H199--Inspection and Certification of Bio Safety Cabinets and Lab Fume Hoods Base plus 4 Option Years

STATEMENT OF WORK

North Texas Veterans Health Care System

INSPECTION & CERTIFICATION OF BIOLOGICAL SAFETY CABINETS AND FUME HOODS.

1. INTRODUCTION AND SCOPE OF WORK:

Contractor shall furnish service as specified for the fiscal year period of December 1, 2023 through November 30, 2028 to ensure that the equipment functions in accordance with NCI Specification General Purpose, Clean Air, Biological Safety Cabinet, NIH specification NIH-03-11ZC; National Sanitation Foundation-Class II, (Laminar Flow) Biohazard Cabinetry-Standard Number 49 [NSF 49]; Federal Standard No. 209E, Clean Room And Work Station Requirements, Controlled Environment ; SAMA Standard LF10-1980 Laboratory Fume Hoods.

Furnished all labor, equipment, tools, materials and travel necessary to test, certify and measure Government owned Biological Safety Cabinets, Animal bedding dump station, Laminar Flow Clean benches, Laboratory fume Hoods, Pathology Workstations and wall- mounted HEPA filters, Histology Grossing tables.

2. REQUIREMENTS: The Contractor shall be available 24 hours a day and located within 100 miles of VA property. The Contractor shall have the capability to responds within 3 hours of contact for emergency repair. Contractor shall furnish COTR with written estimate of cost to make necessary repairs.

a. Equipment is identified on the attached listing.

b. The annual certification shall be performed during May/October and the semi-annual certification shall be performed during February/August of each year.

c. Reporting required service beyond the contract scope:

d. The Contractor shall immediately, but no later than 24 consecutive hours after discovery, notify the COTR in writing of the existence or the development of any defects in, or repairs required, to the scheduled equipment which the Contractor considers he/she is not responsible for under the terms of the contract. The Contractor shall furnish the COTR with a written estimate of the cost to make necessary repairs.

3. COMPETENCY OF PERSONNEL SERVICING EQUIPMENT:

Each respondent must have an established business, with an office and full -time staff.

The contractor must meet Joint Commission requirements for providing competency of the service technician. All technicians who perform work under this contract will have a current NSF accreditation. Contractor will provide a copy of NSF accreditation to COTR.

If subcontractor(s) are used, they must be approved by the COTR; the Contractor shall submit any proposed change in subcontractor(s) for approval/disapproval.

Prior to commencement of work on this contract, the Contractor shall provide the VAMC with a copy of the current calibration certification of all test equipment which is to be used by the Contractor on VAMC's equipment. This certification shall also be provided on a periodic basis when requested by the VAMC. Test equipment calibration shall be traceable to a national standard.

4. REFERENCES:

Contract service shall ensure that the equipment functions in accordance with the following standards/guidelines: NCI Specification General Purpose, Clean Air, Biological Safety Cabinet, revised August 19, 1975 , NIH specification NIH-03-11ZC dated Sept 17, 1974; National Sanitation Foundation-Class II, (Laminar Flow) Biohazard Cabinetry-Standard Number 49 [NSF 49]; Federal Standard No. 209E-April 24, 1973, Clean Room And Work Station Requirements, Controlled Environment ; SAMA Standard LF10-1980 Laboratory Fume Hoods, USP 797 and USP 800, Facilities and Engineering controls.

5. REPORTING REQUIREMENTS:

The Contractor shall be required to report to Safety Office to log in. This check in is mandatory. When the service is completed, the FSE shall document services rendered on a legible ESR(s). The FSE shall be required to log out with the COTR. ALL ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COTR for an "authorization signature". If the COTR is unavailable, a signed copy of the ESR will be sent to the COTR after the work is performed.

VA Contact Person(s): Natalie Marjasovs

Location (Building/Room Number): Building TT49, Room 106

Telephone Number & Extension(s) :(214) 857-2595 or (214) 857-2080

6. Biosafety Cabinet Certification

The Pharmacy externally exhausting biosafety cabinets, laminar flow clean bench and isolation barriers shall be certified twice per year. All other biosafety cabinets will be certified once per year. Certification shall consist of the following:

Down flow velocity test.

Inflow velocity test.

Airflow smoke pattern test.

HEPA filter leak test.

Cabinet leak test (A1 cabinets only).

Alarm function test.

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

Electrical leakage on the main cabinet (those that aren t UL listed).

GFCI outlet trip test.

A visual inspection to identify defects, damage or missing parts.

Documentation of the certification and inspection results.

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

Posting an Out of Service sign on cabinets that fail certification.

Notifying the cabinet user and the COTR of cabinets that fail certification.

7. Lab Fume Hood Certification

Lab fume hoods shall be certified once per year, in June. Certification shall consist of the following:

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

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

Airflow smoke pattern test.

GFCI outlet trip test.

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

Documentation of the certification and inspection results.

A decal or label affixed in a visible location that indicates the sash certification height, the face velocity, and the date of certification.

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

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

8. Maintenance and Repair:

The main purpose of this Contract is to eliminate unscheduled shutdowns and contribute significantly to the continuous operating economy and integrity of the system. All work is to be in compliance with NSF-49 and ASHRAE 110.

The following items shall be provided at no additional cost to the VA:

Biosafety cabinet and laminar flow clean bench filters shall be recommended for replacement when they fail a leak test and can t be repaired.

When applicable, cabinets will be marked inside to indicate the safe capture air zone to prevent contamination of the outside work area.

Cabinet dampers shall be adjusted to provide required flow and marked to indicate correct position.

The Contractor s equipment shall be calibrated according to the manufacturer s specifications.

Consult with operator regarding unit performance.

9. DOCUMENTATION/REPORTS:

The documentation will include detailed descriptions of the scheduled and unscheduled maintenance procedures performed (i.e., Emergency repairs), including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with the manufacturer s specifications. Such documentation shall meet the guidelines as set forth in paragraph 3, References. In addition, each ESR must, at a minimum, document the following data legibly and in complete detail:

a. Name of contractor.

b. Name of FSE who performed services.

Contractor service ESR number/log number.

Date, time (starting and ending), equipment downtime, and hours on-site for the service call.

VA purchase order numbers(s) covering the call if outside normal working hours.

Description of problem reported by COTR (If applicable).

Identification of the equipment to be serviced:

Inventory ID number

Manufacturer s name

Device name

Model number

Serial Number

Any other manufacturer s identification numbers

Itemized Description of Service Performed (including Costs associated with after normal working hour services) including:

Materials and Circuit

Location of problem/corrective action.

Total Cost to be billed (If Applicable --i.e., part(s) not covered, or service rendered after normal hours of coverage).

Signatures:

FSE performing services described.

VA Employee who witnessed service described.

Failure to provide this information in the service report may result in non-payment of invoice.

11. NOTES AND OTHER INFORMATION:

ADDITIONAL CHARGES: There will be no additional charge for time spent at the site (during, or after the normal hours of coverage) awaiting the arrival of additional FSE and/or delivery of parts. Note: Any additional charges claimed must be approved by the COTR before the service is completed!

Security Issues: There is no known security issues associated with this Statement of Work.

DEFINITIONS/ACRONYMS:

COTR - Contracting Officer's Technical Representative

PM - Preventive Maintenance Inspection. Services which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or inoperative conditions.

FSE - Field Service Engineer. A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the VAMC premises.

ESR - Vendor Engineering Service Report. A documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract.

Acceptance Signature - VA employee who indicates FSE demonstrated service conclusion/status and User has accepted work as complete/pending as stated in ESR

Authorization Signature - COTR's signature; indicates COTR accepts work status as stated in ESR.

NFPA - National Fire Protection Association.

CDRH - Center for Devices and Radiological Health.

VAMC - Department of Veterans Affairs Medical Center

VAH - Department of Veterans Affairs Hospital

13. There are no known security issues with this Statement of Work.

14. Contractors are responsible for finding their own parking.

15. Contractors are required to obtain Temporary ID Badge from Safety, Bldg TT49, 4500 S. Lancaster Rd. Dallas TX 75216, while on VA property if not escorted during entire visit by a Safety SVC employee.

Contract Period December 1 , 2023 thru November 30, 2028:

QUANTITY

UNIT

UNIT COST

TOTAL COST

Fume Hoods

33 ea.

Inspections/Certifications (1 per year)

__________

____________

Biological Safety Cabinets (Dallas 27, Bonham-1, FWOPC -1)

29 ea.

Inspections/Certifications (1 per year)

__________

____________

QUANTITY

UNIT

UNIT COST

TOTAL COST

Repair and parts

4 ea.

Inspections/Certifications (1 per year)

__________

____________

Decontamination of Biological Safety Cabinets

5 ea.

Inspections/Certifications (1 per year)

___________

____________

Recertification of Biological Safety Cabinets

5 ea.

Inspections/Certifications (1 per year)

___________

____________

QUANTITY

UNIT

UNIT COST

TOTAL COST

Histology Grossing tables

3 ea.

Inspections/Certifications (1 per year)

__________

__________

TOTAL ANNUAL COST:

$

Information System Officer, Information Protection:Â The contractor will/will not have access to VA Desktop computers they will not have access to online resources belonging to the government.

Privacy Officer: The Contractor will/will not have access to protected Patient Health Information (PHI) nor will they have capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage device will remain in VA control and will not be removed from VA custody. All research data available for Contractor analysis is de-identified.

Records Manager:Â

Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

The Government Agency owns the rights to all data/records produced as part of this contract.

The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

Responsible sources having relevant experience may submit their statement of interest and capabilities, including business size classification to this notice via email to the Contracting Specialist, marzetta.austin@va.gov. Responses shall be emailed with 36C25724Q0093 in the subject line by 10:00 A.M. Central, 07 November 2023. Facsimile or Telephonic responses will not be accepted.

End of Document