Amendment 01_W81K00-24-Q-0066.pdf

W40M USA HCA

MEDICAL READINESS CONTR OFFICE WEST

POC: MEDINA L. WOODSON

3551 ROGER BROOK DR BLDG 3600

FORT SAM HOUSTON TX 78236-6200

0012003461-0001

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

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

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

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

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

FAR (48 CFR) 53.243

The purpose of this Solicitation, Amendment 0001 is to provide the follow ing:

1. Provide the answ ers to the Offeror's questions received in response to the solicitation issued on 10 June 2024.

2. Incorporate the Government response to the revised statement of w ork dated 21 June 2024.

3. Extend the proposal due date and time to Thursday, 27 June 2024 at 9:00 AM CST.

4. All other solicitation terms and conditions remain the same.

1. CONTRACT ID CODE PAGE OF PAGES

1 7

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

16C. DATE SIGNED

BY 21-Jun-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 W81K0024Q0066

X 9B. DATED (SEE ITEM 11)

10-Jun-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

21-Jun-2024

CODE

W40M USA HCA

MEDICAL READINESS CONTR OFFICE WEST

3160 MCINDOE BLDG 1103

JBSA FT SAM HOUSTON TX 78234-4504

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

4. REQUISITION/PURCHASE REQ. NO.

CODE W81K00

FACILITY CODECODE

EMAIL:TEL:

W81K0024Q0066

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:

QUESTIONS & ANSWERS

The Government Response to the Offeror’s questions received on 17 June 2024:

1. Offeror Question - Is the incubation and spin requirement for Anti-Fyb listed correctly? If yes, would an IAT, 15-minute incubation be an acceptable to meet the requirement?

Government Response: Yes, IAT at 15 min would be acceptable, but immediate spin is preferred to complete the testing faster.

2. Offeror Question - Would an alternative solution be considered or acceptable for the Papain-treated

Antibody ID Panel, such as Ficin?

Government Response: Yes, Ficin treated Ab ID Panel is acceptable, but Papain treated Ab ID panel is preferred since this is what we currently use.

3. Offeror Question - Would an equivalent testing solution for the Expanded Rh-Screen be consider, such using selected cells from antibody panel cells?

Government Response: No, we already have antibody panels, we are looking for an Rh Expanded screen panel to screen for alloantibodies in Rh Neg pregnant women who received RHIG. Using the select cells from current antibody panels uses up these cells faster, wasting the rest of the panel.

4. Offeror Question - Would an alternative packaging solution be acceptable for the Antibody ID Panel (16 cell)

Government Response: No, we already have a 10-cell screen antibody panel. We are looking for an expanded 16-cell screen for additional selected cells to assist with antibody detection for our sickle cell patients that already have multiple antibodies that may mask new clinically significant antibodies.

SECTION SF 1449 - CONTINUATION SHEET

The following have been added by full text:

REVISED STATEMENT OF WORK

STATEMENT OF WORK (SOW) / PERFORMANCE WORK STATEMENT (PWS)

Brooke Army Medical Center, Blood Services, Fort Sam Houston, Texas

1. DESCRIPTION OF WORK: Brooke Army Medical Center (BAMC) requires immunohematology benchtop blood banking reagents and antibody identification panels. Total estimated cost is total $555,426.50 for the base year plus four option years. The Contractor shall perform to all the standards contained within this SOW.

1.1. The Contractor shall provide, as outlined below, traditional reagents for immunohematology testing listed in

Table 1. All components outlined will be supplied through a single Contractor (to whom the contract is awarded), including supplies not manufactured or provided by the Contractor. Analytical reagents must be approved by the Food & Drug Administration (FDA).

1.2. Estimated annual volume for base and first option year of performance. Additional option years may see up to a 10% increase per year in test volume.

Traditional Reagents Estimated Annual Volume (Each

ABO Typing Reagents:

Anti-A (10x10 mL) 8 Anti-B (10x10 mL) 8 Anti-D Blend (10x10 mL) 8 Anti-A,B (10x10 mL) 4 Anti-A1 Lectin (1x5 mL) 2

Antigen Typing Reagents:

Anti-C (5 min incub) (1x5mL) 16 Anti-c (5 min incub) (1x5mL) 8 Anti-E (5 min incub) (1x5mL) 16 Anti-e (5 min incub) (1x5mL) 8 Anti-Lea (15 min incub) (1x5mL) 2 Anti-Leb (15 min incub) (1x5mL) 2 Anti-Fya (IAT, 15 min incub) (1x5mL) 12 Anti-Fyb (Imm spin or IAT, 15 min incub) (1x5mL) 12 Anti-K (5 min incub) (1x5mL) 12 Anti-M (5 min incub) (1x5mL) 8 Anti-N (5 min incub) (1x5mL) 4 Anti-S (IAT, 15 min incub) (1x5mL) 4 Anti-s (IAT, 15 min incub) (1x5mL) 4 Anti-Jka (Imm spin) (1x2mL) 12 Anti-Jkb (Imm spin) (1x2mL) 12 Anti-P1 (Imm spin) (1x5mL) 4 Competency Testing Kit (10x2mL) 4

Anti-Human Globulin Reagents:

Anti-IgG (10x10mL) 24

Potentiators:

PEG (10x10mL) 2

Bovine Serum Albumin 22% (10x10mL) 2

LISS Additive (10x10mL) 32

Reagent Red Cells:

Complement (C3) Control Cells (1x3mL) 13

QC Kit (4x10mL) 84

A1 cells (1x10mL) 120

B cells (1x10mL) 120

A2 cells (1x10mL) 13

IgG Sensitized Cells (1x10mL) 120

Antibody Screening Cells (3-cell) (3x10mL) 108

Papain or Ficin-treated Antibody ID Panel (10-cell) (10x5mL) 13

Antibody ID Panel (16 cell) (16x5mL) 13

Expanded Rh- Screen (4x5mL) 13

1.3. The government contemplates a base performance period from 01 October 2024 – 30 September 2025, plus four

(4) Option Years, for twelve (12) months options years from 01 October 2025 to 30 September 2029 for a total of five years. The Contractor shall provide benchtop reagents above for the following Period of Performance:

Period of Performance Estimated Annual Total(s)

Base Year: 01-October-24 – 30-September-25 $111,085.30

Year 1: 01-October-25 – 30-September-26 $111,085.30

Year 2: 01-October-26 – 30-September-27 $111,085.30

Year 3: 01-October-27 – 30-September-28 $111,085.30

Year 4: 01-October-28 – 30-September-29 $111,085.30

Estimated Total: $555,426.50

2. DELIVERIES: All orders will be delivered to the following location:

Brooke Army Medical Center Transfusion Services, Department of Pathology 4th Floor, Room 429-18 3551 Roger Brooke Drive Fort Sam Houston, TX 78234

2.1. The Contractor will provide, upon shipment, an electronic tracking mechanism whereby the Government is able to identify the shipping status of any reagents or materials.

2.2. Deliveries of required items must be in monthly drop shipments or as called in by the COR or ACOR. Large items should be shipped in a split order to arrive 2 weeks apart.

2.3. Orders must arrive no later than one week from the requested date/designated delivery date.

2.4. Any supplies that are placed on back order shall be communicated electronically to the Government, clearly identified on the shipping documents, and delivered in a timely manner, not to exceed ten (10) working days. In the instance a back-order exceeds 10 working days, the Contractor must provide testing services through local sub-contract at their cost.

2.5. Routine or scheduled orders will arrive no earlier than one week before or later than one week after the scheduled date of delivery.

2.6. All reagents/reagent packs shall be provided as follows: Typing and potentiators reagents must have a minimum unopened shelf-life of six (6) months, and reagent red cells must have a minimum unopened shelf life of at least one

(1) month upon receipt by the Government.

2.7. If this shelf-life requirement cannot be met, the Contractor shall (must) identify the guaranteed shelf life after receipt that can be accommodated in their response to the Request for Proposal/Request for Quote.

2.8. Reagents used for troubleshooting analytical systems must be reimbursed (or replaced) by the Contractor at no additional cost.

2.9. Emergency orders will be delivered within 24 hours after the order is placed.

2.10. An alternate quality control material must be provided by the contractor if the new lot of controls cannot be delivered one week prior to the expiration date of the lot currently in use.

2.11. Preservation and packing shall be performed in accordance with the best commercial practice and in such a manner to afford adequate protection against any damage during shipment from source to destination. All packaging and shipping information shall be clearly marked as to contents on both the shipping documents and the shipping container/box.

2.12. Reagents/materials must be maintained at the proper storage temperature during transportation from the Contractor’s storage facility to the Government acceptance site and be delivered on time at the appropriate storage temperature.

2.13. All deliveries will be made Monday through Friday, to exclude Federal Holidays.

3. CONTRACTOR REQUIREMENTS

3.1. This contract is a non-personal services contract under which the personnel rendering the services are not subject, either by the contract's terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the government and its employees.

3.2. The Contractor shall provide safety data sheets (SDS) for each item delivered under this contract that is considered to be hazardous material. The SDS shall contain information on the hazards associated with each specific chemical or material. The SDS shall be printed in the English language and shall contain as a minimum the following information: identification of the specific hazard, the required practice for the safe use of the product, first aid procedures, and what to do in the event of a spill or other mishap or accident.

3.3. The Contractor shall submit reports to the COR or Contracting Officer as requested for use in monitoring Contractor performance.

4. BILLING AND PAYMENTS.

4.1. Payment will be made by Defense Finance and Accounting Service, (DFAS Indianapolis), Indianapolis, IN (address in Block 18a), after receipt of services. Contractor submits their 2-n-1 invoice in the Wide Area Workflow (WAWF) system for payment. The Contracting Officer's Representative (COR) shall verify for acceptance to be submit to DFAS Indianapolis. Government Payment will only be authorized for services actually rendered. Advance payments under this contract are not authorized.

4.2. The vendor must identify and train how to retrieve the required workload document from the analyzers for appropriate billing.

4.3. The vendor must provide a reagent list with each fixed price for the appropriate test upon award of the contract to the COR. This will be the firm, fixed price for the entire term of the contract to include option years.

4.4. BAMC COR will submit this document for billing to the vendor on the 1st of each month for the previous month. The vendor must supply the POC for who will receive these for billing.

4.5. The vendor must bill in WAWF within 30 days of receiving the billing statement.

4.6. The vendor must attach an itemized invoicing in order for invoices to be paid.

4.7. The contractor shall submit monthly, in arrears, itemized invoices in accordance with DFARS 252.232-7003, for services rendered under this contract. Information regarding IRAPT is available on the Internet at https://wawf.eb.mil/.

5. CONTRACTOR CONDUCT

5.1. The Contractor is responsible for the conduct of his/her employees. All services shall be provided in accordance with established standards, principles, and ethics of the profession and applicable professional specialty organizations and shall ensure the highest regard to patient dignity.

5.2. Complaints. Complaints will be validated by the COR and be reported in writing to the Contracting Officer and the Contractor for action, if it constitutes a failure to perform, as determined by the Government. The Contractor shall have no more than one substantiated complaint for each period of performance.

5.3. Contractor Representation. The Contractor shall designate a Contract Officer Technical Representative (COTR) for the contract. The COTR shall be the only authorized representative of contractor authorized to discuss with the COR, any and all sustainment services required by the contract and ensure response to requests for performance of the contract. The COTR shall have the authority to make decision for the Contractor. The Contracting Officer or the COR shall be notified promptly whenever the POC changes. COTR shall be submitted no later than 10 days after award of contract, and shall include as a minimum name, title, and telephone number.

6. PERFORMANCE MEASUREMENT. The following performance objectives and measures will be used to evaluate Contractor performance and compliance under the contract. This information will be used to prepare annual past performance evaluations. See Exhibit 1, Quality Assurance Surveillance Plan (QASP), for additional details.

PERFORMANCE

REQUIREMENT

PERFORMANCE

STANDARD

PERFORMANCE

LEVEL

SURVEILLANCE

METHOD

1. The Contractor delivers reagents within one (1) week after delivery is requested.

SOW Para 2.5

Agents delivered as required. Meets – 100% based on the number of reagents delivered each month

Review of delivery documents. Technical Evaluator Monitors

2. Packaging and temperature control requirements for all Reagents and Supplies. SOW Para 2.12.

Meets packaging and temperature controls as required.

Meets – 100% based on Each shipment of supplies and reagents.

Inspection upon receipt. Technical Evaluator and COR

3. Reagent replacement at no cost SOW Para 2.8.

Performed by the technologist, QA must perform within historical records established and be within federal and manufacturer limits. QC discrepancies/problems will be handled by the vendor and may result in refund or additional kits to replace those used to malfunction with QC material.

Meets – 100% Technical Evaluator

4. WAWF/Payment SOW Para 4.5.

Vendor must submit payment request within 30 days of receiving order at BAMC.

Vendor must submit itemized invoice to accompany the request for payment.

Meets – 100% COR

6.1 The inspection and acceptance point for all services rendered under this contract will be by the BAMC Transfusion Services. The performance by the Contractor shall be subject to continuous inspection, surveillance, and review for acceptance by the Contracting Officer Representative (COR) or designated representative. The purpose of this section is to list the contract requirements considered most critical to acceptable contract performance.

6.1.1. Show the maximum allowable degree of deviation from perfect performance for each requirement or Minimum Acceptable Standards (MAS) that will be allowed by the Government before contract performance is considered unsatisfactory.

6.1.2. Explain the Quality Assurance methods the Government will use to evaluate the Contractor’s performance in meeting the contract requirements.

6.2. The Government’s primary quality assurance procedures are based on variability seen in short- and long-term quality control performance (accuracy and precision of instrument performance), shelf life of reagents (whether the reagents are supplied with the requisite shelf life remaining and whether reagent performance is stable up to the advertised expiration date), stability of test calibrations (whether excessive re-calibrations are required), reproducibility of Analytic Measurement Range at 6 month intervals, proficiency test performance, frequency and duration of instrument downtime, Contractor response to requests for assistance/repair of the instruments, and customer complaints.

6.3. Criteria for acceptable and unacceptable performance will be based on the MAS for each contract requirement.

When the number of defects in the Contractor’s performance which are discovered by the COR exceeds the unacceptable level, the Contracting Officer may complete a CDR. The CDR requires the Contractor to explain, in writing, why performance was unacceptable, how performance will be returned to acceptable levels and how recurrence of the problem will be prevented in the future.

End of document.

(End of Summary of Changes)