SF30 Amendment No. 0001.pdf

W40M USA HCA

MEDICAL READINESS CONTR OFFICE WEST

POC: JOHN C. FINKENSTADT

3551 ROGER BROOK DR BLDG 3600

JBSA FORT SAM HOUSTON, TX 78234-6200

0012030524-0001

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 address industry generated questions and answ ers, and to incorporate a revised Statement of Work (SOW), dated 13 February 2024. The complete quotation deadline w ill also be extended to NLT 11:00AM CST on 22 February 2024.

POC: J. Chris Finkenstadt, john.c.finkenstadt2.civ@health.mil

1. CONTRACT ID CODE PAGE OF PAGES

J 1 22

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

16C. DATE SIGNED

BY 13-Feb-2024

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 W81K0024Q0037

X 9B. DATED (SEE ITEM 11)

31-Jan-2024

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

14-Feb-2024

CODE

W40M USA HCA

MEDICAL READINESS CONTR OFFICE WEST

3160 MCINDOE BLDG 1103

JBSA FT SAM HOUSTON TX 78234-4504

W81K00 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE W81K00

FACILITY CODECODE

EMAIL:TEL:

W81K0024Q0037

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:

INDUSTRY GENERATED Q&A

1. Q: "Referencing Date of Submission: Question/Point of Clarification: We respectfully request an extension to the due date of 1-2 weeks."

A: "Extended 1 week to 22 February 2024 NLT 11:00AM CST.”

2. Q: "Referencing Page Limitations: Question/Point of Clarification: We request that the 30- page limit for the Technical Capability responses (page 2/94) be expanded to allow for 80-100pages."

A: “No change, comments made on the Statement of Work will not count against the page limit.”

3. Q: "Referencing Page Limitations: Question/Point of Clarification: We request that responses to the Statement of Work not be included in the count against the 30-page limit for the Technical Capability."

A: “Comments made on the SOW will not count against the page limit.”

4. Q: "Page 79/94, Point 5.1.3.3 requires the contractor to provide linearity material for the Method Validation.

Question/Point of Clarification: We request that this requirement be removed."

A: “No change.”

5. Q: "Page 82/94, Point 5.39 states that Reagents shall (must) have a minimum of six months shelf life or contractor shall identify guaranteed shelf life. Question/Point of Clarification: We request that this requirement be removed.”

A: “No change.”

6. Q: "Page 82/94, Point 5.3.10 requires Calibration frequency for all assays shall not be less than once every thirty

(30) days under routine operation. Question/Point of Clarification: We request that this be modified to read that Cal frequency for all immunoassays shall not be less than once every thirty (days) and that calibration frequency for all chemistry analyzers be illustrated by the vendor in a list."

A: “See revised statement of work para 5.3.10.”

7. Q: "Page 82/94, Point 5.3.10 requires Calibration frequency for all assays shall not be less than once every thirty

(30) days under routine operation. Question/Point of Clarification: We request that the list not count against the 30-page technical page limit."

A: “See revised statement of work para 5.3.10.”

8. Q: "Page 80/94, point 5.2.8. The analyzer systems and all reagents shall be approved by the Food & Drug Administration (FDA). All analyzers and associated parts and accessories shall be new. No used, refurbished, or like-new equipment shall be provided in support of this contract at any time. Question/Point of Clarification: We request that the need for new instrumentation be removed.”

A: “No change.”

9. Q: "Page 69, point 5.2.1 Individual analyzer shall have fully automated, discrete random-access capabilities for chemistry, immunometric, potentiometric, and colorometric assays within one integrated analyzer. Question/Point of Clarification: We ask that this be reworded to state the need for ‘multiple technologies’ within one integrated analyzer, as the list of assay types are specific to one vendor."

A: “See revised statement of work Para 5.2.1.”

10. Q: "-Already Requested- In order to ensure we have time to create a high-quality response for your review, would Raymond W. Bliss Army Health Center consider moving the deadline from February 15th to February 29th?”

A: “Extended 1 week to 22 February 2024 NLT 11:00AM CST.”

11. Q: "Does Raymond Bliss do Autoverification of Results?"

A: “No.”

12. Q: "IF so, where are the Autoverificaiton rules built? (DI vs Cerner)" A: “N/A.”

13. Q: "Does Raymond Bliss have a DI type middleware system? If so, is that from their current chemistry vendor?

Or an enterprise DI Milddleware” A: “No.”

14. Q: "Does Raymond Bliss desire Autoverifcation capabilities in the newly Chosen Vendor middleware system?"

A: “No.”

15. Q: "Does Raymond Bliss use a QC program currently, and if so, what is it?"

A: “Unity Web. All QC results are transferred from analyzer by CD.”

16. Q: "Does Raymond Bliss have their own instance of Cerner?"

A: “No, utilizes MHS Genesis.”

17. Q: "Does Raymond Bliss do Peer Review and if so, what software do they use?"

A: “Yes; Bio-Rad Unity Web.”

18. Q: "Does Raymond Bliss do Patient Moving Average review? And, if so, what software is used for that" A: “No.”

19. Q: "Does Raymond Bliss have their own IT resources and server bank?"

A: “No.”

20. Q: "How Does Raymond Bliss handle IT downtimes in relating to patient reporting?"

A: “Patient reporting is not performed during downtime.”

21. Q: "Respectfully requesting a two-week extension from the due date to prepare a complete and accurate response."

A: “Extended 1 week to 22 February 2024 NLT 11:00AM CST.”

22. Q: "Please clarify if you are a highly or moderately complex lab."

A: “High.”

23. Q: "Please clarify if this should be a CPT or CPRR solicitation? In the previous solicitation the solution was a cost per reportable."

A: “CPT.”

24. Q: "5.1.1 and 5.2.1- please clarify the number of analyzers required as both requirements state a different requirement."

A: “See revised statement of work para 5.1.1 and 5.2.1.”

25. Q: "Section 5.2.4 lists the minimum throughput for immunometric (50 T/hr.), photometric 400 (T/hr.) and ISE assays (100 T/hr.). Does Bliss Army process Photometric and ISE testing together? If so, is the minimum throughput still 400 T/hr. for photometric tests and 100 T/hr. for ISE tests?"

A: “Yes; Yes.”

26. Q: "Maintenance is listed 71 times in SOW, can you elaborate on the total (Automated and Hands-on) maximum allowable maintenance times for the analyzer per day, per week and per month?"

A: “Daily: 40 minutes Weekly: 1 hour; Monthly: 1 hour.”

27. Q: "Section 5.2.6 references start up time from shutdown, and section 9/6/1 references that the analyzer shall be operational 99.9% of the time, what is the requirement for the frequency of the analyzer to be shut down? In a 40-hour work week what is the maximum number of times the analyzer can be shut down?"

A: “No requirement for analyzer to be shut down.”

28. Q: "Sections 5.3.3 and 5.3.10 reference calibration requirements and the need for the user to meet work test requirements and section 9.6.4 references the evaluation of linearity measurement procedures, can you elaborate on the calibrator requirements in regard to linearity. With the goal of enhancing user efficiency and reducing total tech time on the analyzer what is the maximum percentage of tests that can have < 3-point calibrators which would require linearity studies?"

A: “As minimal as possible.”

29. Q: "5.3.10- Respectfully requesting for this requirement to be removed as this is unduly restrictive as only one vendor meets this requirement."

A: “See revised statement of work para 5.3.10.”

30. Q: "9.6.1 Respectfully requesting for this requirement to be removed. The reporting of uptime is a vendor tracked and reported specification without 3rd party validation, making this specification arbitrary with unverifiable reportable data. It is noteworthy that there is no gold standard for reporting, tracking or calculating uptime with each vendor defining travel, planned and unplanned incidents differently resulting in a skewed and unfair comparisons between vendors even if same formula is applied."

A: “No change.”

31. Q: "5.4.3.6- Please clarify what is needed for unlimited emergency service."

A: “Service requiring immediate repair; an unscheduled maintenance/service requirement.”

32. Q: "Section 3.4.1 references the utilities necessary for the full functionality of the equipment, what is the maximum heat output measured by BTU’s that is allowable for the analyzer?"

A: “8,000 BTU per hour.”

33. Q: "This section references the water purification system, what is the maximum liters of water per hour allowable for the analyzer? 12. EQUIPMENT. The government will provide an existing water purification system meeting requirements of the contractor’s chemistry analyzer."

A: “480 gallons per hour.”

34. Q: "5.3.4. All Reagents shall (must) have the ability to be placed on the analyzer with no waiting period. (i.e., reagents shall be taken straight from refrigerator to the analyzer)- Respectfully request removal of 5.3.4 as this specification is targeted to eliminate a technology and specific vendor(s). Specification has no impact on quality of testing, turn around time, down time, nor time to first result and arguably no impact on workflow when compared to requirements that different technologies require, and other technologies do not."

A: “See revised statement of work para 5.3.4.”

STATEMENT OF WORK

STATEMENT OF WORK

Chemistry and Immunoassay Reagent Testing Supplies in Support of Raymond W. Bliss Army Health Center

(RWBAHC), at Fort Huachuca, Arizona Dated: 13 February 2024

1. GENERAL REQUIREMENTS:

1.1. SCOPE OF WORK: The Contractor shall provide Chemistry and Immunoassay Reagents (including equipment, maintenance, and support at no extra cost to the Government) in support of Raymond W. Bliss Army Health Center (RWBAHC), Fort Huachuca, Arizona. The Contractor shall be responsible for furnishing maintenance, services, repairs, and parts as required in order to maintain the systems in optimal operating condition.

The Contractor shall perform to the standards of this Statement of Work (SOW).

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

1.2. The Contractor shall provide a Quality Control (QC) Plan that contains, at a minimum, the items listed in 1.2.2 (below) to the Contracting Officer and Contract Officers Representative (COR) for acceptance not later than 10 days AFTER the start of the contract (see table 5.2). The Contracting Officer will notify the Contractor of acceptance or required modifications to the plan. The Contractor shall make appropriate modifications and obtain acceptance of the plan by the Contracting Officer.

1.2.1.1. The QC Plan shall include:

1.2.1.1.1. A description of the inspection system to cover all incidental support and maintenance services listed on the Performance Requirements Summary (PRS) listed in table 5.2. Description shall include specifics as to the areas to be inspected on both a scheduled and unscheduled basis, frequency of inspections, and the title and organizational placement of the inspectors. Additionally, control procedures for any Government provided keys or lock combinations shall be included.

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

1.2.1.1.3. A description of the records to be kept to document inspections and corrective or preventive actions taken.

NOTE: The records of inspections shall be kept and made available to the Government throughout the contract performance period and for the period after contract completion until final settlement of any claims, if any, under this contract.

1.2.2. Quality Assurance (QA).

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

1.2.3. Equipment Troubleshooting. When the Government performs troubleshooting with the Contractor, the Contractor shall replace all reagents, calibrators, controls and any other materials used at no additional cost to the Government IAW Paragraphs 5.4.2.1 and 5.4.2.2 (below).

1.2.4. Performance Evaluation Meetings.

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

1.2.4.2. The Contractor may request a meeting with the Contracting Officer, when the Contractor believes such a meeting is necessary. If required, written minutes of any such meetings shall be recorded in the contract and signed by the Contractor and the Contracting Officer. If the Contractor does not concur with any portion of the minutes, such non concurrence shall be provided in writing to the Contracting Officer within 10 calendar days following receipt of the minutes.

1.3. HOURS OF OPERATION:

1.3.1. Normal Hours of Operation, Monday through Friday between the hours of 0700- 1600.

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

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

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

New Year's Day 1 January Martin Luther King's Birthday Third Monday in January President's Day Third Monday in February Memorial Day Last Monday in May Juneteenth 19 June Independence Day 4 July Labor Day First Monday in September Columbus Day Second Monday in October Veteran's Day 11 November Thanksgiving Day Fourth Thursday in November Christmas Day 25 December

NOTE: Any of the above holidays falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. Any holidays that are declared by Presidential Executive Order shall be observed in the same manner as the holidays listed above.

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

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

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

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

1.4.4. Environmental and Hazardous Materials Handling. If the disposal of any waste or byproduct of the analyzers cannot be safely dumped into each of the facility's drain system, the Contractor must provide guidelines for safely disposing these wastes or byproducts in accordance with local and national guidelines.

1.5. RECORDS.

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

1.6. REMOVAL OF EQUIPMENT. The Contractor shall not remove any equipment from the Government work site without prior approval of the Contracting Officer or his/her designated representative.

1.7. UPGRADE OF EQUIPMENT. Subject to mutual agreement between the Government and the Contractor, instrumentation may be upgraded within the specifications of the contract as new technology may become available.

Additionally, the Government will add reagents through the life of this contract as a result of advances in technology or changes to clinical practice standards. Any such change to the reagents or equipment shall be mutually agreed upon by the contractor and the Government through a bilateral modification.

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

1.9. CONTRACTOR PERSONNEL.

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

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

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

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

2. DEFINITIONS/ACRONYMS.

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

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

2.1.2. CONTRACTING OFFICER'S REPRESENTATIVE (COR): A Government employee selected and designated in writing by the Contracting Officer to act as his/her designated representative in administering a contract. NOTE: The COR is not authorized to make any changes to the terms and conditions of the contract.

2.1.3. QUALITY ASSESSMENT AND IMPROVEMENT. Those actions taken by the Government to check services to determine if they meet the requirements of the CLIA/DoD CLIP '88 & '03, CAP, JCAHO, U.S. Army Medical Command quality assurance and risk management programs, and ensure compliance with the terms and conditions of the contract.

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

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

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

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

AR Army Regulation COR Contracting Officer's Representative CAP College of American Pathologists DA Department of the Army DOD CLIP Department of Defense Clinical Laboratory Improvement Program HIPAA Health Insurance Portability & Accountability Act of 1996 MAS Minimum Acceptable Standards MEDCOM U.S. Army Medical Command JC Joint Commission OSHA Occupational Safety and Health Administration PMS Preventive Maintenance Services PRS Performance Requirements Summary QA Quality Assurance QA&I Quality Assessment & Improvement QC Quality Control SOW Statement of Work

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

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

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

12. EQUIPMENT. The government will provide an existing water purification system meeting requirements of the contractor’s chemistry analyzer.

3.3. MATERIALS. No materials will be provided.

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

3.4.1. The Government will provide the normal range of facility utilities (e.g. electricity, water, heating, refuse collection, etc.) and other utilities necessary for the full functionality of the equipment/instrumentation.

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

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

4. CONTRACTOR FURNISHED PROPERTY

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

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

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

5. SPECIFIC TASK

5.1. DESCRIPTION

5.1.1. The Contractor shall provide one integrated fully automated, discrete random-access chemistry and immunoassay analyzer system capable of performing all of the required assays listed in Appendix 1. The analyzer systems will be from a single Contractor. The contract for the analyzer will be five (5) years beginning 01 October 2024 to 30 September 2029. The system shall provide redundancy (to ensure continuous operations), training, supplies, reagents, unscheduled maintenance, and preventive maintenance for the equipment. All equipment displays and supporting literature must be in the English language. Contractor shall include delivery, installation, all calibrators/standards, reagents/reagent packs, and quality control materials necessary to perform the specified assays, initial Method Validations per CLSI QM guidelines and analyzer removal at the termination of the contract. All costs will be calculated on a cost per test to include QC, Calibrations, Proficiency Testing, and repeat testing basis based on the number of patients/tests listed for each Mandatory Test or Desired Test listed on Appendix 1. Costs shall be amortized over the total number of tests described in this SOW and factored into the cost per reportable or test.

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

- Any and all analyzers

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

5.1.1.2. The analyzer system will be located at:

Raymond W. Bliss Army Health Center Dept. of Pathology 2240 E Winrow Ave Fort Huachuca, AZ 85613

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

5.1.3. Method Validation will be conducted in accordance with method validation protocols established by the Laboratory's Quality Management Program (these protocols are in concordance with applicable standards as described by the Clinical Laboratory Standards Institute (CLSI) and/or required by the College of American Pathologists (CAP). Relevant guidelines listed are the minimum guidelines that will be referenced when conducting method validation. Additional guidelines may be required, depending on regulatory requirements.

5.1.3.1. Method Validation will include but not be limited to, normal range verification, demonstration of linearity with limit of quantitation verification (LOQ), limit of detection verification (LOD), reportable range, correlation with current methods (comparison of methods study), validation of analytical measurement range (AMR), validation of clinical reportable range (CRR), validation of precision (replication study) and accuracy (recovery study), and establishment of initial control ranges using control materials, to include third party controls, as designated by the Laboratory Director.

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

5.1.3.2. The Contractor shall provide a qualified Technical Service Representative, who possesses a thorough knowledge of method validation and is familiar with the use of statistical evaluation software as determined by the Laboratory Director (e.g., EP Evaluator®), to provide technical assistance for the method validation studies. The assigned Technical Service Representative will be responsible for the entire Method Validation.

5.1.3.3. All reagents, calibrators and linearity materials used in the Method Validation Study will be provided by the Contractor at no additional cost to the Government. These materials will not be used in the analysis of specimens for patient care.

5.1.3.4. The Government's Technical Supervisor will 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 shall assist in procuring additional specimens. These specimens may be obtained from other laboratories or from Contractor sources.

5.1.3.5. Both the Contractor and Contractor personnel at each location shall abide by all Health Insurance Portability & Accountability Act of 1996 (HIPAA) rules and regulations when conducting the Method Validation Study.

5.1.4. The Contractor shall provide one paper and two (2) CD copies of the Operator's and Maintenance manuals and a statement of the warranty terms in the English language. The level of detail required of appropriate instrument maintenance manuals extends only to routine maintenance procedures performed by the user. All instrumentation specified is non-Government owned leased equipment that is serviced and maintained by the Contractor.

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

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

5.2. ANALYZERS:

5.2.1. Individual analyzer shall have multiple technologies within one integrated analyzer.

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

5.2.2. The analyzer shall be a random access, discrete analyzer system with STAT interrupt capability and a primary tube sampling system capable of handling 5 mL, 7 mL, 10 mL tubes; 1.5 mL sample cups; 1.0 mL small sample containers and pediatric tubes. The analyzer will be capable of accommodating both Becton-Dickinson and Greinier tubes.

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

5.2.4. Minimum actual through-put shall be 50 tests per hour for immunometric assays, 400 tests per hour for enzymatic/rate and colorimetric/photometric assays and 100 tests per hour for ISE assays.

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

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

5.2.7. Each analyzer system shall (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 15 to 20 minutes.

5.2.8. The analyzer systems and all reagents shall be approved by the Food & Drug Administration (FDA). All analyzers and associated parts and accessories shall be new. No used, refurbished, or like-new equipment shall be provided in support of this contract at any time.

5.2.9 The Government will provide an existing space of 12 ft. by 4 ft. and height of 8 ft. The door entry measure

44.5 inches wide. The Government will provide filtered water source and electrical outlets; however, the contractor will be responsible for all connections.

5.3. REAGENTS.

5.3.1. The analyzer shall (must) have the on-board ability to maintain reagents at the proper storage temperatures for the assays listed in Appendix 1. All assays must be FDA approved.

5.3.1.1. The workload listed in Appendix 1 is an estimate based on projected patient workload. Actual workload may vary. The workload numbers represent patient reportable results, and do not include calibrators, controls, or reruns due to troubleshooting or specimen dilutions.

5.3.1.1.1. The actual workload may fluctuate in the first year of the contract due to changes in the distribution of patient care. In addition, workload may expand in subsequent option years due to fluctuations in patient volume.

Appendix 1 provides the estimated workload for Contract Year 1 as well as an estimated workload for each option year. All workload numbers represent total estimated patient reportable/billable results for the indicated year.

5.3.2. The assays listed in Table 5 shall (must) be approved by the FDA for plasma as well as serum samples. In addition, the Contractor shall clearly demonstrate an acceptable correlation, as defined in section 5.1.3 between plasma and serum values during the initial set up and correlation studies.

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

5.3.4. All reagent waiting period requirements (i.e., period of time for reagents taken from refrigerator until reagent can be placed on the analyzer) shall be listed in a table provided by the vendor.

5.3.5. The assays listed in Table 5.2 shall (must) be present on the analyzer at all times.

Table 5.2- Assays that must be Approved for use with plasma and serum samples

Albumin Creatinine Potassium

Blood Urea Nitrogen Creatinine Kinase (CK) Total Protein

Alcohol (Ethanol) HCG, Quant Phosphorus

Alkaline Phosphatase Direct Bilirubin Glucose

Calcium (Total) Total Bilirubin Sodium

Enzymatic Carbonate (ECO2) Uric Acid GGT

Chloride TSH AST

Cholesterol Total & Free PSA LDH

Free T4 Magnesium ALT

HDL Triglyceride Direct LDL

Free T3 B12/Folate LH/FSH

A1C (whole blood) Amylase Vitamin D

5.3.6. The assays listed in Table 5.3 shall (must) be approved by the FDA for urine sample.

Table 5.3- Listing of Assays that must be Approved for use with Urine Samples

Protein (Total) Creatinine Microalbumin (Quantitative)

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

5.3.8. The Contractor shall provide an estimate of the yearly quantities of reagent/reagent packs, calibrators/standards required to perform the volume of patient reportable tests for each assay as provided in Appendix 1.

5.3.8.1. The Contractor shall provide quality control materials including third party controls IAW requirements outlined in the Laboratory QA program and approved by the Laboratory Director.

5.3.8.2. The Contractor shall ensure that requirements for routine quality control runs (as defined by the Laboratory Director and outlined in the Laboratory QA program), routine calibration, periodic calibration/calibration verification (i.e., each assay must be calibrated or have calibration verification performed at intervals not to exceed a 6-month period of time), specimen dilutions, and for troubleshooting of out-of-control assays be considered when calculating the yearly requirements.

5.3.8.3. The Contractor shall estimate the volume of user-replaceable maintenance items that will be required to support the analyzer, and any analyzer specific tools/supplies necessary to perform operator-level periodic maintenance tasks, at the level of use specified in Appendix 1. An operator level maintenance tool/spare parts kit will be provided, and replenishment of all expended items will be made by the contractor, at no additional cost to the Government. Replenishment shall be made as needed or on a periodic basis not to exceed the normal preventive maintenance cycle.

5.3.9. Reagents shall (must) have a minimum shelf life of six (6) months to a year upon receipt by the Government, or, if this shelf-life requirement cannot be met, the Contractor shall (must) identify the guaranteed shelf life after receipt that can be accommodated in their response to the Request for Proposal.

5.3.10. The Contractor shall sequester the required test reagents and ensure that no more than two (2) lot change for the analytes occurs per contract shipment. Assays shall (must) be stable enough to maintain a single control run per 24 hours of testing. Calibration frequency for all immunoassays shall not be less than once every thirty (30) days and that calibration frequency for all chemistry analyzers be illustrated by the vendor in a list. This calibration frequency does not include calibrations required following instrument repair or servicing (e.g., field service type maintenance or service, major changed in instrument components that affect readout, QC troubleshooting, etc.) or other instances as described in the Laboratory QA Program or approved by the Laboratory Director.

5.3.11. All reagents provided shall be identical to those used in the FDA 510K approval application. All reagents/reagent packs shall be provided as follows:

5.3.11.1. Be provided by the manufacturer of the equipment.

5.3.11.2. Be marked with the required storage temperature.

5.3.11.3. Be maintained at the proper storage temperature during transportation from the Contractor's storage facility to the Government acceptance site and be delivered on time at the appropriate storage temperature.

5.3.12. The Contractor shall provide the reagents/reagents packs, calibrators/standards, quality control materials, user-replaceable maintenance items, and analyzer specific tools/supplies as outlined in the Schedule of Supplies/Services.

5.3.13. Deliveries. Deliveries of required items shall be per monthly periodic orders and/or agreed upon shipment dates or emergent deliveries called in to the Contractor by the Contracting Officer as identified in the contract.

Orders shall arrive within one week of requested date of delivery. Any supplies that are placed on back order shall be clearly identified on the shipping documents and shall be delivered in a timely manner, not to exceed ten (10) working days. In the instance a back-order exceeds 10 working days, the Contractor shall provide testing services through local sub-contract at their cost.

5.3.13.1. Emergency orders shall be delivered within 24 hours after the order is placed and be of the same lot number of calibrators/standards, reagents/reagent packs currently in use for the assay(s) for which supplies are being requested.

5.3.14. Preservation and packing - Preservation and packing shall be performed in accordance with the best commercial practice and in such a manner to afford adequate protection against any damage during shipment from source to destination. All packaging and shipping information shall be clearly marked as to contents on both the shipping documents and the shipping container/box. All deliveries will be made Monday through Friday, to exclude Federal Holidays.

Deliveries will be sent to:

Raymond W. Bliss Army Health Center ATTN: Laboratory 2240 E Winrow Ave

BLDG 45001

Fort Huachuca, AZ 85613

5.4. Chemistry Analyzer MAINTENANCE AND SERVICE

5.4.1. Chemistry Analyzer MAINTENANCE. The Contractor shall be responsible for furnishing maintenance, services, repairs, and parts as required in order to maintain the systems in optimal operating condition.

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

5.4.1.2. The Contractor shall provide all personnel, equipment, tools, materials, supervision, parts, transportation, and other items and services necessary to perform all required repairs and scheduled preventive maintenance/safety inspections and calibrations of equipment. The performance of scheduled periodic preventive maintenance, safety checks, and calibrations that are not normally performed at the operator level shall be performed by Contractor service personnel in accordance with requirements as specified in the Contractor's instrument maintenance manual.

Completion of installation of the analyzers will establish time zero for determination of time frames for performance of the above periodic services.

5.4.1.3. The Contractor shall provide a full unscheduled and preventive maintenance service for the lease period at no additional cost. Service shall include repair and replacement of defective parts, complete maintenance program (as required by the manufacturer's maintenance manuals), and hotline telephone service, to assist operators in troubleshooting problems in accordance with section 5.4.3.1 of this SOW.

5.4.2. REPAIR. Upon notification of equipment failure, the Contractor's qualified service technician shall establish telephonic contact within 60 minutes of the Government notification to the Contractors Customer Service "Hotline" and shall be on-site to provide unlimited emergency service (service requiring immediate repair) within twenty-four

(24) hours of establishing telephonic contact. The equipment shall be repaired and operational within 48 hours after initial response by the Contractor. The Contractor shall provide replacement parts as necessary for operator level maintenance.

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

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

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

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

5.4.2.5. Preventive maintenance services shall be performed in accordance with the manufacturer's standards/procedures. A preventive maintenance service shall include, but is not limited to, safety, calibration, complete operational testing, lubrication, adjustments, and cleaning of equipment to which the operator does not have access. This also includes the installation of all non-operator parts required to ensure proper operation.

5.4.2.6. The Contractor shall notify the COR or Chemistry Technical Supervisor of the exact date and time for performance of a preventive maintenance service within ten (10) days prior to the scheduled preventive maintenance services.

5.4.2.7. Prior to performing Scheduled Maintenance and Unscheduled Repair Services work, the Contractor's representative shall report to the laboratory at Raymond W. Bliss Army Health Center and then be escorted to Security to get a visitors badge and then to Medical Maintenance to notify them what maintenance is being completed. The badge must be returned to security prior to departing the MTF.

5.4.2.8. Within one (1) working day after completion of a repair, the Contractor's representative shall furnish the chemistry supervisor, laboratory representative or COR one (1) copy of a service report for all services performed.

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

Nomenclature and serial number Date Description of services performed (i.e., preventive maintenance service, or unscheduled repair service) Location of services performed.

Duration of performance (hours) List of parts replaced, or other actions taken to restore operability of the instrument.

Name of technician

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

5.4.2.10. When required, the Contractor shall comply with the Occupational Safety and Health Administration lockout and tag out procedures while performing maintenance on electrical equipment.

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

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

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

5.4.3. SERVICE:

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

5.4.3.2. The Contractor shall perform Preventive Maintenance Services (PMS), safety tests, calibrations, and unscheduled repair services in accordance with procedures and practices prescribed by the manufacturer of the equipment.

5.4.3.3. The Contractor shall provide a full unscheduled and PMS throughout the contract. PMS shall be at no additional cost to the Government inclusive of all costs for the performance of scheduled periodic maintenance (as required by the Contractor's instrument maintenance manuals), unscheduled maintenance and repair of the analyzer and any associated equipment provided by the Contractor as part of the analyzer system, including replacement parts, replacement part shipment costs, and service technician travel costs for performance of maintenance services.

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

5.4.3.5. The Contractor's qualified service technician shall be on site to provide routine services; service requiring immediate repair; and one (1), two (2) or four (4) scheduled services for preventive maintenance (as specified in the Contractor's instrument maintenance manual), safety and calibration as required by this statement of work. The equipment shall be repaired and operational within 48 hours after initial response by the Contractor.

5.4.3.6. Upon analyzer failure, the Contractor's qualified service technician shall be on-site to provide unlimited emergency service (service requiring immediate repair; an unscheduled maintenance/service requirement). The Contractor's qualified service technician shall establish telephonic contact within 60 minutes of the Government notification to the Contractors Customer Service "Hotline" and shall be on-site to provide unlimited emergency service (service requiring immediate repair) within four (24) hours of establishing telephonic contact. The equipment shall be repaired and operational within 48 hours after initial response by the Contractor.

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

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

5.4.3.6.3. The Contractor's qualified service technician shall ensure all repairs are completed and the analyzer is fully operational prior to departing the lab. In addition, the service technician or Customer Service "Hotline" will verify the repairs corrected the problem and the analyzer is operational in a follow-up call. This call will be made in a timely fashion (not to exceed 48 hours) after the service technician departs the lab.

5.4.3.7. Should the analyzers become inoperable, the technical repair specialist shall be on-site as described in 5.4.3.6.

5.4.3.7.1. The Contractor's qualified service technician shall be on-site to provide unlimited emergency service as described in 5.4.3.6.

5.4.3.8.2. The repair of the analyzer must be completed within one business day of initial notification. If deemed necessary after consultation with the COR, if the analyzer cannot be repaired within two business days of the initial notification, the Government will ship all patients’ specimens to a College of American Pathologists accredited clinical laboratory and all…