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InfoCardff: PBMT-GEN-065 Rev. 03 Effective Date: 26 Mar 2019 PEbIATRIC BLOOb AND MARROW TRANSPLANT PROGRAM DOCUMENT NUMBER: PBMT-GEN-065 DOCUMENT TITLE: Environmental Standards - Air Handling System DOCUMENT NOTES: Document Information Revision: 03 Vault: PBMT-General-rel Status: Release Document Type: PBMT Date Information Creation Date: 25 Feb 2019 Release Date: 26 Mar 201 9 Effective Date: 26 Mar 2019 Expiration Date: Control Author: Previous Information MOORE171 Number: PBMT-GEN-065 Rev 02 Owner: Change MOORE171 Number: PBMT-CCR-237 CONFIDENTIAL - Printed by: ACM93 on 26 Mar 2019 08:04:29 am

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Page 1: PEbIATRIC BLOOb AND MARROW TRANSPLANT PROGRAMspitfire.emmes.com/study/duke/SOP/Section B...- Document reformatted into standard SOP formatting, including addition of a purpose statement

InfoCardff: PBMT-GEN-065 Rev. 03 Effective Date: 26 Mar 2019

PEbIATRIC BLOOb AND MARROWTRANSPLANT PROGRAM

DOCUMENT NUMBER: PBMT-GEN-065

DOCUMENT TITLE:Environmental Standards - Air Handling System

DOCUMENT NOTES:

Document Information

Revision: 03 Vault: PBMT-General-rel

Status: Release Document Type: PBMT

Date Information

Creation Date: 25 Feb 2019 Release Date: 26 Mar 201 9

Effective Date: 26 Mar 2019 Expiration Date:

Control

Author:

Previous

Information

MOORE171

Number: PBMT-GEN-065 Rev 02

Owner:

Change

MOORE171

Number: PBMT-CCR-237

CONFIDENTIAL - Printed by: ACM93 on 26 Mar 2019 08:04:29 am

Page 2: PEbIATRIC BLOOb AND MARROW TRANSPLANT PROGRAMspitfire.emmes.com/study/duke/SOP/Section B...- Document reformatted into standard SOP formatting, including addition of a purpose statement

lnfoCard#: PBMT-GEN-065 Rev. 03 Effective Date: 26 Mar 2019

PBMT-GEN-065ENVIRONMENTAL STANDARDS: AIR HANDLING SYSTEM

PURPOSE

1.1 To outline the procedure for the use and maintenance of the Air Handling Systemon the Pediatric Blood and Marrow Transplant (PBMT) Unit.

INTRODUCTION

2.1

2.2

The specialized High Efficiency Particulate Air (HEPA) Filter system is used toremove fine particles from the ah-, reducing the risk of infection in thecompromised host.

Stem cell transplant recipients are at a higher risk of developing respiratory tractinfections from airborne pathogens. HEPA filtration removes sub-micronparticles from the air, reducing the risk of exposure to airborne microbes.

SCOPE AND RESPONSIBILIY

3. 1 Multidisciplinary - Hospital Engineering and Operations (E&O) and Nursing.

3. 2 Maintenance:

3. 2. 1 Duke University Hospital Engineering and Operations are responsiblefor the maintenance of the air handling system on the unit.

3. 3 Nursing Responsibilities:

3. 3. 1 Educate patients and visitors regarding the infection control practices onthe unit.

3. 3.2 Limit all entrance to unit through the front doors.

3. 3. 3 Keep doors to patient rooms closed at all times.

3. 3.4 Maintain sealed windows in all rooms.

3. 3. 5 Keep all exit doors closed unless required for emergencies.

3. 3. 6 Minimize clutter in patient rooms to allow for adequate daily cleaning.

3. 3. 7 Notify Engineering and Operations if there is any disruption in theairflow system.

DEFINITIONS/ACRONYMS

4. 1 E&O Engineering and Operations

High Efficiency Particulate Air

Health Unit Coordinator

Pediatric Blood and Marrow Transplant

4.2

4.3

4.4

HEPA

HUC

PBMT

MATERIALS

5.1 N/A

PBMT-GEN-065 Environmental Standards - Air Handling SystemPBMT, DUMCDurham, NC

CONFIDENTIAL - Printed by: ACM93 on 26 Mar 2019 08:04:29 am

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InfoCardff: PBMT-GEN-065 Rev. 03 Effective Date: 26 Mar 2019

6 EQUIPMENT

6. 1 N/A

7 SAFETY

7. 1 N/A

8 PROCEDURE

8. 1 The entu-e 5200 unit is HEPA filtered, allowing the corridors to act as anterooms.Positive air pressure occurs through a system of fans. Room pressure is createdwhen one space (corridor) is at a different pressure than an adjoining space(patient room). When a pressure differential is created between two spaces, air isforced from the higher-pressure space to the lower pressure space. Each room isequipped with a "ball-in-the-wall" pressure indicator and the ball should be on thecorridor side to indicate positive pressure within the patient's room. The positivepressure gradient of 5200 corridors and the 5200 anteroom to the hospitalcorridors is verified monthly. The positive pressure gradients of patient rooms tothe 5200 corridors are verified quarterly.

8.2 Patient rooms 5201 through 5216 are positively pressurized with respect to thebathrooms and corridors. Corridors, nurse's stations, clean utility rooms, offices,and entry corridor are positively pressurized with respect to the dirty utility room,staff lockers, staff bathrooms, housekeeping closet, and galley. The entire unit ispositively pressurized with respect to the adjacent areas of the hospital in order tominimize the risk of airborne contaminants entering from other areas.

8. 3 Each room has one overhead terminal HEPA filter hood with supply diffuserslocated in the ceiling. The filter hoods include an optional aerosol injectionsystem that allows for a means of conducting filter certification tests withouthaving to access the system from above the ceiling. Particulate testing of 5200HEPA-fiItered air handling system is performed biannually. These supply airfilter systems will be located above the head of the bed and diffused in such a wayas to minimize drafts on the patients. They will sweep au- from the head of thebed toward 2 return registers, one located 12" above the floor on the opposite walland one located in the ceiling near the door to the corridor. Each room ispositively pressurized and will provide greater than 12 air exchanges hourly.

8.4 The anteroom has a balanced pressurized system with respect to the hospitalcorridor. HEPA filtered air will be delivered to the patient room the same as allother patient rooms, and all air will be exhausted through the building infectiousdisease exhaust system.

8. 5 Patient rooms 5209 and 5210 have a shared bathroom. This will accommodate for

one baby room and for one other patient of any age who will use the bathroom. Inorder to maintain adequate air exchanges, the bathroom door that leads to eachpatient room must remain closed.

9 REFERENCES

9. 1 Design Development Report, IES Engineers

PBMT-GEN-065 Environmental Standards - Air Handling SystemPBMT, DUMCDurham, NC

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lnfoCard#: PBMT-GEN-065 Rev. 03 Effective Date: 26 Mar 2019

9. 2 Dykewicz, C. Hospital Infection Control in Hematopoietic Stem Cell TransplantRecipients Emerging Infectious Diseases. March-April 2001

9.3 Guidelines for Preventing Opportunistic Infections in Stem Cell TransplantRecipients. Recommendations ofCDC, the Infectious Disease Society ofAmerica and American Society of Blood and Marrow Transplantation October2000

10 REVISION HISTORY

Revision No.

03

Author

SallyMcCollum

Description of Change(s)- Document reformatted into standard SOP formatting,including addition of a purpose statement and introductionsection.

- New statements added to reflect current testing:The positive pressure gradient of 5200 corridors and the5200 anteroom to the hospital corridors is verifiedmonthly. The positive pressure gradients of patient roomsto the 5200 corridors are verified quarterly. Particulatetesting of 5200 HEPA-filtered air handling system isperformed biannual ly.-Removed information regarding "key switch".

PBMT-GEN-065 Environmental Standards - Air Handling SystemPBMT, DUMCDurham, NC

CONFIDENTIAL - Printed by: ACM93 on 26 Mar 2019 08:04:29 am

Page 3 of 3

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lnfoCard#: PBMT-GEN-065 Rev. 03 Effective Date: 26 Mar 2019

Signature Manifest

Document Number: PBMT-GEN-065

Title: Environmental Standards - Air Handling System

Revision: 03

All dates and times are in Eastern Time.

PBMT-GEN-065 Environmental Standards - Air Handling System

Author

i Name/Signature | Title

Sally McCollum (MOORE171)

Medical Director

Date

08 Mar 2019, 09:06:13 AM

Meaning/Reason

Approved

Jl?.T?^13I]. alu-.re.Joanne Kurtzberg(KURTZ001)

Quality

! Title Date

08 Mar 2019, 09:43:48 AM

i Meaning/Reason

Approved

, Name/Signature

Bing Shen (BS76)

Document Release

Title ! Date08 Mar 2019, 02:47:09 PM

i Meaning/Reason

Approved

Name/Signature

Betsy Jordan (BJ42)

Title Date

12 Mar 2019, 09:09:12 AM

Meaning/Reason

Approved

CONFIDENTIAL - Printed by: ACM93 on 26 Mar 2019 08:04:29 am