This Sources Sought Notice is for planning purposes only and shall not be considered as an invitation for bid, request for quotation, request for proposal, or as an obligation on the part of the Government to acquire any products and/or services. Your response to this Sources Sought Notice will be treated as information only. No entitlement to payment of direct or indirect costs or charges by the Government will arise because of contractor submission of responses to this announcement or the Government use of such information. This request does not constitute a solicitation for proposals or the authority to enter negotiations to award a contract. No funds have been authorized, appropriated, or received for this effort. The information provided may be used by the Department of Veterans Affairs in developing its acquisition approach, statement of work/statement of objectives and performance specifications. Interested parties are responsible for adequately marking proprietary or competition sensitive information contained in their response. The Government does not intend to award a contract based on this Sources Sought Notice or to otherwise pay for the information submitted in response to this Sources Sought Notice. The submission of pricing, capabilities for planning purposes, and other market information is highly encouraged and allowed under this Sources Sought Notice in accordance with (IAW) FAR Part 15.201(e). The purpose of this Sources Sought Notice announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service-Disabled Veteran Owned Small Businesses, Veteran Owned Small Businesses, 8(a), HubZone and other Small Businesses interested and capable of providing the products and/or services described below. Documentation of technical expertise must be presented in sufficient detail for the Government to determine that your company possesses the necessary functional area expertise and experience to compete for this acquisition. Responses to this notice shall include the following: (a) Company Name; (b) Address; (c) Point of Contact; (d) Phone, Fax, and Email; (e) UEI Number; (f) Cage Code; (g) Tax ID Number; (h) Type of Small Business, e.g., Services Disabled Veteran Owned Small Business, Veteran Owned Small business, 8(a), HUBZone, Women Owned Small Business, Small Disadvantaged Business, or Small Business HUBZone business, etc.; (i) State if your business has an FSS contract with GSA, VA NAC, NASA SEWP, or any other federal contract, that can be utilized to procure the requirement listed below and provide the contract number; and (j) Must provide a capability statement that addresses the organization s qualifications and ability to perform as a contractor for the work described below. Requirement: The VA Heartland Network 15 Contracting Office located at 3450 South 4th Street, Leavenworth, KS, 66048-5055 is seeking a potential qualified contractor to provide Service for IV ROOM CERTIFICATION AND PERSONNEL TRAINING for VISN 15 VAMC s. Please see the Performance Statement of Work for more specifics and details. The North American Industry Classification System Code (NAICS Code) is 621511 (Medcial Laboratories), size standard $41.5. Based on this information, please indicate whether your company would be a Large or Small Business and have a socio-economic designation as a Small Business, VOSB or SDVOSB. Important Information: The Government is not obligated to, nor will it pay for or reimburse any costs associated with responding to this source sought synopsis request. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to an acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. Currently a total set-aside for Service-Disabled Veteran Owned Small Business firms is anticipated based on the Veterans Administration requirement with Public Law 109-461, Section 8127 Veterans Benefit Act. However, if response by Service-Disabled Veteran Owned Small Business firms proves inadequate, an alternate set-aside or full and open may be used. Responses to this notice shall be submitted via email to Lisa Buchanan at lisa.buchanan1@va.gov. Telephone responses will not be accepted. Responses must be received no later than Friday, August 22, 2025, at 10:00AM CST. Please reference 36C25526Q005 in the subject line. Please provide your Unique Entity ID so that your organization can be identified in SAM.GOV. Only organizations with an active SAM.GOV account can be considered. If a solicitation is issued it shall be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this source sought. Responses to this source sought notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation. STATEMENT OF WORK VISN 15 IV Room Certification and Personnel Training REQUIREMENT: The VA Heartland Health Care Network (VISN15) VAMC facilities listed below require testing and certification of all the VA Heartland Health Care Network (VISN 15) facilities primary engineering controls (PECs) and clean rooms used for preparation of compounded sterile preparations (CSPs). PECs include biological safety cabinets (BSCs), laminar airflow workbenches (LAFWs), compounding aseptic containment isolators (CACIs), compounding aseptic isolators (CAIs) and Isolators. Testing and certification will be completed in accordance with United States Pharmacopeia (USP) Chapter <797> (<797>), USP Chapter <800> (<800>), or current guidelines. This requirement also includes personnel training, evaluation and requalification to compound CSPs in accordance with <797>, <800>, or current guidelines. BACKGROUND: VHA compounding practice is governed by 1108.12, Management and Monitoring of Pharmaceutical Compounded Preparation. Within this document is noted that VA pharmacy compounding practice must adhere to the standards under USP <797>, <800>, and <795> including the requirement that certification must occur and must follow CETA standards. Correspondingly, after the 2012 national fungal outbreak, Congress established new federal law under the Drug Quality and Safety Act (DQSA) that designates specific operational requirements to compound medications. VA facilities are categorized as 503A compounding pharmacy, and as such must comply with 21 U.S. Code § 353a - Pharmacy compounding. The USP establishes standards for cleanroom design, environmental monitoring, and competencies for the preparation, handling, and storage of CSPs. The Joint Commission (TJC) Accreditation Manual for Home Care, effective January 13, 2018, established new Medication Compounding (MC) standards for non-sterile and sterile compounded preparations which are based on USP standards. In 2023, the AUSH for Health for Clinical Services/Chief Medical Officer issued an advisement that VA Laboratories do not have environmental testing certification, specifically, International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025 certifications. VA Laboratory s Clinical Laboratory Improvement Amendments (CLIA) license does not allow for environmental quality testing. VA Laboratories could not meet the external accreditation requirements of the American Association for Laboratory Accreditation and the Joint Commission. Only one VA Laboratory in the nation could meet the requirements for environmental requirements, however, this facility could not be used for the following reasons: The automated equipment the facility purchased to improve performance in sample testing requires the use of 100mm media plates. USP <797> requires the use of convex plates for surface sampling. Most of the 100mm plates we have identified are not convex. Supplies could not be located. VISN 15 facilities have either upgraded/constructed or are in the process of upgrading/constructing compounding spaces to continuously meet 797 and 800 standards. As such, VISN 15 requires contractors to adjust quantity, and perhaps types, of services to meet the changing needs of the facilities as upgrades and construction are completed. Pharmacies are required to validate staff competency in aseptic technique to compound preparations at required intervals. This includes Media Fill testing, Gloved Fingertip testing and surface sample testing. The same policies and regulatory requirements as the cleanroom certification justify this requirement, additionally: Federal law under the Drug Quality and Safety Act (DQSA) designates specific operational requirements to compound medications. VA facilities are categorized as 503A compounding pharmacy, and as such must comply with 21 U.S. Code § 353a - Pharmacy compounding SEC. 503A. PHARMACY COMPOUNDING FDCA (a)(2)(A) addresses conditions whereby compounded preparations are deemed to be adulterated if it has been prepared, packed, or held under insanitary conditions. FDA Insanitary Guidance provides specifics associated with this law, among them, lack of documented staff competency. Certification procedures defined in CETA CAG-003-2006 shall be performed by a CETA CNBT certified testing individual no less than every 6 months or whenever the PEC or room is relocated or altered or when major service to the sterile compounding facility is performed. PERIOD OF PERFORMANCE This procurement is for an IDIQ with Four (4) ordering periods. Ordering Period 1 FEBRUARY 12, 2026 through FEBRUARY 11, 2027 Ordering Period 2 FEBRUARY 12, 2027 through FEBRUARY 11, 2028 Ordering Period 3 FEBRUARY 12, 2028 through FEBRUARY 11, 2029 Ordering Period 4 FEBRUARY 12, 2029 through FEBRUARY 11, 2030 Ordering Period 5 FEBRUARY 12, 2030 through FEBRUARY 11, 2031 PLACES OF PERFORMANCE Facility Name Address VISN 15 589 Kansas City, MO 4801 E. Linwood Blvd. Kansas City, MO 64128 VISN 15 589A4 Columbia, MO 800 Hospital Drive Columbia, MO 65201 VISN 15 589A5 Topeka, KS 2200 SW Gage Blvd. Topeka, KS 66622 VISN 15 589A6 Leavenworth, KS 4101 4th St. Trafficway Leavenworth, KS 66048 VISN 15 589A7 Wichita, KS 5500 E. Kellogg Drive Wichita, KS 67218 VISN 15 657 St. Louis, MO J. Cochran 915 N. Grand Blvd. St. Louis, MO 63106 VISN 15 657A0 St. Louis, MO J. Barracks 1 Jefferson Barracks Dr. St. Louis, MO 63125 VISN 15 657A4 Poplar Bluff, MO 1500 N. Westwood Blvd. Poplar Bluff, MO 63901 VISN 15 657A5 Marion, IL 2401 West Main Street Marion, IL 62959 VISN 15 657GJ Evansville IN 6211 East Waterford Blvd. Evansville, IN 47715 PERFORMANCE REQUIREMENTS The VA Heartland Health Care Network (VISN 15) requires a VISN-wide contract for standardized testing criteria appropriate for all PECs used pursuant to current <797> and <800> standards using Controlled Environment Testing Association (CETA) Certified National Board of Testing (CNBT) certified individuals to establish consistent PEC certification procedures using the Certification Guide for Sterile Compounding Facilities CAG-003-2006. Although <797> states that certification procedures or an equivalent of those outlined in CAG-003-2006 shall be performed, Veterans Affairs (VA) will be requiring that CAG-003-2006 be used in lieu of any other equivalent procedures that may exist. Depending on the period of performance and ordering periods, testing procedures shall be maintained in compliance with all current applicable USP standards. a. CETA REGISTRATION: All vendors used to conduct primary and secondary engineering controls certifications/assessments must be registered with CETA. b. PEC TESTING AND CERTIFICATION i. The contractor shall test and certify each PEC according to <797> and <800> using certification procedures from the CETA Certification Guides for Sterile Compounding Facilities (CAG-003-2006 and CAG-002-2006). ii. All PECs must: Be certified to meet ISO Class 5 or better Maintain unidirectional airflow Be supplied by HEPA filtered air iii. The list of tests, depending on CETA and manufacturer guidance for the type of PEC, includes, but is not limited to: HEPA filter leak test Induction leak/back-streaming test Cabinet leak test In-flow velocity test to include exhaust airflow volume rate Dynamic airflow smoke pattern test Total airborne particle testing Viable microbial air testing Viable microbial surface testing iv. LAFWs, Integrated Vertical Laminar Flow Zones (IVLFZs), and BSCs must be tested and certified according to CETA CAG-003-2006 guidelines and to manufacturer s specifications. v. Horizontal laminar flow cabinets shall be certified according to The Institute of Environmental Sciences (IEST) RP-CC-002 Testing Laminar Air Flow Devices and Induction Leak/Back-streaming Test and IEST-RP-CC034 HEPA Filter Leak Test. vi. Certifications for Class II Biological Safety Cabinets (BSCs) must be accomplished in accordance with the most current National Sanitation Foundation/American National Standards Institute (NSF/ANSI) Standard 49 Class II (laminar flow) Biosafety Cabinetry. The contractor shall use a National Institute of Standards and Technology (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 POCs upon request. vii. The contractor shall report each individual face velocity reading and the average of those readings, the downstream concentration reading of the HEPA filter leak test and the results of the induction leak test and back-streaming test. Any failures shall be reported directly to the identified site POCs as soon as practicable. Any unit that fails to meet required specifications shall be clearly marked with a sign that will notify technicians that the unit is out of order until further notice. In addition, any failures shall be reported directly to the site identified POC as soon as immediately. viii. Restricted Access Barrier Systems (CAIs, CACIs, and isolators (e.g. PECs with a controlled workspace, transfer devices, access devices, and a decontamination system) must be certified according to CETA CAG-002-2006 and CAG-003-2006 guidelines and to manufacturer s specifications. Any unit that fails to meet required specifications shall be clearly marked with a sign that will notify technicians that the unit is out of order until further notice. In addition, any failures shall be reported directly to the site identified point(s) of contact (POCs) immediately. ix. Hazardous compounding PEC certification is required for: Negative pressure hoods Isolators PECs where robotic enclosure is used inside of the PEC x. The contractor shall test and certify each hazardous PEC to the manufacturer s specifications. Tests shall include: Face velocity test Airflow smoke pattern test Low flow alarm test xi. If the hazardous PEC has an air flow monitor (AFM) or controller (AFC), the contractor shall confirm the unit is calibrated and operating within +/-10% of actual velocity. If it is not calibrated appropriately the contractor shall calibrate the AFM or AFC. The contractor shall use a NIST traceable or comparable calibrated piece of equipment to calculate the face velocity. xii. The contractor shall report each individual face velocity reading and the average of those readings, a pass/fail grade for the airflow smoke pattern test and a pass/fail grade for the low flow alarm test. Any failures shall be reported directly to the POC(s) as soon as practicable xiii. For each PEC passing the required certification tests, the contractor will supply each unit with a certification sticker with the following information: Company name and phone number Unit model and serial number Report number reflecting the room certification Certification date Recertification date Sash height (for fume hoods) Technician signature c. CLEAN ROOM CERTIFICATION i. All classified areas must be tested and certified in accordance with ISO 14644-1 Classifications of Air Cleanliness, CETA CAG-003-2006 and CETA CAG-009-00 specifications. The contractor will provide comprehensive cleanroom testing and certification services with frequency required by most current <797> and <800> standards. To include testing needed when new cleanroom construction is completed or significant corrective actions or repairs are needed in existing compounding spaces. Test equipment used for certification will be clean, in good working order and calibrated on a calibration frequency not to exceed 12 months or more frequently if recommended by the manufacturer. Calibration certificates should be provided upon request by the facility POC for all calibrated test equipment. USP Compliance Testing for Cleanrooms and Controlled Environment certification will include, but is not limited to, the following: Air velocity and volume Air exchange rate Room pressure differential Leak testing of HEPA filters Temperature, relative humidity measurements Lighting measurement Sound level measurement Electrical leakage and ground circuit resistance and polarity tests Pass-through chamber air quality Pass-through HEPA filter leak test (where present) Total airborne particle testing Viable microbial air testing Viable microbial surface testing ii. Air Changes Per Hour (ACPH). The contractor shall calculate the total room volume for each buffer, ante room, and hazardous drug (HD) 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 ACPH for each buffer room, ante room, Containment Segregated Compounding Area (C-SCA), and HD storage room and include their findings in the report. In the event a room does not meet <797> or <800> requirements for ACPH the identified site POC(s) shall be informed immediately. iii. Pressure Requirements The contractor shall include in their report differential pressure readings from each buffer/ante room to surrounding areas. The report shall indicate whether the room is required to be a negative or positive pressure room per <797> or <800>. The contractor shall report all pressures to an accuracy of 0.001 inch water column (3 decimal places). Pressure differentials will be reflected on a report showing the sketch of the room(s). iv. Total Airborne Particles The contractor shall perform total airborne particle testing under dynamic operating conditions every 6 months. The contractor shall derive the minimum number of sampling locations using Annex A in the ISO 14644-1.2 standard. The volume sampled at each location shall be at least 2 liters, with a minimum sampling time at each location of 1 minute. Testing shall be performed by qualified operators using current, state-of-the-art electronic equipment with results of the following: ISO Class 5: not more than 3,520 particles 0.5 µm and larger size per cubic meter of air for any area primary engineering control. ISO Class 7: not more than 352,000 particles 0.5 µm and larger size per cubic meter of air for any buffer area or hazardous compounding ante room. ISO Class 8: not more than 3,520,000 particles 0.5 µm and larger size per cubic meter of air for any non-hazardous compounding ante room. v. Microbial Air Monitoring The contractor shall perform viable air sampling every 6 months for fungi and bacteria using an impaction device in all classified areas during dynamic operating conditions. A sufficient volume of air (1,000 liters or more) shall be tested at each location to maximize sensitivity. Samples of less than 1,000 liters will not be acceptable. A general microbiological growth media that supports the growth of bacteria and fungi must be used (e.g. trypticase soy agar (TSA)). Alternately, malt extract agar (MEA) or sabouraud dextrose agar (SDA) can be used for sampling of fungi. Samples will be incubated at the temperature and duration specified in <797>. The contractor must be willing and able to supply, upon request, the certificates of analysis (COAs) verifying the media meets the expected growth promotion, pH, and sterilizing requirements of <797>. vi. Microbial Surface Monitoring The contractor shall perform viable surface sampling every month for fungi and bacteria. A general microbiological growth media that supports the growth of bacteria and fungi and supplemented with neutralizing additives (e.g., lecithin and polysorbate 80) to neutralize the effects of any residual disinfecting agents must be used (e.g. TSA). Alternately, MEA or SDA can be used for sampling of fungi. Samples will be incubated at the temperature and duration specified in <797>. Surface sampling must be performed at the end of the compounding activities or shift, but before the area has been cleaned and disinfected. Sampled surfaces are to include: The interior of the PEC and the equipment contained in it Staging or work area(s) near the PEC Frequently touched surfaces Pass-through chamber(s) d. ADDITIONAL SERVICES. Additional services to maintain environmental controls as needed. Individual facilities may opt in: Change out HEPA Filters in cleanrooms and hoods when damaged or according to manufacturer recommendations Change hood HEPA filter when damaged or according to manufacturer recommendations Change hood pre-filters when damaged, dirty, or according to manufacturer recommendations Install externally accessible HEPA filter smoke study ports to perform HEPA leak testing when needed to prevent damaging HEPA filter Room smoke study as needed (such as completed new construction or significant room remodeling prior to opening) to identify airflow, eddies and employ risk mitigation strategies to account for such airflow obstructions identified e. ENVIRONMENTAL WIPE SAMPLING The contractor will perform environmental wipe sampling for HD surface residue every 6 months, or more frequently From EK/Katie: States a total of 6 surface samples We have a negative SCA with BSC contingency room we used in Topeka. We do mix chemotherapy in the room if our main IV HD room is not available or if we have high chemo volume days and have another IV pharmacy technicians to mix. Are we limited to just 6 or can we opt in more samplings since we have additional space? as needed, to verify containment, for those facilities that perform HD compounding and opt in for this testing. The kits used to complete wipe sampling must be verified prior to use to ensure the method and reagent used have been tested to recover a specific percentage of known marker drugs from surface types found in the sample area(s). The contractor must be able to test for the following: Cyclophosphamide Ifosfamide Methotrexate Fluorouracil Platinum-containing drugs Additional Drugs Additional drugs may be requested based upon identified need per site. Upon identified need, the applicable site will work directly with the contractor where additional cost will be clarified and agreed upon by both parties prior to testing. Surface wipe sampling may include the following areas: Interior of PEC and equipment contained in it. Pass-through chambers Surfaces in staging or work areas near PEC Areas adjacent to PECs (e.g. floors directly under C-PEC, staging, and dispensing area) Areas immediately outside the HD buffer room or C-SCA Patient administration areas f. CERTIFICATION AND ENVIRONMENT RESULTS REPORTING All of the following information shall be included in the report for clean room certification. Pass/Fail notifications should be included on a per-test basis where applicable. Executive summary or summary of findings to include: Room Certification Pass/Fail Hood Certification Pass/Fail Viable Air Sampling Pass/Fail Viable Surface Sampling Pass/Fail Specific deficiencies by location (room and/or hood), if identified. Room number and/or location Room type (e.g. oncology prep room) Standards used to test room List of equipment utilized to include make, model, serial number, and calibration date Room air changes per hour (The ACPH from HVAC, ACPH contributed from the PEC, and the total ACPH) Pressure differentials Indication when dynamic operating conditions were used Total airborne particle counts, action level for target ISO level Action levels for ISO area tested Total room area and volume Date of next required certification Type of PEC certified Serial number of the PEC certified Date and time samples collected and particle counts tested Technician collecting the samples COAs of media used Viable sample results (CFUs), action level for target ISO level Viable sample results graph showing trends over time Genus identification of bacterial and/or fungal isolates Highly pathogenic microorganism isolates highlighted in the report notes Room sketch (location of supply/exhaust diffusers, equipment, room dimensions) Sketch identifying location of each viable particle and surface samples obtained Location of positive HD wipe sample results Room humidity and temp g. REPORT DISTRIBUTION The contractor will immediately notify the POCs with any results indicating failure. A formalized written report including all required aspects specified in this SOW will be provided in a timely manner with receipt no more than 14 days from certification evaluation. All completed reports will be provided via email to the POCs and Report Distribution Lists. See 12. GENERAL ADMINISTRATION section of this document for identification and email addresses of POCs and Report Distribution Lists. Contractor will be notified by facilities of any updates to identified points of contact on an as needed basis. h. TESTING FREQUENCY Certification procedures for PEC and room defined in CETA CAG-003-2006 and CETA CAG-009-00 shall be performed by a CETA CNBT certified testing individual no less than every 6 months, whenever the PEC or room is relocated or altered, when major service to the sterile compounding facility is performed, or to assess corrective actions associated with prior failed testing resultsPreviously had issues with vendor requesting additional line item for travel for additional testing outside the every 6 month certification for room failures, particularly when there were ongoing extended corrective action plans being implemented. Contracting deemed that the SOW that was agreed upon would not allow us to pay additional line item for this travel since it was not included in the SOW or as a line item with the contract. Tighten wording on this as needed. Same for subsequent 2 bullets in this section. . More frequent testing may be required should USP standards change during the performance period or ordering periods. Viable surface sampling will be completed every month, or more frequently if required to assess corrective actions associated with prior failed results. More frequent testing may be required should USP standards change during the performance period or ordering periods. Viable airborne particle sampling will be completed every 6 months, or more frequently if required to assess corrective actions associated with prior failed testing results. More frequent testing may be required should USP standards change during the performance period or ordering periods. Environmental wipe sampling for HD residue will be performed every 6 months, or more frequently if required to verify containment for those facilities who opt to perform this testing as part of their HD sterile compounding quality assurance activities.  i. PERSONNEL COMPETENCY ASSESSMENT From EK/Katie: Regarding visual IV compounding, to my understanding KCVA utilized the closed transfer device training with staff during this time. This is something we are looking into as well for those staff members that may admix chemotherapy. Wondered if this needs to be included in this SOW since this is more of a time commitment whoever is conducting the training and may need to be onsite more than a couple of days. Contractor shall provide a written description of media fill testing and gloved fingertip testing (MFT/GFT) procedures training and assessment procedures, consistent with USP <797> and USP <800>, to include hand hygiene and garbing observations, gloved fingertip and thumb sampling, and media fill testing. Contractor shall visually observe compounding personnel while performing hand hygiene and garbing procedures initially, with frequency outlined in current USP <797> standards and USP <800> standards for each successfully trained employee.  Contractor shall obtain gloved fingertip and thumb samples three separate times after performing a separate and complete hand hygiene and full garbing procedure initially for new personnel. Contractor shall obtain gloved fingertip and thumb sampling after completing the media-fill test, for those personnel who successfully completed initial competency evaluations with frequency outlined in current USP <797> standards and USP <800> standards. Contractor shall obtain media fill test with frequency outlined in current USP <797> standards and USP <800> standards for those personnel who successfully completed initial competency and evaluations. Contractor shall incubate gloved fingertip and thumb samples and media fill tests in controlled temperature environments in accordance with USP <797> guidance and USP <800> standards, and report results and action levels to the facility POC as soon as results are available. The contractor will designate at least 2 separate days for each facility to re-qualify successfully trained personnel, to maintain current re-qualification of all staff. If gloved fingertip and thumb samples and/or media fill tests are failed by an employee, contractor will provide re-testing of those employees within 30 days of the date the failed test was performed. Facility will contact contractor upon learning of need for new employee training and contractor will perform training of new employees within a mutually agreed upon time frame.   Contractor will offer closed system transfer device (CSTD) media fill testing at the request of the facility. This may be requested for sites who compound chemotherapy and other hazardous drugs. Training and competency assessment frequency will be adjusted, as needed, in compliance with USP standards.  j. PERSONNEL TRAINING AND COMPETENCY REPORTING Each employee s written test will be provided to the facility point of contact for competency documentation. A summary of each employee s training and qualification assessment shall be included in a report to document personnel training.  Employee name Date of testing Testing procedures for hazardous and/or non-hazardous compounding Date of next required qualification assessment(s)  Written test results noting score and PASS/FAIL result  Observed hand hygiene and garbing procedures with PASS/FAIL result Gloved fingertip and thumb samples results including action levels, cfu per hand, and PASS/FAIL result Media fill testing results with PASS/FAIL result k. ESTIMATED SERVICE NEEDS See VISN 15 IV Room/Hood/Training Services Estimate worksheet for estimated quantities of services needed for each facility over the contract period. 6. DESCRIPTION OF WORK The VA Heartland Health Care Network (VISN 15) requires a VISN-wide contract for standardized testing criteria appropriate for all PECs used pursuant to current <797> and <800> standards using Controlled Environment Testing Association (CETA) Certified National Board of Testing (CNBT) certified individuals to establish consistent PEC certification procedures using the Certification Guide for Sterile Compounding Facilities CAG-003-2006. Achieving and maintaining certification will ensure full compliance with VHA Directive 1108.12, USP standards and FDA Insanitary Conditions Guidance. This contract will prevent the risk of contamination, ensuring the safety and efficacy of compounded medications provided to patients. Certification will prevent potential regulatory actions that could disrupt compounding operations, thereby allowing VISN 15 pharmacies to continue delivering essential compounded medications to patients without interruption. 7. DELIVERABLES The contractor shall furnish all necessary materials, supplies, equipment, personnel and supervision to complete required tasks. CONTRACTOR FURNISHED MATERIALS. All materials and tools to complete the work identified. Contractor to ensure all staff that perform on-site testing arrive wearing non-shedding clothing. All equipment will be stored and transported by the contractor in a manner that maintains cleanliness of equipment and introduces minimal microorganisms into the clean environments being tested. All equipment will be wiped/cleaned prior to taking into clean testing environments. b. GOVERNMENT FURNISHED MATERIALS AND SERVICES. The Government will provide all necessary personnel protective equipment (PPE) required for contractors on site. The Government will provide oversight and verification of contractor personnel completion of donning of PPE and hand hygiene prior to testing/sampling. The Government will, on rare occasion, provide office or meeting space to discuss test results, projects, or plans. May also provide desk phone service as needed. c. COMMUNICATION The contractor (or Representative) shall contact the facility identified POC(s) to schedule work and prior to the beginning of work. Scheduling of work will be at the direction of facility identified POC(s) to ensure services are incorporated into current facility certification cycles. Local facility COR(s) will provide the contractor with additional facility specific procedures which include: Check in and check out procedures Contractor badging requirements Parking procedures Any additional facility specific procedures. The contractor will be expected to adhere to those procedures. If a contractor is willing to perform services after 4:00pm (CST) this service must be included within the bid pricing as no extra charge. The ability to perform work after hours is not required; however, preferences will be given to contractors that offer flexible work hours. 8. SECURITY REQUIREMENTS There are no security requirements required for this work, as samples are retrieved by the contractor and a test report is received in return. Contractor does not have access to electronic health records or VA network. 9. INVOICES: Payment will be made upon receipt of a properly prepared detailed invoice, prepared by the Contractor and submitted through Tungsten Network (formerly known as OB10) http://www.tungsten-network.com/us/en/. A properly prepared invoice shall contain: Invoice Number and Date Contractor s Name and Address Accurate Purchase Order Number Supply or Service provided Period Supply or Service Provided Total Amount Due b. Please begin submitting your electronic invoices through the Tungsten Network for payment processing, free of charge. c. If you have questions about the e-invoicing program or Tungsten Network, contact information is as follows: Tungsten e-Invoice Setup Information: 1-877-489-6135 Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com FSC e-Invoice Contact Information: 1-877-353-9791 FSC e-invoice email: vafsccshd@va.gov Web Address: HTTP://WWW.FSC.VA.GOV/EINVOICE.ASP Payment will be completed by invoicing from each facility by assigned PO# on awarded task order for every ordering period. 10. TERMINATION FOR CONVENIENCE In accordance with FAR 52.212-4 (l) The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. 11. RECORDS MANAGEMENT LANGUAGE FOR CONTRACTS The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract: Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. 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 by the Freedom of Information Act. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. The Government Agency owns the rights to all data/records produced as part of this contract. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its Contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. 12. GENERAL ADMINISTRATION POINTS OF CONTACT (POCs). The contractor will contact the POC to schedule the work to be completed; upon arrival, the contractor will contact the POC. The POC will escort the contractor to the appropriate area and monitor the work being done. Upon completion of the work, the POC will escort the contractor out of the area. Facility Name CSP POC & Supervisor E-Mail Address VISN 15 589 Kansas City, MO Janna.Kittle@va.gov Joshua.Howitt@va.gov VISN 15 589A4 Columbia, MO Danielle.Field@va.gov Kellie.Ellyson@va.gov VISN 15 589A5 Topeka, KS Katherine.Foster1@va.gov Erik.Leon@va.gov VISN 15 589A6 Leavenworth, KS Katherine.Foster1@va.gov Morkisha.Dobard@va.gov VISN 15 589A7 Wichita, KS Clint.Owens@va.gov Austin.Durant@va.gov VISN 15 657 St. Louis, MO J. Cochran Don.Wilson2@va.gov Jamie.Murphy@va.gov VISN 15 657A0 St. Louis, MO J. Barracks Don.Wilson2@va.gov Jamie.Murphy@va.gov VISN 15 657A4 Poplar Bluff, MO Kasey.Tubb@va.gov Stephanie.Berrong@va.gov VISN 15 657GH Cape Girardeau, MO Craig.Eaton@va.gov Stephanie.Berrong@va.gov VISN 15 657A5 Marion, IL Lindsay.Oliveira@va.gov Shyannon.McFarland@va.gov VISN 15 657GJ Evansville IN Nick.Ratcliffe@va.gov John.Hays@va.gov REPORT DISTRIBUTION LISTS Facility Name CSP E-Mail Address VISN 15 589 Kansas City, MO vhakanpharmacysupervisors@va.gov VISN 15 589A4 Columbia, MO VHACMOPHARMEnvironmentalControlTests@va.gov VISN 15 589A5 Topeka, KS EKHCSPharmacyManagement@va.gov VISN 15 589A6 Leavenworth, KS EKHCSPharmacyManagement@va.gov VISN 15 589A7 Wichita, KS vhawiccspcertification@va.gov VISN 15 657 St. Louis, MO J. Cochran STLCSPG@va.gov VISN 15 657A0 St. Louis, MO J. Barracks STLCSPG@va.gov VISN 15 657A4 Poplar Bluff, MO popbluff-pharmacycsp@va.gov VISN 15 657GH Cape Girardeau, MO popbluff-pharmacycsp@va.gov VISN 15 657A5 Marion, IL VHAMRNCSPCERTIFICATION@va.gov VISN 15 657GJ Evansville IN VHAMRNCSPCERTIFICATION@va.gov CONTRACTING OFFICERS OF RECORD (CORS). Facility Name COR E-Mail Address VISN 15 589 Kansas City, MO Stephen.LaCerte@va.gov VISN 15 589A4 Columbia, MO Carlton.Foust@va.gov VISN 15 589A5 Topeka, KS Debra.Reynolds2@va.gov VISN 15 589A6 Leavenworth, KS Debra.Reynolds2@va.gov VISN 15 589A7 Wichita, KS Anna.Johnson1@va.gov Ronnette.Graves@va.gov VISN 15 657 St. Louis, MO J. Cochran Jerry.Flowers1@va.gov VISN 15 657A0 St. Louis, MO J. Barracks Jerry.Flowers1@va.gov VISN 15 657A4 Poplar Bluff, MO Jeanne.Schoonover@va.gov VISN 15 657GH Cape Girardeau, MO Jeanne.Schoonover@va.gov VISN 15 657A5 Marion, IL Timothy.Barton2@va.gov VISN 15 657GJ Evansville IN Timothy.Barton2@va.gov CONTRACT ADMINISTRATION DATA. All contract administration functions will be retained by the Department of Veterans Affairs. The Contracting Officer will be the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer will be authorized to make commitments or issue changes that affect price, or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof. NON-PERSONAL SERVICES. This is a non-personal services contract. Personnel rendering services under this contract are not subject either by the contract s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the government and its employees. The Government shall not exercise any supervision or control over the contract service providers performing services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn, is responsible to the Government. HOURS OF OPERATIONS. Business hours: Monday through Friday, 8:00 a.m. 4:30 p.m. National Holidays: The holidays observed by the Federal Government are: New Year s Day; Martin Luther King s Birthday; Presidents Day; Memorial Day; Juneteenth National Independence Day; Independence Day; Labor Day; Columbus Day; Veterans Day; Thanksgiving; Christmas; and Any other observed Federal holiday. CONTRACT PERFORMANCE MONITORING. The COR(s) may perform surveillance of services by any of the methods listed below: Observing actual performance Inspecting the services to determine whether the performance meets the performance standards Review of any other appropriate records When unacceptable performance occurs, the POC shall inform the Contractor and the Contracting Officer. This will normally be in writing unless circumstances necessitate verbal communication. In any case, the POC shall document the discussion and place it in the POC file. When the POC determines that formal written communication is required, the POC shall prepare a Contract Discrepancy Report (CDR) and present it to the contractor program manager. The Contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the Contractor is required to prepare a corrective action plan to document how the Contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the Contractor must present this corrective action plan to the POC. The Government shall review the Contractor corrective action plan to determine acceptability. Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the Contracting Officer. Pursuant to VAAR Provision 852.270-1, Representatives of Contracting Officer representative(s); The Government shall periodically evaluate the Contractor performance by appointing a POC to monitor performance to ensure services are received. The Government representative(s) shall evaluate the Contractor performance through inspections of observations, inspection of services or any other form of documentation and all complaints from VA personnel. The Government may inspect as each task is completed or increase the number of quality assurance inspections if deemed appropriate because of repeated failures or because of repeated customer complaints. Likewise, the Government may decrease the number of quality assurance inspections if performance dictates. The Government Contracting Officer shall make final determination of the validity of customer complaint(s). If any of the services do not conform to contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount. When the defects in services cannot be corrected by re-performance, the Government may require the Contractor to take necessary action to ensure that future performance conforms to contract requirements at no additional cost to the Government. Require the Contractor to take necessary action to ensure that future performance conforms to contract requirements at no additional cost to the Government. CONTRACT SECURITY. The C&A requirements do not apply, and a Security Accreditation Package is not required. Also, no BAA is required.
