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[Federal Register Volume 79, Number 138 (Friday, July 18, 2014)]
[Notices]
[Pages 42013-42016]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-16670]

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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 September 16, 2014.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, by email at 
doris.lefkowitz@AHRQ.hhs.gov.
    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

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email 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 legal obligations of PSOs when 
they or the organization of which they are a part report certain 
information to the Food and Drug Administration (FDA) under the Federal 
Food, Drug, and Cosmetic Act (FDCA) and its implementing regulations. 
This includes providing the FDA with access to its records, including 
access during an inspection of its facilities. This Guidance applies to 
all entities that seek to be a PSO, or are one currently, either alone 
or as a component if another organization that have mandatory FDA-
reporting obligations under the FDCA and its implementing regulations 
(``FDA-regulated reporting entities''). It also covers PSOs that 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 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.

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. 299b-24(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(b)(1)(E); 42 CFR 3.102(d)(2).
    5. PSO Profile Form. This form, previously called the PSO 
Information Form, gathers information on PSOs and the type of health 
care 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, 
required by 42 U.S.C. 299b-23(c).
    6. PSO Change of Listing Information Form. The Secretary is 
required under 42 U.S.C. 299b-24(d) and the Patient Safety Rule to 
maintain a publicly available list of PSOs that includes, among other 
information, contact information for each entity. The Patient Safety 
Rule, section 3.102(a)(vi), also requires that a PSO must promptly 
notify the Secretary during its period of listing if there have been 
any changes in the accuracy of the information submitted for listing, 
along with the pertinent changes. This form is to be

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used by a PSO to revise its listing information, to include updating 
its contact information that will be used in the Secretary's list of 
PSOs.
    The forms described above, other than the PSO Change of Listing 
Information Form, are revised collection instruments that were 
previously approved by OMB in 2008 and 2011. These forms, along with 
the new PSO Change of Listing Information Form, will be used by AHRQ to 
obtain information necessary to implement the Patient Safety Act and 
Patient Safety Rule, e.g., obtaining initial and subsequent 
certifications from entities seeking to be listed as PSOs and for 
making the statutorily-required determinations prior to and during an 
entity's period of listing as a PSO. This information is used by the 
PSO Program Office housed in AHRQ's Center for Quality Improvement and 
Patient Safety.
    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 
the OCR so that there is 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, the forms will be implemented at different times and frequency 
due to the voluntary nature of seeking listing and remaining listed as 
a PSO, filing a Patient Safety Confidentiality Complaint Form, 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 100,704 hours annually and the 
total cost burden is estimated to be $3,618,294.72 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 17 respondents per year and an estimated 
time of 18 hours per response. The estimated response number not only 
includes submissions by entities that are successfully listed as PSOs, 
but also submissions by entities that submit an initial listing form 
that do not become a PSO. During the past three years, AHRQ has 
provided substantial technical assistance about the PSO Program, 
including to entities seeking initial listing. After submitting an 
initial listing form, an entity may withdraw its form or submit a 
revised form, particularly after receiving technical assistance from 
AHRQ. In addition, AHRQ, on behalf of the Secretary, may deny listing 
if an entity does not meet the requirements of the Patient Safety Act 
and Patient Safety Rule or if the entity does not provide other 
information determined to be necessary to make the listing 
determination, such as a lack of response to requests for 
clarifications by AHRQ on the attestations and responses on the form. 
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 an 
estimated time of eight hours per response and 16 responses annually. 
The Certification for Continued Listing Form must be completed by any 
interested PSO at least 75 days before the end of its current three-
year listing period. The number of respondents is based upon the 
estimate that 65% of the projected 77 listed PSOs will submit forms for 
continued listing. The estimated number of responses reflects the fact 
that a PSO can choose to voluntarily relinquish its status as a PSO for 
any reason or that a PSO can choose to not seek continued listing and 
allow its listing to expire. In addition, AHRQ, on behalf of the 
Secretary, can revoke the listing of a PSO if it is found to no longer 
meet the requirements of the Patient Safety Act or Patient Safety Rule. 
Therefore, AHRQ estimates that approximately two thirds of PSOs will 
seek continued listing and submit the form.

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 
30 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 2 
respondents and thus presumably overestimating respondent burden. The 
average annual burden estimate of six 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.

Profile Form

    The overall annual burden estimate of 231 hours for the collection 
of information requested by the PSO Profile Form is based upon an 
estimate of 77 respondents per year and an estimated three hours per 
response. Newly listed PSOs first report in the calendar year after 
their listing by the Secretary.

Patient Safety Confidentiality Complaint Form

    The overall annual burden estimate of one hour for the collection 
of information requested by the form is based on an estimate of three 
respondents per year and an estimated 20 minutes per response. OCR's 
information collection using this form will not begin until after there 
is an allegation of a violation of the statutory protection of PSWP.

PSO Change of Listing Information Form

    The average annual burden for the collection of information 
requested by the change of listing information forms is based upon a 
total average estimate of 24 respondents per year and an estimated time 
of five minutes per response. This collection of information takes 
place when the PSO notifies the Secretary that its listing information 
has changed.

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. In the previous submission, AHRQ 
estimated that 1,000 hospitals would be using the Common

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Formats in year 3. AHRQ estimates the number of hospitals using Common 
Formats will remain level for the next three years at 1,000 hospitals.

                                  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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Certification for Initial Listing Form *........              17               1              18             306
Certification for Continued Listing Form *......              16               1               8             128
Two Bona Fide Contracts Requirement Form **.....              30               1               1              30
Disclosure Statement Form ***...................               2               1               3               6
Profile Form ****...............................              77               1               3             231
Patient Safety Confidentiality Complaint Form                  3               1           20/60               1
 ***............................................
Change of Listing Information ***...............              24               1           05/60               2
Common Formats..................................           1,000               1             100         100,000
                                                 ---------------------------------------------------------------
    Total ***...................................           1,169              NA              NA         100,704
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* AHRQ expects the number of PSOs to remain relatively stable, with 65% of listed PSOs seeking continued
  listing. The number of new entities seeking listing as PSOs and PSOs seeking continued listing will be offset
  by the number of entities that will voluntarily relinquish their status as a PSO, allow their listing to
  expire, or have their listing revoked for cause by AHRQ.
** The Two Bona Fide Contracts Requirement Form will be completed by each PSO within the 24-month period after
  listing by the Secretary.
*** The Disclosure Statement Form and the Change of Listing Information form may be submitted by individual PSOs
  in different years. Due to changes in their operations, a PSO can submit more than one Change of Listing
  Information in a year. OCR is anticipating considerable variation in the number of complaints per year. Hence,
  the total for each year is expressed as an average of the expected total over the three year collection
  period.
**** The Profile Form collects data from listed PSOs each calendar year. The prior version of this form, the PSO
  Information Form, began collecting data from listed PSOs each calendar year in 2011.

                                   Exhibit 2--Estimated Annualized Cost Burden
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                                              Number of       Total burden     Average hourly
                   Form                      respondents          hours          wage rate *       Total cost
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Certification for Initial Listing Form..                17               306            $35.93        $10,994.58
Certification for Continued Listing Form                16               128             35.93          4,599.04
Two Bona Fide Contracts Requirement Form                30                30             35.93          1,077.90
Disclosure Statement Form...............                 2                 6             35.93            215.58
Profile Form............................                77               231             35.93          8,299.83
Patient Safety Confidentiality Complaint                 3                 1             35.93             35.93
 Form...................................
Change of Listing Information...........                24                 2             35.93             71.86
Common Formats..........................             1,000           100,000             35.93      3,593,000.00
                                         -----------------------------------------------------------------------
    Total...............................             1,169           100,704                NA      3,618,294.72
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* Based upon the mean of the hourly wages for healthcare practitioner and technical occupations, 29-0000,
  National Compensation Survey, May 2013, ``U.S. Department of Labor, Bureau of Labor Statistics.'' (http://www.bls.gov/oes/current/oes_nat.htm#29-0000).

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 health care research and 
health care 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: July 1, 2014.
Richard Kronick,
AHRQ Director.
[FR Doc. 2014-16670 Filed 7-17-14; 8:45 am]
BILLING CODE 4160-90-M
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