Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF NOVEMBER 27, 2016 FBO #5483
DOCUMENT

H -- Inspection, testing and certification of: Biological Safety Cabinets (BSCs), Laminar Flow Work Stations (LFWs) and Pharmacy Clean Room(s) at the Birmingham VA Medical Center - Attachment

Notice Date

11/25/2016
 

Notice Type

Attachment
 

NAICS

541990 — All Other Professional, Scientific, and Technical Services
 

Contracting Office

Department of Veterans Affairs;VISN 7 Network Contracting Office;LaVista Business Park - Bldg A;2008 Weems Road;Tucker GA 30084
 

ZIP Code

30084
 

Solicitation Number

VA24717Q0047
 

Response Due

12/6/2016
 

Archive Date

2/4/2017
 

Point of Contact

Jessica Coleman-Smith
 

Small Business Set-Aside

Total Small Business
 

Description

1 STATEMENT OF WORK INSPECTION & CERTIFICATION OF: BIOLOGICAL SAFETY CABINETS, LABORATORY FUME HOODS & PHARMACY CLEAN ROOMS 1. INTRODUCTION AND SCOPE OF WORK: Contractor shall furnish service as specified below to ensure that the equipment functions in accordance with 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 and USP 797. Furnish all labor, equipment, tools, materials, and travel necessary to test, certify and measure Government owned Biological Safety Cabinets (BSCs), Laminar Flow Work Stations (LFWs), and Pharmacy clean rooms. Contract Period: One Year from the Date of Award 2. REQUIREMENTS: a. Equipment is identified on the list below. Pharmacy cleanrooms and pharmacy equipment will be tested/certified semi-annually beginning December 2016. Pathology & Laboratory and Medical Research equipment will be tested/certified annually beginning December 2016. b. The annual/semi-annual certifications shall be performed in sufficient time to insure that none shall lapse (contractor will schedule testing that builds in time for repairs should that be necessary to insure certifications never lapse). c. The Contractor shall provide certification reports upon completion of semi- annual and annual testing/certification. Report will include training/certifications of technicians performing the work and calibration certificates of the equipment used during the testing/certification. d. Contractor will immediately notify COR in writing (letter) or by email, in the event any/all regulatory guidance governing the certifications of any subject equipment changes. Written advisement will include any issues which will impact testing/certification. Contractor will also advise BVAMC COR of recommendations to resolve any issues related to the regulatory changes. When testing/servicing/certifying equipment, the Contractor will provide on-site consultation to BVAMC staff (answer questions, make recommendations to maintain at optimum level) that use the Pharmacy cleanroom, the biosafety cabinets, and the laminar flow hoods. Technicians knowledgeable about certification requirements will converse with staff/COR to inform them of recommended adjustments to behaviors used in daily use, cleaning of area, maintenance of equipment, and any structural/HVAC/electrical/engineering issues related to the equipment or rooms encompassing equipment. Technicians will brief COR of any issues/questions raised by staff upon checking out post-certification. e. All requirements outlined in this contract as applying to prime contractor will also apply to any/all sub-contractors engaged in work under this contract. NOTE: Contractor shall have the capability to respond within 24 hours of contact for emergency repair. Contractor shall furnish the Contracting Officer Representative (COR) with written estimate of cost to make necessary repairs and receive COR approval prior to initiating repairs. 3. COMPETENCY OF PERSONNEL SERVICING EQUIPMENT: All technicians who perform work under this contract will have a current NSF accreditation. Contractor will provide a copy of NSF accreditation to COR. Prior to commencement of work on this contract, the Contractor shall provide the BVAMC with a copy of the current calibration certification of all test equipment which is to be used by the Contractor on BVAMC's equipment. This certification shall also be provided on a periodic basis when requested by the BVAMC. 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: National Safety Foundation (NSF) 49-2010: Biosafety Cabinetry: Design, Construction, Performance and Field Certification. American Society of Heating, Refrigeration and Air Conditioning Engineers (ASHRAE) 110-1995: Method of Testing Performance of Laboratory Fume Hoods. Federal Standard No. 209E-April 24, 1992: Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones. The Science Equipment and Furniture Association (SEFA) 1.2-1996: Laboratory Fume Hoods Recommended Practices. American Conference of Governmental Industrial Hygienist (ACGIH). The United States Pharmacopeial Convention (USP) 2008, Chapter 797. American Society Health-System Pharmacy (ASHP) Minimum Standards for Pharmacies in Hospitals. CETA Certification Guide for Sterile Compounding Facilities (CAG-003-2006). 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 Field Service Representative (FSR) shall document services rendered on a legible Engineering Service Reports(s). The FSR shall be required to log out with the COR. ALL ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COR for an "authorization signature". If the COR is unavailable, a signed copy of the ESR will be sent to the COR after the work is performed. 6. Biosafety Cabinet Certification The Pharmacy biosafety cabinet shall be certified semi-annually. All other Biosafety cabinets will be certified annually. Certification shall consist of the following: Down flow velocity test Inflow velocity test Airflow smoke pattern test HEPA filter leak test Alarm function test Blower interlock test (Class II, type B cabinets) Electrical leakage on the main cabinet (those that aren t UL listed) Ground Fault Circuit Interrupter (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 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 COR of cabinets that fail certification. 7. Laminar Flow Workstations Certification Pharmacy laminar flow workstations (LFWs) shall be certified semi-annually. 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 (e.g., 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 COR of lab fume hoods that fail certification. 8. Pharmacy Cleanroom(s) Testing and Certification Testing and certification (under CAG-003-2006-11 and to SUO 797 Standards) of the Pharmacy: Ante Room, Hazardous Buffer (IV) Room and Non-Hazardous Buffer (Chemo) Room as well as viable air and surface sampling for mold and bacteria will be semi-annually. Certification and testing shall consist of the following: Test and validate the number of air changes per hour (ACH) through the rooms Heating Ventilation and Air Conditioning (HVAC) equipment and exhaust hood. Test and validate that the hood and room exhaust provide a unidirectional/laminar flow of air. Inspect HVAC filter assembly for air bypass issues. Test and calibrate the existing air balancing monitors (Chemo and Ante Rooms). Take viable air samples for mold and bacteria (1 location in each PEC: LFWs, BSC, Pass Thru, and 1 location in the room Ante, and 2 locations Chemo and IV Room. Colony forming units (CFU) results from the cultures shall be calculated in cfu per cubic meter (m3) of air. Take viable surface samples for bacteria (1 each in LFWs, BSC, Pass Thru, Ante, Chemo and IV Room. 9. 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 BVAMC as part of the testing/certification process: Biosafety cabinet and laminar flow workstation filters shall be recommended for replacement when they fail a leak test and cannot 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 BVAMC staff/operators regarding unit performance. 10. 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 technicians and/or delivery of parts. Note: Any additional charges claimed must be approved by the COR before the service is completed! Security Issues: There are no known security issues associated with this Statement of Work other than the Pharmacy is a controlled access area. 11. DEFINITIONS: Acceptance Signature - VA employee who indicates technician demonstrated service conclusion/status and User has accepted work as complete/pending as stated in work estimate. Authorization Signature - COR's signature; indicates COR accepts work status as stated in work estimate. 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 Office, room 2710, 700 19th Street South, Birmingham, AL 35233, while on BVAMC property if not escorted during entire visit by a Safety Office employee. 12. LIST OF EQUIPMENT Medical Research Equipment: Equipment Qty Work performed Unit Cost Total Cost NuAire 425-400 BSC 5 Annual Inspection/Certification Thermo Scientific 1300 A2 BSC 1 Annual Inspection/Certification Pathology and Laboratory Equipment: Equipment Qty Work performed Unit Cost Total Cost NuAire 425-400 BSC 1 Annual Inspection/Certification NuAire 425-600 BSC 1 Annual Inspection/Certification Pharmacy Equipment: Equipment Qty Work performed Unit Cost Total Semi Annual Cost Total Annual Cost NuAire 425-400 BSC with non viable particle counts 1 Semi Annual Inspection/Certification NuAire 301-530 LFH with non viable particle counts 2 Semi Annual Inspection/Certification Pharmacy Cleanrooms Room Approximate Square Footage Total Semi Annual Cost Total Annual Cost Ante 56.60 Chemo 84.94 Buffer (IV) 104.16 13. CONFIDENTIALITY AND NONDISCLOSURE It is agreed that: 1. The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the COR at the conclusion of the task order. 2. The COR will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the COR for response. 3. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the COR. 14. MANDATORY RECORDS MANAGEMENT/PRIVACY ACT/FOIA COMPLIANCE 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. TECHNICAL EVALUATION FACTORS SERVICES REQUIRED: Inspection, testing and certification of: Biological Safety Cabinets (BSCs), Laminar Flow Work Stations (LFWs) and Pharmacy Clean Room(s) at the Birmingham VA Medical Center. Offers will be evaluated on Lowest Price Technically Acceptable as it meets the specification of this Statement of Work. RESULTS (ACCEPTABLE / UNACCEPTABLE) EVALUATION FACTORS RATING (Satisfactory or unsatisfactory) Management Approach and Technical Capabilities Demonstrates an Understanding of the objectives of the SOW and specific tasks, and planned execution of the services. Evidence of specific methods & techniques for completing each task, to include such items as quality assurance (QA) and quality control (QC). Ability to address potential problem areas and to have contingency plans should the need arrive. Demonstrates an understanding of logistics, scheduling and facility layout. Demonstrates an ability to be flexible with allocation of personnel and resources. Overall Management Approach & Technical Capabilities Personnel Qualifications: Provides documented (in writing) evidence of all accreditations and certifications of service technicians. Provides documented (in writing) evidence of education, training and work experience of service technicians. Overall Personnel Qualifications Vendor Capability: The service vendor has the capability to provide the requested services to Birmingham VA Medical Center in accordance with the Statement of Work (SOW). Service Compliance: Fully describes and includes all specification information that demonstrates the ability and expertise to inspect, test and certify under CAG-003-2006-11 and to USP 797 Standards. Experience/Past Performance: The vendor has documented experience of successful completion of projects; history of producing high quality reports; history of staying on schedule. Vendor has provided at a minimum, three (3) references and two (2) successfully completed contracts. The vendor s specific past performance on prior similar services specified within this SOW. Overall Experience/Past Performance The lowest price technically acceptable source selection process will be used as basis of award. Award will be made on the basis of the lowest evaluated price of proposals meeting or exceeding the acceptability standards for all non-cost/price factors. **ALL factors must be rated ACCEPTABLE to be considered for award. Non-Cost/Price Factors Each factor will be scored as Acceptable or Unacceptable as defined below. Each proposal will be evaluated against the SOW and the stated evaluation criteria. Each proposal is evaluated using the same standards. "Lowest Price, Technically Acceptable" Evaluation Standards Acceptable ALL of the minimum acceptable criteria are clearly met by the proposal. The offeror's proposal meets the performance and technical capability requirements defined in the SOW. NOTE: Once the proposals have been determined to be "technically acceptable," award will based on cost/price only. Unacceptable Not all of the minimum acceptable criteria are met by the proposal. An unacceptable proposal contains one or more deficiencies. Proposal fails to meet specified minimum performance and technical capability requirements defined in the SOW. All proposals must be received by 5:00PM EST on December 6, 2016 via email to the Contracting Officer, Jessica Coleman-Smith at Jessica.Coleman-Smith@va.gov. No late proposals will be accepted.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/AtlVAMC/VAMCCO80220/VA24717Q0047/listing.html)
 

Document(s)

Attachment
 

File Name: VA247-17-Q-0047 VA247-17-Q-0047_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3127929&FileName=VA247-17-Q-0047-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3127929&FileName=VA247-17-Q-0047-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN04336379-W 20161127/161125233146-840e206bd3ae41144d73aa4be04e0d33 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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