F107-- Pharmacy USP Sampling Services

THIS IS A SOURCES SOUGHT NOTICE ONLY. This is not a solicitation for bids, proposals, proposal abstracts, or quotations. The purpose of this Sources Sought Notice is for market research to obtain information regarding the availability and capability of all qualified sources to perform or provide a potential requirement. The responses received from interested vendor will assist the Government in determining the appropriate acquisition method. The Department of Veterans Affairs (VA), Network Contracting Office 16 (NCO 16) is seeking to identify potential qualified vendors capable of providing the requirement. This requirement is for the Veterans Health Care System of the Ozarks (VHSO) at 1100 N. College Ave Fayetteville, AR 72703. The North American Industry Classification Code (NAICS) is 541380 (Testing Laboratories and Services), and PSC code F107 (Environmental Systems Protection- Toxic and Hazardous Substance Analysis), with a size standard of $19.0 Million. REQUESTED RESPONSES: All responsible vendors and interested parties please respond to this source sought announcement if you can fulfill the requirements. Responses to this source sought shall include the following information: 1. Your company name, address, contact person name, phone number, fax number, e-mail address(s), UEI number, number of employees, and company website if available. 2. If you are an GSA/FSS contract holder are the referenced services available on your schedule/contract? Provide your company GSA/FSS contract number and contract expiration date, if applicable. 3. If you are a NASA SEWP V contract holder are the referenced services available on your schedule/contract? Provide your company NASA SEWP V contract number, contract group, and contract expiration date, if applicable. 4. Is your company a contract holder on any other federal contract? If so, please provide the contract number. 5. Socio-economic status of business such as but not limited to (Service-Disabled Veteran Owned Small Businesses (SDVOSB) or Veteran Owned Small Businesses (VOSB) SDVOSB/VOSB, 8(a), HUB Zone, Women Owned Small Business, Small disadvantaged business, or Small Business HUB Zone business, Large Business, etc.). 6. Is your company considered small under the NAICS code identified in this source sought announcement? 7. Is your company a service provider for the services being offered? If so, can you provide documentation confirming authorization to provide the referenced services being offered per the Statement of Work? 8. If your company is a large business, do you have any designated distributors? If so, please provide their company name, telephone, point of contact and size status (if available). 9. Vendors are requested to submit estimated market research pricing with their responses. The estimated pricing will be considered when determining the procurement strategy for the future solicitation. (e.g., if Contracting Officer determines that capable small businesses cannot provide fair and reasonable pricing, then the solicitation will not be set-aside). Please note that if incomplete responses are received. Lack of documentation proving your business can conduct the services being offered or all questions not being answered within this notice, your response will not be taken into consideration. CONTACT INFORMATION AND RESPONSE DUE DATE: Please email all responses to contact@example.gov. Please respond to this source sought notice no later than 01-29-2025, 5:00 PM Central. DISCLAIMER: This source sought is issued solely for informational and planning purposes and does not constitute a solicitation. Responses to this notice are not offers and cannot be accepted by the Department of Veterans Affairs to form a binding contract. Respondents are solely responsible for all expenses associated with responding to this source sought notice. Statement of Work for Environmental Microbiology Laboratory Analytical Services GENERAL REQUIREMENTS: An ISO/TEC 17025 accredited laboratory under the Environmental Microbiology Lab Accreditation Program (EMLAP) will process (incubate, analyze, record and report results) microbiological surface samples, Gloved Fingertip and Thumb samples (GFS) and Media Fill Testing (MFT) samples obtained and submitted by Veterans Healthcare System of the Ozarks (VHSO). Samples will be processed according to the most current version of CAG-009-2011 (or its successor) and results will be compared to recommendations provided in USP <797>. All sampling supplies, plates and media fill will be provided by the laboratory pursuant to this contract. Certificate of analysis from the manufacturer will be provided for each lot of growth media to verify that the media meet the expected growth promotion, pH, and sterilization requirements. The contractor shall process personnel related assessment testing GFS samples according to CAG-009-2011 (or its successor), and 2022 USP <797> standards. GFS results will be reported for each plate, with the amount of colony forming units (cfu) present on each plate reported. If there is no growth present that shall be indicated on the report (0 CFU or < 1 CFU). The contractor shall process MFT testing samples according to CAG-009-2011 (or its successor) and 2022 USP <797> standards. MFT results will be reported as negative (pass) or positive (fail); failure is indicated by visible turbidity or other visual manifestations of growth in the media in one or more container closure unit(s) on or before 14 days. The contractor shall process viable surface samples according to the most current version of CAG-009-2011 and 2019 USP <797> standards. If cfu measured during viable sampling exceed USP <797> threshold levels, the report will at minimum identify genus and, when possible, species of any microorganism recovered on the report, in addition to the sample name and the number of CFU. If there is no growth present that shall be indicated on the report (0 CFU or < 1 CFU). SCOPE: The contractor shall perform routine work detailed in this Statement of Work (SOW) on a regular schedule, mutually agreed upon by the Contractor and Contracting Officer Representave (COR). The number of surface sampling, gloved fingertip testing (GFS) and media fill testing (MFT) may change throughout the contract period. This is VHSO's best estimate of the number and type expected to be tested and sampled by the contract. VHSO reserves the right to delete or add units as required. 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. Work items or services not already included in this SOW, but relevant to it, may be ordered by the CO without further competition. Only the CO has the right to obligate funding or order work not expressly detailed in this SOW. The Government shall not be held responsible for payment for any work performed by the Contractor that is outside the scope of this contract or without the prior approval of the CO. Task: Bacteria and Fungi surface incubation and sample analysis Gloved Fingertip and Thumb Sample incubation and sample analysis Media Fill Testing sample incubation and sample analysis Pharmacy IV personnel will conduct gloved fingertip and thumb testing, media fill testing and surface sampling according to USP <797> guidelines and pharmacy needs. The Pharmacy Designated Person or their designee shall collect, label, and prepare all samples for shipping pursuant to instructions provided by the contractor ensuring viability of samples during shipping. Every effort will be made to ship samples the same day as sampled and will be shipped for next day delivery to the contractor according to instructions. If samples are not able to be shipped the same day as sampled, they will be shipped no later than the day after sampling takes place. Days of sampling will be coordinated so delivery occurs according to contractor s normal hours. Gloved Fingertip Sampling Plates: Pharmacy compounding staff must be evaluated in Gloved Fingertip and Thumb Sampling (GFS) to demonstrate competency in garbing and hand hygiene, as set forth in USP <797>. VHSO will perform GFS on site, using one sampling device per hand (e.g., plates, paddles, or slides) containing general microbial growth agar {e.g., trypticase soy agar (TSA)} supplemented with neutralizing additives (e.g., lecithin and polysorbate 80) as this agar supports both bacterial and fungal growth. Contractor will incubate fingertip sampling plates immediately upon receipt at a temperature of 30-35° C for no less than 48 hours and then at 20° 25° C for no less than 5 additional days. Sampling plates will be stored during incubation to prevent condensate from dropping onto the agar and affecting the accuracy of the cfu reading (e.g., invert plates). Contractor will record and report the number of cfu per hand (left hand, right hand), as well as the starting temperature for each interval of incubation, dates of incubation, and the identification of the person who reads and documents the results. Contractor personnel who analyze sampling plates including reading of plates, counting cfu, and performing identification of recovered microorganisms will be a licensed and qualified environmental microbiologist. Failure is if total cfu for both hands is greater than the action level for the type sampling (i.e., initial or bi-annual). The contractor will notify the USP Program Manager, or if unavailable, the Chief Pharmacy Services, within 1 (one) business day of any failure. All results will be transmitted the facility within one business day of final analysis. Table 1. Action Level for Gloved Fingertip Sampling and Thumb Sampling Gloved Fingertip & Thumb Sampling Action Level* Initial sampling after garbing >0 Subsequent sampling after media-fill testing (every 6 months) >3 *Action levels are based on the total cfu count from both hands. Surface Sample Plates: Surface sampling plates are preferred over paddles or slides. One plate each of general microbial growth agar [e.g. typticase soy agar (TSA)] supplemented with neutralizing additives (e.g. lecithin & polysorbate 80 will be used at each sampling site. Microbiological surface monitoring will be performed monthly in the Segregated Compounding Area and all classified areas including: Pass-through chambers The interior of the Primary Engineering Controls (PECs) and any equipment contained within Staging or work area(s) near the PEC Frequently touched surfaces * Additional surface sampling may be performed during certification of new facilities and equipment, after servicing facilities or equipment, in response to identified problems, in response to identified trends, or in response to changes that could impact the sterile compounding environment. One sample of TSA will be obtained per sample location. Contractor will incubate surface sampling plates immediately upon receipt at a temperature of 30-35° C for no less than 48 hours and then at 20° 25°C for no less than 5 additional days. Sampling plates will be stored during incubation to prevent condensate from dropping onto the agar and affecting the accuracy of the cfu reading (e.g., invert plates). If levels measured during surface sampling exceed the levels in USP <797> Table 6, an attempt must be made to identify any microorganism recovered to the genus level, and when possible, to species of the microorganism recovered. Staff direct surface sample readings do not require any additional identification of microorganisms recovered to the genus level. Contractor will identify which surface sampling method is included with bid. Contractor will report the number of cfu per plate as well as the starting temperature for each interval of incubation, dates of incubation, and the identification of the person who reads and documents the results. Contractor personnel who analyze sampling plates including reading of plates, counting cfu, and performing identification of recovered microorganisms will be a licensed and qualified environmental microbiologist. Failure is indicated if cfu of any plate is greater than the action level for the classified area. The contractor will notify the Pharmacy Designated Person and the Chief of Pharmacy Services, within 1 (one) business day of any failure. All results will be transmitted the facility within one business day of final analysis. Table 8. Action Levels for Surface Sampling ISO Class Surface Sampling Action Levels (cfu per media device) 5 >3 7 >5 8 >50 Media Fill Samples: Media fill tests will be designed and developed by the Pharmacy Designated Person to reflect the most complicated manipulations performed at VHSO. The contractor will be provided with the final Media Fill Testing sample (one sample) per staff member tested. Contractor will incubate MFT samples immediately upon receipt at a temperature of 20° 25°C for 7 (seven) days followed by 7 (seven) days at 30° 35°C to detect a broad spectrum of microorganisms. Contractor will report pass/fail results as well as the starting temperature for each interval of incubation, dates of incubation, and the identification of the person who reads and documents the results. Contractor personnel who analyze media fill including reading results licensed and qualified environmental microbiologist and or technician. Failure is indicated by visible turbidity or other visual manifestations of growth in the media in one or more container closure unit(s) on or before 14 days. The contractor will notify the Pharmacy Designated Person and the Chief of Pharmacy Services, within 1 (one) business day of any failure. All results will be transmitted the facility within one business day of final analysis. Place of Performance: Veterans Healthcare System of the Ozarks 1100 N College Avenue Fayetteville, AR 72703 +1 (555) 000-0000 Period of Performance: Table 3. Performance Years 2025 (Base year) 14 July 2025 - 30 September 2025 2026 (Option year 1) 1 October 2025 - 30 September 2026 2027 (Option year 2) 1 October 2026 - 30 September 2027 2028 (Option year 3) 1 October 2027 - 30 September 2028 2029 (Option year 4) 1 October 2028 - 30 September 2029 2030 (Option year 5) 1 October 2029 - 30 September 2030 Contractor Qualifications: An ISO/TEC 17025 accredited laboratory under the Environmental Microbiology Lab Accreditation Program (EMLAP). Copies of pertinent certifications, licenses and EMLAP accreditation will be required. Performance Requirement Summary: Facility surface sampling analysis for viable particles from samples taken in the Segregated Compounding Area (SCA), Chemo Ante Room, Chemo Buffer Room, IV Ante Room, IV Buffer, and associated Primary Engineering Controls (PECs) Viable Surface Sampling analysis Identification to at least genus for any growth that exceed the levels in USP <797> Table 8, and when possible, to species of the microorganism recovered. Personnel related assessments include the following: Gloved Fingertip and Thumb Sample incubation and sample analysis Media Fill Testing incubation and sample analysis Number of Samples: Gloved fingertip samples (620 per year) Media-fill tests for staff (85 per year) Direct surface sample readings for initial staff certification and staff biannual competencies (115 per year) Surface sample readings for monthly for IV compounding areas (sample locations to be determined by VHSO) and staff direct compounding area surface samples (195 per year) Sampling Reports: Results of viable samples and/or surface sampling must be submitted to the Pharmacy Designated Person and the Chief of Pharmacy within one (1) business days of the receipt of the results. Failure to follow these procedures may result in delay of payment or nonpayment. Pass/Fail notifications should be included where applicable. Each sampling reports shall contain, at a minimum, the following information: An SOP or protocol that describes the process for the handling, incubation and analysis for each sampling plate or MFT. Growth and Sterility Control Reports (where applicable) Price Schedule: The contract rate is an all-inclusive rate. No separate fees will be allowed. 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. 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. Records Manager: The 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. chapters 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. 14. Records Management Obligations A. - Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists. - B. - Definitions Federal record as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them. - The term Federal record: Includes Veterans Health Care System of the Ozarks records. Does not include personal materials. Applies to records created, received, or maintained by Contractors pursuant to their VHSO contract. May include deliverables and documentation associated with deliverables. C. - Requirements 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. VHSO 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 VHSO 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 VHSO. 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 [contract vehicle]. 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 VHSO 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 VHSO 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 VHSO policy. The Contractor shall not create or maintain any records containing any non-public VHSO 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 VHSO 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 VHSO 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 VHSO-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training. D. - Flowdown of requirements to subcontractors The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor. Authorized Government Representative(s) The authorized Government representative will be responsible for technical monitoring of the contractor's performance and deliveries. The authorized Government representative and the Contractor's Representative shall work together to ensure that all contractual requirements are being met. The authorized Government representative will interpret specifications or technical portions of the work. The authorized Government representative(s) for this contract is: Final Invoicing Instructions: It is your firm s responsibility to submit a completed and signed Final Invoice Memo (see attached template) in accordance with the terms and conditions of this contract. The Final Invoice Memo must be signed and attached to your firm s submission of the final invoice for final payment or within seven (7) calendar days after the period of performance or contract expiration. If the CO or designated representative does not receive a signed copy of the Final Invoice Memo with your firm s final invoice for final payment and/or if the Government does not hear from your firm via e-mail after seven (7) calendar days, after the period of performance or contract expiration, the Government will accept that there is adequate evidence that all supplies and services have been delivered and accepted, all invoices have been paid, and that there are no outstanding invoices or issues concerning this contract; thus, the Government will continue with a unilateral de-obligation of any remaining funds and issue the signed modification to all parties. Further, failure to submit a signed Final Invoice Memo could result in a negative CPARS entry as a lack of business-like concern for the interest of the customer which in this case is the VAMC. Notwithstanding the claim period stated in FAR 52.233-1, Disputes, and pursuant to FAR 33.206, Initiation of a Claim, the contractor agrees to submit any claim related to this contract within 12 months after accrual.