Federal Register / Vol. 79, No. 168 / Friday, August 29, 2014 / Notices 51567 

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 healthcare 

research and healthcare information 

dissemination functions, including 

whether the information will have 

practical utility; (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: August 20, 2014. 

Richard Kronick, 

Director. 

[FR Doc. 2014–20423 Filed 8–28–14; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Patient Safety Organizations: 

Voluntary Relinquishment From 

Patient Safety Services, LLC 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), Department of 

Health and Human Services (HHS). 

ACTION: Notice of Delisting. 

SUMMARY: The Patient Safety and 

Quality Improvement Act of 2005, 42 

U.S.C. 299b–21 to b–26, (Patient Safety 

Act) and the related Patient Safety and 

Quality Improvement Final Rule, 42 

CFR Part 3 (Patient Safety Rule), 

published in the Federal Register on 

November 21, 2008, 73 FR 70732– 

70814, provide for the formation of 

Patient Safety Organizations (PSOs), 

which collect, aggregate, and analyze 

confidential information regarding the 

quality and safety of health care 

delivery. The Patient Safety Rule 

authorizes AHRQ, on behalf of the 

Secretary of NHS, to list as a 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 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 has accepted a notification of 

voluntary relinquishment from Patient 

Safety Services, LLC of its status as a 

PSO, and has delisted the PSO 

accordingly. 

DATES: The directories for both listed 

and delisted PSOs are ongoing and 

reviewed weekly by AHRQ. The 

delisting was effective at 12:00 Midnight 

ET (2400) on July 30, 2014. 

ADDRESSES: Both directories can be 

accessed electronically at the following 

HHS Web site: http://

www.pso.AHRQ.gov/listed. 

FOR FURTHER INFORMATION CONTACT: 

Eileen Hogan, Center for Quality 

Improvement and Patient Safety, AHRQ, 

540 Gaither Road, Rockville, MD 20850; 

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.qov. 

SUPPLEMENTARY INFORMATION: 

Background 

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 

the 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 federally approved PSOs. 

AHRQ has accepted a notification 

from Patient Safety Services, LLC, PSO 

number P0129, to voluntarily relinquish 

its status as a PSO. Accordingly, Patient 

Safety Services, LLC was delisted 

effective at 12:00 Midnight ET (2400) on 

July 30, 2014. 

More information on PSOs can be 

obtained through AHRQ’s PSO Web site 

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

index.html. 

Dated: August 20, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–20424 Filed 8–28–14; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Scientific Information Request on 

Health Information Exchange 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Request for Scientific 

Information Submissions. 

SUMMARY: The Agency for Healthcare 

Research and Quality (AHRQ) is seeking 

scientific information submissions from 

the public. Scientific information is 

being solicited to inform our review of 

Health Information Exchange, which is 

currently being conducted by the 

Evidence-based Practice Centers for the 

AHRQ Effective Health Care Program. 

Access to published and unpublished 

pertinent scientific information will 

improve the quality of this review. 

AHRQ is conducting this systematic 

review pursuant to Section 1013 of the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003, Public Law 108–173, and Section 

902(a) of the Public Health Service Act, 

42 U.S.C. 299a(a). 

DATES: Submission Deadline on or 

before September 29, 2014. 

ADDRESSES: Online submissions: http:// 

effectivehealthcare.AHRQ.gov/

index.cfm/submit-scientificinformation-packets/. Please select the 

study for which you are submitting 

information from the list to upload your 

documents. Email submissions: SIPS@

epc-src.org. 

Print Submissions 

Mailing Address: Portland VA 

Research Foundation, Scientific 

Resource Center, ATTN: Scientific 

Information Packet Coordinator, P.O. 

Box 69539, Portland, OR 97239. 

Shipping Address (FedEx, UPS, etc.): 

Portland VA Research Foundation, 

Scientific Resource Center, ATTN: 

Scientific Information Packet 

Coordinator, 3710 SW U.S. Veterans 

Hospital Road, Mail Code: R&D 71, 

Portland, OR 97239. 

FOR FURTHER INFORMATION CONTACT: 

Ryan McKenna, Telephone: 503–220– 

8262 ext. 58653 or Email: SIPS@epcsrc.org. 


wreier-aviles on DSK5TPTVN1PROD with NOTICES
51568 Federal Register / Vol. 79, No. 168 / Friday, August 29, 2014 / Notices 

SUPPLEMENTARY INFORMATION: The 

Agency for Healthcare Research and 

Quality has commissioned the Effective 

Health Care (EHC) Program Evidencebased Practice Centers to complete a 

review of the evidence for Health 

Information Exchange. 

The EHC Program is dedicated to 

identifying as many studies as possible 

that are relevant to the questions for 

each of its reviews. In order to do so, we 

are supplementing the usual manual 

and electronic database searches of the 

literature by requesting information 

from the public (e.g., details of studies 

conducted). We are looking for studies 

that report on Health Information 

Exchange, including those that describe 

adverse events. The entire research 

protocol, including the key questions, is 

also available online at: http://effective

healthcare.AHRQ.gov/search-for-guidesreviews-and-reports/

?pageaction=display

product&productID=1943. 

This notice is to notify the public that 

the EHC Program would find the 

following information on Health 

Information Exchange helpful: 

• A list of completed studies that 

your organization has sponsored for this 

indication. In the list, please indicate 

whether results are available on 

ClinicalTrials.gov along with the 

ClinicalTrials.gov trial number. 

• For completed studies that do not 

have results on ClinicalTrials.gov, 

please provide a summary, including 

the following elements: Study number, 

study period, design, methodology, 

indication and diagnosis, proper use 

instructions, inclusion and exclusion 

criteria, primary and secondary 

outcomes, baseline characteristics, 

number of patients screened/eligible/

enrolled/lost to follow-up/withdrawn/

analyzed, effectiveness/efficacy, and 

safety results. 

• A list of ongoing studies that your 

organization has sponsored for this 

indication. In the list, please provide the 

ClinicalTrials.gov trial number or, if the 

trial is not registered, the protocol for 

the study including a study number, the 

study period, design, methodology, 

indication and diagnosis, proper use 

instructions, inclusion and exclusion 

criteria, and primary and secondary 

outcomes. 

• Description of whether the above 

studies constitute ALL Phase II and 

above clinical trials sponsored by your 

organization for this indication and an 

index outlining the relevant information 

in each submitted file. 

Your contribution will be very 

beneficial to the EHC Program. The 

contents of all submissions will be made 

available to the public upon request. 

Materials submitted must be publicly 

available or can be made public. 

Materials that are considered 

confidential; marketing materials; study 

types not included in the review; or 

information on indications not included 

in the review cannot be used by the EHC 

Program. This is a voluntary request for 

information, and all costs for complying 

with this request must be borne by the 

submitter. 

The draft of this review will be posted 

on AHRQ’s EHC Program Web site and 

available for public comment for a 

period of 4 weeks. If you would like to 

be notified when the draft is posted, 

please sign up for the email list at: 

http://effectivehealthcare.AHRQ.gov/

index.cfm/ioin-the-email-list1/. 

The systematic review will answer the 

following questions. This information is 

provided as background. AHRQ is not 

requesting that the public provide 

answers to these questions. The entire 

research protocol, is also available 

online at: http://effectivehealth

care.AHRQ.gov/search-for-guidesreviews-and-reports/

?pageaction=display

product&productID=1943. 

The Key Questions 

The draft Key Questions (KQs) 

developed during Topic Refinement 

were available for public comment from 

February 6 to February 26, 2014. The 

comments did not lead to significant 

changes but were helpful in identifying 

additional factors of interest in KQ 4 

and KQ 5, and for clarifying the wording 

of the questions. 

Based on the public comments and 

subsequent discussions with AHRQ, the 

following changes of note were made to 

the KQs: 

• KQ 4: Added ‘‘provider type’’ to KQ 

4b. Added an additional sub question of 

‘‘Do level of use and primary uses vary 

by data source?’’ 

• KQ 5: Added an additional sub 

question of ‘‘How does usability vary by 

health care settings or systems?’’ 

The revised KQs are as follows: 

KQ 1: Is health information exchange 

(HIE) effective in improving clinical (e.g. 

mortality and morbidity), economic 

(e.g., costs and resource use, the value 

proposition for HIE) and population 

(e.g., syndromic surveillance) outcomes? 

• Does effectiveness vary by type of 

HIE? 

• Does effectiveness vary by health 

care settings and systems? 

• Does effectiveness vary by IT 

system characteristics? 

• What evidence exists that the lack 

of HIE leads to poorer outcomes? 

KQ 2: What harms have resulted from 

HIE? (e.g., violations of privacy, errors in 

diagnosis or treatment from too much, 

too little or inaccurate information, or 

patient or provider concerns about 

HIE)? 

• Do harms vary by type of HIE? 

• Do harms vary by health care 

settings and systems? 

• Do harms vary by the IT system 

characteristics? 

KQ 3: Is HIE effective in improving 

intermediate outcomes such as patient 

and provider experience, perceptions or 

behavior; health care processes; or the 

availability, completeness, or accuracy 

of information? 

• Does effectiveness in improving 

intermediate outcomes vary by type of 

HIE? 

• Does effectiveness in improving 

intermediate outcomes vary by health 

care settings and systems? 

• Does effectiveness in improving 

intermediate outcomes vary by IT 

system characteristics? 

• What evidence exists that the lack 

of HIE leads to poorer intermediate 

outcomes? 

KQ 4: What is the current level of use 

and primary uses of HIE? 

• Do level of use and primary uses 

vary by type of HIE? 

• Do level of use and primary uses 

vary by health care settings and systems, 

or provider type? 

• Do level of use and primary uses 

vary by IT system characteristics? 

• Do level of use and primary uses 

vary by data source? 

KQ 5: How does the usability of HIE 

impact effectiveness or harms for 

individuals and organizations? 

• How usable are various types of 

HIE? 

• What specific usability factors 

impact the effectiveness or harms from 

HIE? 

• How does usability vary by health 

care settings or systems? 

KQ 6: What facilitators and barriers 

impact implementation of HIE? 

• Do facilitators and barriers that 

impact implementation vary by type of 

HIE? 

• Do facilitators and barriers that 

impact implementation vary by health 

care settings and systems? 

• Do facilitators and barriers that 

impact implementation vary by IT 

system characteristics? 

KQ 7: What facilitators and barriers 

impact use of HIE? 

• Do facilitators and barriers that 

impact use vary by type of HIE? 


wreier-aviles on DSK5TPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 168 / Friday, August 29, 2014 / Notices 51569 

• Do facilitators and barriers that 

impact use vary by health care settings 

and systems? 

• Do facilitators and barriers that 

impact use vary by IT system 

characteristics? 

KQ 8: What factors influence 

sustainability of HIE? 

PICOTS (Populations, Interventions, 

Comparators, Outcomes, Timing, 

Setting) 

Populations 

Any individual or group of health 

care providers, patients, managers, 

health care institutions, or regional 

organizations. 

Intervention 

Heath Information Exchange (HIE). 

HIE is defined as the electronic sharing 

of clinical information among users 

such as health care providers, patients, 

administrators or policy makers across 

the boundaries of health care 

institutions, health data repositories, 

States and others, typically not within a 

single organization or among affiliated 

providers, while protecting the integrity, 

privacy, and security of the information. 

Comparators 

• Time period prior to HIE 

implementation 

• Locations (geographic or 

organizational without HIE) 

• Situations in which HIE is not 

available, akin to ‘‘usual care’’ in a 

clinical study 

• Comparisons across types of HIE 

• Comparisons of the characteristics 

of the different settings, health care 

system, and IT systems in which HIE is 

used 

Outcomes (specified for each Key 

Question) 

KQ 1: Effectiveness is defined in 

terms of clinical outcomes (e.g., 

mortality and morbidity), economic 

outcomes (e.g., costs and resource use, 

the value proposition for HIE) and 

population outcomes (e.g., syndromic 

surveillance for the identification of 

trends or clusters). 

KQ 2: Harms include unintended 

negative consequence or adverse events 

experienced by individuals, institutions, 

or organizations. Harms from HIE may 

include negative outcomes or the risk of 

negative outcomes resulting from 

information that is wrong, not provided 

in a timely manner, or in formats that 

inhibit its identification, 

comprehension, and use. Harms also 

may result from too much information 

as well as lack of information. Harms 

can also include negative impacts on 

attitudes (e.g., patients not trusting the 

privacy will be protected, clinicians’ 

concerns about legal liability). 

KQ 3: Intermediate outcomes include 

outcomes such as provider and patient 

experience and perceptions; changes in 

provider behavior and health care 

processes; and changes in the 

availability, completeness, or accuracy 

of information. 

KQ 4: Level of use is the rate of HIE 

use by individuals, health care 

institutions, or regional organizations. 

KQ 5: Usability focuses on the 

function of the HIE in terms of the 

interaction between users and HIE and 

their ability to navigate and accomplish 

tasks. 

KQ 6: Implementation of HIE is 

defined as the realization of an HIE 

project such that the exchange of data is 

operational. 

KQ 7: Use is the incorporation of the 

HIE into the workflow and decisions of 

patients, providers or organizations. 

KQ 8: Sustainability is long-term 

maintenance, and improvement or 

expansion of HIE, after the 

implementation period. 

Timing 

No minimum duration of time lapsed 

from implementation of HIE to the 

measurement of outcomes. 

Settings 

Any aspect of the setting in which 

health information is exchanged for the 

purpose of improving health or health 

care decisions that is hypothesized to 

impact effectiveness, use, usability or 

sustainability. This may include the 

type(s) of clinical environments (e.g., 

ambulatory care, hospital, nursing 

home, etc.), payment/reimbursement 

model(s) (e.g., fee-for-service, managed 

care setting, risk/value-based model 

such as an accountable care 

organization, etc.), and legislative 

requirements (e.g., participation in HIE 

required to participate in Medicaid). 

Dated: August 20, 2014. 

Richard Kronick, 

AHRQ Director. 

[FR Doc. 2014–20425 Filed 8–28–14; 8:45 am] 

BILLING CODE 4160–90–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10147, CMS– 

2540–10, CMS–265–11, CMS–10106 and 

CMS–10537] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by September 29, 

2014. 

ADDRESSES: When commenting on the 

proposed information collections, 

please reference the document identifier 

or OMB control number. To be assured 

consideration, comments and 

recommendations must be received by 

the OMB desk officer via one of the 

following transmissions: OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–5806 or Email: 

OIRA_submission@omb.eop.gov. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ Web site address at 

http://www.cms.hhs.gov/

PaperworkReductionActof1995. 


wreier-aviles on DSK5TPTVN1PROD with NOTICES