Prevalence Survey of Healthcare-Associated Infections and Antimicrobial Use in U.S.
Hospitals
(OMB Control No. 0920-0852, Expiration 12/31/2016)
Request for Approval of a Nonsubstantive Change
Part A
July 2014
Contact:
Amy McMillen
Public Health Analyst
National Center for Emerging and Zoonotic Infectious Diseases
Centers for Disease Control and Prevention
Phone: (404) 639-1045
Fax: (404) 639-7090
Email: [email protected]
Table of Contents
A.1. Circumstances Making the Collection of Information Necessary……………….….6
A.2. Purpose and Use of Information Collection……………………………………........10
A.3. Use of Improved Information Technology and Burden Reduction…………..….….12
A.4. Efforts to Identify Duplication and Use of Similar Information……………..……..12
A.5. Impact on Small Businesses or Other Entities………………………………….......14
A.6. Consequences of Collecting the Information Less Frequently……………………..15
A.7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5………….…...15
A.8. Comments in Response to the Federal Register Notice and Efforts to
Consult Outside the Agency……………………………………………………..…15
A.9. Explanation of Any Payment or Gift to Respondents……………………………...15
A.10. Assurance of Confidentiality Provided to Respondents…………………………..15
A.11. Justification for Sensitive Questions………………………………………….…...16
A.12. Estimates of Annualized Burden Hours and Costs…………………………….….17
A.13. Estimates of Other Total Annual Cost Burden to Respondents
or Record Keepers…………………………………………………………………20
A.14. Annualized Cost to the Government………………………………………………20
A.15. Explanation for Program Changes or Adjustments………………………………..21
A.16. Plans for Tabulation and Publication and Project Time Schedule………………...22
A.17. Reason(s) Display of OMB Expiration Date is Inappropriate……………………..23
A.18. Exceptions to Certification for Paperwork Reduction Act Submissions……..........23
References………………………………………………………………………………...24
List of Attachments……………………………………………………………………….26
Prevalence Survey of Healthcare Associated Infections and
Antimicrobial Use in U.S. Hospitals
This is a request for OMB approval of a request for non-substantive change of an approved data collection for the Centers for Disease Control and Prevention (CDC) Healthcare-Associated Infections (HAI) and Antimicrobial Use Prevalence Survey (OMB control number 0920-0852). This data collection was initially funded with the American Recovery and Reinvestment Act of 2009 (ARRA), and was approved through May 2013. A request for reinstatement with change was approved in October 2013, with an expiration date of 12/16/2016. The first approved prevalence survey was planned for 2014, but it had to be delayed due to resource constraints and timeline issues. The CDC is now requesting to conduct a modified, less expensive data collection in 2014 in place of a full-scale prevalence survey, and to conduct the full-scale prevalence survey in 2015.
Summary of the data collections approved by OMB in October 2013:
Two prevalence surveys were approved to be conducted during the 3-year approval period.
Each approved prevalence survey consists of 6 components:
Healthcare Facility Assessment (public burden form)—a questionnaire completed one time in each survey for each hospital participating in the survey. The questionnaire is completed by hospital staff and asks questions about hospital characteristics, and infection control and antimicrobial stewardship policies and practices. See Attachment D
Patient Information Form (public burden form)—completed by hospital staff for each patient included in the survey. It collects information on patient demographics and limited clinical data. See Attachment E.
Antimicrobial Use Form (government burden form)—completed by Emerging Infections Program staff through review of medical records of patients included in the survey who are identified as being administered antimicrobials at the time of the survey. See Attachment G.
Healthcare-Associated Infection (HAI) Form (government burden form)—completed by Emerging Infections Program staff through review of medical records of patients included in the survey. See Attachment G.
Emerging Infections Program Healthcare Facility Assessment Form (government burden form)—completed by Emerging Infections Program staff, this is a one-page form on which staff will record basic, publicly-available information about each participating hospital. This is information that the Emerging Infections Program staff can obtain without burdening hospital staff. See Attachment J.
Antimicrobial Prescribing Quality Assessment forms (government burden forms)—completed by Emerging Infections Program staff through review of medical records of patients included in the survey who are identified on the Antimicrobial Use Form as having received specific types of antibiotics or identified as having been treated with antibiotics for specific types of infections. See Attachment K.
The total public burden hours associated with components a and b of the prevalence surveys, annualized over 3 years, was 6325 hours.
Summary of the proposed change to the data collections:
One prevalence survey during the 3-year approval period (in 2015):
This prevalence survey will consist of the same 6 components listed above (a through f).
It will be conducted using the methods approved in October 2013.
In 2014, instead of a prevalence survey, an Antimicrobial Prescribing Quality Assessment data collection will be performed. This will consist of the following components:
Healthcare Facility Assessment (public burden form)—a questionnaire completed one time in each survey for each hospital participating in the Prescribing Quality Assessment. The questionnaire is completed by hospital staff and asks questions about hospital characteristics, and infection control and antimicrobial stewardship policies and practices. See Attachment D.
Emerging Infections Program Healthcare Facility Assessment Form (government burden form)—completed by Emerging Infections Program staff, this is a one-page form on which staff will record basic, publicly-available information about each participating hospital. This is information that the Emerging Infections Program staff can obtain without burdening hospital staff. See Attachment J.
Antimicrobial Prescribing Quality Assessment forms (government burden forms)—completed by Emerging Infections Program staff through review of medical records of patients included in the Prescribing Quality Assessment who are identified through queries of hospital administrative and pharmacy databases as having received specific types of antibiotics or identified as having specific types of infections. See Attachment K.
The methods to be used to select hospitals and patients for the proposed Antimicrobial Prescribing Quality Assessment are different than the methods used in the prevalence survey:
Emerging Infections Program sites will engage convenience samples of up to10 hospitals per site to facilitate rapid completion of the project. Sites are encouraged to engage an approximately equal number of small, medium, and large acute care general and children’s hospitals, since it is possible that Antimicrobial Prescribing Quality varies by hospital size.
Patients will be selected through queries of hospital administrative and pharmacy databases. Patients with selected ICD-9 codes for pneumonia and urinary tract infections, and patients who received at least one dose of selected antimicrobials (intravenous vancomycin or fluoroquinolones) are eligible. A random sample of medical records of patients meeting eligibility criteria during 2013 in each hospital will undergo review and data collection by Emerging Infections Program staff using the Antimicrobial Prescribing Assessment forms.
The goal is to achieve a sample size of 500 patients for each of 7 antimicrobial prescribing events: adult community-acquired pneumonia, pediatric community-acquired pneumonia, adult urinary tract infection, pediatric urinary tract infection, adult intravenous vancomycin, pediatric intravenous vancomycin, and adult fluoroquinolone. Pediatric fluoroquinolone use is uncommon, and will not be assessed.
The sample size of 500 patients per event will result in the desired precision of +/- 5% around the estimate of the proportion of inappropriate antimicrobial use.
The medical record reviews for each event will be distributed evenly across all Emerging Infections Program sites. This means that each site will be responsible for reviewing 50 medical records for each event (or a total of 350 medical records per site for all 7 antimicrobial prescribing events).
Goal of the prevalence survey effort and the purpose of the proposed data collection change:
The ultimate goal of the overall HAI and Antimicrobial Use Prevalence Survey effort are to determine:
Prevalence of HAIs;
Types of HAIs and causative pathogens;
Nature and extent of antimicrobial use in healthcare facilities;
Prevalence of inappropriate antimicrobial use and opportunities for improvement in antimicrobial use;
Prevalence of antimicrobial resistance among pathogens causing HAIs.
Because a survey was conducted in 2011, and the same methods will be used in 2015, it will be possible to assess changes in the above over time.
The proposed Antimicrobial Prescribing Quality Assessment in 2014 serves three purposes related to the Emerging Infections Program HAI and Antimicrobial Use Prevalence Survey effort:
It represents a valuable and important use of awarded funding that will allow CDC and Emerging Infections Program staff to assess the quality of hospital antimicrobial prescribing and the prevalence of inappropriate use (goal c above) in a large sample of patients and hospitals, while working within the limits of currently available resources.
Robust estimates of antimicrobial prescribing quality are critically needed to inform the development of tools to aid hospitals in measuring and improving antimicrobial use. This assessment can be done rapidly, over a period of a few months, in contrast to the full-scale prevalence survey, which takes 1-2 years for data collection, entry and analysis.
This assessment will allow CDC and Emerging Infections Program staff to gain valuable experience in training for and using the Healthcare Facility Assessment Form and the Antimicrobial Prescribing Quality Assessment forms. These forms were not used in the 2011 survey, and therefore data collectors have the least amount of knowledge and experience using these forms as compared to the other forms, such as the Patient Information Form and the HAI Form, that were used in the 2011 survey. Experience gained in 2014 will improve training provided to data collectors for the 2015 survey.
Consequences of the proposed data collection change:
Conducting the full-scale survey in 2015 instead of 2014 means there will be one less data point (during the time period of 2011-2016) to use in evaluating changes in HAI epidemiology over time; however, at this time we do not have the resources identified to conduct a second survey. We continue to work to identify a sustainable means of conducting periodic HAI and Antimicrobial Use Prevalence Surveys to evaluate the impact of prevention programs and changes in HAI epidemiology and burden, and to identify new HAI-related threats to patient safety.
Using available (and already awarded) funds to assess antimicrobial prescribing quality with the Emerging Infections Program addresses a key need and priority area for CDC and for HHS, while at the same time contributing to improved training and therefore better data quality for the 2015 survey.
A. Justification
Circumstances Making the Collection of Information Necessary
Background
This is a request for change of an approved data collection (0920-0852). The change is requested because the prevalence survey initially planned for 2014 had to be postponed until 2015. Conducting the survey at regular intervals provides important information about changes in HAI and antimicrobial use prevalence and epidemiology. This information is necessary to evaluate the success of infection control and antimicrobial stewardship interventions and to understand infections and types of antimicrobial use that should be targeted for more intensive surveillance or prevention and improvement efforts. A change to the existing approval is requested, because changes to data collection plan for 2014 are anticipated. In addition, the full-scale prevalence survey initially planned for 2014 will now take place in 2015. Changes to the full-scale prevalence survey were approved in October 2013. The approved changes to the public data collection were: 1) minor changes (modifications, additions and deletions) to the data collection form (now called the “Patient Information Form”), and 2) addition of a Healthcare Facility Assessment (a questionnaire that collects information regarding the characteristics and infection control and antimicrobial stewardship policies and practices in place in healthcare facilities participating in the survey).
Changes to the data collection performed by agents of the government have also been made, and were included in the approved request for reinstatement with change. These consist of: 1) minor changes (modifications, additions and deletions) to forms entitled the “Antimicrobial Use Form” and the “HAI Form,” and 2) addition of a limited Healthcare Facility Assessment, and 3) addition of assessments of quality of inpatient antimicrobial prescribing. These prescribing quality assessments are made using antimicrobial prescribing quality assessment forms.
Elimination of HAIs is a priority of the U.S. Department of Health and Human Services (HHS) (see http://www.hhs.gov/ash/initiatives/hai/) and a CDC “Winnable Battle” (see http://www.cdc.gov/winnablebattles/healthcareassociatedinfections/index.html). Understanding the scope and magnitude of all types of HAIs across patient populations in U.S. healthcare facilities is essential to the development of effective prevention and control strategies and policies. CDC currently conducts HAI surveillance through the National Healthcare Safety Network (NHSN) (OMB Control No. 0920-0666, expiration date 01/31/2015). Most healthcare facilities participating in the NHSN report incident device-associated HAIs occurring in high-risk patient locations (such as intensive care units, ICU) and infections related to selected types of surgeries; therefore CDC currently cannot estimate from NHSN data alone the scope and magnitude of all HAIs affecting the wide spectrum of patient populations. Furthermore, CDC does not currently collect detailed, patient-level data within the NHSN or other surveillance systems on inpatient antimicrobial use in a national sample of healthcare facilities. Such data are essential in the effort to develop and implement strategies to reduce inappropriate antimicrobial use and prevent the emergence and spread of resistant pathogens. Improving antimicrobial prescribing is a critical component of strategies to reduce antimicrobial resistance, and is a priority for CDC and other government agencies (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6309a4.htm?s_cid=mm6309a4_w).
HAI prevalence estimates as well as estimates of antimicrobial use can be obtained through prevalence surveys, in which data are collected in healthcare facilities during a short, specified time period. Although providing only a snapshot of the frequency and nature of HAI and antimicrobial use, prevalence surveys represent an efficient and cost-effective alternative to prospective, hospital-wide incidence studies. In 2009, the CDC proposed to conduct two surveys (referred to as “Phase 2” and “Phase 3”) to evaluate the prevalence of HAIs and antimicrobial use in acute care hospitals in multiple states. This survey development initiative was initially a three phase project. The first phase, a small, single-city pilot survey with less than 10 respondents, was completed in 2009 [1]. Phases 2 and 3 were conducted in collaboration with state public health authorities and with the CDC’s Emerging Infections Program (EIP). Phase 2 was a limited roll-out survey involving 22 healthcare facilities in the 10 states with EIP sites (CA, CO, CT, GA, MD, MN, NM, NY, OR, TN). Phase 2 received OMB approval on May 18, 2010. Phase 2 data collection by local infection control personnel in participating hospitals and by EIP personnel was completed in 2010. In 2011, CDC completed the Phase 3 HAI and antimicrobial use prevalence survey using experience and knowledge gained during Phase 2. In this Phase 3 survey, approximately 4% of the 11,282 patients surveyed had one or more HAIs at the time of the survey. In addition, more than half of all HAIs detected were not associated with medical devices or procedures, and more than half of all HAIs were attributed to non-ICU patient locations. Pneumonia and other lower respiratory infections were the most common type of HAI, accounting for more than one quarter of all HAIs reported. Only 39% of pneumonias were ventilator-associated. The most common pathogens were Clostridium difficile and Staphylococcus aureus. Antimicrobial use was prevalent; approximately half of all surveyed patients were receiving at least one antimicrobial agent at the time of the survey. Vancomycin, a drug used to treat infections with resistant Gram-positive pathogens such as methicillin-resistant S. aureus (MRSA), was the most common antimicrobial used.
The next survey, planned for 2015, will include up to 500 healthcare facilities in the 10 EIP sites. Although the overall survey methods will be the same as those used in Phases 2 and 3, minor changes to the public burden data collection instrument were made based on experience gained in the prior surveys. These changes were approved with the reinstatement in October 2013. Data are collected from medical records and healthcare facility information systems. Patients are not interviewed. Data collectors may consult with healthcare facility staff on inpatient units to obtain information regarding patients with selected medical devices in place, patients on antimicrobial therapy, etc. In addition to the minor data collection instrument changes approved for the next survey, a healthcare facility assessment was added and also approved in October 2013. The assessment constitutes burden to the public, as it will be completed by hospital staff before the survey is conducted, and will allow for a description of the survey hospitals and their infection control and antimicrobial stewardship resources and practices; this information was not gathered in Phases 2 and 3, and this information gap was a limitation of those survey phases.
In preparation for the next full-scale prevalence survey in 2015, we will administer the approved healthcare facility assessment to up to 100 healthcare facilities in the 10 EIP sites in 2014. Also in 2014, rather than conducting the full-scale prevalence survey, EIP data collectors will conduct an assessment of antimicrobial prescribing quality in up to 100 healthcare facilities in the 10 EIP sites using the antimicrobial prescribing quality assessment forms developed for the full-scale survey.
This data collection is authorized by Section 301 of the Public Health Service Act (42 U.S.C. 241) (Attachment A) and the American Recovery and Reinvestment Act of 2009 (ARRA) (Attachment C).
1.1 Privacy Impact Assessment
As in Phase 2 and Phase 3, patient and healthcare facility data in the next surveys will be collected on paper forms from existing sources of information, including electronic and paper medical records and healthcare facility information systems, and entered into a CDC-developed, data management system. For the 2014 data collection, an Access database or other similar database will be utilized. For the full-scale prevalence survey in 2015, a web-based data management system will be used. Data collection and data entry partners will include local healthcare facility staff (e.g., infection preventionists and other staff working in their own healthcare facilities), EIP site personnel, academic collaborators, and local and state public health professionals. EIP sites will have access to data submitted from facilities within their catchment areas. The information in the CDC database will be maintained indefinitely, since this data collection will be repeated at regular intervals for comparison purposes. Information in identifiable form (potentially including name, date of birth, medical record numbers, and medical information) will be maintained by local facilities and/or EIP sites until completion of all survey activities, and according to local and/or state requirements and regulations, but names, dates of birth, and medical record numbers will not be transmitted to CDC. Medical information, including certain dates, will be transmitted to CDC as described below.
Two types of data will be collected: healthcare facility data and patient data.
Healthcare facility information will be collected using the “Healthcare Facility Assessment” (HFA) (Attachment D). The HFA will be completed in 2014 and as part of the survey in 2015. In both years, the HFA will be completed by healthcare facility staff. It includes information regarding the numbers of facility beds, annual discharges, and selected staff members in the facility, and information about infection control and antimicrobial stewardship resources, policies and practices. EIP personnel will also gather a limited amount of healthcare facility information using an EIP HFA (Attachment J). Attachment G, J and K are provided as supplemental information only; the EIP data collection is not part of the public burden (see Section 14).
Patient data will be collected through review of medical records. Patients will not be interviewed. Data collectors may consult with healthcare facility staff on inpatient units to confirm information such as patients with selected medical devices in place or patients on antimicrobial therapy. Several patient-level data collection forms will be completed, including a “Patient Information Form” (PIF), “Antimicrobial Use Form” (AUF), “HAI Form” (HAIF), and antimicrobial prescribing quality assessment forms. The forms to be completed in 2014 are the antimicrobial prescribing quality assessment forms. In 2014, the PIF, HAIF and AUF will not be used. In 2015, all forms will be used.
Most data collection and data collection forms will be completed by EIP site personnel. In 2014, EIP site personnel will perform medical record review to complete the antimicrobial prescribing quality assessment forms. Healthcare facility staff will not participate in patient-level data collection in 2014. In 2015, healthcare facility staff may participate in collection of data on the PIF (see Attachment E; example of draft instructions provided in Attachment F). Information from the PIF that is transmitted to CDC includes: unique patient identification code, state, data collection date, age, gender, race, ethnicity, primary payer, survey date, patient location within the healthcare facility, hospital admission and discharge date, weight and height (or birth weight in neonatal locations), outcome, presence and numbers of medical devices (urinary catheter, central line, ventilator), and whether the patient was on antimicrobial therapy.
In 2015, EIP site personnel may assist healthcare facility staff in completing PIF. EIP site personnel are responsible for completing an EIP HFA, the AUF, the HAIF, and the antimicrobial prescribing quality assessment forms (Attachments G, J and K). Data collection pertaining to antimicrobial use includes drug names, route of administration, dose information, start dates, indication or rationale for use, location of onset of the infection for which antimicrobials were prescribed, and therapeutic sites. Data collection pertaining to HAIs includes whether an HAI was present, the types of HAI, and details of the HAI (the specific type, whether device or procedure-associated, location and dates of onset and treatment, dates on which all definition criteria were met, causative pathogens, and antimicrobial susceptibility of those pathogens). Data collected to assess quality of antimicrobial prescribing will include detailed information on antimicrobial treatment, patient allergies or other adverse events, underlying conditions and diagnoses, clinical signs and symptoms of infection, and results of laboratory and microbiological testing. Prescribing quality will be assessed for several different prescribing events: adult and pediatric pneumonia, adult and pediatric urinary tract infection, adult and pediatric intravenous vancomycin prescribing, and adult fluoroquinolone prescribing. Attachments G, J and K are provided as supplemental information only; the EIP data collection is not part of the public burden (see Section 14). Note that the data collection items appearing in Attachment G, J and K are subject to minor modification, based on practical and scientific considerations that may come to light during the planning, training, and implementation of the EIP data collection.
Although medical information and hospital admission and discharge date, survey dates (in 2015) and data collection dates, infection and therapy dates, and other dates pertaining to clinical information (such as date of collection of specimens for testing) will be transmitted to CDC, other patient identifiers, such as name, medical record number and address, will not be transmitted to CDC. Each patient will be assigned a unique identification code that will not contain identifying information. CDC will know the names of healthcare facilities that agree and do not agree to participate in the information collection. EIP personnel will be able to link facility codes with facility names, but CDC will not have these linkages. Local data collectors in participating healthcare facilities and EIP personnel will need to collect information in identifiable form (IIF) for patients within their own facility or catchment area, such as patient name, date of birth, medical record number, healthcare facility unit name and patient’s room number. This information will not be transmitted to CDC.
If resources are available, data validation of patient-level data will be performed as part of the 2015 survey through a Contractor. The Contractor will identify and engage qualified, local or regional expert infection preventionists (referred to as the “Evaluation Team” or “EVALT”) to validate data collection in each EIP site. The EVALT will perform retrospective medical record review for a sample of surveyed patients in each EIP site. We anticipate that this sample in each EIP site will consist of an approximately 10-20% random sample of patients surveyed by local hospital staff and/or EIP personnel. The EVALT will collect similar patient data as the local hospital staff and EIP personnel (Attachments E and G). The EVALT will also be asked to record on a worksheet the criteria utilized in making HAI determinations for those patients found to have HAIs.
2. Purpose and Use of Information Collection
Preventing HAIs and encouraging appropriate use of antimicrobials are HHS and CDC priorities. Essential steps in reducing the occurrence of HAIs and prevalence of resistant pathogens are to estimate accurately the burden of HAIs in U.S. healthcare facilities, describe the types of infections and causative organisms, and assess the nature and extent of antimicrobial use. Until the 2011 prevalence survey was performed, the burden of HAIs in acute care hospitals in the United States was last estimated in 2002 [2]; this number, 1.7 million HAIs (causing approximately 99,000 deaths), continued to be cited for many years by scientists, public health officials, and policy makers. New estimates were needed for public health priority setting, for policy-making purposes, and for communications with the public and other stakeholders. New estimates were also needed for public health priority setting, for policy-making purposes, and for communications with the public and other stakeholders. Updated estimates, and a current understanding of HAI and antimicrobial use epidemiology, continue to be necessary for collaborations with partners in other parts of the world (the European Union, for example) and internally within state health departments and the CDC for setting surveillance and prevention priorities.
The 2011 Phase 3 survey results have been summarized earlier in this Information Collection Request (see Section A.1). Updated HAI burden estimates have been generated using 2011 survey data and data from the Nationwide Inpatient Sample (NIS), Healthcare Cost and Utilization Project (HCUP), Agency for Healthcare Research and Quality. The HAI survey results and burden estimates were published in The New England Journal of Medicine on March 27, 2014 [37]. We estimated that approximately 722,000 HAIs occurred in 648,000 acute care hospital patients in 2011. Approximately 75,000 patients with HAIs died during their hospitalizations (http://www.cdc.gov/HAI/surveillance/).
Results from the 2011 survey have been used in a variety of settings, including the following:
State health departments of participating EIP sites have shared 2011 survey data with their HAI Committees to inform priority setting for public health initiatives to improve antimicrobial use;
The CDC has used the 2011 survey data to launch a targeted evaluation of the clinical correlates of events detected by surveillance definitions of non-ventilator-associated pneumonia and lower respiratory infection (the most common HAI type overall in the 2011 survey). This evaluation is a first step toward developing better surveillance definitions and prevention approaches for these common infections (which have not to date been a focus of prevention efforts).
The CDC used the survey results to inform development of forms to assess antimicrobial prescribing quality. The current forms are based on the most common scenarios encountered in the 2011 survey, including use of antimicrobial agents for urinary tract infection and community-onset pneumonia, and use of vancomycin (the most commonly-used antimicrobial agent overall) and fluoroquinolones (the most commonly prescribed class of antimicrobial agents).
The CDC has collaborated with the European Centre for Disease Prevention and Control (ECDC) to harmonize HAI and antimicrobial use prevalence survey methods to allow for selected comparisons of prevalence and burden, and facilitate international situational awareness of HAI and antimicrobial use. Collaborations on prevalence survey methods between the CDC and the ECDC are included in the work plan for the Transatlantic Task Force on Antimicrobial Resistance (see http://ecdc.europa.eu/en/activities/diseaseprogrammes/TATFAR/Documents/210911_TATFAR_Report.pdf).
Burden estimates for selected HAIs generated using survey data have been used to validate estimates obtained through other surveillance systems, such as the National Healthcare Safety Network (e.g., central line-associated bloodstream infections, surgical site infections).
Because there is no ongoing surveillance for all HAI types occurring across patient populations in U.S. healthcare facilities, understanding the impact of prevention programs and ensuring that prevention initiatives are targeted to the highest-priority, highest-impact conditions requires repeating the prevalence survey at regular intervals. Without ongoing surveys, knowledge of the entire spectrum of HAIs and antimicrobial use will be lost. There are no other surveillance systems currently in the United States that can provide this information. In addition, the proposed data collection on antimicrobial prescribing quality in 2014 will be the CDC’s first large-scale attempt to evaluate the prescribing quality in the inpatient setting, and will contribute greatly toward understanding those agents or infections that should be the focus of local, state or national stewardship programs and will improve the quality of data collected during the full-scale survey in 2015. To our knowledge, no other large-scale, patient-level assessment of inpatient antimicrobial prescribing quality use is underway in the United States.
2.1 Privacy Impact Assessment
The antimicrobial prescribing quality assessment and healthcare facility assessment data collected in 2014, and the antimicrobial use, healthcare facility assessment, and HAI data collected in the 2015 survey will be used to determine the prevalence of HAIs, the types of HAIs and causative pathogens, the nature and extent of antimicrobial use in healthcare facilities as well as opportunities for improvement in antimicrobial use, the prevalence of antimicrobial resistance among pathogens causing HAIs, and the prevalence of certain risk factors for infection, such as medical devices. HAIs are recognized as a major cause of morbidity and mortality in the United States, as well as a major contributor to excess healthcare costs (see http://www.hhs.gov/ophs/initiatives/hai/). Eliminating HAIs is a priority of the CDC and other federal agencies. The prevalence survey in 2015, like the 2011 survey, will provide estimates of the magnitude and burden of HAIs in a large sample of U.S. acute care inpatients forming the foundation for development and implementation of effective prevention measures, and will enable an assessment of change in burden and epidemiology of HAIs and antimicrobial use over time. During this data collection, CDC will neither receive nor share IIF, with the exception of medical information as described above. Sensitive information being collected includes information race and ethnicity, information on the presence of underlying conditions such as HIV/AIDS, drug use, and alcoholism, and the presence of HAIs and appropriateness of antimicrobial use. Data will be entered into the electronic data management system and retrieved by CDC using identification codes that do not contain patient identifiers. CDC will analyze and report aggregated data obtained during the data collection. The results may be shared in local, state, national and international presentations and publications, and will be used by local, state and federal public health authorities to inform the development of HAI prevention and antimicrobial stewardship strategies and policies. Individual healthcare facilities may also request their own results from EIP sites and use the data to inform institution-level practice and policy.
3. Use of Improved Information Technology and Burden Reduction
As in Phases 2 and 3, the proposed data collection in 2014 and the survey in 2015 will use paper data collection forms because survey personnel will in some cases need to travel to multiple patient units within healthcare facilities to collect data and will not necessarily have reliable, timely access to computers or the internet. Electronic health record systems are not currently in use in all healthcare facilities, and information technology resources vary widely among healthcare facilities. Data will be entered by EIP site personnel into a CDC-developed database such as Microsoft Access, or into a CDC-developed, web-based, electronic data management system. No personal identifiers such as name or medical record number will be submitted to CDC. Dates as noted above will be recorded on paper forms and in the data management system, and will be submitted to CDC.
As part of the proposed data collection, healthcare facility staff will complete a HFA (see Section A.1.1 and Attachment D). The HFA is a questionnaire that will be completed on a one-time basis by staff members in participating facilities in 2014 and in 2015. EIP personnel will provide the HFA and instructions to healthcare facility staff either in person or via electronic communication. The HFA will be completed in paper form, due to the wide array of electronic communication capabilities across healthcare facilities and because it is anticipated that the healthcare facility staff member completing the HFA may need to consult with other colleagues in the facility to answer some of the HFA questions. EIP personnel will enter HFA data into the data management system for sharing with CDC.
4. Efforts to Identify Duplication and Use of Similar Information
CDC’s first large-scale HAI prevalence survey was conducted in the 1970s (Study on the Efficacy of Nosocomial Infection Control, SENIC), using a team of trained abstractors to collect comprehensive HAI data from a probability sample of 338 hospitals [3]. The SENIC project, which took several years to complete, found that approximately 5% of hospitalized patients acquired an infection not present or incubating at the time of admission [4]. In the 1980s and 1990s CDC conducted voluntary, hospital-wide infection surveillance through the National Nosocomial Infections Surveillance (NNIS) system (OMB Control Number 0920-0012); in NNIS, data were reported from local hospital personnel rather than a common team of CDC-trained data collectors (http://www.cdc.gov/ncidod/dhqp/nnis.html). As demands on infection control grew, voluntary NNIS hospitals began to perform targeted surveillance in high-risk hospital areas (such as intensive care units) that were most useful in calculating risk-adjusted HAI incidence rates. The NNIS system’s hospital-wide HAI surveillance component was eliminated in 1996. CDC’s successor to the NNIS system, the National Healthcare Safety Network (NHSN) (OMB Control No. 0920-0666), is not designed to estimate the scope and magnitude of HAIs hospital-wide; rather, it focuses on device-associated and procedure-associated infections (e.g., central-line associated bloodstream infections, catheter-associated urinary tract infections, surgical site infections, etc.) (http://www.cdc.gov/nhsn/about.html), and selected infections due to resistant organisms. A new reporting module also allows healthcare facilities to submit location-specific antimicrobial consumption data to the NHSN; data submission must be done electronically (i.e., no manual data entry), and facility-wide data submission is not required. Patient-level data are not submitted to the antimicrobial use reporting option. Healthcare facility participation in the NHSN is in many cases driven by state HAI reporting mandates and by requirements of the Centers for Medicare and Medicaid Services’ (CMS) Hospital Inpatient Quality Reporting (IQR) Program, which includes selected HAIs. In its current form, the NHSN cannot provide estimates of HAI for all types of HAIs or antimicrobial use throughout an entire hospital. Measurements of the magnitude and types of HAIs and nature and extent of antimicrobial use occurring across all acute care patient populations are needed to inform decisions by local and national policy makers and by hospital infection control personnel regarding appropriate targets and strategies for HAI prevention, measures to encourage appropriate antimicrobial use, and/or justification to focus efforts at specific antimicrobial resistant infections. Such measurements, while not directly obtainable within the current NHSN infrastructure, can be obtained in prevalence surveys. Prevalence surveys have been conducted in several countries around the world in recent years [5-29]. The first large-scale U.S. prevalence survey since the 1970s was conducted in 2011. There are currently no duplicate efforts underway within the United States, although it is our understanding that a global prevalence survey focusing on antimicrobial use (not HAIs) is being planned by a biotechnology company (http://www.biomerieux.com/en/4th-world-hai-forum-antimicrobial-resistance). The extent to which U.S. hospitals will be included in this effort is uncertain.
While the information collected in the prevalence survey is broader in scope than the data collected in the NHSN, there may be some minimal overlap. Most hospitals in the United States are participating in central line-associated bloodstream infection (CLABSI) surveillance and catheter-associated urinary tract infection (CAUTI) surveillance in intensive care units through the NHSN as part of required reporting for the CMS IQR program. Most hospitals are also reporting deep incisional and organ/space SSI data from colon surgeries and abdominal hysterectomies to the NHSN because of CMS requirements. Other, more recent additions to the CMS IQR program requirements include reporting of facility-wide MRSA bacteremia and C. difficile infection through the NHSN. We estimate that these infections account for approximately 24% of all HAIs, based on 2011 Phase 3 survey results. It is important to note that while we estimate that approximately 24% of the HAIs identified in the prevalence survey in a given hospital will have to be entered in to the NHSN system, each facility will conduct the prevalence survey over a very short period of time (one day) and will only be collecting data on a sample of patients in the facility during that short time period. For example, a hospital with 500 acute care beds may be asked to review 100 patient medical records for the purposes of the prevalence survey. If 4% of these patients have HAIs (4 patients) and we estimate that 24% of HAIs detected will also need to be entered into NHSN, that represents a burden of approximately one patient record for that facility.
Other CDC systems that have the capability of collecting information on HAIs in acute care inpatients include the National Health Care Survey (NHCS), run by the National Center for Health Statistics (NCHS). The NHCS integrates three surveys: the National Hospital Discharge Survey (NHDS), the National Hospital Ambulatory Medical Care Survey, and the Drug Abuse Warning Network. The NHCS collects data on inpatients and visits to emergency departments and outpatients departments including ambulatory surgery. We in the Division of Healthcare Quality Promotion (DHQP) previously worked with NCHS staff to incorporate a CLABSI event detection component into the redesigned NHDS, precursor to the NHCS, in 2007-2008. The conclusion of a 9-facility pilot of this event detection component (presented by Ms. Nancy Sonnenfeld in June 2008 to DHQP) was that the required sampling of charts to enhance the likelihood of detecting a CLABSI was successful in only half of the pilot hospitals. The required data elements to detect CLABSI events (which represent less than 10% of all HAIs) more than doubled the chart abstraction time compared to the typical redesigned NHDS review, rendering this component impractical for inclusion in the NHDS.
With the implementation of the NHCS in 2011, a new sample of approximately 500 hospitals is being recruited to participate. Hospital recruitment is anticipated to be completed in the next 1-2 years. Hospitals participating in the NHCS submit their inpatient and ambulatory UB-04 administrative claims data to the NHCS. Questionnaires are also completed to gather facility-level information. While studies have shown that administrative claims data are not acceptable for identifying HAIs [30-33], we understand that in future years, it will be possible to conduct special projects within the NHCS, such as projects involving detailed medical record abstraction and collection of clinical data. We have begun discussions with NCHS colleagues (Clarice Brown, Paul Beatty and Carol DeFrances) to explore the possibility of using the NHCS infrastructure in future years to conduct or enhance the HAI and antimicrobial use prevalence survey, recognizing the potential limitations, such as loss of comparability with data collected using the EIP infrastructure in 2011 and 2015.
5. Impact on Small Businesses or Other Small Entities
Small healthcare facilities may participate in the data collection in 2014 and 2015. Participation is voluntary, but we anticipate that most facilities selected for participation will agree to participate. Elimination of HAIs and improving antimicrobial prescribing are major goals of all U.S. healthcare institutions, large and small, and we expect that facilities will be highly motivated to participate. The data collection and management burden for participating healthcare facilities will be minimized as much as possible. This will be accomplished by having EIP personnel perform most of the data collection. In hospitals that agree to participate but that have insufficient resources to perform any data collection, EIP personnel may perform all of the data collection.
6. Consequences of Collecting the Information Less Frequently
The survey was developed with the goal of repeating it at regular but infrequent intervals (e.g., once every 3 years). Repeating the survey will provide information on changes in HAI prevalence over time as well as changes in the burden and distribution of infection types and causative organisms. There are no technical or legal obstacles to reducing the burden.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances that require the information to be collected in any of the formats identified, and the request fully complies with regulations.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency
A. A Federal Register Notice was published on 12/04/2012, volume 77, No. 233, page 71798-71899. No public comments were received. (Attachment B)
As required in the Notice of Action for the Phase 2 survey, on June 14, 2010 we consulted with colleagues in the National Center for Health Statistics (Dr. Jane Sisk, former Director of the Division of Health Care Statistics, Attachment H). In the process of developing and conducting Phases 2 and 3 of the prevalence survey we also consulted with experts in the ECDC, where our primary point of contact is Dr. Carl Suetens, Senior Expert. We have continued our communications with ECDC experts, participating in conference calls (such as a call of the Transatlantic Task Force on Antimicrobial Resistance on June 13, 2013) and attending meetings (including a meeting of the European Antimicrobial Resistance and HAI Networks in Berlin, Germany in November 2012), and expect to maintain this collaboration in the years to come.
9. Explanation of Any Payment or Gift to Respondents
Participating healthcare facilities may receive a certificate or letter of appreciation. EIP sites or state health departments may choose to provide education and/or training resources to participating facilities.
10. Assurance of Confidentiality Provided to Respondents
Data will be treated in a secure manner, and will not be disclosed, unless otherwise compelled by law. As in previous survey phases, a unique code will be assigned to each patient included in the survey. These codes will not include patient identifiers. The codes will be linked at the facility level and EIP site level to the individual patient from whose record the data were collected; however, those links and patient identifiers other than certain dates will not be shared with CDC. CDC will know the identities of healthcare facilities within EIP catchment areas, those facilities within the catchment areas that are eligible for participation, those facilities that are selected to participate, and those facilities that agreed or did not agree to participate. EIP sites will use codes to identify specific facilities. Data collection forms will be filled out using patient and facility codes. Links between facility codes and names will be maintained by EIPs and will not be shared with CDC. Participating facilities’ data will be aggregated by CDC to provide HAI and antimicrobial use prevalence estimates. Data may be analyzed to determine whether certain facility characteristics (e.g., bed size, etc.) or patient characteristics are associated with aspects of HAI prevalence or antimicrobial prescribing. An individual participating facility may have access to its own data (e.g., provided in a report prepared by the EIP site staff). Individual states and/or CDC may choose to present or publish state-specific survey data. Individual states, in consultation with participating facilities in that state, may elect to present or publish facility-specific information.
The data management system for Phases 2 and 3 was certified and accredited as a Level 1 system. The same data management system will be used for the 2015 survey, with some minor modifications to reflect changes to the data collection forms. These modifications will also undergo the appropriate approval processes prior to implementation. For the proposed 2014 data collection, a database such as Microsoft Access will be utilized. Data entry may be performed in individual EIP sites or at CDC; in cases where sites perform data entry, Access databases will be uploaded to a CDC-established, encrypted FTP site. CDC staff will download site-specific databases from the encrypted FTP site and merge them for analysis purposes.
IRB Approval
The 2011 Phase 3 survey was determined not to be human subjects research. The 2014 Antimicrobial Prescribing Quality Assessment has preliminarily been deemed not to be human subjects research. A formal determination has not yet been sought for the 2015 survey, but we do not anticipate it to differ from the Phase 3 survey determination since the objectives, methods and the nature of the data collection have not changed substantially.
10.1 Privacy Impact Assessment
Healthcare facilities selected to participate in the data collection are informed that participation is voluntary. Individual patients are not the respondents for this data collection, and are not informed of their inclusion in the data collection. There is no interaction of EIP or CDC personnel with individual patients. Participating facilities are provided with their individual results by the EIP sites, upon request. Information received by CDC will be stored in a secure database. Information received by CDC will be provided only to those individuals at CDC with a need to know. Data will be treated in a secure manner, and will not be disclosed, unless otherwise compelled by law. This information collection request has been reviewed by CDC/Information Collection Review Office who has determined that the Privacy Act does not apply.
11. Justification for Sensitive Questions
Information on criminal behavior, sexual behavior and attitudes, and religious beliefs, will not be collected, with the exception of collection of drug use (which impacts the need for vancomycin treatment in patients with skin and soft tissue infections). We will also collect information on patient location within healthcare facilities, and one type of location is a jail unit. Race and ethnicity will be collected by healthcare facility staff and EIP personnel. We believe it is important to collect data on race and ethnicity because studies have indicated that there is a higher burden of some types of HAIs in minority patients. For example, a study published in 2010 showed that post-operative infections were significantly more common among black patients than white patients [34]. Similarly, data from the Emerging Infections Program’s invasive MRSA surveillance have shown that the incidence of healthcare-associated invasive MRSA infections was significantly higher in black persons than in white persons [35]. Data on race and ethnicity will be collected in accordance with federal standards, except that a classification of “other race” will be provided. This category is present in the Nationwide Inpatient Sample database (see http://www.hcup-us.ahrq.gov/db/vars/race/nisnote.jsp), and where possible we have sought to align prevalence survey patient demographic variables with those in the Nationwide Inpatient Sample. For the 2014 antimicrobial prescribing quality assessment, we will collect information on the presence of underlying conditions, including alcoholism, drug use and HIV/AIDS, because these conditions are risk factors for certain types of infections and may warrant modifications to antimicrobial treatment in certain circumstances. The reporting of adverse events occurring in hospitalized patients, including infections, could be considered sensitive unless healthcare facilities are assured that the data-aggregating organization will provide security for the data and maintain the institution’s confidentiality. Data security will be protected as described above.
12. Estimates of Annualized Burden Hours and Costs
A. Infection preventionists (or other designated staff) in participating healthcare facilities will be asked to do the following: 1) complete the HFA on a one-time basis in 2014 and in advance of the survey in 2015, 2) provide lists of patients to EIP staff on a one-time basis for the antimicrobial prescribing assessment in 2014, 3) participate in training for the 2015 survey, and 3) collect survey patient data, limited to basic demographic and clinical information on the PIF.
For the HFA (Table A), respondents will be infection preventionists (or other designated healthcare facility staff). We anticipate up to a total of 500 respondents, one for each participating facility, who will complete the assessment one time in either 2014 or 2015 prior to the survey. The time required to complete the assessment is estimated to be 45 minutes.
For the provision of patient lists in 2014, respondents will be computer systems analysts or other designated healthcare facility staff (such as pharmacy staff or billing/administrative staff). We anticipate a total of up to 100 respondents in 2014. The time required in each facility to generate the patient lists is estimated to be 4 hours.
For the training and PIF completion burden on infection preventionists in participating facilities in the 2015 survey (Table A), we incorporated knowledge gained from the conduct of the Phase 2 and 3 surveys. Please note: throughout this Information Collection Request, any reference to number of patients surveyed or included in the survey should be interpreted to mean the number of patients’ medical records that are reviewed/included in the survey; it does not mean that patients are actually being interviewed or interacted with directly. This is made clear in Section 1.1, above: “Patient data will be collected through review of medical records. Patients will not be interviewed.” In Phase 3, EIP sites asked each participating facility to survey a fixed number of patient records, 75-100 randomly-selected acute care inpatients, depending upon hospital size. Small and medium facilities were asked to survey 75 patients each (or, if the hospital has <75 beds, the facility surveyed all patients), while large hospitals were asked to survey 100 patients each. Small hospitals accounted for 51% of facilities in the survey (and not all of these hospitals had 75 patients to survey), medium hospitals accounted for approximately 37% of facilities in the survey, and large hospitals accounted for 12% of facilities in the survey. With an estimated maximum of 500 facilities participating in the survey, 255 of these would be small hospitals, 185 would be medium hospitals, and 60 would be large hospitals. Of the 255 small hospitals, we estimate that 20% of these (51 hospitals) would be able to review 75 patients, while in the other 80% (204 hospitals), we estimate that 37 patients would be available for review. Therefore, the total number of records reviewed was estimated as follows: [(51 small facilities)*(75 records)] + [(204 small facilities)*(35 records)] + [(185 medium facilities)*(75 records)] + [60 large facilities)*(100 records)] = 30,840 records, which translated to an average of 62 responses per respondent. The time required to participate in training and data collection to complete the PIF is estimated to be 17 minutes.
If 1 Antimicrobial Prescribing Quality Assessment data collection (which includes the HFA) and 1 full-scale survey are conducted during the 3-year approval period:
The estimated burden associated with the HFA (with 2 responses from 500 respondents over 3 three years) is annualized to 0.67 responses per year (rounded to 1 response per year), for each of the 500 respondents, or 375 annual burden hours (Infection preventionist burden, Table A first row).
The estimated annualized burden associated with the provision of patients lists (2014 only in 100 hospitals, 1 response per respondent, 4 hours per response) is annualized to 0.33 responses per year for the provision of patient lists, rounded to 1 response per year (4 hours per year for each of 100 respondents, or 400 hours) (computer analyst burden, Table A second row).
The estimated burden for training and completion of PIFs (2015 only, with 62 responses for 1 survey from 500 respondents) is annualized over 3 years to 20.7 responses per year for the 2015 PIFs, rounded to 21 responses per year (6 hours per year for each of the 500 respondents), or 2975 hours (infection preventionist burden, Table A third row)
Table A: Estimated Annualized Burden Hours
Type of Respondent |
Form Name |
Number of Respondents |
Number of Responses per Respondent |
Average Burden per Responses (in hours) |
Total Burden Hours |
Infection preventionist |
Healthcare Facility Assessment (HFA) |
500 |
1 |
45/60 |
375 |
Computer systems analyst |
NA (provision of patient lists) |
100 |
1 |
240/60 |
400 |
Infection preventionist |
Patient Information Form (PIF) |
500 |
21 |
17/60 |
2975 |
Total |
|
|
|
|
3750 |
Although 17 minutes represents a 2-minute increase in the estimated data collection time from the approved burden for Phases 2 and 3 (and is related to the addition of data collection items), the overall burden to the public (i.e., infection preventionists, hospital computer systems analysts or other designated healthcare facility staff) for the HFA and PIF combined is 3750 hours when annualized over the 3 year approval period.
B. The total cost burden for the infection preventionist respondents in healthcare facilities is estimated as follows: With a total annual burden of 3750 hours, the total cost of the time to respond to the proposed survey is estimated to be $125,891 (Table B). We have utilized the mean hourly wage for a Registered Nurse, $32.66, obtained from the Bureau of Labor Statistics, Occupational and Employment Statistics Section May 2012 data (accessed June 14, 2013 at http://www.bls.gov/oes/current/oes291141.htm). We utilized this wage because: 1) infection preventionists are in many cases Registered Nurses; and 2) there is no wage information specifically for infection preventionists available in the Bureau of Labor Statistics database cited above. We have also utilized the mean hourly wage for a Computer Systems Analyst, $41.02, obtained from the Bureau of Labor Statistics, Occupational and Employment Statistics Section May 2013 data (accessed May 6, 2014 at http://www.bls.gov/oes/current/oes151121.htm). There will be no direct costs to facilities and local data collectors other than their time to participate in the study.
Table B: Estimated Annualized Burden Costs
Type of Respondent |
Form Name |
No. of Respondents |
No. Responses per Respondent |
Avg. Burden per Response (in hours) |
Total Burden Hours |
Hourly Wage Rate |
Total Respondent Cost |
Registered Nurse |
HFA |
500 |
1 |
45/60 |
375 |
$32.66 |
$12,247.50 |
Computer Systems Analyst |
NA (provision of patient lists) |
50 |
1 |
240/60 |
4-200 |
$41.02 |
$ 16,480.00 |
Registered Nurse |
PIF |
500 |
21 |
17/60 |
2975 |
$32.66 |
$97,163.50 |
Total |
|
|
|
|
|
|
$125,891 |
13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers
None.
14. Annualized Cost to the Government
Costs to the government include costs for CDC and EIP site personnel to develop and coordinate data collection activities, EIP site personnel to perform local coordination and data collection and entry activities, costs for a database manager, costs for photocopying survey materials, and costs for an external Contractor to perform data validation activities.
CDC personnel working on the data collection are estimated to include a 0.3 full-time-equivalent (FTE) public health analyst or epidemiologist (see Row #1 of Table C) and a 0.2 FTE database developer and a 0.2 FTE data database manager (see Row #2 of Table C). The mean hourly wage for an epidemiologist is $34.33 (obtained from the Bureau of Labor Statistics, Occupational and Employment Statistics Section May 2012 data, available at http://www.bls.gov/oes/current/oes191041.htm), for a total cost of $21,421. The mean hourly wage for a database administrator is $38.04 (obtained from the Bureau of Labor Statistics, Occupational and Employment Statistics Section May 2012 data, available at: http://www.bls.gov/oes/current/oes151141.htm), for a total cost of $15,825 for a database developer and $15,825 for a database manager.
EIP sites (see Row #4 of Table C) are supported through a Cooperative Agreement with CDC. During a May 7, 2010 teleconference with Dr. Margo Schwab and Ms. Julie Wise from OMB, Dr. Schwab informed CDC prevalence survey personnel that because the EIP is a CDC-run program under a Cooperative Agreement, EIP personnel (and therefore, the forms included in Attachment G, J and K) should not be included in the annualized public burden estimate, but rather in the estimate of annualized cost to the government. We estimate that on an annualized basis, 1.5 FTE employees are needed in each site to conduct survey activities. These employees are epidemiologists, with an estimated hourly wage of $34.33 (obtained from the Bureau of Labor Statistics, Occupational and Employment Statistics Section May 2012 data, available at: http://www.bls.gov/oes/current/oes191041.htm). Therefore, in each EIP site, the estimated annual cost is $107,096. The estimated cost across the 10 EIP sites is $1,070,960.
If resources are available, CDC will work with a Contractor (see Rows #4 and #5 of Table C) to identify external expert infection preventionists to perform data validation in Phase 3. These expert infection preventionists will comprise the Evaluation Team, or EVALT. We estimate that the EVALT will review approximately 6168 medical records (20% sample of all records). Review time for each record on average (including time to fill out the AUF and HAIF for a limited number of records) is estimated to be 27 minutes, including time to account for training and other survey-related activities. Based on previous experience, the hourly cost for these medical record reviews is estimated to be $100.00. The total cost for record review alone is therefore estimated to be $273,750. We estimate an additional $100,000 for coordination and travel- and supply-related expenses. The total estimated cost of this contract is therefore $377,600. If 2 data collections are conducted during the 3-year approval period, the annualized cost of the contract is therefore (2)*($377,600), divided by 3, or $251,733.33.
There will also be costs related to photocopying of forms and instructions. The cost is estimated to be $10,452 ($0.05 to copy each page, estimated 209,040 copies made to support survey activities in 500 facilities in 10 EIP sites). If 2 data collections are conducted during the 3-year approval period, the annualized cost is (2)*($10,452) divided by 3, or $6968.00.
The total annualized cost to the federal government for personnel and photocopying is therefore estimated to be $1,382,732.
Table C: Annualized cost to the federal government
Government Employee Title |
Total Number of Hours Dedicated per Year |
Hourly Rate |
|
CDC epidemiologist |
624 |
$34.33 |
$21,421 |
Database developer |
416 |
$38.04 |
$15,825 |
Database manager |
416 |
$38.04 |
$15,825 |
EIP epidemiologists (1.5 FTE in each of 10 sites) |
31,200 |
$34.33 |
$1,070,960 |
Photocopying |
-- |
-- |
$6,968 |
Contractor—data validation |
2,776 |
$100 |
$251,733 |
Contractor—data validation travel, coordination and supply–related costs |
-- |
-- |
$100,000 |
Total |
|
|
$1,382,732 |
15. Explanation for Program Changes or Adjustments
The program change for the 2014 data collection was made because the resources to conduct a 2014 full-scale prevalence survey did not become available within the time frame in which they were needed.
The program changes for the full-scale survey (change in the year in which it will be conducted, and minor changes to the government data collection forms) were made because of resource limitations in 2014 (necessitating the delay till 2015), and because additional discussions and field testing experience since December 2013 resulted in some refinements to the government data collection for the antimicrobial prescribing quality assessment (see Attachment K).
Note that the annualized burden for the current nonsubstantive change request is 5350 hours, which is less than the burden approved with the reinstatement (6325 hours) and the previously approved burden of 9158 hours for the Phase 3 survey. This difference is because the current burden estimate has been developed with the anticipation of performing 2 data collections during a 3-year approval period (one in year 1 of the approval period, and one in year 2 of the approval period), and dividing that total burden over the 3 years of the approval period. In the original, approved ICR, the total burden approved represented the burden for performing the survey during the single year in which it was conducted; the burden was not divided into equal parts over the 3-year approval period.
16. Plans for Tabulation and Publication and Project Time Schedule
A patient-level surveillance dataset will continue to be maintained at CDC. This dataset will be used to determine HAI prevalence and antimicrobial use prevalence, the distribution of HAI types and causative organisms, and the distribution of types of antimicrobials and rationale for their use. Analysis will occur in SAS version 9.3 or newer versions as they become available (SAS Institute, Carey, NC) and OpenEpi versions 2.3.1 and 3.01 (or newer versions as they become available). Categorical and continuous variables will be compared in patients with and without HAIs (and receiving and not receiving antimicrobials) using chi-square tests and Wilcoxon rank-sum or median tests, respectively. Associations between patient and facility-level characteristics and HAIs and antimicrobial use will be explored using univariate and multivariable log binomial regression modeling or other appropriate methods. HAI and antimicrobial use prevalence will be converted to incidence using the formula of Rhame and Sudderth [36]. HAI and antimicrobial use burden estimates will be generated using prevalence survey data and data from the Nationwide Inpatient Sample, Healthcare Cost and Utilization Project, Agency for Healthcare Research and Quality.
Results from this data collection will be presented at national meetings and published in a manuscript format in a peer-reviewed scientific journal. Publications will include a discussion of potential biases and other limitations of the project.
Because of planning and funding considerations, we will conduct the 2014 portion of the data collection as soon as possible following OMB approval of this change to the Information Collection Request.
Table A.16.1: Project time schedule
Activity |
Time Schedule |
Initiating work with hospital computer systems analysts to generate patient lists from which records will be reviewed for the antimicrobial prescribing assessment in 2014 |
Immediately, or within 1-2 months after OMB approval (August 2014) |
Data collection by EIP personnel |
Within 4 months after OMB approval (October 2014) |
Transmission of data to CDC |
Within 7 months after OMB approval (January 2015) |
Analysis and presentation of results |
Within 10 months after OMB approval (April 2015) |
Training of infection preventionists in participating hospitals |
Immediately, or within 1-2 months after OMB approval (April 2015) |
Conduct of survey |
Within 2-6 months after OMB approval (April-August 2015) |
Data collection by EIP personnel |
Within 3-12 months after OMB approval (May 2014-April 2016) |
Transmission of all survey data to CDC |
Within 15 months after OMB approval (July 2016) |
Analysis and presentation of results |
Within 15-20 months after OMB approval (July 2016-November 2016) |
17. Reason(s) Display of OMB Expiration Date is Inappropriate
The display of the OMB expiration date is not inappropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.
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List of Attachments
A: United States Code, Title 42, Chapter 6A Part 241 (referenced in Part A)
B: 60-day Federal Register Notice (referenced in Part A)
C: American Recovery and Reinvestment Act of 2009 (referenced in Part A)
D: Healthcare-Associated Infections and Antimicrobial Use Prevalence Survey Healthcare Facility Assessment (HFA) (referenced in Part A)
E: Healthcare-Associated Infections and Antimicrobial Use Prevalence Survey Patient Information Form (PIF) (referenced in Part A)
F: Primary Team instructions for data collection (draft example) (referenced in Part A)
G: Antimicrobial Use Form and Healthcare-Associated Infection Form: supplemental information; data collection forms utilized by EIP personnel and the Contractor, but NOT completed by infection preventionists in participating healthcare facilities, and not part of the public burden (referenced in Part A)
H: Email correspondence from Dr. Jane Sisk, Director, Division of Healthcare Statistics, National Center for Health Statistics (referenced in Part A)
I: Example of informational document distributed to healthcare facilities in EIP catchment areas (referenced in Part B)
J: EIP Healthcare Facility Assessment Form: supplemental information, not part of the public burden (referenced in Part A)
K: Antimicrobial Prescribing Quality Assessment Forms: draft, supplemental information, not part of public burden (referenced in Part A)
| File Type | application/msword |
| File Title | OMB Package |
| Author | hgx8 |
| Last Modified By | CDC User |
| File Modified | 2014-07-31 |
| File Created | 2014-07-31 |