[Federal Register Volume 83, Number 38 (Monday, February 26, 2018)]
[Notices]
[Pages 8274-8277]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03854]


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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 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 April 27, 2018.

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 emails 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 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 PSO 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, see Attachment B) which 
became effective on January 19, 2009. The Patient Safety Rule 
establishes a framework by which hospitals, doctors, and other health 
care providers may voluntarily report information to PSOs, on a 
privileged and confidential basis, for the aggregation and analysis of 
patient safety events. 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

[[Page 8275]]

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 (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 as a PSO by the Secretary for each successive three-
year period.
    3. PSO Two Bona Fide Contracts Requirement Certification Form 
(Attachment G). To remain listed, a PSO must meet a statutory 
requirement in 42 U.S.C. 299b-24(b)(1)(C) attests 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 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 entity; and (ii) if applicable, the fact that the 
entity is not managed, controlled, and operated independently from any 
provider that contracts with the entity. 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, previously called the PSO 
Information Form, gathers information on the type of health care 
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 data necessary to develop aggregate 
statistics relating to the Patient Safety Act, including types of 
institutions participating and their general location in the US. 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 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.
    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 (hereafter Common Formats). As 
authorized by 42 U.S.C. 299b-23(b) and the Patient Safety Rule, AHRQ 
coordinates the development of the Common Formats that allow PSOs and 
health care providers to voluntarily collect and submit standardized 
information regarding patient safety events to fulfill the national 
learning system as envisioned by the Patient Safety Act.
    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. 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. This information is used by the PSO Program Office housed in 
AHRQ's Center for Quality Improvement and Patient Safety.

OCR

    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.

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

[[Page 8276]]

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 
entities 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 health care 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 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 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 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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                                                                                  Average hourly
                      Form                           Number of     Total burden     wage rate *   Total cost ($)
                                                    respondents        hours            ($)
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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

[[Page 8277]]

 
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 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.

Karen J. Migdail,
Chief of Staff.
[FR Doc. 2018-03854 Filed 2-23-18; 8:45 am]
 BILLING CODE 4160-90-P