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Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices
of Information Collection: CLIA
Collection of Information Requirements Related to SARSCoV2 Test Results Reporting; Use: In order to be in compliance with the new CLIA
mandatory SARSCoV2 test results reporting requirements, laboratories will need to develop a mechanism to track, collect, and report test results as well as update policies and procedures. In addition, Accreditation Organizations AOs and Exempt States ESs will need to update laboratory standards to reflect the reporting requirements and update policies and procedures related to reporting laboratories that do not report test results as required.
The CDC has an information collection request OMB Control Number 09201299 in order to collect laboratory data related to the COVID19
Pandemic Response. The CMS package ICR is for laboratory implementation and CMS monitoring of compliance with the CMS3401IFC CLIA-certified laboratory reporting requirements.
The information collected by the Centers for Medicare and Medicaid Services CMS or its designee, such as a CMS agent or CMS approved laboratory accreditation organization, when conducting inspections will be used to determine a laboratorys compliance with the CLIA SARSCoV
2 test result reporting requirements.
During an on-site survey, the Conditionlevel laboratory requirement at 42 CFR
493.41and 493.1100a are assessed for compliance. The information is used by CMS in determining appropriate Civil Money Penalties CMPs when laboratories fail to report as required.
Form Number: CMS10757 OMB
control number: 09381391; Frequency:
Daily; Affected Public: Private Sector Not-for-profit institutions and State, Local and Tribal Governments; Number of Respondents: 77,033; Total Annual Responses: 308,114; Total Annual Hours: 1,386,873 For policy questions regarding this collection contact Sarah Bennett at 4107863354.
Dated: July 26, 2021.
William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living Agency Information Collection Activities; Submission for OMB
Review; Public Comment Request;
State Annual Long-Term Care Ombudsman Report-National Ombudsman Reporting System; OMB
09850005
Administration for Community Living, HHS.
ACTION: Notice.
AGENCY:

The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget OMB for review and clearance as required under section 506c2A of the Paperwork Reduction Act of 1995.
This 30-Day notice collects comments on the information collection requirements related to the State Annual Long-Term Care Ombudsman ReportNational Ombudsman Reporting System OMB 09850005.
DATES: Submit written comments on the collection of information by August 30, 2021.
ADDRESSES: Submit written comments and recommendations for the proposed information collection within 30 days of publication of this notice to www.reginfo.gov/public/do/PRAMain.
Find the information collection by selecting Currently under 30-day ReviewOpen for Public Comments or by using the search function. By mail to the Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW, Rm. 10235, Washington, DC 20503, Attn: OMB Desk Officer for ACL.
FOR FURTHER INFORMATION CONTACT:
Louise Ryan, Administration for Community Living, Washington, DC
20201, 206 6152299 or by email:
louise.ryan@acl.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, ACL
has submitted the following proposed collection of information to OMB for review and clearance.
The Administration for Community Living ACL is requesting approval to collect data for the State Annual LongTerm Care Ombudsman Report-National Ombudsman Reporting System OMB
09850005. This request covers minor changes and corrections to the current information collection, with a total of 11,154 annual burden hours. The data collection tool will enhance ACLs ability to understand and report on SUMMARY:

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Long-Term Care Ombudsman LTCO
program operations, experiences of long-term care facility residents and will reflect changes in LTCO program operations and long-term supports and services policies, research, and practices. States will continue to provide the following data and narrative information in the report:
1. Numbers and descriptions of cases filed and complaints made on behalf of long-term care facility residents to the statewide ombudsman program;
2. Major issues identified impacting on the quality of care and life of longterm care facility residents;
3. Statewide program operations;
4. Ombudsman activities in addition to complaint investigation; and 5. Organizational conflict of interest reporting as required by 45 CFR part 1324.21.
Comments in Response to the 60-Day Federal Register Notice A notice was published in the Federal Register on March 10, 2021 86 FR
13720. There were four public comments received during the 60-day FRN. Please see ACLs response to comment listed below.
Two of the four respondents Maryland Ombudsman program and the National Association of State Ombudsman Programs NASOP
recommended adding a new complaint code infection control.
Response: ACL agrees to add one complaint code infection control and corresponding definition, examples and reporting tips. The Iowa Ombudsman program recommended adding clarifying information to the Code I05
Housekeeping to be inclusive of infection control, ACL will incorporate its suggestion into the new Infection control code. Two of the four respondents Maryland Ombudsman program and NASOP recommended changes to the examples and reporting tips under complaint code J01.
Response: ACL agrees to modify the examples and reporting tips on Complaint Code J01 Administrative oversight to incorporate problems with a facility planning and responding to an emergency.
ACL received the following comments and did not accept them for inclusion in NORS.
The Maryland Ombudsman proposed adding more detail and examples in the description fields in the following cells:
S02, S06, S08, S09, S12.1, and S13
stating that this would give the State Ombudsman more guidance on how to approach the narratives and to help ensure greater consistency across the country.

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