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Agency Information Collection Activities: Proposed Collection; Comment Request

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Information about this document as published in the Federal Register.

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Agency for Healthcare Research and Quality, HHS.




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: “Medical Office Survey on Patient Safety Culture Comparative Database.” In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.

This proposed information collection was previously published in the Federal Register on March 23rd, 2014 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.


Comments on this notice must be received by August 17, 2015.


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 (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 the AHRQ Reports Clearance Officer.

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Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at

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Proposed Project

Medical Office Survey on Patient Safety Culture Comparative Database

Background on the Medical Office Survey on Patient Safety Culture (Medical Office SOPS). In 1999, the Institute of Medicine called for health care organizations to develop a “culture of safety” such that their workforce and processes focus on improving the reliability and safety of care for patients (IOM, 1999; To Err is Human: Building a Safer Health System). To respond to the need for tools to assess patient safety culture in health care, AHRQ developed and pilot tested the Medical Office SOPS with OMB approval (OMB NO.0935-0131; Approved July 5, 2007).

The survey is designed to enable medical offices to assess provider and staff opinions about patient safety issues, medical error, and error reporting. The survey includes 38 items that measure 10 composites of patient safety culture. In addition to the composite items, 14 items measure how often medical offices have problems exchanging information with other settings and other patient safety and quality issues. AHRQ made the survey publicly available along with a Survey User's Guide and other toolkit materials in December 2008 on the AHRQ Web site (located at​professionals/​quality-patient-safety/​patientsafetyculture/​medical-office/​index.html). Since its release, the survey has been voluntarily used by hundreds of medical offices in the U.S.

The Medical Office SOPS Comparative Database consists of data from the AHRQ Medical Office SOPS. Start Printed Page 42498Medical offices in the U.S. are asked to submit data voluntarily from the survey to AHRQ, through its contractor Westat. The Medical Office SOPS Database (OMB NO. 0935-0196, last approved on June 12, 2012) was developed by AHRQ in 2011 in response to requests from medical offices interested in knowing how their patient safety culture survey results compare to those of other medical offices in their efforts to improve patient safety.

Rationale for the information collection. The Medical Office SOPS and the Comparative Database support AHRQ's goals of promoting improvements in the quality and safety of health care in medical office settings. The survey, toolkit materials, and comparative database results are all made publicly available on AHRQ's Web site. Technical assistance is provided by AHRQ through its contractor at no charge to medical offices, to facilitate the use of these materials for medical office patient safety and quality improvement.

The goal of this project is to renew the Medical Office SOPS Comparative Database. This Database will:

(1) Allow medical offices to compare their patient safety culture survey results with those of other medical offices,

(2) Provide data to medical offices to facilitate internal assessment and learning in the patient safety improvement process, and

(3) Provide supplemental information to help medical offices identify their strengths and areas with potential for improvement in patient safety culture.

This study is being conducted by AHRQ through its contractor—Westat, pursuant to AHRQ's statutory authority to conduct and support research on healthcare and on systems for the delivery of such care, including activities with respect to: The quality, effectiveness, efficiency, appropriateness and value of health care services; quality measurement and improvement; and database development. 42 U.S.C. 299a(a)(1), (2), and (8).

Method of Collection

To achieve the goal of this project the following activities and data collections will be implemented:

(1) Eligibility and Registration Form—The medical office point-of-contact (POC) completes a number of data submission steps and forms, beginning with the completion of an online eligibility and registration form. The purpose of this form is to determine the eligibility status and initiate the registration process for medical offices seeking to voluntarily submit their Medical Office SOPS data to the Medical Office SOPS Comparative Database.

(2) Data Use Agreement—The purpose of the data use agreement, completed by the medical office POC, is to state how data submitted by medical offices will be used and provides confidentiality assurances.

(3) Medical Office Site Information Form—The purpose of the site information form is to obtain basic information about the characteristics of the medical offices submitting their Medical Office SOPS data to the Medical Office SOPS Comparative Database (e.g., number of providers and staff, ownership, and type of specialty). The medical office POC completes the form.

(4) Data Files Submission—The number of submissions to the database is likely to vary each year because medical offices do not administer the survey and submit data every year. Data submission is typically handled by one POC who is either an office manager, nurse manager, or a survey vendor who contracts with a medical office to collect their data. POCs submit data on behalf of 10 medical offices, on average, because many medical offices are part of a health system that includes many medical office sites, or the POC is a vendor that is submitting data for multiple medical offices. After registering, if registrants are deemed eligible to submit data, an automated email is sent to authenticate the account and update the user password. Next the POC enters medical office information and uploads their survey questionnaire and submits a data use agreement. POCs then upload their data file(s), using the medical office data file specifications, to ensure that users submit standardized and consistent data in the way variables are named, coded, and formatted.

Survey data from the AHRQ Medical Office SOPS are used to produce three types of products: (1) A Medical Office SOPS Comparative Database Report that is produced periodically and made publicly available on the AHRQ Web site (see​professionals/​quality-patient-safety/​patientsafetyculture/​medical-office/​2014/​index.html); (2) Individual Medical Office Survey Feedback Reports that are confidential, customized reports produced for each medical office that submits data to the database (the number of reports produced is based on the number of medical offices submitting each year); and (3) Research data sets of individual-level and medical office-level de-identified data to enable researchers to conduct analyses.

Medical offices are asked to voluntarily submit their Medical Office SOPS survey data to the Comparative Database. The data are then cleaned and aggregated and used to produce a Comparative Database Report that displays averages, standard deviations, and percentile scores on the survey's 38 items that measure 10 composites of patient safety culture, and 14 items measuring how often medical offices have problems exchanging information with other settings and other patient safety and quality issues. The report also displays these results by medical office characteristics (size of office, specialty, geographic region, etc.) and respondent characteristics (staff position).

Data submitted by medical offices are used to give each medical office its own customized survey feedback report that presents the medical office's results compared to the latest comparative database results.

Medical offices use the Medical Office SOPS, Comparative Database Reports and Individual Medical Office Survey Feedback Reports for a number of purposes, to

  • Raise staff awareness about patient safety.
  • Diagnose and assess the current status of patient safety culture in their medical office.
  • Identify strengths and areas for improvement in patient safety culture.
  • Evaluate the cultural impact of patient safety initiatives and interventions.
  • Compare patient safety culture survey results with other medical offices in their efforts to improve patient safety and health care quality.

Estimated Annual Respondent Burden

Exhibit 1 shows the estimated annualized burden hours for the respondents' time to participate in the database. An estimated 150 POCs, each representing an average of 10 individual medical offices each, will complete the database submission steps and forms annually. Completing the registration form will take about 3 minutes. The Medical Office Information Form is completed by all POCs for each of their medical offices (150 × 10 = 1,500 forms in total) and is estimated to take 5 minutes to complete. Each POC will complete a data use agreement which takes 3 minutes to complete and submitting the data will take an hour on average. The total burden is estimated to be 291 hours.

Exhibit 2 shows the estimated annualized cost burden based on the respondents' time to submit their data. Start Printed Page 42499The cost burden is estimated to be $13,968 annually.

Exhibit 1—Estimated Annualized Burden Hours

Form nameNumber of respondents/POCsNumber of responses per POCHours per responseTotal burden hours
Eligibility/Registration Form15013/608
Data Use Agreement15013/608
Medical Office Information Form150105/60125
Data Files Submission15011150

Exhibit 2—Estimated Annualized Cost Burden

Form nameNumber of respondents/ POCsTotal burden hoursAverage hourly wage rate *Total cost burden
Registration Form1508$48.00$384
Data Use Agreement150848.00384
Medical Office Information Form15012548.006,000
Data Files Submission15015048.007,200
* Mean hourly wage rate of $48.00 for Medical and Health Services Managers (SOC code 11-9111) was obtained from the May 2013 National Industry-Specific Occupational Employment and Wage Estimates, NAICS 621100—Offices of Physicians located at​oes/​2013/​may/​naics4_​621100.htm.

Request for Comments

In accordance with the Paperwork Reduction Act, comments on AHRQ's information collection 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 and health care 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.

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Sharon B. Arnold,


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[FR Doc. 2015-17635 Filed 7-16-15; 8:45 am]