[Federal Register Volume 74, Number 16 (Tuesday, January 27, 2009)]
[Notices]
[Pages 4748-4751]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-1009]


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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.

[[Page 4749]]


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.

DATES: Comments on this notice must be received by March 30, 2009.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, 540 Gaither Road, Room  5036, 
Rockville, MD 20850, or by e-mail 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 AHRQ's Reports Clearance Officer.

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

SUPPLEMENTARY INFORMATION: ``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 1, 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 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

[[Page 4750]]

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 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
                                                               Number of    responses    Hours per      Total
                            Form                              respondents      per        response      burden
                                                                            respondent                  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
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.
*** 1AThe 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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                                                                              Total       Average
                            Form                               Number of      burden    hourly wage   Total cost
                                                              respondents     hours         rate        burden
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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
    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.

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.

------------------------------------------------------------------------
                         Description                             Amount
------------------------------------------------------------------------
 Personnel & Support Staff...................................     $7,500
 Consultant (sub-contractor) services........................          0

[[Page 4751]]

 
 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 approximately 
0.05 FTE or $7,500 per year 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'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: January 11, 2009.
Carolyn M. Clancy,
Director, AHRQ.
 [FR Doc. E9-1009 Filed 1-26-09; 8:45 am]
BILLING CODE 4160-90-M