[Federal Register Volume 89, Number 200 (Wednesday, October 16, 2024)]
[Notices]
[Pages 83499-83502]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23708]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Agency for Healthcare Research and Quality, HHS.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995, this 
notice announces the intention of the Agency for Healthcare Research 
and Quality (AHRQ) to request that the Office of Management and Budget 
(OMB) approve the reinstatement with change of the information 
collection project ``Patient Safety Organization Certification for 
Initial Listing and Related Forms, Patient Safety Confidentiality 
Complaint Form, and Common Formats'', OMB No. 0935-0143 for which 
approval expired on September 30, 2024. This information collection was 
previously published in the Federal Register on August 12th, 2024 and 
allowed 60 days for public comment. AHRQ received no substantive 
comments from members of the public. The purpose of this notice is to 
allow an additional 30 days for public comment.

DATES: Comments on this notice must be received by November 15, 2024.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular 
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports 
Clearance Officer, (301) 427-1477, or by email 
<a href="/cdn-cgi/l/email-protection#431106130c111710000f060211020d00060c05050a00061103222b31326d2b2b306d242c35"><span class="__cf_email__" data-cfemail="4e1c0b1e011c1a1d0d020b0f1c0f000d0b010808070d0b1c0e2f263c3f6026263d60292138">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

Proposed Project

    Title: Patient Safety Organization Certification for Initial 
Listing and Related Forms, Patient Safety Confidentiality Complaint 
Form, and Common Formats.
    OMB No.: 0935-0143.
    OMB Expiration Date: September 30th, 2024.
    Type of Request: Reinstatement, with change, of previously approved 
collection for which approval has expired.

[[Page 83500]]

    The Patient Safety and Quality Improvement Act of 2005 (the Patient 
Safety Act), signed into law on July 29, 2005, was enacted in response 
to growing concern about patient safety in the United States and the 
Institute of Medicine's 1999 report, ``To Err is Human: Building a 
Safer Health System''. The Patient Safety Act signifies the Federal 
Government's commitment to fostering a culture of patient safety among 
health care providers; it offers a mechanism for creating an 
environment in which the causes of risks and hazards to patient safety 
can be thoroughly and honestly examined and discussed without fear of 
penalties and liabilities. It provides for the voluntary formation of 
Patient Safety Organizations (PSOs) that can collect, aggregate, and 
analyze confidential information reported voluntarily by health care 
providers. By analyzing substantial amounts of patient safety event 
information across multiple institutions, PSOs are able to identify 
patterns of failures and propose measures to eliminate or reduce risks 
and hazards.
    In order to implement the Patient Safety Act, the Department of 
Health and Human Services (HHS) issued the Patient Safety and Quality 
Improvement Final Rule (Patient Safety Rule, 42 CFR part 3), which 
became effective on January 19, 2009. The Patient Safety Rule outlines 
the requirements that entities must meet to become and remain listed as 
PSOs, the process by which the Secretary of HHS (Secretary) will accept 
certifications and list PSOs, and provisions pertaining to the 
confidentiality and privilege protections for patient safety work 
product (PSWP).
    When specific statutory requirements are met, the information 
collected and the analyses and deliberations regarding the information 
receive confidentiality and privilege protections under this 
legislation. The Secretary delegated authority to the Director of the 
Office for Civil Rights (OCR) to interpret and enforce the 
confidentiality protections of the Patient Safety Act (Federal 
Register, 71 FR 28701-2, May 17, 2006). Civil money penalties may be 
imposed for knowing or reckless impermissible disclosures of 
identifiable PSWP. AHRQ implements and administers the rest of the 
statute's provisions.
    Pursuant to the Patient Safety Rule (42 CFR 3.102), an entity that 
seeks to be listed as a PSO by the Secretary must certify that it meets 
certain requirements and, upon listing, would meet other criteria. To 
remain listed for renewable three-year periods, a PSO must re-certify 
that it meets these obligations and would continue to meet them while 
listed. The Patient Safety Act and Patient Safety Rule also impose 
other obligations discussed below that a PSO must meet to remain 
listed. In accordance with the requirements of the Patient Safety Rule 
(see, e.g., 42 CFR 3.102(a)(1), 3.102(b)(2)(i)(E), 3.102(d)(1), and 
3.112), the entities seeking to be listed and to remain listed must 
complete the proposed forms, in order to attest to compliance with 
statutory criteria and the corresponding regulatory requirements.

Proposed Revisions

    The following forms have revisions for clarification which are 
described below:
    1. PSO Certification for Initial Listing--This form has been 
revised to include clarification on the role of the primary point of 
contact.
    2. PSO Certification for Continued Listing--This form has been 
revised to include clarifications on the role of the primary point of 
contact, more precise language about whether there are any changes to 
the parent organization or any additional parent organizations and an 
additional note to clarify how users should determine the response to 
the standardized way they collect patient safety work product (PSWP).
    3. PSO Profile form--The form has been revised to add a new 
clinical discipline, ``Clinical Dialysis Services''.
    4. PSO Change of Listing Form--This form has been revised to note 
clarifications for the parent and the point of contact sections.
    5. PSO Voluntary Relinquishment Form--This form has been revised to 
include a change from street to mailing address for future contacts 
with delisted PSOs.
    6. Patient Safety Confidentiality Complaint Form--The form has two 
parts, the complaint form and the consent form. The complaint form was 
updated (1) to conform the notice to individuals about confidentiality 
of identifying information submitted on the complaint form with the 
existing approved OCR HIPAA Rules complaint form and (2) to update OCR 
contact information. The consent form was updated (1) to conform notice 
to individuals about confidentiality of identifying information 
submitted on the consent form with the existing approved OCR HIPAA 
Rules consent form, (2) to more fully describe OCR authorities allowing 
collection of information in Privacy Act of 1974 notices, and (3) to 
update OCR contact information.
    7. Common Formats--Since the last approval, AHRQ has released 
Common Formats Event Reporting for Diagnostic Safety, Version 1.0 
(CFER-DS V1.0) and the Common Formats for Surveillance- Hospital V1.0 
(CFS-H V1.0), which is a revision/update from the last version (CFS- H 
V0.3 Beta).
    OMB previously approved the Common Formats and forms described 
above in 2008, 2011, 2014, 2018, and 2021. AHRQ will use these forms, 
other than the Patient Safety Confidentiality Complaint Form, to obtain 
information necessary to carry out its authority to implement the 
Patient Safety Act and Patient Safety Rule. This includes obtaining 
initial and subsequent certifications from entities seeking to be or 
remain listed as PSOs and for making the statutorily required 
determinations prior to and during an entity's period of listing as a 
PSO. The PSO Division, housed in AHRQ's Center for Quality Improvement 
and Patient Safety, uses this information. OCR will use the Patient 
Safety Confidentiality Complaint Form to collect information for the 
initial assessment of an incoming complaint. The form is modeled on 
OCR's form for complaints alleging violations of the privacy of 
protected health information.

Method of Collection

    The PSO forms are available in a format that allows completion and 
submission of the information online. AHRQ has updated the electronic 
submission of all forms, except the Patient Safety Confidentiality 
Compliant For which is administered by OCR, including the capability of 
the system to auto populate certain fields based on prior submissions 
by the PSOs. In addition, paper forms can be downloaded, completed and 
submitted through electronic mail, to <a href="/cdn-cgi/l/email-protection#5222213d12333a20237c3a3a217c353d24"><span class="__cf_email__" data-cfemail="6e1e1d012e0f061c1f4006061d40090118">[email protected]</span></a>, or via postal 
mail. The Common Formats, accompanying user guide, and technical 
specifications are available as printable electronic files on the 
PSOPPC website at www.PSOPPC.org.
    In addition to paper submission of complaints, OCR facilitates 
electronic submission of complaints. First, the Patient Safety 
Confidentiality Complaint Form is available on the OCR website at 
https://www.hhs.gov/hipaa/filing-a-complaint/patient-safety-confidentiality/index.html. The form is available to be downloaded 
electronically to a user's own computer in a form that allows a 
complainant to fill out the form electronically if they so choose. The 
Patient Safety Confidentiality Complaint Form can then be printed and 
submitted, or submitted electronically via electronic mail. Second, the 
form is available in a

[[Page 83501]]

format that allows completion and submission of the information online.

Estimated Annual Respondent Burden

    Exhibit 1 shows the estimated annualized burden hours for the 
respondent to provide the requested information and Exhibit 2 shows the 
estimated annualized cost burden associated with the respondents' time 
to provide the requested information. The total burden hours are 
estimated to be 100,811.58 hours annually and the total cost burden is 
estimated to be $4,946,824.23 annually.
    1. PSO Certification for Initial Listing Form: The average annual 
burden for the collection of information requested by the certification 
forms for initial listing is based upon a total average estimate of 11 
respondents per year and an estimated time of 18 hours per response. 
The estimated response number includes submissions by not only entities 
listed as PSOs, but also entities that submit initial listing forms 
that do not become PSOs.
    2. PSO Certification for Continued Listing Form: The average annual 
burden for the collection of information requested by the certification 
form for continued listing has an estimated time of eight hours per 
response and 40 responses annually.
    3. PSO Two Bona Fide Contracts Requirement Certification Form: The 
average annual burden for the collection of information requested by 
the PSO Two Bona Fide Contract Certification Form is based upon an 
estimate of 56 respondents per year and an estimated one hour per 
response.
    4. PSO Disclosure Statement Form: The overall annual burden for the 
collection of information requested by the PSO Disclosure Statement 
Form is based upon an estimate of 3 respondents per year and estimated 
3 hours per response.
    5. PSO Profile Form: The overall annual burden for the collection 
of information requested by the PSO Profile Form is based upon an 
estimate of 74 respondents per year and an estimated three hours per 
response.
    6. PSO Change of Listing Information Form: The average annual 
burden for the collection of information requested by the PSO Change of 
Listing Information Form is based upon an estimate of 51 respondents 
per year and an estimated time of five minutes per response.
    7. PSO Voluntary Relinquishment Form: The average annual burden for 
the collection of information requested by the PSO Voluntary 
Relinquishment Form is based upon a total average estimate of four 
respondents per year and an estimated time of thirty minutes per 
response.
    8. OCR Patient Safety Confidentiality Complaint Form: The overall 
annual burden estimate of one hour for the collection of information 
requested by the form is based on an estimate of one respondent per 
year and an estimated twenty minutes per response.
    9. Common Formats: AHRQ estimates that 5% FTE of a patient safety 
manager at a facility will be spent to administer the Common Formats, 
which is approximately 100 hours a year.

                                  Exhibit 1--Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                       Number of
                        Form                            Number of    responses per    Hours per    Total burden
                                                       respondents     respondent      response        Hours
----------------------------------------------------------------------------------------------------------------
1. PSO Certification for Initial Listing Form.......            11                1           18             198
2. PSO Certification for Continued Listing Form.....            40                1            8             320
3. PSO Two Bona Fide Contracts Requirement Form.....            56                1            1              56
4. PSO Disclosure Statement Form....................             3                1            3               9
5. PSO Profile Form.................................            74                1            3             222
6. PSO Change of Listing Information................            51                1        05/60            4.25
7. PSO Voluntary Relinquishment Form................             4                1        30/60               2
8. OCR Patient Safety Confidentiality Complaint Form             1                1        20/60             .33
9. Common Formats...................................         1,000                1          100         100,000
                                                     -----------------------------------------------------------
    Total...........................................  ............               NA           NA      100,811.58
----------------------------------------------------------------------------------------------------------------


                                   Exhibit 2--Estimated Annualized Cost Burden
----------------------------------------------------------------------------------------------------------------
                                                                 Total burden    Average hourly
                             Form                                    hours        wage rate \*\     Total cost
----------------------------------------------------------------------------------------------------------------
1. PSO Certification for Initial Listing Form.................             198            $49.07       $9,715.86
2. PSO Certification for Continued Listing Form...............             320             49.07       15,702.40
3. PSO Two Bona Fide Contracts Requirement Form...............              56             49.07        2,747.92
4. PSO Disclosure Statement Form..............................               9             49.07          441.63
5. PSO Profile Form...........................................             222             49.07       10,893.54
6. PSO Change of Listing Form.................................            4.25             49.07          208.55
7. PSO Voluntary Relinquishment Form..........................               2             49.07           98.14
8. OCR Patient Safety Confidentiality Complaint Form..........             .33             49.07           15.35
9. Common Formats.............................................         100,000             49.07       4,907,000
                                                               -------------------------------------------------
    Total.....................................................  ..............  ................    4,946,824.23
----------------------------------------------------------------------------------------------------------------
* Based upon the mean of the hourly average wages for healthcare practitioner and technical occupations, 29-
  0000, National Compensation Survey, May 2023, ``U.S. Department of Labor, Bureau of Labor Statistics.'' https://www.bls.gov/oes/current/oes290000.htm

Request for Comments

    In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-
3520, comments on AHRQ's information collection are requested with 
regard to any of the following: (a) whether the proposed collection of 
information is necessary for the proper performance of AHRQ's health 
care research and health care information dissemination functions, 
including whether the

[[Page 83502]]

information will have practical utility; (b) the accuracy of AHRQ's 
estimate of burden (including hours and costs) of the proposed 
collection(s) of information; (c) ways to enhance the quality, utility 
and clarity of the information to be collected; and (d) ways to 
minimize the burden of the collection of information upon the 
respondents, including the use of automated collection techniques or 
other forms of information technology.
    Comments submitted in response to this notice will be summarized 
and included in the Agency's subsequent request for OMB approval of the 
proposed information collection. All comments will become a matter of 
public record.

    Dated: October 3, 2024.
Marquita Cullom,
Associate Director.
[FR Doc. 2024-23708 Filed 10-15-24; 8:45 am]
BILLING CODE 4160-90-P


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