36C25919Q0105.docx

36C25919Q0105

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

36C25919Q0105 01-04-2019 Lance Davis 918-577-3838 01-10-2019 36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

1011 Honor Heights Drive Muskogee OK 74401 X X 811219 $20.5 Million X N/A X Oklahoma City VA Health Care System 921 NE 13th St Oklahoma City OK 73104 36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

1011 Honor Heights Drive Muskogee OK 74401

Department of Veterans Affairs Financial Service Center PO Box 149971 Austin TX 78714-9971 See CONTINUATION Page Respond to Solicitation:

e-mail to Lance.Davis2@va.gov by due date and time in Block 8 above.

**Faxes will not be Accepted** Contractor must provide NSF Accrediation Certificate with Quote.

Location of Performance: (see block 15 above) Base Year and Option Year Line Items are not exactly the same Due to some inspections have recently been completed.

Contractor must provide NSF Accreditation Certificate with Quote.

$0.00 See CONTINUATION Page X X Lance Davis

NCO1616L2-5045

Table of Contents

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 36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

1011 Honor Heights Drive Muskogee OK 74401

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

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 Financial Service Center PO Box 149971 Austin TX 78714-9971

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

B.2 Statement of Work

Inspection & Certification of Biological Safety Cabinets, Laboratory Hoods & Pharmacy Clean/Ante Rooms and Specialized Room Ventilation Systems

Oklahoma City VA Medical Center Oklahoma City, Oklahoma

1. PURPOSE

1.1 This requirement is for procuring services for testing and certification of specialized room ventilation systems, chemical hoods, Laminar Flow Workstations (LFWs) and Biological Safety Cabinets (BSCs) to provide a safe environment for laboratory personnel at multiple locations. Contractor shall test and certify laboratory equipment, sterile processing areas, and pharmacy clean/ante rooms. Location includes: Oklahoma City VA Medical Center, 921 NE 13th St., Oklahoma City, Oklahoma 73104.

2. SCOPE

2.1 Contractor shall furnish service as specified below to ensure that the equipment functions in accordance with:

· NCI Specification “General Purpose, Clean Air, Biological Safety Cabinet, revised August 19, 1975”,

· NIH specification NIH-03-11ZC dated Sept 17, 1974;

· National Sanitation Foundation-Class II, (Laminar Flow) Biohazard Cabinetry-Standard Number 49 [NSF 49];

· Federal Standard No. 209E-April 24, 1973, “Clean Room and Work Station Requirements, Controlled Environment”;

· SAMA Standard LF10-1980 Laboratory Fume Hoods and USP 797

· USP General Chapter <800> Hazardous Drugs-Handling in Healthcare Settings 2017

· CAG-002-2006

· CAG-003-2006

· CAG-007-2010

· CAG-008-2010

· IEST RP-CC-034

· CETA Compounding Testing Guide 2006

· FDA Insanitary conditions for Compounding

· CETA Viable Sampling SOP

· CETA Certification Guide May 2015

2.2 Furnish all labor, equipment, tools, materials, and travel necessary to test, certify and measure Government – owned Biological Safety Cabinets (BSCs), Laminar Flow Work Stations (LFWs), and Pharmacy clean rooms.

2.3 Equipment and locations are identified on the Schedule of Items.

2.4 The annual/semi-annual certifications shall be performed in sufficient time to ensure that none shall lapse (contractor will schedule testing that builds in time for repairs should that be necessary to insure certifications never lapse). With two lab hoods in Chemo and two hoods in IV mixing areas. Lab hoods are to be staggered for certification with two hoods certified in the months of December/June and the other two hoods certified during the months of March and September each year. Research provides backup bariatric hoods for mixing chemo and IV’s and these hoods are certified during the months of March/September.

2.5 The Contractor shall provide certification reports upon completion of semi-annual and annual testing/certification. Report will include training/certifications of technicians performing the work and calibration certificates of the equipment used during the testing/certification.

2.6 Contractor will immediately notify COR in writing (letter) or by email, in the event any/all regulatory guidance governing the certifications of any subject equipment changes. Written advisement will include any issues which will impact testing/certification. Contractor will also advise Oklahoma City VA Medical Center of recommendations to resolve any issues related to the regulatory changes.

2.7 When testing/servicing/certifying equipment, the Contractor will provide on-site consultation to Oklahoma City VA staff (answer questions, make recommendations to maintain at optimum level) that use the Pharmacy cleanroom, the biosafety cabinets, and the laminar flow workstations. Technicians knowledgeable about certification requirements will converse with staff/COR to inform them of recommended adjustments to behaviors used in daily use, cleaning of area, maintenance of equipment, and any structural/HVAC/electrical/engineering issues related to the equipment or rooms encompassing equipment. Technicians will brief COR of any issues/questions raised by staff upon checking out post-certification.

2.8 Contractor shall have the capability to respond within 24 hours of contact for emergency repair. Contractor shall furnish the Contracting Officer Representative (COR) with written estimate of cost to make necessary repairs and receive COR approval prior to initiating repairs.

2.9 All of the following information should be included in the report for clean room certification. 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, Room sketch, Total room area and volume, Room humidity and temperature, Air changes per hour, Pressure differential, Non-viable particle counts, and viable particle count analysis. Pass/Fail notifications should be included on a per test basis where applicable.

3. CERTIFICATION AND TESTING REQUIREMENTS

3.1. Biological Safety Cabinets (BSC): The Pharmacy biosafety cabinet shall be certified semi-annually. All other Biosafety cabinets will be certified annually. Certification shall consist of the following:

· Down flow velocity test

· Inflow velocity test

· Airflow smoke pattern test (videotaping must be included for Pharmacy hoods only)

· HEPA filter leak test

· Alarm function test

· Blower interlock test (Class II, type B cabinets)

· Electrical leakage on the main cabinet (those that aren’t UL listed)

· Ground Fault Circuit Interrupter (GFCI) outlet trip test.

· A visual inspection to identify defects, damage, misuse or missing parts

· Documentation of the certification and inspection results

· A decal or label affixed to the cabinet in a visible location that indicates the results and date of the certification

· Posting an “Out of Service” sign on cabinets that fail certification;

· Notifying the cabinet user and the COR of cabinets that fail certification.

3.2 Laminar Airflow Workstations (LAFW): All LAFWs will be certified annually. Certification shall consist of the following:

· Measurement of sash face velocity according to the current version of ASHRAE 110.

· Comparison of the sash face velocity to the current ACGIH recommendation.

· Airflow smoke pattern test.

· GFCI outlet trip test.

· A visual inspection to identify defects, damage, misuse or missing parts;

· Documentation of the certification and inspection results (e.g., a decal or label affixed in a visible location that indicates the sash certification height, the face velocity and the date of certification).

· Posting an “Out of Service” sign on lab fume hoods that fail certification.

· Notifying the lab fume hood user and the COR of lab fume hoods that fail certification.

3.3 Pharmacy Cleanroom(s) Testing and Certification:

Testing and certification (under CAG-003-2006-11 and to USP797 Standards and 800 Hazardous Drugs—Handling in Healthcare Settings.) of the Pharmacy: Ante Room, Hazardous Buffer (IV) Room and Non-Hazardous Buffer (Chemo) Room as well as viable air and surface sampling for mold and bacteria will be semi-annually. Certification and testing shall consist of the following:

· Test and validate the number of air changes per hour (ACH) through the rooms Heating Ventilation and Air Conditioning (HVAC) equipment and exhaust hood.

· Pressure Requirements: The contractor shall include in their report differential pressure reading from each buffer/ante room to all surrounding areas

· Non-viable Particle Testing: The contractor shall perform environmental nonviable particle testing semiannually

· Test and validate that the hood and room exhaust provide a unidirectional/laminar flow of air.

· Inspect HVAC filter assembly for air bypass issues.

· Test and calibrate the existing air balancing monitors (Chemo and Ante Rooms).

· Take viable air samples for mold and bacteria (1 location in each PEC: LFWs, BSC, Pass Thru, and 1 location in the room Ante, and 2 locations Chemo and IV Room. Colony forming units (CFU) results from the cultures shall be calculated in cfu per cubic meter (m3) of air.

· Take viable surface samples for bacteria (1 each in LFWs, BSC, Pass Thru, Ante, Chemo and IV Room.

4. PERSONNEL ACCREDITATION REQUIREMENTS

4.1 Contractor services personnel must be NSF accredited and submit their NSF accreditation certificates with their bid proposal.

4.2 Technician performing on-site testing for Pharmacy must be CETA certified.

5. PERIOD OF PERFORMANCE AND WORK HOURS

5.1 The period of performance shall be for one base year with four possible one-year option periods (as outlined with the schedule / line items).

5.2 The Contractor (or Representative) shall contact the COR, Contracting Officer’s Representative, to schedule work and prior to the beginning of work.

5.3 Services are to be performed during our business hours between 7:30 a.m. and 4:00 p.m. central time, excluding federal holidays. Because of the workload of the pharmacy during business hours, the contractor may need to work after 4:00 p.m. in order 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 4:00 p.m. this service must be included within the bid pricing as no extra charge will be allowed. The ability to perform work after hours is not required; however, preference will be given to contractors that offer flexible work hours.

6. DELIVERY

6.1 No delivery of items

7. INSPECTION AND ACCEPTANCE:

7.1 The Contractor shall conduct a joint inspection with the COR upon certification and testing of equipment.

8. DELIVERABLES

8.1 After work is completed, the contractor is to submit in writing, a complete report of services performed for each item of equipment and must include a listing of replacement parts, when applicable. Within one week of obtaining sampling results, the vendor will electronically report ventilation and sampling data semiannually to Oklahoma City VA Medical Center Safety Management has a means of evaluating the overall control of the compounding environment. The report should have guidance on interpreting results, possible contamination pathways and proper corrective actions to remediate contamination.

8.2 The contractor shall supply every unit that passes required certification specifications with a certification sticker.

9. TRAINING

9.1 No training is required from the contractor.

10. Transportation Visits = 6 visits a year (4 required and 2 additional trips for troubleshooting/retesting etc.)

12. Facility Information Security Officer (FISO) SECURITY LANGUAGE:

12.1 GENERAL

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

13. See Price Schedule for Line Items.

14. Pharmacy IV Room Agar Plate Sample Log: (also as an attachment for convenience)

Sample collection (30 samples) for the following areas in Pharmacy on a Semi-annual basis.

Additional 5 samples for re-testing for any positive test results.

Pharmacy (119) IV Room Agar Plate Sample Log

Agar Contact Plates

ISO-5 Environment

IV Hood #1 (left)

IV Hood #1 (right)

IV Hood #2 (left)

IV Hood #2 (right)

IV Hood #3 (Chemo) (left)

IV Hood #3 (Chemo) (right)

IV Hood #4 (Chemo) (left)

IV Hood #4 (Chemo) (right)

Chemo Barrier Isolator (left)

Chemo Barrier Isolator (right)

Non-Hazardous Barrier Isolator (left)

Non-Hazardous Barrier Isolator (right)

ISO-7 Environment

IV room Counter-top

IV room clean-cart

IV room Storage cart

IV room Supply cart

IV room floor

IV room wall

Chemo room counter-top

Chemo room supply cart

Chemo room chemo storage cart

Chemo room floor

Chemo room wall

Chemo ante-room cart

Chemo ante-room supply cart

Chemo ante-room wall

Chemo ante-room floor

ISO-8 Environment

IV Ante-room cart

IV Ante-room wall

IV Ante-room floor

See attached document: Equipment Listing (Biosafety Cabinets).

See attached document: Sample Log Pharmacy IV Room Agar Plate.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

Hood, Biosafety Cabinet (BSL3), MFG/Model NUAIRE Labguard ES, Located in Room 4F115-C1, Annual Certification to be completed as per the SOW.

Contract Period: Base POP Begin: 02-01-2019 POP End: 09-30-2019

Hood, Biosafety Cabinet (Lab), MFG/Model NUAIRE Labguard ES, SN# 164095070314, Located in Room 4F105, Annual Certification to be completed as per the SOW.

Hoods, Pharmacy IV, MFG/Model Laminar Air Flow / Baker Edgard, Located in Room GA142A1, Semi-Annual Certifications to be completed as per the SOW. (2 Hoods to be Certified twice a year (But only 3 total inspections for this Base Year as one Hood Certification has already been completed)

Room GA142A1, Pharmacy IV Room, Semi-Annual Certification to be completed as per the SOW to include leak testing and to include viable air sampling to include 5 extra samples mentioned in the SOW. (1 Room to be Certified twice a year (But only 1 total inspection for this Base Year as one Room inspection has already been completed)

Hoods, Pharmacy Chemo Compounding, MFG/Model Baker Steril Chemgard III Advance, Located in Room GA-142B1, Semi-Annual Certifications to be completed as per the SOW. (2 Hoods to be Certified twice a year (But only 3 total inspections for this Base Year as one Hood Certification has already been completed)

Room GA142B1, Pharmacy Chemo Compounding, Semi-Annual Certification to be completed as per the SOW to include leak testing and to include viable air sampling to include 5 extra samples mentioned in the SOW. (But only 1 total inspection for this Base Year as one Room inspection has already been completed)

Room GA142A, Pharmacy IV Anteroom, Semi-Annual Certification to be completed as per the SOW to include leak testing and to include viable air sampling to include 5 extra samples mentioned in the SOW. (But only 1 total inspection for this Base Year as one Room inspection has already been completed)

Room GA142B, Pharmacy Chemo Anteroom, Semi-Annual Certification to be completed as per the SOW to include leak testing and to include viable air sampling to include 5 extra samples mentioned in the SOW. (But only 1 total inspection for this Base Year as one Room inspection has already been completed)

Hoods & the Baker SS400 SterilShield Isolator, Research Pharmacy Chemo/IV, MFG/Model Baker Chemoshield, Located in Room GR-102, Semi-Annual Certifications to be completed as per the SOW. (2 Hoods & 1 Isolator to be Certified twice a year (4 total inspections))

Room GR-102, Research Pharmacy Chemo/IV, Semi-Annual Certification to be completed as per the SOW. (1 Room to be Certified twice a year (2 total inspections))

Chamber, Induction Chamber, MFG/Model AEROMED Sputum Induction Booth, Located in Room 5F-130, Annual Certification to be completed as per the SOW.

Filter, Isolation Room (HEPA), Located in Room 5F-116, Annual, to be completed as per the SOW.

Filter, Isolation Room (HEPA), Located in Room 5F-144, Annual, to be completed as per the SOW.

Filter, Isolation Room (HEPA), Located in Room BF-132/133, Annual, to be completed as per the SOW.

Transportation Visits as per the SOW. 4 required and 2 additional as needed for troubleshooting and/or retesting.

Sample Collection of Pharmacy IV Room Agar Plate as per area listing in SOW. (30 samples required with 5 additional samples as needed for retesting of any positive test results) on a Semi-Annual basis.

Hood, Biosafety Cabinet (Microbiology Lab) MFG/Model NUAIRE Labguard ES, SN# 159780102513, Located in Room 4F115, Annual Certification to be completed as per the SOW.

Contract Period: Option 1 POP Begin: 10-01-2019 POP End: 09-30-2020

Hood, Biosafety Cabinet (BSL3), MFG/Model NUAIRE Labguard ES, Located in Room 4F115-C1, Annual Certification to be completed as per the SOW.

Hood, Biosafety Cabinet (Cytology) MFG/Model NUAIRE Labguard ES, SN# 159781102513, Located in Room 4F133, Annual Certification to be completed as per the SOW.

Hood, Biosafety Cabinet (Molecular) MFG/Model NUAIRE Labguard ES, SN# 159779102513, Located in Room 4F137, Annual Certification to be completed as per the SOW.

Hood, Biosafety Cabinet (Lab), MFG/Model NUAIRE Labguard ES, SN# 164095070314, Located in Room 4F105, Annual Certification to be completed as per the SOW.

Hoods, Pharmacy IV, MFG/Model Laminar Air Flow / Baker Edgard, Located in Room GA142A1, Semi-Annual Certifications to be completed as per the SOW. (2 Hoods to be Certified twice a year (4 total inspections))

Room GA142A1, Pharmacy IV Room, Semi-Annual Certification to be completed as per the SOW to include leak testing and to include viable air sampling to include 5 extra samples mentioned in the SOW. (1 Room to be Certified twice a year (2 total inspections))

Hoods, Pharmacy Chemo Compounding, MFG/Model Baker Steril Chemgard III Advance, Located in Room GA-142B1, Semi-Annual Certifications to be completed as per the SOW. (2 Hoods to be Certified twice a year (4 total inspections))

Room GA142B1, Pharmacy Chemo Compounding, Semi-Annual Certification to be completed as per the SOW to include leak testing and to include viable air sampling to include 5 extra samples mentioned in the SOW. (1 Room to be Certified twice a year (2 total inspections))

Room GA142A, Pharmacy IV Anteroom, Semi-Annual Certification to be completed as per the SOW to include leak testing and to include viable air sampling to include 5 extra samples mentioned in the SOW. (1 Room to be Certified twice a year (2 total inspections))

Room GA142B, Pharmacy Chemo Anteroom, Semi-Annual Certification to be completed as per the SOW to include leak testing and to include viable air sampling to include 5 extra samples mentioned in the SOW. (1 Room to be Certified twice a year (2 total inspections))

Hoods & the Baker SS400 SterilShield Isolator, Research Pharmacy Chemo/IV, MFG/Model Baker Chemoshield, Located in Room GR-102, Semi-Annual Certifications to be completed as per the SOW. (2 Hoods & 1 Isolator to be Certified twice a year (4 total inspections))

Room GR-102, Research Pharmacy Chemo/IV, Semi-Annual Certification to be completed as per the SOW to include leak testing and to include viable air sampling to include 5 extra samples mentioned in the SOW. (1 Room to be Certified twice a year (2 total inspections))

Chamber, Induction Chamber, MFG/Model AEROMED Sputum Induction Booth, Located in Room 5F-130, Annual Certification to be completed as per the SOW.

Filter, Isolation Room (HEPA), Located in Room 5F-116, Annual, to be completed as per the SOW.

Filter, Isolation Room (HEPA), Located in Room 5F-144, Annual, to be completed as per the SOW.

Filter, Isolation Room (HEPA), Located in Room BF-132/133, Annual, to be completed as per the SOW.

Transportation Visits as per the SOW. 4 required and 2 additional as needed for troubleshooting and/or retesting.

Sample Collection of Pharmacy IV Room Agar Plate as per area listing in SOW. (30 samples required with 5 additional samples as needed for retesting of any positive test results) on a Semi-Annual basis.

Hood, Biosafety Cabinet (Microbiology Lab) MFG/Model NUAIRE Labguard ES, SN# 159780102513, Located in Room 4F115, Annual Certification to be completed as per the SOW.

Contract Period: Option 2 POP Begin: 10-01-2020 POP End: 09-30-2021

Hood, Biosafety Cabinet (BSL3), MFG/Model NUAIRE Labguard ES, Located in Room 4F115-C1, Annual Certification to be completed as per the SOW.

Hood, Biosafety Cabinet (Cytology) MFG/Model NUAIRE Labguard ES, SN# 159781102513, Located in Room 4F133, Annual Certification to be completed as per the SOW.

Hood, Biosafety Cabinet (Molecular) MFG/Model NUAIRE Labguard ES, SN# 159779102513, Located in Room 4F137, Annual Certification to be completed as per the SOW.

Hood, Biosafety Cabinet (Lab), MFG/Model NUAIRE Labguard ES, SN# 164095070314, Located in Room 4F105, Annual Certification to be completed as per the SOW.

Hoods, Pharmacy IV, MFG/Model Laminar Air Flow / Baker Edgard, Located in Room GA142A1, Semi-Annual Certifications to be completed as per the SOW. (2 Hoods to be Certified twice a year (4 total inspections))

Room GA142A1, Pharmacy IV Room, Semi-Annual Certification to be completed as per the SOW to include leak testing and to include viable air sampling to include 5 extra samples mentioned in the SOW. (1 Room to be Certified twice a year (2 total inspections))

Hoods, Pharmacy Chemo Compounding, MFG/Model Baker Steril Chemgard III Advance, Located in Room GA-142B1, Semi-Annual Certifications to be completed as per the SOW. (2 Hoods to be Certified twice a year (4 total inspections))

Room GA142B1, Pharmacy Chemo Compounding, Semi-Annual Certification to be completed as per the SOW to include leak testing and to include viable air sampling to include 5 extra samples mentioned in the SOW. (1 Room to be Certified twice a year (2 total inspections))

Room GA142A, Pharmacy IV Anteroom, Semi-Annual Certification to be completed as per the SOW to include leak testing and to include viable air sampling to include 5 extra samples mentioned in the SOW. (1 Room to be Certified twice a year (2 total inspections))

Room GA142B, Pharmacy Chemo Anteroom, Semi-Annual Certification to be completed as per the SOW to include leak testing and to include viable air sampling to include 5 extra samples mentioned in the SOW. (1 Room to be Certified twice a year (2 total inspections))

Hoods & the Baker SS400 SterilShield Isolator, Research Pharmacy Chemo/IV, MFG/Model Baker Chemoshield, Located in Room GR-102, Semi-Annual Certifications to be completed as per the SOW. (2 Hoods & 1 Isolator to be Certified twice a year (4 total inspections))

Room GR-102, Research Pharmacy Chemo/IV, Semi-Annual Certification to be completed as per the SOW to include leak testing and to include viable air sampling to include 5 extra samples mentioned in the SOW. (1 Room to be Certified twice a year (2 total inspections))

Chamber, Induction Chamber, MFG/Model AEROMED Sputum Induction Booth, Located in Room 5F-130, Annual Certification to be completed as per the SOW.

Filter, Isolation Room (HEPA), Located in Room 5F-116, Annual, to be completed as per the SOW.

Filter, Isolation Room (HEPA), Located in Room 5F-144, Annual, to be completed as per the SOW.

Filter, Isolation Room (HEPA), Located in Room BF-132/133, Annual, to be completed as per the SOW.

Transportation Visits as per the SOW. 4 required and 2 additional as needed for troubleshooting and/or retesting.

Sample Collection of Pharmacy IV Room Agar Plate as per area listing in SOW. (30 samples required with 5 additional samples as needed for retesting of any positive test results) on a Semi-Annual basis.

Hood, Biosafety Cabinet (Microbiology Lab) MFG/Model NUAIRE Labguard ES, SN# 159780102513, Located in Room 4F115, Annual Certification to be completed as per the SOW.

Contract Period: Option 3 POP Begin: 10-01-2021 POP End: 09-30-2022

Hood, Biosafety Cabinet (BSL3), MFG/Model NUAIRE Labguard ES, Located in Room 4F115-C1, Annual Certification to be completed as per the SOW.

Hood, Biosafety Cabinet (Cytology) MFG/Model NUAIRE Labguard ES, SN# 159781102513, Located in Room 4F133, Annual Certification to be completed as per the SOW.

Hood, Biosafety Cabinet (Molecular) MFG/Model NUAIRE Labguard ES, SN# 159779102513, Located in Room 4F137, Annual Certification to be completed as per the SOW.

Hood, Biosafety Cabinet (Lab), MFG/Model NUAIRE Labguard ES, SN# 164095070314, Located in Room 4F105, Annual Certification to be completed as per the SOW.

Hoods, Pharmacy IV, MFG/Model Laminar Air Flow / Baker Edgard, Located in Room GA142A1, Semi-Annual Certifications to be completed as per the SOW. (2 Hoods to be Certified twice a year (4 total inspections))

Room GA142A1, Pharmacy IV Room, Semi-Annual Certification to be completed as per the SOW to include leak testing and to include viable air sampling to include 5 extra samples mentioned in the SOW. (1 Room to be Certified twice a year (2 total inspections))

Hoods, Pharmacy Chemo Compounding, MFG/Model Baker Steril Chemgard III Advance, Located in Room GA-142B1, Semi-Annual Certifications to be completed as per the SOW. (2 Hoods to be Certified twice a year (4 total inspections))

Room GA142B1, Pharmacy Chemo Compounding, Semi-Annual Certification to be completed as per the SOW to include leak testing and to include viable air sampling to include 5 extra samples mentioned in the SOW. (1 Room to be Certified twice a year (2 total inspections))

Room GA142A, Pharmacy IV Anteroom, Semi-Annual Certification to be completed as per the SOW to include leak testing and to include viable air sampling to include 5 extra samples mentioned in the SOW. (1 Room to be Certified twice a year (2 total inspections))

Room GA142B, Pharmacy Chemo Anteroom, Semi-Annual Certification to be completed as per the SOW to include leak testing and to include viable air sampling to include 5 extra samples mentioned in the SOW. (1 Room to be Certified twice a year (2 total inspections))

Hoods & the Baker SS400 SterilShield Isolator, Research Pharmacy Chemo/IV, MFG/Model Baker Chemoshield, Located in Room GR-102, Semi-Annual Certifications to be completed as per the SOW. (2 Hoods & 1 Isolator to be Certified twice a year (4 total inspections))

Room GR-102, Research Pharmacy Chemo/IV, Semi-Annual Certification to be completed as per the SOW to include leak testing and to include viable air sampling to include 5 extra samples mentioned in the SOW. (1 Room to be Certified twice a year (2 total inspections))

Chamber, Induction Chamber, MFG/Model AEROMED Sputum Induction Booth, Located in Room 5F-130, Annual Certification to be completed as per the SOW.

Filter, Isolation Room (HEPA), Located in Room 5F-116, Annual, to be completed as per the SOW.

Filter, Isolation Room (HEPA), Located in Room 5F-144, Annual, to be completed as per the SOW.

Filter, Isolation Room (HEPA), Located in Room BF-132/133, Annual, to be completed as per the SOW.

Transportation Visits as per the SOW. 4 required and 2 additional as needed for troubleshooting and/or retesting.

Sample Collection of Pharmacy IV Room Agar Plate as per area listing in SOW. (30 samples required with 5 additional samples as needed for retesting of any positive test results) on a Semi-Annual basis.

Hood, Biosafety Cabinet (Microbiology Lab) MFG/Model NUAIRE Labguard ES, SN# 159780102513, Located in Room 4F115, Annual Certification to be completed as per the SOW.

Contract Period: Option 4 POP Begin: 10-01-2022 POP End: 09-30-2023

Hood, Biosafety Cabinet (BSL3), MFG/Model NUAIRE Labguard ES, Located in Room 4F115-C1, Annual Certification to be completed as per the SOW.

Hood, Biosafety Cabinet (Cytology) MFG/Model NUAIRE Labguard ES, SN# 159781102513, Located in Room 4F133, Annual Certification to be completed as per the SOW.

Hood, Biosafety Cabinet (Molecular) MFG/Model NUAIRE Labguard ES, SN# 159779102513, Located in Room 4F137, Annual Certification to be completed as per the SOW.

Hood, Biosafety Cabinet (Lab), MFG/Model NUAIRE Labguard ES, SN# 164095070314, Located in Room 4F105, Annual Certification to be completed as per the SOW.

Hoods, Pharmacy IV, MFG/Model Laminar Air Flow / Baker Edgard, Located in Room GA142A1, Semi-Annual Certifications to be completed as per the SOW. (2 Hoods to be Certified twice a year (4 total inspections))

Room GA142A1, Pharmacy IV Room, Semi-Annual Certification to be completed as per the SOW to include leak testing and to include viable air sampling to include 5 extra samples mentioned in the SOW. (1 Room to be Certified twice a year (2 total inspections))

Hoods, Pharmacy Chemo Compounding, MFG/Model Baker Steril Chemgard III Advance, Located in Room GA-142B1, Semi-Annual Certifications to be completed as per the SOW. (2 Hoods to be Certified twice a year (4 total inspections))

Room GA142B1, Pharmacy Chemo Compounding, Semi-Annual Certification to be completed as per the SOW to include leak testing and to include viable air sampling to include 5 extra samples mentioned in the SOW. (1 Room to be Certified twice a year (2 total inspections))

Room GA142A, Pharmacy IV Anteroom, Semi-Annual Certification to be completed as per the SOW to include leak testing and to include viable air sampling to include 5 extra samples mentioned in the SOW. (1 Room to be Certified twice a year (2 total inspections))

Room GA142B, Pharmacy Chemo Anteroom, Semi-Annual Certification to be completed as per the SOW to include leak testing and to include viable air sampling to include 5 extra samples mentioned in the SOW. (1 Room to be Certified twice a year (2 total inspections))

Hoods & the Baker SS400 SterilShield Isolator, Research Pharmacy Chemo/IV, MFG/Model Baker Chemoshield, Located in Room GR-102, Semi-Annual Certifications to be completed as per the SOW. (2 Hoods & 1 Isolator to be Certified twice a year (4 total inspections))

Room GR-102, Research Pharmacy Chemo/IV, Semi-Annual Certification to be completed as per the SOW to include leak testing and to include viable air sampling to include 5 extra samples mentioned in the SOW. (1 Room to be Certified twice a year (2 total inspections))

Chamber, Induction Chamber, MFG/Model AEROMED Sputum Induction Booth, Located in Room 5F-130, Annual Certification to be completed as per the SOW.

Filter, Isolation Room (HEPA), Located in Room 5F-116, Annual, to be completed as per the SOW.

Filter, Isolation Room (HEPA), Located in Room 5F-144, Annual, to be completed as per the SOW.

Filter, Isolation Room (HEPA), Located in Room BF-132/133, Annual, to be completed as per the SOW.

Transportation Visits as per the SOW. 4 required and 2 additional as needed for troubleshooting and/or retesting.

Sample Collection of Pharmacy IV Room Agar Plate as per area listing in SOW. (30 samples required with 5 additional samples as needed for retesting of any positive test results) on a Semi-Annual basis.

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in 32.608-2 of the Federal Acquisition Regulation in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience.