H935--Pharmacy Certification Base + Options 797> and USP 800> Certification

COMBINED SYNOPSIS/SOLICITATION GENERAL INFORMATION Document Type: Combined Solicitation/Synopsis Solicitation Number: 36C24920Q0082 Posted Date: 01/24/2020 Original Response Date: 01/31/2020 9:30 AM CST Product of Service Code: H935 NAICS Code: 541380 Contracting Office Address NCO 9 ATTN: Chaz D. Bowling Department of Veterans Affairs Contracting Office, 4th Floor 1639 Medical Center Parkway Murfreesboro, TN 37129 Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued. This solicitation is a request for quotations (RFQ). The solicitation document and incorporated provisions and clauses are

those in effect through Federal Acquisition Circular 2020-04 / 01-15-2020. The associated North American Industrial Classification System (NAICS) code for this procurement is 541380, with a small business size standard of $15 million. The Network Contracting Office 9 is seeking to purchase pharmacy cleaning room and equipment certifications services for the James H. Quillen VA Medical Center. All questions regarding this RFQ must be in writing and may be sent by e mail to Chaz.Bowling@va.gov. Questions must be received no later than January 29, 2020 at 9:30 AM CST. No further questions will be accepted after that date and time. You are reminded that representatives from your company SHALL NOT contact any VA Medical Center employees to discuss this RFQ during this RFQ process. All questions and concerns regarding this RFQ shall be directed to the Contracting Officer. All interested companies shall provide quotation(s) for the following: CLIN(S) DESCRIPTION QTY UNIT $ TOTAL $ 0001 Base year of certifications (1 year of performance outlined in the SOW) 1 1001 Option one of certifications (1 year of performance outlined in the SOW) 1 2001 Option two of certifications (1 year of performance outlined in the SOW) 1 3001 Option three of certifications (1 year of performance outlined in the SOW) 1 4001 Option four of certifications (1 year of performance outlined in the SOW) 1 Total Contract Pricing $ STATEMENT OF WORK (SOW) A - GENERAL INFORMATION A.1 INTRODUCTION: The Food and Drug Administration (FDA) has the authority to inspect VA medical facilities and the Joint Commission (TJC) establishes compounding standards for sterile compounded preparations based on the United States Pharmacopeia (USP) standards. The USP establishes standards for sterile compounding room design, environmental monitoring, and competencies for the preparation, handling, and storage of compounded sterile products (CSPs). To meet regulatory requirements in accordance with USP 797> and USP 800>, the James H. Quillen VA Medical Center (JHQVAMC) requires certification of primary engineering controls (PECs), secondary engineering controls (SECs), and testing of compounding personnel for aseptic technique by gloved fingertip and thumb sampling, and media fill testing. A.2 SCOPE OF WORK: The Contractor will provide all parts, labor, equipment, material, travel expenses to test and certify the operation and performance of equipment systems and personnel per the Statement of Work listed below. A.3 PERFORMANCE: Period of Performance This will be a base + four (4) one (1) year options. The estimated effective date is 02/17/2020 with an end date of 02/16/2021 with the option years following the same period of performance each year if exercised IAW 52.217-9. Place of Performance Address: Department of Veterans Affairs James H. Quillen VA Medical Center Corner of Lamont & Veterans Way Mountain Home, 37684 Voice: 423-926-1171 Hours of Work Work is to be performed primarily between the hours of 8:00AM 3:30PM EST, Monday through Friday. The Contractor shall coordinate any work required with the hospital or the (COR). Any work to be conducted after normal business hours must be coordinated with Contracting Officer or COR at the facility with at least a weeks notice. Any work at the Government site shall not take place on Federal holidays or weekends unless directed by the Contracting Officer (CO). There are 10 Federal holidays set by law (USC Title 5 Section 6103) that VA follows: Under current definitions, four are set by date: New Year's Day January 1 Independence Day July 4 Veterans Day November 11 Christmas Day December 25 If any of the above falls on a Saturday, then Friday shall be observed as a holiday. Similarly, if one falls on a Sunday, then Monday shall be observed as a holiday. The other six are set by a day of the week and month: Martin Luther King's Birthday Third Monday in January Washington's Birthday Third Monday in February Memorial Day Last Monday in May Labor Day First Monday in September Columbus Day Second Monday in October Thanksgiving Fourth Thursday in November B WORK REQUIREMENTS B.1 TASKS TO BE ACCOMPLISHED: All work must be conducted, coordinated, and scheduled based on the needs of the Pharmacy Service. The testing of the Sterile Compounding Suites and equipment must be conducted during dynamic operating conditions to assure smooth even flow across the DCA and out to the returns. In the presence of the Medication Safety Program Manager. The JHQVAMC will notify the contractor a minimum of 2 business days to a maximum of 5 business days to schedule testing/retesting of the Sterile Compounding Suites and Media Fill Testing/Gloved Fingertip testing. The contractor must respond and be available on site to perform testing/retesting within the specified time frame. The Contractor will provide a Qualified Tester and appropriate tools/test equipment to complete the work as covered in Section C.3. Due to the sensitive nature of the work area, prior to entering sterile compounding areas (buffer room, ante room), the Contractor will maintain a clean work area at all times by wearing appropriate personal protective equipment (set forth by USP 797> standards) and cleaning any equipment with 70% sterile isopropyl alcohol. The Contractor will test each PEC and SEC according to Certification Guide for Sterile Compounding Facilities (CETA) and USP 797> regulations every six months. The Contractor will provide JHQVAMC with the original certification documents that includes all measurements and results of each PEC and SEC. Certification should include identifying information of each PEC and SEC as well as all test equipment used for certification. See Section B for specific requirements. The Contractor will immediately notify identified points of contact (POC) with any results indicating failure. A formalized written report including all required aspects specified in this statement of work will be provided in a timely manner by email with receipt by identified POC no more than 10 business days from certification evaluation. Any failure of engineering controls to meet required specifications shall be clearly marked with a sign that will notify pharmacy staff. B.2 PRIMARY ENGINEERING CONTROLS (PECs) TO CERTIFY PEC tested and certified according to CETA and USP 797> regulations, and to manufacturer s specifications. The contractor will utilize DCA with a NIST traceable or comparable calibrated piece of equipment (calibrated within past 12 months) to perform all testing and provide copies of the calibration tests to the POC The Contractor shall report each individual face velocity reading and the average of those readings, the downstream concentration ready of the HEPA filter leak test and the results of the induction leak test and back streaming test. The Contractor will provide and label with a certification sticker that contains the following: company name, phone number, PEC model and serial number, service number, certification date, recertification date, certifiers signature. Total particle count testing must be performed under dynamic operating conditions using calibrated electronic equipment. Documentation of test results must also include the number of personnel present in each PEC during testing. Viable Air Sampling shall be conducted with high volume impaction samplers to conduct the sampling of a sufficient volume of air (1000 liters) at each specified location. The reports shall indicate site locations*, volume of air sampled, media manufacturer, lot #, expiration date, incubation start date & time, number of CFU s with locations, identification of CFU s, date & time of sample results. Viable Surface Sampling reports to indicate site locations*, media manufacturer, lot #, expiration date, incubation start date & time, number of CFU s with locations, identification of CFU s, date & time of sample results. Documentation of the smoke study results shall include the number of personnel present in the PEC during the dynamic airflow smoke pattern test. Line Item Description Qty Frequency per Year Qty per Year 1 Restricted Access Barrier- Nu-Aire CAI IV Hood ISO Class 5, Building 77 Room FA126A 1 2 2 2 8 BVBI-8SSRX Laminar Vertical Flow Workstation ISO Class 5, Building 77 Room FA126A 1 2 2 3 6 BBF-6SS Biological Safety Cabinet Class II Type A ISO Class 5, Building 77 Room J140A 1 2 2 B.2A SERVICES TO BE PERFORMED FOR PECs Line Item Description Qty Frequency per Year Qty per Year 1 Total particle count testing under dynamic operating conditions using calibrated electronic equipment for each of the listed PECs. 7 or more 2 varies 2 Viable Air Sampling number and location as determined by the Contractee (bacterial and fungal samples) 8 or more 2 varies 3 Viable Surface Sampling number and location as determined by the Contractee (bacterial and fungal samples) 12 or more 2 varies 4 Both static and dynamic smoke studies verifying a continuous flow of HEPA filtered air void of turbulence, dead air zones, and refluxing from the HEPA filters to and across the entire work area and to the air returns must be performed and documented by video. Video of dynamic smoke test must document the demonstration of unidirectional airflow and sweeping action over and away from the preparation(s). Contractor to leave video of smoke test on site prior to completion of certification process for each of the listed PECs. 3 2 2 5 HEPA filter leak test 3 2 6 6 Cabinet leak test 3 2 6 7 Inflow velocity test to include exhaust airflow volume rate 3 2 6 8 Electrical leakage and ground circuit resistance and polarity tests 3 2 6 9 Lighting intensity test 3 2 6 10 Vibration test 3 2 6 11 Noise level test 3 2 6 12 Ultraviolet (UV) lamp test 3 2 6 13 Airflow testing under dynamic conditions to include air velocity and volume, the air exchange rate. 2 2 6 14 Hazardous drug contamination to include cyclophosphamide, ifosfamide, methotrexate, fluorouracil, taxanes, and platinum-containing drugs. Additional drugs may be requested. 4 2 8 B.3 SECONDARY ENGINEERING CONTROLS (SECs) TO CERTIFY The Contractor shall calculate the total room volume for each buffer, ante room, and hazardous drug storage room. A sketch of the room with dimensions, exhaust/supply diffuser locations and equipment locations shall be included in the report. The report provided will specify flow rates detailing returns and supply that were obtained during the testing. The contractor shall calculate air changes per hours (ACPH) from HVAC, ACPH contributed from the PEC, and the total ACPH for each buffer, ante room, and storage room shall be documented on the certification report. Total particle count testing must be performed under dynamic operating conditions using calibrated electronic equipment. Documentation of test results must also include the number of personnel present in each SEC during testing. Viable Air Sampling shall be conducted with high volume impaction samplers to conduct the sampling of a sufficient volume of air (1000 liters) at each specified location. The reports shall indicate site locations*, volume of air sampled, media manufacturer, lot #, expiration date, incubation start date & time, number of CFU s with locations, identification of CFU s, date & time of sample results. Viable Surface Sampling reports to indicate site locations*, media manufacturer, lot #, expiration date, incubation start date & time, number of CFU s with locations, identification of CFU s, date & time of sample results. Hazardous drug contamination sampling report to include manufacturer, lot #, and expiration date of sampling kit, sample site locations, name of products tested for, and results. Line Item Description Qty Frequency per Year (minimum) Qty per Year (minimum) 1 Non-Hazardous IV Anteroom Certification ISO Class 8, Building 77 Room FA126 1 2 2 2 Non-Hazardous IV Buffer Room Certification ISO Class 7, Building 77 Room FA126A 1 2 2 3 Hazardous IV Anteroom Certification ISO Class 7, Building 77 Room J140 1 2 2 4 Hazardous IV Buffer Room Certification ISO Class 7, Building 77 Room J140A 1 2 2 5 Hazardous Drug Storage Room Building 77 Room J139 1 2 2 B.3A SERVICES TO BE PERFORMED FOR SECS Line Item Description Qty Frequency per Year (minimum) Qty per Year (minimum) 1 Total particle count testing under dynamic operating conditions using calibrated electronic equipment, for the SECs 7 or more 2 varies 2 Viable Air Sampling number and location as determined by the Contractee (bacterial and fungal samples) 8 or more 2 varies 3 Viable Surface Sampling number and location as determined by the Contractee (bacterial and fungal samples) 12 or more 2 varies 4 HEPA filter integrity testing 7 2 14 5 Airflow profiling and uniformity testing for listed SECs 2 2 6 Particulate monitoring For listed SECs 2 2 7 Room pressurization monitoring For listed SECs 2 2 8 Temperature and Humidity monitoring For listed SECs 2 2 9 Air pattern analysis For listed SECs 2 2 10 Airflow testing under dynamic conditions to include air velocity and volume, the air exchange rate, and the room pressure differential in doorways between adjacent rooms. For listed SECs 2 2 11 Hazardous drug sampling to include: cyclophosphamide, ifosfamide, methotrexate, fluorouracil, taxanes, and platinum-containing drugs. Additional drugs may be requested. 4 2 8 C SUPPLEMENTAL TESTING Media Fill Testing will occur in Laminar Vertical Flow Workstation in Building 77 Room FA126A and simulate the most difficult and challenging compounding procedures and processing conditions encountered by the person replacing all the components used in the CSPs with soybean casein digest media. A certificate of analysis (COA) must be provided if commercial sterile microbial growth media is used for the media fill testing Initial Certification: gloved fingertip testing will occur after garbing procedures. Media Fill Testing will occur after gloved fingertip. Media Fill Testing will occur prior to gloved fingertip and thumb testing for recertification. The Contractor shall incubate media fill tests in controlled temperature environments in accordance with USP 797> guidance (and 800>). Documentation of the media fill test will include the name of the person evaluated, evaluation date/time, media and components used, including manufacturer, expiration date and lot number, starting temperature for each interval of incubation, dates of incubation, the results, and the identification of the observer and the person who reads and documents the results. The Contractor shall perform three separate gloved fingertip and thumb tests during initial testing (one sampling device per hand) for each designated employee. Subsequent sampling shall occur every 6 months. Gloved fingertip and thumb samples shall be performed in controlled temperature environments and incubated in accordance with USP 797> and 800> guidance. Each sample shall be labeled with a personnel identifier, whether it was from the right or left hand, and the date and time of sampling. Documentation results for gloved fingertip and thumb sampling will include the name of the person evaluated, evaluation date/time, media and components used, including manufacturer, expiration date and lot number, starting temperature for each interval of incubation, dates of incubation, the results, and the identification of the observer and the person who reads and documents the number of colonies forming units (CFU) for the left and right hand. A formalized written report including all required aspects specified in this statement of work will be provided in a timely manner by email with receipt by identified POC no more than 14 business days for media fill and gloved fingertip tests. Line Item Description Qty Frequency per Year Qty per Year (minimum) 1 Media Fill Testing 25 or more varies 50 2 Gloved Fingertip and thumb testing 25 or more varies 50 D SPECIAL CONSIDERATIONS: D.1 Place of Performance: James H. Quillen VA Medical Center, Corner of Lamont and Veterans Way, Johnson City, Tennessee 37601 D.2 Contractor Furnished Materials: All labor, materials, equipment to perform the job. When furnish , provide , install , or similar term is used it shall mean a complete installation, ready for use. The Contractor shall supply all parts that is currently not covered under warranty, equipment, material and labor to conduct work as listed in the Statement of Work above. The work will include all items as described in the Scope of Work listed above. D.3 Government Furnished Materials and Services: Government furnished property, if any, will be identified and will only be used for the performance of this contract unless otherwise authorized by the Contracting Officer. The Contractor shall, at all times, take any and all steps necessary for maintenance and preservation of all Government-furnished property. The Contractor shall comply with all reasonable requests of the Contracting Officer to enclose, or specifically protect, Government-furnished property. D.4 Qualifications of Key Personnel: The Contractor will provide three references for showing the completion of at least three jobs of similar size and scope at other hospital facilities with at least one of those facilities being a VA Medical Center, in addition will also provide three references for each Qualified Tester that performs work at JHQVAMC. The Contractor s Qualified Tester must possess current CETA, NSF and CNBT Certification for Sterile Compounding Facilities. The Contractor will provide copies of the Qualified Tester s accreditation prior to conducting certification. D.5 Other Requirements: The Contract will provide sample reports of prior certification reports from other contracted Sterile Compounding Suites certifications include Primary and Secondary Engineering Controls. The sample reports should include the calibration reports of equipment used to certify the Sterile Compounding Suites. D.6 Security Requirements: Contractor shall identify which employees will be working under the awarded contract. Contractor personnel shall include employees, sub-contractors, subcontractor employees, suppliers and delivery personnel entering the Medical Center. This does not apply to suppliers and delivery personnel making deliveries to the VA warehouse dock only. Those employees shall bring photo ID to obtain a VA Contractor identification badge that shall be worn above the belt at all times while on Medical Center property. Contractor s employees shall return all I.D. badges to designated personnel at time designated in the task order. D.7 Inspection of Work: The COR is responsible for the inspection of the work called for in this job. The Contracting Officer s Representative will be identified in the task order by name, telephone number and location. Inspections made by the COR are for the sole benefit of the Government and do not relieve the Contractor of any quality control responsibilities. The Contractor will be notified by the Contractee of any updates to identified points of contact list on an as needed basis and in turn the Contractor will provide the Contractee with any updates. D.8 Safety: The Safety Manger is responsible for safety inspections of all contract operations. The Safety Manager will be identified in the task order by name, phone number and location. D.9 Drawings General: Contract drawings (if applicable) will indicate the extent and location of work. If any departure from the contract drawings are deemed necessary by the Contractor, the details of such departure and the reasons therefore shall be submitted to the Contracting Officer for approval as soon as practical. No such departure shall be made without proper written permission of the Contracting Officer. The Contractor is responsible for all information and requirements in drawings and specifications that pertain to the task order. D.10 Verification of Dimensions: The Contractor shall visit the job site to thoroughly familiarize themselves with all the details of the work and working conditions. The Contractor shall also verify all dimensions in the field and shall advise the Contracting Officer of any discrepancy before performing any work. The Contractor shall be specifically responsible for the coordination and proper relation of their work to the building, structure, phasing and ensure the safety of employees and workmen. D.11 Smoking Policy: The Contractor shall ensure employees do no smoke on the VA grounds as JHQVAMC is a smoke-free facility. D.12 Parking/Traffic Regulations: The Contractor shall not park on grassy areas unless approved by the COR and the Contractor agrees to restore areas back to VA standards. Drivers should be particularly concerned with pedestrian traffic. Yield to pedestrians in crosswalks. Posted speed limits and all other traffic controls are to be observed by operators at all times. Seat belt use is mandatory on the VA grounds. (End of SOW) Quote Format and Evaluation Criteria Offers shall provide only one quote. The quote should be emailed to chaz.bowling@va.gov NLT 01/31/2020, 9:30 AM CST. Non-Compliance with this requirement will result in disqualification of the quote. Award shall be made to the Business who offers the BEST VALUE to the Government, considering price, past performance, and meeting the specifications outlined in the SOW. All SDVOSB s/ VOSB s must be VIP verified by the close of solicitation if applicable. All vendors must be registered and complete all entries in the System for Award Management (SAM) by the close of this solicitation in order to be considered for an award. Potential vendors may register and the following website: https://www.sam.gov/portal/public/SAM The government intends to award a contract as a result of this RFQ that will include the terms and conditions set forth herein. To facilitate the award process, ALL quotes shall include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the RFQ are acceptable to be included in the award document without modification, deletion, or addition." OR "The terms and conditions in the RFQ are acceptable to be included in the award document with the exception, deletion, or addition of the following:" Offeror shall list exception(s) and rationale for the exception(s). Offerors must complete annual representations and certifications on-line at http://www.acquisition.gov in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. Offeror shall list exception(s) and rationale for the exception(s). Offerors must complete annual representations and certifications on-line at http://www.acquisition.gov in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. CLAUSES/PROVISION Provisions that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) 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): http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/ (End of Clause) FAR Number Title Date 52.212-4 CONTRACT TERMS AND CONDITIONS COMMERCIAL OCT 2018 ITEMS 52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018 52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE JUL 2016 MAINTENANCE 52.228-5 INSURANCE-WORK ON GOVERNMENT INSTALLATION JAN 1997 52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL DEC 2013 BUSINESS SUBCONTRACTORS 52.237-2 PROTECTION OF GOVERNMENT BUILDINGS, EQUIPMENT, AND VEGETATION APR 1984 52.237-3 CONTINUITY OF SERVICES JAN 1991 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999) 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 30 Days. (End of Clause) 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) (a) The Government may extend the term of this contract by written notice to the Contractor within 30 days provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. 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 66 months. (End of Clause) VAAR 852.203-70 COMMERCIAL ADVERTISING (JAN 2008) The bidder or offeror agrees that if a contract is awarded to him/her, as a result of this solicitation, he/she will not advertise the award of the contract in his/her commercial advertising in such a manner as to state or imply that the Department of Veterans Affairs endorses a product, project or commercial line of endeavor. (End of Clause) VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2012) (a) Definitions. As used in this clause (1) Contract financing payment has the meaning given in FAR 32.001. (2) Designated agency office has the meaning given in 5 CFR 1315.2(m). (3) Electronic form means an automated system transmitting information electronically according to the Accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests. (4) Invoice payment has the meaning given in FAR 32.001. (5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract. (b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required. (c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following: (1) VA s Electronic Invoice Presentment and Payment System. (See Web site at http://www.fsc.va.gov/einvoice.asp.) (2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org) includes additional information on EDI 810 and 811 formats. (d) Invoice requirements. Invoices shall comply with FAR 32.905. (e) Exceptions. If, based on one of the circumstances below, the contracting officer directs that payment requests be made by mail, the contractor shall submit payment requests by mail through the United States Postal Service to the designated agency office. Submission of payment requests by mail may be required for: (1) Awards made to foreign vendors for work performed outside the United States; (2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information; (3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies; (4) Solicitations or contracts in which the designated agency office is a VA entity other than the VA Financial Services Center in Austin, Texas; or (5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above. (End of Clause) VAAR 852.270-1 REPRESENTATIVES OF CONTRACTING OFFICERS (JAN 2008) The contracting officer reserves the right to designate representatives to act for him/her in furnishing technical guidance and advice or generally monitor the work to be performed under this contract. Such designation will be in writing and will define the scope and limitation of the designee s authority. A copy of the designation shall be furnished to the contractor. 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS COMMERCIAL ITEMS (OCT 2018) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items: 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)). 52.204 23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115 91). 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015). (4) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553). (5) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)). The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: [] (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402). [] (2) 52.203-13, Contractor Code of Business Ethics and Conduct (OCT 2015) (41 U.S.C. 3509). [] (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.) [] (4) 52.204 10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) (Pub. L. 109 282) (31 U.S.C. 6101 note). [] (5) [Reserved] [] (6) 52.204 14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111 117, section 743 of Div. C). [] (7) 52.204 15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016) (Pub. L. 111 117, section 743 of Div. C). [] (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (OCT 2015) (31 U.S.C. 6101 note). [] (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C. 2313). [] (10) [Reserved] [] (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (NOV 2011) (15 U.S.C. 657a). [] (ii) Alternate I (NOV 2011) of 52.219-3. [] (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a). [] (ii) Alternate I (JAN 2011) of 52.219-4. [] (13) [Reserved] [X] (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2011) (15 U.S.C. 644). [] (ii) Alternate I (NOV 2011). [] (iii) Alternate II (NOV 2011). [] (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644). [] (ii) Alternate I (Oct 1995) of 52.219-7. [] (iii) Alternate II (Mar 2004) of 52.219-7. [] (16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)). [] (17)(i) 52.219-9, Small Business Subcontracting Plan (AUG 2018) (15 U.S.C. 637(d)(4)). [] (ii) Alternate I (NOV 2016) of 52.219-9. [] (iii) Alternate II (NOV 2016) of 52.219-9. [] (iv) Alternate III (JAN 2017) of 52.219-9. [] (v) Alternate IV (AUG 2018) of 52.219-9. [] (18) 52.219-13, Notice of Set-Aside of Orders (NOV 2011) (15 U.S.C. 644(r)). [] (19) 52.219-14, Limitations on Subcontracting (JAN 2017) (15 U.S.C. 637(a)(14)). [] (20) 52.219-16, Liquidated Damages Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)). [] (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (NOV 2011) (15 U.S.C. 657f). [X] (22) 52.219-28, Post Award Small Business Program Re-representation (Jul 2013) (15 U.S.C 632(a)(2)). [] (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (DEC 2015) (15 U.S.C. 637(m)). [] (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (DEC 2015) (15 U.S.C. 637(m)). [] (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755). [X] (26) 52.222 19, Child Labor Cooperation with Authorities and Remedies (JAN 2018) (E.O. 13126). [X] (27) 52.222-21, Prohibition of Segregated Facilities (APR 2015). [X] (28)(i) 52.222 26, Equal Opportunity (SEP 2016) (E.O. 11246). [] (ii) Alternate I (FEB 1999) of 52.222-26. [] (29)(i) 52.222-35, Equal Opportunity for Veterans (OCT 2015) (38 U.S.C. 4212). [] (ii) Alternate I (JULY 2014) of 52.222-35. [] (30)(i) 52.222-36, Equal Opportunity for Workers with Disabilities (JUL 2014) (29 U.S.C. 793). [X] (ii) Alternate I (JULY 2014) of 52.222-36. [] (31) 52.222-37, Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212). [] (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496). [X] (33)(i) 52.222-50, Combating Trafficking in Persons (MAR 2015) (22 U.S.C. chapter 78 and E.O. 13627). [] (ii) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627). [] (34) 52.222-54, Employment Eligibility Verification (OCT 2015). (E. O. 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.) [] (35)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA- Designated Items (May 2008) (42 U.S.C.6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.) [] (ii) Alternate I (MAY 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.) [] (36) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN 2016) (E.O. 13693). [] (37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693). [] (38)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514). [] (ii) Alternate I (OCT 2015) of 52.223-13. [] (39)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514). [] (ii) Alternate I (JUN 2014) of 52.223-14. [] (40) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007)(42 U.S.C. 8259b). [] (41)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (E.O.s 13423 and 13514). [] (ii) Alternate I (JUN 2014) of 52.223-16. [X] (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) [] (43) 52.223-20, Aerosols (JUN 2016) (E.O. 13693). [] (44) 52.223-21, Foams (JUN 2016) (E.O. 13693). [] (45) (i) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a). [] (ii) Alternate I (JAN 2017) of 52.224-3. [X] (46) 52.225-1, Buy American Supplies (MAY 2014) (41 U.S.C. chapter 83). [] (47)(i) 52.225-3, Buy American Free Trade Agreements Israeli Trade Act (MAY 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109- 283, 110-138, 112-41, 112-42, and 112-43. [X] (ii) Alternate I (MAY 2014) of 52.225-3. [] (iii) Alternate II (MAY 2014) of 52.225-3. [] (iv) Alternate III (MAY 2014) of 52.225-3. [] (48) 52.225 5, Trade Agreements (AUG 2018) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). [] (49) 52.225-13, Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury). [] (50) 52.225 26, Contractors Performing Private Security Functions Outside the United States (OCT 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note). [] (51) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). [] (52) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150). [] (53) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)). [] (54) 52.232-30, Installment Payments for Commercial Items (JAN 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)). [] (55) 52.232-33, Payment by Electronic Funds Transfer System for Award Management (Oct 2018) (31 U.S.C. 3332). [] (56) 52.232-34, Payment by Electronic Funds Transfer Other than System for Award Management (Jul 2013) (31 U.S.C. 3332). [] (57) 52.232-36, Payment by Third Party (MAY 2014) (31 U.S.C. 3332). [] (58) 52.239-1, Privacy or Security Safeguards (AUG 1996) (5 U.S.C. 552a). [] (59) 52.242-5, Payments to Small Business Subcontractors (JAN 2017)(15 U.S.C. 637(d)(12)). [] (60)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). [] (ii) Alternate I (Apr 2003) of 52.247-64. [] (iii) Alternate II (FEB 2006) of 52.247-64. The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: [] (1) 52.222-17, Nondisplacement of Qualified Workers (MAY 2014) (E.O. 13495). [] (2) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67). [] (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). [] (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards Price Adjustment (Multiple Year and Option Contracts) (AUG 2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67). [] (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards Price Adjustment (MAY 2014) (29 U.S.C 206 and 41 U.S.C. chapter 67). [] (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment Requirements (MAY 2014) (41 U.S.C. chapter 67). [] (7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services Requirements (MAY 2014) (41 U.S.C. chapter 67). [] (8) 52.222-55, Minimum Wages Under Executive Order 13658 (DEC 2015). [] (9) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706). [] (10) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (MAY 2014) (42 U.S.C. 1792). Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records Negotiation. The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor's directly pertinent records involving transactions related to this contract. The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved. As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law. (e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause 52.203-13, Contractor Code of Business Ethics and Conduct (OCT 2015) (41 U.S.C. 3509). 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)). 52.204 23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115 91). 52.219 8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219 8 in lower tier subcontracts that offer subcontracting opportunities. 52.222-17, Nondisplacement of Qualified Workers (MAY 2014) (E.O. 13495). Flow down required in accordance with paragraph (l) of FAR clause 52.222-17. 52.222-21, Prohibition of Segregated Facilities (APR 2015). 52.222 26, Equal Opportunity (SEP 2016) (E.O. 11246). 52.222-35, Equal Opportunity for Veterans (OCT 2015) (38 U.S.C. 4212). 52.222-36, Equal Opportunity for Workers with Disabilities (JUL 2014) (29 U.S.C. 793). 52.222-37, Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212). 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40. 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67). (xiii)(A) 52.222-50, Combating Trafficking in Persons (MAR 2015) (22 U.S.C. chapter 78 and E.O. 13627). (B) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627). 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment Requirements (MAY 2014) (41 U.S.C. chapter 67). 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services Requirements (MAY 2014) (41 U.S.C. chapter 67). 52.222-54, Employment Eligibility Verification (OCT 2015) (E. O. 12989). 52.222-55, Minimum Wages Under Executive Order 13658 (DEC 2015). 52.222-62 Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706). (xix)(A) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a). (B) Alternate I (JAN 2017) of 52.224-3. 52.225 26, Contractors Performing Private Security Functions Outside the United States (OCT 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note). 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (MAY 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6. 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64. (2) While not required, the Contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations. (End of Clause) 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998) 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 http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/ FAR Number Title Date 52.204-7 SYSTEM FOR AWARD MANAGEMENT OCT 2018 52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING JULY 2016 52.212-1 INSTRUCTIONS TO OFFERORS OCT 2018 52.217-5 EVALUATION OF OPTIONS JUL 1990 52.237-1 SITE VISIT APR 1984 FAR 52.212-2 EVALUATION-COMMERCIAL ITEMS (OCT 2014) (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: Best Value considering lowest price and meeting the technical specification outlined in the SOW (b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). For purposes of award of this Contract, the Government intends to evaluate the option to extend services under FAR 52.217-8 as follows: The evaluation will consider the possibility that the option can be exercised at any time and can be exercised in increments of one to six months, but not for more than a total of six months during the life of the contract. The evaluation will assume that the prices for any option exercised under FAR 52.217-8 will be those rates in effect under the contract each time an option is exercised under this clause. The evaluation will therefore assume that the addition of the price or prices of any possible extension or extensions under FAR 52.217-8 to the total price for the basic requirement and the total price for the priced options has the same effect on the total price of all proposals relative to each other, and will not affect the ranking of proposals based on price, unless, after reviewing the proposals, the Government determines that there is a basis for finding otherwise. This evaluation will not obligate the Government to exercise any option under FAR 52.217-8. (c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. (End of Provision)