Hazardous Drug Sample Analysis

Amendment / Modification

This amendment provides answers to questions previously submitted regarding the solicitation.

• Hazardous Drugs: The PWS lists 6 possible Hazardous Drugs that may be requested: 5-Fluorouracil, Methotrexate, Ifosfamide, Cyclophosphamide Monohydrate, Doxorubicin Hydrochloride, and Paclitaxel. The government will not specify which combination of drugs will be requested for each sample batch.
• Wipes: The Government will supply the wipes.
• Sample Collection: The client (Government) will collect the samples; the contract lab will not perform sample collection.

This amendment addresses questions related to the PWS and general solicitation terms.

No changes to proposal deadlines or submission requirements are indicated by this amendment.

Form / Attachment / Pricing Sheet

This document is a Quality Assurance Surveillance Plan (QASP) for Hazardous Drug Sample Analysis Services. It outlines the government's process for monitoring contractor performance to ensure it meets contract standards. The QASP details what will be monitored, how monitoring will occur, who will conduct it, and how efforts and results will be documented.

• Purpose and Mission: Defines the DHA's vision and mission related to public health services and the specific purpose of the QASP in assessing contractor performance.
• Roles and Responsibilities: Identifies key personnel involved in surveillance, including the Program/Project Manager (PM)/Functional Services Manager (FSM), Contracting Officer (CO), and Contracting Officer's Representative (COR), along with their duties.
• Performance Requirements and Method of Surveillance: Describes how contractor performance will be monitored against performance objectives and standards, using a Surveillance Matrix.
• Performance Rating Definitions: Provides definitions for performance ratings (Exceptional, Very Good, Satisfactory, Marginal, Unsatisfactory) based on FAR 42.1503 Table 42-1.
• Performance Reporting: Outlines the documents used for performance measurement and deficiency reporting, including Corrective Action Reports (CAR), Customer Complaint Forms, and Performance Assessment Reports (PAR).
• Forms: Includes templates for CAR, Customer Complaint Form, and PAR, detailing the information required for each.

This QASP provides insight into how the government will evaluate the contractor's performance. Bidders should review the performance standards, rating definitions, and reporting mechanisms to understand the expected quality of service and the government's oversight process. This information is crucial for developing a robust Quality Control Plan and ensuring compliance with contract requirements.

Performance Work Statement (PWS)

To provide analysis of wipe/swab samples for the presence of hazardous drugs to support pharmacies and Military Treatment Facilities (MTFs) within the Department of War (DoW). This testing is mandated by USP 800 and TB-MED 515 to ensure safety and prevent cross-contamination.

• Perform analysis on government-provided wipe/swab samples for hazardous drugs contamination.

• Provide quality analysis using accredited methodologies.

• Dispose of unused samples according to quality manual/Standing Operating Procedures.

• Supply sampling media upon request.

• Perform analysis within stated turnaround times (TAT): 15 calendar days for STANDARD samples and 8 calendar days for HIGH PRIORITY samples.

• Quality assurance and quality control (QA/QC) protocols must be followed.

• Adherence to chain-of-custody procedures.

• Liquidated damages may be assessed for late or deficient reporting.

• Base Period: 1 May 2026 – 30 April 2027

• Option to Extend Services: 1 May 2027 - 31 October 2027

• Work to be performed at the Contractor's or Sub-Contractor's laboratory facility.

• Contractor must provide all personnel, equipment, supplies, and services necessary for the analysis, except for government-furnished property.

• Contractor must have appropriate laboratory instrumentation and facilities meeting accreditation requirements.

• Contractor must be accredited by a recognized external accrediting body for hazardous drugs analysis.

• Key personnel include a Quality Manager and Program Manager, who must be employees of the laboratory.

• Contractor personnel requiring access to Army installations must complete AT Level I Awareness training.

• Contractor and subcontractors must complete iWATCH Training.

• Deliverables include: NDA, AT Level I Training confirmation, iWATCH Training confirmation, Final PDF Copy, Electronic Data Deliverable (EDD), Monthly Financial Tracking Report, and Results Status Report.

• Government will provide testing swabs/wipes and the Outsource Document.

Solicitation / RFP / RFQ

This solicitation (HT942726QE008) is a Request for Quotation (RFQ) for Hazardous Drugs Sample Analysis (HDSA) Services. The government intends to award a Single Firm-Fixed-Price (FFP) contract with a 12-month base period, potentially including a six-month option to extend services.

• The contractor shall perform Hazardous Drug Sample Analysis services as defined in Section 5 of the Performance Work Statement (PWS).

• The contractor shall provide all necessary personnel, equipment, supplies, facilities, transportation, tools, materials, and supervision, except for government-furnished items.

• The PWS and Quality Assurance Surveillance Plan (QASP) are attached.

• Contract Type: Firm-Fixed-Price (FFP)

• Period of Performance: Base period of 12 months, with an option for a 6-month extension.

• Estimated Value: The NAICS code is 541380 (Testing Laboratories and Services) with a Small Business Size Standard of $19 Million. The estimated award amount is not explicitly stated, but the solicitation references a potential award value of USD 19,000,000.00 in block 13b.

• Quotation Due Date: 24 APRIL 2026 by 11:00 AM Eastern Standard Time.

• Submission Method: Electronic/Digital delivery is required. No hard copies will be accepted.

• Submission Format: The quotation must include two volumes: Technical Capability and Past Performance Volume, and a Cost/Price Volume.

• Evaluation: A BEST VALUE TRADEOFF Source Selection Process will be utilized. Offers will be evaluated on Technical Approach, Past Performance, and Price. The government may award to other than the lowest-priced Quoter.

• Questions Due Date: 20 APRIL 2026 by 1:00 PM Eastern Standard Time (EST).

• This acquisition is UNRESTRICTED.

• NAICS Code: 541380 - Testing Laboratories and Services.

• Small Business Size Standard: $19 Million.

• Offerors must submit signed and dated offers.

• Quotations must hold prices firm for a minimum of 30 days from the submission date.

• The contract will include FAR 52.217-8, Option to Extend Services.

• Payment will be made via Wide Area Workflow (WAWF).