1 The Minneapolis VA Healthcare System requires decontamination and cleaning of the Pharmaceutical Clean Room per the Statement of Work (SOW) for the Minneapolis VAMC. This is a sources sought/proof of capability solicitation looking for small business vendors to perform the services per the SOW for market research purposes. No awards of a contract will be made from this announcement. If you are a vendor that can complete the work described in the SOW with competitive pricing, please send your information with a description of proof of capability to:
[email protected] on or before February 4th, 2022. STATEMENT OF WORK General Contractor shall provide labor and training of said employees to successfully support the VA Minneapolis Pharmaceutical Compounding Areas to meet cleaning requirements of USP 797 and USP 800 at the VA Minneapolis Minnesota campus, Building 70. The Minneapolis VA Medical Center shall provide all chemicals, equipment and garb (other than respiratory PPE). All services shall be performed in accordance with the terms and conditions specified in this solicitation and in compliance with the statement of work. The contract will cover a minimum of twelve (12) months from start date, with a maximum of 5 years. The company must be regularly established in the business of Pharmaceutical Clean Room Cleaning, be ISSO 9001:2015 certified, be able to provide primary services under the condition and scope of work, in the judgment of the Contracting Officer, are financially responsible, and show evidence of their reliability, ability, experience, facilities and personnel directly employed or supervised by them to render prompt, detailed service in accordance with USP Chapters 797 & 800, and satisfactory standards. The Contractor shall be licensed by the State or local health authority in those localities where licenses are required. The contractor shall have a robust training program to include classroom training, cleanroom cleaning protocols, cross-contamination procedures, and an on-going education for all employees. Certified contractor personnel shall be required for performance of work under this contract. Each servicemen designated by the Contractor to perform work under this contract shall be cleared for access through restricted areas of customer s facilities. The Contractor shall conform to all Federal, State, Health Authority and local regulations governing the servicing and compliance to meet USP Chapters 797 & 800 as well as use of chemicals and equipment used. The company must furnish a copy of state certification to perform said service contracted. The company must provide documentation to the Contracting Officer prior to performing any work under the contract. Certification shall mean a current certificate of competency in compliance with industry standards including ASTM E2042 and USP 797 & USP 800. Company servicemen must be certified to clean ISO 7/8 clean rooms. All company servicemen shall have their name and their company s name indicated on their uniform or a name badge at all times, so they are easily recognizable as a contractor employee. In cases when contractor has two or more employees reporting to work, under this contract one of these employees shall be designated as a supervisor/foreman. The supervisor shall be fully certified and knowledgeable of the location and work site to perform USP sterile room cleaning. On each visit the company servicemen shall report to the COR or their designee prior to performing services. Description of Services: Clean Room Cleaning (Sterile Maintenance) Cleanroom Cleaning Services must comply with industry standards ASTM E2042 and USP Chapters 797 USP 800. Cleaning will be performed in BR-118 Ante Room, 195.2 sq. ft. (ISO 7), BR-118B Buffer Room, 292.2 sq. ft. (ISO 7), BR-118C Hazardous Drug (HD) Buffer Room, 260 sq. ft. (ISO 7), BR-119 HD Storage Room, 206.8 sq. ft. (unclassified), 2R-103a OR Satellite Buffer Room, 50.5 sq. ft., 2R-103b OR Satellite Buffer Room, 101.3 sq. ft. and 3F-117a Containment Segregated Compounding Area (C-SCA), 187.5 sq. ft. (unclassified). The below areas are all expected to be cleaned on monthly basis: BR-118 Time and day of the week TBD BR-118B Time and day of the week TBD BR-118C Saturday & Sunday anytime, Monday-Friday 0001-6am and 5pm BR-119 Sunday-Saturday any hours 2R-103a & b Mon Fri 7:30am to 3:00pm (or Mon-Fri 3pm-11pm if arranged ahead of time and works for both parties) excluding federal holidays 3F-117a Mon Fri 7:30am to 3:00pm (or Mon-Fri 3pm-11pm if arranged ahead of time and works for both parties) excluding federal holidays Schedule Needs to be approximately 1 month apart for monthly cleaning (give or take 7 days). Need prior notice for when they are coming. Will need fit testing and wear full face respirator or PAPR with organic vapor/acid gas cartridge/P100 filter, in areas where Acetic Acid levels are exceeded. Contractor must check in with IV room staff prior to starting any cleaning and check out after service is completed. All personal servicing MVAHCS must complete appropriate clearance through MVAHCS security process. Contracted workers must be on MVAHCS access roster prior to entering Pharmacy Compounding space. The cleaning of all cleanroom areas will be accomplished in accordance with USP 797, USP 800 and ASTM E2042. The work and services include the following: Monthly: Cleaning will be performed with a sporicidal detergent cleaner chosen by the MVAHCS. After proper dwell time, select items (generally metal and glass surfaces) will be cleaned with sterile isopropyl alcohol (sIPA) Cleaning must be done per procedures outlined in facility SOPs (SOPs will be provided to vendor) General cleaning procedure Non-HD areas: sporicidal cleaning agent applied once with 3 minute dwell HD areas: sporicidal cleaning agent applied twice with 3 minute dwell on second pass Non-HD and HD area: sIPA applied after sporicidal dwell time on all metal and glass to remove sporicidal residue. Cleaning Tools must be cleaned with sporicidal cleaner (with proper dwell time) followed by sIPA both before beginning cleaning and after cleaning is complete. Cleaning Solutions: Currently, MVAHCS uses Ready to Use (RTU) cleaning solutions. MVAHCS reserves the right to change to a concentrated cleaning product(s). If mixing is required, the contractor will mix all chemicals fresh on site and document preparation in accordance with facility SOP. Ceilings, Walls, Doors and Windows Ceilings and walls are cleaned with sporicidal cleaning agent only. Windows, window trim, and doors are cleaned with sporicidal cleaning agent followed by sIPA as they are glass and/or metal. Sporicidal cleaning agent will be applied to mop head. Ceilings and walls will be mopped in a unidirectional fashion utilizing overlapping strokes. Mop head will be rewetted as necessary to ensure surfaces remain sufficiently wet for the proper dwell time. See SOP for detailed procedures. Mop head will be changed when visibly soiled >15% Sprinkler heads are not to be cleaned or touched by vendor. Carts, Counters, Shelves, Bins, Trash cans, Sharps Containers, HD Waste Containers Refrigerator, Freezer, Outside of LAFW/BSCs, etc. Clean all surfaces of carts, counters, shelves, trash cans, outside of sharps containers, outside of HD waste containers, outside of refrigerator, freezer with sporicidal cleaning agent (2 passes of sporicidal in HD area) with proper dwell. Metal and glass will be cleaned with sIPA after sporicidal dwell time is met. Items containing chemo or prescription drugs will be cleaned by MVAHCS employees Clean all surfaces of bins and contents of bins which contain non-critical solutions and supplies with sporicidal cleaning agent (2 passes of sporicidal in HD area) with proper dwell. Metal and glass will be cleaned with sIPA after sporicidal dwell time is met. Any bins containing chemo or prescription drugs will be cleaned by MVAHCS employees Hoods: Laminar Airflow Workbenches (LAFWs) and Biological Safety Cabinets (BSCs) Interior of hoods will be cleaned by MVAHCS pharmacy personnel Exterior of hoods will be cleaned by vendor Sink Drain in Anteroom Sporicidal cleaning agent will be poured into sink drain and allowed to dwell for 10 minutes then flushed with water for 2 minutes. Floors Floors are cleaned with sporicidal cleaning agent from cleanest to dirtiest area following procedure outlined in SOP. Repeat a second pass with 3-minute dwell in HD areas. All cleaning supplies must be disposed of properly. Saturated and/or used wipers and mop heads may be required to be placed in ziplock bags prior to disposal to contain odors. Cleaning supplies used in HD compounding areas are disposed in hazardous waste containers. Documentation: Record cleaning in Simplifi software, web based application. Document cleaning agents used (product, manufacturer, lot number, expiration) Emergency Provision Up to 10 times a year. Terminal cleaning is generally done in response to known contamination of an area with the intent to fully clean the entire space in one period in order to remove all contamination prior to use of the room. This may be in place of monthly cleaning or in addition to monthly cleaning, depending on when the incident occurs. It would require that the cleaning be done from beginning to end with no compounding during cleaning session (in some rooms this may be done over consecutive days). This will need to be arranged between the vendor and the MVAHCS pharmacy on an as-needed basis. Additional charges may be incurred if additional cleaning is required. In areas open for compounding during the period of cleaning, there may occasionally be a need to compound an emergent compounded sterile product. When this occurs, cleaning will be halted so that the compounding can occur (compounding and cleaning cannot be done at the same time) Monitoring: MVAHCS will do environmental monitoring to verify appropriate cleaning of cleanroom areas. If results are out of allowable limits per USP 797, MVAHCS will work with vendor to investigate the situation to identify the potential cause and implement corrective actions to remediate the issue. Garb / Contracted Employee Conduct Requirements for Contracted Cleaning Employees Personal hygiene and garbing are essential to maintain microbial control of the environment. Contacted cleaning staff must maintain proper personal hygiene to minimize the risk of contaminating the sterile compounding environment. Cleanroom garb that is required for entry into the cleanroom suite/SCA will be provided by MVAHCS (includes mask, beard cover, headcover, shoe covers, gown(s), gloves) Hand hygiene and garbing will be done per facility SOP Contracted cleaning employees will wear MVAMC supplied scrubs in the cleanroom Contracted employee must change into scrubs at the start of shift and change out of scrubs before leaving facility Scrubs are not allowed to be worn outside Contracted cleaning employees will wear socks that cover above the ankles Personal outer garments such as sweaters, vests, scarves, or jackets must be removed prior to entering the cleanroom suite/C-SCA. Eyeglasses will be cleaned before entering the anteroom/C-SCA Fingernails will be kept neat and trimmed as per SOP Training and evaluation/competency for hand hygiene and donning and doffing of garb by contracted cleaning personnel will be done by MVAMC IV Room staff. Contracted cleaning employees with rashes, oozing sores, conjunctivitis, respiratory infection, or recent tattoos are prohibited from entering the cleanroom suite/C-SCA. Prohibited in cleanroom suite/C-SCA.: Jewelry (including hand/wrist, neck, lip, eyebrow, ear, nose) Cosmetics (foundation, tinted moisturizer, eye shadow, mascara) Nail polish/gel and nail applique Eyelash extensions/artificial eyelashes Food, drink, and gum are not allowed in cleanroom areas Electronic devices that are not used for compounding/VA assigned tasks cannot be taken into the anteroom or cleanroom. This includes cell phones, music players, earbuds, headphones, or other personal devices. Personal Protective Equipment: The MVAMC requires use of respiratory protection when cleaning with agents that have OSHA/NIOSH limits. Not all spaces have been tested. Some spaces have exceeded limits. Testing is based on the number of personnel cleaning in a space at one time. If more personnel are cleaning in the space than when testing was done, respiratory PPE is required. Respiratory protection will be necessary in some areas/situations. The vendor will select, provide and fit test their employees with one of the following options: An appropriate full face cartridge mask with organic vapor/acid gas cartridge/P100 filter full-facepiece chemical cartridge-type respirator An appropriate half face cartridge mask with organic vapor/acid gas cartridge/P100 filter in addition to goggles A powered air-purifying respirator (PAPR) mask with organic vapor/acid gas cartridge/P100 filter Contractor Personnel Security Requirements: Contractor employees who have access to the MVAMC, Minneapolis (Building 70) shall be the subject of a background investigation and must receive a favorable adjudication from the VA Office of Security and Law Enforcement prior to contract performance. The requirement is applicable to all subcontractor personnel requiring the same access. If the investigation is not completed prior to the start of the contract, the Contractor will be responsible for the actions of the individuals who perform on the contract. a. Position Sensitivity - The position sensitivity has been designated as low risk. b. Background Investigation - The level of background investigation commensurate with the required level of access is National Agency Check with Written Inquiries. c. Agency Responsibilities: The Contracting Officer will initiate the Background Investigation request into the Security and Investigations Center (SIC). d. Vendor Responsibilities: The Contractor has two key responsibilities: getting all employees who will work in a VA facility electronically fingerprinted at a local VA hospital or police station and having those same employees fill out the E-QIP questionnaire that will be emailed to them once the contracting officer initiates the investigation. When the request is submitted the Contractor Request Database will generate an "initial" email with the website link and instructions to all email addresses listed on the request worksheet. This email will indicate what level of investigation was requested and how to complete the process. This is not considered an initiated investigation at this point. A case is not initiated until we have received a complete security package from the contract employee and can forward that security package to OPM. e. Time Frames: Below is a breakdown by level of each investigation handled by the SIC. Times frames may vary due to OPM. Low Risk (NACI) The case is only open for 30 days except in rare occasions when something in the person's background requires an extension. This investigation is done by mail and that is why we have to be so stringent with the paperwork. The average turn around on these cases is 45 days. Contractor Quality Control and Assurance Requirements: The Contractor will be required to provide their Quality Control and Assurance program. This program shall detail all steps required to maintain and continuously provide a clean room environment in accordance with published criteria for USP 797 Sterile Compounding areas. The Government intends to take the Contractors Quality Control Plan and implement it in the Quality Assurance Surveillance Plan (QASP). Please see FAR provision 52.212-2 for further instructions on how to submit to the Contracting Officer.