36C26321Q0212.docx

36C26321Q0212

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 ATTACHED

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. SIGNATURE 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

PR 656-21-1-065-0024

36C26321Q0212 12-22-2020 Angela Beck 605.720.7314 01-12-2021 11:00

MST

36C568 Department of Veterans Affairs Network 23 Contracting Office (NCO 23) 113 Comanche Rd.

Fort Meade SD 57741 X X 541380 $16.5 Million N/A X 36C656 Department of Veterans Affairs

VA ST CLOUD HCS

4801 Veterans Dr.

Saint Cloud MN 56303 36C568 Department of Veterans Affairs Network 23 Contracting Office (NCO 23) 113 Comanche Rd.

Fort Meade SD 57741

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971 See CONTINUATION Page Important notice to Offerors:

Review and follow INSTRUCTIONS TO OFFERORS - Commercial Items in Clause 52.212-1.

Note block #28 - this document must be signed and returned to the Contracting Officer by the Offer Due Date in order to be considered. E-mail ALL required and completed documents to:

Angela Beck angela.beck@va.gov ***Submit any written questions via e-mail - no telephonic questions will be accepted. Responses to questions pertaining to this solicitation will be provided through DEC 31, 2020 only.

See CONTINUATION Page 656-3610160-065-822400 Pharmacy- 2631 Drugs/Medicines-010041080 X X X

ONE

Angela Beck Contracting Officer 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 36C263 Angela Beck Department of Veterans Affairs Network 23 Contracting Office (NCO 23)

113 Comanche Rd.

Fort Meade SD 57741

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

FMS-VA-2(101)

Financial Services Center 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 PRICE/COST SCHEDULE BASE YEAR Detail (2/1/2021 – 1/31/2022) ONLY

ITEM INFORMATION

Certification and inspection: Class II Biological Safety Cabinet (BSC)(2 sterile BSC units, 1 nonsterile BSC unit, semi-annual testing)

Certification of LAFW (2 vertical LAFW, semi-annual testing)

Clean Room HEPA Filter Test (per filter) Semi-annual (7 HEPA Filters, semi-annual)

Clean room suite certification per USP797 and USP800 Specifications (ACPH, Pressure Relationships, Nonviable air sampling etc.) for ISO Class 7 spaces - (3 rooms: anterroom, positive pressure buffer room, negative pressure buffer room - semi-annual)

Room certification for Segregated compounding areas (C-SCA) hazardous drug storage area - Pressure differential, 12 ACPH,externally vented (1 unit - semi-annual)

Viable Air and Surface sampling in PECs and Rooms for fungal and microbial contamination - (14 surface samples and 7 air samples - Semi-annual)

USP-797 / USP-800 Consulting per hour (twice per year -semi-annual - total of 2 hours)

Plates, lab fees for monthly surface sampling. St. Cloud VA staff will conduct the surface sampling and send the plates to the lab. Once a month 14 samples will be completed. St. Cloud VA would conduct the monthly surface sampling for the 10 months and send to lab. Contract would allow purchase of the plates and send to the site. Contractor will conduct sampling on the months they are here for certification. (Testing once per month - 10 months by VA employees and 2 months by contractor)

Wipe Test (hazardous drug material traces) semi-annual. At least 10 samples. St. Cloud VA will conduct wipe tests and send them to the lab. Contract would allow purchase of the kit and send to testing site. Any remediation and follow-up wipe testing would be paid for and done by St. Cloud VA. (Testing twice per year)

Smoke visualization study with video for each PEC (4 sterile PECs plus 1 non-sterile PEC, semi-annual testing)

Trip charge (2 scheduled trips per year, 2 unscheduled trips per year only if needed for additional testing, troubleshooting, repairs, adjustments, etc)

Annual Price Schedule

Line Item

PERFORMANCE WORK STATEMENT

St. Cloud VA Health Care System

1. Background: The St. Cloud VA Health Care System (VASTCHCS) is required to maintain compliance of all primary and secondary engineering controls (PECs and SECs) used for compounding sterile preparations. This requirement will describe all testing and certification activities required for PECs and SECs. The intent of this contract is to have a vendor provide the required testing and services identified in the most current versions of United States Pharmacopeia (USP) Chapter <797> and Chapter <800> in addition to any services required by the St. Cloud VA Health Care System using Controlled Environment Testing Association (CETA) Certified National Board of Testing (CNBT) professionals. The United States Pharmacopeial (USP) establishes standards for cleanroom design, environmental monitoring, and certification and recertification of the compounding area. Testing procedures shall be maintained in compliance with all current applicable standards. The Certification Guide for Sterile Compounding Facilities CAG-003-2006 or current guidelines shall also be used.

2. Contractor Qualifications/Requirements:

i. The contractor’s testing personnel shall have training on fundamental practices and precautions within current USP <797> and <800> standards and operations within ISO 5 and 7 environments (donning/doffing personal protective equipment and hand washing procedures).

ii. All testing and certifications must be signed by an NSF/ANSI-49 certified technician.

iii. The contractor shall test and certify using Controlled Environment Testing Association (CETA) Certified National Board of Testing (CNBT) professionals as required by VA Directive 1108.12 to ensure consistent certification procedures using the Certification Application Guide for Sterile Compounding Facilities (CAG-003-2006) or current standards. A copy of the CETA certification for all technicians must be attached to the bid documentation.

iv. The laboratory shall be American Industrial Hygiene Association (AIHA) accredited for all viable sampling and hazardous drug wipe sampling analysis.

3. Scope of Work:

i. Access/Scheduling: The onsite work hours are 8:00 AM to 4:00 PM Central Standard Time (CST) Monday through Friday, excluding federal holidays. Any work on site shall be coordinated and approved at least 2 weeks prior to any testing or services. The Service Line POC will collaborate with other service lines to determine if any work has a significant impact on the operations of the facility, especially the pharmacy compounding schedule. The vendor shall follow all federal, state, and Veterans Affairs codes, regulations, and standards. All services will be coordinated through the designated Service Line POC.

ii. Requested Services:

Table 1: Overview of Requested Services

· Positive Pressure Buffer Room (Rm 104A)

· Negative Pressure Buffer Room (Rm 104B)

· C-SCA Nonsterile HD Storage Room (Rm 105) Semi-Annually

· #2 BSC’s in Negative Pressure Buffer Room (Rm 104B)

· #1 BSC in Nonsterile HD Storage Room C-SCA (Rm 105) Semi-Annually

· Anteroom (Rm 104)

· Positive Pressure Buffer Room (Rm 104A)

· Negative Pressure Buffer Room (Rm 104B) Semi-Annually

· #2 BSC’s in Negative Pressure Buffer Room (Rm 104B)

· #1 BSC in Nonsterile HD Storage Room C-SCA (Rm 105) Semi-Annually

· Anteroom (Rm 104)

· Positive Pressure Buffer Room (104A)

· Negative Pressure Buffer Room (104B) Semi-Annually

· Positive Pressure Buffer Room (Rm 104A)

· Negative Pressure Buffer Room (Rm 104B)

· C-SCA Nonsterile HD Storage Room (Rm 105) Semi-Annually

Item 1 – Clean Room Suite and C-SCA Certification: The contractor will test and certify the ante room and buffer rooms within the cleanroom suite (Rm 104, 104A, and 104B) in accordance with ISO 14644-1 Classifications of Air Cleanliness, CETA CAG 03-2006, and CETA CAG-009-00 specifications. The contractor will also test and certify the C-SCA Nonsterile HD Storage Room (Rm 105) according to the most current USP <795>, <797> and <800> specifications. The contractor will provide cleanroom testing and certification services with the frequency required by the most current USP <797> and USP <800> standards. 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 and Fungal Air Testing

· Viable Microbial and Fungal Surface Testing

· Airflow Volume Measurements

· Air Velocity Profile

· Room Air Exchange Rates

· Room Pressure Measurement (in water columns)

· In-Place Leak Testing of HEPA Filters

· Temperature, Relative Humidity Measurements

· Smoke test under dynamic conditions (contractor will provide video documentation of each test to facility POCs)

USP Compliance Testing for the C-SCA Nonsterile HD Storage Room will include, but is not limited to, the following:

· Non-Viable Particle Counting under dynamic operating conditions

· Airflow Volume Measurements

· Air Velocity Profile

· Room Air Exchange Rates

· Room Pressure Measurement (in water columns)

· Temperature, Relative Humidity Measurements

· Smoke test under dynamic conditions (contractor will provide video documentation of each test to facility POCs)

Item 2 – PEC Testing and Certification: The contractor shall test and certify each PEC according to current USP <797> and <800> standards using certification procedures from the Controlled Environment Testing Association (CETA) Certification Guides for Sterile Compounding Facilities (CAG-003-2006) and/or ANSI/NSF-49 or the equivalent. PECs include two sterile Biological Safety Cabinets (BSC’s) and two sterile Vertical Laminar Airflow Workbenches (LAFW’s) within the pharmacy’s cleanroom suite and one nonsterile BSC within a C-SCA HD Storage Room.

All PECs used for compounded sterile preparations shall be certified to:

· Provide ISO Class 5 or better environment

· Provide unidirectional HEPA-filtered airflow

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

· Airflow velocity testing

· Non-Viable Particle Counting under dynamic operating conditions

· HEPA filter integrity/leak testing

· Viable Microbial and Fungal Air Testing

· Viable Microbial and Fungal Surface Testing

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

· Induction leak/back-streaming test

· Cabinet leak test

· Airflow smoke pattern test under dynamic operating conditions

For each PEC that passes the required certification tests, the contractor will supply each unit with a certification sticker that has the following information:

· Company name, address, and phone number

· Unit make, model, and serial number

· Report number reflecting the room certification

· Identification of passing certification

· Location (room number)

· Certification date

· Next recertification date

· Technician signature

Item 3 – Nonviable Environmental Sampling (Total Particle Counts): The contractor shall perform environmental nonviable particle testing semiannually. 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 per USP797, Section 4.1.

Item 4 – Viable Environmental Sampling (Air and Surface): The contractor shall perform viable environmental (air) sampling and surface sampling every 6 months for fungi and bacteria in classified areas that includes hazardous and non-hazardous buffer rooms, the anteroom, all PECs within classified areas (not within the C-SCA). Air sampling should be conducted using a high-volume impaction device and must be performed during dynamic operating conditions. Surface sampling must be performed at the end of the compounding activities or shift, but before the area has been cleaned and disinfected. The contractor shall provide a means for the facility to complete monthly surface sampling for the 10 months within the year that the contractor does not complete this as part of their semi-annual certification visit. All samples must be incubated at temperatures and time periods that comply with the most updated USP <797> standards. The lab chosen to analyze the samples must be verified prior to testing and be certified. Any laboratory results greater than the action level requires immediate notification to the POCs upon receipt of these results. Additionally, microorganisms must be identified and recovered to the genus level automatically if CFU action levels are exceeded for any viable sample based on current USP <797> standards. Surface sampling areas must include:

· The interior of the PECs and equipment contained in it

· Staging or work areas near the PEC

· Frequently touched surfaces

· Pass-through chambers

Air sampling: At least 1000 liters of air shall be tested at each location. Samples less than 1000 liters will not be acceptable.

Air and Surface sampling growth media: The contractor shall use Tryptic Soy Agar (TSA) contact plates for bacteria and TSA, Malt Extract Agar (MEA) or Sabouraud Dextrose agar (SDA) contact plates for fungi. TSA may be used for both bacteria and fungi.

Item 5 – Smoke Pattern Testing: This will be completed in accordance with CAG-003-2006 for each pharmacy PEC initially, semi-annually, and when changes are made to the PEC or room configuration. The testing will be video-recorded, and the contractor must have experience with collecting these videos. The facility will designate a minimum of one pharmacy technician to conduct simulated drug compounding in each PEC during the smoke visualization testing. The testing must show that first air conditions/unidirectional airflow are achieved at the critical site during all compounding tasks within the respective PEC. It is important that the contractor recognizes that this testing is beyond the typical scope of an equipment certification. These videos are to capture both the effective operation of the PEC and the effective compounding techniques of the pharmacy staff. The contractor should understand that coordination with the pharmacy staff and management is imperative in collecting useful PEC smoke visualization videos as intended by CAG-003-2006.

Item 6 – Pressure Differential Requirements: The contractor shall include in their report differential pressure readings from each C-SCA, buffer room, and anteroom 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 0.0001” water column (4 decimal places). Pressure differentials will be reflected on a report showing the sketch of the room(s).

Item 7 – Air Changes Per Hour: The contractor shall calculate the total room volume for each buffer, ante room, and C-SCA nonsterile 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, and containment segregated compounding area (C-SCA) and include their findings in the report. If a room does not meet USP<797> or USP <800> requirements for ACPH the identified site, the POC(s) shall be informed immediately.

Item 8 – HEPA Filter Leak Testing: The contractor shall perform a proper High Efficiency Particulate Air (HEPA) filter leak test of all room air supply HEPA filters semi-annually. The POCs shall be notified immediately of a leak or compromise in the integrity of any HEPA filters.

Item 9 – Environmental HD Wipe Sampling: The contractor will at a minimum provide environmental wipe sampling testing kits for hazardous drug surface residue/contamination semi-annually. The kits used to complete wipe sampling must be verified prior to ensure appropriateness of detectability and method used. If retesting is needed more frequently than semi-annually, this will be done by the St. Cloud VA Health Care System.

The drugs required for testing include:

· Cyclophosphamide

· Doxorubicin HCl

· Etoposide

· Irinotecan HCl

· Paclitaxel

· Cisplatin

· Gemcitabine

· Carboplatin

· Oxaliplatin

· 5-Fluorouracil

· Additional drugs

· Additional drugs may be requested based on identified need by site. Upon identified need, the site will notify the contractor and clarify additional cost which will be agreed upon by both parties prior to testing.

A minimum of 10 wipe samples will be completed semi-annually. Areas to be sampled include:

· Interior of all PECs and equipment contained in it (i.e. camera/BD Cato)

· Pass through chambers

· Surfaces in staging or work areas/carts near the PECs

· Areas adjacent to PECs (i.e. floors directly under C-PEC, staging, dispensing area)

· Areas immediately outside the hazardous drug buffer room or C-SCA

· Patient administration areas (i.e. infusion center)

iii. Report Requirements: The testing and certification reports shall include, at a minimum, the following information:

· Pass/fail notifications for each test performed, if applicable

· Date of testing

· Date of next required certification

· Standards used to test room/equipment

· Summary of findings/test results and recommendations

· Room number and/or specific location of testing

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

· Type of PEC certified

· Serial number of PEC/equipment certified

· Action level for ISO area tested

· Date and time samples are collected

· Specific temperature or temperature range samples/ were incubated

· The date/time period samples were incubated

· Viable particle counts (CFU’s), action levels for target ISO level

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

· Gloved fingertip counts (CFU’s), action level for initial or subsequent sampling

· Media fill test pass/fail

· The bacterial/fungal species grown on samples, if identified due to exceeded CFU limits

· The identification of highly pathogenic microorganisms will be highlighted in the report.

· Sketch identifying location of each sample obtained

· Certificates of analysis of media used, if applicable

· Total room area and volume

· Copy of lab report

· Notes

· Name of technician collecting samples and performing testing

· Comments indicating when dynamic operating conditions were used

· If dynamic conditions were used, then the number of personnel present during these tests must be documented

· Room humidity and temperatures

· Room air changes per hour

· Pressure differentials in water columns

iv. Additional Trip/Service Charges: If additional testing, troubleshooting, adjustments, or repairs are required, the contractor shall provide 4 additional service visits each contract year. These additional visits will only be utilized at the request of the Service Line POC. The additional site visit line item shall include all costs associated with travel, per diem, lodging, mileage, movement/shipping of equipment, overnight pay or any other costs the contractor may incur while visiting the facility outside of the normal semi-annual visits. The cost must cover a site visit which may exceed a single workday (depending on the additional work required).

v. Place of Performance and Points of Contact: The St. Cloud VA Health Care System contains equipment and facilities for CSP’s at the locations on the attached list. These locations are all within the St. Cloud VA Health Care System. The Service Line POC and CSP Program Manager will be the primary contacts for this contract. The Service Line POC is the Administrative Officer in pharmacy and can be contacted at (320)-255-6480 x6464 to discuss certification/inspection inquiries. Inspections must be scheduled with the Service Line POC at least two weeks in advance. This is to notify all personnel using the equipment/facilities well in advance to allow their workflow to be adjusted in order to ensure availability for certifications.

vi. Report Distribution: The contractor will immediately notify the Service Line POC and/or CSP Program Manager with any results indicating failure, so the appropriate steps can be taken. A formal written report including all required documentation and services specified in this Performance Work Statement will be provided to designated points of contact no more than 21 days from the certification evaluation. These reports will be provided via email to the Service Line POC. The contractor will be notified by the St. Cloud VA Health Care System of any updates to these points of contact on an as needed basis.

vii. Testing Frequency: Frequency of requested testing is shown in Table 1 above. Semi-annual testing shall occur no later than 6 months from the date of the previous certification. More frequent testing or changes to the frequency of testing than what is requested in Table 1 may occur due to the following reasons:

· If the PEC or room is relocated/altered

· If a major service to the compounding facility is performed

· To assess/verify corrective actions associated with negative/failing results

· If USP standards change during the performance period or option years

The St. Cloud VA also requires the following additional task as outlined in the current USP <797> and USP <800>:

· 2 hours of USP 797/USP 800 consulting

viii. Contractor Equipment Calibration Standards: All equipment used for testing and sampling will be provided by the contractor. All equipment used shall be calibrated within the last 12 months to meet manufacturer and industry requirements/standards. Certification of equipment calibration must be included in the semi-annual testing reports. The calibration certification shall also be kept with the contractor technician for review by the Service Line POC or CSP Program Manager at the time of recertification, if needed.

ix. Contractor Furnished Materials:

· All materials and tools to complete the work identified

· Contractor to ensure all staff that perform on-site testing arrive wearing non-shedding clothing

· 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 down/cleaned prior to taking into the clean testing environments.

36C26321Q0212

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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 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 15 calendar days of contract expiration.

(End of Clause)

C.3 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 calendar days of contract expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 calendar 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 + six (6) months.

(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.

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

[] 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.

[X] 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.

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

(a) This solicitation includes VAAR 852.219-10 VA Notice of Total Service- Disabled Veteran-Owned Small Business Set-Aside.

(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) (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 (NOV 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:

[] (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.

[] (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 (NOV 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 (NOV 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)(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)).

[X] (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 (NOV 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 (OCT 2020) (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) 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).

[] (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 Executive orders applicable to acquisitions of commercial items:

[] (1) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67).

[] (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

[] (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (Multiple Year and Option Contracts) (AUG 2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

[] (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (MAY 2014) (29 U.S.C 206 and 41 U.S.C. chapter 67).

[X] (5) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (MAY 2014) (41 U.S.C. chapter 67).

[] (6) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services—Requirements (MAY 2014) (41 U.S.C. chapter 67).

[] (7) 52.222-55, Minimum Wages Under Executive Order 13658 (NOV 2020).

[] (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

[] (9) 52.226–6, Promoting Excess Food Donation to Nonprofit Organizations (JUN 2020) (42 U.S.C. 1792).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, as defined in FAR 2.101, on the date of award of this contract, and does not contain the clause at 52.215-2, Audit and Records—Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor's directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

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

(ii) 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)).

(iii) 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…