ATTACHMENT 4 March 2017 Hand Washing Study

ATTACHMENT 4 March 2017 Hand Washing Study

DEB IP LTD. Handwashing Study Among

Childcare Workers

March 2017 GLM 17044

A Full-Service Marketing Research Firm Since 1964

Table of Contents

Background .................................................................................. 1

Objectives .................................................................................... 1

Institutional Review Board .......................................................... 1

Disclosures ................................................................................... 1

Methodology ............................................................................... 2

Inclusion & Exclusion Criteria ...................................................... 2

Results ......................................................................................... 3

Conclusions .................................................................................. 6

Appendix

Appendix A: Test Site Pictures

Appendix B: Example Observation Form

Appendix C: Example Employee Questionnaire

Appendix D: Example Test Site Consent Form

Appendix E: Consent Form Signatures

Appendix F: Example Scoping Questionnaire

Appendix G: State of Ohio Handwashing Regulations

CONTACT INFORMATION

Great Lakes Marketing Associates, Inc. 3361 Executive Parkway • Suite 200

Toledo, OH 43606 419.534.4700 • 419.531.7117 (fax)

[email protected] • www.GLM.com TIN 34-0947132 • Women-Owned Business

Handwashing Study Great Lakes Marketing Toledo, OH March 2017 Page 1

Handwashing Study Deb IP Ltd.

March 2017

Background The FDA has requested that manufacturers conduct a pharmacokinetic (PK) Maximal Usage Trial (MUsT) to support the safety of active ingredients that are to remain on the final Consumer and Healthcare Monographs for topical antiseptic hand washes. The FDA has deferred their decision about several active ingredients until the MUsT studies are complete. There is limited information about the actual number of daily hand hygiene events that occur in the institutional consumer settings such as schools, daycare centers, and factories. This preliminary study will determine the maximal number of daily hand hygiene events (hand washes with soap and water) per employee in a typical institutional setting (i.e., daycare centers) where consumer products are used and will be used to develop a MUsT protocol for consumer hand hygiene products.

Objectives The primary objective of this study is to learn the number of handwashing occurrences during a typical full-day shift (7.5 to 8 hours) for childcare workers. This information will be used to provide a representative number of washes per hour that should be used in the pivotal Maximal Usage Trial for consumer antiseptic hand wash products. The secondary objectives of this study are to gauge usage pattern variation between employees, differences in hand hygiene (washes only) events between childcare centers, and differences in hand hygiene (washes only) events between areas within each childcare center.

Institutional Review Board Great Lakes Marketing Research has an experienced Institutional Review Board (IRB) registered under IORG0008878 with the Department of Health and Human Services. This study was exempt from IRB review.

Disclosures All facilities included in this study follow a hand wash compliance program as required by the State of Ohio (regulations are included in Appendix G). The soap types present in the childcare centers were liquid or foam soaps from dispensers affixed to the wall above or next to the sink. Hand sanitizer is not permitted in childcare centers due to the safety risk it poses to children if ingested (these regulations are documented by the State of Ohio). Of the eleven facilities observed in the study, ten use antibacterial hand soaps. Over the Rainbow (Site #41) does not use antibacterial hand soap.

All of the facilities segregate children into different classrooms according to age. Each classroom is equipped with at least one handwashing sink (photographs of the sinks are shown in Appendix A). All facilities also include one or more outside play areas.


Great Lakes Marketing personnel were assigned to observe a specific sink, not a specific person. One observer recorded the handwashing activity of all childcare workers who used the sink. The only handwashing recorded was that which occurred at a sink being observed by GLM personnel. While observers noted instances in which an employee washed their hands with only water, used hand sanitizer, or left the room to use the restroom (and presumably washed their hands), these instances are not included in the reported results. GLM personnel observed a total of 153 childcare center employees for this study; however, because some of the shifts were less than 7.5 to 8 hours, only 100 employees who met the 7.5 hours per day of observation were included in the analysis.

Methodology This analysis was conducted with a total of 100 participants at 11 daycare centers in the greater Toledo, Ohio area. Each participant was observed by a GLM employee during a single 7.5 to 8-hour shift. In order to minimize the potential for behavioral influence, the purpose of the study was not disclosed to the participants until the conclusion of their shift.

• Each observer was stationed near a specific handwashing sink

• Every time the sink was used, the observer recorded: o The name of the employee using soap and water at the sink o The time the handwashing occurred o The type of soap that was used during each handwashing (i.e., liquid soap or bar soap).

If no soap was used (i.e., only water was used), the event was not counted as a handwashing.

• At the end of the participant’s shift, the observer tallied and recorded the number of hand washes that each employee performed at all observation sinks throughout the 7.5 to 8-hour shift and completed a questionnaire with the employee.

Inclusion & Exclusion Criteria Prior to observation, the following information was confirmed for each participant. Those included in the study were:

• Employees who come into contact with children during the day

• Full-time staff (working a full shift for more than one day per week)

• Women or men who are greater than 18 years of age Those excluded from the study were:

• Employees who don’t come into contact with children during the day (e.g., office and janitorial staff)

• Part-time staff

• Children

• Visitors (e.g., parents) Informed consent documents were signed by the facility managers prior to initiating the study at each site. (A sample form is in Appendix D.)


Results Childcare Centers The eleven facilities agreeing to participate in this study were compensated for their willingness to allow observers in their centers. All centers were located in Ohio, and as such, follow the licensing regulations in Ohio (which strictly limit access to hand sanitizer).

Childcare Workers The childcare workers observed were predominantly female (98%) and under the age of 40 years. Only those working a full shift (7.5 to 8 hours) were included in the final analysis. These workers typically were assigned to one room throughout their shift; however, if they moved between rooms during their shift, washings occurring in the other rooms were included in the total number of handwashing events for that employee. The majority (89%) of the employees who were observed reported being in normal health. Mild ailments such as a cold, cough, or runny nose were reported in the remaining 11% (one employee also reported having a sinus infection, and another reported possible laryngitis). The majority (85%) of the employees also reported the frequency of handwashing for the day to be normal. The employees who reported washing their hands more often than usual did so due to mild illness (i.e., runny noses) among the children and a higher number of diaper changes. One employee reported washing her hands less than normal due to fewer diaper changes.

Demographics of Childcare Workers Observed

Age Total (n=100) Female (n=98) Male (n=2)

18 to 29 years 44 42 2

30 to 39 years 30 30 --

40 to 49 years 21 21 --

50 to 59 years 4 4 --

60 years & older 1 1 --

Handwashing Events by Sink Location Employees assigned to the infant room washed their hands considerably more often than those assigned to rooms for children ages two and over. For example, those in the infant room washed their hands between 1 and 42 times during their shift. Those in the toddler room (ages two to three) washed their hands between 1 and 35 times during their shift. Those in the preschool room (ages three to four) washed their hands between 0 and 16 times. ,


Handwashing Frequency by Observation Location

Total Hand

Wash Count Total

Infant (birth to 18 mos.)

Toddler (ages 2-3)

Preschool (ages 3-4)

Pre-K (ages 4-5)

School

Age EHS

(mixed ages)

0 2 -- -- 1 1 -- --

1 12 1 3 6 2 -- --

2 8 1 -- 5 -- -- 2

3 8 1 2 4 1 -- --

4 6 -- -- 3 2 -- 1

5 12 2 2 4 3 -- 1

6 7 1 2 2 2 -- --

7 7 -- 3 -- -- 1 3

8 1 1 -- -- -- -- --

9 2 1 1 -- -- -- --

10 4 1 1 1 -- -- 1

11 5 3 -- -- 1 -- 1

12 1 -- -- -- -- -- 1

13 1 -- 1 -- -- -- --

14 3 2 1 -- -- -- --

15 2 1 1 -- -- -- --

16 2 -- 1 1 -- -- --

17 1 -- -- -- -- -- 1

18 2 -- 1 -- -- -- 1

20 1 1 -- -- -- -- --

23 3 2 -- -- -- -- 1

24 3 2 1 -- -- -- --

27 1 -- 1 -- -- -- --

33 2 -- 2 -- -- -- --

35 1 -- 1 -- -- -- --

38 1 -- -- -- -- -- 1

41 1 1 -- -- -- -- --

42 1 1 -- -- -- -- --

Total

Occurrences 940 322 299 98 51 7 163

Number of

Employees 100 22 24 27 12 1 14

Average per

Employee 9.4 14.64 12.46 3.63 4.25 7 11.64

*Approximate age ranges. Ranges may vary slightly by facility.


Total Handwashing Events Across all 100 childcare employees, 95% washed their hands 33 times or less during their shift (7.5 to 8 hours) at an observed sink. The average number of washings per the total shift was 9.4. The following table shows the number of employees (on the vertical axis) who washed their hands between 1 and 42 times (on the horizontal axis). Of the 100 employees observed, 95 washed their hands 33 times or less during their shift (indicated by the shaded area).

Average Handwashings per Hour The average number of handwashing events per hour is 1.2, calculated by dividing the total number of observed handwashing events by the length of the shift. This did not include handwashing events that might have occurred in a restroom while the employee was on break. Of the 100 employees observed, 95 washed their hands an average of 4.1 times or less per hour during their shift.

0

2

4

6

8

10

12

14

0 5 10 15 20 25 30 35 40 45

Nu

mb

er

of

Em

plo

ye

es

Total Hand Wash Count

Total Hand Wash Frequency

95/100 washed 33 times or

less during a full shift


Conclusions The objective of this study was to determine the number of handwashing events, not to evaluate if proper procedures were followed. These findings indicate that the expected maximum number of handwashing events among those working in a childcare setting is 42, with 95% of the employees expected to wash their hands with soap 33 times or less during their shift. Workers who are handling infants wash their hands more often than those working in rooms with older children. Therefore, the results of any sample drawn from a childcare center will be skewed toward a higher maximum number of washings if the sample includes more workers from infant rooms and will be skewed toward a lower number if the sample includes more workers from rooms with older children. It is assumed that employees use the restroom during their shift (between the time the shift begins and the time the shift ends) and it is further assumed that employees wash their hands before exiting the restroom. These results do not include those washings so the maximum observed number of washings is less than the total number of washings which would occur during a shift.

0

2

4

6

8

10

12

0 1 2 3 4 5 6

Nu

mb

er

of

Em

plo

ye

es

Average Number of Hourly Hand Washes Per Employee

Average Hourly Hand Wash Frequency

95/100 washed an average

of 4.1 times or less per

hour


Appendix A Test Site Pictures

Handwashing Study Great Lakes Marketing Toledo, OH March 2017 Appendix

Educare Academy II (Site #64)

School Age

Infant

Toddler

EHS (birth-3yrs)


Educare Academy III (Site #193)

Preschool

Toddler

EHS 1

ECE & Grade School


EHS 2

Infant

Infant

EHS


Educare Academy IV (Site #1226)

EHS 2 (6wks – 3yrs)

EHS 1 (6wks – 3yrs)

Infant 1 (6wks – 18mos)

Infant 2 (12mos – 18mos)


Toddler 2 (2yrs - 21/2yrs)

Toddler1 (18mos – 24mos)

Preschool/Grade School (3,4,5yrs/5-12yrs)

Toddler bathroom (18mos – 36 mos)


Educare Academy V (Site #1266)

Four (4yrs)

Infant (6wks – 18mos)

Preschool (3-5yrs)

Toddler (18mos-3yrs)


Educare Academy VI (Site #1368)

Infant (6wks-18mos)

Preschool 1

Pre-K

EHS 1


EHS 2

Toddler

Preschool 2


Educare Academy VII (Site #1393)

Preschool 1

Preschool 2

Wabbler

Toddler


Infant


Educare Academy IX (Site #7388)

Preschool HS

ECE (4-5yrs)

Infant (6wks-18mos)

Toddler (18mos-2.5yrs)

Half wall separates sinks 4 & 5


EHS (6wks-3yrs)

Half wall separates sinks 4 & 5


Educare Academy X (Site #7384)


ECE & Grade School (4-5yrs)

Infant (6wks-12mos & 12mos-18mos)

One sink for both classes separated by

half wall

Preschool (3-5yrs)


HS Preschool (3-5yrs)


Kids 2 Treasure (Site #906)

Three (3yrs)

Three’s/Toddler Bathroom

(between both 1 & 3 sinks)


Pre-K (4 & 5yrs)


Over the Rainbow (Site #41)

Infant (6wks-18mos)

Toddler (18mos-35mos)

Preschool (3-4yrs)

Pre-K (4-5yrs)


St. Charles Development Center (Site #47)

Infant #2 (12-18mos)

Infant #2 (12-18mos)

Infant (6-12mos)

Toddler (18-24mos)


Two (2yrs)

Three (3yrs)

Four (4yrs)


Appendix B Example Observation Form


Observation Date: Start Time: End Time: ______

Site Name: Site #: ______

Location of Wash Station: Station #: ______

Action of Occurrence

Employee’s Name Time of Washing

Bar Soap & water

Liquid Soap & water

Water only

Hand Sanitizer

Other (specify) Comments

Observer Initial:


Appendix C Example Test Site Consent Form


MAXIMUM USE OF HYGIENIC HAND WASH/HAND RUB –

EMPLOYEE QUESTIONNAIRE

Complete one per employee

Site Name/Site #: (# )

Location of Wash Station/Station #:

(# )

Observation Date:

Observation Period:

End of Shift Hand Wash Count:

Employee’s Name: (First name & last initial)

Age Category: 18 to 29 30 to 39 40 to 49 50 to 59 60 & older

Job Title:

Work Shift for the Day:

General Health of

Employee:

Normal health Cold/other condition which influenced behaviour—explain: ______________________________________________________

1) Health of children in your care:

2) Is the frequency of your handwashing today:

Normal frequency

More frequent than normal, if yes please state the reasons why: ____________________________________________________________________

Less frequent than normal, if yes please state the reasons why: ____________________________________________________________________

3) Answer only if “Less frequent than normal” was chosen above; If you think about a normal day in work, how many extra hand washes would you expect to be required?

Observer Initial:


Appendix D Example Employee Questionnaire


INFORMED CONSENT FORM

Deb North America

2815 Coliseum Centre Drive, Suite 600,

Charlotte, North Carolina, 28217, USA

EVALUATION OF MAXIMUM USE OF HYGIENIC HAND ANTISEPTICS

AT CHILDCARE FACILITIES

SUMMARY

A supplier of antibacterial soap, hand sanitizers (handrubs), and foaming handwash products is conducting

a study that will provide information about the use of hygiene products in childcare facilities available in

your center to better understand the safety of these products. This information is required to help the Food

and Drug Administration (FDA) better understand the safety of will continue to allow antibacterial

handwashes and santizersto be used to prevent infections and other hygiene related issues in childcare

facilities; thereby reducing the risk to workers and children.

If your center is accepted in the study, your employees will be encouraged to follow your center’s regular

daily work routine which includes normal hand hygiene practices. The products that they will use are those

already in place at the facility.

At the end of the shift we will ask staff a few questions related to their use of the handwash and handrub

products in the facility. The identity of participants and the name of the centers will remain confidential.

No findings will be attributed to individuals or to specific centers.

There are no anticipated expenses to your center for participating in this study. All study materials will be

provided at no cost to you.

QUALIFICATIONS

The staff asked to participate in the study must:

• work directly with children at the facility

• work at least 2 days per week for a minimum of 8 hours per shift

• use only hand wash or handrub products provided by the childcare facility

TEST PERIOD

The test period will be the entire workday of at least 8 hours.

At the end of the shift, there will be a very short questionnaire to complete with one of the study monitors.

RISKS

There are no anticipated risks associated with this study.

CONFIDENTIALITY


Records of participation in this study will be aggregated and presented in total across all centers and

participants. Copies of all data generated during this study will be sent to the sponsor of the study. Your

name will not be disclosed with the data gathered from this study. In the study report that will be generated

from this study, there will be no names or identification of any type used in the summary of data.

BENEFITS AND ALTERNATIVE TREATMENTS

You will not benefit medically by participating in this study however the hygienic use of handwash and

handrub products has the inherent benefit of reducing the risk of bacterial exposure or infection.

This study is for research purposes only. There are no alternative procedures or courses of treatment.

COMPENSATION

TBD

ACKNOWLEDGEMENTS

I am at least 18 years of age and voluntarily, without reservation, give my informed consent to all

observation to occur at this facility.

After reading and understanding all of the above information, I voluntarily consent to all observation to

occur at our center(s).

I have read and understand the information contained in and have received a copy of the INFORMED

CONSENT FORM.

Participating Center’s Signature Date

Consent Obtained By Date


Appendix E Consent Form Signatures


Appendix F Example Scoping Questionnaire


SCOPING QUESTIONNAIRE FOR CHILDCARE FACILITY

1) Number of employees (per individual facility and by room)

2) Number of handwashing stations (per individual facility and by room)

3) How many stations use dispensers for handwash or handrub products?

4) Child care capacity (maximum number of children for each room by type of room)

5) Shift patterns used by those working with children (please state start and finish times)

6) Age group of the children cared for

7) Are the children segregated by age group into different rooms?

8) Is there an outside play area?

9) Is there a hand-wash compliance programme in use?

If yes, please supply details what it is and where it is supplied from.

10) Please put a tick against each product type used in the facility;

• Alcohol Sanitiser

• Other sanitizers

• Antibacterial Hand Soap

• Lotion, bar, or Foam Hand Soap


Appendix G State of Ohio Handwashing Regulations



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ATTACHMENT 4 March 2017 Hand Washing Study

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