36C24120Q0616_3.docx

36C24120Q0616

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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

650-20-4-7058-0057 36C24120Q0616 09-22-2020 Cory Dionne

(774) 826-4806 09-25-2020

4:30 PM

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 Providence VAMC 830 Chalkstone Avenue Providence RI 02908-4734 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 See CONTINUATION Page This solicitation is a Request for Quotation for Environmental Monitoring Services. The government intends to award a firm fixed price contract for a minimum of one year with 4 possible option years to follow. Contractor shall provide all necessary personnel, supervision, labor, equipment, materials and disposal necessary to provide Environmental Monitoring Services at Providence VAMC pursuant to the Performance Work Statement described herein.

Quoters should carefully follow instructions included i n evaluation criteria specified in section E(52.212-2 Addenda) Pricing should be identified in B.3 Price/Cost Schedule attached to the RFQ.

Wage Determination Number: 2015-4048 Revision Numbers: 14 Date Of Last Revision: 04/13/2020 beta.sam.gov All quotes shall be emailed to cory.dionne@va.gov Any quote not complaint with RFQ requirements will not be considered.

See CONTINUATION Page X Cory Dionne

VA-VHA-SAOE-2019-1F2A7A6A

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 Cory Dionne 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

Pharmacy Primary Engineering Control Certification, Testing, Preventative Maintenance Service, Employee Competencies

PART A – GENERAL INFORMATION

INTRODUCTION: This requirement is for testing and certification of all Providence VA Medical Center’s primary engineering controls (PECs) and secondary engineering controls (ISO classified clean rooms and hazardous drug storage areas), which are utilized for preparation of Compounded Sterile Preparations (CSPs) for human administration. PECs include biological safety cabinets (BSCs), laminar airflow workstation (LAFW) hoods, and compounding aseptic containment isolators (CACI), used to create an ISO Class 5 area for aseptic processing. The requirement will also include facilitating gloved fingertip/thumb and media fill testing for compounding personnel at the Providence VAMC. Testing and certification will be completed in accordance with United States Pharmacopeia (USP) Chapter <797>, or current guidelines.

BACKGROUND: The Providence VAMC Pharmacy Service wishes to establish a contract for initial equipment certification, recertification and maintenance using standardized testing criteria appropriate for all PECs. The criteria must meet the most current USP Chapter <797> and Chapter <800> standards, follow the most current Controlled Environment Testing Association (CETA) best practice guidelines, and the work must be performed by a CETA National Board of Testing (CNBT) certified individual to establish consistent PEC/SEC certification procedures. Although USP <797> states that certification procedures “such as” those outlined CAG-003-2006 shall be performed, Veterans Affairs (VA) will be requiring that CAG-003-2006 be used in lieu of any other “such as” procedures that may exist. Depending on the period of performance and option year(s), testing procedures shall be maintained in compliance with all current applicable USP standards.

The USP establishes standards for cleanroom design, environmental monitoring, and competencies for the preparation, handling, and storage of CSPs. The Joint Commission (TJC) Accreditation Manual for Home Care, effective January 13, 2018, established new Medication Compounding (MC) standards for non-sterile and sterile compounded preparations which are based on USP standards. The Food and Drug Administration (FDA) also has the authority to inspect VA medical facility sterile compounding facilities.

Certification procedures defined in CETA CAG-003-2006 shall be performed by a CETA National Board of Testing (CNBT) certified individual no less than every 6 months or whenever the PEC/SEC is relocated/altered or when major service to the sterile compounding facility is performed.

Employees at Providence VAMC must complete initial/semi-annual gloved fingertip and thumb sampling and media fill test prior to compounding sterile products for human administration. Procedures for completing these tests are outlined in USP 797 and must be completed no less than every 6 months or if remedial action required.

SCOPE OF WORK: This contract will include the following locations, services, and equipment. Replacement equipment or new equipment added by the covered service(s) will be included within this service contract.

I. Location & Equipment:

Providence VA Medical Center 830 Chalkstone Ave.

Providence, RI 02908

1. (Contingency) Inpatient Pharmacy, 2nd Floor, Building 1, Room 238B

A. Non-Hazardous IV Compounding Room, 2nd Floor, Building 1, Room 238 (Anteroom and Prep Room)-Contingency

· Unclassified, unclassified and ISO 5 for Ante room, Buffer Room and CAI

· Germfree Versaflow

B. Inpatient Pharmacy Hazardous IV Compounding Room, 2nd Floor, Building 1, Room 238A (Anteroom and Prep Room)- Contingency

· Unclassified, unclassified and ISO 5 for Ante room, Buffer Room and CACI

· Germfree Laminar Flow LFGI CACI

2. New Inpatient Pharmacy Room, 2nd Floor, Building 1, Room 253

A. Non-Hazardous IV Compounding Room, 2nd Floor, Building 1, Room 253B (Anteroom) and Room 253C (Prep Room)

· ISO 8, ISO 7 and ISO 5 for Ante room, Buffer Room and Laminar Flow Hood

· Baker EdgeGARD HF Horizontal Flow Clean Bench

B. Hazardous IV Compounding Room, 2nd Floor, Building 1, Room 253D (Anteroom), Room 253E (Prep Room), and Room 253F (Storage area).

· ISO 8, ISO 8, ISO 7 and ISO 5 for Storage Area, Ante room, Buffer Room and Biosafety Cabinet

· Baker SterilGARD E3 Class II, Type A2 Biological Safety Cabinet

3. Filter Replacement and Disposal

A. Replacement in PEC units when deemed necessary per industry standards

II. Employee Competencies: (~10 employees)

1. Gloved fingertip and thumb sampling

2. Media Fill testing

· Competencies must be performed according to most current USP Chapter <797> and Chapter <800> standards (one to two times yearly)

III. PEC Testing and Certification: The contractor shall test and certify each PEC according to USP <797> and USP <800> using certification procedures from the Controlled Environment Testing Association (CETA) Certification Guides for Sterile Compounding Facilities (CAG-003-2006 and CAG-002-2006). All PECs must:

· Be certified to meet ISO Class 5 or better

· Maintain unidirectional airflow

· Be supplied by HEPA filtered air

The list of tests, depending on CETA and manufacturer guidance for the type of PEC, includes, but is not limited to:

· Viable and non-viable air particle counts

· Airflow testing

· HEPA filter leak test

· Induction leak/back-streaming test

· Cabinet leak test

· In-flow velocity test to include exhaust airflow volume rate

· Surface sampling

· Airflow smoke pattern test

· Airflow Smoke pattern test under dynamic operating conditions (contractor will provide video documentation of each test to facility POCs). Any media files must be provided in a format consistent with VHA media guidance.

1. Laminar Flow Hoods: Laminar Airflow Workbench (LAWF) and Class II Biological Safety Cabinet (BSC) must be tested and certified according to CETA CAG-003-2006 guidelines and to manufacturer’s specifications. Horizontal laminar flow cabinets shall be certified according to The Institute of Environmental Sciences (IEST) RP-CC-002 Testing Laminar Air Flow Devices and Induction Leak/Back-streaming Test and IEST-RP-CC034 HEPA Filter Leak Test.

Certifications for Class II Biological Safety Cabinets (BSCs) must be accomplished in accordance with the most current National Sanitation Foundation/American National Standards Institute (NSF/ANSI) Standard 49 Class II (laminar flow) Biosafety Cabinetry. The contractor shall use a National Institute of Standards and Technology (NIST) traceable or comparable calibrated piece of equipment (calibrated within past 12 months) to perform all testing and provide copies of the calibration tests to the POCs upon request.

The contractor shall report each individual face velocity reading and the average of those readings, the downstream concentration reading of the HEPA filter leak test and the results of the induction leak test and back-streaming test. Any failures shall be reported directly to the identified site point of contact(s) (POC see A.3.2.6) as soon as practicable. Any unit that fails to meet required specifications shall be clearly marked with a sign that will notify technicians that the unit is out of order until further notice. In addition, any failures shall be reported directly to the site identified POC as soon as practicable.

2. Restricted access barrier system: Compounding Aseptic Containment Isolator (CACI), must be certified according to CETA CAG-002-2006 and CAG-003-2006 guidelines and to manufacturer’s specifications. Any unit that fails to meet required specifications shall be clearly marked with a sign that will notify technicians that the unit is out of order until further notice. In addition, any failures shall be reported directly to the site identified point(s) of contact (POC) as soon as practicable.

3. Hazardous Compounding PECs: Hazardous compounding PEC certification is required for Negative Pressure Hoods. The contractor shall test and certify each hazardous PEC to the manufacturer’s specifications. Tests shall include; face velocity test, airflow smoke pattern test and low flow alarm test. If the hazardous PEC has an air flow monitor or controller, the contractor shall confirm the unit is calibrated and operating within +/-10% of actual velocity. If it is not calibrated appropriately the contractor shall calibrate the AFM or AFC. The contractor shall use a NIST traceable or comparable calibrated piece of equipment to calculate the face velocity. The contractor shall report each individual face velocity reading and the average of those readings, a pass/fail grade for the airflow smoke pattern test and a pass/fail grade for the low flow alarm test. Any failures shall be reported directly to the POC(s) as soon as practicable. For each PEC passing the required certification tests, the contractor will supply each unit with a certification sticker with the following information:

A. Company name, address and phone number B. Unit make, model and serial number C. Report number reflecting the room certification D. Location (room number) E. Certification date F. Recertification date G. Technician signature

IV. Testing and Certification Requirements: All CSP Facilities must be tested and certified in accordance to ISO 14644-1 Classifications of Air Cleanliness, CETA CAG-03-2006 and CETA CAG-009-00 specifications. The contractor will provide comprehensive cleanroom testing and certification services with frequency required by most current USP <797> standards and USP <800>. Test equipment used for certification will be clean, in good working order and calibrated on a calibration frequency not to exceed 12 months or more frequently if recommended by the manufacturer. Calibration certificates should be provided upon request by the facility POC for all calibrated test equipment. USP Compliance Testing for Cleanrooms and Controlled Environment certification will include but is not limited to the following:

· Non-Viable Particle Counting under dynamic operating conditions

· Viable / Microbial Air Testing

· Viable / Microbial Surface Testing

· Airflow Volume Measurements

· Air Velocity Profile

· Room Air Exchange Rates

· Room Pressure Measurement

· In-Place Leak Testing of HEPA Filters

· Temperature, Relative Humidity Measurements

· Lighting Measurement

· Sound Level Measurement

· Airflow visualization test (Smoke study)

· Electrical leakage and ground circuit resistance and polarity tests

· Pass-through chamber air quality

1. Viable and Non-viable Particle Counts: For the PECs, viable and non-viable particle counts samples will be collected. Viable samples will be collected for each device (both bacterial and fungal) for the air and surface in accordance with USP <797> and USP <800>

2. Air Changes per Hour: The contractor shall calculate the total room volume for each buffer, ante room, and hazardous drug storage room. A sketch of the room with dimensions, exhaust/supply diffuser locations and equipment locations shall be included in the report. The report provided will specify flow rates detailing returns and supply that were obtained during the testing. The contractor shall calculate air changes per hour (ACPH) for each buffer, ante room, hazardous drug storage room and include their findings in the report. If a room does not meet USP<797> and USP <800> requirements for ACPH the identified site POC(s) shall be informed immediately.

3. Pressure Requirements: The contractor shall include in their report differential pressure readings from each buffer/ante room to all surrounding areas. The report shall indicate whether the room is required to be a negative or positive pressure room per USP<797> (or USP <800> when applicable). The contractor shall report all pressures to an accuracy of 0.001” water column (3 decimal places). Pressure differentials will be reflected on a report showing the sketch of the room(s).

4. Viable Environmental Sampling: The contractor shall perform the minimum number of sampling locations using Annex A viable environmental (air/surface) sampling every 6 months for fungi and bacteria using high volume impaction samplers to conduct the sampling.

A. In addition, monthly viable environmental surface sampling of designated classified areas will be performed.

· The interior of the PEC and any equipment contained in it (i.e. automated compounding devices, pumps or IV workflow system components)

· Staging or work area(s) near the PEC

· Frequently touched surfaces (as determined by department subject matter expert(s))

· Pass-through chamber(s) B. Air sampling: A sufficient volume of air (1000 liters) shall be tested at each location in order to maximize sensitivity. Samples of less than 1000 liters will not be acceptable.

C. Surface Sampling: The contractor shall perform surface samples for bacteria using Tryptic Soy Agar (TSA) contact plates as directed by USP <797>. Surface sampling must be performed at the end of the compounding activities or shift, but before the area has been cleaned and disinfected. Media used for viable surface tests must contain additives that neutralize disinfectant residues.

5. Nonviable Particle Testing: The contractor shall perform environmental nonviable particle testing semiannually (e.g. every 6 months). The contractor shall derive the minimum number of sampling locations using Annex A in the ISO 14644-1.2 standard. Testing shall be performed by qualified operators using current, state-of-the-art electronic equipment with results of the following:

A. ISO Class 5: not more than 3520 particles 0.5 μm and larger size per cubic meter of air for any area primary engineering control (BSC or LAFW).

B. ISO Class 7: not more than 352,000 particles 0.5 μm and larger size per cubic meter of air for any buffer area or hazardous compounding ante room.

C. ISO Class 8: not more than 3,520,000 particles 0.5 μm and larger size per cubic meter of air for any non-hazardous compounding ante room.

6. Employee Competencies: The contractor shall facilitate both gloved fingertip and thumb sampling and media file testing for each compounding employee every 6 months using general microbial growth agar with neutralizing additives that support both bacterial and fungal growth. Employee Competencies will be labeled with the following:

· Name of employee

· What hand sampling occurred (gloved fingertip/thumb sampling only)

· Date and time of sampling.

· If initial or semiannual test A. Media fill testing should simulate the most difficult and challenging compounding procedures and processing conditions encountered by the employee. The test will be approved by the facility in advance.

B. Providence VAMC has approximately 10 employees that require the above competency. As this is required every 6 months, we will need ~ 20 tests performed per year. The vast majority being annual tests, with some needing initial testing that would increase the number of tests performed.

7. Filter Assessment, Replacement, and Disposal: The contractor will make recommendations for the replacement of any HEPPA filters every 6 months during the certification.

A. If a filter(s) is identified as needing replacement, the contractor will procure and install the required filter B. Installation will occur during an agreed upon time that will minimize interruptions to patient care.

C. Filters that are/could be contaminated with hazardous drugs will be disposed of by the contractor.

8. Report Requirements: The following information should be included in the report when applicable for clean room certification and employee certification. Pass/Fail notifications should be included on a per-test basis where applicable.

· Reports to include at a minimum:

· Date and time of testing on each page of report. Page numbers should be in the following format “page X of Y”

· Environmental sampling reports will contain both the quantitative number of bacterial/fungal isolates as well as the genus or species grown (reference USP <797> and USP <1116>)

· Action level for ISO area and competency tested

· Executive summary or summary of findings.

· Room number and/or location

· Room type (e.g. oncology prep room)

· Type of PEC certified

· Serial number of the PEC certified

· Date and time samples collected, and particle counts tested

· Technician collecting the samples

· Date of next required certification

· Standards used to test room

· Comments indicating when dynamic operating conditions were used

· Notes (comments, observations and findings as documented by field technician(s))

· Room sketch (location of supply/exhaust diffusers, equipment, room dimensions)

· Sketch identifying location of each sample obtained

· Total room area and volume

· Room humidity and temp

· Room air changes per hour

· Pressure differentials

· Nonviable particle counts (cfu’s), action level for target ISO level

· Viable particle count analysis

· Sketch of viable particle test location in room

· Viable sample results (cfu’s), action level

· Certificates of analysis of media used

· Comments indicating when dynamic operating conditions were used including number of personnel present, brief activity description.

9. Report Distribution: The contractor will immediately notify identified points of contact with any results indicating failure prior to departing the VA facility. A formalized written report including all required aspects specified in this Statement of Work will be provided in a timely manner with receipt by identified points of contact no more than 14 days from certification evaluation.

All completed reports will be provided via email to Kevin.Jarvis@va.gov and Robert.Licalzi@va.gov.

10. Testing Frequency:

A. Certification procedures defined in CETA CAG-003-2006 shall be performed by a CETA National Board of Testing (CNBT) certified testing individual no less than every 6 months or whenever the PEC or room is relocated or altered or when major service to the sterile compounding facility is performed.

B. Air environmental sampling (viable/non-viable) will be completed every 6 months, or more frequently by facility request if required to assess corrective actions associated with prior negative results. More frequent testing may be required should USP standards change during the performance period or option year(s).

C. Surface environmental sampling will be completed every month, or more frequently by facility request if required to assess corrective actions associated with prior negative results. More frequent testing may be required should USP standards change during the performance period or option year(s).

D. Room HEPA filter testing will be completed at least every 6 months, or more frequently, if required, to assess corrective actions associated with prior positive results. More frequent testing may be required should USP standards change during the performance period or option year(s).

11. Testing Schedule:

A. Testing will be performed on a set rotation to assure that certification remains current and valid. This includes monthly scheduled contractor visits rotating room, hood, and personnel certifications. All certifications should be separated out to ensure continuation of services.

V. Personnel Training:

A. Contractor will provide a written documentation and credentials of technicians performing testing, service, certification or quality review. A resume or curriculum vitae will be provided along with copies of current certifications.

VI. Specific Contractor Requirements:

1. CETA certified technicians

2. Certify equipment and facility per USP Chapter 797/800 requirements

3. Environmental Monitoring

a. Obtain viable (air and surface) and non-viable air particulate samples

b. Offers training for government personnel on environmental monitoring sampling

c. Can support environmental monitoring sampling performed by Pharmacy service personnel by providing sampling media

4. Facilitates employee competencies

a. Supports facility employee competencies per USP 797 and current facility protocols

b. Provides necessary equipment needed to complete both gloved fingertip and thumb sampling and media fill tests

c. Incubates tests per USP 797 standards

VII. PART B- SUPPORTING INFORMATION

1. Required Services Per Facility: Changes to facility PEC will be communicated in a timely manner to contractor and facility costs will be adjusted accordingly based on these changes. Contractor to provide unit-based costs for services to allow for adjustments in equipment.

VIII. SPECIAL CONSIDERATIONS:

1. Contractor Furnished Materials:

A. All materials and tools to complete the work identified.

B. Contractor to ensure all staff that perform on-site testing arrive in clean apparel. Contractors will follow facility and service hand hygiene and gowning procedures for testing areas.

C. All equipment will be stored and transported by the contractor in a manner that maintains cleanliness of equipment and introduces minimal microorganisms into the clean environments being tested. All equipment will be wiped/cleaned prior to taking into clean testing environments. Equipment must be visibly clean and in good repair. Government may request new equipment be obtained by the contractor for use within the cleanroom environment.

2. Government Furnished Materials and Services:

A. The Government will provide all necessary personnel protective equipment (PPE) required for contractors on site.

B. The Government will provide oversight and verification of contractor personnel completion of donning of PPE and hand hygiene prior to testing/sampling.

C. The Government will, on rare occasion, provide office or meeting space to discuss test results, projects, or plans.

D. May also provide desk phone service as needed.

3. Security Requirements:

A. There are no security requirements required for this work, as samples are retrieved by the vendor and a test report is received in return. Contractor will not require access to VA information technology systems or handle patient identifiable information (PII).

4. Additional Considerations A. The contractor (or Representative) shall contact the facility identified POC(s) to schedule work and prior to the beginning of work. Scheduling of work will be at the direction of facility identified POC(s) to ensure services are incorporated into current facility certification cycles. Local facility POC(s) will provide the contractor with additional facility specific procedures which include: check in and check out procedures; contractor badging requirements; parking procedures; and any additional facility specific procedures. The contractor will be expected to adhere to those procedures. Services are to be performed during the hours between 8:00 AM and 4:00 PM Eastern Standard Time (CST), Monday through Friday, excluding federal holidays. Due to the workload of the pharmacy during business hours, the contractor may need to work after 4:00 PM EST (CST) to accommodate the compounding schedule at the pharmacy. Contractors that are willing to perform after-hours work should include this information in their bid documentation. If a contractor is willing to perform services after 4:00pm (CST) this service must be included within the bid pricing as no extra charge. The ability to perform work after hours is not required; however, preferences will be given to contractors that offer flexible work hours.

5. Liable Insurance Requirements A. Contractor must provide proof of liability insurance

Hazardous IV Compounding Room, 2nd Floor, Building 1, Room 253D (Anteroom), Room 253E (Prep Room), and Room 253F (Storage area).

A. ISO 8, ISO 8, ISO 7 and ISO 5 for Storage Area, Ante room, Buffer Room and Biosafety Cabinet

· Baker SterilGARD E3 Class II, Type A2 Biological Safety Cabinet

Non-Hazardous IV Compounding Room, 2nd Floor, Building 1, Room 253B (Anteroom) and Room 253C (Prep Room) A. ISO 8, ISO 7 and ISO 5 for Ante room, Buffer Room and Laminar Flow Hood

· Baker EdgeGARD HF Horizontal Flow Clean Bench

Hazardous IV Compounding Room, 2nd Floor, Building 1, Room 238A (Anteroom and Prep Room)- Contingency A. Unclassified, unclassified and ISO 5 for Ante room, Buffer Room and CACI

· Germfree Laminar Flow LFGI CACI

Non-Hazardous IV Compounding Room, 2nd Floor, Building 1, Room 238 (Anteroom and Prep Room)-Contingency A. Unclassified, unclassified and ISO 5 for Ante room, Buffer Room and CAI

· Germfree Versaflow

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ENVIRONMENTAL MONITORING FOR IV CLEAN ROOMS

Contract Period: Base POP Begin: 09-28-2020 POP End: 09-27-2021

ENVIRONMENTAL MONITORING FOR IV CLEAN ROOMS

Contract Period: Option 1 POP Begin: 09-28-2021 POP End: 09-27-2022

ENVIRONMENTAL MONITORING FOR IV CLEAN ROOMS

Contract Period: Option 2 POP Begin: 09-28-2022 POP End: 09-27-2023

ENVIRONMENTAL MONITORING FOR IV CLEAN ROOMS

Contract Period: Option 3 POP Begin: 09-28-2023 POP End: 09-27-2024

ENVIRONMENTAL MONITORING FOR IV CLEAN ROOMS

Contract Period: Option 4 POP Begin: 09-28-2024 POP End: 09-27-2025

Page 1 of Page 1 of

SECTION C - CONTRACT CLAUSES

C.1 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 5 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 10 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.2 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.

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

[] 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.3 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND COMPLIANCE (JUL 2018)

(a) This solicitation includes FAR 52.219-4 Notice of Price Evaluation Preference for HubZone Small Business Concerns.

(b) Accordingly, any contract resulting from this solicitation is subject to the limitation on subcontracting requirements in 13 CFR 125.6, or the limitations on subcontracting requirements in the FAR clause, as applicable. The Contractor is advised that in performing contract administration functions, the Contracting Officer may use the services of a support contractor(s) retained by VA to assist in assessing the Contractor's compliance with the limitations on subcontracting or percentage of work performance requirements specified in the clause. To that end, the support contractor(s) may require access to Contractor's offices where the Contractor's business records or other proprietary data are retained and to review such business records regarding the Contractor's 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's compliance with the limitations on subcontracting or percentage of work performance requirement.

(End of Clause) C.4 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)

C.5 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)

(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 (JUN 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 2019) (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:

[] (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).

[] (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.

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

[] (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 (MAR 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).

[] (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).

[] (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 (DEC 2007)(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) 52.225–26, Contractors Performing Private Security Functions Outside the United States (OCT 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

[] (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

[] (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

[X] (55) 52.229–12, Tax on Certain Foreign Procurements (JUN 2020).

[] (56) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

[] (57) 52.232-30, Installment Payments for Commercial Items (JAN 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

[X] (58) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Oct 2018) (31 U.S.C. 3332).

[] (59) 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award Management (Jul 2013) (31 U.S.C. 3332).

[] (60) 52.232-36, Payment by Third Party (MAY 2014) (31 U.S.C. 3332).

[] (61) 52.239-1, Privacy or Security Safeguards (AUG 1996) (5 U.S.C. 552a).

[] (62) 52.242-5, Payments to Small Business Subcontractors (JAN 2017)(15 U.S.C. 637(d)(13)).

[] (63)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).

[] (ii) Alternate I (Apr 2003) of 52.247-64.

[] (iii) Alternate II (FEB 2006) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or…