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 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 as a result 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 into 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 purpose of this sources sought 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 services described below. Documentation of technical expertise must be presented in enough 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) DUNS 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 and (i) must provide a capability statement that addresses the organizations qualifications and ability to perform as a contractor for the work described below. 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 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 (), USP Chapter (), or current guidelines. This requirement also includes personnel training, evaluation and requalification to compound CSPs in accordance with , , or current guidelines. Background VISN 15 is pursuing a VISN-wide contract for standardized testing criteria appropriate for all PECs used pursuant to current and 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 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 option year(s), testing procedures shall be maintained in compliance with all current applicable USP standards. 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. VISN 15 facilities have either upgraded/constructed or are in the process of upgrading/constructing compounding spaces to continuously meet and 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. Adjustments are included in the Independent Government Cost Estimates (IGCEs) to reflect planned work and changing needs in the contract year they are expected. 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. Special Work Requirements All vendors used to conduct primary and secondary engineering controls certifications/assessments must be registered with CETA. a. PEC Testing and Certification. The contractor shall test and certify each PEC according to and using certification procedures from the CETA Certification Guides for Sterile Compounding Facilities (CAG-003-2006 and CAG-002-2006). All PECs must: Be certified to meet ISO Class 5 or better Maintain unidirectional airflow Be supplied by HEPA filtered air 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 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. 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. 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. 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. 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. Hazardous compounding PEC certification is required for: Negative pressure hoods Isolators PECs where robotic enclosure is used inside of the PEC 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 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. 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. 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 b. Clean Room Certification. All classified areas must be tested and certified in accordance to 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 and . 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 c. 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 or requirements for ACPH the identified site POC(s) shall be informed immediately. d. 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 or . 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). e. 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 m 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 m 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 m and larger size per cubic meter of air for any non-hazardous compounding ante room. f. 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 in order 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 . 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 . g. 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 . 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) h. Environmental Wipe Sampling. The contractor will perform environmental wipe sampling for HD surface residue every 6 months, or more frequently 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 i. Report Requirements. 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 j. 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 PART IV: GENERAL ADMINSTRATION 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. k. 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 results. More frequent testing may be required should USP standards change during the performance period or option year(s). 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 option year(s). 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 option year(s). 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. Special Considerations a. 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. Qualifications/References. VISN 15 is seeking a qualified contractor that meets the following specifications: Provide three references showing the completion of at least 3 jobs of similar size and scope at other hospital facilities with at least one of those facilities being a VA Medical Center. Reference information is to include: Hospital/Medical Center name, POC name, email address and phone number. All certifications must be signed by an NSF 49 certified technician. A copy of NSF 49 certifications must be attached to the bid documentation for any technicians that will be performing work at the facility. All cleanroom performance testing must be supervised by a technician with CETA CNBT certification. A copy of the certification must be attached to the bid documentation for the supervisor or project manager of the team that will be performing work at the facility. Provide AIHA accredited laboratory certification for all viable sampling analysis. Certification must be attached with bid documentation. Provide copy of clean room certification report for evaluation. If required, contractor (employees performing services at the facility) will attain VA clearance (e.g. attend VA training, identification card) 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 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 a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. Attention: Michael Murphy Email:
[email protected]