36C24121Q0004_1.docx

36C24121Q0004

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9.

ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE

WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15

CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTA

CHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNAT

URE OF OFFEROR/CONTRACTOR

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C24121Q0004 11-05-2020 Cory Dionne

(774) 826-4806 11-13-2020

04:30 PM

EST

Department of Veterans Affairs VA Boston Healthcare System Contracting Officer (90C) 940 Belmont Street Brockton MA 02301 X 541380 $16.5 Million N/A X Department of Veterans Affairs Manchester VAMC 718 Smyth Road Manchester NH 03104-7007 Department of Veterans Affairs VA Boston Healthcare System Contracting Officer (90C) 940 Belmont Street Brockton MA 02301

Department of Veterans Affairs Financial Services Center http://www.fsc.va.gov/einvoice.asp PO Box 149971 Austin TX 78714-9971 877-752-0900 See CONTINUATION Page This solicitation is a request for quote for Environmental Monitoring and training to support to Pharmacy cleanroom at Manchester VAMC. The government intends to award a firm fixed price contract with one base year plus 4 option years possible. Contractor shall provide all necessary personnel, supervision, labor, equipment, materials and disposal to provide the required services pursuant to the Performance Work Statement described herein.

Offerors should carefully follow unstructions included in 52.212-1 a nd for evaluation criteria specified in Section E.

Pricing should be identified B.3 Price/Cost Schedule attached to the RFQ.

The following wage determination applies to the solicitation Wage Determination: 2015-4020 Revision: 14 Dated:04/28/2020 beta.sam.gov All quotes shall be emailed to cory.dionne@va.gov Any quote not compliant with RFQ requirements will not be considered.

No questions after 11/09/2020 at 4:30pm.

See CONTINUATION Page X X Mercedes Blanton

VA-VHA-SAOE-2016-70627244

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C241 Mercedes Blanton Department of Veterans Affairs VA Boston Healthcare System Contracting Officer (90C) 940 Belmont Street Brockton MA 02301

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Department of Veterans Affairs Financial Services Center http://www.fsc.va.gov/einvoice.asp PO Box 149971 Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 PERFORMANCE WORK STATEMENT

Compounding Cleanroom Environmental Monitoring and Training Introduction

The Manchester VA Healthcare System currently prepares and compounds necessary intravenous medications (and other sterile products) to assigned patients. As a healthcare facility, the pharmacy is required to provide these compounded products according to all relevant USP compounding guidelines including USP 797/800. In order for this to be done, a multidisciplinary approach has been adopted to provide safe compounded medications. Included in this multidisciplinary approach is the requirement for environmental monitoring. Environmental monitoring (on site sampling, laboratory analysis and reporting) services are required at the Manchester VAMC. This must be accomplished according to Industry Standards, Manchester VAMC Pharmacy IV Room Standard Operating Procedures (SOP) and applicable USP guidelines.

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.

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 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, 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 (Revised 3/01/2020 and is attached to the solicitation).

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 through 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 xper 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 requirementsit 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 three 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

1. Training of BHS staff

Contractor will perform employee training and certification in regards to gowning procedures (garments provided by the contractor). The contractor must be well versed in maintaining aseptic technique and educate the pharmacy department in regards to 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.

Contractor Personnel Security Requirements:

Contractor employees who have access to the Manchester VAMC 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.

1. Position Sensitivity - The position sensitivity has been designated as low risk.

1. Background Investigation - The level of background investigation commensurate with the required level of access is National Agency Check with Written Inquiries.

1. Agency Responsibilities:

The Contracting Officer will initiate the Background Investigation request into the Security and Investigations Center (SIC).

1. 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 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 continuously provide optimal Environmental Monitoring services within Pharmacy compounding clean room environments in accordance with published criteria for USP 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.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

0.00

Monthly Viable air sampling for Bacteria clean room environmental sampling in accordance with CETA cag-009 or current version sampling locations include (3 each) sec/room e123 e124 e125 930 PEC/MAIN chamber S/N 181161072417, S/N 181160072417, S/N 181162072417 (3) PEC/ANTECHAMBER Positive and negative control Contract Period: Base POP Begin: 11-16-2020 POP End: 11-15-2021 LOCAL STOCK NUMBER: bacteria

0.00

Viable air sampling for fungal Monthly clean room environmental sampling in accordance with CETA cag-009 or current version sampling locations include (3 each) sec/room e123 e124 e125 930 PEC/MAIN chamber S/N 181161072417, S/N 181160072417, S/N 181162072417 (3) PEC/ANTECHAMBER Positive and negative control

POP Begin: 11-16-2020

LOCAL STOCK NUMBER: fungal

0.00

viable surface sampling for Bacteria in accordance with CAG/009 or current version for sampling locations 1 door handle buffer caci room (1) fridge handle caci room (1) door handle buffer caci room (3) surface sample cai room PEC/ main chamber units (3) PEC/PAss thru door. (3) PEC/antechamber (1) door handle in Anteroom (1) sink in anteroom (1) wall in anteroom (1) surface in anteroom (1) handle of pass thru anteroom (1) positive and negative control

POP Begin: 11-16-2020

0.00

viable surface sampling for Fungal in accordance with CAG/009 or current version for sampling locations 1 door handle buffer caci room (1) fridge handle caci room (1) door handle buffer caci room (3) surface sample cai room PEC/ main chamber units (3) PEC/PAss thru door. (3) PEC/antechamber (1) door handle in Anteroom (1) sink in anteroom (1) wall in anteroom (1) surface in anteroom (1) handle of pass thru anteroom (1) positive and negative control

POP Begin: 11-16-2020

Costs of testing, reports to include report generation fee overnight freight, unedited video taping of BSC/PEC Smoke pattern testing

POP Begin: 11-16-2020

LOCAL STOCK NUMBER: funds

0.00

BI-Annual certification services for 2 negative pressure and one positive pressure Nuaire AIsolator hoods Located in VA manchester Pharmacy service performed in accordance with current ISO-17025, ISO-14644, USP-<797> standards. Specifications comply with applicable Institute of Environmental Sciences and Technology recommended practices, CETA CAG-002-6006 Rev. 08-Dec-2008, CETA CAG-003-2006-13 for Sterile Compounding Facilities Current Version, CETA CAG-009-00 for USP<797> BI-ANNUAL videotaped dynamic smoke study services for 2 NuAire Pharmagard model NU-NTE 800-400 Compounding Aseptic Containment Isolator Cabinets and 1 NuAire Pharmagard Compounding Aseptic Isolator model NU-PR797-400 Cabinet.

POP Begin: 11-16-2020

LOCAL STOCK NUMBER: BIANUAL CERTIFICATION

0.00

Monthly Viable air sampling for Bacteria clean room environmental sampling in accordance with CETA cag-009 or current version sampling locations include (3 each) sec/room e123 e124 e125 930 PEC/MAIN chamber S/N 181161072417, S/N 181160072417, S/N 181162072417 (3) PEC/ANTECHAMBER Positive and negative control Contract Period: Option 1 POP Begin: 11-16-2021 POP End: 11-15-2022

0.00

Viable air sampling for fungal Monthly clean room environmental sampling in accordance with CETA cag-009 or current version sampling locations include (3 each) sec/room e123 e124 e125 930 PEC/MAIN chamber S/N 181161072417, S/N 181160072417, S/N 181162072417 (3) PEC/ANTECHAMBER Positive and negative control

POP Begin: 11-16-2021

0.00

viable surface sampling for Bacteria in accordance with CAG/009 or current version for sampling locations 1 door handle buffer caci room (1) fridge handle caci room (1) door handle buffer caci room (3) surface sample cai room PEC/ main chamber units (3) PEC/PAss thru door. (3) PEC/antechamber (1) door handle in Anteroom (1) sink in anteroom (1) wall in anteroom (1) surface in anteroom (1) handle of pass thru anteroom (1) positive and negative control

POP Begin: 11-16-2021

0.00

viable surface sampling for Fungal in accordance with CAG/009 or current version for sampling locations 1 door handle buffer caci room (1) fridge handle caci room (1) door handle buffer caci room (3) surface sample cai room PEC/ main chamber units (3) PEC/PAss thru door. (3) PEC/antechamber (1) door handle in Anteroom (1) sink in anteroom (1) wall in anteroom (1) surface in anteroom (1) handle of pass thru anteroom (1) positive and negative control

POP Begin: 11-16-2021

Costs of testing, reports to include report generation fee overnight freight, unedited video taping of BSC/PEC Smoke pattern testing

POP Begin: 11-16-2021

0.00

BI-Annual certification services for 2 negative pressure and one positive pressure Nuaire AIsolator hoods Located in VA manchester Pharmacy service performed in accordance with current ISO-17025, ISO-14644, USP-<797> standards. Specifications comply with applicable Institute of Environmental Sciences and Technology recommended practices, CETA CAG-002-6006 Rev. 08-Dec-2008, CETA CAG-003-2006-13 for Sterile Compounding Facilities Current Version, CETA CAG-009-00 for USP<797> BI-ANNUAL videotaped dynamic smoke study services for 2 NuAire Pharmagard model NU-NTE 800-400 Compounding Aseptic Containment Isolator Cabinets and 1 NuAire Pharmagard Compounding Aseptic Isolator model NU-PR797-400 Cabinet.

POP Begin: 11-16-2021

0.00

Monthly Viable air sampling for Bacteria clean room environmental sampling in accordance with CETA cag-009 or current version sampling locations include (3 each) sec/room e123 e124 e125 930 PEC/MAIN chamber S/N 181161072417, S/N 181160072417, S/N 181162072417 (3) PEC/ANTECHAMBER Positive and negative control Contract Period: Option 2 POP Begin: 11-16-2022 POP End: 11-15-2023

0.00

Viable air sampling for fungal Monthly clean room environmental sampling in accordance with CETA cag-009 or current version sampling locations include (3 each) sec/room e123 e124 e125 930 PEC/MAIN chamber S/N 181161072417, S/N 181160072417, S/N 181162072417 (3) PEC/ANTECHAMBER Positive and negative control

POP Begin: 11-16-2022

0.00

viable surface sampling for Bacteria in accordance with CAG/009 or current version for sampling locations 1 door handle buffer caci room (1) fridge handle caci room (1) door handle buffer caci room (3) surface sample cai room PEC/ main chamber units (3) PEC/PAss thru door. (3) PEC/antechamber (1) door handle in Anteroom (1) sink in anteroom (1) wall in anteroom (1) surface in anteroom (1) handle of pass thru anteroom (1) positive and negative control

POP Begin: 11-16-2022

0.00

viable surface sampling for Fungal in accordance with CAG/009 or current version for sampling locations 1 door handle buffer caci room (1) fridge handle caci room (1) door handle buffer caci room (3) surface sample cai room PEC/ main chamber units (3) PEC/PAss thru door. (3) PEC/antechamber (1) door handle in Anteroom (1) sink in anteroom (1) wall in anteroom (1) surface in anteroom (1) handle of pass thru anteroom (1) positive and negative control

POP Begin: 11-16-2022

Costs of testing, reports to include report generation fee overnight freight, unedited video taping of BSC/PEC Smoke pattern testing

POP Begin: 11-16-2022

0.00

BI-Annual certification services for 2 negative pressure and one positive pressure Nuaire AIsolator hoods Located in VA manchester Pharmacy service performed in accordance with current ISO-17025, ISO-14644, USP-<797> standards. Specifications comply with applicable Institute of Environmental Sciences and Technology recommended practices, CETA CAG-002-6006 Rev. 08-Dec-2008, CETA CAG-003-2006-13 for Sterile Compounding Facilities Current Version, CETA CAG-009-00 for USP<797> BI-ANNUAL videotaped dynamic smoke study services for 2 NuAire Pharmagard model NU-NTE 800-400 Compounding Aseptic Containment Isolator Cabinets and 1 NuAire Pharmagard Compounding Aseptic Isolator model NU-PR797-400 Cabinet.

POP Begin: 11-16-2022

0.00

Monthly Viable air sampling for Bacteria clean room environmental sampling in accordance with CETA cag-009 or current version sampling locations include (3 each) sec/room e123 e124 e125 930 PEC/MAIN chamber S/N 181161072417, S/N 181160072417, S/N 181162072417 (3) PEC/ANTECHAMBER Positive and negative control Contract Period: Option 3 POP Begin: 11-16-2023 POP End: 11-15-2024

0.00

Viable air sampling for fungal Monthly clean room environmental sampling in accordance with CETA cag-009 or current version sampling locations include (3 each) sec/room e123 e124 e125 930 PEC/MAIN chamber S/N 181161072417, S/N 181160072417, S/N 181162072417 (3) PEC/ANTECHAMBER Positive and negative control

POP Begin: 11-16-2023

0.00

viable surface sampling for Bacteria in accordance with CAG/009 or current version for sampling locations 1 door handle buffer caci room (1) fridge handle caci room (1) door handle buffer caci room (3) surface sample cai room PEC/ main chamber units (3) PEC/PAss thru door. (3) PEC/antechamber (1) door handle in Anteroom (1) sink in anteroom (1) wall in anteroom (1) surface in anteroom (1) handle of pass thru anteroom (1) positive and negative control

POP Begin: 11-16-2023

0.00

viable surface sampling for Fungal in accordance with CAG/009 or current version for sampling locations 1 door handle buffer caci room (1) fridge handle caci room (1) door handle buffer caci room (3) surface sample cai room PEC/ main chamber units (3) PEC/PAss thru door. (3) PEC/antechamber (1) door handle in Anteroom (1) sink in anteroom (1) wall in anteroom (1) surface in anteroom (1) handle of pass thru anteroom (1) positive and negative control

POP Begin: 11-16-2023

Costs of testing, reports to include report generation fee overnight freight, unedited video taping of BSC/PEC Smoke pattern testing

POP Begin: 11-16-2023

0.00

BI-Annual certification services for 2 negative pressure and one positive pressure Nuaire AIsolator hoods Located in VA manchester Pharmacy service performed in accordance with current ISO-17025, ISO-14644, USP-<797> standards. Specifications comply with applicable Institute of Environmental Sciences and Technology recommended practices, CETA CAG-002-6006 Rev. 08-Dec-2008, CETA CAG-003-2006-13 for Sterile Compounding Facilities Current Version, CETA CAG-009-00 for USP<797> BI-ANNUAL videotaped dynamic smoke study services for 2 NuAire Pharmagard model NU-NTE 800-400 Compounding Aseptic Containment Isolator Cabinets and 1 NuAire Pharmagard Compounding Aseptic Isolator model NU-PR797-400 Cabinet.

POP Begin: 11-16-2023

0.00

Monthly Viable air sampling for Bacteria clean room environmental sampling in accordance with CETA cag-009 or current version sampling locations include (3 each) sec/room e123 e124 e125 930 PEC/MAIN chamber S/N 181161072417, S/N 181160072417, S/N 181162072417 (3) PEC/ANTECHAMBER Positive and negative control Contract Period: Option 4 POP Begin: 11-16-2024 POP End: 11-15-2025

0.00

Viable air sampling for fungal Monthly clean room environmental sampling in accordance with CETA cag-009 or current version sampling locations include (3 each) sec/room e123 e124 e125 930 PEC/MAIN chamber S/N 181161072417, S/N 181160072417, S/N 181162072417 (3) PEC/ANTECHAMBER Positive and negative control

POP Begin: 11-16-2024

0.00

viable surface sampling for Bacteria in accordance with CAG/009 or current version for sampling locations 1 door handle buffer caci room (1) fridge handle caci room (1) door handle buffer caci room (3) surface sample cai room PEC/ main chamber units (3) PEC/PAss thru door. (3) PEC/antechamber (1) door handle in Anteroom (1) sink in anteroom (1) wall in anteroom (1) surface in anteroom (1) handle of pass thru anteroom (1) positive and negative control

POP Begin: 11-16-2024

0.00

viable surface sampling for Fungal in accordance with CAG/009 or current version for sampling locations 1 door handle buffer caci room (1) fridge handle caci room (1) door handle buffer caci room (3) surface sample cai room PEC/ main chamber units (3) PEC/PAss thru door. (3) PEC/antechamber (1) door handle in Anteroom (1) sink in anteroom (1) wall in anteroom (1) surface in anteroom (1) handle of pass thru anteroom (1) positive and negative control

POP Begin: 11-16-2024

Costs of testing, reports to include report generation fee overnight freight, unedited video taping of BSC/PEC Smoke pattern testing

POP Begin: 11-16-2024

0.00

BI-Annual certification services for 2 negative pressure and one positive pressure Nuaire AIsolator hoods Located in VA manchester Pharmacy service performed in accordance with current ISO-17025, ISO-14644, USP-<797> standards. Specifications comply with applicable Institute of Environmental Sciences and Technology recommended practices, CETA CAG-002-6006 Rev. 08-Dec-2008, CETA CAG-003-2006-13 for Sterile Compounding Facilities Current Version, CETA CAG-009-00 for USP<797> BI-ANNUAL videotaped dynamic smoke study services for 2 NuAire Pharmagard model NU-NTE 800-400 Compounding Aseptic Containment Isolator Cabinets and 1 NuAire Pharmagard Compounding Aseptic Isolator model NU-PR797-400 Cabinet.

POP Begin: 11-16-2024

GRAND TOTAL

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SECTION C - CONTRACT CLAUSES

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/

(End of Clause)

C.2 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 15; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.

(End of Clause)

C.3 SUPPLEMENTAL INSURANCE REQUIREMENTS

In accordance with FAR 28.307-2 and FAR 52.228-5, the following minimum coverage shall apply to this contract:

(a) Workers' compensation and employers liability: Contractors are required to comply with applicable Federal and State workers' compensation and occupational disease statutes. If occupational diseases are not compensable under those statutes, they shall be covered under the employer's liability section of the insurance policy, except when contract operations are so commingled with a Contractor's commercial operations that it would not be practical to require this coverage. Employer's liability coverage of at least $100,000 is required, except in States with exclusive or monopolistic funds that do not permit workers' compensation to be written by private carriers.

(b) General Liability: $500,000.00 per occurrences.

(c) Automobile liability: $200,000.00 per person; $500,000.00 per occurrence and $20,000.00 property damage.

(d) The successful bidder must present to the Contracting Officer, prior to award, evidence of general liability insurance without any exclusionary clauses for asbestos that would void the general liability coverage.

(End of Clause) C.4 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

(a) The Contractor agrees to comply with any provision or clause that is incorporated herein by reference to implement agency policy applicable to acquisition of commercial items or components. The following provisions and clauses that have been checked by the Contracting Officer are incorporated by reference.

[X] 852.203–70, Commercial Advertising.

[] 852.209–70, Organizational Conflicts of Interest.

[] 852.211–70, Equipment Operation and Maintenance Manuals.

[] 852.214–71, Restrictions on Alternate Item(s).

[] 852.214–72, Alternate Item(s). [Note: this is a fillable clause.] [] 852.214–73, Alternate Packaging and Packing.

[] 852.214–74, Marking of Bid Samples.

[X] 852.215–70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors.

[X] 852.215–71, Evaluation Factor Commitments.

[] 852.216–71, Economic Price Adjustment of Contract Price(s) Based on a Price Index.

[] 852.216–72, Proportional Economic Price Adjustment of Contract Price(s) Based on a Price Index.

[] 852.216–73, Economic Price Adjustment—State Nursing Home Care for Veterans.

[] 852.216–74, Economic Price Adjustment—Medicaid Labor Rates.

[] 852.216–75, Economic Price Adjustment—Fuel Surcharge.

[] 852.219–9, VA Small Business Subcontracting Plan Minimum Requirements.

[] 852.219–10, VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside.

[] 852.219–11, VA Notice of Total Veteran-Owned Small Business Set-Aside.

[] 852.222–70, Contract Work Hours and Safety Standards—Nursing Home Care for Veterans.

[] 852.228–70, Bond Premium Adjustment.

[] 852.228–71, Indemnification and Insurance.

[] 852.228–72, Assisting Service-Disabled Veteran-Owned and Veteran-Owned Small Businesses in Obtaining Bonds.

[X] 852.232–72, Electronic Submission of Payment Requests.

[X] 852.233–70, Protest Content/Alternative Dispute Resolution.

[X] 852.233–71, Alternate Protest Procedure.

[] 852.237–70, Indemnification and Medical Liability Insurance.

[] 852.246–71, Rejected Goods.

[] 852.246–72, Frozen Processed Foods.

[] 852.246–73, Noncompliance with Packaging, Packing, and/or Marking Requirements.

[X] 852.270–1, Representatives of Contracting Officers.

[] 852.271–72, Time Spent by Counselee in Counseling Process.

[] 852.271–73, Use and Publication of Counseling Results.

[] 852.271–74, Inspection.

[] 852.271–75, Extension of Contract Period.

[] 852.273–70, Late Offers.

[] 852.273–71, Alternative Negotiation Techniques.

[] 852.273–72, Alternative Evaluation.

[] 852.273–73, Evaluation—Health-Care Resources.

[] 852.273–74, Award without Exchanges.

(b) All requests for quotations, solicitations, and contracts for commercial item services to be provided to beneficiaries must include the following clause:

[] 852.237–74, Nondiscrimination in Service Delivery.

(End of Clause) C.5 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE (JUL 2018)

(a) This solicitation includes the clause: 852.215-70 Service-disabled veteran-owned and veteran-owned small business evaluation factors. Accordingly, any contract resulting from this solicitation will include the clause 852.215-71 Evaluation factor commitments.

(b) The Contractor is advised that in performing contract administration functions, the Contracting Officer may use the services of a support contractor(s) to assist in assessing Contractor compliance with the subcontracting commitments incorporated into the contract. To that end, the support contractor(s) may require access to the Contractor's business records or other proprietary data to review such business records regarding contract compliance with this requirement.

(c) All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the Contractor's business records or other proprietary data reviewed or obtained in the course of assisting the Contracting Officer in assessing the Contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs.

(d) Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the Contractor to protect proprietary information as required by FAR 9.505-4, Obtaining access to proprietary information, paragraph (b). The Contractor is required to cooperate fully and make available any records as may be required to enable the Contracting Officer to assess the Contractor compliance with the subcontracting commitments.

(End of Clause) (End of Addendum to 52.212-4)

C.6 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (AUG 2020)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204–23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115–91).

(3) 52.204–25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (AUG 2020) (Section 889(a)(1)(A) of Pub. L. 115–232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[X] (1) 52.203–6, Restrictions on Subcontractor Sales to the Government (JUN 2020), with Alternate I (OCT 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

[] (2) 52.203–13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509).

[] (3) 52.203–15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

[X] (4) 52.204–10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109–282) (31 U.S.C. 6101 note).

[] (5) [Reserved] [] (6) 52.204–14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

[] (7) 52.204–15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

[X] (8) 52.209–6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (JUN 2020) (31 U.S.C. 6101 note).

[] (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C. 2313).

[] (10) [Reserved] [] (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (MAR 2020) (15 U.S.C. 657a).

[] (ii) Alternate I (MAR 2020) of 52.219-3.

[X] (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (MAR 2020) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

[] (ii) Alternate I (MAR 2020) of 52.219-4.

[] (13) [Reserved] [] (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (MAR 2020) (15 U.S.C. 644).

[] (ii) Alternate I (MAR 2020) of 52.219-6.

[] (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (MAR 2020) (15 U.S.C. 644).

[] (ii) Alternate I (MAR 2020) of 52.219-7.

[X] (16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).

[] (17)(i) 52.219–9, Small Business Subcontracting Plan (JUN 2020) (15 U.S.C. 637(d)(4)).

[] (ii) Alternate I (NOV 2016) of 52.219-9.

[] (iii) Alternate II (NOV 2016) of 52.219-9.

[] (iv) Alternate III (JUN 2020) of 52.219–9.

[] (v) Alternate IV (JUN 2020) of 52.219–9.

[] (18)(i) 52.219-13, Notice of Set-Aside of Orders (MAR 2020) (15 U.S.C. 644(r)).

[] (ii) Alternate I (MAR 2020) of 52.219-13.

[] (19) 52.219-14, Limitations on Subcontracting (MAR 2020) (15 U.S.C. 637(a)(14)).

[] (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

[] (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (MAR 2020) (15 U.S.C. 657f).

[X] (22)(i) 52.219-28, Post Award Small Business Program Rerepresentation (MAY 2020) (15 U.S.C 632(a)(2)).

[] (ii) Alternate I (MAR 2020) of 52.219-28.

[] (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (MAR 2020) (15 U.S.C. 637(m)).

[] (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (MAR 2020) (15 U.S.C. 637(m)).

[] (25) 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR 2020) (15 U.S.C. 644(r)).

[] (26) 52.219-33, Nonmanufacturer Rule (MAR 2020) (15 U.S.C. 637(a)(17)) [X] (27) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

[] (28) 52.222–19, Child Labor—Cooperation with Authorities and Remedies (JAN 2020) (E.O. 13126).

[X] (29) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

[X] (30)(i) 52.222–26, Equal Opportunity (SEP 2016) (E.O. 11246).

[] (ii) Alternate I (FEB 1999) of 52.222-26.

[X] (31)(i) 52.222–35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).

[] (ii) Alternate I (JULY 2014) of 52.222-35.

[X] (32)(i) 52.222–36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).

[] (ii) Alternate I (JULY 2014) of 52.222-36.

[X] (33) 52.222–37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).

[X] (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496).

[X] (35)(i) 52.222-50, Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O. 13627).

[] (ii) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

[X] (36) 52.222-54, Employment Eligibility Verification (OCT 2015). (E. O. 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

[] (37)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C.6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

[] (ii) Alternate I (MAY 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

[] (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN 2016) (E.O. 13693).

[] (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693).

[] (40)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514).

[] (ii) Alternate I (OCT 2015) of 52.223-13.

[] (41)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).

[] (ii) Alternate I (JUN 2014) of 52.223-14.

[] (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (MAY 2020) (42 U.S.C. 8259b).

[] (43)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (E.O.s 13423 and 13514).

[] (ii) Alternate I (JUN 2014) of 52.223-16.

[X] (44) 52.223–18, Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) (E.O. 13513).

[] (45) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).

[] (46) 52.223-21, Foams (JUN 2016) (E.O. 13693).

[] (47) (i) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

[] (ii) Alternate I (JAN 2017) of 52.224-3.

[] (48) 52.225-1, Buy American—Supplies (MAY 2014) (41 U.S.C. chapter 83).

[] (49)(i) 52.225-3, Buy American—Free Trade Agreements—Israeli Trade Act (MAY 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

[] (ii) Alternate I (MAY 2014) of 52.225-3.

[] (iii) Alternate II (MAY 2014) of 52.225-3.

[] (iv) Alternate III (MAY 2014) of 52.225-3.

[] (50) 52.225–5, Trade Agreements (OCT 2019) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

[X] (51) 52.225-13, Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

[] (52)…