36C24925Q0381_1.docx

36C24925Q0381

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

36C24925Q0381 07-24-2025 Christina Lawrence 615-225-3426 08-01-2025

10:00 AM

CDT

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

NCO 9

1639 Medical Center Parkway, Suite 204 Murfreesboro TN 37129 X X 541380 $19 Million N/A X Department of Veterans Affairs Tennessee Valley Healthcare System 1310 24th Avenue South Nashville TN 37212 90C Network Contracting Office 9 Department of Veterans Affairs Network Contracting Office (90C) 1639 Medical Center Parkway Suite 204 Murfreesboro TN 37129

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 This request for Quote (RFQ) is posted in accordance with (IAW) Federal Acquisition Regulations (FAR) 13. Tennessee Valley Healthcare System seeks quote for Pharmacy Bi-annual Certification and Monthly Viable Surface and viable Air testing. Comparative evaluations of quotes will be performed IAW FAR 13.106-2(b), best value based on price other factors This solicitation will be a total small business set-aside.

Prospective contractors must follow the submission instructions specified in FAR Provision 52.212-1 and Submit all questions to Christina Lawrence via email only at christina.lawrence2@va.gov.

Questions are due NLT 07/31/2025 at 10:00 a.m., Central.

Quotes are due NLT 08/07/2025 at 10:00 a.m., Central.

Wage Determination No. 2015-4647 revision 29 will apply See CONTINUATION Page X X Christina Lawrence Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C249 Department of Veterans Affairs Network Contracting Office 9 (90C)

NCO 9

1639 Medical Center Parkway, Suite 204 Murfreesboro TN 37129

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

3. INVOICES: Invoices shall be submitted in arrears:

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

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

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

PHARMACY CERTIFICATION AND MONTHLY VIABLE TESTING IN STERILE PREPARATION AREAS. CONTRACTOR WILL PROVIDE ALL LABOR, MATERIALS, AND EQUIPMENT NECESSARY TO PERFORM MONTHLY AIR MICROBIOLOGICAL SAMPLING, AND SEMI-ANNUAL CONTROLLED ENVIRONMENTAL TESTING ASSOCIATION (CETA) CERTIFICATION ON PRIMARY ENGINEERING CONTROLS, SECONDARY ENGINEERING CONTROLS AND STERILE PREPARATION AREAS OF TVHS PHARMACIES LOCATED IN BUILDING 3, ROOMS G12H, G12J AND G12K AT THE MURFREESBORO CAMPUS AND BUILDING 1, ROOMS G105B, G105V, G105D, AND G105E AT THE NASHVILLE CAMPUS. REQUIRED ALSO ARE PERSONNEL TESTING, MEDIA FILL TESTING, GLOVED FINGERTIP AND THUMB TESTING, SURFACE SAMPLING, GARBING COMPETENCY OBSERVATION AND CLEANING COMPETENCY OBSERVATION.

Contract Period: Base POP Begin: 10-01-2025 POP End: 09-30-2026 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services PRODUCT/SERVICE CODE: Q301 - Medical - Reference Laboratory Testing

Air Samples Murf (10)

POP Begin: 10-01-2025 POP End: 09-30-2026

Surface Samples Murf (17)

POP Begin: 10-01-2025 POP End: 09-30-2026

Air Samples Nash (13)

POP Begin: 10-01-2025 POP End: 09-30-2026

Surface Samples Nash (23)

POP Begin: 10-01-2025 POP End: 09-30-2026

HEPA Filters Murf (5)

POP Begin: 10-01-2025 POP End: 09-30-2026

Room's PC/RAER/Pressure Murf

POP Begin: 10-01-2025 POP End: 09-30-2026

Air Samples Murf (10)

POP Begin: 10-01-2025 POP End: 09-30-2026

Surface Samples Murf (17)

POP Begin: 10-01-2025 POP End: 09-30-2026

LFCB Murf (2)

POP Begin: 10-01-2025 POP End: 09-30-2026

HD Storage RAER Murf

POP Begin: 10-01-2025 POP End: 09-30-2026

HD Storage Room Pressure Murf

POP Begin: 10-01-2025 POP End: 09-30-2026

Isolators Nash (1)

POP Begin: 10-01-2025 POP End: 09-30-2026

HEPA Filters Nash (6)

POP Begin: 10-01-2025 POP End: 09-30-2026

Room's PC/RAER/Pressure Nash

POP Begin: 10-01-2025 POP End: 09-30-2026

Air Samples Nash (13)

POP Begin: 10-01-2025 POP End: 09-30-2026

Surface Samples Nash (23)

POP Begin: 10-01-2025 POP End: 09-30-2026

BSC Nash (2)

POP Begin: 10-01-2025 POP End: 09-30-2026

LFCB Nash (2)

POP Begin: 10-01-2025 POP End: 09-30-2026

Pass Throughs Nash (4)

POP Begin: 10-01-2025 POP End: 09-30-2026

HD Storage RAER Nash (1)

POP Begin: 10-01-2025 POP End: 09-30-2026

HD Storage Room Pressure Nash (1)

POP Begin: 10-01-2025 POP End: 09-30-2026

Overnight Shipping Fees of Viable Samples

POP Begin: 10-01-2025 POP End: 09-30-2026

Report Generation Fees

POP Begin: 10-01-2025 POP End: 09-30-2026

Technician Service Fees

POP Begin: 10-01-2025 POP End: 09-30-2026

BSC Murf (1)

POP Begin: 10-01-2025 POP End: 09-30-2026

Self-Serve Sampling: Initial Testing Incubation / Analysis; Viable, Surface; with ID: Glove/Fingertip (8 plates per tech, Media fill, post surface sample)

POP Begin: 10-01-2025 POP End: 09-30-2026

Self-Serve Sampling: Ongoing Testing Incubation / Analysis; Viable, Surface; with ID: Glove/Fingertip (4 plates per tech, Media fill, post surface sample)

POP Begin: 10-01-2025 POP End: 09-30-2026

Self-Serve Sampling: Ongoing garbing retest, incubation Analyses: (2 plates per test, one sleeve media)

POP Begin: 10-01-2025 POP End: 09-30-2026

Self-Serve Sampling: Ongoing garbing Inital, incubation Analyses: (6 plates per test, one sleeve media)

POP Begin: 10-01-2025 POP End: 09-30-2026

PHARMACY CERTIFICATION AND MONTHLY VIABLE TESTING IN STERILE PREPARATION AREAS. CONTRACTOR WILL PROVIDE ALL LABOR, MATERIALS, AND EQUIPMENT NECESSARY TO PERFORM MONTHLY AIR MICROBIOLOGICAL SAMPLING, AND SEMI-ANNUAL CONTROLLED ENVIRONMENTAL TESTING ASSOCIATION (CETA) CERTIFICATION ON PRIMARY ENGINEERING CONTROLS, SECONDARY ENGINEERING CONTROLS AND STERILE PREPARATION AREAS OF TVHS PHARMACIES LOCATED IN BUILDING 3, ROOMS G12H, G12J AND G12K AT THE MURFREESBORO CAMPUS AND BUILDING 1, ROOMS G105B, G105V, G105D, AND G105E AT THE NASHVILLE CAMPUS. REQUIRED ALSO ARE PERSONNEL TESTING, MEDIA FILL TESTING, GLOVED FINGERTIP AND THUMB TESTING, SURFACE SAMPLING, GARBING COMPETENCY OBSERVATION AND CLEANING COMPETENCY OBSERVATION.

Contract Period: Option 1 POP Begin: 10-01-2025 POP End: 09-30-2026

Air Samples Murf (10)

POP Begin: 10-01-2026 POP End: 09-30-2027

Surface Samples Murf (17)

POP Begin: 10-01-2026 POP End: 09-30-2027

Air Samples Nash (13)

POP Begin: 10-01-2026 POP End: 09-30-2027

Surface Samples Nash (23)

POP Begin: 10-01-2026 POP End: 09-30-2027

HEPA Filters Murf (5)

POP Begin: 10-01-2026 POP End: 09-30-2027

Room's PC/RAER/Pressure Murf

POP Begin: 10-01-2026 POP End: 09-30-2027

Air Samples Murf (10)

POP Begin: 10-01-2026 POP End: 09-30-2027

Surface Samples Murf (17)

POP Begin: 10-01-2026 POP End: 09-30-2027

LFCB Murf (2)

POP Begin: 10-01-2026 POP End: 09-30-2027

HD Storage RAER Murf

POP Begin: 10-01-2026 POP End: 09-30-2027

HD Storage Room Pressure Murf

POP Begin: 10-01-2026 POP End: 09-30-2027

Isolators Nash (1)

POP Begin: 10-01-2026 POP End: 09-30-2027

HEPA Filters Nash (6)

POP Begin: 10-01-2026 POP End: 09-30-2027

Room's PC/RAER/Pressure Nash

POP Begin: 10-01-2026 POP End: 09-30-2027

Air Samples Nash (13)

POP Begin: 10-01-2026 POP End: 09-30-2027

Surface Samples Nash (23)

POP Begin: 10-01-2026 POP End: 09-30-2027

BSC Nash (2)

POP Begin: 10-01-2026 POP End: 09-30-2027

LFCB Nash (2)

POP Begin: 10-01-2026 POP End: 09-30-2027

Pass Throughs Nash (4)

POP Begin: 10-01-2026 POP End: 09-30-2027

HD Storage RAER Nash (1)

POP Begin: 10-01-2026 POP End: 09-30-2027

HD Storage Room Pressure Nash (1)

POP Begin: 10-01-2026 POP End: 09-30-2027

Overnight Shipping Fees of Viable Samples

POP Begin: 10-01-2026 POP End: 09-30-2027

Report Generation Fees

POP Begin: 10-01-2026 POP End: 09-30-2027

Technician Service Fees

POP Begin: 10-01-2026 POP End: 09-30-2027

BSC Murf (1)

POP Begin: 10-01-2026 POP End: 09-30-2027

Self-Serve Sampling: Initial Testing Incubation / Analysis; Viable, Surface; with ID: Glove/Fingertip (8 plates per tech, Media fill, post surface sample)

POP Begin: 10-01-2026 POP End: 09-30-2027

Self-Serve Sampling: Ongoing Testing Incubation / Analysis; Viable, Surface; with ID: Glove/Fingertip (4 plates per tech, Media fill, post surface sample)

POP Begin: 10-01-2026 POP End: 09-30-2027

Self-Serve Sampling: Ongoing garbing retest, incubation Analyses: (2 plates per test, one sleeve media)

POP Begin: 10-01-2026 POP End: 09-30-2027

Self-Serve Sampling: Ongoing garbing Inital, incubation Analyses: (6 plates per test, one sleeve media)

POP Begin: 10-01-2026 POP End: 09-30-2027

PHARMACY CERTIFICATION AND MONTHLY VIABLE TESTING IN STERILE PREPARATION AREAS. CONTRACTOR WILL PROVIDE ALL LABOR, MATERIALS, AND EQUIPMENT NECESSARY TO PERFORM MONTHLY AIR MICROBIOLOGICAL SAMPLING, AND SEMI-ANNUAL CONTROLLED ENVIRONMENTAL TESTING ASSOCIATION (CETA) CERTIFICATION ON PRIMARY ENGINEERING CONTROLS, SECONDARY ENGINEERING CONTROLS AND STERILE PREPARATION AREAS OF TVHS PHARMACIES LOCATED IN BUILDING 3, ROOMS G12H, G12J AND G12K AT THE MURFREESBORO CAMPUS AND BUILDING 1, ROOMS G105B, G105V, G105D, AND G105E AT THE NASHVILLE CAMPUS. REQUIRED ALSO ARE PERSONNEL TESTING, MEDIA FILL TESTING, GLOVED FINGERTIP AND THUMB TESTING, SURFACE SAMPLING, GARBING COMPETENCY OBSERVATION AND CLEANING COMPETENCY OBSERVATION.

Contract Period: Option 2 POP Begin: 10-01-2027 POP End: 09-30-2028

Air Samples Murf (10)

POP Begin: 10-01-2027 POP End: 09-30-2028

Surface Samples Murf (17)

POP Begin: 10-01-2027 POP End: 09-30-2028

Air Samples Nash (13)

POP Begin: 10-01-2027 POP End: 09-30-2028

Surface Samples Nash (23)

POP Begin: 10-01-2027 POP End: 09-30-2028

HEPA Filters Murf (5)

POP Begin: 10-01-2027 POP End: 09-30-2028

Room's PC/RAER/Pressure Murf

POP Begin: 10-01-2027 POP End: 09-30-2028

Air Samples Murf (10)

POP Begin: 10-01-2027 POP End: 09-30-2028

Surface Samples Murf (17)

POP Begin: 10-01-2027 POP End: 09-30-2028

LFCB Murf (2)

POP Begin: 10-01-2027 POP End: 09-30-2028

HD Storage RAER Murf

POP Begin: 10-01-2027 POP End: 09-30-2028

HD Storage Room Pressure Murf

POP Begin: 10-01-2027 POP End: 09-30-2028

Isolators Nash (1)

POP Begin: 10-01-2027 POP End: 09-30-2028

HEPA Filters Nash (6)

POP Begin: 10-01-2027 POP End: 09-30-2028

Room's PC/RAER/Pressure Nash

POP Begin: 10-01-2027 POP End: 09-30-2028

Air Samples Nash (13)

POP Begin: 10-01-2027 POP End: 09-30-2028

Surface Samples Nash (23)

POP Begin: 10-01-2027 POP End: 09-30-2028

BSC Nash (2)

POP Begin: 10-01-2027 POP End: 09-30-2028

LFCB Nash (2)

POP Begin: 10-01-2027 POP End: 09-30-2028

Pass Throughs Nash (4)

POP Begin: 10-01-2027 POP End: 09-30-2028

HD Storage RAER Nash (1)

POP Begin: 10-01-2027 POP End: 09-30-2028

HD Storage Room Pressure Nash (1)

POP Begin: 10-01-2027 POP End: 09-30-2028

Overnight Shipping Fees of Viable Samples

POP Begin: 10-01-2027 POP End: 09-30-2028

Report Generation Fees

POP Begin: 10-01-2027 POP End: 09-30-2028

Technician Service Fees

POP Begin: 10-01-2027 POP End: 09-30-2028

BSC Murf (1)

POP Begin: 10-01-2027 POP End: 09-30-2028

Self-Serve Sampling: Initial Testing Incubation / Analysis; Viable, Surface; with ID: Glove/Fingertip (8 plates per tech, Media fill, post surface sample)

POP Begin: 10-01-2027 POP End: 09-30-2028

Self-Serve Sampling: Ongoing Testing Incubation / Analysis; Viable, Surface; with ID: Glove/Fingertip (4 plates per tech, Media fill, post surface sample)

POP Begin: 10-01-2027 POP End: 09-30-2028

Self-Serve Sampling: Ongoing garbing retest, incubation Analyses: (2 plates per test, one sleeve media)

POP Begin: 10-01-2027 POP End: 09-30-2028

Self-Serve Sampling: Ongoing garbing Inital, incubation Analyses: (6 plates per test, one sleeve media)

POP Begin: 10-01-2027 POP End: 09-30-2028

PHARMACY CERTIFICATION AND MONTHLY VIABLE TESTING IN STERILE PREPARATION AREAS. CONTRACTOR WILL PROVIDE ALL LABOR, MATERIALS, AND EQUIPMENT NECESSARY TO PERFORM MONTHLY AIR MICROBIOLOGICAL SAMPLING, AND SEMI-ANNUAL CONTROLLED ENVIRONMENTAL TESTING ASSOCIATION (CETA) CERTIFICATION ON PRIMARY ENGINEERING CONTROLS, SECONDARY ENGINEERING CONTROLS AND STERILE PREPARATION AREAS OF TVHS PHARMACIES LOCATED IN BUILDING 3, ROOMS G12H, G12J AND G12K AT THE MURFREESBORO CAMPUS AND BUILDING 1, ROOMS G105B, G105V, G105D, AND G105E AT THE NASHVILLE CAMPUS. REQUIRED ALSO ARE PERSONNEL TESTING, MEDIA FILL TESTING, GLOVED FINGERTIP AND THUMB TESTING, SURFACE SAMPLING, GARBING COMPETENCY OBSERVATION AND CLEANING COMPETENCY OBSERVATION.

Contract Period: Option 3 POP Begin: 10-01-2028 POP End: 09-30-2029

Air Samples Murf (10)

POP Begin: 10-01-2028 POP End: 09-30-2029

Surface Samples Murf (17)

POP Begin: 10-01-2028 POP End: 09-30-2029

Air Samples Nash (13)

POP Begin: 10-01-2028 POP End: 09-30-2029

Surface Samples Nash (23)

POP Begin: 10-01-2028 POP End: 09-30-2029

HEPA Filters Murf (5)

POP Begin: 10-01-2028 POP End: 09-30-2029

Room's PC/RAER/Pressure Murf

POP Begin: 10-01-2028 POP End: 09-30-2029

Air Samples Murf (10)

POP Begin: 10-01-2028 POP End: 09-30-2029

Surface Samples Murf (17)

POP Begin: 10-01-2028 POP End: 09-30-2029

LFCB Murf (2)

POP Begin: 10-01-2028 POP End: 09-30-2029

HD Storage RAER Murf

POP Begin: 10-01-2028 POP End: 09-30-2029

HD Storage Room Pressure Murf

POP Begin: 10-01-2028 POP End: 09-30-2029

Isolators Nash (1)

POP Begin: 10-01-2028 POP End: 09-30-2029

HEPA Filters Nash (6)

POP Begin: 10-01-2028 POP End: 09-30-2029

Room's PC/RAER/Pressure Nash

POP Begin: 10-01-2028 POP End: 09-30-2029

Air Samples Nash (13)

POP Begin: 10-01-2028 POP End: 09-30-2029

Surface Samples Nash (23)

POP Begin: 10-01-2028 POP End: 09-30-2029

BSC Nash (2)

POP Begin: 10-01-2028 POP End: 09-30-2029

LFCB Nash (2)

POP Begin: 10-01-2028 POP End: 09-30-2029

Pass Throughs Nash (4)

POP Begin: 10-01-2028 POP End: 09-30-2029

HD Storage RAER Nash (1)

POP Begin: 10-01-2028 POP End: 09-30-2029

HD Storage Room Pressure Nash (1)

POP Begin: 10-01-2028 POP End: 09-30-2029

Overnight Shipping Fees of Viable Samples

POP Begin: 10-01-2028 POP End: 09-30-2029

Report Generation Fees

POP Begin: 10-01-2028 POP End: 09-30-2029

Technician Service Fees

POP Begin: 10-01-2028 POP End: 09-30-2029

BSC Murf (1)

POP Begin: 10-01-2028 POP End: 09-30-2029

Self-Serve Sampling: Initial Testing Incubation / Analysis; Viable, Surface; with ID: Glove/Fingertip (8 plates per tech, Media fill, post surface sample)

POP Begin: 10-01-2028 POP End: 09-30-2029

Self-Serve Sampling: Ongoing Testing Incubation / Analysis; Viable, Surface; with ID: Glove/Fingertip (4 plates per tech, Media fill, post surface sample)

POP Begin: 10-01-2028 POP End: 09-30-2029

Self-Serve Sampling: Ongoing garbing retest, incubation Analyses: (2 plates per test, one sleeve media)

POP Begin: 10-01-2028 POP End: 09-30-2029

Self-Serve Sampling: Ongoing garbing Inital, incubation Analyses: (6 plates per test, one sleeve media)

POP Begin: 10-01-2028 POP End: 09-30-2029

B.3 STATEMENT OF WORK

TVHS VAMC Pharmacy Service Statement of Work Sterile Compounding Bi-annual Certification, Monthly Viable Testing, and Personnel Gloved Fingertip and Media Fill Testing

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 1, 2023, defines organizational responsibility for USP <797> standards for cleanroom design and engineering controls and environmental monitoring and biannual certification of these areas. 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 biannual certification of the areas and equipment and monthly environmental testing of the same and Chapter USP<800> requires further testing of hazardous drug areas. In addition, USP Chapter <797> requires biannual gloved fingertip and media fill testing of all compounding personnel.

2. OBJECTIVE: VA Tennessee Valley Healthcare System (TVHS) seeks a contract for biannual certification, monthly viable surface and air testing, and personnel required testing. All 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. Bi-annual Certification: All primary and secondary engineering controls (SECs) must be tested to the most current CETA Certification and USP <797>, USP<800> guidelines every 6 months.

3.1.1. Viable air sampling with genus (and species if available) identification if actionable level of colony forming units (cfus) are found

3.1.2. Viable surface sampling with genus identification (and species if available) if actionable level of colony forming units (cfus) are found

3.1.3. Primary engineering control certifications for biologic safety cabinets and laminar airflow workstations to include (if applicable)

3.1.3.1. Non-viable particle count

3.1.3.2. Downflow Velocity test

3.1.3.3. HEPA filter integrity leak test (and patching if needed)

3.1.3.4. Low airflow alarm test

3.1.3.5. Video airflow smoke studies

3.1.4. Secondary engineering control certifications to include:

3.1.4.1. Air changes

3.1.4.2. Pressure differentials

3.1.4.3. Non-viable particle counts

3.1.4.4. Temperature and pressure monitor verification (note on report measured matches/does not match within 10%)

3.1.4.5. HEPA filter integrity leak test (and patching if needed)

3.1.5. Hazardous drug storage room testing to include:

3.1.5.1. Air exchanges

3.1.5.2. Pressure differential

3.1.5.3. Temperature and pressure monitor verification.

3.2. Monthly Viable Testing: All primary and secondary engineering controls must be tested for viable growth to the most current CETA Certification and USP797/USP800 guidelines monthly at both campuses.

3.2.1. The Contractor will perform testing within the first 10 days of each month.

3.2.2. Viable air sampling with genus (and species if available) identification if actionable level of colony forming units (cfus) are found

3.2.3. Viable surface sampling with genus identification (and species if available) if actionable level of colony forming units (cfus) are found

3.2.4. Provide a viable sampling results report no later than 12 business days after testing completed.

3.2.5. Provide retesting within the same month/prior to next scheduled time if there is a failure or other issue if requested by TVHS. Retesting should occur within 5 business days upon request by TVHS.

3.3. Personnel Testing:

3.3.1. Contractor will provide testing supplies for gloved fingertip and media fill testing for employees.

3.3.2. Media must be in compliance with USP Chapter<797>

3.3.3. TVHS designated employees will oversee the testing of compounders but utilizing supplies and lab services provided by the contractor.

3.3.4. Contractor will provide Certified Environmental Microbiology Laboratory - ISO/IEC 17025:2005 Accreditation to incubate and report.

3.3.5. Incubation, processing and reporting must be in accordance with USP Chapter <797>.

3.3 Billing: All above services and other items (ie. per diem, travel etc.) billed in an itemized fashion and separately for each campus.

Period of Performance Ordering Period 1: 10/01/2025-09/30/2026 Ordering Period 2: 10/01/2026-09/30/2027 Ordering Period 3: 10/01/2027-09/30/2028 Ordering Period 4: 10/01/2028-09/30/2029

Locations:

Department of Veterans Affairs Tennessee Valley Healthcare System 1310 24th Avenue South Nashville, TN 37212-2637

Alvin C. York VAMC 3400 Lebanon Pike Murfreesboro, TN 37129-1237

4. REPORTING REQUIREMENTS: The Contractor must provide a preliminary report at the time of certification testing completion, viable sampling results reports no later than 12 business days after testing completed, and a comprehensive biannual certification electronic report no later than 45 business days after testing is completed, unless greater time is agreed upon in advance by the COR. Personnel testing reports must be received no later than 12 business days. All reports must include all items required by USP<797>, USP <800> and CETA testing. 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 for the technician performing the work and/or the person who reviews and signs and reviews the reports.

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

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

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

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

5.8. Contractor must have working knowledge of current ISO standards.

5.9. 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 if there is a failure.

6. PLACE OF PERFORMANCE: Tennessee Valley Healthcare System has two campuses requiring testing: Nashville VA Medical Center, 1310 24th Ave S, Nashville, Tennessee 37212 and Alvin C. York VA Medical Center, 3400 Lebanon Pike, Murfreesboro, TN.

6.1. Nashville VA campus has the following needs for each biannual certification every 6 months (2 months per contract year in addition to monthly air and surface viable sampling):

6.1.1. Biologic safety cabinet certifications (including videos of smoke studies and filter integrity) #2

6.1.2. Laminar airflow workstation certifications (including videos of smoke studies and filter integrity) #2

6.1.3. Secondary engineering control certifications (each with 1 HEPA filter with patching if needed) #6

6.1.4. Hazardous drug storage room certification #1

6.2. Murfreesboro VA campus has the following needs for each biannual certification (2 months per contract year in addition to monthly air and surface viable sampling):

6.2.1. Biologic safety cabinet certifications (including videos of smoke studies) #1

6.2.2. Laminar airflow workstation certifications (including videos of smoke studies) #2

6.2.3. Secondary engineering control certifications (each with 1 HEPA filter with patching if needed) #5

6.2.4. Hazardous drug storage room certification #1

6.3. Nashville VA campus has the following needs for monthly viable sampling (12 months per contract year):

6.3.1. Viable air samples (including one control) #11

6.3.2. Viable surface samples (including one control) #23

6.4. Murfreesboro VA campus has the following needs for monthly viable sampling (12 months per contract year):

6.4.1. Viable air samples (including one control) #9

6.4.2. Viable surface samples (including one control) #17

6.5. In addition to above testing, would also like to include in the contract, in case of failure or other needs, the following extra testing if needed at either campus:

6.5.1. Viable surface samples #40

6.5.2. Viable air samples #10

6.5.3. Secondary engineering control certification (each with 2 HEPA filter) #4

6.5.4. Biologic safety cabinet certification (including videos of smoke studies) #2

6.5.5. Laminar airflow workstation certification (including videos of smoke studies) #2

6.5.6. HEPA filter integrity test (with patching if needed) #2

6.5.7. HEPA filter changed and tested (with patching if needed) #2

6.5.8. Travel cost for one trip #4

6.6. Personnel Testing needs are below for both campuses combined:

6.6.1. Initial full testing kit (8 fingertip plates, 1 surface plate, 1 media fill) #20

6.6.2. Ongoing full testing kit (4 fingertip plates, 1 surface plate, 1 media fill) #190

6.6.3. Ongoing glove fingertip garbing retests (2 plates per test) = #30

6.6.4. Initial glove fingertip garbing retests (6 plates per test) = #10

6.6.5. Lab processing per each item listed for supply needs in 6.6.1 through 6.6.4

7. TERM OF CONTRACT AND PRICING: This contract is for four 12 month ordering periods (48 months). All pricing to be given and billed per line item completed. Travel expenses and any other costs not listed above must be listed separately. Report generation may be built into prices above or listed separately. Invoices should be submitted monthly for total work completed and may be combined for both campuses if completed during the same travel time.

8. PERFORMANCE PERIOD: The contract term is for 12 months with three additional ordering periods of 12 months each beginning upon signature and to start October 1, 2025. 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.

VA NOTICE 24-12 April 22, 2024

VA INFORMATION AND INFORMATION SYSTEM SECURITY AND PRIVACY LANGUAGE FOR INCLUSION IN CONTRACTS, AS APPROPRIATE

1. GENERAL. This entire section applies to all acquisitions requiring any Information Security and Privacy language. Regarding this software contract, the Contractors, contractor personnel, subcontractors and subcontractor personnel will have access to log into the VA system using his PIV card to perform updates to their software but will not have access to patient or employee records or be required to have access to patient or employee records on behalf of VA.

2. VA INFORMATION CUSTODIAL LANGUAGE. This entire section applies to all acquisitions requiring any Information Security and Privacy language. The Contractors, contractor personnel, subcontractors and subcontractor personnel will not have access to the VA systems or VASI.

a. The Government shall receive unlimited rights to data/intellectual property first produced and delivered in the performance of this contract or order (hereinafter “contract”) unless expressly stated otherwise in this contract. This includes all rights to source code and all documentation created in support thereof. The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General. The primary clause used to define computer software license (not data/intellectual property first produced under this contractor or order) is FAR 52.227-19, Commercial Computer Software License.

b. Information made available to the contractor by VA for the performance or administration of this contract will be used only for the purposes specified in the service agreement, SOW, PWS, PD, and/or contract. The contractor shall not use VA information in any other manner without prior written approval from a VA Contracting Officer (CO). The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General.

c. VA information will not be co-mingled with any other data on the contractor’s information systems or media storage systems. The contractor shall ensure compliance with Federal and VA requirements related to data protection, data encryption, physical data segregation, logical data segregation, classification requirements and media sanitization.

d. VA reserves the right to conduct scheduled or unscheduled audits, assessments, or investigations of contractor Information Technology (IT) resources to ensure information security is compliant with Federal and VA requirements. The contractor shall provide all necessary access to records (including electronic and documentary materials related to the contracts and subcontracts) and support (including access to contractor and subcontractor staff associated with the contract) to VA, VA's Office Inspector General (OIG), and/or Government Accountability Office (GAO) staff during periodic control assessments, audits, or investigations.

e. The contractor may only use VA information within the terms of the contract and applicable Federal law, regulations, and VA policies. If new Federal information security laws, regulations or VA policies become applicable after execution of the contract, the parties agree to negotiate contract modification and adjustment necessary to implement the new laws, regulations, and/or policies.

f. The contractor shall not make copies of VA information except as specifically authorized and necessary to perform the terms of the contract. If copies are made for restoration purposes, after the restoration is complete, the copies shall be destroyed in accordance with VA Directive 6500, VA Cybersecurity Program and VA Information Security Knowledge Service.

g. If a Veterans Health Administration (VHA) contract is terminated for default or cause with a business associate, the related local Business Associate Agreement (BAA) shall also be terminated and actions taken in accordance with VHA Directive 1605.05, Business Associate Agreements. If there is an executed national BAA associated with the contract, VA will determine what actions are appropriate and notify the contactor.

h. The contractor shall store and transmit VA sensitive information in an encrypted form, using VA-approved encryption tools which are, at a minimum, Federal Information Processing Standards (FIPS) 140-2, Security Requirements for Cryptographic Modules (or its successor) validated and in conformance with VA Information Security Knowledge Service requirements. The contractor shall transmit VA sensitive information using VA approved Transport Layer Security (TLS) configured with FIPS based cipher suites in conformance with National Institute of Standards and Technology (NIST) 800-52, Guidelines for the Selection, Configuration and Use of Transport Layer Security (TLS) Implementations.

i. The contractor’s firewall and web services security controls, as applicable, shall meet or exceed VA’s minimum requirements.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor may use and disclose VA information only in two situations: (i) in response to a qualifying order of a court of competent jurisdiction after notification to VA CO (ii) with written approval from the VA CO. The contractor shall refer all requests for, demands for production of or inquiries about, VA information and information systems to the VA CO for response.

k. Notwithstanding the provision above, the contractor shall not release VA records protected by Title 38 U.S.C. § 5705, Confidentiality of medical quality- assurance records and/or Title 38 U.S.C. § 7332, Confidentiality of certain medical records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse or infection with Human Immunodeficiency Virus (HIV). If the contractor is in receipt of a court order or other requests for the above- mentioned information, the contractor shall immediately refer such court order or other requests to the VA CO for response.

l. Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract will be protected and secured in accordance with VA Directive 6500 and Identity and Access Management (IAM) Security processes specified in the VA Information Security Knowledge Service.

m. Any data destruction done on behalf of VA by a contractor shall be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management, VA Handbook 6300.1, Records Management Procedures, and applicable VA Records Control Schedules.

n. The contractor shall provide its plan for destruction of all VA data in its possession according to VA Directive 6500 and NIST 800-88, Guidelines for Media Sanitization prior to termination or completion of this contract. If directed by the COR/CO, the contractor shall return all Federal Records to VA for disposition.

o. Any media, such as paper, magnetic tape, magnetic disks, solid state devices or optical discs that is used to store, process, or access VA information that cannot be destroyed shall be returned to VA.The contractor shall hold the appropriate material until otherwise directed by the Contracting Officer’s Representative (COR) or CO. Items shall be returned securely via VA-approved methods. VA sensitive information must be transmitted utilizing VA-approved encryption tools which are validated under FIPS 140-2 (or its successor) and NIST 800-52. If mailed, the contractor shall send via a trackable method (USPS, UPS, FedEx, etc.) and immediately provide the COR/CO with the tracking information. Self-certification by the contractor that the data destruction requirements above have been met shall be sent to the COR/CO within 30 business days of termination of the contract.

p. All electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.) used to store, process or access VA information will not be returned to the contractor at the end of lease, loan, or trade-in. Exceptions to this paragraph will only be granted with the written approval of the VA CO.

3. SECURITY INCIDENT INVESTIGATION. Regarding this software contract, the Contractors, contractor personnel, subcontractors and subcontractor personnel will NOT have access to the VA systems or VASI.

"The Authorization requirements do not apply, and that a Security Accreditation Package is not required".

2. The purpose of this amendment is to incorporate the following answers to questions submitted by interested vendors:

Q: Are the total Viable Sampling Locations listed for each locations include both Bacterial and Fungal samples.

A: Yes- these can be single plate method or double plate method.

Q: Are the total Viable Sampling Locations listed for each location including the Pos & Neg controls per media type?

A: Sampling location numbers include positive and negative primary and secondary engineering controls.

Q: What are the primary engineering controls A: The primary engineering controls are listed in the SOW but listed here for clarity:

Nashville- 2 BSCs and 2 LAFWs Murfreesboro- 1 BSC and 2 LAFWs Q: Are you able to provide MFR, Model and SN or each hood ?

A: Including specs for each Q: Can you supply the dimensions on the cleanroom and the qty of HEPA in each room ? (Can you provide a Reflective Ceiling plan?)

A: 1 HEPA per SEC. Defer to engineering for room plans/measurements.

Q: How many magneheic gauges do you have in each location ? and should they be included in this certification service?

A: This service is not included in this certification

36C24925Q0381

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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,…