Inactive

VAMC Southern Nevada Healthcare System Statement of Work (SOW) 2237#: 593-21-3-140-0214 CONTRACT TITLE. Certification and Testing of Pharmacy Cleanrooms, Laminar Flow Hoods, and Isolators. DEFINITIONS... VAMC Southern Nevada Healthcare System Statement of Work (SOW) 2237#: 593-21-3-140-0214 CONTRACT TITLE. Certification and Testing of Pharmacy Cleanrooms, Laminar Flow Hoods, and Isolators. DEFINITIONS. Testing and Certification Service Contract. SCOPE OF WORK : Contractor shall provide tests and certifications to all Pharmacy Laminar Flow Hoods and Isolators installed in the Oncology Suite and Main Pharmacy Suite; and the Oncology Suite three (3) rooms; all located at the VA SNHCS 6900 North Pecos Road, North Las Vegas, NV 89086. SPECIFIC TASKS: Testing and Certification (in both the Main and Oncology Pharmacies), the Laminar Flow Hoods, the Isolators, and the three (3) rooms in the Oncology Pharmacy as per and in accordance with USP 797/800 CETA ISO Standards 14644 and IES-006 specifications. During the term of this contract Main Pharmacy will have a remodel which will add three (3) additional rooms bringing the total to six (6) rooms and seven (7) Hoods. Testing and Certification shall be performed by CETA Certified technicians. Providing copies of technician s certification and proof of maintaining certification shall be required as a condition of contract award. Specific Equipment/Hoods List as follows: EE80961; BVBI 4SSRX Laminar Flow Hood; S/N 4S-15-BVBI-18930 (Located in Oncology Pharmacy 1A149B) EE80962; BVBI 4SSRX Laminar Flow Hood; S/N 4S-15-BVBI-18932 (Located in Main Pharmacy) EE80963; BVBI 4SSRX Laminar Flow Hood; S/N 4S-15-BVBI-18931 (Located in Main Pharmacy) EE80964; LFGI-3USP Laminar Flow Hood; S/N 3S-15-LGU-18927 (In Storage awaiting install as part of scheduled Pharmacy Remodel) EE80965; LFGI-3USP Laminar Flow Hood; S/N 3S-15-LGU-18926 (Located in Oncology Pharmacy 1A149A) EE80966; LFGI-3USP Laminar Flow Hood; S/N 3S-15-LGU-18929 (Located in Oncology Pharmacy 1A149A) EE80967; LFGI-3USP Laminar Flow Hood; S/N 3S-15-LGU-18928 (Located in Main Pharmacy) Specific Room/Suite list as follows: Oncology Suite Room 1A149 ANTE ROOM Oncology Suite Room 1A149A HAZARDOUS COMPOUNDING Negative Pressure Room. Oncology Suite Room 1A149B NON-HAZARDOUS COMPOUNDING Positive Pressure Room Specific Tasks for Hoods as Follows: Monthly Surface Sampling Testing for Hoods in Oncology Suite IV Room in accordance with USP 797/800 CETA ISO Standards 14644 and IES-006 specifications: Negative pressure buffer room: EE80965 & EE80966. Positive pressure buffer room: EE80961 Monthly Surface Sampling Testing for Hoods in Main Pharmacy IV Prep Room in accordance with USP 797/800 CETA ISO Standards 14644 and IES-006 specifications: Negative pressure buffer room: EE80967 Positive pressure buffer room: EE80962 & EE80963 Note: Monthly Hood Sampling will consist of: 1 Bacterial in each BVBI 4SSRX Laminar Flow Hood, 1 fungal in each BVBI 4SSRX Laminar Flow Hood. 1 Bacterial in each LFGI-3USP Main chamber & antechamber, 1 fungal in each LFGI-3USP Main chamber & antechamber. Semi-Annual certification of all hoods (except any in storage or temporarily out of service during Pharmacy remodel activities) in accordance with USP 797/800 CETA ISO Standards 14644 and IES-006 specifications. Semi-Annual certification of all hoods AND rooms in accordance with USP 797/800 & CETA standards including: Non-Viable Particle Counts in each hood & room Air velocity profile/total airflow in each hood Hood Airflow Visualization Profile w/ video Hood pressure testing Ingress/egress test in each LFGI-3USP Laminar Flow Hood Leak Testing of each Terminal HEPA Filter in each hood and room Viable (Bacterial & Fungal) surface sampling in each hood & room Viable (Bacterial & Fungal) air sampling in each hood & room Room pressure test Room airflow exchange rates for each room Temperature and % Relative Humidity verification Replacement of Hood built-in Hepa Filters in accordance with OEM recommendations Bi-Annually. Contractor is responsible for cost of said Hepa Filters. Specific Tasks for Pharmacy Oncology Rooms Monthly Surface Sampling of all three (3) rooms in accordance with USP 797/800 CETA ISO Standards 14644 and IES-006 specifications. Note: Monthly Room Surface Sampling will consist of: 1 Bacteria & 1 Fungal in each of the three (3) rooms. Semi-Annual Certifications of all three (3) rooms in accordance with USP 797/800 CETA ISO Standards 14644 and IES-006 specifications. Semi-Annual certification of all hoods AND rooms in accordance with USP 797/800 & CETA standards including: Non-Viable Particle Counts in each hood & room Air velocity profile/total airflow in each hood Hood Airflow Visualization Profile w/ video Hood pressure testing Ingress/egress test in each LFGI-3USP Laminar Flow Hood Leak Testing of each Terminal HEPA Filter in each hood and room Viable (Bacterial & Fungal) surface sampling in each hood & room Viable (Bacterial & Fungal) air sampling in each hood & room Room pressure test Room airflow exchange rates for each room Temperature and % Relative Humidity verification There is a total of eight (8) each, ceiling mounted Hepa Filters (2 x4 ) that will be replaced every 5th year at no additional cost to VA. During Semi-Annual room certifications, if the testing indicates the Hepa Filter needs replacement, and it isn t the 5th year replacement cycle, then at no additional Labor Cost the Hepa Filters that need replacing will be replaced with the VA only paying the cost of the Filters. NOTE: Our FUTURE layout for Main Pharmacy (AFTER construction, unknown timeline, estimate 2022; and will need all the services as stated in the Oncology Pharmacy) will be: Main Pharmacy IV Room Suite: Main pharmacy, room 1D352 BVBI 4SSRX Laminar Flow Hood; S/N 4S-15-BVBI-18932 BVBI 4SSRX Laminar Flow Hood; S/N 4S-15-BVBI-18931 Â LFGI-3USP Laminar Flow Hood; S/N 3S-15-LGU-18928 LFGI-3USP Laminar Flow Hood; S/N 3S-15-LGU-18927 1 positive pressure ante room 1 positive pressure buffer room 1 negative pressure buffer room Service Needs Monthly Surface Sampling Testing of all hoods AND rooms Semi-Annual certification of all hoods AND rooms in accordance with USP 797/800 & CETA standards HEPA Filters 1 positive pressure ante room = 4 HEPA filters 1 positive pressure buffer room = 2 HEPA filters 1 negative pressure buffer room = 2 HEPA filters. PERIOD AND PLACE OF PERFORMANCE. Period: 7/12/2021 - 7/11/2022 7/12/2022 - 7/11/2023 7/12/2023 - 7/11/2024 7/12/2024 - 7/11/2025 7/12/2025 - 7/11/2026 Place: VAMC 6900 North Pecos Road, North Las Vegas, Nevada, 89086 CONTRACTING OFFICER S REPRESENTATIVE (COR). The Contractor shall not accept any instructions issued by any other person(s) other than the Contracting Officer. The Government may appoint a COR. If so, a Delegation of Authority letter shall be forwarded to the using service and the Contractor after contract has been signed, identifying the individual(s) as the COR(s) SECURITY Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. A prohibition on unauthorized disclosure: "Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA." See VA Handbook 6500.6, Appendix C, paragraph 3.a. A requirement for data breach notification: Upon discovery of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access, the contractor/subcontractor shall immediately and simultaneously notify the COR, the designated ISO, and Privacy Officer for the contract. The term 'security incident' means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. See VA Handbook 6500.6, Appendix C, paragraph 6.a. A requirement to pay liquidated damages in the event of a data breach: "In the event of a data breach or privacy incident involving any SPI the contractor processes or maintains under this contract, the contractor shall be liable to VA for liquidated damages for a specified amount per affected individual to cover the cost of providing credit protection services to those individuals." See VA Handbook 6500.6, Appendix C, paragraph 7.a., 7.d. A requirement for annual security/privacy awareness training: "Before being granted access to VA information or information systems, all contractor employees and subcontractor employees requiring such access shall complete on an annual basis either: (i) the VA security/privacy awareness training (contains VA's security/privacy requirements) within 1 week of the initiation of the contract, or (ii) security awareness training provided or arranged by the contractor that conforms to VA's security/privacy requirements as delineated in the hard copy of the VA security awareness training provided to the contractor. If the contractor provides their own training that conforms to VA's requirements, they will provide the COR or CO, a yearly report (due annually on the date of the contract initiation) stating that all applicable employees involved in VA's contract have received their annual security/privacy training that meets VA's requirements and the total number of employees trained. See VA Handbook 6500.6, Appendix C, paragraph 9. A requirement to sign VA's Rules of Behavior: "Before being granted access to VA information or information systems, all contractor employees and subcontractor employees requiring such access shall sign on an annual basis an acknowledgment that they have read, understand, and agree to abide by VA's Contractor Rules of Behavior which is attached to this contract." See VA Handbook 6500.6, Appendix C, paragraph 9, Appendix D. Note: If a medical device vendor anticipates that the services under the contract will be performed by 10 or more individuals, the Contractor Rules of Behavior may be signed by the vendor's designated representative. The contract must reflect by signing the Rules of Behavior on behalf of the vendor that the designated representative agrees to ensure that all such individuals review and understand the Contractor Rules of Behavior when accessing VA's information and information systems. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes." See VA Handbook 6500.6, Appendix C, paragraph 5.h., for the specific options. INVOICE AND PAYMENTS. Payment to be made in arrears. Contractor shall submit invoice in the original, addressed to: Department of Veterans Affairs Financial Services Center P.O. Box 149971 Austin, TX 78714 Toll-free telephone number: 877-353-9791 Fax Number: 512-460-5540 The invoice SHALL be itemized to include the following information. Any information listed below not provided on an invoice shall render that invoice incomplete and the invoice shall be returned for immediate correction. a. Time period being invoiced. d. Extended amount due. b. Description of services. e. Invoice number, date, and c. Unit Cost billed. f. Contract, Order, and Obligation number.

Inactive Total Small Business Set-Aside (FAR 19.5)

VAMC Southern Nevada Healthcare System Statement of Work (SOW) 2237#: 593-21-3-140-0214 CONTRACT TITLE. Certification and Testing of Pharmacy Cleanrooms, Laminar Flow Hoods, and Isolators. DEFINITIONS... VAMC Southern Nevada Healthcare System Statement of Work (SOW) 2237#: 593-21-3-140-0214 CONTRACT TITLE. Certification and Testing of Pharmacy Cleanrooms, Laminar Flow Hoods, and Isolators. DEFINITIONS. Testing and Certification Service Contract. SCOPE OF WORK : Contractor shall provide tests and certifications to all Pharmacy Laminar Flow Hoods and Isolators installed in the Oncology Suite and Main Pharmacy Suite; and the Oncology Suite three (3) rooms; all located at the VA SNHCS 6900 North Pecos Road, North Las Vegas, NV 89086. SPECIFIC TASKS: Testing and Certification (in both the Main and Oncology Pharmacies), the Laminar Flow Hoods, the Isolators, and the three (3) rooms in the Oncology Pharmacy as per and in accordance with USP 797/800 CETA ISO Standards 14644 and IES-006 specifications. During the term of this contract Main Pharmacy will have a remodel which will add three (3) additional rooms bringing the total to six (6) rooms and seven (7) Hoods. Testing and Certification shall be performed by CETA Certified technicians. Providing copies of technician s certification and proof of maintaining certification shall be required as a condition of contract award. Specific Equipment/Hoods List as follows: EE80961; BVBI 4SSRX Laminar Flow Hood; S/N 4S-15-BVBI-18930 (Located in Oncology Pharmacy 1A149B) EE80962; BVBI 4SSRX Laminar Flow Hood; S/N 4S-15-BVBI-18932 (Located in Main Pharmacy) EE80963; BVBI 4SSRX Laminar Flow Hood; S/N 4S-15-BVBI-18931 (Located in Main Pharmacy) EE80964; LFGI-3USP Laminar Flow Hood; S/N 3S-15-LGU-18927 (In Storage awaiting install as part of scheduled Pharmacy Remodel) EE80965; LFGI-3USP Laminar Flow Hood; S/N 3S-15-LGU-18926 (Located in Oncology Pharmacy 1A149A) EE80966; LFGI-3USP Laminar Flow Hood; S/N 3S-15-LGU-18929 (Located in Oncology Pharmacy 1A149A) EE80967; LFGI-3USP Laminar Flow Hood; S/N 3S-15-LGU-18928 (Located in Main Pharmacy) Specific Room/Suite list as follows: Oncology Suite Room 1A149 ANTE ROOM Oncology Suite Room 1A149A HAZARDOUS COMPOUNDING Negative Pressure Room. Oncology Suite Room 1A149B NON-HAZARDOUS COMPOUNDING Positive Pressure Room Specific Tasks for Hoods as Follows: Monthly Surface Sampling Testing for Hoods in Oncology Suite IV Room in accordance with USP 797/800 CETA ISO Standards 14644 and IES-006 specifications: Negative pressure buffer room: EE80965 & EE80966. Positive pressure buffer room: EE80961 Monthly Surface Sampling Testing for Hoods in Main Pharmacy IV Prep Room in accordance with USP 797/800 CETA ISO Standards 14644 and IES-006 specifications: Negative pressure buffer room: EE80967 Positive pressure buffer room: EE80962 & EE80963 Note: Monthly Hood Sampling will consist of: 1 Bacterial in each BVBI 4SSRX Laminar Flow Hood, 1 fungal in each BVBI 4SSRX Laminar Flow Hood. 1 Bacterial in each LFGI-3USP Main chamber & antechamber, 1 fungal in each LFGI-3USP Main chamber & antechamber. Semi-Annual certification of all hoods (except any in storage or temporarily out of service during Pharmacy remodel activities) in accordance with USP 797/800 CETA ISO Standards 14644 and IES-006 specifications. Semi-Annual certification of all hoods AND rooms in accordance with USP 797/800 & CETA standards including: Non-Viable Particle Counts in each hood & room Air velocity profile/total airflow in each hood Hood Airflow Visualization Profile w/ video Hood pressure testing Ingress/egress test in each LFGI-3USP Laminar Flow Hood Leak Testing of each Terminal HEPA Filter in each hood and room Viable (Bacterial & Fungal) surface sampling in each hood & room Viable (Bacterial & Fungal) air sampling in each hood & room Room pressure test Room airflow exchange rates for each room Temperature and % Relative Humidity verification Replacement of Hood built-in Hepa Filters in accordance with OEM recommendations Bi-Annually. Contractor is responsible for cost of said Hepa Filters. Specific Tasks for Pharmacy Oncology Rooms Monthly Surface Sampling of all three (3) rooms in accordance with USP 797/800 CETA ISO Standards 14644 and IES-006 specifications. Note: Monthly Room Surface Sampling will consist of: 1 Bacteria & 1 Fungal in each of the three (3) rooms. Semi-Annual Certifications of all three (3) rooms in accordance with USP 797/800 CETA ISO Standards 14644 and IES-006 specifications. Semi-Annual certification of all hoods AND rooms in accordance with USP 797/800 & CETA standards including: Non-Viable Particle Counts in each hood & room Air velocity profile/total airflow in each hood Hood Airflow Visualization Profile w/ video Hood pressure testing Ingress/egress test in each LFGI-3USP Laminar Flow Hood Leak Testing of each Terminal HEPA Filter in each hood and room Viable (Bacterial & Fungal) surface sampling in each hood & room Viable (Bacterial & Fungal) air sampling in each hood & room Room pressure test Room airflow exchange rates for each room Temperature and % Relative Humidity verification There is a total of eight (8) each, ceiling mounted Hepa Filters (2 x4 ) that will be replaced every 5th year at no additional cost to VA. During Semi-Annual room certifications, if the testing indicates the Hepa Filter needs replacement, and it isn t the 5th year replacement cycle, then at no additional Labor Cost the Hepa Filters that need replacing will be replaced with the VA only paying the cost of the Filters. NOTE: Our FUTURE layout for Main Pharmacy (AFTER construction, unknown timeline, estimate 2022; and will need all the services as stated in the Oncology Pharmacy) will be: Main Pharmacy IV Room Suite: Main pharmacy, room 1D352 BVBI 4SSRX Laminar Flow Hood; S/N 4S-15-BVBI-18932 BVBI 4SSRX Laminar Flow Hood; S/N 4S-15-BVBI-18931 Â LFGI-3USP Laminar Flow Hood; S/N 3S-15-LGU-18928 LFGI-3USP Laminar Flow Hood; S/N 3S-15-LGU-18927 1 positive pressure ante room 1 positive pressure buffer room 1 negative pressure buffer room Service Needs Monthly Surface Sampling Testing of all hoods AND rooms Semi-Annual certification of all hoods AND rooms in accordance with USP 797/800 & CETA standards HEPA Filters 1 positive pressure ante room = 4 HEPA filters 1 positive pressure buffer room = 2 HEPA filters 1 negative pressure buffer room = 2 HEPA filters. PERIOD AND PLACE OF PERFORMANCE. Period: 7/12/2021 - 7/11/2022 7/12/2022 - 7/11/2023 7/12/2023 - 7/11/2024 7/12/2024 - 7/11/2025 7/12/2025 - 7/11/2026 Place: VAMC 6900 North Pecos Road, North Las Vegas, Nevada, 89086 CONTRACTING OFFICER S REPRESENTATIVE (COR). The Contractor shall not accept any instructions issued by any other person(s) other than the Contracting Officer. The Government may appoint a COR. If so, a Delegation of Authority letter shall be forwarded to the using service and the Contractor after contract has been signed, identifying the individual(s) as the COR(s) SECURITY Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. A prohibition on unauthorized disclosure: "Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA." See VA Handbook 6500.6, Appendix C, paragraph 3.a. A requirement for data breach notification: Upon discovery of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access, the contractor/subcontractor shall immediately and simultaneously notify the COR, the designated ISO, and Privacy Officer for the contract. The term 'security incident' means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. See VA Handbook 6500.6, Appendix C, paragraph 6.a. A requirement to pay liquidated damages in the event of a data breach: "In the event of a data breach or privacy incident involving any SPI the contractor processes or maintains under this contract, the contractor shall be liable to VA for liquidated damages for a specified amount per affected individual to cover the cost of providing credit protection services to those individuals." See VA Handbook 6500.6, Appendix C, paragraph 7.a., 7.d. A requirement for annual security/privacy awareness training: "Before being granted access to VA information or information systems, all contractor employees and subcontractor employees requiring such access shall complete on an annual basis either: (i) the VA security/privacy awareness training (contains VA's security/privacy requirements) within 1 week of the initiation of the contract, or (ii) security awareness training provided or arranged by the contractor that conforms to VA's security/privacy requirements as delineated in the hard copy of the VA security awareness training provided to the contractor. If the contractor provides their own training that conforms to VA's requirements, they will provide the COR or CO, a yearly report (due annually on the date of the contract initiation) stating that all applicable employees involved in VA's contract have received their annual security/privacy training that meets VA's requirements and the total number of employees trained. See VA Handbook 6500.6, Appendix C, paragraph 9. A requirement to sign VA's Rules of Behavior: "Before being granted access to VA information or information systems, all contractor employees and subcontractor employees requiring such access shall sign on an annual basis an acknowledgment that they have read, understand, and agree to abide by VA's Contractor Rules of Behavior which is attached to this contract." See VA Handbook 6500.6, Appendix C, paragraph 9, Appendix D. Note: If a medical device vendor anticipates that the services under the contract will be performed by 10 or more individuals, the Contractor Rules of Behavior may be signed by the vendor's designated representative. The contract must reflect by signing the Rules of Behavior on behalf of the vendor that the designated representative agrees to ensure that all such individuals review and understand the Contractor Rules of Behavior when accessing VA's information and information systems. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes." See VA Handbook 6500.6, Appendix C, paragraph 5.h., for the specific options. INVOICE AND PAYMENTS. Payment to be made in arrears. Contractor shall submit invoice in the original, addressed to: Department of Veterans Affairs Financial Services Center P.O. Box 149971 Austin, TX 78714 Toll-free telephone number: 877-353-9791 Fax Number: 512-460-5540 The invoice SHALL be itemized to include the following information. Any information listed below not provided on an invoice shall render that invoice incomplete and the invoice shall be returned for immediate correction. a. Time period being invoiced. d. Extended amount due. b. Description of services. e. Invoice number, date, and c. Unit Cost billed. f. Contract, Order, and Obligation number.