[Federal Register Volume 86, Number 90 (Wednesday, May 12, 2021)]
[Notices]
[Pages 26036-26039]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09973]


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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: This notice announces the intention of the Agency for 
Healthcare Research and Quality (AHRQ) to request

[[Page 26037]]

that the Office of Management and Budget (OMB) approve the proposed 
information collection project ``Patient Safety Organization 
Certification for Initial Listing and Related Forms, Patient Safety 
Confidentiality Complaint Form, and Common Formats.''

DATES: Comments on this notice must be received by July 12, 2021

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, by email at 
[email protected].
    Copies of the proposed collection plans, data collection 
instruments, and specific details on the estimated burden can be 
obtained from the AHRQ Reports Clearance Officer.

FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports 
Clearance Officer, (301) 427-1477, or by email at 
[email protected].

SUPPLEMENTARY INFORMATION:

Proposed Project

``Patient Safety Organization Certification for Initial Listing and 
Related Forms, Patient Safety Confidentiality Complaint Form, and 
Common Formats''

    The Patient Safety and Quality Improvement Act of 2005 (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 goal of the statute is to create a national learning 
system. By providing incentives of nation-wide confidentiality and 
legal privilege, the Patient Safety Act learning system improves 
patient safety and quality by providing an incentive for health care 
providers to work voluntarily with experts in patient safety to reduce 
risks and hazards to the safety and quality of patient care. 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, Vol. 71, No. 95, May 17, 2006, p. 28701-2). 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.

Method of Collection

    With this submission, AHRQ is requesting approval of the following 
proposed administrative forms:
    1. PSO Certification for Initial Listing Form. This form, 
containing certifications of eligibility and a capacity and intention 
to comply with statutory criteria and regulatory requirements, is to be 
completed, in accordance with 42 U.S.C. 299b-24(a)(1) and the above-
cited regulatory certification provisions, by an entity seeking to be 
listed by the Secretary as a PSO for an initial three-year period.
    2. PSO Certification for Continued Listing Form. In accordance with 
42 U.S.C. 299b-24(a)(2) and the above-cited regulatory certification 
provisions, this form is to be completed by a listed PSO seeking 
continued listing by the Secretary as a PSO for each successive three-
year period.
    3. PSO Two Bona Fide Contracts Requirement Certification Form. To 
remain listed, a PSO must meet the requirement in 42 U.S.C. 299b-
24(b)(1)(C) that it has contracts with more than one provider, within 
successive 24-month periods, beginning with the date of the PSO's 
initial listing. This form is to be used by a PSO to certify whether it 
has met this statutory requirement and the corresponding regulatory 
provision.
    4. PSO Disclosure Statement Form. This form provides detailed 
instructions to a PSO regarding the disclosure statement it must submit 
and provides for the required certification by the PSO of the 
statement's accuracy in accordance with 42 U.S.C. 299b-24(b)(1)(E), 
when it (i) has a contract with a provider to carry out patient safety 
activities, and (ii) it has other financial, reporting, or contractual 
relationship(s) with that contracting provider, or it is not managed, 
controlled, and operated independently from that contracting provider. 
In accordance with the Patient Safety Act and the Patient Safety Rule, 
the Secretary is required to review each such report and make public 
findings as to whether a PSO can fairly and accurately carry out its 
responsibilities.
    5. PSO Profile Form. This form is designed to collect voluntarily a 
minimum level of data necessary to develop aggregate statistics 
relating to PSOs, the types of providers they work with, and their 
general location in the US. The PSO Profile is intended to be completed 
annually by all PSOs that are ``AHRQ-listed'' during any part of the 
previous calendar year. This information is collected by AHRQ's PSO 
Privacy Protection Center (PSOPPC) and is used to populate the AHRQ PSO 
selection tool on the AHRQ PSO website, to generate slides presented at 
the PSO Annual Meeting, and to develop content for the AHRQ National 
Healthcare Quality and Disparities Report, an annual quality report 
required by 42 U.S.C. 299b-2(b)(2).
    6. PSO Change of Listing Information Form. The Secretary is 
required under 42 U.S.C. 299b-24(d) to maintain a publicly available 
list of PSOs. Under the Patient Safety Rule, that list includes, among 
other information, each

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PSO's current contact information. The Patient Safety Rule, at 42 CFR 
3.102(a)(1)(vi), also requires that, during its period of listing, a 
PSO must promptly notify the Secretary of any changes in the accuracy 
of the information submitted for listing.
    7. PSO Voluntary Relinquishment Form. A PSO may voluntarily 
relinquish its status as a PSO for any reason. Pursuant to 42 CFR 
3.108(c)(2), in order for the Secretary to accept a PSO's notification 
of voluntary relinquishment, the notice must contain certain 
attestations and future contact information. This form provides an 
efficient manner for a PSO seeking voluntary relinquishment to provide 
all of the required information.
    OCR is requesting approval of the following administrative form:

Patient Safety Confidentiality Complaint Form. The purpose of this 
collection is to allow OCR to collect the minimum information needed 
from individuals filing patient safety confidentiality complaints with 
OCR so that there is a basis for initial processing of those 
complaints.

    In addition, AHRQ is requesting approval for a set of common 
definitions and reporting formats (Common Formats). As authorized by 42 
U.S.C. 299b-23(b), AHRQ coordinates the development of the Common 
Formats that facilitate aggregation of comparable data at local, PSO, 
regional and national levels. The Common Formats allow PSOs and health 
care providers to voluntarily collect and submit standardized 
information regarding patient safety events to fulfill the national 
learning system envisioned by the Patient Safety Act.
    OMB previously approved the Common Formats and forms described 
above in 2008, 2011, 2014, and 2018. 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. Use of the 
form is voluntary. It may help a complainant provide the essential 
information. Alternatively, a complainant may choose to submit a 
complaint in the form of a letter or electronically. An individual who 
needs help to submit a complaint in writing may call OCR for 
assistance.

Estimated Annual Respondent Burden

    The PSO information collection forms described below will be 
implemented at different times and frequencies due to the voluntary 
nature of seeking listing and remaining listed as a PSO, filing an OCR 
Patient Safety Confidentiality Complaint Form, and using the Common 
Formats. The burden estimates are based on the average of the form 
submissions received over the past three years.
    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 100,795.83 hours annually and the total cost burden is 
estimated to be $4,053,000.33 annually.
    PSO Certification for Initial Listing Form: The average annual 
burden for the collection of information requested by the certification 
form for initial listing is based upon a total average estimate of 10 
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. After submitting a PSO Certification for 
Initial Listing Form, an entity may withdraw its form or submit a 
revised form, particularly after receiving technical assistance from 
AHRQ. In addition, AHRQ, on behalf of the Secretary, may deny listing 
if an entity does not meet the requirements of the Patient Safety Act 
and Patient Safety Rule.
    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 42 responses annually. The PSO Certification for Continued 
Listing Form must be completed by any interested PSO at least 75 days 
before the end of its current three-year listing period.
    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 51 respondents per year and an estimated one hour per 
response. This collection of information takes place once per 24-month 
period when the PSO notifies the Secretary that it has two contracts 
with providers that meet the requirements.
    PSO Disclosure Statement Form: The average burden for the 
collection of information requested by the Disclosure Statement Form is 
based upon an estimate of two respondents per year and estimated three 
hours per response. This information collection takes place within 45 
days of when a PSO begins having any of the specified types of 
additional relationships with a provider with which it has a contract 
to carry out patient safety activities.
    PSO Profile Form. The overall annual burden for the collection of 
information requested by the PSO Profile Form is based upon an estimate 
of 72 respondents per year and an estimated three hours per response. 
The collection of information takes place annually; newly listed PSOs 
may first submit the form in the calendar year after their initial 
listing by the Secretary.
    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 54 respondents 
per year and an estimated time of five minutes per response. This 
collection of information takes place on an ongoing basis as needed 
when there are changes to the PSO's listing information.
    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.
    OCR Patient Safety Confidentiality Complaint Form: The overall 
annual burden estimate for the collection of information requested by 
the OCR Patient Safety Confidentiality Complaint Form is based on an 
estimate of one respondent per year and an estimated twenty minutes per 
response. The voluntary use of the form may occur when an allegation of 
a violation of the confidentiality protections of the Patient Safety 
Act is made.
    Common Formats: AHRQ estimates that 5% full time equivalent (FTE) 
of a patient safety manager at a facility will be spent to administer 
the Common Formats, which is approximately 100 hours a year. The use of 
the formats by PSOs and other entities is voluntary and is on an 
ongoing basis. This estimate of

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the 1,000 respondents is based on the feedback that AHRQ has received 
during meetings and technical assistance calls from PSOs and other 
entities that have been utilizing the formats.

                                  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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PSO Certification for Initial Listing Form......              10               1              18             180
PSO Certification for Continued Listing Form....              42               1               8             336
PSO Two Bona Fide Contracts Requirement Form....              51               1               1              51
PSO Disclosure Statement Form...................               2               1               3               6
PSO Profile Form................................              72               1               3             216
PSO Change of Listing Information...............              54               1           05/60            4.50
PSO Voluntary Relinquishment Form...............               4               1           30/60               2
OCR Patient Safety Confidentiality Complaint                   1               1           20/60             .33
 Form...........................................
Common Formats..................................           1,000               1             100         100,000
                                                 ---------------------------------------------------------------
    Total.......................................  ..............              NA              NA      100,795.83
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                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                     Number of     Total burden   Average hourly
                      Form                          respondents        hours        wage rate *     Total cost
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PSO Certification for Initial Listing Form......              10             180          $40.21       $7,237.80
PSO Certification for Continued Listing Form....              42             336           40.21       13,510.56
PSO Two Bona Fide Contracts Requirement Form....              51              51           40.21        2,050.71
PSO Disclosure Statement Form...................               2               6           40.21          241.26
PSO Profile Form................................              72             216           40.21        8,685.36
PSO Change of Listing Form......................              54            4.50           40.21          180.95
PSO Voluntary Relinquishment Form...............               4               2           40.21           80.42
OCR Patient Safety Confidentiality Complaint                   1             .33           40.21           13.27
 Form...........................................
Common Formats..................................           1,000         100,000           40.21    4,021,000.00
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............    4,053,000.33
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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 2019, ``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-
3521, 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 information will have practical utility; and, for 
OCR's enforcement of confidentiality; (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: May 6, 2021.
Marquita Cullom,
Associate Director.
[FR Doc. 2021-09973 Filed 5-11-21; 8:45 am]
BILLING CODE 4160-90-P