[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
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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
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Total....................................... 500/3 67 29.82 2,504.88
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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.
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Description Amount
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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.
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Description Amount
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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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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]
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