[Federal Register Volume 73, Number 77 (Monday, April 21, 2008)]
[Notices]
[Pages 21349-21351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-8440]


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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, Department of 
Health and Human Services.

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) allow information collection related to 
implementation of the Patient Safety and Quality Improvement Act of 
2005, 42 U.S.C. 299b-21 to 299b-26, in: ``Patient Safety Organization 
Certification and Related Forms and a Patient Safety Confidentiality 
Complaint Form.'' In accordance with the Paperwork Reduction Act of 
1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on 
this proposed information collection.
    This proposed information collection was previously published in 
the Federal Register on February 20th, 2008 and allowed 60 days for 
public comment. The purpose of this notice is to allow an additional 30 
days for public comment.

DATES: Comments on this notice must be received by May 21, 2008.

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 [email protected] (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 AHRQs Reports Clearance Officer.

FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ, Reports 
Clearance Officer, (301) 427-1477.

SUPPLEMENTARY INFORMATION: ``Patient Safety Organization Certification 
and Related Forms and a Patient Safety Confidentiality Complaint 
Form.''
    The Department of Health and Human Services (HHS) Agency for 
Healthcare Research and Quality (AHRQ) has been delegated the authority 
to implement the provisions of the Patient Safety and Quality 
Improvement Act of 2005 (for brevity referenced here as the Patient 
Safety Act) that call for submission to the Secretary of certifications 
by entities seeking to become listed by the Secretary as Patient Safety 
Organizations (PSOs). These entities must certify that they meet or 
will meet specified statutory criteria and requirements for PSOs.
    The HHS Office for Civil Rights (OCR) has been delegated the 
authority to enforce the provisions of the Patient Safety Act that 
mandate confidentiality of ``patient safety work product.'' This term 
is defined in the statute, at 42 U.S.C. 299b-21(7), and further 
explained in the related Notice of Proposed Rulemaking published in the 
Federal Register on February 12, 2008, 73 FR 8112-8183. Individuals may 
voluntarily submit complaints to OCR if they believe that an individual 
or organization in possession of patient safety work product unlawfully 
disclosed it.

Methods of Collection

    While there are a number of information collection forms described 
below, they will be implemented at different times, some near the end 
of the three year approval period for these standard forms. The forms 
for certifications of information will collect only the minimum amount 
of information from entities necessary for the Secretary to determine 
compliance with statutory requirements for PSOs, i.e., each of the 
required certification forms will consist of short attestations 
followed by ``yes'' and ``no'' checkboxes to be checked and initialed.

Initial PSO Certification and PSO Recertification Forms

    The Patient Safety Act, in 42 U.S.C. 299b-24(a) and the proposed 
rule in 45 CFR 3.102 provide that an entity may seek an initial three-
year listing as a PSO by submitting an initial certification that it 
has policies and procedures in place to perform eight patient safety 
activities (enumerated in the statute and the proposed regulation), and 
that it will comply, upon listing, with seven other statutory criteria. 
The draft initial certification form also includes four questions 
related to other requirements for listing related to eligibility and 
pertinent organizational history. Similarly, the proposed certification 
form for continued listing as a PSO (for each successive three-year 
period after the initial listing period) would require certifications 
that the PSO is performing, and will continue to perform, the eight 
patient safety activities, and is complying with, and will continue to 
comply with, the seven statutory criteria. The average annual burden in 
the first three years of 17 hours per year for the collection of 
information requested by the certification forms for initial and 
continued listing is based upon a total average estimate of 33 
respondents per year and an estimated time of 30 minutes per response. 
Information collection, i.e., collection of initial certification 
forms, will begin as soon as the forms are approved for use. Collection 
of forms for continued listing will not begin until several months 
before a date that is three years after the first PSOs are listed by 
the Secretary. (See Note after Exhibit 1.)

Two-Contract Certification

    To implement 42 U.S.C. 299b-24(b)(1)(C), AHRQ plans to adopt the 
following procedure, published in the proposed regulation: In order to

[[Page 21350]]

maintain its PSO listing, a PSO will be required only to submit a brief 
attestation, at least once in every 24-month period after its initial 
date of listing, indicating that it has entered into contracts with two 
providers. The annualized burden of 8 hours for the collection of 
information requested by the two-contract requirement is based upon an 
estimate of 33 respondents per year and an estimated 15 minutes per 
response. This collection of information will begin when the first PSO 
timely notifies the Secretary that it has entered into two contracts.

Disclosure Form

    The Patient Safety statute at 42 U.S.C. 299b-24(b)(1)(E) requires a 
PSO to fully disclose information to the Secretary if the PSO has 
additional financial, contractual, or reporting relationships with any 
provider to which the PSO provides services pursuant to the Patient 
Safety Act under contract or if the PSO is managed or controlled by, or 
is not operated independently from, any of its contracting providers. 
Disclosure forms will be collected only when a PSO has such 
relationships with a contracting provider to report. The Secretary is 
required to review each disclosure statement and make public findings 
as to whether a PSO can fairly and accurately carry out its 
responsibilities. AHRQ assumes that only a small percentage of entities 
will need to file such disclosure forms. However, AHRQ is providing a 
high estimate of 17 respondents annually and thus presumably 
overestimating respondent burden. In summary, the annual burden of 8 
hours for the collection of information requested by the disclosure 
form is based upon the high estimate of 17 respondents per year and an 
estimated 30 minutes per response. This information collection will 
begin when a PS0 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.

PSO Information Form

    Annual completion of a PSO information form will be voluntary and 
will provide information to HHS on the type of healthcare settings that 
PSOs are working with to carry out patient safety activities. This form 
is designed to collect a minimum amount of data in order to gather 
aggregate statistics on the reach of the Patient Safety Act with 
respect to types of institutions participating and their general 
location in the United States. This information will be included in 
AHRQ's annual quality report, as required under section 923(c) of the 
Patient Safety Act. No PSO-specific data will be released without PSO 
consent. The overall annual burden estimate of 17 hours for the 
collection of information requested by the PSO Information Form is 
based upon an estimate of 33 respondents per year and an estimated 30 
minutes per response. This information collection will begin toward the 
end of the calendar year in which the first PSOs are listed by the 
Secretary.

OCR Complaint Form

    The complaint form will collect from individuals only the minimum 
amount of information necessary for OCR to process and assess incoming 
complaints. The overall annual burden estimate of 17 hours for the 
collection of information requested by the underlying form is based 
upon an estimate of 50 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 
patient safety work product and there is an allegation of a violation 
of the statutory protection of patient safety work product.

All Administrative Forms

    The overall maximum anticipated annual burden estimate is 75 hours 
for all the above described collections of information. Because the 
forms filled out by PSOs vary over each of their first three years, the 
table below includes three-year total estimates divided by three to 
arrive at an annual estimate of burden hours. (See below.)

                                  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 Form..           100/3               1           30/60              17
Recertification Form*...........................            50/3               1           30/60               8
Disclosure Form.................................            50/3               1           30/60               8
Two-Contract Requirement Form**.................           100/3               1           15/60               8
Information Form***.............................           100/3               1           30/60              17
Patient Safety Confidentiality Complaint Form...           150/3               1           20/60              17
                                                 ---------------------------------------------------------------
    Total****...................................           500/3              na              na             75
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Note: * The Recertification Form will be completed by any interested PSO at least 45 days before the end of its
  current three-year listing period. The three-year period for computing respondent burden begins with the date
  when the approved forms are officially made available for submission. Thus the burden period does not
  correspond exactly to the three-year period of listing. The burden period begins shortly (approximately 30
  days) before any PSO's listing period. As a result, the burden for the first PSOs to submit certifications for
  continued listing at least 45 days before their listing lapses is likely to fall just before the three-year
  anniversary of their first burden, i.e. their completion of their initial certifications and before the end of
  their third year of listing. We assume completing this form will require 30 minutes, the same time as for the
  Certification Form. In the out-years, we expect the number of PSOs to remain stable, with the number of new
  entrants offset by the number of entities that will relinquish their status or be revoked.
** The Two-Contract Requirement Form will be completed by each PSO within the 24-month period after initial
  listing by the Secretary.
*** The Information Form will collect data by calendar year, beginning close to the end of the calendar year
  when PSOs are first listed.
**** A total of 100 PSOs are expected to apply over three years: 50 in year 1; 25 in year 2; and 25 in year 3.
  Relationship Disclosure, Two-Contract, and even voluntary Information Forms may be submitted by individual
  PSOs in different years. OCR is anticipating considerable variation in the number of complaints per year.
  Hence we have expressed the total for each year as the average of the expected total over the three year
  collection period.


[[Page 21351]]


                                  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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Patient Safety Organization Certification Form..           100/3              17          $29.82         $506.94
Recertification Form............................            50/3               8           29.82          238.56
Disclosure Form.................................            50/3               8           29.82          238.56
Two-Contract Requirement Form...................           100/3               8           29.82          506.94
Information Form................................           100/3              17           29.82          506.94
Patient Safety Confidentiality Complaint Form...           150/3              17           29.82          506.94
                                                 ---------------------------------------------------------------
    Total.......................................           500/3              67           29.82        2,504.88
----------------------------------------------------------------------------------------------------------------

Estimated Annual Costs to the Federal Government

a. AHRQ

    By statute, AHRQ must collect and review certifications from an 
entity that seeks listing or continued listing as a PSO under the 
Patient Safety Act. Additional information collection is also required 
for entities to remain listed as a PSO (i.e., submissions regarding 
compliance with the two-contract requirement and reports of certain 
relationships between a PSO and each of its contracting providers). The 
cost to AHRQ of processing the information collected with the above-
described forms is minimal; an estimated equivalent of only 
approximately 0.05 FTE or $7,500 per year for each agency and virtually 
no new overhead costs.

------------------------------------------------------------------------
                         Description                             Amount
------------------------------------------------------------------------
Personnel & Support Staff....................................     $7,500
Consultant (sub-contractor) services.........................          0
Equipment....................................................          0
Supplies.....................................................          0
All other expenses...........................................          0
Average Annual Cost..........................................      7,500
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b. OCR

    OCR cannot conduct its work without collecting information through 
its proposed complaint forms. Even if OCR did not use complaint forms 
and only took information orally, it would still have to capture the 
same information in order to begin processing a complaint. Therefore, 
the incremental cost to OCR of processing the information collected 
from the complaint form is minimal and is equivalent to only 
approximately 0.05 FTE or $7,500 per year with, with virtually no new 
overhead costs.

------------------------------------------------------------------------
                         Description                             Amount
------------------------------------------------------------------------
Personnel & Support Staff....................................     $7,500
Consultant (sub-contractor) services.........................          0
Equipment....................................................          0
Supplies.....................................................          0
All other expenses...........................................          0
Average Annual Cost..........................................      7,500
------------------------------------------------------------------------

Request for Comments

    In accordance with the above-cited Paperwork Reduction Act 
legislation, comments on the above-described AHRQ and OCR information 
collection to implement the Patient Safety Act 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, quality improvement and 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: April 14, 2008.
Carolyn M. Clancy,
Director, AHRQ.
 [FR Doc. E8-8440 Filed 4-18-08; 8:45 am]
BILLING CODE 4160-90-M