36C25022Q0534_1.docx

36C25022Q0534

GENERAL INFORMATION

Ann Arbor Healthcare System Network Contracting Office 10 2215 Fuller Road Ann Arbor MI 48105

POINT OF CONTACT*

Contract Specialist Jeannie Ortiz jeanne.ortiz@va.gov

NO PHONE CALLS ACCEPTED

PLACE OF PERFORMANCE

1500 Weiss Street

Saginaw, MI 48602

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

Combined Synopsis/Solicitation Notice Combined Synopsis/Solicitation Notice

DESCRIPTION

Combined Synopsis/Solicitation Notice

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested. The Government reserves the right to make no award from this solicitation.

Solicitation number 36C25022Q0534 is being issued as a Request for Quote (RFQ). The government anticipates awarding a firm-fixed price contract resulting from this solicitation. This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2022-06, effective May 1, 2022.

The associated North American Industry Classification System (NAICS) code for this procurement is 541380 (size standard $16.5 million).

This requirement is 100% set aside for Service-Disabled Veteran-Owned Small Business (SDVOSB).

The Department of Veterans Affairs, Veterans Health Administration, Network Contracting Office (NCO) 10 requires a contractor to provide hood testing and certification for the Saginaw VA Medical Center, located in Saginaw, Michigan, for a period of performance of one year with four possible option years. Please reference the Statement of Work for specific information and requirements.

The anticipated contract period is September 1, 2022 - August 31, 2027, if all options are exercised.

Quotes shall be received on or before the date and time specified in Block 8 of the SF1449 Solicitation. Solicitation posting and closing dates are subject to change as necessary and amendments will be issued accordingly.

This solicitation requires registration with the System for Award Management (SAM) at time of offer, pursuant to applicable regulations and guidelines. Registration information is at www.sam.gov.

This is an open-market combined synopsis/solicitation for services as defined herein. The government intends to award a contract as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows:

"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

Offerors shall list exception(s) and rationale for the exception(s).

Offerors shall only submit quotes via email to Jeanne Ortiz, Contract Specialist, at Jeanne.Ortiz@va.gov. Only electronically submitted quotes will be accepted.

Any questions for this solicitation shall be sent via email to Jeanne Ortiz, Contract Specialist, at jeanne.ortiz@va.gov. There will only be one question and answer period. The deadline for submitting all questions is Monday, May 9, 2022 at 10:00 AM Eastern Time. All questions shall have “36C25022Q0534 - Question” as the subject line. The Government will not respond directly to any questions submitted but will gather questions and post the answers to this Contract Opportunities posting for all potential businesses to access.

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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)

c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

655-22-4-039-0140 36C25022Q0534 05-0 -2022 Jeannie Ortiz 734-222-7167 -2022

10:00 AM

EDT

36C250 Department of Veterans Affairs Ann Arbor Healthcare System Network Contracting Office 10 2215 Fuller Road Ann Arbor, MI 48105 X X 541380 $16.5 Million N/A X 36C655 Department of Veterans Affairs Saginaw VA Healthcare System Pathology & Medicine Laboratories 1500 Weiss Street Saginaw, MI 48602 36C250 Department of Veterans Affairs Ann Arbor Healthcare System Network Contracting Office 10 2215 Fuller Road Ann Arbor, MI 48105

Department of Veterans Affairs Financial Management System PO Box 149971 Austin, TX 78714-9971 877-353-9791 512-460-5540 See CONTINUATION Page Contractor shall provide a quote for hood testing and certification in accordance with the Statement of Work and the Price Schedule.

Estimated period of performance is 09/01/2022-08/31/2023, with (4) one-year option periods anticipated.

**THIS IS A TOTAL SET-ASIDE FOR SERVICE-DISABLED VETERAN-

OWNDED SMALL BUSINESS (SDVOSB

See CONTINUATION Page 655-3620160-039-822300-2660 010022390 X X X

JENNIFER A. JOHNSON

CONTRACTING OFFICER

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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: Contract Specialist Jeanne Ortiz Department of Veterans Affairs Ann Arbor Healthcare System Network Contracting Office 10 2215 Fuller Road Ann Arbor, MI 48105

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 Management System 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

Biological and Chemical Hood Testing and Certification of Sterile Compounding Facilities The Aleda E Lutz Veteran Affairs Medical Center has a requirement for certification of laboratory biological safety hoods and sterile compounding facilities including testing of room and equipment on a semi-annual basis. All testing is to be performed by personnel accredited by NSF or CNBT for certification of sterile compounding facilities. Contractor personnel will follow VAMC protocols for use of personal protective equipment in sterile compounding areas.

LOCATION: Aleda E. Lutz VA Medical Center, 1500 Weiss Street, Saginaw, Michigan 48602.

SCOPE OF WORK: The contractor shall provide all resources necessary to accomplish the deliverables described in this Statement of Work (SOW). The contractor shall provide all labor, materials, instrumentation, supervision, certification showing passing functions, and all other resources required to perform semi-annual and annual testing certification on all laboratory biological and safety hoods and sterile compound facilities within Aleda E. Lutz VAMC. Recertification shall be performed no less than every six months, or sooner if equipment is relocated or altered or major service is performed.

EQUIPMENT LOCATIONS:

WORK PERFORMANCE & PERIOD: The contractor shall complete the work required under this SOW in September and again in March, of the contract award term. Some critical areas may require testing to be scheduled in advance in order to gain access, which shall be scheduled through the Contracting Officer’s Representative (COR). The contractor shall complete all testing within five (5) business days from the start date of the initial work.

Certification of facilities will be conducted from cleanest to dirtiest area – LAFW, then general pharmacy area. The contractor shall perform the designated testing and sampling in accordance with the most recent version of the identified standards and testing methods (or those referenced therein). Procedures described in this document are a general description; the designated methods shall be referenced for detailed guidance of testing and sampling procedures. All particle counts will measure particles of 0.5 microns and larger. Where instruments are used for testing, they shall be calibrated in accordance with current industry practice or as designated, no less frequently than every 12 months.

Inspection, testing, certification, and acceptance criteria shall be in accordance with the most recent version of the following recognized standards, as applicable:

i. United States Pharmacopeia, Chapter 797

ii. United States Pharmacopeia, Chapter 1116

iii. CAG-002-2006

iv. CAG-003-2006

v. CAG-008-2010

vi. CAG-009-2011

vii. ISO 14644-1

viii. IEST RP CC-006

ix. IEST RP CC-034

x. Manufacturer Recommendations

Upon recertification, viable sampling will occur prior to facility and equipment certification. Sampling will be conducted from cleanest to dirtiest area – LAFW, then general pharmacy area. Contractor will provide agar plates for viable samples, which will be double or triple wrapped and certificate of quality for each lot will be provided. Aseptic technique per CAG-009-2011 will be followed and care will be taken by certification personnel to not contaminate agar plates or surfaces to be tested. Agar plates will be stored and transported inverted and cool, but not frozen. All viable samples must be sent same day or overnight to an appropriately credentialed laboratory for analysis. In addition to samples, two unopened agar plates of each media type will be sent for negative and positive controls. Chain of custody must be maintained. Reported results will include all data designated in CAG-009-2011, including colony counts and genus determination. Staphylococci will be designated as coagulase-positive or coagulase-negative.

The results of each sampling and testing shall be recorded and submitted as a comprehensive report, along with a statement of compliance or non-compliance with the specified tests. A written report of certification for all primary engineering controls, with statement of Pass/Fail, will be furnished to the COR on the day of certification. Full report will be furnished to the COR, timely, upon completion of all analyses, including identification of viables, not to exceed 10 calendar days from certification date.

The report shall be informative and comprehensive, including the following at minimum:

· Name, address, and contact information of the testing organization;

· Written and signed names of certification personnel, with appropriate accreditations;

· Date on which the certification was performed;

· Reference to appropriate standards (CAG or other, most recent version) and testing/sampling method(s);

· Explanation of test procedures, or referral to SOP, and justification for any deviations from established industry practices;

· Clear identification of the physical location of the areas tested (in relation to the physical layout of the compounding facilities, including equipment) and specific designations for coordinates and nomenclature of all sampling locations, via diagram;

· All reported values designated in CAG-008-2010 for the specified tests;

· Specified designation criteria for the areas, including the ISO classification and considered particle size(s), relevant occupancy state(s), airflow volume or velocity, and pressure differential;

· Instruments and equipment used for data collection, including make, model, serial number, documentation of most recent calibration with date performed and date calibration due;

· Test results, including particle concentration data for all sampling location coordinates and aggregates, as applicable, and laboratory reports;

· A clear indication of Pass or Fail for each test or sample conducted, as indicated by the included criteria;

· An overall indication of Pass or Fail for each sterile compounding area and primary engineering control.

DESIGNATED TESTING AND SAMPLING

Primary Engineering Controls

1. Airflow Test

a. Citations: USP <797>, CAG-001-2005, CAG-002-2006, Manufacturer Specifications

b. Methods: CAG-002-2006

c. Locations: LAFW

d. Procedure: Appropriate airflow parameters will be measured using a validated method which will be kept on file. Air velocity will be measured by thermal anemometer using equally spaced readings across a horizontal plane producing the most repeatable readings. The locations within the plane, and the level of the plane in relationship to the filter diffuser will be documented. Reported in feet per minute with % uniformity.

e. Pass/Fail Criteria:

i. PASS – Average velocity and uniformity within manufacturer specifications

ii. FAIL – Average velocity and uniformity outside manufacturer specifications

2. HEPA Filter Integrity Test

a. Citations: USP <797>, CAG-002-2006

b. Methods: CAG-002-2006, IEST-RP-CC034.2 Section 6.2.1 for filters that can be scan tested IEST-RP-CC034.2 Section 6.2.3 for filters that cannot be scan tested

c. Locations: LAFW

d. Procedure: HEPA filters will be leak tested using a validated method which will be kept on file. An aerosol challenge of 10-90 micrograms per liter of polydispersed dioctylphthalate, polyalphaolefin, or equivalent will be introduced upstream and filter efficacy verified by aerosol photometer scan. Certifier shall have capability to patch and repair HEPA filter up to 3% of the face area per side and not to exceed 1.5 inches in width or provide replacement HEPA filter with filter of like size and construction (Type C or K) on same day.

e. Pass/Fail Criteria:

i. PASS – leakage of less than or equal to 0.01% of upstream concentration for filters that can be scanned, or 0.005% for filters that cannot be scanned

ii. FAIL – leakage of greater than 0.01% or patch size exceeds IEST-RP-CC034 (current version) limit

3. Airflow Smoke Pattern Test

a. Citations: USP <797>, CAG-001-2005, CAG-002-2006

b. Methods: CAG-002-2006

c. Locations: LAFW

d. Procedure: Visual observation of airflow patterns, under dynamic operating conditions, demonstrating first-air flow through critical sites within the DCA. Minimal dead spots or reflux away from critical sites is allowable. Methods will be kept on file. Delivery velocity of smoke generator shall not overcome isolator airflow patterns. Results to be video recorded and provided to Facility Program Manager for IV/Sterile Preparations.

e. Pass/Fail Criteria:

i. PASS – Airflow demonstrates smooth downflow with no dead spots or refluxing across critical sites.

ii. FAIL – Airflow does not meet direction or turbulence standards

4. Particle Count Survey

a. Citations: USP <797>, CAG-001-2005, CAG-002-2006

b. Methods: CAG-002-2006, ISO 14644-1

c. Locations: LAFW

d. Procedure: Air particle counts will be measured using a validated method which will be kept on file. The pass-through will be tested under static (at-rest) condition and the main chamber under both static and dynamic operating conditions. A discrete particle counter capable of detecting particles of 0.5 micron and larger shall be used. Sampling probe is to be oriented upward and located no more than 12” above the work surface (static test) and 12” away from the critical site (dynamic test). A minimum sample of two liters of air over one minute will be taken for each testing location. Three particle counts will be taken from the geometric center of the pass-through and five particle counts each will be taken in the main chamber under static and dynamic conditions – one near each corner, and one in the geometric center. Particle counts will be reported individually for each sampling location and designated by location and testing condition.

e. Pass/Fail Criteria (each PEC):

i. PASS – ISO Class 5 or better for all samples: less than or equal to 3,520 particles (0.5 micron and larger) per cubic meter

ii. FAIL – greater than 3,520 particles (0.5 micron and larger) per cubic meter for any sample

5. Viable Air Sampling

a. Citations: USP <797>, USP <1116>, CAG-009-2011

b. Methods: CAG-009-2011

c. Locations: One of each bacterial and fungal near the geometric center of the work surface in the LAFW and outside the LAFW.

d. Procedure: All samples shall be collected under dynamic operating conditions by volumetric impaction. Bacterial samples will be collected using 55mm plates containing TSA with neutralizing agents (lecithin and polysorbate 80). Samples will be incubated inverted at 30-35° C for 48-72 hours. Fungal samples will be collected using 55mm plates containing MEA or SDA with neutralizing agents (lecithin and polysorbate 80). Samples will be incubated at 26-30° C for 5-7 days. Colony forming units will be assessed daily and counts will be adjusted per manufacturer MPN calculation or statistical correction factor and reported as CFU per cubic meter.

e. Pass/Fail Criteria:

i. PASS – ≤ 1CFU per plate and no highly pathogenic organisms

ii. FAIL – >1 CFU per plate or ≥ 1 CFU of highly pathogenic organisms

iii. Highly pathogenic organisms defined as gram-negative rods, coagulase-positive staphylococci, molds and yeasts

f. Pass/Fail Criteria (Outside CAI):

i. PASS – ≤ 100 CFU per plate

ii. FAIL – >100 CFU per plate

6. Viable Surface Sampling

a. Citations: USP <797>, USP <1116>, CAG-009-2011

b. Locations: One of each bacterial and fungal near the geometric center of the work surface in the LAFW, and outside the LAFW.

c. Methods: CAG-009-2011

d. Procedure: All samples shall be collected under dynamic operating conditions using convex agar plates by gently rolling across the surface once in a single direction. Surface to be disinfected by wiping with non-shedding wipe saturated with sterile 70% isopropyl alcohol (provided by facility) immediately after each sample is collected. Bacterial samples will be collected using 55mm plates containing TSA with neutralizing agents (lecithin and polysorbate 80). Samples will be incubated inverted at 30-35° C for 48-72 hours. Fungal samples will be collected using 55mm plates containing MEA or SDA with neutralizing agents (lecithin and polysorbate 80). Samples will be incubated at 26-30° C for 5-7 days. Colony forming units will be assessed daily and reported as CFU per plate.

e. Pass/Fail Criteria (CAI):

i. PASS – ≤ 3 CFU per plate and no highly pathogenic organisms

ii. FAIL – >3 CFU per plate or ≥ 1 CFU of highly pathogenic organisms

iii. Highly pathogenic organisms defined as gram-negative rods, coagulase-positive staphylococci, molds and yeasts

f. Pass/Fail Criteria (Outside CAI):

i. PASS – ≤ 100 CFU per plate

ii. FAIL – >100 CFU per plate

CONFORMANCE STANDARDS: All testing of equipment, hoods, and areas shall meet any VHA standards, Joint Commission for Accreditation of Hospital Organization (JCAHO) or National Codes, Controlled Environment Testing Association (CETA) Sterile Compounding Facilities (or equivalent) guidelines, and USP 797/800 standards.

WORK HOURS & DAYS: All testing shall be performed Monday through Friday between the hours of 8:00am and 4:30pm, except Federal Holidays or any Federal Holiday designated by the President of the United States. Federal holidays include: New Year’s Day, Birthday of Martin Luther King, Jr., Washington’s Birthday, Memorial Day, Juneteenth National Independence Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, and Christmas Day. Any time change requests shall be cleared through the COR.

GOVERNMENT RESPONSIBILITIES: The Government will provide access to the rooms that need certification and to the hoods so that contractor can perform testing/certifications. The government will supply room maps for all areas of work. The COR will provide an escort, if needed, to find rooms and locations for the contractor.

CONTRACTOR RESPONSIBILITIES:

1. Visitor Pass: The contractor must obtain a visitor pass from Facilities Management Service (FMS) for any on-site work.

2. Safety: The contractor shall provide any and all personal protective equipment (PPE) their employees need such as safety glasses, hearing protection, safety shoes, gloves as required to meet OSHA requirements.

3. Reports: The contractor shall be responsible for submitting to the service point of contact, detailed reports within 14 days of completion of each semi-annual inspection, for each area and each type of hood. The report shall include all elements included above. The contractor shall notify the COR of any hoods or areas that do not meet certification criteria and supply the COR with a quote for repairs needed to meet compliance, prior to leaving the facility.

VHA SUPPLEMENTAL CONTRACT REQUIREMENTS FOR ENSURING ADEQUATE COVID-19 SAFETY PROTOCOLS FOR FEDERAL CONTRACTORS A. VHA Supplemental Contract Requirements for Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors as shown below is hereby incorporated into the scope of work for the subject contract.

1. Contractor employees who work in or travel to VHA locations must comply with the following:

a. Documentation requirements:

1. If fully vaccinated, shall show proof of vaccination.

i. NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813 r, published on September 3, 2020), or a copy of medical records documenting the vaccination.

2. If unvaccinated and granted a medical or religious exception, shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor’s order or an FDA approved over-the-counter test.

3. Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel.

4. Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

2. Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the COVID-19 Screening Tool. Check regularly for updates.

a. Contractor employees who work away from VA locations, but who will have direct contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance, each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

3. Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.

B. All other terms and conditions remain unchanged.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

LABCONCO Logic Type 2 Biosafety Hood testing and certification in accordance with the Statement of Work.

Contract Period: Base POP Begin: 09-01-2022 POP End: 08-31-2023 PRINCIPAL NAICS CODE: 541380 - Testing Laboratories PRODUCT/SERVICE CODE: L066 - Technical Representative - Instruments and Laboratory Equipment

AirClean 600 Chemical Safety Hood testing and certification in accordance with the Statement of Work.

Contract Period: Base POP Begin: 09-01-2022 POP End: 08-31-2023

GermFree Vertical Laminar Flow Workstation Pharmacy Hood testing and certification in accordance with the Statement of Work Contract Period: Base POP Begin: 09-01-2022 POP End: 08-31-2023

LABCONCO Logic Type 2 Biosafety Hood testing and certification in accordance with the Statement of Work.

Contract Period: Option 1 POP Begin: 09-01-2023 POP End: 08-31-2024

AirClean 600 Chemical Safety Hood testing and certification in accordance with the Statement of Work.

Contract Period: Option 1 POP Begin: 09-01-2023 POP End: 08-31-2024

GermFree Vertical Laminar Flow Workstation Pharmacy Hood testing and certification in accordance with the Statement of Work Contract Period: Option 1 POP Begin: 09-01-2023 POP End: 08-31-2024

LABCONCO Logic Type 2 Biosafety Hood testing and certification in accordance with the Statement of Work.

Contract Period: Option 2 POP Begin: 09-01-2024 POP End: 08-31-2025

AirClean 600 Chemical Safety Hood testing and certification in accordance with the Statement of Work.

Contract Period: Option 2 POP Begin: 09-01-2024 POP End: 08-31-2025

GermFree Vertical Laminar Flow Workstation Pharmacy Hood testing and certification in accordance with the Statement of Work Contract Period: Option 2 POP Begin: 09-01-2024 POP End: 08-31-2025

LABCONCO Logic Type 2 Biosafety Hood testing and certification in accordance with the Statement of Work.

Contract Period: Option 3 POP Begin: 09-01-2025 POP End: 08-31-2026

AirClean 600 Chemical Safety Hood testing and certification in accordance with the Statement of Work.

Contract Period: Option 3 POP Begin: 09-01-2025 POP End: 08-31-2026

GermFree Vertical Laminar Flow Workstation Pharmacy Hood testing and certification in accordance with the Statement of Work Contract Period: Option 3 POP Begin: 09-01-2025 POP End: 08-31-2026

LABCONCO Logic Type 2 Biosafety Hood testing and certification in accordance with the Statement of Work.

Contract Period: Option 4 POP Begin: 09-01-2026 POP End: 08-31-2027

AirClean 600 Chemical Safety Hood testing and certification in accordance with the Statement of Work.

Contract Period: Option 4 POP Begin: 09-01-2026 POP End: 08-31-2027

GermFree Vertical Laminar Flow Workstation Pharmacy Hood testing and certification in accordance with the Statement of Work Contract Period: Option 4 POP Begin: 09-01-2026 POP End: 08-31-2027

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SECTION C - CONTRACT CLAUSES

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES 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.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/

(End of Clause) C.2 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

(a) The Contractor agrees to comply with any provision or clause that is incorporated herein by reference to implement agency policy applicable to acquisition of commercial items or components. The following provisions and clauses that have been checked by the Contracting Officer are incorporated by reference.

[X] 852.203–70, Commercial Advertising.

[] 852.209–70, Organizational Conflicts of Interest.

[] 852.211–70, Equipment Operation and Maintenance Manuals.

[] 852.214–71, Restrictions on Alternate Item(s).

[] 852.214–72, Alternate Item(s). [Note: this is a fillable clause.] [] 852.214–73, Alternate Packaging and Packing.

[] 852.214–74, Marking of Bid Samples.

[] 852.215–70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors.

[] 852.215–71, Evaluation Factor Commitments.

[] 852.216–71, Economic Price Adjustment of Contract Price(s) Based on a Price Index.

[] 852.216–72, Proportional Economic Price Adjustment of Contract Price(s) Based on a Price Index.

[] 852.216–73, Economic Price Adjustment—State Nursing Home Care for Veterans.

[] 852.216–74, Economic Price Adjustment—Medicaid Labor Rates.

[] 852.216–75, Economic Price Adjustment—Fuel Surcharge.

[] 852.219–9, VA Small Business Subcontracting Plan Minimum Requirements.

[X] 852.219–10, VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside.

[] 852.219–11, VA Notice of Total Veteran-Owned Small Business Set-Aside.

[] 852.222–70, Contract Work Hours and Safety Standards—Nursing Home Care for Veterans.

[] 852.228–70, Bond Premium Adjustment.

[] 852.228–71, Indemnification and Insurance.

[] 852.228–72, Assisting Service-Disabled Veteran-Owned and Veteran-Owned Small Businesses in Obtaining Bonds.

[X] 852.232–72, Electronic Submission of Payment Requests.

[] 852.233–70, Protest Content/Alternative Dispute Resolution.

[] 852.233–71, Alternate Protest Procedure.

[] 852.237–70, Indemnification and Medical Liability Insurance.

[] 852.246–71, Rejected Goods.

[] 852.246–72, Frozen Processed Foods.

[] 852.246–73, Noncompliance with Packaging, Packing, and/or Marking Requirements.

[X] 852.270–1, Representatives of Contracting Officers.

[] 852.271–72, Time Spent by Counselee in Counseling Process.

[] 852.271–73, Use and Publication of Counseling Results.

[] 852.271–74, Inspection.

[] 852.271–75, Extension of Contract Period.

[] 852.273–70, Late Offers.

[] 852.273–71, Alternative Negotiation Techniques.

[] 852.273–72, Alternative Evaluation.

[] 852.273–73, Evaluation—Health-Care Resources.

[] 852.273–74, Award without Exchanges.

(b) All requests for quotations, solicitations, and contracts for commercial item services to be provided to beneficiaries must include the following clause:

[] 852.237–74, Nondiscrimination in Service Delivery.

(End of Clause)

C.3 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days of contract expiration.

(End of Clause)

C.4 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 of contract expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.

(End of Clause) C.5 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND COMPLIANCE (JUL 2018) (DEVIATION)

(a) This solicitation includes VAAR 852.219-10 VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside.

(b) Accordingly, any contract resulting from this solicitation is subject to the limitation on subcontracting requirements in 13 CFR 125.6, or the limitations on subcontracting requirements in the FAR clause, as applicable. The Contractor is advised that in performing contract administration functions, the Contracting Officer may use the services of a support contractor(s) retained by VA to assist in assessing the Contractor's compliance with the limitations on subcontracting or percentage of work performance requirements specified in the clause. To that end, the support contractor(s) may require access to Contractor's offices where the Contractor's business records or other proprietary data are retained and to review such business records regarding the Contractor's compliance with this requirement.

(c) All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the Contractor's business records or other proprietary data reviewed or obtained in the course of assisting the Contracting Officer in assessing the Contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs.

(d) Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the Contractor to protect proprietary information as required by FAR 9.505-4, Obtaining access to proprietary information, paragraph (b). The Contractor is required to cooperate fully and make available any records as may be required to enable the Contracting Officer to assess the Contractor's compliance with the limitations on subcontracting or percentage of work performance requirement.

(End of Clause)

C.6 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

The Contracting Officer reserves the right to designate an Administrative Contracting Officer (ACO) for the purpose of performing certain tasks/duties in the administration of the contract. Such designation will be in writing through an ACO Letter of Delegation and will identify the responsibilities and limitations of the ACO. A copy of the ACO Letter of Delegation will be furnished to the Contractor.

(End of Clause) (End of Addendum to 52.212-4)

C.7 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2021) (DEVIATION)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204–23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115–91).

(3) 52.204–25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (AUG 2020) (Section 889(a)(1)(A) of Pub. L. 115–232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[] (1) 52.203–6, Restrictions on Subcontractor Sales to the Government (JUN 2020), with Alternate I (OCT 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

[] (2) 52.203–13, Contractor Code of Business Ethics and Conduct (JUN 2020) (41 U.S.C. 3509).

[] (3) 52.203–15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

[] (4) 52.204–10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109–282) (31 U.S.C. 6101 note).

[] (5) [Reserved] [] (6) 52.204–14, Service Contract Reporting Requirements (OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

[] (7) 52.204–15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016) (Pub. L. 111–117, section 743 of Div. C).

[] (8) 52.209–6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (JUN 2020) (31 U.S.C. 6101 note).

[] (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C. 2313).

[] (10) [Reserved] [] (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (MAR 2020) (15 U.S.C. 657a).

[] (ii) Alternate I (MAR 2020) of 52.219-3.

[] (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (MAR 2020) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

[] (ii) Alternate I (MAR 2020) of 52.219-4.

[] (13) [Reserved] [] (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2020) (15 U.S.C. 644).

[] (ii) Alternate I (MAR 2020) of 52.219-6.

[] (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (NOV 2020) (15 U.S.C. 644).

[] (ii) Alternate I (MAR 2020) of 52.219-7.

[] (16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).

[] (17)(i) 52.219–9, Small Business Subcontracting Plan (JUN 2020) (15 U.S.C. 637(d)(4)).

[] (ii) Alternate I (NOV 2016) of 52.219-9.

[] (iii) Alternate II (NOV 2016) of 52.219-9.

[] (iv) Alternate III (JUN 2020) of 52.219–9.

[] (v) Alternate IV (JUN 2020) of 52.219–9.

[] (18)(i) 52.219-13, Notice of Set-Aside of Orders (MAR 2020) (15 U.S.C. 644(r)).

[] (ii) Alternate I (MAR 2020) of 52.219-13.

[] (19) 52.219-14, Limitations on Subcontracting (MAR 2020) (15 U.S.C. 637(a)(14)).

[] (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

[X] (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (MAR 2020) (15 U.S.C. 657f).

[X] (22)(i) 52.219-28, Post Award Small Business Program Rerepresentation (NOV 2020) (15 U.S.C 632(a)(2)).

[] (ii) Alternate I (MAR 2020) of 52.219-28.

[] (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (MAR 2020) (15 U.S.C. 637(m)).

[] (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (MAR 2020) (15 U.S.C. 637(m)).

[] (25) 52.219-32, Orders Issued Directly Under Small Business Reserves (MAR 2020) (15 U.S.C. 644(r)).

[] (26) 52.219-33, Nonmanufacturer Rule (MAR 2020) (15 U.S.C. 637(a)(17)) [X] (27) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

[] (28) 52.222–19, Child Labor—Cooperation with Authorities and Remedies (JUL 2020) (DEVIATION) (E.O. 13126).

[X] (29) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

[X] (30)(i) 52.222–26, Equal Opportunity (SEP 2016) (E.O. 11246).

[] (ii) Alternate I (FEB 1999) of 52.222-26.

[] (31)(i) 52.222–35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).

[] (ii) Alternate I (JULY 2014) of 52.222-35.

[X] (32)(i) 52.222–36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).

[] (ii) Alternate I (JULY 2014) of 52.222-36.

[] (33) 52.222–37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212).

[] (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496).

[X] (35)(i) 52.222-50, Combating Trafficking in Persons (OCT 2020) (22 U.S.C. chapter 78 and E.O. 13627).

[] (ii) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

[] (36) 52.222-54, Employment Eligibility Verification (OCT 2015). (E. O. 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

[] (37)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C.6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

[] (ii) Alternate I (MAY 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

[] (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN 2016) (E.O. 13693).

[] (39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693).

[] (40)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514).

[] (ii) Alternate I (OCT 2015) of 52.223-13.

[] (41)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).

[] (ii) Alternate I (JUN 2014) of 52.223-14.

[] (42) 52.223-15, Energy Efficiency in Energy-Consuming Products (MAY 2020) (42 U.S.C. 8259b).

[] (43)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (E.O.s 13423 and 13514).

[] (ii) Alternate I (JUN 2014) of 52.223-16.

[X] (44) 52.223–18, Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) (E.O. 13513).

[] (45) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).

[] (46) 52.223-21, Foams (JUN 2016) (E.O. 13693).

[] (47) (i) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

[] (ii) Alternate I (JAN 2017) of 52.224-3.

[] (48) 52.225-1, Buy American—Supplies (JAN 2021) (41 U.S.C. chapter 83).

[] (49)(i) 52.225-3, Buy American—Free Trade Agreements—Israeli Trade Act (JUL 2020) (DEVIATION) (19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, 19 U.S.C. chapter 29 (sections 4501-4732), Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

[] (ii) Alternate II (JUL 2020) (DEVIATION) of 52.225-3.

[] (iii) Alternate III (JUL 2020) (DEVIATION) of 52.225-3.

[] (50) 52.225–5, Trade Agreements (JUL 2020) (DEVIATION) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

[X] (51) 52.225-13, Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

[] (52) 52.225–26, Contractors Performing Private Security Functions Outside the United States (OCT 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

[] (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

[] (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

[] (55) 52.229–12, Tax on Certain Foreign Procurements (JUN 2020).

[] (56) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

[] (57) 52.232-30, Installment Payments for Commercial Items (JAN 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

[X] (58) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Oct 2018) (31 U.S.C. 3332).

[] (59) 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award Management (Jul 2013) (31 U.S.C. 3332).

[] (60) 52.232-36, Payment by Third Party (MAY 2014) (31 U.S.C. 3332).

[] (61) 52.239-1, Privacy or Security Safeguards (AUG 1996) (5 U.S.C. 552a).

[] (62) 52.242-5, Payments to Small Business Subcontractors (JAN 2017)(15 U.S.C. 637(d)(13)).

[] (63)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).

[] (ii) Alternate I (Apr 2003) of 52.247-64.

[] (iii) Alternate II (FEB 2006) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[] (1) 52.222-41, Service Contract Labor Standards (AUG 2018) (41 U.S.C. chapter 67).

[] (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

[] (3) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (Multiple Year and Option Contracts) (AUG 2018) (29 U.S.C. 206 and 41 U.S.C.