S03 36C26324Q0149.pdf

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. UEI: EFT:

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. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

636-24-1-9073-0010

36C26324Q0149 12-01-2023

Steve Ashby 319-887-4935 12-08-2023

10:00 CST

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

2501 W. 22nd Street Sioux Falls SD 57105

X 100

X

238220

$19 Million

N/A

X

Central Iowa VA Health Care System 3600 30th Street Des Moines IA 50310

NETWORK 23 CONTRACTING OFFICE

Sioux Falls SD 57105

Tungsten Electronic Invoicing VATungsten Number: AAA544240062 va.registration@tungsten-network.com Refer to VAAR Clause 852.232-72

See CONTINUATION Page

Pharmacy Clean Room and Hood Testing Certification for VA Central Iowa Health Care System.

Period of Performance: 12/25/2023 - 12/24/2024

Plus four 1 year option periods.

This is a 100% Service Disabled Veteran Owned Small Business set-aside.

Contractors are responsible for the correct SCA Wage and

Determination classification of workers and compliance with all wage and hour laws.

Prospective offerors must be verified as a SDVOSB in the

VIP system and have an active SAM system registration prior to submission of their offer.

See CONTINUATION Page

X X

X ONE

John Milroy Contracting Officer

36C26324Q0149

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2023)

C.2 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (NOV 2023)

C.3 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.4 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ... 28

C.5 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.6 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED

SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESSES (JAN 2023)

(DEVIATION)

C.7 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023)

(DEVIATION)

C.8 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.9 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ... 34

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.2 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

E.3 ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS— COMMERCIAL

ITEMS

E.4 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

E.6 52.216-1 TYPE OF CONTRACT (APR 1984)

E.7 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

(Continuation from Standard Form 1449, block 18A.)

1. CONTRACT ADMINISTRATION. All contract administration matters will be handled by the following individuals:

a) Contractor Information Company Name and Address:

Data Universal Numbering System (DUNS) Number:

Contact Person(s) Name:

Contact Person(s) Email:

Contact Person(s) Telephone:

b) Government Information

Steve Ashby Contract Specialist Department of Veterans Affairs Network Contracting Office 23 (NCO 23)

Sioux Falls, South Dakota 57105

2. CONTRACT REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with FAR 52.232-33, Payment by Electronic Funds Transfer – System for Award Management, and VAAR 852.232-72, Electronic Submission of Payment Requests.

3. INVOICES: Invoices shall be submitted in arrears. Submission will be monthly for the previous 30-day period of performance and no later than 15 calendar days after the close of the period of performance being invoiced for. Invoices shall be based on the applicable fixed rates for services provided to VA as in accordance with the contract terms and conditions. The VA Technical Representative (VATR) will review all invoices submitted. The VATR is responsible for certifying invoices for payment for only those services received and deemed acceptable by VA.

4. GOVERNMENT INVOICE ADDRESS: All invoices shall be submitted by the contractor via the Tungsten Network (previously OB10) electronic invoicing system. Refer to the Tungsten Network website at http://www.tungsten-network.com/us/en/veterans-affairs-us/ for additional information for system registration, user guides, and help desk contacts.

5. ACKNOWLEDGEMENT OF AMENDMENTS: The offeror acknowledges receipt of Amendments to the Solicitation numbered and dated as follows:

Amendment Date

B.2 STATEMENT OF WORK

Central Iowa Veterans Affairs Health Care System Pharmacy Clean Room and Hood Testing and Certification

Background: The Veterans Affairs, Central Iowa Health Care System (VACIHCS) 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 VACIHCS 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.

Contractor Qualifications/Requirements:

• 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). Contractor will provide a yearly update on testing personnel’s training/competency evaluations.

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

• 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.

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

Scope of Work:

http://www.tungsten-network.com/us/en/veterans-affairs-us/ http://www.tungsten-network.com/us/en/veterans-affairs-us/

Access/Scheduling: The onsite work hours for VACIHCS are 7:00 AM to 3:00 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 contracting officer representative (COR) 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 COR.

Requested Services:

Table 1: Overview of Requested Services for the Clean Rooms:

Item Service Description Location Minimum Frequency of Testing

Clean Room Suite and Containment Segregated Compounding Area Certification

(C-SCA)

• Anteroom (room 1382)

• Positive pressure buffer room (Room 1383)

• Negative pressure buffer room (room 1383a) Semi-Annual

2 PEC Testing and Certification

• #2 Vertical LAFW's in Positive Pressure Buffer Room (Room 1383)

• #1 CACI in Negative Pressure Buffer Room (Room 1383A)

• #1 CAI in Anteroom (Room 1382) Semi-Annual

3 Nonviable Particle Testing

• All PECs (#2 Vertical LAFW's, #1 CAI, #1 CACI), Anteroom (room 1382)

• Positive Pressure Buffer Room (room 1383)

• Negative pressure Buffer Room (Room 1383A) Semi-Annual

4 Viable Environmental Sampling Refer to diagram attached

Semi-Annual by certifier, monthly surface sampling by facility

Airflow Smoke Pattern Testing (with video)

• #2 Vertical LAFW's in Positive Pressure Buffer Room (Room 1383),

• #1 CACI in Negative Pressure Buffer Room (Room 1383A),

• #1 CAI in Anteroom (Room 1382) Semi-Annual

6 Pressure Differential

• #2 Vertical LAFW's in Positive Pressure Buffer Room (Room 1383),

• #1 CACI in Negative Pressure Buffer Room (Room 1383A),

• #1 CAI in Anteroom (Room 1382) Semi-Annual

7 Air Changes Per Hour

• #2 Vertical LAFW's in Positive Pressure Buffer Room (Room 1383),

• #1 CACI in Negative Pressure Buffer Room (Room 1383A),

• #1 CAI in Anteroom (Room 1382) Semi-Annual

8 HEPA Filter Leak Test

• #11 HEPA filters within Cleanroom Suite (Rm 1382, 1383, 1383A) Semi-Annual

Table 2: Overview of Requested Services for Equipment:

The Semi-Annual Inspection for the pharmacy equipment shall be performed in January and July of the base year and each option years.

The Annual Inspection for the fume hood shall be performed in January of the base year and each option years.

Pharmacy equipment Inspections

Equipment ID Room Number Serial Number

1778895 1383A-1

D-LAB HOODS, SEMI-

ANNUAL

4S-15-BH-

17578

4 FT HORIZONTAL

LAMINAR HOOD

1779032 1382-1

D-GLOVE BOXES,

SEMI-ANNUAL 182203092917

POSITIVE PRESSURE

ISOLATOR

1779036 1383-1

D-GLOVE BOXES,

SEMI-ANNUAL 182204092917

NEGATIVE PRESSURE

ISOLATOR

361423 1383A-1

D-LAB HOODS, SEMI-

ANNUAL

45-15-BH-

13848

6 FT LAMINAR FLOW

HOOD

Laboratory annual fume hood inspections

Equipment ID Room Number Serial Number

364940 1245-1

D-CABINETS:

BIOLOGICAL SAFETY,

ANNUAL MB600A13002

ELEVATING

GROSSING

WORKSTATION

368211 1245-1

D-CABINETS:

BIOLOGICAL SAFETY,

ANNUAL BF748B14001

ELEVATING

GROSSING

WORKSTATION

435989 1248-1

D-CABINETS:

BIOLOGICAL SAFETY,

ANNUAL 21784243

HYPERCLEAN 1

FUME HOOD

361126 1205-01W- D

D-LAB HOODS,

ANNUAL 140633101510

HOOD

BACTERIOLOGIC

SAFETY

2100188 1205-01W- D

D-CABINETS:

BIOLOGICAL SAFETY,

ANNUAL 198269042820

BIOLOGICALSAFETY

HOOD

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 1382, 1383, 1383A) in accordance with ISO 14644-1 Classifications of Air Cleanliness, CETA CAG 03-2006, and CETA CAG-009-00 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)

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 Vertical Laminar Airflow Workbenches (LAFW’s), one compounding aseptic isolator (CAI), and one compounding aseptic containment isolator (CACI) within the pharmacy’s cleanroom suite.

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. 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). If a room does not meet USP<797> or USP <800> requirements for pressure differential at the identified site, the POC(s) shall be informed immediately.

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.

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 o 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.

o 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

Additional Trip/Service Charges: If additional testing, troubleshooting, adjustments, or repairs are required, the contractor shall provide 6 additional service visits for the life of the contract. These additional visits will only be utilized at the request of the COR and/or POCs. 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).

Place of Performance and Points of Contact: The VACIHCS contains equipment and facilities for CSP’s at the locations on the attached list. These locations are all at the VACIHCS. The COR and CSP Program Manager will be the primary contacts for this contract. The COR is the Administrative Officer in pharmacy and can be contacted at (515)-699-5999 x4616 to discuss certification/inspection inquiries. Inspections must be scheduled with the COR 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.

Report Distribution: The contractor will immediately notify the COR 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 Statement of Work 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 COR. The contractor will be notified by the VACIHCS of any updates to these points of contact on an as needed basis.

Testing Frequency: Frequency of requested testing is shown in Table 1 above.

Semi-annual testing shall occur no later than exactly 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 Central IA VA also required the following additional task as outlined in the current USP <797> and USP <800>:

• 2 hours of USP 797/USP 800 consulting

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 COR or other POC at the time of recertification, if needed.

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 environment.

Invoice and Payments:

• All invoices shall be submitted by the contractor via the Tungsten Network (previously OB10) electronic invoicing system. Refer to the Tungsten Network website at http://www.tungsten-network.com/us/en/veterans-affairsus/. All payments will be made in arrears.

Provisions:

• The Central Iowa Health Care is a tobacco free facility.

• Contractors must comply with the VA and Federal requirements for

COVID and all other infectious diseases.

• All Contractor personnel performing work on the requirement must comply with VHA Directive 0710, VHA Personnel Security and Suitability Program and are subject to finger printing and background checks.

Pharmacy Clean Room Layout:

http://www.tungsten-network.com/us/en/veterans-affairsus/ http://www.tungsten-network.com/us/en/veterans-affairsus/

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

1.00 SV __________________ __________________

Pharmacy Clean Room & Hood Testing & Certification Service Contract

Contract Period: Base POP Begin: 12-25-2023 POP End: 12-24-2024 PRINCIPAL NAICS CODE: 238220 - Plumbing, Heating, and Air-Conditioning Contractors PRODUCT/SERVICE CODE: H266 - Equipment and Materials Testing - Instruments and Laboratory Equipment

Contract Period: Option 1 POP Begin: 12-25-2024 POP End: 12-24-2025 PRINCIPAL NAICS CODE: 238220 - Plumbing, Heating, and Air-Conditioning Contractors

Contract Period: Option 2 POP Begin: 12-25-2025 POP End: 12-24-2026 PRINCIPAL NAICS CODE: 238220 - Plumbing, Heating, and Air-Conditioning Contractors

Contract Period: Option 3 POP Begin: 12-25-2026 POP End: 12-24-2027 PRINCIPAL NAICS CODE: 238220 - Plumbing, Heating, and Air-Conditioning Contractors

Contract Period: Option 3 POP Begin: 12-25-2027 POP End: 12-24-2028 PRINCIPAL NAICS CODE: 238220 - Plumbing, Heating, and Air-Conditioning Contractors

GRAND TOTAL __________________

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered;

and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212- 5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in FAR 32.608-2 in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause)

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

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:

(End of Addendum to 52.212-4)

C.2 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

(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 products and commercial services:

(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 (NOV 2021) (Section 1634 of Pub. L.

115–91).

(3) 52.204–25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115–232).

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

(5) 52.232–40, Providing Accelerated Payments to Small Business Subcontractors (MAR 2023) (31 U.S.C. 3903 and 10 U.S.C. 3801).

(6) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(7) 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 products and commercial services:

[] (1) 52.203–6, Restrictions on Subcontractor Sales to the Government (JUN 2020), with Alternate I (NOV 2021) (41 U.S.C. 4704 and 10 U.S.C. 4655).

[] (2) 52.203–13, Contractor Code of Business Ethics and Conduct (NOV 2021) (41 U.S.C.

3509).

[X] (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.)

[] (4) 52.203–17, Contractor Employee Whistleblower Rights (NOV 2023) (41 U.S.C. 4712);

this clause does not apply to contracts of DoD, NASA, the Coast Guard, or applicable elements of the intelligence community—see FAR 3.900(a).

[X] (5) 52.204–10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109–282) (31 U.S.C. 6101 note).

[] (6) [Reserved]

[] (7) 52.204–14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

[] (8) 52.204–15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

[X] (9) 52.204–27, Prohibition on a ByteDance Covered Application (JUN 2023) (Section 102 of Division R of Pub. L. 117–328).

[X] (10) 52.209–6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (NOV 2021) (31 U.S.C. 6101 note).

[] (11) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters

(OCT 2018) (41 U.S.C. 2313).

[] (12) [Reserved]

[] (13) 52.219–3, Notice of HUBZone Set-Aside or Sole-Source Award (OCT 2022) (15 U.S.C. 657a).

[] (14) 52.219–4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

[] (15) [Reserved]

[] (16)(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.

[] (17)(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.

[] (18) 52.219-8, Utilization of Small Business Concerns (SEP 2023) (15 U.S.C. 637(d)(2) and (3)).

[] (19)(i) 52.219–9, Small Business Subcontracting Plan (SEP 2023) (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 (SEP 2023) of 52.219–9.

[X] (20)(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.

[X] (21) 52.219–14, Limitations on Subcontracting (OCT 2022) (15 U.S.C. 657s).

[] (22) 52.219-16, Liquidated Damages—Subcontracting Plan (SEP 2021) (15 U.S.C.

637(d)(4)(F)(i)).

[X] (23) 52.219–27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (OCT 2022) (15 U.S.C. 657f).

[X] (24) (i) 52.219–28, Post-Award Small Business Program Rerepresentation (SEP 2023) (15 U.S.C. 632(a)(2)).

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

[] (25) 52.219–29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (OCT 2022) (15 U.S.C. 637(m)).

[] (26) 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 (OCT 2022) (15 U.S.C. 637(m)).

[] (27) 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR 2020) (15 U.S.C. 644(r)).

[] (28) l(26) 52.219–33, Nonmanufacturer Rule (SEP 2021) (15 U.S.C. 657s).

[X] (29) 52.222-3, Convict Labor (JUN 2003) (E.O. 11755).

[] (30) 52.222–19, Child Labor—Cooperation with Authorities and Remedies (DEC 2022) (E.O. 13126).

[X] (31) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

[X] (32)(i) 52.222–26, Equal Opportunity (SEP 2016) (E.O. 11246).

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

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

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

[X] (34)(i) 52.222–36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C.

793).

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

[] (35) 52.222–37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).

[] (36) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act

(DEC 2010) (E.O. 13496).

[X] (37)(i) 52.222-50, Combating Trafficking in Persons (NOV 2021) (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).

[] (38) 52.222-54, Employment Eligibility Verification (MAY 2022). (E. O. 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in FAR 22.1803.)

[] (39)(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)).