HT940825R0004 0002.pdf

HT940825R0004

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

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

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

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

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

FAR (48 CFR) 53.243

The purpose of this amendment is to:

1. Include an additional CLIN to faciliate pricing.

2. Provide Government response to Questions.

3. Update SOO to clarify section 2.1.6

4. Update Addendum to FAR 52.212-2 Evaluation

1. CONTRACT ID CODE PAGE OF PAGES

J 1 23

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

16C. DATE SIGNED

BY 06-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 HT940825R0004

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 is extended, X 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

06-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:

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SUPPLIES OR SERVICES AND PRICES

CLIN 0001

The CLIN extended description has changed from:

Microbiology equipment to include equipment, maintenance, supplies/reagents. One (1) automated system that performs microbial identification and antimicrobial susceptibility testing and one (1) automated microbial detection system for the monitoring of the presence or absence of microorganisms from both blood and other sterile body fluid samples. Met via a Cost Per Test.

Service coverage for instruments: Periodic instrument preventative maintenance and calibration along with 24/7 technical support and service and repairs to keep instrumentation operational is included at no additional cost. Response to service needs provided not later than 24 hours and resolution 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.Per monthly test quantity:Bacterial Gram-negative identification - 75Bacterial Gram-positive identification – 42Neisseria/Haemophilus identification - 10Anaerobic bacterial identification – 8Yeast identification – 8.3Bacterial Gram-negative susceptibility testing - 125Bacterial Gram-positive susceptibility testing – 108Bacterial Streptococcus susceptibility testing - 10Yeast susceptibility testing – 8.3Not to exceed the yearly test quantity located at paragraph 2.1.7 in the Statement of Objectives. The Government will pay actual Cost-per-Test, not to exceed the estimated yearly test quantities. Base Period of Performance: 01 APR 2025 - 31 MAR 2026

To:

Microbiology equipment to include equipment, maintenance, supplies/reagents. One (1) automated system that performs microbial identification and antimicrobial susceptibility testing.

Met via a Cost Per Test. Service coverage for instruments: Periodic instrument preventative maintenance and calibration along with 24/7 technical support and service and repairs to keep instrumentation operational is included at no additional cost. Response to service needs provided not later than 24 hours and resolution 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.Per monthly test quantity:Bacterial Gram-negative identification - 75Bacterial Gram-positive identification – 42Neisseria/Haemophilus identification - 10Anaerobic bacterial identification – 8Bacterial Gram-negative susceptibility testing - 125Bacterial Gram-positive susceptibility testing – 108Bacterial Streptococcus susceptibility testing - 10Not to exceed the yearly test quantity located at paragraph 2.1.7 in the Statement of Objectives. The Government will pay actual Cost-per-Test, not to exceed the estimated yearly test quantities. Base Period of Performance: 01 APR 2025 - 31 MAR 2026

CLIN 0002

This CLIN has been renumbered to CLIN 0003.

CLIN 1001

Microbiology equipment to include equipment, maintenance, supplies/reagents. One (1) automated system that performs microbial identification and antimicrobial susceptibility testing and one (1) automated microbial detection system for the monitoring of the presence or absence of microorganisms from both blood and other sterile body fluid samples. Met via a Cost Per Test.

Service coverage for instruments: Periodic instrument preventative maintenance and calibration along with 24/7 technical support and service and repairs to keep instrumentation operational is included at no additional cost. Response to service needs provided not later than 24 hours and resolution 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.Per monthly test quantity:Bacterial Gram-negative identification - 75Bacterial Gram-positive identification – 42Neisseria/Haemophilus identification - 10Anaerobic bacterial identification – 8Yeast identification – 8.3Bacterial Gram-negative susceptibility testing - 125Bacterial Gram-positive susceptibility testing – 108Bacterial Streptococcus susceptibility testing - 10Yeast susceptibility testing – 8.3Not to exceed the yearly test quantity located at paragraph 2.1.7 in the Statement of Objectives.The Government will pay actual Cost-per-Test, not to exceed the estimated yearly test quantities. Base Period of Performance: 01 APR 2026 - 31 MAR 2027 automated system that performs microbial identification and antimicrobial susceptibility testing.

Met via a Cost Per Test. Service coverage for instruments: Periodic instrument preventative maintenance and calibration along with 24/7 technical support and service and repairs to keep instrumentation operational is included at no additional cost. Response to service needs provided not later than 24 hours and resolution 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.Per monthly test quantity:Bacterial Gram-negative identification - 75Bacterial Gram-positive identification – 42Neisseria/Haemophilus identification - 10Anaerobic bacterial identification – 8Bacterial Gram-negative susceptibility testing - 125Bacterial Gram-positive susceptibility testing – 108Bacterial Streptococcus susceptibility testing - 10Not to exceed the yearly test quantity located at paragraph 2.1.7 in the Statement of Objectives.The Government will pay actual Cost-per-Test, not to exceed the estimated yearly test quantities. Base Period of Performance: 01 APR 2026 - 31 MAR 2027

CLIN 2001

Microbiology equipment to include equipment, maintenance, supplies/reagents. One (1) automated system that performs microbial identification and antimicrobial susceptibility testing and one (1) automated microbial detection system for the monitoring of the presence or absence of microorganisms from both blood and other sterile body fluid samples. Met via a Cost Per Test.

Service coverage for instruments: Periodic instrument preventative maintenance and calibration along with 24/7 technical support and service and repairs to keep instrumentation operational is included at no additional cost. Response to service needs provided not later than 24 hours and resolution 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.Per monthly test quantity:Bacterial Gram-negative identification - 75Bacterial Gram-positive identification – 42Neisseria/Haemophilus identification - 10Anaerobic bacterial identification – 8Yeast identification – 8.3Bacterial Gram-negative susceptibility testing - 125Bacterial Gram-positive susceptibility testing – 108Bacterial Streptococcus susceptibility testing - 10Yeast susceptibility testing – 8.3Not to exceed the yearly test quantity located at paragraph 2.1.7 in the Statement of quantities. Base Period of Performance: 01 APR 2027 - 31 MAR 2028 automated system that performs microbial identification and antimicrobial susceptibility testing.

Met via a Cost Per Test. Service coverage for instruments: Periodic instrument preventative maintenance and calibration along with 24/7 technical support and service and repairs to keep instrumentation operational is included at no additional cost. Response to service needs provided not later than 24 hours and resolution 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.Per monthly test quantity:Bacterial Gram-negative identification - 75Bacterial Gram-positive identification – 42Neisseria/Haemophilus identification - 10Anaerobic bacterial identification – 8Bacterial Gram-negative susceptibility testing - 125Bacterial Gram-positive susceptibility testing – 108Bacterial Streptococcus susceptibility testing - 10Not to exceed the yearly test quantity located at paragraph 2.1.7 in the Statement of Objectives.The Government will pay actual Cost-per-Test, not to exceed the estimated yearly test quantities. Base Period of Performance: 01 APR 2027 - 31 MAR 2028

CLIN 3001

Microbiology equipment to include equipment, maintenance, supplies/reagents. One (1) automated system that performs microbial identification and antimicrobial susceptibility testing and one (1) automated microbial detection system for the monitoring of the presence or absence of microorganisms from both blood and other sterile body fluid samples. Met via a Cost Per Test.

Service coverage for instruments: Periodic instrument preventative maintenance and calibration along with 24/7 technical support and service and repairs to keep instrumentation operational is included at no additional cost. Response to service needs provided not later than 24 hours and resolution 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.Per monthly test quantity:Bacterial Gram-negative identification - 75Bacterial Gram-positive identification – 42Neisseria/Haemophilus identification - 10Anaerobic bacterial identification – 8Yeast identification – 8.3Bacterial Gram-negative susceptibility testing - 125Bacterial Gram-positive susceptibility testing – 108Bacterial Streptococcus susceptibility testing - 10Yeast susceptibility testing – 8.3Not to exceed the yearly test quantity located at paragraph 2.1.7 in the Statement of quantities. Base Period of Performance: 01 APR 2028 - 31 MAR 2029 automated system that performs microbial identification and antimicrobial susceptibility testing.

Met via a Cost Per Test. Service coverage for instruments: Periodic instrument preventative maintenance and calibration along with 24/7 technical support and service and repairs to keep instrumentation operational is included at no additional cost. Response to service needs provided not later than 24 hours and resolution 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.Per monthly test quantity:Bacterial Gram-negative identification - 75Bacterial Gram-positive identification – 42Neisseria/Haemophilus identification - 10Anaerobic bacterial identification – 8Bacterial Gram-negative susceptibility testing - 125Bacterial Gram-positive susceptibility testing – 108Bacterial Streptococcus susceptibility testing - 10Not to exceed the yearly test quantity located at paragraph 2.1.7 in the Statement of Objectives.The Government will pay actual Cost-per-Test, not to exceed the estimated yearly test quantities. Base Period of Performance: 01 APR 2028 - 31 MAR 2029

CLIN 4001

Microbiology equipment to include equipment, maintenance, supplies/reagents. One (1) automated system that performs microbial identification and antimicrobial susceptibility testing and one (1) automated microbial detection system for the monitoring of the presence or absence of microorganisms from both blood and other sterile body fluid samples. Met via a Cost Per Test.

Service coverage for instruments: Periodic instrument preventative maintenance and calibration along with 24/7 technical support and service and repairs to keep instrumentation operational is included at no additional cost. Response to service needs provided not later than 24 hours and resolution 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.Per monthly test quantity:Bacterial Gram-negative identification - 75Bacterial Gram-positive identification – 42Neisseria/Haemophilus identification - 10Anaerobic bacterial identification – 8Yeast identification – 8.3Bacterial Gram-negative susceptibility testing - 125Bacterial Gram-positive susceptibility testing – 108Bacterial Streptococcus susceptibility testing - 10Yeast susceptibility testing – 8.3Not to exceed the yearly test quantity located at paragraph 2.1.7 in the Statement of quantities. Base Period of Performance: 01 APR 2029 - 31 MAR 2030 automated system that performs microbial identification and antimicrobial susceptibility testing.

Met via a Cost Per Test. Service coverage for instruments: Periodic instrument preventative maintenance and calibration along with 24/7 technical support and service and repairs to keep instrumentation operational is included at no additional cost. Response to service needs provided not later than 24 hours and resolution 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.Per monthly test quantity:Bacterial Gram-negative identification - 75Bacterial Gram-positive identification – 42Neisseria/Haemophilus identification - 10Anaerobic bacterial identification – 8Bacterial Gram-negative susceptibility testing - 125Bacterial Gram-positive susceptibility testing – 108Bacterial Streptococcus susceptibility testing - 10Not to exceed the yearly test quantity located at paragraph 2.1.7 in the Statement of Objectives.The Government will pay actual Cost-per-Test, not to exceed the estimated yearly test quantities. Base Period of Performance: 01 APR 2029 - 31 MAR 2030

CLIN 0002 is added as follows:

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0002 1 Job Microbiology - Cost-per-Test

FFP

Microbiology equipment to include equipment, maintenance, supplies/reagents.

One (1) automated microbial detection system for the monitoring of the presence or absence of microorganisms from both blood and other sterile body fluid samples. Met via a Cost Per Test.

Service coverage for instruments: Periodic instrument preventative maintenance and calibration along with 24/7 technical support and service and repairs to keep instrumentation operational is included at no additional cost. Response to service needs provided not later than 24 hours and resolution 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.

The Government will pay actual Cost-per-Test, not to exceed the estimated yearly test quantities.

Base Period of Performance: 01 APR 2025 - 31 MAR 2026

NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

FOB: Destination

NET AMT

CLIN 1002 is added as follows:

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

1002 1 Job OPTION Microbiology - Cost-per-Test

FFP

Microbiology equipment to include equipment, maintenance, supplies/reagents.

One (1) automated microbial detection system for the monitoring of the presence or absence of microorganisms from both blood and other sterile body fluid samples. Met via a Cost Per Test.

Service coverage for instruments: Periodic instrument preventative maintenance and calibration along with 24/7 technical support and service and repairs to keep instrumentation operational is included at no additional cost. Response to service needs provided not later than 24 hours and resolution 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.

The Government will pay actual Cost-per-Test, not to exceed the estimated yearly test quantities.

Base Period of Performance: 01 APR 2026 - 31 MAR 2027

NOTE: The requirements in DFARS 252.211-7003, Item Identification and Valuation, are applicable for this line item. The contractor shall provide DoD unique identification or a DoD recognized unique identification equivalent.

CLIN 2002 is added as follows:

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

2002 1 Job OPTION Microbiology - Cost-per-Test

FFP

Microbiology equipment to include equipment, maintenance, supplies/reagents.

One (1) automated microbial detection system for the monitoring of the presence or absence of microorganisms from both blood and other sterile body fluid samples. Met via a Cost Per Test.

Service coverage for instruments: Periodic instrument preventative maintenance and calibration along with 24/7 technical support and service and repairs to keep instrumentation operational is included at no additional cost. Response to service needs provided not later than 24 hours and resolution 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.

The Government will pay actual Cost-per-Test, not to exceed the estimated yearly

Base Period of Performance: 01 APR 2027 - 31 MAR 2028 unique identification or a DoD recognized unique identification equivalent.

CLIN 3002 is added as follows:

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

3002 1 Job OPTION Microbiology - Cost-per-Test

FFP

Microbiology equipment to include equipment, maintenance, supplies/reagents.

One (1) automated microbial detection system for the monitoring of the presence or absence of microorganisms from both blood and other sterile body fluid samples. Met via a Cost Per Test.

Service coverage for instruments: Periodic instrument preventative maintenance and calibration along with 24/7 technical support and service and repairs to keep instrumentation operational is included at no additional cost. Response to service needs provided not later than 24 hours and resolution 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.

The Government will pay actual Cost-per-Test, not to exceed the estimated yearly

Base Period of Performance: 01 APR 2028 - 31 MAR 2029 unique identification or a DoD recognized unique identification equivalent.

CLIN 4002 is added as follows:

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

4002 1 Job OPTION Microbiology - Cost-per-Test

FFP

Microbiology equipment to include equipment, maintenance, supplies/reagents.

One (1) automated microbial detection system for the monitoring of the presence or absence of microorganisms from both blood and other sterile body fluid samples. Met via a Cost Per Test.

Service coverage for instruments: Periodic instrument preventative maintenance and calibration along with 24/7 technical support and service and repairs to keep instrumentation operational is included at no additional cost. Response to service needs provided not later than 24 hours and resolution 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.

The Government will pay actual Cost-per-Test, not to exceed the estimated yearly

Base Period of Performance: 01 APR 2029 - 31 MAR 2030 unique identification or a DoD recognized unique identification equivalent.

DELIVERIES AND PERFORMANCE

The following Delivery Schedule Item has been deleted from CLIN 0002:

DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

31-MAR-2026 81ST MDG SGL - MM

LEN VAN SITTERT

CP 338 377 6365 301 FISHER ST

STE 101

KEESLER AFB MS 39534-2519

228-376-5000

HT1123

The following Delivery Schedule item has been added to CLIN 0002:

CAGE

31-MAR-2026 1 81ST MDG SGL - MM

LEN VAN SITTERT

CP 338 377 6365 301 FISHER ST

STE 101

KEESLER AFB MS 39534-2519

228-376-5000

The following Delivery Schedule for CLIN 0003 has been added:

CAGE

31-MAR-2026 81ST MDG SGL - MM

LEN VAN SITTERT

CP 338 377 6365 301 FISHER ST

STE 101

KEESLER AFB MS 39534-2519

228-376-5000

The following Delivery Schedule for CLIN 1002 has been added:

CAGE

31-MAR-2027 1 81ST MDG SGL - MM

LEN VAN SITTERT

CP 338 377 6365 301 FISHER ST

STE 101

KEESLER AFB MS 39534-2519

228-376-5000

The following Delivery Schedule for CLIN 2002 has been added:

CAGE

31-MAR-2028 1 81ST MDG SGL - MM

LEN VAN SITTERT

CP 338 377 6365 301 FISHER ST

STE 101

KEESLER AFB MS 39534-2519

228-376-5000

The following Delivery Schedule for CLIN 3002 has been added:

CAGE

31-MAR-2029 1 81ST MDG SGL - MM

LEN VAN SITTERT

CP 338 377 6365 301 FISHER ST

STE 101

KEESLER AFB MS 39534-2519

228-376-5000

The following Delivery Schedule for CLIN 4002 has been added:

CAGE

31-MAR-2030 1 81ST MDG SGL - MM

LEN VAN SITTERT

CP 338 377 6365 301 FISHER ST

STE 101

KEESLER AFB MS 39534-2519

228-376-5000

INSPECTION AND ACCEPTANCE

The following Acceptance/Inspection Schedule was added for CLIN 0002:

INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

N/A N/A N/A Government

The following Acceptance/Inspection Schedule was added for CLIN 1002:

The following Acceptance/Inspection Schedule was added for CLIN 2002:

The following Acceptance/Inspection Schedule was added for CLIN 3002:

The following Acceptance/Inspection Schedule was added for CLIN 4002:

The following have been added by full text:

Q & A Questions HT940825R0004 – Microbiology

1. Will all the items requested in the solicitation need to be purchased from 1 single supplier?

The requirement is for 2 separate analyzers and do not need to be the same manufacturer/supplier. The solicitation and pricing sheet has been amended to add an additional CLIN to facilitate pricing.

2. Can this bid be separated out into ID/AST testing separated from Blood Culture testing?

Addendum to 52.212-2 has been updated to allow for partial quotes:

Award will be made to no more than two offerors. Each offeror shall identify the system(s) they are offering with associated supplies/reagents. The Government will consider partial quotes but must provide all associated supplies/reagents with the system offered.

An approved ATO is not required prior to award but is required prior to use and any subsequent billing.

3. Section 2.1.6 - This section states that the instrument must read the panels manually. Should this say the panels can be read manually offline?

This should state that panels can be read and/or incubated manually offline. The associated section in the SOO has been revised.

The following have been modified:

STATEMENT OF OBJECTIVES

STATEMENT OF OBJECTIVES

The Keesler Medical Center Clinical Laboratory at Keesler AFB, Mississippi requires one (1) automated system that performs microbial identification and antimicrobial susceptibility testing and one (1) automated microbial detection system for the monitoring of the presence or absence of microorganisms from both blood and other sterile body fluid samples. The successful offeror shall furnish all equipment, reagents, and any necessary services (e.g., maintenance of furnished equipment) to Keesler Medical Center, Keesler AFB, MS for the purpose of Microbiology testing. This requirement will be met via equipment rental/lease or on a Cost Per Reportable Result (CPRR) basis. The requirement must include equipment and reagents to perform the following number of tests per year:

Required capability Estimated test quantity per year Bacterial Gram-negative identification 900 Bacterial Gram-positive identification 500 Neisseria/Haemophilus identification 120 Anaerobic bacterial identification 100 Bacterial Gram-negative susceptibility testing 1,500 Bacterial Gram-positive susceptibility testing 1,300 Bacterial Streptococcus susceptibility testing 120 Aerobic bottles for microorganism monitoring 1,500

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 authority 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. The Contractor must have an approved ATO is required prior to use and any subsequent billing, 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.

Anaerobic bottles for microorganism monitoring 1,500 Pediatric bottles for microorganism monitoring 600

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

2.1. Instruments/Equipment

2.1.1. The new equipment is to be in place and fully operational, i.e. ready for patient testing, no later than 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.

2.1.2. Instrument must be Food and Drug Administration (FDA) approved for microbial identification and antimicrobial susceptibility testing. Testing must include confirmatory identification and minimum inhibitory concentration of microorganisms. The testing must also be current with the Clinical Laboratory Standards Institute (CLSI) breakpoints through 2026.

2.1.3. Must supply benchtop for instrument to fit in a space approximately 28” wide by 27” deep with the instrument approximately 24” in height.

2.1.4. Instrument must use existing 100/120 VAC (50-60 HZ) power capability that is within 5’ of the installation location.

2.1.5. The instrument must have the capability of sample and reagent bar-code reading.

2.1.6. The instrument must have automatic dilution of patient samples, so that no manual predilutions are necessary. The instrument must have the ability to be read and/or incubated manually offline.

2.1.7. The Contractor will include all equipment and supplies capable of comprehensive microbial identification and susceptibility testing to include Gram negative, Gram positive, aerobic, and anaerobic bacteria for the estimated annual quantities in the table below.

Required capability Estimated test quantity per year Bacterial Gram-negative identification 900 Bacterial Gram-positive identification 500 Neisseria/Haemophilus identification 120 Anaerobic bacterial identification 100 Bacterial Gram-negative susceptibility testing 1,500 Bacterial Gram-positive susceptibility testing 1,300 Bacterial Streptococcus susceptibility testing 120

2.1.8. Instrument and reagents must have the ability to determine inducible clindamycin resistance, extended-spectrum beta-lactamase producing organisms and methicillin resistant Staphylococcus aureus.

2.1.9. Instrument and reagents must have the ability to produce minimum inhibitory concentration results, following CLSI recommendations and breakpoints through 2026, for the following antimicrobials and organisms with the opportunity to expand to test for additional antimicrobials as deemed necessary by the Keesler Medical Center Antimicrobial Stewardship Committee. Expansion will include validation and will be at no cost to the government:

Gram Negative Organisms Ampicillin Ampicillin/Sulbactam Cefazolin Piperacillin/Tazobactam Ceftazidime Ceftriaxone Cefepime Aztreonam Ertapenem Meropenem Amikacin Gentamicin Ciprofloxacin Tigecycline Nitrofurantoin Trimethoprim/Sulfamethoxazole

Gram Positive Organisms Ampicillin Ciprofloxacin Clindamycin Daptomycin Doxycycline Erythromycin Gentamicin Gentamicin High Level

(synergy) Levofloxacin Linezolid Moxifloxacin Nitrofurantoin Oxacillin Rifampicin Tetracycline Streptomycin High Level

(synergy) Tigecycline Vancomycin Trimethoprim/Sulfamethoxazole

Streptococcus sp.

Ampicillin Benzylpenicillin Cefotaxime Ceftriaxone Clindamycin Erythromycin Levofloxacin Linezolid Moxifloxacin Tetracyclines Tigecycline Trimethoprim/Sulfamethoxazole Vancomycin

2.1.10. Contractor must perform periodic instrument preventative maintenance and calibration along with 24/7 technical support and service and repairs to keep instrumentation operational.

Response to service needs provided not later than 24 hours and resolution 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).

2.2. Microbial detection system for the monitoring of the presence or absence of microorganisms.

2.2.1. Instrument must be Food and Drug Administration (FDA) approved for the monitoring of the presence or absence of microorganisms from both blood and other sterile body fluid samples.

2.2.2. The analyzers must meet all necessary power and waste requirements as dictated by the current laboratory workspace. Instrument must fit in a space approximately 48” wide by 36” deep for the blood culture platform. This equipment is 12” from an outlet. The microbial identification and susceptibility testing platform must fit into a space of 60” wide by 36” deep, with approximately 40” from two (2) wall outlets. For a benchtop instrument, a workbench must be provided.

2.2.3. Instrument must use existing 100/120 VAC (50-60 HZ) power capability.

2.2.4. Instrument must have minimum capacity to monitor 120 bottles at one time.

2.2.5. Bottles must be plastic and be FDA approved for the detection of microorganisms in blood and other sterile body fluids to include synovial fluid for the estimated quantities listed in the table below:

Required capability Estimated test quantity per year Aerobic bottles for microorganism monitoring 1,500 Anaerobic bottles for microorganism monitoring 1,500 Pediatric bottles for microorganism monitoring 600

2.2.6. Instrument must have the capability to interface and be fully interoperable with the laboratory information system (LIS), MHS Genesis, and must have an approved authorization to operate (ATO) on the DHA network as listed on CSTAR (https://info.health.mil/apps/HIT/cstar/Pages/Systems.aspx). An approved ATO is required prior to use and any subsequent billing and must be maintained and valid through the life of the contract.

2.2.8. Usage of all computer components, printers and accessories needed to operate instrument and middleware must be interoperable with MHS Genesis. Middleware must have an approved ATO prior to use and any subsequent billing. ATO approval must be maintained and valid through the life of the contract.

2.2.9. Each interface must allow for recognition and interpretation of MHS Genesis generated bar-code labels on all sample container types. Connectivity between the Contractor’s 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.

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

3.1 Contractor must perform periodic instrument preventative maintenance and calibration along with 24/7 technical support and service and repairs to keep instrumentation operational.

Response to service needs provided not later than 24 hours and resolution 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 Contractor shall provide product service and support to include updates to operational software throughout the life cycle of the equipment.

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

4. Training (Subfactor 1D) Instrument training.

4.1. Each Contractor will provide the training for each individual piece of equipment, software, middleware and accessories 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, local transportation) expenses to/from Keesler AFB, hotel, and training location (offsite location). Additional training, upon request, for one operator per year per instrument (lodging (hotel), per diem, and travel (airfare, local transportation) 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 for each piece of equipment, 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 Clinical Laboratory 81 MDTS/SQQC 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.

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

5.3.2. Contractor must include Utility layout required and CAD drawing with detailed analyzer layout with proposal, including facility modifications proposed if applicable. See attachment 1 for current floorplan.

5.4. Contract must include instrument installation, set-up, validation with current breakpoints for 2026, supplies, and labor. 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 range, and any other required validation studies by a Contractor provided Clinical Application Specialist. The Clinical Application Specialist 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 Clinical Application Specialist 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 Microbiology 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 with procedures as required by the 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.

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

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(s) 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) source selection process. Award will be made to the responsible offeror(s) 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. 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 to no more than two offerors. Each offeror shall identify the system(s) they are offering with associated supplies/reagents. The Government will consider partial quotes but must provide all associated supplies/reagents with the system offered.

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, with respect to at least one or both systems, 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 at least one of the systems required in 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 for at least one of the systems 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.

(b) 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).

(c) 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)