Attachment 1 - Statement of Work.docx

DOCX document 24 KB Posted

Attached to
H241--Pharmacy Hood and Area Certification
Solicitation number
36C25926Q0056
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About this file

This is a Statement of Work (SOW) for pharmacy compounding area and hood testing and certification services for the Sheridan VA Medical Center in Wyoming. The contractor will be responsible for performing comprehensive environmental testing and certification, including airflow testing, particle count measurements, smoke studies, pressure measurements, and bacterial/fungal testing for specific areas such as the pharmacy compounding area, buffer and ante rooms, and two specific hoods (Baker EG-6320 and NuAire NU-430-400).

The testing must comply with Controlled Environment Testing Association (CETA) Standards, with certification required every six months for the pharmacy compounding area and annually for the VA Laboratory Bio-Safety hood. Deliverables include detailed certification reports documenting air changes per hour (ACPH) from HVAC and primary engineering controls, hood certification documentation, and service reports to be submitted in PDF format. The work will be performed during standard business hours (8:00am-4:30pm, Monday-Friday) at the Sheridan VAMC, with the contractor also providing 24/7 technical phone support. The testing is critical for maintaining accreditation by the College of American Pathologists (CAP) and The Joint Commission (TJC).

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Other files

File Type Posted
Attachment 3 -SOP 119-15 IV Room Air and Surface Monitoring.pdf PDF
Attachment 1 - Statement of Work - Revised 7 NOV 25.pdf PDF
S06 - 36C25926Q0056 0001.docx DOCX document
Attachment 2 - Questions and Answers.pdf PDF
36C25926Q0056 0001_1.docx DOCX document
36C25926Q0056_1.docx DOCX document
S02 - 36C25926Q0056.docx DOCX document

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Text version

Scope:

The contractor shall provide all personnel, labor, technical support, and equipment for testing and certification (including recertification as needed in the event of certification failure) of the pharmacy compounding area, including the buffer and ante rooms and provide hood certification for the laminar flow hood - Baker EG-6320 S/N 114140 and NuAire Brand, model NU-430-400 hood. Services shall be performed in accordance with (IAW) the most current versions of Controlled Environment Testing Association (CETA) Standards and all personnel performing testing shall have current CETA certification.

Service Frequency and Schedule:

1. The Pharmacy Compounding area requires CETA certification every six months in October and April.

2. The VA Laboratory Bio-Safety hood (NuAire Brand) requires CETA certification every year in October.

Standard Business Hours at the VA Medical Center (VAMC) are between 8:00am and 4:30pm Monday-Friday excluding Federal holidays, except by special alternate arrangement, coordinated and authorized by the VAMC point of contact.

Current Federal Holidays can be found at the OPM website: https://www.opm.gov

Location:

The place of performance is various locations at the Sheridan VAMC, located at 1898 Fort Rd., Sheridan, WY 82801.

Specific Tasks:

Specific tasks the Contractor shall provide include, but are not limited to, the following:

Airflow testing, airflow measurements, airflow balancing, room airflow exchange rate calculations, room segregation smoke tests, room pressurization measurements, room differential pressure measurements, nonviable particle count in dynamic conditions measurements, leak testing of room termination HEPA filters, documentation and verification of room pressure gauge readings, DCA Smoke Studies with Video, Positive and negative plate, bacterial and fungal testing in LAFW Hood 114140, buffer room, and anteroom in dynamic conditions. Provide controls needed. Provide Positive and negative plate, bacterial and fungal testing in area Air Handler. Provide controls needed. Adjusted HVAC system to provide the code required Air Changes Per Hour (ACPH) in each space.

The Contractor shall provide Bio-Safety Cabinet (hood) certification tests for a NuAire Brand, model NU-430-400 hood. Testing shall include Inflow and Downflow air volume measurement tests, Particle Counts, Smoke pattern test, Lighting, Vibration, Noise, and Electrical inspections. Certification testing will also include leak testing of the HEPA filters in the hood. The tests performed shall be for the purpose of maintaining the accreditation of the cabinet/hood processes by CAP (College of American Pathologists) and TJC (the Joint Commission).

The Contractor shall work with VA maintenance staff to ensure mechanical systems are adjusted to perform at required capacities. Additionally, the Contractor shall provide technical support by phone as needed 24 hours per day seven days per week, including holidays.

Deliverables:

The Contractor shall provide a Pharmacy Compounding area Certification report.

1. The certification report must "separately" document the ACPH from HVAC and the ACPH from the primary engineering control (PEC) and then the total ACPH combined for the room.

2. The Contractor shall ensure the HVAC system is adjusted to provide the code required Air Changes Per Hour (ACPH) in each space.

Statement of Work Pharmacy Compounding and Hood Testing and Certification

3. The certification report shall "separately" document the ACPH from HVAC and the ACPH from the primary engineering control (PEC) and then the total ACPH combined for the room.

4. The Contractor shall provide Hood Certification for the Laminar Flow Hood - Baker EG-6320 S/N 114140.

5. The Contractor shall provide a Hood Certification for the NuAire Bio-Safety Hood, model NU- 430-400 in the Sheridan VA Laboratory.

The Contractor shall provide the VA local POC field certification report. Field certification report shall document associated findings and recommendations once the work has been completed and lab results finalized. The Contractor shall email copies of service reports to CO and VA local POC in Adobe PDF format.

Each Service Report shall legibly document the following to be considered complete:

1. Name of Contractor and contract number

2. Contractor Service Report number/log number

3. Description of services performed during the applicable Service period or phase of requirement.

4. Description of any problems during service (if applicable)

5. The final report, signed.

(End of Statement of Work)

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