36C26320Q0386-001.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. DUNS: DUNS+4:

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. 2/2012)

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

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 127

636-20-4-5058-0078

36C26320Q0386 05-15-2020

John Becker, john.becker3@va.gov 605-336-3230 x7960 05-29-2020

11:59 PM EST

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

2501 W. 22nd St.

Sioux Falls SD 57105

John Becker, 605-336-3230 x7960 john.becker3@va.gov

X 100

X

541380

$22 Million

N/A

X

Nebraska Western Iowa Health Care Sys

Omaha, Lincoln, & Grand Island NE

4101 Woolworth Avenue

Omaha NE 68105-1850

NETWORK 23 CONTRACTING OFFICE

2501 W. 22nd St.

Sioux Falls SD 57105

Tungsten Electronic Invoicing

VA Tungsten Number: AAA544240062 va.registration@tungsten-network.com

Refer to VAAR Clause 852.232-72

See CONTINUATION Page

Testing and Certification of Fume Hoods and Clinical

Laboratory Biological Safety Cabinets (BSCs) to support the Nebraska Western Iowa Health Care System (NWIHCS) for the facilities of Omaha, Lincoln, and Grand Island NE. See the Statement of Work for specific requirements.

Period of Performance: 7/1/2020 to 6/30/2021

Contract includes four (4) one-year option periods

This procurement is set-aside for SDVOSB entities. SDVOSB firms shall be registered and verified in the VIP database at the time of submission of offer and prior to award.

Subcontracting limitations apply; verified through payroll reporting.

DOL Wage Determination 2015-5369 Revision 7 applies to services performed under this requirement.

See FAR Clause 52.212-2, Evaluation of Offers for specific details and submission requirements.

See CONTINUATION Page

636-3600162-5058-8551002543-010055592

636-20-4-5058-0078

X X

X one(1)

John Becker

VA-VHA-2020-BEE57D1B

36C26320Q0386

Table of Contents

SECTION A

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

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK

B.3 PRICE/COST SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT

2018)

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

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) ...42

C.5 52.228-5 INSURANCE—WORK ON A GOVERNMENT INSTALLATION (JAN 1997)

C.6 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.7 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (NOV 2018)

C.8 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND

COMPLIANCE (JUL 2018)

C.9 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.10 VAAR 852.237-75 KEY PERSONNEL (OCT 2019)

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

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (MAR 2020)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 PHARM-126, STERILE PRODUCT COMPOUNDING

D.2 WAGE DETERMINATION DOUGLAS COUNTY NEBRASKA

D.3 WAGE DETERMINATION LANCASTER COUNTY NEBRASKA

D.4 WAGE DETERMINATION HALL COUNTY NEBRASKA

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (OCT 2018)

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

1998)

E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (DEC 2019)

E.4 52.212-2 EVALUATION – COMMERCIAL ITEMS (OCT 2014)

E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS (MAR 2020)

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:

Business Name:

DUNS Number:

Contact Person:

Email:

Phone:

b. GOVERNMENT: Contracting Officer

Contracting Officer: John Becker

Email: John.becker3@va.gov

Phone: 605-336-3230 ext 7960

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] Within 30 days of completion of services

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

Requests.

Department of Veterans Affairs Tungsten Electronic Invoicing

VA Tungsten Number: AAA544240062 mailto:John.becker3@va.gov va.registration@tungsten-network.com Refer to VAAR Clause 852.232-72

6. ADDITIONAL INVOICING INSTRUCTIONS. In addition to information required for submission of a “proper” invoice in accordance with FAR 52.212-4 (g), all invoices must include:

• Name and Address of Contractor

• Contractor’s Invoice Date and Invoice Number

• Contract Number, Task Order Number, and/or Purchase Order Number

• Date(s) of Service

• Cost of service, i.e., hourly rate, quantity, job cost, trip, etc.

• Total price

Electronic Invoice Submission Method. Invoice(s) shall be electronically submitted through the Tungsten Network: https://www.tungsten-network.com/customer-campaigns/veterans-affairs/ The VA-FSC pays all associated transaction fees for VA orders.

The Tungsten direct vendor support number is 877-489-6135 for VA contracts.

During Implementation (technical set-up) Tungsten will confirm your Taxpayer ID Number with the VA- FSC. This process can take up to five (5) business days to complete to ensure your invoice is automatically routed to your Certifying Official for approval and payment. https://www.tungsten-network.com/us/support/’ The VA-FSC pays all associated transaction fees for VA orders. For additional information, please contact:

• Tungsten Support, Phone: 1-877-752-0900, Email: va.registration@tungsten-network.com

• Department of Veterans Affairs Financial Service Center, Phone: 1-877-353-9791, Email:

vafscched@va.gov

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

AMENDMENT NO DATE

B.2 STATEMENT OF WORK

Statement of Work (SOW)

For Fume Hood Testing & Certification

A. General Requirements:

1. Contractor to provide all labor, material, to inspect fume hoods at the following VA Health System facilities located in Nebraska:

a. Omaha VAHCS: 4101 Woolworth Ave. Omaha, NE 68105

b. Lincoln VAHCS: 600 South 70th St Lincoln, NE 68510 (physical location scheduled to be deactivated on or about August 2021; subject to change; a new facility will be identified)

c. Grand Island: 2201 North Broadwell Ave. Grand Island, NE 68803

2. Contract Employee Conduct:

a. 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.

b. Employee clothing and shoes shall be cleaned of all dirt and debris before entering the medical center, and before leaving the work site. Employees shall wear closed toed shoes, long pants, and shirts that cover the shoulders and upper arms at all times while in the medical center.

c. 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.

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

3. Prior to commencing work, general contractor shall provide proof that an OSHA certified

“competent person” (CP) (29 CFR 1926.20(b)(2) will supervise all work under this contract and maintain a continual presence at the work site whenever the general or subcontractors are present. In accordance with FAR 52.236-6, at all times during performance of this contract and until the work is completed and accepted, the Contractor shall directly superintend the work or assign and have on the worksite a competent superintendent who is satisfactory to the Contracting Officer and has authority to act for the Contractor.

B. Scope of Work:

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

B.2 BACKGROUND: VA Nebraska Western Iowa 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, NWI 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, 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-003-2006 shall be performed by a CETA National Board of Testing (CNBT) certified testing individual/company no less than every 6 months or whenever the PEC or room is relocated or altered or when major service to the sterile compounding facility is performed.

B.3 SCOPE OF WORK:

B.3.1 NSF 49 Field Testing Requirements for Biological Safety Cabinets The contractor shall certify all Class II biosafety cabinets to the current version (2016 or higher) of NSF/ANSI 49, Annex F specifications. All equipment used to certify biological safety cabinets shall have National Institute of Standards and Technology (NIST) traceable or comparable calibration certification.

Any unit that fails to meet NSF 49 specifications shall be clearly marked with a sign that will notify technicians that the unit is out of order until further notice. In addition, any failures shall be reported directly to the COR or identified point(s) of contact (POC) as soon as failure is identified.

This contract will also cover emergency repair with in 24hr period, maintenance, and recertification of the below stated equipment. Contractor shall furnish service as specified for one base year with four (4) option year pickup. Contractor will provide all parts, tools, test equipment, software, labor, travel, and equipment necessary to provide inspections, perform preventive maintenance, make repairs, decontamination of hoods if needed, and certifications of Laminar Flow Hoods, Chemical Fume Hoods, Class II Biological Cabinets (Type A and Type B), Laminar Flow Work Benches, Pharmacy Clean Rooms, and Barrier Isolators for the Nebraska Western Iowa Health Care System (NWIHCS), which includes campuses in Omaha, Lincoln and Grand Island, Nebraska.

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 signature

B.3.2 Fume Hood/Testing and Certification The contractor shall test and certify each fume hood to the manufacturer’s specifications. Tests shall include: face velocity test, airflow smoke pattern test and low flow alarm test. In the event that the fume hood has an air flow monitor or controller, the contractor shall confirm the unit is calibrated and operating within +/-10% of actual velocity. If it is not calibrated appropriately the contractor shall calibrate the AFM or AFC. The contractor shall use a NIST traceable or comparable calibrated piece of equipment to calculate the face velocity. The contractor shall report each individual face velocity reading and the average of those readings, a pass/fail grade for the airflow smoke pattern test and a pass/fail grade for the low flow alarm test. Any failures shall be reported directly to the COR or POC(s) prior to leaving facility.

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

• Certification date

• Recertification date

• Average face velocity

• Sash height (only for fume hoods)

• Technician name and signature

B.3.3 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 calibrated piece of equipment to perform all testing. 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 COR or pharmacy site manager prior to leaving the facility.

Horizontal laminar flow cabinets shall be certified according to The Institute of Environmental Sciences RP-CC-002 Testing Laminar Air Flow Devices. All annual and semi-annual 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

• Electrical leakage and ground circuit resistance and polarity tests

• Lighting intensity test

• Vibration test

• Noise level test

• Ultraviolet (UV) lamp test

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.

Fume hoods certifications must be accomplished in accordance with the most current version of the American Conference of Government Industrial Hygienists (ACGIH), Industrial Ventilation: A Manual of Recommended Practice.

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

B.3.4 Viable and Non-viable Particle Counts For the PECs, 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>. Refer to the description of these tests in the section A.3.5.3 and A.3.5.4 for details.

B.3.5 USP<797> Testing for Pharmacy Clean Rooms The contractor will adhere to NWI hand hygiene and garbing policies. The contractor will provide comprehensive cleanroom testing and certification services every 6 months to include:

• HEPA filter integrity testing

• Airflow profiling and uniformity testing

• Particulate monitoring

• Room pressurization monitoring

• Temperature and Humidity monitoring

• Air pattern analysis

• Environmental Sampling -Viable surface and air impaction

• Written Report

• Smoke test must be videotaped – contractor to leave video of smoke test on site prior to completion of certification process. Smoke test must be done under dynamic conditions within the Primary Engineering Controls (PEC) to verify unidirectional flow and confirmation of “Frist Air.”

B.3.5.1 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, and HD storage room, 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 COR and the identified POC(s) shall be informed immediately.

B.3.5.2 Pressure Requirements The contractor shall include in their report differential pressure readings from each buffer/ante room and to all surrounding HD storage 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). Verify the accuracy of all gauges and calibrate as needed or replace and recalibrate. Contractor shall verify accuracy of gauges and calibrate as needed.

B.3.5.3 Viable Environmental Sampling

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

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

• Surface Sampling: The contractor shall perform surface samples for bacteria and fungi using Tryptic Soy Agar (TSA) contact plates Sampling will be conducted in all classified areas and pass-through chambers including interior of PEC and equipment contained in it, staging or work area near the PEC and frequently touched surfaces. Sampling must be performed at end of compounding activities or shift, but before area has been cleaned and disinfected.

• Any laboratory results equal to or greater than the action level will require notification to the COR and the POC(s) immediately upon receipt of results. A follow up resampling with will scheduled immediately. The contractor will need to work with FMS to obtain a PO prior to the scheduled resampling.

• Reports to include at a minimum:

o Date and time sampling were taken.

o Environmental sampling reports will contain both the quantitative number of bacterial/fungal isolates as well as the species grown if required under current inspection standards. Any questions about current standards contact the Nebraska Western Iowa Veterans Administration Health Care Pharmacy Department.

▪ Report shall immediately notify the COR and identified POC(s) of any highly pathogenic microorganisms identified.

o Medial lots used for samples o Comments indicating when dynamic conditions were used o Certificates of analysis of media used o Sketch identifying location of each sample obtained o Technician collecting the samples

B.3.5.4 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 should be included in the report for clean room certification. Pass/Fail notifications should be included on a per-test basis where applicable.

• Executive summary or summary of findings.

• Room number and/or location

• Room type (e.g. oncology prep 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)

• Total room area and volume

• Room humidity and temp

• Air changes per hour

• Pressure differential

• Nonviable particle counts

• Viable particle count analysis

• Picture of viable particle test location in room

Note: All PECs shall follow report requirements for a non-USP<797> units but shall include viable and nonviable particle sampling.

B.3.5.5 Report Distribution 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 listed below no more than 14 days from certification evaluation. All completed reports will be provided via email to the following points of contact: NOTE: A distribution email address may be created by the Government to preclude separate email addresses to the individuals identified below. When a distribution email address has been created, it will be forwarded and used in lieu of the individuals identified below.

• Omaha:

o Tracie Balvanz (Tracie.Balvanz2@va.gov) o Steven Nissen (Stephen.Nissen@va.gov) o Jeff Fryman (Jeffrey.Fryman@va.gov) o Dave Blanton (Dave.Blanton@va.gov) o Erica Garris (Erica.garris@va.gov)

• Lincoln:

o Tracie Balvanz (Tracie.Balvanz2@va.gov) o Chad Bartholomew (Chad.Bartholomew@va.gov) o Jeff Fryman (Jeffrey.Fryman@va.gov) o Dave Blanton (Dave.Blanton@va.gov) o Erica Garris (Erica.garris@va.gov)

• Grand Island VAMC:

o Tracie Balvanz (Tracie.Balvanz2@va.gov) o Jeremy McIntyre (Jeremy.McIntyre@va.gov) o Jeff Fryman (Jeffrey.Fryman@va.gov) o Dave Blanton (Dave.Blanton@va.gov) o Erica Garris (Erica.garris@va.gov)

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

Maintenance and Repair The main purpose of this Contract is to eliminate unscheduled shutdowns and contribute significantly to the continuous operating economy and integrity of the system. All work is to be in compliance with NSF- 49 and ASHRAE 110.

INSPECTIONS:

a. The contractor shall notify the COR or his/her designee at least one week in advance of the date of the contemplated inspection. All inspections shall be performed during normal hours of the VA. COR will be responsible for scheduling service.

b. The inspection shall be thorough and shall conform to manufacturer and industry standards for the medical equipment. The contractor will immediately notify the COR or identified points of contact listed mailto:Tracie.Balvanz2@va.gov mailto:Stephen.Nissen@va.gov mailto:Jeffrey.Fryman@va.gov mailto:Dave.Blanton@va.gov mailto:Erica.garris@va.gov mailto:Tracie.Balvanz2@va.gov mailto:Chad.Bartholomew@va.gov mailto:Jeffrey.Fryman@va.gov mailto:Dave.Blanton@va.gov mailto:Erica.garris@va.gov mailto:Tracie.Balvanz2@va.gov mailto:Jeremy.McIntyre@va.gov mailto:Jeffrey.Fryman@va.gov mailto:Dave.Blanton@va.gov mailto:Erica.garris@va.gov 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 notify the COR within a week of when they will return to fix the failed items and reinspect. The contractor will not schedule a repair without notification to the COR. 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.

c. Upon completion of each inspection, a signed certificate for each unit inspected will be left with the COR. Test reports shall be certified as to its content and accuracy. The report shall include an itemized list of all procedures performed and the results of each procedure.

d. Certification sticker will be placed on the biological safety cabinets and hoods ONLY when the units meet certification standards and not beforehand. Hoods will not be stickered as passing certification before all calculations have been completed.

e. Service personnel will be required to sign in and obtain a Contractor ID badge. Certification will be completed Monday through Friday between the hours of 8:00 AM and 4:30 PM. Times for certification must be coordinated with the COR at (402) 995-5961.

Testing Frequency:

• 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 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 more frequently if required to assess corrective actions associated with prior negative results.

Parts for Repair The CLIN for Parts for Repairs is not defined, priced, or awarded for a specific repair and is subject to a Not to Exceed (NTE) ceiling price. The Contractor will provide all replacement parts needed to keep the system in operating condition as originally designed by the manufacturer. Parts may be repaired or replaced, as the contractor deems appropriate. NO GRAY MARKET or used parts will be used to repair the equipment. Contactor shall furnish the COR or VA Technical Representative with a written estimate of the cost to make necessary repairs. Contractor shall also provide a comparison quote for what that item would have cost for commercial pricing, so the Government has a basis for determining the price fair and reasonable or as an alternative, provide a quote used for another federal agency for similar item.

Sterile Product Compounding and Cleanroom Safety Requirements.

Contractor employees will adhere to the NWIHCS Sterile Product Compounding policy PHARM-126 when accessing cleanrooms. This NWIHCS policy is updated annually and will apply throughout the contract period of performance. A revised copy will be forwarded annually or upon revision. The most recent copy of PHARM-126, Sterile Product Compounding, is attached to this SOW.

C. DOCUMENTATION/REPORTS:

The documentation will include detailed descriptions of the scheduled maintenance procedures performed including replaced parts required to maintain the equipment in accordance with the manufacturer’s specifications. In addition, each service report must, at a minimum, document the following data legibly and in complete detail:

a. Name of contractor.

b. Name of field service engineer who performed services.

c. Contractor service report number/log number.

d. Description of problem reported by COTR (If applicable).

e. Identification of the equipment to be serviced:

1. Inventory ID number

2. Manufacturer’s name

3. Device name

4. Model number

5. Serial Number

6. Any other manufacturer’s identification numbers

f. Itemized Description of Service Performed

g. Location of problem/corrective action.

PERFORMANCE:

Normal hours of coverage are Monday through Friday from 8:00 AM to 4:30 PM excluding holidays. All inspections will be performed during normal hours of coverage unless requested or approved by the COR or his/her designee.

SERVICE TECHNICIANS:

The contractor must meet Joint Commission requirements for proving competency of the service technician. All technicians who perform work under this contract will have a current NSF accreditation.

Contractor will provide a copy of NSF accreditation. Contractor will provide a copy of NSF accreditation for each individual who will be performing work under the contract. Minimum qualifications include:

• NSF Accredited Class II Biosafety Cabinet Field Certification

• CETA (Certified Environmental Testing Association) certification

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.

D. SUPPORTING INFORMATION

FACILITY REQUIRED INSPECTIONS

Omaha VA Medical Center 4101 Woolworth Avenue Omaha, Ne 68105

Research Service Equipment:

Fume Hoods Quantity: 27 each Inspection/Certification (1 per year)

Biological Safety Cabinets Quantity: 15 each Inspection/Certification (1 per year)

Laminar Flow Hoods Quantity: 3 each

Inspection/Certification (1 per year)

Pathology & Lab Medicine Equipment:

Fume Hoods Quantity: 1 each Inspection/Certification (1 per year)

Biological Safety Cabinet Quantity: 4 each Inspection/Certification (1 per year)

Laminar Flow Hood (BSL-3 Laboratory) Quantity: 1 each Inspection/Certification (1 per year)

Laminar Flow Hood (BSL-3 Laboratory) Quantity: 1 each Inspection/Certification (1 per year)

BSL-3 Room Certification Quantity: 1 each Inspection/Certification (1 per year)

Pharmacy Service Equipment:

Biological Safety Cabinets Quantity: 2 each Inspection/Certification (2 per year)

Laminar Flow Hoods (IV Room) Quantity: 2 each Inspection/Certification (2 per year)

Lincoln VA Medical Center 600 South 70th Street Lincoln, NE 68510

Pathology & Lab Medicine Equipment:

Fume Hoods

Quantity: 1 each Inspection/Certification (2 per year)

Laminar Flow Hoods

Grand Island VA Medical Center 2201 North Broadwell Avenue Grand Island, NE 68803

Pathology & Lab Medicine Equipment:

Fume Hoods Quantity: 1 each Inspection/Certification (1 per year)

Biological Safety Cabinets

Quantity: 1 each Inspection/Certification (2 per year)

Laminar Flow Hoods

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0.00 JB __________________ __________________

OMAHA VAHCS

Testing and Certification of Fume Hoods and Clinical Laboratory Biological Safety Cabinets (BSCs), and other similar devices.

Contractor to provide all labor and materials to test, certify, and mark clean areas, all fume hoods and laminar flow hoods (vertical, horizontal, and unidirectional). Repair services to be provided as needed and on emergency basis, as required, for the laminar flow hoods. Service includes parts and replacement filters. See Statement of Work (SOW) for a list of equipment.

Inspections and certifications shall be completed on a recurring schedule. The specific date/time shall be coordinated with Omaha VA Technical Representative.

Contract Period: Base POP Begin: 07-01-2020 POP End: 06-30-2021

0001AA

1.00 JB __________________ __________________

Annual and Bi-annual Testing and Certification of Fume Hoods, and Clinical Laboratory Biological Safety Cabinets (BSCs), Pressure Differential Testing.

Contractor to provide all labor and materials to test, certify, and mark clean areas, all fume hoods and laminar flow hoods (vertical, horizontal, and unidirectional). Repair services to be provided as needed and on emergency basis for the laminar flow hoods plus parts and filters. See Statement of Work (SOW) for a list of equipment.

PHARMACY: Bi-annual inspection and certification in the Months of February and August of each year unless a mutually agreed upon change is established between the Government and the Contractor. The specific date/time shall be coordinated with facility Technical Representative.

RESEARCH, PATHOLOGY, AND LABORATORY: Annually in the Month of March of each year unless a mutually agreed upon change is established between the Government and the Contractor. The specific date/time shall be coordinated with facility Technical Representative.

Contract Period: Base

0001AB

4.00 EA __________________ __________________

Retesting and Recertification due to repair or malfunction of BSC. The quantity is estimated and does not reflect an actual requirement. This is an estimated quantity and does not reflect the actual quantity that will be required.

Contract Period: Base

0001AC

Decontamination (gas sterilization) of BSC. The quantity is estimated and does not reflect an actual requirement. This is an estimated quantity and does not reflect the actual quantity that will be required.

Contract Period: Base

0001AD

8.00 HR __________________ __________________

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

OMAHA VAHCS

Maintenance labor, per hour, for repairs. The quantity is estimated and does not reflect an actual requirement. This is an estimated quantity and does not reflect the actual quantity that will be required.

Contract Period: Base

0001AE

1.00 LT __________________ __________________

Parts for Repairs. This lot is not defined, priced, or awarded for a specific repair and is subject to a Not to Exceed (NTE) ceiling price. The Contractor will provide all replacement parts needed to keep the system in operating condition as originally designed by the manufacturer. Parts may be repaired or replaced, as the contractor deems appropriate. NO GRAY MARKET or used parts will be used to repair the equipment. Contactor shall furnish the COR or VA Technical Representative with a written estimate of the cost to make necessary repairs.

Contractor shall also provide a comparison quote for what that item would have cost for commercial pricing, so the Government has a basis for determining the price fair and reasonable or as an alternative, provide a quote used for another federal agency for similar item. This is an estimated quantity and does not reflect the actual quantity that will be required.

Contract Period: Base

GRAND ISLAND VAHCS

Testing and Certification of Fume Hoods and Clinical Laboratory Biological Safety Cabinets (BSCs), and other similar devices.

Contractor to provide all labor and materials to test, certify, and mark clean areas, all fume hoods and laminar flow hoods (vertical, horizontal, and unidirectional). Repair services to be provided as needed and on emergency basis, as required, for the laminar flow hoods. Service includes parts and replacement filters. See Statement of Work (SOW) for a list of equipment.

Inspections and certifications shall be completed on a recurring schedule. The specific date/time shall be coordinated with Omaha VA Technical Representative.

Contract Period: Base

0002AA

Annual and Bi-annual Testing and Certification of Fume Hoods, and Clinical Laboratory Biological Safety Cabinets (BSCs), Pressure Differential Testing.

Contractor to provide all labor and materials to test, certify, and mark clean areas, all fume hoods and laminar flow hoods (vertical, horizontal, and unidirectional). Repair services to be provided as needed and on emergency basis for the laminar flow hoods plus parts and filters. See Statement of Work (SOW) for a list of equipment.

PHARMACY: Bi-annual inspection and certification in the Months of February and August of each year unless a mutually agreed upon change is established between the Government and the Contractor. The specific date/time shall be coordinated with facility Technical Representative.

PATHOLOGY AND LABORATORY: Annually in the Month of March of each year unless a mutually agreed upon change is established between the Government and the Contractor. The specific date/time shall be coordinated with facility Technical Representative.

Contract Period: Base

NUMBER

DESCRIPTION OF

0002AB

Retesting and Recertification due to repair or malfunction of BSC. The quantity is estimated and does not reflect an actual requirement. This is an estimated quantity and does not reflect the actual quantity that will be required.

Contract Period: Base

0002AC

Decontamination (gas sterilization) of BSC. The quantity is estimated and does not reflect an actual requirement. This is an estimated quantity and does not reflect the actual quantity that will be required.

Contract Period: Base

0002AD

Maintenance labor, per hour, for repairs. The quantity is estimated and does not reflect an actual requirement. This is an estimated quantity and does not reflect the actual quantity that will be required.

Contract Period: Base

0002AE

Parts for Repairs. This lot is not defined, priced, or awarded for a specific repair and is subject to a Not to Exceed (NTE) ceiling price. The Contractor will provide all replacement parts needed to keep the system in operating condition as originally designed by the manufacturer. Parts may be repaired or replaced, as the contractor deems appropriate. NO GRAY MARKET or used parts will be used to repair the equipment. Contactor shall furnish the COR or VA Technical Representative with a written estimate of the cost to make necessary repairs.

Contractor shall also provide a comparison quote for what that item would have cost for commercial pricing, so the Government has a basis for determining the price fair and reasonable or as an alternative, provide a quote used for another federal agency for similar item. This is an estimated quantity and does not reflect the actual quantity that will be required.

Contract Period: Base

LINCOLN VAHCS

NOTE: The Lincoln VAHCS is scheduled to close on or about August 2021 at which time services will be required at the new facility. The closure date is an estimated date and is subject to change. A Contract Modification may be needed to revise the quantity of devices.

Testing and Certification of Fume Hoods and Clinical Laboratory Biological Safety Cabinets (BSCs), and other similar devices.

Contractor to provide all labor and materials to test, certify, and mark clean areas, all fume hoods and laminar flow hoods (vertical, horizontal, and unidirectional). Repair services to be provided as needed and on emergency basis, as required, for the laminar flow hoods. Service includes parts and replacement filters. See Statement of Work (SOW) for a list of equipment.

Inspections and certifications shall be completed on a recurring schedule. The specific date/time shall be coordinated with Omaha VA Technical Representative.

Contract Period: Base

NUMBER

DESCRIPTION OF

0003AA

Annual and Bi-annual Testing and Certification of Fume Hoods, and Clinical Laboratory Biological Safety Cabinets (BSCs), Pressure Differential Testing.

Contractor to provide all labor and materials to test, certify, and mark clean areas, all fume hoods and laminar flow hoods (vertical, horizontal, and unidirectional). Repair services to be provided as needed and on emergency basis for the laminar flow hoods plus parts and filters. See Statement of Work (SOW) for a list of equipment.

PHARMACY: Bi-annual inspection and certification in the Months of February and August of each year unless a mutually agreed upon change is established between the Government and the Contractor. The specific date/time shall be coordinated with facility Technical Representative.

PATHOLOGY AND LABORATORY: Annually in the Month of March of each year unless a mutually agreed upon change is established between the Government and the Contractor. The specific date/time shall be coordinated with facility Technical Representative.

Contract Period: Base

0003AB

Retesting and Recertification due to repair or malfunction of BSC. The quantity is estimated and does not reflect an actual requirement. This is an estimated quantity and does not reflect the actual quantity that will be required.

Contract Period: Base

0003AC

Decontamination (gas sterilization) of BSC. The quantity is estimated and does not reflect an actual requirement. This is an estimated quantity and does not reflect the actual quantity that will be required.

Contract Period: Base

0003AD

Maintenance labor, per hour, for repairs. The quantity is estimated and does not reflect an actual requirement. This is an estimated quantity and does not reflect the actual quantity that will be required.

Contract Period: Base

0003AE

Parts for Repairs. This lot is not defined, priced, or awarded for a specific repair and is subject to a Not to Exceed (NTE) ceiling price. The Contractor will provide all replacement parts needed to keep the system in operating condition as originally designed by the manufacturer. Parts may be repaired or replaced, as the contractor deems appropriate. NO GRAY MARKET or used parts will be used to repair the equipment. Contactor shall furnish the COR or VA Technical Representative with a written estimate of the cost to make necessary repairs.

Contractor shall also provide a comparison quote for what that item would have cost for commercial pricing, so the Government has a basis for determining the price fair and reasonable or as an alternative, provide a quote used for another federal agency for similar item. This is an estimated quantity and does not

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

reflect the actual quantity that will be required.

Contract Period: Base

Testing and Certification of Fume Hoods and Clinical Laboratory Biological Safety Cabinets (BSCs), and other similar devices.

Contractor to provide all labor and materials to test, certify, and mark clean areas, all fume hoods and laminar flow hoods (vertical, horizontal, and unidirectional). Repair services to be provided as needed and on emergency basis, as required, for the laminar flow hoods. Service includes parts and replacement filters. See Statement of Work (SOW) for a list of equipment.

Inspections and certifications shall be completed on a recurring schedule. The specific date/time shall be coordinated with Omaha VA Technical Representative.

Contract Period: Option 1 POP Begin: 07-01-2021 POP End: 06-30-2022

1001AA

Annual and Bi-annual Testing and Certification of Fume Hoods, and Clinical Laboratory Biological Safety Cabinets (BSCs), Pressure Differential Testing.

Contractor to provide all labor and materials to test, certify, and mark clean areas, all fume hoods and laminar flow hoods (vertical, horizontal, and unidirectional). Repair services to be provided as needed and on emergency basis for the laminar flow hoods plus parts and filters. See Statement of Work (SOW) for a list of equipment.

PHARMACY: Bi-annual inspection and certification in the Months of February and August of each year unless a mutually agreed upon change is established between the Government and the Contractor. The specific date/time shall be coordinated with facility Technical Representative.

RESEARCH, PATHOLOGY, AND LABORATORY: Annually in the Month of March of each year unless a mutually agreed upon change is established between the Government and the Contractor. The specific date/time shall be coordinated with facility Technical Representative.

Contract Period: Option 1

1001AB

Retesting and Recertification due to repair or malfunction of BSC. The quantity is estimated and does not reflect an actual requirement. This is an estimated quantity and does not reflect the actual quantity that will be required.

Contract Period: Option 1

1001AC

Decontamination (gas sterilization) of BSC. The quantity is estimated and does not reflect an actual requirement. This is an estimated quantity and does not reflect the actual quantity that will be required.

Contract Period: Option 1

1001AD

Maintenance labor, per hour, for repairs. The quantity is estimated and does

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

not reflect an actual requirement. This is an estimated quantity and does not reflect the actual quantity that will be required.

Contract Period: Option 1

1001AE

Parts for Repairs. This lot is not defined, priced, or awarded for a specific repair and is subject to a Not to Exceed (NTE) ceiling price. The Contractor will provide all replacement parts needed to keep the system in operating condition as originally designed by the manufacturer. Parts may be repaired or replaced, as the contractor deems appropriate. NO GRAY MARKET or used parts will be used to repair the equipment. Contactor shall furnish the COR or VA Technical Representative with a written estimate of the cost to make necessary repairs.

Contractor shall also provide a comparison quote for what that item would have cost for commercial pricing, so the Government has a basis for determining the price fair and reasonable or as an alternative, provide a quote used for another federal agency for similar item. This is an estimated quantity and does not reflect the actual quantity that will be required.

Contract Period: Option 1

Testing and Certification of Fume Hoods and Clinical Laboratory Biological Safety Cabinets (BSCs), and other similar devices.

Contractor to provide all labor and materials to test, certify, and mark clean areas, all fume hoods and laminar flow hoods (vertical, horizontal, and unidirectional). Repair services to be provided as needed and on emergency basis, as required, for the laminar flow hoods. Service includes parts and replacement filters. See Statement of Work (SOW) for a list of equipment.

Inspections and certifications shall be completed on a recurring schedule. The specific date/time shall be coordinated with Omaha VA Technical Representative.

Contract Period: Option 1

1002AA

Annual and Bi-annual Testing and Certification of Fume Hoods, and Clinical Laboratory Biological Safety Cabinets (BSCs), Pressure Differential Testing.

Contractor to provide all labor and materials to test, certify, and mark clean areas, all fume hoods and laminar flow hoods (vertical, horizontal, and unidirectional). Repair services to be provided as needed and on emergency basis for the laminar flow hoods plus parts and filters. See Statement of Work (SOW) for a list of equipment.

PHARMACY: Bi-annual inspection and certification in the Months of February and August of each year unless a mutually agreed upon change is established between the Government and the Contractor. The specific date/time shall be coordinated with facility Technical Representative.

PATHOLOGY AND LABORATORY: Annually in the Month of March of each year unless a mutually agreed upon change is established between the Government and the Contractor. The specific date/time shall be coordinated with facility Technical Representative.

Contract Period: Option 1

1002AB

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

Retesting and Recertification due to repair or malfunction of BSC. The quantity is estimated and does not reflect an actual requirement. This is an estimated quantity and does not reflect the actual quantity that will be required.

Contract Period: Option 1

1002AC

Decontamination (gas sterilization) of BSC. The quantity is estimated and does not reflect an actual requirement. This is an estimated quantity and does not reflect the actual quantity that will be required.

Contract Period: Option 1

1002AD

Maintenance labor, per hour, for repairs. The quantity is estimated and does not reflect an actual requirement.