Meeting for Software Developers on the Common Formats for Patient Safety Data Collection and Event Reporting, 7605-7606 [2015-02590]

Download as PDF Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices technology to minimize the information collection burden. DEPARTMENT OF HEALTH AND HUMAN SERVICES Darius Taylor, Information Collection Clearance Officer. Agency for Healthcare Research and Quality [FR Doc. 2015–02760 Filed 2–10–15; 8:45 am] Meeting for Software Developers on the Common Formats for Patient Safety Data Collection and Event Reporting BILLING CODE 4150–37–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Decision To Evaluate a Petition To Designate a Class of Employees From the Carborundum Company in Niagara Falls, New York, To Be Included in the Special Exposure Cohort National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention, Department of Health and Human Services. AGENCY: ACTION: Notice. NIOSH gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from the Carborundum Company in Niagara Falls, New York, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Carborundum Company. Location: Niagara Falls, New York. Job Titles and/or Job Duties: All employees who worked in any area. Period of Employment: January 1, 1943 through December 31, 1976. SUMMARY: FOR FURTHER INFORMATION CONTACT: Stuart L. Hinnefeld, Director, Division of Compensation Analysis and Support, National Institute for Occupational Safety and Health, 1090 Tusculum Avenue, MS C–46, Cincinnati, OH 45226–1938, Telephone 877–222–7570. Information requests can also be submitted by email to DCAS@CDC.GOV. tkelley on DSK3SPTVN1PROD with NOTICES John Howard, Director, National Institute for Occupational Safety and Health. [FR Doc. 2015–02803 Filed 2–10–15; 8:45 am] BILLING CODE 4163–19–P VerDate Sep<11>2014 17:07 Feb 10, 2015 Jkt 235001 Agency for Healthcare Research and Quality (AHRQ), Department of Health and Human Services (HHS). ACTION: Notice of public meeting. AGENCY: The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act) provides for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of healthcare delivery. The Patient Safety Act (at 42 U.S.C. 299b–23(b)) authorizes the collection of this information in a standardized manner, as explained in 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 70731–70814). AHRQ coordinates the development of common definitions and reporting formats (Common Formats) that allow healthcare providers to voluntarily collect and submit standardized information regarding patient safety events. In order to support the Common Formats, AHRQ has provided technical specifications to promote standardization by ensuring that data collected by PSOs and other entities are clinically and electronically comparable. More information on the Common Formats, including the technical specifications, can be obtained through AHRQ’s PSO Web site: http:// www.PSO.AHRQ.GOV. The purpose of this notice is to announce a meeting to discuss the Common Formats. This meeting is designed as an interactive forum where software developers and PSOs can provide input on the formats. AHRQ especially requests participation by and input from those entities which have used AHRQ’s technical specifications and implemented, or plan to implement, the formats electronically. DATES: The meeting will be held from 10:00 a.m. to 3:30 p.m. on Friday, April 24, 2015. ADDRESSES: The meeting will be held at the John M. Eisenberg Conference Center, Agency for Healthcare Research and Quality, 540 Gaither Road, Rockville, MD 20850. SUMMARY: PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 7605 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.gov. SUPPLEMENTARY INFORMATION: Background The Patient Safety Act and Patient Safety Rule establish a framework by which doctors, hospitals, skilled nursing facilities, and other health care providers may voluntarily report information regarding patient safety events and quality of care. Information that is assembled and developed by providers for reporting to PSOs and the information received and analyzed by PSOs—called patient safety work product—is privileged and confidential. Patient safety work product is used to identify events, patterns of care, and unsafe conditions that increase risks and hazards to patients. Definitions and other details about PSOs and patient safety work product are included in the Patient Safety Rule. The Patient Safety Act and Patient Safety Rule require PSOs, to the extent practicable and appropriate, to collect patient safety work product from providers in a standardized manner in order to permit valid comparisons of similar cases among similar providers. The collection of patient safety work product allows the aggregation of sufficient data to identify and address underlying causal factors of patient safety problems. Both the Patient Safety Act and Patient Safety Rule, including any relevant guidance, can be accessed electronically at: http:// www.PSO.AHRQ.GOV/LEGISLATION. In collaboration with the interagency Federal Patient Safety Workgroup (PSWG), the National Quality Forum (NQF) and the public, AHRQ has developed Common Formats for two settings of care—acute care hospitals and skilled nursing facilities—in order to facilitate standardized data collection. AHRQ’s Common Formats include: • Event descriptions (descriptions of patient safety events and unsafe conditions to be reported), • Specifications for patient safety aggregate reports and individual event summaries, • Delineation of data elements to be collected for different types of events to populate the reports, • A user’s guide and quick guide, and • Technical specifications for electronic data collection and reporting. E:\FR\FM\11FEN1.SGM 11FEN1 tkelley on DSK3SPTVN1PROD with NOTICES 7606 Federal Register / Vol. 80, No. 28 / Wednesday, February 11, 2015 / Notices AHRQ convenes the PSWG to assist AHRQ with developing and maintaining the Common Formats. The PSWG includes major health agencies within HHS—the Centers for Disease Control and Prevention, Centers for Medicare and Medicaid Services, Food and Drug Administration, Health Resources and Services Administration, Indian Health Service, National Institutes of Health, National Library of Medicine, Office of the National Coordinator for Health Information Technology, Office of Public Health and Science, and Substance Abuse and Mental Health Services Administration—as well as the Department of Defense and Department of Veterans Affairs. When developing Common Formats, AHRQ first reviews existing patient safety event reporting systems from a variety of health care organizations. In collaboration with the PSWG and Federal subject matter experts, AHRQ drafts and releases beta versions of the Common Formats for public review and comment. Through a contract with AHRQ, the NQF solicits feedback on the initial and subsequent versions of the Common Formats from private sector organizations and individuals. The NQF, a nonprofit organization that focuses on health care quality, then convenes an expert panel to review the comments received and provide feedback to AHRQ. Based upon the expert panel’s feedback, AHRQ, in conjunction with the PSWG, further revises the Common Formats. The technical specifications promote standardization of collected patient safety event information by specifying rules for data collection and submission, as well as by providing guidance for how and when to create data elements, their valid values, conditional and go-to logic, and reports. These specifications will ensure that data collected by PSOs and other entities have comparable clinical meaning. The technical specifications also provide direction to software developers, so that the Common Formats can be implemented electronically, and to PSOs, so that the Common Formats can be submitted electronically to the PSO Privacy Protection Center (PSOPPC) for data deidentification and transmission to the Network of Patient Safety Databases (NPSD). Common Formats technical specifications consist of the following: Æ Data dictionary—defines data elements and their attributes (data element name, answer values, field length, guide for use, etc.) included in Common Formats; VerDate Sep<11>2014 17:07 Feb 10, 2015 Jkt 235001 Æ clinical document architecture (CDA) implementation guide—provides instructions for developing a file to transmit the Common Formats Patient Safety data from the PSO to the PSOPPC using the Common Formats; Æ validation rules and errors document—specifies and defines the validation rules that will be applied to the Common Formats data elements submitted to the PSOPPC; Æ Common Formats flow charts— diagrams the valid paths to complete generic and event specific formats (a complete event report); Æ local specifications—provides specifications for processing, linking and reporting on events and details specifications for reports; and Æ metadata registry—includes descriptive facts about information contained in the data dictionary to illustrate how such data corresponds with similar data elements used by other Federal agencies and standards development organizations [e.g., HL—7, International Standards Organization (ISO)]. Agenda, Registration, and Other Information About the Meeting The 2015 meeting will be an interactive forum designed to allow meeting participants not only to provide input but also to respond to the input provided by others. The meeting agenda will include: An overview of Federal efforts related to the Common Formats; presentations and discussion of implementation of Common Formats Event Reporting—Hospital Versions 1.1 and 1.2; and, a review of data submission both by PSOs and by vendors on behalf of PSOs. AHRQ requests that interested persons send an email to the PSOPPC at support@psoppc.ORG for registration information. The meeting space will accommodate approximately 150 participants. Before the meeting, a detailed agenda and logistical information will be provided to registrants. Prior to the meeting, AHRQ invites review of the technical specifications for Common Formats which can be accessed through AHRQ’s PSO Web site at http:// www.pso.AHRQ.GOV/formats/ commonfmt.htm. Dated: February 3, 2015. Richard Kronick, Director. [FR Doc. 2015–02590 Filed 2–10–15; 8:45 am] BILLING CODE 4160–90–P PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Opportunity To Collaborate in the Evaluation of Simplified Nucleic Acid Tests for Detecting and Quantifying HIV Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS). ACTION: General notice. AGENCY: The Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS) announces an opportunity for industry and the public to collaborate on a project to evaluate simplified nucleic acid tests. HHS/CDC is interested in evaluating simplified nucleic acid tests that (1) can be used near a patient with rapid turn-around of results (2) can be used to aid in the diagnosis of HIV–1 infection, and (3) have the potential to be used in moderately complex and/or waived laboratories as defined under the Clinical Laboratory Improvement Amendment (CLIA) regulations. Tests of interest include those that use whole blood, serum, plasma, or dried blood spots. Performance will be evaluated relative to HHS/Food and Drug Administration (FDA)-approved qualitative and quantitative nucleic acid tests as well as antibody immunoassays. More than one collaborator may be selected. DATES: Formal proposals must be received on or before April 13, 2015. ADDRESSES: Formal proposals should be submitted to Division of HIV/AIDS Prevention, National Center for HIV/ AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, 1600 Clifton Road NE., Mailstop E–46, Atlanta, Georgia 30329, Attn: Simplified Nucleic Acid Tests Evaluation Project. If you are interested in submitting a proposal, please send a letter of interest to Dr. Michele Owen at smo2@cdc.gov by March 13, 2015. The letter of interest is not considered a formal proposal and is not required; however, it is highly recommended, as it will assist CDC in planning for the review process. The formal proposal will still need to be submitted according to the instructions in this notice. FOR FURTHER INFORMATION CONTACT: Questions on the project should be addressed to: Laura Wesolowski, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and SUMMARY: E:\FR\FM\11FEN1.SGM 11FEN1

Agencies

[Federal Register Volume 80, Number 28 (Wednesday, February 11, 2015)]
[Notices]
[Pages 7605-7606]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02590]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Meeting for Software Developers on the Common Formats for Patient 
Safety Data Collection and Event Reporting

AGENCY: Agency for Healthcare Research and Quality (AHRQ), Department 
of Health and Human Services (HHS).

ACTION: Notice of public meeting.

-----------------------------------------------------------------------

SUMMARY: The Patient Safety and Quality Improvement Act of 2005, 42 
U.S.C. 299b-21 to b-26, (Patient Safety Act) provides for the formation 
of Patient Safety Organizations (PSOs), which collect, aggregate, and 
analyze confidential information regarding the quality and safety of 
healthcare delivery. The Patient Safety Act (at 42 U.S.C. 299b-23(b)) 
authorizes the collection of this information in a standardized manner, 
as explained in 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 70731-70814). AHRQ 
coordinates the development of common definitions and reporting formats 
(Common Formats) that allow healthcare providers to voluntarily collect 
and submit standardized information regarding patient safety events. In 
order to support the Common Formats, AHRQ has provided technical 
specifications to promote standardization by ensuring that data 
collected by PSOs and other entities are clinically and electronically 
comparable. More information on the Common Formats, including the 
technical specifications, can be obtained through AHRQ's PSO Web site: 
http://www.PSO.AHRQ.GOV.
    The purpose of this notice is to announce a meeting to discuss the 
Common Formats. This meeting is designed as an interactive forum where 
software developers and PSOs can provide input on the formats. AHRQ 
especially requests participation by and input from those entities 
which have used AHRQ's technical specifications and implemented, or 
plan to implement, the formats electronically.

DATES: The meeting will be held from 10:00 a.m. to 3:30 p.m. on Friday, 
April 24, 2015.

ADDRESSES: The meeting will be held at the John M. Eisenberg Conference 
Center, Agency for Healthcare Research and Quality, 540 Gaither Road, 
Rockville, MD 20850.

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.gov.

SUPPLEMENTARY INFORMATION: 

Background

    The Patient Safety Act and Patient Safety Rule establish a 
framework by which doctors, hospitals, skilled nursing facilities, and 
other health care providers may voluntarily report information 
regarding patient safety events and quality of care. Information that 
is assembled and developed by providers for reporting to PSOs and the 
information received and analyzed by PSOs--called patient safety work 
product--is privileged and confidential. Patient safety work product is 
used to identify events, patterns of care, and unsafe conditions that 
increase risks and hazards to patients. Definitions and other details 
about PSOs and patient safety work product are included in the Patient 
Safety Rule.
    The Patient Safety Act and Patient Safety Rule require PSOs, to the 
extent practicable and appropriate, to collect patient safety work 
product from providers in a standardized manner in order to permit 
valid comparisons of similar cases among similar providers. The 
collection of patient safety work product allows the aggregation of 
sufficient data to identify and address underlying causal factors of 
patient safety problems. Both the Patient Safety Act and Patient Safety 
Rule, including any relevant guidance, can be accessed electronically 
at: http://www.PSO.AHRQ.GOV/LEGISLATION.
    In collaboration with the interagency Federal Patient Safety 
Workgroup (PSWG), the National Quality Forum (NQF) and the public, AHRQ 
has developed Common Formats for two settings of care--acute care 
hospitals and skilled nursing facilities--in order to facilitate 
standardized data collection. AHRQ's Common Formats include:
     Event descriptions (descriptions of patient safety events 
and unsafe conditions to be reported),
     Specifications for patient safety aggregate reports and 
individual event summaries,
     Delineation of data elements to be collected for different 
types of events to populate the reports,
     A user's guide and quick guide, and
     Technical specifications for electronic data collection 
and reporting.

[[Page 7606]]

    AHRQ convenes the PSWG to assist AHRQ with developing and 
maintaining the Common Formats. The PSWG includes major health agencies 
within HHS--the Centers for Disease Control and Prevention, Centers for 
Medicare and Medicaid Services, Food and Drug Administration, Health 
Resources and Services Administration, Indian Health Service, National 
Institutes of Health, National Library of Medicine, Office of the 
National Coordinator for Health Information Technology, Office of 
Public Health and Science, and Substance Abuse and Mental Health 
Services Administration--as well as the Department of Defense and 
Department of Veterans Affairs.
    When developing Common Formats, AHRQ first reviews existing patient 
safety event reporting systems from a variety of health care 
organizations. In collaboration with the PSWG and Federal subject 
matter experts, AHRQ drafts and releases beta versions of the Common 
Formats for public review and comment.
    Through a contract with AHRQ, the NQF solicits feedback on the 
initial and subsequent versions of the Common Formats from private 
sector organizations and individuals. The NQF, a nonprofit organization 
that focuses on health care quality, then convenes an expert panel to 
review the comments received and provide feedback to AHRQ. Based upon 
the expert panel's feedback, AHRQ, in conjunction with the PSWG, 
further revises the Common Formats.
    The technical specifications promote standardization of collected 
patient safety event information by specifying rules for data 
collection and submission, as well as by providing guidance for how and 
when to create data elements, their valid values, conditional and go-to 
logic, and reports. These specifications will ensure that data 
collected by PSOs and other entities have comparable clinical meaning.
    The technical specifications also provide direction to software 
developers, so that the Common Formats can be implemented 
electronically, and to PSOs, so that the Common Formats can be 
submitted electronically to the PSO Privacy Protection Center (PSOPPC) 
for data de-identification and transmission to the Network of Patient 
Safety Databases (NPSD).
    Common Formats technical specifications consist of the following:
    [cir] Data dictionary--defines data elements and their attributes 
(data element name, answer values, field length, guide for use, etc.) 
included in Common Formats;
    [cir] clinical document architecture (CDA) implementation guide--
provides instructions for developing a file to transmit the Common 
Formats Patient Safety data from the PSO to the PSOPPC using the Common 
Formats;
    [cir] validation rules and errors document--specifies and defines 
the validation rules that will be applied to the Common Formats data 
elements submitted to the PSOPPC;
    [cir] Common Formats flow charts--diagrams the valid paths to 
complete generic and event specific formats (a complete event report);
    [cir] local specifications--provides specifications for processing, 
linking and reporting on events and details specifications for reports; 
and
    [cir] metadata registry--includes descriptive facts about 
information contained in the data dictionary to illustrate how such 
data corresponds with similar data elements used by other Federal 
agencies and standards development organizations [e.g., HL--7, 
International Standards Organization (ISO)].

Agenda, Registration, and Other Information About the Meeting

    The 2015 meeting will be an interactive forum designed to allow 
meeting participants not only to provide input but also to respond to 
the input provided by others. The meeting agenda will include: An 
overview of Federal efforts related to the Common Formats; 
presentations and discussion of implementation of Common Formats Event 
Reporting--Hospital Versions 1.1 and 1.2; and, a review of data 
submission both by PSOs and by vendors on behalf of PSOs.
    AHRQ requests that interested persons send an email to the PSOPPC 
at support@psoppc.ORG for registration information. The meeting space 
will accommodate approximately 150 participants. Before the meeting, a 
detailed agenda and logistical information will be provided to 
registrants. Prior to the meeting, AHRQ invites review of the technical 
specifications for Common Formats which can be accessed through AHRQ's 
PSO Web site at http://www.pso.AHRQ.GOV/formats/commonfmt.htm.

    Dated: February 3, 2015.
Richard Kronick,
Director.
[FR Doc. 2015-02590 Filed 2-10-15; 8:45 am]
BILLING CODE 4160-90-P