[Federal Register Volume 83, Number 107 (Monday, June 4, 2018)]
[Notices]
[Pages 25668-25670]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11926]



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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 (AHRQ), Department 
of Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: This notice announces the intention of AHRQ to request 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.''
    This proposed information collection was previously published in 
the Federal Register on February 26, 2018 and allowed 60 days for 
public comment. AHRQ did not receive any substantive comments.

DATES: Comments on this notice must be received by July 5, 2018.

ADDRESSES: Written comments should be submitted to: AHRQ's OMB Desk 
Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by 
email at [email protected] (attention: AHRQ's desk 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

    In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-
3521, AHRQ invites the public to comment on this proposed information 
collection. 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 quality and 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 for the voluntary 
formation of Patient Safety Organizations (PSOs). By analyzing 
substantial amounts of information across multiple institutions, PSOs 
are able to identify patterns of failures and propose quality and 
safety improvements. The Patient Safety Act signifies the Federal 
Government's commitment to fostering and creating an environment in 
which the causes of health care risks and hazards can be thoroughly and 
honestly examined and discussed without fear of penalties and 
liabilities.
    In order to implement the Patient Safety Act, HHS issued the 
Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) 
which became effective on January 19, 2009. The Patient Safety Rule 
establishes a framework for the reporting of quality and patient safety 
information--by hospitals, doctors, nurses, pharmacists, and other 
providers--to PSOs, on a privileged and confidential basis, for 
aggregation and analysis. In addition, the Patient Safety Rule outlines 
the requirements that entities must meet to become and remain listed as 
PSOs and the process by which the Secretary of HHS (Secretary) will 
accept certifications and list PSOs.
    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 enforce the confidentiality 
protections of the Patient Safety Act (Federal Register, Vol. 71, No. 
95, May 17, 2006, p. 28701-2). OCR is responsible for enforcing 
confidentiality protections regarding patient safety work product 
(PSWP), which may include: Patient-, provider-, and reporter-
identifying information that is collected, created, or used for or by 
PSOs for patient safety and quality activities. Civil money penalties 
may be imposed for knowing or reckless impermissible disclosures of 
PSWP. AHRQ implements and administers the rest of the statute's 
provisions.
    Pursuant to the Patient Safety Rule, 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 (42 CFR 
3.102). 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 corresponding regulatory 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 corresponding regulatory 
provisions, this form is to be completed by a listed PSO seeking 
continued listing as a PSO by the Secretary for each successive 
three-year period.
    3. PSO Two Bona Fide Contracts Requirement Certification Form. 
To remain listed, a PSO must meet a statutory requirement in 42 
U.S.C. 299b-24(b)(1)(C) that it has bona fide contracts with more 
than one provider, within successive 24-month periods, beginning 
with the date of the PSO's initial listing, for the purpose of 
receiving and reviewing patient safety work product. This form is to 
be used by a PSO to certify whether it has met this statutory 
requirement and the corresponding regulatory provisions.
    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 of the 
statement's accuracy by the PSO in accordance with the 42 U.S.C. 
299b-24(b)(1)(E) whereby the entity shall fully disclose: (i) Any 
financial, reporting, or contractual relationship between the entity 
and any provider that contracts with the PSO; and (ii) if 
applicable, the fact that the PSO is not managed, not controlled, 
and operated independently from any provider that contracts with the 
PSO. 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 patient safety activities.
    5. PSO Profile Form. This form gathers information on the type 
of providers and settings with which PSOs are working to conduct 
patient safety activities in order to improve patient safety. It is 
designed to collect a minimum level of information necessary to 
develop aggregate data relating to the Patient Safety Act. This 
information will be included in AHRQ's 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

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information, each 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 choose to 
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.

    AHRQ will use these forms 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. This information is used by the 
PSO Program Office housed in AHRQ's Center for Quality Improvement and 
Patient Safety.
    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.
    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 
violation 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.
    The forms described above, other than the PSO Voluntary 
Relinquishment Form, are revised collection instruments that were 
previously approved by OMB in 2008, 2011, and 2014.
    In addition, AHRQ is requesting approval for a set of common 
definitions and reporting formats (hereafter Common Formats). AHRQ 
coordinates the development of the Common Formats, as authorized by 42 
U.S.C. 299b-23(b), that allow PSOs and providers to voluntarily collect 
and submit standardized information regarding patient safety events to 
ensure that data collected by PSOs and other entities have comparable 
clinical meaning. The Common Formats facilitate aggregation of 
comparable data at local, PSO, regional and national levels.

Estimated Annual Respondent Burden

    The information collection forms that are the subject of this 
notice 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 forms 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 100,724.88 hours annually and the total cost burden is 
estimated to be $3,833,588.92 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 16 
respondents per year and an estimated time of 18 hours per response. 
The estimated response number not only includes submissions by entities 
subsequently listed as PSOs, but also entities that submit an initial 
listing form that do not become a PSO. 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 21 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 42 respondents per year and an estimated one hour per 
response. This collection of information takes place at least every 24 
months when the PSO notifies the Secretary that it has entered into two 
contracts with providers.
    PSO Disclosure Statement Form: Because only a small percentage of 
PSOs will need to file a Disclosure Statement Form, the average burden 
for the collection of information requested by the disclosure form is 
based upon an estimate of three 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 70 respondents per year and an estimated three hours per response. 
The collection of information takes place annually, with newly listed 
PSOs initially requested to submit the form in the calendar year after 
their listing by the Secretary.
    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 61 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.
    OCR Patient Safety Confidentiality Complaint Form: The overall 
annual burden estimate of one third of an hour for the collection of 
information requested by the form is based on an estimate of one 
respondent per year and an estimated 20 minutes per response; the 
estimate of one form is provided due to the fact that no submissions 
have been received. OCR's information collection using this form will 
not begin until after there is an allegation of a violation of the 
confidentiality protections of PSWP.
    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 five 
respondents per year and an estimated time of five minutes per 
response.
    Common Formats: AHRQ estimates that 5% FTE of a patient safety 
manager at a facility will be spent to administer

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the Common Formats, which is approximately 100 hours a year. The use of 
the Common Formats by PSOs and other entities is voluntary and is on an 
ongoing basis. This estimate of the number of 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 Common Formats. As the network for patient safety databases (NPSD) 
becomes operational, AHRQ will revise the estimate based on actual 
submissions.

                                  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......              16               1              18             288
PSO Certification for Continued Listing Form....              21               1               8             168
PSO Two Bona Fide Contracts Requirement Form....              42               1               1              42
PSO Disclosure Statement Form...................               3               1               3               9
PSO Profile Form................................              70               1               3             210
PSO Change of Listing Information...............              61               1           05/60            5.08
OCR Patient Safety Confidentiality Complaint                   1               1           20/60            0.33
 Form...........................................
PSO Voluntary Relinquishment Form...............               5               1           30/60            2.50
Common Formats..................................           1,000               1             100         100,000
                                                 ---------------------------------------------------------------
    Total.......................................  ..............              NA              NA      100,724.91
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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......              16             288          $38.06      $10,961.28
PSO Certification for Continued Listing Form....              21             168           38.06        6,394.08
PSO Two Bona Fide Contracts Requirement Form....              42              42           38.06        1,598.52
PSO Disclosure Statement Form...................               3               9           38.06          342.54
PSO Profile Form................................              70             210           38.06        7,992.60
PSO Change of Listing Form......................              61            5.08           38.06          193.34
OCR Patient Safety Confidentiality Complaint                   1            0.33           38.06           12.55
 Form...........................................
PSO Voluntary Relinquishment Form...............               5            2.50           38.06           95.15
Common Formats..................................           1,000         100,000           38.06    3,806,000.00
                                                 ---------------------------------------------------------------
    Total.......................................  ..............  ..............  ..............    3,833,590.06
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* Based upon the mean of the hourly average wages for health care practitioner and technical occupations, 29-
  0000, National Compensation Survey, May 2016, ``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, 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 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.

Francis D. Chesley, Jr.,
Acting Deputy Director.
[FR Doc. 2018-11926 Filed 6-1-18; 8:45 am]
 BILLING CODE 4160-90-P