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Airflow Studies


Maryland, United States
Government : Federal
RFQ
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This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, in conjunction with FAR 13, as applicable, and as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested and a written solicitation will not be issued. Solicitation number NIH-CC-19-016756 is being issued as a Request for Quotation (RFQ). This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisitions Circular Circular FAC 2019-05 (Effective 13 AUG, 2019) (Class Deviation 2018-017).
This acquisition will be processed under Simplified Acquisition Procedures (SAP) and is set aside for small business. Only responsible small business sources may submit an offer that will be considered by this agency. All offers must be received by the response deadline, September 19, 2020, 9:00 a.m. Eastern 

Background:
The Clinical Center (CC) is the clinical research facility of the National Institutes of Health (NIH) and serves as the premier center for clinical research. It provides patient care, services, training, and the environment in which NIH clinicians-scientists translate emerging knowledge into the better understanding, direction, treatment, and prevention of human diseases. The CC, through NIH's Intramural Research Program, provides patient support services for the NIH Institutes that admit patients and health volunteers for the purpose of participating in intramural biomedical research studies.


The CC Pharmacy employs inpatient and outpatient pharmacists and inpatient and outpatient pharmacy technicians. The inpatient section is further divided into Unit Dose and IVAU. The pharmacy is open 24 hours a day, seven days a week. Pharmacists and pharmacy technicians cover approximately 30 or more different shifts during this time period. The Unit Dose section of the Pharmacy Department dispenses unit dose-packaged medications. The IVAU is responsible for the compounding of sterile preparations for clinical use.


Purpose:
The purpose of this solicitation is to procure Airflow visualization studies for the IVAU room to visualize the air flow patterns under static conditions and dynamic conditions to ensure the room(s) demonstrate laminar airflow without any turbulence, eddies, dead-spots or reflux and if these are observed, steps are taken to mitigate them. Static studies are performed with equipment in place but not running and dynamic studies are performed with equipment in place and operational, with the minimum required number of personnel performing routine activity.


Statement of Work:
PROJECT DESCRIPTION
The contractor shall provide an In situ Air Visualization Study (AVS) for two cGMP facilities at the National Institutes of Health (NIH). The first facility is the I-IVAU aseptic processing facility (APF) which operates under, cGMP regulations and USP <797> and <800> standards. The AVS shall include six (6) Primary Engineering Controls (PEC). The PECs shall include 3 Laminar Flow workbenches and 3 Biological Safety Cabinets (BSCs). The second facility is the Center for Cellular Engineering (CCE). The scope the CCE work is limited to one (1) room and a BSC.


Airflow visualization testing will be conducted per NIH Protocol, pre-approved by I-IVAU and CCE management and Quality Assurance (QA). A minimum of three subject matter expert (SME) in airflow visualization testing will be provided by the contractor to execute the study. One of the three SMEs will control the smoke, the second SME will document visualization in the protocol, and the third SME will perform real-time video recording of the protocol execution. The contractors will have authority to direct the work and quality of the airflow visualization testing. The contractor shall furnish all labor, materials, equipment, and supervision necessary to accomplish the work. NIH will provide additional personnel required for dynamic AVS testing. The vendor shall provide resumes of all personnel scheduled to perform work for the NIH at least three (3) business days before the execution of the task. Furnished resumes shall depict the level of experience, education, and training commensurate with AVS testing. The contractor shall follow all facility requirements, e.g. facility entry standard operating procedures. Work will be conducted during normal working hours and may involve multiple mobilizations.


The NIH shall coordinate a kick-off meeting and provide sample deliverables as indicated in the Deliverables and Schedule section.


The contractor shall coordinate and provide cleanroom AVS testing to include the following and as detailed in the Deliverables and Schedule section. The testing shall be performed in Operating-Facility conditions as coordinated with the End User. The contractor shall perform all testing and provide executed protocol, edited and unedited videos, and detailed summary report.


Deliverables and Schedule


1) The NIH shall coordinate a kick-off meeting within 3 days of contract award. The contractor will have the opportunity to review the NIH AVS protocol for completeness and clarity. Contractor may suggest improvements to the protocol for clarity and ease of execution prior to work commencement. All suggested improvements and edits shall comply with applicable regulations and standards.
2) All work shall be conducted utilizing the pre-approved NIH executable protocol and summary report templates.
3) The study will include the introduction of a visible vapor generated from Food Grade Propylene Glycol or Liquid Nitrogen.
4) All video footage shall be captured using HD cameras and not cell phones
5) The executed protocol shall be completed in its entirety by the contactor on the day of execution.
6) The initial edited video files as well as initial summary report shall be made available to the I-IVAU and CCE no more than two weeks post-execution.
7) NIH shall review the submitted summary report and video footage and provide comments and feedback to the contractor.
8) The contactor shall resolve all NIH comments and edits and shall submit the final summary report to NIH for review and approval within two weeks.
9) The contactor shall submit the final edited video and the unedited video to NIH within two weeks post-comment resolution.
10) Video:
a. During video recording a shot marque/cover sheet shall be used to differentiate between each cleanroom and each test, and equipment. The marque/cover sheet shall include the following:
i. Air Visualization Study: I-IVAU/CCE Facility
ii. Protocol Number: XXXXXXXXXXXX
iii. Date of execution: DDMMMYYYY
iv. Room/Equipment Description
v. Test ID:
b. Final edited and unedited video shall be submitted to NIH on USB drives.
11) Protocol
a. Protocols shall be authored and pre-approved by NIH I-IVAU and CCE with input from each facility's Quality Assurance and the contractor.
b. NIH quality assurance shall complete section 13.0 of the protocol prior to execution protocol by the contractor.
c. The contractor shall document all activities required by the protocol in the "performed by" section using Good Documentation Practice (GDP).
d. The I-IVAU and CCE Quality Heads shall complete the "reviewed by" section of the protocol during the initial video footage review.
12) Materials and Equipment
a. The contractor shall disclose the chemical content of all smoke material used to NIH at least four days before protocol execution.
b. The contractor shall provide applicable certifications (i.e. NIST), model and serial numbers for all equipment used during the execution of the protocol.
13) Contractor Qualification:
a. The contractor shall provide qualification documentation of all SMEs performing testing and review of Airflow Visualization study.


14) The contractor shall re-execute the study or portions of the study at no cost to the NIH if quality of Videos are considered unacceptable by NIH smoke studies SME. Examples of such quality issues includes, but is not limited to, inadequate smoke, inaccurate assessments or conclusions in summary reports, and failure to execute protocol.


Working Hours/Duration:
This project task shall be performed during resaonable business hours agreed upon by both NIH and contractor.
Duration: As needed from date of award.
The schedule must be submitted and approved by the Contract Officer in advance of work to be performed. Notify Project Contracts Team, prior to beginning work for verification of location, scheduling, and posting of required (WORK AREA) signs. Contractors must obtain prior-written approval for system shutdown and shutdown must be coordinated and approved by Facility Manager before work can begin.

Period of Performance: Must be scheduled within the month of September, 2019.
FAR Clauses 52.212-4, 52.212-5 and Standard Form 1449 are attached.


Lisa L. Schaupp, Contract Specialist, Phone 3014020735, Email Lisa.Schaupp@nih.gov

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