HT940825R0003 P0003.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of this amendment is to:

A. Amend Statement Objectives and CLIN descriptions.

B. Extend closing date.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 14

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

16C. DATE SIGNED

BY 30-Jan-2025

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X HT940825R0003

X 9B. DATED (SEE ITEM 11)

13-Dec-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 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

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

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

30-Jan-2025

CODE

DHA CONTRACTING OFFICE SA HT9408

7800 W IH-10

STE 235

SAN ANTONIO TX 78230

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

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

HT940825R0003

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SOLICITATION/CONTRACT FORM

The required response date/time has changed from 31-Jan-2025 10:00 AM to 06-Feb-2025 10:00 AM.

SUPPLIES OR SERVICES AND PRICES

CLIN 0001

The CLIN extended description has changed from:

Hematology equipment to include equipment, maintenance, supplies/reagents.One (1) Hematology system with two

(2) functioning analyzer, slide maker stainer, digital cell morphology system, with advanced red blood cell morphology software Met via a Cost Per Reportable Result (CPRR). Approximately 2,500 per month, but no more than 31,000 annually, Complete Blood Counts (CBC) with at least a 6-part differential and approximately 125, but no more than 1,500 annually, reticulocyte panels. The Government will pay a set monthly price, provided the actual number of results does not exceed these quantities per year. Service coverage for instruments: Preventative maintenance and 24/7 technical support along with all replacement parts, supplies and labor included at no additional charge.

Response to service needs provided not later than 24 hours and resolution/completed repairs not later than 48 hours from report of service need or receipt of replacement parts within standard business hours (5 days, 8 hours). If both analyzers are down, service personnel must be on-site within 4 hours of initial notification.Of the 31,000 CBC test, expect at least 25% (7,750) for IPF. Initial training for two key operators and additional training, upon request, for one operator per year per instrument (on-site, off-site, e-Learning, and Virtual Instructor Led Training) is included at no additional cost.Base Period of Performance: 01 APR 2025 - 31 MAR 2026

To:

Hematology equipment to include equipment, maintenance, supplies/reagents.One (1) Hematology system with two

(2) functioning analyzer, slide maker stainer, digital cell morphology system, with advanced red blood cell morphology software Met via a Cost Per Reportable Result (CPRR). Approximately 2,500 per month, but no more than 31,000 annually, Complete Blood Counts (CBC) with at least a 6-part differential and approximately 125, but no more than 1,500 annually, reticulocyte or equivalent panels.

The Government will pay a set monthly price, provided the actual number of results does not exceed these quantities per year. Service coverage for instruments: Preventative maintenance and 24/7 technical support along with all replacement parts, supplies and labor included at no additional charge. Response to service needs provided not later than 24 hours and resolution/completed repairs not later than 48 hours from report of service need or receipt of replacement parts within standard business hours (5 days, 8 hours). If both analyzers are down, service personnel must be on-site within 4 hours of initial notification.Initial training for two key operators and additional training, upon request, for one operator per year per instrument (on-site, off-site, e-Learning, and Virtual Instructor Led Training) is included at no additional cost.Base Period of Performance: 01 APR 2025 - 31 MAR 2026

CLIN 1001

Hematology equipment to include equipment, maintenance, supplies/reagents.One (1) Hematology system with two

(2) functioning analyzer, slide maker stainer, digital cell morphology system, with advanced red blood cell morphology software Met via a Cost Per Reportable Result (CPRR). Approximately 2,500 per month, but no more than 31,000 annually, Complete Blood Counts (CBC) with at least a 6-part differential and approximately 125, but no more than 1,500 annually, reticulocyte panels. The Government will pay a set monthly price, provided the actual number of results does not exceed these quantities per year. Service coverage for instruments: Preventative maintenance and 24/7 technical support along with all replacement parts, supplies and labor included at no additional charge.

Response to service needs provided not later than 24 hours and resolution/completed repairs not later than 48 hours from report of service need or receipt of replacement parts within standard business hours (5 days, 8 hours). If both analyzers are down, service personnel must be on-site within 4 hours of initial notification.Of the 31,000 CBC test, expect at least 25% (7,750) for IPF. Initial training for two key operators and additional training, upon request, for one operator per year per instrument (on-site, off-site, e-Learning, and Virtual Instructor Led Training) is included at no additional cost.1st Option Period of Performance: 01 APR 2026 - 31 MAR 2027

Hematology equipment to include equipment, maintenance, supplies/reagents.One (1) Hematology system with two

(2) functioning analyzer, slide maker stainer, digital cell morphology system, with advanced red blood cell morphology software Met via a Cost Per Reportable Result (CPRR). Approximately 2,500 per month, but no more than 31,000 annually, Complete Blood Counts (CBC) with at least a 6-part differential and approximately 125, but no more than 1,500 annually, reticulocyte or equivalent panels.

The Government will pay a set monthly price, provided the actual number of results does not exceed these quantities per year. Service coverage for instruments: Preventative maintenance and 24/7 technical support along with all replacement parts, supplies and labor included at no additional charge. Response to service needs provided not later than 24 hours and resolution/completed repairs not later than 48 hours from report of service need or receipt of replacement parts within standard business hours (5 days, 8 hours). If both analyzers are down, service personnel must be on-site within 4 hours of initial notification.Initial training for two key operators and additional training, upon request, for one operator per year per instrument (on-site, off-site, e-Learning, and Virtual Instructor Led Training) is included at no additional cost.1st Option Period of Performance: 01 APR 2026 - 31 MAR 2027

CLIN 2001

Hematology equipment to include equipment, maintenance, supplies/reagents.One (1) Hematology system with two

(2) functioning analyzer, slide maker stainer, digital cell morphology system, with advanced red blood cell morphology software Met via a Cost Per Reportable Result (CPRR). Approximately 2,500 per month, but no more than 31,000 annually, Complete Blood Counts (CBC) with at least a 6-part differential and approximately 125, but no more than 1,500 annually, reticulocyte panels. The Government will pay a set monthly price, provided the actual number of results does not exceed these quantities per year. Service coverage for instruments: Preventative maintenance and 24/7 technical support along with all replacement parts, supplies and labor included at no additional charge.

Response to service needs provided not later than 24 hours and resolution/completed repairs not later than 48 hours from report of service need or receipt of replacement parts within standard business hours (5 days, 8 hours). If both analyzers are down, service personnel must be on-site within 4 hours of initial notification.Of the 31,000 CBC test, expect at least 25% (7,750) for IPF. Initial training for two key operators and additional training, upon request, for one operator per year per instrument (on-site, off-site, e-Learning, and Virtual Instructor Led Training) is included at no additional cost. 2nd Option Period of Performance: 01 APR 2027 - 31 MAR 2028

Hematology equipment to include equipment, maintenance, supplies/reagents.One (1) Hematology system with two

(2) functioning analyzer, slide maker stainer, digital cell morphology system, with advanced red blood cell morphology software Met via a Cost Per Reportable Result (CPRR). Approximately 2,500 per month, but no more than 31,000 annually, Complete Blood Counts (CBC) with at least a 6-part differential and approximately 125, but no more than 1,500 annually, reticulocyte or equivalent panels.

The Government will pay a set monthly price, provided the actual number of results does not exceed these quantities per year. Service coverage for instruments: Preventative maintenance and 24/7 technical support along with all replacement parts, supplies and labor included at no additional charge. Response to service needs provided not later than 24 hours and resolution/completed repairs not later than 48 hours from report of service need or receipt of replacement parts within standard business hours (5 days, 8 hours). If both analyzers are down, service personnel must be on-site within 4 hours of initial notification.Initial training for two key operators and additional training, upon request, for one operator per year per instrument (on-site, off-site, e-Learning, and Virtual Instructor Led Training) is included at no additional cost.

2nd Option Period of Performance: 01 APR 2027 - 31 MAR 2028

CLIN 3001

Hematology equipment to include equipment, maintenance, supplies/reagents.One (1) Hematology system with two

(2) functioning analyzer, slide maker stainer, digital cell morphology system, with advanced red blood cell morphology software Hematology equipment to include equipment, maintenance, supplies/reagents.One (1) Hematology system with two (2) functioning analyzer, slide maker stainer, digital cell morphology system, with advanced red blood cell morphology software Met via a Cost Per Reportable Result (CPRR). Approximately 2,500 per month, but no more than 31,000 annually, Complete Blood Counts (CBC) with at least a 6-part differential and approximately 125, but no more than 1,500 annually, reticulocyte panels. The Government will pay a set monthly price, provided the actual number of results does not exceed these quantities per year. Service coverage for instruments: Preventative maintenance and 24/7 technical support along with all replacement parts, supplies and labor included at no additional charge. Response to service needs provided not later than 24 hours and resolution/completed repairs not later than 48 hours from report of service need or receipt of replacement parts within standard business hours (5 days, 8 hours). If both analyzers are down, service personnel must be on-site within 4 hours of initial notification.Of the 31,000 CBC test, expect at least 25% (7,750) for IPF. Initial training for two key operators and additional training, upon request, for one operator per year per instrument (on-site, off-site, e- Learning, and Virtual Instructor Led Training) is included at no additional cost.3rd Option Period of Performance:

01 APR 2028 - 31 MAR 2029

Hematology equipment to include equipment, maintenance, supplies/reagents.One (1) Hematology system with two

(2) functioning analyzer, slide maker stainer, digital cell morphology system, with advanced red blood cell morphology software Met via a Cost Per Reportable Result (CPRR). Approximately 2,500 per month, but no more than 31,000 annually, Complete Blood Counts (CBC) with at least a 6-part differential and approximately 125, but no more than 1,500 annually, reticulocyte or equivalent panels.

The Government will pay a set monthly price, provided the actual number of results does not exceed these quantities per year. Service coverage for instruments: Preventative maintenance and 24/7 technical support along with all replacement parts, supplies and labor included at no additional charge. Response to service needs provided not later than 24 hours and resolution/completed repairs not later than 48 hours from report of service need or receipt of replacement parts within standard business hours (5 days, 8 hours). If both analyzers are down, service personnel must be on-site within 4 hours of initial notification.Initial training for two key operators and additional training, upon request, for one operator per year per instrument (on-site, off-site, e-Learning, and Virtual Instructor Led Training) is included at no additional cost.3rd Option Period of Performance: 01 APR 2028 - 31 MAR 2029

CLIN 4001

Hematology equipment to include equipment, maintenance, supplies/reagents.One (1) Hematology system with two

(2) functioning analyzer, slide maker stainer, digital cell morphology system, with advanced red blood cell morphology software Met via a Cost Per Reportable Result (CPRR). Approximately 2,500 per month, but no more than 31,000 annually, Complete Blood Counts (CBC) with at least a 6-part differential and approximately 125, but no more than 1,500 annually, reticulocyte panels. The Government will pay a set monthly price, provided the actual number of results does not exceed these quantities per year. Service coverage for instruments: Preventative maintenance and 24/7 technical support along with all replacement parts, supplies and labor included at no additional charge.

Response to service needs provided not later than 24 hours and resolution/completed repairs not later than 48 hours from report of service need or receipt of replacement parts within standard business hours (5 days, 8 hours). If both analyzers are down, service personnel must be on-site within 4 hours of initial notification.Of the 31,000 CBC test, expect at least 25% (7,750) for IPF. Initial training for two key operators and additional training, upon request, for one operator per year per instrument (on-site, off-site, e-Learning, and Virtual Instructor Led Training) is included at no additional cost.4th Option Period of Performance: 01 APR 2029 - 31 MAR 2030

Hematology equipment to include equipment, maintenance, supplies/reagents.One (1) Hematology system with two

(2) functioning analyzer, slide maker stainer, digital cell morphology system, with advanced red blood cell morphology software Met via a Cost Per Reportable Result (CPRR). Approximately 2,500 per month, but no more than 31,000 annually, Complete Blood Counts (CBC) with at least a 6-part differential and approximately 125, but no more than 1,500 annually, reticulocyte or equivalent panels.

The Government will pay a set monthly price, provided the actual number of results does not exceed these quantities per year. Service coverage for instruments: Preventative maintenance and 24/7 technical support along with all replacement parts, supplies and labor included at no additional charge. Response to service needs provided not later than 24 hours and resolution/completed repairs not later than 48 hours from report of service need or receipt of replacement parts within standard business hours (5 days, 8 hours). If both analyzers are down, service personnel must be on-site within 4 hours of initial notification.Initial training for two key operators and additional training, upon request, for one operator per year per instrument (on-site, off-site, e-Learning, and Virtual Instructor Led Training) is included at no additional cost.4th Option Period of Performance: 01 APR 2029 - 31 MAR 2030

The following have been modified:

52.212-1 ADDENDUM

ADDENDUM TO 52.212-1

Volume I. Administrative

Provide the following items:

o Completed SF 1449: Blocks 12, 17 (to include CAGE code and UEI number), 30a - c o Point of Contact Information (Name, Telephone Number, Fax Number, and Email) o Statement that the offeror will hold its quote firm for at least 180 days from the due date for receipt of quotes, subject to any changes that may occur as a result of discussions if applicable.

Potential contractors must be registered in the System for Award Management (SAM) to be eligible for award. The SAM website is http://www.sam.gov. Offers are due by 06 February 2025, 1300 (10:00 AM), Central Standard Time. The deadline for questions is on 19 December 2024, 1300 (1:00 PM) , Central Standard Time. All questions must be submitted in writing to carolynn.j.benn.civ@health.mil and David.k.erpelding.civ@health.mil. Offers shall be submitted via e-mail to the same emails as well.

Please provide completed provisions, as listed in the solicitation. Alternately, complete all provisions in

SAM and provide confirmation of completion with offer.

Volume II. Technical Capability Factor 1. Technical Capability. Offerors shall demonstrate how their proposed items comply with the Government's Statement of Objectives via the submission of a written capability statement, product literature, or other materials, to include proof where applicable (e.g., Food and Drug Administration approval of equipment and assays).

Offerors shall separately address each paragraph AND subparagraph within the Statement of Objectives. Failure to separately address each paragraph will be construed to mean the offeror is unable to meet the requirements of that particular paragraph and would thus not be eligible for award.

Subfactor 1A. Authorization to Operate (ATO)

Subfactor 1B. Instruments/Equipment and Reagents/Consumables

Subfactor 1C. Service and Maintenance

Subfactor 1D. Training

Subfactor 1E. Delivery and Installation

Volume III. Price.

Factor 2. Price. Offerors shall separately address each paragraph AND subparagraph within the Statement of Objectives. Failure to separately address each paragraph will be construed to mean the offeror is unable to meet that the requirements of that particular paragraph and would thus not be eligible for award. This is an "all or none" solicitation. Failure to provide a quote for any CLIN, unless it is specifically identified as "not separately priced" within the quote, will be construed to mean the offeror is not quoting that CLIN and thus, not eligible for award.

The quantities listed herein are the Government’s best estimate of its needs for the five-year performance period and are based on historical data and future projected usage. The final unit prices for each test established in any contract resulting from this solicitation are final. The Government will only pay for the actual number of tests (i.e., equivalent reagents) ordered and accepted, regardless of the quantities established on the contract. Therefore, the offeror is hereby informed that the final awarded unit (i.e., test) prices are not subject to adjustment on the basis of a difference between test quantities estimated on the solicitation, quantities established on the contract, and actual quantities used.

(End of provision)

STATEMENT OF OBJECTIVES

STATEMENT OF OBJECTIVES

The Keesler Medical Center at Keesler AFB, Mississippi requires one (1) Hematology system with two (2) functioning analyzers, slide maker stainer, digital cell morphology system, with advanced red blood cell morphology software. The successful offeror shall furnish all equipment, to include instrument installation, set-up, equipment validation (along with the associated supplies, labor), and reagents, controls, and any necessary services (e.g., maintenance of furnished equipment) to Keesler Medical Center, Keesler AFB, MS for the purpose of Hematology testing. This requirement will be met via equipment rental/lease or on a Cost Per Reportable Result (CPRR) basis. The requirement must include reagents to perform 31,000 Complete Blood Counts (CBC) results, as defined by the FDA, with at least a 6-part differential and 1,500 reticulocyte or equivalent panels annually for 5 years (base plus 4 one-year options).

All equipment and reagents shall be supplied and serviced through the Contractor to include all parts, equipment, supplies, and other services required to ensure Keesler Medical Center is able to meet its objectives as listed herein.

Equipment and associated peripherals must be delivered in such a time that installation, set-up, and validations are completed and approved by the Laboratory Director to begin patient testing by the start of the base year of the period of performance. In addition, an approved authorization to operate (ATO) is required prior to use and any subsequent billing. ATO approval must be maintained and valid through the life of the contract.

Period of Performance:

Base: 1 April 2025 – 31 March 2026 Option 1: 1 April 2026 – 31 March 2027 Option 2: 1 April 2027 – 31 March 2028 Option 3: 1 April 2028 – 31 March 2029 Option 4: 1 April 2029 – 31 March 2030

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

1.1. Analyzers must have a bi-directional interface that can connect to and be fully interoperable with the laboratory information system (LIS) Military Health System Genesis, as listed on CSTAR (https://info.health.mil/apps/HIT/cstar/Pages/Systems.aspx). Newly installed instruments will require an approved ATO to operate on the DHA network and approval must be maintained and valid through the life of the contract.

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

1.3. Each interface must allow for recognition and interpretation of MHS Genesis generated bar-code labels on all sample tube types. Connectivity between the Contractor instrument systems and middleware to each LIS will be required at varying times during the contracted period of performance. Location: 81MDTS/SGQC Clinical Laboratory, Keesler Medical Center, Keesler Air Force Base, MS.

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

2.1. Instruments/Equipment.

2.1.1. Instruments must be Food and Drug Administration (FDA) approved for testing to include body fluids, including synovial fluid.

2.1.2. Each analyzer must be able to perform a complete blood count (CBC) with red blood cell indices and a 6-part differential to include Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils and Immature granulocytes. The CBC must include at least the following:

White Blood Cell Count (WBC) Red Blood Cell Count (RBC) Hemoglobin (Hgb) Hematocrit (Hct) Mean corpuscular volume (MCV) Mean corpuscular hemoglobin (MCH) Mean corpuscular hemoglobin concentration (MCHC) Red cell distribution width (RDW) Platelet (Plt) Mean platelet volume (MPV)

2.1.3. Each analyzer must be able to perform a reticulocyte panel or equivalent test to measure bone marrow production of reticulocytes.

2.1.4. Each analyzer must be able to perform an FDA approved test directly measuring immature platelets or an equivalent direct measurement in the peripheral blood in a manner that can be used to monitor bone marrow activity in thrombocytopenic patients for oncology purposes. An estimated 25% (7,750) of CBC tests will require this parameter.

2.1.4.1 Reticulated and/or immature platelet measurements or its equivalent will be used for differentiating between hyperdestructive and hypoproductive thrombocytopenia (i.e. determining whether low platelet numbers are a result of a condition that is destroying or damaging platelets, or a matter of the bone marrow not producing enough platelets). This parameter will also be used for the evaluation of thrombopoietic recover following chemotherapy, to assess risk for future thrombotic events in patients with cardiovascular disease.

2.1.5. Each analyzer must have a reagent bar-code identification system containing the lot number, expiration date, and unique identification code.

2.1.6. Users must be able to program on board user defined decision rules according to laboratory needs. Any additional software required to meet these requirements must be included in the offer price.

2.1.7. Each analyzer must have the capability to perform automatic repeat of samples and reflex testing without technician intervention based on result criteria and defined decision rules and provide further action comments on patient printouts.

2.1.8. Each analyzer must retain a recent patient history for side-by-side comparison of past results.

2.1.9. The analyzers must meet all necessary power and waste requirements as dictated by the current laboratory workspace. Workspace power and waste requirements are as follows: Power supply must be 120VAC. Drain is plumbed at the back of analyzers. Access point to the drain is required in case of leaks. The drain is located at the rear in approximately the middle of the available space’s length.

2.1.10. Both analyzers and all additional attachments (computer, slide stainer, digital cell morphology system) fit in a 49.75” (depth) x 144” (length) x 80” (height) space limitation. The offeror shall provide a diagram or other graphical representation demonstrating how its proposed equipment fits within the dimensions below with its quote. (See Attachment 1)

2.1.11. Analyzers must be able to connect to and interface with slide maker stainer. Slides must have compatibility with a digital cell morphology system.

2.1.12. Instruments must be able to interrupt routine processing for STAT sample processing.

2.1.13. Contractor must have a Quality control program for peer group comparison and program shall meet or exceed all accreditation requirements (monthly statistics monitoring). User must be able to upload QC data to program using CD/DVD. Thumb drives and remote access are unauthorized.

2.1.14. Each analyzer must be able to perform positive identification of patient samples and sample cassettes shall have Positive sample identification.

2.1.15. Contract must include middleware if needed for auto-validation (instrument results flow directly to electronic health record based on user defined rules in middleware). Middleware must have an approved ATO prior to use and subsequent billing, and approval must be maintained and valid through the life of the contract. If no approved ATO, middleware billing will be dormant until the ATO is approved for use and middleware is put in to use.

2.1.16. The entire system must be independent of remote connections (internet, cloud, etc.) to be functional and serviceable.

2.1.17. Medical Technicians shall have the ability to walk away without any negative impact during the operational running of cycle.

2.1.18. Peripherals shall include at a minimum; Instrument stands (as needed), uninterruptable power sources (UPSs), electrical line conditioners, as required, instrument-specific computer terminals/CPUs, keyboards, computer mouse; Printers shall include at a minimum, initial toner for each as needed, and other equipment where required.

2.2. Reagents/Consumables.

2.2.1. The Contractor will include all calibrators, controls and reagents in the contract. The requirement must include reagents to perform 31,000 Complete Blood Counts (CBC) results, as defined by the FDA, with at least a 6-part differential and 1,500 reticulocyte or equivalent panels annually for 5 years (base plus 4 one-year options).

2.2.2. In determining reagent requirements, the Contractor shall consider requirements for routine quality control runs, routine calibration, periodic calibration/calibration verification in accordance with departmental policy and troubleshooting of out-of-control assays when calculating the yearly requirements.

2.2.3. Reagents must be billed and shipped monthly.

3. Service and Maintenance (Subfactor 1C). The Contractor shall meet the following service and maintenance requirements.

3.1. Preventative maintenance and 24/7 technical support included with service contract along with all replacement parts, supplies and labor. Response to service needs provided not later than 24 hours and resolution/completed repairs not later than 48 hours (local service personnel preferred) from report of service need or receipt of replacement parts within standard business hours (5 days, 8 hours). If both analyzers are down, service personnel must be on-site within 4 hours of initial notification.

3.2. Service contract 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 analyzer installation will establish time-zero for determining the time frame for performance of periodic services.

3.3. Any service technician provided by the Contractor shall adhere to all required reporting procedures for Keesler Air Force Base.

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

3.5. If an analyzer move is deemed necessary, the Contractor shall relocate/revalidate any instrument if requested by the Government at no additional cost.

3.6. Contractor shall provide product service and support to include updates to operational software throughout the life cycle of the equipment.

4. Training (Subfactor 1D).

4.1. The Contractor shall provide the following training at no additional cost to the Government:

4.1.1. Initial training (upon award) for two (2) key operators including lodging (hotel), per diem, and travel (airfare, rental car) expenses to/from Keesler AFB, hotel, and training location if off-site. Additional training, upon request, for one operator per year per instrument (lodging (hotel), per diem, and travel (airfare, rental car) expenses included to/from Keesler AFB, hotel, and training location. Alternative training delivery (i.e. distance training), if determined by the Government customer to be of equivalent quality, may be entertained in lieu of offsite, in-person training for non-initial training.

4.1.2 All training shall include basic analyzer operation, troubleshooting procedures, performance of operator level periodic preventive maintenance procedures, and the use of any data management/quality control software.

5. Delivery and Installation (Subfactor 1E).

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

Keesler Medical Center 81MDTS/SGQC Clinical Laboratory Rm 1E326 301 Fisher St Keesler AFB, MS 39534

5.2. The Contractor shall assign a Project Manager to oversee all operations required for successful implementation and execution of the requirement.

5.2.1. The Project Manager will provide a timeline identifying critical points in the delivery/installation phase, wherein Day 0 = Notice of Award.

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

5.3.1. Contractor must include Utility layout required and CAD drawing with detailed analyzer layout with proposal. (See current layout – attachment 1).

5.4. Contract must include instrument installation, set-up, validation, supplies, and labor.

Instruments must be installed, validated and ready for patient testing by the start of the base year of the period of performance. The on-site installation process should begin no less than 90 days after award, but as soon as necessary to ensure equipment is fully operational on first day of the base year of the period of performance. This includes all correlation, precision, linearity, normal ranges, and any other required validation studies by a Contractor provided technical service representative (TSR) or clinical application specialist (CAS). The TSR and/or CAS should possess a thorough knowledge of method validation/verification and, where applicable, is familiar with the use of clinical laboratory statistical evaluation software (e.g. EP Evaluator®).

The assigned TSR and/or CAS will be responsible for the entire method validation to the standards of the acting medical director. The completed validation studies and raw data must be provided to the Hematology management staff electronically and, in a binder, at least 3 weeks prior to analyzer functionality.

5.5. Method validation/verification will be conducted in accordance Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and the College of American Pathologists (CAP) requirements.

5.6. The method validation/verification 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.

5.7. All instrument reagents, calibrators, linearity materials and other required reagents/materials used in the method validation/verification study will be provided by the Contractor at no additional cost to the Government. Assay lots will be quality checked upon delivery. Contractor’s customer samples may also be used. These materials will not be used in the analysis of specimens for patient care.

ATTACHMENT 1

52.212-2 EVALUATION – COMMERCIAL ITEMS

Evaluation—Commercial Products and Commercial Services (Nov 2021)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

Paragraph (a) is hereby replaced by the following:

Award will be made using lowest price technically acceptable (LPTA) through simplified acquisition procedures. Award will be made to the responsible offeror on the basis of the lowest evaluated price of offers meeting or exceeding the acceptability standards for non-cost factors. Award may be made without discussions with offerors (except communications conducted for the purpose of minor clarification).

Therefore, each initial offer should contain the offeror’s best terms from a technical and price standpoint.

Keesler Medical Center Hematology department available space for connected instrumentation and peripherals Back wall with 1 data port (blue) Back wall with 6 emergency outlets (Red)

1 Floor drain is available UPS UPS UPS

SPACE AVAILABLE

49.7 5”

144”

Total area for equipment to be placed on is 144” X 49.75”

24” required at a minimum behind the instrument and in front of the back wall for floor drain and all UPSs

However, the Government reserves the right to conduct discussions if it is later determined by the contracting officer to be necessary. Award will be made on an all or none basis.

1.Technical Capability. The following adjectival ratings will be used in evaluating the offeror’s technical capability:

Acceptable – An Acceptable rating will be assessed on any offeror whose quote clearly meets each aspect of the Statement of Objectives and other requirements listed in the solicitation.

Unacceptable – An Unacceptable rating will be assessed on any offeror that presents a quote that demonstrates any of the following:

a) Failure to meet each aspect of the Statement of Objectives and other requirement of the solicitation.

b) Failure to provide sufficient detail for the Government to determine whether its offer meets the Statement of Objectives and the requirements of the solicitation.

c) Failure to provide all of the tests required in the solicitation.

Authorization to Operate Capability:

As part of the Technical Capability Evaluation above, evaluation of an Offeror’s ability to acquire an Authorization to Operate (ATO) will be based on the attached ATO form (attachment 2), which will be filled out in its entirety. The evaluation will be based on the Offeror’s capability to obtain approval for an ATO. This evaluation criteria will be rated as follows:

Acceptable – An Acceptable rating will be assessed on any Offerors whose completed form provides the Government with a high confidence that an ATO will be approved.

Unacceptable -An Unacceptable rating will be assessed on any Offerors whose completed form provides the Government with a low confidence that an ATO will be approved.

2. Price. Pricing must be determined to be fair and reasonable prior to award.

(a) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(b) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of provision)

(End of Summary of Changes)