The Patient Safety and Quality Improvement Act was enacted to a law in July 2005, and the Final Rule, "Patient Safety and Quality Improvement", was issued in November 2008. The Final Rule established a process for designating and creating patient safety work product (PSWP) allowing providers the ability to confidentially report PSWP to Patient Safety Organizations (PSOs). PSWP encompasses any data, reports, records, memoranda, analyses, and written or oral statements that could improve patient safety, quality, or outcomes. PSOs are encouraged to submit two types of data to the Patient Safety Organization Privacy Protection Center (PSOPPC): patient safety event and PSO Profile data.
PSOs and vendors submit patient safety event data to the PSOPPC. Analysis of this data is intended to facilitate the development and adoption of interventions and solutions to improve patient safety. Patient safety event data is aggregated and made non-identifiable by the PSOPPC for transmission to the Network of Patient Safety Databases (NPSD).
On an annual basis, PSOs submit the PSO Profile form which provides Agency for Healthcare Research and Quality (AHRQ) and the Department of Health and Human Services (HHS) information regarding the types of health care providers, settings, and reports for which PSOs conduct patient safety activities.
Data Submission overview for Common Formats - Community Pharmacy Version 1.0 , Common Formats - Hospital Version 1.1 and Common Formats - Hospital Version 1.2 describe the steps necessary for a Patient Safety Organization (PSO) or vendor to complete the steps necessary to submit patient safety events to the PSOPPC and to the Network of Patient Safety Databases (NPSD).
PSE Data Submission Process Overview Posted on: 05/14/2014, 201 KB
The PSOPPC compiled a list of common questions associated with the patient safety event data submission process. The following document is updated as additional questions are received.
Data Submission FAQs Posted on: 06/18/2014, 306 KB
The PSOPPC is responsible for the aggregation and de-identification of data received from PSOs. To assist in the creation of non-identifiable data, PSOs assign a unique provider identifier to each healthcare provider contracting with the PSO.
The PSO-Assigned Provider Identifier Code (Provider ID Code) serves as a surrogate Provider ID Code. When the PSO assigns a surrogate ID code to the provider, the identity of the submitting provider is not revealed to the PSOPPC, thus providing anonymity to the healthcare providers. The Implementation Guide provides instructions on how to create a PSO-Assigned Provider ID Code for inclusion in a CDA XML file.
It is imperative that the same PSO-Assigned Provider ID Code be used for all XML files submitted to the PSOPPC for that particular provider. Using the same PSO-Assigned Provider ID Code allows for data aggregation by the provider.
Before a PSO can submit patient safety event data to the PSOPPC, the PSO must sign a PSO Data Use Agreement. For PSOs choosing to submit patient safety information, an agreement must be executed to specify the respective rights and responsibilities of the PSO and the PSOPPC. The agreement specifies the types of patient safety information, format of data elements, explains how the data may be used, which elements will be transferred to the NPSD, how long the PSOPPC may use the data, and how the data will be protected.
Data Use Agreement Posted on: 04/03/2015, 282 KB
A PSO may designate a PSO Vendor to act on their behalf for certain functionalities on the PSOPPC Web site such as submitting patient safety event data. A PSO Vendor must register with the PSOPPC in order to submit patient safety event data on behalf of a PSO. PSO Vendors may preemptively complete the Vendor Organization Registration Form prior to contracting with any PSOs.
Vendor Organization Registration Form Posted on: 05/12/2014, 34 KB
Implementation Guides provide valuable information on how to submit data from PSOs to the PSOPPC. Refer to the below Implementation Guides based on setting and version.
Implementation Guide-CFV1.1 Posted on: 10/10/2012, 904 KB
Implementation Guide-CFV1.2 Posted on: 03/23/2016, 1,035 KB
CPV1_0_Implementation_Guide.pdf Posted on: 12/19/2016, 1,542 KB
Resources Workbooks provide the set of validation rules. In combination with the conformance statements provided in the Implementation Guides, these validation rules must be adhered to for maintaining data integrity when creating a CDA XML file for data submission.
Resources Workbook-CFV1.1 Posted on: 10/10/2012, 326 KB
Resources Workbook-CFV1.2 Posted on: 03/23/2016, 154 KB
CPV1_0_Resources_Workbook.xls Posted on: 12/19/2016, 203 KB
The Common Formats Flow Charts provide the data elements and associated answer values (where applicable) recommended for collection based on the report type and event category associated with the patient safety event report. The Common Formats Flow Charts also outline the path for a complete patient safety event report. For more information regarding the Common Formats Flow Charts, please refer to the following pages:
A user is required to have a signed DUA and a Level 3 account registered with the PSOPPC Web site in order to submit patient safety event data. The user must log into the secure site to submit an XML File(s) as a "Test" submission. Submitting the data as a "Test" file will provide confirmation that the XML file(s) is structured correctly; additionally, PSOs and vendors are encouraged to review their Test data for any data integrity issues. Tools such as the Submission Management Summary Report, Submission Management Detail Report, and Aggregate Report will provide PSOs and vendors the opportunity to review their "Test" submissions for accuracy, completeness, and reasonableness.
If errors are discovered in the XML "Test" file(s), the PSO or vendor will be required to make the appropriate revisions and resubmit the revised XML file(s) to "Test". After a "Test" submission is completed and no errors are found, the PSO or vendor will then be able to submit the XML file(s) as a "Production" submission.
Helpful Hints for submitting XML file(s) to the PSOPPC:
With the help of an intuitive Web Interface, authorized PSOPPC users can upload a list of XML files to the PSOPPC application. For more information regarding the Web interface method, please refer to the PSOPPC Web site User's Manual posted below.
The PSOPPC has also implemented an SFTP solution as an alternative to the Web interface for data submission. Submitting data via the an SFTP system will require the same prerequisites for submitting data through the PSOPPC Web site; additionally, users will need to register for an an SFTP account by contacting the PSOPPC Help Desk.
For detailed instructions on how to submit XML file(s) via the Web Interface and an SFTP, please refer to the PSOPPC Web site User's Manual and PSOPPC Web Services User guide.
PSOPPC SFTP Data Submission Users Manual Posted on: 08/28/2015, 613 KB
Once patient safety event XML file(s) have been successfully submitted to the PSOPPC, it is important to review the processing results of the submitted XML file(s). Only data with a processing status of Accepted undergo contextual de-identification prior to being sent to the NPSD. The data from the XML files with a processing status of Rejected are not considered for contextual de-identification and are not sent to the NPSD.
When the file processing is complete, an e-mail notification is sent to the user who submitted the file(s) confirming the file(s) processing is complete. Upon receiving the e-mail notification, the user should generate a Submission Management Summary Report and/or the Submission Management Detail Report to view the processing results.
To view the submission results, PSOPPC Users can utilize the Web Service or generate Submission Management reports on the PSOPPC application.
The Web Service allows PSOs and vendors who have submitted data to the PSOPPC the ability to query the submission status, amongst other details, of their patient safety event data submissions. In addition to an existing Level 3 User Account, an additional username and password will be required to access the Web Service tool.
The following document provides information on how to utilize the Web Service as an alternative way to review the status of the patient safety event data submissions.
PSOPPC Web Service Users Manual Posted on: 08/31/2016, 765 KB
The Patient Safety Event Submission Management Summary Report displays summary file processing information for submitted XML files. This is the report used to determine whether an XML file was "Accepted" or "Rejected" by the PSOPPC. Submission Management Summary Reports are available for both PSO Profile and patient safety event submissions; these reports are available on the secure PSOPPC Web site (sign-in required).
The Patient Safety Event Submission Management Detail Report provides information on the specific error that occurred in a "Rejected" file. Error messages are generated for the XML files and provide the error message description, error message code, and message type. The Common Formats Version 1.1 Data Submission Error Messages document provides all possible error messages for patient safety event data submissions. Within this document the validation rule that was not adhered to is presented alongside the error message to assist PSOs in the revisions of the XML file. Submission Management Detail Reports are available for both PSO Profile and patient safety event submissions; these reports are available on the secure PSOPPC Web site (sign-in required).
Common Formats Version 1.1 Data Submission Error Messages Posted on: 09/14/2016, 210 KB
The PSOs are encouraged to generate and review the appropriate Aggregate Reports following the "Test" submission of their data to ensure the data reported to the PSOPPC accurately reflects the data received from providers. As the data is passed from providers to the PSO and then to the PSOPPC, data transformation and/or mapping issues may occur. This report provides PSOs and vendors the opportunity to perform validation of their data. The following document provides suggestions for evaluating the data and may be used as a starting point for the PSOs to develop their own method for reviewing and interpreting the data submitted by the providers.
How to Use the Aggregate Report Posted on: 05/13/2014, 185 KB
The PSO Profile form provides information to AHRQ and HHS on the types of healthcare providers, settings, and reports for which PSOs conduct patient safety activities. This form is designed to collect data that will be for used to generate aggregate statistics necessary to administer the Patient Safety and Quality Improvement Act of 2005, as well as report on the Act's impact.
The PSOPPC provides guidance on how to update PSO Profile information every year. For questions related to the PSO Profile form, please contact the PSOPPC Help Desk or submit a request form on the Contact Us page.
The PSO Profile form includes two sections: PSO Profile and Provider Profile. The PSO Profile collects administrative information of the PSO, including the number of providers, type of entity, type of patient safety events collected, and specialty focus. The Provider Profile collects information of the providers with which the PSO has a contract pursuant to the Patient Safety and Quality Improvement Act. Information should be collected of all providers that currently submit, or intend to submit patient safety events to the PSO.
2016_PSO_Profile_Form Posted on: 01/26/2017, 72 KB
The PSOPPC accepts the PSO Profile via paper form. For questions regarding how to submit the PSO Profile form please contact the PSOPPC Help Desk.
The PSOs with a Level 2 or Level 3 account may submit PSO Profile information via an online form by accessing the secure pages of the PSOPPC Web site. PSOs may also submit PSO and Provider Data XML files.
The following documents provide information related to PSO Profile XML File specifications:
AHRQ PSO and Provider Profile Tech. Specs. for Data Submission from PSO to PSOPPC Posted on: 12/12/2013, 468 KB
AHRQ_PSO_Provider_Profile_2016_Tech_Specs_Appendix_A Posted on: 12/19/2016, 106 KB
After submitting PSO Profile related XML file(s), it is important to review the submission results. PSO Profile Submission Management Summary Report and Submission Management Detail reports can provide file processing status(es) information for the XML File(s) as well as if there is any error(s) then the validation messages can be helpful to resolve any issues.
The PSO Profile Submission Management Summary Report displays summary file information, including processing status(es) (i.e. Accepted, Rejected), for submitted PSO and Provider Information files.
The PSO Profile Submission Management Detail Report provides information on the messages received by PSO/Provider Information Submission files submitted to the PSOPPC. For files that received a message, the report displays the message description, message code, and message type.
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