689-20-1-4813-0001: Pharmacy Cleaning Contract
Pharmacy Cleanroom Cleaning in support of the Veterans Integrated Service Network Region 1 (VISN 1) locations specified below. THIS IS A SOURCES SOUGHT NOTICE ONLY. This announcement is seeking information from industry, which will be used for preliminary planning purposes. No quotes are being requested or accepted with this synopsis. THIS IS NOT A SOLICITATION FOR QUOTES AND NO CONTRACT SHALL BE AWARDED FROM THIS SYNOPSIS.
The purpose of this synopsis is to gain knowledge of interest, capabilities and qualifications of various members of industry, namely Service Disabled Veteran Owned Small Businesses (SDVOSB) and/or Veteran Owned Small Businesses (VOSB) in accordance with the requirements of Public Law 109-461. However, all small business owners are encouraged to respond. The Department of Veterans Affairs, Veterans Integrated Service Network (VISN) 1 has a requirement for a Contractor to furnish all personnel, supervision, labor, equipment, materials and disposal necessary to perform the following:
Performance Work Statement
General
Contractor shall provide all necessary equipment, tools, and supporting materials to successfully support the cleaning and disinfection of the VA Connecticut Healthcare pharmaceutical compounding spaces at VACT West Haven campus (Building 1, Building, 2, and any mobile compounding or new construction locations). VACT Connecticut Pharmacy Department will provide the garbing and personal protective equipment (PPE) used during cleaning. Any additional PPE that the VA does not normally provide to it s compounding staff should be provided by the contracting company. 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.
The company must be regularly established in the business, the company must be able to provide primary services under the condition of scope of work, in the judgment of the Contracting Officer, be 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 Chapter 797 and satisfactory standards. The Contractor shall be licensed by the State or local health authority in those localities where licenses are required.
Certified contractor personnel shall be required for performance of work under this contract. Each serviceman 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 with USP Chapter 797 and use of approved chemicals and equipment. 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. All chemicals (SDS) used to perform service must be submitted and filed with the Contracting Officer's Representative (COR). Certification shall mean a current certificate of competency in compliance with industry standards including ASTM E2042 and USP 797. Company servicemen must certify for Ante Rooms (ISO 7/8).
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 cleaning. On each visit, the company servicemen shall report to the COR or his 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 Chapter 797.
Cleaning will be performed in Inpatient Segregated Compounding Area (182.94 SQFT), Cancer Center Segregated Compounding Area (270.12 SQFT), and a mobile compounding trailer (335 SQFT).
The required cleaning for the inpatient segregated compounding area (Building 1, Room G-220) is to be performed daily Monday through Sunday (To include Federal Holidays including Christmas, New Years and Thanksgiving) between the hours of 4:00 PM - 7:00 AM.
The required cleaning for the cancer center segregated compounding area (Building 2, Room 5202) is to be performed daily Monday through Friday (to include Federal Holidays excluding Christmas, New Years and Thanksgiving) between the hours of 6 AM-7:30AM.
Because the mobile compounding trailer is only open for compounding of medications on a Monday- Friday basis for Cancer Center patient infusions, the required cleaning for the mobile compounding trailer is to be conducted daily Monday through Friday (to include Federal Holidays excluding Christmas, New Years and Thanksgiving) between the hours of 5:30AM-7:00AM, (note that the 5:30 AM start time is for weekly cleaning only, with a 6 am cleaning start time most days). Both frequency of cleaning and timing of cleaning are subject to change based on trailer operations needing to change to accommodate patient care.
For each individual area being cleaned, separate logs documenting cleaning activities must be maintained and provided to the VACT Pharmacy Department. Cleaning logs should note whether daily, weekly, or monthly cleaning was performed as well as the cleaning/disinfecting agent used (including whether it was mixed or available in a ready to use (RTU) form), surfaces cleaned, and name and signature of staff member completing cleaning.
All cleaning and disinfection must be performed by trained personnel using contractors equipment and supplies. However, note that the garbing and personal protective equipment used during cleaning that is normally available to compounding staff are provided by the VACT Pharmacy Department. Cleaning and disinfection of all ISO classified cleanroom and segregated compounding areas will be accomplished in accordance with USP 797 and ASTM E2042. Cleaning and disinfection must be performed in the direction of clean to dirty areas utilizing overlapping unidirectional strokes and working from top to bottom. Cleaning/disinfection of a room starts at the top and rear of a room and personnel work towards the bottom and front (start at side of room furthest away/opposite from door). Cleaning and disinfection must begin in the buffer room (cleanroom or compounding room) and always follows the order of the cleanest to the dirtiest location (i.e. Buffer Room ->Ante Room -> Workroom).
All materials and equipment utilized by contractor for cleaning and disinfection will be stored in the Housekeeping Closet in the storage space on site (i.e. double bucket container, cleaning pads, extension poles). This minimizes external items in and out of the clean/sterile environment. The contractor must take responsibility for assuring that all cleaning and disinfectant solutions are used prior to their expiration date. Any expired solution must be removed and should not be used for cleaning/disinfecting.
Contractor must log in when reporting to the pharmacy cleanroom and segregated compounding areas to perform service and must log out after service is conducted. All personnel servicing VACT must complete appropriate clearance through the VACT security process. Vendor workers must be on VACT access roster prior to entering pharmacy compounding space.
The contractor must assure that there is a system for having alternate personnel available to perform the cleaning at the specified times in the event that the personnel who normally come to perform the cleaning are unable (i.e. personnel have an active respiratory infection, conjunctivitis, or other condition which would prohibit them from working in a compounding environment, as noted in the the pharmacy code of conduct for sterile compounding standard operating procedure). All personnel coming onsite are expected to follow the pharmacy department standard operating procedures for proper conduct and garbing in cleanroom and compounding environments. The specific cleaning and disinfectant solutions to be used and dwell times for solutions will be followed in accordance with VACT policies and procedures. The USP Compliance Manager or designee will conduct an observation of all contractor personnel s garbing and cleaning/disinfecting tasks to assure they are compliant with VACT policies and procedures. The USP Compliance Manager or designee will provide feedback to contractor personnel, contractor supervisor, and VA contracting officer on any areas requiring retraining.
When working in compounding environment, personnel are responsible for cleaning all items before placing them into a segregated compounding area, pass through, anteroom, or buffer room.
Each item must be wiped with sterile 70% isopropyl alcohol.
Once the item is wiped with sterile 70% isopropyl alcohol, it must be allowed to dry before it can be placed in the compounding environment. This will include all trash receptacles, waste buckets, mops, and cleaning solutions going into any segregated compounding area or pass through and any ISO classified clean room space (i.e. pass through, anteroom, and buffer room).
Equipment to be used should be composed of non-shedding material; so, only lint free mops, sponges, and wipes must be used for all cleaning and disinfection tasks.
Dedicated cleaning materials are to be clearly labeled for use in the non-hazardous and hazardous compounding areas.
There is to be a dedicated mop for hazardous compounding spaces and other mop(s) dedicated for non-hazardous compounding spaces.
The mops used for hazardous compounding room cleaning are not to be used in any non-hazardous area unless it is first de-contaminated by wiping down with a decontaminating agent.
Mop heads and sponges are changed and discarded daily after each use or more frequently if heavily soiled.
Cleaning and disinfectant solutions should be provided in ready to use (RTU) forms. If a specific cleaning and disinfectant solution is not available in an RTU form, then it is to be diluted (or mixed) according to manufacturer recommendations.
In the cases where a cleaning and disinfectant solution has to be mixed, both the water and the solution concentrate must be measured using containers with appropriate gradations.
The contractor is to mix all chemicals.
Cleaning solutions must never be mixed together.
Garbing and personal protective equipment (PPE) for cleaning is worn.
Safety goggles are used while conducting cleaning with all disinfecting agents (Hydrogen Peroxide Agents, Acid Phenolic Agents, Alkaline Phenolic Agents and Peroxyacetic Acid and Hydrogen Peroxide Agents).
While cleaning/disinfecting with Peroxyacetic Acid containing agents, staff must pre-soak lint-free wipes and/or the mop head covers prior to starting cleaning/disinfecting.
Cleaning and disinfection instructions for each compounding area are noted below.
Daily (for the mobile pharmacy trailer and any ISO classified cleanroom spaces):
Clean and disinfect the pass throughs.
Clean and disinfect designated surfaces (all vertical and horizontal surfaces) including benches, carts and exteriors of hoods.
Clean and disinfect the doors/door handles.
Clean and disinfect the floors.
Clean and disinfect the sinks.
Empty all trash receptacles, replace liners, and place bagged trash in designated areas.
Seal and remove all trace waste chemotherapy bins from compounding spaces.
Weekly (for the mobile pharmacy trailer and any ISO classified cleanroom spaces):
Weekly cleaning and disinfection includes walls in addition to all other areas cleaned and sanitized daily (including pass throughs, designated surfaces (all vertical and horizontal surfaces) including benches, carts and exteriors of hoods, floors, sinks, and doors/door handles).
Empty all trash receptacles, replace liners, and place bagged trash in designated areas.
Seal and remove all trace waste chemotherapy bins from compounding spaces.
Monthly cleaning (for the mobile pharmacy trailer and any ISO classified cleanroom):
Monthly cleaning and disinfection includes the ceilings, all storage shelving, bins, equipment outside of the hoods, chairs, and trash receptacles, in addition to all other areas cleaned daily (including pass throughs, designated surfaces (all vertical and horizontal surfaces) including benches, carts and exteriors of hoods, floors, sinks, and doors/door handles) and weekly (walls).
Empty all trash receptacles, replace liners, and place bagged trash in designated areas.
Seal and remove all trace waste chemotherapy bins from compounding spaces.
Daily (for segregated compounding areas):
Clean and disinfect the pass throughs.
Clean and disinfect the designated surfaces (all vertical and horizontal surfaces) including benches, carts and exteriors of hoods.
Clean and disinfect the doors/door handles.
Clean and disinfect the floors.
Clean and disinfect the sinks.
Empty all trash receptacles, replace liners, and place in designated areas.
Monthly cleaning (for segregated compounding areas):
Monthly cleaning and disinfection includes the ceilings and walls, all storage shelving, bins, equipment outside of the hoods, chairs, and trash receptacles, in addition to all other areas cleaned daily (including pass throughs, designated surfaces (all vertical and horizontal surfaces) including benches, carts and exteriors of hoods, floors, sinks, and doors/door handles).
Empty all trash receptacles, replace liners, and place bagged trash in designated areas.
Contract or Personnel Security Requirements:
Contractor employees who have access to the VAMC West Haven, CT (Building 1) 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.
Position Sensitivity - The position sensitivity has been designated as low risk.
Background Investigation - The level of background investigation commensurate with the required level of access is National Agency Check with Written Inquiries.
Agency Responsibilities:
The Contracting Officer will initiate the Background Investigation request into the Security and Investigations Center (SIC).
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.
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 must 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 provision 52.212-2 for further instructions on how to submit to the Contracting Officer.
Limitations on Subcontracting, the prime contractor must perform 50% or more of the contract. For services, this is defined as 50 percent of the cost of personnel for contract performance (direct labor cost on payroll). Prior Government contract work is not required to submit a response under this sources sought synopsis. The intent of the project is to award a five (5) year single award Blanket Purchase Agreement (BPA). The NAICS Code is 561720 and the size standard is $18 Million. This notice is published to conduct market research to determine if there is a sufficient number of certified Service Disabled Veteran Owned Small Businesses (SDVOSB) or Veteran Owned Small Businesses (VOSB) capable of performing the requirements to warrant a solicitation set-aside. Registration may be accomplished at http://www.vClip.vetbiz.gov/. All interested firms must be registered in VETBIZ.GOV and Verified by VA CVE and registered in SAM to be eligible for award of Government contracts. Interested parties responding to this sources sought request shall submit the following information at a minimum: (1) company name and address, point of contact with phone number, and DUNS number; (2) documentation relating to technical capability of performance for requirements to include references with current point of contact and phone number); (3) proof of registration in the VA Vet Biz website and verification by VA Center for Veterans Enterprise (CVE) (4) include socio-economic status to identify business as being an SDVOSB, VOSB, SB, Woman Owned, etc. and (5) any other pertinent company documentation.
The response date to this Sources Sought notice is August 29, 2019 at 2:30 PM EST. This market research is for informational and planning purposes only to determine if a SDVOSB or VOSB set-aside is appropriate. This is not a solicitation and does not obligate the Government to issue a solicitation. Please be advised the Government will not pay any costs for responses and information submitted. Electronic submissions are acceptable via cory.dionne@va.gov. This announcement constitutes an official Request for Information (RFI) as defined by FAR 15.201(e). RESULTS INFORMATION: Respondents will not be notified of the results of the evaluation. Firms responding to this sources sought announcement, who fail to provide ALL of the required information requested, will not be used to help the Government make the acquisition decision, which is the intent of this sources sought announcement.
Cory Dionne
Contracting Officers Email
