Service Contract for Sterile Compounding Compliance Quality VA Medical Center

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 36C25720Q0593 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 Network Contracting Office 17 Regional Procurement Office (RPO) West 124 E. Hwy 67 Suite 100 Duncanville, TX 75137 Mailing Address: Department of Veterans Affairs Network Contracting Office 17 Regional Procurement Office (RPO) West 124 E. Hwy 67 Suite 100 Duncanville, TX 75137 (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 24, 2020 at 10:00am CST. Email your questions directly to Victoria.Rone3@va.gov. The subject line must specify: RFQ 3 36C25720Q0593- 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 29, 2020 10:00am CST. Email your quote directly to Victoria.Rone3@va.gov. The subject line must specify: RFQ 36C25720Q0593- 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: Controlled Environment Testing Association (CETA) National Board of Testing (CNBT) accredited Registered Cleanroom Certification Professional for Sterile Compounding Facilities National Safety Foundation (NSF) accredited Biosafety Cabinet Field Certifier Contractor shall have 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 as the requirement being solicited. GENERAL REQUIREMENTS: The contractor shall perform facility-related testing and sampling according to the most current version of CAG-003-2006 and CAG-009v3 to determine whether the cleanroom, LAFW, and BSC within the sterile compounding facility can be certified for use. Facility-related testing for LAFW and BSC certification includes the following: Air Velocity Test HEPA Filter Integrity Test Induction Leak/Backstreaming Test Non-Viable Particle Counting Particle Count Tests Lighting Test (upon request) Noise Test (upon request) Airflow Visualization Test (at rest) Exhaust Alarm Test (BSC Cert only) Airflow Visualization Test (dynamic operating conditions) Facility-related testing for cleanroom certification includes the following: Airflow Testing Room Segregation Airflow Visualization Test (when applicable) Room Pressurization Non-Viable Particle Counting Airflow Displacement (when applicable) Noise Level Test (upon request) Lighting Level and Uniformity Test (upon request) HEPA Filter Installation Leak Test General Temperature and Moisture Uniformity Test (upon request) Facility-related environmental sampling for the cleanrooms, LAFW, and BSC includes the following: Viable Surface Sampling Viable Air Sampling Environmental Wipe Sampling (for hazardous drug surface residue) The contractor shall perform personnel-related assessments and testing according to the most current version of CAG-009-2011v3 to ensure that sterile compounding personnel are properly trained to asepctically compound hazardous and non-hazardous sterile compounded products within the sterile compounding facility. Personnel-related assessments and tests include the following: Media-Fill Testing Gloved Fingertip Sampling Garbing and Gloving Assessment PERFORMANCE REQUIREMENT SUMMARY: Facility-related LAFW and BSC certification, test, and samplings Performance Objective Standard Performance Threshold Method of Surveillance Air Velocity Test IEST-RP-CC002.3 IEST-RP-CC034.3 IEST-RP-CC001.5 ISO Standard 14644-1 IEST-RP-CC002.2 CAG-003 CAG-002 NSF/ANSI 49 Annex F CAG-009 USP <797> USP <800> Facility-related performance requirements are to be performed for each LAFW and BSC every 6 month. Viable surface sampling to be done monthly Contractor provided reports Direct observation Video surveillance HEPA Filter Integrity Test Induction Leak/Backstreaming Test Non-Viable Particle Counting Particle Count Tests Lighting Tests Noise Test Airflow Visualization Test Exhaust Alarm Test Viable Surface Sampling Viable Air Sampling Environmental Wipe Sampling Facility-related cleanroom certification, tests, and samplings Performance Objective Standard Performance Threshold Method of Surveillance Airflow Testing IEST-RP-CC006.3 IEST-RP-CC013.2 IEST-RP-CC014.1 IEST-RP-CC006.3 IEST-RP-CC034.3 ISO 14644:4 CAG-003 CAG-002 IEST-RP-CC013.2 IEST-RP-CC001.5 ISO Standard 14644-1 IEST-RP-CC006.3 IEST-RP-CC006.3 IEST-RP-CC006.3 NSF/ANSI 49-2016 CAG-010-2011 CAG-009v3 USP <797> USP <800> OSHA 1910 Subpart Z Facility-related performance requirements are to be performed for each cleanroom every 6 month. Viable surface sampling to be done monthly Contractor provided reports Direct Observation Video surveillance Room Segregation Room Pressurization Airflow Displacement Airflow Visualization Test HEPA Filter Installation Leak Test Non-Viable Particle Counting Lighting Level and Uniformity Test Noise Level Test General Temperature and Moisture Uniformity Test Viable Surface Sampling Viable Air Sampling Environmental Wipe Sampling Testing Equipment Calibration Report Personnel-related Tests Performance Objective Standard Performance Threshold Method of Surveillance Garbing and Gloving Assessment OSHA/1910 Subpart I CAG-009 USP <797> USP <800> Validation of 100% of designated personnel every 6 months. Contractor provided reports Direct Observation Video surveillance Gloved Fingertip Sampling Media-Fill Testing ADDITIONAL REQUIREMENTS: Scheduling of work: The contractor shall coordinate a schedule with the COR to provide the services at the required intervals at VANTHCS. A total of 4 (four) LAFW certifications are required each year, or whenever the device is relocated, or whenever major service to the equipment is performed. LAFW to be certified are shown on Table A. A total of 14 (fourteen) BSC certifications are required each year, or whenever the device is relocated, or whenever major service to the equipment is performed. BSC to be certified are shown on Table A. A total of 4 (four) CAI certifications are required each year, or whenever the device is relocated, or whenever major service to the equipment is performed. CAI to be certified are shown on Table A. A total of 16 (sixteen) cleanroom certifications are required each year, or whenever the room is altered, or whenever major service to the facility is performed. Cleanroom and segregated compounding areas to be tested for cleanroom certification are shown on Table A. A total of 92 (ninety-two) viable air samplings and 276 (two-hundred and seventy-six) viable surface samplings are required annually. Suggested sampling locations are the LAFW, BSC, CAI, and rooms shown in Table A (passthroughs should also be included). Additional sampling may be done after any of the following: Initial certification but prior to recertification Any situation which may impact the normal operation of the cleanroom, LAFW, BSC, or CAI Movement of the LAFW, BSC, or CAI Servicing of facilities and/or equipment Any patient incident in which the compounded material is suspect Changes to the process that affect the cleanroom environment Observation of incorrect work practices such as gowning, technique, material flow, cleaning etc. Identified problems with end-product Significant changes in work flow or addition of new procedures or equipment 12 (twelve) environmental wipe samplings are requested semi-annually using a single panel hazardous drug wipe kit. Additional samplings may be done upon request. Suggested sampling locations are shown in Table B. 40 (forty) garbing, hand hygiene, and initial gloved fingertip testing are required annually to validate personnel according to the following criteria: For the initial assessment, garbing, hand hygiene, and gloved fingertip testing shall be completed three times on separate occassions with zero colony forming units across both hands before compounding All assessments after the initial assessment shall be completed one time successfully to resume compounding 40 (forty) of those assessments are to validate personnel who receive, compound, and dispense hazardous compounded sterile products and therefore should demonstrate gloving and garbing appropriate for hazardous drug receiving, compounding, dispense and/or administration. 20 (twenty) of those assessments are to validate personnel who administer hazardous compounded sterile products and therefore should demonstrate gloving and garbing appropriate for hazardous drug handling and administration. 40 (forty) media-fill test are required annually to validate personnel. 20 (twenty) of those media fill test will be for those personnel who compound hazardous compounded sterile products and therefore should demonstrate validity using a chemotherapy media fill test Certification Reports- The contractor shall provide to the COR a certificate for each cleanroom, LAFW, BSC, and CAI that is certified before leaving the facility. Any cleanroom, LAFW, BSC, or CAI that is not certifiable shall be brought to the attention of the COR by the contractor before leaving the facility. In addition, the cleanroom, LAFW, BSC, or CAI in question will be marked as such with clear signage that the unit is out of service until further notice. Failure to follow these procedures may result in delay of payment or nonpayment. Each certification report from the contractor shall contain, at a minimum, the following information: Contractor name, address and contact information also listing contract personnel with appropriate accreditations. Confirming remark that the most current version of this CAG was referenced for this certification and the actual date the certification was completed. Simple and clear method of identification of the approximate location of the collected data in relation to the physical layout of the equipment or facility tested, including specific and clear nomenclature for the data locations. Explanation of test procedure used for data collection and justification for any deviations from established industry practices encountered during the certification process. Comparison of data recorded against expected values or specific equipment performance criteria established in the VANTHCS Pharmacy Service Standard Operating Procedures (SOP). In the absence of a current VANTHCS Pharmacy Service SOP; the contractor s SOP, USP 797, recommended practices, and manufacturer s specifications will be used. Safety data sheets (SDS) for all chemical products that will be used during certification procedures. A list of equipment utilized in data collection to include make, model, serial number, and calibration date A copy of the current calibration documentation for each piece of equipment utilized in data collection, when applicable. A written report detailing the airflow patterns from the airflow visualization test must be provided. The report shall contain a definitive statement of acceptabiity for the intended purpose. The documentation shall clearly identify the area or equipment being assessed along with the appropriate aseptic technique performed by the compounding personnel. A vidoe recording shall be used to support this written statement. The plan for recording and transmitting this video to VANTHCS shall be established and mutually agreed upon prior to scheduled testing. Pass/Fail notifications, where applicable Listing of replacement parts provided, when applicable Assessment Reports: The contractor shall ensure that the COR signs the personnel assessment before the contractor leaves the facility. Failure to follow these procedures may result in delay of payment or nonpayment. Pass/Fail notifications should be included where applicable. Sampling Reports: The contractor shall contact the COR upon completion of work to verbally report any sampling issues before the contractor leaves the facility. Larger formal reports as required for the pharmacy clean rooms that include viable sampling and environmental sampling kits for hazardous drug detection shall be submitted to the COR within fifteen (15) business days following the collection of the viable sampling and /or surface sampling kit. Results of viable samples and/or surface sampling kit shall be submitted to the COR within one (1) business day of the receipt of the results from a properly accredited laboratory. All microbiological samples shall be analyzed by an ISO/IEC 17025 accredited laboratory accredited under the Environmental Microbiology Lab Accreditation Program (EMLAP). All environmental wipe samples shall be analyzed by an ISO/IEC 17025 accredited laboratory accredited under the Industrial Hygiene Laboratory Accreditation Program (IHLAP). Failure to follow these procedures may result in delay of payment or nonpayment. Pass/Fail notifications should be included where applicable. Each sampling reports from the contractor shall contain, at a minimum, the following information: An SOP or protocol that describes the procedures used for sampling along with the volume, ISO classification, method of collection, frequency, activity level, action levels, response to exceeded concerns levels, media types, risk level, laboratory analysis, incubation time and temperature. A sampling map of the cleanroom, LAFW, and BSC noting the locations and types of samples to be taken where applicable. Growth and Sterility Control Reports (where applicable) Excluded services: The contractor shall not be obligated to provide services under this contract for damage to or destruction of instrument(s) covered where such damage or destruction is a result of or caused by: Fire or explosion of any origin, riot, civil commotion, aircraft, war Act of God or other force majure including but not limited to lightning, windstorm, hail, flood, earthquake VAMC misuse or abuse of such instrument Decontamination due to spillage by VA personnel due to their own negligence Installation of unauthorized field modifications. Schedule of Insurance: The contractor shall procure and maintain for the entire contract period, Workmen's Compensation and employer's general liability Insurance. The contractor shall provide proof of insurance for the entire contract period with their technical proposal. The parties agree that such personnel shall not be considered a VA employee for any purpose and shall be considered employees of the contractor. Operational Coverage: The contractor shall perform certification services during normal work hours of 8:00am to 4:30pm, Monday-Friday (excluding weekends and federal holidays). The ten holidays observed by the Federal Government are: New Year s Day, Martin Luther King s Birthday, President s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran s Day, Thanksgiving Day and Christmas Day, along with any other day specifically declared by the President of the United States to be a national holiday. Exception: work may be performed outside of regular administrative working hours when deemed necessary. The contractor shall receive prior approval from the COR for irregular testing hours. Environment of Care: The contractor shall maintain a clean and safe environment at all times. Contracting with Parties Listed on the OIG List of Excluded Individuals/Entities: In accordance with HIPAA and the Balanced Budget Act (BBA) of 1977, the Office of Inspector General has established a list of parties and entities excluded from Federal health care programs. Specifically, the listed parties and entities may not receive Federal payments due to fraud and/or abuse of the Medicare and Medicaid programs. The list of excluded individuals/entities can be found on the OIG web site at www.hhs.gov/oig. With submittal of proposal, the contractor shall provide evidence than none of the contractor s employees are on the Excluded Parties list. Invoices/Payments: This provision shall survive the termination or ending of the contract. Payment for services rendered by the Contractor under the terms of this contract will be made upon receipt of a properly executed invoice. Invoice to be submitted within fourteen (14) workdays following completion of the Contractors rendered services. VA will verify services performed and certify invoice for payment within thirty (30) days following date of receipt of sampling reports. Any identified discrepancy(s) in billings shall be cause for extending provisions of this paragraph until the discrepancy or other identified problem with the billing invoice has been resolved. Invoices shall: Be electronically prepared and submitted in accordance with FAR 52.212-4(g) Clearly state the terms of any discounts offered Include the current fiscal year and purchase order number Include the period of performance covered by the invoice Accept payment for services rendered under this contract as payment in full. This provision shall survive the termination or ending of the contract. Information Security Officer, Information Protection: The contractor will not have access to VA Desktop computers nor online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody. Privacy Officer: The contractor will not have access to Patient Health Information (PHI) nor have the capability of accessing patient information during the services provided to the VA. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody. All research data available for Contractor analyses is de-identified. Records Manager: Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data. VANTHCS and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VANTHCS or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to VANTHCS. The agency must report promptly to NARA in accordance with 36 CFR 1230. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the indefinite delivery contract. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to VANTHCS control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4). The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VANTHCS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VANTHCS policy. The Contractor shall not create or maintain any records containing any non-public VANTHCS information that are not specifically tied to or authorized by the contract. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act. The VANTHCS owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VANTHCS shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #3873736, Records Management for Records Officers and Liaisons. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training. Security: The contractor shall be liable for security of all areas accessed by the technician(s). All doors, passageways, windows and accesses to equipment and service areas, shall be locked and/or secured after passage. In no instance will any door, window or access be rendered unlocked, propped open, mechanism taped open or rendered to prevent securing. Contractor shall be responsible to physically ensure such accesses are secured to prevent unauthorized entry. Contractor Personnel Badges and Parking: The contractor technician shall acquire an access badge upon entrance into the VANTHCS buildings. Contractor shall safeguard the access badge and report any lost, stolen, or destroyed badges to the COR. Contractor shall ensure technicians properly display their access badges. Access badges shall be worn at or above the waist (facing forward). Access badges shall be returned to the COR at the end of each site visit. Contractor shall ensure technician parks in the appropriate designated parking areas. Parking information shall be coordinated with the COR. Contractor shall be aware that VANTHCS does not validate or make reimbursement for parking violations of the contractor technician under any circumstance. Interference to Normal Function: Contractor may be required to adjust their work at any time so as not to interfere with the normal functioning of the facility, including utility services, fire protection (detection and suppression) systems, passage of facility patients, personnel, equipment and carts and patient care activities (e.g. preparing sterile compounds). In the event of an emergency, contractor services may be stopped by the VANTHCS and rescheduled at no additional cost to the government. Contractor personnel shall inform the COR of the need to gain access to secured areas. If access is required to secure areas, prearranged scheduling will be made with the COR. r. Changes to Contract or PWS: Changes to this PWS or the impending contract shall only be authorized and approved through written correspondence form the CO. A copy of each change shall be kept in a project folder along with all other documents or items pertaining to the project. Costs incurred by the Contractor through the actions of parties other than the CO shall be borne by the Contractor. APPENDIX: Table A Facility Location Room Type* LAFW / BSC / CAI Rooms VANTHCS Mobile Pharmacy Trailer Non-hazardous cleanroom LAFW - Mfg: Germfree Model: BVBI-3SSRX / Serial#3S-15-BVBI-18300 buffer room ante room LAFW - Mfg: Germfree Model: BVBI-4SSRX / Serial# 4S-15-BVBI-18301 VANTHCS Mobile Pharmacy Trailer Hazardous cleanroom Class II Type A1 BSC Mfg: Germfree Model: BBF-3SSRX / Serial# 3S-15-BR2-16796 buffer room ante room Class II Type A1 BSC Mfg: Germfree Model: BBF-3SSRX / Serial# 3S-15-BR2-18284 VANTHCS Room 1B-520CA BSC - Mfg: Nuaire Model: NU-425-400 S/N: 73125 Segregated compounding area BSC - Mfg: Nuaire Model: NU-425-600 Serial#: 114151041307 BSC - Mfg: Nuaire Model: NU-425-400 Serial#: 114150041307 VANTHCS Room 1B-520CB BSC - Mfg: Nuaire Model: NU-430-600 (Series 40) S/N: 116989081507 Hazardous Drug segregated compounding area BSC - Mfg: Nuaire Model: NU-430-600 (Series 50) S/N: 123309051608 VANTHCS Room 5B-243 CAI - Mfg: Nuaire Model: NU-PR797-400 (SERIES 25) S/N: 184870031218 Segregated compounding area VANTHCS Room 5A-116 CAI - Mfg: Nuaire Model: NU-PR797-400 (SERIES 25) S/N: 184869031218 Segregated compounding area Table B Facility Location Room* Sampling location VANTHCS - Mobile Pharmacy Trailer hazardous buffer room Counter VANTHCS - Mobile Pharmacy Trailer hazardous buffer room Chemo Cart VANTHCS - Mobile Pharmacy Trailer Office area Passthrough area VANTHCS - Room 1B-520CB: Hazardous segregated compounding area Storage area VANTHCS - Room 1B-520CB: Hazardous segregated compounding area Counter VANTHCS - Room 1B-520CB: Hazardous segregated compounding area Garbing area WAGE DETERMINATION: The DOL Wage Determination for the specific locality applies to this solicitation and any contract awarded and is available at https://wdolhome.sam.gov/. It is the contractor s responsibility to obtain and evaluate the applicable wage determination(s).