Supporting Statement Part B -- Pharm SOPS Comparative Database for submission_sfs

SUPPORTING STATEMENT

Part B

Pharmacy Survey on Patient Safety Culture Comparative Database

Version October 23, 2013

Agency for Healthcare Research and Quality (AHRQ)

Table of Contents

B. Collection of Information Employing Statistical Methods 2

1. Respondent universe and sampling methods 2

2. Information Collection Procedures 3

3. Methods to Maximize Response Rates 5

4. Tests of Procedures 5

5. Statistical Consultants 5

B. Collection of Information Employing Statistical Methods

1. Respondent universe and sampling methods

The AHRQ Pharmacy Survey on Patient Safety Culture (Pharmacy SOPS) Comparative Database serves as a central U.S. repository for data on the survey and AHRQ houses the largest database of the survey’s results. However, the database is comprised of data that are voluntarily submitted by pharmacies that have administered the survey, and is not a statistically selected sample, nor is it a representative sample of all U.S. pharmacies. The Pharmacy SOPS was pilot tested in 2012 (OMB #0935-0183, approved on 8/12/2011). Preliminary comparative results from the 55 pharmacies that participated in the pilot test are included in Attachment G.

There are estimated to be around 61,036 retail pharmacies in the United States (National Association of Chain Drug Stores (NACDS). NACDS 2011-2012 Chain Pharmacy Industry Profile. 2011). The distribution of pharmacies by type is presented in Table 1.

Table 1. Distribution of Pharmacies by Type of Store for U.S. Pharmacies and Pilot Study Pharmacies

Pharmacy Type	U.S. Pharmacies*		Pilot Study Pharmacies
	Number	Percent	Number	Percent
Mass merchant/discount retailer pharmacy	8,273	14%	19	35%
Supermarket pharmacy	9,333	15%	18	33%
Independent pharmacy	20,835	34%	8	15%
Integrated health system pharmacy/chain drugstore (local, regional, national)	22,595	37%	10	18%
Total	61,036	100%	55	100%

*Source of data for U.S. pharmacies: National Association of Chain Drug Stores. NACDS 2011-2012 Chain Pharmacy Industry Profile. 2011. Statistics for integrated health system pharmacies that are open to the public are combined with statistics for chain drugstores in the NACDS results.

Pharmacies that submit data to the database receive a free, customized feedback report that displays their pharmacy’s results against the database. Pharmacies that do not submit data to the database can still compare their results using the Comparative Database report. The report provides instructions on how to calculate percent positive scores to enable pharmacies to calculate their own scores to compare their results against the database. As part of a toolkit of support materials for the Pharmacy SOPS survey, pharmacies can also use a Microsoft® Excel-based Data Entry and Analysis Tool that is an Excel file with macros that will automatically produce graphs and charts of a pharmacy’s results once data are entered into a data sheet. Many pharmacies use this tool to produce their results.

In the overall database report, pharmacies are provided with a detailed description and explanation of the statistics that are presented and given examples and guidance on how to compare their pharmacy’s results against the comparative results from the database.

Most pharmacies simply compare their percent positive scores against the database percentiles and averages and do not attempt any statistical comparisons. To help pharmacies simplify comparisons and provide conservative guidance on what level of difference would be considered meaningful, the report recommends a 5 percentage point difference in scores as a rule of thumb to determine whether its scores can reasonably be considered higher or lower than the database scores.

2. Information Collection Procedures

Information collection for the AHRQ Pharmacy Survey on Patient Safety Culture Comparative Database occurs in a periodic data collection cycle beginning September 15 – November 1, 2014 and then October 3 – 21, 2016. Information collection procedures for submitting and processing data are shown in Figure 1.

Figure 1. Pharmacy SOPS Comparative Database Data Submission

Step 1: Call for Data Submission. Announcements about the opening of data submission go out through various publicity sources. AHRQ’s electronic newsletter targets approximately 50,000 subscribers. In addition, the AHRQ Surveys on Patient Safety Culture listserv targets approximately 22,000 subscribers. An example of email announcements calling for data submission is shown in Attachment D, Email #1 and #3. Through these efforts, U.S. pharmacies are made aware of and invited to submit their survey data to the database.

As the administrator of the database and under contract with AHRQ, Westat provides free technical assistance to submitting pharmacies through a dedicated email address (DatabasesonSafetyCulture@westat.com) and toll-free phone number (1-888-324-9790).

Step 2: Registration for Potential Participants. A secure data submission Web site allows interested parties such as pharmacies and health systems to register and submit data. Login for registration is one page that takes about 3 minutes to complete and asks for contact and other basic information (see Attachment A). After registering, if registrants are deemed eligible to submit data, an automated email is sent to authenticate the account and update the user password (see Attachment D, Email #2).

Once users are registered and have a password, they can enter the main page menu of the Web site. Information about eligibility requirements, data use agreements, and data file specifications regarding how to prepare their data for inclusion in the SOPS database is posted and can be reviewed.

Step 3: Enter Pharmacy Information and Upload Questionnaire. At this step, users provide information about each of their pharmacies, such as point of contact, method of survey administration, overall response rate, and other pharmacy characteristics (e.g., type of pharmacy, number of locations, average number of prescriptions dispensed per week, and number of pharmacists and pharmacy technicians) (see Attachment B). They also upload their survey questionnaire that they administered to enable us to determine whether any changes were made to the survey (see Attachment J, Figure 1 in Supporting Statement Part A).

Step 4: Submit Data Use Agreement (DUA). To protect the confidentiality of all participating pharmacies, a duly authorized representative from the pharmacy must sign a data use agreement (DUA) (see Attachment C). The DUA language was reviewed and approved by AHRQ’s general counsel. The DUA states that the pharmacy’s data will be handled in a secure manner using necessary administrative, technical and physical safeguards to limit access to it and maintain its confidentiality. In addition, the DUA states the data are used for the purposes of the database, that only aggregated results will be reported, and that the pharmacy will not identified by name. Data are not included in the database without this signed data use agreement. Users can fax and/or mail a copy of the signed agreement.

Step 5: Upload Data File(s). At this step, users are asked to upload their individual-level survey data for each pharmacy (see Attachment J, Figure 2 in Supporting Statement Part A). Data submitted through the secure data submission Web site are encrypted to ensure secure, confidential transmission of the survey data. Data are accepted in Microsoft Excel® format since this is the format preferred by pharmacies. Users must upload one data file per pharmacy. If a user has multiple pharmacies within a retail chain or integrated health care system, users can upload one data file that identifies all of the pharmacies in their system. The data file specifications (see Attachment E) are provided to data submitters to ensure that users submit standardized and consistent data in the way variables are named, coded, and formatted.

Once a data file is uploaded, a separate load program developed in Visual Basic (VB) reads the submitted files and loads them into the SQL database that stores the data. A data quality report is then produced and made available to the participant. This report displays item frequencies and flags out-of-range values and incorrectly reverse-coded items. If there are no problems with the data, an acknowledgement of data upload and accepted will be granted during the user session. If data are improperly coded, the user is informed that the data file failed during the user session by having a message post on the screen. Users are expected to fix any errors and resubmit their data file(s) for processing. Once there are no problems, the user is informed of the acceptance of data during the user session with an online message of acceptance..

Step 6: Approve Data Submission. Once all of the information required for submission has been submitted and approved, an email is sent to the pharmacy contact indicating that their data have received final acceptance.

3. Methods to Maximize Response Rates

AHRQ makes a number of toolkit materials available to assist pharmacies with the SOPS surveys. The Pharmacy SOPS has a Survey User’s Guide that gives users guidance and tips about survey administration on the following topics: planning; selecting a sample; determining their data collection method; data collection procedures, with a section on Web surveys; and analyzing data and producing reports (at http://www.ahrq.gov/legacy/qual/patientsafetyculture/pharmsurvindex.htm). The Survey User’s Guide also gives pharmacies tips about how to increase response rates through publicity efforts, top management support, use of incentives, and following all steps of proper data collection protocols.

As noted earlier in this document under Information Collection Procedures, Step 1 – Call for Data Submission, announcements about the opening of data submission go out through various publicity sources as a way to boost pharmacy participation in the database. AHRQ’s electronic newsletter targets approximately 50,000 subscribers. In addition, the AHRQ Surveys on Patient Safety Culture listserv targets approximately 22,000 subscribers. AHRQ, through its contractor Westat, provides free technical assistance to users through a dedicated email box and toll-free phone number. In addition, reminders are sent to database registrants to remind them of the deadline for data submission.

4. Tests of Procedures

Input and Feedback for the Development of the SOPS Database Submission System. Because the Surveys on Patient Safety Culture are public-use instruments, the SOPS program has generally modeled its data submission processes after those utilized by the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Database that has been in operation for many years. SOPS staff consulted with CAHPS Database staff and programmers to determine best practices for data submission. This information, as well as feedback obtained during the provision of technical assistance each year the database has been running, has been used to improve the SOPS online data submission system and process over time.

5. Statistical Consultants

Joann Sorra, PhD

Westat

1600 Research Blvd.

Rockville, MD 20850

joannsorra@westat.com

Naomi Dyer, PhD

Westat

1600 Research Blvd.

Rockville, MD 20850

naomidyer@westat.com