PWS Template.docx

Quentin N. Burdick Memorial Healthcare Facility

(QNBMHCF)

Pharmacy Department

Performance Work Statement for the USP <797> Sterile Compounding Competency Laboratory Processing and Testing Services

May 2026

Document Revision History

[Example – Post-award]

05/19/2026

0X

0Y

0Z

[Note: The document revision history is most useful for tracking changes in a major acquisition. It may not be needed for less complex acquisitions. Pre-award, it can be used internally by the agency to track the origin of and/or changes to specific requirements (not included in the solicitation when released). Post-award, it can be used to provide a centralized list of changes incorporated by modification.]

Table of Contents

Note that while, as a matter of policy, some agencies require the government to prepare the PWS, the guidance at FAR 37.602(a) stipulates that “a Performance work statement (PWS) may be prepared by the Government or result from a Statement of objectives (SOO) prepared by the Government where the offeror proposes the PWS.”

Performance Work Statement (PWS) for the <Insert Acquisition Title>

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.

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 of this contract shall be from May 1, 2026 through Sept 29, 2026.

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

· 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.

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.

· 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.

· 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:

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:

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.

· 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.

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.]

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:

1.3.3.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

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] Source Selection Information—See FAR 2.101 and 3.104 Developed by Virtual Acquisition Office™ for federal government use and customization.

Table 1: Model for List of Deliverables For fixed-price line items:

OR

Period of performance Destination

OR

Place of performance SOW reference*

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