S03. 36C26324Q1194.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

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

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

636-25-1-4208-0001

36C26324Q1194 09-20-2024

Arielle Lifto arielle.lifto@va.gov 651-293-3031 10-11-2024

4:00 PM CDT

36C263 Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

316 Robert Street N. STE. 506 St. Paul MN 55101

X 100

X

541380

$19 Million

N/A

X

36C368

Department of Veterans Affairs

Iowa City Medical Center 601 Highway 6 West Iowa City IA 52246

36C263

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

316 Robert Street N. STE. 506 St. Paul MN 55101

Y

Department of Veterans Affairs Financial Services Center PO Box 149971

Austin TX 78714-9971

See CONTINUATION Page

Hood and Cleanroom Certification This requirement is for testing and certification of all the Iowa City VA Health Care System hoods either once or twice a year. This requirement is also for testing and certification of all PECs, SECs and SCAs as described on an attached table below located in statement of work.

Anticipated period of performance for this contract:

Base: 11/01/2024-10/31/2025 Option Year 1: 11/01/2025-10/31/2026 Option Year 2: 11/01/2026-10/31/2027 Option Year 3: 11/01/2027-10/31/2028 Option Year 4: 11/01/2028-10/31/2029

See Attached P07 Wage-Determination for Johnson County

See CONTINUATION Page

X X

X One

Jesse Sweesy

VA-VHA-RPOC-2023-0042

36C26324Q1194

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 DESCRIPTION / SPECIFICATION / WORK STATEMENT

B.2 PRICE/COST SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 IT CONTRACT SECURITY

C.2 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2023)

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

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

C.5 SUPPLEMENTAL INSURANCE REQUIREMENTS

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

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

(DEVIATION)

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

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023)

(DEVIATION)

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

2018)

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

C.10 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.11 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAY 2024)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

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

COMMERCIAL SERVICES (SEP 2023)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.3 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT

ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)

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

E.5 52.216-1 TYPE OF CONTRACT (APR 1984)

E.6 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.7 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.8 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.9 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

ADDENDUM to 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES

E.10 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT:

Contracting Officer 36C263 Jesse Sweesy Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

316 Robert Street N. STE. 506 St. Paul MN 55101

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

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

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

AMENDMENT NO DATE

B.2 DESCRIPTION / SPECIFICATION / WORK STATEMENT

Iowa City VA Health Care System

Biosafety Cabinet, Hood, Pharmacy Cleanroom Certification

STATEMENT OF WORK – GENERAL INFORMATION

INTRODUCTION:

Certification of Hoods This requirement is for testing and certification of all the Iowa City VA Health Care System hoods either once a year (every 12 months +/- 30 days) or twice per year (every 6 months +/- 20 days) as described in the attached list. Hoods refers to all the following: Biosafety cabinets, chemical fume hoods, research animal housing units, research animal change stations and a HEPA unit for research animal allergen control during cage changes.

Certification of Primary Engineering Controls (PEC) and Secondary Engineering Controls (SEC) and/or Segregated Compounding areas (SCA) This requirement is also for testing and certification of all PECs, SECs and SCAs as described on the attached list. PECs include biological safety cabinets (BSCs), laminar airflow workstation (LAFW), compounding aseptic containment isolators (CACI), and compounding aseptic isolators (CAI). All PECs, SECs and SCAs are certified twice a year (every 6 months +/_ 20 days) as described in the attached list.

All PECs and SECs are certified twice a year (every 6 months +/_ 20 days) as described in the attached list.

Testing and certification of all PECs, SECs and SCAs will be completed in accordance with the latest version of United States Pharmacopeia (USP) Chapter <797>, and USP Chapter <800> or current guidelines as delineated below

BACKGROUND:

The ICVAHCS is required to maintain all Hoods, PECs, SECs and SCAs that are in use for staff and product protection. This requirement will describe all testing and certification activities required for all Hoods, PECs, SECs, and SCAs All are considered engineering controls used for personnel protection and/or product protection and must be certified to industry standards to ensure they are providing the required protection.

The ICVAHCS is pursuing a contract for standardizing testing criteria appropriate for all PECs, SECs, and SCAs used pursuant to current USP Chapter <797> and Chapter <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-003-2022 or current guidelines.

Although USP <797> states that certification procedures “such as” those outlined CAG-003- 2022 shall be performed, Veterans Affairs (VA) will be requiring that CAG-003-2022 be used in lieu of any other “such as” procedures that may exist. Testing procedures shall be maintained in compliance with all current applicable standards. CAG 001-2005 CETA Guide for the use of Compounding Aseptic Isolators in Healthcare Facilities, Revised December 8, 2008 and CAG- 002-2006 CETA Compounding Isolator Testing Guide Revised December 8, 2008, or current guidelines, will also be used as the applicable standard for their respective PEC.

The United States Pharmacopeial Convention (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. The Food and Drug Administration (FDA) has the authority to inspect VA medical facilities under the Draft Guidance on “Insanitary Conditions at Compounding Facilities” which was published in August 2016.

Certification procedures defined in CETA CAG-003-2022 shall be performed by a CETA National Board of Testing (CNBT) certified testing individual no less than every 6 months (= or – 20 days) or whenever the PEC or room is relocated or altered or when major service to the sterile compounding facility is performed.

ICVAHCS is also pursuing contracting for the following tasks as outlined in current USP <797> and USP <800 >.

• Monthly surface sampling of described PECs, SECs and SCAs under dynamic operating conditions

• Semi-Annual viable air and surface sampling (Fungal and Microbial) of described PECs and SECs under dynamic operating conditions.

• Semi-annual Hazardous Drug (HD) Wipe Sampling of thirty pre-determined locations where HDs are handled. Locations will be determined by the COR in collaboration with Pharmacy.

• A semi-annual airflow Smoke Visualization Study of each PEC and SEC under dynamic operating conditions

• Replacement of cleanroom HVAC ceiling filters once every 5 years, including all room certification activities following the filter replacement(s)

• 2 hours of USP797/USP800 consulting

SCOPE OF WORK:

Hood and Primary Engineering Control Testing and Certification Biological Safety Cabinets (BSCs), CACI, CAI, LAFW All certification of BSC, CAI, CACI and LFW shall comply with the latest version of NSF/ANSI Standard 49 Appendix F. A test report will be generated, and any comments or problems noted. The contractor will immediately notify the Contracting Officer’s Representative (COR) with any results indicating failure. The unit will be marked with signage to let the user know that the unit shall not be used and contain the contact information of the facility contact (COR).

Repairs resulting in expenses outside of this contract will be negotiated with the VA Maintenance and Operations Manager or with Research Service who will contract with a qualified company to perform the repairs and required recertification before the unit can be used.

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

- Company name, address, and phone number

- Unit make, model and serial number

- Report number reflecting the room certification

- Location (room number)

- Certification date

- Recertification date

- Technician signature

Chemical Fume Hoods All certification of Laboratory Chemical Fume hoods will comply with the latest version of ANSI/ASHRAE Standard 110. Face velocity testing and smoke visualization testing will be required; however, the tracer gas containment test using sulfur hexafluoride will not be required.

The sash height achieving the required 100 fpm will be marked with a sticker designed for this purpose. A test report will be generated, and any comments or problems noted. Additionally, any fume hoods with face velocity monitors or controllers will be recalibrated to the correct velocity. The contractor will immediately notify the Contracting Officer’s Representative (COR) with any results indicating failure. The unit will be marked with signage to let the user know that the unit shall not be used and contain the contact information of the facility contact (COR).

Repairs resulting in expenses outside of this contract will be negotiated with the VA Maintenance and Operations Manager or with Research Service who will contract with a qualified company to perform the repairs and required recertification before the fume hood can be used.

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

- Company name, address, and phone number

- Unit make, model and serial number

- Report number reflecting the room certification

- Location (room number)

- Certification date

- Recertification date

- Sash height (only for fume hoods)

- The average recorded face velocity

- Technician signature

CSP PEC Testing and Certification

The contractor shall test and certify each PEC according to USP <797> and <800> using certification procedures from the Controlled Environment Testing Association (CETA) Certification Guides for Sterile Compounding Facilities (CAG-003-2022), ANSI/NSF-49 and/or the CETA Applications Guide for the Use of Compounding Aseptic Isolators in Compounding Sterile Preparations in Healthcare Facilities (CAG-001-2005 Revised Dec. 8, 2008) and/or CETA Compounding Isolator Testing Guide (CAG-002-2006 Revised Dec. 8, 2008) or the equivalent. All PECs must:

- be certified to meet ISO Class 5 or better

- maintain unidirectional airflow

- be supplied by HEPA filtered air

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

• Viable and non-viable particle counts

• Airflow velocity testing

• HEPA filter leak test

• Induction leak/back-streaming test

• Cabinet leak test

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

• Surface microbial and fungal sampling

• Air microbial and fungal sampling

• Airflow Smoke pattern test under dynamic operating conditions (contractor will provide video documentation of each test to facility POCs).

Airflow smoke pattern testing will be completed in accordance with CAG-003-2022 for each pharmacy PEC initially and when changes are made to the PEC or room configuration. The testing will be video recorded, and the contractor must have experience in collecting these videos. The facility will provide a minimum of one pharmacy technician to conduct simulated drug compounding in each PEC during the smoke visualization testing. The testing must show that first air conditions are achieved at the critical site during all compounding tasks within the respective PEC. This may mean that the contractor provides movement of the smoke source and/or multiple camera angles to ensure that each compounding task is effectively shown to be completed within an area receiving first air. It is important that the contractor recognize that this testing is beyond the typical scope of an equipment certification. These videos are to capture both the effective operation of the PEC and the effective compounding techniques of the pharmacy staff. The contractor should understand that coordination with the pharmacy staff and management is imperative in collecting useful PEC smoke visualization videos as intended by

CAG-003-2022.

Laminar Flow Hoods Biological Safety Cabinet (BSC)) must be tested and certified according to CETA CAG-003-2022 guidelines and to manufacturer’s specifications.

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

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. Confirmation of this calibration shall be listed in the final certification report.

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. The contractor will immediately notify the Contracting Officer’s Representative (COR) with any results indicating failure. The unit will be marked with signage to let the user know that the unit shall not be used and contain the contact information of the facility contact (COR).

Repairs resulting in expenses outside of this contract will be negotiated with the VA Maintenance and Operations Manager or with Research Service who will contract with a qualified company to perform the repairs and required recertification before the fume hood can be used.

Restricted access barrier system (Compounding Aseptic Isolator (CAI), Compounding Aseptic Containment Isolator (CACI), and Isolators (i.e., PECs with a controlled workspace, transfer devices, access devices, and a decontamination system) must be certified according to CETA CAG-002-2006, Revised December 2008 and CAG-003-2022 guidelines and to manufacturer’s specifications. The contractor will immediately notify the Contracting Officer’s Representative (COR) with any results indicating failure. The unit will be marked with signage to let the user know that the unit shall not be used and contain the contact information of the facility contact (COR). Repairs resulting in expenses outside of this contract will be negotiated with the VA Maintenance and Operations Manager or with Research Service who will contract with a qualified company to perform the repairs and required recertification before the fume hood can be used.

All CSP Facilities, SECs and SCAs, must be tested and certified in accordance with ISO 14644- 1 Classifications of Air Cleanliness, CETA CAG-03-2022 and CETA CAG-009- 2020specifications. The contractor will provide comprehensive cleanroom testing and certification services with the frequency required by most current USP <797> standards and USP <800>. 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. USP Compliance Testing for Cleanrooms and Controlled Environment certification will include but is not limited to the following:

• Non-Viable Particle Counting under dynamic operating conditions

• Viable / Microbial and Fungal Air Testing

• Viable / Microbial and Fungal Surface Testing

• Airflow Volume Measurements

• Air Velocity Profile

• Room Air Exchange Rates

• Room Pressure Measurement (in water columns)

• In-Place Leak Testing of HEPA Filters

• Temperature, Relative Humidity Measurements

• Smoke test under dynamic conditions

Viable and Non-viable Particle Counts for CSP Facilities For the PECs and SECs, viable and non-viable particle counts samples will be collected. Viable samples will be collected for each device (both bacterial and fungal) for the air and surface in accordance with USP <797> and <800>. If levels measured during surface and/or air sampling exceed the levels in the Table 1 below, an attempt must be made to identify any microorganism recovered to the genus level with the assistance of a microbiologist.

Table 1. Action Levels for Viable Airborne Particle Air and Surface Sampling per USP <797>

ISO Class Air Sampling Action Levels

[cfu/cubic meter (1000 liters) of air/media device]

Surface Sampling Action Levels (cfu/media device)

5 >1 >3 7 >10 >5 8 >100 >50

Air Changes per Hour The contractor shall calculate the total room volume for each buffer, ante room, and hazardous drug storage room. A sketch of the room with dimensions, exhaust/supply diffuser locations and equipment locations shall be included in the report. The report provided will specify flow rates detailing returns and supply that were obtained during the testing. The contractor shall calculate air changes per hour (ACPH) for each buffer, ante room, segregated compounding area (SCA) and HD storage room and include their findings in the report. If a room does not meet USP<797> or USP <800> requirements for ACPH the identified site POC(s) shall be informed immediately.

Pressure Requirements The contractor shall include in their report differential pressure readings from each buffer/ante room to all surrounding areas as well as the static pressure of the hazardous drug SCA and the hazardous drug storage room. The report shall indicate whether the room is required to be a negative or positive pressure room per USP<797> (or USP <800> when applicable). The contractor shall report all pressures to an accuracy of 0.0001” water column (4 decimal places).

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

Viable Environmental Sampling

• The contractor shall perform viable environmental (air) sampling every 6 months for fungi and bacteria using high volume impaction samplers to conduct the sampling.

• In addition, semi-annual viable environmental surface sampling of classified areas will be performed. This includes the hazardous and non-hazardous buffer rooms, the ante room, the HD storage room, and each segregated compounding area. When conducted, surface sampling must be performed at the end of the compounding activities or shift, but before the area has been cleaned and disinfected. Air and surface sampling shall be performed in the following areas:

• The interior of the PEC and the equipment contained in it

• Staging or work area(s) near the PEC

• Frequently touched surfaces

• Pass-through chamber(s)

• Air sampling: A sufficient volume of air (1000 liters) shall be tested at each location to maximize sensitivity. Samples of less than 1000 liters will not be acceptable.

• Surface Sampling: The contractor shall perform surface samples for bacteria using Tryptic Soy Agar (TSA) contact plates and Malt Extract Agar (MEA) or Sab DEX contact plates for sampling of fungi. Surface sampling must be performed at the end of the compounding activities or shift, but before the area has been cleaned and disinfected.

• The lab chosen to analyze the samples must be verified prior to testing and be certified.

Environmental Wipe Sampling for Hazardous Drug Residue The contractor will perform environmental wipe sampling for hazardous drug surface residue semi-annually (e.g., every 6 months). 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. Retesting, if required to mitigate any contamination found over a locally established action level, will be done by the ICVAHCS.

The drugs required for testing include:

• Cyclophosphamide

• Doxorubicin HCL

• Etoposide

• Irinotecan HCL

• Paclitaxel

• Cisplatin

• Carboplatin

• Oxaliplatin

• 5-Fluorouracil

• Platinum-containing drugs

• Additional Drugs o Additional drugs may be requested based upon identified need per site.

o 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.

A total of 30 surface samples will be completed per certification. Surface sampling will include areas identified by Pharmacy staff, including but not exclusive to the following:

• Interior of PEC and equipment contained in it (i.e., camera).

• Pass-through chambers

• Surfaces in staging or work areas near PEC

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

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

• Patient administration areas

Nonviable Particle Testing The contractor shall perform environmental nonviable particle testing semiannually (e.g., every 6 months). The contractor shall derive the minimum number of sampling locations using Annex A in the ISO 14644-1.2 standard. Testing shall be performed by qualified operators using current, state-of-the-art electronic equipment with results per USP797, Section 4.1.

Report Requirements:

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

Pass/Fail notifications should be included on a per-test basis where applicable.

Reports to include at a minimum:

• Environmental sampling reports will contain both the quantitative number of bacterial/fungal isolates as well as the species grown.

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

• Action level for ISO area tested

• Executive summary or summary of findings.

• Room number and/or location

• Room type (e.g., oncology prep room)

• Type of PEC certified

• Serial number of the equipment certified

• Bldg. Asset number of the equipment certified

• Date and time samples collected, and particle counts tested

• Name of Technician collecting the samples

• Date of next required certification

• Standards used to test room or equipment

• Comments indicating when dynamic operating conditions were used

• Notes

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

• Sketch identifying location of each sample obtained

• Total room area and volume

• Room humidity and temp

• Room air changes per hour

• Pressure differentials in water columns

• Nonviable particle counts (cfu’s)

• Viable particle count analysis, action level for target ISO level

• Sketch of viable particle test location in room

• Certificates of analysis of media used

• Comments indicating when dynamic operating conditions were used

Report Distribution The contractor will immediately notify the Contracting Officer’s Representative (COR) with any results indicating failure. A formalized written report including all required aspects specified in this Statement of Work will be provided in a timely manner with receipt by identified points of contact no more than 14 business days from certification evaluation.

All completed reports will be provided via email to the COR. Contractor will be notified by the facility of any updates to identified points of contact list on an as needed basis.

Testing Frequency:

• Certification procedures for Pharmaceutical Compounding Areas defined in CETA CAG- 003-2022 and other references CETA documents, shall be performed by a CETA mailto:Shauna.Leonard@VA.Gov

National Board of Testing (CNBT) certified testing individual no less than every 6 months (+ or – 20 days) or whenever the PEC or room is relocated or altered or when major service to the sterile compounding facility is performed.

• Environmental sampling (air and surface) will be completed semi-annually (every 6 months + or – 20 days), or more frequently if required to assess corrective actions associated with prior negative results.

• An airflow smoke pattern test under dynamic operating conditions initially and every 6 months per USP 797.

• Environmental wipe sampling for hazardous drug residue will be performed every 6 months,

• Monthly surface sampling in areas where CSPs are prepared.

• Class II Biological Safety Cabinets will be certified semi-annually or annually per the equipment/task list.

• Replacement of cleanroom HVAC ceiling filters once every 5 years, including all room certification activities following the filter replacement(s)

• 2 hours of consulting time per year.

Additional trip charges Additional trip fees have been built into the contract to us if additional testing, troubleshooting, adjustment or repair is required. These additional site visits will only be utilized at the request of the COR. The additional site visit line item shall include all costs associated with travel, per diem, lodging, mileage, movement/shipping of equipment, overnight pay, or any other costs the contractor may incur in visiting the facility during and outside of the normal semi-annual visits. The cost must cover a site visit which may exceed a single workday (depending on the additional work required).

Test equipment and contractor standards All test equipment will be supplied by the contractor and must be calibrated within the last 12 months to an industry standard and manufacturer specifications. Calibration certification letters for equipment must be kept with the contractor technician for review by the VA COR at the time of inspection, if needed.

All technicians performing the work must be qualified by education and experience. At least one technician performing the work in areas where CSPs are prepared must be CETA certified.

Per VHA Directive 1108.12, all certification procedures defined in the applicable CETA Application Guides must be performed by a CETA National Board Testing (CNBT) Registered Certified Professional (RCP) for Sterile Compounding Facility (SCF) individual or a vendor that employs at least one of these individuals initially and no less than every 6 months. Areas additionally must be recertified if there are any changes to the area such as redesign, construction, replacement or relocation of any PEC, or alteration in the configuration of the room that could affect airflow or air quality.

Place of Performance and Logistics:

The Iowa City VA Health Care System contains equipment and facilities for CSP at locations listed on the attached list. These locations are all in Iowa City on the hospital campus or nearby at the University of Iowa. The Contracting Officers Representative (COR) will be the primary contact for this contract. This person is the Facility Industrial Hygienist who is located in Bldg. 2, Room 203. They can be contacted at (319) 338-0581 Extension 636805 to discuss certification/inspection inquiries. Inspections must be scheduled with the COR at least 2 weeks in advance. This is to notify all personnel using the equipment/facilities well in advance to allow their workflow to be adjusted and enable the equipment and/or rooms to be available for certification procedures.

Required Services and Equipment List.

See table below for a detailed list of equipment and tasks included in this contract. This spreadsheet contains an overview of tasks with cost estimates, a detailed equipment/task list for Pharmacy/CSP areas, a detailed equipment list for non-pharmacy equipment, cost estimate for hazardous drug wipe sampling in all areas using or compounding hazardous drugs, a cost estimate and plan for monthly surface sampling for microbial and fungal contamination in CSP areas. Monthly surface sampling can be performed by in house pharmacy staff, but all supplies and lab services should be supplied by the contractor.

Changes to facility equipment or tasks will be communicated in a timely manner to the contractor and facility costs will be adjusted accordingly based on these changes. The contractor is to provide unit-based costs for services to allow for adjustments in equipment and tasks. If the total quantity of any line item exceeds the cost allocated in the contract, a modification will be submitted.

Background check and badging requirements – PDAT Determination, the contractor will submit SAC (Finger Prints) as well as acquire a Non-PIV Badge.

Contractor will complete the Training Requirements TMS 10176 Infosec/ROB, and TMS 20939 No Access. Contract agrees to National Archives and Records Administration (NARA). This non-PIV badge must be worn at all times while on site. If the contractor works at multiple VA facilities, the background check and non-PIV badge issuance only needs to be done once.

Payment-Invoicing The contractor will provide a telephone and email contact for billing inquiries.

Payment will be made from invoices at the completion of each service visit. Total payment will be denied for failure to comply with any of the contract requirements.

Period of Performance: Contract period is from date of award for five (5) years. Performance is to begin 15 calendar days from date of award. The contact is expected to start on November 1 to allow certification activities be done within the required time frame from the last certification.

Special Considerations:

Contractor Furnished Materials:

• All materials and tools to complete the work identified.

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

• All equipment will be stored and transported by the contractor in a manner that maintains cleanliness of equipment and introduces minimal microorganisms into the clean environments being tested. All equipment will be wiped/cleaned prior to taking into clean testing environments.

Government Furnished Materials and Services:

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

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

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

Qualifications/References: ICVAHCS is seeking a qualified contractor that meets the following specifications:

• Provide three references showing the completion of at least 3 jobs of similar size and scope at other hospital facilities with at least one of those facilities being a VA Medical Center. Reference information is to include Hospital/Medical Center name, POC name, email address and phone number.

• All certifications must be signed by an NSF 49 certified technician. A copy of NSF 49 certifications must be attached to the bid documentation for any technicians that will be performing work at the facility.

• All cleanroom performance testing must be supervised by a technician with a CETA National Board of Testing (CNBT) certification. The CETA-certified technician must be onsite and working within the clean room areas while testing is being conducted.

Supervision or oversight from a different location is not allowed. A copy of the certification must be attached to the bid documentation for the supervisor or project manager of the team that will be performing work at the facility.

• Provide AIHA accredited laboratory certification for all USP<797> viable sampling analysis. Certification must be attached with bid documentation.

• Provide copy of clean room certification report for evaluation.

• Provide certification from accredited laboratory performing analysis of Hazardous Drug wipe samples.

• Contractor (employees performing services at the facility) will attain VA clearance and obtain a PIV identification card.

Security Requirements:

• Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

• Vendor must ensure their use of this technology/standard is consistent with VA policies and standards, including, but not limited to, VA Handbooks 6102 and 6500; VA Directives 6004, 6512, 6513, 6517 and 6550 (if applicable); and National Institute of Standards and Technology (NIST) standards, including Federal Information Processing Standards (FIPS). Users must ensure sensitive data is properly protected in compliance with all VA regulations.

• Vendor will not sell VA Data gathered for profit or gain without the express approval of the VA.

Additional Considerations

• The contractor (or Representative) shall contact the COR to schedule work and prior to the beginning of work. Scheduling of work will be at the direction of COR to ensure services are incorporated into current facility certification cycles.

• COR will provide the contractor with additional facility specific procedures which include check in and check out procedures; contractor badging requirements; parking procedures; and any additional facility specific procedures. The contractor will be expected to adhere to those procedures. Services are to be performed during the hours between 8:00 AM and 4:00 PM Central Standard Time (CST), Monday through Friday, excluding federal holidays. Due to the workload of the pharmacy during business hours, the contractor may need to work after 4:00 PM CST to accommodate the compounding schedule at the pharmacy. Contractors that are willing to perform after-hours work should include this information in their bid documentation. 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.

Invoicing Payment will be made following each visit, invoices will be prepared by the Contractor, and submitted through Tungsten Network https://vaww.ipps.fsc.va.gov/A properly prepared invoice shall contain:

• Invoice Number and Date

• Contractor’s Name and Address

• Accurate Purchase Order Number

• Supply or Service provided

• Period Supply or Service Provided

• Total Amount Due

Contractor questions about the e-invoicing program (Tungsten Network), contact information is as follows:

• Tungsten e-Invoice Setup Information: 1-877-489-6135

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

• FSC e-Invoice Contact Information: 1-877-353-9791

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

Web Address for information and registration: HTTP://WWW.FSC.VA.GOV/EINVOICE.ASP

The contractor will provide an electronic copy of each invoice to the identified POC(s).

http://www.fsc.va.gov/EINVOICE.ASP http://www.fsc.va.gov/EINVOICE.ASP

Item # Description Freq Per Year

Total Contract Qty Location

1 Barrier Isolator/Glovebox (CACI or CAI), vented units 2 2 BW110C

2 Class II BSC- Pharmacy 2 12

8W19A (Qty 2) 8W19C (Qty 2)

BS04G

BW110C

3 Clean Room Ceiling Supply HVAC HEPA Filter Test 2 18

8W19A (Qty 2) 8W19B (Qty 2) 8W19C (Qty 3) 8W19A Passthrough (Qty 1) 8W19C Passthrough (Qty 1)

Clean Room Suite Certification USP797/800 (USP797 ISO Class Spaces) 2 6

8W19A 8W19B 8W19C

Room certification for Segreated Compounding (SCA) spaces 12 ACPH 2 6

BW110C

BS04G

8W19D

Viable Air and Surface Sampling in PECs, fungal and microbial 2 34

8W19A PEC (Qty 2) 8W19C PEC (Qty 2)

BS04G PEC

BW110C PEC

BW110C Isolator BW110C Isolator Passthrough

BW110C PEC

Viable Air and Surface Sampling in Rooms, fungal and microbial 2 33

8W19A 8W19B 8W19C

BS04G

BW110C

8W19A Passthrough (Qty 1) 8W19C Passthrough (Qty 1)

8 USP797/800 Consulting per hour 1 2 Consulting

9 Monthly Surface Sampling- 25 samples 1 12

10 Hazardous Drug Wipe Sampling- 36 samples 2 2 Varies

11 Smoke Visualization Study in PECs 2 14

8W19A PEC (Qty 2) 8W19C PEC (Qty 2)

BS04G PEC

BW110C Isolator

BW110C BSC

12 Smoke Visualization Study in Rooms 2 10

8W19A 8W19B 8W19C

BS04G

BW110C

13 Class II BSC (36 identified, 4 extra) 1 42 14 Class II BSC 2X 2 2 BW119A 15 Fume Hood 1 19 16 Research Animal Housing Units 1 18 17 Research Animal Change Station 1 8 18 Biobubble, HEPA filtration 1 2

19 Trip Charge 8 8

RECORDS MANAGEMENT OBLIGATIONS

A. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes Iowa City Medical Center records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their

Iowa City Medical Center contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5

Items below are needed once during the 5 year contract.

Item # Description

Freq Per Year (Done once in 5 years)

Total Contract Qty Location

Clean Room Ceiling Supply HVAC HEPA Filter Replacement - Filter cost & Consumables <1 8

8W19A (Qty 2) 8W19B (Qty 2) 8W19C (Qty 3) 8W19D

Clean Room Ceiling & Passthrough HEPA Filter Replacement - Labor & Consumables <1 2

8W19A Passthrough (Qty 1) 8W19C Passthrough (Qty 1)

Viable Air and Surface Sampling in Rooms, fungal and microbial <1 6

8W19A 8W19B 8W19C 8W19D 8W19A Passthrough (Qty 1) 8W19C Passthrough (Qty 1)

23 Smoke Visualization Study in Rooms <1 3

8W19A 8W19B 8W19C

U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. Iowa City Medical Center and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation.

Records may not be removed from the legal custody of Iowa City Medical Center or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity.

Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to Iowa City Medical Center. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to Iowa City Medical Center control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle].

Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and Iowa City Medical Center guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with [Agency] policy.

8. The Contractor shall not create or maintain any records containing any non-public Iowa City Medical Center information that are not specifically tied to or authorized by the contract.

9. The 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 from public disclosure by an exemption to the Freedom of Information Act.

10. The Iowa City Medical Center owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S.

Government for which [Agency] shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take Iowa City Medical Center provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.] D. Flowdown of requirements to subcontractors

1. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this Firm-Fixed Price Contract and require written subcontractor acknowledgment of same.

2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

B.3 PRICE/COST SCHEDULE

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

2.00 EA __________________ __________________

Barrier Isolator/Glovebox (CACI or CAI), vented units

PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services PRODUCT/SERVICE CODE: H399 - Inspection - Miscellaneous

12.00 EA __________________ __________________

Class II BSC - Pharmacy

18.00 EA __________________ __________________

Clean Room Ceiling Supply HVAC HEPA Filter Test

6.00 EA __________________ __________________

Clean Room Suite Certification USP 797/800 (USP 797 ISO Class

Spaces)

6.00 EA __________________ __________________

Room Certification for Segregated Compounding (SCA) spaces (12

ACPH)

34.00 EA __________________ __________________

Viable Air and Surface Sampling in PECs (fungal and microbial)

33.00 EA __________________ __________________

Viable Air and Surface Sampling in Rooms (fungal and microbial)

USP 797/800 Consulting per hour

12.00 EA __________________ __________________

Monthly Surface Sampling (25 Samples)

Hazardous Drug Wipe Sampling (36 Samples)

14.00 EA __________________ __________________

Smoke Visualization Study in PECs

10.00 EA __________________ __________________

Smoke Visualization Study in Rooms

42.00 EA __________________ __________________

Class II BSC (36 identified, 4 extra)

Class II BSC 2X

19.00 EA __________________ __________________

Fume Hood

18.00 EA __________________ __________________

Research Animal Housing Units

8.00 EA…