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Tags: complainant, consignee, depositions, e mail, federal register, further information contact, gaither road, genuine issues, huatai, initial decision, long beach ca, material fact, ocean freight, patient safety, port of discharge, shipper, singapore pte ltd, sworn statements, toll free 866, wan hai lines,Pages: 3
Language: english
Created: Fri Aug 29 04:15:52 2008
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50974 Federal Register / Vol. 73, No. 169 / Friday, August 29, 2008 / Notices
Complainant alleges that the goods showing that there are genuine issues of FOR FURTHER INFORMATION CONTACT:
were loaded on a Wan Hai Lines material fact that cannot be resolved on Susan Grinder, Center for Quality
(Singapore) PTE Ltd. (``Wan Hai'') the basis of sworn statements, affidavits, Improvement and Patient Safety, AHRQ,
vessel, under a Wan Hai bill of lading depositions, or other documents or that 540 Gaither Road, Rockville, MD 20850;
naming Henan Huatai as Shipper, and the nature of the matter in issue is such Telephone (toll free): (866) 4033697;
Complainant as Consignee; and that the that an oral hearing and cross- Telephone (local): (301) 4271111; TTY
cargo arrived at the port of discharge, examination are necessary for the (toll free): (866) 4387231; TTY (local):
Long Beach, CA, mid-June 2008. development of an adequate record. (301) 4271130; E-mail:
Complainant further alleges that it paid Pursuant to the further terms of 46 CFR psoc@ahrq.hhs.gov.
the full amount of the ocean freight and 502.61, the initial decision of the SUPPLEMENTARY INFORMATION:
other charges to Wan Hai. Complainant presiding officer in this proceeding shall
claims that Shipper, Henan Huatai, be issued by August 26, 2009, and the Background
went out of business in June 2008, and final decision of the Commission shall The Patient Safety Act establishes a
Respondent, acting as a freight be issued by December 24, 2009. framework by which doctors, hospitals,
forwarder in China on behalf of the and other health care providers may
Shipper, is unlawfully holding the Karen V. Gregory,
Assistant Secretary. voluntarily report information on a
original bill of lading, alleging debts
[FR Doc. E820115 Filed 82808; 8:45 am]
privileged and confidential basis
owed by Shipper to Respondent.
regarding patient safety events and
Complainant alleges that BILLING CODE 673001P
Respondent's refusal to provide the quality of care. The Patient Safety Act
original bill of lading to Complainant, provides for voluntary formation of
unless Complainant paid to Respondent PSOs, which can be public or private
the amount owed by the Shipper, DEPARTMENT OF HEALTH AND organizations, that collect, aggregate,
constitutes an unreasonable regulation HUMAN SERVICES and analyze information regarding the
or practice related to the delivery of quality and safety of care delivered in
property in violation of 46 U.S.C. Agency for Healthcare Research and any healthcare setting. Information that
41102(c) (formerly § 10(d)(1) of the Quality is assembled and developed by
Shipping Act of 1984). Complainant providers and PSOs--called ``patient
claims injury in the form of demurrage Common Formats for Patient Safety safety work product''--is privileged and
charges in the amount of $16,944.00; Data Collection and Event Reporting confidential; it can be used to identify
loss of its funds held in an escrow patient safety events and unsafe
AGENCY: Agency for Healthcare Research conditions that increase risks to
account required by Wan Hai in the and Quality (AHRQ), DHHS.
amount of $47,801.42; and liquidated patients.
ACTION: Notice of Availability-- The Patient Safety Act requires PSOs,
damages imposed by Wal-Mart for lost
Common Formats for Safety Data to the extent practical and appropriate,
sales in the amount $106,115.00; for a
Collection and Event Reporting. to collect patient safety work product
total of $170,860.42, with liquidated
damages continuing to accrue. from providers in a standardized
SUMMARY: The Patient Safety and
Complainant requests that the manner in order to permit valid
Quality Improvement Act of 2005
Commission issue as relief, an Order: (1) comparisons of similar cases among
(Patient Safety Act) provides for the
Compelling Respondent to answer the similar providers.
formation of Patient Safety
charges in the subject complaint, and One of the goals of the legislation is
Organizations (PSOs), which would
scheduling a hearing in Washington, to allow aggregation of sufficient data to
collect and analyze confidential
DC; (2) finding that Respondent's identify and address underlying causal
information reported by healthcare
activities were unlawful and in factors of patient safety problems. In
providers. The Patient Safety Act (at 42
violation of the Shipping Act; (3) order to facilitate standardized data
U.S.C. 299b23) authorizes the
compelling Respondent to pay collection, the Secretary of DHHS
collection of this information in a
reparations of $170,860.42 plus interest, requested AHRQ to coordinate the
standardized manner, as explained in
costs, and attorney's fees; and (4) development of Common Formats for
the related Notice of Proposed
requiring Respondent to provide patient safety events.
Rulemaking published in the Federal
Complainant with the original bill of Definitions and other details about
Register on February 12, 2008: 73 FR
lading to allow Complainant to secure PSOs and patient safety work product
81128183. As requested by the
release of its escrow deposit from Wan have been prepared for publication at 42
Secretary of DHHS, AHRQ has
Hai and stop other liquidated damages CFR Part 3; a Notice of Proposed
coordinated the development of a set of
from accruing. Additionally, Rulemaking was published in the
common definitions and reporting
Complainant requests that the Federal Register on February 12, 2008,
formats (Common Formats) which
Commission issue further relief as it as noted above, and a final regulation
would facilitate the voluntary collection
deems just and proper. implementing the Patient Safety Act is
This proceeding has been assigned to of patient safety data and reporting of
under review.
the Office of Administrative Law Judges. this information to PSOs. The purpose
Hearing in this matter, if any is held, of this notice is to announce the initial Definition of Common Formats
shall commence within the time release of the Common Formats, Version The term Common Formats is used to
limitations prescribed in 46 CFR 502.61, 0.1 Beta, and the process for describe technical requirements
and only after consideration has been development of future versions. developed for the uniform collection
mstockstill on PROD1PC66 with NOTICES
given by the parties and the presiding DATES: Ongoing public input. and reporting of patient safety data,
officer to the use of alternative forms of ADDRESSES: The Common Formats can including all supporting material:
dispute resolution. The hearing shall be accessed electronically at the · Descriptions of patient safety events
include oral testimony and cross- following Web site of the Department of and unsafe conditions to be reported,
examination in the discretion of the Health and Human Services: http:// · Delineation of data elements to be
presiding officer only upon proper www.pso.ahrq.gov/index.html. collected for specific types of events,
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Federal Register / Vol. 73, No. 169 / Friday, August 29, 2008 / Notices 50975
· Examples of patient safety dvelopment and release of Common framework, and definitions contained in
population reports, Formats is outside the scope of the their draft International Classification
· A metadata registry with data regulations implementing the Patient for Patient Safety (ICPS). The ICPS is
element attributes and technical Safety Act, AHRQ described its currently under development.
specifications, proposed development process in the AHRQ's initial construction of
· Paper forms to allow immediate Notice of Proposed Rulemaking Common Formats thus draws on
implementation, and referenced above and sought public information from systems in both the
· A users guide. comment. There were a significant public and private sectors, but was
Common Formats delineate number of strongly supportive completed by a work group comprising
definitional and reporting specifications comments about the process; there were only Federal agencies. To allow for
that will allow healthcare providers to no negative comments. greater participation by the private
collect and submit standardized In anticipation of the need for sector in the subsequent development of
information regarding patient safety Common Formats, AHRQ began their the Common Formats, AHRQ has
events. The Common Formats are not development in 2005 by creating an engaged the National Quality Forum
intended to replace any current inventory of functioning private and (NQF) to solicit comments and advice to
mandatory reporting system, public sector patient safety reporting guide future versions, as described
collaborative/voluntary reporting systems. This inventory provides an below. It should be noted that the
system, research related reporting evidence base to inform construction of Common Formats Version 0.1 Beta can
system, or other reporting/recording the Common Formats. The inventory be implemented now, using AHRQ
systems. now numbers 64 and includes many paper forms and the users guide. Other
systems from the private sector, supporting materials will be made
Scope of Common Formats
including prominent academic settings, available shortly via the AHRQ Web
The scope of Common Formats will hospital systems, and international site.
apply to all patient safety concerns reporting systems (e.g., from the United
including: Commenting on Common Formats
Kingdom and the Commonwealth of
· Incidents--patient safety events Version 0.1 Beta
Australia). In addition, virtually all
that reached the patient, whether or not major Federal patient safety reporting AHRQ is committed to continuing
there was harm, systems are included, such as those refinement of the Common Formats. The
· Near misses or close calls--patient from the Centers for Disease Control and Agency is specifically interested in
safety events that did not reach the Prevention (CDC), the Food and Drug obtaining feedback from both the private
patient, and Administration (FDA), the Department and public sectors--particularly from
· Unsafe conditions. of Defense (DoD), and the Department of those who use the Common Formats--
In the interest of supporting PSO data Veterans Affairs (VA). and it has established a process to
collection from the outset, AHRQ is AHRQ convened an interagency receive initial feedback that will guide
releasing Version 0.1 Beta of the Patient Safety Work Group (PSWG) to rapid improvement of the formats.
Common Formats, which have a defined develop draft formats. Included in the AHRQ has contracted with the NQF,
focus on patient safety reporting for PSWG are major health agencies within a non-profit organization focused on
hospital inpatients. It should be noted, the Department--CDC, Centers for healthcare quality, to assist with
however, that the Patient Safety Act Medicare and Medicaid Services (CMS), gathering and analyzing feedback on the
confers both privilege and FDA, Health Resources and Services Common Formats. In this role, the NQF
confidentiality on all patient safety Administration (HRSA), the Indian will assist AHRQ in updating future
work product developed under the aegis Health Service (IHS), the National versions of the formats by: Soliciting
of a PSO with respect to healthcare in Institutes of Health (NIH), the Office of public comments from providers,
any setting. AHRQ anticipates the National Coordinator for Health professional organizations, the general
expanding future versions of the Information Technology (ONC)--as well public, and PSOs; triaging comments in
Common Formats to include other as the DoD and the VA. terms of immediacy of importance;
settings such as: Nursing homes and The PSWG reviewed the AHRQ setting priorities; and convening expert
other bedded facilities; ambulatory inventory, created draft Common panel(s) to offer advice on suggested
surgery centers; other ambulatory care Format data sets, harmonized individual improvements to the formats. This
settings, including community health data elements where possible, and process will be a continuing one,
centers, rehabilitation centers, and created new data elements where guiding periodic updates of the
hemodialysis centers; physician and necessary. From February through May Common Formats and, most
practitioner offices; and retail of 2008, the draft Common Formats importantly, reflecting the feedback of
establishments such as pharmacies. underwent two pilot tests in a those using the formats. This latter
significant number of healthcare group, the users, will be the most
Common Formats Development facilities within DoD, IHS, and VA. sensitive to and aware of needed
AHRQ has established a process to These pilot tests were designed to updates and improvements to the
develop Common Formats that: (1) Is provide guidance to refine the draft formats.
evidence based; (2) harmonizes across formats prior to their release as Version
governmental health agencies; (3) 0.1 Beta. The PSWG, acting as the focus Future Releases
incorporates feedback from the private for original development and continuing While AHRQ's Version 0.1 Beta has
sector, including professional upgrading/maintenance will assure been developed based on evidence,
associations/organizations, those who consistency of definitions/formats with consensus of the PSWG, and results
mstockstill on PROD1PC66 with NOTICES
use the formats, and the public; and (4) those of relevant government agencies from initial testing, this version does not
permits timely updating of these as refinement of the Common Formats reflect the refinement that will come
clinically-sensitive formats. It is continues. from large-scale use and repeated
planned that updated versions of the The PSWG aligned the formats, to the revision. We anticipate that we may get
formats will be released annually by extent practicable, with World Health much helpful guidance from early users
AHRQ as guidance. While the Organization (WHO) concepts, of the formats. For this reason, AHRQ
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50976 Federal Register / Vol. 73, No. 169 / Friday, August 29, 2008 / Notices
plans to release a second version of the 1. Type of Information Collection Attention: Document Identifier/OMB
formats in six to nine months, or Request: Extension of a currently Control Number ____, Room C42605,
perhaps sooner, depending on the approved collection; Title of 7500 Security Boulevard, Baltimore,
nature of initial feedback. Once the Information Collection: Information Maryland 212441850.
formats are stabilized, AHRQ plans to Collection Requirements in Final Peer
Dated: August 22, 2008.
release new versions annually. The Review Organizations Sanction
Agency will follow the same process for Regulations--42 CFR 1004.4, 1004.50, Michelle Shortt,
formats developed for other settings. 1004.60, and 1004.70; Use: The Peer Director, Regulations Development Group,
AHRQ realizes that using Version 0.1 Review Improvement Act of 1982 Office of Strategic Operations and Regulatory
Beta paper forms is not the optimal way amended Title XI of the Social Security Affairs.
to collect patient safety data. Over time, Act (the Act), creating the Utilization [FR Doc. E819975 Filed 82808; 8:45 am]
computer software (developed in the and Quality Control Peer Review BILLING CODE 412001P
private sector) will make use of the Organization Program. Section 1156 of
formats much more efficient. However, the Act imposes obligations on health
because the Agency plans an early care practitioners and others who DEPARTMENT OF HEALTH AND
second release of the Common Formats, furnish or order services or items under HUMAN SERVICES
it cautions software developers to Medicare. This section also provides for
understand that the first release of the sanction actions, if the Secretary Food and Drug Administration
formats will likely be substantially determines that the obligations as stated
enhanced. by this section are not met. Quality [Docket No. FDA2008N0313]
More information on the feedback Improvement Organizations (QIOs) are
process can be obtained through responsible for identifying violations. Agency Information Collection
AHRQ's PSO Web site: http:// QIOs may allow practitioners or other Activities; Submission for Office of
www.pso.ahrq.gov/index.html. entities, opportunities to submit Management and Budget Review;
relevant information before determining Comment Request; Request for
Dated: August 21, 2008.
that a violation has occurred. The Inspection Under the Inspection by
Carolyn M. Clancy, information collection requirements Accredited Persons Program
Director. contained in this information collection
[FR Doc. E819910 Filed 82808; 8:45 am] request are used by the QIOs to collect AGENCY: Food and Drug Administration,
BILLING CODE 416090M the information necessary to make their HHS.
decision. Form Number: CMSR65
(OMB# 09380444); Frequency: ACTION: Notice.
DEPARTMENT OF HEALTH AND Reporting--On occasion; Affected
HUMAN SERVICES Public: Business or other for-profit and SUMMARY: The Food and Drug
not-for-profit institutions; Number of Administration (FDA) is announcing
Centers for Medicare & Medicaid Respondents: 53; Total Annual that a proposed collection of
Services Responses: 53; Total Annual Hours: information has been submitted to the
14,310. Office of Management and Budget
[Document Identifier: CMS-R65] To obtain copies of the supporting (OMB) for review and clearance under
statement and any related forms for the the Paperwork Reduction Act of 1995.
Agency Information Collection proposed paperwork collections
Activities: Proposed Collection; referenced above, access CMS' Web site DATES: Fax written comments on the
Comment Request at http://www.cms.hhs.gov/ collection of information by September
PaperworkReductionActof1995, or 29, 2008.
AGENCY: Centers for Medicare &
e-mail your request, including your ADDRESSES: To ensure that comments on
Medicaid Services.
address, phone number, OMB number, the information collection are received,
In compliance with the requirement and CMS document identifier, to
of section 3506(c)(2)(A) of the OMB recommends that written
Paperwork@cms.hhs.gov, or call the comments be faxed to the Office of
Paperwork Reduction Act of 1995, the Reports Clearance Office on (410) 786
Centers for Medicare & Medicaid Information and Regulatory Affairs,
1326. OMB, Attn: FDA Desk Officer, FAX:
Services (CMS) is publishing the In commenting on the proposed
following summary of proposed 2023956974, or e-mailed to
information collections please reference
collections for public comment. baguilar@omb.eop.gov. All comments
the document identifier or OMB control
Interested persons are invited to send should be identified with the OMB
number. To be assured consideration,
comments regarding this burden control number 09100569. Also
comments and recommendations must
estimate or any other aspect of this include the FDA docket number found
be submitted in one of the following
collection of information, including any in brackets in the heading of this
ways by October 28, 2008:
of the following subjects: (1) The 1. Electronically. You may submit document.
necessity and utility of the proposed your comments electronically to http:// FOR FURTHER INFORMATION CONTACT:
information collection for the proper www.regulations.gov. Follow the Denver Presley, Jr., Office of Information
performance of the agency's functions; instructions for ``Comment or Management (HFA710), Food and Drug
(2) the accuracy of the estimated Submission'' or ``More Search Options'' Administration, 5600 Fishers Lane,
burden; (3) ways to enhance the quality, to find the information collection Rockville, MD 20857, 3017963793.
mstockstill on PROD1PC66 with NOTICES
utility, and clarity of the information to document(s) accepting comments.
be collected; and (4) the use of 2. By regular mail. You may mail SUPPLEMENTARY INFORMATION: In
automated collection techniques or written comments to the following compliance with 44 U.S.C. 3507, FDA
other forms of information technology to address: CMS, Office of Strategic has submitted the following proposed
minimize the information collection Operations and Regulatory Affairs, collection of information to OMB for
burden. Division of Regulations Development, review and clearance.
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