemistry 10,000 4 CLARK Health Clinic Urine Microscopy 7,500 5 Robinson Health Clinic Urine Chemistry 10,000 6 Robinson Health Clinic Urine Microscopy 7,500

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