Statement of Work for 123A9423Q0020.pdf

US Department of Agriculture (USDA)

Statement of Work for

123A9423Q0020

Contents Project General Information

1.0 Scope of Work

2.0 Background

Contractor Requirements

3.0 Technical Requirements / Tasks

4.0 Government Furnished

5.0 Deliverables / Schedule

6.0 Travel

7.0 Contractor’s Key Personnel

8.0 Security Requirements

9.0 Data Rights

10.0 Section 508 – Electronic and Information Technology Standards

Project Biosafety Cabinet, room magnehelic gauges, and HEPA filter Certifications

General Information

1.0 Scope of Work

FSIS Eastern Laboratory wishes to contract the services of a professional with expertise to perform annual certifications and service for BSL3 laboratory HEPA filters, room magnehelic gauges, and biological safety cabinets. In addition, the contractor will provide certifications for all biosafety cabinets located in Biosafety Level 2 laboratories in Eastern Laboratory.

2.0 Background

FSIS maintains a Biosafety Level 3 (BSL3) facility for use in handling high consequence select agents/toxins and for handling food samples potentially contaminated with such hazardous agents. The Select Agent Program imposes strict requirements for BSL3 laboratories that include annual testing and certifications to assure that the systems are functioning properly and efficiently, therefore assuring employee safety and protection from release of hazardous agents from the lab. Also, in other microbiology labs OSHA specifies that biological safety cabinets shall be certified when installed, whenever they are moved and at least annually [OSHA 1910.1030(e)(2)(iii)(B)]. Applicable requirements:

APHIS/CDC Select Agent Rule: 42 CFR 73, 7 CFR 331 and 9 CFR 121 http://www.selectagents.gov/Regulations.html

Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition https://www.cdc.gov/labs/BMBL.html

National Sanitation Foundation / American National Standards Institute (NSF/ANSI) Standard 49, Annex F http://www.nsf.org/business/biosafety_accreditation/standards.asp?program=BiosafetyCabCert

Occupational Safety and Health Standards, Subpart Z, Toxic and Hazardous Substances, Bloodborne Pathogens, Appendix A, [1910.1030(e)(2)(iii)(B)] https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_id=10051&p_table=STANDARDS

Contractor Requirements

3.0 Technical Requirements / Tasks

• The contractor shall perform Annual leak testing and HEPA Filter certification services once per contractual period.

• The contractor shall perform annual leak testing and certifications of BSL 3 laboratory HEPA filter housings.

• The contractor shall perform annual certifications of Eastern Laboratory biological safety cabinets

• As HEPA filters need to be replaced due to decreased efficiency, the contractor shall perform on-site decontamination of filter housings and biological safety cabinets, removal and bagging of used filters for disposal, and replacement, followed by leak testing and certification of the new filters.

• The contract shall cover purchase of 8 HEPA filters for 4 exhaust HEPA filter housings (over a 3-year period), decontamination service for the filter housings and biological safety cabinets, and leak testing/certification.

• The contractor shall also provide certification of magnehelic gauges in the BSL3 lab.

• Prior to repairs or installation of new parts the contractor shall advise FSIS of recommended repairs or replacement of parts.

• The contractor performing housing leak testing and HEPA filter certifications must comply with HEPA housing manufacturer’s specifications and appropriate guidelines.

http://www.selectagents.gov/Regulations.html https://www.cdc.gov/labs/BMBL.html http://www.nsf.org/business/biosafety_accreditation/standards.asp?program=BiosafetyCabCert https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_id=10051&p_table=STANDARDS

• The contractor performing biological safety cabinet testing and certification should be accredited to test and certify biological safety cabinets.

• Contractor must certify the biological safety cabinets in accordance with National Sanitation Foundation / American National Standards Institute (NSF/ANSI) Standard 49, Annex F and assure that the technician performing is NSF certified.

• The contractor shall provide on-site call maintenance to include all labor and travel.

• Repairs shall be made in accordance with manufacturer specifications.

• The contractor shall respond on-site within 2 workdays or suitable negotiation with the COTR after notification of the repair call.

• The contractor shall be responsible for assuring repair is accomplished within 8 working hours of the onsite service visit.

4.0 Government Furnished

The COTR, will act, on-site, as the technical point of contact for the Government, initiate service calls, and perform acceptance of equipment after maintenance and repairs. The COTR’s authority is limited to technical issues and he/she is not authorized to make contractual decisions. The authority to resolve monetary issues and contractual interpretation is the responsibility of the Contracting Officer.

The COTR shall coordinate the annual certifications with the annual Test and Balance of the laboratory. This would involve the coordinating timing with the service provider for the test and balance, the existing contractor for lab controls, and the onsite mechanical contractor.

Parts, equipment or other materials required in the performance of the maintenance services not included above, but needed for accomplishing the work of this agreement shall be at the expense of FSIS (except parts covered by manufacturer’s warranty). Prior to repairs or installation of new parts the contractor shall advise FSIS of recommended repairs or replacement of parts. Parts will be charged to FSIS based on cost at the time of repair and are subject to availability.

5.0 Deliverables / Schedule

Period of Performance Base Year: June 6th 2023 thru June 5th 2024 Option Year 1: June 6th 2024 thru June 5th 2025 Option Year 2: June 6th 2025 thru June 5th 2026 Option Year 3: June 6th 2026 thru June 5th 2027 Option Year 4: June 6th 2027 thru June 5th 2028

Under the contract, the contractor shall perform annual testing and certification services at FSIS Eastern Laboratory, located at USDA, FSIS, OPHS, Eastern Laboratory, 950 College Station Road, Athens, GA 30605.

Hours of Service. Maintenance services shall be provided during normal working hours, between 8:00am to 5:00pm EST, Monday through Friday, excluding Federal Holidays (see http://www.opm.gov/Fedhol/ for a listing of the Federal Holidays). Additional service calls, emergency service or service outside of normal working hours will be at billed rates as negotiated with the contractor.

• The contractor shall perform annual certifications of biosafety cabinets (Decontaminate and replace HEPA filters as needed for operational efficiency):

a. 1 laminar flow Hoods

b. 10 each Class II Biosafety Cabinets

c. 1 Ductless Fume Hood

• Calibration of Magnehelic gauges (5) for rooms in PB5.

• Decontaminate HEPA housings prior to certifications

• Replace filter housing prefilters –

a. Prepleat 40:24242 http://www.opm.gov/Fedhol/

b. Change-out bag 70Cx72

• Leak testing and Certification of Flanders HEPA Filter housings (Flanders job#23-283):

a. BF1-1H2W-GGF /12-304-D1 (P-1-HF-1)

b. BF1-2H2W-GGF /12-304-D1 (P-1-HF-2)

c. BF1-1H1W-GGF /12-304-D1 (P-B-HF-3)

d. BF1-1H1W-CCD /12-304-D1 (1st floor, plumbing vent housing)

• Replace room HEPA filters, and properly dispose of filters (At least once, and on as needed basis thereafter):

a. Vent HEPA filter (Replace annually; bag in/bag out stainless steel, 12”x12”x5.875”)

i. filter: 0-007-D-08-05-SU-51-00-CC-D

ii. change out bag 54Cx54

b. First floor and basement housings (replace 4 in base year and 4 in subsequent option year):

i. Filter absorbers m/n T-007-W-04-05-SU-52-00-GG-F (7 each: basement housing, 1 filter; 1st floor housing, 3X2 deep=6)

ii. Change out bags 90CX96

• After all service and/or repairs are completed, the contractor shall perform certifications to verify proper performance of the system.

• Upon completion of a satisfactory assessment, the contractor shall provide to the COTR a report and certificates for HEPA filters, Biological Safety Cabinets, magnehelic gauges, and documentation of certificates for the testing equipment used for all measurements.

6.0 Travel

The contractor shall provide on-site call maintenance to include all labor and travel. Repairs shall be made in accordance with manufacturer specifications. The contractor shall respond on-site within 2 workdays or suitable negotiation with the COTR after notification of the repair call. The contractor shall be responsible for assuring repair is accomplished within 8 working hours of the onsite service visit.

7.0 Contractor’s Key Personnel

The contractor performing housing leak testing and HEPA filter certifications must comply with HEPA housing manufacturer’s specifications and appropriate guidelines. The contractor performing biological safety cabinet testing and certification should be accredited to test and certify biological safety cabinets. Contractor must certify the biological safety cabinets in accordance with National Sanitation Foundation / American National Standards Institute (NSF/ANSI) Standard 49, Annex F and assure that the technician performing is NSF certified.

National Sanitation Foundation / American National Standards Institute (NSF/ANSI) Standard 49, Annex F http://www.nsf.org/business/biosafety_accreditation/standards.asp?program=BiosafetyCabCert

8.0 Security Requirements

The contractor shall abide by USDA, FSIS requirements for security including showing state provided identification upon entry at facilities and staying with escorts in the building.

New mandates for entry include attesting to SARS-COV-2 vaccination status, wearing masks while onsite, and maintaining social distances apply at this Federal facility.

9.0 Data Rights

Upon completion of a satisfactory assessment, the contractor shall provide to the COTR a report and certificates for HEPA filters, Biological Safety Cabinets, magnehelic gauges, and documentation of certificates for the testing equipment used for all measurements.

10.0 Section 508 – Electronic and Information Technology Standards Not IT - Section 508 does not apply.

http://www.nsf.org/business/biosafety_accreditation/standards.asp?program=BiosafetyCabCert