Attachment 5 - Statement of Work_36C26226Q0729.pdf

STATEMENT OF WORK

1. CONTRACT TITLE: Preventative Maintenance, Inspection, and Repair Services (PMI&R) for Government-Owned Fume Hood/Safety Cabinets.

2. BACKGROUND: The Long Beach Veterans Affairs Healthcare System (LBVAHCS) requires PMI&R Services for Government-owned fume hood systems throughout the facility. Additional testing and certifications will also be required for these systems.

3. SCOPE OF WORK: The Contractor shall provide all parts, labor, transportation, equipment, supervision, and certified personnel to perform on-site bi-annual and monthly inspections and certifications of Government-owned fume hoods, ventilation devices, biological safety cabinets (BSC), Laminar Flow Devices, isolators, biosafety hazard hoods, sterile workbenches, radiation safety hoods, buffer, ante spaces, and pharmacy clean rooms. Testing/Certification will be done at the manufacturer’s recommended frequency in accordance with the VA Long Beach’s maintenance schedule. Travel expenses for certification inspection(s) will be provided by the Contractor. The Contractor shall be responsible for removing or disposing of Hazmat under the terms and conditions of a full-service contract. All services shall cover the following LBVAHCS’s owned equipment listed in Section 6.

a. Non-Cycle Day Visits: The contractor shall provide a non-cycle day visit.

The contractor shall also perform the two jobs below for Building 164, Room 125 and Building 2, Room 214P:

i. Particle counting (airborne non-viable particle counting) as per USP

797 and ISO14655-1 (1999). The Buffer area will be tested to ISO Class 7 criteria; Ante areas will be tested to ISO Class 8 criteria and the PEC’s will be tested to ISO Class 8 criteria. Testing and report will be completed in accordance with ISO14644-1 (1999) for an “operational occupancy” state, at particle sizes of 0.5 um.

1. Additional test below be performed:

a. HEPA filter integrity challenge

b. Airflow Rate

c. Room air changes 4. Pressure Differential 5. Testing report.

b. The Contractor will collect one airborne sample and one surface sample in each ISO Class 7, and ISO Class 8 location. One airborne sample and one surface sample will be collected in each ISO Class 5.14 compounding personnel with be evaluated for hand hygiene and garbing competency. All work performed by a contractor industrial hygienist will be under the direction of a contractor Certified Industrial Hygienist (CIH). The CIH will review sampling protocol, techniques, and methods performed. The CIH will also review all technical reports related to industrial hygiene report findings and recommendations and co-sign the final report. The Contractor will not perform USP 797 Mediafill testing. Colonies will be quantified and not identified.

4. SERVICES TO BE PROVIDED:

a. Parts:

i. The Contractor will supply, at its own expense, necessary factory-certified equipment manufactured parts, if replacement of the parts is required because of normal wear and tear, or outright failure or as otherwise deemed necessary by the Contractor.

ii. Hardware and software upgrades will be scheduled and performed during normal working hours, at no additional charge to LBVAHCS.

These upgrades are those required for the correct function of the system; not those purchased to enhance function.

b. Labor:

i. The contractor will provide all labor associated with the testing and certification of the equipment covered under the contract agreement. Inadequate or improper certification performed by the contractor will be correctly certified at a time convenient to the VA at no additional expense to the VA. There will be no limitation to the number of labor hours provided within the stipulated timeframes of contract coverage.

c. Response Times: The Contractor will acknowledge requests by telephone for service within 2 hours.

5. DOCUMENTATION: For Preventive Maintenance (PM), The Contractor will provide a PM checklist to LBVAHCS’s Biomedical Engineering, listing each action taken to complete the maintenance.

a. The Contractor will provide individual results which describe services performed (in sufficient detail to be acceptable to the field inspectors of

The Joint Commission). The following information must be provided in each report:

i. Date of service

ii. Summary of problem and action taken

iii. Parts replaced

iv. Labor hours

v. Travel time

vi. Equipment serviced (description, Equipment ID #, serial number, etc.)

vii. Purchase order number

Note: This report must be approved and signed by Biomedical Engineering personnel or their representative. The service report must be provided to Biomedical Engineering within 5 business days of service provided. A copy of each report, email or hardcopy, will be left with Biomedical Engineering. If Biomedical Engineering is not available to receive the service report (outside normal working hours), the service report will be left with the supervising official of the equipment that was serviced; the supervising official will forward the service report to Biomedical Engineering (138M) the next working day.

Note: To ensure proper equipment history documentation, the contractor will forward all preventive maintenance records within 5 working days of completion to Biomedical Engineering.

6. CERTIFICATIONS/TESTING:

a. The Contractor shall have the following certifications: NSF Accredited Biohazard Cabinet Field Certification, ANAB Accredited, ISO/IEC 17025 ANSI/NCSL Z540-1. Service includes two (2) Certifications per year per device. The Contractor will schedule the testing and certification 4560 days in advance with Biomedical Engineering.

b. Testing/Certification will be done at the manufacturer’s recommended frequency in accordance with the VA Long Beach’s maintenance schedule.

Service includes two (2) Certifications per year per device. The Contractor will schedule the testing and certification 45-60 days in advance with Biomedical Engineering. Travel expenses for certification inspection(s) will be provided by the Contractor.

c. It is the sole responsibility of the Contractor to perform all testing and certification. The VA will not assume the responsibility of reminding the

Contractor that a certification is due to be performed. If a Certification is not performed within the month specified, the corresponding amount will be deducted from the contractor’s payments.

7. EQUIPMENT LIST:

a. Biological Safety Cabinet or Transfer Station QTY: 72

b. Fume Hood QTY: 80

c. Isolator QTY: 4

d. Lanimar Flow Devices QTY: 6

e. Pec's Airborne Non-Viable Counting Test QTY: 8

f. Pec's Viable Particle Surface and Air Sampling QTY: 8

g. Non-Viable Testing USP797 (Clean Room, Buffer, Ante) QTY: 4

h. Viable Particle Surface and Air Sampling (Clean Room) QTY: 4

i. Non-Cycle Trip Charge QTY: 2

j. Qualifications: The Contractor shall be engaged full-time in the service and support of the equipment listed in Section 6.

i. The Contractor shall have access to complete service manuals.

ii. The Contractor shall have access to software diagnostic keys.

iii. The Contractor shall, without exception, provide all hand tools, diagnostic test equipment, ladders, and anything else necessary to perform the work.

8. HOURS OF COVERAGE: Normal hours of coverage will be Monday through

Friday from 5am to 5pm PT. All services and repairs will be performed during stipulated hours of coverage unless requested or approved by Biomedical Engineering.

a. Federal Holidays observed by the LBVAHCS are:

New Year’s Day Labor Day Martin Luther King Day Columbus Day President's Day Veterans Day Memorial Day Thanksgiving Day Juneteenth Christmas Day Independence Day

9. PERIOD OF PERFORMANCE: Five-year contract consisting of one base year and four one-year option periods.

10. PLACE OF PERFORMANCE:

Long Beach Veterans Affairs Healthcare System (LBVAHCS)

5901 E. 7th Street

Long Beach, CA 90822

11. CONTRACTOR BADGING: The Contractor will always contact the Biomedical Engineering Section, (562) 826-5977 before and after arrival at the site.

a. Compliance with VA Handbook 0735 – HSPD-12 Program

b. To comply with Department of Veterans Affairs (VA) Handbook 0735, Homeland Security Presidential Directive 12 (HSPD-12) requirements, the Prime Contractor shall coordinate with the Contracting Officer’s Representative (COR) regarding all site visits to the VA Long Beach Healthcare System. Badges are mandatory for all contractors and subcontractors entering the facility.

c. The Prime Contractor is responsible for ensuring that all required information and documentation are submitted to the COR with sufficient lead time to allow for proper processing of badge requests. No contractor or subcontractor may begin work onsite without an approved badge, except under emergency conditions as outlined below.

d. Processing Time :

i. Badge issuance may take up to 30 calendar days due to required background checks. The Prime Contractor must begin coordination with the COR immediately upon contract award to avoid repair, service, or project delays.

e. Onsite Visits for Badging :

i. Contractors should anticipate at least two separate onsite visits:

ii. One visit for fingerprinting.

iii. One visit to pick up the issued badge.

12. REPORTING PROCEDURES:

a. The Contractor must report to the Biomedical Engineering Department (Building 5, Room 138) to sign the visitor logbook. In addition to signing-in, the Contractor personnel shall wear their VA issued badge and identify him/herself to the Using Service before proceeding to the job site.

b. For services to be performed outside normal working hours, the Contractor must obtain approval from the Biomedical Engineering COR prior to performing any after-hours’ work. If the afterhours request is approved, the Contractor must report to the Biomedical Engineering Department (Building 5, Room 138) to sign the visitor logbook and pick up a visitor badge. In addition to signing-in, the Contractor personnel shall identify him/herself to the Using Service before proceeding to the job site.

c. Prior to leaving the facility, the Contractor shall communicate status of equipment to the Using Service and sign out of the logbook in the

d. Biomedical Engineering Department.

13. MADATORY TRAINING: All contractors and subcontractors must complete mandatory training assigned through the VA’s electronic Training Management System (TMS) before badges are issued. This training typically requires approximately two (2) hours to complete. Badge issuance and retention are contingent upon successful completion of this training. Information to be provided by assigned LBVAHCS Biomedical Equipment Technician working with the Contractor for services.

14. EMERGENCY REPAIRS EXCEPTION: In cases where an emergency repair or service is required and the contractor or subcontractor has not yet been issued a permanent LBVAHCS badge, a temporary day badge may be issued by LBVAHCS Police, Building 5 for that emergency only. The Contractor must still ensure that permanent badging is pursued without delay following the emergency event.