S02_36C24923Q0576_1 TVHS Pharmacy Certification Sterile Compounding.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

36C24923Q0576 08-31-2023

Michael McCarthy 615-225-6889 09-15-2023 10:00 a.m. CDT

Department of Veterans Affairs Network Contracting Office 9 (90C)

NCO 9

1639 Medical Center Parkway, Suite 400 Murfreesboro TN 37129

X 100

X

541690

$19 Million

N/A

X

NCO - 9

3400 Lebanon Pike

Murfreesboro TN 37129

90C

Network Contracting Office 9 Department of Veterans Affairs Network Contracting Office (90C) 1639 Medical Center Parkway Suite 400

90C

FSC e-Invoicing Payment http://www.fsc.va.gov/fsc/einvoice.asp Invoice Setup Information 1-877-489-6135 Invoice must be submitted electronically

Setup 1-877-489-6135

See CONTINUATION Page

TVHS Pharmacy Certification of Sterile Compounding Set aside for a Service-Disabled Veteran Owned Small Business

Contractor must be registered in vendor information page at the time quotes are received and at the time of contract award.

Firm Fixed Price Contract with 5 one year ordering periods.

Period of Performance Ordering Period 1, October 1, 2023 to September 30, 2024 Ordering Period 2, October 1, 2024 to September 30, 2025 Ordering Period 3, October 1, 2025 to September 30, 2026 Ordering Period 4, October 1, 2026 to September 30, 2027 Ordering Period 5, October 1, 2027 to September 30, 2028

See CONTINUATION Page

626-3640160-701-822400-2580 010022400

X X

X 1

36C24923Q0576

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 (DEC 2022)

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

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

C.4 52.219-27 NOTICE OF SERVICE-DISABLED VETERAN-OWNED SMALL

BUSINESS SET-ASIDE (OCT 2022)

C.5 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

C.6 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.7 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED

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

(DEVIATION)

C.8 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023)

(DEVIATION)

C.9 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.10 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (JUN 2023)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

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

COMMERCIAL SERVICES (MAR 2023)

E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.4 VAAR 852.239-75 INFORMATION AND COMMUNICATION TECHNOLOGY

ACCESSIBILITY NOTICE (FEB 2023)

E.5 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.6 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

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 36C249

Network Contracting Office 9 (90C)

NCO 9

1639 Medical Center Parkway, Suite 400

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award

Management, or [] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] 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.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.2 STATEMENT OF WORK

TVHS VAMC Pharmacy Service Statement of Work

Certification of Sterile Compounding Facilities and Equipment

1. BACKGROUND: The United States Pharmacopeia (USP) establishes standards for cleanroom design, environmental monitoring, and competencies for the preparation, handling, and storage of Compounded Sterile Preparations (CSPs). The Joint Commission (TJC) established new Medication Compounding (MC) standards for non-sterile and sterile compounded preparations which are based on USP standards. Additionally, the Food and Drug Administration (FDA) has the authority to inspect VA medical facilities.

VHA Directive 1108.12, Management and Monitoring of Pharmaceutical Compounded Sterile Preparations, dated November 5, 2018, defines organizational responsibility for USP <797> standards for cleanroom design and engineering controls, environmental monitoring and cleaning of primary and secondary engineering controls, and the core competencies for personnel involved in the processes of compounding sterile preparations including HDs (both sterile and nonsterile dosage form preparations). It is VHA policy that each VA medical facility that provides CSPs have a pharmaceutical CSP program in place that conforms to the standards in USP Chapter <797> “Pharmaceutical Compounding‐Sterile Compounding” Sterile Preparations USP Chapter <797> standards require successful demonstration of initial and ongoing competency of garbing and hand hygiene by all compounding personnel.

2. OBJECTIVE: VA Tennessee Valley Healthcare System (TVHS) seeks a contract for testing of compounding personnel for aseptic technique by gloved fingertip and thumb sampling and media fill testing as well as observation of garbing procedure competency and primary engineering control (PEC) cleaning procedures. In addition, a surface sample will be taken in the direct compounding area. All observation, evaluation, and testing must be in accordance with all applicable USP Chapter <797> and USP Chapter <800> standards, VHA Directive, medical center policies, standard operating procedures, and Controlled Environment Testing Association (CETA) guides.

3. SCOPE OF WORK

3.1. Personnel Testing: All compounding personnel must perform gloved fingertip and thumb testing and media-fill testing to assess their sterile technique and related practices initially and every 6 months thereafter.

3.1.1. The Contractor will perform personnel initial testing within ten business days of being notified of a new employee requirement.

3.1.2. The Contractor will perform personnel recertification testing within the first 12 days of each month for those employees due during the month to ensure results are returned prior to the last day of the same month.

3.1.3. TVHS will provide the number of employees requiring recertification to the Contractor at no later than the 15th day of the month prior.

3.1.4. Media Fill Testing

3.1.4.1. Media Fill Testing will occur in Laminar Horizontal Flow Workstation and simulate the most difficult and challenging compounding procedures and processing conditions encountered by the person replacing all the components used in the CSPs with soybean–casein digest media.

3.1.4.2. A certificate of analysis (COA) must be provided for commercial sterile microbial growth media is used for the media fill testing

3.1.4.3. Media Fill Testing will occur prior to a gloved fingertip testing for initial media fill.

3.1.4.4. Media Fill Testing will occur after the first gloved fingertip testing and prior to the second gloved fingertip and thumb testing for recertification.

3.1.4.5. The Contractor shall incubate media fill tests in controlled temperature environments in accordance with USP <797> guidance.

3.1.4.6. Documentation of the media fill test will include the name of the person evaluated, evaluation date/time, media and components used, including manufacturer, expiration date and lot number, starting temperature for each interval of incubation, dates of incubation, the results, and the identification of the observer and the person who reads and documents the results.

3.1.4.7. If an employee does not pass in accordance with USP<797> requirements, the Contractor will return for retesting within three business days after receiving the results.

3.1.5. Gloved Fingertip and Thumb Testing

3.1.5.1. The Contractor shall perform three separate gloved fingertip and thumb tests during initial testing after 3 separate garbing (one sampling device per hand) and one gloved fingertip and thumb test after media fill testing for each designated employee.

3.1.5.2. The Contractor shall perform two gloved fingertip and thumb tests for recertification testing (one sampling device per hand) for each designated employee.

3.1.5.3. Recertification sampling shall occur every 6 months.

3.1.5.4. A certificate of analysis (COA) must be provided for commercial sterile microbial growth media is used for the media fill testing

3.1.5.5. Gloved fingertip and thumb samples shall be performed in controlled temperature environments and incubated in accordance with USP <797> and <800> guidance.

3.1.5.6. Each sample shall be labeled with a personnel identifier, whether it was from the right or left hand, and the date and time of sampling.

3.1.5.7. Documentation results for gloved fingertip and thumb sampling will include the name of the person evaluated, evaluation date/time, media and components used, including manufacturer, expiration date and lot number, starting temperature for each interval of incubation, dates of incubation, the results, and the identification of the observer and the person who reads and documents the number of colony forming units (CFU) for the left and right hand.

3.1.5.8. If an employee does not pass according to USP<797> requirements, the Contractor will return for retesting within three business days after receiving the results.

3.1.6. Surface Sampling

3.1.6.1. The Contractor shall perform one surface sample of the direct compounding area after the media fill is completed.

3.1.6.2. Documentation results for surface sampling must contain the following at least: Date and time sampling was taken, both the quantitative number of bacterial/fungal isolates reported as colony forming units (CFUs) as well as the species grown, identification of highly pathogenic microorganisms will be highlighted in the report, media lots used for samples, comments indicating when dynamic conditions were used, certificates of analysis of media used, results of quality assurance media plates, calibration of equipment used

3.1.7. Garbing Competency Observation

3.1.7.1. The Contractor shall observe garbing of each employee in accordance with

TVHS SOPs and USP797 requirements

3.1.7.2. Initial garbing will be observed three separate times in succession for each employee

3.1.7.3. Ongoing garbing will be observed once every 6 months with ongoing media fill and glove fingertip

3.1.8. Cleaning Competency Observation

3.1.8.1. The Contractor shall observe the employee cleaning at least a portion of the

PEC

3.1.8.2. Cleaning competency maybe supplemented by employee verbally explaining to the contractor how the full PEC is to be cleaned according to TVHS SOPs

4. REPORTING REQUIREMENTS: The Contractor must provide testing results electronically to the Sterile Compounding Program Manager and other designated facility staff no later 72 hours after the incubation is completed. Reports must include all items as listed above in Section 3 and within compliance with USP<797> requirements for reports. If the contractor cannot report within the specified timeline, an extension must be requested and agreed upon by TVHS.

5. CONTRACTOR QUALIFICATIONS: The Contractor will provide all parts, labor, equipment, material, travel expenses to test and certify the operation and performance of equipment systems and personnel per the Statement of Work listed in Section 3. All testing and observations must be performed by properly trained and appropriately accredited on-site field certification technicians. These certified technicians must be trained on all the types of equipment listed in this SOW. All training and competency must be recent and in-date.

Documentation shall be provided to the VA certifying that each field certification technician has been trained and certified in the work required by this SOW as follows:

5.1. Contractor must have a working knowledge of most recent publications of USP<797> Pharmaceutical Compounding-Sterile Preparations

5.2. Contractor must have a working knowledge of NSF/ANSI 49-2016 Biosafety Cabinetry:

Design, Construction, Performance and Field Certification.

5.3. Contractor must be able to provide a technician with current certification as a Registered Cleanroom Certified Professional for Sterile Compounding Facilities by the

CNBT for cleanroom certification. Proof of current CETA-accredited certification for a specific individual must be provided to facility’s POC prior to performing any work.

5.4. Contractor must provide Certified Environmental Microbiology Laboratory - ISO/IEC 17025:2005 Accreditation

5.5. Contractor must have documented competencies for any technicians sent to perform testing and for any technicians who read the media tests. Copies of each technician’s current competencies must be provided to facility’s POC prior to performing any work.

5.6. Contractor must follow all TVHS facility SOPs for the sterile compounding area at all times.

5.7. Note: A Certified Industrial Hygienist (CIH) credential does not waive any of the above certification requirements.

5.8. Technicians must successfully demonstrate competency in garbing and hand hygiene when performing work in classified areas.

5.9. Due to the sensitive nature of the work area, prior to entering sterile compounding areas (buffer room, ante room), the Contractor will maintain a clean work area at all times by wearing appropriate personal protective equipment (set forth by USP <797> standards) and cleaning any equipment with at least 70% sterile isopropyl alcohol.

5.10. Contractor must have working knowledge of the following CETA Documents referenced by USP <797>:

5.10.1. CAG-003-2006 Sterile Compounding Facilities (Revised May 2015)

5.10.2. CAG-009-2011v3 CETA Certification Application Guide USP <797> Viable

Environmental Sampling & Gowning Evaluation

5.11. Contractor must have working knowledge of the following ISO standards:

5.11.1. 14644-1:2015 Cleanrooms and associated controlled environments -- Part 1:

Classification of air cleanliness by particle concentration

5.11.2. 14644-2:2015 - Cleanrooms and associated controlled environments -- Part 2:

Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration

5.11.3. 14644-3:2005 Cleanrooms and associated controlled environments -- Part 3:

Test methods

5.11.4. 14644-9:2012 Cleanrooms and associated controlled environments -- Part 9:

Classification of surface cleanliness by particle concentration

5.11.5. 14698-2:2003 - Cleanrooms and associated controlled environments -- Biocontamination control -- Part 2: Evaluation and interpretation of biocontamination data

5.12. Contractor must have technicians available in a reasonable proximity to the facilities to eliminate/minimize travel expenses, to meet the time frames for testing and to accommodate possible multiple dates for testing each month based on employees’ schedules.

6. PLACE OF PERFORMANCE: Nashville VA Medical Center, 1310 24th Ave S, Nashville, Tennessee 37212 Room G-105 and Alvin C. York VA Medical Center, 3400 Lebanon Pike, Murfreesboro, TN, Building 3, Room G12

6.1. TVHS anticipates having a maximum of 90 employees for ongoing tests/observations and a maximum of 30 new employees requiring initial tests/observations yearly between the two campuses.

6.2. Amount for quote would be based on above employees. Please quote per each test and/or plate/observation/media fill/surface sampling. Do not quote a combined sum:

6.2.1. Initial glove fingertip tests (2 plates per test) = #100

6.2.2. Glove fingertip tests after media fill (2 plates per test) = #270

6.2.3. Media fill tests = #270

6.2.4. Garbing competency observation #320

6.2.5. Cleaning competency observation #270

6.2.6. Surface sampling after Media fill tests #270

7. TERM OF CONTRACT AND PRICING: This contract is for five, one year ordering periods.

8. PERFORMANCE PERIOD: The contract term is for 12 months with five ordering periods of 12 months each beginning upon signature of the contract. TVHS will issue a delivery order only for the current fiscal year. The VA's obligation under this contract shall terminate at the end of each fiscal year. TVHS shall unilaterally renew by issuing a renewal delivery order that shall be effective on the first day of each succeeding fiscal year.

9. HOURS OF WORK: Work required in the performance of the contract shall be performed during hours agreed upon between the Contractor and TVHS Sterile Compounding Program Manager and/or Pharmacy Supervisors. The Contractor shall provide services during the facility hours of operation, except for the following federal holidays set by law (5 U.S.C.

§6103), or as approved by the Ordering Contracting Officer. The following are recognized United States (US) federal holidays:

• New Year’s Day: January 1st

• Martin Luther King, Jr.’s Birthday

• President’s Day

• Memorial Day

• Juneteenth Independence Day

• Independence Day: July 4th

• Labor Day

• Columbus Day

• Veteran’s Day: November 11th

• Thanksgiving Day

• Christmas Day: December 25th

10. GOVERNMENT RESPONSIBILITIES: The government will work in concert with the Contractor to help enable completion of the work of the contract.

11. CONFIDENTIALITY AND NONDISCLOSURE: It is agreed that:

11.1. The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order.

11.2. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response.

11.3. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

1.00 JB __________________ __________________

CERTIFICATION OF STERILE COMPOUNDING FACILITIES AND

EQUIPMENT FOR THE NASHVILLE VA PHARMACY TO INCLUDE

PERSONNEL TESTING, MEDIA FILL TESTING, GLOVED

FINGERTIP AND THUMB TESTING, SURFACE SAMPLING,

GARBING COMPETENCY OBSERVATION AND CLEANING

COMPETENCY OBSERVATION. PERIOD OF PERFORMANCE:

10/1/2023 - 9/30/2024 Contract Period: Base POP Begin: 10-01-2023 POP End: 09-30-2024

EQUIPMENT FOR THE MURFREESBORO VA PHARMACY TO

INCLUDE PERSONNEL TESTING, MEDIA FILL TESTING,

GLOVED FINGERTIP AND THUMB TESTING, SURFACE

SAMPLING, GARBING COMPETENCY OBSERVATION AND

CLEANING COMPETENCY OBSERVATION. PERIOD OF

PERFORMANCE: 10/1/2023 - 9/30/2024

Contract Period: Base POP Begin: 10-01-2023 POP End: 09-30-2024

EQUIPMENT FOR THE NASHVILLE VA PHARMACY TO INCLUDE

PERSONNEL TESTING, MEDIA FILL TESTING, GLOVED

FINGERTIP AND THUMB TESTING, SURFACE SAMPLING,

GARBING COMPETENCY OBSERVATION AND CLEANING

COMPETENCY OBSERVATION. PERIOD OF PERFORMANCE:

10/1/2023 - 9/30/2024 Contract Period: Option 1 POP Begin: 10-01-2024 POP End: 09-30-2025

EQUIPMENT FOR THE MURFREESBORO VA PHARMACY TO

INCLUDE PERSONNEL TESTING, MEDIA FILL TESTING,

GLOVED FINGERTIP AND THUMB TESTING, SURFACE

SAMPLING, GARBING COMPETENCY OBSERVATION AND

CLEANING COMPETENCY OBSERVATION. PERIOD OF

PERFORMANCE: 10/1/2023 - 9/30/2024

Contract Period: Option 1 POP Begin: 10-01-2024 POP End: 09-30-2025

EQUIPMENT FOR THE NASHVILLE VA PHARMACY TO INCLUDE

PERSONNEL TESTING, MEDIA FILL TESTING, GLOVED

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

FINGERTIP AND THUMB TESTING, SURFACE SAMPLING,

GARBING COMPETENCY OBSERVATION AND CLEANING

COMPETENCY OBSERVATION. PERIOD OF PERFORMANCE:

10/1/2023 - 9/30/2024 Contract Period: Option 2 POP Begin: 10-01-2025 POP End: 09-30-2026

EQUIPMENT FOR THE MURFREESBORO VA PHARMACY TO

INCLUDE PERSONNEL TESTING, MEDIA FILL TESTING,

GLOVED FINGERTIP AND THUMB TESTING, SURFACE

SAMPLING, GARBING COMPETENCY OBSERVATION AND

CLEANING COMPETENCY OBSERVATION. PERIOD OF

PERFORMANCE: 10/1/2023 - 9/30/2024

Contract Period: Option 2 POP Begin: 10-01-2025 POP End: 09-30-2026

EQUIPMENT FOR THE NASHVILLE VA PHARMACY TO INCLUDE

PERSONNEL TESTING, MEDIA FILL TESTING, GLOVED

FINGERTIP AND THUMB TESTING, SURFACE SAMPLING,

GARBING COMPETENCY OBSERVATION AND CLEANING

COMPETENCY OBSERVATION. PERIOD OF PERFORMANCE:

10/1/2023 - 9/30/2024 Contract Period: Option 3 POP Begin: 10-01-2026 POP End: 09-30-2027

EQUIPMENT FOR THE MURFREESBORO VA PHARMACY TO

INCLUDE PERSONNEL TESTING, MEDIA FILL TESTING,

GLOVED FINGERTIP AND THUMB TESTING, SURFACE

SAMPLING, GARBING COMPETENCY OBSERVATION AND

CLEANING COMPETENCY OBSERVATION. PERIOD OF

PERFORMANCE: 10/1/2023 - 9/30/2024

Contract Period: Option 3 POP Begin: 10-01-2026 POP End: 09-30-2027

EQUIPMENT FOR THE NASHVILLE VA PHARMACY TO INCLUDE

PERSONNEL TESTING, MEDIA FILL TESTING, GLOVED

FINGERTIP AND THUMB TESTING, SURFACE SAMPLING,

GARBING COMPETENCY OBSERVATION AND CLEANING

COMPETENCY OBSERVATION. PERIOD OF PERFORMANCE:

10/1/2023 - 9/30/2024 Contract Period: Option 4 POP Begin: 10-01-2027 POP End: 09-30-2028

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

EQUIPMENT FOR THE MURFREESBORO VA PHARMACY TO

INCLUDE PERSONNEL TESTING, MEDIA FILL TESTING,

GLOVED FINGERTIP AND THUMB TESTING, SURFACE

SAMPLING, GARBING COMPETENCY OBSERVATION AND

CLEANING COMPETENCY OBSERVATION. PERIOD OF

PERFORMANCE: 10/1/2023 - 9/30/2024

Contract Period: Option 4 POP Begin: 10-01-2027 POP End: 09-30-2028

GRAND TOTAL __________________

SECTION C - CONTRACT CLAUSES

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

PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

(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; 41 U.S.C. 4712 and 10 U.S.C. 4701 relating to whistleblower protections; 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:

C.2 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):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

FAR

Number

Title Date

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

(End of Clause)

AUG 2020

C.3 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 days.

(End of Clause)

C.4 52.219-27 NOTICE OF SERVICE-DISABLED VETERAN-OWNED SMALL

BUSINESS SET-ASIDE (OCT 2022)

(a) Definition. "Service-disabled veteran-owned small business concern"—

(1) Means a small business concern—

(i) Not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

(ii) The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran.

(2) "Service-disabled veteran" means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

(b) Applicability. This clause applies only to—

(1) Contracts that have been set aside or for service-disabled veteran-owned small business concerns;

(2) Part or parts of a multiple-award contract that have been set aside for service-disabled veteran-owned small business concerns;

(3) Orders set aside for service-disabled veteran-owned small business concerns under multiple-award contracts as described in 8.405-5 and 16.505(b)(2)(i)(F); and

(4) Orders issued directly to service-disabled veteran-owned small business concerns under multiple-award contracts as described in 19.504(c)(1)(ii).

(c) General.

(1) Offers are solicited only from service-disabled veteran-owned small business concerns.

Offers received from concerns that are not service-disabled veteran-owned small business concerns shall not be considered.

(2) Any award resulting from this solicitation will be made to a service-disabled veteran-owned small business concern.

(d) A joint venture may be considered a service-disabled veteran owned small business concern if—

(1) At least one party to the joint venture complies with the criteria defined in paragraph (a) of this clause and 13 CFR 125.18(b)(2); and

(2) Each party to the joint venture is small under the size standard corresponding to the NAICS code assigned to the procurement, or the protégé is small under the size standard corresponding to the NAICS code assigned to the procurement in a joint venture comprised of a mentor and protégé with an approved mentor-protégé agreement under an SBA mentor-protégé program.

(e) In a joint venture that complies with paragraph (f) of this clause, the service-disabled veteran-owned small business party or parties to the joint venture shall perform at least 40 percent of the work performed by the joint venture. Work performed by the service-disabled veteran-owned small business party or parties to the joint venture must be more than administrative functions.

(End of Clause)

C.5 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC

2022) The Contracting Officer reserves the right to designate representatives to act for him/her in furnishing technical guidance and advice or generally monitor the work to be performed under this contract. Such designation will be in writing and will define the scope and limitation of the designee’s authority. A copy of the designation letter shall be furnished to the Contractor.

C.6 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

The Contractor shall not make reference in its commercial advertising to Department of Veterans Affairs contracts in a manner that states or implies the Department of Veterans Affairs approves or endorses the Contractor’s products or services or considers the Contractor’s products or services superior to other products or services.

(End of Clause)

C.7 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED

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

(DEVIATION)

(a) Definition. for the Department of Veterans Affairs, ‘‘Service-disabled Veteran-owned small business concern or SDVOSB’’:

(1) Means a small business concern—

(i) Not less than 51 percent of which is owned by one or more service-disabled Veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled Veterans or eligible surviving spouses (see VAAR 802.201, Surviving Spouse definition);

(ii) The management and daily business operations of which are controlled by one or more service-disabled Veterans (or eligible surviving spouses) or, in the case of a service-disabled Veteran with permanent and severe disability, the spouse or permanent caregiver of such Veteran;

(iii) The business meets Federal small business size standards for the applicable North American Industry Classification System (NAICS) code identified in the solicitation document;

(iv) The business has been certified for ownership and control pursuant to 38 U.S.C. 8127, 13 CFR 128, and is listed as certified in the SBA certification database at https://veterans.certify.sba.gov/; and

(v) The business agrees to comply with VAAR subpart 819.70 and Small Business Administration (SBA) regulations regarding small business size, government contracting, and the Veteran Small Business Certification Program at 13 CFR parts 121, 125, and 128.

(2) The term ‘‘Service-disabled Veteran’’ means a Veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

(3) The term ‘‘small business concern’’ has the meaning given that term under section 3 of the Small Business Act (15 U.S.C. 632).

(4) The term ‘‘small business concern owned and controlled by Veterans with service-connected disabilities’’ has the meaning given the term ‘‘small business concern owned and controlled by service-disabled veterans’’ under section 3(q)(2) of the Small Business Act (15 U.S.C. 632(q)(2)).

https://veterans.certify.sba.gov/

(5) The term “SDVOSB participant” or certified SDVOSB means a small business that has been certified in the SBA Veteran Small Business Certification Program and listed in the SBA certification database (see 13 CFR 128.102).

(b) General. In order for a concern to submit an offer and be eligible for the award of an SDVOSB set-aside or sole source contract, the concern must qualify as a small business concern under the size standard corresponding to the NAICS code assigned to the contract and be listed as an SDVOSB participant in the SBA certification database as set forth in 13 CFR 128.

(1) Offers received from entities that are not certified SDVOSBs and listed in the SBA certification database at the time of offer shall not be considered.

(2) Any award resulting from this solicitation shall be made to a certified SDVOSB listed in the SBA certification database who is eligible at the time of submission of offer(s) and at the time of award.

(3) The requirements in this clause apply to any contract, order or subcontract where the firm receives a benefit or preference from its designation as an SDVOSB, including set-asides, sole source awards, and evaluation preferences.

(c) Representation. Pursuant to 38 U.S.C. 8127(e), only certified SDVOSBs listed in the SBA certification database are considered eligible to receive award of a resulting contract. By submitting an offer, the prospective contractor represents that it is an eligible and certified SDVOSB as defined in this clause, 13 CFR 121, 125, and 128, and VAAR subpart 819.70.

(d) Agreement/LOS certification. When awarded a contract action, including orders under multipleaward contracts, an SDVOSB agrees that in the performance of the contract, the SDVOSB shall comply with requirements in VAAR subpart 819.70 and SBA regulations on small business size, and government contracting programs at 13 CFR part 121 and part 125, including the non-manufacturer rule and limitations on subcontracting (LOS) requirements in 13 CFR 121.406(b) and 13 CFR 125.6. For the purpose of limitations on subcontracting, only certified SDVOSBs listed in the SBA certification database (including independent contractors) shall be considered eligible and/or ‘‘similarly situated’’ (i.e., a firm that has the same small business program status as the prime contractor). An otherwise eligible firm further agrees to comply with the required LOS certification requirements in this solicitation (see 852.219–75 or 852.219–76 as applicable). These requirements are summarized as follows:

(1) Services. In the case of a contract for services (except construction), the SDVOSB prime contractor will not pay more than 50% of the amount paid by the government to the prime for contract performance to firms that are not certified SDVOSBs listed in the SBA certification database (excluding direct costs to the…