H266--USP 797 EMPLOYEE COMPETENCY TESTING - HUDSON VALLEY HEALTHCARE SYSTEM

36CI0X18P0081 COMBINED SYNOPSIS/SOLICITATION COMBINED SYNOPSIS/SOLICITATION USP 797 EMPLOYEE COMPETENCY TESTING HUDSON VALLEY HEALTHCARE SYSTEM (i) 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, and FAR 13.5 Simplified Procedures for Certain Commercial Items as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued. (ii) This solicitation is issued as a request for quote (RFQ). Request for Quote will be submitted through beta.sam.gov on RFQ reference number 36C24224Q0499. (iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2024-02 (eff. 01/22/2024) and VAAR Update 2008-36 (eff.

03/22/2023). (iv) This solicitation is a Total Small Business Set-Aside Open-Market solicitation. The associated North American Industrial Classification System (NAICS) code for this procurement is 541380: Testing Laboratories and Services and has a small business size standard of $19 Million. The FSC/PSC is H266: Equipment and Materials Testing Instruments and Laboratory Equipment. (v) This is a services contract to provide USP 797 Employee Competency Testing Hudson Valley Healthcare System. Below is a template for pricing. Contractors may provide their own pricing document, but it must be broken down to allow for price reasonableness determination. PRICING TABLE FOR: USP 797 Employee Competency Testing LINE ITEM DESCRIPTION QUANTITY UNIT UNIT PRICE TOTAL PRICE 0001 Base Period: Viable Surface Sampling 12 MO 0002 Base Period: Gloved Fingertip Sampling 12 MO 0003 Base Period: Media Fill Testing 12 MO 0004 Base Period: Low Complexity Kit 1 UN 0005 Base Period: Tryptic soy augur plates 1 UN 0006 Base Period: Labor costs 12 MO Total Base Year: 1001 Option Year 1: Viable Surface Sampling 12 MO 1002 Option Year 1: Gloved Fingertip Sampling 12 MO 1003 Option Year 1: Media Fill Testing 12 MO 1004 Option Year 1: Low Complexity Kit 1 UN 1005 Option Year 1: Tryptic soy augur plates 1 UN 1006 Option Year 1: Labor costs 12 MO Total Option Year 1: 2001 Option Year 2: Viable Surface Sampling 12 MO 2002 Option Year 2: Gloved Fingertip Sampling 12 MO 2003 Option Year 2: Media Fill Testing 12 MO 2004 Option Year 2: Low Complexity Kit 1 UN 2005 Option Year 2: Tryptic soy augur plates 1 UN 2006 Option Year 2: Labor costs 12 MO Total Option Year 2: 3001 Option Year 3: Viable Surface Sampling 12 MO 3002 Option Year 3: Gloved Fingertip Sampling 12 MO 3003 Option Year 3: Media Fill Testing 12 MO 3004 Option Year 3: Low Complexity Kit 1 UN 3005 Option Year 3: Tryptic soy augur plates 1 UN 3006 Option Year 3: Labor costs 12 MO Total Option Year 3: 4001 Option Year 4: Viable Surface Sampling 12 MO 4002 Option Year 4: Gloved Fingertip Sampling 12 MO 4003 Option Year 4: Media Fill Testing 12 MO 4004 Option Year 4: Low Complexity Kit 1 UN 4005 Option Year 4: Tryptic soy augur plates 1 UN 4006 Option Year 4: Labor costs 12 MO Total Option Year 4: Base and All Options Total: (vi) The required work is as contained below in the Statement of Work. STATEMENT OF WORK USP 797 Employee Competency Testing Introduction and Overview To provide pharmacy quality testing in compliance with USP 797> by a certified ISO/IEC 17025 laboratory. VA will submit samples for analysis to laboratory for proper testing. Background VA Hudson Valley Healthcare System Clinical Laboratory Services has historically performed United States Pharmacopeia Chapter 797 (USP 797>) pharmacy quality testing for all VA Hudson Valley Healthcare System compounding personnel to ensure competency per USP 797> regulations. Updated Department of Veteran Affairs regulations state this process can no longer be performed under the laboratory s Clinical Laboratory Improvement Amendments (CLIA) license. Clinical Laboratory Services must obtain International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025 certification to continue this testing. VA Hudson Valley Healthcare System Clinical Laboratory Services has decided not to seek ISO/IEC 17025 certification and therefore this testing must be conducted externally by a certified ISO/IEC 17025 laboratory. Any lapse in testing may lead to pharmacy cleanroom to be shut down and negatively affecting patient care. Scope of Work Vendor will comply with USP 797> and provide the following services to submission of samples: Media Fill Testing, Glove Finger Testing, and Direct Compounding Area Surface Sampling Testing Perform the incubation in controlled temperature environments in accordance with latest USP 797 requirements. Identify microorganism if growth occurs regardless CFU level. Document dates of incubation and the person who reads and documents the number of CFU this information is automatically captured by our laboratory information system (LIMS) and is available upon request for audit purposes. Provide TSA plates and certificates of analysis (COA) Testing to be performed for a maximum of 60 employees biannually. Period of Performance The period of performance shall be 4/1/2024 through 3/31/2025 with provision of four options years. Requirements Lab must meet all criteria and maintain all certifications needed to function as an International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025 certified laboratory. Tasks General Specifications: Media fill test is the first measure of the aseptic technique of compounders simulating 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. Vendor must perform the incubation for sampling in controlled temperature environments in accordance with USP 797 and reading of media fill test done by VA staff. The sample will be documented with the name of the person evaluated, evaluation time & date, media manufacturer, expiration date, and lot #. Incubate for 7 days at 20-25°C and then 7 days at 30-35°C Complete clarity of the test solution indicates a negative test result (Pass). Turbidity (cloudiness) of the test medium, or non-resoluble sedimentation present at many times during the incubation period constitutes a positive test result. Document dates of incubation, the result, and the person who reads and documents the results. Vendor must perform incubation and reading for approximately sixty (60) samples from VA staff (one sample per staff) twice a year. Total 120 for year. Commercially available MFT kits that are made from sterile microbial growth media will be used for media fill testing and will be provided by vendor. A certificate of analysis (COA) must be provided. Gloved fingertip and thumb sampling (GFS) testing. Vendor must perform the incubation in controlled temperature environments in accordance with USP 797 and reading of each sample collected by VA staff. Each sample shall: be labeled with a personnel identifier, whether it was from the right or left hand, the date and time of sampling, will include the name of the person evaluated, evaluation date/time, media and components used, including manufacturer, expiration date and lot number. Incubate the sampling at a temperature of 30-35°C for 48 hours. Examine for growth. Record the total number of discrete colonies of microorganisms on each device as colony-forming units (CFU) per sample. Incubate at 20-25°C for 5 additional days. Examine the device for growth. Record the total number of discrete colonies of microorganisms on each device as CFU per sample. Identify microorganism if growth occurs regardless CFU level. Document dates of incubation and the person who reads and documents the number of CFU. Vendor must perform incubation and reading for minimum of 424 samples to determine employee competency. There are approximately 53 employees that will need testing twice a year. Four (4) samples per existing employee for total 400 samples (50 employees X2 hands, pre and post media fill testing) Eight (8) samples per newly hired employee for total of 24 samples for initial testing. (Currently hired 3 new employees). Vendor will provide at least 424 Tryptic Soy Ager plates for said testing. These must be ordered periodically as supply needs replenishing. A certificate of analysis (COA) must be provided. Direct Compounding Area Surface Sampling Testing is performed at the end of a media fill activity but before the area has been cleaned and disinfected to confirm that the required environmental quality is maintained. Vendor must perform the incubation in controlled temperature environments in accordance with USP 797> and reading of each sample collected by VA staff. Each sample report to indicate: Name of person evaluated, site location, media manufacturer, lot #, expiration date, and time/day of sampling. Incubate at 30° 35° for 48 hours. Examine for growth. Record the total number of discrete colonies of microorganisms on each device as colony-forming units (CFU) per sample. Incubate at 20° 25° for 5 additional days. Examine the device for growth. Record the total number of discrete colonies of microorganisms on each device as CFU per sample. Identify microorganism if growth occurs regardless CFU level. Vendor must perform incubation and reading for estimated 60 samplings twice yearly. Vendor must provide TSA plates for said testing. A certificate of analysis (COA) must be provided. Services and media supplies to be provided upon request: USP Microbial Monitoring Single Plate 1 plate for bacteria & fungus Counts Only or No growth air, surface, garb Counts Only or No growth fingertip set Genus identification Species identification (ID) Swabs Count w/genus identification Pre-incubated Plate Counts w/Genus identification Counts w/Species identification (ID) Negative Control Positive Control inoculated with 5 ATCC bacterial & fungal stains Media Fill Incubated by lab presence / absence of growth Enverify Surface Sampling Competency Kit Monthly Surface Sampling Kits includes materials, analysis, controls, shipping Media USP Agar Media Triple bagged Gamma irradiated Room Temperature Storage Tryptic Soy Agar 90 mm Tryptic Soy Agar w/ lecithin & polysorbate 80 (LP) 90 mm & 55 mm Sabouraud Dextrose Agar w/ lecithin & polysorbate 80 (LP) 90 mm & 55 mm Media Fill Supplies Low Complexity Kit Medium Complexity Kit - Basic Medium Complexity Kit Comprehensive High Complexity Kit Individual media fill components Regulatory Mandates: To meet regulatory requirements in accordance with USP and to ensure compliance with VHA Directive 1108.12. Verification of Services completed: The Compliance and Quality Program Manager within Pharmacy Service will conduct all testing and will evaluate the reports received from the lab. CONTRACTING OFFICE ADDRESS: VISN 2 Network Contracting Office Albany Stratton VA Medical Center 113 Holland Ave Albany, NY 12208 (vii) Awardee shall coordinate with the Contracting Officer s Representative (COR) prior to performance. (viii) The following solicitation provisions apply to this acquisition: The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html FAR 52.212-1, Instructions to Offerors Commercial Items (Nov 2021) Solicitation number for this requirement as 36C24224Q0499; The time specified in the solicitation for receipt of offers; Name, address and telephone number of offeror; Technical description of services to be performed in accordance with the Statement of Work. This Technical description should address the requirement specifically. Capability statements that are merely an overview of what the contractor offers will be determined incomplete. Please address all the technical evaluation sub-factors. Failure to address all the sub-factors will result in your package being determined incomplete; Terms of any express warranty; Price should be for all services detailed in section v of this document. The pricing must be broken down in a manner that allows for price reasonableness to be determined. Failure to provide complete pricing will result in contractors package being determined to be incomplete; Remit to address, if different than mailing address; A completed copy of the representations and certifications at FAR 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that the offeror shall complete electronically); Acknowledgement of any solicitation amendments; Past performance information; A statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Offers that fail to furnish required representation or information or reject the terms and conditions of the solicitation will be excluded from consideration. The following solicitation provisions are included as addenda to FAR 52.212-1: 52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998) 52.204-7 System for Award Management (OCT 2018) 52.204-16 Commercial and Government Entity Code Reporting (Aug 2020) 52.216-1 Type of Contract (APR 1984) The Government contemplates award of a Firm Fixed Price contract resulting from this solicitation. 52.217-5 Evaluation of Options (JUL 1990) 852.252-70 Solicitation Provisions or Clauses Incorporated by Reference (JAN 2008) Addendum to FAR 52-212-1 INSTRUCTIONS TO OFFERORS COMEMRCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021): This Request for Quote (RFQ) is issued in accordance with FAR Part 12 in conjunction with Simplified Acquisition Procedures at FAR 13.5. All instances of FAR 15 procedures in FAR 52.212-1 shall not apply to this RFQ and are hereby substituted with FAR 13 procedures. Eligibility: In order for a quote to be eligible for award, offerors submitting a quote must have the NAICS Code 541380: Testing Laboratories and Services and current registration in both the System for Award Management (SAM): https://www.sam.gov/portal/public/SAM, as well as current certification in Small Business Administration (SBA): https://www.sba.gov/. Submission Instructions: Technical packages shall be submitted to Levi.Russin@va.gov by 12:00 PM ET on 4/4/2024. The email shall identify Solicitation 36C24224Q0499. Offerors that do not adhere to these instructions may be determined to be incomplete and, therefore, risk being rejected without further consideration for award. Offer submissions must include: EVALUATION FACTOR SUPPORTING DOCUMENTS: Technical Capability: Technical capability is defined as an offeror s ability to satisfy the solicitation s requirements, providing the highest quality service to the specified facilities Technical Capability will be determined on the basis of the qualification of the quoter that are detailed in the quoter s capability statement. Quoter must provide a technical capability statement of 15 pages or less demonstrating it has trained personnel, equipment, and working experience in providing USP 797 Employee Competency Testing services. Documentation must include proof of providing work on at least three (3) contracts of similar nature, scope, complexity, difficulty, and size to that which will be supplied to the work detailed in the SOW for this requirement. Quoter must provide proof/certification that it is a licensed business to conduct Facility Fire Protection System Testing and Maintenance in accordance with VHA Directive 1108.12 Management and Monitoring of Pharmaceutical Compounded Sterile Preparations, and have an International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025 certified laboratory. (2) Past performance: Quoter will be evaluated on how well their past performance information supports that they are a capable vendor who can adequately perform services of this scope and complexity without issues with performance. Relevant past performance information shall include key personnel who have relevant experience, predecessor companies, and subcontractors who will perform major or critical elements of this solicitation. The contractors Past Performance shall also be reviewed in PPIRs; Individuals with no past performance shall receive a neutral rating for this evaluation factor. Quoter must provide at least three (3) past performances references for contracts of similar nature, scope, complexity, difficulty, and size to that which will be supplied to the work detailed in the SOW for this requirement. (3) Price: The government will evaluate quotes for award purposes based on the pricing for the total requirement. Quotes for partial requirement will not be evaluated and will be deemed non-responsive upon receipt. END OF ADDENDUM (ix) The provision at FAR 52.212-2, Evaluation Commercial Items (November 2021), applies to this acquisition. 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, considering technical capability, past performance, and price. A Technical Evaluation Team comprised of representatives of the Department of Veterans Affairs will evaluate the proposals. The identities of the Technical Evaluation Team are confidential, and any attempt by the offerors to contact these individuals is prohibited. The evaluation will be based on the content of the proposal and any subsequent discussions, if necessary, as well as information obtained from other sources, e.g. past performance information. Quoters are advised that the technical evaluation and rating of proposals will be conducted in strict confidence in that technical and past performance proposals are reviewed and rated without knowledge of the price offered. During deliberation, the number and identities of quoters are not revealed to anyone who is not involved in the evaluation and award process or to other quoters. Quotes will be evaluated based on the factors described herein, and award will be made to the responsive responsible quoter whose offer in conformance with this solicitation, results in the best value to the Government, price and other factors considered. The evaluation process essentially consists of two parts: Technical/Past Performance Evaluation and Price Evaluation. 1. Technical/Past Performance Evaluation: Proposals shall be evaluated against the Evaluation Factors and Criteria. 2. Price Evaluation: The CO will evaluate price proposals independent of the technical/past performance evaluation. The Technical Evaluation Team will not have access to price information until completion of the technical/quality evaluation. NOTE: Price/Technical Trade-off Analysis: Once above evaluations are complete, the Technical Evaluation Team will compare the relative advantages and disadvantages of technical proposals and weigh against the prices. Technical Approach and Past Performance are equal and when combined are significantly more important than Price. The Technical Evaluation Team will then consider all factors and recommend an awardee to the CO, the quote offering the best value to the Government. The CO s decision shall be based on a comparative assessment of proposals against all source selection criteria in the solicitation. The government shall evaluate information based on the following evaluation criteria. Evaluation Factors: Technical Capability: Technical capability is defined as a quoter s ability to satisfy the solicitation s requirements, providing the highest quality service to the specified facilities. Contractor shall provide a maximum 15-page capability statement demonstrating it has trained personnel, equipment and working experience and ability to meet all the requirements of the Statement of Work (SOW) A) Technical Proficiency: Quoter shall submit a proposal that verifies it is a firm that specializes in providing USP 797 Employee Competency Testing services. The proposal shall be comprehensive and demonstrates its understanding of the requirement and not a copy and paste of the SOW requirements. It shall outline the contractor s ability to perform the services adequately and satisfactorily in accordance with the SOW and the extent to which potential risks are identified and mitigated. B) Contractor Experience: The quoter shall provide three (3) instances of past-experience similar in nature, scope, complexity, difficulty, and size to that which will be supplied under the prospective contract contemplated by this solicitation. The experience shall reflect of no less than three (3) years of experience in providing USP 797 Employee Competency Testing services. C) Licensing/Certifications: Quoter will be evaluated on how well they meet the requirement to provide proof that it is a licensed business to providing USP 797 Employee Competency Testing services in accordance with VHA Directive 1108.12 Management and Monitoring of Pharmaceutical Compounded Sterile Preparations, and have a International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025 certified laboratory. Past performance: Quoter must provide three references for contract of similar scope and magnitude to be evaluated. Relevant past performance information shall include key personnel who have relevant experience, predecessor companies, and subcontractors who will perform major or critical elements of this solicitation. The quoters Past Performance shall also be reviewed in PPIRs; Quoter s with no past performance shall receive a neutral rating for this evaluation factor. Price: The government will evaluate quotes for award purposes based on the pricing for the total requirement. Quotes for partial requirement will not be evaluated and will be deemed non-responsive upon receipt. Options: The Government will evaluate quotes for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that a quote is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). A written notice of award or acceptance of a quote, mailed or otherwise furnished to the successful quoter within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the quote s specified expiration in time, the Government may accept a quote (or part of a quote), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. Failure to provide the information requested in the evaluation criteria may result in being found non-responsive. (End of Provision) (x) The provisions at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2021) applies to this acquisition. * All firms or individuals submitting a quote shall include a completed copy of this provision OR have current Representations and Certifications in the System for Award Management (SAM - https://www.sam.gov). Representations, Certifications, and SAM must be current at award. IF NOT CURRENT AND/OR YOU DO NOT SUBMIT A COMPLETED COPY OF THIS PROVISION, YOUR QUOTE WILL BE CONSIDERED NON-RESPONSIVE. (xi) FAR 52.212-4, Contract Terms and Conditions Commercial Items Nov 2021 applies to this acquisition. The following clauses are incorporated into Addendum to FAR 52.212-4, 52.252-2 Clauses Incorporated by Reference (FEB 1998) 52.204-13 System for Award Management Maintenance (OCT 2018) 52.204-18 Commercial and Government Entity Code Maintenance (AUG 2020) 52.217-9 Option to Extend the Term of the Contract (MAR 2000) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (DEC 2013) 852.212-70 Provisions and Clauses Applicable to VA Acquisition of Commercial Items (APR 2020) - 852.201-70 Contracting Officer s Representative (DEC 2022) - 852.203-70 Commercial Advertising. - 852.232-72 Electronic Submission of Payment Requests - 852.242-71 Administrative Contracting Officer (OCT 2020) 852.242-71 Administrative Contracting Officer (OCT 2020) (xii) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders- Commercial Items (Jan 2022) The following subparagraphs of FAR 52.212-5 are applicable: 52.204-10 Reporting Executive Compensation & First-Tier Subcontract Awards (JUN 2020) 52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business Concerns (SEP 2021) 52.219-6 Notice of Total Small Business Set-Aside (NOV 2020) 52.219-13 Notice of Set-Aside of Orders (MAR 2020) 52.219-28 Post Award Small Business Program Representation (NOV 2020) 52.219-32 Orders Issued Directly Under Small Business Reserves (MAR 2020) 52.222-3 Convict Labor (JUN 2003) 52.222-21 Prohibition of Segregated Facilities (APR 2015) 52.222-26 Equal Opportunity (SEP 2016) 52.222-36 Equal Opportunity for Workers with Disabilities (JUN 2020) 52.222-41 Service Contract Labor Standards (AUG 2018) 52.222-42 Statement of Equivalent Rates for Federal Hires (MAY 2014) Employee Class: 23465 Monetary Wage-Fringe Benefits: $33.87 52.222-42 Statement of Equivalent Rates for Federal Hires (MAY 2014) 52.222-43 Fair Labor Standards Act and Service Contract Labor Standards - Price Adjustment (Multiple Year and Option Contracts) (AUG 2018) 52.222-50 Combating Trafficking in Persons (OCT 2020) 52.222-55 Minimum Wages Under Executive Order 13658 (NOV 2020) 52.222-62 Paid Sick Leave Under Executive Order 13706 (JAN 2017) 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) 52.225-13 Restrictions on Certain Foreign Purchases (JUN 2008) 52.232-33 Payment by Electronic Funds Transfer System for Award Management (OCT 2018) (xiii) The Service Contract Act of 1965 does apply to this procurement. See attached Wage Determination (xiv) All quoters shall submit the following: one copy of technical capability and pricing, and an additional redacted copy. All quotations shall be sent ONLY to Levi Russin at Levi.Russin@va.gov This is a Total Service-Disabled Veteran-Owned Small Business Set-Aside Open-Market solicitation for USP 797 Employee Competency Testing for the Hudson Valley Healthcare System as defined herein. The government intends to award a contract as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" Quoter shall list exception(s) and rationale for the exception(s). Submission shall be received not later than 12:00 PM ET on 4/4/2024 at Levi.Russin@va.gov. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). Faxed or postal mailed quotes will NOT be accepted. Request for information (RFI) shall be received no later than 12:00 PM ET on 4/1/2024. Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Contract Specialist Levi Russin at Levi.Russin@va.gov. All communication shall have RFQ number and requirement title in the subject line. Point of Contact Levi Russin, Contract Specialist Levi.Russin@va.gov