J065--NEW (Base+4): HEPA Hoods and Biosafety Cabinet Certification (695)

DRAFT

Statement of Work (SOW)

HEPA HOODS Preventative Maintenance and Certification Testing

Milwaukee VA Medical Center

Description of Services: The contractor shall provide all material, supplies, equipment, and qualified personnel to provide certification of Pharmacy Clean Rooms, and Biological Safety Cabinets for the Clement J Zablocki VA Medical Center, 5000 W National Ave, Milwaukee, WI. The service provided shall be performed in such a manner as to assure the safety and welfare of patients, visitors, and staff. The Contractor shall furnish all transportation, management, supervision, personnel, equipment and supplies necessary to provide certification services as defined in the DRAFT Statement of Work (SOW).

SCOPE OF WORK TO BE PERFORMED:

CERTIFICATION

Research Service Biological Safety Cabinets (Biohoods)

Annual preventative maintenance will be performed on all biological safety cabinets in accordance with all applicable standards at the Milwaukee VA Medical Center. At a minimum, it will include cleaning, lubrication, checking all alarms for proper function, checking sash integrity, and filter repair (as needed).

Testing of the biological safety cabinets shall follow current standards set by National Sanitation Foundation (NSF)/ANSI 49, the NSF Certification policies for Biosafety Cabinetry, and manufacturer specification.

Annual certification will be performed on biosafety cabinets used in Building 70 Research area. Listed below is the current inventory.

4. Additional biohoods may be added over the life of the contract through contract modification

PLMS (lab) Biological Safety Cabinets (Biohoods)

Annual preventative maintenance will be performed on all biological safety cabinets in accordance with all applicable standards at the Milwaukee VA Medical Center. At a minimum, it will include cleaning, lubrication, checking all alarms for proper function, checking sash integrity, and filter repair (as needed).

Testing of the biological safety cabinets shall follow current standards set by National Sanitation Foundation (NSF)/ANSI 49, the NSF Certification policies for Biosafety Cabinetry, and manufacturer specification

.

Annual certification will be performed on the biohoods listed below.

Pharmacy Service semi-annual hood and room certification will be performed in accordance with the most current edition of USP 797, NSF/ANSI 49 and ISO 14644.1 standards. Certification must include the following: certification of the laminar flow clean benches and sterile preparation rooms, air quality evaluation (total particle count), microbial sampling, dynamic airflow smoke pattern test and a semi-annual HEPA filter integrity/leakage test. Additional details are outlined in subparagraphs 1-4 below.

Semi-annual certification and annual cleaning and replacement/change out of the pre-filters on these units.

Semi-annual certification of rooms used for sterile preparations and must include measurement of air changes per hour, room segregation test, room pressurization test, air quality evaluation (total particle count), microbial air and surface sampling, and room supply air HEPA (6) filter integrity/leakage tests .

Semi-annual air quality evaluation (total particle count) will be performed in accordance with most recent edition of ISO 14644.1 and must include at a minimum the samples specified below.

Semi-annual microbial air and surface sampling will be performed in accordance with the most recent edition of USP 797 and must include the locations listed below. The testing procedures must include controls for each testing media/area.

Oncology Service - Semi-annual certification of the biological safety cabinets. Testing of the biological safety cabinets shall follow current standards set by National Sanitation Foundation (NSF)/ANSI 49, the NSF Certification policies for Biosafety Cabinetry, and manufacturer specification. It will also include air quality evaluation (total particle count), microbial air and surface sampling, dynamic airflow smoke pattern test and a semi-annual HEPA filter integrity/leakage test. Additional details are outlined in subparagraphs 1-4 below.

Semi-annual certification and annual preventative maintenance will be performed on all biological safety cabinets listed below in accordance with all applicable standards at the Milwaukee VA Medical Center. Preventative maintenance will include cleaning, lubrication, checking all alarms for proper function, checking sash integrity, and filter repair (as needed).

Semi-annual certification of rooms used for sterile preparations and must include measurement of air changes per hour, room segregation test, room pressurization test, air quality evaluation (total particle count), microbial air and surface sampling, and room supply air HEPA filter integrity/leakage tests.

Semi-annual air quality evaluation (total particle count) will be performed in accordance with most recent edition of ISO 14644.1 and must include at a minimum the samples specified below.

Semi-annual microbial air and surface sampling will be performed in accordance with the most recent edition of USP 797 and must include the locations listed below. The testing procedures must include controls for each testing media/area.

General requirements

The contractor shall document all certifications performed by placing a certification sticker on the certified equipment immediately after certification. The certification sticker should be in accordance with the most recent edition of NSF/ANSI 49.

The contractor shall document all certifications by providing reports detailing each certification or test performed within 15 business days.

The contractor

shall not be required to go on the roof of the medical center to check or work on the motors for the exhaust during normal testing operations.

The contractor is responsible for providing all contract employees with required personal protective equipment, respiratory protection, and an occupational health program to ensure a safe work environment consistent with current OSHA regulations.

Follow-up/Repeat

Repeat Oncology Service certification. In the event of significant failure during semi-annual certification or damage to or contamination of the Oncology pharmacy, full certification as outlined in paragraph I(d) will be performed again. Re-certification must be completed within 2 weeks of request for services.

Repeat Pharmacy Service certification. In the event of significant failure during semi-annual certification or damage to or contamination of the pharmacy, full certification as outlined in paragraph I(c) will be performed again. Re-certification must be completed within 2 weeks of request for services.

Repeat Particle Counts. Repeat particle counts if values during certification exceed USP 797 limits. After notification that corrective actions have been completed, sampling will be completed within 2 weeks of notification. Not to exceed 2 rooms and 2 hoods semi-annually.

Repeat Microbial Air Samples. Repeat sampling following positive samples. After notification that corrective actions have been completed, sampling will be completed within 2 weeks of notification. Not to exceed 6 samples semi-annually.

Repeat Microbial Surface Samples. Repeat sampling following positive samples. After notification that corrective actions have been completed, sampling will be completed within 2 weeks of notification. Not to exceed 6 samples semi-annually.

Repeat Biohood certification. Performed following acquisition of a new hood, following hood decontamination, or following repairs. Certification will be completed within 2 weeks of request. Not to exceed 2 certifications semi-annually.

Repeat Laminar Flow certification. After notification that corrective actions have been completed, certification will be completed within 2 weeks. Not to exceed 1 certification semi-annually.

Maintenance

Decontaminate Biohood. Biohoods in need of repair or disposal will be decontaminated in accordance with NSF/ANSI 49. Not to exceed 4 decontaminations per year.

Replace Biohood HEPA filter. HEPA filters that cannot be certified or repaired will be replaced. Not to exceed 4 HEPA replacements per year. See tables above for lists of Biohoods on hand.

SERVICE:

Service shall consist of annual (performed in January) and/or semi-annual (performed in January and July) inspections as outlined above and certifications that the equipment is functioning properly according to manufacturer s specifications. The contractor shall provide all labor, materials, travel, supervision, tools, and facilities required for testing and certification of all equipment listed in this contract that the Medical Center.

Contractor shall ensure that the equipment functions in conformance with the latest published edition of applicable standards, such as: NFPA 99, NFPA 101, UL, NSF/ANSI 49, ASHRAE 110, SAFA, ANSI, OSHA, VA, IEST, ISO, USP, CDRH, etc.

The contractor shall provide interim service calls for follow-up/maintenance activities as outlined in paragraphs II and III. Only the Contracting Officer, the Contracting Officer s Representative (COR) or a designated VA representative (Jon Wardecke or Michael Moran) are authorized to call in the contractor for service.

Scheduled Preventive Maintenance work is required in the performance of this contract and shall be performed during the hospital s regular hours of 7:00 a.m. and 3:30 p.m., local time, excluding federal holidays. The contractor shall notify the COR at least 7 days prior to the normal testing/inspection cycle visit. VA may consider allowing work outside of the above-listed hours of operation at the convenience of the Government. The COR is Alex Paul at Telephone Number: (414) 384-2000 ext. 42631; alternate contact is Michael Moran (414) 384-2000, ext. 42933.

Federal Holidays observed by the VAMC(s) are:

New Years Day Labor Day

Martin Luther King Day Columbus Day

Presidents Day Veterans Day

Memorial Day Thanksgiving Day

Juneteenth Christmas Day

Independence Day

REPAIRS:

The Contractor shall inform the COR or designee of repairs needed prior to commencement of work. Only the COR or designee may authorize payment for repairs.

The Contractor shall not leave the premises with any equipment out of service without prior authorization of the COR or designee.

IDENTIFICATION OF CONTRACTOR EMPLOYEES:

All contract personnel attending meetings, answering Government telephones, and working in other situations where their Contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by Contractors are suitably marked as Contractor products or that Contractor participation is appropriately disclosed. VA identification badges are required for all contractor employees working at the VA. Before beginning work on any project, all outside contractors shall obtain a VA contractor identification badge. The Contractor shall complete the badge application and submit it to the COR or designee, who will forward to the Police. The contractor shall stop at the Police ID office after approximately 2 business days to complete the badge application process (including fingerprinting and background checks). The outside contractor will supply the following information: location of work site, authorization, duration, and any pertinent information that is required.

REPORTING REQUIREMENTS:

At the end of each day that service is performed, the contractor shall report to the COR (Alex Paul) or a designated VA representative (Jon Wardecke or Michael Moran) and provide a written list of work completed and report any identified defects and/or repairs that are needed.

All preventative maintenance and other repairs will be done according to the manufacturer s recommendations.

Any authorized repairs/maintenance activities mandate only new standard parts (manufactured by the maker of the equipment) to be furnished by the contractor. All parts shall be of current manufacture and shall have full compatibility with the equipment being repaired. If new parts are not available, the COR must approve the installation of used/refurbished parts prior to work being performed.

Retesting and expansion/reduction of equipment inventory may change based on the needs of the Medical Center. Only those services specified within the contract are authorized under this contract. Before performing any services of a non-contract nature, the COR must be advised of the reasons for these additional services. If appropriate, the Contracting Officer, or his/her designee, may authorize the additional services under separate purchase order.

DOCUMENTATION/REPORTS:

Certification reports shall include full documentation of exactly what service was performed. Each report shall include a unique identification of equipment and all readings and measurements found. In addition, each report shall contain a written comment on the visual condition and use of each cabinet and hood. An identifying certification sticker shall be placed on each unit at the time of inspection indicating status of unit. Reports must include a diagram of the room and location of all measurements/samples collected and pressure gradient (required and measured). All completed reports are due within 15 business days of final on-site inspection.

INVOICES:

The Contractor shall submit all invoices for payment within 30 days after completion of work.

The Contractor shall provide itemized invoices that must include:

Invoice number

Contract PO for the performance year in which the work was done

Date of Service(s)

Building and Room number

Department

Service/repair/replacement performed

Equipment ID/Serial Number

Unit price

Total Cost by line item

Total Cost of invoice

LINE ITEMS: costs must include all charges. No additional charges for travel or per diem are authorized.

CLIN

Paragraph

Description

Cost per item

Total cost

1

I a

Research Service Biohoods

2

I b

PLMS (lab) Biohoods

3

I c

Pharmacy Service

4

I d

Oncology Service

5

II a

Repeat Oncology Service certification

6

II b

Repeat Pharmacy Service certification

7

II c

Repeat Particle Count

8

II d

Repeat Microbial Air Samples

9

II e

Repeat Microbial Surface Samples

10

II f

Repeat Biohood Certification

11

II g

Repeat Laminar Flow Certification

12

III a

Decontaminate Biohood

13

III b

Replace HEPA filter

PERFORMANCE STANDARDS:

All work must be performed by competent technicians, experienced and qualified to work on the listed equipment. At least one Service Technician conducting on-site inspection, testing and certification of equipment, must be currently certified as a Technical Certifier by the National Sanitation Foundation (NSF). The Service Technician conducting all the associated USP 797 testing shall be CETA-CNBT accredited. All work must be performed in accordance with commercial practices. Documentation indicating qualifications (CV, certificates, etc.) must be submitted to the COR, Alex Paul, prior to initiation of any work on station. Documentation indicating Standard Operating Procedures (SOPs) for all required testing must be submitted to the COR, Alex Paul, prior to initiation of any work on station, for approval.

APPROVAL OF CONTRACTOR PERSONNEL:

The VA reserves the right to refuse employment under this contract or require dismissal from contract work of any contractor employee who, by reason of previous unsatisfactory performance at the VA or for any other reasonable reason, is considered by the Contracting Officer s Representative and Contracting Officer to be objectionable.

TEST EQUIPMENT:

Prior to commencement of work on this contract, the contractor shall make available to the VAMC a copy of the current calibration certification of all test equipment which is to be used by the contractor on the 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.

QUALITY ASSURANCE:

This quality assurance has been developed to evaluate contractor performance while implementing this SOW. The quality assurance provides a systematic method to monitor the services the contractor is required to furnish. The plan is as follows:

Inspections completed according to schedule.

All certification reports received within 15 business days of completion of service

All certification stickers applied to equipment immediately after completion of certification process.

SURVEILLANCE:

The COR or designee at the VAMC Milwaukee will evaluate the services provided by the contractor on an ongoing basis.

STANDARD:

The contractor shall perform all work required under the terms of the SOW in a satisfactory manner. The COR shall not consider the work complete until all deficiencies have been corrected.

PROCEDURES:

When a deficiency per the requirements of the SOW exists, it shall be brought to the attention of the COR. The COR or designee will confirm said deficiency by inspection and record results, noting the date and time of inspection of the deficiencies for correction. The contractor shall be given four hours after notification to correct the unacceptable performance or alternate timeframe agreed upon by the COR or a designated VA representative (Jon Wardecke or Michael Moran).

Consultation Calls:

Telephone calls:

During Business Hours, the Contractor shall return all telephone calls within sixty (60) minutes of receipt.

Outside Business Hours, the Contractor shall return all telephone calls within two (2) hours of receipt.

On-site Service Calls: In the event a problem cannot be remedied by a telephone call, the COR or designated VA representative (Jon Wardecke or Michael Moran) will make the decision as to whether an on-site Service Call is needed and notify the Contractor. A Service Call request may be made by telephone, e-mail, or any other means reasonably able to communicate this requirement to the Contractor. The Contractor shall arrive during Business Hours at a scheduled time that is mutually agreeable to both parties.