14558 Federal Register / Vol. 74, No. 60 / Tuesday, March 31, 2009 / Notices 

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. 

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 email 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 


tjames on PRODPC61 with NOTICES
Federal Register / Vol. 74, No. 60 / Tuesday, March 31, 2009 / Notices 14559 

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

Form Number of 

respondents 

Number of 

responses per 

respondent 

Hours per 

response 

Total burden 

hours 

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 

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

Form Number of 

respondents 

Total burden 

hours 

Average hourly wage rate* Total burden 

cost 

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 

* 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. 


tjames on PRODPC61 with NOTICES
14560 Federal Register / Vol. 74, No. 60 / Tuesday, March 31, 2009 / Notices 

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 abovedescribed 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 

Equipment ....................................... 0 

Supplies .......................................... 0 

All other expenses .......................... 0 

Average Annual Cost .............. 7,500 

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: March 18, 2009. 

Carolyn M. Clancy, 

Director, AHRQ. 

[FR Doc. E9–6955 Filed 3–30–09; 8:45 am] 

BILLING CODE 4160–90–M 

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. 

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: ‘‘CAHPS 

Field Test of Proposed Health 

Information Technology Questions and 

Methodology.’’ In accordance with the 

Paperwork Reduction Act of 1995, 

Public Law 104–13 (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 June 1, 2009. 

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 

e-mail at doris.lefkowitz@ahrq.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

‘‘CAHPS Field Test of Proposed Health 

Information Technology Questions and 

Methodology’’ 

The Consumer Assessment of 

Healthcare Providers and Systems 

(CAHPS®) program is a multi-year 

initiative of the Agency for Healthcare 

Research and Quality. AHRQ first 

launched the program in October 1995 

in response to concerns about the lack 

of good information about the quality of 

health plans from the enrollees’ 

perspective. Numerous public and 

private organizations collected 

information on enrollee and patient 

satisfaction, but the surveys varied from 

sponsor to sponsor and often changed 

from year to year. The CAHPS® program 

was designed to: 

• Make it possible to compare survey 

results across sponsors and over time; 

and 

• Generate tools and resources that 

sponsors can use to produce 

understandable and usable comparative 

information for consumers. 

Over time, the program has expanded 

beyond its original focus on health 

plans to address a range of health care 

services and meet the various needs of 

health care consumers, purchasers, 

health plans, providers, and 

policymakers. Based on the literature 

review and an assessment of currently 

available survey instruments, AHRQ 

identified the need to develop a new 

health information technology module 

of the CAHPS® survey. The intent of the 

planned module is to examine in greater 

detail than previously patients’ 

perspective on health information 

technology use by their health care 

professionals. The intent of the new 

module is to provide information to 

clinicians, group practices, health plans, 

and other interested parties regarding 

the impact of the use of health 

information technology on patients’ 

experiences with care. The set of 

questions about health information 

technology will be tested as a part of 

CAHPS® Clinician & Group Survey, 

Adult Primary Care Questionnaire. 

This study, funded through 

cooperative agreements with RAND and 

Harvard, is being conducted pursuant to 

AHRQ’s statutory authority to conduct 

research and evaluations on health care 

and systems for the delivery of such 

care, including activities with respect to 

(1) the quality, effectiveness, efficiency, 

appropriateness and value of health care 

services and (2) health care 


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