HT940825R0005 Amendment 0001.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

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

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

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

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

FAR (48 CFR) 53.243

The purpose of this amendment is to:

1. Publish the Government's response to Questions.

2. Amend the SOO to clarify language.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 8

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

16C. DATE SIGNED

BY 30-Dec-2024

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

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

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X HT940825R0005

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

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

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

12. ACCOUNTING AND APPROPRIATION DATA (If required)

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

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

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

CONTRACT ORDER NO. IN ITEM 10A.

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

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

D. OTHER (Specify type of modification and authority)

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

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

10A. MOD. OF CONTRACT/ORDER NO.

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

6. ISSUED BY

3. EFFECTIVE DATE

30-Dec-2024

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:

HT940825R0005

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 02-Jan-2025 01:00 PM to 09-Jan-2025 10:00 AM.

The following have been added by full text:

Q&A

1. Page 3, Statement of Objectives (SOO) states “The Keesler Medical Center at Keesler AFB, Mississippi requires one (1) Urinalysis (UA) system with two (2) functioning analyzers, one primary and one backup.”

a) Can you please confirm the instrumentation the lab requires? One (1) Urinalysis system would consist of 2 functioning analyzers; specifically, Chemistry and Microscopic analyzers connected. However, they are not redundant instruments and therefore are not a primary and backup.

The requirement is for 1 fully automated urine chemistry analyzer and 1 fully automated urine microscopic analyzer, whose results must be able to be merged automatically (i.e. the primary UA system). In addition, a second automated chemistry analyzer is required (i.e. the back-up), which can be either fully or semi-automated. In sum, 2 urine chemistry analyzers and one microscopic analyzer are required.

b) Is a backup required? If so, can you specify what kind of backup is needed?

A back up is required but only for the urine chemistry portion of testing, not for microscopies.

The SOO has been updated to reflect the following “The Keesler Medical Center at Keesler AFB, Mississippi requires one (1) Urinalysis (UA) system with two (2) functioning analyzers, a Fully Automated Urine Chemistry and Microscopic analyzer, as a primary. A backup chemistry analyzer is required but can be either fully or semi-automated.”

2. Can you please confirm that the actual monthly test counts we should be using?

Varies by month but historically between 500-600 urinalysis chemistries and 300-350 microscopies monthly, this data is pulled directly from the analyzer. The requirement is for 900 UA chemistries and 700 UA microscopies monthly, allowing for returning, and increasing services and reference testing capabilities.

3. Can you please confirm that the spacing dimensions/description of the space provided in 2.1.4 on page 4 is accurate?

The dimensions/description of the space on page 4 are accurate.

4. If there is an established MDERA for Urinalysis instrumentation, are we still required to complete the version 6.4.1 as requested on page 28?

A completed MDERA, version 6.4.1, is required per the solicitation. If an established MDERA is available, that information may be included in the response to the solicitation.

The following have been modified:

STATEMENT OF OBJECTIVES

STATEMENT OF OBJECTIVES

The Keesler Medical Center at Keesler AFB, Mississippi requires one (1) Urinalysis (UA) system with two (2) functioning analyzers, a Fully Automated Urine Chemistry and Microscopic analyzer, as a primary. A backup chemistry analyzer is required but can be either fully or semi-automated. The successful offeror shall furnish all equipment to include instrument installation, set-up, equipment validation (along with the associated supplies and labor), reagents, controls, and any necessary services (e.g., maintenance of furnished equipment) to Keesler Medical Center, Keesler AFB, MS for the purpose of Urinalysis testing under an equipment lease agreement. 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 900 UA chemistry test monthly and 700 UA microscopic exams monthly for 5 years (12-month base plus four 12-month 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, the Contractor must have an approved authority to operate (ATO) 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 Primary and back up analyzer must have a bi-directional interface that can connect to and be fully interoperable with the laboratory information system (LIS), as listed on CSTAR (https://info.health.mil/apps/HIT/cstar/Pages/Systems.aspx). Analyzers will require an approved ATO on the DHA network in order to interface with the LIS. An approved ATO is required prior to use and any subsequent billing. ATO approval must be maintained and valid through the life of the contract.

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

1.3. Each interface 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.

2.1.2. The primary analyzer must be able to perform a complete urinalysis exam to include 12-part macroscopic chemistry (glucose, protein, bilirubin, urobilinogen, pH, blood, ketone, nitrite, leukocyte esterase, clarity, specific gravity and color) and microscopic exam.

2.1.3. The analyzers must meet all necessary power requirements as dictated by the current laboratory workspace. Workspace power is as follows: Power supply must be 120VAC.

2.1.4. Both analyzers and any additional attachments ideally fit in a 30” (depth) x 60 (length) x 50” (height) space limitation. Analyzers must fit within this space to keep from interfering with the specimen window operation. Outlets are approximately 4’ from workbench. The offeror shall provide a diagram or other graphical representation demonstrating how its proposed equipment fits within the prescribed dimensions with its quote.

2.1.5. Each analyzer must be able to perform positive identification of patient samples.

2.1.6. The entire system must have an approved ATO, prior to use and any subsequent billing, for remote connections (internet, cloud, etc.) to be functional and serviceable.

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

2.1.8. Must test for 10 urine chemistries (including specific gravity) and color and clarity.

2.2. Reagents/Consumables.

2.2.1. The Contractor will include all calibrators, controls and reagents and supplies in the contract.

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 College of American Pathologists requirements and troubleshooting of out-of-control assays when calculating the yearly requirements.

2.2.3. Reagents/supplies must be shipped on a regular schedule.

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 (with local service personnel preferred) included with service contract along with all replacement parts, supplies and labor.

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.

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.

3.7. Must have minimal daily (equal or less than 20 minute hands-on), weekly (equal or less than 30 minutes hands-on) and monthly (equal or less than 2 hour hands-on) maintenances.

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, local transportation) expenses to/from Keesler AFB, hotel, and training location (offsite location). Additional training, upon request, for one operator per year per instrument (offsite, 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, troubleshooting procedures, performance of operator level periodic preventive maintenance procedures, and use 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 Laboratory 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.

5.3. 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 quote, including any proposed facility modifications if applicable. (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, normal ranges, and any other required validation studies by a Contractor provided technical service representative (TSR) and/or Clinical Application Specialist (CAS). The TSR and/or CAS should possess a thorough knowledge of method validation/verification. The assigned TSR 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 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 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, 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

(End of Summary of Changes)