Inactive

Page 4 of 4 This is a Sources Sought Notice. (a) The Government does not intend to award a contract on the basis of this Sources Sought or to otherwise pay for the information solicited. (b) Although ... Page 4 of 4 This is a Sources Sought Notice. (a) The Government does not intend to award a contract on the basis of this Sources Sought or to otherwise pay for the information solicited. (b) Although "proposal," "offeror," contractor, and "offeror" may be used in this Sources Sought notice, any response will be treated as information only. It shall not be used as a proposal. (c) Any information received from a contractor in response to this Sources Sought may be used in creating a solicitation. Any information received which is marked with a statement, such as "proprietary" or "confidential," intended to restrict distribution will not be distributed outside of the Government, except as required by law. (d) This Sources Sought is issued by VISN 2 Contracting Office in Syracuse, NY for the purpose of collecting information about Recurring Testing of: Pharmacy and Non-Pharmacy Specific Safety Cabinets, Fume Hoods, Laminar Flow Benches, Room Environments, and HEPA Filters/Filtration Units for the Syracuse VA Medical Center. The VA is seeking to provide for this requirement within 60 days of the award of the contract. The NAICS code identified for this requirement is 621511 Medical Laboratories. The requirement is detailed in the Statement of Work section of this document. (e) Cursory market research has identified several businesses that may be able to provide for this requirement. Contractors that are able to meet the requirements in the attachment are encouraged to email a capability statement and full information to Jason Rundle at jason.rundle@va.gov. Please send all inquiries to: jason.rundle@va.gov by 14:00 pm EST on Tuesday, November 24, 2020. Phone calls will not be accepted. - Part of the purpose of this Sources Sought is to determine the viability of set aside to a specific socio-economic category. Contractors shall identify the NAICS code for the services being offered as well as their size status under said NAICS. This information will be used to determine the viability of a set aside for this requirement. Contractors Shall Also Identify: Federal Supply Schedules that may carry the desired services. Pertinent point of contact for company, contractor DUNS number for size standard and socioeconomic verification in SAM and VIP. Include any relevant comments about the Attachment(s) if applicable. Statement of Work: The Syracuse VAMC located at: 800 Irving Avenue Syracuse, NY 13210 intends to award a firm fixed-price purchase order for: Recurring Testing of Pharmacy and Non-Pharmacy Specific Safety Cabinets, Fume Hoods, Laminar Flow Benches, Room Environments, and HEPA Filters/Filtration Units currently in use at the Syracuse VAMC for a Base Period from 01/01/2021 through 12/31/2021 with the provision of four (4) option years. Note: All equipment and filtration units that require testing are attached to this Statement of Work (SOW). Testing and certification dates contained herein this Statement of Work are best documented; Contractor shall be responsible to confirm and/or adjust certification/testing dates to ensure no lapse in time between the required annual and semi-annual certifications and testing. Hours of Work: Normal business hours, 8:00 am 4:30 pm Monday Friday (excluding Federal Holidays). The following are Federal Holidays observed by the facility and the Contractor shall not expect access to the VA Facility of VA employees on these dates unless notified otherwise by the COR. Preventive maintenance or other services are not to be scheduled on these dates: New Year's Day Birthday of Martin Luther King, Jr. Washington's Birthday Memorial Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day The Contractor shall notify the Contracting Officers Representative (COR) a minimum of five (5) working days prior to visiting the hospital for inspection purposes. This notification is required to ensure that potential hazards of the hoods being inspected will be communicated to the COR prior to beginning inspection. The contractor will be responsible for communicating the potential hazards to the COR. Pharmacy-specific certification scheduling will be approved in advance by Pharmacy Chief. Scope of Work (Non-Pharmacy): A. All non-Pharmacy Biological Safety Cabinets, Atmos Tech in Line HEPA Filtered exhaust fan Attachment A, and laboratory fume hoods Attachment B, shall be tested in accordance with (IAW) the manufacturer s specifications, and IAW the latest version of NSF/ANSI 49 standards, and GP17-A2 Clinical Laboratory Safety Guidelines. B. All Non-Pharmacy Laminar Flow Benches and Dump Station Attachment A shall be tested IAW the manufacturer s specifications, and IAW NSF/ANSI 49 standards, and GP17-A2 Clinical Laboratory Safety Guidelines. Scope of Work (Pharmacy): A. All Pharmacy-specific equipment will obtain CETA certification every six (6) calendar months from the date of last certification/testing of bio-safety cabinets, Compounding Aseptic Isolator see Attachment C, laminar flow hoods see Attachment D, ceiling mounted HEPA filters see Attachment E, and room spaces/environments see Attachment F in accordance with VHA Directive 1108.12, VHA Guidance on Compounding Sterile Preparations Recommendations Segregated Compounding Areas, USP 797 and USP 800. Pharmacy-specific spaces and equipment are broken down as follows: Pharmacy Contingency space (currently room D407 and subject to relocation): one (1) bio-safety cabinet, one (1) compounding aseptic isolator, and four (4) ceiling mount HEPA filters shall be certified and tested in January and July; staggered frequency against primary Pharmacy spaces and equipment to ensure available redundancy in the event of primary space or equipment process interruptions. Contingency space shall be certified semi-annually for non-viable particle counts; contractor shall increase viable count testing to monthly upon implementation of updated USP 797 guidelines and notification from the contract COR. Pharmacy Primary Spaces (B133, B134, B135, B135A, B135B): two (2) bio-safety cabinets, two (2) Laminar Flow Workbenches, and twelve (12) ceiling mount HEPA filters. Quantity five (5) areas shall be certified semi-annually in February and August for non-viable particle counts; contractor shall increase viable count testing to monthly upon implementation of USP 800 guidelines and notification from the contract COR. Certification periodicities shall be confirmed by contractor, post award, and adjusted as necessary to meet the needs of the Syracuse VA Hospital through consolidation of equipment/area due dates. Certification and testing shall conform to USP and OSHA standards. The Contractor shall comply with Federal, State, and Local Laws, plus any Federal Regulations as applicable to the performance of this contract; to include USP 797 and USP 800. The individual performing the testing shall be CETA certified to perform this work, in accordance with USP 797 and USP 800. The contractor shall provide a copy of the individual s CETA credentials prior to start of work. Volumetric air sampling for viable airborne particles must be completed in all classified areas (ISO 5 PEC, ISO 7 & 8 rooms) and must be done using an impaction device during dynamic operating conditions at least every 6 months. Surface sampling of all six (6) classified areas and three (3) pass-through chambers connected to classified areas for microbial contamination must be conducted at least every six months but will increase to at least monthly upon implementation of updated USP 797 standards. Sampling must be performed at the end of compounding activity but before the area has been cleaned & disinfected. Additional Requirements: The contractor shall: Obtain all necessary licenses and/or permits required to perform the work herein. Perform Annual and Semi-Annual certification of Pharmacy-specific equipment contained within Attachment C and Attachment D. Perform semi-annual certification of engineering controls consisting of: Non-viable particle count testing in a Dynamic operating condition ISO Class 8 (FED Class 100,000) Garb Room B133 ISO Class 7 (FED Class 10,000) Sterile Preparation Ante Room B135 ISO Class 7 (FED Class 10,000) Non-Hazardous Compounding B135A ISO Class 7 (FED Class 10,000) Hazardous Compounding B135B Unclassified Space Hazardous Drug Storage Room B134 Segregated Compounding Area/ Contingency Space D407 Measure and document HEPA air volumes and velocities. Measure and document space pressurization in relationship to adjacent room(s): B133 Garb Room B134 Hazardous Drug Storage Room B135 Sterile Preparation Ante Room B135A Non-Hazardous Compounding B135B Hazardous Compounding D407 Segregated Compounding Area/Contingency Space Perform room calculations to determine air changes per hour in each room. Measure and document average air temperature and relative humidity in each room. Perform semi-annual ceiling HEPA filter leak / challenge testing (See Attachment E). Perform semi-annual/monthly (frequency dependent upon USP standards) Viable Environmental Sampling for microorganisms (Bacterial/Fungal counts with ID s). All environmental testing to be performed by accredited laboratory. Each location listed will consist of quantity: one (1) air bacterial, one (1) air fungal, one (1) surface bacterial, and one (1) surface fungal sampling (See Attachment F). Reporting: Certification and Testing and Documentation Layout Pharmacy results only: Contractor shall provide a written report of all testing and certification results, no later than fourteen (14) days following completion of all work. Contractor shall include Summary tables listing all rooms or areas tested and the acceptable limits, actual readings and indication of testing results (e.g. pass/fail) for the designated testing criteria for compliance. Designated testing criteria should include room differential pressure, room air change rates, HEPA Filter leak challenge test, non-viable air particulate, room temperature, and relative humidity. Contractor shall use Attachment G as an example of testing and certification results layout. Emergency Requirements: In order to provide the most efficient service to our veterans, our Pharmacy service may require emergency/short notice certification in the event of any unforeseen facility failure (mechanical, electrical, etc.) or unplanned disruption that causes Pharmacy service to be interrupted. Contractor shall be available to provide on-site CETA certification within 96-hour notice, if required. Representatives of Contracting Officer: The Contracting Officer reserves the right to designate representatives to act for him/her in furnishing technical guidance and advice or generally supervise the work to be performed under this contract. Such designation will be in writing and will define the scope and limitations of the designee's authority. A copy of the designation shall be furnished the Contractor. Safety Requirements: In the performance of this contract, the Contractor shall take such safety precautions as the Contracting Officer or his designee may determine to be reasonably necessary to protect the lives and health of human and animal occupants of the buildings. The Contracting Officer or his designee will notify the Contractor of any noncompliance with the foregoing provisions and the action to be taken. The Contractor shall, after receipt of such notice, immediately correct the conditions to which attention has been directed. Such notice, when served on the Contractor or his representative at the site of the work, shall be deemed sufficient for the purpose aforesaid. If the Contractor fails or refuses to comply promptly, the Contracting Officer may issue an order stopping all or any part of the work and hold the Contractor in default in accordance with the Default clause of this contract. Damage to Government Property From Causes Other Than Contractor's Negligence: Nothing in this contract shall be considered to preclude the Government from receiving the benefits of any insurance the Contractor may carry which provides for indemnification for any loss, destruction of, or damages to property in the custody and care of the Contractor, where such loss, destruction of, or damage is to Government property. The Contractor shall do nothing to prejudice the Government's right to recover against third parties for any loss, destruction of, or damage to Government property and upon request of the Contracting Officer, shall, at the Government's expense, furnish to the Government all reasonable assistance and cooperation (including assistance in the prosecution of suit and the execution of instruments of assignment in favor of the Government) in obtaining recovery.