SOLICITATION NOTICE
R -- Service Contract for Sterile Compounding Compliance Quality Program for the North Texas Health Care System
- Notice Date
- 4/16/2020 12:49:37 PM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541620
— Environmental Consulting Services
- Contracting Office
- 257-NETWORK CONTRACT OFFICE 17 (36C257) ARLINGTON TX 76006 USA
- ZIP Code
- 76006
- Solicitation Number
- 36C25720Q0434
- Response Due
- 4/29/2020 12:00:00 AM
- Archive Date
- 05/29/2020
- Point of Contact
- Victoria Rone Victoria.Rone3@va.gov
- E-Mail Address
-
Victoria.Rone3@va.gov
(Victoria.Rone3@va.gov)
- Small Business Set-Aside
- SDVOSBC Service-Disabled Veteran-Owned Small Business (SDVOSB) Set-Aside (FAR 19.14)
- Awardee
- null
- Description
- 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 36C25720Q0434 is issued as a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular. SET-ASIDE: This requirement is a 100% Total Service-Disabled Veteran Owned Small Business (SDVOSB) set aside under the authority of 38 U.S.C. 8127(d). In order to be eligible for award an offeror must be certified/verified in Vetbiz (www.vip.vetbiz.gov), and small for the applicable NAICS code at the time of the quote submission and at the time of award. Status as a qualified SDVOSB concern is under the authority of 38 CFR Part 74 in accordance with the VA Acquisition Regulation (VAAR) Part 819. Eligibility determination is performed by the Center for Veterans Enterprise (CVE). Only qualified offerors may submit bids. NAICS Code: 541620 and Size Standard is $16.5 Million Introduction: The Government intends to award a firm fixed price base with four option year renewal contract based on this solicitation. Description of Services: Network Contracting Office (NCO 17) RPO West is seeking to purchase a service contract for a Sterile Compounding Compliance Quality Management Program the North Texas Health Care System. Type of Contract: A Firm Fixed Price Period of Performance: Base Period: May 1, 2020 April 30, 2021 Option Period One: May 1, 2021 April 30, 2022 Option Period Two: May 1, 2022 April 30, 2023 Option Period Three: May 1, 2023 April 30, 2024 Option Period Four: May 1, 2024 April 30, 2025 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. (End of Clause) 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 Addendum) 52.217-9, Option to Extend the Term of the Contract 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 52.219-8, 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 52.232-19, Availability of Funds for the Next Fiscal Year 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) 52.233-3, 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 VAAR 852.219-10 VA NOTICE OF TOTAL SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESS SET-ASIDE (JUL 2016) (DEVIATION) (a) Definition. For the Department of Veterans Affairs, Service-disabled veteran-owned small business concern or SDVSOB : (1) Means a small business concern: (i) Not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans or eligible surviving spouses (see VAAR 802.201 Surviving Spouse definition); (ii) The management and daily business operations of which are controlled by one or more service-disabled veterans (or eligible surviving spouses) or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran; (iii) The business meets Federal small business size standards for the applicable North American Industry Classification System (NAICS) code identified in the solicitation document; (iv) The business has been verified for ownership and control pursuant to 38 CFR 74 and is so listed in the Vendor Information Pages database, (https://www.vip.vetbiz.gov); and (v) The business will comply with subcontracting limitations in 13 CFR 125.6, as applicable (2) Service-disabled veteran means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16). (b) General. (1) Offers are solicited only from verified service-disabled veteran-owned small business concerns. Offers received from concerns that are not verified service-disabled veteran-owned small business concerns shall not be considered. (2) Any award resulting from this solicitation shall be made to a verified service-disabled veteran-owned small business concern. (c) Agreement. A service-disabled veteran-owned small business concern agrees that in the performance of the contract, the concern will comply with the limitation on subcontracting requirements in 13 CFR �125.6. (d) A joint venture may be considered a service-disabled veteran owned small business concern if the joint venture complies with the requirements in 13 CFR 125.15, provided that any reference therein to SDVO SBC is to be construed to apply to a VA verified SDVOSB as appropriate. (e) Any service-disabled veteran-owned small business concern (non-manufacturer) must meet the requirements in FAR 19.102(f) of the Federal Acquisition Regulation to receive a benefit under this program. (End of Clause) 852.219-74 LIMITATIONS ON SUBCONTRACTING MONITORING AND COMPLIANCE (JUL 2018) LIMITATIONS ON SUBCONTRACTING MONITORING AND COMPLIANCE (a) This solicitation includes VA Acquisition Regulation (VAAR) 852.219-10, VA Notice of Total Service-Disabled Veteran-Owned 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) 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE (JUL 2018) SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE (a) This solicitation includes the clause: 852.215-70 Service-disabled veteran-owned and veteran-owned small business evaluation factors. Accordingly, any contract resulting from this solicitation will include the clause 852.215-71 Evaluation factor commitments. (b) The Contractor is advised that in performing contract administration functions, the Contracting Officer may use the services of a support contractor(s) to assist in assessing Contractor compliance with the subcontracting commitments incorporated into the contract. 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 contract 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 commitments. (End of clause) 52.233-2 SERVICE OF PROTEST (SEP 2006) Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the Government Accountability Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from: Hand-Carried Address: Department of Veterans Affairs VAMC (688) Chief, Contracting (90C) 50 Irving Street NW Washington DC 20422 Mailing Address: Department of Veterans Affairs VAMC (688) Chief, Contracting (90C) 50 Irving Street NW Washington DC 20422 (b) The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO. (End of Provision) VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (OCT 2018) (a) Any protest filed by an interested party shall (1) Include the name, address, fax number, email and telephone number of the protester; (2) Identify the solicitation and/or contract number; (3) Include an original signed by the protester or the protester s representative and at least one copy; (4) Set forth a detailed statement of the legal and factual grounds of the protest, including a description of resulting prejudice to the protester, and provide copies of relevant documents; (5) Specifically request a ruling of the individual upon whom the protest is served; (6) State the form of relief requested; and (7) Provide all information establishing the timeliness of the protest. (b) Failure to comply with the above may result in dismissal of the protest without further consideration. (c) Bidders/offerors and Contracting Officers are encouraged to use alternative dispute resolution (ADR) procedures to resolve protests at any stage in the protest process. If ADR is used, the Department of Veterans Affairs will not furnish any documentation in an ADR proceeding beyond what is allowed by the Federal Acquisition Regulation. (End of Provision) VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018) (a) As an alternative to filing a protest with the Contracting Officer, an interested party may file a protest by mail or electronically with: Executive Director, Office of Acquisition and Logistics, Risk Management and Compliance Service (003A2C), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420 or Email: EDProtests@va.gov. (b) The protest will not be considered if the interested party has a protest on the same or similar issue(s) pending with the Contracting Officer. (End of Provision) PLEASE NOTE: The correct mailing information for filing alternate protests is as follows: Deputy Assistant Secretary for Acquisition and Logistics, Risk Management Team, Department of Veterans Affairs 810 Vermont Avenue, N.W. Washington, DC 20420 Or for solicitations issued by the Office of Construction and Facilities Management: Director, Office of Construction and Facilities Management 811 Vermont Avenue, N.W. Washington, DC 20420 REQUIRED REGISTRATION WITH CONTRACTOR PERFORMANCE SYSTEM (CPARS): As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates contractor past performance on all contracts that exceed $100,000 and shares those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database, the Contractor Performance System (CPARS), which is maintained by the National Institutes of Health (NIH). The CPS database information is shared with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. Each contractor whose contract award is estimated to exceed $100,000.00 is required to register with the NIH CPS database at the following web address: http://www.cpars.gov/ Training and help in registering can be obtained by contacting the point of contact information listed at this website and the hyper-link for training or by phone at 207-438-1690. For contracts with a period of one year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the contractor s performance annually. Interim reports will be filed each year until the last year of the contract, when the final report will be completed. The report shall be assigned in CPS to the contractor s designated representative for comment. The contractor representative will have thirty days to submit any comments and re-assign the report to the VA contracting officer. The Duncan Hunter National Defense Authorization Act of 2009 (Public Law 110-417) was enacted on October 14, 2008. Section 872 of this Act required the development and maintenance of an information system that contains specific information on the integrity and performance of covered Federal agency contractors and grantees. The Federal Awardees Performance and Integrity Information System (FAPIIS) were developed to address these requirements. FAPIIS is a distinct application that is accessed through the Past Performance Information System (PPIRS) and is available to federal acquisition professionals for their use in award and responsibility determinations. FAPIIS provides users access to integrity and performance information from the FAPIIS reporting module in the Contractor Performance Assessment Reporting System (CPARS), proceedings information from the Central Contractor Registration (CCR) database, and suspension/disbarment information from the Excluded Parties List system (EPLS). 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. The offeror shall meet the limitation in subcontracting clause. The subcontract vendor must be similarly situated in the same The offeror shall outline how they will be in agreeance/compliance with the limitations on subcontracting requirements in 13 CFR �125.6. Any quotes using subcontractors or teaming partners to perform any part of the work must show the subcontractor or teaming partner to be similarly situated as the prime. A similarly situated subcontractors or teaming partners is a company who has the same size standard and NAICS code as the prime offeror/vendor. Similarly situated entity is a subcontractor that has the same small business program status as the prime contractor. This means that: For a HUBZone requirement, a subcontractor that is a qualified HUBZone small business concern; for a small business set-aside, partial set-aside, or reserve a subcontractor that is a small business concern; for a SDVO small business requirement, a subcontractor that is a self-certified SDVO SBC; for an 8(a) requirement, a subcontractor that is an 8(a) certified Program Participant; for a WOSB or EDWOSB contract, a subcontractor that has complied with the requirements of part 127. In addition to sharing the same small business program status as the prime contractor, a similarly situated entity must also be small for the NAICS code that the prime contractor assigned to the subcontract the subcontractor will perform. QUOTE SUBMISSION INSTRUCTIONS AND EVALUATIONS: Evaluation of quotes will be conducted using Simplified Acquisition Procedures in accordance with FAR 13.106-2 Evaluation of Quotes. The Government intends to award one contract resulting from this solicitation. Please read each section below carefully for the submittals and information required as part of the evaluation. Failure to provide the requested information below shall be considered non-compliant and your quote could be removed from the evaluation process. The Government will evaluate quotations using the comparative evaluation process outlined in FAR 13.106-2(b)(3), where quotations will be compared to one another to determine which provides the best benefit to the Government. Therefore, the Government is not obligated to determine a competitive range, conduct discussions with all contractors, solicit final revised quotes, and use other techniques associated with FAR Part 15. The contracting techniques associated with FAR Part 15 are not mandatory. The Government reserves the right to consider a quotation other than the lowest price that provides additional benefit(s). Quotes may exceed minimum requirements of the solicitation. The Government reserves the right to select a quotation that provides benefit to the Government that exceeds the minimum requirements of the solicitation but is not required to do so. Each response must meet the minimum requirements of the solicitation. The Government will award a contract resulting from this solicitation to the responsible vendor whose quote conforming to the solicitation will be most advantageous to the Government, price considered. The following factors shall be used to evaluate quotes: Price (Follow these instructions): Offeror shall complete the Price Schedule, with offerors proposed contract line item prices inserted in appropriate spaces.� Ensure your representations and certifications are complete in the System for Award Management (SAM)( https://www.sam.gov). Otherwise, you will need to fill out solicitation Clause 52.212-3 ""Offeror Representation and Certifications -Commercial Items"" and submit with the quote. Federal Acquisition Regulations require that federal contractors register in the SAM database at http://www.sam.gov and enter all mandatory information into the system. Award cannot be made until the contractor has registered. Offerors are encouraged to ensure that they are registered in SAM prior to submitting their quotation. Past Performance: Provide (3) references of work, similar in scope and size with the requirement detailed in the Performance Work Statement. References must include contact information; brief description of the work completed, and contract # (if relevant).� References may be checked by the Contracting Officer to ensure your company is capable of performing the work outlined in the Performance Work Statement.� The Government also reserves the right to obtain information for use in the evaluation of past performance from any and all sources. The offeror shall utilize the Past Performance Form provided. The Contracting Officer may also use information available in the Past Performance Retrieval System (PPIRS) when evaluating contractor past performance. The contracting will review PPIRS for offerors for the last 3 years. If no past performance is available in PPIRS it will be considered acceptable and or neutral. Technical: The offeror s quote shall be evaluated to determine if the organization has the experience and capabilities to provide the requested services IAW the Performance Work Statement in a timely efficient manner.� The offeror shall provide their relevant experience for at least 2 pharmacy cleanroom certification projects within the past 5 years of the same or similar size, scope and complexity within a state or federal government medical facility. The offeror shall utilize the Relevant Experience Form provided. The offeror shall submit a copy of accreditation certification in Controlled Environment Testing Association s National Board of Testing (CNBT) Sterile Compounding Facilities. The offeror shall submit a copy of accreditation certification from National Safety Foundation (NSF) accredited Biosafety Cabinet Field Certifier. TECHNICAL QUESTION SUBMISSION: Questions must be received no later than April 22, 2020 at 10:00am CST. Email your questions directly to Victoria.Rone3@va.gov. The subject line must specify: RFQ 36C25720Q0434- Questions. There will be no automated email notification of receipt of questions. An amendment/modification to the Solicitation will be posted to FBO answering all questions submitted. RFQ QUOTE SUBMISSION: Quotes must be received no later than April 28, 2020 11:59pm CST. Email your quote directly to Victoria.Rone3@va.gov. The subject line must specify: RFQ 36C25720Q0434.- Quotes/Offers. There will be no automated email notification of receipt of quotes. All quotes received without requested documentation will not be considered. QUOTE SHOULD BE BROKEN DOWN AS FOLLOWS: PRICE/COST SCHEDULE Base Period: May 1, 2020 April 30, 2021 CLIN* DESCRIPTION: YEARLY/ANNUALY ESTIMATED QUANTITY: UNIT PRICE TOTAL PRICE: 0001 LAFW Certifications 12 Months 4 $______ $______ 0002 BSC Certifications 12 Months 14 $______ $______ 0003 CAI Certifications 12 Months 4 $______ $______ 0004 Cleanroom Certifications 12 Months 16 $______ $______ 0005 Viable Air Samplings 12 Months 92 $______ $______ 0006 Viable Surface Samplings 12 Months 276 $______ $______ 0007 Environmental Wipe Samplings 12 Months 12 $______ $______ 0008 Garbing, Hand Hygiene, And Initial Gloved Fingertip Testing 12 Months 40 $______ $______ 0009 Media-Fill Test 12 Months 40 $______ $______ Base Year Total $______ Option Period One: May 1, 2021 April 30, 2022 CLIN* DESCRIPTION: YEARLY/ANNUALY ESTIMATED QUANTITY: UNIT PRICE TOTAL PRICE: 0001 LAFW Certifications 12 Months 4 $______ $______ 0002 BSC Certifications 12 Months 14 $______ $______ 0003 CAI Certifications 12 Months 4 $______ $______ 0004 Cleanroom Certifications 12 Months 16 $______ $______ 0005 Viable Air Samplings 12 Months 92 $______ $______ 0006 Viable Surface Samplings 12 Months 276 $______ $______ 0007 Environmental Wipe Samplings 12 Months 12 $______ $______ 0008 Garbing, Hand Hygiene, And Initial Gloved Fingertip Testing 12 Months 40 $______ $______ 0009 Media-Fill Test 12 Months 40 $______ $______ Option Year One Total: $______ Option Period Two: May 1, 2022 April 30, 2023 CLIN* DESCRIPTION: YEARLY/ANNUALY ESTIMATED QUANTITY: UNIT PRICE TOTAL PRICE: 0001 LAFW Certifications 12 Months 4 $______ $______ 0002 BSC Certifications 12 Months 14 $______ $______ 0003 CAI Certifications 12 Months 4 $______ $______ 0004 Cleanroom Certifications 12 Months 16 $______ $______ 0005 Viable Air Samplings 12 Months 92 $______ $______ 0006 Viable Surface Samplings 12 Months 276 $______ $______ 0007 Environmental Wipe Samplings 12 Months 12 $______ $______ 0008 Garbing, Hand Hygiene, And Initial Gloved Fingertip Testing 12 Months 40 $______ $______ 0009 Media-Fill Test 12 Months 40 $______ $______ Option Year Two Total: $______ Option Period Three: May 1, 2023 April 30, 2024 CLIN* DESCRIPTION: YEARLY/ANNUALY ESTIMATED QUANTITY: UNIT PRICE TOTAL PRICE: 0001 LAFW Certifications 12 Months 4 $______ $______ 0002 BSC Certifications 12 Months 14 $______ $______ 0003 CAI Certifications 12 Months 4 $______ $______ 0004 Cleanroom Certifications 12 Months 16 $______ $______ 0005 Viable Air Samplings 12 Months 92 $______ $______ 0006 Viable Surface Samplings 12 Months 276 $______ $______ 0007 Environmental Wipe Samplings 12 Months 12 $______ $______ 0008 Garbing, Hand Hygiene, And Initial Gloved Fingertip Testing 12 Months 40 $______ $______ 0009 Media-Fill Test 12 Months 40 $______ $______ Option Year Three Total: $______ Option Period Four: May 1, 2024 April 30, 2025 CLIN* DESCRIPTION: YEARLY/ANNUALY ESTIMATED QUANTITY: UNIT PRICE TOTAL PRICE: 0001 LAFW Certifications 12 Months 4 $______ $______ 0002 BSC Certifications 12 Months 14 $______ $______ 0003 CAI Certifications 12 Months 4 $______ $______ 0004 Cleanroom Certifications 12 Months 16 $______ $______ 0005 Viable Air Samplings 12 Months 92 $______ $______ 0006 Viable Surface Samplings 12 Months 276 $______ $______ 0007 Environmental Wipe Samplings 12 Months 12 $______ $______ 0008 Garbing, Hand Hygiene, And Initial Gloved Fingertip Testing 12 Months 40 $______ $______ 0009 Media-Fill Test 12 Months 40 $______ $______ Option Year Four Total: $_______ Total Contract Value: $___________ PERFORMANCE WORK STATEMENT TITLE: Sterile Compounding Compliance Quality Management Plan for the North Texas Health Care System SCOPE: The contractor shall provide all labor, equipment, materials (including specialized replacement parts upon request), supplies, tools, certified personnel, transportation, and travel necessary to perform all facility and personnel related assessments, monitoring, sampling, and testing necessary to supplement the VA North Texas Health Care System (VANTHCS) Sterile Compounding Compliance Quality Management Program. The contractor shall perform routine work detailed in this PWS on a regular schedule, mutually agreed upon by the Contractor and Contracting Officer Representavie (COR). The contractor shall perform unscheduled work or emergency request within seven (7) days of a request from the COR. No additional funding will be provided to pay for travel to the VANTHCS for service. VANTHCS uses a variety of engineering ventilation controls to maintain employee exposures to hazardous air contaminants below applicable regulatory limits. The VANTHCS Pharmacy Service has both Secondary Engineering Controls (SEC) and Containment Secondary Engineering Controls (C-SEC) which make up the USP 797 compliant cleanrooms which contain a variety of Primary Engineering Controls (PEC) and Contaiment Primary Engineering Controls (C-PEC). The PEC includes Laminar Airflow Workbenches (LAFW) and Compounding Aseptic Isolators (CAI) for all other non-hazardous sterile drug compounding and the C-PEC includes Class II Biological Safety Cabinets (Class II BSCs) for hazardous sterile drug compounding. The number of cleanrooms, LAFW, BSC, and CAI in service may change throughout the contract period. Table A is the Government's best estimate of the number and type expected to be tested, sampled, serviced, and certified by the contractor. The Government reserves the right to add and/or delete units as required. VANTHCS requires 40 personnel validations for all personnel responsible for the receipt, storage, compounding, dispense or administration of non-hazardous and hazardous sterile compounded products. All of these validations are done annually. If the numbers of listed items will be exceeded, no work is authorized without the prior written approval of the Contracting Officer (CO) to account for it. PLACES OF PERFORMANCE: VA North Texas Health Care System 4500 S. Lancaster Road Dallas, TX 75216 PERIOD OF PERFORMANCE: Base Period: May 1, 2020 April 30, 2021 Option Period One: May 1, 2021 April 30, 2022 Option Period Two: May 1, 2022 April 30, 2023 Option Period Three: May 1, 2023 April 30, 2024 Option Period Four: May 1, 2024 April 30, 2025 CONTRACTOR QUALIFICATIONS: The contractor and requisite technicians shall meet the following qualifications: Co...
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- Place of Performance
- Address: Department of Veterans Affairs;North Texas Health Care System;Dallas VA Medical Center;4500 South Lancaster Road;Dallas, Texas 75216, USA
- Zip Code: 75216
- Country: USA
- Zip Code: 75216
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