36C26325Q0427.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

437-25-3-6058-0649

36C26325Q0427

Becky De Los Santos 320-255-6480 02-27-2025

10:00 AM CST

36C263 Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

1303 5th St Suite 300 Coralville IA 52241

X 100

X

541380

$19 Million

N/A

X

Department of Veteran Affairs Fargo VA Health Care System 2101 Elm St North Fargo, ND 58102

36C263

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

1303 5th St, Suite 300 Coralville IA 52241

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971

See CONTINUATION Page

RFQ for Fume Hood Certification Service at Fargo VA.

See Statement of Work inserted in RFQ

This is a Service Disabled Veteran Small Business Set-aside.

The time of submission of offer, the offeror shal have an active registration in the System for Award Management(SAM) at www.sam.gov. All offerors shall fill out the certificate of compliance for limitations on sub-contracting at C.5 and return with the quote. Failure to sign the

Limitation of Subcontracting will result in quote being unresponsive.

Base Year: 05/01/2025-04/30/2026

Option Year 1: 05/01/2026-04/30/2027 Option Year 2: 05/01/2027-04/30/2028

Option Year 3: 05/01/2028-04/30/2029 Option Year 4: 05/01/2029-04/30/2030

See CONTINUATION Page

437-3650162-6058-855100-2670-010050192 437-25-3-6058-0649 x X x 01

Melissa Garrett

VA-VHA-RPOC-2023-0009

Table of Contents

SECTION A

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

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

SECTION C - CONTRACT CLAUSES

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

AND COMMERCIAL SERVICES (NOV 2023)

C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ...42

C.4 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED

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

(DEVIATION)

C.5 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023)

(DEVIATION)

C.6 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.7 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.8 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.9 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (JAN 2025)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 WAGE DETERMINATION…………………………………………………………… 58

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 52.216-1 TYPE OF CONTRACT (APR 1984)

E.5 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.6 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

ADDENDUM to 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

E.7 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

NETWORK 23 CONTRACTING OFFICE

1303 5th St

Suite 300

Coralville IA 52241

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] Upon receipt and acceptance

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.

Department of Veterans Affairs http://www.tungsten-network.com/US/en/veterans-affairs

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

AMENDMENT NO DATE

* INVOICING: All invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission.

Please go to this website: http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.

More information on the VA Financial Services Center is available at http://www.fsc.va.gov/einvoice.asp.

Vendor e-Invoice Set-Up Information:

Please contact the phone numbers or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have question about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below:

• e-Invoice Setup Information:

• e-Invoice email:

• FSC e-Invoice Contact Information:

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

Tungsten e-Invoice set-up information: 877-489-6135 Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com FSC e-Invoice Contact Information: 877-353-9791 FSC e-Invoice email: vafsccshd@va.gov More information on the FSC electronic invoicing process can be found at http://www.fsc.va.gov/einvoice.asp.

* VA ISSUED BADGE: Contract employees may be required to obtain a VA Flash Badge or Visitor Badge while physically located within the VA facility. Determination of badging will be made by the Omaha Project Manager. If required to obtain a VA Flash Badge, contract employees will be required to present 2 forms of government identification for verification of contract employee.

*CONTRACTOR ATTIRE AND IDENTIFICATION. The Contractor shall wear industry clothing that enables easy recognition as a “Contract Employee.” Clothing shall present a neat, distinctive appearance; shall be clean and maintained in good repair; and shall be worn as designed by the manufacturer. The Contractor shall wear appropriate clothing with logo identifying the contractor’s and employee’s name. The Contractor’s attire and presentation shall be appropriate per industry standard.

* EMERGENCY PROCEDURES. The Contractor shall take such safety precautions as necessary to protect the lives and health of occupants of the buildings. The Contractor shall comply with applicable Federal, State, Local and facility safety and fire regulations and codes which are in effect at the beginning of the contract period. The Contractor shall keep abreast of and comply with changes in these regulations and codes applicable to the contract. The Contractor shall follow applicable facility policies concerning fire and/or disaster events. The

Contractor shall display approved warning devices in all areas where operations may cause traffic obstruction or personnel hazard.

B.2 STATEMENT OF WORK

Pharmacy’s Compounded Sterile and Nonsterile Preparations USP Compliant Certification Program Statement of Work

Fargo Veteran Affairs Health Care System

Background: The Fargo Veterans Affairs Healthcare System (VAHCS) in Fargo ND, is seeking services to test, repair and certify a variety of pharmacy equipment and clean rooms on an annual and semiannual basis to maintain United States Pharmacopeia (USP) Certification compliance.

Scope: The contractor shall provide all labor, equipment, materials (including replacement parts), supplies, tools, transportation, any associated freight and travel necessary to perform all inspections, testing, certifications/recertifications, preventative maintenance, and repair or replacement of High Efficiency Particulate Air (HEPA) and other filters, as required throughout the contract period at Fargo VAHCS.

Fargo VAHCS uses a variety of engineering controls to limit employee exposures to hazardous contaminants while also providing a safe and effective preparation for patients. Fargo VAHCS’ Pharmacy Service has both secondary engineering controls (SECs) and containment secondary engineering controls (C-SECs) which make up the USP 797 and USP 800 compliant cleanroom suite. The cleanroom suite contains a variety of primary engineering controls (PECs) and containment primary engineering controls (C-PECs). The PECs include laminar airflow work benches (LAFW) for all non-hazardous sterile compounding and the C-PECs include externally vented Class II biological safety cabinets (BSCs) for hazardous sterile compounding, and a containment ventilated enclosure (CVE) for hazardous non-sterile compounding

The contractor shall perform routine work detailed in this performance of work statement (PWS).

The procurement is for a multi-year service contract, base year plus 4 option years, for the testing, certification, repair, and maintenance of the below listed Pharmacy Hoods and Laboratory hoods.

Certification of Laminar Airflow Workbenches (LAFWs) - 2 LAFWs up to 4 times per year

Certification of Biological Safety Cabinets (BSCs) - 3 BSCs up to 4 times per year

Certification of Containment Ventilated Enclosure (CVE) - 1 up to 3 times per year

Certification of Ante-Room (ISO 7) - up to 4 times per year

Certification of HD Storage Room (CVE) - up to 4 times per year

Certification of Positive Pressure Buffer Room (ISO 7) - up to 4 times per year

Certification of Negative Pressure Buffer Room (ISO 7) - up to 4 times per year

Certification of Pass-thru HEPA filter - up to 4 times per year

Monthly Viable Surface Sampling - 10 viable locations per month

Smoke Analysis of 3 Classified Rooms for Commissioning of Rooms

Travel Round Trip 2 Tech's - up to 6 times per year

The number of cleanrooms, segregated compounding areas (SCAs), LAFWs, CAIs, CACIs, CVEs, and BSCs in service may change throughout the contract period. Table A is the Government's best estimate of the number and type expected to be tested, sampled, serviced, and certified by the contract. The Government reserves the right to delete or add (+/- 2) units as required without modification.

Table A

Facility Location Room Name

ISO Classification

LAFW/BSC/CVE

BB-90

Ante-room

ISO Class 7

N/A

BB-90A

Negative Pressure Buffer

Room ISO Class 7

Class II, Type A2 BSC Manufacturer: Nuaire Model: NU-543-600 Class II, Type A2 BSC Manufacturer: Nuaire Model: NU-543-600 Class II, Type A2 BSC Manufacturer: Nuaire Model: NU-543-400

BB-90B

Positive Pressure Buffer

Room ISO Class 7

LAFW

Manufacturer: Nuaire Model: NU-340-630 AireGard ES

LAFW

Manufacturer: Nuaire Model: NU-340-630 AireGard ES

BB-78

Negative Pressure HD

Storage Room/Nonsterile C-

SCA

Unclassified

CVE

Model: NU-813-300 LabGard

If additional testing/certification, troubleshooting, adjustment, or repair is required, the contractor shall provide additional services/certifications of the engineering controls to ensure continuation of pharmacy operations in full compliance with USP 795, USP 797, USP 800, and all applicable CETA Application Guides. These additional site visits will only be utilized at the concurrence of the point of contact (POC) at the facility.

• The additional site visit(s) 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 outside of the normal annual and semiannual visits. The cost must cover a site visit which may exceed a single workday (depending on the additional work required).

• The contractor shall perform unscheduled work or emergency requests within five (5) days of a request from the POC.

Only the Contracting Officer (CO) has the right to obligate funding or order work not expressly detailed in this PWS. The Government shall not be held responsible for payment for any work performed by the contractor that is outside the scope of this contract or without the prior approval of the CO.

Place of Performance:

Fargo VAHCS 2101 North Elm Street Fargo, ND 58102

Work Performance

Certification results must be received with-in 6 months of previous certification date.

Completion of all hoods and rooms must be completed in one trip when completing routine scheduled services.

Contractor Qualifications

Contractor must have at least one CETA National Board of Testing (CNBT) Registered Certified Professional (RCP) for Sterile Compounding Facilities (SCF) with 2 or more years of experience on staff.

1. All certification testing/sampling should be supervised or performed by an individual with the aforementioned accreditations.

2. It is preferred that the on-site certification individual(s) have received NSF accreditation for the field certification of Class II Biosafety Cabinets and are accredited through CNBT as a RCP-SCF.

a. At minimum, the CNBT RCP-SCF individual on staff will review and sign the final certification report.

3. All technicians performing work must be qualified by education/on the job experience and have required CETA competencies and training related to the certification of primary and secondary engineering controls.

a. Verification of experience and competencies may be requested by Fargo

VAHCS.

4. Copies of pertinent certifications, accreditations, and/or licenses will be required upon submission of bids.

5. All service personnel will become familiar with and will be compliant with VA Medical Center policies and procedures pertaining to safety, fire, severe weather, and emergency procedures.

General Requirements

1. Contractor shall perform all required facility related testing and sampling according to the most current versions of CAG-003-2022, CAG-002-2022, ANSI/NSF-49, and/or their replacement application guides to determine whether the facility’s cleanroom suite, C-SCA, LAFWs, CAIs, CACIs, and/or BSCs used for sterile compounding meets requirements to be certified for use under current USP 797 and USP 800 standards.

2. Contractor shall perform all required facility related testing and sampling to determine if the C-SEC and CVE utilized for non-sterile HD compounding meets requirements to be certified for use under current USP 795 and USP 800 standards.

3. Contractor must use CETA CAGs to define certification procedures for assessing if the primary and secondary engineering controls are operating as designed, to maintain a sterile environment for the preparation of CSPs and no “equivalent” standards may be used for certification purposes.

4. Testing for PEC and C-PEC certification will ensure an ISO Class 5 or better-quality environment is present. To accomplish this, depending on CETA and manufacturer guidance for the type of PEC, related testing will include but is not limited to the following:

a. Airflow Velocity Tests including inflow velocity where applicable

b. HEPA Filter Integrity Tests

c. Induction Leak/Backstreaming Test

d. Cabinet Leak Test

e. Non-Viable Particle Count Tests

f. Viable Impact Volumetric Airborne Particulate Sampling (bacterial and fungal)

g. Viable Surface Sampling (bacterial and fungal)

h. Airflow Visualization Test (under dynamic operating conditions)

i. Exhaust Alarm Test (for BSC and/or CACI certification only)

j. Chamber Pressure Testing (main chamber and pass-through chamber for CAIs and CACIs)

k. Preparation Ingress and Egress Test

l. Particle Containment Integrity and Enclosure Leak Test

5. Testing for cleanroom suite certification will ensure an ISO Class 7 or better-quality environment is present. To accomplish this, testing will include at a minimum the following:

a. Airflow Velocity Testing

b. Air Changes Per Hour (ACPH) Testing/Air Exchange Rate Testing

c. Pressure Differential Testing of Each Opening (reported in water columns)

d. Airflow Displacement (when applicable)

e. Airflow Visualization Tests

f. HEPA Filter Integrity Testing (performed without breaching ceiling)

g. Non-Viable Particle Count Tests under dynamic operating conditions

h. Viable Impact Volumetric Airborne Particulate Sampling (bacterial and fungal)

i. Viable Surface Sampling (bacterial and fungal)

j. Temperature and relative humidity measurements

6. Facility related testing for C-SEC where non-sterile HD compounding is performed will include, but is not limited to the following:

a. Air Changes Per Hour (ACPH) Testing/Air Exchange Rate Testing

b. Airflow Visualization Test(s)

c. Pressure Differential Testing of Each Opening (reported in water columns)

d. HEPA filter Integrity Testing

e. Temperature and relative humidity measurements

7. Testing for CVE certification will include, but is not limited to the following:

a. Airflow Velocity Tests

b. Airflow Visualization Tests

c. HEPA Filter Integrity Tests

d. Particle Containment Integrity and Enclosure Leak Tests

8. Any safety data sheet (SDS) must be supplied to POC prior to using chemical on station

Performance Requirement Details

1. All compounding areas used to prepare either Category 1 or Category 2 CSPs must be certified using procedures outlined in the most current Controlled Environment Testing Association (CETA) application guide for Sterile Compounding Facilities.

2. Recertification of ALL classified areas must be performed no less than every 6 months and up to 14 days prior.

3. Per USP 797 requirements recertification testing must be re-performed if there are changes to the classified area(s) that could affect airflow or air quality. Such changes include but are not limited to:

a. Redesign

b. Construction

c. Replacement or relocation of any PEC

d. Alteration in the configuration of the room

e. The POC will work with the contractor to schedule repeat certification testing in response to such changes.

4. The contractor shall document:

a. Each individual face velocity reading and the average of those readings

b. The downstream concentration reading of the HEPA filter leak test and the results of the induction leak test and back-streaming test

c. Any failures shall be reported directly to the POC immediately

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

i. Contractor or POC can place the sign

5. Total airborne particle count testing must be performed in all classified areas every 6 months or up to 14 days prior.

a. This testing must be conducted under dynamic operating conditions.

b. When performing this testing in a PEC, personnel shall avoid disturbing the unidirectional airflow within the PEC.

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

6. Environmental monitoring (microbiological air and surface monitoring) must be performed every 6 months or up to 14 days prior and whenever:

a. equipment within the room is relocated

b. after servicing of the facility or equipment within the cleanroom suite

c. in response to identified problems or trends

d. or after any other alteration is performed within the cleanroom suite that could be reasonably expected to affect the quality of air (i.e., HVAC alterations, changing of HEPA filters, etc.).

i. The POC will work with the contractor to schedule repeat certification testing in response to such changes.

e. Viable volumetric airborne particulate sampling will be completed utilizing an impaction device and it must be performed in all classified areas at least every 6 months or up to 14 days prior. This sampling must be conducted under dynamic operating conditions. When performing this sampling in a PEC, personnel shall avoid disturbing the unidirectional airflow within the PEC.

f. A general microbiological growth media that supports growth of bacteria and fungi must be used.

i. Certificates of analysis from the manufacturer verifying the media meets expected growth promotion, pH, and sterilization requirements must be provided as documentation.

ii. The manufacturer’s instructions for operation of the impaction device must be followed.

iii. A minimum of 1 cubic meter or 1000 liters of air from each location must be sampled.

iv. Immediately retrieve and cover media devices following conclusion of sampling.

v. Media devices should be inverted to prevent condensate from dropping onto the agar and affecting the accuracy of the CFU reading.

vi. Inverted media must be appropriately incubated as specified in most current version of USP 797 by contractor. Currently, requirement is for incubation at 30 to 35 degrees Celsius for no less than 48 hours prior to examining the media for growth. The total number of discrete colonies of microorganisms must be recorded.

vii. Media must remain inverted and be further incubated by contractor at 20 to 25 degrees Celsius for no less than 5 additional days at which time the total number of discrete colonies of microorganisms must be recorded.

1. to shorten the incubation period UPS 797 currently allows two samples to be collected at each location and each sample incubated concurrently allowing for more timely delivery of results.

2. Both samples may be trypticase soy agar (TSA) or one sample may be TSA and the other sample a fungal media such as malt extract agar (MEA) or sabouraud dextrose agar (SDA).

3. If using this method, contractor will incubate samples in separate calibrated incubators (i.e., incubate one at 30 to 35 degrees Celsius for a minimum of 48 hours and the other sample at 20 to 25 degrees Celsius for a minimum of 5 days). If fungal media is used for one sample this is the sample that must be incubated for a minimum of 5 days.

viii. All recovered growth on each media device must be documented and action levels applied to each sampling media device separately.

ix. Temperature of incubators must be monitored by contractor during incubation. This can be accomplished by manually monitoring or via use of a continuous recording device. The results of monitoring must be documented.

g. Results must be reported by contractor as CFU per cubic meter of air and the document must note the sample type, sample location, and sample date.

i. If the results of viable air sampling exceed the action levels identified by USP 797, the contractor will at minimum identify the organism recovered to the genus level and when possible provide the species. This identification will be included in the certification cost. This information along with all other certification/recertification documents will be provided to Fargo VAHCS.

7. Viable surface sampling of all classified areas and pass-through chambers connecting to classified areas must be performed at a minimum frequency of once per month.

a. This testing will include:

i. sampling all five PECs

ii. the work area near the PECs (estimated as at least one location in each buffer room)

iii. pass-through located between the negative pressure HD buffer room and negative pressure HD storage area

iv. pass-through located between the inpatient pharmacy and the ante-room

v. frequently touched surfaces (suggested for contractor to identify at least one area in each SEC).

8. Monthly surface sampling may be performed by pharmacy personnel when the semi-annual certification is not performed and contractor is not onsite.

a. Contractor will provide adequate training/instruction to at least four pharmacy personnel prior to initial sample collection to ensure accurate results. Sampling must be performed at the end of compounding activity, but prior to cleaning and disinfecting the area.

9. Surface sampling devices for sampling flat surfaces must have a raised convex surface and contain a general microbiological growth media.

a. Certificates of analysis from the manufacturer verifying the media meets expected growth promotion, pH, and sterilization requirements must be provided.

b. Contractor will be required to supply the surface sampling devices and the postage required for shipping samples from Fargo VAHCS to the contractor for incubation and analysis.

c. The cover of the sampling device must be removed immediately prior to sampling.

Using a rolling motion, the media surface must be firmly pressed against the surface being sampled. The media device shall be covered and inverted immediately following sampling.

d. Any residue left from the media device must be removed from the surface utilizing sterile cleaning agents followed by sterile 70% IPA.

e. Inverted media must be appropriately incubated as specified in most current version of USP 797 by contractor. Currently, requirement is for incubation at 30 to 35 degrees Celsius for no less than 48 hours prior to examining the media for growth.

The total number of discrete colonies of microorganisms must be recorded.

i. Media must remain inverted and be further incubated by contractor at 20 to 25 degrees Celsius for no less than 5 additional days at which time the total number of discrete colonies of microorganisms must be recorded.

1. To shorten the incubation period USP 797 currently allows two samples to be collected at each location and each sample incubated concurrently allowing for more timely delivery of results.

2. Both samples may be TSA or one sample may be TSA and the other sample a fungal media such as MEA or SDA.

3. Contractor will incubate samples in separate calibrated incubators (i.e., incubate one at 30 to 35 degrees Celsius for a minimum of 48 hours and the other sample at 20 to 25 degrees Celsius for a minimum of 5 days). If fungal media is used for one sample this is the sample that must be incubated for a minimum of 5 days.

ii. Number of CFU(s) are to be counted on each media device and recorded as CFU per media device.

iii. Temperature of incubators must be monitored by contractor during incubation. This can be accomplished by manually monitoring or via use of a continuous recording device. The results of monitoring must be documented and reported.

10. Results must be reported by contractor as CFU per media device and the document must note the sample type, sample location, and sample date.

a. If the results of viable surface sampling exceed the action levels identified by USP 797 for the respective ISO classification, the contractor will at minimum identify the organism recovered to the genus level and when possible provide the species. This identification will be included in the certification/monthly sampling cost. Contractor will provide this information to Fargo VAHCS.

11. Airflow visualization testing must be performed under dynamic operating conditions.

a. This can be accomplished by performing a smoke pattern test in each PEC

b. demonstrating unidirectional airflow and sweeping action over and away from the preparation.

c. A smoke pattern test can be utilized to demonstrate proper airflow in a SEC following relocation of equipment located within a SEC.

i. The testing must show that first air conditions are achieved at the critical site during all compounding tasks within the respective PEC.

1. 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.

2. It is important that the contractor recognize that this testing is beyond the typical scope of an equipment certification as these videos are to capture both the effective operation of the PEC and also the effective compounding techniques of the pharmacy staff.

3. 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.

4. A written interpretation with the results of this testing must be documented on all certification/recertification reports.

5. A video recording of the test will also be provided to the Fargo VAHCS in a VA approved manner.

12. When used to prepare hazardous CNSPs the C-PEC must be certified at the minimum frequency recommended by the manufacturer or every 12 months (and up to 21 days prior), whichever is more frequent.

a. The C-SEC must be certified in that it maintains at least 12 ACPH and a negative pressure between 0.01 and 0.03 inches of water column relative to adjacent areas.

13. Contractor will supply and replace the prefilters for the two LAFWs annually as part of their preventative maintenance.

a. This is to occur in coordination with their semi-annual certification.

14. Contractor will supply all materials, shipping costs and tools to complete the required work.

15. Contractor will follow all Fargo VAHCS procedures for hand hygiene, garbing, and introduction of items into the classified area as outlined in MCP.

a. Will be provided to personnel while on site

16. Contractor will not wear cosmetics, nail products, visible jewelry, earbuds, or personal outer garments inside the cleanroom suite.

17. All required equipment will be stored and transported by the contractor in a manner that maintains cleanliness of equipment and reduces likelihood of equipment contaminating the classified areas.

18. Testing equipment will be in good condition and not have insanitary conditions (e.g., rust, dirt, etc.) present.

19. Testing equipment shall have National Institute of Standards and Technology (NIST) traceable or comparable calibration certification completed annually or as recommended by the manufacturer, whichever is more frequent.

a. The VA has the right to request proof of the calibration documentation of the Contractor’s testing equipment.

20. Equipment will be wiped down with a facility approved disinfectant-cleaner or sterile 70% isopropyl alcohol prior to introduction to a classified area provided by the Pharmacy.

a. PPE and disinfectant-cleaner will be provided by the Fargo VAHCS Pharmacy.

Additional Requirements

1. Scheduling of work: The contractor must coordinate a schedule with the POC or designee to provide the services at the required intervals. Each sampling/testing session will be conducted during normal business hours, Monday through Friday from 8:00am to 4:00pm excluding weekends and Federal Holidays.

a. Routine services must be scheduled with the POC or designee at least two (2) weeks in advance. This is to notify applicable personnel well in advance to allow their workflow to be adjusted to ensure staff is available to assist with dynamic portions of certification procedures as well as answer questions related to the facility, facility equipment, medical center policy outlined procedures, etc.

i. Two (2) LAFW certifications are required at a minimum of every 6 months (and up to 14 days prior), or whenever the device is relocated, major service to the equipment is performed, equipment is placed within, or another issue arises.

ii. Three (3) BSC certifications are required at a minimum of every 6 months (and up to 14 days prior), or whenever the device is relocated, major service to the equipment is performed, equipment is placed within, or another issue arises.

iii. Three (3) ISO Classified room certifications are required at a minimum of every 6 months (and up to 14 days prior), or whenever the room is altered, major service to the facility is performed, replacement or relocation of any PEC, or alteration in the configuration of the room that could affect airflow or air quality, or another issue arises.

iv. Seven (7) ceiling-mounted HEPA filters require certification at a minimum of every 6 months (and up to 14 days prior) and/or if an issue arises.

v. One (1) CVE certification is required at a minimum frequency recommended by the manufacturer or every 12 months (and up to 21 days prior) whichever is sooner, or whenever the device is relocated, major service to the equipment is performed, or another issue arises.

vi. One (1) C-SCA for non-sterile HD compounding certification is required at a minimum of every 12 months (and up to 21 days prior), or whenever the room is altered, major service to the facility is performed, or another issue arises.

vii. One (1) ceiling-mounted HEPA filter requires certification at a minimum of annually (and up to 21 days prior) and/or if an issue arises.

viii. One (1) HEPA-filtered pass-through is required to be certified at a minimum of every 6 months (and up to 14 days prior), or whenever major service is performed, or another issue arises.

b. Any certification failures and/or sampling results at or above action levels determined by USP 797 will result in mandatory re-testing/resampling following action deemed appropriate by the Chief of Pharmacy to remediate the likely cause. This retesting/resampling shall occur no later than one week after results at or above an action level are reported unless POC requests or agrees to delayed retesting/resampling.

c. Additional testing/sampling may also be required after any of the following:

i. Any patient incident in which the compounded material is suspect

ii. Problems with CSP are discovered upon end-product evaluation

iii. Significant changes in workflow or addition of new procedures or equipment

iv. Observation of incorrect work practices such as gowning, technique, material flow, cleaning, etc.

v. Other changes that could be reasonably expected to impact the sterile compounding environment (i.e., changes to cleaning agents utilized, etc.)

2. Certification Reports: The contractor shall provide to the POC or designee a certificate for each classified and unclassified area that has been certified prior to leaving the facility.

a. Any classified or unclassified area that is not certifiable must be brought to the attention of the POC or designee by the contractor prior to leaving the facility.

i. The engineering control in question will be marked as such with clear signage that the unit is out of service until further notice.

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

i. company name, address and phone number, unit make, model, serial number, location (room number), certification date, recertification date, and technician signature.

c. Reports are included in the certification price.

i. Reports must include recommendations for mitigation and correction if failure occurs to remedy the issues and reduce the chances of failure during the next certification.

d. Communication (emails, phone calls, texts) between the POC or authorized VA representative to aid in developing recommendations and mitigation strategies will be provided at no additional cost.

e. Each certification report from the contractor shall contain, at a minimum, the following information:

i. Contractor name, address and contact information also listing contract personnel with appropriate accreditations.

ii. Confirming remark that the most current version of the CAG was referenced for this certification and the actual date the certification was completed.

iii. Simple and clear method of identification of the approximate location of the collected data in relation to the physical layout of the equipment or facility tested, including specific and clear nomenclature for the data locations. A sample map can be utilized.

iv. Explanation of test procedure used for data collection and justification for any deviations from established industry practices encountered during the certification process.

v. Date and time testing/sampling was performed.

vi. Date of next required certification.

vii. Pressure differentials in water columns.

viii. Nonviable particle counts and the most up-to-date corresponding action levels for the ISO classification according to USP 797.

ix. Results of all leak/integrity tests performed.

x. Comparison of data recorded against expected values or specific equipment performance criteria established in Fargo VAHCS Pharmacy Service Medical Center Policy (MCP). In the absence of a current Fargo VAHCS Pharmacy Service MCP, the contractor’s SOP, current USP 797 and USP 800 standards, recommended practices, and manufacturer’s specifications will be used.

xi. Safety data sheets (SDS) for all chemical products that are to be used during certification procedures.

xii. A list of equipment utilized in data collection to include make, model, serial number, and calibration date.

xiii. A copy of the current calibration documentation for each piece of equipment utilized in data collection, when applicable (i.e., impaction devices, micromanometers, hygrometer, thermometer, etc.).

xiv. A written interpretation of the Airflow Visualization Test which is to be video recorded and provided to the Fargo VAHCS in a VA approved manner.

xv. The ACPH from the HVAC system, ACPH contributed from the PEC, and the total ACPH.

xvi. The number of personnel present in each PEC and SEC during particle count tests and dynamic airflow smoke pattern tests.

xvii. Pass/Fail notifications, where applicable.

xviii. Listing of replacement parts provided, adjustments made, etc. when applicable.

3. Sampling Reports: The contractor must contact the POC or designee upon completion of work to verbally report any sampling issues before the contractor leaves the facility.

a. Larger formal reports that include viable sampling results must be submitted to the POC, Chief of Pharmacy, and/or designee within ten (10) business days following the collection of the viable air sampling and/or surface sampling.

b. These formal reports may be delivered electronically via email if provided to the Fargo VAHCS in a VA approved manner.

c. Any media with recovered growth equal to or greater than the corresponding action level described within USP 797 for the respective ISO classification must be immediately relayed to the POC, Chief of Pharmacy, and/or designee.

i. If growth from viable sampling exceeds the action levels outlined in USP 797 for the respective ISO classification, an attempt must be made by an accredited laboratory with a microbiologist on staff to identify the microorganisms recovered to at least the genus level.

ii. The identification of microorganisms present in viable air samples and/or surface samples must be submitted to the POC, Chief of Pharmacy, and/or designee within one (1) business day of the receipt of the results from a properly accredited laboratory.

iii. Laboratory analyzing and identifying microorganisms on viable samples must have ISO/IEC 17025 certification from an external accrediting body (e.g., American Industrial Hygiene Association [AIHA] or American Association for Laboratory Accreditation [A2LA]) for all USP 797 viable sample analysis.

iv. Pass/Fail notifications should be included where applicable.

v. Reports are included in the certification/sampling price.

1. Reports must include recommendations for mitigation and correction if failure occurs to remedy the issues and reduce the chances of failure during the next certification.

2. Communication (emails, phone calls, texts) between the POC or authorized VA representative to aid in developing recommendations and mitigation strategies will be provided at no additional cost.

d. Each sampling report from the contractor shall contain, at a minimum, the following information:

i. Contractor name, address and contact information also listing contract personnel with appropriate accreditations.

ii. All viable sample results (CFUs)

iii. If the result(s) of viable sampling exceed the action levels identified by

USP 797, the contractor will at minimum identify the organism recovered to the genus level and when possible, provide the species.

iv. An SOP or protocol that describes the procedures used for sampling along with the volume, ISO classification, method of collection, frequency, activity level, action levels, response to exceeded concern levels, media types, laboratory analysis, incubation time and temperature.

v. A sampling map of the cleanroom suite and all PECs/C-PECs noting the locations and types of samples to be taken where applicable.

vi. A closed chain of custody.

vii. Growth and Sterility Control Reports for all used media.

4. Excluded services: The contractor shall not be obligated to provide services under this contract for damage to or destruction of instrument(s) covered where such damage or destruction is a result of or caused by:

1. Fire or explosion of any origin, riot, civil commotion, aircraft, war

2. Act of God or other force of nature including but not limited to lightning, windstorm, hail, flood, earthquake.

3. VAMC misuse or abuse of such instrument

4. Decontamination due to spillage by VA personnel due to their own negligence

5. Installation of unauthorized field modifications.

5. Schedule of Insurance: The contractor shall procure and maintain for the entire contract period, Workmen's Compensation and employer's general liability insurance. The contractor shall provide proof of insurance for the entire contract period with their technical proposal.

The parties agree that such personnel shall not be considered a VA employee for any purpose and shall be considered employees of the contractor.

6. Operational Coverage: The contractor shall perform certification services during normal work hours of 8:00am to 4:00pm, Monday-Friday (excluding weekends and federal holidays). Exception: work may be performed outside of regular administrative working hours when deemed necessary. The contractor shall receive prior approval from the POC or designee for irregular testing hours.

7. Price Schedule: The contract rate is an all-inclusive rate. No separate fees will be allowed.

No freight charges will be allowed.

8. Environment of Care: The contractor shall maintain a clean and safe environment at all times.

9. Period of Performance: The contract term is for 12 months with four options of 12 months each beginning upon signature of the contract.

a. 2025 (Base year) 1 May 2025– 30 April 2026

b. 2026 (Option year 1) 1 May 2026- 30 April 2027

c. 2027 (Option year 2) 1 May 2027- 30 April 2028

d. 2028 (Option year 3) 1 May 2028- 30 April 2029

e. 2029 (Option year 4) 1 May 2029- 30 April 2030

14. APPENDIX

Table A

Facility Location Room Name

ISO Classification

LAFW/BSC/CVE

BB-90

Ante-room

N/A

BB-90A

Negative Pressure Buffer

Room

Class II, Type A2 BSC

Model: NU-543-600 Class II, Type A2 BSC Manufacturer: Nuaire Model: NU-543-600 Class II, Type A2 BSC Manufacturer: Nuaire Model: NU-543-400

BB-90B

Positive Pressure Buffer

Room ISO Class 7

LAFW

Manufacturer: Nuaire Model: NU-340-630 AireGard ES

LAFW

Manufacturer: Nuaire Model: NU-340-630 AireGard ES

BB-78

Negative Pressure HD

Storage Room/Nonsterile C-

SCA

Unclassified

CVE

Model: NU-813-300 LabGard

INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR

INCLUSION INTO CONTRACTS, AS APPROPRIATE

PURPOSE: The purpose of this notice is to amend the Department of Veterans Affairs (VA) Handbook 6500.6, Contract Security, to include updated security language for Appendix C.

NARA Records Management Language for Contracts (National Archives and Records Administration)

Link: https://www.archives.gov/records-mgmt/policy/records-mgmt-language

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 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 https://www.archives.gov/records-mgmt/policy/records-mgmt-language 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. Department of Veterans Affairs 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 Department of Veterans Affairs 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 Department of Veterans Affairs. 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 Department of Veterans Affairs 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 Department of Veterans Affairs 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 Department of Veterans Affairs policy.

8. The Contractor shall not create or maintain any records containing any non-public Department of Veterans Affairs 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…