[Federal Register Volume 76, Number 122 (Friday, June 24, 2011)]
[Notices]
[Pages 37115-37118]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-15578]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Agency for Healthcare Research and Quality, HHS.
ACTION: Notice.
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SUMMARY: This notice announces the intention of the Agency for
Healthcare Research and Quality (AHRQ) to request that the Office of
Management and Budget (OMB) approve the proposed information collection
project: ``Patient Safety Organization Certification for
[[Page 37116]]
Initial Listing and Related Forms, Patient Safety Confidentiality
Complaint Form, and Common Formats.'' In accordance with the Paperwork
Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment
on this proposed information collection.
This proposed information collection was previously published in
the Federal Register on April 18th, 2011 and allowed 60 days for public
comment. No comments were received. The purpose of this notice is to
allow an additional 30 days for public comment.
DATES: Comments on this notice must be received by July 25, 2011.
ADDRESSES: Written comments should be submitted to: AHRQ's OMB Desk
Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by
e-mail at OIRA_submission@omb.eop.gov (attention: AHRQ's desk
officer).
Copies of the proposed collection plans, data collection
instruments, and specific details on the estimated burden can be
obtained from the AHRQ Reports Clearance Officer.
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by e-mail at
doris.lefkowitz@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
Proposed Project
Patient Safety Organization Certification for Initial Listing and
Related Forms, Patient Safety Confidentiality Complaint Form, and
Common Formats
The Patient Safety and Quality Improvement Act of 2005 (hereafter
the Patient Safety Act), 42 U.S.C. 299b-21 to 299b-26, was enacted in
response to growing concern about patient safety in the United States
and the Institute of Medicine's 1999 report, To Err is Human: Building
a Safer Health System. The goal of the statute is to improve patient
safety by providing an incentive for health care providers to work
voluntarily with experts in patient safety to reduce risks and hazards
to the safety and quality of patient care. The Patient Safety Act
signifies the Federal Government's commitment to fostering a culture of
patient safety among health care providers; it offers a mechanism for
creating an environment in which the causes of risks and hazards to
patient safety can be thoroughly and honestly examined and discussed
without fear of penalties and liabilities. It provides for the
voluntary formation of Patient Safety Organizations (PSOs) that can
collect, aggregate, and analyze confidential information reported
voluntarily by health care providers. By analyzing substantial amounts
of patient safety event information across multiple institutions, PSOs
will be able to identify patterns of failures and propose measures to
eliminate or reduce patient safety risks and hazards.
In order to implement the Patient Safety Act, the Department of
Health and Human Services (HHS) issued the Patient Safety and Quality
Improvement Final Rule (hereafter the Patient Safety Rule), 42 CFR part
3, which became effective on January 19, 2009. The Patient Safety Rule
establishes a framework by which hospitals, doctors, and other health
care providers may voluntarily report information to PSOs, on a
privileged and confidential basis, for the aggregation and analysis of
patient safety events. In addition, the Patient Safety Rule outlines
the requirements that entities must meet to become PSOs and the process
by which the Secretary of HHS (hereafter the Secretary) will review and
accept certifications and list PSOs.
In addition to the Patient Safety Act and the Patient Safety Rule,
HHS issued Guidance Regarding Patient Safety Organizations' Reporting
Obligations and the Patient Safety and Quality Improvement Act of 2005
(hereafter Guidance) on December 30, 2010. The Guidance addresses
questions that have arisen regarding the obligations of PSOs where they
or the organization of which they are a part are legally obligated
under the Federal Food, Drug, and Cosmetic Act (FDCA) and its
implementing regulations to report certain information to the Food and
Drug Administration (FDA) and to provide FDA with access to its
records, including access during an inspection of its facilities. This
Guidance applies to all entities that seek to be or are PSOs or
component PSOs that have mandatory FDA-reporting obligations under the
FDCA and its implementing regulations (``FDA-regulated reporting
entities'') or are organizationally related to such FDA-regulated
reporting entities (e.g., parent organizations, subsidiaries, sibling
organizations).
When PSOs meet the requirements of the Patient Safety Act, the
information collected and the analyses and deliberations regarding the
information receive Federal confidentiality and privilege protections
under this legislation. The Secretary delegated authority to the
Director of the Office for Civil Rights (OCR) to enforce the
confidentiality protections of the Patient Safety Act. 71 FR 28701-
28702 (May 17, 2006). OCR is responsible for enforcing protections
regarding patient safety work product (PSWP), which generally includes
information that could improve patient safety, health care quality, or
health care outcomes and (1) is assembled or developed by a provider
for reporting to a PSO and is reported to a PSO or (2) is developed by
a PSO for the conduct of patient safety activities. Civil money
penalties may be imposed for knowing or reckless impermissible
disclosures of PSWP. AHRQ implements and administers the rest of the
Patient Safety Act's provisions.
Pursuant to 42 CFR 3.102, an entity that seeks to be listed as a
PSO by the Secretary must certify that it meets certain requirements
and, upon listing, will meet other criteria. To remain listed for
renewable three-year periods, a PSO must recertify that it meets these
obligations and will continue to meet them while listed. The Patient
Safety Act and Patient Safety Rule also impose other obligations,
discussed below, that a PSO must meet to remain listed. In order for
the Secretary to administer the Patient Safety Act and Rule, the
entities seeking to be listed and to remain listed must complete the
proposed forms attached hereto.
Method of Collection
With this submission, AHRQ is requesting approval of the following
proposed administrative forms:
1. PSO Certification for Initial Listing Form. This form, which is
to be completed by an entity seeking to be listed by the Secretary as a
PSO for an initial three-year period, contains certifications that the
entity meets the requirements for listing as a PSO, in accordance with
42 U.S.C. 299b-24(a)(1) and 42 CFR 3.102.
2. PSO Certification for Continued Listing Form. In accordance with
42 U.S.C. 299b-24(a)(2) and the Patient Safety Rule, this form is to be
completed by a listed PSO seeking continued listing as a PSO by the
Secretary for an additional three year period.
3. PSO Two Bona Fide Contracts Requirement Certification Form. To
remain listed, a PSO must have contracts with more than one provider,
within successive 24 month periods, beginning with the date of its
initial listing. 42 U.S.C. 299(b)(1)(C). This form is to be used by a
PSO to certify whether it has met this requirement.
4. PSO Disclosure Statement Form. A PSO must submit this form when
it (i) has a Patient Safety Act contract with-a health care provider
and (ii) it has financial, reporting, and contractual relationships
with that contracting provider or is not independent of that
contracting provider. 42 U.S.C. 299b-24; 42 CFR 3.102(d)(2).
[[Page 37117]]
5. PSO Information Form. This form gathers information on PSOs and
the type of healthcare providers and settings that they are working
with to conduct patient safety activities in order to improve patient
safety. It is designed to collect a minimum level of data necessary to
develop aggregate statistics relating to the Patient Safety Act,
including types of institutions participating and their general
location in the US. This information will be included in AHRQ's annual
quality report, as required by 42 U.S.C. 299b-23(c).
OCR is requesting approval of the following administrative form:
Patient Safety Confidentiality Complaint Form. The purpose of this
collection is to allow OCR to collect the minimum information needed
from individuals filing patient safety confidentiality complaints with
our office so that we have a basis for initial processing of those
complaints.
In addition, AHRQ is requesting approval for a set of common
definitions and reporting formats (hereafter Common Formats). Pursuant
to 42 U.S.C. 299b-23(b), AHRQ coordinates the development of the Common
Formats that allow PSOs and health care providers to voluntarily
collect and submit standardized information regarding patient safety
events.
Estimated Annual Respondent Burden
While there are a number of information collection forms described
below, they will be implemented at different times and frequency due to
the voluntary nature of seeking listing as a PSO and using the Common
Formats. Exhibit 1 shows the estimated annualized burden hours for the
respondent to provide the requested information, and Exhibit 2 shows
the estimated annualized cost burden associated with the respondents'
time to provide the requested information. The total burden hours are
estimated to be 75,764 hours annually and the total cost burden is
estimated to be $2,538,852 annually.
PSO Certification for Initial Listing Form
The average annual burden for the collection of information
requested by the certification forms for initial listing is based upon
a total average estimate of 15 respondents per year and an estimated
time of 18 hours per response. This collection of information takes
place on an ongoing basis.
Certification for Continued Listing Form
The average annual burden for the collection of information
requested by the certification form for continued listing is based upon
the estimate that 90% of the listed PSOs during the 3 years of this
clearance, or 24 PSOs annually, will submit forms with an estimated
time of eight hours per response. The Certification for Continued
Listing Form will be completed by any interested PSO at least 75 days
before the end of its current three-year listing period.
Two Bona Fide Contracts Requirement Certification
The average annual burden for the collection of information
requested by the two-contract requirement is based upon an estimate of
40 respondents per year and an estimated one hour per response. This
collection of information takes place when the PSO notifies the
Secretary that it has entered into two contracts.
Disclosure Statement Form
AHRQ assumes that only a small percentage of entities will need to
file a disclosure form. However, AHRQ is providing a high estimate of 7
respondents annually and thus presumably overestimating respondent
burden. The average annual burden estimate of 21 hours for the
collection of information requested by the disclosure form is based
upon an estimated three hours per response. This information collection
takes place when a PSO first reports having any of the specified types
of additional relationships with a health care provider with which it
has a contract to carry out patient safety activities.
Information Form
The overall annual burden estimate of 240 hours for the collection
of information requested by the PSO Information Form is based upon an
estimate of 80 respondents per year and an estimated three hours per
response. This information collection will begin in 2011; newly listed
PSOs will first report in the calendar year after their listing by the
HHS Secretary.
Patient Safety Confidentiality Complaint Form
The overall annual burden estimate of 1 hour for the collection of
information requested by the form is based on an estimate of two
respondents per year and an estimated 20 minutes per response. OCR's
information collection using this form will not begin until after there
is at least one PSO receiving and generating PSWP and there is an
allegation of a violation of the statutory protection of PSWP.
Common Formats
AHRQ estimates that 5% FTE of a Patient Safety Manager at a
hospital will be spent to administer the Common Formats, which is
approximately 100 hours a year. AHRQ estimates the number of hospitals
using Common Formats in the first year as 500, then 750 in year 2, and
1000 in year 3, for an annual average of 750 over 3 years.
Exhibit 1--Estimated Annualized Burden Hours
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Number of
Form Number of responses per Hours per Total burden
respondents respondent response hours
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Patient Safety Organization Certification for 15 1 18 270
Initial Listing Form...........................
Certification for Continued Listing Form........ 24 1 8 192
Two Bona Fide Contracts Requirement Form........ 40 1 1 40
Disclosure Statement Form....................... 7 1 3 21
Information Form................................ 80 1 3 240
Patient Safety Confidentiality Complaint Form... 2 1 20/60 1
Common Formats.................................. 750 1 100 75,000
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Total....................................... 918 NA NA 75,764
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Exhibit 2--Estimated Annualized Cost Burden
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Average
Form Number of Total burden hourly wage Total cost
respondents hours rate* burden
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Certification for Initial Listing Form.......... 15 270 33.51 9,048
Certification for Continued Listing Form........ 24 192 33.51 6,434
Two Bona Fide Contracts Requirement Form........ 40 40 33.51 $1,340
Disclosure Statement Form....................... 7 21 33.51 704
Information Form................................ 80 240 33.51 8,042
Patient Safety Confidentiality Complaint Form... 2 1 33.51 34
Common Formats.................................. 750 75,000 33.51 2,513,250
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Total....................................... 918 75,764 NA 2,538,852
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* Based upon the mean of the hourly wages for healthcare practitioner and technical occupation, National
Compensation Survey, May 2009, ``U.S. Department of Labor, Bureau of Labor Statistics.''
Estimated Annual Costs to the Federal Government
a. AHRQ
The total cost to the Federal Government for the PSO forms and
Common Formats is $1,737,390 per year, including project management and
support for the review and administration of the PSO forms and the
development and maintenance of the Common Formats.
b. OCR
Through an interagency agreement (IAA), OCR provides management for
and support of the enforcement of the confidentiality protections of
the Patient Safety Act and the Patient Safety Rule. The cost of this
IAA is approximately $300,000 annually.
Request for Comments
In accordance with the Paperwork Reduction Act, comments on AHRQ's
information collection are requested with regard to any of the
following: (a) Whether the proposed collection of information is
necessary for the proper performance of AHRQ healthcare research and
healthcare information dissemination functions, including whether the
information will have practical utility; (b) the accuracy of AHRQ's
estimate of burden (including hours and costs) of the proposed
collection(s) of information; (c) ways to enhance the quality, utility,
and clarity of the information to be collected; and (d) ways to
minimize the burden of the collection of information upon the
respondents, including the use of automated collection techniques or
other forms of information technology.
Comments submitted in response to this notice will be summarized
and included in the Agency's subsequent request for OMB approval of the
proposed information collection. All comments will become a matter of
public record.
Dated: June 10, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011-15578 Filed 6-23-11; 8:45 am]
BILLING CODE 4160-90-M