S02 36C25625Q0275_RFQ.pdf

Combined Synopsis/Solicitation Notice

*= Required Field Combined Synopsis/Solicitation Notice

SUBJECT* RFQ: Pharmacy Hoods Semi-Annual Inspection PM Svc (MEDVAMC)

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 77056-5643

SOLICITATION NUMBER* 36C25625Q0275

RESPONSE DATE/TIME/ZONE

Question Response date

01-29-2025 3pm CENTRAL TIME, CHICAGO, USA 01-21-2025 3pm CENTRAL TIME, CHICAGO, USA

ARCHIVE 7 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

SET-ASIDE SDVOSBC

PRODUCT SERVICE CODE* J065

NAICS CODE* 811210

CONTRACTING OFFICE ADDRESS Department of Veterans Affairs

Network Contracting Office 16 5075 Westheimer Road, Suite 750

Houston TX 77056-5643

POINT OF CONTACT* Contract Specialist Quentin Chew Quentin.Chew@va.gov

-and-

Contract Specialist

Shasta Britt

Shasta.Britt@va.gov

PLACE OF PERFORMANCE

ADDRESS Michael E DeBakey VA Medical Center

2002 Holocombe BLVD Houston Tx

POSTAL CODE 77030

COUNTRY USA

ADDITIONAL INFORMATION

AGENCY’S URL https://www.va.gov URL DESCRIPTION Department of Veterans Affairs AGENCY CONTACT’S EMAIL ADDRESS Quentin.Chew@va.gov EMAIL DESCRIPTION 36C25625Q0275 RFQ: Pharmacy Hoods Semi-Annual

Inspection mailto:Quentin.Chew@va.gov https://www.va.gov/ mailto:Quentin.Chew@va.gov

DESCRIPTION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for

Evaluation and Solicitation for Commercial Items,” in conjunction with FAR Part 13.5 for Certain

Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; a quote is being requested, and a written solicitation document will not be issued.

This solicitation is issued as a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular

FAC 2025-01 (eff.11/12/2024), VAAM Alert 24-10 (eff. 04/09/2024), and Acquisition Policy Flash

24-08 (eff. 05/22/2024).

Contractor is required to be actively registered in the System for Award Management (SAM) and certified with the Small Business administrative (SBA) Veteran Small Business Certification

(VetCert) as a Service-Disable Veteran-Owned Small Business (SDVOSB). Vendor quote may be considered non-compliant and rejected if the Contracting Officer is unable to verify registration and certification status.

The Michael E. DeBakey VA Medical Center (MEDVAMC) 2002 Holcombe Blvd, Houston, Texas 77030 is seeking to purchase Pharmacy Hoods Semi-Annual Inspection. This solicitation is a SDVOSB set-aside. The government expects this announcement to result in a Firm-Fixed

Price Single-Award contract for a base year plus four (4) option years not to exceed five (5) years.

See attached RFQ…

36C25625Q0275

Table of Contents

SECTION B - CONTINUATION CONTRACT OPPORTUNITIES COMBINED SYNOPSIS

SOLICITATION

B. 1CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.2 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.4 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022) 9

C.5 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.6 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED

SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESSES (JAN 2023)

(DEVIATION)

C.7 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023)

(DEVIATION)

C.8 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.9 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.10 VAAR 852.249-70 TERMINATION FOR DEFAULT—SUPPLEMENT FOR

MORTUARY SERVICES (MAY 2020)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 STATEMENT OF WORK

D.2 WAGE DETERMINATIONS No.: 2015-5233 REV. 28 (JUL2024)

SECTION E - SOLICITATION PROVISIONS

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

1998)

E.2 52.201-1 ACQUISITION 360: VOLUNTARY SURVEY (SEP 2023)

E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.4 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT ORDERS—

REPRESENTATION AND DISCLOSURES (DEC 2023)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 VAAR 852.215-72 NOTICE OF INTENT TO RE-SOLICIT (OCT 2019)

E.7 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

E.8 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.9 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.10 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)

SECTION B - CONTINUATION CONTRACT OPPORTUNITIES

COMBINED SYNOPSIS SOLICITATION

B. 1CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individual:

a. CONTRACTOR: Company Name:

ATTN/POC Name:

Address:

Phone:

Email:

UEI:

b. GOVERNMENT: Contracting Officer 36C256 Department of Veterans Affairs Network Contracting Office 16 Galleria Financial Center 5075 Westheimer Road, Suite 750 Houston TX 77056-5643

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

a. 52.232-33 Payment by Electronic Funds Transfer - System for Award Management through TUNGSTEN

3. INVOICES: Invoices shall be submitted in arrears:

a. Other: Monthly - Upon receipt and acceptance by the Government

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.

5. Offeror shall complete the following located in Sections B thru E of this solicitation to be deemed eligible:

a. Section B- CONTRACT ADMINISTRATION DATA, CONTRACTOR contact information.

b. Section B- PRICE/COST SCHEDULE, unit price, amount, and grand total

c. Section C- 852.219-75

d. Section E- 52.204-24

e. Section E- 52.212-3 (if not current in SAM.gov)

f. Submission of manufacturer’s authorized distributor letter, cut-sheets, and specifications.

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

AMENDMENT NO DATE

(End of Contract Administration Data)

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM # DESCRIPTION OF

SERVI CES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

0001 12.00 EA

The Michael E. DeBakey VA Medical Center (MEDVAMC) must perform semi-annual inspections and certifications of pharmacy biological safety cabinets (BCS), compounding aseptic isolators (CAI), compounding aseptic containment isolators (CACI), containment segregated compounding areas (C-SCA), clean rooms, ante rooms, laminar airflow hoods (LAFH), alarms, and glove box/isolator and ISO classified areas to include particle counts per the most current United States Pharmacopeia (USP) 797 and 800 requirements. Additional requirements include inspection and installation of all HEPA filters and the installation of pre- filters for required instruments.

Contract Period: Base POP Begin: 02-15-2025 POP End: 02-14-2026 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance PRODUCT/SERVICE CODE: J065 - Maintenance, Repair, and Rebuilding of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

1001 12.00 EA

The Michael E. DeBakey VA Medical Center (MEDVAMC) must perform semi-annual inspections and certifications of pharmacy biological safety cabinets (BCS), compounding aseptic isolators (CAI), compounding aseptic containment isolators (CACI), containment segregated compounding areas (C-SCA), clean rooms, ante rooms, laminar airflow hoods (LAFH), alarms, and glove box/isolator and ISO classified areas to include particle counts per the most current United States Pharmacopeia (USP) 797 and 800 requirements. Additional requirements include inspection and installation of all HEPA filters and the installation of pre- filters for required instruments.

Contract Period: Option 1

POP Begin: 02-15-2026 POP End: 02-14-2027 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance PRODUCT/SERVICE CODE: J065 - Maintenance, Repair, and Rebuilding of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

2001 12.00 EA

The Michael E. DeBakey VA Medical Center (MEDVAMC) must perform semi-annual inspections and certifications of pharmacy biological safety cabinets (BCS), compounding aseptic isolators (CAI), compounding aseptic containment isolators (CACI), containment segregated compounding areas (C-SCA), clean rooms, ante rooms, laminar airflow hoods (LAFH), alarms, and glove box/isolator and ISO classified areas to include particle counts per the most current United States Pharmacopeia (USP) 797 and 800 requirements. Additional requirements include inspection and installation of all HEPA filters and the installation of pre-filters for required instruments.

Contract Period: Option 2 POP Begin: 02-15-2027 POP End: 02-14-2028 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance PRODUCT/SERVICE CODE: J065 - Maintenance, Repair, and Rebuilding of Equipment - Medical, Dental, and

3001 12.00 EA

pharmacy biological safety cabinets (BCS), compounding aseptic isolators (CAI), compounding aseptic containment isolators (CACI), containment segregated compounding areas (C-SCA), clean rooms, ante rooms, laminar airflow hoods (LAFH), alarms, and glove box/isolator and ISO classified areas to include particle counts per the most current United States Pharmacopeia (USP) 797 and 800 requirements. Additional requirements include inspection and installation of all HEPA filters and the installation of pre-filters for required instruments.

Contract Period: Option 3 POP Begin: 02-15-2028 POP End: 02-14-2029 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance PRODUCT/SERVICE CODE: J065 - Maintenance, Repair, 4001 12.00 EA pharmacy biological safety cabinets (BCS), compounding aseptic isolators (CAI), compounding aseptic containment isolators (CACI), containment segregated compounding areas (C-SCA), clean rooms, ante rooms, laminar airflow hoods (LAFH), alarms, and glove box/isolator and ISO classified areas to include particle counts per the most current United States Pharmacopeia (USP) 797 and 800 requirements. Additional requirements include inspection and installation of all HEPA filters and the installation of pre-filters for required instruments.

Contract Period: Option 4 POP Begin: 02-15-2029 POP End: 02-14-2030 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance PRODUCT/SERVICE CODE: J065 - Maintenance, Repair, GRAND TOTAL

B.3 DELIVERY SCHEDULE

ITEM #

SHIPPING INFORMATION

QUANTITY

DELIVERY DATE

0001 SHIP TO: IAW SOW 12.00/MO 02/15/2025 - 02/14/2026

FOB: DESTINATION

1001 SHIP TO: IAW SOW 12.00/MO 02/15/2026 - 02/14/2027

FOB: DESTINATION

2001 SHIP TO: IAW SOW 12.00/MO 02/15/2027 - 02/14/2028

FOB: DESTINATION

3001 SHIP TO: IAW SOW 12.00/MO 02/15/2028 - 02/14/2029

FOB: DESTINATION

4001 SHIP TO: IAW SOW 12.00/MO 02/15/2029 - 02/14/2030

FOB: DESTINATION

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):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

FAR

Number

Title Date

52.203-16 PREVENTING PERSONAL CONFLICTS OF INTEREST JUN 2020

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

AUG 2020

52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

NOV 2023

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLEMENT STATUTES OR EXECUTIVE ORDERS—

COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES

MAY 2024

52.217-8 OPTION TO EXTEND SERVICES NOV 1999

52.223-5 POLLUTION PREVENTION AND RIGHT-TO-KNOW

INFORMATION

MAY 2024

52.223-10 WASTE REDUCTION PROGRAM MAY 2024

52.228-5 INSURANCE—WORK ON A GOVERNMENT

INSTALLATION

JAN 1997

52.237-2 PROTECTION OF GOVERNMENT BUILDINGS,

EQUIPMENT, AND VEGETATION

APR 1984

52.247-34 F.O.B. DESTINATION NOV 1991

(End of Clause)

C.2 SUPPLEMENTAL INSURANCE REQUIREMENTS

In accordance with FAR 28.307-2 and FAR 52.228-5, the following minimum coverage shall apply to this contract:

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

(a) Workers' compensation and employers liability: Contractors are required to comply with applicable Federal and State workers' compensation and occupational disease statutes. If occupational diseases are not compensable under those statutes, they shall be covered under the employer's liability section of the insurance policy, except when contract operations are so commingled with a Contractor's commercial operations that it would not be practical to require this coverage. Employer's liability coverage of at least $100,000 is required, except in States with exclusive or monopolistic funds that do not permit workers' compensation to be written by private carriers.

(b) General Liability: $500,000.00 per occurrences.

(c) Automobile liability: $200,000.00 per person; $500,000.00 per occurrence and $20,000.00 property damage.

(d) The successful bidder must present to the Contracting Officer, prior to award, evidence of general liability insurance without any exclusionary clauses for asbestos that would void the general liability coverage.

(End of Clause)

C.3 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 Government gives the Contractor a preliminary written notice of its intent to extend at least 60 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.4 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC

2022)

The Contracting Officer reserves the right to designate representatives to act for him/her in furnishing technical guidance and advice or generally monitor the work to be performed under this contract. Such designation will be in writing and will define the scope and limitation of the designee’s authority. A copy of the designation letter shall be furnished to the Contractor.

(End of Clause)

C.5 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

The Contractor shall not make reference in its commercial advertising to Department of

Veterans Affairs contracts in a manner that states or implies the Department of Veterans Affairs approves or endorses the Contractor’s products or services or considers the Contractor’s products or services superior to other products or services.

(End of Clause)

C.6 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED

SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESSES (JAN 2023)

(DEVIATION)

(a) Definition. for the Department of Veterans Affairs, ‘‘Service-disabled Veteran-owned small business concern or SDVOSB’’:

(1) Means a small business concern—

(i) Not less than 51 percent of which is owned by one or more service-disabled Veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled Veterans or eligible surviving spouses (see VAAR

802.201, Surviving Spouse definition);

(ii) The management and daily business operations of which are controlled by one or more service-disabled Veterans (or eligible surviving spouses) or, in the case of a service-disabled

Veteran with permanent and severe disability, the spouse or permanent caregiver of such

Veteran;

(iii) The business meets Federal small business size standards for the applicable North

American Industry Classification System (NAICS) code identified in the solicitation document;

(iv) The business has been certified for ownership and control pursuant to 38 U.S.C. 8127, 13 CFR 128, and is listed as certified in the SBA certification database at https://veterans.certify.sba.gov/; and

(v) The business agrees to comply with VAAR subpart 819.70 and Small Business

Administration (SBA) regulations regarding small business size, government contracting, and the Veteran Small Business Certification Program at 13 CFR parts 121, 125, and 128.

(2) The term ‘‘Service-disabled Veteran’’ means a Veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

(3) The term ‘‘small business concern’’ has the meaning given that term under section 3 of the Small Business Act (15 U.S.C. 632).

(4) The term ‘‘small business concern owned and controlled by Veterans with service-connected disabilities’’ has the meaning given the term ‘‘small business concern owned and controlled by service-disabled veterans’’ under section 3(q)(2) of the Small Business Act (15

U.S.C. 632(q)(2)).

(5) The term “SDVOSB participant” or certified SDVOSB means a small business that has been certified in the SBA Veteran Small Business Certification Program and listed in the SBA certification database (see 13 CFR 128.102).

https://veterans.certify.sba.gov/

(b) General. In order for a concern to submit an offer and be eligible for the award of an

SDVOSB set-aside or sole source contract, the concern must qualify as a small business concern under the size standard corresponding to the NAICS code assigned to the contract and be listed as an SDVOSB participant in the SBA certification database as set forth in 13 CFR

128.

(1) Offers received from entities that are not certified SDVOSBs and listed in the SBA certification database at the time of offer shall not be considered.

(2) Any award resulting from this solicitation shall be made to a certified SDVOSB listed in the

SBA certification database who is eligible at the time of submission of offer(s) and at the time of award.

(3) The requirements in this clause apply to any contract, order or subcontract where the firm receives a benefit or preference from its designation as an SDVOSB, including set-asides, sole source awards, and evaluation preferences.

(c) Representation. Pursuant to 38 U.S.C. 8127(e), only certified SDVOSBs listed in the SBA certification database are considered eligible to receive award of a resulting contract. By submitting an offer, the prospective contractor represents that it is an eligible and certified

SDVOSB as defined in this clause, 13 CFR 121, 125, and 128, and VAAR subpart 819.70.

(d) Agreement/LOS certification. When awarded a contract action, including orders under multipleaward contracts, an SDVOSB agrees that in the performance of the contract, the

SDVOSB shall comply with requirements in VAAR subpart 819.70 and SBA regulations on small business size, and government contracting programs at 13 CFR part 121 and part 125, including the non-manufacturer rule and limitations on subcontracting (LOS) requirements in 13

CFR 121.406(b) and 13 CFR 125.6. For the purpose of limitations on subcontracting, only certified SDVOSBs listed in the SBA certification database (including independent contractors) shall be considered eligible and/or ‘‘similarly situated’’ (i.e., a firm that has the same small business program status as the prime contractor). An otherwise eligible firm further agrees to comply with the required LOS certification requirements in this solicitation (see 852.219–75 or

852.219–76 as applicable). These requirements are summarized as follows:

(1) Services. In the case of a contract for services (except construction), the SDVOSB prime contractor will not pay more than 50% of the amount paid by the government to the prime for contract performance to firms that are not certified SDVOSBs listed in the SBA certification database (excluding direct costs to the extent they are not the principal purpose of the acquisition and the SDVOSB/ VOSB does not provide the service, such as airline travel, cloud computing services, or mass media purchases). When a contract includes both services and supplies, the 50 percent limitation shall apply only to the service portion of the contract.

(2) Supplies/products.

(i) In the case of a contract for supplies or products (other than from a non-manufacturer of such supplies), the SDVOSB prime contractor will not pay more than 50% of the amount paid by the government to the prime for contract performance, excluding the cost of materials, to firms that are not certified SDVOSBs listed in the SBA certification database. When a contract includes both supply and services, the 50 percent limitation shall apply only to the supply portion of the contract.

(ii) In the case of a contract for supplies from a non-manufacturer, the SDVOSB prime contractor will supply the product of a domestic small business manufacturer or processor, unless a waiver as described in 13 CFR 121.406(b)(5) has been granted. Refer to 13 CFR

125.6(a)(2)(ii) for guidance pertaining to multiple item procurements.

(3) General construction. In the case of a contract for general construction, the SDVOSB prime contractor will not pay more than 85% of the amount paid by the government to the prime for contract performance, excluding the cost of materials, to firms that are not certified

SDVOSBs listed in the SBA certification database.

(4) Special trade construction contractors. In the case of a contract for special trade contractors, no more than 75% of the amount paid by the government to the prime for contract performance, excluding the cost of materials, may be paid to firms that are not certified

SDVOSBs listed in the SBA certification database.

(5) Subcontracting. An SDVOSB subcontractor must meet the NAICS size standard assigned by the prime contractor and be certified and listed in the SBA certification database to count as similarly situated. Any work that a first tier SDVOSB subcontractor further subcontracts will count towards the percent of subcontract amount that cannot be exceeded. For supply or construction contracts, the cost of materials is excluded and not considered to be subcontracted. When a contract includes both services and supplies, the 50 percent limitation shall apply only to the portion of the contract with the preponderance of the expenditure upon which the assigned NAICS is based. For information and more specific requirements, refer to 13

CFR 125.6.

(e) Required limitations on subcontracting compliance measurement period. An SDVOSB shall comply with the limitations on subcontracting as follows:

[] By the end of the base term of the contract or order, and then by the end of each subsequent option period; or

[] By the end of the performance period for each order issued under the contract.

(f) Joint ventures. A joint venture may be considered eligible as an SDVOSB if the joint venture complies with the requirements in 13 CFR 128.402 and the managing joint venture partner makes the representations under paragraph (c) of this clause. A joint venture agrees that, in the performance of the contract, the applicable percentage specified in paragraph (d) of this clause will be performed by the aggregate of the joint venture participants.

(g) Precedence. The VA Veterans First Contracting Program, as defined in VAAR 802.101, subpart 819.70, and this clause, takes precedence over any inconsistencies between the requirements of the SBA Veteran Small Business Certification Program and the VA Veterans

First Contracting Program.

(h) Misrepresentation. Pursuant to 38 U.S.C. 8127(g), any business concern, including all its principals, that is determined by VA to have willfully and intentionally misrepresented a company’s SDVOSB status is subject to debarment from contracting with the Department for a period of not less than five years (see VAAR 809.406–2 Causes for Debarment).

(End of Clause)

C.7 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON

SUBCONTRACTING—CERTIFICATE OF COMPLIANCE FOR SERVICES AND

CONSTRUCTION (JAN 2023) (DEVIATION)

(a) Pursuant to 38 U.S.C. 8127(l)(2), the offeror certifies that—

(1) If awarded a contract (see FAR 2.101 definition), it will comply with the limitations on subcontracting requirement as provided in the solicitation and the resultant contract, as follows:

(i) [X] Services. In the case of a contract for services (except construction), the contractor will not pay more than 50% of the amount paid by the government to it to firms that are not certified SDVOSBs listed in the SBA certification database as set forth in 852.219–73 or certified VOSBs listed in the SBA certification database as set forth in 852.219–74. Any work that a similarly situated certified SDVOSB/VOSB subcontractor further subcontracts will count towards the 50% subcontract amount that cannot be exceeded. Other direct costs may be excluded to the extent they are not the principal purpose of the acquisition and small business concerns do not provide the service as set forth in 13 CFR 125.6.

(ii) [] General construction. In the case of a contract for general construction, the contractor will not pay more than 85% of the amount paid by the government to it to firms that are not certified SDVOSBs listed in the SBA certification database as set forth in 852.219–73 or certified VOSBs listed in the SBA certification database as set forth in 852.219–74. Any work that a similarly situated certified SDVOSB/VOSB subcontractor further subcontracts will count towards the 85% subcontract amount that cannot be exceeded. Cost of materials are excluded and not considered to be subcontracted.

(iii) [] Special trade construction contractors. In the case of a contract for special trade contractors, the contractor will not pay more than 75% of the amount paid by the government to it to firms that are not certified SDVOSBs listed in the SBA certification database as set forth in

852.219–73 or certified VOSBs listed in the SBA certification database as set forth in 852.219–

74. Any work that a similarly situated certified SDVOSB/VOSB subcontractor further subcontracts will count towards the 75% subcontract amount that cannot be exceeded. Cost of materials are excluded and not considered to be subcontracted.

(2) The offeror acknowledges that this certification concerns a matter within the jurisdiction of an Agency of the United States. The offeror further acknowledges that this certification is subject to Title 18, United States Code, Section 1001, and, as such, a false, fictitious, or fraudulent certification may render the offeror subject to criminal, civil, or administrative penalties, including prosecution.

(3) If VA determines that an SDVOSB/ VOSB awarded a contract pursuant to 38 U.S.C. 8127 did not act in good faith, such SDVOSB/VOSB shall be subject to any or all of the following:

(i) Referral to the VA Suspension and Debarment Committee;

(ii) A fine under section 16(g)(1) of the Small Business Act (15 U.S.C. 645(g)(1)); and

(iii) Prosecution for violating 18 U.S.C. 1001.

(b) The offeror represents and understands that by submission of its offer and award of a contract it may be required to provide copies of documents or records to VA that VA may review to determine whether the offeror complied with the limitations on subcontracting requirement specified in the contract. Contracting officers may, at their discretion, require the contractor to demonstrate its compliance with the limitations on subcontracting at any time during performance and upon completion of a contract if the information regarding such compliance is not already available to the contracting officer. Evidence of compliance includes, but is not limited to, invoices, copies of subcontracts, or a list of the value of tasks performed.

(c) The offeror further agrees to cooperate fully and make available any documents or records as may be required to enable VA to determine compliance with the limitations on subcontracting requirement. The offeror understands that failure to provide documents as requested by VA may result in remedial action as the Government deems appropriate.

(d) Offeror completed certification/fill-in required. The formal certification must be completed, signed and returned with the offeror’s bid, quotation, or proposal. The Government will not consider offers for award from offerors that do not provide the certification, and all such responses will be deemed ineligible for evaluation and award.

Certification

I hereby certify that if awarded the contract, [insert name of offeror] will comply with the limitations on subcontracting specified in this clause and in the resultant contract. I further certify that I am authorized to execute this certification on behalf of [insert name of offeror].

Printed Name of Signee:

Printed Title of Signee:

Signature:

Date:

Company Name and Address:

(End of Clause)

C.8 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT

REQUESTS (NOV 2018)

(a) Definitions. As used in this clause—

(1) Contract financing payment has the meaning given in FAR 32.001;

(2) Designated agency office means the office designated by the purchase order, agreement, or contract to first receive and review invoices. This office can be contractually designated as the receiving entity. This office may be different from the office issuing the payment;

(3) Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests;

(4) Invoice payment has the meaning given in FAR 32.001; and

(5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract.

(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a

Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required.

(c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following:

(1) VA’s Electronic Invoice Presentment and Payment System at the current website address provided in the contract.

(2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National

Standards Institute (ANSI).

(d) Invoice requirements. Invoices shall comply with FAR 32.905.

(e) Exceptions. If, based on one of the circumstances in this paragraph (e), the Contracting

Officer directs that payment requests be made by mail, the Contractor shall submit payment requests by mail through the United States Postal Service to the designated agency office.

Submission of payment requests by mail may be required for—

(1) Awards made to foreign vendors for work performed outside the United States;

(2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information;

(3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies;

(4) Solicitations or contracts in which the designated agency office is a VA entity other than the VA Financial Services Center in Austin, Texas; or

(5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above.

C.9 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)

C.10 VAAR 852.249-70 TERMINATION FOR DEFAULT—SUPPLEMENT FOR

MORTUARY SERVICES (MAY 2020)

The FAR clause entitled Default (Fixed-Price Supply and Service), at 52.249–8, is supplemented as follows:

The Contracting Officer may terminate this contract for default by written notice without the ten-day notice required by paragraph (a)(2) of the Default clause if—

(a) The Contractor, through circumstances reasonably within its control or that of its employees, performs any act under or in connection with this contract, or fails in the performance of any service under this contract and the act or failures may reasonably be considered to reflect discredit upon the Department of Veteran Affairs in fulfilling its responsibility for proper care of remains;

(b) The Contractor, or its employees, solicits relatives or friends of the deceased to purchase supplies or services not under this contract. (The Contractor may furnish supplies or arrange for services not under this contract, only if representatives of the deceased voluntarily request, select, and pay for them.);

(c) The services or any part of the services are performed by anyone other than the Contractor or the Contractor’s employees without the written authorization of the Contracting Officer;

(d) The Contractor refuses to perform the services required for any particular remains; or

(e) The Contractor mentions or otherwise uses this contract in its advertising in any way.

(End of Addendum to 52.212-4)

[End of Section C]

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR

ATTACHMENTS

D.1 STATEMENT OF WORK

Pharmacy Semi-Annual CETA Equipment Certification and Maintenance Requirement

1. General

The Michael E. DeBakey VA Medical Center (MEDVAMC) must perform semi-annual inspections and certifications of pharmacy biological safety cabinets (BCS), compounding aseptic isolators (CAI), compounding aseptic containment isolators (CACI), containment segregated compounding areas (C-SCA), clean rooms, ante rooms, laminar airflow hoods

(LAFH), alarms, and glove box/isolator and ISO classified areas to include particle counts per the most current United States Pharmacopeia (USP) 797 and 800 requirements. Additional requirements include inspection and installation of all HEPA filters and the installation of pre-filters for required instruments.

Quotation is to be for one (1) Base Year and four (4) Option Years. Additional fees or travel charges of any kind will not be paid. Work not covered by this contract shall not be performed without first obtaining permission of the Contracting Officer Representative (COR) and/or the

Contracting Officer (CO). Invoices resulting from additional work performed without prior approval will not be honored.

2. Maintenance and Parts Rider

This contact shall include a maintenance and parts rider per year to provide for normal hours, after hours, or emergency repairs of the BCSs, CAIs, CACIs, C-SCA, clean rooms, ante rooms, laminar airflow hoods, alarms, and glove box isolator deficiencies discovered during execution of this contract.

a. All repair work must be approved by the COR or the Contracting Officer.

b. This parts rider is not to be an assumed line item to the awardees contract.

3. Work Summary

The Contractor will perform an inspection, prior to certification, of the clean/buffer rooms, ante rooms, grossing stations, Biological Safety Cabinets (BSCs), Chemical Fume Hoods

(CFHs), Laminar Air Flow Hoods (LAFHs) to assess the extent of the work necessary to complete the semi-annual and annual certifications of the rooms and hoods. The Contractor is required prior to issuance of the contract to present any issues which would preclude completion of required work. A parts and labor rider will be included in this requirement when repairs are necessary to prevent facility work stoppage. Recertification of the equipment will be required after the completion of all maintenance and repairs, inclusive of decontamination as necessary.

For any unit that fails to pass required certification tests, the COR shall be notified immediately.

The Contractor shall mark each failing unit or room with professional signage that states the unit is out of service until further notice. The Contractor shall provide an electronic report quarterly of all work completed. Prior to the end of 12 months/first year the Contractor shall send a complete report to the COR of all equipment serviced under this contract.

Particle counts conducted in the pharmacy clean room locations that contain pharmacy biological safety cabinets will be tested in compliance with the most current United States Pharmacopeia chapters (USP) 797 and 800. The three Pharmacy Department clean rooms, biological safety cabinets and glove box/isolators require semi-annual certifications based on the nature of the work conducted in the BSCs and Clean Rooms.

The Contractor’s field personnel shall have training and be certified in fundamental practices and precautions listed in USP 797 and 800 and operation of ISO 5 clean rooms. (e.g., gowning, gloving, and hand washing procedures). The Contractor shall have a current National

Environmental Balancing Bureau (NEBB) certification and shall provide CETA certified technicians for all work completed for the pharmacy. The Contractor shall have its own laboratory contractor for growth and assessing micro-bacterial samples. The laboratory shall perform batch sampling of all shipments of growing media plates; to confirm the plates are sterile from the manufacturer. The Contractor’s chemical fume hood/ biological safety cabinet testing personnel shall have current certifications demonstrating knowledge of NSF/ANSI-49.

Evidence shall be provided of all necessary certifications, training, and any other special skills required to comprehensively perform the duties as listed within this solicitation. All testing personnel must have at least five (5) years of experience, inclusive of work conducted at a federal medical facility, on the equipment specifically listed. Contractor must provide at least three (3) references or evidence of performing work of a similar scope to the specific equipment described within the last calendar year for all key personnel involved in servicing any/all VA equipment listed. The Contractor must have the ability to maintain test results and reports for at least 12 months for the government to access and download as necessary.

The Contractor shall issue a certificate (as a pdf) to verify tested pharmacy equipment has passed a specific test with respect to the requirements of USP 797 and 800. The certificate will display the test date, the expiration date, and signature of the company’s appropriately trained or competent Industrial Hygienist to make such a declaration. Chemical Fume Hoods and

Biological Safety Cabinets must have a certification sticker applied directly by the Contractor to the equipment in addition to the 8.5 x 11” pdf performance certificate. The MEDVAMC requests that each room and unit tested is accompanied with a report specific for the room or unit respectively. The certification reports shall include the building number, room number of the equipment tested, and microbials results. Labels for each room shall be consistent without variation or abbreviation. Certification reports shall display all units (hoods) properly labeled with their respective serial number. Each room and unit shall be listed on separate reports and under no circumstances be combined.

NOTE: The Contractor must be able to respond on station within 24 hours of receiving notification from the COR that services within the scope of this contract are required.

**Contractor must provide proof of applicable certifications for all technicians and that all technicians are all in good standing before work commences. Contractor shall be responsible for notifying the Pharmacy Department of any updates, additions and/ or omissions.

4. Semi-Annual Inspection and Certification:

All BSCs, LAFHs, CAIs and CACIs shall be tested to the following regulatory standards: National Sanitation Foundation/American National Standards Institute

(NSF/ANSI) Standard 49-2009, Annex F (BSCs), CETA Compounding Isolator Testing, CAG-003-2006, CETA Compounding Facility Guidelines, GAG-003-2006, CETA USP

797 Viable Environmental Sampling and Gowning, GAG-009 and CETA Certification

Matrix for Sterile Comp Facilities-008. Specifications and/or manufacturer specifications to include any additional USP 797 and 800 viable and nonviable particle testing.

Certification documents shall be placed inside of a plastic sleeve and taped to each hood after successfully passing certification. Markers will be placed on each hood to indicate the sash level at which each hood provides proper protection and dated stickers displaying current certification placed on each hood.

Testing/Certification

1. CERTIFICATION OF THE C-SCA AND CLASSIFIED AREAS:

a. To be performed under dynamic conditions.

b. C-SCA and classified areas to include twelve (12) PECs, six (6) ISO classified 7

Rooms, five (5) ISO classified, and five (5) pass-throughs.

c. Certification to include:

i. Airflow Testing

ii. HEPA filter integrity testing

iii. Airflow pattern smoke testing

iv. Total particle count testing

v. Site installation assessment testing

d. Certification of classified areas is required to be completed every six months per

USP 797 and 800 and CETA-CAG guidelines.

e. In the case of certification failure, contractor will have to recertify after corrective actions are completed. Retesting will be through a separate purchase order at the established unit rate.

f. Due to operational requirements, the semi-annual certification of the CAI and

CACI shall be on a different schedule than the semi-annual certification of the

BSC and LAFW.

2. ENVIRONMENTAL SAMPLING

a. Air Sampling - Impaction volumetric air sampling under dynamic conditions with a sample size of at least 1000 liters in each location detailed below.

i. Two (2) sample locations (to consist of one (1) fungal and one (1) bacterial for each location) in the direct compounding area (DCA) of the twelve (12) primary engineering controls (PEC) and one Glove Box

Isolator. Total of fifty-two (52) samples.

ii. One (1) sample location (to consist of one (1) fungal and one (1) bacterial) in the three (3) buffer rooms. Total of six (6) samples

iii. One (1) sample location (to consist of one (1) fungal and one (1) bacterial) in the three (3) ante rooms. Total of six (6) samples.

iv. One (1) sample location (to consist of one (1) fungal and one (1) bacterial) in the ante room on the clean side of the line of demarcation. Total of six

(6) samples.

v. One (1) sample location (to consist of one (1) fungal and one (1) bacterial) in the five (5) pass-through windows Total of ten (10) samples.

vi. Three (3) sample locations (to consist of one (1) fungal and one (1) bacterial) to be determined on work patterns and approved by the COR or their approved representative. Total of six (6) samples. (Allergy Clinic)

vii. Total of eighty-six (86) samples for bacterial and/or fungal contaminates.

b. Surface Sampling – Contact plates with general growth media supplemented with neutralizing additives which neutralizes cleaning agents and prevents false negative. Sampling to take place at the end of the of the compounding activity prior to cleaning in designated areas detailed below.

i. Two (2) sample locations (to consist of one (1) fungal and one (1) bacterial for each location) in the direct compounding area (DCA) of the twelve (12) primary engineering controls (PEC) and one glovebox isolator. Total of fifty-two (52) samples.

ii. One (1) sample location (to consist of one (1) fungal and one (1) bacterial) in the three (3) buffer rooms. Total of six (6) samples

iii. One (1) sample location (to consist of one (1) fungal and one (1) bacterial) in the three (3) ante rooms. Total of six (6) samples.

iv. One (1) sample location (to consist of one (1) fungal and one (1) bacterial) in the ante room on the clean side of the line of demarcation. Total of six

(6) samples

v. One (1) sample location (to consist of one (1) fungal and one (1) bacterial) in the five (5) pass-through windows Total of eight (10) samples.

vi. Three (3) sample locations (to consist of one (1) fungal and one (1) bacterial) to be determined on work patterns and approved by the COR or their approved representative. Total of six (6) samples.

vii. Total of eighty-six (86) samples for bacterial and/or fungal contaminates for bi-annual certifications.

c. Monthly Surface Sampling- Shall take place at least monthly except during bi-annual recertification in designated areas detailed below.

i. Two (2) sample locations (to consist of one (1) fungal and one (1) bacterial for each location) in the direct compounding area (DCA) of the twelve (12) primary engineering controls (PEC) and one glovebox isolator. Total of fifty-two (52) samples.

ii. One (1) sample location (to consist of one (1) fungal and one (1) bacterial) in the three (3) buffer rooms. Total of six (6) samples

iii. One (1) sample location (to consist of one (1) fungal and one (1) bacterial) in the three (3) ante rooms. Total of six (6) samples.

iv. One (1) sample location (to consist of one (1) fungal and one (1) bacterial) in the ante room on the clean side of the line of demarcation. Total of six

(6) samples.

v. One (1) sample location (to consist of one (1) fungal and one (1) bacterial) in the five (5) pass-through windows Total of ten (10) samples.

vi. Three (3) sample locations (to consist of one (1) fungal and one (1) bacterial) to be determined on work patterns and approved by the COR or their approved representative. Total of six (6) samples. (Allergy Clinic)

vii. Total of eighty-six (86) samples for bacterial and/or fungal contaminates for monthly testing.

d. If a positive result is received, retesting will be performed after the MEDVAMC has taken remedial action. Within 72 hours of notification from the MEDVAMC the contractor will be onsite to perform the retest.

3. SMOKE STUDY - Smoke study to be performed and videoed bi-annually. One (1) in each of the twelve (12) PECs. Each study of adequate length for viewer to see the directional air flow completely. Video to be provided via digital versatile disc (DVD).

4. HAZARDOUS DRUG SURFACE WIPE SAMPLING- Hazardous drug surface sampling to be performed bi-annually. Sampling to be performed in all areas where hazardous drugs are handled.

5. Air Changes Per Hour

The Contractor shall calculate the total room volume for each buffer and ante room. A sketch of the room with dimensions, exhaust/supply diffuser locations and equipment locations shall be included in the report. The Contractor shall calculate air changes per hour (ACPH) for each buffer and ante room and include their findings in the report. If a room does not meet USP 797 requirements for ACPH the COR and end user shall be informed immediately.

6. Pressure Requirements

The Contractor shall include in their report differential pressure reading from each buffer/ante room to all surrounding areas. The report shall indicate whether the room is required to be a positive or negative pressure room per USP 797. The Contractor shall report all pressures to an accuracy of 0.0001.

7. Viable Environmental Sampling

The Contractor shall perform viable environmental sampling monthly and semiannually. The

Contractor shall perform monthly surface samples for bacteria using Tryptic Soy Agar (TSA) contact plates and Malt Extract Agar (MEA) contact plates for sampling of fungi. Semiannual air samples collected using high volume sampling pumps capable of achieving and maintaining the required flow rate of 28 liters per minute and impaction samplers to conduct the sampling. A sufficient volume of air (1000 liters) shall be tested at each location in order to maximize sensitivity.

8. Nonviable Particle Testing

The Contractor shall perform environmental nonviable particle sampling semiannually. The

Contractor shall derive the minimum number of sampling locations using Annex A in the

ISO/DIS 14644-1.2 standard. Sampling shall be performed by qualified operators using state-of-the-art electronic equipment. The equipment must have current calibration labels and capable of providing the following results:

- ISO Class 5: not more than 3520 particles 0.5 µm and larger size per cubic meter of air for any LAFW, BSC, CAI and CACI.

- ISO Class 7: not more than 352,000 particles 0.5 µm and larger size per cubic meter of air for any buffer area

- ISO Class 8: not more than 3,520,000 particles 0.5 µm and larger size per cubic meter of air for any ante area.

9 . NSF 49 Field Testing Requirements for Biological Safety Cabinets

The Contractor shall certify all Class II biological safety cabinets (BSC) to NSF/ANSI 49, Annex F specifications. All equipment used to certify biological safety cabinets shall have NIST traceable or comparable calibration certification. Any unit that fails to meet NSF 49 specifications shall be clearly marked with a sign that will notify technicians that the unit is out of order until further notice.

Semi-Annual testing shall include inspection of all HEPA filters, inclusive of two (2) in the main pharmacy, two (2) in the cancer…