75H70626Q00199 RFQ.pdf

SEE ADDENDUMIS CHECKED

CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

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

OFFEROR

163IHSBELCOURT CODE 16. ADMINISTERED BYCODE

X

X

X

541380

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED OR163

REQUEST FOR

PROPOSAL

(RFP)

INVITATION

FOR BID (IFB)

10. THIS ACQUISITION ISCODE

REQUEST FOR

QUOTE (RFQ)

14. METHOD OF SOLICITATION

13b. RATING

NORTH AMERICAN INDUSTRY

CLASSIFICATION STANDARD

(NAICS):

SMALL BUSINESS

07/23/2026

701-477-8416JODY KEPLIN

(No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIME

08/06/2026 1200 CT

b. TELEPHONE NUMBERa. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

75H70626Q00199

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 2 IHS1527302OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

TELEPHONE NO.

17a. CONTRACTOR/

15. DELIVER TO

Belcourt ND 58316

P.O. Box 160

1300 Hospital Road

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

$19

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

ISSUE DATE

DELIVERY FOR FREE ON BOARD

(FOB) DESTINATION UNLESS

BLOCK IS MARKED

11.

SEE SCHEDULE

12. DISCOUNT TERMS THIS CONTRACT IS A RATED

ORDER UNDER THE DEFENSE

PRIORITIES AND ALLOCATIONS

SYSTEM - DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

(SDVOSB)

HUBZONE SMALL

BUSINESS

8(A)

Belcourt PHS Indian Hospital WOMEN-OWNED SMALL

BUSINESS (WOSB)

ECONOMICALLY DISADVANTAGED

WOMEN-OWNED SMALL

BUSINESS (EDWOSB)

Belcourt ND 58316

PO Box 160

1300 Hospital Road

Q.N.B.M.H.C.F

BELCOURT SERVICE UNIT

Belcourt ND 58316

PO Box 160

1300 Hospital Road

Belcourt PHS Indian Hospital

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

100 % SB Set Aside, Firm Fixed Price, lab processing and competency testing for the pharmacy department at QNBMHCF in Belcourt North Dakota 58316.

Delivery: 08/31/2027 Period of Performance: 09/01/2026 to 08/31/2027

1 Purchase order for lab processing and competnecy testing from AT Analytical for the pharmacy Continued ...

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

HEREIN, IS ACCEPTED AS TO ITEMS:

DATED

WILLIAM C. KOHL

. YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

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

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

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

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

AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Government Use Only)

OFFER

STANDARD FORM 1449 (REV. 11/2021)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

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

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT: REFERENCE

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32c. DATE 32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

40. PAID BY39. S/R VOUCHER NUMBER38. S/R ACCOUNT NUMBER

37. CHECK NUMBER

FINALPARTIAL

36. PAYMENT

FINALPARTIAL

35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER33. SHIP NUMBER

COMPLETE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

42d. TOTAL CONTAINERS42c. DATE REC'D (YY/MM/DD)

42b. RECEIVED AT (Location)

42a. RECEIVED BY (Print)

41c. DATE41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

STANDARD FORM 1449 (REV. 11/2021) BACK

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

department at QNBMHCF in Belcourt ND Lab processing includes incubation results and reporting of upto 10 customers supplied media products person

2 Parts and Cosumables Shipping coolers and return 18 EA labels

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

2 2 of

Source Selection Information—See FAR 2.101 and 3.104

[This footer applies during internal development of the PWS. Remove the footer when officially releasing the PWS to vendors as a draft for comment or in the formal solicitation]

Performance Work Statement (PWS) for the

<Insert Acquisition Title>

1.0 General

1.1 Introduction

The Quentin N. Burdick Memorial Health Care Facility (QNBMHCF), an Indian Health Service (IHS) facility located in Belcourt, North Dakota, provides comprehensive healthcare services to eligible beneficiaries. The Pharmacy Department supports safe medication preparation and dispensing services in compliance with applicable federal standards and professional practice requirements.

The mission is for laboratory processing and testing services associated with sterile compounding competency testing in accordance with United States Pharmacopeia (USP) <797> standards. The services are required to support compliance with sterile compounding competency requirements and ensure patient safety.

1.2 Objective

The objective of this requirement is to obtain laboratory processing, incubation, analysis, and reporting services for sterile compounding competency testing using Government-supplied media fill kits. The contractor shall provide all required laboratory support services and shipping materials necessary to process and report sterile compounding competency testing results.

1.3 Scope of Work

The contractor shall provide all labor, supervision, materials, equipment, supplies, shipping materials and shipping costs necessary to perform laboratory processing and testing of Government-supplied sterile compounding competency samples.

Services include: incubation and analysis of submitted samples, contamination monitoring, reporting of laboratory findings, and provision of compliant shipping materials and return labels.

The contractor shall support processing of up to eighteen (18) sterile compounding competency samples per submission during the period of performance.

1.4 Background

[USP <797> establishes standards for sterile compounding practices intended to ensure patient safety and reduce contamination risk associated with compounded sterile preparations.

QNBMHCF Pharmacy personnel must complete competency testing to maintain compliance with IHS and applicable USP requirements.

PWS for <Project> Page 1 of 8

Developed by Virtual Acquisition Office™ for federal government use and customization.

The Pharmacy Department requires external laboratory services capable of receiving, processing, incubating, monitoring, and reporting sterile compounding competency test results using Government-provided media fill kits. AT Analytical has been our previous vendor we received services from.

1.5 Type of Contract Contemplated

Firm-Fixed-Price (FFP) contract.

1.6 Period of Performance

The period of performance after award made

1.7 Place of Performance

Government activities shall be performed at:

Quentin N Burdick Memorial Health Care Facility Pharmacy Department 1300 Hospital Loop Belcourt, ND 58316

1.1. Applicable Documents

The contractor shall comply with the following applicable standards and regulations:

• United States Pharmacopeia (USP) <797> Pharmaceutical Compounding – Sterile Preparations

• Federal Acquisition Regulation (FAR)

• Applicable federal, state, and local shipping and laboratory handling regulations

• Applicable Occupational Safety and Health Administration (OSHA) requirements

• Applicable Department of Transportation (DOT) shipping requirements for biological samples

2.0 Specific Requirements/Tasks

2.1 Laboratory Processing and Testing

• Receive Government-supplied sterile compounding media fill kits

• Provide shipping containers and labels

• Perform incubation, monitoring, and analysis of submitted media samples.

• Maintain chain of custody and proper handling procedures for all received samples.

• Conduct contamination analysis in accordance with USP <797> standards.

• Document all laboratory findings and results.

• Process up to eighteen (18) media samples per submission.

PWS for <Project> Page 2 of 8

Developed by Virtual Acquisition Office™ for federal government use and customization.

2.1.1 Sample Integrity

2.1.1. The contractor shall ensure all samples are handled, stored, processed, and analyzed in accordance with industry standards and applicable regulatory requirements.

2.1.2 Reporting

The contractor shall provide written electronic reports documenting:

• Sample Identification

• Incubation Results

• Contamination findings

• Pass/Fail determinations, if applicable

• Date of processing and analysis

Final reports shall be provided electronically within five (5) days following completion of sample incubation and analysis.

2.2 Shipping and Materials

The contractor shall provide:

• Up to eighteen (18) insulated shipping coolers suitable for biological sample transport.

• Prepaid return shipping labels for all sample submissions.

• Packaging materials compliant with applicable federal shipping regulations.

• Shipping Instructions necessary for proper packaging and submissions.

2.3 Regulatory Compliance

The contractor shall:

• Perform all services in accordance with USP <797> standards.

• Maintain all required licenses, certifications, and accreditations necessary to perform laboratory testing services.

• Ensure laboratory procedures comply with all applicable federal, state, and local regulations.

• Maintain confidentiality and integrity of all Government information and testing results.

3.0 Contractor Quality Assurance.

The contractor shall maintain a quality assurance program designed to ensure accurate and reliable laboratory testing and reporting.

Performance standards include:

PWS for <Project> Page 3 of 8

Developed by Virtual Acquisition Office™ for federal government use and customization.

Performance Objective Standard

Acceptable Quality Level (AQL) Surveillance Method

Timely processing of samples

Samples processed upon receipt and according to laboratory procedures

100% COR review of reports

Timely delivery of reports

Reports submitted within required timeframe

95% COR review

Accuracy of testing and reporting

Reports contain complete and accurate results

100% COR review

Provision of shipping materials

Shipping materials and labels provided as required

100% COR review

Regulatory compliance

Compliance with USP <797> and applicable regulations

100% CO and COR monitoring

The Government reserves the right to review contractor performance and inspect deliverables to ensure compliance with contract requirements.

4.0 Delivery or Deliverables

The contractor shall provide the following deliverables:

Deliverable Description Frequency Delivery Method Due Date Shipping Coolers Insulated shipping coolers and materials

As required Physical delivery Prior to sample submission

Shipping Labels Prepaid return shipping labels

As required Electronic or physical delivery

Prior to sample submission

Laboratory Processing

Incubation and analysis of submitted samples

Per submission Contractor laboratory processing

Upon receipt

Laboratory Reports

Electronic reports documenting testing results

Per submission Electronic delivery

Within 5 business days after analysis completion

PWS for <Project> Page 4 of 8

Developed by Virtual Acquisition Office™ for federal government use and customization.

All reports shall be submitted electronically unless otherwise directed by the Contracting Officer or Contracting Officer’s Representative (COR).

Notice to Contractors:

All information and data related to this project that the contractor gathers or obtains shall be protected from unauthorized release and considered property of the Government. The Contracting Officer shall be the only authorized official to approve release of any information pertaining to this contract.

Notice to contractors:

All information and data related to this project that the contractor gathers or obtains shall be both protected from unauthorized release and considered the property of the government. The contracting officer will be the sole authorized official to release verbally or in writing, any data, the draft deliverables, the final deliverables, or any other written or printed materials pertaining to this contract.

Press releases, marketing material, or any other printed or electronic documentation related to this project, must not be publicized without the written approval of the contracting officer.]

5.0 Meetings

Meetings may be conducted virtually, telephonically, or at a Government facility as determined by the government.

5.1 Post-award Kickoff Meeting

Within ten (10) business days of contract award, the Government will conduct a post-award kickoff meeting at <insert location> (specific date and time to be mutually agreed-upon).

5.2 Status Reviews

The Government may conduct periodic status reviews as necessary to discuss contract performance, deliverables, risks, issues, and corrective actions.

6.0 Required Travel and Other Direct Costs (ODCs)

Travel is not anticipated under this requirement.

Any contractor travel requested by the Government must receive prior written approval from the Contracting Officer.

All costs associated with shipping, packaging, laboratory processing, reporting, labor, equipment, and materials shall be included in the firm-fixed-price.

7.0 Special Instructions

• The contractor shall ensure proper handling and processing of sterile compounding test samples.

PWS for <Project> Page 5 of 8

Developed by Virtual Acquisition Office™ for federal government use and customization.

• The contractor shall comply with all applicable USP <797> requirements.

• The contractor shall maintain confidentiality of all Government information.

• Contractor personnel shall comply with all applicable federal, state, and local regulations.

• The contractor shall immediately notify the Government of any issues affecting sample integrity, testing accuracy, or contract performance.

8.0 Government Furnished Property/Equipment/Information

The Government shall provide:

• Media fill kits

• Sterile compounding competency materials

• Samples for testing and analysis

The Government shall package and ship samples using contractor-provided shipping materials and labels.

No Government-furnished equipment is anticipated under this requirement.

9.0 Glossary of Abbreviations and Acronyms

Acronym Definition AQL Acceptable Quality Level COR Contracting Officer’s Representative DOT Department of Transportation FAR Federal Acquisition Regulation FFP Firm-Fixed-Price IHS Indian Health Service OSHA Occupational Safety and Health Administration PWS Performance Work Statement QNBMHCF Quentin N. Burdick Memorial Health Care Facility USP United States Pharmacopeia USP <797> Pharmaceutical Compounding – Sterile Preparations

Source Selection Information—See FAR 2.101 and 3.104

Your agency may have its own preferred restrictive legend. Check with your supervisor, policy department, agency FAR supplement, or the Office of General Counsel.]

PWS for <Project> Page 6 of 8

Developed by Virtual Acquisition Office™ for federal government use and customization.

CONTRACTOR AUTHORITY:

1. Authority

1.1. No person other than the Contracting Officer has authority to bind the Government with respect to this contract.

1.2. No action or omission of any government employee or representative other than the Contracting Officer shall increase or decrease the scope of this contract or shall otherwise modify the terms and conditions of this contract.

1.3. In no event shall any of the following be effective or binding on the Government or imputed to the Contracting Officer with respect to this contract:

1.3.1. An understanding or agreement between the Contractor and anyone other than the Contracting Officer.

1.3.2.A purported modification or change order issued by anyone other than the Contracting Officer.

1.3.3.A promise by anyone other than the Contracting Officer to provide additional funding or make payments; or

1.3.4. An order, direction, consent, or permission from anyone other than the Contracting Officer to:

1.3.4.1. Incur costs in excess of a specified estimated

cost, allotment of funds, or other ceiling; or

1.3.4.2. Expend hours in excess of a specified level of effort.

COR INFORMATION:

Tiffany Parisien Quentin N Burdick Memorial Health Care Facility Belcourt Indian Health Service Pharmacy Administrative Support Assistant 1300 Hospital Loop PO Box 160 Belcourt, ND 58316

Tiffany.Parisien@ihs.gov

[This footer applies during internal development of the PWS. Remove the footer when officially releasing the PWS to vendors as a draft for comment or in the formal solicitation]