36C26325Q0338 0002.docx

5. PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER

16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) 01-30-2025 Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

1303 5th St Suite 300 Coralville IA 52241 Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

1303 5th St, Suite 300 Coralville IA 52241

36C26325Q0338 01-08-2025

X X X ** HOUR & DATE for Receipt of Offers is EXTENDED to: 02-05-2025 12:00 CST See CONTINUATION Page X See Following Pages

Jeffrey Brown Contracting Officer

VA-VHA-RPOC-2024-0033

CONTINUATION PAGE

The purpose of this amendment is to:

1. Extend the offer deadline to the time and date listed in box 11 above.

2. Edit the Schedule to change the units from JB to MO.

3. Make changes to the Statement of Work to account for emergency quotes and spelling errors.

See the updated Statement of Work and Schedule below, changes highlighted.

A.1 PRICE/COST SCHEDULE

ITEM INFORMATION

IV Sterile compounding services require IV room and IV hood certification bi-annually per USP797/800 regulations Contract Period: Base POP Begin: 01-27-2025 POP End: 01-26-2026 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories and Services PRODUCT/SERVICE CODE: H366 - Inspection - Instruments and Laboratory Equipment

IV Sterile compounding services require IV room and IV hood certification bi-annually per USP797/800 regulations Contract Period: Option 1 POP Begin: 01-27-2026 POP End: 01-26-2027

IV Sterile compounding services require IV room and IV hood certification bi-annually per USP797/800 regulations Contract Period: Option 2 POP Begin: 01-27-2027 POP End: 01-26-2028

IV Sterile compounding services require IV room and IV hood certification bi-annually per USP797/800 regulations Contract Period: Option 3 POP Begin: 01-27-2028 POP End: 01-26-2029

IV Sterile compounding services require IV room and IV hood certification bi-annually per USP797/800 regulations Contract Period: Option 4 POP Begin: 01-27-2029 POP End: 01-26-2030

B.3 STATEMENT OF WORK

PART A – GENERAL INFORMATION

A.1 INTRODUCTION: This requirement is for testing and certification of the Minneapolis VA Healthcare System (MVAHCS) facility’s primary engineering controls (PECs) and sterile compounding clean rooms used for preparation of Compounded Sterile Preparations (CSPs). PECs include biological safety cabinets (BSCs) and laminar airflow workstations (LAFWs) hoods. Testing and certification will be completed in accordance with United States Pharmacopeia (USP) Chapter <797> and <800> guidelines.

A.2 BACKGROUND: The MVAHCS is pursuing a contract for standardizing testing criteria appropriate for all PECs used pursuant to USP Chapter <797> and Chapter <800> standards using Controlled Environment Testing Association (CETA) Certified National Board of Testing (CNBT) certified individuals/companies to establish consistent PEC certification procedures using the Certification Guide for Sterile Compounding Facilities CAG-003-2006. Although USP <797> states that certification procedures “such as” those outlined CAG-003-2006 shall be performed, the MVAHCS will be requiring that CAG-003-2006 be used in lieu of any other “such as” procedures that may exist.

The USP establishes standards for cleanroom design, environmental monitoring, competencies for the CSP preparation, handling, and storage. The Joint Commission (TJC) surveys VA facilities using the TJC Medication Management Chapter. The Food and Drug Administration (FDA) has the authority to inspect VA medical facilities under the Insanitary Conditions at Compounding Facilities: Guidance for Industry

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

This contract covers following at the MVAHCS:

1) Semi-annual testing and certification for pharmacy related Laminar Flow Workstations and Class II Biological Safety Cabinets (BSCs) (Type A and Type B)

2) Semi-annual testing and certification of pharmacy anterooms, Hazardous and Non-Hazardous buffer rooms, Hazardous Drug storage room, and a hazardous drug containment segregated compounding area (C-SCA).

3) Provide copies of finished reports within 14 business days.

4) Smoke testing with video recording provided on SD video card (or other electronic format) for PECs and any rooms without low wall returns (e.g., OR Satellite anteroom). Electronic format will be provided within 14 business days.

Contractor will provide all parts, tools, test equipment, software, labor, travel, and equipment necessary to provide the services performed under this contract. Equipment used in performance of the contract by Contractor employees will function in conformance with the latest published edition of the applicable standards including the NSF, NIH, EPA, Joint Commission, UL, OSHA, CDRH, CETA and VA standards.

Contractor shall ensure that the MVAHCS equipment functions in conformance with the most up to date published edition of the applicable standards including but not limited to the following: NSF, NIH, EPA, Joint Commission, UL, OSHA, CDRH, CETA and VA standards.

B.3 SCOPE OF WORK:

B.3.1 PEC Testing and Certification

The Contractor shall test and certify each PEC to the most current version of IEST RP CC002 (Unidirectional-flow, clean-air devices) and to the manufacturer’s specifications. The Contractor shall use a NIST traceable or comparable currently calibrated piece of equipment to perform all testing. In the case of equipment failure on the day of scheduled certification service, the Contractor shall have back up equipment available to complete the testing on the same day or reschedule service within 5 business days. 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. Any failures shall be reported directly to the identified site point of contact(s) (POCs) as soon as practicable.

If there is a need to perform work on a specific date, in order to maintain the standards/certifications listed in the current SOW (including the VA standards), then the Contractor will need to provide someone to perform that work (equipment cert. expiration dates included). In the event the Contractor is unable to perform work on the originally scheduled date, the Contractor shall complete work within 2 business days. The Contractor should have a minimum of two technicians whose primary assigned coverage area includes the MVAHCS location. If the Contractor cannot complete rescheduled work within 2 business days, then the Contractor could be considered in default of their contractual obligations. Even though the current contract does not specify sickness coverage, it does specify response time standards that must be maintained. Due to patient safety, if sufficient units fail and Contractor is not able to meet the needs to repair and/or certify the units, the VA has the right to obtain services from another Contractor to meet the needs of patient care and safety.

Assistance from VHA Staff is not guaranteed, therefore, Contractor shall provide sufficient personnel to accomplish all the tasks required by the contract.

Horizontal laminar flow cabinets shall be certified according to The Institute of Environmental Sciences RP-CC-002 Testing Laminar Air Flow Devices. All on-site certifications for 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 list of tests includes, but is not limited to:

· HEPA filter leak test

· Cabinet leak test

· Inflow velocity test to include exhaust airflow volume rate.

· Airflow Smoke pattern test recorded and provided electronically (e.g., SD card or another format)

· Electrical leakage and ground circuit resistance and polarity tests

· Lighting intensity test

· Vibration test

· Noise level test

· Ultraviolet (UV) lamp test

· Airflow Visualization Tests (Pass / Fail)

· Downflow Test

· View retention Screen Test

· Work Opening Edge Retention Test

· Sash/Window Seal Test

· Site Installation Tests (Pass/Fail)

· Sash Height Low/High Alarm

· Exhaust Airflow/Pressure Alarm (B2 Only)

· Blower Interlock Alarm Verification (B2 Only)

· Exhaust Performance Alarms

Laminar Flow Hoods certifications must be accomplished in accordance with the most current version of the National Sanitation Foundation/American National Standards Institute (NSF/ANSI) Standard 49 Class II Biosafety Cabinetry, Annex F, test method A-D, 1992 or most current issue.

Certification stickers will be placed on each PEC ONLY when the unit meets certification standards and not beforehand. PECs will not be stickered as passing certification before all calculations have been completed. For each PEC passing the required certification tests, the Contractor will supply each unit with a certification sticker with the following information:

· Company name and address

· Unit make, model and serial number.

· Report number.

· Location (room number)

· Certification date

· Recertification date

· Technician name and signature

Smoke testing must be done under static and dynamic conditions. Dynamic conditions within the PEC will verify unidirectional flow and confirmation of “First Air”. The Contractor will ensure videotaping is NOT done when patient-specific information is visible.

Contractor will immediately notify a POC of any failures of the anterooms, HD and/or Non-HD buffer rooms, C-SCA, hazardous drug storage rooms and/or BSC/LAFW upon completion of testing. Contractor will place “out of service” notice on failed unit.

B.3.2 Non-viable Particle Counts For the PECs, non-viable particle counts samples will be performed in accordance with USP <797>.

B.3.3 USP <797> and USP <800> Testing for Pharmacy Anterooms, HD and Non-HD Buffer Rooms, Hazardous Drug Storage Room, and C-SCA.

The Contractor will provide comprehensive room testing and certification services every 6 months for anterooms, HD and Non-HD buffer rooms, C-SCA, and hazardous drug storage room to include:

HEPA filter integrity testing

· Airflow profiling and uniformity testing

· Particulate monitoring

· Room pressurization monitoring

· Temperature and Humidity monitoring

· Air pattern analysis

· Written Report

· Smoke testing and video recording for rooms without low air returns (e.g., OR Satellite anteroom)

B.3.3.1 Air Changes per Hour The Contractor shall calculate the total room volume for each anteroom, buffer room, hazardous drug storage room, and containment segregated compounding area (C-SCA). 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 pressure differentials, flow rates detailing returns and supply that were obtained during the testing. The Contractor shall calculate air changes per hour (ACPH) for each anteroom, buffer room, hazardous drug storage room, and C-SCA and including ACPH from HVAC and ACPH contributed from PEC and include their findings in the report. In the event that a room does not meet USP<797> and USP<800> requirements for ACPH the identified site POC(s) shall be informed immediately.

B.3.3.2 Pressure Requirements The Contractor shall include in their report differential pressure readings from each anteroom, buffer room, C-SCA, and hazardous drug storage room to all surrounding areas. The report shall indicate whether the room is required to be a negative or positive pressure room per USP<797> and USP<800>. 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).

B.3.3.3 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 of the following:

ISO Class 5: Not more than 3520 particles 0.5 µm and larger size per cubic meter of air for any area primary engineering control (BSC or LAFW).

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

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

Report Requirements: All of the following information shall be included in the report for clean room certification and meet the requirements to show compliance with USP <797> and USP<800> requirements for engineering controls. Pass/Fail notifications should be included on a per-test basis where applicable.

· Executive summary or summary of findings.

· Room number and/or location

· Room type (e.g. anteroom, HD buffer room, Non-HD Buffer Room, C-SCA, or hazardous drug storage room)

· Date of testing

· Date of next required certification

· Standards used to test room.

· Notes

· Room sketch (location of supply/exhaust diffusers, equipment, room dimensions, ceiling HEPAs)

· Total room area and volume

· Room humidity and temp with locations tested.

· Air changes per hour

· Pressure differentials.

· Nonviable particle counts with locations tested.

· HEPA filter integrity testing results with locations in ceiling

· Smoke test and video recordings where required per USP<797>

B.3.4 Report Distribution The Contractor will immediately notify identified POCs 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 following points of contact:

TBD

Contractor will be notified by facility of any updates to identified POC list on an as needed basis.

INSPECTIONS:

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

The inspection shall be through and shall conform to manufacturer and industry standards. The Contractor will immediately notify POCs listed above with any results indicating failure. The Contractor will remain onsite for a reasonable amount of time (up to 3 hours) to allow VA Engineering to work on any potential HVAC issues related to the failure. If the failure cannot be completed by the VA Engineering Staff in a reasonable amount of time the Contractor will return within a week to assist with fixing the failed item and reinspect. The Contractor will not schedule a repair without notification to a POC. If a specific area or unit cannot be inspected due to day-to-day operation of the Hospital, the Contractor will come back to the site as needed to complete the certification per the contract at no extra expense to the VA.

Testing Frequency:

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

STATEMENT OF WORK PART C – SUPPORTING INFORMATION

C.1 Place of Performance

C.2 Specific Pharmacy Rooms and PEC Information The following are to be tested and certified semi-annually (2 times per year) according to USP<797> and USP<800> requirements.

The Following Pharmacy Areas and Equipment to be Tested and Certified Semiannually

Main Compounding Suite

Rooms:

BR-118 (Anteroom): 2 Certifications/year

ISO 7

195.15 ft2 (1561.2 cu ft) Ceiling HEPAs = 4 with port access

ACPH

Pressure Differentials Temperature / Humidity BR-118B Non-HD Buffer Room: 2 Certifications/year

ISO 7

292.21 sq (2314.3 cu ft) Ceiling HEPAs = 5 with port access Pressure Differentials Temperature / Humidity BR-118C HD Buffer Room: 2 Certifications/year

ISO 7

260 ft2 (2319 cu ft) Ceiling HEPAs = 5 with port access Pass throughs with HEPAs = 2 Pressure Differentials Temperature / Humidity Equipment:

BR-118B Laminar Flow Hoods Quantity: 3 NuAire: NU-240-630 NuAire: NU-240-630 NuAire: NU-301-630 – likely to be replaced with model NU-240-630 in near future.

Inspection/Certification per year: 6 (2 each) To include static and dynamic smoke testing with video BR-118C Biological Safety Cabinets Quantity: 3 NuAire A2 BSC: NU-543-500 NuAire A2 BSC: NU-543-500 NuAire B2 BSC: NU-560-400 Inspection/Certification per year: 6 (2 each) To include static and dynamic smoke testing with video

BR-119: 2 Certifications/year.

Unclassified

206.8 ft2 (2319 cu ft)

ACPH

Pressure Differentials Temperature / Humidity Equipment:

BSC

Quantity: 1 NuAire A2 BSC: NU-543-500 Inspection/Certification per year: 2 To include static and dynamic smoke testing with video

2R-103A (Anteroom): 2 Certifications/year

ISO 8

50.55 sq ft (404 cu ft) Ceiling HEPAs = 1 with port access

ACPH

Pressure Differentials Temperature / Humidity Smoke study with video required No low wall air return.

2R-103B (Non-HD Buffer Room): 2 certifications/year

ISO 7

101.26 sq ft (810 cu ft) Ceiling HEPAs = 2 with port access

ACPH

Pressure Differentials Temperature / Humidity

Equipment:

2R-103B Laminar Flow Hood Quantity: 2 NuAire: NU-301-430 NuAire: NU-301-430 Inspection/Certification per year: 6 (2 each) To include static and dynamic smoke tests with video

3F-117A: 2 Certifications/year Unclassified

187.5 ft2 (1560 cu ft) Ceiling HEPAs = 4 with port access

ACPH

Pressure differentials.

Temperature / Humidity Equipment:

BSCs Quantity: 2 NuAire A2 BSC: NU-540-400 NuAire A2 BSC: NU-543-600 Inspection/Certification per year: 4 (2 each) To include static and dynamic smoke tests with video

Additional testing and certification will be required if the VA determines there is sufficient reason such as failure of equipment or modification based on the needs of the VA for patient care. Anticipate additional recertification of 2 PEC units per year related to repair work (e.g., replacement of a HEPA filter, replacement of an electronic control panel, etc.)

Changes to Pharmacy PEC or rooms will be communicated in a timely manner to Contractor and facility costs will be adjusted accordingly based on these changes. Contractor to provide unit-based costs for services to allow for adjustments in equipment.

C.3 Period of Performance Contract period is from date of award for five (5) years (base year plus 4 option years).

C.4 Special Considerations

C.4.1 Contract Employee Conduct Employees of the Contractor and sub-Contractors shall conduct themselves in a professional manner at all times while on medical center property. The Contractor shall ensure all personnel working on this contract are aware of Medical Center rules pertaining to employee behavior and conduct.

Employee clothing and shoes shall be non-shedding and cleaned of all dirt and debris before entering the medical center. Employees shall wear closed toed shoes, long pants, tall sock (e.g., no ankle socks), and shirts that cover the shoulders and upper arms at all times while in the medical center.

Employee shall be void of make-up, artificial nails, nail polish, and jewelry (hand, wrist, neck, ear, and facial piercing).

Physical or verbal misconduct may be grounds for removing employees from Medical Center property, or grounds for arrest by the VA Police.

Employees may be banned from Medical Center property as a result of inappropriate or illegal behavior. The Contractor shall not be entitled to any compensation from the Government for any costs resulting from employee misconduct (including, but not limited to, delays in contract completion) and may be held liable for costs incurred by the Government as a result of employee misconduct.

Smoking: Smoking is prohibited on VA property unless otherwise noted.

C.4.2 Contractor Furnished Materials All materials and tools to complete the work identified.

All necessary personnel protective equipment (PPE) required for entering cleanrooms.

C.4.3 Government Furnished Materials and Services The Contractor will adhere to MVAHCS hand hygiene and garbing Standard Operating Procedures. The MVAHCS will provide oversight and verification of Contractor personnel completion of donning of garb/PPE and hand hygiene prior to testing/sampling. If the Contractor’s staff arrive not wearing clean non-shedding clothing, the MVAHCS will provide surgical scrubs for Contractor staff to change into prior to donning garb/PPE to enter sterile compounding areas and hazardous drug storage room.

All equipment must be wiped down per Pharmacy procedures prior to entering sterile compounding areas and hazardous drug storage room.

The MVAHCS will, on rare occasion, provide office or meeting space to discuss test results, projects, or plans and may also provide desk phone as needed.

C.4.4 Qualifications of Key Personnel MVAHCS is seeking a qualified Contractor that meets the following specifications:

Contractor technicians must possess at least 2 years of experience in this subject matter outlined in this Statement of Work.

All cleanroom performance testing must be supervised by a technician with a CETA National Board of Testing (CNBT) certification.

C.4.5 Security Requirements Vendor personnel shall be escorted by VA staff while on VA property.

C.4.6 Additional Considerations Contractor shall be able to provide quotes for out-of-scope work within 24 hours to accommodate potential emergency situations in the sterile compounding areas that may impact quality of patient care.

Local facility POC(s) 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 7:00 AM and 4:30 PM Central Standard Time (CST), excluding federal holidays, unless scheduled at other mutually agreeable times. 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.

C.4.7 Contract Monitoring and Oversight Management Quality control and administrative oversight of the overall contract agreement and basic processes of contract operations are the primary responsibilities of the COR. COR’s will be responsible for placing task orders for service.