Attachment 1 - PWS_21 Jun 24.pdf

Attachment 1 – Performance Work Statement

Performance Work Statement

Hazardous Clean Room Testing

21 June 2024

1.0. BACKGROUND: The 88 MDG Pharmacy clean rooms are required by The Joint Commission and Defense Health Agency to comply with 797 USP and 800 USP standards.

The 797/800 USP standards require the clean room to be tested every six months to ensure standards are met. The required tests are USP 797 viable active air samplings, USP 797 viable surface samplings, and USP 797 clean room environmental certifications for hazardous anteroom, hazardous buffer room, non-hazardous anteroom, and non-hazardous buffer room.

2.0. SCOPE: The 88 MDG is a 60-bed hospital with a hematology/oncology infusion center, supporting 55K beneficiaries. The current workload for the clean rooms is approximately 20K sterile intravenous admixtures annually. Sterile preparations required to meet BUDs of at least USP 797 Category 2. There are 3 HEPA Hazardous Mixing, 1 HEPA Ante Hazardous, 1 HEPA Non-Hazardous, 1 HEPA Non-Hazardous Ante room. Test ports are located before each HEPA. The Hoods that require testing are HD cleanroom has: 2x Baker BSC (ISO 5) hoods. Non- HD cleanroom: 1x Panasonic BSC (ISO 5) hood. There is only one pass through located in the hazardous clean room (ISO 7). PECs are covered by our Time and Materials contract. Our Bio-Medical Equipment Technicians schedule all maintenance and certifications.

3.0. REQUIREMENTS: The contractor shall provide the following:

3.1. Certification in USP 797 Viable Active Air Sampling

3.1.1. The technician must have knowledge of how testing should be conducted, if not certified then some other kind of training/knowledge presentation.

3.2. Hazardous USP 797 Viable Active Air Sampling Per Location-TSA Single Plate

Method:

3.2.1.1.Viable active air samples will be collected by using one Tryptic Soy Agar (TSA) plate per sampling location, The default air sample volume to be collected will be 1000 liters per sampling location unless superseded by Customer procedures.

Each sample will be incubated twice, first for 48-72 hours to recover any bacterial growth, then 5 to 7 days for fungal growth. You will receive one preliminary notification of results after the first incubation period. A final report that reflects Colony Forming Unit (CFU) counts and genus level organism identification will be issued upon completion of analysis and technical review.

3.3. Hazardous USP 797 Viable Surface Sampling Per Location-TSA Single Plate Method:

3.3.1. Viable surface samples will be collected by using one Tryptic Soy Agar (TSA) contact plate per sampling location. Each sample will be incubated twice, first for 48-72 hours to recover any bacterial growth, then 5 to 7 days for fungal growth. You will receive one preliminary notification of results after the first incubation period. A final report that reflects Colony Forming

Unit (CFU) counts and genus level organism identification will be issued upon completion of analysis and technical review. Required monthly surface sampling will be completed by the embedded pharmacy team and tested through our embedded lab.

3.4. Hazardous Cleanroom Certification Per Room HAZ anteroom (1U25) / HAZ buffer room (1U26):

3.4.1. Service includes a completed report with the summary of testing performed, including the test criteria, Pass or Fail status, recorded data, and applicable drawings.

3.4.1.1. Testing Included:

3.4.1.2. Room Air Change Calculations (Air Changes Per Hour)

3.4.1.3. Room-to-Room Differential Pressures/Room Pressurization

3.4.1.4. Airborne Particle Count Survey

3.4.1.5. Additional Testing Not Included (Unless specified on this quote):

3.4.1.6. Work Height Velocity (Unidirectional)

3.4.1.7. Airflow Parallelism

3.4.1.8. Airflow Uniformity

3.4.1.9. Airflow Smoke Pattern Tests

3.4.1.10. Room Recovery – any testing needed to bring the room back to confidence, a failed semiannual test or required testing after significate down time, this exact verbiage may not be in 797 but the requirement to retest failed items and test out of cycle following significant room downtime are requirements that need to be available to execute when needed

3.4.1.11. Enclosure Integrity Leak Test

Particle Count Statistical Analysis

3.4.1.12. Lighting and Noise Level Tests

3.5. Non-Hazardous USP 797 Viable Active Air Sampling Per Location-TSA Single Plate Method

3.5.1. Viable active air samples will be collected by using one Tryptic Soy Agar (TSA) plate per sampling location, The default air sample volume to be collected will be 1000 liters per sampling location unless superseded by Customer procedures. Each sample will be incubated twice, first for 48-72 hours to recover any bacterial growth, then 5 to 7 days for fungal growth.

You will receive one preliminary notification of results after the first incubation period. A final report that reflects Colony Forming Unit (CFU) counts and genus level organism identification will be issued upon completion of analysis and technical review. Required monthly surface sampling will be completed by the embedded pharmacy team and tested through our embedded lab.

3.6. Non-Hazardous USP 797 Viable Surface Sampling Per Location-TSA Single Plate Method:

3.6.1. Viable surface samples will be collected by using one Tryptic Soy Agar (TSA) contact plate per sampling location. Each sample will be incubated twice, first for 48-72 hours to recover any bacterial growth, then 5 to 7 days for fungal growth. You will receive one preliminary notification of results after the first incubation period. A final report that reflects Colony Forming Unit (CFU) counts and genus level organism identification will be issued upon completion of analysis and technical review.

3.7. Non-Hazardous Cleanroom Certification Per Room nonHAZ anteroom (1U27) / nonHAZ buffer room (1U28):

3.7.1. Service includes a completed report with the summary of testing performed, including the test criteria, Pass or Fail status, recorded data, and applicable drawings.

3.7.2. Testing Included:

3.7.3. Room Air Change Calculations (Air Changes Per Hour)

3.7.4. Room-to-Room Differential Pressures/Room Pressurization

3.7.5. Airborne Particle Count Survey

3.7.6. Temperature and Humidity (single point)

3.7.7. Additional Testing Not Included (Unless specified on this quote):

3.7.8. Work Height Velocity (Unidirectional)

3.7.9. Airflow Parallelism

3.7.10. Airflow Uniformity

3.7.11. Airflow Smoke Pattern Tests

3.7.12. Room Recovery – any testing needed to bring the room back to confidence, a failed semiannual test or required testing after significate down time, this exact verbiage may not be in 797 but the requirement to retest failed items and test out of cycle following significant room downtime are requirements that need to be available to execute when needed

3.7.13. Enclosure Integrity Leak Test Particle

Count Statistical Analysis

3.7.14. Lighting and Noise Level Tests

4.0. Period of Performance: The Government shall require testing of the facilities as outlined within this Performance Work Statement every 6 months in accordance with USP 797/800 and The Joint Commission (TJC) requirements. The period of May 2024 through April 2025.