FR Doc E9-6955

[Federal Register: March 31, 2009 (Volume 74, Number 60)]
[Notices]
[Page 14558-14560]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31mr09-66]

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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 for Initial Listing 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 January 27, 2009 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 April 30, 2009.

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 AHRQs Reports Clearance Officer.

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

SUPPLEMENTARY INFORMATION:

Proposed Project

``Patient Safety Organization Certification for Initial Listing 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 as
further explained in the final rule to implement the Patient Safety
Act, published in the Federal Register on November 21, 2008: 73 FR
70732.
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 final rule (published in the Federal Register on
November 21, 2008). 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., most of the
required certification forms will consist of short attestations
followed by ``yes'' and ``no'' checkboxes to be checked and initialed.

PSO Certification for Initial Listing and PSO Certification for
Continued Listing Forms

The Patient Safety Act, at 42 U.S.C. 299b-24(a), and the final rule
at 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 final rule), and that it
will comply, upon listing, with seven other statutory criteria. The
proposed Certification for Initial Listing Form also includes
additional questions related to other requirements for listing related
to eligibility and pertinent organizational history. Similarly, the
proposed Certification for Continued Listing Form (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 form for
initial 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. The
average annual burden in the first three years of 8 hours per year for
the collection of information requested by the certification form for
continued listing is based upon a total average estimate of 17
respondents per year and an estimated time of 30 minutes per response.
Collection of forms for continued listing will not begin until several
months before November 2011 which is three years after the first PSOs
were listed by the Secretary. (See Note after Exhibit 1.)

PSO Two Bona Fide Contracts Requirement Certification

To implement 42 U.S.C. 299b-24(b)(1)(C), the final rule states
that, in order to maintain its PSO listing, a PSO will be required to
submit a certification, at least once in every 24-month period after
its initial date of listing, indicating that it has contracts with two
providers (45 CFR 3.102(d)(1)). The annualized burden of 8 hours for
the collection of information requested by the two bona fide contracts
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.

PSO Disclosure Statement 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 Statement 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

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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 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.

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 (42 U.S.C. 299b-23(c)). 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 one year after 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 safely 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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Certification for Initial Listing Form.......... 100/3 1 30/60 17
Certification for Continued Listing Form*....... 50/3 1 30/60 8
Two Bona Fide Contracts Requirement Form**...... 100/3 1 15/60 8
Disclosure Statement Form....................... 50/3 1 30/60 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 Certification for Continued Listing Form will be completed by any interested PSO at least 75 days
before the end of its then-current three-year listing period. Therefore, we anticipate that only those PSOs
that have completed the Certification for Initial Listing Form in the first year that these forms are
available will complete the Certification for Continued Listing Form during the three-year approval period for
these forms. 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 Bona Fide Contracts 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 in 2010, at a time when it is anticipated
that PSOs will have submitted appreciable data to the Network of Patient Safety Databases.
**** A total of 100 PSOs are expected to apply over three years: 50 in year one; 25 in year two; and 25 in year
three. Disclosure Statement, Two Bona Fide Contracts Requirement, 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.

Exhibit 2--Estimated Annualized Cost Burden
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Number of Total burden Average hourly Total burden
Form respondents hours wage rate* cost
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Certification for Initial Listing Form.......... 100/3 17 $31.26 $531.42
Certification for Continued Listing Form........ 50/3 8 31.26 250.08
Two Bona Fide Contracts Requirement Form........ 100/3 8 31.26 250.08
Disclosure Statement Form....................... 50/3 8 31.26 250.08
Information Form................................ 100/3 17 31.26 531.42
Patient Safety Confidentiality Complaint Form... 150/3 17 31.26 531.42
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Total....................................... 500/3 75 na 2,344.50
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* Based upon the mean of the hourly wages for healthcare practitioner and technical occupation, National
Compensation Survey: Occupational wages in the United States 2007, U.S. Department of Labor, Bureau of Labor
Statistics.

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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 bona fide contracts 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
approximately 0.05 FTE or $7,500 per year 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
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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 approximately
0.05 FTE or $7,500 per year with virtually no new overhead costs.

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's 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: March 18, 2009.
Carolyn M. Clancy,
Director, AHRQ.
[FR Doc. E9-6955 Filed 3-30-09; 8:45 am]

BILLING CODE 4160-90-M