attachment 5 december 2017 hand washing study

ATTACHMENT 5 December 2017 Hand Washing Study

DEB IP LTD. Handwashing Study Among Childcare Workers

December 2017 GLM 17191

Handwashing Behaviors among Childcare Workers December 2017

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 Test Site Consent Form

Appendix D: Example Employee Questionnaire

Appendix E: 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


Great Lakes Marketing Research Page 1 GLM 17191

Handwashing Study

Deb IP Ltd. December 2017

Background Limited information exists about the actual number of daily hand hygiene events that occur in institutional consumer settings such as schools, daycare centers, and factories. This study is the second of two studies1 designed to determine the maximal number of daily hand hygiene events (handwashes with soap and water) for an employee in a childcare center where consumer handwashing products are used. This study is different from the first study (conducted in March 2017) in that twenty childcare workers were observed for three consecutive days instead of only one day.

Objectives The primary objective of this study was to learn the number of handwashing occurrences during a typical full-day shift for childcare workers. A full-day shift is typically 6 to 8 hours for this setting. A handwashing occurrence is defined as using soap and water at a sink in the classroom. The observations occurred in the infant and toddler rooms of seven childcare centers. The secondary objectives of this study were to gauge handwashing pattern variation between days (based on monitoring a single employee for three days) and between employees. Other data collected included:

• The type of soap in the dispenser (which was foam in these centers) • The number of seconds the employee washed her hands • The number of pumps of soap used • The number of times an employee left the classroom (and could have washed her hands at a

different sink)

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.

1 The first study was conducted by GLM in March 2017; reference number GLM 17044.



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 E). The soap types used in the childcare centers were foam 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).

In summary, of the seven sites used for this study:

• 7 use antibacterial soap • 7 use foam soap • 2 use alcohol sanitizer (not in the classrooms)

All of the facilities segregate children into different classrooms according to age. For this study, only infant and toddler classrooms were monitored. Each classroom monitored had at least one handwashing sink (photographs of the sinks are shown in Appendix A). All facilities had 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 handwashings recorded were those that occurred at a sink being observed by GLM personnel.

Methodology GLM personnel recorded handwashing events for twenty childcare center employees for this analysis. Observations were conducted at seven different childcare centers in the greater Toledo, Ohio area. Each participant was observed by a GLM employee during a single shift for three consecutive days. 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 third shift. However, employees from the centers were potentially observed during the research conducted for GLM 17044 (about eight months prior to this second study).

• 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 number of pumps of soap o The number of seconds of washing o The type of soap (foam or liquid) o Other comments

• Observers also recorded when employees entered and exited the room



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 in an infant or toddler room • Full-time staff (working a full shift for more than one day per week) • Over the age of 18

Those excluded from the study were:

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

Results Childcare Centers The seven facilities that agreed 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 a child’s access to hand sanitizer). Childcare Workers The childcare workers observed were female and ages 18 to over 60 years. Only those working a full shift (about 7 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 observed rooms were included in the total number of handwashing events for that employee. The majority of the employees who were observed reported being in normal health for all three shifts. One employee reported having a cold all three days; however, she reported the frequency of handwashings to be normal. Mild ailments such as a cough or runny nose were reported among a few employees. The employees reported the frequency of handwashing for the three shifts to be normal. Demographics of Childcare Workers Observed

Age Total (n=20)

18 to 29 years 10

30 to 39 years 3

40 to 49 years 4

50 to 59 years 0

60 years & older 1

No answer 2



Handwashing Frequency by Each Employee The following table shows the number of handwashings with foam soap for each of the three days the employee was observed. The range shows the variance between the shift in which the employee had the most washings and the shift in which the employee had the least number of washings. The employees are listed in order of the center being observed. This helps show the variance between workers at the same center.

Center Code Emp

Code Day 1 Total

Day 2 Total

Day 3 Total

Range (Highest less Lowest)

Over the Rainbow Nikki 46 26 41 20 Educare III Carly 24 16 24 8 Educare III Crystal 33 21 18 15 Educare III Penny 9 14 6 8 Educare III Sarah 13 7 11 6 Educare III Stacy 12 19 1 18 Educare III Tiffany 42 61 41 20 Educare IV Ariel 23 29 25 6 Educare IV Marissah 3 3 0 3 Educare V Andrea 12 8 9 4 Educare V Antanique 2 1 4 3 Educare V Danielle 7 4 2 5 Educare VII Amy 18 10 5 13 Educare VII Becky 14 10 18 8 Educare VII Otivia 19 12 12 7 Educare X Brandi 17 9 10 8 Educare X Heather 25 14 28 14 Educare X Nikki 13 15 18 5 Educare X Patricia 13 6 14 8 Educare X Tracy 11 7 8 4 Average 17.8 14.6 14.8 9.2 Standard Deviation 11.7 13.2 12.0 -

95% CI (range) 12.7 – 22.9 8.8 – 20.4 9.5 - 20 -

The range was diverse between and within employees. For example, Tiffany (employee on seventh line) typically washed her hands while washing the hands of a child. Ariel (employee on eighth line) washed her hands in association with a diaper change in about half of the occurrences. Thus, the variation in daily child care activities impacts the number handwashing occurrences per day. At Educare III, six workers were observed. On any given day, the variance between the workers at this one center varied by an average of about 40 handwashing events.



Handwashing Averages for Each Employee The following table shows the daily and hourly average number of handwashings with foam soap and the average duration of handwashings over the three shifts for each employee.

Center Code

Emp Code

Daily Average Washings

Daily Average Duration (seconds)

Total Washings

Over Three Days

Total Observation

Hours

3-Day Hourly

Average Over the Rainbow Nikki 37.67 10.7 113 24 4.71

Educare III Carly 21.33 4.1 64 22.5 2.84 Educare III Crystal 24.00 6.5 72 23.75 3.03 Educare III Penny* 9.67 7.3 29 24 1.21 Educare III Sarah 10.33 9.4 31 21 1.50 Educare III Stacy 10.67 4.0 32 18 1.78 Educare III Tiffany 48.00 11.1 144 22.5 6.40 Educare IV Ariel 25.67 4.6 77 24 3.21 Educare IV Marissah 2.00 5.2 6 18 0.33 Educare V Andrea 9.67 11.8 29 24 1.21 Educare V Antanique 2.33 8.2 7 19.5 0.36 Educare V Danielle* 4.33 4.9 13 20.25 0.64 Educare VII Amy 11.00 3.0 33 18 1.83 Educare VII Becky 14.00 3.1 42 21 2.00 Educare VII Otivia 14.33 9.4 43 21.5 2.00 Educare X Brandi 12.00 5.7 36 24 1.50 Educare X Heather 22.33 5.5 66 24 2.75 Educare X Nikki* 15.33 11.0 46 24 1.92 Educare X Patricia 11.00 6.5 33 21 1.57 Educare X Tracy 8.67 5.6 26 22.5 1.16 Range 2.0 – 48.0 3.0 – 11.8 7.0-113.0 18.0-24.0 0.33 – 6.4 Average 15.72 6.9 47.1 21.88 2.10 Standard Deviation 11.48 2.82 4.83 2.20 1.46

*Toddler Room (the rest were infant rooms or mixed infant/toddler rooms) These data indicate that the average number of handwashing occurrences per day is as low as 2.0 and as high as 48. The hourly average also varies from a low of less than one handwahing to over six handwashings. The variance is not necessarily correlated to the worker being assigned the toddler room or the infant room. These data also show that handwashing duration was between an average of 3.0 seconds per handwashing event to 11.8 seconds. The daily average not only varies by person but also varies within centers. For example, among the six observed employees at Educare III, the daily average duration of handwashing ranged from 4.1 seconds to 11.1 seconds. No average duration exceeded 12 seconds.



Handwashing Duration for Each Employee The following table shows the average duration of handwashings with foam soap for each of the three days the employee was observed. The range shows the variance between the shift in which the employee had the longest handwashing event and the shift in which the employee had the shortest handwashing event. The employees are listed in order of the center being observed. This helps show the variance between workers at the same center.

These data show that the range of average handwashing duration differs between employees but less so within observations for the same employee. The largest range (9 seconds) can be attributed to that employee’s low total number of handwashings, where the daily average duration would be affected greater by each handwashing event. Of the twenty observed employees, average handwashing durations varied by less than two seconds for thirteen of the employees over the three days.

Center Code

Emp Code

Day 1 Average Duration (seconds)



Range (Highest Total less Lowest Total)

Over the Rainbow Nikki 10.3 9.9 11.8 1.9

Educare III Carly 4.5 3.6 4.2 0.9 Educare III Crystal 6.3 7 6.1 0.9 Educare III Penny 7.8 7.2 7 0.8 Educare III Sarah 8.3 9.9 10 1.7 Educare III Stacy 4.5 5.5 2 3.5 Educare III Tiffany 11.2 10.8 11.4 0.6 Educare IV Ariel 5.1 4 4.7 1.1 Educare IV Marissah 6.3 4 NA 2.3 Educare V Andrea 14.6 11 9.7 4.9 Educare V Antanique 3 12 9.7 9.0 Educare V Danielle 5.3 6.3 3 3.3 Educare VII Amy 2.5 3.4 3 0.9 Educare VII Becky 2.6 3.7 2.9 1.1 Educare VII Otivia 8.6 12.4 7.3 5.1 Educare X Brandi 4.6 6.8 5.7 2.1 Educare X Heather 5.8 5.5 5.1 0.7 Educare X Nikki 11.8 10.1 11.1 1.7 Educare X Patricia 6.2 6.7 6.8 0.6 Educare X Tracy 5.4 5.6 5.8 0.4 Average 6.7 7.3 6.7 2.2 Standard Deviation 3.2 3.0 3.1 -

95% CI (range) 5.3 – 8.2 6.0 – 8.6 5.3-8.1 -



Summary of Handwashing Events and Product Usage

Summary Maximum Handwashings Per Any Shift 61

Second Highest Handwashings Per Any Shift 46

Mean Average Across All Shifts 15.72

Standard Deviation between Shifts of Single Employee 4.83

Average Number of Pumps* 1.8

Average Number of Seconds of Washing 6.9

*The amount dispensed in ten pumps ranged from 3.6 grams to 9.1 grams.

These data indicate that the highest number of handwashings observed in a single shift (61) was an anomaly since the second highest (46) was similar to other heavy shifts (i.e., of the 60 shifts observed, 4 shifts were associated with between 41 and 46 handwashings. The remaining 55 shifts observed were associated with 33 or fewer handwashing events.

Conclusions Direct observation of handwashing occurrences in a childcare center indicates that significant variance exists among the workers and between a single worker over three days. In a typical shift, the average number of handwashings is approximately 16. However, the average range (as high as 48 washings in a shift to as low as 2 washings in a shift) shows that the mean is not necessarily representative of handwashing occurrences.

The maximum number of handwashings observed in a single shift was 61 washings. However, this is significantly more than the average of 16 and higher than other observations in the “high” range (i.e., the second highest number of washings in a shift was 46).

Childcare workers typically use about two pumps of foam soap. They wash their hands for about 7 seconds with only four of the twenty employees averaging more than 10 seconds of wash time over the three days (ranging from 10.7 seconds to 11.8 seconds).



Appendix A Test Site Pictures



Over the Rainbow

Sink 13 Infant Room (6 weeks – 18 months)

Sink 14 Toddler Room (18 months – 3 years)



Educare III





Educare IV





Educare V





Educare VII





Educare X





Educare XII

Sink 1 EHS Room (6 weeks – 3 years)




Appendix B Example Observation Form



Appendix C Example Test Site Consent Form



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 hand wash 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 sanitizer to 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 D Example Employee Questionnaire



Appendix E State of Ohio Handwashing Regulations

attachment 5 december 2017 hand washing study

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