Inactive

1 This is a SOURCES SOUGHT ANNOUNCEMENT ONLY. It is neither a solicitation announcement nor a request for proposals or quotes and does not obligate the Government to award a contract. Requests for a s... 1 This is a SOURCES SOUGHT ANNOUNCEMENT ONLY. It is neither a solicitation announcement nor a request for proposals or quotes and does not obligate the Government to award a contract. Requests for a solicitation will not receive a response. Responses to this sources sought must be in writing. 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 and Veteran Owned Small Businesses interested and capable of providing the 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) 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 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 Veterans Health Administration (VHA) has a requirement at the Phoenix VA Medical Center, located at 650 E. Indian School Rd., Phoenix, AZ 85012, for Pharmacy Intravenous (IV) Cleanroom Cleaning, Disinfecting, and Application of Sporicidal Agent services at the Phoenix VA Health Care System (PVAHCS). Important information: The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this sources 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. The VA is mandated by Public Law 109-461 to consider a total set-aside for Service Disabled Veteran Owned Small Business set aside. However, if response by Service Disabled Veteran Owned Small Business firms proves inadequate, an alternate set-aside or full and open competition may be determined. No sub-contracting opportunity is anticipated. The North American Classification System (NAICS) code for this acquisition is 561720 Janitorial Services ($18.0M Average Annual Receipts). Notice to potential offerors: All offerors who provide goods or services to the United States Federal Government must be registered in the System for Award Management (SAM) at www.sam.gov and complete Online Representations and Certifications Application (ORCA). Additionally, all Service Disabled Veteran Owned Businesses or Veteran Owned Businesses who respond to a solicitation on this project must be registered with the Department of Veterans Affairs Center for Veterans Enterprise VetBiz Registry located at http://vip.vetbiz.gov. All interested Offerors should submit information by e-mail to william.cook2@va.gov. All information submissions shall be received no later than 12:00 PM Arizona Time on Friday, May 22, 2020. After review of the responses to this announcement, the Government intends to proceed with the acquisition and a subsequent solicitation may be published. Please see the following Statement of Work (SOW) for a description of the required services. USP General Chapter 797, Pharmaceutical Compounding Sterile Preparations available at www.usp.org. Statement of Work Inpatient Pharmacy Intravenous (IV) Room Cleaning Service Phoenix Veterans Administration Health Care System (PVAHCS) 650 E. Indian School Road Phoenix, AZ 85012 1.0 Background The purpose of this Statement of Work (SOW) is to provide IV room cleaning services that will keep PVAHCS Inpatient Pharmacy IV Cleanroom Suite cleanliness and sterility in full compliance with United States Pharmacopeia (USP) 797/800 standards and regulations. The scope of work includes cleaning, disinfecting, and applying a sporicidal agent to designated surfaces to remove organic and inorganic materials, usually with a cleaning agent; disinfecting, which involves destruction of microorganisms, usually with a chemical agent; applying a sporicidal agent to destroy bacterial and fungal spores; and applying sterile 70% Isopropyl Alcohol (IPA) to remove any residue. 2.0 Tasks: The contractor shall provide all labor, equipment, Personal Protective Equipment (PPE), disinfecting solutions, and sporicidal agents to perform all Inpatient Pharmacy IV cleanroom Level 1, daily, and Level 3, monthly, cleaning services in accordance with USP 797 and USP 800 standards. 2.1 Selection of Supplies: The contractor shall select chemicals and supplies and use them in accordance with USP 797 and USP 800 standards: The contractor shall select cleaning, disinfecting, and sporicidal agents to be used with careful consideration of compatibilities, effectiveness, and user safety. Considerations when selecting and using disinfectants include their antimicrobial activity, inactivation by organic matter, residue, shelf life, preparation requirements of the agent, and suitability for surfaces being disinfected. After the disinfectant or sporicidal agent is applied to the surface, the agent must be allowed to dwell for the minimum contact time specified by the manufacturer. All cleaning supplies (e.g., wipers, sponges, and mop heads) with the exception of tool handles and holders shall be low-lint. Wipers, pads, and mop heads should be disposable. Disposable cleaning supplies shall be discarded after each cleaning activity. Reusable cleaning tools shall be made of cleanable materials (e.g., no wooden handles) and shall be cleaned and disinfected before and after each use. Reusable cleaning tools shall be dedicated for use in the classified areas or Segregated Compounding Area (SCA) and shall not be removed from these areas except for disposal. They shall be discarded as determined, based on the condition of the tools. Cleaning supplies used in the classified areas and SCAs shall be disposed in a manner that minimizes the potential for dispersing contaminants into the air (e.g., with minimal agitation, away from work surfaces). Items and equipment brought into the ISO Classified areas will be appropriately disinfected before they are brought across the line of demarcation in the anteroom. 2.2 Work Requirements: The contractor shall perform the following cleaning, disinfecting, and application of sporicidal agent activities on a daily or monthly basis as designated by protocol and in accordance with USP 797 and USP 800 standards: Daily Level 1 cleaning and disinfecting activities shall be accomplished using the appropriate supplies, cleaners and disinfectants and be in accordance with USP 797 and USP 800 standards and include, but not necessarily limited to, the following: The contractor shall remove visible particles, debris, or residue with an appropriate solution (e.g., Sterile Water for Injection or Sterile Water for Irrigation) using sterile, low-lint wipers. Using a low-lint wiper, the contractor shall apply a cleaning agent, followed by a disinfecting agent, or apply an Environmental Protection Agency (EPA)-registered (or equivalent) one-step disinfectant cleaner to equipment and all interior surfaces. The contractor shall ensure the contact time specified by the manufacturer is achieved. Using a low-lint wiper, the contractor shall apply sterile 70% IPA to equipment and all interior surfaces. Surfaces shall be completely dry before PVAHCS staff begins compounding. The contractor shall follow proper protocol when entering and exiting the cleanroom environment. The contractor shall follow proper protocol for donning PPE when entering the cleanrooms (including using second pair of booties and hazardous drug (HD) gown for cleaning in HD IV room). The contractor shall follow proper protocol for use of cleaning equipment in the cleanrooms. The contractor shall follow proper protocol for use of all supplies and solutions used for cleaning in the cleanrooms. The contractor shall empty waste receptacles, clean containers (inside and out) and replace liners. The contractor shall vacuum floors with a cleanroom-certified vacuum cleaner having High-Efficiency Particulate Air (HEPA) or Ultra Low Particulate Air (ULPA) filtration. The contractor shall mop floors with a cleanroom-certified bucket, mop, and mop head and shall ensure baseboards are also cleaned and disinfected. The contractor shall remove and/or change tacky mats per protocol. The contractor shall clean and disinfect doors, door handles, door frames, light switches, and high touch areas, including glass surfaces on doors. The contractor shall clean and disinfect sinks and fixtures. The contractor shall clean and disinfect pass throughs (inside and out, including glass, handles, etc.). The contractor shall clean and disinfect each laminar flow hood (2) and each Biological Safety Cabinet (BSC) (in HD room) (2) 4 in total. The contractor shall wipe down tables and tops of designated equipment (e.g. outside of refrigerators). The contractor shall wipe down all designated horizontal surfaces, including tables and work surfaces. The contractor shall wipe down all designated vertical surfaces. The contractor shall document attendance by log sign-off as per customer protocol. The contractor shall document procedure completion by log sign-off as per customer protocol. Monthly Level 3 terminal cleaning shall be in accordance with USP 797 and USP 800 standards and include, but not necessarily limited to, daily cleaning and disinfecting, along with the following additional tasks: The contractor shall remove visible particles, debris, or residue with an appropriate solution (e.g., Sterile Water for Injection or Sterile Water for Irrigation) using sterile, low-lint wipers. After cleaning and disinfecting in accordance with the Level 1 protocols mentioned above, and in accordance with USP 797 and USP 800, the contractor shall apply the sporicidal agent using a low-lint wiper to all surfaces of primary engineering controls and the area underneath the work tray (if applicable). If the sporicidal agent is an EPA-registered (or equivalent) one-step disinfectant sporicidal cleaner, separate cleaning and disinfecting steps are not required. The contractor shall ensure the contact time specified by the manufacturer is achieved. Using a low-lint wiper, the contractor shall apply sterile 70% IPA to all interior surfaces of primary engineering control, including underneath the work tray (if applicable). Surfaces shall be allowed to dry completely before PVAHCS staff begins compounding. The contractor shall wash and apply a sporicidal agent to ceilings and walls. The contractor shall wipe down and apply a sporicidal agent to all medication/supply bins and shelves (in ante-area, HD room, and IV room), including wheels. The contractor shall wipe down and apply a sporicidal agent to all medication bins in refrigerator. The contractor shall wipe down and apply a sporicidal agent to castors on shelving units and tables. The contractor shall wipe down and apply a sporicidal agent to outside surfaces of all hoods. The contractor shall wipe down and apply a sporicidal agent to air returns and air grids. The contractor shall wipe down and apply a sporicidal agent to all chairs, wheels included (2 in IV room, 1 in HD room). 3.0 Evaluation of contractor personnel performance: Phoenix VAHCS personnel shall perform routine evaluation of contractor personnel to assess that proper cleaning, disinfecting, and application of sporicidal agents activities are properly executed in accordance with this Statement of Work and USP 797 and USP 800 standards. Contractor personnel shall perform the following functions, which are subject to evaluation by PVAHCS: Contractor personnel shall present themselves clean, groomed, and in a clean appropriate attire. The Contractor shall not have any personnel cleaning if they have any respiratory illness, gastrointestinal illness, conjunctivitis, sunburn or any skin condition where there is possibility of weeping/oozing, or any other illness that may be considered contagious Contractor personnel, prior to entering the anteroom, shall be dressed in appropriate attire and perform all necessary steps to prepare for cleaning activities. Contractor personnel shall be aware of the line of demarcation separating clean and dirty sides in the anteroom, as well as the line of donning/doffing in the HD room. Contractor personnel shall don hair covering, beard covering (if applicable), and mask, prior to donning shoe covers. Contractor personnel shall properly don shoe covers, one at a time, placing the shoe cover on the clean side of line of demarcation as appropriate. Contractor personnel shall properly don PPE in the correct order prior to entering a non-HD room. Contractor personnel shall properly don PPE in the correct order prior to entering the HD room, prior to crossing the donning/doffing line (HD gown shall be worn over non-HD gown/bunny suit). Contractor personnel shall perform proper hand-washing procedures prior to the start of cleaning services. Contractor personnel shall prepare all cleaning, disinfecting, and sporicidal solutions, if applicable, and in accordance with manufacturer s guidelines. Contractor personnel shall clean, disinfect, and apply sporicidal agents to ceilings, walls, and doors using the appropriate chemicals according to Level 1 and 3 protocols. Contractor personnel shall clean, disinfect, and apply sporicidal agents to all designated equipment going from top to bottom format using the appropriate chemicals according to Level 1 and 3 protocols. Contractor personnel shall mop floors starting at the wall opposite the room entry door, mopping the floor surface in even strokes towards the operator. Contractor personnel shall ensure baseboards are cleaned, to include disinfecting and the application of a sporicidal agent, according to Level 1 and 3 protocols. Contractor personnel shall allow for the sporicidal agent to dwell for the minimum contact time, in accordance with manufacturer recommendations. Contractor personnel shall use proper deactivating/decontaminating agents for all HD areas and surfaces. Contractor personnel shall properly doff top shoe covers, chemo gown and gloves prior to crossing the doffing line in the HD room. These items shall be discarded in the appropriate trace chemotherapy (yellow) bags that are in the HD room, prior to leaving HD room. Contractor personnel shall properly doff PPE and washes hands prior to leaving the anteroom. Contractor personnel shall not remove inner shoe covers until crossing the line of demarcation while departing the anteroom. Contractor personnel shall document all cleaning activities as to who performed what activities, date performed, agent(s) used, and in accordance with local procedures. The documentation shall be done on a log that is approved by the contractor and PVAHCS; and, the log shall remain in the anteroom for the month it is in use. 4.0 Security and Health Insurance Portability and Accountability Act (HIPAA) Compliance: In reference to VHA Handbook 6500.6 Appendix A, block 6 and 7, the cleaning service requested in this contract does NOT involve connection of Information Technology (IT) devices to a VA network and no sensitive information is accessed. Therefore, certification and accreditation (C&A), Systems Applications and Products in Data Processing (SAP), and the following from Appendix C apply: During contract performance, contractor may require access to VA facility, equipment, information systems, or sensitive data to provide services, install, train, maintain, or repair equipment. VA Course No. VA10176 is privacy training required for VA contractors requiring access to VA facilities for more than 2 consecutive days or any access to VA information systems. Training shall be completed prior to being granted access to facilities, equipment, or to the data therein. Training is available on the VA Training Management System (TMS) website at: http://www.tms.va.gov/SecureAuth35/. The contractor shall provide evidence of training to the Contracting Officer s Representative (COR) if requested. The Contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards and VA directives and Handbooks regarding information protection, patient privacy and information system security as delineated in this contract. 5.0 Guidance and oversight: Contractor personnel will work with the PVAHCS Regulatory and Compliance Quality Pharmacy Program Manager to ensure cleanroom cleaning complies with USP 797 and 800 standards and regulations, appropriate written Standard Operating Procedures (SOPs), and this SOW. Routine monthly evaluations of contractor cleaning services will also be conducted by the Regulatory and Compliance Quality program manager or designee. Evaluations may be conducted more frequently as deemed necessary. Documentation logs shall be reviewed for completeness, along with a physical check of area(s) to be cleaned. Any question on cleanliness, quality of cleanliness, issues with documentation, or other concerns will be brought to the attention of the contractor. Any issue with recertification of ISO classified areas that reveal microbial or fungal contamination will also be brought to the attention of the vendor. NOTE: This diagram of the cleanroom is not drawn to scale and is only a spacial representation.