Evaluation of Hospital Preparedness in a Mass Casualty Event (MCE)
Submitted
by:
Department of Health and Human Services
Center for Disease Control and Prevention
National Center for Injury Prevention and Control
Division of Unintentional Injury Prevention
4770 Buford Highway, NE F62
Atlanta, GA 30341-3717
Project Officer: Mark Faul, PhD, MA Team Lead
Tel: 770.488.1276
Email: [email protected]
Fax:
770.488.1317
September 17, 2014
A. Justification 4
1. Circumstances Making the Collection of Information Necessary 4
1.1 Privacy Impact Assessment 6
2. Purpose and Use of the Information Collection 6
2.1 Privacy Impact Assessment 7
3. Use of Improved Information Technology and Burden Reduction 7
4. Efforts to Identify Duplilcation and Use of Similar Information 7
5. Impact on Small Businesses and Other Small Entities 8
6. Consequences of Collecting Information Less Frequently 8
7. Special Circumstances Relating to Guidelines of 5 CFR 1320.5 8
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency 8
9. Explanation of Any Payment or Gift to Respondent 10
10. Assurance of Confidentiality Provided to Respondents 10
10.1 Privacy Impact Assessment Information 11
11. Justification of Sensitive Questions 12
12. Estimates of Annualized Burden Hours and Costs 12
13. Estimates of Other Total Annual Cost Burden to Respondents and Record Keepers 13
14. Annualized Cost to the Federal Government 13
15. Explanation for Program Changes or Adjustments 14
16. Plans for Tabulation and Publication and Project Time Schedule 14
17. Reason(s) Display of OMB Expiration Date is Inappropriate 17
18. Exceptions to Certification for Paperwork Reduction Act Submissions 17
Attachment A – Authorizing Legislation
Attachment B – Published 60 Day FRN
Attachment C – Letters to CEO and Preparedness Coordinator
Attachment D – Web Survey Screenshots
Attachment E – Follow-up Phone Call to CEO
Attachment F – IRB: NCIPC Determination
Attachment G – Public Comment
Attachment H – Consent Form
In accordance with the Centers for Disease Control and Prevention (CDC)’s mission to protect Americans from health, safety and security threats, both foreign and domestic and the mission of CDC’s National Center for Injury Prevention and Control (NCIPC) to prevent violence and injuries, and reduce their consequences, NCIPC requests approval of a new information collection request for 12 months to allow CDC and its partner, SciMetrika, LLC, to collect the data that will enable them to better understand the current status of hospital preparedness for responding to mass casualty incidents including bombings and non-bombing explosions and disasters that give rise to a rapid influx of large numbers of patients. Additionally, our nation’s emergency departments and hospitals are facing enormous daily challenges and are not prepared to respond to the clinical and system challenges posed by mass casualty events. The survey will assess areas in which hospital preparedness may be lacking as targets for future intervention.
There is an ICR from HHS/ASPR already approved with OMB# 0990-0391“The Hospital Preparedness Program,” and related to hospital preparedness information. The CDC has coordinated this work with the Chief Emergency Care Coordination Center, and Division Director of Health Systems and Health Care Policy within the Office of the Assistant Secretary for Preparedness and Response. CDC will also coordinate the final report with ASPR.
Once OMB approval has been received, the questionnaire will be administered to a nationally representative sample of US hospitals. An estimated 400 hospitals will be approached and invited to participate, but the sample size of eligible hospitals that agree to participate is estimated to be no more than 320. A sample of 320 hospitals will provide sufficient data of hospital preparedness activities for certain subgroups, such as trauma level or pediatric/adult facility. Data gathered from the survey will be compiled, responses will be analyzed, and a detailed summary of the analysis will be provided.
Sample hospitals came from the AHA hospital directory, which includes trauma level designation and location. Using a random number generator 400 hospitals were chosen at random from four hospital types: 100 community trauma centers, 200 regional resource trauma centers, 50 rural trauma hospitals, and 50 non-trauma centers. The selections were made proportional to the number of hospitals of each type in four regions of the U.S. as defined by the Census Bureau: Midwest, Northeast, South, and West.
The overarching goal of this data collection is to assess national capacity of trauma and non-trauma hospitals to respond to mass casualty incidents involving bombings or non-bombing explosions. Understanding the current capacities will allow the CDC Division of Unintentional Injury Prevention (DUIP), in collaboration with SciMetrika, LLC to develop strategies that address major hospital preparedness gaps. The information gleaned from the survey results are also needed to inform development of a dissemination plan and training manual for improving this capacity. Without the knowledge that the survey will provide, DUIP’s effort to develop a thorough and comprehensive guide tailored to hospitals’ preparedness needs will not meet the needs of hospitals for improving their levels of preparedness. The purpose of this project will be to (1) develop minimum standards into the assessment tool to enable a review or an evaluation of hospital readiness and (2) develop strategies for dissemination and implementation of the interview tool. A pilot of the questionnaire, sent to 4 respondents, has been completed and necessary adjustments to the overall questionnaire have been made during March of 2014.
The survey instrument will be implemented as a web-based tool. All respondents will submit responses through the web tool.] An Injury Coordinator will likely be tasked with gathering data from different parts of the hospital. Depending on the hospital, much of the data requested by the survey is likely contained within automated systems. While the initial letter is addressed to the hospital CEO, it is up to each participating hospital on how they wish to complete the survey. We think that it is unlikely that other people will be burdened in the data collection effort. Hospital participants reviewed and completed the survey prior to having one to one discussions with representatives of the survey development team about clarity of the questions, time burden to complete the survey, and suggestions for survey implementation. Participants indicated that a web-based survey will facilitate completion of survey due to the length and extensiveness of the questionnaire. Survey completion requires the collection of data from multiple hospital departments and typically takes an estimated 2 hours including time to gather information from multiple departments and completing the survey. Therefore, a web-based platform will reduce the burden of data collection by allowing the participants to complete the questionnaire over multiple sessions. Computer-generated skip patterns will also be utilized to allow participants to skip non-applicable sections, thus reducing the overall number of questions answered. Screen shots of the web survey are shown in Appendix D.
Prior to development of the survey instrument, DUIP and SciMetrika undertook a number of endeavors to identify previous or current data collection efforts including national surveys on hospital preparedness for mass casualty events focusing exclusively on bombings, non-bombing explosions and natural disasters. These efforts included conducting a review of domestic and international literature on hospital emergency preparedness and surge capacity strategies, consulting with representatives from 17 hospitals and hospital-related organizations, and reaching out to representatives from the American College of Emergency Physicians (ACEP) and the Office of the Assistant Secretary for Preparedness and Response (ASPR). The outcome of these activities indicated that the planned survey does not duplicate other data collection efforts. Similar efforts to this proposed data collection include the annual National Hospital Ambulatory Medical Care (NHAMC) survey, which is a survey of ambulatory medical care visits to non-institutional, nonfederal, acute care, and short-stay hospitals and the National Association of Public Hospitals and Health Systems (NAPH) survey on Emergency Preparedness in Public Hospitals. However, unlike these surveys, the current survey is not geared towards a specific sector of hospitals (e.g. acute care, short-stay, public hospitals). Moreover, unlike previous or current hospital preparedness surveys, this survey focuses exclusively on mass casualty incidents related to bombing, non-bombing explosions and natural disasters and examines preparedness across multiple hospital functional areas (e.g. pediatrics, radiology, pathology, etc.) as opposed to only general preparedness efforts to mass casualty events. Discussion with participants who completed the cognitive evaluation of the survey also confirmed that there are currently no similar data collection efforts that extensively examine hospital preparedness for mass casualty incident related to bombings, non-bombing explosion and natural disasters at multiple hospital functional-areas. Reviews of prior studies on hospital preparedness, such as the 2006-2007 Emergency Preparedness Study conducted by the National Association of Public Hospitals and Health Systems and the 2008 U.S. Hospital Preparedness for Emergency Response study by the CDC National Center for Health Statistics were completed to minimize duplication of the types of information gathered.
The present CDC’s information request is designed to collecting information that was not asked previously in the studies mentioned above. Such information includes the following topics: Hospital Security, Electronic Data Storage, Protection of Evidence, Continuation of Operations, Department Level Response (e.g., blood bank, surgery, morgue, radiology, laboratory, etc.), and Leadership Participation.
The 2008 U.S. Hospital Preparedness for Emergency Response study found that hospital preparedness actions (i.e., emergency response plans, MOUs with burn centers, and drills) for explosive events was less than that of other mass casualty event causes. In addition the 2006-2007 study included only hospitals that are part of the National Association of Public Hospitals and Health Systems (now called America’s Essential Hospitals). This hospital sample is primarily urban. The present CDC’s information request plans to survey both urban and rural hospitals, and to include differences by hospital type or trauma level designation. Topics not covered by the other studies.
As mentioned before, the OMB approved ICR from HHS/ASPR OMB# 0990-0391“The Hospital Preparedness Program” relating to hospital preparedness information has a similar topic to this collection. The CDC has coordinated this work with ASPR, and will also coordinate the final report with ASPR. Also, the ICR that HHS/ASPR received approval for (0990-0391) is a generic request that is designed to collect information for a specific emergency in a specific community. That ICR is scheduled to expire on 31 March 2015. The present information request from CDC uses standardized questions and will inform the CDC on overall hospital preparedness in the United States. In this sense, the two information requests are different and not duplicative.
Survey respondents will primarily be the emergency preparedness coordinators/managers for various sizes of hospitals. While most of the organizations are large, some may be small businesses. The survey’s requirements do not have a significant impact on small businesses. CDC has kept the sample for this survey to the minimum needed to achieve reliable data. The survey content has also been limited to information essential to research objectives. Furthermore, the survey is voluntary and the time estimate includes time needed to read the study background and consent form and gather requested information. The web-based tool also allows participants to skip sections of the survey that do not pertain to their facility, hence reducing the burden for smaller facilities.
Data collection will occur only once.
This request fully complies with the regulation 5 CFR 1320.5.
A. Federal Register Notice
A 60-day Federal Register Notice was published in the Federal Register on April 30, 2014, vol. 79, No. 83), pp. 24440) (see Attachment B). A comment was received (Attachment G), and a standard CDC response was sent.
B. Efforts to consult with persons outside the agency
The CDC Division of Unintentional Injury Prevention (DUIP), in collaboration with SciMetrika, LLC consulted with representatives from 17 hospitals and organizations on availability of survey instruments on hospital preparedness for mass casualty events related to bombings, non-bombing explosions and natural disasters, the need to create a new survey instrument and obtain their input on survey objective, content and recruitment process. The survey instrument was developed by survey methodologists at SciMetrika, LLC. After development of the survey, the instrument was shared with the consultants for review. Several consultants reviewed the instrument and provided comments on the structure, instructions and content of the survey. All received comments were addressed and the survey instrument went through several rounds of review and revision by CDC and SciMetrika staff. Table A.8.1 below provides a list of CDC staff, SciMetrika staff and external consultants who provided input during the review process. There were no major problems that were not resolved.
Table A.8.1: Survey Design: CDC Staff and Outside Consultation
Organization |
Name |
Title |
Contact Information |
CDC |
Lisa Garbarino, COR |
Public Health Advisor |
770.488.1496 / lgt1@cdc.gov |
|
Mark Faul, PhD, MA |
Senior Health Scientist |
770.488.1276 / [email protected] |
University of South Carolina School of Medicine - Greenville |
Scott Sasser, MD, FACEP |
Emergency Medicine |
864.797.6440 / [email protected] |
SciMetrika |
Darryl Cooney, MSTAT |
Lead Statistician |
919.354.5212/ [email protected] |
|
Russ Foushee, PhD |
Project Manager |
919.354.5272/ [email protected] |
|
Dena Elimam, MPH |
Project Coordinator |
404.325.5002/ [email protected] |
|
Charles Hallman |
Survey Programmer |
919.354.5224/ [email protected] |
|
Ram Jain, PhD |
Statistician |
404.325.5002/ [email protected] |
|
Michael Samuhel, PhD |
Technical Advisor |
919.354.5263/ [email protected] |
Department of Health and Human Services |
Gregg Margolis, PhD, NREMT-P |
Director, Division of Healthcare Systems and Health Policy |
Gregg.Margolis@hhs.gov |
Emory University |
Alexander Isakov, MD, MPH, FACEP |
Executive Director Office of Critical Event Preparedness and Response
|
404.712.1301/ [email protected]
|
American College of Emergency Physicians |
Chris Kang, MD, FACEP |
ACEP Disaster Medicine Section, WA Chapter President |
|
American Hospital Association |
Roslyne Schulman, MHA, MBA |
Director, Policy Development |
202.626.2273/ [email protected] |
Harbor-UCLA Medial Center |
Amy Kaji, MD, PhD |
Medical Director, South Bay Disaster Resource Center |
310. 222.3500/ [email protected] |
Eastern Virginia Medical School |
Leonard J. Weireter, MD, FACS |
Professor of Surgery |
|
HealthEast Bethesda Hospital |
Kathryn Schultz, Pharm. D, FASHP |
Director of Pharmacy |
651.232.2343/ [email protected] |
University of Texas Medical School at Houston |
Susan John, MD |
Professor of Diagnostic and Interventional Imaging and Pediatrics |
713.500.7700/ [email protected] |
This submission has been reviewed by CIO who determined that the Privacy Act does not apply.
All information provided by hospitals will be kept secure to the extent allowed by law. Responses will be reported in summary form only. No personal or specific facility identifiers will be included in either oral or written presentation of the study results. Although data collection will be completed by SciMetrika, LLC, CDC will have complete ownership of all collected data. Any transfer of identifying data between CDC and its survey contractor, is completed using encryption software, so that the data cannot be read by third parties. All identifying information are protected and masked with a pre-coded identification number. Only the survey contractor has access to the identities associated with each number. The survey contractor will protect the web survey application with a password and identification number. Sampled participants can access the web survey only with the password and ID assigned to them. Small analytic cells are also automatically suppressed so that contractors cannot generate frequencies that would allow for identification of an individual provider.
Finally, the survey material includes the following text:
Information being collected is about the organization (i.e. hospital) at which the respondent is employed. CEO names and contact information will be derived from the Hospital Guide while respondent names will be supplied by the CEOs. The selected respondent is chosen as the person who is the hospital’s emergency preparedness manager or coordinator as the person most knowledgeable about their hospital’s emergency preparedness activities. The name and contact information of the designated responder will be obtained to facilitate primary data collection and for communication purposes during the data collection process only. That information will not be reported or included in any written or oral presentation of the results. Any shared data files will have contact information removed
An NCIPC Determination has been provided (Attachment F), which satisfies the project’s IRB review requirement.
Individuals’ contact information will be collected to facilitate data collection and allow for follow up as necessary. This includes their name, work address, work telephone number, and work email address. Respondent race or other demographic information is not being collected. The survey information collected will cover hospital planning, training, and implementation of preparedness activities for bombing and mass casualty incidents. The study questionnaire is shown in Attachment D. The survey utilizes multiple question formats including yes/no, multiple choices, and open-ended questions.
Individuals will be informed that the survey is voluntary. Individuals will have an opportunity to consent prior to survey completion. Data will be stored on a firewall and password protected system with physical and electronic security controls. The name and contact information of the designated responder will be obtained to facilitate primary data collection and for communication purposes during the data collection process only. That information will not be reported or included in any written or oral presentation of the results.
The contractor, SciMetrika LLC, will employ technical, physical, and administrative controls to protect participants’ information. The technical controls being used to safeguard data are user identification and password, firewall, encryption, and an intrusion detection system. Physical controls being used include identification badges, key cards, and video monitoring. Administrative controls include the following:
There will be a system security plan for this information collection
There is not a contingency plan for this information collection
Files will be backed up daily (overnight)
Backup files are stored off-site
There will be user manuals (e.g. data collection methods, survey codebook) for this information collection
Study personnel complete annual training for the protection of human subjects and HIPAA along with training on computer security
We will adhere to privacy provisions and practices
Only study personnel will have access to study files
Digital and non-digital media is sanitized by physical destruction with a licensed, bonded, and insured vendor, thus preventing unauthorized individuals from access or use of the data. Records will be retained and destroyed in accordance with the applicable CDC Records Control Schedule
The process for handling security incidents is defined in SciMetrika’s Security Plan. Event monitoring and incident response is a shared responsibility between SciMetrika and the CDC Office of the Chief Information Security Officer (OCISO). Reports of suspicious security or adverse privacy related events should be directed to the component’s Information Systems Security Officer, CDC helpdesk, or to the CDC Incident Response Team. The CDC OCISO reports to the HHS Secure One Communications Center, which reports incidents to US-CERT as appropriate.
Survey data will be provided to the CDC by SciMetrika, LLC. Data transfer will be encrypted for privacy protection. The data will be used for analysis of preparedness. No other entities will have access to study data. Considering that the focus of the study is collecting data on hospitals’ preparedness for mass casualty incidents, it is anticipated that there would be minimal impact on respondent privacy from the proposed data collection.
Respondent Burden - Screening Activities
400 CEOs from sampled hospitals will be screened to ask for participation. They will be mailed an introductory letter, contacted by telephone a few days later and asked if the facility’s emergency preparedness coordinator/manager can complete the survey. CEOs will only respond once to the invitation inquiry. Burden estimates from the cognitive evaluation phase indicate that the initial letter takes an average of ten minutes for a CEO respondent to review and respond to the telephone follow up. The total estimated annualized burden for screening activities is 100 hours.
The emergency preparedness coordinator/manager will complete the main survey. Three hundred twenty emergency preparedness coordinators/managers are expected to complete the survey once. The estimated burden per response is 2 hours, including reading the instructions and gathering information from other hospital departments based on cognitive interviewing conducted with a sample of nine representative respondents. The total estimated annualized burden for surveys is 640 hours.
Note that burden will be placed only on those sampled providers that make a submission. Those who reject a request to participate and do not complete the survey will not be burdened.
Table A.12.1 shows how many respondents are estimated to submit the survey as well as corresponding hour burdens. The tables also include the potential burden on non-responders.
Type of Respondents |
Form Name |
No. of Respondents |
No. of Responses per Respondent |
Avg. Burden per Response (in hours) |
Total Burden Hours |
CEO |
Follow-up Phone Call |
400 |
1 |
15/60 |
100 |
Emergency Preparedness Coordinator / Manager |
Survey |
320 |
1 |
2 |
640 |
Total 740 |
|
|
|
|
|
The bureau of labor statistics estimates that the average annual salary of a CEO is about $176,840 (http://www.bls.gov/oes/current/oes111011.htm) and emergency management director is about $64,730 (http://www.bls.gov/oes/current/oes119161.htm). Using the hourly wages of $85.02 and $31.12, respectively the estimated cost burden on respondents can be calculated using the average wage per minute multiplied by total time burden.
Table A.12.2 shows how many respondents are estimated to submit the survey as well as corresponding minutes and cost burdens. The tables also include the potential burden on non-responders.
Type of Respondents |
Form Name |
No. of Respondents |
No. of Responses per Respondent |
Avg. Burden per Response (in hours) |
Total Burden Hours |
Hourly Wage Rate |
Total Respondent Costs |
CEO |
Invitation Letter |
400 |
1 |
15/60 |
100 |
$85.02 |
$8,502.00 |
Emergency Preparedness Coordinator / Manager |
Survey |
320 |
1 |
2 |
640 |
$31.12 |
$19,916.80 |
Total |
|
|
|
|
|
|
$28,418.80 |
There is no capital, operation, or record keeping costs to respondents.
Costs to the federal government is $162,562.05 in 2013-2014, which includes: updating and testing the secure internet website for the survey, creating and cleaning the sample frame, drawing a clean sample, collecting data, processing data, weighting and analyzing survey data, and reporting survey results. The total anticipated cost to the federal government is comprised of the participation of the following contractor personnel: health science administrator to assist in project management; public health analyst to assist with recruitment and data collection, data collection and reporting; statistician to assist with data analysis and reporting; and management analyst / consultant to design and manage the project. The total estimated costs including time commitments and the hourly and annual cost of proposed staff are shown in Table A.14.1.
Table A.14.1. Annualized Cost to the Federal Government
Personnel
|
Number of Personnel |
Time Commitment per Year |
Hourly Wage |
Average Annual Salary |
July 20 – December 31, 2013 |
||||
Health Science Administrator |
1 |
25.00 |
$87.29 |
$2,182.25 |
Public Health Analyst |
1 |
362.50 |
$73.39 |
$26,603.88 |
Statistician |
1 |
45.83 |
$72.21 |
$3,309.38 |
Management Analyst / Consultant |
1 |
240.00 |
$126.85 |
$30,444.00 |
January 1 – July 19, 2014 |
||||
Health Science Administrator |
1 |
35.00 |
$90.78 |
$3,177.30 |
Public Health Analyst |
1 |
507.50 |
$76.33 |
$38,737.48 |
Statistician |
1 |
64.17 |
$75.10 |
$4,819.17 |
Management Analyst / Consultant |
1 |
336.00 |
$131.93 |
$44,328.48 |
Material Costs |
|
|
|
$8,960.11 |
TOTAL |
|
|
|
$162,562.05 |
This is a new data collection.
Table A.16.1 provides a draft time schedule we currently use for the survey.
Activity |
Time Schedule |
Pilot Survey feedback (4 responses) |
March 2014 |
Sample contact begins |
1 month after OMB approval |
Telephone follow-ups begins |
1 month after OMB approval |
Survey field period ends |
6 months after OMB approval |
Draft reports created |
7 months after OMB approval |
Final public report available |
9 months after OMB approval |
Outreach begins after results are released |
10 months after OMB approval |
Outreach ends |
18 months after OMB approval |
The project analysis plan will examine the following research questions.
What are the characteristics of the surveyed hospitals?
What MCE-related preparedness activities have hospitals undertaken?
Are there differences in preparedness activities by trauma level and patient population?
To address the first research question, analysis will include descriptive statistics (e.g. frequencies, means, medians, and variance) on survey questions regarding hospital characteristics such as number of beds, trauma level designation, geographic location, and number of staff. Tables A.16.2 and A.16.3 present shell tables as examples to be used for descriptive statistics.
Table A.16.2 Shell Table for Trauma Level Designation |
|
|
Trauma Level Designation |
Frequency |
Percent |
Adult Hospitals Not Designated Trauma Level I Trauma Level II Trauma Level III Trauma Level IV Trauma Level V Trauma Level Other Pediatric Hospitals Not Designated Trauma Level I Trauma Level II Trauma Level III Trauma Level IV Trauma Level V Trauma Level Other |
|
|
Table A.16.3 Shell Table for Average Number of Staffed Beds |
|
|
Number of Staffed Beds by Unit |
Mean |
Range |
Burn Beds Emergency Department (ED) Emergency Department (Pediatrics) Intensive Care (Medical) Intensive Care (Surgical) Intensive Care (Neonatal) Intensive Care (Pediatrics) Medical-Surgical Beds (Adult) Medical-Surgical Beds (Pediatrics) Obstetrics Operating Room Post Anesthesia Care |
|
|
The second research questions will similarly be addressed using descriptive statistics. Analyses will assess emergency operations planning, emergency supplies, mutual aid agreements, and emergency preparedness training. Table A.16.4 presents a shell table for the frequency and characteristics of Emergency Operations Plans.
Table A.16.4 Shell Table for Frequency of Emergency Operations Plan |
||
Emergency Operations Plan |
Frequency |
Percent |
Hospital has Emergency Operation Plan (EOP) EOP is integrated into local emergency preparedness planning EOP includes preparedness for MCE EOP addresses needs of people with functional and access difficulties EOP addresses credentialing of volunteer practitioners EOP includes procedures to stand up an Incident Command System |
|
|
The third research question will be assessed by examining differences in preparedness activity levels between hospital groups. Analyses will examine differences based on trauma level, patient population (adult vs. pediatric), and number of beds. Statistical analyses will include chi-square, t-test, and logistic regression modeling. Specific analyses will be determined by the number of responses received per group. Groups may be combined to allow for sufficient numbers to estimate differences. Table A.16.5 presents a shell table for reporting odds ratios for the existence of an Emergency Operations Plan.
Table A.16.5 Shell Table for Odds Ratios for Existence of Emergency Operations Plan |
||||
|
N |
% |
OR |
95% CI |
Trauma Level I II III IV/V/Other None (reference) Patient Population Pediatric (reference) Adult |
|
|
|
|
The display of the OMB expiration date is not inappropriate.
There are no exceptions to the certification.
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| File Created | 2021-01-26 |