[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
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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
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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