HT940825R0008 0002.pdf

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:

1. Provide Government response to Questions received in response to the solicitation.

2. Update to SOO.

3. Extend the solicitation closing date and time.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 17

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

16C. DATE SIGNED

BY 09-Jul-2025

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 HT940825R0008

X 9B. DATED (SEE ITEM 11)

17-Jun-2025

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

09-Jul-2025

CODE

DHA CONTRACTING OFFICE SA HT9408

7800 W IH-10

STE 235

SAN ANTONIO TX 78230

HT9408 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

HT940825R0008

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:

Q&A

1. Page 55 Section 6.1.1 – Requirement – The Offeror provided Excel Pricing Worksheet, Attachment #3, shall be incorporated into the contract. The Pricing Worksheet requires unit pricing for each result which is multiplied by the annual quantities provided in the SOO. The Pricing Worksheet’s CLIN total will be divided by 12 to derive the firm-fixed monthly unit price on the resultant contract. The Government will order items on as-needed basis. The quantities listed herein are the Government’s best estimate of its needs for the five-year performance period and are based on historical data and future projected usage. The final unit prices for each result established in any contract resulting from this solicitation are final. The Government will pay a firm-fixed price per month based on the estimated quantities provided. Actual number of results (i.e., equivalent reagents) ordered and accepted, may fluctuate monthly but shall not exceed the annual quantities provided. In the event the Government needs additional results, Attachment 3 will provide the basis for pricing any modification. Therefore, the offeror is hereby informed that the final awarded unit (i.e., result) prices are not subject to adjustment on the basis of a difference between result quantities estimated on the solicitation, quantities established on the contract, and actual quantities used.

a. Question: may the vendor initiate a request for a modification based on actual test numbers if the volume exceeds the estimated test volume quantities provided?

ANSWER: The vendor may initiate a request for a modification with the Contracting Officer if the estimated annual volume is expected to be exceeded.

b. Question: if any one particular assay test volume exceeds the estimated test volume provided, may the vendor initiate a request for a modification?

ANSWER: The vendor may initiate a request for a modification with the Contracting Officer if the estimated annual volume is expected to be exceeded.

2. Page 51 Section 2.4.4 – Requirement – The entire system shall have an approved ATO for remote connections (internet, cloud, etc.) to be functional and serviceable. Middleware will be on a physical server provided and maintained by vendor.

a. Question: Vendor understanding is that the current DoD directives state that middleware should be housed on DoD servers, not physical servers maintained by the vendor. Please advise if DoD directives have changed in this matter and provide documentation with these details.

ANSWER: Cyber has confirmed that middleware should be housed on DoD servers and do not need be physical servers (they can be virtual), however, the vendor does maintain them. Reference update to SOO.

3. Page 49 Section 2.1.12 – Requirement – Will have a Quality Control, Linearity and Precision program that will meet College of American Pathologist (CAP) requirements. Ability to program quality control ranges, calibration set points and system parameters without stopping or pausing the system.

a. Question: please provide examples of the types of "system parameters" programming requested to be available without stopping or pausing the system.

ANSWER: When a technician adds quality controls to a chemistry analyzer to include Physically loading the quality controls samples on board, input all quality controls nomenclatures (quality controls name, quality controls lot number etc…) , quality controls means, quality controls standard deviations and/or ranges, quality controls performance frequency (time of day quality controls will be performed) and all other parameters for a new quality controls lot, the chemistry analyzer will not be placed in a pause /stop mode. Patient samples will continue to process without interruption.

When a technician adds calibrations to a chemistry analyzer to include Physically loading the calibrator samples on board, input all calibration nomenclatures (calibration name, calibration lot number etc…), and parameters/set points for a new calibration lot, the chemistry analyzer will not be placed in a pause /stop mode. Patient samples will continue to process without interruption.

4. Page 50 Section 2.2.11 – Requirement – Adequate number of trays to be used for archiving capabilities

a. Question: are trays required for off-line storage, or is a refrigerated storage module required to be connected to a track?

ANSWER: Trays used on the automated line will be removed and placed in a stand-alone refrigerator. There will not be a refrigerated storage module on the automated track system.

5. Page 51 Section 2.4.2 – Requirement – A middleware system with 4 additional computers with points of access to the middleware network.

b. Question: please confirm this requires sufficient middleware licenses to access the middleware from 4 computer workstations and that 4 physical computers are not required.

ANSWER: Additional computer workstations are not available locally. Therefore, the vendor must provide 4 physical workstations/computers.

6. Page 53 Section 3.9 – Requirement - The Vendor shall relocate/revalidate any instrument if requested by the Government at no additional cost. This includes any location within the Keesler AFB Medical Center.

c. Question: are the proposed moves only intended for a transition phase while validating new equipment before Go Live and then moving to the Go Live location?

ANSWER: In the event future major renovations and facilities modifications require the laboratory to relocate after the automated track and chemistry systems are in place and validated.

d. Question: are multiple instrument moves anticipated during the contract besides during initial validation and Go Live? If so, how many moves?

ANSWER: No moves are anticipated.

e. Question: please provide the distance in feet for the proposed move(s) and whether the move(s) would be to a different floor in the facility?

ANSWER: No moves are anticipated.

f. Question: please confirm the proposed move would include both instruments and automation components.

ANSWER: Yes.

7. Page 55 Section 5.3.1 – Requirement – Contract must include instrument installation, set-up, validation, supplies, and labor. Instruments must be installed, validated and ready for patient testing by the start of the base year of the period of performance. The on-site installation process should begin no less than 90 days after award, but as soon as necessary to ensure equipment is fully operational on first day of the base year of the period of performance.

a. Question: as the contract award date will be less than 90 days until the first day of the base year, please remove the words “but as soon as necessary to ensure equipment is fully operational on first day of the base year of the period of performance” to ensure the awarded vendor has up to 90 days to complete this requirement.

ANSWER: Reference updated SOO.

b. Question: Please confirm “Instrument(s)” in this requirement refers to the actual analyzers performing the assay testing and not the automation. Due to the customization of an automation solution for each customer, we request 180 days for the automation portion of this requirement.

ANSWER: Chemistry analyzer systems only. We anticipate up to a 6-month delay with automated track system.

c. Question: If implementation timelines extend beyond 90 days for instruments/analyzers or 180 days for automation, through no fault of the vendor and is a delay due to the Government, please add wording so the vendor is not penalized.

ANSWER: Reference updated SOO.

8. Pages 56-58 Assay test menu

a. QUESTION: For "C-Reactive Protein" and "High Sensitivity C-Reactive Protein", please confirm two different tests are required.

ANSWER: Yes. Required by medical physicians treating patients at Keesler AFB

b. QUESTION: Please provide the reportable ranges and cutoff levels required for “C- Reactive Protein" and "High Sensitivity C-Reactive Protein”.

ANSWER: Reportable ranges and cutoff levels are determined at method validation.

c. Assay: RAPID/INTACT PARATHYROID HORMONE (PTH) THAT IS

INTRAOPERATIVE CAPABLE

i. QUESTION: Request: the intraoperative PTH claim is source-limiting. Please revise to accept PTH assays that do not require the intraoperative claim.

ANSWER: Parathyroid surgeries are performed routinely at Keesler Medical Center. Intraoperative PTH test is required by Physicians’ performing these surgeries. A delay in PTH results will negatively impact the patient who is on the surgery table waiting for the laboratory to perform testing.

d. QUESTION: Should infectious disease testing assays be included, such as Hepatitis, HIV, and Syphilis? If so, please provide annual test volumes.

ANSWER: No. All infectious disease testing conducted at epi lab in Wright Patterson AFB OH or other military reference laboratories.

e. QUESTION: Should Fentanyl, Methadone, or Oxycodone be added to the Drugs of Abuse assays? If so, should the same annual test volumes be added as the other Drugs of Abuse on the Test Menu provided or should different test volumes be used for each? If different test volumes are to be used, please provide those.

ANSWER: No test volumes are only for the 7 specific Urine Drugs of Abuse test listed used for medical screening. depending on the test requested.

all other Drugs of Abuse or compliance testing are conducted at commercial or military reference laboratory.

f. QUESTION: For the Drugs of Abuse assays, please state whether each assay is qualitative or semi-quantitative and what cutoff level is used for each.

ANSWER: Cutoff levels are determined at method validation.

Amphetamine – qualitative Barbiturate - qualitative Benzodiazepine – qualitative Cannabinoid - qualitative Cocaine – qualitative Opiate - qualitative

Phencyclidine – qualitative

9. QUESTION: Are vendors able to access this page/file? We have tried unsuccessfully; it appears that only official government users can access. We would like to double-check that our offering is on this list based on our eMass numbers.

ANSWER: If the Vendor has difficulty accessing the page, they may contact the Contracting Office POC to provide confirmation of the status of the offering.

10. QUESTION: It has been our experience that the government prefers to use their own servers so that the government can control what is loaded, the anti-virus, etc.. Will the government consider changing this requirement to allow middleware to be housed on the government servers?

ANSWER: According to Cyber, the servers will be DoD servers however they will need to be maintained by the vendor. Reference update to SOO.

11. QUESTION: Please clarify the “per diem” requirement. Does this refer to meals while in training?

ANSWER: Yes, per diem is for food expenses to include travel days and training days.

SECTION SF 1449 - CONTINUATION SHEET

SOLICITATION/CONTRACT FORM

The required response date/time has changed from 15-Jul-2025 10:00 AM to 23-Jul-2025 10:00 AM.

The following have been modified:

STATEMENT OF OBJECTIVES

STATEMENT OF OBJECTIVES

The successful offeror shall furnish all chemistry analyzers, immunoassay analyzers and automated specimen track system including any necessary maintenance services, supplies and reagents needed to perform automated specimen processing to the Department of Clinical Laboratory and Pathology Services, Keesler Air Force Base Medical Center, Keesler Air Force Base Mississippi. All analyzers, automated specimen track system and bidirectional vendor supplied computer interface must have ability to connect to and be fully interoperable with Cerner Military Health System (MHS) Genesis Lab Information System. Training for all equipment, software and accessories will be provided by the vendor at no additional charge to the government. This requirement will be met on a Cost Per Reportable Result (CPRR) basis. Analyzers must be in place and fully operational i.e. ready for patient testing to include MHS Genesis build and validation and be approved by the Laboratory Director to begin patient testing by the start of the base year period of performance. In addition, an approved authorization to operate (ATO) is required prior to use and any subsequent billing. ATO approval must be maintained and valid through the life of the contract. Vendor must include Utility layout required and CAD drawing with detailed analyzer layout with proposal.

Period of Performance:

Base: 1 October 2025 – 30 September 2026 (CLIN 0001) Option 1: 1 October 2026 – 30 September 2027 (CLIN 1001) Option 2: 1 October 2027 – 30 September 2028 (CLIN 2001) Option 3: 1 October 2028 – 30 September 2029 (CLIN 3001) Option 4: 1 October 2029 – 30 September 2030 (CLIN 4001)

1. Authorization to Operate (ATO) (Subfactor 1A)

1.1. Analyzers must have a bi-directional interface that can connect to and be fully interoperable with the laboratory information system and have an approved ATO as listed on CSTAR (https://info.health.mil/apps/HIT/cstar/Pages/Systems.aspx) prior to use and any subsequent billing. ATO approval must be maintained and valid through the life of the contract.

1.2. Middleware must have an approved ATO prior to use and any subsequent billing, and approval must be maintained and valid through the life of the contract.

1.3. Each interface shall allow for recognition and interpretation of MHS Genesis generated bar-code labels on all sample tube types. Connectivity between the Vendor instrument systems and middleware to each LIS will be required at varying times during the contracted period of performance. Location:

81MDTS/SGQC Clinical Laboratory, Keesler Medical Center, Keesler Air Force Base, MS.

2. Instruments/Equipment and Reagents/Consumables (Subfactor 1B).

2.1. Chemistry /Special Chemistry analyzers shall meet the following minimum requirements:

2.1.1. Supply two floor standing integrated clinical chemistry /immunoassay analyzers with discrete random access of patient specimen, Reagents, Calibrators, Controls, and Consumables.

2.1.2. Capable of processing the full chemistry and immunoassay result menu performed at Keesler AFB, listed in section 5 with all reagents needed to perform the total of all patient results specified for each fiscal year. Allowing for Mirror image analyzer backup with capability of running the full result menu.

2.1.2.1. If the Vendor’s automated system does not offer FDA approved results performed at Keesler AFB listed in section 6, Vendor will provide an alternate FDA approved bench top test at vendor’s expense.

2.1.3. The entire system shall have an approved ATO for remote connections (internet, cloud, etc.) to be functional and serviceable.

2.1.4. Will have sample and reagent bar-code reading capability.

2.1.5. Will have On-board test auto inventory, automatic dilution of patient samples and user configurable automatic rerun/reflex.

2.1.6. Will have Short Sample, Clot, and Bubble Detection.

2.1.7. Will have Hemolysis, Lipemia and Icteria detection with no impact on sample throughput.

2.1.8. Will have the ability to perform all results in inventory with no manual sample pretreatment or predilution for any assay including whole blood or urine specimen.

2.1.9. All analyzers will connect to automated track system and be fully interoperable with MHS Genesis.

2.1.10. Will have 90% of reagents ready-to-use requiring limited preparation.

2.1.11. Will have On Board Maintenance Records.

2.1.12. Will have a Quality Control, Linearity and Precision program that will meet College of American Pathologist (CAP) requirements. Ability to program quality control ranges, calibration set points and system parameters without stopping or pausing the system.

2.1.13. Will have a Quality Control program which has Bar-code identification with the ability to use third party bar-coded control material, Ability to setup, process and correlate multiple quality control lots simultaneously.

2.1.14. Shall have the ability to continually load and unload bar-coded liquid third party quality control material at any time, store at least 50% of liquid controls on the system, and automatically run liquid controls at user-defined intervals.

2.1.15. Shall have 90% of calibrators are liquid ready for use.

2.1.16. Shall have the ability to continually load and unload bar-coded calibrators at any time, store at least 50% of liquid calibrators on the system and automatically run liquid calibrators at user-defined intervals.

2.1.17. Shall have the ability to correlate reagent lot to lot runs by having simultaneous lots on board the analyzer.

2.1.18. Reagents must be designed to allow for error proof loading. Safety measures must be in place preventing capped reagent loading errors such as failure to remove cap causing probe crash.

2.1.19. Error free reagent loading where Bulk reagents are keyed and color coded for designated locations.

2.1.20. Chemistry/Immunoassay analyzers must have the capability to interface and be fully interoperable with the laboratory information system (LIS), MHS Genesis.

2.2. Automation will meet the following minimum requirements:

2.2.1. Supply one floor standing continuous loop automated track system.

2.2.2. Process multiple tube sizes.

2.2.3. Process multiple sample tube types from multiple tube suppliers. Tube types include lithium heparin tubes (Green Cap), serum tubes (Red or Gold Cap), urine tubes (White Cap), EDTA tubes (Purple Cap) and Oxalate tubes (Grey Cap).

2.2.4. Ability to identify sample tube type by tube cap color and analyze tube type for proper patient testing.

2.2.5. Connect and interface with all analyzers offered.

2.2.6. Front end processing to include sample priority sorting with a single input and output module.

2.2.7. A centrifuge located on the track system.

2.2.8. Automatic sample rerun and reflex.

2.2.9. On-board test auto inventory.

2.2.10. Processing to include:

2.2.10.1. On-board recapping/sealing

2.2.10.2. On-board decapping/desealing.

2.2.11. Adequate number of trays to be used for archiving capabilities.

2.3. Reagents/Consumables.

2.3.1. Vendor will supply all consumables, parts and accessories needed by the analyzers to function and process all patient testing.

2.3.1.1. The vendor shall provide all reagents/reagents packs, calibrators/standards, calibration verification materials, quality control materials, user-replaceable maintenance items, consumables, accessories, and analyzer specific tools/supplies to support the ongoing delivery of laboratory services using the equipment outlined in this section.

2.3.1.2. Materials must meet the College of American Pathologist (CAP) requirements.

2.3.2. The Vendor shall provide paper and electronic copies of safety data sheets (SDSs) for each reagent item delivered under this contract (as appropriate).

2.4. Middleware network must have:

2.4.1. Middleware must have an approved ATO to operate on the DHA network and interface with the LIS. Refer to CSTAR (https://info.health.mil/apps/HIT/cstar/Pages/Systems.aspx In addition, an approved authorization to operate (ATO) is required prior to use and any subsequent billing. ATO approval must be maintained and valid through the life of the contract.

2.4.2. A middleware system with 4 additional computers with points of access to the middleware network.

2.4.3. Usage of all computer components, printers and accessories needed to operate instruments, middleware, and track system.

2.4.4. The entire system shall have an approved ATO for remote connections (internet, cloud, etc.) to be functional and serviceable. Middleware will be on a DoD server and maintained by vendor.

2.4.5. All software updates or file exchange shall be completed using CD/DVDs only. At no time will USB, internet or cloud-based services be allowed.

2.4.6. Turn-key operation where all user configurable auto-validation, auto-reflex of results using either internal rulesets or user-defined auto-reflex parameters, normal ranges, linear ranges, panic values, delta checks, instrument errors, calculated tests shall be written, tested, and validated by the vendor.

2.4.7. The system shall have a comprehensive quality control software or provide a 3rd party vendor quality control software program approved by Keesler AFB Medical center that includes, test lockout when Quality Control falls out of range, ability to assess quality controls using Westgard rules, the ability to use third party bar-coded control material, Quality Control timeout, Ability to setup, process and correlate multiple quality control lots simultaneously and on board or access to a quality control statistical program to include Daily/monthly Levy-Jenning’s quality control graphs available for review and printing or saving to backup disks.

2.5. Peripherals

2.5.1. Vendor shall include at a minimal, Uninterruptable Power Sources (UPSs), electrical line conditioners as required, instrument-specific computer terminals/CPUs; Printers shall include at a minimal, initial toner for each as needed, Reagent Grade Water system, Air Compressor and other equipment where required.

2.5.2. Each analyzer, including printer, monitor, UPS, and computer system, shall fit within the dimensions outlined in section 2.6. and complete operations on one platform. Sufficient room for proper exhaust and heat clearance based on manufacture’s site specifications shall be maintained, with at minimum a 36” clearance between the existing wall and instruments. Any sliding compartments or access drawers for servicing cannot extend beyond the width of each individual unit outlined in figure below when fully expanded.

2.6. Lab Layout.

2.6.1. The Vendor shall provide a diagram or other graphical representation demonstrating proposed equipment fitment within the dimensions with the proposal. NOTE: A floor drain (1), and dedicated water system is available. (See current layout – attachment 1).

2.6.1.1. Vendor shall provide two diagrams or other graphical representations demonstrating proposed equipment fitment within the dimensions listed below for final placement (1of 2) and another for fitment during the validation period (2 of 2).

2.6.2. The Vendor shall provide a diagram or other graphical representation demonstrating temporary and permanent plumbing, water supply, power supply and other equipment required with quote (i.e. facility modification requirements).

2.6.3. The Vendor shall meet the following facilities requirements:

2.6.3.1. Space (not to exceed):

Ceiling Height: 95” Door opening: 82” Floor Space availability: 36’ x 12’6”

2.6.3.2. Circuit availability:

2ea 208V 30AMP 6ea 110V 15AMP

2.6.3.3. Water and Drain availability:

1ea DI water lines 30L/HR. 7-57 PSI with 1/2' barbed hose One 2” Drain

2.6.3.4. HVAC:

Total CFM 2919 Area Heat load capability 33K BTU/hr

3. Service and Maintenance (Subfactor 1C). The Vendor shall meet the following service and maintenance requirements for all testing locations at Keesler AFB Medical Center.

3.1. The Vendor shall provide direct customer service and support, 24 hours/7 days a week, to include hotline telephone service (provided in English) and on-call on-site emergency repair, to assist operators in correcting equipment problems. Emergency repair includes but is not limited to malfunction of both analyzers during the same period, malfunction that may cause a safety issue, etc.

3.2. The Vendor will maintain all equipment installed under this contract. This includes emergency repairs as well as routine Preventive Maintenance Services (PMS), safety tests, calibrations/calibration verifications, and unscheduled repair services in accordance with procedures and practices prescribed by the manufacturer of the equipment.

3.3. The Vendor shall provide all personnel, equipment, tools, materials, supervision, parts, transportation, and other items and services necessary to perform all required repairs and scheduled preventive maintenance/safety inspections and calibrations of equipment. The performance of scheduled periodic preventive maintenance, safety checks, and calibrations that are not normally performed at the operator level shall be performed by Vendor service personnel in accordance with requirements as specified in the Vendor’s instrument maintenance manual. Completion of analyzer installation will establish time-zero for determining the time frame for performance of periodic services.

3.4. Any service technician provided by the Vendor shall adhere to all required reporting procedures for Keesler AFB Medical Center prior to reporting to the laboratory for work. Current procedures will be made available.

3.5. For equipment supporting the Laboratory, the service technician shall be on-site to provide unlimited service within twenty-four (24) hours of establishing telephonic contact. The equipment shall be repaired and operational within 48 hours after initial on-site response by the Vendor.

3.5.1. Should all analyzers become inoperable, the Vendor’s service technician shall be on-site within four

(4) hours of initial notification. The repair of at least one (1) analyzer shall be completed within eight (8) hours of initial notification.

3.6. In all cases, the Vendor shall provide all reagents, calibrators, controls, and any other materials necessary to troubleshoot instrument failure. Replacement parts used, as necessary, claimed from local operator-level maintenance kits as well as any reagents that may have been used shall be replaced at no cost by the Vendor.

3.7. The Vendor shall schedule the date and time for performance of a preventive maintenance service no later than ten (10) days prior to the scheduled preventive maintenance services.

3.8. Within one (1) working day after completion of a repair, the Vendor’s representative shall furnish the one (1) copy of a service report for all services performed with a copy to the Equipment Management Branch and the Laboratory Representative for the Keesler AFB Medical Center. The report shall be in English and shall contain, as a minimum, the following information:

- Nomenclature and serial number

- Date of service

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

- Location of services performed

- Duration of performance (hours)

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

- Name of technician

3.9. The Vendor shall relocate/revalidate any instrument if requested by the Government at no additional cost. This includes any location within the Keesler AFB Medical Center.

3.10. Shall provide product service and support to include updates to operational software throughout the lifecycle of the equipment.

4. Training (Subfactor 1D).

4.1. Prior to implementation of the analyzer for patient testing, the Vendor shall provide training for two

(2) primary (key) operators, per analyzer.

4.1.1 The Vendor will provide the training for each piece of equipment, including the track system, at no additional cost to the Government. The following will be provided at Vendor expense: lodging (hotel), per diem, and travel (airfare, local transportation) expenses to/from Keesler AFB, hotel, and training location (offsite location). Additional training, upon request, for one operator per year per instrument (lodging (hotel), per diem, and travel (airfare) expenses included to/from Keesler AFB, hotel, and training location).

4.2. Prior to implementation of the analyzer for patient testing, The Vendor shall provide non-key operator training to assigned technicians. Total number of training slots will be coordinated and scheduled with Vendor at installation.

4.2.1. Training will be performed at Keesler Medical Center. The Vendor will provide the training for each piece of equipment, including the track system, at no additional cost to the Government.

4.2.2. This training will include basic analyzer operation, troubleshooting procedures, performance of operator level periodic preventive maintenance procedures and use any data management/quality control software.

4.3. Upon renewal of the option years and in the case of any significant software or assay procedural updates, the Vendor shall provide one (1) primary (key) operator training slot per analyzer. Total of 2 primary (key) operators training slots per option year.

4.3.1. This training will be at a Vendor location at no additional cost to the Government. The Vendor will provide the training for each piece of equipment, including the track system, at no additional cost to the Government. The following will be provided at Vendor expense: lodging (hotel), per diem, and travel (airfare, local transportation) expenses to/from Keesler AFB, hotel, and training location (offsite location). Additional training, upon request, for one operator per year per instrument (lodging (hotel), per diem, and travel (airfare) expenses included to/from Keesler AFB, hotel, and training location)

4.4. If training for the automated track system is separate from the analyzer training, Vendor to provide initial track system training for 2 laboratory personnel and annual track system training for 1 laboratory personnel. Training may be conducted at a Vendor or Government location at no additional cost to the Government.

5. Delivery and Installation (Subfactor 1E).

5.1. All systems shall be delivered to the appropriate location indicated below.

Keesler Air Force Base Medical Center Pathology and Laboratory Department 301 Fisher St.

Keesler AFB, MS 39554

5.2. Vendor to provide a project manager to perform/oversee system installation, correlation, and validation. Vendor also to provide all validation reagent/materials needed to perform these tasks at no additional cost to the Government. During the initial implementation, a primary, dedicated Clinical Application Specialist shall be assigned and available on site throughout the entire implementation period.

Substitutions shall be coordinated with and approved by Keesler Medical Center.

5.3. No less than 10 calendar days from the contract award, vendor shall coordinate and conduct a post-award site visit for the purpose of coordinating the schedule for equipment installation and validations.

5.3.1. Contract must include instrument installation, set-up, validation, supplies, and labor. Instruments must be installed, validated and ready for patient testing by the earliest date practicable within the period of performance. The on-site installation process should begin no less than 90 days after award, but as soon as necessary to ensure equipment is fully operational at the earliest date practicable within the period of performance.

5.4. The Vendor shall provide a qualified Clinical Application Specialist, who possesses a thorough knowledge of method validation/verification and, where applicable, is familiar with the use of clinical laboratory statistical valuation software (e.g. EP Evaluator®), to provide technical assistance for the method validation/verification studies. The assigned Clinical Application Specialist will be responsible for the entire method validation to the standards of the acting medical director. Additional Clinical Application Specialists may be brought in to assist in method validations/verifications.

5.5. Method validation/verification will be completed by qualified Clinical Application Specialists within two weeks of analyzer and component installation and functionality and will be conducted in accordance with Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and the College of American Pathologists (CAP) requirements.

5.6. Method validation/verification will include, but not be limited to normal range (reference interval) verification, verification of reportable range (AMR), correlation to current methods, verification of precision, carryover studies and establishment of initial ranges using control materials, to include third party controls as required.

5.7. Once completed, the method validation/verification must be approved by the Laboratory Director prior to reporting of patient results. Payment for services will not begin until the analyzer system has been approved for reporting of patient results.

5.8. All instrument reagents, calibrators, linearity materials and other required reagents/materials used in the method validation/verification study will be provided by the Vendor at no additional cost to the Government.

5.9 Vendor to provide a timeline identifying critical points in the delivery/installation phase, wherein Day 0 = Notice of Award. For example, if the offeror is notified that they are awarded the contract on 1 July 2025, delivery of the equipment would occur on 15 July 2025, with installation on 1 August 2025, the timeline would be: Day 0 = Notification of Award; Day 15 = Delivery of equipment; Day 33 = Installation.

6. Result Menu

6.1. The table below lists the results required with estimated number of results per year.

6.1.1. The Offeror provided Excel Pricing Worksheet, Attachment #3, shall be incorporated in to the contract. The Pricing Worksheet requires unit pricing for each result which is multiplied by the annual quantities provided in the SOO. The Pricing Worksheet’s CLIN total will be divided by 12 to derive the firm-fixed monthly unit price on the resultant contract.

The Government will order items on as-needed basis. The quantities listed herein are the Government’s best estimate of its needs for the five-year performance period and are based on historical data and future projected usage. The final unit prices for each result established in any contract resulting from this solicitation are final. The Government will pay a firm-fixed price per month based on the estimated quantities provided. Actual number of results (i.e., equivalent reagents) ordered and accepted, may fluctuate monthly but shall not exceed the annual quantities provided. In the event the Government needs additional results, Attachment 3 will provide the basis for pricing any modification. Therefore, the offeror is hereby informed that the final awarded unit (i.e., result) prices are not subject to adjustment on the basis of a difference between result quantities estimated on the solicitation, quantities established on the contract, and actual quantities used.

6.2. The Vendor will perform validation requirements in accordance with CLIA regulations and CAP standards for newly added results when requested by the Government and at Vendor’s expense.

6.2.1. The Vendor will assist the laboratory in performing additional result validations to meet CAP requirements for validating result modification such as those that were not part of the original manufacture’s result validations such as, but not limited to, neonatal populations.

6.2.1.1. The vendor will provide all materials (e.g. specimens and reagents) required for said validations.

GENERAL CHEMISTRY Base Year Estimated number of Results/Year

ALANINE AMINOTRANSFERASE (ALT) 17,498

ALBUMIN 36,205

ALKALINE PHOSPHATASE (ALP) 16,972

AMMONIA 117

AMYLASE 222

ASPARTATE AMINOTRANSFERASE (AST) 17,693

BLOOD UREA NITOGEN 34,060

CALCIUM 33,793

CARBON DIOXIDE 33,513

CHOLESTEROL 8,994

C-REACTIVE PROTIEN 1,817

CREATINE KINASE - TOTAL 536

CREATININE 44,130

DIRECT BILIRUBIN 2,917

ETHANOL (ETOH) 451

GAMMA-GLUTAMYL TRANSFERASE 328

GLUCOSE 34,928

GLYCOCYLATED HEMAGLOBIN A1C 10,754

HIGH DENSITY LYPOPROTIEN - DIRECT 8,978

IRON (NO PRETREATMENT) 5,370

LACTATE 1,702

LACTIC DEHYDROGENASE 697

LIPASE 2,420

LOW DENSITY LYPOPROTIEN - DIRECT 8,982

MAGNESIUM 10,568

PHOSPHOROUS 15,468

PREALBUMIN 103

TOTAL BILIRUBIN 17,367

TOTAL PROTEIN 17,029

TOTAL/ UNSATURATED IRON BINDING CAPACITY 5,376

TRANSFERRIN 5,307

TRIGLYCERIDE 9,044

URIC ACID 1,433

ELECTROLYTES

CHLORIDE 39,084

POTASSIUM 39,084

SODIUM 39,084

IMMUNOCHEMISTRY

25-OH, VITAMIN D 6,948

3RD GENERATION THYROID STYMULATING HORMONE

(TSH)

8,623

B12, VITAMIN 3,081

Beta HUMAN CHORIONIC GONADOTROPIN (Beta- HCG) 998

CORTISOL 267

ESTRADIOL 299

FERRITIN 3,674

FOLATE 3,081

FOLLICLE STIMULATING HORMONE (FSH) 489

FREE THYROXINE (FT4) 4,030

INSULIN 158

LUTEINIZING HORMONE (LH) 489

PROCALCITONIN 263

PROGESTERONE 138

PROLACTIN 860

RAPID/INTACT PARATHYROID HORMONE (PTH) THAT IS

INTRAOPERATIVE CAPABLE

2,041

TOTAL TESTOSTERONE 433

TRIIODOTHYRONINE (FREE T3) 312

URINE DRUGS OF ABUSE

AMPHETAMINE 1,028

BARBITURATE 1,028

BENZODIAZEPINE 1,028

CANNOBINOID 1,028

COCAINE 1,028

OPIATE 1,028

PHENCYCLIDINE 1,028

IMMUNONOLOGY

ANTI STREPTOLYSIN O (ASO) 27

IMMUNOGLOBULIN A 262

IMMUNOGLOBULIN G 227

IMMUNOGLOBULIN M 227

RHEUMATOID FACTOR (RF) 378

THERAPEUTIC DRUGS

ACETAMINOPHEN 297

CARBAMAZEPINE 30

DIGOXIN 59

GENTAMICIN 24

LITHIUM 50

PHENOBARBITAL 31

PHENYTOIN 27

SALICYLATE 254

TOBRAMYCIN 21

THEOPHYLLINE 23

VALPORIC ACID 62

VANCOMYCIN 250

Tumor Markers

3RD GENERATION TOTAL PROSTATE SPECIFIC ANTIGEN

(PSA)

2,576

ALPHA FETAL PROTIEN 212

CA-125 ANTIGEN 95

CARCINOEMBRYONIC ANTIGEN (CEA) 231

FREE PROSTATE SPECIFIC ANTIGEN (PSA) 458

URINE CHEMISTRY

MICROALBUMIN 8,119

URINE TOTAL PROTEIN/ CSF TOTAL PROTEIN 2,103

CARDIAC TESTS

CREATINE KINASE - MUSCLE BRAIN 84

HIGH SENSITIVEITY TROPONIN I 4,936

HIGH SENSITIVITY C-REACTIVE PROTIEN 135

N TERMINAL-PRO BRAIN NATRIURETIC PEPTIDE 2,244

Total # of results annual 588,843

ATTACHMENT 1

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