SUPSTAT_HHS OMB 0970-0466_Final

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Initial Medical Exam Form and Dental Exam Form

OMB: 0970-0466

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Initial Medical Exam Form and Dental Exam Form


OMB Information Collection Request

0970 - 0466




Supporting Statement Part A - Justification

September 2020















Submitted By:

Office of Refugee Resettlement

Administration for Children and Families

U.S. Department of Health and Human Services













SUPPORTING STATEMENT A – JUSTIFICATION



Executive Summary


The Administration for Children and Families’ Office of Refugee Resettlement (ORR) is requesting an extension of the approved Initial Medical Exam Form (which includes the Supplemental Tuberculosis (TB) Screening Form) and Dental Exam Form (previously called the “Initial Dental Exam Form”) data collection for unaccompanied children (UAC) in custody (OMB #0970-0446).


ORR received emergency approval in March 2020 to include COVID-related questions to this previously approved information collection and is now requesting approval to continue the information collection. Since approval in March, ORR has needed to make changes to the forms, including: formatting for the new electronic data repository, adding and rewording a few additional fields, adding additional burden for routine dental exams, and amending the existing burden estimate to account for burden assumed by healthcare providers.



  1. Circumstances Making the Collection of Information Necessary

Pursuant to Exhibit 1, part A.2 of the Flores Settlement Agreement (Jenny Lisette Flores, et al., v. Janet Reno, Attorney General of the United States, et al., Case No. CV 85-4544-RJK (C.D. Cal. 1996), the Administration for Children and Families’ Office of Refugee Resettlement (ORR), on behalf of the Department of Health and Human Services (DHHS), is directed to provide unaccompanied children in their custody with medical, mental, and dental care until reunification with a qualified sponsor. Unaccompanied minors in ORR custody are placed in grantee-operated licensed care provider facilities that arrange for appropriate healthcare as directed by ORR. All children are required to receive a complete medical examination including screening for infectious diseases and immunizations recommended by the Centers for Disease Control and Prevention within 2 business days of admission into an ORR-funded licensed care provider facility. If children are still in ORR custody 60 to 90 days after admission, they are required to receive an initial dental exam, or sooner if directed by state licensing requirements. Additional required services include routine medical and dental care, family planning, and emergency health care.


ORR requires grantees to maintain records on each child to ensure that health-related evaluations, diagnosed conditions/illnesses, immunizations, and treatments are documented and included in the child’s discharge packet at the time of reunification. ORR requires the Initial Medical Exam and Dental Exam information collections to implement and maintain compliance with the Flores Settlement Agreement (Attachment A).

  1. Purpose and Use of the Information Collection

The purpose of these instruments is to collect standardized health information on unaccompanied children during 1) an initial medical exam, 2) an initial dental exam, and 3) subsequent preventive dental visits. Data collection for urgent and routine medical and mental healthcare visits, however, is conducted under a separate OMB-approved information collection: Medical Complaint Form, Contact Investigation Form: Non-TB Illness, and Contact Investigation Form (OMB #0970-0509).


The Initial Medical Exam, Supplemental TB Screening, and Dental Exam Forms are completed by healthcare providers and then returned to grantee staff for data entry into an electronic version of the form that resides in ORR’s secure data repository known as the “UAC PATH”. ORR will use data from these forms to identify and track illnesses and conditions that require monitoring, control, and follow-up and to ensure that grantees and healthcare providers are following ORR guidelines.


While TB screening is an intrinsic part of the initial medical exam, ORR created a supplemental form for recording TB screening results because grantee staff may be required to take children to the health department for screening if the healthcare provider performing the initial medical exam lacks onsite testing or is unable to perform the testing in the stipulated timeframe.


ORR also requires documentation of all health-related services rendered (e.g., immunization record, lab results, imaging study reports, office notes) in order to provide oversight on medically complex cases, authorize additional diagnostic work-ups and procedures, and verify entered health data. The collection of this information in a central location allows for continuity of care for transferred and readmitted children.



  1. Use of Improved Information Technology and Burden Reduction

Grantee staff will enter data from the Initial Medical Exam, Supplemental TB Screening and Dental Exam forms into UAC PATH and upload the original form to the child’s record. Fields in the UAC PATH are designed to reduce data entry time and errors by utilizing dropdowns, business requirements, and system logic. UAC PATH will create and send automated notifications on significant events (e.g., reportable infectious diseases) to ORR. Data from the forms will be accessible to ORR and, in the event of a transfer, staff at the new care provider facility in order to ensure continuity of care. Critical health information (e.g., medications, allergies, pending medical appointments) will be collated and displayed on a “UAC Health Dashboard”.





  1. Efforts to Identify Duplication and Use of Similar Information

The information being collected by these instruments are not obtainable from other sources.

.

  1. Impact on Small Businesses or Other Small Entities

The proposed information collection request does not impact small businesses or other small entities. This information collection primarily affects the operations of the federal government, particularly, ORR’s management of the care and custody of unaccompanied children.



  1. Consequences of Collecting the Information Less Frequently

ORR mandates that the initial medical and dental exam data collections occur at a single time as part of the admission process. The initial medical exam is performed within 48 hours of admission (excluding weekends and holidays); the initial dental exam is performed when a child has been in custody from 60 to 90 days (depending on state regulations where program is located). The preventive dental exams occur as recommended by the healthcare provider. Performing the data collection less frequently would prohibit ORR from tracking, monitoring, and advising on medical and dental health issues in a timely manner and consequently, cause ORR to be in violation of the Flores Settlement Agreement.



  1. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

This request fully complies with the regulation 5 CFR 1320.5.



  1. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency


In accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13) and Office of Management and Budget (OMB) regulations at 5 CFR Part 1320 (60 FR 44978, August 29, 1995), ACF published a notice in the Federal Register announcing the agency’s intention to request an OMB review of this information collection activity.  This notice was published on March 18, 2020 Volume 85, Number 53, page 15477-15478, and provided a sixty-day period for public comment.  During the notice and comment period, we did not receive comments. 


During development of these forms in fiscal year 2015, ORR consulted with two subject matter experts on migrant screening from the Centers for Centers for Disease Control and Prevention (CDC) and the American Academy of Pediatrics (AAP) determine the appropriate fields to include, process flow, reporting format, and clarity of intent. Name and contact information is as follows:

  1. Steve Benoit, MD

Former Medical Officer

Immigrant, Migrant, and Refugee Health

Division of Global Migration and Quarantine

CDC

Email: [email protected]

Office phone: 404-639-5013, mobile phone: 404-852-4252


  1. Janine Young, MD

Medical Director, Denver Health Refugee Clinic

Assistant Professor, Dept. of General Pediatrics

Denver Health and Hospitals

University of Colorado School of Medicine

Lowry Family Health Center

AAP member

Email: [email protected]

Office phone: 303-602-4558, mobile phone: 720-281-8934


  1. Explanation of Any Payment or Gift to Respondents

No monetary incentives or gifts are provided to respondents.



  1. Assurance of Confidentiality Provided to Respondents

ORR established a system of records to ensure the level of confidentiality pursuant to the Privacy Act. 5 U.S.C. 552a. ORR’s system of records notice was published on July 18, 2016 at 81 FR 46682.


Deidentified data is shared with stakeholders (e.g., Department of Health and Human Services leadership, Congress, The Centers for Disease Control and Prevention) on an ad hoc basis several times a year. Examples of shared data include immunization rates, COVID-19 case numbers, and the number of children in isolation.







  1. Justification for Sensitive Questions

ORR collects sensitive health information on medical, reproductive, physical, sexual and substance use history, current symptoms, mental health status, lab results and diagnoses in order to monitor, counsel, and treat children as directed by the Flores Agreement. Recorded information becomes part of the child’s health record and is viewable only to grantee staff who are/were directly responsible for the minor, ORR field-based program managers, and ORR federal staff.



  1. Estimates of Annualized Burden Hours and Costs


The calculation of annual burden estimates is based on the following factors:

  • The number of times these data are collected is dependent upon the number of unaccompanied children crossing over the U.S. border on an annual basis. Based on the average number of children entering the U.S. between 2017 and 2019, ORR estimates that the number of children will be approximately 52,800 annually.

  • ORR funds approximately 195 care provider grantee-operated licensed care provider facilities and expects to continue the trend of increasing capacity each year. This includes approximately 30 long-term foster care programs and 15 restrictive placement programs.

  • All children receive an initial medical exam, including screening for tuberculosis, within 48 hours of admission (excluding weekends and holidays).

  • Children who are in ORR custody 60 to 90 days after admission receive an initial dental exam and subsequent preventive dental care, as recommended by the dental provider. Approximately 17% of children in ORR custody in fiscal year 2019 received an initial dental exam and routine preventive dental care

  • Recordkeeping burden, including entering data from the forms into UAC PATH and uploading documentation of all health-related services rendered, will be incurred only by grantee staff; pediatricians and dentists will not incur recordkeeping burden for this collection.

  • The cost to respondents was calculated using hourly wage data, accessed in August 2020, from the Bureau of Labor Statistics (BLS):





Estimated Opportunity Costs for Respondents:

Job code 29-1221 Pediatricians, General

Information Collection Title

Annual Number of Respondents

Annual Number of Responses Per Respondent

Average Burden Hours Per Response

Total Burden Hours

Annual Burden Hours

Average Hourly Wage

Total Annual Cost

Initial Medical Exam Form (excluding Appendix A: Supplemental TB Screening Form)


195


271


0.22


34,878


11,626


$177.32


$2,061,522

Estimated Annual Burden Total:

11,626

Estimated Annual Cost Total:

$2,061,522



Job code 21-1021 Child, Family, and School Social Workers in the industry of Other Residential Care Facilities



Information Collection Title

Annual Number of Respondents

Annual Number of Responses Per Respondent

Average Burden Hours Per Response

Total Burden Hours

Annual Burden Hours

Average Hourly Wage

Total Annual Cost

Appendix A: Supplemental TB Screening Form


195


271


0.05


7,926


2,642


$49.06


$129,617

Estimated Annual Burden Total:

2,642

Estimated Annual Cost Total:

$129,617



Job code 29-1021 Dentists, General

Information Collection Title

Annual Number of Respondents

Annual Number of Responses Per Respondent

Average Burden Hours Per Response

Total Burden Hours

Annual Burden Hours

Average Hourly Wage

Total Annual Cost

Dental Exam Form

195

46

0.08

2,154

718

$171.40

$123,065

Estimated Annual Burden Total:

718

Estimated Annual Cost Total:

$123,065


Estimated Recordkeeping Costs:


Job code 21-1021 Child, Family, and School Social Workers in the industry of Other Residential Care Facilities


Information Collection Title

Annual Number of Respondents

Annual Number of Responses Per Respondent

Average Burden Hours Per Response

Total Burden Hours

Annual Burden Hours

Average Hourly Wage

Total Annual Cost

Initial Medical Exam Form

195

271

0.33

52,317

17,439

$49.06

$855,557

Appendix A: Supplemental TB Screening Form

195

271




$49.06


Dental Exam Form

195

46

0.17

4,575

1,525

$49.06

$74,817

Estimated Annual Burden Total:

18,964

Estimated Annual Cost Total:

$930,374



The estimated total cost for respondents (healthcare providers and grantee staff) to collect the information is $3,244,578.



  1. Estimates of Other Total Annual Cost Burden to Respondents and Record Keepers

There is no additional cost burden to respondents or record keepers.





  1. Annualized Cost to the Federal Government

The forms were developed by a GS-13, step 3-level public health analyst in the Boston area who spent approximately 640 hours revising the forms and creating electronic versions for UAC PATH. To account for fringe benefits and overhead, the hourly rate for this position ($52) was multiplied by two for a total of $104. Therefore, the cost to create the paper and electronic versions of the form was $66,560. It is estimated that the annual cost to the government for this information collection is $22,187 over the next 3 years.



  1. Explanation for Program Changes or Adjustments

In March 2020, ORR requested and received emergency approval for a revision to the previously approved information collection (OMB #0970-0466) in order to collect data on COVID-19 potential exposures, testing, and diagnosis on UAC in ORR custody. Since that time, ORR has begun work to replace its current electronic data repository called the UAC Portal with a modernized system called UAC PATH (“PATH”) to be launched in January 2021. To account for the new design in PATH, changes were made to the formatting of the Initial Medical Exam and Supplemental TB Screening forms. Based on review of forms completed by healthcare providers, ORR also realized that there were insufficient fields for capturing critical info (e.g., hearing exam results, diagnoses) and the intent of some fields was unclear. To correct these issues, a few new fields have been added and existing fields reworded in each form.


In addition to initial dental exam data, ORR is also proposing to capture health information collected during routine preventive dental visits in order to ensure appropriate care of unaccompanied children’s dental health. ORR intends to utilize the same form for both types of dental visits and has consequently renamed the Initial Dental Exam Form, the Dental Exam Form.


Also, in the previously approved information collection, the annual burden estimate did not include the time required by healthcare providers and dentists to complete the forms, as it was assumed this information was already collected by the provider and did not impose additional burden. In order to account for the time needed for healthcare providers and dentists to fill out the ORR-developed forms, however, ORR has since increased the burden estimate for this request. New opportunity burden tables have been added to A12.



  1. Plans for Tabulation and Publication and Project Time Schedule

ORR does not plan to publish the results of these information collections. Portions of the data from the information collections may be included in public reports, but the primary purpose of the information collections is to allow ORR to identify and track illnesses and conditions that require monitoring, control, and follow-up, and to ensure that grantees and healthcare providers are following ORR guidelines. These information collections are ongoing.



  1. Reason(s) Display of OMB Expiration Date is Inappropriate

ORR intends to display the expiration date for OMB approval of the information collections on the instruments.

  1. Exceptions to Certification for Paperwork Reduction Act Submissions

ORR does not request any exception to Certification for the Paperwork Reduction Act.

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