F107--Cleanroom Environmental Monitoring and Training
1. INTRODUCTION: This notice is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Department of Veterans Affairs (VA). The VA is currently conducting market research to locate qualified, experienced and interested potential sources. Responses will not be considered as quotes, nor will any award be incurred by interested parties in responding to this sources sought announcement. NCO 1 Contracting is seeking interested sources for a future solicitation and procurement. Currently, no solicitation exists. This requirement is for Compounding Cleanroom Environmental Monitoring and Training at the Manchester, NH Veterans Affairs Medical Center. Manchester VAMC 718 Smyth Road Manchester NH 03104-7007 2. BACKGROUND: The Manchester VAMC is located at: 714 Smyth Road Manchester, NH 03104. This location has a compounding suite that adheres strictly to USP guidelines. Adhering to the applicable directives referenced below helps reduce the potential for bacterial contamination of compounded products. 3. SCOPE: The Contractor shall provide all necessary personnel, supervision, labor, equipment, materials (Including gowning materials/sterilized jumpsuits and environmental monitoring tools) and disposal necessary to successfully support the Manchester VAMC USP compounding areas. All services shall be performed in accordance with the Performance Work Statement, terms and conditions specified in the solicitation and the applicable directives described below . The resulting contract will cover a minimum of twelve (12) months from start date. The company must be able to provide primary services as called out in this performance work statement and the Manchester VAMC Pharmacy IV Room Standard Operating Procedure (SOP). The contractor (per evaluation by the Contracting Officer) must be financially responsible, show evidence of their reliability, ability and experience performing in sterile compounding environments and USP 797/800 environmental monitoring. The contractor and personnel directly employed or supervised by them must render prompt, detailed service in accordance with the applicable directives referenced in this document. The Contractor shall be licensed by the State or local health authority in those localities where licenses are required. Contractor personnel shall be trained appropriately and deemed competent for performance of work under this contract. Each serviceman designated by the Contractor to perform work under this contract shall be cleared for access tough restricted areas of customer s facilities. The Contractor shall conform to all Federal, State, VA and local regulations governing Environmental Monitoring in USP environments. This includes the use of any related chemicals and equipment. The company must furnish a copy of state certification to perform contracted service. The company must provide this documentation to the Contracting Officer prior to performing any work under the contract. All chemical (SDS) or control substance used to perform service must be submitted and filed with the Contracting Officer s Representative (COR). All company servicemen shall have their name and their company s name indicated on their uniform or a name badge all the time, 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 USP Environmental Monitoring Services. On each visit the company servicemen shall report to the COR or his designee prior to performing services. The employee(s) shall provide approved Environmental Monitoring service on a routine basis without deviation. These services may be discussed and agreed upon by the employees of each department and the approved contractor. If services are interrupted the contractor must contact pharmacy management within the pharmacy department to provide a follow up date and time to complete cleaning and monitoring procedures per protocol. At time of contract award the Contractor will be supplied with a list of the COR s on site representatives for each location. Applicable Directives USP 797 (Most Recent Version) USP 800, Hazardous Compounding (Most Recent Version) Manchester VAMC Pharmacy IV Room Standard Operating Procedures Vendor will stay appraised of current related USP directives to ensure optimal Environmental Monitoring support to Manchester VAMC. Vendor will keep the COR informed on relevant changes to USP guidance in an effort to facilitate continuous improvement. Performance Requirements (Tasks) Description of Services: Environmental Monitoring (On Site Sampling, Laboratory Analysis/Reporting) These services are to be conducted in support of the following locations: Note: A representative floor plan is attached to the solicitation. Room E124-A NON-HAZ Ante Room, area 144.2sf. ISO 7 Room E123- HAZ Clean Room, area 88.1sf. ISO 7 Room E125 NON-HAZ Ante Room, area 88.1. ISO 7 Environmental Monitoring Contractor will provide on- site MONTHLY clean room Environmental Monitoring services for 1 ante room area, 2 NuAire Pharmagard model NU-NTE 800-400 Compounding Aseptic Containment Isolators (including the rooms they are in) and 1 NuAire Pharmagard Compounding Aseptic Isolator model NU-PR797-400 Cabinet. These monthly services must be provided Monday tough Friday (excluding federal holidays) between the hours of 8:00 am 4pm, as negotiated with the COR s specific site representative. The environmental surface testing must be completed by an independent biology lab that is not in direct supervision of the Cleanroom Cleaning contractor. The contractor must collect the samples from the site and deliver the samples to be evaluated to the laboratory that same day before close of business, on the day of sample. There will be no shipping of samples via air/train/mail system outside of the New England area. Plates will be stored in accordance with the manufacturers guidelines before and after use. The Contractor shall utilize a laboratory that is FDA registered and/or accredited by the American Industrial Hygiene Association (AIHA) or the American Association for Laboratory Accreditation (A2LA) for analysis and reporting of the samples collected. The reports are then to be provided to the Contracting Officer s Representative (COR). The environmental monitoring report should identify the following: i. Media used/lot numbers of medias and corresponding expiration dating ii. Location of samples taken (with corresponding map) iii. Equipment used (calibration date) iv. Surface testing (tests must include medias used to identify mold, yeast, gram positive bacteria and gram-negative bacteria) v. The identifiable bacteria including genus and species Samples to include: i. 12 surface samples /E123 (total: 2 cabinets x 1 room with 2 surface samples) and 2 samples from compounding aseptic containment isolator. ii. 8 surface samples/E124 Ante room iii. 10 surface samples/E125 (Total: 1 cabinet x per 1 room x 3 surface sample), 2 sample per compounding aseptic isolator. The contractor will provide environmental monitoring on a monthly basis without interruption. In the event that the contractor cannot meet these monthly requirements it is up to the contractor to provide a contingency date to fulfill the work order/contract details. The contractor must use current USP standards and the Manchester VAMC standard operating procedure when evaluating bacterial growth within the ante room and buffer areas. If the colony counts exceed the parameters defined in the Manchester VAMC Pharmacy IV Room SOP, the contractor will notify the pharmacy service. The contractor will also identify high-risk organisms (yeast, mold, gram negative bacteria and coag positive Staph) within the monthly surface sampling. High-risk organisms include staph, yeast, mold as outlined in the referenced guidelines. If a high-risk organism is found within the hazardous or non-hazardous rooms, the contractor will notify the pharmacy department in a timely manner and identify the organism genus and species. The pharmacy department will implement an action plan as follows: i. Identify the source of the high-risk organism ii. Initiate a cleaning process (clean the area tee times) to eliminate the fungal/bacterial growth iii. Re-test the affected area iv. Shorten beyond use dating until environmental monitoring reports are clear The Contacting Officer s Representative (COR) or their site representative from the corresponding campus will coordinate the timing of the re-cleaning/re-testing of the affected area(s) with the respective Contractors and internal departments as necessary. Cleanroom Training i. Training of BHS staff Contractor will perform employee training and certification regarding gowning procedures (garments provided by the contractor). The contractor must be well versed in maintaining aseptic technique and educate the pharmacy department regarding proper disposal of items which are used by the contractor. This training will need to include the entire clean room team at all locations (Total of 55 personnel combined). Contractor will be available for additional training services for new employees. Once annual VA employee testing is completed (gowning technique, fingertip testing for regular garbing and glove box technique) the contractor will provide certification to the pharmacy department. All proficiency tests will be scheduled in advance to allow the pharmacy department adequate central coverage. 4. OBJECTIVES: Manchester VAMC is looking for small business concerns, especially Service-Disabled Veteran Owned Small Business (SDVOSB) and Veteran Owned Small Business (VOSB) contractors that can provide the requested related services for Providence VAMC within VISN 1. All capable companies are encouraged to respond. The current primary NAICS code is 541380 (Testing Laboratories). 5. SUBMITTAL INFORMATION: Contractors having the skills and capabilities necessary to perform the stated requirements should submit a response as detailed below. Companies should provide clear and unambiguous evidence to substantiate their capability to fulfill the requirements above. Interested parties shall furnish the following minimum information: I. Company name and address ensure your company is registered in the System for Award Management (SAM) at beta.sam.gov. II. Company point of contact name, telephone number, and email address. III. Evidence that you are a small business (if applicable): A Small Business ensure you are listed as small business in SAM, reps and certifications. Provide the NAICS codes you are listed as a small business under. A SDVOSB or VOSB (or in the process of certification) ensure you are certified in the veteran database at www.vetbiz.gov. Provide evidence of certification. IV. If your company holds a Federal Supply Schedule (FSS) Contract, list the Contract Number and SINs. V. Capabilities/Qualifications: A written response providing clear and unambiguous evidence to substantiate the capacity to fulfill this requirement. Description of the capabilities/qualifications/skills your company possesses to perform services described above. VI. Past Experience: Brief summary of the company history relative to similar requirements. Response may provide information on a maximum of tee similar projects for which the responder was a prime or subcontractor. It is requested that the above information be provided no later than October 12th, 2020 at 4:30PM EDT. Responses should be emailed to the contracting specialist at cory.dionne@va.gov.
36C24121Q0004 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 1
11/5/20, 7:42 AM F107--Cleanroom Environmental Monitoring and Training
1. INTRODUCTION: This notice is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Department of Veterans Affairs (VA). The VA is currently conducting market research to locate qualified, experienced and interested potential sources. Responses will not be considered as quotes, nor will any award be incurred by interested parties in responding to this sources sought announcement. NCO 1 Contracting is seeking interested sources for a future solicitation and procurement. Currently, no solicitation exists. This requirement is for Compounding Cleanroom Environmental Monitoring and Training at the Manchester, NH Veterans Affairs Medical Center. Manchester VAMC 718 Smyth Road Manchester NH 03104-7007 2. BACKGROUND: The Manchester VAMC is located at: 714 Smyth Road Manchester, NH 03104. This location has a compounding suite that adheres strictly to USP guidelines. Adhering to the applicable directives referenced below helps reduce the potential for bacterial contamination of compounded products. 3. SCOPE: The Contractor shall provide all necessary personnel, supervision, labor, equipment, materials (Including gowning materials/sterilized jumpsuits and environmental monitoring tools) and disposal necessary to successfully support the Manchester VAMC USP compounding areas. All services shall be performed in accordance with the Performance Work Statement, terms and conditions specified in the solicitation and the applicable directives described below . The resulting contract will cover a minimum of twelve (12) months from start date. The company must be able to provide primary services as called out in this performance work statement and the Manchester VAMC Pharmacy IV Room Standard Operating Procedure (SOP). The contractor (per evaluation by the Contracting Officer) must be financially responsible, show evidence of their reliability, ability and experience performing in sterile compounding environments and USP 797/800 environmental monitoring. The contractor and personnel directly employed or supervised by them must render prompt, detailed service in accordance with the applicable directives referenced in this document. The Contractor shall be licensed by the State or local health authority in those localities where licenses are required. Contractor personnel shall be trained appropriately and deemed competent for performance of work under this contract. Each serviceman designated by the Contractor to perform work under this contract shall be cleared for access tough restricted areas of customer s facilities. The Contractor shall conform to all Federal, State, VA and local regulations governing Environmental Monitoring in USP environments. This includes the use of any related chemicals and equipment. The company must furnish a copy of state certification to perform contracted service. The company must provide this documentation to the Contracting Officer prior to performing any work under the contract. All chemical (SDS) or control substance used to perform service must be submitted and filed with the Contracting Officer s Representative (COR). All company servicemen shall have their name and their company s name indicated on their uniform or a name badge all the time, 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 USP Environmental Monitoring Services. On each visit the company servicemen shall report to the COR or his designee prior to performing services. The employee(s) shall provide approved Environmental Monitoring service on a routine basis without deviation. These services may be discussed and agreed upon by the employees of each department and the approved contractor. If services are interrupted the contractor must contact pharmacy management within the pharmacy department to provide a follow up date and time to complete cleaning and monitoring procedures per protocol. At time of contract award the Contractor will be supplied with a list of the COR s on site representatives for each location. Applicable Directives USP 797 (Most Recent Version) USP 800, Hazardous Compounding (Most Recent Version) Manchester VAMC Pharmacy IV Room Standard Operating Procedures Vendor will stay appraised of current related USP directives to ensure optimal Environmental Monitoring support to Manchester VAMC. Vendor will keep the COR informed on relevant changes to USP guidance in an effort to facilitate continuous improvement. Performance Requirements (Tasks) Description of Services: Environmental Monitoring (On Site Sampling, Laboratory Analysis/Reporting) These services are to be conducted in support of the following locations: Note: A representative floor plan is attached to the solicitation. Room E124-A NON-HAZ Ante Room, area 144.2sf. ISO 7 Room E123- HAZ Clean Room, area 88.1sf. ISO 7 Room E125 NON-HAZ Ante Room, area 88.1. ISO 7 Environmental Monitoring Contractor will provide on- site MONTHLY clean room Environmental Monitoring services for 1 ante room area, 2 NuAire Pharmagard model NU-NTE 800-400 Compounding Aseptic Containment Isolators (including the rooms they are in) and 1 NuAire Pharmagard Compounding Aseptic Isolator model NU-PR797-400 Cabinet. These monthly services must be provided Monday tough Friday (excluding federal holidays) between the hours of 8:00 am 4pm, as negotiated with the COR s specific site representative. The environmental surface testing must be completed by an independent biology lab that is not in direct supervision of the Cleanroom Cleaning contractor. The contractor must collect the samples from the site and deliver the samples to be evaluated to the laboratory that same day before close of business, on the day of sample. There will be no shipping of samples via air/train/mail system outside of the New England area. Plates will be stored in accordance with the manufacturers guidelines before and after use. The Contractor shall utilize a laboratory that is FDA registered and/or accredited by the American Industrial Hygiene Association (AIHA) or the American Association for Laboratory Accreditation (A2LA) for analysis and reporting of the samples collected. The reports are then to be provided to the Contracting Officer s Representative (COR). The environmental monitoring report should identify the following: i. Media used/lot numbers of medias and corresponding expiration dating ii. Location of samples taken (with corresponding map) iii. Equipment used (calibration date) iv. Surface testing (tests must include medias used to identify mold, yeast, gram positive bacteria and gram-negative bacteria) v. The identifiable bacteria including genus and species Samples to include: i. 12 surface samples /E123 (total: 2 cabinets x 1 room with 2 surface samples) and 2 samples from compounding aseptic containment isolator. ii. 8 surface samples/E124 Ante room iii. 10 surface samples/E125 (Total: 1 cabinet x per 1 room x 3 surface sample), 2 sample per compounding aseptic isolator. The contractor will provide environmental monitoring on a monthly basis without interruption. In the event that the contractor cannot meet these monthly requirements it is up to the contractor to provide a contingency date to fulfill the work order/contract details. The contractor must use current USP standards and the Manchester VAMC standard operating procedure when evaluating bacterial growth within the ante room and buffer areas. If the colony counts exceed the parameters defined in the Manchester VAMC Pharmacy IV Room SOP, the contractor will notify the pharmacy service. The contractor will also identify high-risk organisms (yeast, mold, gram negative bacteria and coag positive Staph) within the monthly surface sampling. High-risk organisms include staph, yeast, mold as outlined in the referenced guidelines. If a high-risk organism is found within the hazardous or non-hazardous rooms, the contractor will notify the pharmacy department in a timely manner and identify the organism genus and species. The pharmacy department will implement an action plan as follows: i. Identify the source of the high-risk organism ii. Initiate a cleaning process (clean the area tee times) to eliminate the fungal/bacterial growth iii. Re-test the affected area iv. Shorten beyond use dating until environmental monitoring reports are clear The Contacting Officer s Representative (COR) or their site representative from the corresponding campus will coordinate the timing of the re-cleaning/re-testing of the affected area(s) with the respective Contractors and internal departments as necessary. Cleanroom Training i. Training of BHS staff Contractor will perform employee training and certification regarding gowning procedures (garments provided by the contractor). The contractor must be well versed in maintaining aseptic technique and educate the pharmacy department regarding proper disposal of items which are used by the contractor. This training will need to include the entire clean room team at all locations (Total of 55 personnel combined). Contractor will be available for additional training services for new employees. Once annual VA employee testing is completed (gowning technique, fingertip testing for regular garbing and glove box technique) the contractor will provide certification to the pharmacy department. All proficiency tests will be scheduled in advance to allow the pharmacy department adequate central coverage. 4. OBJECTIVES: Manchester VAMC is looking for small business concerns, especially Service-Disabled Veteran Owned Small Business (SDVOSB) and Veteran Owned Small Business (VOSB) contractors that can provide the requested related services for Providence VAMC within VISN 1. All capable companies are encouraged to respond. The current primary NAICS code is 541380 (Testing Laboratories). 5. SUBMITTAL INFORMATION: Contractors having the skills and capabilities necessary to perform the stated requirements should submit a response as detailed below. Companies should provide clear and unambiguous evidence to substantiate their capability to fulfill the requirements above. Interested parties shall furnish the following minimum information: I. Company name and address ensure your company is registered in the System for Award Management (SAM) at beta.sam.gov. II. Company point of contact name, telephone number, and email address. III. Evidence that you are a small business (if applicable): A Small Business ensure you are listed as small business in SAM, reps and certifications. Provide the NAICS codes you are listed as a small business under. A SDVOSB or VOSB (or in the process of certification) ensure you are certified in the veteran database at www.vetbiz.gov. Provide evidence of certification. IV. If your company holds a Federal Supply Schedule (FSS) Contract, list the Contract Number and SINs. V. Capabilities/Qualifications: A written response providing clear and unambiguous evidence to substantiate the capacity to fulfill this requirement. Description of the capabilities/qualifications/skills your company possesses to perform services described above. VI. Past Experience: Brief summary of the company history relative to similar requirements. Response may provide information on a maximum of tee similar projects for which the responder was a prime or subcontractor. It is requested that the above information be provided no later than October 12th, 2020 at 4:30PM EDT. Responses should be emailed to the contracting specialist at cory.dionne@va.gov.
36C24121Q0004 Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 1
10/2/20, 11:45 AM