36C24221Q1367 9.2.pdf

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Attached to: H265--USP and CETA Certifications & BSC/Fume Hood Cert * TIERED EVALUATIONS *
Solicitation number: 36C24221Q1367
Issued by: Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 2

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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

36C24221Q1367 09-02-2021

HARRIS, LISA A 585-393-8297 09-17-2021

14:00 EDT

Department of Veterans Affairs 400 Fort Hill Ave.

Canandaigua, NY 14424

X 100

621511

$35 Million

N/A

Stratton VA Medical Center 113 Holland Ave.

Albany, NY 12208

Network Contracting Activity 400 Fort Hill Ave.

Canandaigua, NY 14424

Tungsten Network https://www.tungsten-network.com/ customer-campaigns/veteransaffairs/ VA TN Number: AAA544240062

1-866-340-4980

See CONTINUATION Page

This solicitation is for a firm fixed-price contract for:

Recurring Certification and Testing of: Pharmacy and Non-Pharmacy Specific Safety Cabinets, Fume Hoods, Environments, and HEPA Filters/Filtration units as outlined Laminar Flow Benches, Room Environments, and HEPA Filters/Filtration units as outlined in the included Statement of Work (SOW).

The place of performance for this contract shall be the Stratton VAMC located at: 20 Madison Ave Extension Albany, NY 12203.

The Period of Performance (POP) Base Year shall be from:

10/01/2021 – 09/30/2022, with the provision of four (4) option years.

SOLICITATION NOTICE OF TIERED EVALUATIONS

See CONTINUATION Page

X X

Lisa Harris Contract Specialist

36C24221Q1367

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 PRICE/COST SCHEDULE

ITEM INFORMATION

SECTION C - CONTRACT CLAUSES

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

2018)

C.2 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ... 32

C.3 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.4 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (NOV 2018)

C.5 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.6 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND

COMPLIANCE (JUL 2018)

C.7 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND

COMPLIANCE (JUL 2018)

C.8 VAAR 852.219-76 SUBCONTRACTING PLANS MONITORING AND

COMPLIANCE (JUL 2018)

C.9 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.10 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2021) (JUL 2020)

(DEVIATION)

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (JUL 2021) 45

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

1998)

E.3 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.4 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS (FEB 2021) (JUL 2020) (DEVIATION)

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 36C242 Lisa Harris

Department of Veterans Affairs

400 Fort Hill Ave.

Canandaigua, NY 14424

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly

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

Tungsten Network https://www.tungsten-network.com/ customer-campaigns/veteransaffairs/

VA TN Number: AAA544240062

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

AMENDMENT NO DATE

Stratton VA Medical Center

Albany, New York

Request for Services - Statement of Work (SOW)

USP Compliant Pharmacy Certification/& Lab BSC/Fume Hood Certification Services

1. Background. Albany VAMC requires a contract to provide all labor, materials and travel to perform the USP compliant certification for the Sterile Compounding Pharmacy areas and Annual BSC/Fume hood recertifications throughout the Medical Center. This is a Base plus four

(4) year contract.

2. Scope (Pharmacy).

A. All pharmacy-specific equipment will obtain CETA certification every six (6) calendar months from the date of the last certification/testing of biological safety cabinets(s), laminar flow hoods, ceiling mounted HEPA filters, and room spaces/environments in accordance with VHA Directive 1108.12, and USP 797 & 800. Recertification may be required sooner if equipment is relocated/altered or a major service is performed.

Pharmacy specific spaces and equipment are as follows:

a. 1B Pharmacy Primary Space(s)

a) B126a: one (1) Ductless Double Filter Fume Hood, Containment

Ventilated Enclosure

1. Test to manufacturer specifications

2. Perform smoke pattern testing with video recording

3. Check velocity

4. Check HEPA filter integrity

b) B122a Anteroom

c) B122b: HD buffer room, three (3) Laminar Airflow Workbenches, and tone (1) ceiling mounted HEPA filter outside cleanroom suite.

Certification periodicities shall be confirmed by contractor, post award, and adjusted as necessary to meet the needs of the Albany VA Medical Center. Certification and testing shall conform to USP and OSHA standards.

d) The contractor shall comply with Federal, State, and Local Laws, plus and federal regulations as applicable to the performance of this contract;

to include USP 797 and USP 800.

e) The individual performing the testing shall be CETA certified to perform this work. The technician/contractor shall provide a copy of the individuals CETA credentials at time of offer. If, during the contract, a different individual(s) is designated by the contractor, CETA certification of the individual(s) must be provided to the CO and COR and approved prior to the start of work.

f) Volumetric air sampling for viable airborne particles must be completed in all classified areas (ISO 5 PEC, ISO 7 & 8 rooms) and must be done using an impaction device during dynamic operating conditions at least every 6 months.

g) Surface sampling of all classified areas and pass-through chambers for microbial contamination must be conducted semi-annually during certification. Sampling must be performed at the end of compounding activity but before the area has been cleaned & disinfected. Sampling must include identification (to genus level) of any resulting microorganisms)

B. 9A Pharmacy Primary Space(s)

a) A921 Anteroom, one (1) ceiling mounted HEPA filter.

b) A920 HD buffer room: two (2) biological safety cabinets and two (2) ceiling mounted HEPA filters. Certification periodicities shall be confirmed by contractor, post award, and adjusted as necessary to meet the needs of the Albany VA Medical Center. Certification and testing shall conform to USP and OSHA standards.

c) The contractor shall comply with Federal, State, and Local Laws, and federal regulations as applicable to the performance of this contract; to include USP 797 and USP 800.

d) The individual performing the testing shall be CETA certified to perform this work. The technician/contractor shall provide a copy of the individuals CETA credentials at time of offer. If, during the contract, a different individual(s) is designated by the contractor, CETA certification of the individual(s) must be provided to the CO and COR and approved prior to the start of work.

e) Volumetric air sampling for viable airborne particles must be completed in all classified areas (ISO 5 PEC, ISO rooms) and must be done using an impaction device during dynamic operating conditions at least every 6 months.

f) Surface sampling of all classified areas for microbial contamination must be conducted semi-annually during certification. Sampling must be performed at the end of compounding activity but before the area has been cleaned & disinfected. Sampling must include identification (to genus level) of any resulting microorganisms

C. 11A Pharmacy Space (s)

a) 11A Anteroom (shared) , one (1) ceiling mounted HEPA filter.

b) 11A HD buffer room: one (1) biological safety cabinets and two (2) ceiling-mounted HEPA filters.

c) 11A non -HD buffer room one (1) LAFW and one (1) ceiling-mounted

HEPA filter

d) Certification periodicities shall be confirmed by contractor, post award, and adjusted as necessary to meet the needs of the Albany VA Medical Center. Certification and testing shall conform to USP and OSHA standards.

e) The contractor shall comply with Federal, State, and Local Laws, plus and federal regulations as applicable to the performance of this contract;

to include USP 797 and USP 800.

f) The individual performing the testing shall be CETA certified to perform this work. The technician/contractor shall provide a copy of the individuals CETA credentials at time of offer. If, during the contract, a different individual(s) is designated by the contractor, CETA certification of the individual(s) must be provided to the CO and COR and approved prior to the start of work.

g) Volumetric air sampling for viable airborne particles must be completed in all classified areas (ISO 5 PEC, ISO rooms) and must be done using an impaction device during dynamic operating conditions at least every 6 months.

h) Surface sampling of all classified areas for microbial contamination must be conducted semi-annually during certification. Sampling must be performed at the end of compounding activity but before the area has been cleaned & disinfected. Sampling must include identification (to genus level) of any resulting microorganisms)

D. Additional Requirements:

The contractor shall:

a. Obtain all necessary licenses and/or permits required to perform the work herein.

b. Measure and document HEPA filter(s) air volumes and velocities

c. PPE

a) Contractor will follow Albany VAMC protocols for use of PPE in the classified spaces and understands the risks associated with facilities and equipment designed for storage and preparation of hazardous drugs.

b) All equipment brought into the cleanroom suite must be disinfected and sanitized prior to entry (with Caviwipe, followed by sterile 70% isopropyl alcohol or as per current standard operating procedure for the cleanroom suite).

d. Primary Engineering Controls (BSCs and LAFWs)

a) HEPA filter leak tests and patching if necessary

b) Prefilter check

c) Non-viable particle count testing (0.5 micron and larger) under dynamic operating conditions inside each PEC to calculate ISO rating

d) Dynamic smoke testing (video recorded and provided to us on a DVD or made available for download on a secure website) for all primary engineering controls; must have sufficient smoke to demonstrate unidirectional airflow and sweeping action over and away from any preparation

e) Perform semi-annual Air & Surface Viable Environmental Sampling (bacterial & fungal) from inside each PEC, including counts and microbial identifications. All environmental testing to be performed by an accredited laboratory and their report issued. Samples must be labeled, and a diagram of sampling locations provided

1. (2) Biological Safety Cabinet (1 air bacterial, 1 air fungal, 1 surface bacterial, & 1 surface fungal)

a. Baker Steril Guard E3 BioSafety Cabinet

i. Model Number: SG604)

ii. Serial Number: 129000

b. Baker Steril Guard E3 BioSafety Cabinet

i. Model Number: SG604)

ii. Serial Number: 128979

2. (3) Laminar Flow Benches (1 air bacterial, 1 air fungal, 1 surface bacterial, & 1 surface fungal)

a. Baker Edgegard Laminar Flow Clean Bench, 4FT

i. Model Number: EG4320)

ii. Serial Number: 102010

b. Baker Edgegard Laminar Flow Clean Bench, 6FT

i. Model Number: EG6320)

ii. Serial Number: 102034

c. Baker Edgegard Laminar Flow Clean Bench, 6FT

i. Model Number: EG6320

ii. Serial Number: 102065

d. Baker Steril Guard E3 BioSafety Cabinet

i. Model Number: SG404

ii. Serial Number: 137983

e. Baker Edgegard Laminar Flow Clean Bench, 4FT

i. Model Number: EG4320

ii. Serial Number: 137953

e. Secondary Engineering Controls (SECs)

a) 1B Pharmacy Secondary Engineering Controls

1. B122a ISO Class 8 Sterile Preparation Anteroom

2. B122b ISO Class 7 Compounding Buffer Room

3. Perform room calculations to determine air changes per hour

(ACPH) in each room. Documented on the certification report should include ACPH for HVAC, ACPH contributed from PEC, and the total ACPH.

4. Perform semi-annual Air & Surface Viable Environmental Sampling for microorganisms (bacterial & fungal), including counts and microorganism identification. All environmental testing to be performed by an accredited laboratory and their report issued.

Samples must be labeled, and a diagram of sampling locations provided. Sample to be taken from at least one high-touch area of each SEC

5. Non-viable particle count testing (0.5 micron and larger) under dynamic operating conditions to calculate room ISO rating

6. HEPA filer leak test (1 in adjacent room)

7. Pressure differentials between each pair of SECs and between ante room and general pharmacy area

8. Smoke pattern testing with video recording of airflow between each pair of SECs and between anteroom and general pharmacy area

9. Temperature and humidity testing

b) 9A Pharmacy Primary Space(s)

1. A921 ISO Class 7 Sterile Preparation Anteroom

2. A920 ISO Class 7 Hazardous Compounding Buffer Room

3. Perform room calculations to determine air changes per hour

(ACPH) in each room. Documented on the certification report should include ACPH for HVAC, ACPH contributed from PEC, and the total ACPH.

Samples must be labeled, and a diagram of sampling locations provided. Sample to be taken from at least one high-touch area of each SEC

5. Non-viable particle count testing (0.5 micron and larger) under dynamic operating conditions to calculate room ISO rating

6. HEPA filer leak test for in-ceiling filters (1 anteroom, 2 buffer room)

7. Pressure differentials between each pair of SECs and between ante room and general pharmacy area

8. Smoke pattern testing with video recording of airflow between each pair of SECs and between anteroom and general pharmacy area

9. Temperature and humidity testing

c) 11A Pharmacy Primary Space(s)

1. A1106a ISO Class 7 Anteroom

2. A1106b ISO Class 7 HD Buffer room

3. A1106c ISO Class 7 non -HD Buffer room

4. Perform room calculations to determine air changes per hour (ACPH) in each room. Documented on the certification report should include ACPH for HVAC, ACPH contributed from PEC, and the total ACPH.

5. Perform semi-annual Air & Surface Viable Environmental Sampling for microorganisms (bacterial & fungal), including counts and microorganism identification. All environmental testing to be performed by an accredited laboratory and their report issued.

Samples must be labeled, and a diagram of sampling locations provided. Sample to be taken from at least one high-touch area of each SEC

6. Non-viable particle count testing (0.5 micron and larger) under dynamic operating conditions to calculate room ISO rating

7. HEPA filer leak test for in-ceiling filters (1 anteroom, 1 in positive pressure buffer room, 2 in negative pressure buffer room)

8. Pressure differentials between each pair of SECs and between ante room and general pharmacy area

9. Smoke pattern testing with video recording of airflow between each pair of SECs and between anteroom and general pharmacy area (and any passthroughs)

10. Temperature and humidity testing

f. Perform calibration of room pressure differential gauges. Gauges will be affixed with calibration sticker.

g. Instruments used for testing will be specified and along with most recent calibration date and date next calibration is due.

h. CAG-003-006 or successor will be followed (per PBM 4/23/18 guidance:

Veterans Health Administration Guidance for Defining, Certifying, and Procuring PECs for Compounded Sterile Preparations) along with VHA Directive 1108.12, and United States Pharmacopeia General Chapters 797 and 800 and Institute of Flow Clean Air Devices, IEST-RP-CC-002.4.

i. Reporting (Pharmacy Results Only)

a) All reports must be sent via email directly to the COR and to the CSP pharmacist

b) Contractor shall provide a written report of all testing and certification results, no later than seven (7) business days following completion of all work (except for viable sampling results).At a minimum, this report must contain:

1. Name of CETA-certified technician performing the testing

2. List of equipment used for the testing: manufacturer, model, serial number and calibration due date

3. Type, make, model and serial number for each PEC

4. Each PEC and SEC nonviable particulate counts (including sample volume and time) and ISO classification

5. Measured air velocity data for PEC, including CFM, average and standard deviation of air velocity measurements and acceptance criteria

6. PEC blower setting and pressure gauge reading (if any)

7. For BSCs: measured downflow air velocity data, acceptance criteria and pass/fail result

8. For BSCs: measured exhaust damper acceptance criteria and pass/fail result

9. For BSCs: inflow velocity test method, measurements and results

10. Total Air Changes Per Hour (ACPH) for each SEC, with indication of ACPH supplied by the PECs

11. Pressure differentials between each SEC and the anteroom/pharmacy

12. Results of HEPA leak tests for all filters tested, as well as the results of any patching that was performed

a. If leaks were detected and sealed, include a diagram showing approximate location of sealed leaks

13. Prefilter type, size and condition for each PEC

14. Viable testing results (once available)

15. SEC temperature and relative humidity

16. Video recording of all smoke pattern testing (airflow and dynamic)

17. Alarm test results (if any)

18. A diagram of the areas tested, noting the approximate location of surface, air and particle counts

19. Any recommendations for HEPA replacement/HEPA lifespan

20. Performance standard used for testing

21. The Microbiology report must include:

a. Sampling location and any organisms identified to the genus level

b. Incubation temperature and duration

c. Manufacturer, lot number and expiration for each media lot

d. Positive and negative controls

e. Determination of whether findings are actionable (pass/fail)

f. Chain of custody for samples

c) The pharmacy must be notified of any microbial growth immediately after it is identified (no later than 48 hours after the report is received by the contractor from the laboratory).

j. The certification tag must be updated on each of the PECs that passes certification

k. Response Time (Pharmacy Only) Contractor shall use commercially reasonable efforts to:

a) Respond by telephone to any report of a malfunction requiring repair within one hour of notification.

b) Provide on-site support within 24 hours of notification unless prevented by unforeseen circumstances

3. Laboratory Equipment Certification:

A. Perform annual certification of twelve (12) Biological Safety Cabinets in accordance with the following standards and per manufacturer specifications:

B. NSF / ANSI 49 (Biological Safety Cabinets) C. IEST-RP-CC034.3 (HEPA Filter Leak Testing)

D. Inventory.

4. Research Equipment

A. Perform annual certification of six (6) Fume Hoods in accordance with the following standards and per manufacturer specifications:

B. ANSI/ASHRAE STANDARD 110-2016

C. Inventory

Equipment Name Model Serial Location

CHEMICAL FUME HOOD UNK FUME010 119

FUME HOOD 4' UNK FUME015 A610

BATERIOLOGICAL SAFETY HOOD (FUME HOOD) UNK F UME016 A610

SAFEAIRE 4' CHEM FUME HOOD 54L502 FUME007 143F (ARF)

SAFEAIRE 4' CHEM FUME HOOD 54L502 FUME008 143A (ARF)

SAFEAIRE 4' CHEM FUME HOOD 54L502 FUME009 143B (ARF)

5. Dental/Prosthetics Equipment

A. Perform annual certification of (2) Fume Hoods in accordance with the following standards and per manufacturer specifications:

B. ANSI/ASHRAE STANDARD 110-2016

C. Inventory.

Equipment Name Model Serial Location

FIBERGLASS 30 LABORATORY FUMEHOOD 3030002 12060004 A106

MOTT FUME HOOD 7221000 44069 A316

a. Reporting

Contractor shall provide a written report of all testing and certification results, no later than seven (7) business days following completion of all work (except for

Equipment Name Model Serial Location

BIOLOGICAL SAFETY CABINET CLASS II, TYPE 2A NU425300 82716AGR B201B

BIOLOGICAL SAFETY CABINET CLASS II, TYPE 2A NU425600 19691UX B316

BSC CLASS II, TYPE B3, OPTION A,D,-P3 NU425400 19692UX B316C

BIOLOGICAL SAFETY CABINET CLASS II, TYPE 2A NU425600 19703UX B316A

BIOLOGICAL SAFETY CABINET CLASS II, TYPE A2 NU425600 19690UX B315

BIOLOGICAL SAFETY CABINET CLASS II, TYPE A2 NU425600 123439052208 B316B

THERMO SCIEN 1300 SERIES CLASS 2 TYPE A2 1377 300401752 C323

THERMO SCIENTIFIC FUMIGATION VENT/HOOD 1335 300174353 B302

THERMO SCIENTIFIC FUME HOOD GROSS STAR 300146453 C305

THERMO SCIENTIFIC FUME HOOD GROSS STAR 300146454 C305

APEX AIR FUME HOOD GP-605 6891-18 C310

APEX AIR FUME HOOD GP-605 6891-19 C310

viable sampling results). Contractor shall include Summary tables listing all rooms or areas tested and the acceptable limits, actual readings and indication of testing results (e.g. pass/fail) for the designated testing criteria for compliance.

6. Travel and Related Expenses

Contractor shall be responsible for its service-related trip expenses including round trip travel, mileage, and overnight living expenses.

7. Title to Equipment

Contractor shall not assume possession or control of any part of the equipment. The Government retains ownership to title thereof.

9. Utilities

Contractor may use Government utilities, (e.g., electrical power, compressed air, and water) which are available and required for any service performed under this contract.

10. Access to Equipment

Contractor shall be provided reasonable access to all equipment that is to be serviced and utility outlets required to do the service. The contractor shall be free to start and stop all primary equipment incidentals to the operation of the maintained equipment after permission is received from on duty personnel responsible for such equipment.

11. Technical Support

Technical support shall be made available from the Contractor to Stratton VAMC 24/7, 365 days a year via telephone.

13. Parts and Materials

All compensation for parts and materials is included in contract price.

14. Parts/Supplies Quality

Parts and Supplies provided under this contract shall be new OEM parts.

15. Field Service Reports

Contractor shall furnish a written or electronic vendor supplied Field Service Report (FSR).

16. Place of Performance.

Stratton VAMC

113 Holland Ave

Albany, NY 12208

17. Period of Performance.

Base plus four (4) option years

Base: 1 Oct 2021-30 Sep 2022

Opt Yr 1: 1 Oct 2022-30 Sep 2023

Opt Yr 2: 1 Oct 2023-30 Sep 2024

Opt Yr 3: 1 Oct 2024-30 Sep 2025

Opt Yr 4: 1 Oct 2025-30 Sep 2026

Attch:

1A Layout

9A Layout

11A Layout

1A Layout

9A Layout

11A Layout

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBE

DESCRIPTION OF

SUPPLIES/SERVIC

QUANTIT

UNI

T UNIT PRICE AMOUNT

0.00

USP compliant certification for the Sterile Compounding Pharmacy suite, Laboratory equipment, Research equipment, and Dental/Prosthetics equipment Contract Period: Base POP Begin: 10-01-2021 POP End: 09-30-2022

0001AA

3.00 JB ________________

CETA certification for the Sterile Compounding Pharmacy suite Contract Period: Base

0001AB

12.00 JB ________________

Perform annual certification of twelve (12) Biological Safety Cabinets in accordance with manufacturer specifications and the following standards: NSF / ANSI 49 (Biological Safety Cabinets) and IEST-RP-CC034.3 (HEPA Filter Leak Testing) Contract Period: Base

0001AC

6.00 JB ________________

Perform annual certification of six (6) Fume Hoods in accordance with the ANSI/ASHRAE standard 110-2016 and per manufacturer specifications Contract Period: Base

0001AD

2.00 JB ________________

Perform annual certification of two (2) Fume Hoods in accordance with the ANSI/ASHRAE standard 110-2016 and per manufacturer specifications Contract Period: Base

Environmental Sampling and Testing Contract Period: Base

0002AA

Primary Engineering Controls (PEC) Biological Safety Cabinets (BSC) and Laminar Airflow Workbenches (LAFWs) Contract Period: Base

0002AB

Secondary Engineering Controls (SECs) Contract Period: Base

Contractor shall provide a written or electronic vendor supplied Field Service Report (FSR) of all testing and certification results, no later than seven (7) business days following completion of all work (except for viable sampling results).

Contractor shall include Summary tables listing all rooms or areas tested and the acceptable limits, actual readings and indication of testing results (e.g. pass/fail) for the designated testing criteria for compliance. And all viable sample test results should include identification (to genus level) of any resulting microorganisms.

Contract Period: Base

USP compliant certification for the Sterile Compounding Pharmacy suite, Laboratory equipment, Research equipment, and Dental/Prosthetics equipment Contract Period: Option 1 POP Begin: 10-01-2022 POP End: 09-30-2023

1001AA

CETA certification for the Sterile Compounding Pharmacy suite Contract Period: Option 1

1001AB

1001AC

Perform annual certification of six (6) Fume Hoods in accordance with the ANSI/ASHRAE standard 110-2016 and per manufacturer specifications Contract Period: Option 1

1001AD

Perform annual certification of two (2) Fume Hoods in accordance with the ANSI/ASHRAE standard 110-2016 and per manufacturer specifications Contract Period: Option 1

Environmental Sampling and Testing Contract Period: Option 1

1002AA

Primary Engineering Controls (PEC) Biological Safety Cabinets (BSC) and Laminar Airflow Workbenches (LAFWs) Contract Period: Option 1

1002AB

Secondary Engineering Controls (SECs) Contract Period: Option 1

Contract Period: Option 1

2001AA

CETA certification for the Sterile Compounding Pharmacy suite Contract Period: Option 2

2001AB

2001AC

Perform annual certification of six (6) Fume Hoods in accordance with the ANSI/ASHRAE standard 110-2016 and per manufacturer specifications Contract Period: Option 2

2001AD

Perform annual certification of two (2) Fume Hoods in accordance with the ANSI/ASHRAE standard 110-2016 and per manufacturer specifications Contract Period: Option 2

Environmental Sampling and Testing Contract Period: Option 2

2002AA

Primary Engineering Controls (PEC) Biological Safety Cabinets (BSC) and Laminar Airflow Workbenches (LAFWs) Contract Period: Option 2

2002AB

Secondary Engineering Controls (SECs) Contract Period: Option 2

Contract Period: Option 2

3001AA

CETA certification for the Sterile Compounding Pharmacy suite Contract Period: Option 3

3001AB

3001AC

Perform annual certification of six (6) Fume Hoods in accordance with the ANSI/ASHRAE standard 110-2016 and per manufacturer specifications Contract Period: Option 3

3001AD

Perform annual certification of two (2) Fume Hoods in accordance with the ANSI/ASHRAE standard 110-2016 and per manufacturer specifications Contract Period: Option 3

Environmental Sampling and Testing Contract Period: Option 3

3002AA

Primary Engineering Controls (PEC) Biological Safety Cabinets (BSC) and Laminar Airflow Workbenches (LAFWs) Contract Period: Option 3

3002AB

Secondary Engineering Controls (SECs) Contract Period: Option 3

Contract Period: Option 3

4001AA

CETA certification for the Sterile Compounding Pharmacy suite Contract Period: Option 4

4001AB

4001AC

Perform annual certification of six (6) Fume Hoods in accordance with the ANSI/ASHRAE standard 110-2016 and per manufacturer specifications Contract Period: Option 4

4001AD

Perform annual certification of two (2) Fume Hoods in accordance with the ANSI/ASHRAE standard 110-2016 and per manufacturer specifications Contract Period: Option 4

Environmental Sampling and Testing Contract Period: Option 4

4002AA

Primary Engineering Controls (PEC) Biological Safety Cabinets (BSC) and Laminar Airflow Workbenches (LAFWs) Contract Period: Option 4

4002AB

Secondary Engineering Controls (SECs) Contract Period: Option 4

Contract Period: Option 4

GRAND TOTAL ________________

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.

(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.

(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;

(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. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause)

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

ITEMS

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.2 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR

2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 30 Days; provided that the…

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