SOLICITATION NOTICE
41 -- Pharmacy USP Clean Room
- Notice Date
- 3/1/2021 9:08:37 AM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 333413
— Industrial and Commercial Fan and Blower and Air Purification Equipment Manufacturing
- Contracting Office
- 257-NETWORK CONTRACT OFFICE 17 (36C257) ARLINGTON TX 76006 USA
- ZIP Code
- 76006
- Solicitation Number
- 36C25721Q0500
- Response Due
- 3/15/2021 8:00:00 AM
- Archive Date
- 04/14/2021
- Point of Contact
- Danise Burt, Contract Specialist, Phone: 972-708-0809
- E-Mail Address
-
DANISED.BURT@va.gov
(DANISED.BURT@va.gov)
- Awardee
- null
- Description
- Page 9 of 9 This is a Combined Synopsis/Solicitation for commercial items prepared in accordance with the format in FAR 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only Solicitation; quotes are being requested and a written solicitation will not be issued. Solicitation number 36C25721Q0500 is issued as a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular. The NAICS is 33413, Industrial and Commercial Fan and Blower and Air Purification Equipment manufacturing, and the small business size standard is 500 Employees. In order to be eligible an offeror must be small for the applicable NAICS code at the time of the quote submission and at the time of award. Only qualified offerors may submit bids. Introduction: A Firm Fixed Price award will be made to the lowest priced quote which conforms to the requirements within this solicitation and represents the best price to the Government. Description of Services: The Contractor shall provide all personnel, supervision, transportation, equipment as outlined in the Statement of Work. See the Statement of Work for full details. Place of Performance: Department of Veterans Affairs Medical, Amarillo Health Care System, 6010 Amarillo Blvd, Amarillo TX 79106 Type of Contract: A Firm Fixed Price Base Period of Performance: Base: TBD Site Visit: NA Instructions to Offerors Evaluation FACTORS for Award Evaluation Factors for Award I. Basis of Award The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation meets or exceeds the requirement at the lowest price. The quotes will be evaluated on the basis of the evaluation factors listed below. The area will be evaluated on an ""acceptable"" or ""unacceptable"" basis. DEFINITION RATING Passes (or meets) minimum standard requirements Acceptable Fails to meet minimum standard requirements Unacceptable General. Amarillo VA Health Care System has requirement for a vendor to provide and install USP 797/800 compliant pharmaceutical grade modular rooms, adaptable IV cleanrooms in existing VA Space for VA pharmacy staff with minimal disruption to existing operations. The vendor must provide all labor, materials, supervision, and administration for the installation of the IV Clean rooms and anteroom. Current space is to have all necessary HVAC equipment with humidity controls, exhaust equipment, electrical, plumbing, and data and IT infrastructure for a complete vendor installation. The contractor is to furnish a turn-key installation of pharmacy cleanrooms for both USP 797/800. Scope. The scope of work shall generally consist of, but not necessarily be limited to, providing all labor, materials, tools, equipment, permits for timely installation of USP 797/800 compliant modular clean rooms without major construction. Minimal utility connections such as electrical, water line and drain lines will be provided by the Amarillo VA Health Care System. Contractor will provide all necessary periodic maintenance required to maintain the clean room in operational status that meets USP 797/800 or other regulatory compliance requirements. Clean Room Specifications: One Unit Must provide for USP 797, USP 800, and VA design guidelines compliant Clean/Ante Rooms and must provide guaranteed compliance to comply with rapidly changing compounding rules and regulations. Unit must be self-contained in structure and support and fit into the existing space provided by pharmacy utilizing the current exhaust structure for hazardous compounding. It must contain a positive pressure clean room, a negative pressure clean room with anteroom connectivity and a USP compliant sink/eye wash station. Modular rooms are to fit inside the currently allotted space with automatic glass doors. Must maintain humidity within the structure between 35 to 60% and maintain an adjustable temperature of between 50 to 68 degrees Fahrenheit per current guidelines. Must guarantee compliance of functionality of the clean and ante rooms to meet USP 797/800 performance standards including ISO class certification, differential pressures, and ACPH s with a third-party certification against the above stated standards. Must provide a service that documents clean room compliance for required periodic inspections on the units for audits. Ability to modify, expand, or reduce the unit for any changes due to USP or any other regulations in the future. The ability to move the unit for future facility planning. Must have real time continuous monitoring with alarms that are visible from outside the unit where the pharmacy staff are not required to enter the unit to view: Airborne Particle Levels Air Pressure Levels Temperature Humidity The cleanroom floor and walls shall have smooth non-porous surfaces and seams that can easily be cleaned. The surfaces should be able to be cleaned with USP approved cleaners, disinfectants, and sporicidal agents. Access/Installation The onsite hours of work are from 8:00 AM to 5:00 PM Monday through Friday; any on site work will have to be previously coordinated and approved via email at least 72 hours prior to any work performed. Any work determined by the contracting officer s representative (COR) as having a significant impact on the operations of the facility shall be conducted on an after-hours schedule or limited hours schedule. The Vendor shall follow all federal, state, Veterans Affairs and local code/regulations/standards. The work shall be coordinated through the designated COR, Contraction Officer, or program manager. Contractor Qualifications/ Requirements: The contractor s field personnel shall have training on fundamental practices and precautions within USP 797/800 and operation of ISO 5 clean rooms. (e.g. gowning, gloving, and hand washing procedures). The contractor s Fume Hood, Biological Safety Cabinets (BSC) or testing personnel shall have current certifications showing knowledge on CETA-CAG guidelines. The contractor shall have the capacity to test the clean room HEPA filters at the air handler via large smoke injection machine in addition to handheld wand for filter bypass testing. The contractor must maintain a file sharing website / web-based application that will maintain test results and reports for at least 12 months for the government to access and download. The contractor shall ensure a certification certificate following CETA-CAG is presented to the VA demonstrating compliance with respect to the requirements of USP 797 and or USP 800. The Certificate will show the test date and the expiration date and be signed by a licensed certifying agency. Task Order Service Schedule Amarillo VA Health Care System is requesting this unit to be purchased as soon as possible to prepare for appropriate demolition, vendor production, delivery coordination and installation. Amarillo VA Health Care System must have unit installed and in compliance with the new VHA Directive. Contractor will provide all necessary periodic maintenance required to maintain the clean room in operational status that meets USP 797/800 or other regulatory compliance requirements. Must provide for USP 797, USP 800, and VA design guidelines compliant Clean/Ante Rooms and must provide guaranteed compliance to comply with rapidly changing compounding rules and regulations. Must maintain humidity within the structure between 35 to 60% and maintain an adjustable temperature of between 50 to 68 degrees Fahrenheit per current guidelines. Must guarantee compliance of functionality of the clean and ante rooms to meet USP 797/800 performance standards including ISO class certification, differential pressures, and ACPH s with a third-party certification against the above stated standards. Must provide a service that documents clean room compliance for required periodic inspections on the units for audits. Must provide three (3) years of maintenance and service including audits, software updates as required and other service and maintenance as needed throughout the term of the lease or service and maintenance agreement. Ability to modify, expand, or reduce the unit for any changes due to USP or any other regulations in the future. The ability to move the unit for future facility planning. Must have real time continuous monitoring with alarms that are visible from outside the unit where the pharmacy staff are not required to enter the unit to view: Airborne Particle Levels, Air Pressure Levels, Temperature, and Humidity. The following clauses and provisions apply to this solicitation: 52.209-5, Certification Regarding Responsibility Matters 52.212-3, Offeror Representations and Certifications-Commercial Items 52.212-4, Contract Terms and Conditions-Commercial Items 52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items 52.217-8, Option to Extend Services The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 60 days. Evaluations of Options (July 1990) Except when it is determined in accordance with FAR 17.206(b) not to be in the Government s best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. This includes options under FAR 52.217-8, Option to Extend Services, which applies to this solicitation. Evaluation of options under FAR 52.217-8 will be accomplished by using the prices offered for the last option period to determine the price for a 6-month option period, which will be added to the base and other option years to arrive at the total price. Evaluation of options will not obligate the Government to exercise the option(s). (End of Clause) 52.217-9, Option to Extend the Term of the Contract a) The Government may extend the term of this contract by written notice to the Contractor within 60 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days. The preliminary notice does not commit the Government to an extension. (b) If the Government exercises this option, the extended contract shall be considered to include this option clause. (c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 5 (five) years. The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 60 days. 52.203-17 Contractor Employee Whistleblower Rights and Requirements to Inform Employees of Whistleblower Right 52.203-99 Prohibition of Contracting with Entities That Require Certain Internal Confidentiality Agreements 52.219-14, Limitations on Subcontracting 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) 52.219-8, Utilization of Small Business Concerns (OCT 2014) (15 U.S.C. 637(d)(2) and (3). 52.222-3, Convict Labor 52.222-41, Service Contract Labor Standards (MAY 2014) (41 U.S.C. chapter 67) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards Price Adjustment (Multiple Year and Option Contracts) (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67) 52.222-55, Minimum Wages Under Executive Order 13658 (DEC 2015) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving 52.228-5 Insurance-Work on a Government Installation (JAN 1997) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management 52.237-3 Continuity of Services (JAN 1991) 52.232-39, Unenforceability of Unauthorized Obligations (In the FAR https://www.acquisition.gov/far/html/52_232.html#wp1160005) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (DEC 2013) 52.233-3, Protest after Award (In the FAR https://www.acquisition.gov/far/html/52_233_240.html) 852.203-70, Commercial Advertising (JAN 2008) 852.232-72, Electronic Submission of Payment Requests 852.237-70, Contractor Responsibilities 52.252-1, Solicitation Provisions Incorporated by Reference: This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es). 52.252-2, Clauses Incorporated by Reference: This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address (es). Full text can be obtained at http://www.acquisition.gov/far/index.html 852.219-74 LIMITATIONS ON SUBCONTRACTING MONITORING AND COMPLIANCE (JUL 2018) LIMITATIONS ON SUBCONTRACTING MONITORING AND COMPLIANCE (a) This solicitation includes far 52.219-6, Notice of Total Small Business Set-Aside. (b) Accordingly, any contract resulting from this solicitation is subject to the limitation on subcontracting requirements in 13 CFR 125.6, or the limitations on subcontracting requirements in the FAR clause, as applicable. The Contractor is advised that in performing contract administration functions, the Contracting Officer may use the services of a support contractor(s) retained by VA to assist in assessing the Contractor's compliance with the limitations on subcontracting or percentage of work performance requirements specified in the clause. To that end, the support contractor(s) may require access to Contractor's offices where the Contractor's business records or other proprietary data are retained and to review such business records regarding the Contractor's compliance with this requirement. (c) All support contractors conducting this review on behalf of VA will be required to sign an Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement to ensure the Contractor's business records or other proprietary data reviewed or obtained in the course of assisting the Contracting Officer in assessing the Contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. (d) Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the Contractor to protect proprietary information as required by FAR 9.505-4, Obtaining access to proprietary information, paragraph (b). The Contractor is required to cooperate fully and make available any records as may be required to enable the Contracting Officer to assess the Contractor's compliance with the limitations on subcontracting or percentage of work performance requirement. (End of clause) 852.219-76 SUBCONTRACTING PLANS MONITORING AND COMPLIANCE. AS PRESCRIBED IN 819.7203(C) INSERT THE FOLLOWING CLAUSE: SUBCONTRACTING PLANS MONITORING AND COMPLIANCE (JUL 2018) (a) This contract includes FAR 52.219-9, Small Business Subcontracting Plan, and VAAR 852.219-9, VA Small Business Subcontracting Plan Minimum Requirement. (b) Accordingly, any contract resulting from this solicitation will include these clauses, unless the contract is awarded to a small business concern. The Contractor is advised in performing contract administration functions, the Contracting Officer may use the services of a support contractor(s) to assist in assessing the Contractor's compliance with the plan, including reviewing the Contractor's accomplishments in achieving the subcontracting goals in the plan. To that end, the support contractor(s) may require access to the Contractor's business records or other proprietary data to review such business records regarding the Contractor's compliance with this requirement. (c) All support contractors conducting this review on behalf of VA will be required to sign an Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement to ensure the Contractor's business records or other proprietary data reviewed or obtained in the course of assisting the Contracting Officer in assessing the Contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. (d) Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the Contractor to protect proprietary information as required by FAR 9.505-4, Obtaining access to proprietary information, paragraph (b). The Contractor is required to cooperate fully and make available any records as may be required to enable the Contracting Officer to assess the Contractor compliance with the subcontracting plan. SUBMISSION OF QUOTE (FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL ITEMS): The Offeror shall submit their quote on company letterhead and shall include unit price, overall total price, name, address, and telephone number of the offeror, firm's DUNS# and ORCA document in SAM at www.sam.gov. Complete copy of 52.212-3 Offerors Representations and Certifications- Commercial Items, and ORCA document. The offeror shall provide sufficient evidence that they possess adequate resources, capability, experience, responsibility and integrity to meet the technical capabilities to comply with the requirements of the resulting contract. All quotes received without this documentation will not be considered. Quotes must be received no later than Monday, March 15, 10:00 am CST. Email your quote to danised.burt@va.gov . The subject line must specify 36C25721Q0500 Cleanroom Unit. There will be no automated email notification of receipt of quotes. All quotes received without requested documentation will not be considered. These services are subject to the Service Contract Act and Wage and Determination (WD 15-5227 Rev.-7) which was first posted on www.wdol.gov on 01/01/2019 and can be assessed at https://www.wdol.gov/wdol/scafiles/std/15-5227.txt?v=6 End of Document
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/8eadd6f996b94bdc92fba793cecfafef/view)
- Place of Performance
- Address: Department of Veterans Affairs Amarillo Healthcare System 6010 Amarillo BLVD, Amarillo TX 79106
- Record
- SN05929663-F 20210303/210301230124 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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