H399--SMALL BUSINESS SET ASIDE | CETA Pharmacy Hood Service Inspection/Certification at the Fargo VA, Fargo, ND

2 Pharmacy s Compounded Sterile and Non-Sterile Preparations USP Compliance Program Statement of Work SCOPE: (please note: this is an abbreviated portion of the SOW for the purpose of this notice) The contractor shall provide all labor, equipment, materials (including replacement parts), supplies, tools, transportation, and travel necessary to perform all inspections, testing, certifications/recertifications, preventative maintenance and repair or replacement of High-Efficiency Particulate Air (HEPA) and other filters, as required throughout the contract period at Fargo Veterans Affairs Healthcare System (VAHCS) upon request. The contractor shall perform routine work detailed in this performance of work statement (PWS) on a regular schedule, mutually agreed upon by the Contractor and Contracting Officer Representavie (COR). If additional testing/certification, troubleshooting, adjustment or repair is required, the contractor shall provide for additional services/certifications of the engineering controls to ensure continuation of pharmacy operations in full compliance with USP 795, USP 797, USP 800, and any and all applicable CETA Application Guides. These additional site visits will only be utilized at the request of the COR. The additional site visit(s) line item shall include all costs associated with travel, per diem, lodging, mileage, movement/shipping of equipment, overnight pay or any other costs the contractor may incur in visiting the facility outside of the normal semiannual visits. The cost must cover a site visit which may exceed a single work day (depending on the additional work required).The contractor shall perform unscheduled work or emergency requests within five (5) days of a request from the COR. Fargo VAHCS uses a variety of engineering controls to limit employee exposures to hazardous contaminants while also providing a safe and effecitive preparation for patients. Fargo VAHCS Pharmacy Service has both secondary engineering controls (SECs) and containment secondary engineering controls (C-SECs) which make up the USP 797 and USP 800 compliant cleanroom suite. The cleanroom suite contains a variety of primary engineering controls (PECs) and contaiment primary engineering controls (C-PECs). The PECs include laminar airflow work-benches (LAFW) or compounding aseptic isolators (CAIs) for all non-hazardous sterile compounding and the C-PECs include externally vented Class II biological safety cabinets (BSCs), an externally vented compounding aseptic containment isolator (CACI) for hazardous sterile compounding, and a containment ventilated enclosure (CVE) for hazardous non-sterile compounding. The number of cleanrooms, segregated compoudning areas (SCAs), LAFWs, CAIs, CACIs, CVEs, and BSCs in service may change throughout the contract period. Table A is the Government's best estimate of the number and type expected to be tested, sampled, serviced, and certified by the contract. The Government reserves the right to delete or add units as required. If the numbers of listed items will be exceeded, no work is authorized without the prior written approval of the Contracting Officer (CO) to account for it. Work items or services not already included in this PWS, but relevant to it, may be ordered by the CO without further competition. Only the CO has the right to obligate funding or order work not expressly detailed in this PWS. The Government shall not be held responsible for payment for any work performed by the contractor that is outside the scope of this contract or without the prior approval of the CO.