Q and A HT940624R0001 Coagulation Hemostasis Analyzer.docx
DOCX document 32 KB Posted
- Solicitation number
- HT940624R0001
- Issued by
-
Defense Health Agency
About this file
This document contains questions and answers regarding a solicitation for coagulation hemostasis analyzers. The Naval Medical Center Portsmouth, Virginia requires two coagulation analyzers under a firm fixed price contract for a base year with four one-year options. The analyzers must be capable of performing prothrombin time, activated partial thromboplastin time, fibrinogen, thrombin time, D-dimer, factor assays, heparin assays, protein assays, von Willebrand factor assays, mixing studies, and anti-thrombin III. The laboratory operates 24 hours daily, seven days a week. One analyzer will be used for routine testing while the other is used for special testing two to three days per week. Responses were due under Solicitation HT940624R0001 issued by the Defense Health Agency Southeastern Contracting Division.
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Other files
| File | Type | Posted |
|---|---|---|
| HT940624R0001 Combined Synopsis Amendment 2.docx | DOCX document | |
| Exhibit 3- Pricing Sheet.xlsx | XLSX spreadsheet | |
| HT940624R0001 Combined Synopsis Amendment 1.docx | DOCX document | |
| HT940624R0001 Combined Synopsis Coagulation Hemostasis Analyzer NMC Portsmouth.pdf |
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Text version
Amendment 2-Q&A for HT940623R0014, Coagulation Hemostasis Analyzers and updates the PWS accordingly.
Q1. Is the solicitation for new coagulation analyzers? Or is the intent to retain the current analyzers?
Answer: This solicitation is for new analyzers. The current analyzers are past their life expectancy and the QC module is no longer supported as of October 2023.
Q2. Does the facility have a need for expanded coagulation testing for the future, for example d-Dimer? Or is PT and PTT testing the only tests that will be run on the analyzers?
Answer: There is a complete listing of assays that are currently run as well as news assays and they are listed on the PWS. Please see below. Amendment 1 revised Section 1.3.1.2 to:
Analyzer #1 & Analyzer #2 shall be capable of performing the following test: Prothrombin Time, Activated Partial Thromboplastin Time, Fibrinogen, Thrombin Time, Di-Dimer, All Factor Assays, Heparin Xa (Unfractioned), Low and High Molecular Weight, Protein C, Proteins S, vWfactor Antigen & Activity, Mixing Studies, Anti-Thrombin III, Factor V Leiden.
Q3. Does the facility intend to use each coagulation analyzer on alternating days/weeks? Or does the facility intend to perform testing on both analyzers on all days of operation?
Answer: The analyzers will be for daily routine test (PT/PTT/Fibrinogen/Thrombin Time/D-Dimer) and special testing (remaining assays) 2-3 days per week. (This has been added as Section 1.3.1.4 and the remaining has been renumbered), Q4. We ask this because supply utilization (cost) is greatly influenced. Is the laboratory part of a hospital that is open 24/7, or is it a separate clinic open only during the day?
Answer: Our laboratory is open 24 hours, 7 days a week. Section 1.7.3 has been revised to reflect this.
Q5. Clarification for Six Sigma Analysis Section 5.2 of the PWS: “The Contractor shall provide validation of the equipment following installation with assays that met the Six Sigma Analysis quality performance as approved by the FDA for testing methodologies”.
Answer: The Six Sigma methodology means that the vendor has proved the efficiency of the assays they are marketing and using for validation purposes and has met the approval of FDA to provide means to identify errors or “defects” and reduce variability in reporting results. Section 5.2 has been revised.
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