HSS Report - PR VA USP 797 Compliance-Nuclear Medicine-20200619.pdf

Health Systems

LLCSCIENCES

REPORT FOR

Nuclear Medicine Microbiological Monitoring for USP 797 Compliance

June 2020 Air and Surface Sampling

Submitted by:

Health Systems Sciences LLC

56342 202nd Street Mankato, MN 56001

June 19, 2020

Table of Contents

EXECUTIVE SUMMARY __________________________________________________ 2

EVALUATION APPROACH ________________________________________________ 2

SAMPLING AND ANALYTICAL METHODOLOGY ___________________________ 2

Sampling Methods _________________________________________________________ 2 Viable Air Sampling Method _______________________________________________ 2 Surface Sampling Method __________________________________________________ 3

Laboratory Analytical Methods _______________________________________________ 3

STANDARDS AND GUIDELINES ___________________________________________ 3

SAMPLING RESULTS _____________________________________________________ 4

Results Overview __________________________________________________________ 4 nuclear medicine Results ____________________________________________________ 4

CONCLUSIONS AND RECOMMENDATIONS ________________________________ 7

APPENDICES _____________________________________________________________ 8

Appendix A – Sampling Diagrams _____________________________________________ 9 Appendix B – Laboratory Analysis Report _____________________________________ 11

Table of Tables Table 1. USP 797 Recommended Action Levels for Air Concentrations Table 2. USP 797 Recommended Action Levels for Surfaces Table 3. Nuclear Medicine Air Sample Results Table 4. Nuclear Medicine Surface Sample Results

EXECUTIVE SUMMARY

Viable air and surface sampling was conducted for the VA Caribbean Healthcare System in San Juan, Puerto Rico on June 1-3, 2020. This survey was conducted to determine the presence and quantity of microbial contamination present in clean rooms located in the Outpatient and Inpatient Pharmacies and the Nuclear Medicine Department. The purpose of the survey was to conduct recertification of the primary and secondary engineering controls to maintain the integrity of the clean rooms.

This report provides the sample results for the locations sampled within the Nuclear Medicine compounding rooms and anteroom. Air and surface samples were collected and testing for fungi and bacteria in accordance with the specifications outline in USP 797, Pharmaceutical Compounding, Sterile Preparations. Laboratory sample result reports and sample location diagrams are provided in the appendix.

All air and surface sample results for the Nuclear Medicine clean room spaces were detected at levels below the action levels.

EVALUATION APPROACH

Air and surface samples were collected at locations identified in collaboration with the VA’s Industrial Hygiene representative and in accordance with the facility USP 797 Sample Plan. Sample locations are provided in Appendix A.

SAMPLING AND ANALYTICAL METHODOLOGY

SAMPLING METHODS

Sampling for the Nuclear Medicine area was conducted on June 1, 2020. Air and surface samples were collected to detect fungal and bacterial organisms. The methodologies for the air and surface sampling and laboratory analysis is described below.

Viable Air Sampling Method Viable air samples were collected using a Buck Bio-Culture Pump Biocontaminate Sampling Pump, Model No. B20120 loaded with nutrient agar media. A flow rate of 100 L/min was used for the air sampling pump. A volume of 1,000 L of air was aspirated through the air sampler for ISO 5 locations and 500 L of air was aspirated through the air sampler for ISO 7 and 8 spaces. To avoid cross-contamination, the interior and exterior sampling head were cleaned with isopropyl alcohol between sampling locations. The equipment was pre- and post-calibrated utilizing a Bio-Culture

Calibrator.

The nutrient agar media was provided by EMLAB P&K in individual 100 x 15 millimeter plates.

Two types of nutrient agar media were utilized to identify culturable fungi and bacteria. Malt extract agar (MEA) was used detect fungi and trypticase soy agar (TSA) was used to detect bacteria Prior to use, the sealed plates were refrigerated. The media was stored in a cooler with ice packs for transport to and from the location to be sampled.

Surface Sampling Method Swabs were used to collect surface samples. The areas swabbed were 30 cm2. Swabs were supplied by EMLab P&K. Each swab was provided in individual tubes containing 1 ml of Phosphate Buffer solution.

LABORATORY ANALYTICAL METHODS

After collection in the field, the samples were transferred following chain-of-custody procedures to

LabEM P&K in Malton, New Jersey. The bacteria samples were incubated at 30°-35° C for 2-3 days and the fungi samples were incubated at 26°-30° C for 5-7 days according to U.S. Pharmacopeia General Chapter 797 guidelines. Following the incubation period all colony forming units are enumerated and identified.

STANDARDS AND GUIDELINES

The following standards and guidelines were referenced for this survey:

1. United States Pharmacopeia (USP), Chapter 797, “Pharmaceutical Compounding, Sterile Preparations”, specifies the monitoring of microbiological concentrations on surfaces and air for sterile pharmaceutical compounding.

USP 797’s recommended actions levels for microbial contamination are provided in the following table:

Table 1. USP 797 Recommended Action Levels for Air Concentrations

USP 797 also specifies recommended actions levels for detected surface contamination which is provided in the following table:

Table 2. USP 797 Recommended Action Levels for Surfaces

2. VA Information Letter 10-2006-008, “Microbiological Assessment of Pharmaceutical Cleanrooms”, also provides recommendations for microbiological assessment of pharmacy cleanrooms and the testing of biocabinets or isolator interiors for VA facilities.

SAMPLING RESULTS

RESULTS OVERVIEW

All sampled locations for the Nuclear Medicine Department resulted in detected levels below the action levels and therefore passed.

Control Samples were also collected and analyzed and are included in the sample reports. The negative control samples did not have any detections. Three of the four positive control samples had detectable quantities of fungal or bacteria. The positive control sample that did not detect growth may have been contributed to improper loading.

NUCLEAR MEDICINE RESULTS

Tables 2 and 3 provide the sample results for the Nuclear Medicine Department. All air and surface sample results were below the action levels.

Table 3. Nuclear Medicine Air Sample Results

Diagram Location

Location Class Fungal Sample Number

Fungal Results (cfu/m3)

Bacterial Sample Number

Bacterial Results (cfu/m3)

Total Microbial Count (cfu/m3)

Highly Dangerous Pathogens

Pass/ Fail

1 Right Isolators in Nuclear Medicine Room A13A 5 NM-AF-1 <1 NM-AB-1 1 1 None Pass

1A Right Isolator Pass-Through Chamber in Nuclear Medicine Room A13A

7 NM-AF-1A <2 NM-AB-1A <2 ND None Pass

2 Left Isolators in Nuclear Medicine Room A13A 5 NM-AF-2 <1 NM-AB-2 <1 ND None Pass 2A Left Isolator Pass-Through Chamber in Nuclear Medicine

Room A13A 7 NM-AF-2A <1 NM-AB-2A <1 ND None Pass

3 Nuclear Medicine Room - By Entrance A13a 7 NM-AF-3 <2 NM-AB-3 <2 ND None Pass 4 Isolator Main Compartment in Nuclear Medicine Room A13b 5 NM-AF-4 <1 NM-AB-4 <1 ND None Pass

4A Isolator Pass-Through Chamber in Nuclear Medicine Room A13b

7 NM-AF-4A <2 NM-AB-4A <2 ND None Pass

5 Nuclear Medicine Room - By Entrance A13b 7 NM-AF-5 2 NM-AB-5 4 6 None Pass

6 Passthrough Anteroom 7 NM-AF-6 2 NM-AB-6 2 4 None Pass

7 Workstation Surface in Anteroom 8 NM-AF-7 2 NM-AB-7 2 4 None Pass

8 Nuclear Medicine Room A13 Anteroom - By Entrance 8 NM-AF-8 <2 NM-AB-8 16 16 None Pass

Table 4. Nuclear Medicine Surface Sample Results

Diagram Location

Location Class Fungal Sample Number

Fungal Results (cfu/m3)

Bacterial Sample Number

Bacterial Results (cfu/m3)

Total Microbial Count (cfu/m3)

Highly Dangerous Pathogens

Pass/ Fail

1 Right Isolators in Nuclear Medicine Room A13A 5 NM-SF-1 ND NM-SB-1 ND ND None pass

1A Right Isolator Pass-Through Chamber in Nuclear Medicine Room A13A

7 NM-SF-1A ND NM-SB-1A ND ND None pass

2 Left Isolators in Nuclear Medicine Room A13A 5 NM-SF-2 ND NM-SB-2 ND ND None pass

2A Left Isolator Pass-Through Chamber in Nuclear Medicine Room A13A

7 NM-SF-2A ND NM-SB-2A ND ND None pass

3 Nuclear Medicine Room A13a: door 7 NM-SF-3 ND NM-SB-3 ND ND None pass

4 Isolator Main Compartment in Nuclear Medicine Room A13b 5 NM-SF-4 ND NM-SB-4 ND ND None pass

4A Isolator Pass-Through Chamber in Nuclear Medicine Room A13b

7 NM-SF-4A ND NM-SB-4A ND ND None pass

5 Nuclear Medicine Room A13b: door 7 NM-SF-5 ND NM-SB-5 1 1 None pass

6 Door to A13A; Anteroom 8 NM-SF-8 ND NM-SB-6 ND ND None pass

7 Workstation Surface in Anteroom by entrance to A13B 8 NM-SF-7 ND NM-SB-7 ND ND None pass

8 Pass Through window between Anteroom and administrative room

7 NM-SF-8 ND NM-SB-8 1 1 None pass

9 Nuclear Medicine Room A13 Anteroom: Touchpad to Exit 8 NM-SF-9 ND NB-SB-9 ND ND None pass

10 Workstation Surface in Anteroom by computer 8 NM-SF-10 ND NM-SB-10 ND ND None pass

11 Door to A13B; Anteroom 8 NM-SF-11 ND NM-SB-11 ND ND None pass

CONCLUSIONS AND RECOMMENDATIONS

The bacterial and fungal sampling conducted for this survey are used to support the specifications outlined within the Environmental Quality and Control section of USP 797. Although USP 797 includes other topics, such as Personnel Training and Quality Control, factors that only pertain to Environmental Quality and Control were evaluated.

Based upon the Environmental Quality and Control criteria, all the Nuclear Medicine Room clean room spaces were within the acceptable ranges for microbial concentrations.

APPENDICES

APPENDIX A - SAMPLING DIAGRAM

APPENDIX B - LABORATORY ANALYSIS REPORT

APPENDIX A – SAMPLING DIAGRAMS

Figure 1. Air Sample Locations Diagram

Figure 2. Surface Sample Locations Diagram

APPENDIX B – LABORATORY ANALYSIS REPORT

Approved by:

Technical Manager Ariunaa Jalsrai

Report for:

David Ausdemore Health Systems Sciences 56342 202nd St Mankato, MN 56001

Regarding: Project: 20200601; PR VA USP 797 Nuclear Medicine Sampling

EML ID: 2418617

All samples were received in acceptable condition unless noted in the Report Comments portion in the body of the report. Due to the nature of the analyses performed, field blank correction of results is not applied. The results relate only to the samples as received. Sample air volume is supplied by the client.

Eurofins EMLab P&K ("the Company") shall have no liability to the client or the client's customer with respect to decisions or recommendations made, actions taken or courses of conduct implemented by either the client or the client's customer as a result of or based upon the Test Results. In no event shall the Company be liable to the client with respect to the Test Results except for the Company's own willful misconduct or gross negligence nor shall the Company be liable for incidental or consequential damages or lost profits or revenues to the fullest extent such liability may be disclaimed by law, even if the Company has been advised of the possibility of such damages, lost profits or lost revenues. In no event shall the Company's liability with respect to the Test Results exceed the amount paid to the Company by the client therefor.

Service SOPs: USP 797 Count & ID 26-30C (EM-USP-S-2082, EM-USP-S-2081, EM-BT-S-1576), USP 797 Count & ID 30-35C

(EM-USP-S-2082, EM-USP-S-2081, EM-BT-S-1576)

EMLab ID: 2418617, Page 1 of 16EMLab P&K, LLC

Eurofins EMLab P&K 3000 Lincoln Drive East, Suite A, Marlton, NJ 08053

(866) 871-1984 Fax (856) 334-1040 www.emlab.comClient: Health Systems Sciences C/O: David Ausdemore Re: 20200601; PR VA USP 797 Nuclear Medicine Sampling

Date of Sampling: 06-01-2020 Date of Receipt: 06-09-2020 Date of Report: 06-18-2020

USP 797 - Detail Sample Analysis Results

Location: NM-AF-1:Right Isolators in

Nuclear Medicine Room

A13A

NM-AB-1:Right Isolators in

Nuclear Medicine Room

A13A

NM-AF-2:Left Isolators in

Nuclear Medicine Room

A13A

NM-AB-2:Left Isolators in

Nuclear Medicine Room

A13A Comments (see below) None A None B Area Designation ISO Class 5 ISO Class 5 ISO Class 5 ISO Class 5 Sample type SAS sample SAS sample SAS sample SAS sample Media used MEA TSA MEA TSA Lot#/Expiration date 457471P/6-7-2020 459444/7-27-2020 457471P/6-7-2020 459444/7-27-2020 Lab ID-Version‡: 11534057-1 11534058-1 11534059-1 11534060-1 Analysis Date 6-16-2020 6-11-2020 6-16-2020 6-11-2020 Incubation 26º - 30ºC for 5-7 days 30º - 35ºC for 2-3 days

26º - 30ºC for 5-7 days

30º - 35ºC for 2-3 days raw ct. cfu*/m3 raw ct. cfu*/m3 raw ct. cfu*/m3 raw ct. cfu*/m3

BACTERIA

Staphylococcus Coagulase (-) 1 1 1 1 §Total ND < 1 1 1 ND < 1 1 1 Sample size 1000 liter 1000 liter 1000 liter 1000 liter Positive Hole 380 380 380 380

*cfu = colony forming units Positive hole correction chart used for all calculations ND = none detected Comments: A) Growth originating from edge of plate suggesting contamination. Result may be affected. Culture media was shrunken upon receipt. B) Culture media was shrunken upon receipt.

EMLab ID: 2418617, Page 2 of 16EMLab P&K, LLC

Identifiers listed without a count or data entry were not detected during the course of the analysis for the respective sample.

Note: Interpretation is left to the company and/or persons who conducted the field work. Some rare strains of Staphylococcus produce free (unbound) coagulase exclusively. The applied coagulase test only measures bound coagulase.

The limit of detection is a raw count of 1. The analytical sensitivity for air samples is equal to 1 raw count divided by sample size and multiplied by the positive hole correction factor. The analytical sensitivity for surface samples is equal to 1 raw count divided by a sample size of 1 plate.

‡ A "Version" indicated by -"x" after the Lab ID# with a value greater than 1 indicates a sample with amended data. The revision number is reflected by the value of "x".

§ Total cfu/unit has been rounded to two significant figures to reflect analytical precision.

(866) 871-1984 Fax (856) 334-1040 www.emlab.comClient: Health Systems Sciences C/O: David Ausdemore Re: 20200601; PR VA USP 797 Nuclear Medicine Sampling

Date of Sampling: 06-01-2020 Date of Receipt: 06-09-2020 Date of Report: 06-18-2020

USP 797 - Detail Sample Analysis Results

Location: NM-AF-3:

Nuclear

Medicine Room - By Entrance

A13a

NM-AB-3:

Nuclear

Medicine Room - By Entrance

A13a

NM-AF-4:

Isolator in Nuclear

Medicine Room A13b

NM-AB-4:

Isolator in Nuclear

Medicine Room A13b

Comments (see below) None A None B Area Designation ISO Class 7 ISO Class 7 ISO Class 5 ISO Class 5 Sample type SAS sample SAS sample SAS sample SAS sample Media used MEA TSA MEA TSA Lot#/Expiration date 457471P/6-7-2020 459444/7-27-2020 457471P/6-7-2020 459444/7-27-2020 Lab ID-Version‡: 11534061-1 11534062-1 11534063-1 11534064-1 Analysis Date 6-16-2020 6-11-2020 6-16-2020 6-11-2020 Incubation 26º - 30ºC for 5-7 days 30º - 35ºC for 2-3 days

26º - 30ºC for 5-7 days

30º - 35ºC for 2-3 days raw ct. cfu*/m3 raw ct. cfu*/m3 raw ct. cfu*/m3 raw ct. cfu*/m3

BACTERIA

Bacillus 1 2 Staphylococcus Coagulase (-) 3 6 §Total ND < 2 4 8 ND < 1 ND < 1 Sample size 500 liter 500 liter 1000 liter 1000 liter Positive Hole 380 380 380 380

*cfu = colony forming units Positive hole correction chart used for all calculations ND = none detected Comments: A) Growth originating from edge of plate suggesting contamination. Result may be affected. Culture plate received cracked/ damaged. B) Culture plate received cracked/damaged.

EMLab ID: 2418617, Page 3 of 16EMLab P&K, LLC

Identifiers listed without a count or data entry were not detected during the course of the analysis for the respective sample.

Note: Interpretation is left to the company and/or persons who conducted the field work. Some rare strains of Staphylococcus produce free (unbound) coagulase exclusively. The applied coagulase test only measures bound coagulase.

The limit of detection is a raw count of 1. The analytical sensitivity for air samples is equal to 1 raw count divided by sample size and multiplied by the positive hole correction factor. The analytical sensitivity for surface samples is equal to 1 raw count divided by a sample size of 1 plate.

‡ A "Version" indicated by -"x" after the Lab ID# with a value greater than 1 indicates a sample with amended data. The revision number is

(866) 871-1984 Fax (856) 334-1040 www.emlab.comClient: Health Systems Sciences C/O: David Ausdemore Re: 20200601; PR VA USP 797 Nuclear Medicine Sampling

Date of Sampling: 06-01-2020 Date of Receipt: 06-09-2020 Date of Report: 06-18-2020

USP 797 - Detail Sample Analysis Results

Location: NM-AF-5:

Nuclear

Medicine Room - By Entrance

A13b

NM-AB-5:

Nuclear

Medicine Room - By Entrance

A13b

NM-AF-6:

Passthrough

Anteroom

NM-AB-6:

Passthrough

Anteroom

Comments (see below) None None None None Area Designation ISO Class 7 ISO Class 7 ISO Class 7 ISO Class 7 Sample type SAS sample SAS sample SAS sample SAS sample Media used MEA TSA MEA TSA Lot#/Expiration date 457471P/6-7-2020 459444/7-27-2020 457471P/6-7-2020 459444/7-27-2020 Lab ID-Version‡: 11534065-1 11534066-1 11534067-1 11534068-1 Analysis Date 6-16-2020 6-11-2020 6-16-2020 6-11-2020 Incubation 26º - 30ºC for 5-7 days 30º - 35ºC for 2-3 days

26º - 30ºC for 5-7 days

30º - 35ºC for 2-3 days raw ct. cfu*/m3 raw ct. cfu*/m3 raw ct. cfu*/m3 raw ct. cfu*/m3

BACTERIA

Micrococcus 2 4 Staphylococcus Coagulase (-) 1 2

FUNGI

Basidiomycetes 1 2 1 2 §Total 1 2 2 4 1 2 1 2 Sample size 500 liter 500 liter 500 liter 500 liter Positive Hole 380 380 380 380

*cfu = colony forming units Positive hole correction chart used for all calculations ND = none detected Comments:

EMLab ID: 2418617, Page 4 of 16EMLab P&K, LLC

Identifiers listed without a count or data entry were not detected during the course of the analysis for the respective sample.

Note: Interpretation is left to the company and/or persons who conducted the field work. Some rare strains of Staphylococcus produce free (unbound) coagulase exclusively. The applied coagulase test only measures bound coagulase.

The limit of detection is a raw count of 1. The analytical sensitivity for air samples is equal to 1 raw count divided by sample size and multiplied by the positive hole correction factor. The analytical sensitivity for surface samples is equal to 1 raw count divided by a sample size of 1 plate.

‡ A "Version" indicated by -"x" after the Lab ID# with a value greater than 1 indicates a sample with amended data. The revision number is

(866) 871-1984 Fax (856) 334-1040 www.emlab.comClient: Health Systems Sciences C/O: David Ausdemore Re: 20200601; PR VA USP 797 Nuclear Medicine Sampling

Date of Sampling: 06-01-2020 Date of Receipt: 06-09-2020 Date of Report: 06-18-2020

USP 797 - Detail Sample Analysis Results

Location: NM-AF-7:

Nuclear

Medicine Room A13 Anteroom -

At Computer Workstation

NM-AB-7:

Nuclear

Medicine Room A13 Anteroom -

At Computer Workstation

NM-AF-8:

Nuclear

Medicine Room A13 Anteroom -

By Entrance

NM-AB-8:

Nuclear

Medicine Room A13 Anteroom -

By Entrance

Comments (see below) None None None None Area Designation ISO Class 8 ISO Class 8 ISO Class 8 ISO Class 8 Sample type SAS sample SAS sample SAS sample SAS sample Media used MEA TSA MEA TSA Lot#/Expiration date 457471P/6-7-2020 459444/7-27-2020 457471P/6-7-2020 459444/7-27-2020 Lab ID-Version‡: 11534069-1 11534070-1 11534071-1 11534072-1 Analysis Date 6-16-2020 6-11-2020 6-16-2020 6-11-2020 Incubation 26º - 30ºC for 5-7 days 30º - 35ºC for 2-3 days

26º - 30ºC for 5-7 days

30º - 35ºC for 2-3 days raw ct. cfu*/m3 raw ct. cfu*/m3 raw ct. cfu*/m3 raw ct. cfu*/m3

BACTERIA

Micrococcus 1 2 2 4 Staphylococcus Coagulase (-) 6 12

FUNGI

Basidiomycetes 1 2 §Total 1 2 1 2 ND < 2 8 16 Sample size 500 liter 500 liter 500 liter 500 liter Positive Hole 380 380 380 380

*cfu = colony forming units Positive hole correction chart used for all calculations ND = none detected Comments:

EMLab ID: 2418617, Page 5 of 16EMLab P&K, LLC

Identifiers listed without a count or data entry were not detected during the course of the analysis for the respective sample.

Note: Interpretation is left to the company and/or persons who conducted the field work. Some rare strains of Staphylococcus produce free (unbound) coagulase exclusively. The applied coagulase test only measures bound coagulase.

The limit of detection is a raw count of 1. The analytical sensitivity for air samples is equal to 1 raw count divided by sample size and multiplied by the positive hole correction factor. The analytical sensitivity for surface samples is equal to 1 raw count divided by a sample size of 1 plate.

‡ A "Version" indicated by -"x" after the Lab ID# with a value greater than 1 indicates a sample with amended data. The revision number is

(866) 871-1984 Fax (856) 334-1040 www.emlab.comClient: Health Systems Sciences C/O: David Ausdemore Re: 20200601; PR VA USP 797 Nuclear Medicine Sampling

Date of Sampling: 06-01-2020 Date of Receipt: 06-09-2020 Date of Report: 06-18-2020

USP 797 - Detail Sample Analysis Results

Location: NM-AF-C1:

Control 1

NM-AB-C1:

Control 2

NM-AF-C2:

Control 1

NM-AB-C2:

Control 2

Comments (see below) None A None B Area Designation None None None None Sample type SAS sample SAS sample SAS sample SAS sample Media used MEA TSA MEA TSA Lot#/Expiration date 457471P/6-7-2020 459444/7-27-2020 457471P/6-7-2020 459444/7-27-2020 Lab ID-Version‡: 11534073-1 11534074-1 11534075-1 11534076-1 Analysis Date 6-16-2020 6-11-2020 6-16-2020 6-11-2020 Incubation 26º - 30ºC for 5-7 days 30º - 35ºC for 2-3 days

26º - 30ºC for 5-7 days

30º - 35ºC for 2-3 days raw ct. cfu*/m3 raw ct. cfu*/m3 raw ct. cfu*/m3 raw ct. cfu*/m3

BACTERIA

Bacillus 4 N/A Gram-positive rods 57 N/A

FUNGI

Yeasts 8 N/A §Total ND N/A ND N/A 8 N/A 61 N/A Sample size 0 liter 0 liter 0 liter 0 liter Positive Hole 0 0 0 0

*cfu = colony forming units Positive hole correction chart used for all calculations ND = none detected Comments: A) Culture media was shrunken upon receipt. B) Growth originating from edge of plate suggesting contamination. Result may be affected. Culture media was shrunken upon receipt.

EMLab ID: 2418617, Page 6 of 16EMLab P&K, LLC

Identifiers listed without a count or data entry were not detected during the course of the analysis for the respective sample.

Note: Interpretation is left to the company and/or persons who conducted the field work. Some rare strains of Staphylococcus produce free (unbound) coagulase exclusively. The applied coagulase test only measures bound coagulase.

The limit of detection is a raw count of 1. The analytical sensitivity for air samples is equal to 1 raw count divided by sample size and multiplied by the positive hole correction factor. The analytical sensitivity for surface samples is equal to 1 raw count divided by a sample size of 1 plate.

‡ A "Version" indicated by -"x" after the Lab ID# with a value greater than 1 indicates a sample with amended data. The revision number is

(866) 871-1984 Fax (856) 334-1040 www.emlab.comClient: Health Systems Sciences C/O: David Ausdemore Re: 20200601; PR VA USP 797 Nuclear Medicine Sampling

Date of Sampling: 06-01-2020 Date of Receipt: 06-09-2020 Date of Report: 06-18-2020

USP 797 - Detail Sample Analysis Results

Location: NM-AF-1A:

Right Isolators in Nuclear Medicine Room

A13A-Entry Compartment

NM-AB-1A:

Right Isolators in Nuclear Medicine RooRight

Isolators in Nuclear

Medicine Room A13A-Entry

Compartmentm A13A

NM-AF-2A:Left Isolators in

Nuclear Medicine Room

A13A-Entry Compartment

NM-AB-2A:Left Isolators in

Nuclear Medicine Room

A13A-Entry Compartment

Comments (see below) None None None A Area Designation ISO Class 7 ISO Class 7 ISO Class 7 ISO Class 7 Sample type SAS sample SAS sample SAS sample SAS sample Media used MEA TSA MEA TSA Lot#/Expiration date 457471P/6-7-2020 459444/7-27-2020 457471P/6-7-2020 459444/7-27-2020 Lab ID-Version‡: 11534077-1 11534078-1 11534079-1 11534080-1 Analysis Date 6-16-2020 6-11-2020 6-16-2020 6-11-2020 Incubation 26º - 30ºC for 5-7 days 30º - 35ºC for 2-3 days

26º - 30ºC for 5-7 days

30º - 35ºC for 2-3 days raw ct. cfu*/m3 raw ct. cfu*/m3 raw ct. cfu*/m3 raw ct. cfu*/m3 §Total ND < 2 ND < 2 ND < 2 ND < 2 Sample size 500 liter 500 liter 500 liter 500 liter Positive Hole 380 380 380 380

*cfu = colony forming units Positive hole correction chart used for all calculations ND = none detected Comments: A) Culture plate received cracked/damaged.

EMLab ID: 2418617, Page 7 of 16EMLab P&K, LLC

Identifiers listed without a count or data entry were not detected during the course of the analysis for the respective sample.

Note: Interpretation is left to the company and/or persons who conducted the field work. Some rare strains of Staphylococcus produce free (unbound) coagulase exclusively. The applied coagulase test only measures bound coagulase.

The limit of detection is a raw count of 1. The analytical sensitivity for air samples is equal to 1 raw count divided by sample size and multiplied by the positive hole correction factor. The analytical sensitivity for surface samples is equal to 1 raw count divided by a sample size of 1 plate.

‡ A "Version" indicated by -"x" after the Lab ID# with a value greater than 1 indicates a sample with amended data. The revision number is

(866) 871-1984 Fax (856) 334-1040 www.emlab.comClient: Health Systems Sciences C/O: David Ausdemore Re: 20200601; PR VA USP 797 Nuclear Medicine Sampling

Date of Sampling: 06-01-2020 Date of Receipt: 06-09-2020 Date of Report: 06-18-2020

USP 797 - Detail Sample Analysis Results

Location: NM-AF-4A:Isolator in Nuclear Medicine Room A13b-Entry

Compartment

NM-AB-4A:Isolator in Nuclear Medicine Room A13b-Entry

Compartment Comments (see below) None None Area Designation ISO Class 7 ISO Class 7 Sample type SAS sample SAS sample Media used MEA TSA Lot#/Expiration date 457471P/6-7-2020 459444/7-27-2020 Lab ID-Version‡: 11534081-1 11534082-1 Analysis Date 6-16-2020 6-11-2020 Incubation 26º - 30ºC for 5-7 days 30º - 35ºC for 2-3 days raw ct. cfu*/m3 raw ct. cfu*/m3 §Total ND < 2 ND < 2 Sample size 500 liter 500 liter Positive Hole 380 380

*cfu = colony forming units Positive hole correction chart used for all calculations ND = none detected Comments:

EMLab ID: 2418617, Page 8 of 16EMLab P&K, LLC

Identifiers listed without a count or data entry were not detected during the course of the analysis for the respective sample.

Note: Interpretation is left to the company and/or persons who conducted the field work. Some rare strains of Staphylococcus produce free (unbound) coagulase exclusively. The applied coagulase test only measures bound coagulase.

The limit of detection is a raw count of 1. The analytical sensitivity for air samples is equal to 1 raw count divided by sample size and multiplied by the positive hole correction factor. The analytical sensitivity for surface samples is equal to 1 raw count divided by a sample size of 1 plate.

‡ A "Version" indicated by -"x" after the Lab ID# with a value greater than 1 indicates a sample with amended data. The revision number is

(866) 871-1984 Fax (856) 334-1040 www.emlab.comClient: Health Systems Sciences C/O: David Ausdemore Re: 20200601; PR VA USP 797 Nuclear Medicine Sampling

Date of Sampling: 06-01-2020 Date of Receipt: 06-09-2020 Date of Report: 06-18-2020

USP 797 - Detail Sample Analysis Results

Location: NM-SF-2:Left Isolator in Nuclear

Medicine Room A13a

NM-SB-2:Left Isolator in Nuclear

Medicine Room A13a

NM-SF-1:Right Isolator in Nuclear

Medicine Room A13a

NM-SB-1:Right Isolator in Nuclear

Medicine Room A13a

Comments (see below) None None None None Area Designation ISO Class 5 ISO Class 5 ISO Class 5 ISO Class 5 Sample type Swab sample Swab sample Swab sample Swab sample Media used MEA TSA w/ Lecithin & Tween MEA TSA w/ Lecithin & Tween

Lot#/Expiration date 128924/6-23-2020 129742/8-16-2020 128924/6-23-2020 129742/8-16-2020 Lab ID-Version‡: 11534083-1 11534084-1 11534085-1 11534086-1 Analysis Date 6-16-2020 6-11-2020 6-16-2020 6-11-2020 Incubation 26º - 30ºC for 5-7 days 30º - 35ºC for 2-3 days

26º - 30ºC for 5-7 days

30º - 35ºC for 2-3 days raw ct. cfu*/plate raw ct. cfu*/plate raw ct. cfu*/plate raw ct. cfu*/plate §Total ND ND ND ND ND ND ND ND

*cfu = colony forming units ND = none detected Comments:

EMLab ID: 2418617, Page 9 of 16EMLab P&K, LLC

Identifiers listed without a count or data entry were not detected during the course of the analysis for the respective sample.

Note: Interpretation is left to the company and/or persons who conducted the field work. Some rare strains of Staphylococcus produce free (unbound) coagulase exclusively. The applied coagulase test only measures bound coagulase.

The limit of detection is a raw count of 1. The analytical sensitivity for air samples is equal to 1 raw count divided by sample size and multiplied by the positive hole correction factor. The analytical sensitivity for surface samples is equal to 1 raw count divided by a sample size of 1 plate.

‡ A "Version" indicated by -"x" after the Lab ID# with a value greater than 1 indicates a sample with amended data. The revision number is

(866) 871-1984 Fax (856) 334-1040 www.emlab.comClient: Health Systems Sciences C/O: David Ausdemore Re: 20200601; PR VA USP 797 Nuclear Medicine Sampling

Date of Sampling: 06-01-2020 Date of Receipt: 06-09-2020 Date of Report: 06-18-2020

USP 797 - Detail Sample Analysis Results

Location: NM-SF-4:

Isolator in Nuclear

Medicine Room A13b

NM-SB-4:

Isolator in Nuclear

Medicine Room A13b

NM-SF-3:

Nuclear

Medicine Room A13a: door

NM-SB-3:

Nuclear

Medicine Room A13a: door

Comments (see below) None None None None Area Designation ISO Class 5 ISO Class 5 ISO Class 7 ISO Class 7 Sample type Swab sample Swab sample Swab sample Swab sample Media used MEA TSA w/ Lecithin & Tween MEA TSA w/ Lecithin & Tween

Lot#/Expiration date 128924/6-23-2020 129742/8-16-2020 128924/6-23-2020 129742/8-16-2020 Lab ID-Version‡: 11534087-1 11534088-1 11534089-1 11534090-1 Analysis Date 6-16-2020 6-11-2020 6-16-2020 6-11-2020 Incubation 26º - 30ºC for 5-7 days 30º - 35ºC for 2-3 days

26º - 30ºC for 5-7 days

30º - 35ºC for 2-3 days raw ct. cfu*/plate raw ct. cfu*/plate raw ct. cfu*/plate raw ct. cfu*/plate §Total ND ND ND ND ND ND ND ND

*cfu = colony forming units ND = none detected Comments:

EMLab ID: 2418617, Page 10 of 16EMLab P&K, LLC

Identifiers listed without a count or data entry were not detected during the course of the analysis for the respective sample.

Note: Interpretation is left to the company and/or persons who conducted the field work. Some rare strains of Staphylococcus produce free (unbound) coagulase exclusively. The applied coagulase test only measures bound coagulase.

The limit of detection is a raw count of 1. The analytical sensitivity for air samples is equal to 1 raw count divided by sample size and multiplied by the positive hole correction factor. The analytical sensitivity for surface samples is equal to 1 raw count divided by a sample size of 1 plate.

‡ A "Version" indicated by -"x" after the Lab ID# with a value greater than 1 indicates a sample with amended data. The revision number is

(866) 871-1984 Fax (856) 334-1040 www.emlab.comClient: Health Systems Sciences C/O: David Ausdemore Re: 20200601; PR VA USP 797 Nuclear Medicine Sampling

Date of Sampling: 06-01-2020 Date of Receipt: 06-09-2020 Date of Report: 06-18-2020

USP 797 - Detail Sample Analysis Results

Location: NM-SF-5:

Nuclear

Medicine Room A13b: door

NM-SB-5:

Nuclear

Medicine Room A13b: door

NM-SF-6:

Anteroom Door to A13A

NM-SB-6:

Anteroom Door to A13A

Comments (see below) None A None None Area Designation ISO Class 7 ISO Class 7 ISO Class 8 ISO Class 8 Sample type Swab sample Swab sample Swab sample Swab sample Media used MEA TSA w/ Lecithin & Tween MEA TSA w/ Lecithin & Tween

Lot#/Expiration date 128924/6-23-2020 129742/8-16-2020 128924/6-23-2020 129742/8-16-2020 Lab ID-Version‡: 11534091-1 11534092-1 11534093-1 11534094-1 Analysis Date 6-16-2020 6-11-2020 6-16-2020 6-11-2020 Incubation 26º - 30ºC for 5-7 days 30º - 35ºC for 2-3 days

26º - 30ºC for 5-7 days

30º - 35ºC for 2-3 days raw ct. cfu*/plate raw ct. cfu*/plate raw ct. cfu*/plate raw ct. cfu*/plate

BACTERIA

Bacillus 1 1 §Total ND ND 1 1 ND ND ND ND

*cfu = colony forming units ND = none detected Comments: A) Spreading bacterial colonies present. Results may be affected.

EMLab ID: 2418617, Page 11 of 16EMLab P&K, LLC

Identifiers listed without a count or data entry were not detected during the course of the analysis for the respective sample.

Note: Interpretation is left to the company and/or persons who conducted the field work. Some rare strains of Staphylococcus produce free (unbound) coagulase exclusively. The applied coagulase test only measures bound coagulase.

The limit of detection is a raw count of 1. The analytical sensitivity for air samples is equal to 1 raw count divided by sample size and multiplied by the positive hole correction factor. The analytical sensitivity for surface samples is equal to 1 raw count divided by a sample size of 1 plate.

‡ A "Version" indicated by -"x" after the Lab ID# with a value greater than 1 indicates a sample with amended data. The revision number is

(866) 871-1984 Fax (856) 334-1040 www.emlab.comClient: Health Systems Sciences C/O: David Ausdemore Re: 20200601; PR VA USP 797 Nuclear Medicine Sampling

Date of Sampling: 06-01-2020 Date of Receipt: 06-09-2020 Date of Report: 06-18-2020

USP 797 - Detail Sample Analysis Results

Location: NM-SF-7:

Nuclear

Medicine Room A13 Anteroom:

work surface by

A13B Door

NM-SB-7:

Nuclear

Medicine Room A13 Anteroom:

work surface by

A13B Door

NM-SF-8:Pass Through window between Anteroom and administrative room

NM-SB-8:Pass Through window between Anteroom and administrative room

Comments (see below) None None None None Area Designation ISO Class 8 ISO Class 8 ISO Class 7 ISO Class 7 Sample type Swab sample Swab sample Swab sample Swab sample Media used MEA TSA w/ Lecithin & Tween MEA TSA w/ Lecithin & Tween

Lot#/Expiration date 128924/6-23-2020 129742/8-16-2020 128924/6-23-2020 129742/8-16-2020 Lab ID-Version‡: 11534095-1 11534096-1 11534097-1 11534098-1 Analysis Date 6-16-2020 6-11-2020 6-16-2020 6-11-2020 Incubation 26º - 30ºC for 5-7 days 30º - 35ºC for 2-3 days

26º - 30ºC for 5-7 days

30º - 35ºC for 2-3 days raw ct. cfu*/plate raw ct. cfu*/plate raw ct. cfu*/plate raw ct. cfu*/plate

BACTERIA

Staphylococcus Coagulase (-) 1 1 §Total ND ND ND ND ND ND 1 1

*cfu = colony forming units ND = none detected Comments:

EMLab ID: 2418617, Page 12 of 16EMLab P&K, LLC

Identifiers listed without a count or data entry were not detected during the course of the analysis for the respective sample.

Note: Interpretation is left to the company and/or persons who conducted the field work. Some rare strains of Staphylococcus produce free (unbound) coagulase exclusively. The applied coagulase test only measures bound coagulase.

The limit of detection is a raw count of 1. The analytical sensitivity for air samples is equal to 1 raw count divided by sample size and multiplied by the positive hole correction factor. The analytical sensitivity for surface samples is equal to 1 raw count divided by a sample size of 1 plate.

‡ A "Version" indicated by -"x" after the Lab ID# with a value greater than 1 indicates a sample with amended data. The revision number is

(866) 871-1984 Fax (856) 334-1040 www.emlab.comClient: Health Systems Sciences C/O: David Ausdemore Re: 20200601; PR VA USP 797 Nuclear Medicine Sampling

Date of Sampling: 06-01-2020 Date of Receipt: 06-09-2020 Date of Report: 06-18-2020

USP 797 - Detail Sample Analysis Results

Location: NM-SF-9:Nuclear Medicine Room A13 Anteroom:

Touchpad to Exit

NM-SB-9:Nuclear Medicine Room A13 Anteroom:

Touchpad to Exit

NM-SF-10:

Nuclear

Medicine Room A13 Anteroom:

work surface

NM-SB-10:

Nuclear

Medicine Room A13 Anteroom:

work surface Comments (see below) None None None None Area Designation ISO Class 8 ISO Class 8 ISO Class 8 ISO Class 8 Sample type Swab sample Swab sample Swab sample Swab sample Media used MEA TSA w/ Lecithin & Tween MEA TSA w/ Lecithin & Tween

Lot#/Expiration date 128924/6-23-2020 129742/8-16-2020 128924/6-23-2020 129742/8-16-2020 Lab ID-Version‡: 11534099-1 11534100-1 11534101-1 11534102-1 Analysis Date 6-16-2020 6-11-2020 6-16-2020 6-11-2020 Incubation 26º - 30ºC for 5-7 days 30º - 35ºC for 2-3 days

26º - 30ºC for 5-7 days

30º - 35ºC for 2-3 days raw ct. cfu*/plate raw ct. cfu*/plate raw ct. cfu*/plate raw ct. cfu*/plate §Total ND ND ND ND ND ND ND ND

*cfu = colony forming units ND = none detected Comments:

EMLab ID: 2418617, Page 13 of 16EMLab P&K, LLC

Identifiers listed without a count or data entry were not detected during the course of the analysis for the respective sample.

Note: Interpretation is left to the company and/or persons who conducted the field work. Some rare strains of Staphylococcus produce free (unbound) coagulase exclusively. The applied coagulase test only measures bound coagulase.

The limit of detection is a raw count of 1. The analytical sensitivity for air samples is equal to 1 raw count divided by sample size and multiplied by the positive hole correction factor. The analytical sensitivity for surface samples is equal to 1 raw count divided by a sample size of 1 plate.

‡ A "Version" indicated by -"x" after the Lab ID# with a value greater than 1 indicates a sample with amended data. The revision number is

(866) 871-1984 Fax (856) 334-1040 www.emlab.comClient: Health Systems Sciences C/O: David Ausdemore Re: 20200601; PR VA USP 797 Nuclear Medicine Sampling

Date of Sampling: 06-01-2020 Date of Receipt: 06-09-2020 Date of Report: 06-18-2020

USP 797 - Detail Sample Analysis Results

Location: NM-SF-11:

Anteroom Door to A13B

NM-SB-11:

Anteroom Door to A13B

NM-SF-C1:

Control 1

NM-SB-C1:

Control 2

Comments (see below) None None None None Area Designation ISO Class 8 ISO Class 8 None None Sample type Swab sample Swab sample Swab sample Swab sample Media used MEA TSA w/ Lecithin & Tween MEA TSA w/ Lecithin & Tween

Lot#/Expiration date 128924/6-23-2020 129742/8-16-2020 128924/6-23-2020 129742/8-16-2020 Lab ID-Version‡: 11534103-1 11534104-1 11534105-1 11534106-1 Analysis Date 6-16-2020 6-11-2020 6-16-2020 6-11-2020 Incubation 26º - 30ºC for 5-7 days 30º - 35ºC for 2-3 days

26º - 30ºC for 5-7 days

30º - 35ºC for 2-3 days raw ct. cfu*/plate raw ct. cfu*/plate raw ct. cfu*/plate raw ct. cfu*/plate §Total ND ND ND ND ND ND ND ND

*cfu = colony forming units ND = none detected Comments:

EMLab ID: 2418617, Page 14 of 16EMLab P&K, LLC

Identifiers listed without a count or data entry were not detected during the course of the analysis for the respective sample.

Note: Interpretation is left to the company and/or persons who conducted the field work. Some rare strains of Staphylococcus produce free (unbound) coagulase exclusively. The applied coagulase test only measures bound coagulase.

The limit of detection is a raw count of 1. The analytical sensitivity for air samples is equal to 1 raw count divided by sample size and multiplied by the positive hole correction factor. The analytical sensitivity for surface samples is equal to 1 raw count divided by a sample size of 1 plate.

‡ A "Version" indicated by -"x" after the Lab ID# with a value greater than 1 indicates a sample with amended data. The revision number is

(866) 871-1984 Fax (856) 334-1040 www.emlab.comClient: Health Systems Sciences C/O: David Ausdemore Re: 20200601; PR VA USP 797 Nuclear Medicine Sampling

Date of Sampling: 06-01-2020 Date of Receipt: 06-09-2020 Date of Report: 06-18-2020

USP 797 - Detail Sample Analysis Results

Location: NM-SF-C2:

Control 1

NM-SB-C2:

Control 2

NM-SF-2A:Left Isolator in Nuclear

Medicine Room A13a-Entry

Compartment

NM-SB-2A:Left Isolator in Nuclear

Medicine Room A13a-Entry

Compartment Comments (see below) None None None None Area Designation None None ISO Class 7 ISO Class 7 Sample type Swab sample Swab sample Swab sample Swab sample Media used MEA TSA w/ Lecithin & Tween MEA TSA w/ Lecithin & Tween

Lot#/Expiration date 128924/6-23-2020 129742/8-16-2020 128924/6-23-2020 129742/8-16-2020 Lab ID-Version‡: 11534107-1 11534108-1 11534109-1 11534110-1 Analysis Date 6-16-2020 6-11-2020 6-16-2020 6-11-2020 Incubation 26º - 30ºC for 5-7 days 30º - 35ºC for 2-3 days

26º - 30ºC for 5-7 days

30º - 35ºC for 2-3 days raw ct. cfu*/plate raw ct. cfu*/plate raw ct. cfu*/plate raw ct. cfu*/plate

FUNGI

Yeasts 20 20 §Total 20 20 ND ND ND ND ND ND

*cfu = colony forming units ND = none detected Comments:

EMLab ID: 2418617, Page 15 of 16EMLab P&K, LLC

Identifiers listed without a count or data entry were not detected during the course of the analysis for the respective sample.

Note: Interpretation is left to the company and/or persons who conducted the field work. Some rare strains of Staphylococcus produce free (unbound) coagulase exclusively. The applied coagulase test only measures bound coagulase.

The limit of detection is a raw count of 1. The analytical sensitivity for air samples is equal to 1 raw count divided by sample size and multiplied by the positive hole correction factor. The analytical sensitivity for surface samples is equal to 1 raw count divided by a sample size of 1 plate.

‡ A "Version" indicated by -"x" after the Lab ID# with a value greater than 1 indicates a sample with amended data. The revision number is

(866) 871-1984 Fax (856) 334-1040 www.emlab.comClient: Health Systems Sciences C/O: David Ausdemore Re: 20200601; PR VA USP 797 Nuclear Medicine Sampling

Date of Sampling: 06-01-2020 Date of Receipt: 06-09-2020 Date of Report: 06-18-2020

USP 797 - Detail Sample Analysis Results

Location: NM-SF-1A:

Right Isolator in

Nuclear Medicine Room

A13a-Entry Compartment

NM-SB-1A:Left Isolator in Nuclear

Medicine Room A13a-Entry

Compartment

NM-SF-4A:

Isolator in Nuclear

Medicine Room A13b-Entry Compartment

NM-SB-4A:

Isolator in Nuclear

Medicine Room A13b-Entry Compartment

Comments (see below) None None None None Area Designation ISO Class 7 ISO Class 7 ISO Class 7 ISO Class 7 Sample type Swab sample Swab sample Swab sample Swab sample Media used MEA TSA w/ Lecithin & Tween MEA TSA w/ Lecithin & Tween

Lot#/Expiration date 128924/6-23-2020 129742/8-16-2020 128924/6-23-2020 129742/8-16-2020 Lab ID-Version‡: 11534111-1 11534112-1 11534113-1 11534114-1 Analysis Date 6-16-2020 6-11-2020 6-16-2020 6-11-2020 Incubation 26º - 30ºC for 5-7 days 30º - 35ºC for 2-3 days

26º - 30ºC for 5-7 days

30º - 35ºC for 2-3 days raw ct. cfu*/plate raw ct. cfu*/plate raw ct. cfu*/plate raw ct. cfu*/plate §Total ND ND ND ND ND ND ND ND

*cfu = colony forming units ND = none detected Comments:

EMLab ID: 2418617, Page 16 of 16EMLab P&K, LLC

Identifiers listed without a count or data entry were not detected during the course of the analysis for the respective sample.

Note: Interpretation is left to the company and/or persons who conducted the field work. Some rare strains of Staphylococcus produce free (unbound) coagulase exclusively. The applied coagulase test only measures bound coagulase.

The limit of detection is a raw count of 1. The analytical sensitivity for air samples is equal to 1 raw count divided by sample size and multiplied by the positive hole correction factor. The analytical sensitivity for surface samples is equal to 1 raw count divided by a sample size of 1 plate.

‡ A "Version" indicated by -"x" after the Lab ID# with a value greater than 1 indicates a sample with amended data. The revision number is