81_FR_60172 81 FR 60003 - Patient Safety Organizations: Voluntary Relinquishment From QAISys, Inc.

81 FR 60003 - Patient Safety Organizations: Voluntary Relinquishment From QAISys, Inc.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality

Federal Register Volume 81, Issue 169 (August 31, 2016)

Page Range60003-60004
FR Document2016-20912

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 HHS, 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 QAISys, Inc. of its status as a PSO, and has delisted the PSO accordingly. QAISys, Inc. submitted this request for voluntary relinquishment after receiving a Notice of Preliminary Finding of Deficiency.

Federal Register, Volume 81 Issue 169 (Wednesday, August 31, 2016) 
[Federal Register Volume 81, Number 169 (Wednesday, August 31, 2016)]
[Notices]
[Pages 60003-60004]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-20912]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Patient Safety Organizations: Voluntary Relinquishment From 
QAISys, Inc.

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

ACTION: Notice of delisting.

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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 HHS, 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 QAISys, Inc. of its 
status as a PSO, and has delisted the PSO accordingly. QAISys, Inc. 
submitted this request for voluntary relinquishment after receiving a 
Notice of Preliminary Finding of Deficiency.

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 August 10, 2016.

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,

[[Page 60004]]

5600 Fishers Lane, Room 06N94B, 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

    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 a 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 the QAISys, Inc., PSO number 
P0161, to voluntarily relinquish its status as a PSO. Accordingly, 
QAISys, Inc. was delisted effective at 12:00 Midnight ET (2400) on 
August 10, 2016. AHRQ notes that that QAISys, Inc. submitted this 
request for voluntary relinquishment following receipt of the Notice of 
Preliminary Finding of Deficiency sent on July 28, 2016. In addition, 
QAISys, Inc., P0046, was previously listed as a PSO in 2009; AHRQ 
accepted its request for voluntary relinquishment in 2013.
    More information on PSOs can be obtained through AHRQ's PSO Web 
site at http://www.pso.AHRQ.gov.

Sharon B. Arnold,
Deputy Director.
[FR Doc. 2016-20912 Filed 8-30-16; 8:45 am]
 BILLING CODE 4160-90-P

Federal Register / Vol. 81, No. 169 / Wednesday, August 31, 2016 / Notices 60003 Estimated labor costs: $21,570. passport number, financial account uses permitted by the Privacy Act, in Commission staff derived labor costs number, or credit or debit card number. the Commission’s privacy policy, at by applying appropriate hourly cost You are also solely responsible for http://www.ftc.gov/ftc/privacy.htm. figures to the burden hours described making sure that your comment does David C. Shonka, above. Staff further assumes that office not include any sensitive health support file clerks will handle the information, such as medical records or Acting General Counsel. Rule’s record retention requirements at other individually identifiable health [FR Doc. 2016–20933 Filed 8–30–16; 8:45 am] an hourly rate of $14.38.13 Based upon information. In addition, do not include BILLING CODE 6750–01–P the above estimates and assumptions, any ‘‘[t]rade secret or any commercial or the total annual labor cost to retain and financial information which is . . . file documents, for the FTC’s allotted privileged or confidential,’’ as discussed DEPARTMENT OF HEALTH AND burden, is $21,570 (1,500 hours × $14.38 in section 6(f) of the FTC Act, 15 U.S.C. HUMAN SERVICES per hour). 46(f), and FTC Rule 4.10(a)(2), 16 CFR Absent information to the contrary, 4.10(a)(2). In particular, do not include Agency for Healthcare Research and staff anticipates that existing storage competitively sensitive information Quality media and equipment that covered such as costs, sales statistics, persons use in the ordinary course of inventories, formulas, patterns, devices, Patient Safety Organizations: business will satisfactorily manufacturing processes, or customer Voluntary Relinquishment From accommodate incremental names. QAISys, Inc. recordkeeping under the Rule. If you want the Commission to give AGENCY: Agency for Healthcare Research Accordingly, staff does not anticipate your comment confidential treatment, and Quality (AHRQ), Department of that the Rule will require any new you must file it in paper form, with a Health and Human Services (HHS). capital or other non-labor expenditures. request for confidential treatment, and ACTION: Notice of delisting. you must follow the procedure Request for Comments explained in FTC Rule 4.9(c), 16 CFR SUMMARY: The Patient Safety and You can file a comment online or on 4.9(c). Your comment will be kept Quality Improvement Act of 2005, 42 paper. Write ‘‘Regulation N: FTC File confidential only if the FTC General U.S.C. 299b–21 to b–26, (Patient Safety No. P134811; K05’’ on your comment. Counsel, in his or her sole discretion, Act) and the related Patient Safety and Your comment—including your name grants your request in accordance with Quality Improvement Final Rule, 42 and your state—will be placed on the the law and the public interest. Postal CFR part 3 (Patient Safety Rule), public record of this proceeding, mail addressed to the Commission is published in the Federal Register on including, to the extent practicable, on subject to delay due to heightened November 21, 2008, 73 FR 70732– the public Commission Web site, at security screening. As a result, the 70814, provide for the formation of http://www.ftc.gov/os/ Commission encourages you to submit Patient Safety Organizations (PSOs), publiccomments.shtm. As a matter of your comments online. To make sure which collect, aggregate, and analyze discretion, the Commission tries to that the Commission considers your confidential information regarding the remove individuals’ home contact online comment, you must file it at quality and safety of health care information from comments before https://ftcpublic.commentworks.com/ delivery. The Patient Safety Rule placing them on the Commission Web ftc/regulationnpra by following the authorizes AHRQ, on behalf of the site. instructions on the web-based form. If Secretary of HHS, to list as a PSO an Because your comment will be made this Notice appears at http:// entity that attests that it meets the public, you are solely responsible for www.regulations.gov, you also may file statutory and regulatory requirements making sure that your comment does a comment through that Web site. for listing. A PSO can be ‘‘delisted’’ by not include any sensitive personal If you file your comment on paper, the Secretary if it is found to no longer information, such as a Social Security write ‘‘Regulation N: FTC File No. meet the requirements of the Patient number, date of birth, driver’s license P134811; K05’’ on your comment and Safety Act and Patient Safety Rule, number or other state identification on the envelope, and mail it to the when a PSO chooses to voluntarily number or foreign country equivalent, following address: Federal Trade relinquish its status as a PSO for any Commission, Office of the Secretary, reason, or when a PSO’s listing expires. entities can be indirectly covered by state 600 Pennsylvania Avenue NW., Suite AHRQ has accepted a notification of recordkeeping requirements for mortgage CC–5610, (Annex J), Washington, DC voluntary relinquishment from QAISys, advertisements and/or retain ads to demonstrate 20580, or deliver your comment to the compliance with state law, as discussed above. See Inc. of its status as a PSO, and has following address: Federal Trade supra note 6. The FTC notes that the CFPB’s recent delisted the PSO accordingly. QAISys, Commission, Office of the Secretary, information collection filing with OMB for Inc. submitted this request for voluntary Regulation N also reflects the view that, in large Constitution Center, 400 7th Street SW., relinquishment after receiving a Notice part, most entities either retain records in the 5th Floor, Suite 5610, (Annex J), ordinary course of business or to demonstrate of Preliminary Finding of Deficiency. Washington, DC 20024. If possible, compliance with other laws. See generally Bureau submit your paper comment to the DATES: The directories for both listed of Consumer Financial Protection, Agency and delisted PSOs are ongoing and Information Collection Activities: Submission for Commission by courier or overnight OMB Review; Comment Review, 80 FR 45645 (July service. reviewed weekly by AHRQ. The 31, 2015), available at https://www.gpo.gov/fdsys/ The FTC Act and other laws that the delisting was effective at 12:00 Midnight pkg/FR-2015-07-31/pdf/2015-18809.pdf. Commission administers permit the ET (2400) on August 10, 2016. mstockstill on DSK3G9T082PROD with NOTICES 13 This estimate is based on mean hourly wages collection of public comments to ADDRESSES: Both directories can be for office support file clerks provided by the Bureau of Labor Statistics. See U.S. Bureau of Labor consider and use in this proceeding as accessed electronically at the following Statistics, Occupational Employment and Wages— appropriate. The Commission will HHS Web site: http:// May 2015, table 1 (‘‘National employment and wage consider all timely and responsive www.pso.ahrq.gov/listed. data from the Occupational Employment Statistics survey by occupation’’), released Mar. 30, 2016, public comments that it receives on or FOR FURTHER INFORMATION CONTACT: available at http://www.bls.gov/news.release/pdf/ before October 31, 2016. You can find Eileen Hogan, Center for Quality ocwage.pdf. more information, including routine Improvement and Patient Safety, AHRQ, VerDate Sep<11>2014 21:59 Aug 30, 2016 Jkt 238001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\31AUN1.SGM 31AUN1

60004 Federal Register / Vol. 81, No. 169 / Wednesday, August 31, 2016 / Notices 5600 Fishers Lane, Room 06N94B, DEPARTMENT OF HEALTH AND that if you include your name, contact Rockville, MD 20857; Telephone (toll HUMAN SERVICES information, or other information that free): (866) 403–3697; Telephone (local): identifies you in the body of your (301) 427–1111; TTY (toll free): (866) Food and Drug Administration comments, that information will be 438–7231; TTY (local): (301) 427–1130; [Docket No. FDA–2016–D–2495] posted on http://www.regulations.gov. Email: PSO@AHRQ.hhs.gov. • If you want to submit a comment Submission of Warning Plans for with confidential information that you SUPPLEMENTARY INFORMATION: Cigars; Draft Guidance for Industry; do not wish to be made available to the Availability public, submit the comment as a Background written/paper submission and in the The Patient Safety Act authorizes the AGENCY: Food and Drug Administration, manner detailed (see ‘‘Written/Paper HHS. Submissions’’ and ‘‘Instructions’’). listing of PSOs, which are entities or component organizations whose ACTION: Notice of availability. Written/Paper Submissions mission and primary activity are to SUMMARY: The Food and Drug Submit written/paper submissions as conduct activities to improve patient Administration (FDA) is announcing the follows: safety and the quality of health care availability of a draft guidance for • Mail/Hand delivery/Courier (for delivery. industry entitled ‘‘Submission of written/paper submissions): Division of HHS issued the Patient Safety Rule to Warning Plans for Cigars.’’ The draft Dockets Management (HFA–305), Food implement the Patient Safety Act. guidance, when finalized, will help and Drug Administration, 5630 Fishers AHRQ administers the provisions of the those involved in the manufacture, Lane, Rm. 1061, Rockville, MD 20852. Patient Safety Act and Patient Safety distribution, and sale of cigars in the • For written/paper comments United States understand the new cigar submitted to the Division of Dockets Rule relating to the listing and operation warning plan requirements under FDA’s Management, FDA will post your of PSOs. The Patient Safety Rule final rule deeming these products to be comment, as well as any attachments, authorizes AHRQ to list as a PSO an subject to the tobacco product except for information submitted, entity that attests that it meets the authorities in the Federal Food, Drug, marked and identified, as confidential, statutory and regulatory requirements and Cosmetic Act (the FD&C Act). The if submitted as detailed in for listing. A PSO can be ‘‘delisted’’ if draft guidance reiterates the required ‘‘Instructions.’’ it is found to no longer meet the health warning statements and the Instructions: All submissions received requirements of the Patient Safety Act requirements for random display and must include the Docket No. FDA– and Patient Safety Rule, when a PSO distribution that should be provided in 2016–D–2495 for ‘‘Submission of chooses to voluntarily relinquish its cigar warning plans, and, when Warning Plans for Cigars.’’ Received status as a PSO for any reason, or when finalized, will help persons determine comments will be placed in the docket a PSO’s listing expires. Section 3.108(d) who should submit a warning plan, and, except for those submitted as of the Patient Safety Rule requires when a plan must be submitted, and ‘‘Confidential Submissions,’’ publicly AHRQ to provide public notice when it what information should be included viewable at http://www.regulations.gov removes an organization from the list of when submitting a plan. or at the Division of Dockets federally approved PSOs. DATES: Although you can comment on Management between 9 a.m. and 4 p.m., AHRQ has accepted a notification any guidance at any time (see 21 CFR Monday through Friday. 10.115(g)(5)), to ensure that the Agency • Confidential Submissions—To from the QAISys, Inc., PSO number considers your comment on this draft submit a comment with confidential P0161, to voluntarily relinquish its information that you do not wish to be status as a PSO. Accordingly, QAISys, guidance before it begins work on the final version of the guidance, submit made publicly available, submit your Inc. was delisted effective at 12:00 comments only as a written/paper either electronic or written comments Midnight ET (2400) on August 10, 2016. submission. You should submit two on the draft guidance by September 29, AHRQ notes that that QAISys, Inc. 2016. copies total. One copy will include the submitted this request for voluntary information you claim to be confidential ADDRESSES: You may submit comments relinquishment following receipt of the with a heading or cover note that states as follows: Notice of Preliminary Finding of ‘‘THIS DOCUMENT CONTAINS Deficiency sent on July 28, 2016. In Electronic Submissions CONFIDENTIAL INFORMATION.’’ The addition, QAISys, Inc., P0046, was Submit electronic comments in the Agency will review this copy, including previously listed as a PSO in 2009; following way: the claimed confidential information, in AHRQ accepted its request for voluntary • Federal eRulemaking Portal: http:// its consideration of comments. The relinquishment in 2013. www.regulations.gov. Follow the second copy, which will have the More information on PSOs can be instructions for submitting comments. claimed confidential information obtained through AHRQ’s PSO Web site Comments submitted electronically, redacted/blacked out, will be available at http://www.pso.AHRQ.gov. including attachments, to http:// for public viewing and posted on http:// www.regulations.gov will be posted to www.regulations.gov. Submit both Sharon B. Arnold, the docket unchanged. Because your copies to the Division of Dockets Deputy Director. comment will be made public, you are Management. If you do not wish your solely responsible for ensuring that your name and contact information to be mstockstill on DSK3G9T082PROD with NOTICES [FR Doc. 2016–20912 Filed 8–30–16; 8:45 am] comment does not include any made publicly available, you can BILLING CODE 4160–90–P confidential information that you or a provide this information on the cover third party may not wish to be posted, sheet and not in the body of your such as medical information, your or comments and you must identify this anyone else’s Social Security number, or information as ‘‘confidential.’’ Any confidential business information, such information marked as ‘‘confidential’’ as a manufacturing process. Please note will not be disclosed except in VerDate Sep<11>2014 21:59 Aug 30, 2016 Jkt 238001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\31AUN1.SGM 31AUN1


Document Created: 2018-02-02 12:15:18
Document Modified: 2018-02-02 12:15:18
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of delisting.
DatesThe 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 August 10, 2016.
ContactEileen Hogan, Center for Quality Improvement and Patient Safety, AHRQ, 5600 Fishers Lane, Room 06N94B, 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 Citation81 FR 60003 
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