14014 Federal Register / Vol. 87, No. 48 / Friday, March 11, 2022 / Notices 

postpartum depression, new-onset 

diabetes) 

• Exclude: 

Æ Individuals with specific health 

conditions not typically managed 

by providers of pregnancy and 

postpartum care, (e.g., multiple 

sclerosis, HIV, cancer, substance 

use disorders other than tobacco). 

Æ Individuals with diagnosed chronic 

conditions—pre-existing (nongestational) diabetes, cardiac 

disease/risk factors (e.g., 

cardiomyopathy, pre-existing [nongestational] hypertension), mood 

disorders (e.g., major depression, 

anxiety), stress urinary 

incontinence, and dyspareunia. 

Interventions 

• More comprehensive insurance 

coverage 

• Extended duration of insurance 

coverage 

• More continuous insurance coverage 

• Better/more continuous access to care 

as the result of a targeted program 

at the state, system, or provider 

level (e.g., Medicaid expansion) 

Comparators 

• Less comprehensive level of or no 

insurance coverage 

• Less continuous insurance coverage 

• Worse, less continuous, or no access 

to healthcare 

Outcomes (* and bold font denotes 

important outcomes that will be used 

when developing Strength of Evidence 

tables) 

• Intermediate and healthcare 

utilization outcomes 

Æ Attendance at postpartum visits * 

Æ Unplanned care utilization (e.g., 

readmissions, emergency room 

visits) * 

Æ Adherence to condition-specific 

screening/testing (e.g., blood 

pressure monitoring, glucose 

tolerance testing) or treatment * 

Æ Transition to primary care provider 

for long-term care * 

• Clinical outcomes (as appropriate, 

outcomes include incidence, 

prevalence/continuation, severity, 

and resolution) 

Æ Maternal mortality * 

Æ Symptoms or diagnosis of mental 

health conditions (e.g., anxiety, 

depression, substance use) * 

Æ Patient-reported outcomes 

D Quality of life (using validated 

measures) * 

D Perceived stress * 

D Pain 

D Sleep quality 

D Fatigue 

D Sexual well-being and satisfaction 

D Awareness of risk factors for longterm ill health 

Æ Physical health/medical outcomes 

D Postpartum onset of preeclampsia 

or hypertension 

D Infections (e.g., mastitis, wound 

infections) 

D Severe maternal morbidity 

Æ Cardiovascular disorders (e.g., 

cardiomyopathy) 

Æ Cerebrovascular disorders (e.g., 

stroke) 

Æ Bleeding 

Æ Venous thromboembolism 

Æ Other 

Æ Interpregnancy interval 

Æ Unintended pregnancies 

Æ Contraceptive initiation and 

continuation 

Æ Breastfeeding intention, initiation, 

duration, and exclusivity 

Æ Reduction in health inequities (e.g., 

by race, ethnicity, geography, 

disability status) 

• Harms 

Æ Health inequities * 

Æ Perceived discrimination * 

Æ Over-utilization of healthcare 

Æ Patient burden regarding 

postpartum care 

Potential Effect Modifiers 

• Patient-level factors 

Æ Age 

Æ Race/ethnicity 

Æ Gender identity 

Æ Sexual identity 

Æ Physical disability status 

Æ Socioeconomic status 

Æ Immigration status 

Æ Barriers to transportation to 

healthcare facility 

Æ Paid family leave policies (e.g., 

presence versus absence, different 

durations of leave) 

Æ Substance use/substance use 

disorder 

Æ Type of insurance coverage 

(insured versus uninsured, private 

versus public [e.g., Medicaid], 

insurance coverage of postpartum 

care, Medicaid insurance coverage 

extension or expansion) 

Æ Presence versus absence of 

disorders of pregnancy (e.g., 

hypertensive, cardiovascular, 

gestational diabetes mellitus) or 

peripartum complications that 

increase risk of postpartum 

complications 

Æ Preterm versus term delivery 

Æ Live birth versus stillbirth/ 

spontaneous abortion/induced 

abortion 

Æ Number of infants (singleton versus 

twins/triplets, etc.) 

Æ Presence versus absence of a 

supportive partner 

Æ Infant health (e.g., neonatal 

intensive care unit [NICU] 

admission, congenital anomalies) 

• Setting factors 

Æ Geographic location (urban versus 

suburban versus rural) 

Æ Different levels of neighborhood 

vulnerability (e.g., social 

vulnerability index) 

Æ Volume of facility/hospital (high 

versus low) 

Æ Type of facility/hospital (private 

versus public) 

Æ Racial/ethnic concordance between 

provider and patient 

Æ Language concordance between 

provider and patient 

Timing 

• Interventions and Comparators: 

Within 1 year after giving birth 

• Outcome measurement: Up to 1 year 

after giving birth (except 

interpregnancy interval, unintended 

pregnancies, and chronic diseases 

[e.g., diabetes, hypertension], which 

can be later) 

Settings 

• U.S. only 

• Outpatient care 

• Exclude: Institutionalized settings 

(e.g., prisons) 

Design 

• Randomized controlled trials (N 

≥10 participants per group) 

• Nonrandomized comparative 

studies, longitudinal (prospective or 

retrospective) or cross-sectional (N 

≥30 participants per group) 

• Case-control studies (N ≥30 

participants per group) 

• Exclude: Single-group 

(noncomparative) studies, 

comparative cross-sectional studies 

(without a discernable time-period 

between intervention and 

measurement of outcomes), 

qualitative studies 

Dated: March 7, 2022. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2022–05141 Filed 3–10–22; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Patient Safety Organizations: 

Voluntary Relinquishment for the 

QCMetrix PSO 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), Department of 

Health and Human Services (HHS). 

ACTION: Notice of delisting. 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 87, No. 48 / Friday, March 11, 2022 / Notices 14015 

SUMMARY: The Patient Safety and 

Quality Improvement Final Rule 

(Patient Safety Rule) authorizes AHRQ, 

on behalf of the Secretary of HHS, to list 

as a patient safety organization (PSO) an 

entity that attests that it meets the 

statutory and regulatory requirements 

for listing. A PSO can be ‘‘delisted’’ by 

the Secretary if it is found to no longer 

meet the requirements of the Patient 

Safety and Quality Improvement Act of 

2005 (Patient Safety Act) and Patient 

Safety Rule, when a PSO chooses to 

voluntarily relinquish its status as a 

PSO for any reason, or when a PSO’s 

listing expires. AHRQ accepted a 

notification of proposed voluntary 

relinquishment from the QCMetrix PSO, 

PSO number P0166, of its status as a 

PSO, and has delisted the PSO 

accordingly. 

DATES: The delisting was effective at 

12:00 Midnight ET (2400) on February 

11, 2022. 

ADDRESSES: The directories for both 

listed and delisted PSOs are ongoing 

and reviewed weekly by AHRQ. Both 

directories can be accessed 

electronically at the following HHS 

website: http://www.pso.ahrq.gov/listed. 

FOR FURTHER INFORMATION CONTACT: 

Cathryn Bach, Center for Quality 

Improvement and Patient Safety, AHRQ, 

5600 Fishers Lane, MS 06N100B, 

Rockville, MD 20857; Telephone (toll 

free): (866) 403–3697; Telephone (local): 

(301) 427–1111; TTY (toll free): (866) 

438–7231; TTY (local): (301) 427–1130; 

Email: pso@ahrq.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

The Patient Safety Act, 42 U.S.C. 

299b–21 to 299b–26, and the related 

Patient Safety Rule, 42 CFR part 3, 

published in the Federal Register on 

November 21, 2008 (73 FR 70732– 

70814), establish a framework by which 

individuals and entities that meet the 

definition of provider in the Patient 

Safety Rule may voluntarily report 

information to PSOs listed by AHRQ, on 

a privileged and confidential basis, for 

the aggregation and analysis of patient 

safety work product. 

The Patient Safety Act authorizes the 

listing of PSOs, which are entities or 

component organizations whose 

mission and primary activity are to 

conduct activities to improve patient 

safety and the quality of health care 

delivery. 

HHS issued the Patient Safety Rule to 

implement the Patient Safety Act. 

AHRQ administers the provisions of the 

Patient Safety Act and Patient Safety 

Rule relating to the listing and operation 

of PSOs. The Patient Safety Rule 

authorizes AHRQ to list as a PSO an 

entity that attests that it meets the 

statutory and regulatory requirements 

for listing. A PSO can be ‘‘delisted’’ if 

it is found to no longer meet the 

requirements of the Patient Safety Act 

and Patient Safety Rule, when a PSO 

chooses to voluntarily relinquish its 

status as a PSO for any reason, or when 

a PSO’s listing expires. Section 3.108(d) 

of the Patient Safety Rule requires 

AHRQ to provide public notice when it 

removes an organization from the list of 

PSOs. 

AHRQ has accepted a notification of 

proposed voluntary relinquishment 

from the QCMetrix PSO to voluntarily 

relinquish its status as a PSO. 

Accordingly, the QCMetrix PSO, PSO 

number P0166, was delisted effective at 

12:00 Midnight ET (2400) on February 

11, 2022. 

QCMetrix PSO has patient safety work 

product (PSWP) in its possession. The 

PSO will meet the requirements of 

section 3.108(c)(2)(i) of the Patient 

Safety Rule regarding notification to 

providers that have reported to the PSO 

and of section 3.108(c)(2)(ii) regarding 

disposition of PSWP consistent with 

section 3.108(b)(3). According to section 

3.108(b)(3) of the Patient Safety Rule, 

the PSO has 90 days from the effective 

date of delisting and revocation to 

complete the disposition of PSWP that 

is currently in the PSO’s possession. 

More information on PSOs can be 

obtained through AHRQ’s PSO website 

at http://www.pso.ahrq.gov. 

Dated: March 7, 2022. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2022–05163 Filed 3–10–22; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Plan for Foster Care and 

Adoption Assistance—Title IV–E (OMB 

#0970–0433) 

AGENCY: Children’s Bureau, 

Administration for Children and 

Families, HHS. 

ACTION: Request for public comment. 

SUMMARY: The Children’s Bureau (CB), 

Administration for Children and 

Families (ACF), U.S. Department of 

Health and Human Services (HHS), is 

requesting a 3-year extension of the Plan 

for Foster Care and Adoption 

Assistance—Title IV–E, (OMB#: 0970– 

0433, expiration 11/30/2022). This plan 

also incorporates the plan requirements 

for the optional Guardianship 

Assistance Program, the Title IV–E 

prevention services plan and the Title 

IV–E Kinship Navigator program. There 

are no changes requested to the form. 

DATES: Comments due within 60 days of 

publication. In compliance with the 

requirements of the Paperwork 

Reduction Act of 1995, ACF is soliciting 

public comment on the specific aspects 

of the information collection described 

above. 

ADDRESSES: You can obtain copies of the 

proposed collection of information and 

submit comments by emailing 

infocollection@acf.hhs.gov. Identify all 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: A title IV–E plan is 

required by section 471, Part IV–E of the 

Social Security Act (the Act) for each 

public child welfare agency requesting 

federal funding for foster care, adoption 

assistance, and guardianship assistance 

under the Act. Section 479B of the Act 

provides for an Indian tribe, tribal 

organization, or tribal consortium (tribe) 

to operate a title IV–E program in the 

same manner as a state with minimal 

exceptions. The tribe must have an 

approved Title IV–E Plan. The Title IV– 

E Plan provides assurances the 

programs will be administered in 

conformity with the specific 

requirements stipulated in Title IV–E. 

The plan must include all applicable 

state or tribal statutory, regulatory, or 

policy references and citations for each 

requirement as well as supporting 

documentation. A title IV–E agency may 

use the pre-print format prepared by CB, 

or a different format, on the condition 

that the format used includes all of the 

Title IV–E Plan requirements. 

Title IV–E of the Act was amended by 

Public Law 115–123, which included 

the Family First Prevention Services Act 

(FFPSA). FFPSA authorized new 

optional Title IV–E funding for timelimited (1 year) prevention services for 

mental health/substance abuse and inhome parent skill-based programs for (1) 

a child who is a candidate for foster care 

(as defined in section 475(13) of the 

Act), (2) pregnant/parenting foster 

youth, and (3) the parents/kin caregivers 

of those children and youth (sections 

471(e), 474(a)(6), and 475(13) of the 

Act). Title IV–E prevention services 

must be rated as promising, supported, 

or well supported in accordance with 

HHS criteria and be approved by HHS 

(section 471(e)(4)(C) of the Act) as part 

of the Title IV–E Prevention Services 

Clearinghouse (section 476(d)(2) of the 


lotter on DSK11XQN23PROD with NOTICES1