Notice2024-23708
Agency Information Collection Activities: Proposed Collection; Comment Request
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 16, 2024
Issuing agencies
Health and Human Services DepartmentAgency for Healthcare Research and Quality
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 200 (Wednesday, October 16, 2024)</title>
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[Federal Register Volume 89, Number 200 (Wednesday, October 16, 2024)]
[Notices]
[Pages 83499-83502]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. 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 <a href="http://www.PSOPPC.org">www.PSOPPC.org</a>.
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
<a href="https://www.hhs.gov/hipaa/filing-a-complaint/patient-safety-confidentiality/index.html">https://www.hhs.gov/hipaa/filing-a-complaint/patient-safety-confidentiality/index.html</a>. 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
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Number of
Form Number of responses per Hours per Total burden
respondents respondent response Hours
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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
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Total........................................... ............ NA NA 100,811.58
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Exhibit 2--Estimated Annualized Cost Burden
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Total burden Average hourly
Form hours wage rate \*\ Total cost
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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
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Total..................................................... .............. ................ 4,946,824.23
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* 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.'' <a href="https://www.bls.gov/oes/current/oes290000.htm">https://www.bls.gov/oes/current/oes290000.htm</a>
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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