36C25526Q0054.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

36C25526Q0054 11-13-2025

Kobulnicky,Erika/Erika.Kobulnicky@va.gov 913-946-1991 12-01-2025

9:00AM CST

36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway

Leavenworth KS 66048

X 100

X

Y

621511

$41.5 Million

N/A

X

VA Heartland Health Care Network (VISN 15) Medical Centers

36C255

Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway

Leavenworth KS 66048

36C255

Financial Services Center http://www.fsc.va.gov/einvoice.asp

Austin TX

877-353-9791 512-460-5429

See CONTINUATION Page

This is a request for quotes (RFQ) to provide testing and certification to all VA Heartland Health Care Network (VISN 15) IV Rooms and personnel training in accordance with Performance Work Statement (PWS).

1. The Government intends to award a single award, five year Indefinite Delivery Indefinite Quantity (IDIQ) with twelve (12) month Ordering Periods; 02/12/2026 - 02/11/2031.

2. Individual bulk funded task orders will be issued by the NCO 15 Contracting Officer.

3. This solicitation is 100% set-aside for Service Disabled Veteran Owned Small Business (SDVOSB).

4. Questions are due no later than 9:00 a.m. CST Wednesday, Nov. 19, 2025 and directed to Lisa.Buchanan1@va.gov.

or Erika.kobulnicky@va.gov.

5. See ADDENDUM to FAR 52.212-1: Instructions to Offerors, which contains key information on how to properly respond to this RFQ.

6. Applicable wage determinations will be issued at time of task order.

See CONTINUATION Page

X X

X one(1)

Buchanan, Lisa A.

Contracting Officer

36C25526Q0054

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

SECTION C - CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.2 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.3 52.216-18 ORDERING (AUG 2020)

C.4 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.5 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.3 52.240-91 Security Prohibitions and Exclusions

C.6 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ... 40

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 WAGE DETERMINATIONS INCORPORATED BY REFERENCE

D.2 Quality Assurance Surveillance Plan (QASP)

SECTION E - SOLICITATION PROVISIONS

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

COMMERCIAL SERVICES (SEP 2023)

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

1998)

E.3 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 52.252-5 AUTHORIZED DEVIATIONS IN PROVISIONS (NOV 2020)

E.7 VAAR 852.252-70 SOLICITATION PROVISIONS OR CLAUSES INCORPORATED

BY REFERENCE (JAN 2008)

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 36C255 Lisa Buchanan/lisa.buchanan1@va.gov

Contract Specialist: Erika Kobulnicky/Erika.kobulnicky@va.gov

Department of Veterans Affairs

Network Contracting Office (NCO) 15

3450 S 4th Street Trafficway

Leavenworth KS 66048

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] Monthly in arrears upon competition of services

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.

Financial Services Center http://www.fsc.va.gov/einvoice.asp mailto:Buchanan/lisa.buchanan1@va.gov

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

VISN 15 IV Room Certification and Personnel Training

1. REQUIREMENT:

The VA Heartland Health Care Network (VISN15) VAMC facilities listed below require testing and certification of all the VA Heartland Health Care Network (VISN 15) facilities’ primary engineering controls (PECs) and clean rooms used for preparation of compounded sterile preparations (CSPs). PECs include biological safety cabinets (BSCs), laminar airflow workbenches (LAFWs), compounding aseptic containment isolators (CACIs), compounding aseptic isolators (CAIs) and Isolators. Testing and certification will be completed in accordance with United States Pharmacopeia (USP) Chapter <797> (<797>), USP Chapter <800> (<800>), or current guidelines. This requirement also includes personnel training, evaluation and requalification to compound CSPs in accordance with <797>, <800>, or current guidelines.

2. BACKGROUND:

VHA compounding practice is governed by 1108.12, Management and Monitoring of Pharmaceutical Compounded Preparation. Within this document is noted that VA pharmacy compounding practice must adhere to the standards under USP <797>, <800>, and <795> including the requirement that certification must occur and must follow CETA standards.

Correspondingly, after the 2012 national fungal outbreak, Congress established new federal law under the Drug Quality and Safety Act (DQSA) that designates specific operational requirements to compound medications. VA facilities are categorized as 503A compounding pharmacy, and as such must comply with 21 U.S. Code § 353a - Pharmacy compounding.

The USP establishes standards for cleanroom design, environmental monitoring, and competencies for the preparation, handling, and storage of CSPs. The Joint Commission (TJC) Accreditation Manual for Home Care, effective January 13, 2018, established new Medication Compounding (MC) standards for non-sterile and sterile compounded preparations which are based on USP standards.

In 2023, the AUSH for Health for Clinical Services/Chief Medical Officer issued an advisement that VA Laboratories do not have environmental testing certification, specifically, International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025 certifications. VA Laboratory’s Clinical Laboratory Improvement Amendments (CLIA) license does not allow for environmental quality testing. VA Laboratories could not meet the external accreditation requirements of the American Association for Laboratory Accreditation and the Joint Commission.

Only one VA Laboratory in the nation could meet the requirements for environmental requirements, however, this facility could not be used for the following reasons:

• The automated equipment the facility purchased to improve performance in sample testing requires the use of 100mm media plates.

• USP <797> requires the use of convex plates for surface sampling.

• Most of the 100mm plates we have identified are not convex. Supplies could not be located.

VISN 15 facilities have either upgraded/constructed or are in the process of upgrading/constructing compounding spaces to continuously meet 797 and 800 standards. As such, VISN 15 requires contractors to adjust quantity, and perhaps types, of services to meet the changing needs of the facilities as upgrades and construction are completed.

Pharmacies are required to validate staff competency in aseptic technique to compound preparations at required intervals. This includes Media Fill testing, Gloved Fingertip testing and surface sample testing. The same policies and regulatory requirements as the cleanroom certification justify this requirement, additionally:

• Federal law under the Drug Quality and Safety Act (DQSA) designates specific operational requirements to compound medications. VA facilities are categorized as 503A compounding pharmacy, and as such must comply with 21 U.S. Code § 353a - Pharmacy compounding SEC. 503A. PHARMACY COMPOUNDING

• FDCA (a)(2)(A) addresses conditions whereby compounded preparations are deemed to be adulterated “if it has been prepared, packed, or held under insanitary conditions. FDA Insanitary Guidance provides specifics associated with this law, among them, lack of documented staff competency.

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

3. PERIOD OF PERFORMANCE

This procurement is for a five (5) year IDIQ with Five (5) twelve(12) month ordering periods.

Ordering Period 1 FEBRUARY 12, 2026 through FEBRUARY 11, 2027

Ordering Period 2 FEBRUARY 12, 2027 through FEBRUARY 11, 2028

Ordering Period 3 FEBRUARY 12, 2028 through FEBRUARY 11, 2029

Ordering Period 4 FEBRUARY 12, 2029 through FEBRUARY 11, 2030

Ordering Period 5 FEBRUARY 12, 2030 through FEBRUARY 11, 2031

4. PLACES OF PERFORMANCE

Facility Name Address

VISN 15 589 Kansas City, MO 4801 E. Linwood Blvd.

Kansas City, MO 64128

VISN 15 589A4 Columbia, MO 800 Hospital Drive

Columbia, MO 65201

VISN 15 589A5 Topeka, KS 2200 SW Gage Blvd.

Topeka, KS 66622

VISN 15 589A6 Leavenworth, KS 4101 4th St. Trafficway

Leavenworth, KS 66048

VISN 15 589A7 Wichita, KS 5500 E. Kellogg Drive

Wichita, KS 67218

VISN 15 657 St. Louis, MO J. Cochran 915 N. Grand Blvd.

St. Louis, MO 63106

VISN 15 657A0 St. Louis, MO J. Barracks 1 Jefferson Barracks Dr.

St. Louis, MO 63125

VISN 15 657A4 Poplar Bluff, MO 1500 N. Westwood Blvd.

Poplar Bluff, MO 63901

VISN 15 657A5 Marion, IL 2401 West Main Street

Marion, IL 62959

VISN 15 657GJ Evansville IN 6211 East Waterford Blvd.

Evansville, IN 47715

5. PERFORMANCE REQUIREMENTS

The VA Heartland Health Care Network (VISN 15) requires a VISN-wide contract for standardized testing criteria appropriate for all PECs used pursuant to current <797> and <800> standards using Controlled Environment Testing Association (CETA) Certified National Board of Testing (CNBT) certified individuals to establish consistent PEC certification procedures using the Certification Guide for Sterile Compounding Facilities CAG-003-2006. Although <797> states that certification procedures “or an equivalent” of those outlined in CAG-003-2006 shall be performed, Veterans Affairs (VA) will be requiring that CAG-003-2006 be used in lieu of any other “equivalent” procedures that may exist. Depending on the period of performance and ordering periods, testing procedures shall be maintained in compliance with all current applicable USP standards.

a. CETA REGISTRATION: All vendors used to conduct primary and secondary engineering controls certifications/assessments must be registered with CETA.

b. PEC TESTING AND CERTIFICATION

i. The contractor shall test and certify each PEC according to <797> and <800> using certification procedures from the CETA Certification Guides for Sterile Compounding Facilities (CAG-003-2006 and CAG-002-2006).

ii. All PECs must:

1. Be certified to meet ISO Class 5 or better

2. Maintain unidirectional airflow

3. Be supplied by HEPA filtered air

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

1. HEPA filter leak test

2. Induction leak/back-streaming test

3. Cabinet leak test

4. In-flow velocity test to include exhaust airflow volume rate

5. Dynamic airflow smoke pattern test

6. Total airborne particle testing

7. Viable microbial air testing

8. Viable microbial surface testing

iv. LAFWs, Integrated Vertical Laminar Flow Zones (IVLFZs), and BSCs must be tested and certified according to CETA CAG-003-2006 guidelines and to manufacturer’s specifications.

v. Horizontal laminar flow cabinets shall be certified according to The Institute of Environmental Sciences (IEST) RP-CC-002 Testing Laminar Air Flow Devices and Induction Leak/Back-streaming Test and IEST-RP-CC034 HEPA Filter Leak Test.

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

vii. The contractor shall report each individual face velocity reading and the average of those readings, the downstream concentration reading of the HEPA filter leak test and the results of the induction leak test and back-streaming test.

1. Any failures shall be reported directly to the identified site POCs as soon as practicable.

2. Any unit that fails to meet required specifications shall be clearly marked with a sign that will notify technicians that the unit is out of order until further notice.

3. In addition, any failures shall be reported directly to the site identified POC as soon as immediately.

viii. Restricted Access Barrier Systems (CAIs, CACIs, and isolators (e.g. PECs with a controlled workspace, transfer devices, access devices, and a decontamination system) must be certified according to CETA CAG-002-2006 and CAG-003-2006 guidelines and to manufacturer’s specifications.

1. Any unit that fails to meet required specifications shall be clearly marked with a sign that will notify technicians that the unit is out of order until further notice.

2. In addition, any failures shall be reported directly to the site identified point(s) of contact (POCs) immediately.

ix. Hazardous compounding PEC certification is required for:

1. Negative pressure hoods

2. Isolators

3. PECs where robotic enclosure is used inside of the PEC

x. The contractor shall test and certify each hazardous PEC to the manufacturer’s specifications. Tests shall include:

1. Face velocity test

2. Airflow smoke pattern test

3. Low flow alarm test

xi. If the hazardous PEC has an air flow monitor (AFM) or controller (AFC), the contractor shall confirm the unit is calibrated and operating within +/-10% of actual velocity. If it is not calibrated appropriately the contractor shall calibrate the AFM or AFC. The contractor shall use a NIST traceable or comparable calibrated piece of equipment to calculate the face velocity.

xii. The contractor shall report each individual face velocity reading and the average of those readings, a pass/fail grade for the airflow smoke pattern test and a pass/fail grade for the low flow alarm test. Any failures shall be reported directly to the POC(s) as soon as practicable

xiii. For each PEC passing the required certification tests, the contractor will supply each unit with a certification sticker with the following information:

1. Company name and phone number

2. Unit model and serial number

3. Report number reflecting the room certification

4. Certification date

5. Recertification date

6. Sash height (for fume hoods)

7. Technician signature

c. CLEAN ROOM CERTIFICATION

i. All classified areas must be tested and certified in accordance with ISO 14644-1 Classifications of Air Cleanliness, CETA CAG-003-2006 and CETA CAG-009-00 specifications. The contractor will provide comprehensive cleanroom testing and certification services with frequency required by most current <797> and <800> standards. To include testing needed when new cleanroom construction is completed or significant corrective actions or repairs are needed in existing compounding spaces. Test equipment used for certification will be clean, in good working order and calibrated on a calibration frequency not to exceed 12 months or more frequently if recommended by the manufacturer. Calibration certificates should be provided upon request by the facility POC for all calibrated test equipment. Testing may not be conducted the week prior to a Federal Holiday. USP Compliance Testing for Cleanrooms and Controlled Environment certification will include, but is not limited to, the following:

1. Air velocity and volume

2. Air exchange rate

3. Room pressure differential

4. Leak testing of HEPA filters

5. Temperature, relative humidity measurements

6. Lighting measurement

7. Sound level measurement

8. Electrical leakage and ground circuit resistance and polarity tests

9. Pass-through chamber air quality

10. Pass-through HEPA filter leak test (where present)

11. Total airborne particle testing

12. Viable microbial air testing

13. Viable microbial surface testing

ii. Air Changes Per Hour (ACPH).

1. The contractor shall calculate the total room volume for each buffer, ante room, and hazardous drug (HD) storage room.

2. A sketch of the room with dimensions, exhaust/supply diffuser locations and equipment locations shall be included in the report.

3. The report provided will specify flow rates detailing returns and supply that were obtained during the testing.

4. The contractor shall calculate ACPH for each buffer room, ante room, Containment Segregated Compounding Area (C-SCA), and HD storage room and include their findings in the report.

5. In the event a room does not meet <797> or <800> requirements for ACPH the identified site POC(s) shall be informed immediately.

iii. Pressure Requirements

1. The contractor shall include in their report differential pressure readings from each buffer/ante room to surrounding areas.

2. The report shall indicate whether the room is required to be a negative or positive pressure room per <797> or <800>.

3. The contractor shall report all pressures to an accuracy of 0.001 inch water column (3 decimal places).

Pressure differentials will be reflected on a report showing the sketch of the room(s).

iv. Total Airborne Particles

1. The contractor shall perform total airborne particle testing under dynamic operating conditions every 6 months.

2. The contractor shall derive the minimum number of sampling locations using Annex A in the ISO 14644-1.2 standard.

3. The volume sampled at each location shall be at least 2 liters, with a minimum sampling time at each location of 1 minute.

4. Testing shall be performed by qualified operators using current, state-of-the-art electronic equipment with results of the following:

a. ISO Class 5: not more than 3,520 particles 0.5 µm and larger size per cubic meter of air for any area primary engineering control.

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

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

v. Microbial Air Monitoring

1. The contractor shall perform viable air sampling every 6 months for fungi and bacteria using an impaction device in all classified areas during dynamic operating conditions.

2. A sufficient volume of air (1,000 liters or more) shall be tested at each location to maximize sensitivity. Samples of less than 1,000 liters will not be acceptable.

3. A general microbiological growth media that supports the growth of bacteria and fungi must be used (e.g. trypticase soy agar (TSA)). Alternately, malt extract agar (MEA) or sabouraud dextrose agar (SDA) can be used for sampling of fungi.

4. Samples will be incubated at the temperature and duration specified in <797>.

5. The contractor must be willing and able to supply, upon request, the certificates of analysis (COAs) verifying the media meets the expected growth promotion, pH, and sterilizing requirements of <797>.

vi. Microbial Surface Monitoring

1. The contractor shall perform viable surface sampling every month for fungi and bacteria.

2. A general microbiological growth media that supports the growth of bacteria and fungi and supplemented with neutralizing additives (e.g., lecithin and polysorbate 80) to neutralize the effects of any residual disinfecting agents must be used (e.g. TSA). Alternately, MEA or SDA can be used for sampling of fungi.

3. Samples will be incubated at the temperature and duration specified in <797>.

4. Surface sampling must be performed at the end of the compounding activities or shift, but before the area has been cleaned and disinfected. Sampled surfaces are to include:

a. The interior of the PEC and the equipment contained in it

b. Staging or work area(s) near the PEC

c. Frequently touched surfaces

d. Pass-through chamber(s)

d. ADDITIONAL SERVICES.

Additional services to maintain environmental controls as needed. Individual facilities may opt in:

i. Change out HEPA Filters in cleanrooms and hoods when damaged or according to manufacturer recommendations

ii. Change hood HEPA filter when damaged or according to manufacturer recommendations

iii. Change hood pre-filters when damaged, dirty, or according to manufacturer recommendations

iv. Install externally accessible HEPA filter smoke study ports to perform HEPA leak testing when needed to prevent damaging HEPA filter

v. Room smoke study as needed (such as completed new construction or significant room remodeling prior to opening) to identify airflow, eddies and employ risk mitigation strategies to account for such airflow obstructions identified

e. ENVIRONMENTAL WIPE SAMPLING

The contractor will perform environmental wipe sampling for HD surface residue every 6 months, or more frequently as needed, to verify containment, for those facilities that perform HD compounding and opt in for this testing. The kits used to complete wipe sampling must be verified prior to use to ensure the method and reagent used have been tested to recover a specific percentage of known marker drugs from surface types found in the sample area(s).

The contractor must be able to test for the following:

i. Cyclophosphamide

ii. Ifosfamide

iii. Methotrexate

iv. Fluorouracil

Schaefer, Monica G. (V15) From EK/Katie: States a total of 6 surface samples – We have a negative SCA with BSC contingency room we used in Topeka. We do mix chemotherapy in the room if our main IV HD room is not available or if we have high chemo volume days and have another IV pharmacy technicians to mix. Are we limited to just 6 or can we opt in more samplings since we have additional space?

v. Platinum-containing drugs

vi. Additional Drugs

1. Additional drugs may be requested based upon identified need per site.

2. Upon identified need, the applicable site will work directly with the contractor where additional cost will be clarified and agreed upon by both parties prior to testing.

vii. Surface wipe sampling may include the following areas:

1. Interior of PEC and equipment contained in it.

2. Pass-through chambers

3. Surfaces in staging or work areas near PEC

4. Areas adjacent to PECs (e.g. floors directly under C-PEC, staging, and dispensing area)

5. Areas immediately outside the HD buffer room or C-SCA

6. Patient administration areas

f. CERTIFICATION AND ENVIRONMENT RESULTS REPORTING

All of the following information shall be included in the report for clean room certification.

Pass/Fail notifications should be included on a per-test basis where applicable. Executive summary or summary of findings to include:

i. Room Certification Pass/Fail

ii. Hood Certification Pass/Fail

iii. Viable Air Sampling Pass/Fail

iv. Viable Surface Sampling Pass/Fail

v. Specific deficiencies by location (room and/or hood), if identified.

vi. Room number and/or location

vii. Room type (e.g. oncology prep room)

viii. Standards used to test room

ix. List of equipment utilized to include make, model, serial number, and calibration date

x. Room air changes per hour (The ACPH from HVAC, ACPH contributed from the PEC, and the total ACPH)

xi. Pressure differentials

xii. Indication when dynamic operating conditions were used

xiii. Total airborne particle counts, action level for target ISO level

xiv. Action levels for ISO area tested

xv. Total room area and volume

xvi. Date of next required certification

xvii. Type of PEC certified

xviii. Serial number of the PEC certified

xix. Date and time samples collected and particle counts tested

xx. Technician collecting the samples

xxi. COAs of media used

xxii. Viable sample results (CFUs), action level for target ISO level

xxiii. Viable sample results graph showing trends over time

xxiv. Genus identification of bacterial and/or fungal isolates

xxv. Highly pathogenic microorganism isolates highlighted in the report notes

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

xxvii. Sketch identifying location of each viable particle and surface samples obtained xxviii. Location of positive HD wipe sample results

xxix. Room humidity and temp

g. REPORT DISTRIBUTION

i. The contractor will immediately notify the POCs with any results indicating failure.

ii. A formalized written report including all required aspects specified in this SOW will be provided in a timely manner with receipt no more than 14 days from certification evaluation.

iii. All completed reports will be provided via email to the POCs and Report Distribution Lists.

iv. See 12. GENERAL ADMINISTRATION section of this document for identification and email addresses of POCs and Report Distribution Lists.

v. Contractor will be notified by facilities of any updates to identified points of contact on an as needed basis.

h. TESTING FREQUENCY

i. Certification procedures for PEC and room defined in CETA CAG-003-2006 and CETA CAG-009-00 shall be performed by a CETA CNBT certified testing individual no less than every 6 months, whenever the PEC or room is relocated or altered, when major service to the sterile compounding facility is performed, or to assess corrective actions associated with prior failed testing results. More frequent testing may be required should USP standards change during the performance period or ordering periods.

ii. Viable surface sampling will be completed every month, or more frequently if required to assess corrective actions associated with prior failed results. More frequent testing may be required should USP standards change during the performance period or ordering periods.

iii. Viable airborne particle sampling will be completed every 6 months, or more frequently if required to assess corrective actions associated with prior failed testing results. More frequent testing may be required should USP standards change during the performance period or ordering periods.

iv. Environmental wipe sampling for HD residue will be performed every 6 months, or more frequently if required to verify containment for those facilities who opt to perform this testing as part of their HD sterile compounding quality assurance activities.

i. PERSONNEL COMPETENCY ASSESSMENT

Contractor shall provide a written description of media fill testing and gloved fingertip testing (MFT/GFT) procedures training and assessment procedures, consistent with USP <797> and USP <800>, to include hand hygiene and garbing observations, gloved fingertip and thumb sampling, and media fill testing.

i. Contractor shall visually observe compounding personnel while performing hand hygiene and garbing procedures initially, with frequency outlined in current USP <797> standards and USP <800> standards for each successfully trained employee.

Schaefer, Monica G. (V15) Previously had issues with vendor requesting additional line item for travel for additional testing outside the every 6 month certification for room failures, particularly when there were ongoing extended corrective action plans being implemented. Contracting deemed that the SOW that was agreed upon would not allow us to pay additional line item for this travel since it was not included in the SOW or as a line item with the contract. Tighten wording on this as needed. Same for subsequent 2 bullets in this section.

Schaefer, Monica G. (V15) From EK/Katie:��Regarding visual IV compounding, to my understanding KCVA utilized the closed transfer device training with staff during this time. This is something we are looking into as well for those staff members that may admix chemotherapy. Wondered if this needs to be included in this SOW since this is more of a time commitment whoever is conducting the training and may need to be onsite more than a couple of days.

ii. Contractor shall obtain gloved fingertip and thumb samples three separate times after performing a separate and complete hand hygiene and full garbing procedure initially for new personnel.

iii. Contractor shall obtain gloved fingertip and thumb sampling after completing the media-fill test, for those personnel who successfully completed initial competency evaluations with frequency outlined in current USP <797> standards and USP <800> standards.

iv. Contractor shall obtain media fill test with frequency outlined in current USP <797> standards and USP <800> standards for those personnel who successfully completed initial competency and evaluations.

v. Contractor shall incubate gloved fingertip and thumb samples and media fill tests in controlled temperature environments in accordance with USP <797> guidance and USP <800> standards, and report results and action levels to the facility POC as soon as results are available.

vi. The contractor will designate at least 2 separate days for each facility to re-qualify successfully trained personnel, to maintain current re-qualification of all staff. If gloved fingertip and thumb samples and/or media fill tests are failed by an employee, contractor will provide re-testing of those employees within 30 days of the date the failed test was performed. Facility will contact contractor upon learning of need for new employee training and contractor will perform training of new employees within a mutually agreed upon time frame.

vii. Contractor will offer closed system transfer device (CSTD) media fill testing at the request of the facility. This may be requested for sites who compound chemotherapy and other hazardous drugs.

viii. Training and competency assessment frequency will be adjusted, as needed, in compliance with USP standards.

j. PERSONNEL TRAINING AND COMPETENCY REPORTING

Each employee’s written test will be provided to the facility point of contact for competency documentation. A summary of each employee’s training and qualification assessment shall be included in a report to document personnel training.

i. Employee name

ii. Date of testing

iii. Testing procedures for hazardous and/or non-hazardous compounding

iv. Date of next required qualification assessment(s)

v. Written test results noting score and PASS/FAIL result

vi. Observed hand hygiene and garbing procedures with PASS/FAIL result

vii. Gloved fingertip and thumb samples results including action levels, cfu per hand, and PASS/FAIL result

viii. Media fill testing results with PASS/FAIL result

k. ESTIMATED SERVICE NEEDS

See VISN 15 IV Room/Hood/Training Services Estimate worksheet for estimated quantities of services needed for each facility over the contract period.

6. DESCRIPTION OF WORK

The VA Heartland Health Care Network (VISN 15) requires a VISN-wide contract for standardized testing criteria appropriate for all PECs used pursuant to current <797> and <800> standards using Controlled Environment Testing Association (CETA) Certified National Board of Testing (CNBT) certified individuals to establish consistent PEC certification procedures using the Certification Guide for Sterile Compounding Facilities CAG-003-2006. Achieving and maintaining certification will ensure full compliance with VHA Directive 1108.12, USP standards and FDA Insanitary Conditions Guidance. This contract will prevent the risk of contamination, ensuring the safety and efficacy of compounded medications provided to patients. Certification will prevent potential regulatory actions that could disrupt compounding operations, thereby allowing VISN 15 pharmacies to continue delivering essential compounded medications to patients without interruption.

7. DELIVERABLES

The contractor shall furnish all necessary materials, supplies, equipment, personnel and supervision to complete required tasks.

a. CONTRACTOR FURNISHED MATERIALS.

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

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

iii. All equipment will be stored and transported by the contractor in a manner that maintains cleanliness of equipment and introduces minimal microorganisms into the clean environments being tested.

iv. All equipment will be wiped/cleaned prior to taking into clean testing environments.

b. GOVERNMENT FURNISHED MATERIALS AND SERVICES.

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

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

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

iv. May also provide desk phone service as needed.

c. COMMUNICATION

i. The contractor (or Representative) shall contact the facility identified POC(s) to schedule work and prior to the beginning of work.

ii. Scheduling of work will be at the direction of facility identified POC(s) to ensure services are incorporated into current facility certification cycles.

iii. Local facility COR(s) will provide the contractor with additional facility specific procedures which include:

1. Check in and check out procedures

2. Contractor badging requirements

3. Parking procedures

4. Any additional facility specific procedures.

a) The contractor will be expected to adhere to those procedures.

b) If a contractor is willing to perform services after 4:00pm (CST) this service must be included within the bid pricing as no extra charge. The ability to perform work after hours is not required; however, preferences will be given to contractors that offer flexible work hours.

8. SECURITY REQUIREMENTS

There are no security requirements required for this work, as samples are retrieved by the contractor and a test report is received in return. Contractor does not have access to electronic health records or VA network.

9. INVOICES:

a. Payment will be made upon receipt of a properly prepared detailed invoice, prepared by the Contractor and submitted through Tungsten Network (formerly known as OB10) http://www.tungsten-network.com/us/en/. A properly prepared invoice shall contain:

i. Invoice Number and Date

ii. Contractor’s Name and Address

iii. Accurate Purchase Order Number

iv. Supply or Service provided

v. Period Supply or Service Provided

vi. Total Amount Due

b. Please begin submitting your electronic invoices through the Tungsten Network for payment processing, free of charge.

c. If you have questions about the e-invoicing program or Tungsten Network, contact information is as follows:

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

i. Tungsten e-Invoice Setup Information: 1-877-489-6135

ii. Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

iii. FSC e-Invoice Contact Information: 1-877-353-9791

iv. FSC e-invoice email: vafsccshd@va.gov

d. Web Address: HTTP://WWW.FSC.VA.GOV/EINVOICE.ASP

e. Payment will be completed by invoicing from each facility by assigned PO# on awarded task order for every ordering period.

10. RECORDS MANAGEMENT LANGUAGE FOR CONTRACTS

The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract:

a. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

b. Contractor shall treat all deliverables under the contract as the property of the U.S.

Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

c. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

d. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

e. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

f. The Government Agency owns the rights to all data/records produced as part of this contract.

g. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

h. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

mailto:VA.Registration@Tungsten-Network.com http://vafsccshd@va.gov http://www.fsc.va.gov/EINVOICE.ASP

i. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its Contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

11. GENERAL ADMINISTRATION

a. POINTS OF CONTACT (POCs).

The contractor will contact the POC to schedule the work to be completed; upon arrival, the contractor will contact the POC. The POC will escort the contractor to the appropriate area and monitor the work being done. Upon completion of the work, the POC will escort the contractor out of the area.

REPORT DISTRIBUTION LISTS

Facility Name CSP E-Mail Address

VISN 15 589 Kansas City, MO vhakanpharmacysupervisors@va.gov

VISN 15 589A4 Columbia, MO VHACMOPHARMEnvironmentalControlTests@va.gov

VISN 15 589A5 Topeka, KS EKHCSPharmacyManagement@va.gov

VISN 15 589A6

Leavenworth, KS EKHCSPharmacyManagement@va.gov

VISN 15 589A7 Wichita, KS vhawiccspcertification@va.gov

VISN 15 657 St. Louis, MO

J. Cochran STLCSPG@va.gov

VISN 15 657A0 St. Louis, MO J.

Barracks STLCSPG@va.gov

VISN 15 657A4

Poplar Bluff, MO popbluff-pharmacycsp@va.gov

VISN 15 657GH popbluff-pharmacycsp@va.gov mailto:popbluff-pharmacycsp@va.gov mailto:popbluff-pharmacycsp@va.gov

Cape Girardeau, MO

VISN 15 657A5 Marion, IL VHAMRNCSPCERTIFICATION@va.gov

VISN 15 657GJ Evansville IN VHAMRNCSPCERTIFICATION@va.gov

b. CONTRACT ADMINISTRATION DATA.

All contract administration functions will be retained by the Department of Veterans Affairs.

The Contracting Officer will be the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer will be authorized to make commitments or issue changes that affect price, or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof.

c. NON-PERSONAL SERVICES.

This is a non-personal services contract. Personnel rendering services under this contract are not subject either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the government and its employees. The Government shall not exercise any supervision or control over the contract service providers performing services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn, is responsible to the Government.

d. HOURS OF OPERATIONS.

i. Business hours: Monday through Friday, 8:00 a.m. – 4:30 p.m.

mailto:VHAMRNCSPCERTIFICATION@va.gov

ii. National Holidays: The holidays observed by the Federal Government are:

New Year’s Day;

Martin Luther King’s Birthday;

Presidents Day;

Memorial Day;

Juneteenth National Independence Day;

Independence Day;

Labor Day;

Columbus Day;

Veterans Day;

Thanksgiving;

Christmas; and

Any other observed Federal holiday.

e. CONTRACT PERFORMANCE MONITORING.

The COR(s) may perform surveillance of services by any of the methods listed below:

i. Observing actual performance

ii. Inspecting the services to determine whether the performance meets the performance standards

iii. Review of any other appropriate records

iv. When unacceptable performance occurs, the POC shall inform the Contractor and the

Contracting Officer. This will normally be in writing unless circumstances necessitate verbal communication. In any case, the POC shall document the discussion and place it in the POC file. When the POC determines that formal written communication is required, the POC shall prepare a Contract Discrepancy Report (CDR) and present it to the contractor program manager. The Contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the Contractor is required to prepare a corrective action plan to document how the Contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the Contractor must present this corrective action plan to the POC. The Government shall review the Contractor corrective action plan to determine acceptability. Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the Contracting Officer.

v. Pursuant to VAAR Provision 852.270-1, Representatives of Contracting Officer representative(s); The Government shall periodically evaluate the Contractor performance by appointing a POC to monitor performance to ensure services are received. The Government representative(s) shall evaluate the Contractor performance through inspections of observations, inspection of services or any other form of documentation and all complaints from VA personnel. The Government may inspect as each task is completed or increase the number of quality assurance inspections if deemed appropriate because of repeated failures or because of repeated customer complaints. Likewise, the Government may decrease the number of quality assurance inspections if performance dictates. The Government Contracting Officer shall make final determination of the validity of customer complaint(s).

vi. If any of the services do not conform to contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount. When the defects in services cannot be corrected by re-performance, the Government may require the Contractor to take necessary action to ensure that future performance conforms to contract requirements at no additional cost to the Government.

vii. Require the Contractor to take necessary action to ensure that future performance conforms to contract requirements at no additional cost to the Government.

f. CONTRACT SECURITY.

The C&A requirements do not apply, and a Security Accreditation Package is not required.

Also, no BAA is required.

B.3 PRICE/COST SCHEDULE

This is a Five-Year (5) IDIQ Contract with five (5), twelve 912) month ordering periods:

The guaranteed Minimum is $50.00.

The Contract Ceiling for the Life of the Contract is $2,500,000.00.

See Attached Excel Spreadsheet for Line Items

See attached document: SCHEDULE.

See attached document: DELIVERY.

SECTION C - CONTRACT CLAUSES

FAR

Number

Title Date

52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

NOV 2023

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

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

(End of Clause)

FAR

Number

Title Date

52.203-6 RESTRICTIONS ON SUBCONTRACTOR SALES TO THE

GOVERNMENT ALTERNATE I (NOV 2021)

NOV 2021

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS NOV 2023

52.203-19 PROHIBITION ON REQUIRING CERTAIN INTERNAL

CONFIDENTIALITY AGREEMENTS OR STATEMENTS

JAN 2017

52.204-9 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR

PERSONNEL

JAN 2011

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE NOV 2025

52.209-6 PROTECTING THE GOVERNMENT'S INTEREST WHEN

SUBCONTRACTING WITH CONTRACTORS DEBARRED,

SUSPENDED, PROPOSED FOR DEBARMENT, OR

VOLUNTARILY EXCLUDED

JAN 2025

52.209-9 UPDATES OF PUBLICLY AVAILABLE INFORMATION

REGARDING RESPONSIBILITY MATTERS

NOV 2025

52.209-10 PROHIBITION ON CONTRACTING WITH INVERTED

DOMESTIC CORPORATIONS

NOV 2025

52.217-8 OPTION TO EXTEND SERVICES NOV 1999

52.219-6 NOTICE OF TOTAL SMALL BUSINESS SET-ASIDE NOV 2020

52.219-8 UTILIZATION OF SMALL BUSINESS CONCERNS JAN 2025

52.219-14 LIMITATIONS ON SUBCONTRACTING OCT 2022

52.222-35 EQUAL OPPORTUNITY FOR VETERANS JUN 2020

52.222-36 EQUAL OPPORTUNITY FOR WORKERS WITH

DISABILITIES

JUN 2020

52.222-37 EMPLOYMENT REPORTS ON VETERANS JUN 2020

52.222-40 NOTIFICATION OF EMPLOYEE RIGHTS UNDER THE

NATIONAL LABOR RELATIONS ACT

DEC 2010

52.222-41 SERVICE CONTRACT LABOR STANDARDS AUG 2018

52.222-42 STATEMENT OF EQUIVALENT RATES FOR FEDERAL

HIRES

MAY 2014

52.222-43 FAIR LABOR STANDARDS ACT AND SERVICE

CONTRACT LABOR STANDARDS—PRICE ADJUSTMENT

(MULTIPLE YEAR AND OPTION CONTRACTS)

AUG 2018

52.222-50 COMBATING TRAFFICKING IN PERSONS OCT 2025

52.222-54 EMPLOYMENT ELIGIBILITY VERIFICATION JAN 2025

52.222-62 PAID SICK LEAVE UNDER EXECUTIVE ORDER 13706 JAN 2022

52.226-8 ENCOURAGING CONTRACTOR POLICIES TO BAN TEXT

MESSAGING WHILE DRIVING

MAY 2024

52.228-5 INSURANCE—WORK ON A GOVERNMENT

INSTALLATION

JAN 1997

C.2 SUPPLEMENTAL INSURANCE REQUIREMENTS

In accordance with FAR 28.307-2 and FAR 52.228-5, the following minimum coverage shall apply to this contract:

(a) Workers' compensation and employers liability: Contractors are required to comply with applicable Federal and State workers' compensation and occupational disease statutes. If occupational diseases are not compensable under those statutes, they shall be covered under the employer's liability section of the insurance policy, except when contract operations are so commingled with a Contractor's commercial operations that it would not be practical to require this coverage. Employer's liability coverage of at least $100,000 is required, except in States with exclusive or monopolistic funds that do not permit workers' compensation to be written by private carriers.

(b) General Liability: $500,000.00 per occurrences.

(c) Automobile liability: $200,000.00 per person; $500,000.00 per occurrence and $20,000.00 property damage.

(d) The successful bidder must present to the Contracting Officer, prior to award, evidence of general liability insurance without any exclusionary clauses for asbestos that would void the…