F107--Cleanroom Environmental Monitoring and Training
1. INTRODUCTION:
This notice is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Department of Veterans Affairs (VA). The VA is currently conducting market research to locate qualified, experienced and interested potential sources. Responses will not be considered as quotes, nor will any award be incurred by interested parties in responding to this sources sought announcement.
NCO 1 Contracting is seeking interested sources for a future solicitation and procurement. Currently, no solicitation exists. This requirement is for Compounding Cleanroom Environmental Monitoring and Training at the Manchester, NH Veterans Affairs Medical Center.
Manchester VAMC
718 Smyth Road
Manchester NH 03104-7007
2. BACKGROUND:
The Manchester VAMC is located at: 714 Smyth Road Manchester, NH 03104. This location has a compounding suite that adheres strictly to USP guidelines. Adhering to the applicable directives referenced below helps reduce the potential for bacterial contamination of compounded products.
3. SCOPE:
The Contractor shall provide all necessary personnel, supervision, labor, equipment, materials (Including gowning materials/sterilized jumpsuits and environmental monitoring tools) and disposal necessary to successfully support the Manchester VAMC USP compounding areas. All services shall be performed in accordance with the Performance Work Statement, terms and conditions specified in the solicitation and the applicable directives described below . The resulting contract will cover a minimum of twelve (12) months from start date.
The company must be able to provide primary services as called out in this performance work statement and the Manchester VAMC Pharmacy IV Room Standard Operating Procedure (SOP). The contractor (per evaluation by the Contracting Officer) must be financially responsible, show evidence of their reliability, ability and experience performing in sterile compounding environments and USP 797/800 environmental monitoring. The contractor and personnel directly employed or supervised by them must render prompt, detailed service in accordance with the applicable directives referenced in this document. The Contractor shall be licensed by the State or local health authority in those localities where licenses are required.
Contractor personnel shall be trained appropriately and deemed competent for performance of work under this contract. Each serviceman designated by the Contractor to perform work under this contract shall be cleared for access through restricted areas of customer s facilities. The Contractor shall conform to all Federal, State, VA and local regulations governing Environmental Monitoring in USP environments. This includes the use of any related chemicals and equipment. The company must furnish a copy of state certification to perform contracted service. The company must provide this documentation to the Contracting Officer prior to performing any work under the contract. All chemical (SDS) or control substance used to perform service must be submitted and filed with the Contracting Officer s Representative (COR).
All company servicemen shall have their name and their company s name indicated on their uniform or a name badge all the time, so they are easily recognizable as a contractor employee. In cases when contractor has two or more employees reporting to work, under this contract one of these employees shall be designated as a supervisor/foreman. The supervisor shall be fully knowledgeable of the location and work site to perform USP Environmental Monitoring Services. On each visit the company servicemen shall report to the COR or his designee prior to performing services. The employee(s) shall provide approved Environmental Monitoring service on a routine basis without deviation. These services may be discussed and agreed upon by the employees of each department and the approved contractor. If services are interrupted the contractor must contact pharmacy management within the pharmacy department to provide a follow up date and time to complete cleaning and monitoring procedures per protocol. At time of contract award the Contractor will be supplied with a list of the COR s on site representatives for each location.
Applicable Directives
USP 797 (Most Recent Version)
USP 800, Hazardous Compounding (Most Recent Version)
Manchester VAMC Pharmacy IV Room Standard Operating Procedures
Vendor will stay appraised of current related USP directives to ensure optimal Environmental Monitoring support to Manchester VAMC. Vendor will keep the COR informed on relevant changes to USP guidance in an effort to facilitate continuous improvement.
Performance Requirements (Tasks)
Description of Services:
Environmental Monitoring (On Site Sampling, Laboratory Analysis/Reporting)
These services are to be conducted in support of the following locations:
Note: A representative floor plan is attached to the solicitation.
Room E124-A NON-HAZ Ante Room, area 144.2sf. ISO 7
Room E123- HAZ Clean Room, area 88.1sf. ISO 7
Room E125 NON-HAZ Ante Room, area 88.1. ISO 7
Environmental Monitoring
Contractor will provide on- site MONTHLY clean room Environmental Monitoring services for 1 ante room area, 2 NuAire Pharmagard model NU-NTE 800-400 Compounding Aseptic Containment Isolators (including the rooms they are in) and 1 NuAire Pharmagard Compounding Aseptic Isolator model NU-PR797-400 Cabinet. These monthly services must be provided Monday through Friday (excluding federal holidays) between the hours of 8:00 am 4pm, as negotiated with the COR s specific site representative. The environmental surface testing must be completed by an independent biology lab that is not in direct supervision of the Cleanroom Cleaning contractor. The contractor must collect the samples from the site and deliver the samples to be evaluated to the laboratory that same day before close of business, on the day of sample. There will be no shipping of samples via air/train/mail system outside of the New England area. Plates will be stored in accordance with the manufacturers guidelines before and after use.
The Contractor shall utilize a laboratory that is FDA registered and/or accredited by the American Industrial Hygiene Association (AIHA) or the American Association for Laboratory Accreditation (A2LA) for analysis and reporting of the samples collected. The reports are then to be provided to the Contracting Officer s Representative (COR).
The environmental monitoring report should identify the following:
i. Media used/lot numbers of medias and corresponding expiration dating
ii. Location of samples taken (with corresponding map)
iii. Equipment used (calibration date)
iv. Surface testing (tests must include medias used to identify mold, yeast, gram positive bacteria and gram-negative bacteria)
v. The identifiable bacteria including genus and species
Samples to include:
i. 12 surface samples /E123 (total: 2 cabinets x 1 room with 2 surface samples) and 2 samples from compounding aseptic containment isolator.
ii. 8 surface samples/E124 Ante room
iii. 10 surface samples/E125 (Total: 1 cabinet x per 1 room x 3 surface sample), 2 sample per compounding aseptic isolator.
The contractor will provide environmental monitoring on a monthly basis without interruption. In the event that the contractor cannot meet these monthly requirements it is up to the contractor to provide a contingency date to fulfill the work order/contract details.
The contractor must use current USP standards and the Manchester VAMC standard operating procedure when evaluating bacterial growth within the ante room and buffer areas. If the colony counts exceed the parameters defined in the Manchester VAMC Pharmacy IV Room SOP, the contractor will notify the pharmacy service.
The contractor will also identify high-risk organisms (yeast, mold, gram negative bacteria and coag positive Staph) within the monthly surface sampling. High-risk organisms include staph, yeast, mold as outlined in the referenced guidelines. If a high-risk organism is found within the hazardous or non-hazardous rooms, the contractor will notify the pharmacy department in a timely manner and identify the organism genus and species. The pharmacy department will implement an action plan as follows:
i. Identify the source of the high-risk organism
ii. Initiate a cleaning process (clean the area three times) to eliminate the fungal/bacterial growth
iii. Re-test the affected area
iv. Shorten beyond use dating until environmental monitoring reports are clear
The Contacting Officer s Representative (COR) or their site representative from the corresponding campus will coordinate the timing of the re-cleaning/re-testing of the affected area(s) with the respective Contractors and internal departments as necessary.
Cleanroom Training
i. Training of BHS staff
Contractor will perform employee training and certification regarding gowning procedures (garments provided by the contractor). The contractor must be well versed in maintaining aseptic technique and educate the pharmacy department regarding proper disposal of items which are used by the contractor. This training will need to include the entire clean room team at all locations (Total of 55 personnel combined). Contractor will be available for additional training services for new employees.
Once annual VA employee testing is completed (gowning technique, fingertip testing for regular garbing and glove box technique) the contractor will provide certification to the pharmacy department.
All proficiency tests will be scheduled in advance to allow the pharmacy department adequate central coverage.
4. OBJECTIVES:
Manchester VAMC is looking for small business concerns, especially Service-Disabled Veteran Owned Small Business (SDVOSB) and Veteran Owned Small Business (VOSB) contractors that can provide the requested related services for Providence VAMC within VISN 1. All capable companies are encouraged to respond. The current primary NAICS code is 541380 (Testing Laboratories).
5. SUBMITTAL INFORMATION:
Contractors having the skills and capabilities necessary to perform the stated requirements
should submit a response as detailed below. Companies should provide clear and unambiguous evidence to substantiate their capability to fulfill the requirements above. Interested parties shall furnish the following minimum information:
I. Company name and address ensure your company is registered in the System for
Award Management (SAM) at beta.sam.gov.
II. Company point of contact name, telephone number, and email address.
III. Evidence that you are a small business (if applicable):
· Small Business ensure you are listed as small business in SAM, reps and certifications. Provide the NAICS codes you are listed as a small business under. · SDVOSB or VOSB (or in the process of certification) ensure you are certified in the veteran database at www.vetbiz.gov. Provide evidence of certification.
IV. If your company holds a Federal Supply Schedule (FSS) Contract, list the Contract
Number and SINs.
V. Capabilities/Qualifications: A written response providing clear and unambiguous
evidence to substantiate the capacity to fulfill this requirement. Description of the capabilities/qualifications/skills your company possesses to perform services described
above.
VI. Past Experience: Brief summary of the company history relative to similar requirements.
Response may provide information on a maximum of three similar projects for which the
responder was a prime or subcontractor.
It is requested that the above information be provided no later than October 12th, 2020 at 4:30PM
EDT. Responses should be emailed to the contracting specialist at cory.dionne@va.gov.
36C24121Q0004 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 1
11/5/20, 7:42 AM DRAEGER
This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. The solicitation number is NCOA00011A and is issued as a Request for Quote (RFQ), unless otherwise indicated herein. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2022-03. The associated North American Industrial Classification System (NAICS) code for this procurement is 325998 with a small business size standard of 500.00 employees. This requirement is a Small Business Set-Aside and only qualified sellers may submit bids. The solicitation pricing on https://marketplace.unisonglobal.com will start on the date this solicitation is posted, and, unless otherwise displayed at https://marketplace.unisonglobal.com, will end on: 2022-02-07 15:00:00.0 Eastern Time. This time supersedes the Offers Due Time listed above. FOB Destination shall be Fort Leonard Wood, MO 65473The MICC End User requires the following items, Brand Name Only (Exact Match), to the following: LI 001: Mask FPS 7000 Small (2018 ed.) - P/N: R63090 +Wireless "HUD" - P/N: 3356555, 4, EA;LI 002: Mask FPS 7000 Medium (2018 ed.) - P/N: R63091 +Wireless "HUD" - P/N: 3356555, 20, EA;LI 003: Mask FPS 7000 Large (2018 ed.) - P/N: R63092 +Wireless "HUD" - P/N: 335655, 4, EA;LI 004: SCBA Assembly PSS 7000, HP, QC w/Sentinel 7000 - P/N: 3367105 +40" Buddy Breather - P/N: 3367426 +UEBSS Bag - P/N: 3367467 + Rigid Orange SCBA Case - P/N: 4059430, 28, EA;LI 005: Cylinder 4500 PSI carbon, blue, HP 60 min - P/N: 4055699 +Not drained - P/N: DN +Quick connect adapter HP - P/N: 4046162, 28, EA;LI 006: HUD (spare), 1, EA;LI 007: Sentinel Docking Station & PC link Software, 1, EA;LI 008: Charging adapter HP for Compressor, 2, EA;LI 009: FPS 7000 Spectacle Kit, 1, EA;LI 010: PSS 5/7000 LDV 2018 Edition (spare), 1, EA;LI 011: FPS 7000 Small Mask (hairnet standard included), 1, EA;LI 012: FPS 7000 Med Mask (hairnet standard included), 1, EA;LI 013: FPS 7000 Large Mask (hairnet standard included), 1, EA;LI 014: FPS COM 5000 P VA (Voice Amp only), 2, EA;Solicitation and Buy Attachments***Question Submission: Interested Offerers must submit any questions concerning the solicitation at the earliest time possible to enable the Buyer to respond. Questions must be submitted by using the 'Submit a Question' feature at https://marketplace.unisonglobal.com. Questions not received within a reasonable time prior to close of the solicitation may not be considered.***For this solicitation, MICC End User intends to conduct an online competitive reverse auction to be facilitated by the third-party reverse auction provider, Unison Marketplace. Unison Marketplace has developed an online, anonymous, browser based application to conduct the reverse auction. An Offeror may submit a series of pricing bids, which descend in price during the specified period of time for the aforementioned reverse auction. MICC End User is taking this action in an effort to improve both vendor access and awareness of requests and the agency's ability to gather multiple, competed, real-time bids. All responsible Offerers that respond to this solicitation MUST submit the pricing portion of their bid using the online exchange located at https://marketplace.unisonglobal.com. There is no cost to register, review procurement data or make a bid on https://marketplace.unisonglobal.com. Offerers that are not currently registered to use https://marketplace.unisonglobal.com should proceed to https://marketplace.unisonglobal.com to complete their free registration. Offerers that require special considerations or assistance may contact Marketplace Support at 1.877.933.3243 or via email at marketplacesupport@unisonglobal.com. Offerers may not artificially manipulate the price of a transaction on https://marketplace.unisonglobal.com by any means. It is unacceptable to place bad faith bids, to use decoys in the https://marketplace.unisonglobal.com process or to collude with the intent or effect of hampering the competitive https://marketplace.unisonglobal.com process. Should Offerers require additional clarification, notify the point of contact or Marketplace Support at 1.877.933.3243 or marketplacesupport@unisonglobal.com.Use of Unison Marketplace: Buyers and Sellers agree to conduct this transaction through Unison Marketplace in compliance with the Unison Marketplace Terms of Use. Failure to comply with the below terms and conditions may result in offer being determined as non-responsive.This is currently an unfunded requirement with a high expectation that funds will be available. When and if funds become available a contract will be awarded at that time.The offeror must comply with the following commercial item terms and conditions: FAR 52.252-1, Solicitation. Provisions Incorporated by Reference; FAR 52.212-1, Instructions to Offerors; 52.212-3, Offeror Representations and Certifications; FAR 52.211-6, Brand name or Equal.The following clauses apply to this solicitation: FAR 52.212-4, Contract Terms and Conditions - Commercial Items. The following FAR clauses in paragraph (b) of FAR clause 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items, apply: 52.204-10, Reporting Executive Compensation and First Tier Subcontract Awards; 52.219-6, Notice of Total Small Business Set-Aside; 52.219-28, Post Award Small Business Program Rerepresentation; 52.222-3, Convict Labor; 52.222-19, Child Labor-Cooperation with Authorities and Remedies; 52.222-21, Prohibition of Segregated Facilities; 52.222-26, Equal Opportunity; 52.222-36, Affirmative Action for Workers with Disabilities; 52.225-13, Restrictions on Certain Foreign Purchases; 52.232-33, Payment by Electronic Funds Transfer--System for Award Management. 52.233-4, Applicable Law for Breach of Contract Claim; The following DFARS clauses apply: DFARS 252.04-7004, Alternate A System for Award Management; 252.211-7003, Item Identification and Valuation; 252.225-7002, Qualifying Country Sources as Subcontractors; 252.232-7010, Levies on Contract Payments; 252.203-7000, Requirements Relating to Compensation of Former DoD Officials; 252.225-7001, Buy American Act and Balance Of Payments Program; 252.225-7036, Buy American Act -- Free Trade Agreements -- Balance of Payments Program; 252.232-7003, Electronic Submission of Payment Requests; 252.247-7023, Primary and ALT III, Transportation of Supplies by Sea.IAW 52.204-7 System for Award Management (SAM) Registration (July 2013), the offeror must be registered in SAM and fully input their Representations and Certifications for a complete record. Information can be found at http://www.sam.gov or by calling 866-606-8220, or 334-206-7828 for international calls. 52.204-13 - System for Award Management MaintenanceShipping is FOB Destination CONUS (CONtinental U.S.).New Equipment ONLY. NO USED OR REMANUFACTURED PRODUCTS WILL BE ACCEPTED.Submitted Quotes will be valid for 45 days after the auction closing.This solicitation is issued as a Request for Quotation (RFQ), not an invitation for bid (IFB).).IAW FAR 52.252-2 Clauses Incorporated by Reference, the full text of FAR and DFARS Clauses may be accessed electronically at http://farsite.hill.af.mil; and are current to the most recent revision dates posted on this site.The associated North American Industrial Classification System (NAICS) code
for this procurement can be found. The small business size
standard for that NAICS code can be found at https://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf"52.204-9, Personal Identity Verification of Contractor Personnel; 52.204-10,
Reporting Executive Compensation and First-Tier Subcontract Awards; 52.222-41, Service Contract Act; 52.237-2, Protection of Government
Buildings, Equipment and Vegetation; 252.201-7000, COR Clause; 252.223-7006,
Prohibition On Storage And Disposal Of Toxic And Hazardous Materials;
252.243-7001, Pricing of Contract Modifications; 252.246-7000, Material
inspection and receiving report"Representation by Corporations Regarding an Unpaid Tax Liability or a Felony Conviction under any Federal Law.Wide Area WorkFlow Payment Instructions252.204-7012 Safeguarding of Unclassified Controlled Technical InformationAll deliveries shall be palletized when the material exceeds 250 lbs. (excluding the pallet), or exceeds 20 cubic feet, to comply with the requirements of Department of the Army Pamphlet 700-32 and MIL-STD-147E.IAW FAR 52.212-2; Evaluation - Commercial Items, the following factors shall be used to evaluate offers: technical capability of the item offered to meet the Government requirement and price. Technical capability is more important than price."No multiple awards will be made. Quotes received through Unison Marketplace will be evaluated and awarded on an all-or-nothing basis.5152.233-4000 AMC-LEVEL PROTEST PROGRAM (Feb 2014) (LOCAL CLAUSE) Prior to submitting an agency protest, it is preferable that you first attempt to resolve your concerns with the responsible contracting officer (Phone: (315)772-7272 or Email: usarmy.drum.acc-micc.mbx.micc@mail.mil). However, you may also file a protest to the Headquarters (HQ), Army Materiel Command (AMC). The HQ AMC-Level Protest Program is intended to encourage interested parties to seek resolution of their concerns within AMC as an Alternative Dispute Resolution forum, rather than filing a protest with the Government Accountability Office (GAO) or other external forum. Contract award or performance is suspended during the protest to the same extent, and within the same time periods, as if filed at the GAO. The AMC protest decision goal is to resolve protests within 35 calendar days from filing. To be timely, protests must be filed within the periods specified in FAR 33.103. If you want to file a protest under the HQ AMC-Level Protest Program, the protest must request resolution under that program and be sent to the address below.
Headquarters U.S. Army Materiel Command
Office of Command Counsel-Deputy Command Counsel
4400 Martin Road
Rm: A6SE040.001
Redstone Arsenal, AL 35898-5000
Fax: (256) 450-8840 or email usarmy.redstone.usamc.mbx.protests@mail.mil
The AMC-Level Protest procedures are found at: https://www.amc.army.mil/Connect/Legal-Resources/ .
If internet access is not available, contact the contracting officer or HQ, AMC to obtain the HQ AMC-Level Protest Procedures.Wide Area WorkFlow Payment InstructionsPlease address your questions through the Unison Marketplace buy. If your questions are not being answered in a timely manner, please send your question to the S2P2 Contracting Officer - usarmy.drum.acc-micc.mbx.micc@army.mil or call 315-772-5582.In accordance with DFAR provision 252.225-7000 Buy American Act--Balance of Payments Program Certificate, I certify that each end product, except those listed in paragraphs (c)(2) or (3) of the attached provision, is a domestic end product.
****YOU MUST FILL OUT THE ATTACHED IF OTHER THAN DOMESTIC END PRODUCT IF YOU DO NOT FILL IT OUT AND YOU DELIVER OTHER THAN A DOMESTIC END PRODUCT YOUR DELIVERY WILL NOT BE ACCEPTED********** ****READ DFARs Clause 252.225-7001 to ensure your product comes from a QUALIFYING COUNTRY******* ****IF YOU QUOTE A PRODUCT OTHER THAN DOMESTIC FROM A NON-QUALIFYING COUNTRY YOUR QUOTE WILL NOT BE ACCEPTED*****Representation and Representation DisclosuresReporting During Contract Performance
NCOA00011A Department of the Army Materiel Command Mission and Installation Contracting Command Fort Drum
1/5/22, 12:28 PM Sources Sought for Lead and Asbestos Sampling and Testing Services in Okinawa, Japan
***THIS IS A SOURCES SOUGHT NOTICE ONLY. THIS IS NOT A REQUEST FOR PROPOSAL, REQUEST FOR QUOTE, OR INVITATION FOR BID****
The intent of this notice is to identify qualified and interested offerors for information and planning purposes. The information received will be utilized within the Navy to facilitate the decision making process and will not be disclosed outside of the agency. No reimbursement will be made for any costs associated with providing information in response to this announcement or any follow-up information requests. In accordance with Federal Acquisition Regulation (FAR) 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract.
The US Navy is conducting Market Research, as such this is a Source Sought Notice. Naval Facilities Engineering Systems Command, Far East (NAVFAC FE) Core Execution Team (CET) is seeking potential sources that are capable of providing Lead and Asbestos Sampling and Testing Services in Okinawa, Japan.
The North American Industry Classification System (NAICS) is 561210, Facilities Support Services. This industry comprises establishments primarily engaged in providing operating staff to perform a combination of support services within a client's facilities. Establishments in this industry typically provide a combination of Government base facilities operation support services. These establishments provide operating staff to carry out these support activities; but are not involved with or responsible for the core business or activities of the client.
1. SCOPE OF WORK
The work includes, but is not limited to, all labor, management, supervision, tools, material, and equipment required to perform environmental services at the above locations. The planned services are both of Routine and Emergency works including, but not limited to:
a. Develop lead, asbestos, and/or other Materials suspected of containing lead, arsenic, barium, cadmium, chromium, mercury, selenium, silver (HMCP) sampling plan(s) to identify and specify the sampling methodology and procedures by which samples will be collected, tested, analyzed, and reported. The sampling plan(s) would also identify the location of samples to be taken, the quantities to sample, and the rationale supporting the determination, among other details.
b. Collect, test, and analyze samples of lead, asbestos, and/or HMCP. Complete report of the results and findings.
The Contractor shall provide personnel with the qualifications, technical knowledge, experience and skills required for efficient operations within the Facilities Investment function. Personnel sampling and preparing reports must be qualified per each laws or regulations.
2. CONTRACTOR LICENSE REQUIREMENT
Any contract resulting from this solicitation will be awarded and performed in its entirety in the country of Japan. Contractors must be duly authorized to operate and conduct business in Japan and must fully comply with all laws, decrees, labor standards, and regulations of Japan during the performance of the contract. Contractors must be registered to do business and possess an appropriate license issued by the Ministry of Land, Infrastructure and Transport or prefectural government in order to perform work under this contract.
3. STATUS OF FORCES AGREEMENT
The U.S. Government shall not offer United States Official Contractor status under Article XIV of the U.S.-Japan Status of Forces Agreement (SOFA) under this solicitation. Furthermore, unless specifically provided in the specific task order request for proposal, the U.S. Government shall not certify any employees of a contractor as Members of the Civilian Component under Article I(b) of the SOFA.
4. SUBMITTAL REQUIREMENTS
Interested firms should submit a brief capabilities statement package (up to 12 single-sided pages or 6 double-sided pages, including attachments, single spaced, 12 point font minimum) demonstrating ability to perform the requested services.
The capabilities package must be complete and sufficiently detailed to allow NAVFAC FE to determine the firm’s qualifications to perform the defined work.
Interested firms may submit information using Enclosure (1), Sources Sought Contractor Information Form, to demonstrate capabilities, capacity and experience.
Please respond to this Sources Sought announcement electronically to Mr. Kyle Monma at kyle.monma@fe.navy.mil and Mr. Ross Yamato at Ross.Yamato@fe.navy.mil no later than 1400 PM Japan Standard Time (JST) on Thursday, 24 February 2022.
NO TELEPHONE CALLS OR FACSIMILES WILL BE ACCEPTED.
Responses received after the deadline or without the required information may not be considered. Since this is a Sources Sought announcement only, evaluation letters will not be issued to any respondent.
N4008422R0060 Department of the Navy Naval Facilities Engineering Command
2/15/22, 12:21 AM