81 FR 92816 - Common Formats for Reporting on Health Care Quality and Patient Safety
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality Federal Register Volume 81, Issue 244 (December 20, 2016)
Agency for Healthcare Research and Quality
Federal Register Volume 81, Issue 244 (December 20, 2016)
| Page Range | 92816-92818 | |
| FR Document | 2016-30604 |
[Federal Register Volume 81, Number 244 (Tuesday, December 20, 2016)] [Notices] [Pages 92816-92818] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-30604] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Common Formats for Reporting on Health Care Quality and Patient Safety 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 sets of common definitions and reporting formats (Common Formats) for reporting on health care quality and patient safety. The purpose of this notice is to announce the release of the Common Formats--Community Pharmacy Version 1.0. DATES: Ongoing public input. ADDRESSES: The Common Formats--Community Pharmacy Version 1.0 and the remaining Common Formats can be accessed electronically at the following HHS Web site: http://www.pso.ahrq.gov/common/. FOR FURTHER INFORMATION CONTACT: Dr. Barbara Choo, Center for Quality Improvement and Patient Safety, AHRQ, 5600 Fishers Lane, Room 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: [email protected]. [[Page 92817]] SUPPLEMENTARY INFORMATION: Background 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 collection of patient safety work product allows the aggregation of data that help to identify and address underlying causal factors of patient safety and quality issues. The Patient Safety Act and Patient Safety Rule establish a framework by which doctors, hospitals, skilled nursing facilities, and other health care providers may assemble 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 conduct patient safety activities, which may include identifying 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 Act and Patient Safety Rule which can be accessed electronically at: http:// www.pso.ahrq.gov/legislation/. Definition of Common Formats The term ``Common Formats'' refers to the common definitions and reporting formats, specified by AHRQ, that allow health care providers to collect and submit standardized information regarding patient quality and safety to PSOs and other entities. The Common Formats are not intended to replace any current mandatory reporting system, collaborative/voluntary reporting system, research-related reporting system, or other reporting/recording system; rather the formats are intended to enhance the ability of health care providers to report information that is standardized both clinically and electronically. In collaboration with the interagency Federal Patient Safety Workgroup (PSWG), the National Quality Forum (NQF), and the public, AHRQ has developed Common Formats for three settings of care--acute care hospitals, skilled nursing facilities, and community pharmacies-- in order to facilitate standardized data collection and analysis. The scope of Common Formats applies to all patient safety concerns including: Incidents--patient safety events that reached the patient, whether or not there was harm; near misses or close calls--patient safety events that did not reach the patient; and unsafe conditions-- circumstances that increase the probability of a patient safety event. AHRQ's Common Formats for patient safety event reporting include:Event descriptions (definitions of patient safety events, near misses, and unsafe conditions to be reported); Specifications for patient safety aggregate reports that derive from event descriptions; Delineation of data elements and algorithms to be used for collection of adverse event data to populate the reports; and Technical specifications for electronic data collection and reporting. 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. They 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 (PPC) for data de-identification and transmission to the Network of Patient Safety Databases. Common Formats Development In anticipation of the need for Common Formats, AHRQ began their development by creating an inventory of functioning private and public sector patient safety reporting systems. This inventory provided an evidence base to inform construction of the Common Formats. The inventory included many systems from the private sector, including prominent academic settings, hospital systems, and international reporting systems (e.g., from the United Kingdom and the Commonwealth of Australia). In addition, virtually all major Federal patient safety reporting systems were included, such as those from the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the Department of Defense (DoD), and the Department of Veterans Affairs (VA). Since February 2005, AHRQ has convened the PSWG to assist AHRQ with developing and maintaining the Common Formats. The PSWG includes major health agencies within HHS--CDC, Centers for Medicare & Medicaid Services, FDA, 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 DoD and VA. Since the initial release of the Common Formats in August 2008, AHRQ has regularly revised the formats based upon public comment. First, AHRQ reviews existing patient safety practices and event reporting systems. Then, AHRQ works in collaboration with the PSWG and Federal subject matter experts to develop and draft the Common Formats. In addition, the PSWG assists AHRQ with assuring the consistency of definitions/formats with those of relevant government agencies as refinement of the Common Formats continues. Next, AHRQ solicits feedback from private sector organizations and individuals. Finally, based upon the feedback received, AHRQ further revises the Common Formats. Participation by the private sector in the development and subsequent revision of the Common Formats is achieved through working with the NQF. The Agency engages the NQF, a non-profit organization focused on health care quality, to solicit comments and advice regarding proposed versions of the Common Formats. AHRQ began this process with the NQF in 2008, receiving feedback on AHRQ's 0.1 Beta release of the Common Formats for Event Reporting--Hospital. After receiving public comment, the NQF solicits the review and advice of its Common Formats Expert Panel and subsequently provides feedback to AHRQ. The Agency then revises and refines the Common Formats and issues them as a production version. AHRQ has continued to employ this process for all subsequent versions of the Common Formats. In 2014, representatives from U.S. community pharmacies approached AHRQ regarding collaboration to develop Common Formats for the community pharmacy setting. Development of the new Formats began using the existing AHRQ Common Formats Medication module from the AHRQ Common Formats for Event [[Page 92818]] Reporting--Hospital, Version 1.2, as a starting point. AHRQ, in conjunction with community pharmacy representatives, designed these new formats to facilitate improved detection and understanding of medication-related events originating in pharmacies. If implemented as specified, the Common Formats--Community Pharmacy Version 1.0 will allow aggregation of medication-related data across different pharmacy providers. On October 6, 2015, AHRQ announced the availability of the--Common Formats Retail Pharmacy Version 0.1 Beta--for review and comment in the Federal Register (80 FR 60385-60387). After obtaining feedback from both the private and public sectors, the Agency finalized the format and renamed it Common Formats--Community Pharmacy Version 1.0. All elements--including the event description, aggregate reports, data elements and algorithms, and technical specifications--will be posted at the PSOPPC Web site: https://www.psoppc.org/psoppc_web. More information on the Common Formats can be obtained through AHRQ's PSO Web site: http://www.pso.ahrq.gov/. Sharon B. Arnold, Deputy Director. [FR Doc. 2016-30604 Filed 12-19-16; 8:45 am] BILLING CODE 4160-90-P
![92816 Federal Register / Vol. 81, No. 244 / Tuesday, December 20, 2016 / Notices
maximum total burden across all three
years is thus 6568.5 hours.
TABLE 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
Number of Hours per Total burden
Data collection type responses per
respondents response hours
respondent
Interviews ......................................................................................................... 375 2 1 750
Focus Groups/Small Discussions .................................................................... 420 1.5 1.5 945
Implementation Logs ....................................................................................... 20 8 1 160
Recruitment and Screening ............................................................................. 139 1 0.5 69.5
Cognitive Testing ............................................................................................. 40 1 1 40
Questionnaires/Brief Surveys .......................................................................... 1,000 1 0.2 200
Collection of Internal Documents .................................................................... 25 1 1 25
Total .......................................................................................................... ........................ ........................ ........................ 2,189.5
TABLE 2—ESTIMATED ANNUALIZED COST BURDEN
Average
Number of Total burden Total cost
Form name hourly
respondents hours burden
wage rate *
Interviews ......................................................................................................... 250 500 a $95.05 $47,525.00
(Clinicians—line 1; Patients—line 2) ............................................................... 125 250 b 27.12 6780.00
Focus Groups/Small Discussions .................................................................... 420 945 c 27.12 25,628.40
Implementation Logs ....................................................................................... 20 160 c 27.12 4,339.20
Recruitment and Screening ............................................................................. 139 69.5 a 95.05 6,605.98
Cognitive Testing ............................................................................................. 40 40 c 27.12 1,084.80
Questionnaires/Brief Surveys .......................................................................... 1000 200 c 27.12 5,424.00
Collection of Internal Documents .................................................................... 25 25 a 95.05 2,376.25
Total .......................................................................................................... ........................ ........................ ........................ 99,763.63
* National Compensation Survey: Occupational wages in the United States May 2015 ‘‘U.S. Department of Labor, Bureau of Labor Statistics:’’
http://www.bls.gov/oes/current/oes_stru.htm.
a Based on the mean wages for 29–1069 Physicians and Surgeons, All Other.
b Based on the mean wages for 00–0000 All Occupations.
c Based on the mean wages for 29–9099 Miscellaneous Health Practitioners and Technical Workers: Healthcare Practitioners and Technical
Workers, All Other.
Using average wage rates for relevant automated collection techniques or Notice of Availability—New
ACTION:
job categories from 2016 BLS data, the other forms of information technology. Common Formats.
total annual costs associated with these Comments submitted in response to SUMMARY: As authorized by the
data collections per year are this notice will be summarized and Secretary of HHS, AHRQ coordinates
$116,746.13 as shown in Table 2 above, included in the Agency’s subsequent the development of sets of common
for a total cost for all three years of request for OMB approval of the definitions and reporting formats
$350,238.39. proposed information collection. All (Common Formats) for reporting on
Request for Comments comments will become a matter of health care quality and patient safety.
public record. The purpose of this notice is to
In accordance with the Paperwork announce the release of the Common
Reduction Act, comments on AHRQ’s Sharon B. Arnold,
Formats—Community Pharmacy
information collection are requested Deputy Director. Version 1.0.
with regard to any of the following: (a) [FR Doc. 2016–30603 Filed 12–19–16; 8:45 am] DATES: Ongoing public input.
Whether the proposed collection of BILLING CODE 4160–90–P ADDRESSES: The Common Formats—
information is necessary for the proper Community Pharmacy Version 1.0 and
performance of AHRQ health care the remaining Common Formats can be
research and health care information DEPARTMENT OF HEALTH AND accessed electronically at the following
dissemination functions, including HUMAN SERVICES HHS Web site: http://
whether the information will have www.pso.ahrq.gov/common/.
practical utility; (b) the accuracy of Agency for Healthcare Research and
FOR FURTHER INFORMATION CONTACT: Dr.
AHRQ’s estimate of burden (including Quality Barbara Choo, Center for Quality
mstockstill on DSK3G9T082PROD with NOTICES
hours and costs) of the proposed Improvement and Patient Safety, AHRQ,
Common Formats for Reporting on
collection(s) of information; (c) ways to 5600 Fishers Lane, Room 06N100B,
enhance the quality, utility and clarity Health Care Quality and Patient Safety
Rockville, MD 20857; Telephone (toll
of the information to be collected; and free): (866) 403–3697; Telephone (local):
AGENCY: Agency for Healthcare Research
(d) ways to minimize the burden of the (301) 427–1111; TTY (toll free): (866)
and Quality (AHRQ), Department of
collection of information upon the 438–7231; TTY (local): (301) 427–1130;
Health and Human Services (HHS).
respondents, including the use of Email: pso@ahrq.hhs.gov.
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![92818 Federal Register / Vol. 81, No. 244 / Tuesday, December 20, 2016 / Notices
Reporting—Hospital, Version 1.2, as a The Director, Management Analysis and reconstruction efforts being
starting point. AHRQ, in conjunction and Services Office, has been delegated performed for purposes of the
with community pharmacy the authority to sign Federal Register compensation program; and advice on
representatives, designed these new notices pertaining to announcements of petitions to add classes of workers to the
formats to facilitate improved detection meetings and other committee Special Exposure Cohort (SEC).
and understanding of medication- management activities, for both CDC In December 2000, the President
related events originating in and the Agency for Toxic Substances delegated responsibility for funding,
pharmacies. If implemented as and Disease Registry. staffing, and operating the Advisory
specified, the Common Formats— Board to HHS, which subsequently
Catherine Ramadei,
Community Pharmacy Version 1.0 will delegated this authority to CDC. NIOSH
Acting Director, Management Analysis and
allow aggregation of medication-related implements this responsibility for CDC.
Services Office, Centers for Disease Control
data across different pharmacy and Prevention. The charter was issued on August 3,
providers. 2001, renewed at appropriate intervals,
[FR Doc. 2016–30525 Filed 12–19–16; 8:45 am]
On October 6, 2015, AHRQ rechartered on March 22, 2016,
BILLING CODE 4163–18–P
announced the availability of the— pursuant to Executive Order 13708, and
Common Formats Retail Pharmacy will expire on September 30, 2017.
Version 0.1 Beta—for review and DEPARTMENT OF HEALTH AND Purpose: The Advisory Board is
comment in the Federal Register (80 FR HUMAN SERVICES charged with (a) providing advice to the
60385–60387). After obtaining feedback Secretary, HHS, on the development of
from both the private and public sectors, Centers for Disease Control and guidelines under Executive Order
the Agency finalized the format and Prevention 13179; (b) providing advice to the
renamed it Common Formats— Secretary, HHS, on the scientific
Community Pharmacy Version 1.0. All Advisory Board on Radiation and validity and quality of dose
elements—including the event Worker Health (ABRWH or the reconstruction efforts performed for this
description, aggregate reports, data Advisory Board), Subcommittee on program; and (c) upon request by the
elements and algorithms, and technical Procedures Review (SPR), National Secretary, HHS, advise the Secretary on
specifications—will be posted at the Institute for Occupational Safety and whether there is a class of employees at
PSOPPC Web site: https:// Health (NIOSH) any Department of Energy facility who
www.psoppc.org/psoppc_web. In accordance with section 10(a)(2) of were exposed to radiation but for whom
More information on the Common the Federal Advisory Committee Act it is not feasible to estimate their
Formats can be obtained through (Pub. L. 92–463), the Centers for Disease radiation dose, and on whether there is
AHRQ’s PSO Web site: http:// Control and Prevention (CDC), reasonable likelihood that such
www.pso.ahrq.gov/. announces the following meeting for the radiation doses may have endangered
aforementioned subcommittee: the health of members of this class. SPR
Sharon B. Arnold,
Time and Date: 11:00 a.m.–4:30 p.m., was established to aid the Advisory
Deputy Director. Board in carrying out its duty to advise
EST, January 10, 2017
[FR Doc. 2016–30604 Filed 12–19–16; 8:45 am] the Secretary, HHS, on dose
Place: Audio Conference Call via FTS
BILLING CODE 4160–90–P
Conferencing. reconstruction. SPR is responsible for
Status: Open to the public, but overseeing, tracking, and participating
without a public comment period. The in the reviews of all procedures used in
DEPARTMENT OF HEALTH AND the dose reconstruction process by the
public is welcome to submit written
HUMAN SERVICES NIOSH Division of Compensation
comments in advance of the meeting, to
the contact person below. Written Analysis and Support (DCAS) and its
Centers for Disease Control and
comments received in advance of the dose reconstruction contractor (Oak
Prevention
meeting will be included in the official Ridge Associated Universities—ORAU).
Mine Safety and Health Research record of the meeting. The public is also Matters for Discussion: The agenda for
Advisory Committee: Notice of Charter welcome to listen to the meeting by the Subcommittee meeting includes:
Renewal joining the teleconference at the USA discussion of procedures in the
toll-free, dial-in number at 1–866–659– following ORAU and DCAS technical
This gives notice under the Federal 0537 and the pass code is 9933701. documents:
Advisory Committee Act (Pub. L. 92– Background: The Advisory Board was OCAS Technical Information Bulletin
463) of October 6, 1972, that the Mine established under the Energy Employees (TIB) 0013 and ORAUT Procedure 0042
Safety and Health Research Advisory Occupational Illness Compensation (‘‘Individual Dose Adjustment
Committee, Centers for Disease Control Program Act of 2000 to advise the Procedure for Y–12 Dose
and Prevention, Department of Health President on a variety of policy and Reconstruction’’ and ‘‘Accounting for
and Human Services, has been renewed technical functions required to Incomplete Personal Monitoring Data on
for a 2-year period through November implement and effectively manage the Penetrating Gamma-Ray Doses to
30, 2018. new compensation program. Key Workers in Radiation Areas at the Oak
For information, contact Jeffrey H. functions of the Advisory Board include Ridge Y–12 Plant Prior to 1961’’);
Welsh, B.A., Designated Federal Officer, providing advice on the development of Program Evaluation Report OCAS–PER–
Mine Safety and Health Research probability of causation guidelines that 011, (‘‘K–25 TBD and TIB Revisions’’),
mstockstill on DSK3G9T082PROD with NOTICES
Advisory Committee, Centers for have been promulgated by the PER–055 (‘‘TBD 6000 Revisions’’), PER–
Disease Control and Prevention, Department of Health and Human 057 (‘‘General Steel Industries’’), PER 60
Department of Health and Human Services (HHS) as a final rule; advice on (‘‘Blockson Chemical Company’’), PER–
Services, 626 Cochrans Mill Road, methods of dose reconstruction, which 064 (‘‘DuPont Deep Water Works’’), and
Mailstop P05, Pittsburgh, Pennsylvania have also been promulgated by HHS as PER–066 (‘‘Huntington Pilot Plant’’),
15236, Telephone (412) 386–4040 or fax a final rule; advice on the scientific and a continuation of the comment-
(412) 386–6614. validity and quality of dose estimation resolution process for other dose
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Document Created: 2018-02-14 09:10:18
Document Modified: 2018-02-14 09:10:18
| 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. Barbara Choo, Center for Quality Improvement and Patient Safety, AHRQ, 5600 Fishers Lane, Room 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: [email protected] | |
| FR Citation | 81 FR 92816 |
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