36C24123Q1141.docx

SUBJECT*

Pharmacy USP Cleanings (VA-24-00010527)

GENERAL INFORMATION

SET-ASIDE

VAMC Manchester

718 Smyth Road Manchester NH 03104

POINT OF CONTACT*

Contract Specialist Nathan Langone Nathan.Langone@va.gov 603-340-0102

PLACE OF PERFORMANCE

950 Campbell Ave

West Haven CT

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

Sources Sought Notice Sources Sought Notice

DESCRIPTION

Sources Sought Notice

This is a Sources Sought notice only. This is not a request for quotes and no contract will be awarded from this announcement. The Government will not provide any reimbursement for responses submitted in response to this Source Sought notice. Respondents will not be notified of the results of the evaluation.

If a solicitation is issued it shall be announced at a later date, and all interest parties must response to that solicitation announcement separately. Responses to this notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation The purpose of this announcement is to perform market research to gain knowledge of potential qualified sources and their size classification relative to NAICS 561720 (Janitorial Services) with a size standard $22 million. The Department of Veterans Affairs (VA), Network Contracting Office 1 (NCO 1) is seeking to identify any vendor capable of providing VAMC West Haven 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. VACT Connecticut Pharmacy Department will provide the garbing and personal protective equipment (PPE) used during cleaning that is typically used by our technicians (gowns, face masks, shoe covers, head covers, non-sterile gloves). Any additional PPE that the VA does not normally provide to its 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. All cleaning will be done when no sterile compounding is taking place. All company servicemen shall have their name and their company's name indicated on their uniform or a name badge, 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 knowledgeable of the location and work site to perform cleaning of the space used for sterile compounding. Procurement will be for VAMC West Haven per the Performance Work Statement (PWS) below.

This Sources Sought notice provides an opportunity for respondents to submit their capability and availability to provide the requirement described below. Vendors are encouraged to submit information relative to their capabilities to fulfill this requirement, in the form of a statement that addresses the specific requirement identified in this Sources Sought. Information received from this Sources Sought shall be utilized to facilitate the Contracting Officer’s review of the market base, for acquisition planning, size determination, and procurement strategy.

Submission Instructions: Interested parties who consider themselves qualified to perform the services are invited to submit a response to this Sources Sought Notice by 17:00 EST, 20th of September 2023. All responses under this Sources Sought Notice must be emailed to Nathan.Langone@va.gov with Sources Sought #36C24123Q1141 in the subject line. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions.

Interested parties should complete the attached Sources Sought Worksheet. Parties may submit additional information related to their capabilities, provided it contains all the requirements contained in the Sources Sought Worksheet. Responses to this Sources Sought shall not exceed 8 pages. In addition, all submissions should be provided electronically in a Microsoft Word or Adobe PDF format.

Performance Work Statement (PWS) 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. VACT Connecticut Pharmacy Department will provide the garbing and personal protective equipment (PPE) used during cleaning that is typically used by our technicians (gowns, face masks, shoe covers, head covers, non-sterile gloves). Any additional PPE that the VA does not normally provide to its 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. All cleaning will be done when no sterile compounding is taking place. All company servicemen shall have their name and their company's name indicated on their uniform or a name badge, 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 knowledgeable of the location and work site to perform cleaning of the space used for sterile compounding. The contract will be offered as a base plus 4 option years for the cleaning service.

Description of Services:

This PWS is for cleaning of the locations where sterile compounding is taking place at West Haven VA.

VAMC West Haven 950 Campbell Ave West Haven, CT 06516 List of locations, with square footage of each area:

Inpatient Pharmacy IV room consist of:

1. Negative pressure buffer room (ISO Class 7, HD-buffer, 313 SqFt), Cleaning Daily (Mon-Sun, 7 days a week, including Federal Holidays like Christmas, New Years and Thanksgiving) between the hours of 4 am and 7 am, unless otherwise authorized), Monthly, and as needed Terminal Cleaning.

2. Positive pressure buffer room (ISO Class 7, Non-HD-buffer, 201 SqFt), Cleaning Daily (Mon-Sun, 7 days a week, including Federal Holidays like Christmas, New Years and Thanksgiving between the hours of 4 am and 7 am, unless otherwise authorized), Monthly, and as needed Terminal Cleaning.

3. Anteroom (ISO Class 7, 374 SqFt), Cleaning Daily (Mon-Sun, 7 days a week, including Federal Holidays like Christmas, New Years and Thanksgiving between the hours of 4 am and 7 am, unless otherwise authorized), Monthly, and as needed Terminal Cleaning.

4. Storage room (room leading to the anteroom, without specifications, but with HEPA filtration, 242 SqFt) . Cleaning Daily (Mon-Sun, 7 days a week, including Federal Holidays like Christmas, New Years and Thanksgiving between the hours of 4am and 7 am, unless otherwise authorized), only (No terminal or monthly cleaning in that area).

Germfree IV room trailer consist of:

1. Negative Pressure Buffer room (ISO Class 7, HD-buffer, 105 SqFt), Daily (Mon-Fri, excluding weekends and Holidays between the hours of 5:30am and 7am), Weekly, Monthly and Terminal Cleaning as needed

2. HD-Anteroom (ISO Class 7, 19 SqFt), Daily (Mon-Fri, excluding weekends and Holidays, between the hours of 5:30am and 7am), Weekly, Monthly and Terminal Cleaning as needed.

3. Positive Pressure Buffer room (ISO Class 7, Non-HD-buffer, 117 SqFt), Daily (Mon-Fri, excluding weekends and Holidays, between the hours of 5:30am and 7am), Weekly, Monthly and Terminal Cleaning as needed.

4. Non-HD anteroom (ISO Class 7, 19 SqFt), Daily (Mon-Fri, excluding weekends and Holidays, between the hours of 5:30am and 7am), Weekly, Monthly and Terminal Cleaning as needed

5. Work room (HEPA filtered air, but not ISO classified, 116 SqFt), Daily (Mon-Fri, excluding weekends and Holidays, between the hours of 5:30am and 7am), Weekly, Monthly and Terminal Cleaning as needed.

5th floor oncology satellite consists of:

1. Segregated Compounding Area (270 SqFt) Daily and Monthly, Terminal Cleaning as needed.

Cleanroom Cleaning Services must comply with USP Chapter <797>, and <800>. 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 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). Both frequency of cleaning and timing of cleaning, as well as cleaning agents are subject to change based on operations needing to change to accommodate patient care.

Logs documenting cleaning activities must be maintained and provided to the VACT Pharmacy Department.

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. 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 Program 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 Program Manager or designee will provide feedback to contractor personnel, contractor supervisor, and VA contracting officer on any areas requiring retraining.

Cleaning and disinfection instructions for this compounding area is noted below.

A. Cleaning Materials

1. All cleaning materials, such as wipers, sponges, and mops must be non-shedding, and dedicated to use in the anteroom or buffer room and shall not be removed from these areas except for disposal.

2. All items to be used in into the anteroom or buffer room must be cleaned prior to entering the room via the anteroom or IV room pass-through chamber. Each item must be cleaned by wiping with a non-shedding wipe wetted with 70% Isopropyl alcohol (IPA).

3. The hazardous mop is not used in any non-hazardous area unless it is decontaminated first by soaking/dwelling with deactivating/decontaminating agent such as PeridoxRTU®. Dedicated cleaning materials are to be clearly labeled for use in the non-hazardous or hazardous compounding areas.

4. Mop Heads and sponges are changed and discarded daily after each use or more frequently if heavily soiled.

A. Personal Protective Equipment (PPE) for Cleaning is worn. Safety goggles are used if needed conducting cleaning with all disinfecting agents.

Frequency and Cleaning Agents:

A. DAILY cleaning tasks

1. This daily cleaning task will be performed by the contracted cleaning vendor and take place when no aseptic operations are in progress.

2. Pass-Through Chamber: PreEmpt Plus, 1 min dwell time

3. Work surface(s) outside the PEC: PreEmpt Plus, 1 min dwell time, using non-shedding wipes.

4. Doors and Door Handles (if applicable), Chairs: PreEmpt Plus, 1 min dwell time, using non-shedding wipes.

5. Floor: PreEmpt Plus, 1 min dwell time, using non-shedding mop covers.

6. Sink(s), Surfaces of sink(s): PreEmpt Plus, 1 min dwell time, using non-shedding wipes/mop covers.

B. The sterile storage room/prep room only needs floor and work surface cleaned.

B. WEEKLY cleaning tasks

1. All tasks are the same as in DAILY Cleaning, but the cleaning solution used is a sporicidal agent, Peridox. Special weekly cleaning is only implemented in Germfree IV room location.

C. MONTHLY cleaning tasks

1. The monthly cleaning tasks will be performed on a designated day of the month by the contracted cleaning vendor and will take place when no aseptic operations are in progress.

2. Agent, tools and Dwell Time:

A. Sporicidal - Peroxyacetic Acid and Hydrogen Peroxide Agent (i.e.: PeridoxRTU®): 3 minute dwell time.

B. Disinfectant – IPA if required (glass door)

3. Areas and Procedure:

A. Monthly cleaning includes ceilings, walls, all storage shelving, equipment outside the PEC, and waste containers, in addition to the daily cleaning tasks as outlined above (including exterior of PECs, all floors, pass-through chambers, sinks, cleanable surfaces, doors/door handles, chairs and walls).

D. TERMINAL cleaning tasks

After semi-annual certification, or in a situation where bio-sampling requires corrective action plan, a terminal cleaning of the space is required. At minimum, terminal cleaning will be done twice per year in each location and when required by quality verification (bio-sampling as required by USP 797).

1. Cleaning is conducted using a 3 step approach (Sterile IPA is utilized for cleaning up any residual disinfectant).

A. PreEmpt Plus - 1 minute dwell time.

B. Sporicidal - Peroxyacetic Acid and Hydrogen Peroxide Agent (i.e.: PeridoxRTU®) - 3 minute dwell time.

C. Disinfectant - sterile IPA

2. Areas and Procedures:

During the terminal clean each and every surface of the IV Cleanroom must be cleaned – the below list is not all inclusive, but includes most items in the IV Cleanroom – please be aware that a terminal cleaning means ALL surfaces and items in the rooms must be cleaned with this process, including:

A. Ceiling, walls, floors B. Counters C. Exterior of top of hoods D. Exterior sides of hoods E. Exterior of refrigerator F. Interior/exterior of pass-through chamber G. Chairs H. Doors/door windows/Door handles (if applicable) I. Exterior of waste basket J. Inside/around sink/faucet/drain K. Bins/racks (inside the bins are cleaned by pharmacy staff only) B. Monitoring of Cleaning Procedures:

1. Random cleaning audits may be conducted by the USP Compliance Program Manager or designee to ensure staff and the contracted cleaning vendor are in full compliance with all standard operating procedures.

Attachment 1 Sources Sought Worksheet

QUALIFICATION INFORMATION:

Company / Institute Name: _______________________________________________________ Address: ______________________________________________________________________ Phone Number: ________________________________________________________________ Point of Contact: _______________________________________________________________ E-mail Address: ________________________________________________________________ Unique Entity Identifier (UEI) #: ___________________________________________________ CAGE Code: __________________________________________________________________ SAM Registered: (Y / N) Other available contract vehicles applicable to this sources sought (GSA/FSS/NASA SEWP/ETC): __________________________________________________________________

SOCIO-ECONOMIC STATUS:

VIP Verified SDVOSB: (Y / N) VIP Verified VOSB: (Y / N) 8(a): (Y / N) HUBZone: (Y / N) Economically Disadvantaged Women-Owned Small Business: (Y / N) Women-Owned Small Business: (Y / N) Small Business: (Y / N) NOTE: Respondent claiming SDVOSB and VOSB status shall be registered and Center for Veterans Enterprise (CVE) verified in VetBiz Registry www.vetbiz.gov.

BASED ON THE RESPONSES TO THIS SOURCES SOUGHT NOTICE/MARKET RESEARCH, THIS REQUIREMENT MAY BE SET-ASIDE FOR SDVOSB, VOSB, SMALL BUSINESSES OR PROCURED THROUGH FULL AND OPEN COMPETITION.

CAPABILITY STATEMENT:

Provide a brief capability and interest in providing the service as listed in Attachment 2 Statement of Work with enough information to determine if your company can meet the requirement. The capabilities statement for this Sources Sought is not a Request for Quotation, Request for Proposal, or Invitation for Bid, nor does it restrict the Government to an ultimate acquisition approach, but rather the Government is requesting a short statement regarding the company’s ability to provide the services outlined in the SOW. Any commercial brochures or currently existing marketing material may also be submitted with the capabilities statement. This synopsis is for information and planning purposes only and is not to be construed as a commitment by the Government. The Government will not pay for information solicited. Respondents will not be notified of the results of the evaluation.