[Federal Register Volume 76, Number 74 (Monday, April 18, 2011)]
[Notices]
[Pages 21744-21746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-9252]


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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 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.

DATES: Comments on this notice must be received by June 17, 2011.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, by e-mail at 
[email protected]. 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 
[email protected].

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 Federal 
Register 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

[[Page 21745]]

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).
    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.

[[Page 21746]]



                                  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
                                                 ---------------------------------------------------------------
    Total.......................................             918              NA              NA          75,764
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                                   Exhibit 2--Estimated Annualized Cost Burden
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                                                     Number of     Total burden   Average hourly   Total burden
                      Form                          respondents        hours        wage rate *        cost
----------------------------------------------------------------------------------------------------------------
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
                                                 ---------------------------------------------------------------
    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: March 29, 2011.
Carolyn M. Clancy,
Director.
[FR Doc. 2011-9252 Filed 4-15-11; 8:45 am]
BILLING CODE 4160-90-M