83 FR 61382 - Common Formats for Patient Safety Data Collection
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality Federal Register Volume 83, Issue 230 (November 29, 2018)
Agency for Healthcare Research and Quality
Federal Register Volume 83, Issue 230 (November 29, 2018)
| Page Range | 61382-61383 | |
| FR Document | 2018-25971 |
[Federal Register Volume 83, Number 230 (Thursday, November 29, 2018)] [Notices] [Pages 61382-61383] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-25971] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Common Formats for Patient Safety Data Collection AGENCY: Agency for Healthcare Research and Quality (AHRQ), Department of Health and Human Services (HHS). ACTION: Notice of availability--New Common Formats. ----------------------------------------------------------------------- SUMMARY: As authorized by the Secretary of HHS, AHRQ coordinates the development of common definitions and reporting formats (Common Formats or formats) for reporting on health care quality and patient safety. The purpose of this notice is to announce the availability of Common Formats for Surveillance--Hospital Version 0.2 Beta. DATES: Ongoing public input. ADDRESSES: The Common Formats for Surveillance--Hospital Version 0.2 Beta can be accessed electronically at the following website: https://www.psoppc.org/psoppc_web/publicpages/commonFormatsOverview. FOR FURTHER INFORMATION CONTACT: Dr. Hamid Jalal, Center for Quality Improvement and Patient Safety, AHRQ, 5600 Fishers Lane, 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: [email protected]. SUPPLEMENTARY INFORMATION: Background on Common Formats Development The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to 299b-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 70731-70814, provide for the formation of Patient Safety Organizations (PSOs), which collect and analyze confidential and privileged information regarding the quality and safety of health care delivery that meets the definition of patient safety work product. Aggregation of these data enables PSOs and others to identify and address underlying causal factors of patient safety and quality issues. The Patient Safety Act provides for the development of standardized reporting formats using common language and definitions to ensure that health care quality and patient safety data collected by PSOs and other entities are comparable. The Common Formats facilitate aggregation of comparable data at local, PSO, regional and national levels. In addition, the formats are intended to enhance the reporting of information that is standardized both clinically and electronically. AHRQ has developed Common Formats for three settings of care--acute care hospitals, skilled nursing facilities and community pharmacies-- for use by health care providers and PSOs. AHRQ-listed PSOs are required to collect patient safety work product in a standardized manner to the extent practical and appropriate; this is a requirement the PSO can meet by collecting such information using Common Formats. Additionally, providers and other organizations not working with an AHRQ-listed PSO can use the Common Formats in their work to improve quality and safety; however, [[Page 61383]] they cannot benefit from the federal confidentiality and privilege protections of the Patient Safety Act. Since February 2005, AHRQ has convened the Federal Patient Safety Work Group (PSWG) to assist with developing and maintaining the Common Formats. The PSWG includes major health agencies within HHS as well as the Departments of Defense and Veterans Affairs. The PSWG helps assure the consistency of definitions/formats with those of relevant government agencies. In addition, AHRQ has solicited comments from the private and public sectors regarding proposed versions of the Common Formats through a contract, since 2008, with the National Quality Forum (NQF), which is a non-profit organization focused on health care quality. After receiving comments, the NQF solicits review of the formats by its Common Formats Expert Panel. Subsequently, NQF provides this input to AHRQ who then uses it to refine the formats. Previously, AHRQ's primary focus with the Common Formats has been to support traditional event reporting. For the Common Formats, it should be noted that AHRQ uses the term ``surveillance'' to refer to the improved detection of events and calculation of adverse event rates in populations reviewed that will allow for collection of comparable performance data over time and across settings. These formats are designed to provide, through retrospective review of medical records, information that is complementary to that derived from event reporting systems. For more information on AHRQ's efforts measuring patient safety in this area, please go to: https://www.ahrq.gov/news/blog/ahrqviews/new-system-aims-to-improve-patient-safety-monitoring.html. AHRQ announced the availability of the, Common Formats for Surveillance--Hospital Version 0.2 Beta, for review and comment on May 9, 2018 in the Federal Register (83 FR 21295-21296). After obtaining feedback, the Agency revised and finalized the formats through the development of event descriptions which are definitions of patient safety events, near misses, and unsafe conditions. The Common Formats for Surveillance--Hospital Version 0.2 Beta will be posted at the PSOPPC website: https://www.psoppc.org/psoppc_web. Additional information about the Common Formats can be obtained through AHRQ's PSO website: https://pso.ahrq.gov/. Francis D. Chesley, Jr., Acting Deputy Director. [FR Doc. 2018-25971 Filed 11-28-18; 8:45 am] BILLING CODE 4160-90-P
![61382 Federal Register / Vol. 83, No. 230 / Thursday, November 29, 2018 / Notices
Commission tries to remove individuals’ Comments containing material for ADDRESSES: The Common Formats for
home contact information from which confidential treatment is Surveillance—Hospital Version 0.2 Beta
comments before placing them on the requested must be filed in paper form, can be accessed electronically at the
Commission website. must be clearly labeled ‘‘Confidential,’’ following website: https://
Postal mail addressed to the and must comply with FTC Rule 4.9(c). www.psoppc.org/psoppc_web/
Commission is subject to delay due to In particular, the written request for publicpages/commonFormatsOverview.
heightened security screening. As a confidential treatment that accompanies FOR FURTHER INFORMATION CONTACT:
result, we encourage you to submit your the comment must include the factual Dr. Hamid Jalal, Center for Quality
comments online, or to send them to the and legal basis for the request, and must Improvement and Patient Safety, AHRQ,
Commission by courier or overnight identify the specific portions of the 5600 Fishers Lane, Rockville, MD
service. To make sure that the comment to be withheld from the public 20857; Telephone (toll free): (866) 403–
Commission considers your online record. See FTC Rule 4.9(c). Your 3697; Telephone (local): (301) 427–
comment, you must file it at https:// comment will be kept confidential only 1111; TTY (toll free): (866) 438–7231;
ftcpublic.commentworks.com/ftc/ if the General Counsel grants your TTY (local): (301) 427–1130; Email:
altfuelspra, by following the request in accordance with the law and pso@ahrq.hhs.gov.
instructions on the web-based form. the public interest. Once your comment
SUPPLEMENTARY INFORMATION:
When this Notice appears at http:// has been posted on the public FTC
www.regulations.gov/#!home, you also website—as legally required by FTC Background on Common Formats
may file a comment through that Rule 4.9(b)—we cannot redact or Development
website. remove your comment from the FTC
If you file your comment on paper, The Patient Safety and Quality
website, unless you submit a Improvement Act of 2005, 42 U.S.C.
write ‘‘Paperwork Comment: FTC File confidentiality request that meets the
No. P134200’’ on your comment and on 299b–21 to 299b–26 (Patient Safety Act),
requirements for such treatment under
the envelope, and mail it to the and the related Patient Safety and
FTC Rule 4.9(c), and the General
following address: Federal Trade Quality Improvement Final Rule, 42
Counsel grants that request.
Commission, Office of the Secretary, The FTC Act and other laws that the CFR part 3 (Patient Safety Rule),
600 Pennsylvania Avenue NW, Suite Commission administers permit the published in the Federal Register on
CC–5610 (Annex J), Washington, DC collection of public comments to November 21, 2008, 73 FR 70731–
20580, or deliver your comment to the consider and use in this proceeding as 70814, provide for the formation of
following address: Federal Trade appropriate. The Commission will Patient Safety Organizations (PSOs),
Commission, Office of the Secretary, consider all timely and responsive which collect and analyze confidential
Constitution Center, 400 7th Street SW, public comments that it receives on or and privileged information regarding
5th Floor, Suite 5610 (Annex J), before January 28, 2019. For information the quality and safety of health care
Washington, DC 20024. If possible, on the Commission’s privacy policy, delivery that meets the definition of
submit your paper comment to the including routine uses permitted by the patient safety work product.
Commission by courier or overnight Privacy Act, see https://www.ftc.gov/ Aggregation of these data enables PSOs
service. site-information/privacy-policy. and others to identify and address
Because your comment will be placed underlying causal factors of patient
on the publicly accessible FTC website Heather Hippsley, safety and quality issues.
at https://www.ftc.gov/, you are solely Deputy General Counsel. The Patient Safety Act provides for
responsible for making sure that your [FR Doc. 2018–25964 Filed 11–28–18; 8:45 am] the development of standardized
comment does not include any sensitive BILLING CODE 6750–01–P reporting formats using common
or confidential information. In language and definitions to ensure that
particular, your comment should not health care quality and patient safety
include any sensitive personal DEPARTMENT OF HEALTH AND data collected by PSOs and other
information, such as your or anyone HUMAN SERVICES entities are comparable. The Common
else’s Social Security number; date of Formats facilitate aggregation of
birth; driver’s license number or other Agency for Healthcare Research and comparable data at local, PSO, regional
state identification number, or foreign Quality and national levels. In addition, the
country equivalent; passport number; formats are intended to enhance the
financial account number; or credit or Common Formats for Patient Safety reporting of information that is
debit card number. You are also solely Data Collection standardized both clinically and
responsible for making sure that your AGENCY: Agency for Healthcare Research electronically.
comment does not include any sensitive and Quality (AHRQ), Department of AHRQ has developed Common
health information, such as medical Health and Human Services (HHS). Formats for three settings of care—acute
records or other individually ACTION: Notice of availability—New care hospitals, skilled nursing facilities
identifiable health information. In Common Formats. and community pharmacies—for use by
addition, your comment should not health care providers and PSOs. AHRQ-
include any ‘‘trade secret or any SUMMARY: As authorized by the listed PSOs are required to collect
commercial or financial information Secretary of HHS, AHRQ coordinates patient safety work product in a
which . . . is privileged or the development of common definitions standardized manner to the extent
confidential’’—as provided by Section and reporting formats (Common practical and appropriate; this is a
khammond on DSK30JT082PROD with NOTICES
6(f) of the FTC Act, 15 U.S.C. 46(f), and Formats or formats) for reporting on requirement the PSO can meet by
FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)— health care quality and patient safety. collecting such information using
including in particular competitively The purpose of this notice is to Common Formats. Additionally,
sensitive information such as costs, announce the availability of Common providers and other organizations not
sales statistics, inventories, formulas, Formats for Surveillance—Hospital working with an AHRQ-listed PSO can
patterns, devices, manufacturing Version 0.2 Beta. use the Common Formats in their work
processes, or customer names. DATES: Ongoing public input. to improve quality and safety; however,
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![Federal Register / Vol. 83, No. 230 / Thursday, November 29, 2018 / Notices 61383
they cannot benefit from the federal through AHRQ’s PSO website: https:// To obtain copies of a supporting
confidentiality and privilege protections pso.ahrq.gov/. statement and any related forms for the
of the Patient Safety Act. proposed collection(s) summarized in
Francis D. Chesley, Jr.,
Since February 2005, AHRQ has this notice, you may make your request
Acting Deputy Director. using one of following:
convened the Federal Patient Safety [FR Doc. 2018–25971 Filed 11–28–18; 8:45 am] 1. Access CMS’ website address at
Work Group (PSWG) to assist with BILLING CODE 4160–90–P https://www.cms.gov/Regulations-and-
developing and maintaining the Guidance/Legislation/Paperwork
Common Formats. The PSWG includes ReductionActof1995/PRA-Listing.html.
major health agencies within HHS as DEPARTMENT OF HEALTH AND 2. Email your request, including your
well as the Departments of Defense and HUMAN SERVICES address, phone number, OMB number,
Veterans Affairs. The PSWG helps and CMS document identifier, to
assure the consistency of definitions/ Centers for Medicare & Medicaid
Paperwork@cms.hhs.gov.
formats with those of relevant Services
3. Call the Reports Clearance Office at
government agencies. In addition, (410) 786–1326.
[Document Identifiers CMS–10137 and
AHRQ has solicited comments from the CMS–10675] FOR FURTHER INFORMATION CONTACT:
private and public sectors regarding William Parham at (410) 786–4669.
proposed versions of the Common Agency Information Collection SUPPLEMENTARY INFORMATION: Under the
Formats through a contract, since 2008, Activities: Submission for OMB Paperwork Reduction Act of 1995 (PRA)
with the National Quality Forum (NQF), Review; Comment Request (44 U.S.C. 3501–3520), federal agencies
which is a non-profit organization must obtain approval from the Office of
focused on health care quality. After AGENCY: Centers for Medicare &
Medicaid Services, HHS. Management and Budget (OMB) for each
receiving comments, the NQF solicits collection of information they conduct
review of the formats by its Common ACTION: Notice. or sponsor. The term ‘‘collection of
Formats Expert Panel. Subsequently, SUMMARY: The Centers for Medicare & information’’ is defined in 44 U.S.C.
NQF provides this input to AHRQ who Medicaid Services (CMS) is announcing 3502(3) and 5 CFR 1320.3(c) and
then uses it to refine the formats. an opportunity for the public to includes agency requests or
Previously, AHRQ’s primary focus comment on CMS’ intention to collect requirements that members of the public
with the Common Formats has been to information from the public. Under the submit reports, keep records, or provide
Paperwork Reduction Act of 1995 information to a third party. Section
support traditional event reporting. For
(PRA), federal agencies are required to 3506(c)(2)(A) of the PRA (44 U.S.C.
the Common Formats, it should be
publish notice in the Federal Register 3506(c)(2)(A)) requires federal agencies
noted that AHRQ uses the term
concerning each proposed collection of to publish a 30-day notice in the
‘‘surveillance’’ to refer to the improved Federal Register concerning each
detection of events and calculation of information, including each proposed
extension or reinstatement of an existing proposed collection of information,
adverse event rates in populations including each proposed extension or
reviewed that will allow for collection collection of information, and to allow
a second opportunity for public reinstatement of an existing collection
of comparable performance data over of information, before submitting the
time and across settings. These formats comment on the notice. Interested
persons are invited to send comments collection to OMB for approval. To
are designed to provide, through comply with this requirement, CMS is
regarding the burden estimate or any
retrospective review of medical records, publishing this notice that summarizes
other aspect of this collection of
information that is complementary to the following proposed collection(s) of
information, including the necessity and
that derived from event reporting utility of the proposed information information for public comment:
systems. For more information on collection for the proper performance of 1. Type of Information Collection
AHRQ’s efforts measuring patient safety the agency’s functions, the accuracy of Request: Revision of a currently
in this area, please go to: https:// the estimated burden, ways to enhance approved collection; Title of
www.ahrq.gov/news/blog/ahrqviews/ the quality, utility, and clarity of the Information Collection: Solicitation for
new-system-aims-to-improve-patient- information to be collected, and the use Applications for Medicare Prescription
safety-monitoring.html. of automated collection techniques or Drug Plan 2020 Contracts; Use: Coverage
other forms of information technology to for the prescription drug benefit is
AHRQ announced the availability of
minimize the information collection provided through contracted
the, Common Formats for prescription drug plans (PDPs) or
Surveillance—Hospital Version 0.2 burden.
through Medicare Advantage (MA)
Beta, for review and comment on May DATES: Comments on the collection(s) of plans that offer integrated prescription
9, 2018 in the Federal Register (83 FR information must be received by the drug and health care coverage (MA–PD
21295–21296). After obtaining feedback, OMB desk officer by December 31, 2018. plans). Cost Plans that are regulated
the Agency revised and finalized the ADDRESSES: When commenting on the under Section 1876 of the Social
formats through the development of proposed information collections, Security Act, and Employer Group
event descriptions which are definitions please reference the document identifier Waiver Plans (EGWP) may also provide
of patient safety events, near misses, or OMB control number. To be assured a Part D benefit. Organizations wishing
and unsafe conditions. The Common consideration, comments and to provide services under the
khammond on DSK30JT082PROD with NOTICES
Formats for Surveillance—Hospital recommendations must be received by Prescription Drug Benefit Program must
Version 0.2 Beta will be posted at the the OMB desk officer via one of the complete an application, negotiate rates,
PSOPPC website: https:// following transmissions: OMB, Office of and receive final approval from CMS.
www.psoppc.org/psoppc_web. Information and Regulatory Affairs, Existing Part D Sponsors may also
Additional information about the Attention: CMS Desk Officer, Fax expand their contracted service area by
Number: (202) 395–5806 OR, Email: completing the Service Area Expansion
Common Formats can be obtained
OIRA_submission@omb.eop.gov. (SAE) application. The information will
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Document Created: 2018-11-28 23:44:22
Document Modified: 2018-11-28 23:44:22
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability--New Common Formats. | |
| Dates | Ongoing public input. | |
| Contact | Dr. Hamid Jalal, Center for Quality Improvement and Patient Safety, AHRQ, 5600 Fishers Lane, 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: [email protected] | |
| FR Citation | 83 FR 61382 |
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