Agency Information Collection Activities: Proposed Collection; Comment Request

Published date12 May 2021
Citation86 FR 26036
Record Number2021-09973
SectionNotices
CourtAgency For Healthcare Research And Quality,Health And Human Services Department
Federal Register, Volume 86 Issue 90 (Wednesday, May 12, 2021)
[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
                [[Page 26038]]
                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
                [[Page 26039]]
                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
                ----------------------------------------------------------------------------------------------------------------
                 Number of
                 Form Number of responses per Hours per Total burden
                 respondents respondent response hours
                ----------------------------------------------------------------------------------------------------------------
                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
                ----------------------------------------------------------------------------------------------------------------
                 Exhibit 2--Estimated Annualized Cost Burden
                ----------------------------------------------------------------------------------------------------------------
                 Number of Total burden Average hourly
                 Form respondents hours wage rate * Total cost
                ----------------------------------------------------------------------------------------------------------------
                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
                ----------------------------------------------------------------------------------------------------------------
                * 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
                

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