Solicitation Amendment - W81K0025QA0650001.pdf

WOMEN-OWNED SMALL

BUSINESS (WOSB)

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

1. REQUISITION NUMBER PAGE 1 OF

2. CONTRACT NUMBER 3. AWARD/EFFECTIVE

DATE

4. ORDER NUMBER 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE

DATE

7. FOR SOLICITATION

INFORMATION CALL:

a. NAME b. TELEPHONE NUMBER (No collect 8. OFFER DUE DATE/

LOCAL TIME

9. ISSUED BY

13b. RATING

14. METHOD OF SOLICITATION

CODE

15. DELIVER TO 16. ADMINISTERED BY CODE

18a. PAYMENT WILL BE MADE BY CODE17a. CONTRACTOR/

OFFEROR

CODE

FACILITY

CODE

CODE

TELEPHONE NUMBER

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN

OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK

BELOW IS CHECKED

REQUEST

FOR QUOTE

(RFQ)

INVITATION

FOR BID

(IFB)

REQUEST

FOR

PROPOSAL

(RFP)

SEE ADDENDUM

19.

ITEM NUMBER

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Government Use Only)

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH

AND DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND

ON ANY ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS

SPECIFIED

29. AWARD OF CONTRACT: REFERENCE OFFER

DATED . . YOUR OFFER ON SOLICITATION

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR

30b. NAME AND TITLE OF SIGNER (Type or print) 30c. DATE SIGNED

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

31b. NAME OF CONTRACTING OFFICER (Type or print) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 11/2021)

Prescribed by GSA - FAR (48 CFR) 53.212

10. THIS ACQUISITION IS UNRESTRICTED OR

NORTH AMERICAN

INDUSTRY CLASSIFICATION

STANDARD (NAICS):

SIZE STANDARD:

13a. THIS CONTRACT IS A

RATED ORDER UNDER

THE DEFENSE PRIORITIES

AND ALLOCATIONS

SYSTEM - DPAS (15 CFR 700)

SET ASIDE: % FOR:

11. DELIVERY FOR FREE ON

BOARD (FOB) DESTINATION

UNLESS BLOCK IS MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

ARE ARE NOT ATTACHED

ARE ARE NOT ATTACHED

27a. SOLICITATION INCORPORATES BY REFERENCE (FEDERAL ACQUISITION REGULATION) FAR 52.212-1, 52.212-4. FAR 52.212-3

AND 52.212-5 ARE ATTACHED. ADDENDA

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

8(A)

ECONOMICALLY

DISADVANTAGED

WOMEN-OWNED SMALL

BUSINESS (EDWOSB)

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

(SDVOSB)

HUBZONE SMALL

BUSINESS

SMALL BUSINESS

NOTE: OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, AND 30.

calls)

Solicitation/Contract Form Continuation

Cost Per Test: Blood Bank Reagent Testing Supplies for Transfusion Services

W81K0025QA0650001

Continuation of Supplies or Services and Prices/Costs

Additional Information/Notes

Item Supplies/Service Quantity Unit Unit Price Amount

MTS080515 MTS/A/B/D MONO&REV GRP5X20

Color: Any color Pricing Arrangement: Firm Fixed Price

48 Package

MTS084024 MTS ANTI-IGG CARD 5X20

Color: Any color Pricing Arrangement: Firm Fixed Price

30 Package

MTS085014 MTS BUFFRD GEL CARD 5X20

Color: Any color Pricing Arrangement: Firm Fixed Price

6 Package

MTS ROUND DIL2 100ML/5BTLS

Color: Any color Pricing Arrangement: Firm Fixed Price

6 Package

MTS ROUND DIL2+ 100ML/5BTLS

Color: Any color Pricing Arrangement: Firm Fixed Price

6 Package

ORTHO 7% BSA

Color: Any color Product Service Code: 6550 Pricing Arrangement: Firm Fixed Price

25 Package

OV SINGLE USE DILUTION TRAY

Color: Any color Pricing Arrangement: Firm Fixed Price

3 Each

0.8 % AFFIRMAGEN 2X10ML

Color: Any color Pricing Arrangement: Firm Fixed Price

78 Each

0.8 % RESOLVE A 11X3ML

Color: Any color Pricing Arrangement: Firm Fixed Price

26 Each

ALBA Q CHEK SWB CONTROLS

Color: Any color Pricing Arrangement: Firm Fixed Price

52 Each

FETAL SCREEN II FMH KIT

Color: Any color Pricing Arrangement: Firm Fixed Price

13 Each

ORTHO CONFIDENCE SYSTEM

Color: Any color Product Service Code: 6550 Pricing Arrangement: Firm Fixed Price

13 Each

0.8% SURG 3X10ML

Color: Any color Pricing Arrangement: Firm Fixed Price

78 Each

6843005 OV Single Use Evaporation Caps

Color: Any color Pricing Arrangement: Firm Fixed Price

1 Each

6904553 Anti-D (Weak D) 1x5ml GEL

Color: Any color Pricing Arrangement: Firm Fixed Price

1 Each

Ortho Daily QC

Color: Any color Pricing Arrangement: Firm Fixed Price

44 Each

Option Line Item

MTS080515 MTS/A/B/D MONO&REV GRP5X20

Color: Any color Pricing Arrangement: Firm Fixed Price

48 Package

Option Line Item

MTS084024 MTS ANTI-IGG CARD 5X20

Color: Any color Pricing Arrangement: Firm Fixed Price

30 Package

Option Line Item

MTS085014 MTS BUFFRD GEL CARD 5X20

Color: Any color Pricing Arrangement: Firm Fixed Price

6 Package

Option Line Item

MTS ROUND DIL2 100ML/5BTLS

6 Package

Option Line Item

MTS ROUND DIL2+ 100ML/5BTLS

Color: Any color Pricing Arrangement: Firm Fixed Price

6 Package

Option Line Item

ORTHO 7% BSA

Color: Any color Product Service Code: 6550 Pricing Arrangement: Firm Fixed Price

25 Package

Option Line Item

OV SINGLE USE DILUTION TRAY

Color: Any color Pricing Arrangement: Firm Fixed Price

3 Each

Option Line Item

0.8 % AFFIRMAGEN 2X10ML

Color: Any color Pricing Arrangement: Firm Fixed Price

78 Each

Option Line Item

0.8 % RESOLVE A 11X3ML

Color: Any color Pricing Arrangement: Firm Fixed Price

26 Each

Option Line Item

ALBA Q CHEK SWB CONTROLS

Color: Any color Pricing Arrangement: Firm Fixed Price

52 Each

Option Line Item

FETAL SCREEN II FMH KIT

Color: Any color Pricing Arrangement: Firm Fixed Price

13 Each

Option Line Item

ORTHO CONFIDENCE SYSTEM

Color: Any color Product Service Code: 6550 Pricing Arrangement: Firm Fixed Price

13 Each

Option Line Item

0.8% SURG 3X10ML

Color: Any color Pricing Arrangement: Firm Fixed Price

78 Each

Option Line Item

6843005 OV Single Use Evaporation Caps

Color: Any color Pricing Arrangement: Firm Fixed Price

1 Each

Option Line Item

6904553 Anti-D (Weak D) 1x5ml GEL

Color: Any color Pricing Arrangement: Firm Fixed Price

1 Each

Option Line Item

Ortho Daily QC

Color: Any color Product Service Code: 6550 Pricing Arrangement: Firm Fixed Price

44 Each

Option Line Item

MTS080515 MTS/A/B/D MONO&REV GRP5X20

Color: Any color Pricing Arrangement: Firm Fixed Price

48 Package

Option Line Item

MTS084024 MTS ANTI-IGG CARD 5X20

Color: Any color Pricing Arrangement: Firm Fixed Price

30 Package

Option Line Item

MTS085014 MTS BUFFRD GEL CARD 5X20

Color: Any color Pricing Arrangement: Firm Fixed Price

6 Package

Option Line Item

MTS ROUND DIL2 100ML/5BTLS

Color: Any color Pricing Arrangement: Firm Fixed Price

6 Package

Option Line Item

MTS ROUND DIL2+ 100ML/5BTLS

Color: Any color Pricing Arrangement: Firm Fixed Price

6 Package

Option Line Item

ORTHO 7% BSA

Color: Any color Product Service Code: 6550 Pricing Arrangement: Firm Fixed Price

25 Package

OV SINGLE USE DILUTION TRAY

Color: Any color Pricing Arrangement: Firm Fixed Price

3 Each

Option Line Item

0.8 % AFFIRMAGEN 2X10ML

Color: Any color Pricing Arrangement: Firm Fixed Price

78 Each

Option Line Item

0.8 % RESOLVE A 11X3ML

Color: Any color Pricing Arrangement: Firm Fixed Price

26 Each

Option Line Item

ALBA Q CHEK SWB CONTROLS

Color: Any color Pricing Arrangement: Firm Fixed Price

52 Each

Option Line Item

FETAL SCREEN II FMH KIT

Color: Any color Pricing Arrangement: Firm Fixed Price

13 Each

Option Line Item

ORTHO CONFIDENCE SYSTEM

Color: Any color Product Service Code: 6550 Pricing Arrangement: Firm Fixed Price

13 Each

Option Line Item

0.8% SURG 3X10ML

Color: Any color Pricing Arrangement: Firm Fixed Price

78 Each

Option Line Item

6843005 OV Single Use Evaporation Caps

Color: Any color Pricing Arrangement: Firm Fixed Price

1 Each

Option Line Item

6904553 Anti-D (Weak D) 1x5ml GEL

Color: Any color Pricing Arrangement: Firm Fixed Price

1 Each

Option Line Item

Ortho Daily QC

44 Each

Product Service Code: 6550 Pricing Arrangement: Firm Fixed Price

Option Line Item

MTS080515 MTS/A/B/D MONO&REV GRP5X20

Color: Any color Pricing Arrangement: Firm Fixed Price

48 Package

Option Line Item

MTS084024 MTS ANTI-IGG CARD 5X20

Color: Any color Pricing Arrangement: Firm Fixed Price

30 Package

Option Line Item

MTS085014 MTS BUFFRD GEL CARD 5X20

Color: Any color Pricing Arrangement: Firm Fixed Price

6 Package

Option Line Item

MTS ROUND DIL2 100ML/5BTLS

Color: Any color Pricing Arrangement: Firm Fixed Price

6 Package

Option Line Item

MTS ROUND DIL2+ 100ML/5BTLS

Color: Any color Pricing Arrangement: Firm Fixed Price

6 Package

Option Line Item

ORTHO 7% BSA

Color: Any color Product Service Code: 6550 Pricing Arrangement: Firm Fixed Price

25 Package

Option Line Item

OV SINGLE USE DILUTION TRAY

Color: Any color Pricing Arrangement: Firm Fixed Price

3 Each

Option Line Item

0.8 % AFFIRMAGEN 2X10ML

Color: Any color Pricing Arrangement: Firm Fixed Price

78 Each

Option Line Item

0.8 % RESOLVE A 11X3ML

Color: Any color Pricing Arrangement: Firm Fixed Price

26 Each

ALBA Q CHEK SWB CONTROLS

Color: Any color Pricing Arrangement: Firm Fixed Price

52 Each

Option Line Item

FETAL SCREEN II FMH KIT

Color: Any color Pricing Arrangement: Firm Fixed Price

13 Each

Option Line Item

ORTHO CONFIDENCE SYSTEM

Color: Any color Product Service Code: 6550 Pricing Arrangement: Firm Fixed Price

13 Each

Option Line Item

0.8% SURG 3X10ML

Color: Any color Pricing Arrangement: Firm Fixed Price

78 Each

Option Line Item

6843005 OV Single Use Evaporation Caps

Color: Any color Pricing Arrangement: Firm Fixed Price

1 Each

Option Line Item

6904553 Anti-D (Weak D) 1x5ml GEL

Color: Any color Pricing Arrangement: Firm Fixed Price

1 Each

Option Line Item

Ortho Daily QC

Color: Any color Product Service Code: 6550 Pricing Arrangement: Firm Fixed Price

44 Each

Option Line Item

MTS080515 MTS/A/B/D MONO&REV GRP5X20

Color: Any color Pricing Arrangement: Firm Fixed Price

48 Package

Option Line Item

MTS084024 MTS ANTI-IGG CARD 5X20

Color: Any color Pricing Arrangement: Firm Fixed Price

30 Package

MTS085014 MTS BUFFRD GEL CARD 5X20

Color: Any color Pricing Arrangement: Firm Fixed Price

6 Package

Option Line Item

MTS ROUND DIL2 100ML/5BTLS

Color: Any color Pricing Arrangement: Firm Fixed Price

6 Package

Option Line Item

MTS ROUND DIL2+ 100ML/5BTLS

Color: Any color Pricing Arrangement: Firm Fixed Price

6 Package

Option Line Item

ORTHO 7% BSA

Color: Any color Product Service Code: 6550 Pricing Arrangement: Firm Fixed Price

25 Package

Option Line Item

OV SINGLE USE DILUTION TRAY

Color: Any color Pricing Arrangement: Firm Fixed Price

3 Each

Option Line Item

0.8 % AFFIRMAGEN 2X10ML

Color: Any color Pricing Arrangement: Firm Fixed Price

78 Each

Option Line Item

0.8 % RESOLVE A 11X3ML

Color: Any color Pricing Arrangement: Firm Fixed Price

26 Each

Option Line Item

ALBA Q CHEK SWB CONTROLS

Color: Any color Pricing Arrangement: Firm Fixed Price

52 Each

Option Line Item

FETAL SCREEN II FMH KIT

Color: Any color Pricing Arrangement: Firm Fixed Price

13 Each

Option Line Item

ORTHO CONFIDENCE SYSTEM

Color: Any color 13 Each

Option Line Item

0.8% SURG 3X10ML

Color: Any color Pricing Arrangement: Firm Fixed Price

78 Each

Option Line Item

6843005 OV Single Use Evaporation Caps

Color: Any color Pricing Arrangement: Firm Fixed Price

1 Each

Option Line Item

6904553 Anti-D (Weak D) 1x5ml GEL

Color: Any color Pricing Arrangement: Firm Fixed Price

1 Each

Option Line Item

Ortho Daily QC

Color: Any color Product Service Code: 6550 Pricing Arrangement: Firm Fixed Price

44 Each

Continuation of Description

STATEMENT OF OBJECTIVE

Blood Bank Reagent Testing Supplies in Support of Bayne-Jones Army Community Hospital(BJACH) Fort Johnson, Louisiana

Dated: 10 April 2025

1.GENERAL REQUIREMENTS:

1.1.SCOPE OF WORK: The Contractor shall provide Blood Bank Reagents (including equipment, maintenance, and support at no extra cost to the Government) testing supplies in support of Bayne-Jones Army Community Hospital(BJACH) Fort Johnson, Louisiana. 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 Objective (SOO).

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 Government POC/Contract Officers Representative (COR) for acceptance not later than 10 days the start of the contract AFTER (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 andmaintenance services listed on the Performance Requirements Summary (PRS)listed in Description shall include specifics as to the areasto be inspected on both a scheduled and unscheduled basis, table 5.2.

frequency ofinspections, and the title and organizational placement of the inspectors.Additionally, control procedures for any Government provided keys or lockcombinations shall be included.

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

1.2.1.1.3.A description of the records to be kept to document inspections and correctiveor preventive actions taken. NOTE: The records of inspections shall be kept andmade available to the Government throughout the contract ordering period andfor the period after contract completion until final settlement of any claims,if any, under this contract.

1.2.2. Quality Assurance (QA).

Governmentpersonnel will record surveillance observations, as needed, and provide to theContractor. The receipt of the observation does not necessarily constituteconcurrence with the observation, only acknowledgment that the Contractor hasbeen made aware of the unacceptable performance. Such surveillance will be doneaccording to standard inspection procedures or other contract provisions. Anyaction taken by the Contracting Officer as a result of surveillance will beaccording 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 Government POC/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.The Transfusion Services is open 24 hours per day, 7 days a week.

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

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

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

New Year's Day 1January

Martin Luther King's Birthday Third Monday inJanuary

President's Day Third Monday in February

Memorial Day Last Monday in May

Juneteenth 19 June

Independence Day 4July

Labor Day First Monday in September

Columbus Day Second Monday in October

Veteran's Day 11November

Thanksgiving Day Fourth Thursday in November

Christmas Day 25December

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 Contractorshall make sure employees practice utilities conservation. The Contractor shallbe responsible for operating under conditions that prevent the waste ofutilities 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 orbyproduct of the analyzers cannot be safely dumped into each of the facility'sdrain system, the Contractor must provide guidelines for safely disposing thesewastes or byproducts in accordance with local and national guidelines.

1.5.RECORDS.

TheContractor shall maintain all records necessary to comply with regulatoryrequirements and Food and Drug Administration (FDA) standards. The Contractorshall be responsible for creating and maintaining those Government requiredrecords that are specifically cited in this SOO or required by the provisionsof a mandatory directive listed in section 5.4, Applicable Publications andForms. If requested by the Government, the Contractor shall provide theoriginal record or a reproducible copy of any such record within 5 working daysof receipt of the request.

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

1.7.UPGRADE OF EQUIPMENT. Subject to mutual agreement betweenthe Government and the Contractor, instrumentation may be upgraded within thespecifications of the contract as new technology may become available.Additionally, the Government will add reagents through the life of thiscontract as a result of advances in technology or changes to clinical practicestandards. Any such change to the reagents or equipment shall be mutuallyagreed 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 tothe applicable Safety and Health Standards as indicated in the current code offederal Regulations, Title 29, Chapter XVII, paragraph 1910, Occupational SafetyHealth Act of 1970.

1.9.CONTRACTOR PERSONNEL.

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

1.9.1.1.Contractor employees shall present a neat appearance and be easily recognizedas Contractor employees. Contractor personnel shall either wear adistinguishable uniform or badge on the exterior of their clothing whileperforming any service at any Government facility.

1.9.1.2.The Contractor shall not employ any person who is an employee of the USGovernment. Additionally, the Contractor shall not employ any person who is anemployee of the Department of Defense, either military or civilian, unless suchperson seeks and receives approval according to DOD 5500.7R, "Joint EthicsRegulation". The Contractor shall not employ any person who is an employeeof the Department of Defense, if such employment would be contrary to localpolicies.

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 determinationsand findings.

2.1.2.GOVERNMENT POINT OF CONTACT (POC)/CONTRACTING OFFICER'S REPRESENTATIVE (COR): AGovernment employee selected and designated in writing by the ContractingOfficer to act as his/her designated representative in administering acontract. NOTE: The Government POC/COR is not authorized to make any changes tothe terms and conditions of the contract.

2.1.3.QUALITY ASSESSMENT AND IMPROVEMENT. Those actions taken by the Government tocheck 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 riskmanagement programs, and ensure compliance with the terms and conditions of thecontract.

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

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

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

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

AR ArmyRegulation

Government POC/COR Government POC/Contracting Officer'sRepresentative

CAP College of American Pathologists

DA Department of the Army

DODCLIP Department of Defense Clinical LaboratoryImprovement Program

HIPAA Health Insurance Portability & Accountability Act of1996

MAS Minimum Acceptable Standards

MEDCOM U.S. Army MedicalCommand

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

SOO Statement of Objective

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

TheGovernment will provide, without additional cost to the Contractor, thefacilities, equipment, materials, and services listed below.

3.1.FACILITIES. The Government will furnish the facilities for set-up and operationof the Contractor equipment analyzers required in support of the SOO.Contractor shall not alter the facility without prior approval from thecontracting officer. The Contractor shall return the facilities to theGovernment in the same condition as received, fair wear and tear and approvedmodifications excepted. These facilities shall be used for performance of thiscontract only.

12.EQUIPMENT. The government will provide an existing water purification systemmeeting requirements of the contractor's Blood Bank analyzer.

3.2.MATERIALS. No materials will be provided.

3.3.SERVICES. The Government will provide the following services at no cost to theContractor:

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

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

3.3.3.Emergency Healthcare for Contractor employees. The MTF will provide emergencyhealth care for injuries or life-threatening medical emergencies occurringwhile on duty. The Contractor shall reimburse the Government for such servicesas billed by the MTF, unless the Contractor employee is otherwise authorized toreceive such services at no cost (e.g., is retired military or is a militarydependent).

4. CONTRACTOR FURNISHED PROPERTY

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

4.2.Transportation. Transportation in support of any equipment and incidentalsupport and maintenance services is the responsibility of the Contractor.

TheGovernment 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-accessblood bank analyzer system capable of performing all of the required assayslisted in Appendix 1. The analyzer systems will be from a single Contractor. The contract for the analyzer will be for thePeriod of Performance of 01 OCT 2025 to 31 MAR 2030. Base Year: 01 OCT 2025 -31SEP 2026; Option year 1: 01 OCT 2026 -31 SEP 2027; Option year 2:

01 OCT 2027-31 SEP 2028; Option year 3: 01 OCT 2028 -31 SEP 2029; Option year 4: 01 OCT2029 -31 SEP 2030. The system shall provide redundancy (to ensurecontinuous operations), training, supplies, reagents, unscheduled maintenance,and preventive maintenance for the equipment.

All equipment displays andsupporting literature must be in the English language. Contractor shall includedelivery, installation, all calibrators /standards, reagents/reagent packs, andquality control materials necessary to perform the specified assays, initialMethod Validations per CLSI QM guidelines and analyzer removal at thetermination 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 listedfor each Mandatory Test or Desired Test listed on

Costs shallbe amortized over the total number of tests described in this SOO and factoredinto the cost per reportable or test.Appendix 1.

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

-Any and all analyzers

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

5.1.1.2.The analyzer system will be located at:

BayneJones Army Community Hospital

Departmentof Pathology

15853rd St

Fort Johnson, LA 71459

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

5.1.3.Method Validation will be conducted in accordance with method validationprotocols established by the Laboratory's Quality Management Program (theseprotocols are in concordance with applicable standards as described by theClinical Laboratory Standards Institute (CLSI) and/or required by the Collegeof American Pathologists (CAP). Relevant guidelines listed are the minimumguidelines 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 rangeverification, demonstration of linearity with limit of quantitationverification (LOQ), limit of detection verification (LOD), reportable range,correlation with current methods (comparison of methods study), validation ofanalytical measurement range (AMR), validation of clinical reportable range(CRR), validation of precision (replication study) and accuracy (recoverystudy), and establishment of initial control ranges using control materials, toinclude 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(r)), 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'sand Maintenance manuals and a statement of the warranty terms in the Englishlanguage. The level of detail required of appropriate instrument maintenancemanuals extends only to routine maintenance procedures performed by the user.All instrumentation specified is non-Government owned leased equipment that isserviced and maintained by the Contractor.

5.1.5.The Contractor shall provide the reagents and shall coordinate exact quantitiesand shipment schedule with the Government POC/COR prior to shipment IAW Section5.3.13, Deliveries (below).

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

5.2. ANALYZERS:

5.2.1.Individual analyzers must have fully automated, discrete random-accesscapabilities. There must be a procedureto allow priority analysis of STAT specimens.

5.2.2.The analyzer must provide results for all testing capabilities listed in Table1. The analyzer must have the on-board ability to maintain reagents at theproper storage temperatures for the assays listed in Table 1. The analyzer must be able utilize andinterpret reagent test cards containing gel card technology.

5.2.3.The system must continually monitor volumes and expiration for all on-boardreagents, providing a warning and testing lockout for reagents that areexpired.

5.2.4.Each analyzer must be capable of performing in low, medium, and high-volumework periods to produce results that are accurate and precise throughout themanufacturer's stated analytical measurement range.

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

5.2.6.Each analyzer must come equipped with an un-interruptible power supply (UPS)capable of providing all necessary electrical power to each analyzer system, toinclude the data management system, for 15 to 20 minutes after loss of power. Further, electrical line conditioners must beprovided to support each analyzer if determined necessary upon evaluation ofthe local facilities.

5.2.7.Each analyzer and all associated reagents shall be approved by the Food &Drug Administration (FDA). All analyzers and associated parts and accessoriesshall be new. No used, refurbished, or like-new equipment shall be provided insupport of this contract at any time.

5.2.8.All assays/reagents outlined in Table 1 must be available directly through theContractor or through use of open-channel systems with third party vendorreagents. Reagents that are notmanufactured by the Contractor must be provided through alternative means bythe Contractor, to include any reagents, calibrators, controls, or otherrequired reagents.

5.2.9All computer systems connecting to the network and MHS-GENESIS must be RMFcompliant, have an authority to operate (ATO) and be Health InsurancePortability and Accountability Act (HIPAA) compliant. Government continuity and continued service encompassing current requires instrument platforms onor before 1 October 2024.

TABLE 1. Mandatory Tests

MANDATORY TESTS

ABORh Testing (Patients & Units)

Antibody Screen

CORD

Direct Antiglobulin Testing

Weak D

AHG Crossmatches

5.3. REAGENTS.

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

All assaysmust be FDA approved.

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

5.3.1.1.1.The actual workload may fluctuate in the first year of the contract due tochanges in the distribution of patient care. In addition, workload may expandin subsequent option years due to fluctuations in patient volume. Appendix 1provides the estimated workload for Contract Year 1 as well as an estimatedworkload for each option year. All workload numbers represent total estimatedpatient 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 aswell as serum samples. In addition, the Contractor shall clearly demonstrate anacceptable correlation, as defined in section 5.1.3 between plasma and serumvalues during the initial set up and correlation studies.

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

5.3.4.The Contractor shall optimize the specific arrangement of the reagents/reagentpacks for assays that are routinely maintained on the analyzer during theinitial installation of the analyzer and when a new assay is added to the testmenu. The Contractor shall (must) ensure that all required reagents/reagentspacks are accounted for in the loading plan for the assays that are routinelymaintained on the analyzer (assays to be routinely maintained on the analyzerswill be specified at the time ofinstallation).

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

5.3.6.The Contractor shall optimize the specific arrangement of the reagents/reagentpacks for assays that are routinely maintained on the analyzer during theinitial installation of the analyzer and when a new assay is added to the testmenu. The Contractor shall (must) ensure that all required reagents/reagentspacks are accounted for in the loading plan for the assays that are routinelymaintained on the analyzer (assays to be routinely maintained on the analyzerswill be specified at the time ofinstallation).

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

5.3.7.1.The Contractor shall provide quality control materials including third partycontrols IAW requirements outlined in the Laboratory QA program and approved bythe Laboratory Director.

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

5.3.7.3.The Contractor shall estimate the volume of user-replaceable maintenance itemsthat will be required to support the analyzer, and any analyzer specifictools/supplies necessary to perform operator-level periodic maintenance tasks,at the level of use specified in Appendix 1. An operator level maintenancetool/spare parts kit will be provided, and replenishment of all expended itemswill 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 thenormal preventive maintenance cycle.

5.3.8.Reagents shall (must) have a minimum shelf life of six (6) months to a yearupon receipt by the Government, or, if this shelf-life requirement cannot bemet, the Contractor shall (must) identify the guaranteed shelf life afterreceipt that can be accommodated in their response to the Request for Proposal.For the reagents that have short shelf lives. The contractor shall provide andfollow the schedule of delivery to ensure the government receives new shipmentsof reagents before the old ones expire.

5.3.9.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 24hours of testing.

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

5.3.10.1.Be provided by the manufacturer of the equipment.

5.3.10.2.Be marked with the required storage temperature.

5.3.10.3.Be maintained at the proper storage temperature during transportation from theContractor's storage facility to the Government acceptance site and bedelivered on time at the appropriate storage temperature.

5.3.11.The Contractor shall provide the reagents/reagents packs,calibrators/standards, quality control materials, user-replaceable maintenanceitems, and analyzer specific tools/supplies as outlined in the Schedule ofSupplies/Services.

5.3.12.Deliveries. Deliveries of required items shall be per monthly periodic ordersand/or agreed upon shipment dates or emergent deliveries called in to theContractor by the Contracting Officer as identified in the contract. Ordersshall arrive within one week of requested date of delivery. Any supplies thatare placed on back order shall be clearly identified on the shipping documentsand 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 shallprovide testing services through local sub-contract at their cost.

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

5.3.13.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 be clearly shall 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:

Bayne Jones Army Community Hospital

Department of Pathology

15853rd St

Fort Johnson, LA 71459

5.4. MAINTENANCE AND SERVICE

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

5.4.1.1.The Contractor shall maintain all equipment installed under this contractexcept for repairs necessitated by willful damage or negligence on the part ofthe 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 SOO.

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 Government POC/COR or Blood Bank 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 visitor's 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 Blood Bank supervisor, laboratory representative or Government POC/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.

- Nameof 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 NFPA99, 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 and on-call emergency repair service support, to assist operators in correcting equipment operation problems.English)

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 0800-1630 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 60minutes 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 48hours 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-upcall. 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.

5.4.3.7.2.The repair of the analyzer must be completed within one business day of initial notification. If deemed necessary after consultation with the Government POC/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 additional costs will be reimbursed by the Contractor.

5.4.3.8.If the equipment is out of service for longer than two business days hours(from the time-of-service technician's arrival on site), the Contractor shall notify the Government POC/COR in writing as to the reason(s) (i.e., non-availability of parts, etc.) for non-compliance.

5.4.3.9.The Contractor shall provide all necessary user-replaceable maintenance items required to support the analyzer and any analyzer specific tools /supplies necessary to perform operator-level periodic maintenance tasks, at no additional cost to the Government.

5.4.3.10.The Government will make the equipment available to the Contractor for servicing at such time and duration necessary to perform needed repairs.

5.5. TRAINING:

5.5.1. The Contractor shall provide initial on-site operator training to all technicians assigned to the Government site (i.e., BJACH Laboratory staff) prior to initiation of use of the analyzer for patient testing. In addition, the Contractor shall provide training for two (2) primary operators for the analyzer at the Contractor's training site, prior to delivery and installation of the analyzer at no cost to the Government.

5.5.1.1The on-site operator training shall be provided by qualified Contractor trained personnel. The training shall encompass basic operation, maintenance and troubleshooting.

5.5.2.The…