S09 - FINAL SOW - Fume Hoods.docx

STATEMENT OF WORK

CONTRACT TITLE: Pharmacy and PALMS, Hood and BSC Certification

PLACE OF PERFORMANCES: VA San Diego Healthcare System, 3350 La Jolla Village Dr., San Diego, CA 92161

PERIOD OF PERFORMANCE: Annual – Base Year plus up to Four (4) Option Years. One (1) year from date of award; this will be the base year. In addition, the Government (VA) shall retain the right to exercise option(s) to extend the contract period for up to four (4) one (1) year option renewals.

CONTRACT TYPE: Firm Fixed Price

BACKGROUND: VA San Diego Healthcare System (VASDHS) has a requirement to inspect and certify BioSafety Cabinets, Chemical Fume Hoods and combination BioSafety & Chemical Fume Hoods on the same machine; and compounding rooms/areas. These are located in Pharmacy in the main hospital Building 1 in 3 East, 5 South, and 5 West; as well as the PALMS area on the first floor of Building 1.

GENERAL REQUIREMENTS: The vendor must be present during testing hours scheduled to minimize disruption to pharmacy workflow and patient care to perform:

· Semi-annual testing and certification of the Pharmacy hoods and compounding rooms/areas in the main hospital Building 1 in 3 East, 5 South, and 5 West.

· Semi-annual certification of the PALMS hoods and BioSafety Cabinets.

The contractor shall:

· Provide all written deliverables phrased in terms and language that can be easily understood by non-technical personnel, i.e., a person without subject matter expertise. All document deliverables, hard copy and electronic, must be in formats as specified-at a minimum, the formats must be in industry accepted standards.

· Shall have knowledge and expertise of the environment for which the work is to be performed. The vendor shall conduct inspection, certification, and testing in accordance with the following policies and recognized standards:

· International Organization for Standardization (ISO) Class 5, 7, and 8 Criteria

· United States Pharmacopeias (USP) 797 and (USP) 800

· Provide semi-annual certifications, and maintenance services for the laminar flow hoods, biological safety cabinets, compounding aseptic isolators, and pharmacy compounding room areas located at the Veteran Affairs San Diego Healthcare System (VASDHS). All services shall be provided in accordance with the terms, conditions, and requirements as specified herein.

· Provide all necessary labor, supervision, materials, and equipment for semi-annual certifications, and maintenance services for the laminar flow hoods, biological safety cabinets, compounding aseptic isolators, and pharmacy compounding room areas. Testing of hoods must be compliant with OSHA, AIHA/ANSI, SEFA, NEBB, and ASHRAE.

· Provide Emergency services upon request by the facility management services (Engineering). The vendor shall respond to emergency service call within two-hour window upon receiving the call from the facility management services. The vendor shall provide after hours and weekend services upon request from facility management services (Engineering).

· Provide the Compounding Sterile Products Program Manager and/or representatives a complete digital report of results via email within 10 business days.

· Schedule repeat testing for failed results.

Tasks: The vendor shall perform the following testing as required by USP 797, USP 800, ASHRAE 110, and/or National Sanitation Foundation (NSF) Standard 49:

Semi-Annual Certification

LAFH and BSC

· HEPA filter leakage

· Outflow velocity

· Pressure

· Airborne non-viable particle counting

· Viable air sampling and colony count (colony ID only if above actionable level)

· At rest airflow visualization test (smoke studies)

· Operational/dynamic airflow visualization test (smoke studies)

Compounding Aseptic Isolator

· HEPA filter leakage

· Average supply velocity

· Pressure for main chamber

· Pressure for interchange chamber (pass through)

· Airborne non-viable particle counting for main chamber

· Airborne non-viable particle counting for interchange chamber

· Viable air sampling and colony count for main chamber (colony ID only if above actionable level)

· Viable air sampling and colony count for interchange chamber (colony ID only if above actionable level)

· At rest airflow visualization test (smoke studies)

· Operational/dynamic airflow visualization test (smoke studies)

Storage Area

· HEPA filter leakage

· Room air exchange rate

· Air pressure differential

· Airborne non-viable particle counting

Anteroom

· HEPA filter leakage

· Room air exchange rate

· Air pressure differential

· Environmental monitoring for temperature and humidity

· Airborne non-viable particle counting

· Viable air sampling and colony count (colony ID only if above actionable level)

Buffer Room

· HEPA filter leakage

· Room air exchange rate

· Room air exchange rate + PEC

· Air pressure differential

· Environmental monitoring for temperature and humidity

· Airborne non-viable particle counting

· Viable air sampling and colony count (colony ID only if above actionable level)

Room/Equipment information

Pharmacy Building 1

PALMS

Building 1

Non-Hazardous Compounding Room 3214

Hazardous Compounding Room 3209

Room 3214 Non-Hazardous Compounding Room Conduct semi-annual certification of Room 3214 and three Laminar Air Flow Hood (LAFH) which includes:

· Testing of the LAFHs.

· Testing of the room ceiling HEPA filters including integrity leak testing and airflow volume measurements.

· Controlled Environmental Monitoring/Room Air Exchange Rate, Calculations and Differential Pressure Readings for all the rooms (storage area, anteroom, buffer room).

· Non-Viable Particle Counting of LAFHs, tested to ISO Class 5 at PPCM (um) ≥ 0.5.

· Non-Viable Particle Counting of Buffer Room to ISO Class 7 at PPCM (um) ≥ 0.5 and Anteroom to ISO Class 8 at PPCM (um) ≥ 0.5. This counting should include temperature and rH (room humidity) at each sample location.

· Airborne Viable Sampling with colony count (colony ID only if above actionable level) which includes two samples in each LAFH (6), two samples in each room (4) and two controls (2). Total 12 samples.

· Airflow Visualization Studies of LAFHs which shows unidirectional airflow and first air contact recorded as video format under dynamic conditions.

· Calibrate magnetic gauge.

· All certification and testing performed need to be formally documented and initial and final reports need to be promptly sent to POC at the facility.

Room 3209 Hazardous Compounding Room Conduct semi-annual certification of Room 3209 and two Class II, Type B2 Biological Safety Cabinets (BSC) which include:

· Testing of two Class II, Type B2 BSCs

· Testing of the room ceiling HEPA filters including integrity leak testing and airflow volume measurements.

· Controlled Environmental Monitoring/Room Air Exchange Rate, Calculations and Differential Pressure Readings for all the rooms (storage area, anteroom, buffer room).

· Non-Viable Particle Counting of BSCs, tested to ISO Class 5 at PPCM (um) ≥ 0.5.

· Non-Viable Particle Counting of Buffer Room to ISO Class 7 at PPCM (um) ≥ 0.5 and Anteroom to ISO Class 7 at PPCM (um) ≥ 0.5. This counting should include temperature and rH (room humidity) at each sample location.

· Airborne Viable Sampling with colony count (colony ID only if above actionable level) which includes two samples in each BSC (4), two samples in each room (4) and two controls (2). Total 10 samples.

· Airflow Visualization Studies of BSCs which shows unidirectional airflow and first air contact recorded as video format under dynamic conditions.

· Calibrate magnetic gauge.

· All certification and testing performed need to be formally documented and initial and final reports need to be promptly sent to POC at the facility.

Room 5102 and 5080: Segregated Compounding Areas (SCA) Conduct semi-annual certification of Room 5102 LAFH and Room 5080 LAFH:

· Testing of two LAFH.

· Non-Viable Particle Counting of LAFH, tested to ISO Class 5 at PPCM (um) ≥ 0.5.

· Airborne Viable Sampling with colony count (colony ID only if above actionable level) which includes two samples in each LAFH (4) and four controls (4). Total 8 samples.

· Airflow Visualization Studies of CAIs which shows unidirectional airflow and first air contact recorded as video format under dynamic conditions.

· Calibrate magnetic gauge.

· All certification and testing performed need to be formally documented and initial and final reports need to be promptly sent to POC at the facility.

Semi-Annual Schedule

Pharmacy: Non-HD: March/September, HD/CAI: April/October PALMS: April/October

DELIVERABLES: The vendor shall complete and provide an electronic copy of the field service report after each service call. This report must contain a detailed description of any services or repairs performed for each item of equipment, and must also include a listing of replacement parts, when applicable, total hours of service, safety check, performance data, and date of service.

· Provide a formal report for work performed in room 3214 Non-Hazardous Compounding Room

· Provide a formal report for work performed in room 3209 Hazardous Compounding Room

· Provide a formal report for work performed in room 5102 ICU

· Provide a formal report for work performed in room 5080 OR

The vendor shall provide a Field Service Report (FSR) via email within ten (10) business days of completed service. The vendor shall provide the following information:

· Type of equipment (i.e. Fume Hood)

· Manufacturer

· Model Number

· Class (i.e. AII)

· Serial Number

· VA Equipment Entry (EE) number

· Building and Room of equipment location

· Test Date

· Certificate of Analysis (COA)

· Pass or Fail inspection

· Date of next inspection

· Affix label to each unit that passes certification. Affix labels on the day the inspection was passed or the certification date. Label must include:

· Company Name

· Mailing Address

· Telephone number

· Certificate Name (“Certificate of Environmental Compliance to CAL or OSHA and NFS Standard NO.49”)

· Equipment Manufacture

· Equipment Name

· Inspection Date

· Date of next inspection

· Signature of inspector

· Full printed name of inspector

· Status: “Certified”

· Unit ID Number from contract

· Affix label to each unit that fails certification. Affix labels on the day of the failed inspection or certification. Label must include:

· Company Name

· Mailing Address

· Telephone number

· Equipment Manufacture

· Equipment Name

· Inspection Date

· Signature of inspector

· Full printed name of inspector

· Status: “Failed”

· Unit ID Number from contract

The vendor shall submit a written statement of repairs needed (to be referred to as Failed Inspection Report), including an itemized listing of parts deemed necessary to certify the unit. This must be submitted prior to leaving the facility on the day of attempted certification. This information must be written in detail so that it may be passed to a Repair Contractor (if selected to be different from the Certification Contractor) thus enabling this other contractor to bring all materials and parts needed at the time of service to effect repairs rendering the unit certifiable.

If a hood is deemed non-repairable, not meeting industry standards and failing the test requirements, the vendor shall provide the Failed Inspection Report outlining specific nonrepairable/replaceable parts that prevent certification on the same day of the inspection. The vendor shall notify verbally and through a written report of any equipment not being repaired prior to leaving the Government premises.

CONTRACTOR QUALIFICATIONS & OTHER RESPONSIBLITES: Contractor shall obtain all necessary licenses required to perform this work. Contractor shall take all precautions necessary to protect people and property from injury or damage during the performance of this contract. Contractor shall be responsible for any injury to himself/herself, his/her employees, or others, as well as for any damage to personal or public property that occurs during the performance of this contract that is caused by him/her or his/her employees’ fault or negligence. Contractors shall maintain personal liability and property damage insurance prescribed by the laws of the Federal Government.

The Government reserves the right to accept or reject Contractor’s employees for the rendering of services. Complaints concerning Contract Personnel’s performance or conduct will be dealt with by the Contractor and COR with the final decision being made by the Contracting Officer.

Contractor personnel performing inspection and certification services shall be fully accredited and certified to conduct tests, evaluations, and certification of the equipment assigned (i.e.: CETA).

Contractor personnel shall have validated Certificate of Accreditation from National Sanitation Foundation (NSF) International: Biohazard Cabinet Field Certifier Accreditation Program. The certificate of accreditation shall specify the initial and expiration dates, and this certification shall be verifiable on the NSF website.

Contractor is required to update accredited contractor personnel certifications throughout the life of the contract as changes occur to staff. New employee credentials of accreditation for equipment on contract and training certificates must be submitted and approved prior to the employee commencing any work on this contract.

SAFETY REQUIREMENTS: All personnel employed by the Contractor in the performance of this contract, or any representative of the Contractor entering on VASDHS shall comply with applicable Federal, State, and VA safety and fire regulations and codes which are in effect during the performance period of the contract.

Contractor shall perform work in strict accordance with existing relevant, accredited standards and codes to minimize the possibility of injury to personnel, or damage to Government equipment. Every effort shall be made to safeguard human life and property.

Contractor shall comply with all applicable Federal, State, and local requirements regarding workers’ health and safety. The requirements include, but are not limited to, those found in Federal and State Occupational Safety and Health Act (OSHA) statutes and regulations, such as applicable provisions of Title 29, Code of Federal Regulations (CFR), Parts 1910 and 1926, NFPA 70E, Article 130.7 29 CFR 1910.132(d)(1)(iii), 29CFR1910.137

Contractors shall provide all necessary tools, and Personal Protective Equipment (PPE) to perform the work safely, effectively, and timely.

The VAMC San Diego building 1, main building, contains asbestos. Any worker entering these asbestos containing areas must have an asbestos certification of no less than 16 hours and a valid fit test certification. Certifications must be presented to the VA project manager before any work in an asbestos area may begin.

CHANGES: The awarded Contractor is advised that only the Contracting Officer, acting within the scope of the contract has the authority to make changes which affect the contract in terms of quality, quantity, price or delivery. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered to have been made without authority, and no adjustment shall be made in the contract price to cover any increase in costs incurred as a result thereof.

NORMAL WORKING HOURS: Normal hours of operation are Monday through Friday from 7:30 am to 4:00 pm Pacific time. All work is expected to be performed generally during normal hours of coverage unless requested or approved by the COR or his/her designee.

Before commencement of work, the Contractor shall confer with the VA COR and Contracting Office to agree on a sequence of procedures; means of access to premises and building. All work performed, to include delivery of materials and equipment, shall be made with minimal interference to Government operations and personnel.

Work performed outside the normal hours of coverage must be approved by the COR or his/her designee.

GOVERNMENT HOLIDAYS: The Vendor is not required to provide service on the following National holidays, nor shall the Vendor be paid for these holidays. The following national holidays observed by the Federal Government:

If a holiday falls on Sunday, the following Monday shall be observed as the National Holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National Holiday by U.S. Government agencies. Also included would be any day specifically declared by the President of the United States.

INVOICES and PAYMENTS: Contractor shall submit monthly invoices in the arrears electronically via the Tungsten-Network System at the end of each month, for payment of the storage containers in that billing period. Contractor shall submit original invoice electronically to:

Department of Veterans Affairs Financial Services Center http://www.tungsten-network.com (Toll-free telephone number: (877) 489-6135

Payment shall be made monthly in the arrears upon receipt of properly prepared invoice.

The invoice MUST be itemized to include the following information. Any information listed below that is not provided on an invoice will be incomplete and the invoice will be returned for immediate correction.

· Dates of service.

· Description of services.

· Invoice number, date.

· Contract number.

· Obligation number

Failure to comply with the above shall delay payment to the Contractor.

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